tests
What are the 4 principles of ethical consideration?
- The principle of equipoise - The principle of distributive justice - The principle of respect for persons - The principles of beneficence and nonmaleficence
List at least 10 examples of possible problems with questions in a survey.
- There are big words in the question - The questions are vague - There are faulty assumptions - The questions have answers that are really detailed and cause the patient to remember a lot of details - Sensitive questions - Questions that lead the responders to a specific answer - Hypothetical questions - There are two questions in one sentence - There are questions that have answers that are impossible to remember - There are double negatives in a question which can confuse the reader
What are the two main goals in recruiting participants?
- to recruit as many members of the sample population as possible - to yield a study population that is reasonably representative of the sample population
Adverse events monitoring includes:
-FDA -Study participant -Drug safety committee -Monitoring board
Clinical researchers must be aware of participants' rights to privacy (HIPAA) in which of the following phases of clinical research?
-Pre-Research Review of Medical Records -Patient recruitment -Enrollment and conduct of study -Publication of results
Hypothesis
A proposed explanation for a phenomenon. To be put forward as a scientific hypothesis, the scientific method requires that one can test it.
Fixed Population
A prospective or longitudinal study design that requires all participants to start the study at the same time and does not allow anyone to join later
Erratum
A published correction to minor error in an article, sometimes called a corrigendum (printer's error)
Green Open Access
A publishing model in which after an embargo period of 1 year or longer authors are allowed to post on their personal websites or in institutional repositories a version of an article they wrote and had published in a subscription journal.
Gold Open Access
A publishing model in which authors pay a fee to make their journal articles freely available to readers on the Internet.
Narrative Analysis
A qualitative analysis method that uses established theories to understand personal stories.
Realist Synthesis
A qualitative analysis technique that uses a systematic process to find and interpret evidence for the complex reasons some programs succeed and others fail.
Semi-Structured Interview
A qualitative conversation with a key informant that covers a range of preselected topics using open-ended questions, probing for clarifications about verbal responses, and observations of body language and other nonverbal communication.
Focus Groups
A qualitative data gathering technique in which groups of about 8 to 10 people spend 1 or 2 hours participating in a moderated discussion.
Phenomenology
A qualitative research approach that seeks to understand how participants understand, interpret, and find meaning in their own unique life experiences and feelings.
Transformative Paradigm
A qualitative research framework in which researchers assume that reality can be changed when research addresses a social justice issue.
Post-Positivism
A qualitative research paradigm in which researchers aim to experimentally test theories about how the world works, but they acknowledge that the unpredictability of human behavior limits the validity of some empirical methods.
Pragmatism
A qualitative research paradigm in which researchers assume that reality is situational, and it is acceptable to use any and all research tools and frameworks to try to understand a particular problem so it can be solved.
Constructivism
A qualitative research paradigm in which researchers have a relativist perspective that considers reality for each individual to be a function of that person's lived experiences.
Critical Theory
A qualitative research paradigm that considers reality to be dependent on social and historical constructs and assumes that reality can be uncovered by identifying and challenging power structures.
In-Depth Interview
A qualitative research technique in which an interviewer spends one or two hours interviewing a key informant using open-ended questions and then transcribes the interview so that the content can be coded.
Photovoice
A qualitative research technique in which participants take photographs that they feel represent their communities and then they share what aspects of their lived experiences they intended to capture in those images.
Odds Ratio (OR)
A ratio of odds in which the denominator represents the reference group
Odds
A ratio of the likelihood of an event happening and the likelihood of that event not occurring
Rate Ratio (RR), Relative Rate, Risk Ratio, Relative Risk
A ratio of two rates, with the reference (comparison) group in the denominator
Crude Statistic
A raw or unadjusted statistic.
Callout
A reference in a text that points readers to an element like a figure or table
NIH Launches "www.clinicaltrials.gov" (2000)
A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Reject and Resubmit
A rejection letter from a journal editor that invites the authors to revise a manuscript and resubmit it to the same journal for consideration as a "new" article; most rejection letters specify that a different version of the same manuscript will not be considered by the journal, but this unusual outcome is akin to a "revise and resubmit" offer.
Association
A relationship between two variables; this term does not indicate anything about whether the relationship is or is not causal
Progress reports may be required by the ethics committee; these reports should include all of the following information, EXCEPT: A. Current versions of the study protocol, informed consent, questionnaire and other study documents B. A report of any adverse effects or complaints C. A summary of study findings D. A report of each individual study participant, including personal information such address and phone number
A report of each individual study participant, including personal information such address and phone number
2 way ANOVA
2 IV's must be categorical!
Chi Square Test
2 categories for IV 2 categories for DV 2 x 2 table
Two-Independent Sample T-Test
2 categories for IV Continuous DV Compares means of groups Parametric because normally distributed If data is not normally distributed, bring it back to normal or use a nonparametric t-test or nonparametric ANOVA
Regression need:
2 continuous variables that are both normally distributed Dose is continuous and BP and is continuous Multivariate: drinking frequency is continuous, study hours is continuous on GPA (continuous)
How long should clinical trial records be maintained for?
2-3 years
A typical article in the health science may refer to ___________ other articles published in peer-review journals. A. 1 or 2 B. 5 or 10 C. 20 or 30 D. 200 or more
20 or 30
Belmont Report
A report published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979 that defined the key research principles of beneficence, respect for persons, and distributive justice.
Case Series
A report that describes a group of individuals who have the same disease or who have undergone the same procedure
Case Report
A report that describes one patient
Tertiary Study
A research analysis that reviews and synthesizes the existing literature on a topic
Beneficence
A research ethics principle that requires a study to do good.
Respect for Persons
A research principle that emphasizes participant autonomy.
Equipoise
A research principle that requires experimental research to be conducted only when there is a genuine uncertainty about which treatment will work better
Time Series Study
A research study that measures participants or samples at multiple points in time
Which is NOT an example of publication costs that could be incurred by the author of an article? A. A publication fee B. A processing fee or charge C. A reviewing fee D. A per-page fee
A reviewing fee
Contingency Table (Crosstab)
A row-by-column table that displays the counts of how often various combinations of events happen
Two-by-Two (2x2) Table
A row-by-column table that displays the counts of how often various combinations of events happen; in epidemiological analysis, the columns typically display disease status (yes/no) and the rows typically display exposure status (yes/no)
Frequency Matching (Group Matching)
A sampling design that is used to ensure that cases and controls in a case-control study or exposed and unexposed participants in a cohort study have similar demographic characteristics
Likert Items (Scales)
A scale of ranked/ordered response items that ask participants to indicate preferences
Graph
A scatter plot, timeline, or other diagram that visually displays quantitative results
Key Informants
A selected group of participants in a qualitative study who have been identified through purposive sampling.
PubMed
A service of the U.S. National Library of Medicine that provides access to more than 25 million abstracts
Bradform Hill Criteria
A set of conditions that provide support for the existence of a causal relationship between an exposure and an outcome
Theoretical Framework
A set of established models in the published literature that can inform the components and flows of the conceptual framework for a new research study
Eligibility Criteria
A set of inclusion criteria that must be present for an individual (or, for a systematic review, a research manuscript) to be allowed to participate in a study along with a set of exclusion criteria that would remove an individual from the study population.
Health Insurance Portability and Accountability Act (HIPAA)
A set of regulations about patient protection that apply in the United States.
Intercorrelation
A situation in which two or more related items in a survey instrument measure various aspects of the same concept.
Pilot Test (Pretest)
A small-scale preliminary study conducted to evaluate the feasibility of a full-scale research project.
Matched-Pairs Odds Ratio
A special kind of odds ratio that compares the number of matched pairs in a study for which the case had the exposure and the control did not to the number of pairs for which the control had the exposure and the case did not
Project
A specific, time-limited activity.
PURPOSE OF NULL HYPOTHESIS (2)
A starting point for analysis - Accepted as true absent other information - Assumes that chance caused any observed differences Provides a benchmark for comparison
THE RESEARCH HYPOTHESIS (2)
A statement of inequality A relationship exists between the independent and dependent variables
Coefficient of Determination (r²)
A statistic that shows how strong a correlation is without indicating the direction of the association; r² values range from 0 to 1, with 1 indicating perfect correlation.
I² Statistic
A statistic used to examine heterogeneity in the studies included in a meta-analysis that adjusts the Q statistic based on the number of studies being pooled.
Confidence Interval (CI)
A statistical estimate of the range of likely values of a statistic in a source population based on the value of that statistic in a study population; a narrow ___ indicates more certainty about a value than a wide ___.
Kappa Statistic
A statistical measure of the agreement between two assessors who are evaluating the same study participants.
Pearson Correlation Coefficient (r)
A statistical measure of the degree to which changes in the value of one numeric variable predict changes in the value of another numeric variable.
Spearman Rank-Order Correlation (ρ)
A statistical measure of the degree to which changes in the value of one rank/order variable predict changes in the value of another rank/order variable.
Factor Analysis
A statistical method for identifying interrelationships among variables intended to measures different aspects of the same construct.
Multiple Logistic Regression
A statistical method that examines the relationships between several ratio/interval and/or nominal predictor variables and the value of one ratio/interval outcome variable
Log-Rank Tests
A statistical test that determines whether survival rates are longer in one population than another
Cochran's Q Statistic
A statistical test used in meta-analysis to examine the heterogeneity (statistical differences) among the included studies.
Federalwide Assurance (FWA)
A status that applies to institutional review boards that are registered with the U.S. federal government.
Delphi Method
A structured consensus-building method in which experts complete questionnaires, a facilitator summarizes and shares the responses, and panelists reconsider their perspectives after reflecting on the opinions expressed by others.
Quantitative Research
A structured survey-based approach for statistically testing hypotheses.
Double-Blind Trial
A study in which both the investigator and the participant are blind to the mature of the treatment the participant is receiving. - Thought to produce the most objective results.
Matched-Pairs Matching (Individual Matching)
A study in which each case is personally linked to a particular individual control, such as a genetic sibling
Single-Blind Trial
A study in which the experimenters but NOT the subjects know the makeup of the test and control groups during the experiment.
After the death of Ellen Roche, what were the two research projects associated with Hopkins that went under investigation?
A study on oral cancer patients led by a professor from the Krieger School of Arts and Sciences and a study on the abatement of lead paint led by the Kennedy Krieger Institute.
Case
A study participant with the infectious or parasitic disease, noncommunicable disease, neuropsychiatric condition, injury, or other disease, disability, or health condition of interest
Dynamic Population (Open Population)
A study population with rolling enrollment
Aggregate Study
A study that analyzes population-level data and does not include any individual-level data.
Experimental Study (Intervention Study)
A study that assigns participants to receive a particular exposure
Case-Control Study
A study that compares the exposure histories of people with disease and without disease
Longitudinal Cohort Study (Panel Study)
A study that follows a group of individuals who are representative members of a selected population forward in time
Cross-Sectional Survey (Prevalence Study)
A study that measures the proportion of a population with a particular exposure or disease at a particular time by recruiting a representative sample of the source population
Repeated Cross-Sectional Study
A study that re-samples representatives from the same source population at two or more different time points
Correlational Study
A study that uses population-level data to look for associations between two or more group characteristics.
Bias
A systematic error in design, conduct, or analysis of a study that causes the results in a study population not to accurately reflect the truth about the source population
What is the definition of research?
A systematic investigation designed to develop or contribute to generalizable knowledge.
Revise and Resubmit (R&R)
A term used by journals when authors are invited to edit their manuscript in response to reviewer comments and then send it back to the journal for another round of consideration.
What is a clinical trial ("Studies")?
A test of an investigational product in a human subject to determine safety and effectiveness
Construct
A theory informed by complex abstractions and not merely by observations.
Concept
A theory informed by observations.
Questionnaire (Survey Instrument)
A tool for systematically gathering information from study participants
Sample Size Calculator (Sample Size Estimator)
A tool used to identify an appropriate number of participants to recruit for a quantitative study; this is more accurate called a "sample size estimator" because the range of suggested sample sizes is based on a series of guesses about the expected characteristics of the sample population.
Back Translation, Double Translation
A translation approach in which one person translates a questionnaire from the original language to a new language and a second person then translates the survey instrument in the new language back into the original language to ensure that the correct meanings were conveyed in the translation.
Gantt Chart
A type of bar chart that visually displays the research timeline and marks critical calendar dates and deadlines.
Hawthorne Effect
A type of bias that occurs when participants in a study change their behavior for the better because they know they are being observed
Cox Proportional Hazards Regression
A type of regression model used for survival analysis that estimates a hazard ratio comparing the duration of times to an event in two populations
Concept Mapping
A visual means of exploring connections between a subject and related ideas and the grouping them to reveal relationships
Sampling Frame
A well-defined subset of individuals from the target population from which potential study participants will be sampled.
Source Population
A well-defined subset of individuals from the target population from which potential study participants will be sampled.
Keyword
A word, MeSH term, or short phrase used in database search
Proposal
A written request for approval of or funding for a research project
Local IRB
Affiliated with an institution (hospital, academic center); physicians are usually required through their relationship/contract to utilize the committee for research conduct in the institution. Usually charge a fee for their services.
At what point should the researcher identify three or more specific objectives that stem from the main study goal?
After finalizing the overarching study goal
Investigator Responsibilities - study drug/device
Administer (or supervise the administration of) the study drug/device and maintain accurate accountability for all clinical supplies received by the site. Observe, measure and record the effects of the drug/device.
At what point should the researcher identify three or more specific objectives that stem from the main study goal? A. Prior to the literature review B. After completion of the abstract C. After finalizing the overarching study goal D. Prior to development of a conceptual model
After finalizing the overarching study goal
Specific Objectives, Specific Aims, Hypotheses
After finalizing the overarching study goal, the researcher should identify these three things that stem from the main study goal
Which of the following uses computers to simulate the actions and interactions of various individuals in a population? A. Machine learning B. Agent-based modeling C. Spatial analysis D. Logistic regression
Agent-based modeling
Which of the following models can assist with developing and testing new theories as well as with understanding complex data? A. SIR models B. Agent-based models C. Deterministic models D. Stochastic models
Agent-based models
Concordant
Agreement
Concordance
Agreement.
Who was the Hopkins associate professor of medicine who began an asthma research protocol titled "Mechanisms of Deep Inspiration-Induced Airway Relaxation"?
Alkis Togias: The study was funded by the NIH.
Hand Searching
All articles in the table of contents of selected volumes of relevant journals are scanned for reports on the topic of interest
Which statement about review articles is FALSE? A. A well written review article often becomes a foundation for new research B. Review articles are often cited more often than reports of individual studies C. All journals publish review articles D. A good review requires meticulous library work
All journals publish review articles
A ___________ should provide enough information so that it can be independently interpreted and understood even in the absence of the text. A. Table B. Figure C. Graph D. All of the above
All of the above
All of the following are good sources of information that a researcher can use to explore what his/her primary area of research interest is, EXCEPT: A. Factsheets B. Newspapers C. Popular magazines D. All of the above are good sources of information
All of the above are good sources of information
Which is NOT considered a helpful resource for locating individuals or groups of individuals who could participate in a case-control study? A. Hospitals B. Public health offices C. Advocacy organizations D. All of the above are helpful resources for locating participants for a case-control study
All of the above are helpful resources for locating participants for a case-control study
All of the following are issues that need to be resolved prior to submission of a research proposal to multiple research ethics committees, EXCEPT: A. The application documents that will be required B. The wording of the informed consent statement C. The order of review D. All of the above are issues that need to be resolved prior to submitting a research proposal to multiple ethics committees
All of the above are issues that need to be resolved prior to submitting a research proposal to multiple ethics committees
All of the following are key points in time, in which researchers working on a research report need to address their motivation, EXCEPT: A. Overcoming the barriers of getting started B. Finding the motivation to persevere and complete the manuscript C. Finding ways to prolong periods of high productivity D. All of the above are key points in time when a researcher needs to address his/her motivation for writing a research report.
All of the above are key points in time when a researcher needs to address his/her motivation for writing a research report.
Which is NOT considered a method for collecting and recording survey data? A. Mail survey B. Interview C. Internet-based survey D. All of the above are methods for collecting and recording survey data
All of the above are methods for collecting and recording survey data
For ratio and interval variables, the central tendency can be described using all of the following, EXCEPT: A. Medians B. Modes C. Means D. All of the above are methods to describe the central tendency
All of the above are methods to describe the central tendency
Which of the following is NOT considered a method for managing research-related data? A. Codebooks B. Data cleaning C. Data recoding D. All of the above are methods used to manage research-related data
All of the above are methods used to manage research-related data
Which is NOT a question that could be asked to ensure the paper tells a compelling "story"? A. Does the paper have a clear "story line"? B. Is the goal of the study clearly stated in the introduction section? C. Are the conclusions fully supported by the data? D. All of the above are questions that could be asked to ensure the paper tells a compelling "story"
All of the above are questions that could be asked to ensure the paper tells a compelling "story"
Which is NOT a step in the research process? A. Identify a study question B. Select a study approach C. Report study findings D. All of the above are steps in the research process
All of the above are steps in the research process
Impact Factor
An annual determination by the Thomson Reuter company about the number of times a typical article in a particular journal is cited in its first year or two after publication.
Journal Citation Reports
An annual publication by Thomson Reuters that offers critical evaluations of peer-reviewed journals based on their impact factors and other metrics.
Evaluation
An assessment process that includes a variety of approaches for examining the goals, processes, and/or outcomes of projects, programs, or policies.
Cost-Effectiveness Analysis (CEA)
An economic analysis that compares the health gains from an intervention to the financial costs of that intervention
Inferential Analysis
An educated statistical guess
Which of the following would be classified as a routine practice activity? A. An epidemiologist working for a health department tracks down the source of an outbreak of gastroenteritis. B. An outbreak investigation team identifies an unusual food item as the cause of the outbreak, does additional survey and laboratory work to confirm the hypothesis, and then shares that discovery by writing a formal report describing their methods and results. C. A clinician conducts a systematic search of the literature, completes a novel synthesis of the compiled articles, and then writes and disseminates that summary. D. A client survey uses a validated questionnaire and sampling methods, is approved by an ethics committee, answers a question that builds on the evidence base provided by previously published articles, and has the results shared through presentation or publication.
An epidemiologist working for a health department tracks down the source of an outbreak of gastroenteritis.
Type 2 Error
An error that occurs when a statistical test of data from the study population finds no significant result even though a significant difference or association actually exists in the source population.
Type 1 Error
An error that occurs when a study population yields a significant statistical test result even though a significant difference or association does not actually exist in the source population.
Habituation
An error that occurs when participants completing a questionnaire or interview become so accustomed to giving a particular response that they continue to reply with the same response even when that does not reflect their true perspective
Autonomy
An ethical principle requiring that only the individual (or his or her legal guardians) is authorized to make a decision about whether to volunteer to participate in a research study.
Standard of Care
An existing therapy that is used as a comparison for a new therapy being experimentally tested
A senior researcher is: A.An experienced researcher who guides the work of a newer investigator B.A researcher who is of advanced age C.A researcher who has a senior position in the institution D.Both B and C
An experienced researcher who guides the work of a newer investigator
Senior Researcher
An experienced researcher who guides the work of a newer investigator
Senior Author (Last Author)
An experienced researcher who guides the work of a newer investigator and may choose to be listed last in the order of authors in the resulting scientific manuscript
Natural Experiment
An experiment in which the independent variable is not manipulated by the research but instead changes due to external forces
Blinding (Masking)
An experimental design that keeps participants (and sometimes members of the research team) from knowing whether a participant is in the active intervention group or the control group
Factorial Design
An experimental design that tests several different interventions in various combinations within one trial
Crossover Design
An experimental study design in which each participant serves as his or her own control; some participants are assigned first to the active intervention and then the control, and others are assigned first to the control and then to the active intervention
Double-Blind Study
An experimental study design in which neither the participants nor the persons assessing the participants' health status know which participants are in the active and control groups
Single-Blind Study
An experimental study design in which the participants don't know whether they are in the active group or a control group but the assessors do
Superiority Trial
An experimental study that aims to demonstrate that a new intervention is better than some type of control, not nearly as good as the control
Risk Factor
An exposure that increases an individual's likelihood of subsequently experiencing a particular disease or outcome
Grant Renewals (Grant Continuations)
An extension of a grant that provides additional funding to continue the research project and expanded in a new direction
No-Cost Extensions
An extension of the timeline for spending grant money in which the closing date moved to a later time but no additional funding is provided
Placebo
An inactive comparison used in an experimental study, such as a sugar pill used as a control for a pill with an active medication, a saline injection used as a control for an injection of an active substance, and a sham procedure that is designed to look and feel like a real clinical procedure used as a control for that active procedure
Minor Revision
An invitation by a journal to make a limited set of manuscript updates in response to reviewer comments and then to resubmit the paper for editorial review and a final decision about acceptance.
Major Revision
An invitation by a journal to significantly update a manuscript in response to reviewer comments and then to resubmit it for another round of review.
Cohort Study
An observational study that follows people forward in time so that the rate of incident (new) cases of disease can be measured
Abstract Database
An online collection of abstracts that allows researchers to search for articles using keywords or other search terms
Database
An organized collection of data created using a specialized software program
Qualitative Research
An unstructured or semistructured approach for using participant observations, in-depth interviews, focus group discussion, and textual data to identify themes and patterns and to formulate new theories.
Treatment-Assigned Approach (Intention-to-Treat Approach)
Analysis of experimental data that includes all participants even if they were not fully compliant with their assigned intervention
Treatment-Received Approach
Analysis of experimental data that includes only the participants who were fully compliant with their assigned intervention
Discourse Analysis
Analysis of qualitative data using the tools of linguistics to evaluate the written, spoken, or nonverbal language used by participants.
________ is an affirmative agreement to participate and does not imply deep understanding.
Assent
All of the following are the first steps that should be carried out when conducting a cross-sectional survey, EXCEPT: A. Define a source population B. Develop a strategy for recruiting a representative sample C. Decide on the methods to be used for data collection D. Assign a case definition
Assign a case definition
Randomization
Assignment of participants to an exposure group in an experimental study using a method that minimizes bias
Parametric Data
Assume normal distribution -Interval or ratio -considered more powerful than nonparametric
Directional
Assume one variable affects another variable
Main focus of IRB
Assure the adequate protection of the rights and welfare of human research subjects
For international research projects, how many local researchers at the study site should be a co-investigator who is involved in every step of the research process, including the identification of the study question, the design of the study, and the collection of data? A. 0 B. At least 1 C. At least 3 D. At least 5
At least 1
Vulnerable Populations
At-risk populations, such as young children and people in prison, whose members might have limited ability to make an autonomous decision about volunteering to participate in a research study.
Each journal provides ___________________ that state how manuscripts should be formatted. A. Author guidelines B. The aims C. The scope D. None of the above
Author guidelines
Mean
Average, sum of all observations Affected by outliers Serves as a basis for the computation of other important measures, such as variability
What type of question forces respondents to select answers that do not truly express their status or opinions? A. Open-ended questions B. Closed-ended questions C. Categorical questions D. Dichotomous questions
Closed-ended questions
Central IRB
Generally contracted by the sponsor/CRO. A written agreement should be executed between the site/institution and the IRB. Usually charge a fee for their services.
Systematic sampling (3)
Get list, determine sampling interval, then select each given interval Easier than random sampling - often used as long as no recurring pattern or particular order exists in the listing Less precise than random sampling - Assumption of each member of population having equal chance of selection is violated
When someone who has made substantial intellectual contribution to the study is not appropriately recognized is known as a: A.Gift authorship B.Hidden authorship C.Ghost authorship D.Reference authorship
Ghost authorship
An individual who is given honorary coauthorship without having significantly contributed to the work is referred to as which of the following? A. Gift authorship B. Ghost authorship C. Silent authorship D. Associate authorship
Gift authorship
Which of the following applies advanced techniques from information science and computer science to the compilation and analysis of health data? A. Health informatics B. Bioinformatics C. Clinical informatics D. Public health informatics
Health informatics
Who are the subjects in Phase 1?
Healthy individuals
What points toward the selection of key indicators that would provide evidence for the success of the intervention?
PICOT
Which of the following points toward the selection of key indicators that would provide evidence for the success of the intervention? A. Brainstorming B. Concept mapping C. PICOT D. Practical questions
PICOT
Which of the following are the two main threats to the validity of a meta-analysis? A. Poor quality of included studies and publication bias B. Poor quality of included studies and information bias C. Publication bias and information bias D. Information bias and assessment bias
Poor quality of included studies and publication bias
Which of the following is NOT an example of an examination a clinician can conduct to examine many health states that machines are unable to assess well? A. Breath sounds and other respiratory functions B. Heart sounds C. Heart rate D. The condition of the skin, hair, and nails
Heart rate
Most exposures and outcomes used in correlational studies are in the form of which of the following? A. Personal level statistics B. Population level statistics C. Regional level statistics D. Global level statistics
Population level statistics
Vital Statistics
Population-level measurements related to birth, deaths, and other demographic indicators
Which of the following examines where a new test is good at predicting the presence of a disease?
Positive likelihood ratio test
Which of the following examines where a new test is good at predicting the presence of disease? A. Positive predictive value B. Negative predictive value C. Positive likelihood ratio test D. Negative likelihood ratio test
Positive likelihood ratio test
What is the 4th phase to clinical trials?
Post-marketing study including adverse effects.
In which paradigm do researchers aim to experimentally test theories about how the world works, but they acknowledge that the unpredictability of human behavior limits the validity of some empirical methods? A. Post-positivism B. Critical theory C. Constructivism D. Pragmatism
Post-positivism
Factors that might influence the relationships between key exposures and outcomes are referred to as which of the following?
Potential cofounders
Factors that might influence the relationships between key exposures and outcomes are referred to as which of the following? A. Categorical variables B. Potential confounders C. Potential variables D. Type 2 errors
Potential confounders
Critical values
If the researcher's test statistic is below the critical z-score (the region of rejection), the null hypothesis can be rejected. If it is above the critical value (the region of acceptance), the researcher cannot reject the null hypothesis.
The scientist that discovered the spread of disease in hospitals could be minimized by handwashing is:
Ignaz Semmelweis
Disease
Illness in general, or the particular adverse health outcome that is the focus of a health science study
The ___________________ is based on the number of times a typical article in a journal is cited in its first year or two after publication. A. Aim B. Impact factor C. Weight of the article D. Scope
Impact factor
Table
In a research report, the concise presentation of key findings in a grid
Figure
In a research report, the visual presentation of key findings in the form of a photograph, map, flowchart, or other image
Test-Retest Reliability
In a survey instrument or other assessment tool, a condition that is demonstrated when people who complete a baseline assessment and then re-take the test later have about the same scores each time they are tested.
Validity (Accuracy)
In a survey instrument, diagnostic test, or other assessment tool, a condition that is established when the responses or measurements are shown to be correct.
Reliability (Precision)
In a survey instrument, diagnostic test, or other assessment tool, a quality that is demonstrated when consistent answers are given to similar questions and when an assessment yields the same outcome when repeated several times
Common (General) Knowledge
Information that a typical person in the discipline knows, so it does not require citations and references in a research report.
Specific Knowledge
Information that is specific to a particular study, such as a particular statistic or a particular laboratory report; specific knowledge derived from the literature requires citations and references in a research project
_________________ is the document by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment. It originates from the legal and ethical right the patient has to direct what happens to her body and from the ethical duty of the physician to involve the patient in her health care.
Informed Consent form
What type of statement provides essential information about research projects to potential research participants so that they can make a thoughtful decision about whether to enroll in a study?
Informed consent
What type of statement provides essential information about research projects to potential research participants so that they can make a thoughtful decision about whether to enroll in a study? A. Waiver B. Informed consent C. Certificate of confidentiality D. Advance directive
Informed consent
Oral (Verbal) Consent
Informed consent for participation in a study that is spoken and witnessed rather than requiring a participant's signature.
What type of sampling is usually the preferred option for producing a sample population that is similar to the source population as a whole?
Probability based sampling
What type of sampling is usually the preferred option for producing a sample population that is similar to the source population as a whole? A. Random sampling B. Cluster sampling C. Multistage sampling D. Probability based sampling
Probability based sampling
____________ research is used to explore and understand people's beliefs, experiences, attitudes, behavior and interactions. It generates non- numerical data, e.g. a patient's description of their pain rather than a measure of pain.
Qualitative
_________________ provide essential information about research projects to potential study participants so that they can make a reasoned decision about whether to enroll in the study. A. Surveys B. Interviews C. Informed consent statements D. Research protocols
Informed consent statements
Cluster Sampling (4)
Instead of randomly selecting individuals Units (groups) of individuals are identified A random sample of units is then selected All individuals in each unit are assigned to one of the treatment conditions
An ____________________________________ is a committee established to review and approve research involving human subjects. The purpose is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.
Institutional Review Board (IRB)
A group formally designated by an institution to review, approve, and conduct periodic review of human subjects research is referred to as the ________.
Institutional Review Board (Research Ethics Board)
Research Ethics Committees are also known as _________________ in the Unites States. A. Institutional review meetings B. Institutional review boards C. Ethical meetings D. Research review committees
Institutional review boards
Author Guidelines (Instructions for Authors)
Instructions from a journal that state how manuscripts should be formatted prior to submission.
Carryover Effects
Residual effects from the first part of an experimental study that may bias the results of the second part of a crossover study if a sufficient washout period between the two arms of the study is not implemented
Governing Principles (4)
Respect for individuals and their rights and welfare are the basic tenets underlying the IRB guidelines. The Nuremberg Code The Helsinki Declaration The Belmont Report
______________ scales use fixed choice response formats designed to measure attitudes or opinions. These ordinal scales measure levels of agreement/disagreement and assume that the strength/intensity of experience is linear, i.e. on a continuum from strongly agree to strongly disagree.
Likert
What typically spells out expectations and procedures for disclosing conflicts of interest, avoiding research misconduct, reporting research ethics or personal violations, and otherwise exhibiting professionalism?
Responsible conduct of research training programs
When a funder reaches out to a researcher and asks that person to submit a __________, the organization might offer a contract rather than a grant. A. Request for applications B. Preproposal C. Solicited proposal D. External proposal
Solicited proposal
When a funder reaches out to a researcher and asks that person to submit a _______________, the organization might offer a contract rather than a grant.
Solicited proposal
All of the following are true statements about a case series study approach EXCEPT: A. Some case series for rare conditions may require at least one hundred participants B. Some case series may include hundreds of individuals C. A clear case definition must be established when using a case series study approach D. Participants may be selected from clinical locations that use ICD codes
Some case series for rare conditions may require at least one hundred participants
Types of Sampling Non-Probability
Some people have a greater, but unknown, chance than others of selection
Nonmaleficence
Something that does not harm.
Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries of evaluation checklists, pharmacy dispensing records, etc) are referred to as:
Source documents
What must be cited when it is referred to in a scientific paper?
Specific knowledge
Which of the following must be cited when it is referred to in a scientific paper? A. Random knowledge B. Common knowledge C. General knowledge D. Specific knowledge
Specific knowledge
Which of the following is a test that measures lung function? A. Spirometry B. Audiometry C. Electrocardiography D. Electroencephalography
Spirometry
Oral Presentations
Spoken presentations, which at conferences usually are about 15 minutes in duration
Measures of ______________ are used to describe the variability and range of responses. A. Central tendency B. Mode C. Spread D. Mean
Spread
Before conducting a statistical analysis of aggregate data, the data from each population must be entered into which of the following?
Spreadsheet
Before conducting a statistical analysis of aggregate data, the data from each population must be entered into which of the following? A. Histogram B. Matrix C. Scatterplot D. Spreadsheet
Spreadsheet
When individuals are randomly assigned within certain subgroups to a particular exposure, this is known as? A. Simple randomization B. Block randomization C. Stratified randomization D. None of the above
Stratified randomization
What is the first step a researcher should take when designing a questionnaire? A. Select specific question topics B. Choose question and answer types C. List the topics that the survey instrument must cover D. None of the above
List the topics that the survey instrument must cover
What will assist the researcher in determining what is already known about the topic and what new information a new study could contribute?
Literature review
Which of the following, related to the candidate question, will assist the researcher in determining what is already known about the topic and what new information a new study could contribute? A. Meta-analysis B. Literature review C. Questionnaires D. Concept mapping
Literature review
In the health sciences there are different types of populations that must be considered by the researcher when preparing to collect data, which of the following is NOT considered to be a type of population? A. Target population B. Local population C. Sample population D. Source population
Local population
Models that are used when the outcome variable is a dichotomous variable are known as: A. Simple linear regression models B. Bi-linear regression models C. Multiple linear regression models D. Logistic regression models
Logistic regression models
What database, developed by the US National Library of Medicine, can be helpful for identifying the full extent of a research area and for narrowing the scope of a research area?
MeSH (Medical Subject Headings Database)
What database, developed by the U.S. National Library of Medicine, can be helpful for identifying the full extent of a research area and for narrowing the scope of a research area? A. PubMed B. MedWatch C. MeSh (Medical Subject Headings Database) D. MEDLINE
MeSh (Medical Subject Headings Database)
Interval Estimation
Mean of sample we're sure will fall within a range.
Probability-Based Sampling
Methods for ensuring that members of a source population have an equal likelihood of being invited to participate in a research study.
Age Adjustment
Methods used to improve the accuracy of comparisons of two populations with very different age distributions; similar methods can be used to statistically adjust for other important differences between comparison populations.
Most researchers serve as what type of coauthors before moving into the lead author role for the first time? A. Mentors B. Consultants C. Middle coauthors D. Last author
Middle coauthors
Median
Middle-most position If even # of scores, median would be the middle point between the middle scores Median is not influenced by extreme scores Sometimes it can be a more realistic measure of central tendency than the mean
Gaps in the Literature
Missing pieces of information in the scientific body of knowledge that a new study proposes to fill
Community-Based Participatory Research (CBPR)
Model used for community-based studies.
Agent-Based Modeling (Agent-Based Simulation, Individual-Based Modeling)
Modeling that uses computers to stimulate the actions and interactions of various individuals (agents) in a population; sometimes called agent-based simulation or individual-based modeling
On a scatter plot used to illustrate correlation, when the points are not exactly linear but a line for trend can be drawn through them, the correlation is said to be which of the following?
Moderate
On a scatterplot used to illustrate correlation, when the points are not exactly linear but a line for trend can be drawn through them, the correlation is said to be which of the following? A. Strong B. Moderate C. Weak D. Nonexistent
Moderate
FACTORIAL DESIGNS (2)
More than one independent variable E.g., want to examine social class, age, and gender's effect on autism.
What is defined as the percentage of members of a population who died of any condition during a specified time period?
Mortality rate
Mode
Most frequently occurring score Quickest estimate of central value and shows most typical case
Models that examine the effects of several predictor variables on the value of the outcome variable are known as: A. Simple linear regression models B. Bi-linear regression models C. Multiple linear regression models D. None of the above
Multiple linear regression models
Declaration of Helsinki Investigator
Must protect the life, health, privacy, and dignity of the participant
Before beginning a clinical trial, the clinical protocol must be approved by all of the following except: -FDA -the sponsor of the trial -IRB -NIH
NIH
The ________________ wrote a policy which ensures that women and members of minorities and their subpopulations are included in all human subject research.
NIH
The organization that assures that sponsors (pharmaceutical companies) are protecting participants in clinical trials is called:
National Institute for Health (NIH)
The ____________ created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines for human subjects research and to oversee and regulate human medical examination.
National Research Act: In 1974 the NRA responded largely to Tuskegee.
A _____________ is the careful compilation and summary of all publications relevant to a particular research topic. A. Meta-analysis B. Literature review C. Systematic review D. Selective review
Systematic review
All of the following are examples of citation styles used in the health sciences, EXCEPT: A. AMA B. APA C. ICMJE D. TPA
TPA
Most journals will reformat which aspect of all accepted manuscripts into their house styles when they convert the text into the single-spaced, small font, multicolumn format that is popular in health science journals? A. Maps B. Graphs C. Tables D. Photographs
Tables
Meta-Analysis
The calculation of a pooled statistic that combines the results of similar studies identified during a systematic analysis
Etiology
The cause of a disease or other health disorder
Stratified Sampling (4)
The characteristic(s) of interest are identified (e.g., Female and Male attitudes toward abortion) The individuals in the population are listed separately according to their classification (e.g., females and males) The proportional representation of each class is determined (e.g., 40% females & 60% males) A random sample is selected that reflects the proportions in the population(e.g., 4 females & 6 males)
AMA Style
The citation and reference style recommended by the American Medical Association, which is widely used by medical and health science journals; a variation of this style is called Vancouver style.
APA Style
The citation and reference style recommended by the American Psychological Association, which is widely used by social science and nursing journals.
Which is NOT an issue to consider when choosing a potential target journal? A. The citation style used in the journal B. The target audience of the journal C. The aims of the journal D. The topics that fall within the scope of the journal
The citation style used in the journal
Corresponding Author
The coauthor who will take the lead on communicating with journal editors and answering questions from readers after a paper is published.
Primary Study
The collection of new data from individuals
Page Proofs (Galley Proofs)
The copyedited version of a manuscript sent to an author for review prior to publication.
Common Rule
The current U.S. federal policy for protecting human research participants.
Inter-Observer Agreement, Inter-Rater Agreement
The degree of concordance among independent raters assessing the same study participants.
Representativeness
The degree to which the participants in a study are similar to the source population from which they were drawn
Range
The difference between the minimum and the maximum values of a variable
Quartiles
The division of a data set into four ordered parts of equal size
Deciles
The division of a data set into ten ordered parts of equal size
Tertiles
The division of a data set into three ordered parts of equal size
Stratified Randomization
The division of a population into subgroups prior to randomly assigning each individual within each subgroup to one of the exposure groups in an experimental study
Thalidomide Tragedy
The drug was marketed as a mild sleeping pill safe even for pregnant women. However, it caused thousands of babies worldwide to be born with malformed limbs. The damage was revealed in 1962.
Data Management
The entire process of record keeping
Reference Standard
The existing "gold standard" that is used as a comparison for a new diagnostic test
Number Needed to Treat (NNT)
The expected number of people who would have to receive a treatment to prevent an unfavorable outcome in one person
The Nuremburg Code (3)
The experiment should be conducted to avoid all unnecessary physical and mental suffering and injury No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur Participant should be able to quit experiment at any time.
Assent
The expressed willingness to participate in a study by a child (or another person who is deemed not legally competent to provide his or her consent).
Affiliation
The name of the school where an author is enrolled or the name of the employer of an author who participated in the project as part of his or her work responsibilities.
Belmont Report
Three core principles are identified: respect for persons, beneficence, and justice.
The cross-sectional study approach should be used when? A. Time is limited and/or budget is small B. The disease is relatively uncommon C. The exposure is relatively uncommon D. A source of cases is available, and no comparison group is required or available
Time is limited and/or budget is small
Usually, what is the goal of any single research project?
To answer one well-defined question
Usually, what is the goal of any single research project? A. To accomplish something no one else has B. To uncover a cure or a treatment C. To answer one well-defined question D. To raise awareness of a particular medical condition
To answer one well-defined question
What is the next step after determining the broad categories of questions and selecting the specific topics to be addressed in a questionnaire? A. To choose question and answer types that are appropriate B. To check the questionnaire's wording C. To choose an order for the questions D. To conduct a pre-test
To choose question and answer types that are appropriate
True or false? Cross-sectional surveys are used to establish baseline data prior to the initiation of longitudinal studies.
True
True or false? Decisions about the types of questions to ask must include considerations of which statistical tests the researcher wants to run on the collected data.
True
True or false? Direct age adjustment requires knowing the exposure or disease rates by age group in each population.
True
True or false? Focus group participants are recruited through purposive sampling because they are able to provide insights about the study question.
True
True or false? For a research project to be considered original, it needs to have only one substantive difference from previous work.
True
True or false? If the power estimates for a study are lower than desired, the easiest way to improve the power is to increase the sample size.
True
True or false? In a case-control study, the controls must be similar to the cases in every way except for their disease status.
True
True or false? It is not uncommon for conference guidelines to prohibit the submission of abstracts for studies that will be published in a journal prior to the conference.
True
True or false? Paraphrasing accurately requires a level of comprehension that direct quoting does not.
True
True or false? Population health involves humans as the unit of investigation, rather than focusing on molecules, genes, cells, or other smaller biological components.
True
True or false? Presenting new research in the form of a poster or an oral presentation can be a particularly useful way to get feedback on a project before submitting the work for review by a journal.
True
True or false? Proposals for analysis of existing data may be significantly shorter than proposals for new data collection.
True
True or false? Prospective cohort studies examining rates of incidence of disease require a series of questions about both exposure status and disease status.
True
True or false? Questions derived from practice often point toward an unmet demand for needs assessments, program evaluations, and clinical effectiveness studies.
True
True or false? Some universities require a professors to be listed as the PI on any research project that involves human subjects even if a student is taking the lead role in the conduct of the project.
True
True or false? The Delphi method is a structured decision-making and forecasting process in which participants engaged in completing individual questionnaires.
True
True or false? The author guidelines of each journal will indicate what information should be provided in the endmatter of submissions.
True
True or false? The disadvantage to using a spreadsheet program is that it is easy to accidentally enter new data or an existing row of data or to input inconsistent codes, which makes cleaning the data much more difficult.
True
True or false? The ethical principle of distributive justice seeks to ensure that the benefits and burdens of research are equitable.
True
True or false? The goal of recruiting is to maximize the participation rate among members of a sample population so as to yield a study population that is reasonably representative of the source population.
True
True or false? The medical information in patient files is not recorded for research purposes, so records are unlikely to contain all the information that researchers would like to know.
True
True or false? The methods section of the research proposal needs to convince the reader that the proposed approach to answering the study question is a valid and efficient one that is worth bankrolling.
True
True or false? The methods section should provide information about ethical considerations such as whether inducements were offered, how informed consent was documented, whether community groups were consulted, and which research ethics committees review the project.
True
True or false? The only way to truly understand a study is to read the full text of the article.
True
True or false? When starting a tertiary analysis, the most important decision is the selection of a topic that is narrow enough that all the relevant publications can be acquired.
True
True or false? When the entire 95% confidence interval is less than 1, the odds ratio is statistically significant and the exposure is deemed to be protective in the study population.
True
True or false? When interpreting results of a systematic review, studies that find no statistically significant results for an item of interest are just as valuable as those that find a significant association.
True
True/False: Prisoners, students/employees, and illicit drug users are considered vulnerable populations.
True
True/False: The Hopkins institutional review board was faulted by internal and external reviews for an inadequate review of the Togias's experiment, and for approving a faulty consent form.
True
True/False: IRB Review is required by law.
True: The Institutional Review Board is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.
Double-Entry
Two individuals enter the same data into two different computer files and then compare the records in the two files for agreement
Cronbach's Alpha & Kuder-Richardson Formula 20 (KR-20)
Two measures of the internal consistency among questionnaire items.
What type of table is used in case-control studies to compare two dichotomous (yes/no) variables?
Two-by-two (2 x 2) table
What type of table is used in case-control studies to compare two dichotomous (yes/no) variables? A. Crosstab B. Bar histogram C. Contingency table D. Two-by-two (2x2) table
Two-by-two (2x2) table
In comparative statistics, what type of error occurs when a test indicates a significant difference between two or more populations even though the null hypothesis is true? A. Type 1 error B. Type 2 error C. Type 3 error D. Type 4 error
Type 1 error
What type of error occurs when a study population yields a significant statistical test result even though a significant difference or association does not actually exist in the source population?
Type 1 error
What type of error occurs when a study population yields a significant statistical test result even though a significant difference or association does not actually exist in the source population? A. Type 1 error B. Type 2 error C. Type 3 error D. Type 4 error
Type 1 error
An error that occurs when a study population yields a significant statistical test result when one does not exist in the source population is known as: A. Type I error B. Type II error C. Type A error D. None of the above
Type I error
An error that occurs when a statistical test of the study population finds no significant result when one actually exists in the source population. A. Type I error B. Type II error C. Type A error D. None of the above
Type II error
Lead Researcher
Typically, the researcher who will do the majority of the work on the project
ANOVA
Univariate relationship: Univariate relationship: 1 IV and 1 DV 1 IV with 5 categories DV is continuous Where to find the difference when p value is significant? Use a post-hoc test
Which is NOT an example of Laboratory research? A. Compare tests of air quality in several metropolitan areas B. Identify biological mechanisms for the emergence of drug-resistant bacteria C. Use a food frequency questionnaire to examine dietary behaviors in a selected population group D. Develop a new vaccine
Use a food frequency questionnaire to examine dietary behaviors in a selected population group
Meta-Analysis
Use data from a bunch of studies Stronger sample size Use good studies!
Point Estimation
Use mean from sample for the place of population mean. Mean score of test from sample is how everyone in population would perform.
Geometric Mean
Used in lab data Using the antilog of logx
ANCOVA
Used when IV is categorical and IV
GPS (Global Positioning System)
Uses satellites to collect data about the latitude, longitude, and sometimes the altitude of locations.
Test Statistic
a value calculated from the study data for a hypothesis test, such as the t-stat used for t-tests or the F-stat used for the one-way ANOVA
power
ability to detect a difference or relationship if one exists attrition will reduce this
Analysis of Covariance (ANCOVA)
acronym for analysis of covariance, which is used to control for control for confounding variables when comparing the means of two or more groups
Which of the following are types of diseases? -injuries -infectious disease -chronic disease -neuropsychiatric disorders
all of the above
Examples of Activities not Generalizable (4)
biographies oral histories that are designed solely to create a record of specific historical events service or course evaluations, unless they can be generalized to other individuals services, courses, or concepts where it is not the intention to share the results beyond the UC community
factorial design
number of independent variables or factors included in an experiment single-factor two-factor multi-factor
Bimodal
numeric variable with a two-peaked distribution
A___________________ describes each variable and specifies how the collected information will be entered into a computer database. A. Data entry B. Book keeping C. Codebook D. None of the above
Codebook
Some case series follow patients for days, months, or even years. In this type of study approach, the case series functionally becomes what type of study?
Cohort study
Some case series follow patients for days, months, or even years. In this type of study approach, the case series functionally becomes what type of study? A. Cross-sectional study B. Cohort study C. Case-control study D. Correlational study
Cohort study
During a conference, what type of sessions occur in which multiple panels of oral presentations are held at the same time in different rooms?
Concurrent sessions
During a conference, what type of sessions occurs in which multiple panels of oral presentations are held at the same time in different rooms? A. Plenary sessions B. Concurrent sessions C. Poster sessions D. Exhibition sessions
Concurrent sessions
What is a major function of an ethics review board?
Conduct continuing review of long-term research projects
All of the following are some of the eight central considerations in research ethics, EXCEPT: A. Compensation B. Confidentiality C. Conflicts of interest D. Content
Content
What type of studies seek to recruit a study population that is representative of a well-defined larger population? A. Case-control studies B. Case series C. Cross-sectional studies D. Meta-analysis
Cross-sectional studies
Which process of qualitative data analysis uses the tools of linguistics to analyze the written, spoken, or nonverbal language used by participants?
Discourse analysis
Which process of qualitative data analysis uses the tools of linguistics to analyze the written, spoken, or nonverbal language used by participants? A. Narrative analysis B. Discourse analysis C. Meta-analysis D. Mixed methods analysis
Discourse analysis
What type of variables typically result from counting something so there are gaps between acceptable values? A. Nominal variables B. Binomial variables C. Continuous variables D. Discrete variables
Discrete variables
Oral presentations involve all of the following, EXCEPT: A. Displaying a poster about the research project B. Facing an open question-and-answer period C. Discussing the work that was completed D. Speaking in front of a group of people
Displaying a poster about the research project
Combination Products (21 CFR Part 3)
Drug/device, biologic/device, drug/biologic, drug/device/biologic, that are physically, chemically or otherwise combined or mixed and produced as a single entity.
________________ aims to develop an insider's view, rather than an outsider's view, of how members of a particular cultural group see their world. A. Phenomenology B. Grounded Theory C. Ethnography D. Focus groups
Ethnography
Ghost Authorship
Failure to include as a coauthor a contributor who has made a substantial intellectual contribution to a research project
True or false? Anthropometric measurements are physiological measurements that can be quantified accurately after minimal instruction.
False
True or false? Cross-sectional surveys measure the incidence of various exposure histories, disease states, and demographic characteristics in well-defined population at one point in time
False
True or false? For closed-ended questions and quantitative surveys, a codebook is even more essential because it provides clear instructions for how to code and enter free-response comments.
False
True or false? If new data will be collected, the researcher has great freedom in selecting study topics and can easily recruit an adequate number of participants.
False
True or false? If the plan is to synthesize current knowledge by conducting a literature review, the researcher must be prepared to track down the abstracts of all relevant articles.
False
True or false? If too many participants are recruited, the whole study will be almost worthless because the sample will not have enough statistical power to answer the study question.
False
True or false? Investigators who make their data available to the public expect to be coauthors on papers written by independent analysts.
False
True or false? Presenting research findings at conferences is a helpful part of the scientific conversation, which is entered into the permanent record of scholarly discourse.
False
True or false? Research ethics committees are usually composed of at least five members with similar backgrounds
False
True or false? Researchers who are kinesthetic learners may find it helpful to create a poster about the research project or to create a slideshow for a presentation about it.
False
True or false? Studies that measure individuals randomly sampled from the same populations at different points in time are using a cohort study approach.
False
True or false? Submitting a manuscript to a journal for review is the final step of a series of conversations about a research report.
False
True or false? The five steps of the research process can vary according to the goal of the research project or according to what methods are used.
False
True or false? The goal of concept mapping is to create a long list of possible research topics.
False
True or false? The sample population consists of individuals from the study population who are invited to participate in the research project.
False
True or false? The variables used as matching criteria must be considered as exposures during analysis.
False
True or false? When writing a research proposal, the researcher should assume that the readers of the proposal have an in-depth knowledge of the particular research area.
False
True or false? The sensitivity is the proportion of people who do not have the disease who test negative with the new test.
False
True/False: Consent by proxy/surrogate is accepted even when the potential participant has indicated refusal to participate.
False: If the potential participants refuses it is a done deal. Consent by proxy/surrogate must be approved by IRB in all instances.
True/False: Range is a measure of central tendency for a set of data.
False: Mode, median, and mean are all measures of central tendency for a set of data.
True/False: The ASU researchers provided the Havasupai Indians with consent forms and therefore had not issues with informed consent.
False: Yes, the ASU researches provided them with 2 consent forms, but there were informed consent issue because of the level of education and amount of English the Havasupai indians could understand.
Publicly available data sets could be found through the following agencies, EXCEPT: A. GIS B. CDC C. UN D. WHO
GIS
Standard Measures
GPA, SAT, GRE Equal units of measurement and are very useful in reporting test scores or doing research involving test results
Facilities and Administrative (F&A) Costs (indirect costs, overhead)
General costs associated with maintaining a research environment
HeLa cells were used to grow the ______ virus and develop a vaccine .
polio
Independent Populations
populations in which each individual can be a member of only one of the groups being compared, for example, in a case-control study each participant can only be a case or control so the case and control populations are independent
Third Variable (Extraneous Variable, Lurking Variable)
potential confounder that may make the association between an exposure variable and an outcome variable appear more or less significant than it truly is
The leader of the research team with primary responsibility for all aspects of the research project is referred to as the ________.
primary investigator
experimental design
type of design actively intervening by manipulating a variable trying to determine the effect of one thing on something else 2+ groups of subjects
quasi-experimental
type of experimental design controlled group of subjects 1 group of subjects NOT random used when there are not enough subjects to form groups or predetermined characteristic
RCT
type of experimental design strongest evidence on whether interventions work or not 2+ groups outcomes are compared b/w groups control vs experimental groups
correlational design
type of non-experimental design attempting to describe something analyzing whether a relationship or pattern exists among the things that you are describing
cross sectional
type of non-experimental design descriptive study b/w disease and other factors completed at one point in time
cohort
type of non-experimental design prospective design used to follow a group of people to see if they develop a condition good for common diagnoses cons: takes longer to do, can be expensive ex) pt's followed 6 months after discharge to determine who fell or not
case control
type of non-experimental design retrospective design used to evaluate the relationship b/w potential exposure and an outcome control group w/ outcome, second group w/o outcome ex) relationship b/w smoking & lung cancer
descriptive
type of non-experimental design used to describe characteristics, behaviors, attitudes, etc.
snowball
type of non-probability sampling recruit subjects who then recruit more subjects used when potential members of the population are difficult to identify ex) word of mouth
convenience
type of non-probability sampling use of readily available subjects consecutive convenience sampling used in prospective trials ex) students
purposive
type of non-probability sampling uses handpicked subjects that meet the researcher's needs often used in qualitative research ex) subjects who demonstrate different levels of variables of interest
stratified sampling
type of probability sampling capsule sub-groups w/in a population based on naturally occurring differences (age, gender, disease severity) used to: ensure certain subgroups are represented in adequate numbers OR preserve proportions of subgroups in population w/in the sample randomly select subjects in each stratum
simple random sampling
type of probability sampling each member of population has random change of being selected for study selection of subjects in INDEPENDENT of one another each population member assigned a number & selected randomly
statistical test
uses the data obtained from a sample to make a decision about whether or not the null hypothesis should be rejected. Asks the question, "Is the difference really a difference?"
Outliers
value in numeric data set that is distant from other observations and outside the expected range of values
Independent Variable (Predictor Variable)
variable in a statistical model that is used to predict the value of some outcome variable; also called predictor variable
Dependent Variable (Outcome Variable)
variable in a statistical model that represents the output or outcome for which the variation is being studied; also called an outcome variable
After your clinical research paper is accepted for publication in a journal:
you may have to wait a long time for publication
A ________________ indicates how many standard deviations away from the sample mean an individual's response is. A. z-score B. Histogram C. Box plot D. Range
z-score
What are the five initial contact methods discussed?
- In-person - Telephone - Mail - E-mail - Internet
Questions on Literature Validity
- Is the researcher at a reputable institution? - Who funded the study? - What is the study reporting? an "unusual" lab reading or real outcomes. - How does this study compare with previous research on the same subject? - How was the study controlled?
Which methods of analysis do experimental studies use that are the same in cohort studies?
- relative rates - attributable risks (excess risk or risk reduction) - attributable risk percentages - measures of survival.
What is a questionnaire?
A tool for systematically gathering information from study participants. They can be designed for self-reporting or as scripts for interviewers.
Medical Devices
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent. Products with an intended use similar to a drug but that do not achieve any of their primary intended purposes through chemical means.
What is an orphan drug?
Drug intended affects <200,000.
Biologics
Include any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of the disease or injuries to humans.
What are the two main types of primary studies?
Interviews and self-reported surveys
On Bullshit
It is worse than an actual lie because it denies the value of truth. It is a misrepresentation of reality, with indifference of the actual truth.
What is the licensure of biologics regulated by?
Public Health Service Act of 1944
What is a treatment IND?
Submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions
What is the number for the New Drug Application?
Title 21 Part 314
What is a biologic?
Virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or allergenic product, arsphenamine application to the prevention, treatment or cure of a disease or condition of human beings
What is a dietary supplement?
Vitamins, minerals, herbs, AA, concentrate, metabolite, constituent, extract, substance to increase total dietary intake---classified as food
Which methods of analysis are specific to experimental studies?
- Efficacy - the proportion of individuals in the control group who experience an unfavorable outcome who could have been expected to have a favorable outcome had they been in the active group instead - The number needed to treat (NNT) - the expected number of people who would have to receive a treatment to prevent an unfavorable outcome in one person - The number needed to harm (NNH) - the number of people who would need to receive a particular treatment in order to expect that one of them would have a particular adverse outcome
Research Ethics Guidlines
- Honesty: convey info truthfully. - Objectivity: let the facts speak for themselves. - Accuracy: Report findings precisely, avoid errors. - Efficiency: Use resources wisely, avoid waste.
What conditions must be met in order for a drug to not require a IND?
1. No new labeling/indication 2. Change in advertising 3. Change anything that significantly increases risks of drugs 4. Compliance with IRB review 5. Compliance with promotion and sale of drugs 6. does not invoke 21 CFR 50.24 (exception from informed consent req. for emergency use)
Medical Products Regulated by the FDA
1.) Drugs 2.)Medical Devices 3.) Biologics, 4.)Combination Products. 5.) Special nutritional products (dietary supplements, infant formulas, medicinal foods) 6.) veterinary and other non-medical products (includes foods and cosmetics)
Role of the FDA
1.) Protect the health and safety of consumers by ensuring that products that they regulate are safe and effective. 2.) ensure that all products packaging and labeling is truthful, informative and not deceptive. 3.) Regulate the processes through which evidence of product safety and efficacy are developed.
What the incentives of orphan drugs?
7 years of marketing exclusivity after approval, tax incentives for clinical research, FDA Office of Orphan Products Development coordinates research study design assistance
Cross-Sectional Study
A class of research methods that involve observation of all of a population, or a representative subset, at a defined time. They aim to provided data on the entire population under study, not just individuals with a specific characteristic. - Often involve data collected at a defined time, to assess the prevalence of acute or chronic conditions, or answer questions about the causes of disease or results of medical intervention.
Non-Blind Study
A study in which neither the experimenter nor the subject are blind to the treatment.
Government's Definition of Research
A systematic investigation including research development, testing and evaluation, designed to develop/contribute to generalizable knowledge/findings BEYOND a single individual. * Thus Case Studies are not considered research by government.
Kerlinger Definition of Research
A systematic, controlled, empirical and critical investigation of natural phenomena guided bu theory and hypothesis about presumed relationships among such phenomena. * Thus Kerlinger considers Case Studies to be research.
Statistical Issues
Always decide on how you will count or adjust your statistics ahead of time. So that during the study, if you have to, you can make the pre-planned adjustments to prevent biased manipulations.
Case-Control Study
An epidemiological study that is used to identify factors that may contribute to a medical condition by comparing subjects who have the condition (the 'case') with patients who do not, but are otherwise similar (the 'control'). - Relatively inexpensive and frequently-used type of study.
What is biologic oversight split between?
CBER and CDER
Research Misconduct
Can be punished by "disbarment" which will prohibit you from working for any government funded program. - For students this includes any externships, residency programs or fellowships.
What are the differences between close-ended questions and open-ended (or free response) questions?
Close ended questions allow a limited number of possible answers and are usually easier to statistically analyze than open-ended or free-response questions. Close ended questions come in a variety of formats, including date and time variables (which can be used to calculate length of time between events), numeric variables. and categorical variables. On the other hand, open ended questions allow participants to explain their selections and qualify their responses, to give multiple answers, and to provide responses not anticipated by the researchers.
Drugs
Compounds used to treat, cure, mitigate or manage a disease or condition, usually through chemical means of action
What is an emergency Use IND?
FDA can authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21 CFR 312
Clinical Trial: Phase I
First real stage of testing in human subjects. Small group 20-100 of healthy subjects. Designed to assess the saftey, tolerability, pharmacokinetics, and pharmacodynamics of a drug.
Which drugs, under NDAs, can be submitted for abbreviated applications?
Generics, duplicates of, or that meet monograph for, an antibiotic drug for which FDA has approved an application, drugs that have been declared suitable for an abbreviated new drug application submission by FDA
How are most drugs discovered?
High-throughput screening; thousands of compounds tested against target using robotics and high-powered computations
What are the issues with Phase 3?
Large sample size, global trial involving many investigative sites, large scale data collection
Retrospective Cohort Study
Less valid because you can choose the people you involve in the study and thus increases chances of biased influences.
What are the types of reviews in the IND?
Medical, chemistry, pharmacology/toxicology, statistical and safety review
What are the issues in Phase 2?
Multiple sites, well controlled, dose ranging
What does CDER regulate in drug development process?
New drugs, drug manufacturing, drug labeling and drug advertising
Clinical Trial: Phase II
Occurs after the initial safety of the drug has been confirmed. Then performed on a medium group 20-300, to assess how well the drug works, as well as continue the safety assessment. * This is the phase when a bad drug is discovered not to work as planned, or to have toxic effects.
What is an IND?
Request for exemption from federal laws so that clinical trials may begin after adequate preclinical data has been obtained
Why are supplemental methods of obtaining information sometimes necessary?
Responders may not tell the truth, either because the do not accurately remember the answers or because they want to provide "correct" answers. Also, they may not know some of their health measures, such as their current weight or blood pressure. Laboratory tests and other objective measures can be used to supplement and validate self-reported data and to explore factors that require independent assessment.
What is the purpose of Phase 2?
Safety and Efficacy
What are the issues in Phase 1?
Safety, PK testing, close monitoring, maximum tolerated dose
What is the purpose of Phase 3?
Safety, efficacy, overall risk-benefit assessment
Food, Drug and Cosmetic Act
Tightened controls over drug sand food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government's ability to enforce the law.
What is the number for the investigational new drug application?
Title 21 Part 312
What is a placebo? When might it not be ethical to use one in a study? What else can be done?
a type of control that is an inactive comparison that is similar to the therapy being tested. It might not be ethical to use in a study when an effective therapy is already available. Instead, if the goal of the experiment is to see whether a new therapy is better than a current one, then it is appropriate to compare the new therapy to some existing "standard of care" whether that is the best therapy currently available or the standard local therapy.
Cohort Study
aka Panel Study, is a form of longitudinal study used in medicine. It analyzes risk factors and follows a group who do NOT have the disease, and uses correlations to determine the absolute risk of subject contraction. - Largely about the life histories of segments of populations. - Prospective Cohort Study - Retrospective Cohort Study
Clinical Trial: Phase IV
aka Post-Marketing Surveillance Trial. Involves the continued safety monitoring (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.
What is blinding? State the difference between single- blind and double - blind.
occurs when a participants in an experimental study and perhaps some research team members do not know whether a participant is in the active intervention group or the control group. A single blind is when the participants are unaware of their exposure status. In a double-blind study, neither the participants nor the persons assessing the participant's health status know which participants are in the active and control groups. Also called masking
Why are experimental studies at a high level of ethical risk?
the researcher assigns participants to exposures that the participants do not choose and may have been unlikely to encounter in normal life has they not volunteered to participate in a research project.
A secondary analysis of data refers to: A.Collecting new data from individuals B.Writing a review article C.Using existing data D.None of the above
Using existing data
In 1968 William Carter Jerkings, founded and edited _______, a newsletter, where he unsuccessfully called for an end to the Tuskegee syphilis study.
"The Drum"
Grounded Theory
A qualitative research approach that uses an inductive reasoning process to develop general theories and explain observed human behavior.
What type of randomization randomly assigns groups of people to an intervention group and other groups of people to a control group?
Block randomization
What type of randomization randomly assigns groups of people to an intervention group and other groups of people to a control group? A. Cluster randomization B. Block randomization C. Stratified randomization D. Cluster randomization
Block randomization
All of the following are examples of anthropometric measurements, EXCEPT: A. Height B. Waist circumference C. Skinfold measurements D. Blood pressure
Blood pressure
Biological specimens such as urine, stool and saliva samples can be useful for identifying all of the following, EXCEPT: A. Risk factors for disease B. Characteristics associated with having the disease C. Blood pressure D. Presence of disease
Blood pressure
How are research results most likely be shared for the first time publicly? A. Oral presentations B. Poster sessions C. Online presentations D. Both A and B
Both A and B
Once a complete manuscript has been drafted, what are the following steps needed to complete the manuscript? A. Revise the manuscript B. Polish the manuscript C. Re-write the manuscript D. Both A and B
Both A and B
A correlational study is also known as a(n): A. Ecological study B. Longitudinal study C. Aggregate study D. Both A and C
Both A and C
A(n) example of a study approach(es) that focuses on individuals with a particular disease is: A.Case-series B.Cross-sectional C.Case-control D.Both A and C
Both A and C
How do most primary studies collect data from individual participants? A. Interviews B. In-person C. Self-administered surveys D. Both A and C
Both A and C
Predictor variables for a logistic regression can be: A. Categorical B. Ratio C. Continuous D. Both A and C
Both A and C
Which is one of the most common methods used to collect data in qualitative studies? A. In-depth interviews B. Questionnaires C. Focus groups D. Both A and C
Both A and C
Prospective Cohort Study
Carries more validity because you can't "pick" the individuals you are studying, thus prevents bias.
_______________ section usually begins with a summary of the key findings of the new study. A. Introduction B. Methods C. Results D. Discussion
Discussion
When participants in an experimental study change their behavior for the better, this is known as? A. Masking B. Blinding C. Equipoise D. Hawthorne effect
Hawthorne effect
________ applies federally to maintain confidentiality practices for dental care.
Health Information Protection and Accountability Act (HIPPA)
What applies advanced techniques from the information science and compute science to the compilation and analysis of health data?
Health informatics
What section of the paper in the health sciences should spell out the core question that the paper will explore and answer?
Introduction
THE FORMAT OF A RESEARCH PROPOSAL (5)
Introduction A (brief) review of the relevant literature Method - Proposed analysis of the data Implications and limitations Appendices
The information already known about a health topic and an explanation of why a clinical trial is necessary should be contained in which section of the clinical protocol?
Introduction/background section
What are the three types of IND?
Investigator, Emergency, Treatment
Population Health Research
Involves humans as the unit of investigation, rather than focusing on molecules, genes, cells, or other smaller biological components.
True or false? Recruiting based on exposure status makes retrospective and prospective cohort studies the optimal study approaches for uncommon exposures.
True
True or false? Regardless of which analytic approach is used, the research protocol should include specific plans for promoting compliance and minimizing dropouts.
True
cluster sampling
type of probability sampling random selection from "pockets" ex) population of 100 sites- randomly select 10 sites & sample from them
systematic sampling
type of probability sampling starting point is chosen via random number table/generator (every nth number) ex) every 10th
block
type of random assignment alternative to random individual assignment predetermine number of subjects to be contained in each group to ensure equal numbers assign each member a number select max number of subjects per group via random number generator
matched assignment
type of random assignment control potential outcomes of characteristics subjects are matched/formed into subsets based on important characteristics members of subsets then randomly assigned to groups
individual
type of random assignment randomly assign each individual to a group pick via coin flip, dice roll may result in unequal group sizes
consecutive assignment
type of random assignment randomly assigned order of group assignment before subjects enrolled in the study subjects coming into study are assigned according to previously composed list
systematic assignment
type of random assignment sample members count off or are numbered repetitively according to group numbers ex) gym class count off
Ordinary Least Squares (OLS)
used to find the best-fit line in linear regression
Maximum Likelihood Estimation (MLE)
used to find the coefficient values that best explain the outcome
Multivariate Analysis of Variance (MANOVA)
used to test for differences in group means when there are multiple dependent variables
Research done in a methodically rigorous manner is:
valid
What is an experimental study?
assigns participants to intervention and control groups in order to examine whether an intervention causes a intended outcome.
A Case Study is considered to be...
"Scholarly Activity" not research technically. * But many case studies are often the basis for future research studies.
Why is it helpful to perform a pilot test?
it helps check: - The wording and clarity of the questions - The order of the questions - The ability and willingness of participants to answer the questions - The responses given, and whether the responses match the intended types of responses - The amount of time it takes to complete the survey
What is a qualitative study?
it looks for the themes and meanings that emerge from the observation and evaluation of a situation or context.
What is the subject in Phase 2?
target population
What is the NDA equivalent for biologics?
BLA
What is the form for an IND?
FDA 1571
What is the definition of a drug?
-Substance intended for use in diagnosis, cure, mitigation, treatment or prevention of disease in man or animals -substance recognized in US Pharmacopoeia - substance intended to affect structure or any function of body of man or animals
Evidence Based Practice
(EBP): a thoughtful integration of the best available evidence, coupled with clinical expertise. - Enables health practitioners to address healthcare questions with an evaluative and qualitative approach. - Also allows identification of relevant literature while differentiating between high-quality and low-quality findings.
Nonrandomized Trial
(Quasi-experiment) An interrupted time series design: measures on a sample, or a series of samples, from the same population are obtained several times before and after a manipulated event or a naturally occurring even.
Randomized Controlled Trial
(RCT) A form of clinical trail, most commonly used in testing the safety and efficacy of healthcare services or health technologies. - The key distinguishing feature is the study subjects, are randomly allocated to receive one or other of the alternative treatments under study. - Double-Blind Trial - Single-Blind Trial - Non-Blind Trial * Considered the 'gold standard' for research design, but are usually expensive, time consuming, and not all studies will fit this design.
What are the differences between self-reported surveys and interviews?
- A self-reported survey is usually the least costly and least time-consuming way to gather information. Self-administered surveys can be completed at a specific research site, such as a workplace or school or hospital, or they can be delivered by mail or the Internet. - However, interviews may allow for more detailed information to be gathered and can be accompanied by laboratory and other tests. They may be conducted in person or via the telephone.
Observational Study Types
- Cohort Study (prospective & retrospective) - Case-Control Study - Cross-Sectional Study
Phases of Clinical Trials
- Phase 0: first-in-human trial, often microdosing. - Phase I: first stage of tesing in humans, small group (20-100) - Phase II: how well it works, medium group (20-300) - Phase III: random-controlled trial, large group (300-3,000) - Phase IV: post-marketing saftey surveillance. - Phase V: effectiveness in widespread public health practices.
What is phenomenology? Grounded theory? Ethnography?
- Phenomenology seeks to understand how participants understand, interpret, and find meaning in their own unique life experiences and feelings. - Grounded theory is an inductive reasoning process that uses observations to develop general theories that explain human behavior. - Ethnography aims to develop an insider's view (an emic perspective), rather than an outsider's view (an etic perspective), of how members of a particular cultural group see their world.
Role of Statistics
- Statistics should be thoughtfully considered before the study begins. - Statistical manipulations cannot be used to rescue an intrinsically flawed study.
What should the description of an intervention contain?
- What the intervention will be - Where and how participants will receive the information - When, how often, and for what duration participants will receive the intervention - The eligibility criteria for participants
What is the number for informed consent?
21 CFR Part 50
What is the purpose of Phase 4?
Additional information
Clinical Trial: Phase III
Randomized controlled, multicenter trials on large group 300-3,000. Aimed at being the definitive assessment of how effective the drug is, in comparison with the current 'golden standard' treatment.
Clinical Trial: Phase V
Refers to comparative effectiveness research and community-based research; it's used to signify the integration of a new clinical treatment into widespread public health practice.
What is the purpose of Phase 1?
Safety
When can the PI begin a clinical trial in the US?
After receiving IRB approval
What is the number for IRB review?
21 CFR Part 56
What are the nine types of supplemental methods mentioned?
- Anthropometric measures - Vital signs - Clinical examination - Tests of Physiological Function - Laboratory Analysis of Biological Specimens - Medical Imaging - Tests of Physical Fitness - Environmental Assessment - GIS (Geographic Information Systems)
Research Ethics
- Conforming to accepted standards of social or professional behavior. - Adhering to ethical and moral principles.
The first step in designing a questionnaire is to list the topics that the survey must cover. What are the four main question areas?
- Demographics - Key Exposures - Key diseases/outcomes - Related exposures and outcomes
Why research is done
- Evidence based medicine. - Discover pathology of disease to enable treatment. - Legal obligation to discover new drugs/devices. - Intellectual curiosity. - Academic credence.
What form is IND?
Form FDA 1571
What are the special circumstances?
Orphan drug and emergency/treatment IND
What is involved in the pre-clinical studies?
Pharmacokinetics, pharmacodynamics, disease models
What are the issues of Phase 4?
Post marketing research, additional safety info, additional risk-benefit analysis, comparison studies
Clinical Trial: Phase 0
Pre-clinical studies: the first-in-human trials conducted in accordance with FDA guidance. Often use microdosing.
Ordinal
Having an inherent order
Dichotomous
Having two responses
Two-tailed Test
Nondirectional statement- SPLIT
Phase 2 of Clinical Trials
- 100 to 300 people with the disease being studied - Used to determine both safety and efficacy
Phase 3 of Clinical Trials
- 100 to thousands - Compare the new treatment with the standard treatment and continue safety
Phase 1 of Clinical Trials
- 15 to 30 healthy people - First time in humans - Used to determine the safe dose
Who is involved?
- Human Subject Volunteers - Physician Investigators & Staff - NIH - National Institutes for Health - Manufacturing companies (Sponsor) - OHRP - Office for Human Research Protections - FDA - Food & Drug Administration (CDER, CBER, CDRH)
Phase 4 of Clinical Trials
- Several hundred to several thousand - Post market safety and efficacy
Informed consent forms should contain:
-A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation -A description of any benefits to the subject or to others which may reasonably be expected from the research -A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
Good Clinical Practice (GCP) guidelines state:
-Clinical trials should be conducted in accordance with ethical principles -The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. -A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
When someone is given honorary coauthorship without having significantly contributed to the work during the study or manuscript is known as: A.Ghost authorship B.Gift authorship C.Informal authorship D.Required authorship
.Gift authorship
In what ways can early learning centers, schools, and colleges/universities address health disparities?
1. Research to identify effective policy and program interventions to reduce health disparities 2. Outreach to increase diversity in health care 3. Offer preventive services for all children, especially those at risk 4. Develop and implement local strategies to reduce health, psychosocial, and environmental conditions that affect school attendance and chronic absenteeism
What is normal salivary flow rate?
1.5-2.0 mL/min
The IRB typically conducts a periodic review for the approval of the study every _______.
12 months
Retrospective Cohort Study (Historic Cohort Study)
A cohort study that recruits participants based on data about their exposure status at some point in the past and typically also measures outcomes that have already occurred
Responsible Conduct of Research (RCR)
A common component of research ethics training that emphasizes professionalism and best practices for collaborative research.
Distributive Justice
A principle of research that requires the benefits and burdens of research to be equitable.
Discriminant Analysis (Discriminant Function Analysis)
A statistical method that identifies the set of ratio/interval and/or nominal variables that most accurately predicts group membership in a model with a nominal dependent variable
Canonical Analysis
A statistical method that identifies the set of ratio/interval and/or nominal variables that most accurately predicts group membership in a model with two ratio/interval and/or nominal dependent variables
Random Effects Model
A statistical model that can be used for meta-analysis when there is considerable variability between the included studies
Fixed Effects Model
A statistical model that can be used for meta-analysis when there is little variability between included studies
Propensity Score Matching
A statistical technique for predicting the probability of group membership while adjusting for covariates
Prospective Study
A study that follows participants forward in time
Kaplan-Meier Plots
A time graph that displays cumulative survival rates in a study popultaion
Block Randomization
Allocation method that randomly assigns groups of people to an intervention group and other groups of people to a control group; randomization occurs at the group rather than individual level
What is an example of a routine practice activity?
An epidemiologist working for a health department tracks down the source of an outbreak of gastroenteritis
SWOT
An evaluation method that identifies the strengths, weaknesses, opportunities, and threats of a program.
Exposure
An intervention, environmental encounter, behavior, or personal characteristic that might change the likelihood of developing a health condition
A Spearman rank-ordered correlation should be used to analyze the data of an ecological study when: A. Continuous variables are used B. Variables that assign a rank to responses are used C. Variables that have ordered categories are used D. Both B and C
Both B and C
Pie Chart
Circle in which each wedge or slice displays the percentage of participants who provided a particular answer to one question; the sum of the percentages for the slices must add up to 100%
The methods section should begin by: A. Clearly identifying the study design used B. Listing person, place, time characteristics C. Providing definitions of key exposures, outcomes or other variables D. None of the above
Clearly identifying the study design used
Prevalence Rate Ratio
Compares the prevalence rates for the same variable in two independent populations by taking a ratio of them
Keys to Success in Simple Random Sampling
Distribution of numbers in table is random Members of population are listed randomly
Potential Confounders
Factors that might influence the relationships between key exposures and outcomes
____________________________ is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.
Fast track approval
Researcher ___________, sought a cell line that would live indefinitely outside the human body to study and cure cancer.
George Grey
Directional Research Hypothesis
Groups are different, and direction is specified
Who was the lady who's cells were sampled for research without consent during a therapeutic intervention?
Henrietta Lacks
Morbidity
Illness
A scale with a defined distance between points but NO true zero is called:
Interval
Loss to Follow-Up
Inability to continue tracking a participant in a prospective or longitudinal study because the person drops out, relocates, dies, or stops responding to study communication for another reason
The scientist that discovered that citrus fruits could prevent scurvy is:
James Lind
What may be helpful for identifying the presence of a disease or markers for a disease?
Laboratory analysis of biological specimens
Which of the following is a key characteristic to watch out for when performing a case series study?
Lack of generalizability
Snowballing
Looking up every article cited by eligible articles in order to identify other articles that might be relevant but not indexed in the selected databases
MANOVA
More than 3 IV's Must be categorical!
Which of the following is defined as the percentage of members of a population who die of any condition during a specified time period? A. Morbidity rate B. Mortality rate C. Case fatality rate D. Proportionate mortality rate
Mortality rate
Researchers attempting to generate a random sample from the source population need to avoid what type of bias that could occur if each individual in the source population does not have an equal chance of being selected for the sample population?
Nonrandom sampling bias
Nominal
Not having a built-in order
Null
Opposite of research question
Two Research Designs
Questionnaire Observation
What is the major limitation when using existing clinical records?
Records are often incomplete
Alternative
Research question
Gray Literature
Research reports that are available to the researchers but have not been externally reviewed and formally published
A Gantt chart can be very helpful for visually displaying what?
Research timeline
Which section of a research article should start with a description of the study population that clearly identifies the sample size and the demographics of the participants?
Results
Which of the following should always be the top priority when designing and implementing an experimental study?
Safety
Replication Studies
Studies that repeat a study in a new population as part of attempting to confirm that the original findings were not due to chance
IRB function
The IRB functions under the mandate of the President of the University of Charleston.
IRB direct communication - informed consent
There are occasions when direct communication between the IRB and sponsor may facilitate resolution of concerns about procedures or wording in an informed consent document. However investigator should be apprised of the discussion.
Interaction between sponsor and central IRBs
There may be more interaction due to the contractual nature of the relationship
Burden of Disease
Type of study that uses DALY
Hypotheses Testing
Usually, the researcher tests the null hypothesis of "no difference". If statistical significance is found, then the investigator rejects the null hypothesis. Null Alternative Directional Nondirectional
A(n) _____________ questionnaire measures what it was intended to measure in the population being assessed. A. Accurate B. Reliable C. Valid D. Discrete
Valid
Population
Whole, large group All college students
a
a
GIS (geographical information system)
a computer-based geographic data set that allows for the mapping of the locations of events, the identification of disease clusters, and the testing of complex spatial associations
Investigators Brochure (IB) or Investigators Drug Brochure (IDB)
a document that provides a summary of all the existing information of an investigational product. It helps the investigator to further understand the investigational product. The IB lists: -a summary of the physical, chemical, and pharmaceutical properties of the product -results of pharmacokinetics, pharmacodynamics, and toxicological studies in animals and humans -rationale of the dose, dose interval, route of administering the drug, and safety monitoring -all countries in which the product has approval and the marketing experience -all interpretation of all the available data about the investigational product
Unimodal
a numeric variable with a one-peaked distribution
Standard Deviation
measure of narrowness or wideness of a normal distribution which is calculated as the square root of the variance, in a normal distribution, 68% of the responses will fall within one standard deviation above or below the mean and 95% of the responses will fall within two standard deviations above or below the mean
Variance
measure of narrowness or wideness of a normal distribution, which is calculated as the sum of squares of the differences between each observation and the mean divided by the sample size
Breslow-Day Test
test for assessing the homogeneity of the odds ratios across strata (that is, across independent populations from within the same data set, such as when separate 2x2 tables are created for males and for females or separate 2x2 tables are created for several age groups)
True or false? A well-trained clinician can make accurate and reliable assessments of many health states that machines are unable to assess well.
True
True or false? Because most journal articles in the health sciences follow the same outline, it is possible to know exactly which paragraphs are needed for a draft even before the first word is written.
True
True or false? The abstract of the report should tell the entire story in one compelling paragraph.
True
True or false? A request for access to a private data set is most likely to be granted when the new researcher has some existing connection to the original researcher.
True
True or false? A strong protocol should be detailed enough that the entire methods section of any paper that will result from the project could be written before data collection begins.
True
True or false? Abstracts may incorrectly or incompletely summarize the methods and results of a study.
True
True or false? Coercion could include social pressure or requests from authority figures that make it difficult for an individual not to agree to enroll in a study.
True
True or false? Correlational studies are a useful starting point for generating hypotheses about associations, but they are not the final word on risk factors for a disease.
True
What is Research? Defined in the Code of Federal Regulations (FDR):
"a systematic investigation designed to develop and contribute to generalizable knowledge."
What are the nine steps of questionnaire design planning?
- Identify general question categories - Select specific question topics - Choose question and answer types - Check wording - Choose order - Format layout - Pre-test - Revise - Use
What are the common ways of collecting data for a qualitative study?
- In depth and semi-structured interviews- use open-ended questions to explore viewpoints. The interviewer is allowed to probe for more details about any response in order to gain fuller understanding of the participant's experiences and perspectives - Focus groups - of about 4 to 12 people are moderated discussions led by a facilitator from the research team. The facilitator encourages participants to interact with one another and to clarify their individual and shared perspectives
What are the main methods of recording data from a survey?
- Record the responses on paper and to enter them into a computer database later - Have interviews or participants enter responses directly into a database
What are the 3 types of randomization mentioned?
- Simple randomization - uses a coin toss, a random generator, or some other simple mechanism to assign each individual to one of the groups - Block randomization - randomly assigns groups of people, such as whole communities or whole schools to an intervention or control group - Stratified randomization - randomly assigns individuals within certain subgroups (such as males and females or various age groups) to a particular exposure. This type of randomization is useful when simple randomization may not result in enough members of certain subgroups being randomized to each of the exposure groups
What are randomized control trials (RCT)?
- Some participants are randomly assigned to an active intervention group - The remaining participants are assigned to a control group - Then all participants from both groups are followed forward in time to see who has a favorable outcome and who does not
Washout Period
A period during an experimental study during which patients receive no treatment
Type 1 Error
-Rejection of null hypothesis when it is true. -The alpha level (α) of significance determines the probability of a Type I error.
The responsibilities of the clinical trial site monitor are to verify that:
-The rights and well-being of human subjects are protected. -The reported trial data are accurate, complete, and verifiable from source documents. -The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
Clinical study close-out involves....
-a review of all regulatory documents (CRF's) -a remaining drug inventory and return -verification that all adverse events were reported -notification to participants
The write-up for your clinical research publication should be:
-clear -concise -structured -organized
Source documents(CRF's) do what?
-confirm protocol adherence -substantiate integrity of data -confirm existence of participiants
The study design/methods section of a clinical trial protocol should contain:
-description of study procedures -delineation of study timeline -inclusion/exclusion criteria -description of the types of assessments used
IRB members should be knowledgeable about...
-ethics -rights -safety -risks -participant seleciton
Lab studies (work done in a laboratory) can include:
-immunology -microbiology -molecular biology
A poster presentation of clinical data at a conference are for:
-improving presentation skills -sharing info with other clinicians -getting feedback -not self-promotion
Some common problems with clinical data management are:
-missing data -transcription errors -lack of source document
What are the key financial factors of clinical research?
-negotiating budges -signing contracts with the sponsor -obtaining funding
Type 2 Error
-null hypothesis is accepted when it is false -As alpha level of significance increases, the possibility of a Type I error is reduced, but the chance of a Type II error (β beta) increases. •Typically, Type I errors lead to unwarranted changes, whereas Type II errors maintain the status quo when a change should occur.
The benefits of electronic case report forms include:
-saves data entry time -saves money/personnel -get immediate feedback
Clinical trial data management should be:
-timely -accurate -verifiable -not complicated
What is unstimulated salivary flow rate?
0.3-0.4 mL/min
A valid study will have a value of kappa that is close to which of the following? A. −1 B. −0.5 C. 0 D. 1
1
Investigator must be:
1.) an appropriately qualified person 2.) Trained and experienced in clinical research 3.) Familiar with the background of the study drug and requirements of the study 4.) known to have high ethical standards and professional integrity
To how many journals can a health sciences manuscript be submitted at one time? A. 1 B. 2 C. 3 D. 5+
1
Natural Language Processing
A machine learning algorithm that is used in the analysis of qualitative and social media to examine how people speak and write in real-life situations
Studies that can be completed within that time frame may not require further review by the research ethics committees after initial approval?
1 year
Studies that can be completed within what time frame may not require further review by the research ethics committee after initial approval? A. 6 months B. 1 year C. 2 years D. 3 years
1 year
Institutional Review Board
1. All clinical trials must be approved and monitored by an IRB. 2. IRB is an independent committee of physicians, nurses, statisticians, community advocates and others. 3. The function of the IRB is to ensure that a clinical trial is ethical and the rights welfare of study participants are protected.
Subject Data Collection
1. Data is collected on case report forms (CRF) 2. Much of clinical data is taken from the subjects medical record (source documents) 3. Pharmaceutical and device trials, data is verified by multiple players
Steps for data analysis
1. Differentials 2. Inferentials 3. Multivariate Regression
What were the two main problems in Togias's study?
1. He did not halt the experiment after the first volunteer began coughing 2. He did not report a change in the study's procedure to the Hopkins IRB
What are three ways the state and local government can address health disparities?
1. Identify populations with greatest risk and implement policies and programs in these populations 2. Improve coordination, collaboration, and opportunities for engaging leaders and members in prevention 3. Improve privacy-protected health data collection for underserved population to improve programs and policies for these populations
In what ways can health care systems, insurers, and clinicians address health disparities?
1. Increase cultural and communication competence of health care providers 2. Train and hire more qualified staff from underrepresented racial and ethnic minorities and people with disabilities 3. Enhance care coordination and quality of care
Measures of Central Tendency
1. Mean 2. Median 3. Mode 4. Geometric Mean
What are the general requirements for voluntary informed consent?
1. Obtain legally effective informed consent 2. Needs to be in a language understandable to the subject 3. Allow subject to consider whether or not to participate, and minimize coercion 4. Subject does not waive any legal rights
Phases of Clinical Trials
1. Phase I (human pharmacology studies)- This phase is a non therapeutical phase. This phase provides data on how the IP is absorbed, distributed, metabolized, and excreted in the body (asses tolerance). Gathers info on the drug safety and the effect of the drug on the human body. The key to this phase is finding a max dosage. Includes healthy patients. 2. Phase II (therapeutic exploratory trials)- Sponsor wants to determine potential efficacy and identify common adverse events (safety). The key of this phase is to find an optimal effective dose. It must be investigated in the target population ("healthiest of the sick") and must take place in a strict medical environment due to unknown reactions to the product. 3. Phase IIIa (therapeutic confirmatory trials)- Gather data to confirm safety and efficacy and asses the risk to benefit ratio. Similar to phase II with a larger population and information on addiction potential. 4. Phase IIIb (therapeutic use trials)- Similar to IIIa with more subjects over a longer period of time. Finds new indications as well as identify long- term effects. This is the phase after requesting regulatory permission to market the drug or after first market launch. 5. Phase IV (post marketing trials)- Investigates long- term effects and identifies previously unknown adverse events. Understand how the product is prescribed and gather additional safety and interaction data. This phase occurs after receiving permission to market the drug.
CRC Responsibilities
1.) facilitate all activities required for timely start of the study 2.) participate with the CRA in various types of monitoring visits 3.) Serve as primary source of contact for both the sponsor/CRA and IRB during the study to manage flow of documents, communications, etc. 4.) Manage investigational product accountability, storage, use and destruction 5.) Recruit subjects, obtain informed consent, and complete all subject lists and study procedures according to the protocol 6.) Collect study data and complete source documents/CRFs 7.) Prepare, process, store and ship laboratory specimens as required by protocol 8.) complete processes and tasks at study completion
Case Definition
A list of the inclusion and exclusion criteria for being considered a person with the disease of interest in a case series, case-control study, or other type of study
What are the three principles for research ethics under the Belmont Report?
1. Respect for Persons (informed consent) 2. Beneficence (risk/benefit evaluations) 3. Justice (fair subject selection)
Key players in a clinical trial
1. Sponsor- A company, institution, government agency, group, or individuals who own the chemical compound or device and maintain financial and legal responsibility for its development 2. Investigator- An individual (physician, dentist, Ph.D., etc.) responsible for the conduct of a clinical trial at a trial site 3. Principal investigator (PI) and Sub investigators- The PI has FULL responsibility for both the conduct of the study and the integrity of the research data. The PI manages other staff members to do trial related activities. When there is more than one investigator, all but the PI are the sub investigators 4. Monitor or Clinical Research Associate (CRA)- A designated individual to oversee the clinical investigation. The monitor acts as the main communication link between the site and the sponsor 5. Research Coordinator (RC) or Study Coordinator (SC)- An individual at the site responsible for certain procedures (as delegated by the Principal Investigator) and the administrative paper work related to the trial. The research coordinator or study coordinator is often a research nurse or study administrator. 6. Subject- The human patient participating in a clinical trial. This individual may be healthy or sick, depending on the phase of the trial.
Hypotheses Testing Steps:
1. State null and alternative hypotheses 2. State level of significance (0.05) -Shrinking from .05-.01 decreases type 1 error but increases type 2 error 3. Compute statistic 4. Determine critical region 5. Reject the null hypothesis if the test statistic falls in the critical region. Do not reject if it falls in the acceptance region 6. State conclusion
What are the top three reasons people participate in research?
1. altruism 2. contribute to science 3. self-interest
Role of the Clinical Research Coordinator (CRC)
1.) Generally works for, employed by the investigator and/or institution 2.) Interchangeable with study coordinators research coordinator, and/or research nurse 3.) Since the CRC role is not defined by FDA regulations, he/she generally is considered to work under the authority of the investigator 4.) The tasks for which a CRC is responsible must be delegated in writing from the Principle Investigator. May vary from site to site.
Sponsor/CRO responsibilities
1.) Recruit qualified investigators 2.) Develop a complete protocol for each trial 3.) Appropriately manage the trial 4.) Select competent CRA(s) to monitor the trial progress 5.) Ensure data is valid
Sponsor responsibilities - Investigator
1.) Recruit qualified investigators and obtain suitable documentation concerning their training and experience (therapeutic area & research) 2.) Secure a signed statement of intention from the investigators to comply with the Federal Regulations (FDA 1572 or Investigator Agreement) 3.) Provide detailed information to investigators concerning the properties of and risks associated with the study product 4.) Obtain the following from each investigator, prior to shipping any investigational product: IRB approval of the protocol and informed consent. Protocol approval/signature page.
Sponsor Responsibilities - CRAs
1.) Select competent monitors to conduct the initiation and closeout visits and to periodically monitor the progress of the trial 2.) Monitor all aspects of study performance to assure compliance with the protocol and good clinical practices (GCP) 3.) Conduct audits of recorded clinical data, preferably by direct comparison with original source documentation.
What is the impact factor for the most prominent journals such as Science, Nature, JAMA, The Lancet, and the New England Journal of Medicine? A. 5-6 B. 6-8 C. 8-10 D. 10 or greater
10 or greater
What percentage of Tennesseans live below the federal poverty line?
17%
Vaccination trials without consent on poor and vulnerable people led to research regulation in Prussia in _______.
1900
In what year did the Code of Federal Regulations establish Title 45 Part 46: Protection of Human Subjects?
1974
What year was the Belmont Report put into action?
1979
Reviewers usually provide how many sets of comments to the journal? A. 1 B. 2 C. 3 D. 5+
2
When can the sponsor begin new drug research in the US? What form is this?
30 days after the FDA has received the research application; Form FDA 1571
Full-length manuscripts for health science journals are usually limited to: A. 1000 words B. 2000 words C. 3000 words D. There is no limit in the number of words used on the manuscript
3000 words
The Tuskegee syphilis study lasted how many years?
40 years
In 37208 zip code, _____ % live below the federal poverty line.
46
What is the prevalence of periodontitis in USA?
47%
What is the prevalence of xerostomia?
5.5-46%
The standard expectation is that a study's analyses should have a power of what value or greater?
80%
The standard expectation is that a study's analyses should have a power of what value or greater? A. 60% B. 70% C. 80% D. 90%
80%
Assuming that α = 0.05, the null hypothesis is rejected when the p-value is: A. > 0.05 B. < 0.05 C. = 0.05 D. None of the above
< 0.05
Preprint
A PDF file of the corrected page proofs posted by a journal on their website prior to assigning the article to a particular issue of the journal.
Every paper should tell a "story" that has all of the following, EXCEPT: A. A beginning - the abstract B. A middle - the methods and results say what happen C. An end - the discussion provides a conclusion that ties all parts of the story together. D. All of the above are what every paper should have to tell a "story"
A beginning - the abstract
Annotated Bibliography
A bibliography that includes, at minimum, a full reference for the document being reviewed and a brief summary
Biosketch
A brief summary of a person's professional and educational accomplishments
Nominal Variables (Categorical Variables)
A categorical variable for which the responses have no inherent order or ranking
Binomial Variable
A categorical variable that has only two possible responses
Recursive Model
A causal analysis model in which all causal pathways are unidirectional
Nonrecursive Model
A causal analysis model in which causal pathways can be bidirectional
Structural Equation Modeling (SEM)
A causal analysis strategy that uses maximum likelihood estimation regression models to examine complex natural patterns
Path Analysis
A causal analysis strategy that uses regression models to examine causal patterns among variables, assuming a recursive model in which all causality
Variable
A characteristic that can be assigned more than one value
Open-Access Fee
A charge that authors pay to journals in order to make their articles freely available to online readers.
Page Fee/Charge
A charge that some journals mandate based on the number of pages in the final PDF of an article accepted for publication.
Submission Fee
A charge that some journals mandate for all manuscripts prior to review; paying the submission fee is not a guarantee of acceptance, and it is not refunded if a manuscript is rejected.
Voluntariness
A choice being made of a person's own free will.
Prospective Cohort Study
A cohort study that recruits participants because they have or do not have an exposure of interest and then follows them forward in time to look for incident cases of disease
KAP Survey
A common type of survey that asks participants about their Knowledge, Attitudes, and Practices
Précis
A concise one- or two-sentence summary of a research study's key finding.
Ecological Study
A correlational study that explores an environmental exposure, such as distance from the equator or level of air pollution.
Population-Based Study
A cross-sectional study, longitudinal cohort study, or other type of study that uses a random sampling method to generate a sample population that is representative of a general population.
Once eligible articles are identified for a systematic review study, the content of these articles is extracted into: A. A book B. An article C. A data extraction table D. None of the above
A data extraction table
Anonymized (Deidentified) Data Set
A data file that has been stripped of all potentially identifying information, such as names, contact information, national identity numbers, health insurance information, or facial photographs.
Kurtosis
A description of how peaked or flat a normal distribution is
Protocol
A detailed written research plan that describes all the processes and procedures that will be used during participant recruitment (if relevant), data collection, and analysis.
Expedited Review
A determination by an institutional review board (IRB) that a full review by the committee is not required because a minor change to a previously approved protocol is being requested or because a new protocol will not expose participants to risks greater than those encountered in ordinary daily life or during routine clinical examinations or procedures.
Exemption from Review
A determination by an institutional review board (IRB) that a research protocol does not require full IRB review because it involves the analysis of existing data, documents, or records or existing biological specimens that cannot be linked to individuals.
Full Review
A determination by an institutional review board (IRB) that the full committee must discuss a study protocol in order to ensure that the requirements for the protection of human subjects are met.
MeSH (Medical Subject Headings)
A dictionary used for searches in MEDLINE
Platykurtic
A distribution curve for a histogram that is relatively flat
Declaration of Helsinki
A document written by the World Medical Association in 1964 to provide ethical guidelines for clinicians conducting experimental studies.
Conflicts of Interest (COI)
A financial or other relationship could influence the design, conduct, analysis, or reporting of the study, or could appear to have caused bias.
A moderated discussion between 4 to 12 people that is led by a facilitator of a research team is known as: A. An in-depth interview B. A focus group C. An informal group discussion D. None of the above
A focus group
Mentorship
A formal or informal relationship in which an experienced mentor offers professional development advice and guidance to a less experienced mentee
All of the following ensure quality data entry except: -Training/certification of personnel -A good night's sleep Edit checks -Common elements for data entry -Regulated data entry procedures
A good night's sleep
Bar Chart
A graph represents categorical data using rectangular bars with lengths proportional to the values they represent
Boxplot (Box-And-Whisker Plot)
A graphical depiction of a numeric variable that displays the median, the interquartile range, and any outliers
Funnel Plot
A graphical display of the results of the studies included in meta-analysis that reveals the likelihood that publication bias has kept relevant studies with null results out of the formal literature
Forest Plot
A graphical display to present the results of a meta-analysis and the pooled statistic calculated from those results
Receiver Operating Characteristic Curve (ROC Curve)
A graphical plot of the true positive rate against the false positive rate for the different possible cutoff points of a diagnostic test
Population
A group (or subgroup) of individuals, communities, or organizations
Program
A group of projects.
Cohort
A group of similar people followed through time together
Normal Distribution (Gaussian Distribution)
A histogram with a bell-shaped curve with one peak in the middle
Correlation
A is related to B (nondirectional)
Certificate of Confidentiality
A legal document that protects the identity of participants in a study of sensitive topics from being subject to court orders and other legal demands for information.
Cover Letter
A letter that accompanies a submitted proposal or manuscript.
Letter of Intent (LOI), Letter of Inquiry, Pre-Posal
A letter to a funding agency representing a preliminary research plan so that the funder can review the initial plan before deciding whether to invite a full proposal to be written and submitted
Control Definition
A list of the eligibility criteria for inclusion in a comparison population
Regression
A makes change in B (directional)
All of the following are true statements about publishing a manuscript, EXCEPT: A. A manuscript has a high likelihood of being published if it is written in decent English B. Submitting the manuscript to a journal as soon as it is revised and polished is critical C. A manuscript has a high likelihood of being published even if the methods research methods are not rigorous and valid D. Additional revision will likely be required after the manuscript has been submitted for review in a journal
A manuscript has a high likelihood of being published even if the methods research methods are not rigorous and valid
Compartmental Model
A mathematical model in which each "individual" in the stimulated population exists in only one of several states at one time, but over time these individuals can move between states
Deterministic Models
A mathematical model in which the outcomes will be the same every time the model is run with the same inputs
SIR Models
A mathematical model of infection transmission that describes how the susceptible (s) individuals in a population may become infected (I) and then eventually recover (R) with immunity
Stochastic Models
A mathematical model with inputs that vary according to a probability distribution so the outcomes differ slightly every time the model is run
Internal Consistency
A measure of how well the items in a survey instrument measure various aspects of the same concept; can be assessed with Cronbach's alpha, KR-20, and other tests.
Mean
A measure of the average value of a variable that is calculated by adding up the values of all responses provided to a question and dividing the sum by the total number of individuals who answered the question
Median
A measure of the average value of a variable that is calculated by putting all the responses in order from least to greatest and finding the middle number
Effectiveness
A measure of the success of an intervention under real-world conditions
Spread (Dispersion)
A measure that describes the variability and distribution of responses to a numeric variable
Direct Age Adjustment
A method of age adjustment that can be conducted when age-specific health data are available for the populations being compared.
Indirect Age Adjustment
A method of age adjustment that can be conducted when age-specific health data are not available for the populations being compared.
Machine Learning
A method of data analysis derived from artificial intelligence in which a computer "learns" more about a data set by running and re-running many rounds of analysis
Participant Observation
A method of qualitative field observation in which a trained viewer enters the group under analysis as a member.
Conceptual Framework
A model that a researcher sketches out using boxes and arrows to illustrate the various relationships that will be evaluated during a study
Hierarchical Model (Multilevel Model)
A multilevel regression model that adjusts for different levels of exposure, such as for both census tract and county
Adverse Event
A negative reaction to an intervention during an experimental study or another bad outcome of research
Derived Variables
A new variable created during data analysis from a system variables in the data file
Observational Study
A non-experimental study in which participants are not asked to change their behavior
Before-and-After Study
A non-experimental study that measures the same individuals before and after an intervention so that participants can serve as their own controls
Purposive Sampling
A nonprobability-based sampling method that recruits participants for a qualitative study based on the special insights they can provide.
Convenience Population
A nonprobability-based source population selected due to ease of access to those individuals, schools, workplaces, organizations, or communities.
Leptokurtic
A numeric distribution curve that is very peaked
Interval Variables
A numeric variable in which "0" does not mean "nothing"
Ratio Variables
A numeric variable that can be plotted on a scale on which a value of zero indicates "nothing"
Continuous Variable
A numeric variable that can take on any value within a range
Discrete Variables
A numeric variable that is not continuous
Abstract
A paragraph-length summary of an article, chapter, or book
Control
A participant in a case-control study who does not have the disease being examined or a participant in a experimental study assigned not to receive the active intervention
Processing Fee/Charge
A per-article charge that some journals mandate prior to an accepted article being published; this may or may not make the article open access.
In which citation style is the first article cited referred to a reference number any time it is cited in the manuscript?
AMA style
In which citation style is the first article cited referred to a reference number any time it is cited in the manuscript? A. AMA style B. APA style C. MLA style D. ICMJE style
AMA style
Linear Regression
Able to predict future scores
A paragraph-length summary of an article, chapter, or book is known as a(n)? A. Abstract B. Summary C. Review D. Database
Abstract
The _________________ is the summary of the article. A. Introduction section B. Methods section C. Abstract D. Discussion section
Abstract
What section of the manuscript is used to thank individuals who did not earn coauthorship but who benefitted the study with their contributions? A. Title page B. Introduction C. Abstract D. Acknowledgments
Acknowledgments
CPT Codes
Acronym for Current Procedural Terminology codes.
EDPs
Acronym for exposures, diseases/outcomes, and populations, which can be combined to form study questions using a standard formal of "Is [exposure] related to [disease/outcome] in [population]?"
PPT
Acronym for person, place, and time, which are essential components of case definitions and descriptive epidemiology studies
What is Sampling?
Act, process, or technique of selecting a suitable sample, or a representative part of a population for the purpose of determining characteristics of the whole population.
Declaration of Helsinki
Adapted Nuremberg Code to Biomedical community
What type of question forces respondents to select answers that do not truly express their status or opinions/
Closed-ended questions
By the time the manuscript is written, there will be imperfections in the completed study that cannot be fixed. What could a researcher do in the manuscript to address these study imperfections? A. Fully explain the actual methods used B. Include a helpful set of references that support the results C. Honestly identify the limitations of the study D. All of the above
All of the above
Cross-sectional surveys measure: A. The prevalence of various demographic characteristics in a well-defined population B. The exposure histories of a well-defined population C. The disease states in a well-defined population D. All of the above
All of the above
Health science abstracts usually provide a brief description of: A.The study design B.The study population C.Key findings of the study D.All of the above
All of the above
Most exposures and outcomes used in correlational studies are in the form of: A. Each population must be assigned its own row in the spreadsheet B. Each exposure/outcome should be assigned its own column in the spreadsheet C. The data should be filled into the cells in each column so that they line up with the correct population D. All of the above
All of the above
Population health research objectives may include: A. Identifying and classifying new health problems. B. Determining risk factors for disease C. Evaluating the impact of health policies on health outcomes D. All of the above
All of the above
When checking the style and clarity of the paper the author should ensure that: A. Words are used carefully B. Sentences are concise and clear C. The voice of the manuscript is consistent D. All of the above
All of the above
When submitting an abstract, the conference organizing committee and other reviewers will: A. Rate the submitted abstracts B. Decide which researchers will be invited to present C. Select who will give an oral presentation or be part of a poster session D. All of the above
All of the above
Which of the following is NOT considered to be a special requirement for a case series study approach? A. All case series require approval by a research ethics committee B. Informed consent is needed from all study participants C. Research must carefully protect the identities of study participants D. All of the above are considered to be special requirements for a case series study approach
All of the above are considered to be special requirements for a case series study approach
Which is NOT an example of a type of population? A. Adults with diabetes B. Teachers with at least 10 years of classroom experience C. Non-governmental organizations working on issues related to HIV/AIDS in Uganda D. All of the above are examples of a type of population
All of the above are examples of a type of population
Which of the following is NOT an example of a manuscript formatting requirements addressed by a journal's author guidelines? A. Listing of the authors, word counts, key words and other information on the title page. B. Specification on if the abstract should be structured using the indicated subheadings or unstructured C. Preference for the labeling and formatting of the manuscript sections D. All of the above are examples of formatting requirements the journal's author guidelines will address
All of the above are examples of formatting requirements the journal's author guidelines will address
Which is an example of health abstract databases available from libraries via subscription? A. Embase B. ISI Web of Science C. MEDLINE D. All of the above are examples of health abstract databases
All of the above are examples of health abstract databases
An example of a placebo used in an experimental study is? A. A sugar pill B. An injection of saline solution C. A sham procedure D. All of the above are examples of placebos
All of the above are examples of placebos
All of the following are examples of reasons to avoid writing the research manuscript, EXCEPT: A. "I don't know how to write a scholarly paper" B. "I don't know what to do next" C. "I don't have time to write" D. All of the above are examples of reasons to avoid writing the research manuscript
All of the above are examples of reasons to avoid writing the research manuscript
Which is NOT an example of resources a researcher needs to consider when creating a research plan? A. Availability of individuals to contribute their time and expertise B. Accessibility to study participants C. Availability of statistical software D. All of the above are examples of resources to consider when creating a research plan
All of the above are examples of resources to consider when creating a research plan
All of the following are examples of spatial analysis that can be conducted using a Geographic Information System (GIS), EXCEPT: A. Identification of spatial disease clusters B. Determination of associations, if any, between social or physical environment and disease C. Estimation of distances between locations D. All of the above are examples of spatial analysis that can be conducted using GIS
All of the above are examples of spatial analysis that can be conducted using GIS
All of the following are examples of statistical tests that can be used to compare independent populations, EXCEPT: A. Independent-samples t-test B. Fisher's exact test C. Chi-square test D. All of the above are examples of statistical tests that can be used to compare independent populations
All of the above are examples of statistical tests that can be used to compare independent populations
Which of the following is an example of a study goal? A.To compare the levels of exposure or disease in two or more populations B.To identify possible risk factors for a particular disease in a population C.To examine the impact of a program or policy D.All of the above are examples of study goals
All of the above are examples of study goals
All of the following are examples of tests of physiological function, EXCEPT: A. Spirometry B. Electrocardiography (ECG) C. Audiometry D. All of the above are examples of test of physiological function
All of the above are examples of test of physiological function
A case series study approach might be useful for all of the following EXCEPT: A. Describing the characteristics and similarities of a group of individuals with the same signs and/or symptoms of disease B. Identifying new syndromes and refining case definitions C. Clarifying typical disease progression D. All of the above are factors for which case series might be a useful study approach
All of the above are factors for which case series might be a useful study approach
Which is NOT a responsibility of a poster presenter during a conference? A. Setting up the poster at the assigned time B. Being prepared with clips, pushpins, and tape for displaying the poster C. Taking down the poster at a specified time D. All of the above are the responsibility of the poster presenter
All of the above are the responsibility of the poster presenter
All of the following are true statements about selecting a target journal, EXCEPT: A. Identify one or more journals that could reasonably be expected to disseminate the research results B. Select a target journal early in the writing process C. Examine recent articles published in the target journal D. All of the above are true statements about selecting a target journal
All of the above are true statements about selecting a target journal
All of the following are typical contents of a research proposal, EXCEPT: A. Goals B. Methods and procedures (i.e. study design, source population) C. Timeline D. All of the above are typical contents of a research proposal
All of the above are typical contents of a research proposal
All of the following are part of the structure of a professional conference, EXCEPT: A. A plenary session where keynote addresses are given B. Poster session in which attendees can mingle while reviewing research posters C. Concurrent sessions in which multiple panels of oral presentations are held in different rooms D. All of the above are ways in which a conference is structure
All of the above are ways in which a conference is structure
Closed-Ended Questions
Allow a limited number of possible answers
What are the 2 main things a clinician needs to embark on a clinical trial?
Altruism and finances
Why was the Nuremberg code largely disregarded in America after 1947?
America felt like the Nuremberg code didn't apply to them because Americans would NEVER do anything that heinous. (yea right -__-)
Unstructured Abstract
An abstract that does not list section titles like Objective, Methods, Results, and Conclusion
Structured Abstract
An abstract that uses subheadings like Objective, Methods, Results, and Conclusion
IACUC
An acronym for Institutional Animal Care and Use Committee.
ICD Codes
An acronym for International Classification of Disease codes
LOINC Codes
An acronym for Logical Observation Identifiers Names and Codes, which are often used in laboratory records.
PICOT
An acronym for Patient/Population, Intervention, Comparison, Outcome, Timeframe, a framework that is helpful for developing clinical research questions and designing intervention studies
REC
An acronym for a research ethics committee, often referred to as an institutional review board (IRB).
DALY
An acronym for disability-adjusted life year, which is the sum of years of life lost (YLL) to premature death and years lived with disability (YLD) in burden of disease studies
EHRs
An acronym for electronic health records.
EMRs
An acronym for electronic medical records.
HRQOL
An acronym for health-related quality of life.
M&E
An acronym for monitoring and evaluation.
QALY
An acronym for quality-adjusted life year, which is commonly used in health economics to quantify population-level gains in health status
AUC
An acronym for the area under the curve of an ROC curve that displays the diagnostic accuracy of a test; values range from 0 to 1 with 1 indicating a perfect test
COREQ
An acronym for the writing checklist for Consolidated Criteria for Reporting Qualitative Research
CONSORT
An acronym for the writing checklist for Consolidated Standards of Reporting Trials (for randomized controlled trials)
PRISMA
An acronym for the writing checklist for Preferred Reporting Items for Systematic Reviews and Meta-Analyses
STROBE
An acronym for the writing checklist for Strengthening the Reporting of Observational Studies in Epidemiology
YLD
An acronym for years lived with disability in a population, a commonly used metric in burden of disease studies
YLL
An acronym for years of life lost to premature death in a population, a commonly used metric in burden of disease studies
FINER
An acronym reminding a researcher that a good research plan is feasible, interesting, novel, ethical, and relevant
Life Tables
An actual table that displays conditional and cumulative survival rates in a population
Which of the following statements is NOT considered to be a challenge when using already available data? A. Analysts are limited to exploring only the topics included in the original survey B. Analysts will always be able find someone who can answer questions about the procedures used for data collection during the research process C. Analysts have to trust that the data were collected using valid and standardized methods D. Data files are not often available for free to the researcher
Analysts will always be able find someone who can answer questions about the procedures used for data collection during the research process
Which is NOT an example of population-based research? A. Compare rates of acute lung diseases in several metropolitan areas and see whether the rates of disease are correlated with local air quality B. Determine whether survival following a breast cancer diagnosis is linked to the presence of certain genes C. Conduct a vaccine trial D. Analyze biochemical composition of selected foods
Analyze biochemical composition of selected foods
Which is NOT a question that should be asked when checking the style and clarity of the manuscript? A. Is the tone of the writing appropriate? B. Are all abbreviations introduced at first use? C. Are conclusions fully supported by the data? D. Is all punctuation correct?
Are conclusions fully supported by the data?
___________ is(are) the measurement of the size / composition of the human body. A. Anthropometry B. Vital signs C. Clinical examinations D. Biological specimens
Anthropometry
Protected Health Information (PHI)
Any information about an individual's health history or health status that by law must be kept confidential
Adverse event
Any unfavorable and unintended medical occurrence, including any abnormal sign symptom or disease temporally associated with the use of a medical treatment whether or not it is considered related to the medical treatment
Institutional Review Boards (IRBs)
Appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects
The responsibilities of the principal investigator in a clinical trial include all of the following except: -Ensuring that a clinical investigation is conducted according to the signed investigator statement for clinical investigations of drugs or medical devices, the investigational plan, and applicable regulations -Approving the sale of the drug -Protecting the rights, safety, and welfare of subjects under the investigator's care -Controlling drugs, biological products, and devices under investigation
Approving the sale of the drug
Conference Papers
Article-length research reports published in the proceedings of a conference
Misclassification Bias
Bias that occurs when participants are not correctly categorized, such as when some controls in a case-control study are incorrectly classified as cases
Nonresponse Bias
Bias that occurs when the members of the sample population who agree to be in the study are systematically different from nonparticipants.
Selection Bias
Bias that occurs when the members of the study population are not representative of the source population from which they were drawn
Investigational Product ("sometimes referred to as the study drug")
Biologics, medical devices, health and nutrition products tested in clinical trials to cure or relieve symptoms of disease
White Space
Blank areas between printed content on a page
PURPOSE OF RESEARCH HYPOTHESIS (2)
Directly tested during research process To compare against null hypothesis
_________________ is(are) physiological measurement(s) that can be accurately taken after minimal instruction. A. Anthropometry B. Basic vital signs C. Clinical examinations D. Biological specimens
Basic vital signs
Which of the following is a compendium of journals with problematic practices that provides helpful guidelines about evaluating questionable journals? A. The Red List B. Beall's List C. The Predatory Chronicles D. The Journal Citation Reports
Beall's List
The 1979 report establish the 3 basic principles of ethics in research is called:
Belmont report
Observer Bias
Bias occurs when an observer intentionally or unintentionally evaluates participants differently based on their group membership, such as systematically evaluating cases and controls in a case-control study differently
Allocation Bias
Bias that occurs as a result of non-random assignment of participants to experimental study groups
Ascertainment Bias
Bias that occurs when a study population is not representative of the source population.
Recall Bias
Bias that occurs when cases and controls in a case-control study systematically have different memories of the past
Non-Random Sampling Bias
Bias that occurs when each individual in the source population does not have an equal chance of being selected for the sample population.
Blind or Open Trial
Blind- an individual associated with the trial does not know if the subject is receiving an active investigational product, active known product, or an inherent placebo. This is done to prevent the bias that could result from people knowing which treatment is allocated to subjects. Single Blind- only one individual (the subject or the observer) does not know if the subject has received the active investigational product. The observer can include the investigator, sponsor, and CRO. Double Blind- Two individuals do not know the nature of the subject's treatment. The subject and observer do not know if the subject received active treatment or not Open- All parties involved know the identity of the subject's treatment
A type of tool used to identify an appropriate sample size goal is known as: A. Sample size calculator B. Sample size estimator C. Sample size program D. Both A and B
Both A and B
One of the most common sources of funding is: A. Internal grants B. External grants C. Gifts D. Both A and B
Both A and B
The person who is most involved in the writing of the manuscript is known as: A.The lead author B.The first author C.The senior author D.Both A and B
Both A and B
CRA vs. CRC
Both roles are vital in the product development process. The CRA is the first line representative of the sponsor of the trials (or its CRO). The CRA oversees the activities of the site personnel who are actually carrying out the clinical research. The CRC is the clinical trials implementation expert and works for the investigator and/or institution. The CRC orchestrates many activities involving the recruitment and participation of study subjects and managing the critical study documentation and data collection necessary for each investigation.
All of the following are true statements about categorical variables, EXCEPT: A. Categorical variables must be have at least four answer options B. Categorical variables can be ranked C. Categorical variables can be unordered D. All of the above are true statements about categorical variables
Categorical variables must be have at least four answer options
Nominal
Categorical, no hierarchy
Ordinal
Categorical, ranked/ hierarchy Freshman/sophomore
What training are all Meharry representatives involved in research required to take?
CITI training
CRA General Responsibilities
CRA may be part of a team that conducts some or all of the following activities: 1.) protocol and study document development 2.) identify and select investigators 3.) Participate in and conduct various types of monitoring visits 4.) Site management and/or administrative activities (ordering supplies, tracking essential docs) 5.) Source doc and CRF review to ensure full data review and accuracy prior to database closure 6.) Management and accountability of study drug/device at sites 7.) Coaching sites to meet enrollment and for protocol compliance 8.) Identification and documentation of monitoring findings
A __________________________________ is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
CRO(contract research organization)
Random-Digit Dialing
Calls made to a computer-generated list of unscreened telephone numbers.
Principal Component Analysis (PCA)
Can provide information about which items in an assessment tool might be redundant or unnecessary and can be removed.
Why sample? (3)
Can you effectively study a population? Sample allows for more control than population - Unless small population Lower costs and easier logistics
Convenience sampling (4)
Captive or easily sampled population Not random Weak representativeness E..g., Asking class to fill out a survey
___________________________ are designed to record data on each trial subject during the course of the trial as defined by the protocol. A CRF for each patient in the study must be completed and signed by the investigator and assessor. All the events that happened in the trial should be fully documented, including adverse reactions.
Case report forms
Comparing exposure histories of people with the disease and people without the disease is the goal for what type of study design? A. Case series B. Case-control C. Cohort D. Experimental
Case-control
What type of study approach uses Odds Ratio (OR) as a comparative statistical test? A. Cohort B. Case-control C. Experimental D. Both A and C
Case-control
Dichotomous Variables
Categorical variable with only two possible answers, usually "yes" and "no"
For what type of variables is it not possible to create a histogram or boxplot? A. Ratio variables B. Interval variables C. Ordinal variables D. Categorical variables
Categorical variables
CBER
Center for Biologics Evaluation and Research
CDRH
Center for Devices and Radiological Health
CDER
Center for Drug Evaluation and Research
CFSAN
Center for Food Safety and Applied Nutrition
CVM
Center for Veterinary Medicine
Nondirectional
Changing A does not predict change in B just looking at relationship
Nonparametric Tests
Chi Square Mann Whitney U Test
____________________ is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use.
Clinical Research
_________ is the justification for conducting a randomized controlled trial.
Clinical equipoise
A ________________ is a contract between a medical institution and the sponsor of a clinical trial (usually a pharmaceutical company). It defines the scope of work and formalizes the understandings between the parties and contains legal and financial terms related to the conduct of a clinical trial.
Clinical trial agreement (CTA)
What type of questions allows a limited number of possible answers to be listed in a questionnaire? A. Open-ended questions B. Free-response questions C. Close-ended questions D. None of the above
Close-ended questions
IRB Review Required (1981)
Committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. It assures that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study.
_______________ refers to what a typical person in the discipline would know about a particular topic. A. Common knowledge B. Professional knowledge C. Specific knowledge D. Required knowledge
Common knowledge
___________________ compare groups of participants by sex or age, by exposure or disease status, or by other characteristic. A. Review statistics B. Comparative statistics C. Relational statistics D. None of the above
Comparative statistics
Coercion
Compelling an individual to participate in a research study; this is a violation of the principles of autonomy and respect for persons.
Investigator Responsibilities - compliance
Comply with all other procedures as specified in the protocol, sponsor SOPs, and Good Clinical Practice (GCP)
The major advantage of what type of survey is that they eliminate the need for later data entry?
Computer-assisted surveys
The major advantage of what type of survey is that they eliminate the need for later data entry? A. In-person interviews B. Telephone interviews C. Postal surveys D. Computer-assisted surveys
Computer-assisted surveys
All of the following are details a researcher needs to keep in mind when preparing an oral presentation, EXCEPT: A. About 10 - 12 minutes will be available for the presentation for a 15-minute presentation time-slot B. About 12 to 20 slides are appropriate for a 10-12 minute presentation C. Computerized slides should attempt to reproduce the paper being presented D. Using images in place of words to represent a key message is appropriate
Computerized slides should attempt to reproduce the paper being presented
Using circles and arrows to visibly group related topics to clarify connections, then considering which of those broad areas might be worth exploring is a process known as which of the following? A. Brainstorming B. Snowballing C. Concept mapping D. Flow charting
Concept mapping
What is sketched out using boxes and arrows that illustrate the various relationships that will be evaluated during the study?
Conceptual framework
Which of the following is sketched out using boxes and arrows that illustrate the various relationships that will be evaluated during the study? A. Conceptual framework B. Theoretical framework C. Experimental framework D. Perceptual framework
Conceptual framework
Which of the following is a major function of an ethics review board? A. Conduct continuing review of long-term research projects B. Protect researchers by preventing them from engaging in activities that could cause harm C. Legally protect the researchers' institution from the liability that could occur as a result of research activities D. Protect the human subjects who will participate in observational or experimental studies or whose personal information will be examined by researchers
Conduct continuing review of long-term research projects
What is generally considered to be previews of works in progress and not final products like published journal articles?
Conference abstracts
Which of the following are generally considered to be previews of works in progress and not final products like published journal articles? A. Conference abstracts B. Oral presentations C. Peer reviews D. Poster presentations
Conference abstracts
In a few scientific subspecialties, which of the following is considered to be equivalent to peer-reviewed journals?
Conference papers
In a few scientific subspecialties, which of the following is considered to be equivalent to peer-reviewed journals? A. Abstracts B. Oral presentations C. Conference papers D. Poster presentations
Conference papers
A _____________ is a statistical estimate of how close to the population value a sample of a particular size is expected to be. A. Confidence interval B. Relative risk C. Odds ratio D. None of the above
Confidence interval
Which of the following is a statistical estimate of how close to the population value a sample of a particular size is expected to be?
Confidence interval
Which of the following is a statistical estimate of how close to the population value a sample of a particular size is expected to be? A. Chi-square statistic B. Confidence interval C. Study power D. p-Value
Confidence interval
Under which paradigm do researchers have a relativist perspective that considers reality for each individual to be a function of that person's lived experiences?
Constructivism
Under which paradigm do researchers have a relativist perspective that considers reality for each individual to be a function of that person's lived experiences? A. Post-positivism B. Critical theory C. Constructivism D. Transformative paradigm
Constructivism
A Pearson correlation coefficient (r) should be used to calculate a correlation when: A. Continuous variables are used B. Variables that assign a rank to responses are used C. Variables that have ordered categories are used D. None of the above
Continuous variables are used
Interval
Continuous/scaled (40 degrees-60 degrees)
Ratio
Continuous/scaled (w/ true zero) GPA
Which of the following usually requires that a particular deliverable, such as a commissioned report, be submitted to the funding agency by the end of the agreement?
Contract
Which of the following usually requires that a particular deliverable, such as a commissioned report, be submitted to the funding agency by the end of the agreement? A. Contract B. Internal grant C. External grant D. Solicited proposal
Contract
Controlled (comparative) or Uncontrolled Studies
Controlled- compares a minimum of two groups of subjects: subjects receiving the drug to be tested and a control group in which subjects will receive a comparator. A comparator can be an inactive compound (placebo) or a reference drug that is marketed for the same indication (active comparator) Uncontrolled- because clinical studies normally compare treatments, uncontrolled studies are very rare
Which is NOT an example of a probability-based sampling method used by a researcher to select a sample population? A. Simple random sampling B. Systematic sampling C. Convenience population D. Cluster sampling
Convenience population
The "story" the manuscript is telling should: A. Never be summarized in one or two sentences B. Contain a précis that summarizes the whole story in one compelling paragraph C. Convey a cohesive story D. None of the above
Convey a cohesive story
Appendices Parts (4)
Copies of instruments that will be used Results of pilot studies IRB application and letter of approval Timeline
What is the key statistical measure used when analyzing an ecological study? A. Numbers needed to treat B. Relative Risk C. Correlation D. None of the above
Correlation
When a study seeks to compare the average levels of exposure and disease in several populations, it is known as a(n)? A.Correlational (ecological) study B.Case series C.Cohort study D.Experimental study
Correlational (ecological) study
The __________________ is the person who will communicate with the journal and answer questions from readers after the paper is published. A. Principal investigator B. First author C. Corresponding author D. All of the above
Corresponding author
Even though most submissions are made via computer instead of by postal delivery, most online submission systems still expect which of the following to be uploaded? A. Proposal B. Abstract C. Cover letter D. Author guidelines
Cover letter
When using medical records as part of the data collection process for a case series, the researcher should: A. Be aware that information found in medical records is recorded for research purposes B. Create a questionnaire that guides the extraction of information from the medical records C. Remember that medical records will have all the information the researcher will like to know D. Keep in mind that less relevant signs and symptoms, patient comments, and clinicians' observations are always recorded on medical records.
Create a questionnaire that guides the extraction of information from the medical records
All of the following are methods to maintaining the confidentiality of any information study participants disclosed to researchers, EXCEPT: A. Safely store paper records, including informed consent statements, in a locked and secure room B. Destroy individually identifying information once the records are no longer needed and research ethics committee has approved of the secure of research-related documents C. Create computerized data files that include individually identifying information from study participants that could be accessed by anyone D. All of the above are methods of maintain the confidentiality of participants' records
Create computerized data files that include individually identifying information from study participants that could be accessed by anyone
Health researchers examine all of the following factors that contribute to health and to disease, illness, disability and death, EXCEPT: A. Developmental B. Socioeconomic C. Biological D. Environmental
Developmental
Heterogeneous
Different; dissimilar
The process of correcting any typographical or other errors in data files is known as: A. Data collection B. Data coding C. Data cleaning D. Data recoding
Data cleaning
Which of the following is the process of correcting any typographical or other errors in data files?
Data cleaning
Which of the following is the process of correcting any typographical or other errors in data files? A. Data capture B. Data cleaning C. Data recoding D. Data security
Data cleaning
_________________ refers to the entire process of record keeping. A. Data organization B. Data management C. Data storage D. Data sorting
Data management
Big Data
Data sets that are so large and complex that they require powerful hardware and special statistical software applications to analyze them.
Nonparametric Data
Data we don't expect to be distributed -Nominal or ordinal -distribution-free tests, no assumption of normal distribution -wider applications and are less difficult to complete
What type of programs typically offer two mechanisms for creating derived variables?
Database and statistical programs
What type of programs typically offer two mechanisms for creating derived variables? A. Database and spreadsheet programs B. Spreadsheet and statistical programs C. Database and statistical programs D. File comparison and database programs
Database and statistical programs
Which of the following are designed to be visually appealing to facilitate consistent entry of the acceptable responses for each question and to perform automatic skips between questions when such jumps are indicated on the survey instrument?
Database programs
Which of the following are designed to be visually appealing to facilitate consistent entry of the acceptable responses for each question and to perform automatic skips between questions when such jumps are indicated on the survey instrument? A. Database programs B. Spreadsheet programs C. Statistical programs D. File comparison programs
Database programs
Mortality
Death
Which of the following is the first step when designing an experimental study?
Decide on the intervention and eligibility criteria
Which of the following is the first step when designing an experimental study? A. Decide on the intervention and eligibility criteria B. Define what will constitute a favorable outcome C. Decide on what control is an appropriate comparison for the intervention D. Select the method for randomizing participants to an intervention or control group
Decide on the intervention and eligibility criteria
What is the first step to complete when using a systematic review approach? A. Decide what story the article will tell B. Decide on the specific objectives of the review C. Select inclusion and exclusion criteria for articles D. Select the search methods that will be used to find potentially relevant articles
Decide on the specific objectives of the review
What should a researcher do if his study participants are constantly calling because of getting incorrect information off of the internet?
Direct them to reliable sources of information
A study goal often includes all of the following EXCEPT: A.Exposure B.Direction C.Disease D.Population
Direction
One-tailed Test
Directional statement- All on one side
_______ was developed by the World Medical Association in 1965 and places interests of the research subject above society's interests.
Declaration of Helsinki: 6 iterations of revisions to update
What is the first step in conducting a cross-sectional survey?
Define a source population
Which of the following would be the first step in conducting a cross-sectional survey? A. Define a source population B. Develop a strategy for recruiting a representative sample C. Decide on methods to be used for data collection D. Describe the exposure and/or disease status in a population
Define a source population
________________ is an example of a method used in qualitative studies when the goal of the study is to identify areas of consensus and areas of contention among individual experts on a particular topic. A. Delphi method B. Socratic method C. Revealing method D. Recurring method
Delphi method
Request for Proposal (RFP), Request for Applications (RFA)
Describe the types of projects the selection committee will consider supporting
Descriptive Statistics
Describes data you have How does the data look? Center point or means?
Codebook
Describes each variable and specifies how the collected information will be entered into a computer database
Linear Correlation
Describes relationship between 2 or more variables or between 2 or more data sets Correlation is nondirectional -1.00 Perfect Strong negative correlation (minutes exercising goes up, anxiety goes down) 0 Weak negative and positive correlation +1.00 Perfect Strong positive correlation (one unit goes up, one goes down)
_____________ are used to describe the basic characteristics of study populations and other data sources A. Analytic statistics B. Descriptive statistics C. Related statistics D. None of the above
Descriptive statistics
Poster Sessions
Designated times at an academic or professional conference when researchers are available to talk about their posters with other attendees
What is the last point of the Nuremberg code?
During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
Simple random sampling (2)
Each member of the population has an equal and independent chance of being chosen The sample should be very representative of the population
Types of Sampling Probability
Each member of the population has an equal chance of being selected
The scientist that worked on the vaccine for smallpox is:
Edward Jenner
A(n) __________________ is a third variable that often represents biologically distinct groups of individuals who might experience different biological responses to various exposures. A. Effect modifier B. Confounder C. Lurking variable D. None of the above
Effect modifier
All of the following are ethical principles an investigator must take into consideration when planning and conducting an experimental study, EXCEPT: A. Equipoise B. Efficacy C. Nonmaleficence D. Distributive justice
Efficacy
The following are benefits of utilizing paper questionnaires when collecting data, EXCEPT: A. Allows for collection of data from large number of participants at one time B. Eliminates the need for later data entry C. Allows for the easy collection of signatures on informed consent statements D. Provides the researcher a paper back-up of the data
Eliminates the need for later data entry
Who was the research subject in the John Hopkins Hexamethonium study who developed a cough followed by respiratory failure and died within a month?
Ellen Roche: She died June 2, 2001.
Investigator Responsibilities - Subjects
Enroll the required number of qualified subjects and obtain informed consent from all subjects
Sponsor Responsibilities - study management
Ensure that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the product. Develop a complete protocol for each trial including detailed descriptions of the study plan and specific procedures. Ship investigational product only to investigators participating in the trial
All of the following are details a researcher needs to pay attention to when preparing a poster presentation, EXCEPT: A. Pay attention to the content of the poster B. Pay attention to the design of the poster C. Ensure the poster is not seen by any other person before the conference D. Ensure a good balance between text, images, and white space
Ensure the poster is not seen by any other person before the conference
Censoring
Ensuring that participants in a prospective or longitudinal study who leave the study early do not make further contributions to the person-time denominator used in survival analysis and other outcome evaluations
________ is genuine uncertainty on the part of the clinical investigator regarding the relative therapeutic merits of each arm in a clinical trial.
Equipoise
Nuremberg Code
Established the requirements for informed consent, absence of coercion, properly formulated scientific experimentation, and beneficence towards experiment participants.
Effect Size
Estimated value of a measure
Investigator Responsibilities - adverse events
Evaluate, manage and report adverse events
Efficiency
Evaluation of the cost effectiveness of an intervention that is based on both its effectiveness and resource considerations
Serious Adverse Events
Events that are serious, unexpected, and related or possibly related to participation in the research must be reported to the Sponsor, FDA and IRB in a timely manner. 1. Death or life-threatening 2. Hospitalization or prolonged hospitalization 3. Persistent or significant disability/incapacity 4. Congenital anomaly/birth defect
Understood Consent
Evidence that a potential study participant comprehends the study benefits, risks, and procedures and his/her rights as a study participant prior to agreeing to participate.
Internal Validity
Evidence that a study measures what is intended to measure
Health Research
Examines a broad spectrum of biological, socioeconomic, environmental, and other factors that contribute to the presence or absence of physical, mental, and social health and well-being.
Negative Likelihood Ratio (LR-) Test
Examines whether a new test is good at predicting the absence of disease
Positive Likelihood Ratio (LR+) Test
Examines whether a new test is good at predicting the presence of disease
What are the two primary types of research reviews?
Exempt from continuing review and full board reviews.
A(n) ______________ may be granted when the research involves the analysis of existing records or existing biological specimens that cannot be linked to individuals. A. Full review B. Expedited review C. Exemption D. Rejection
Exemption
After publication, what is the next goal of a research scientist?
Expand the research in a new but related direction
After publication, what is the next goal of a research scientist? A. Republish the same results B. Move on to a new course of study C. Expand the research in a new but related direction D. Mentor researchers with similar research goals
Expand the research in a new but related direction
Allowable Cost
Expenses that are approved for a funding grant or contract as opposed to items that are not acceptable according to terms of a grant or contract
Comparing outcomes in participants assigned to an intervention or control group is the objective for what type of study approach? A. Case-series B. Case-control C. Retrospective cohort D. Experimental
Experimental
What type of study approach is considered to be the 'gold standard' in assessing causality? A. Cohort B. Experimental C. Case-control D. Ecological
Experimental
Quasi-Experimental Designs
Experimental studies that assign participants to an intervention or control group using a non-random method
two classifications
Experimental: Explains how a researcher would manipulate a variable Measured: Describes how a variable will be measured
Which type of clinical study provides the lowest level of evidence?
Expert opinions
Research proposals that will be submitted for review to a research ethics committee need to include all of the following information, EXCEPT: A. Discuss the risks and benefits of the study B. Explain how study participants' information will be distributed to the public C. Disclose potential conflicts of interest D. Describe the expected study participants
Explain how study participants' information will be distributed to the public
Predatory Open-Acess Journals
Exploitative journals that charge authors hidden publication fees without providing the quality editorial and publishing services associated with legitimate journals.
The creation of fake data, such as creating a fictitious row of data in a spreadsheet for people who never completed a questionnaire or never participated in an experiment is referred to as which of the following? A. Fabrication B. Falsification C. Plagiarism D. Justification
Fabrication
Orphan Drug Act (1983)
Facilitates development of orphan drugs — drugs for rare diseases such as Huntington's disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States.
All of the following are considered to be formal sources of information that can be cited in a research report, EXCEPT: A. Official organization report B. Fact sheet C. Articles from peer-reviewed journals D. Book or book chapters
Fact sheet
A good way to begin writing the research report is by: A. Writing the protocol of the study B. Having the appropriate software to analyze the data C. Finding a model article and use it as a template to create an outline for what to cover on the paper D. None of the above
Finding a model article and use it as a template to create an outline for what to cover on the paper
For early career professionals, what is the first step in conducting scientific research? A. Developing a focused research question B. Identifying an area of original research C. Identifying a professor or other experienced researcher to serve as a mentor D. Finding one or more senior colleagues who are willing to serve as formal or informal mentors
Finding one or more senior colleagues who are willing to serve as formal or informal mentors
What is the 1st phase to clinical trials?
First human testing, few subjects, evaluate toxicity and dosage.
Longitudinal studies use what type of population in which all participants start the study at the same time and no one is permitted to join later?
Fixed population
Longitudinal studies use what type of population in which all participants start the study at the same time and no one is permitted to join later? A. Open population B. Limited population C. Fixed population D. Dynamic population
Fixed population
When study participants start the study at the same time, is known as? A. Dynamic population B. Fixed population C. Stationary population D. None of the above
Fixed population
Two-Dependent Sample T-Test
For pre and post tests Compares overall scores on pre versus overall score on post Testing effect is a limitation to this
_________________________ may be conducted if during the monitoring process a sponsor has continual documented accounts of possible noncompliance, data discrepancies or concerns over the ethical conduct of the study by the investigator.
Four-cause audit
Participants in the Tuskegee syphilis study received which 3 things for their participation?
Free meals, burial, medical exams
What is usually required when an intervention will be tested in individuals or a community, data will be collected through interaction with individuals, or identifiable private information will be collected?
Full review of the research proposal
Which of the following is usually required when an intervention will be tested in individuals or a community, data will be collected through interaction with individuals, or identifiable private information will be collected? A. Exemption from review of the research proposal B. Expedited review of the research proposal C. Abbreviated review of the research proposal D. Full review of the research proposal
Full review of the research proposal
External Grants
Funded by outside organizations
Internal Grants
Funds provided by the researcher's school or employer
Measures of Spread or Variation
Gives more info to go on from central tendency The degree of spread or variation among scores Ex. Did people perform similarly on the test or was there a wide range? Narrow spread Intermediate spread Wide spread Means are the same for all three, but spreads are different 1. Range 2. Standard Deviation/Variance 3. Standard Measures
Which is NOT a reason for attending an academic or professional conference? A. Meet new people working in the same field of interest B. Learn about what others are doing in the field C. Go on vacation D. Learn new methods or techniques in a discipline
Go on vacation
In which model of publishing do authors or their funders pay to make an article freely available to the public? A. Gold open access B. Green open access C. Gray open access D. Granted open access
Gold open access
Because many peer-reviewed journals are not included in the databases, especially journals in languages other than English, which search engine may be helpful for identifying additional relevant abstracts?
Google Scholar
Because many peer-reviewed journals are not included in the databases, especially journals in languages other than English, which search engine may be helpful for identifying additional relevant abstracts? A. SPORTDiscus B. Ovid C. Google Scholar D. LexisNexis
Google Scholar
Histogram
Graphical representation of the distribution of ratio/interval data in which the x-axis shows the values of responses and the y-axis displays the count of the number of times each response was given
What should provide enough information in the title, figure, and/or legend or key for a reader to be able to interpret it without reading the related portion of the text?
Graphs
Which of the following should provide enough information in the title, figure, and/or legend or key for a reader to be able to interpret it without reading the related portion of the text? A. Tables B. Graphs C. Maps D. Flowcharts
Graphs
Nondirectional Research Hypothesis
Groups are different, but direction is not specified
Haphazard Sampling
Haphazard sampling is a strategy that is almost guaranteed to introduce bias into your study. It should be avoided if possible.
Control Variable (2)
Has a potential influence on the dependent variable Best way to address control variables is through Random Assignment.
Extraneous Variable
Has an unpredictable impact on the dependent variable (not part of experiment)
Categorical Questions
Have as few as two options to dozens of possible answers
Which is a good starting point when selecting a research topic? A. Having a brainstorming session B. Refining research areas of interest C. Compiling a list of key words D. Both A and C
Having a brainstorming session
Recording responses to open-ended questions verbatim without rephrasing, paraphrasing, "correcting", or interpreting them is an example of what type of characteristic of well-trained interviewers?
Honest
Recording responses to open-ended questions verbatim without rephrasing, paraphrasing, "correcting," or interpreting them is an example of what type of characteristic of well-trained interviewers? A. Honest B. Careful C. Impartial D. Consistent
Honest
In order to ensure that clinical trial participants remain in the trial until completion, there should be:
Honest/respectful communication
R^2
How much variance that this model describes when you put variables together, how much is this actually explaining? Power? .58= .58% of variables are explained (pretty good)
Variance
How spread out the data is Wide range of age has more variance than a narrow range of age
Population-based studies are typically conducted using: A. Human subjects B. Animals C. Research facilities D. None of the above
Human Subjects
Which statistic is reported as a percentage from 0% to 100%, where higher percentages indicate a greater presence of heterogeneity? A. Kappa statistic B. Chi-square statistic C. Cochran's Q statistic D. I2 statistic
I2 statistic
Which of the following can be part of the case definition but is rarely sufficient to cover all inclusion and exclusion criteria on its own? A. ICD code B. Disease description C. Relevant person, place, and time characteristics D. Records from clinical locations
ICD code
The Committee that established authorship criteria in the health sciences that most journals have adopted is: A.ICMJE B.ICETS C.COHS D.None of the above
ICMJE
21 CFR 56
IRB must be established and operated in compliance with this
UC IRB Board (3)
IRB or Board Protect Human Research Participants Acts collectively
What would be performed by the researcher if existing data is going to be analyzed?
Identify an appropriate data source and supporting materials
Which of the following tasks would need to be performed by the researcher if existing data is going to be analyzed? A. Identify an appropriate way to sample and recruit participants B. Develop a questionnaire and other data collection tools C. Prepare an application for a research ethics review committee D. Identify an appropriate data source and supporting materials
Identify an appropriate data source and supporting materials
Cross-sectional surveys are used for all of the following EXCEPT: A. Evaluating programs B. Establishing baseline data prior to initiating longitudinal studies C. Assessing population needs D. Identifying new syndromes and refining case definitions
Identifying new syndromes and refining case definitions
All of the following are true statements regarding the characteristics of the journal that should be considered by the article author, EXCEPT: A. If the article is of a systematic review, make sure the journal accepts reviews B. If the article is more likely to surpass the 3000-3500-word limit, a journal with more flexible word limits needs to be identified C. The method of submitting the articles to the journal D. If the article is a short report, it will be accepted by any journal
If the article is a short report, it will be accepted by any journal
Discordant
In disagreement
Emic Perspective
In ethnography, a study that aims to develop an insider's view.
Etic Perspective
In ethnography, a study that aims to develop an outsider's view.
In what manner are authors generally listed on a manuscript? A. In alphabetical order B. In order according to level of education C. In order according to contribution to the project D. In reverse order according to contribution to the project
In order according to contribution to the project
Gift Authorship
Inclusion as a coauthor of someone who has not earned authorship according to disciplinary standards, such as those spelled out in the ICMJE authorship criteria
___________________________ help researchers find the most suitable candidates to participate in clinical trials. Participants cannot join a clinical study without satisfying them first.
Inclusion/exclusion criteria
What statistical test could be used to compare the mean ages of cases and controls participating in a case-control study? A. Independent samples t-test B. Fisher's exact test C. Chi-square test D. Kruskal-Wallis H test
Independent samples t-test
THE RELATIONSHIP BETWEEN INDEPENDENT AND DEPENDENT VARIABLES: (3)
Independent variable is not confounded - Levels do not vary systematically with other variables to explain dependent variable. Dependent variable is sensitive to changes in the independent variable Confounding variable - When variables compete to explain effects
Sample Population
Individuals from the source population who are invited to participate in a research study.
An interviewer who will be collecting data in a study should receive a comprehensive interviewer handbook that provides information about all of the following, EXCEPT: A. Purpose of the study B. Details about interview logistics C. Annotated script of the interview D. Information about individual study participants
Information about individual study participants
Drug Efficacy Study Implementation (1968)
Intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.
Critical reading involves asking a series of questions about what aspect of a study in order to ascertain how well a particular study was designed, conducted, interpreted, and reported and to assess how likely it is that the resulting paper presents the truth about a particular research question in a particular population at a particular place and time?
Internal validity
Critical reading involves asking a series of questions about what aspect of a study in order to ascertain how well a particular study was designed, conducted, interpreted, and reported and to assess how likely it is that the resulting paper presents the truth about a particular research question in a particular population at a particular place and time? A. Internal validity B. External validity C. Specificity D. Sensitivity
Internal validity
Study in which the participants undergo some kind of medical or surgical procedure, a new drug, or a lifestyle change are called:
Interventional (experimental) studies
What section of a paper in the health sciences should spell out the core question that the paper will explore and answer? A. Abstract B. Introduction C. Methods D. Discussion
Introduction
WHAT MAKES A GOOD HYPOTHESIS? (5)
Is stated in declarative form Posts a relationship between variables Reflects theory or literature Is brief and to the point Is testable
All of the following are questions that could be asked to check the structure and content of the paper, EXCEPT: A. Does the introduction make the research project appear necessary and important? B. Are the methods described in adequate detail? C. Is enough statistical analysis presented? D. Is technical jargon used?
Is technical jargon used?
Operational definition (3)
Is the means of showing what was done with respect to each variable Allows for replication The more ambiguous the variable, the more the need for a good operational definition
All of the following are true statements about the introduction section of an article, EXCEPT: A. It provides the background information that the reader must know to understand the methods and results of the article B. It often includes information about the study population C. It might include the results of the study being reported D. It may include a discussion of what is novel about the new study
It might include the results of the study being reported
An electronic database system is chosen for all of the following reasons except: -It is user friendly -It ensures privacy -It only works with the operating system of the research facility -It is economic (within budget)
It only works with the operating system of the research facility
The researcher who will do the majority of the work is defined as which of the following? A. Primary investigator B. Lead researcher C. Statistical consultant D. Mentor
Lead researcher
Coauthorship
Jointly authoring a research report with one or more collaborators
What commonly used type of cross-sectional study asks participants about their knowledge, attitudes, beliefs, perceptions, practices, and behaviors? A. KAP survey B. Repeated cross-sectional survey C. Longitudinal cohort survey D. Meta-analytical survey
KAP survey
Which of the following display cumulative survival rates in a study population? A. Log-rank tests B. Cox proportional hazards regression C. Kaplan-Meier plots D. Hazard ratios
Kaplan-Meier plots
What type of learners may find it helpful to take a long walk away from a computer and use that time to think through the story that needs to be written?
Kinesthetic learners
What type of learners may find it helpful to take a long walk away from a computer and use that time to think through the story that needs to be written? A. Oral learners B. Visual learners C. Kinesthetic learners D. Productive learners
Kinesthetic learners
Which of the following may be helpful for identifying the presence of a disease or markers for a disease? A. Tests of physiological function B. Laboratory analysis of biological specimens C. Medical imaging D. Clinical examination
Laboratory analysis of biological specimens
The core collaborators in the support team should include all of the following EXCEPT: A. Cultural expert B. Subject matter expert C. Laboratory technician D. Lead researcher
Laboratory technician
Which of the following is a key characteristic to watch out for when performing a case series study? A. Lack of specificity B. Lack of sensitivity C. Lack of generalizability D. Lack of validity
Lack of generalizability
All of the following are true statements about large sample sizes, EXCEPT: A. Large samples are usually better than small ones. B. The confidence interval will be narrower when the sample size is large. C. In large sample sizes, the mean is expected to be closer to the mean of the total population. D. Larger sample sizes make it less likely that a study will yield statistically significant results.
Larger sample sizes make it less likely that a study will yield statistically significant results.
What is the 3rd phase to clinical trials?
Larger study, fine-tuning efficacy data.
All of the following are true statements about regression models, EXCEPT: A. They seek to understand the relationship between one or more predictor variables and one outcome B. Linear regression is one of the most common types of regression C. Logistic regression models can be used when the outcome variable is a ratio or interval variable D. Logistic regression is commonly used in case-control studies
Logistic regression models can be used when the outcome variable is a ratio or interval variable
Participants of what kind of study are recruited based on membership in a well-defined source population?
Longitudinal cohort study
Participants of what kind of study are recruited based on membership in a well-defined source population? A. Historic cohort study B. Retrospective cohort study C. Prospective cohort study D. Longitudinal cohort study
Longitudinal cohort study
A researcher conducting a case series must do all of the following EXCEPT: A. Select one disease of interest B. Determine what will be new and interesting about the study C. Identify an appropriate and available source of cases D. Look at individuals with the disease and those without the disease
Look at individuals with the disease and those without the disease
1962 Kefauver-Harris Amendments Food, Drug and Cosmetic Act (4)
Looked at practices of pharmaceutical companies Had to prove safety and effectiveness Required more testing before widespread use Informed consent from patients receiving experimental drugs
Multivariate
Looks at many variables to see how they relate 2 IV's and 1 DV
Which database is sponsored by the U.S. National Library of Medicine and features only journals that have applied for inclusion and passed through a review process? A. LILACS B. MEDLINE C. SciELO D. EBSCO
MEDLINE
Which database is sponsored by the US National Library of Medicine and features only journals that have applied for inclusion and passed through a review process?
MEDLINE
The most important decision an investigator can make when selecting a topic for a review article is to: A. Make the topic as general as possible that all relevant publications can be acquired B. Make the topic narrow enough that all relevant publications can be acquired C. Ensure that only other review articles are examined D. Ensure that the topic is narrow enough to only find a few articles on the topic
Make the topic narrow enough that all relevant publications can be acquired
What is the first step in the editing process?
Making sure the big picture message is being clearly communicated
Which of the following is the first step in the editing process? A. Making sure the big picture message is being clearly communicated B. Making sure the paper has a clear storyline C. Making sure the title of the paper reflects the key message of the study D. Making sure the introduction overtly asks the main research question
Making sure the big picture message is being clearly communicated
Which of the following is NOT one of the three main principles in biomedical research ethics? A. Beneficence B. Autonomy C. Maleficence D. Distributive justice
Maleficence
What type of matching approach is common in genetic studies that link each case to a genetic sibling or another close genetic relative for analysis?
Matched-pairs matching
What type of matching approach is common in genetic studies that link each case to a genetic sibling or another close genetic relative for analysis? A. Frequency matching B. Group matching C. Matched-pairs matching D. Contingency matching
Matched-pairs matching
Boolean Operators
Mathematical and logical search operators such as AND, OR, and NOT
What is the name of the database that is helpful in narrowing the scope of your research?
MeSH
Which database, developed by the U.S. National Library of Medicine, can be helpful in narrowing the scope of the research area? A. ISI Web B. MeSH C. HELLP D. CINAHL
MeSH
Which of the following are the two main threats to the validity of a meta-analysis?
Poor quality of included studies and publication bias
Declaration of Helsinki (2)
Medical research involving human participants must conform to generally accepted scientific principles Must be good research design
Which is NOT a method to report the 'average' response to a variable in a study population? A. Mean B. Median C. Medium D. Mode
Medium
All of the following are examples of vulnerable populations, EXCEPT: A. Prisoners B. Individuals with severe mental health disorders C. Children D. Men
Men
A _____________ creates a summary statistic for the results of systematically identified articles. A. Meta-analysis B. Systematic review C. Literature review D. Secondary study
Meta-analysis
Which of the following study designs is used under the 'tertiary analysis' approach? A.Ecological B.Cross-sectional C.Meta-analysis D.Experimental
Meta-analysis
Which section of a research article can often be written even before data collection begins?
Methods
Which section of a research article can often be written even before data collection begins? A. Introduction B. Methods C. Results D. Discussion
Methods
Which section of a paper in the health sciences provides all necessary clues for answering the main research question and demonstrates that those observations are valid, sufficiently comprehensive, and reasonably unbiased?
Methods and results
Which section of a paper in the health sciences provides all necessary clues for answering the main research question and demonstrates that those observations are valid, sufficiently comprehensive, and reasonably unbiased? A. Abstract B. Introduction C. Methods and results D. Discussion
Methods and results
Which of the following is NOT considered to be a source of data for secondary analysis studies? A. Clinical records B. New data collected by the researcher conducting the study C. Governmental organizations D. All of the above are considered to be sources of data for secondary analysis studies
New data collected by the researcher conducting the study
Qualitative data (how something happens rather than what happens) is:
Nominal
The most basic form of data measurement that divides information into categories is called:
Nominal
Skips
Non applicable questions that are jumped over in interviews because of the response to a previous question
When using random sampling as a method of selecting a sample population, what type of bias should the researcher be most concerned with? A. Ascertainment bias B. Non-random sampling bias C. Non-response bias D. All of the above are biases a researcher should avoid when using random sampling
Non-random sampling bias
Spearman Rank Order Correlation
Nonparametric Determines relationship between 2 ranked variables
Researchers attempting to generate a random sample from the source population need to avoid what type of bias that could occur if each individual in the source population does not have an equal chance of being selected for the sample population? A. Nonrandom sampling bias B. Ascertainment bias C. Nonresponse bias D. Convenience bias
Nonrandom sampling bias
Direct sponsor-IRB contacts
Not prohibited although interactions are customarily through the investigator. Device trials have more interaction between the sponsor and IRB relating to sending annual reports and Investigator Brochures. Investigator should always be apprised of any communication with IRB.
Provisional Acceptance
Notification from a journal that a final acceptance will be granted once minor adjustments to the manuscript are submitted.
The _______________ describes the expected result of a statistical test if there is no difference between the two values being compared. A. Null hypothesis B. Alternative hypothesis C. p-value D. Test
Null hypothesis
Inferential Statistics
Observation of sample from a population Unlike descriptive data analysis Generalizations can be made from the sample to the respective population (assuming random sampling) 2 Types: 1. Estimation of Parameters 2. Hypotheses Testing
Investigator Responsibilities - IRB approval
Obtain IRB approval of study protocol and informed consent before the study starts and keep the IRB informed of study progress
Publication Bias
Occurs when all articles with statistically significant results are more likely to be published than those will null results
Non-probability sampling (3)
Occurs when samples are chosen using other than random selection Some segment of the population could be under or over represented Decreases generalizability of study
The key statistical measure for case-control studies is: A. Prevalence B. Correlation C. Odds Ratio (OR) D. Risk Ratio (RR)
Odds Ratio (OR)
What is the measure of association that readers will expect to be reported for a case-control study?
Odds ratio
Which of the following is the measure of association that readers will expect to be reported for a case-control study? A. Odds ratio B. Chi-square C. Confidence interval D. p-value
Odds ratio
Homogeneous
Of a similar kind
Sponsor arranging non-local IRB
Often sponsor may arrange this to consider at the beginning of a trial. Often sponsor sends protocols, amendments and safety info directly to the IRB for all investigators but this is not automatic, the CRC and CRA should be sure to verify if these arrangements have been formally agreed upon.
Secondary data collection might become labor intensive if which of the following have to be retrieved, read, coded, and entered into a database? A. Questionnaires B. Abstracts C. Full-text journal articles D. Old hospital charts
Old hospital charts
Nuremberg Doctors Trial of 1946
On December 9, 1946, an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity.
At what point is the research manuscript sent to a copyeditor, who checks the paper carefully for grammar, spelling, and adherence to the journal's style? A. Immediately following peer review B. Once the paper has been formally accepted C. Once the article has been assigned an issue D. Once the article has been published in print
Once the paper has been formally accepted
At what point is the full research cycle complete? A. Once the paper has been formally accepted B. Once the article has been assigned an issue C. Once the article has been published in print D. Once the published article has been cited for the first time in another article
Once the published article has been cited for the first time in another article
Nuremberg Code
One of the first codes of research ethics, which in 1947 mandated voluntary consent for experimental studies of humans.
Randomized Controlled Trial (RCT)
One of the most common experimental study designs in the health sciences
Creative Commons (CC) Licenses
One option for allowing a research article to be freely available for others to use while the authors retain the copyright and are credited for their work.
A case report describes: A. One patient with a disease condition B. Two or more patients with the same disease condition or who have undergone the same procedure C. People with the disease and people without the disease D. None of the above
One patient with a disease condition
Monitoring
Ongoing assessment to ensure that a project or program is staying on track.
All of the following are true statements about online journals, EXCEPT: A. Some printed journals also offer their articles online to subscribers B. Open-access journals are free for authors and readers C. Some online-only journals are legitimate and are indexed in relevant databases D. Some online-only, open access journals have a reputation for not having rigorous review standards
Open-access journals are free for authors and readers
Developing an "elevator pitch" that tells the main lesson learned from the project in 30 seconds can greatly assist researchers who process their thoughts in which manner?
Orally
Developing an "elevator pitch" that tells the main lesson learned from the project in 30 seconds can greatly assist researchers who process their thoughts in which manner? A. Orally B. Verbally C. Kinesthetically D. Intellectually
Orally
The ordering of points on a numerical scale in which the distance between points is known is called:
Ordinal
Variables that organize responses from first to last or from best to worst are known as: A. Ratio variables B. Interval variables C. Nominal variables D. Ordinal variables
Ordinal variables
All of the following are criteria listed under the Uniform Requirements for Manuscripts Submitted to Biomedical Journals that each coauthor must have meet EXCEPT: A.Substantial contribution to conception, design and/or data acquisition, analysis, or interpretation of the data B.Organization of the list of authors as they should appear on the manuscript C.Drafting the manuscript and/or revising it critically D.Final approval of the version of the manuscript to be published
Organization of the list of authors as they should appear on the manuscript
Declaration of Helsinki (4)
Originally developed in 1964 Six revisions since was developed by the World Medical Association (WMA) set of ethical principles for the medical community regarding human experimentation It is widely regarded as the cornerstone document of human research ethics
All of the following are the primary goals of research ethics committees, EXCEPT: A. Protect the 'human subjects' who will participate in observational or experimental studies or whose personal information will be examined by researchers B. Oversee research carried out on animals C. Legally protect the researcher's institution from the liability that could occur as a result of research activities D. Protect researchers by preventing them from engaging in activities that could cause harm
Oversee research carried out on animals
Pearson Product-Moment Correlation
Parametric Most precise/common coefficient of correlation Raw score equation
A benefit of what is that it helps ensure that the article being cited has been understood?
Paraphrasing
A benefit of which of the following is that it helps ensure that the article being cited has been understood? A. Quoting B. Referencing C. Paraphrasing D. Plagiarism
Paraphrasing
Method Parts (4)
Participants Research design Data collection plans - Operational definitions - Reliability and validity of instruments - Results of pilot studies Proposed analysis of data
Think-Aloud Protocol, Talk-Aloud Protocol
Participants in a qualitative study are asked to describe their thoughts and actions while they complete a task.
Information Bias
Participants or assessors are able to evaluate outcomes differently based on the results they expect for an exposure
All of the following are true statements about recruiting study participants, EXCEPT: A. One goal of recruiting a study population is to recruit as many members of the sample population as possible B. Participation rates will be lower if study recruits understand the importance and value of the research project C. Random-digit dialing can be used as a way to recruit study participants D. Participating is higher if multiple invitations and opportunities to participate are available
Participation rates will be lower if study recruits understand the importance and value of the research project
Which of the following uses regression models to examine causal patterns among variables, assuming a recursive model in which all causality is unidirectional? A. Path analysis B. Structural equation modeling C. Survival analysis D. Analysis of covariance
Path analysis
Vital Signs
Physiological measurements such as body temperature and blood pressure.
All of the following are categories of cohort studies, EXCEPT: A. Retrospective cohort B. Planned cohort C. Prospective cohort D. Longitudinal cohort
Planned cohort
For continuous variables and other variables with responses that can be plotted on a number line, what is used to calculate correlation?
Pearson correlation coefficient
For continuous variables and other variables with responses that can be plotted on a number line, which of the following is used to calculate the correlation? A. Pearson correlation coefficient B. Spearman rank-order correlation C. Kendall's rank-order correlation D. Linear regression models
Pearson correlation coefficient
A new author's best opportunity for publishing clinical data comes from:
Peer review journal
What can be viewed as an opportunity to receive expert and constructive feedback about a draft report?
Peer-review process
Which of the following can be viewed as an opportunity to receive expert and constructive feedback about a draft report? A. Question and answer sessions B. Oral presentations C. Peer-review process D. Poster presentations
Peer-review process
Formal Sources
Peer-reviewed journal articles and reports that are appropriate to cite in formal research reports
In a case-control study, 'cases' are: A.People without the disease B.People with the disease C.People with the exposure D.People without the exposure
People with the disease
Waiver (of consent documentation)
Permission from an institutional review board not to collect signed consent forms from participants because they could be harmed by being able to be linked to participation in a study on a sensitive topic.
Informed Consent
Permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits. 1. Research study purpose 2. Risks/Benefits 3. Alternative treatments 4. Confidentiality of records 5. Medical treatment available if injury occurs 6. Whom to contact for answers to questions 7. Statement that participation is voluntary
What is the highest cost associated with interviews?
Personnel
Which of the following is the highest cost associated with interviews? A. Postage B. Personnel C. Data entry D. Photocopying
Personnel
Who is the man who wrote a letter to the director of Venereal Disease Division showing concern for the ethics and morality of the Tuskegee syphilis study?
Peter Buxtun
In what phase of clinical research do researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects?
Phase I
In what phase of clinical research is the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety?
Phase II
In what phase of clinical research is the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely?
Phase III
In what phase of clinical research are studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use?
Phase IV
Which approach to gather and interpret qualitative data seeks to understand how participants understand, interpret, and find meaning in their own life experiences and feelings?
Phenomenology
Which approach to gather and interpret qualitative data seeks to understand how participants understand, interpret, and find meaning in their own life experiences and feelings? A. Phenomenology B. Grounded theory C. Ethnography D. Critical theory
Phenomenology
Which of the following calculates the correlation between two binomial variables? A. Spearman's rho B. Kendall's tau C. Phi coefficient D. Cramér's V
Phi coefficient
Estimation of Parameters
Point Estimation Interval Estimation Confidence Intervals
_______________ is related to the ability of a statistical test to detect significant differences in a population when differences really do exist. A. Power B. Errors C. Size D. None of the above
Power
Which of the following is normally submitted by the researcher so that the funder can confirm that there is a reasonable match between the sponsor and the proposed research plan before inviting a full proposal to be written and submitted?
Preproposal
Which of the following is normally submitted by the researcher so that the funder can confirm that there is a reasonable match between the sponsor and the proposed research plan before inviting a full proposal to be written and submitted? A. Request for applications B. Preproposal C. Solicited proposal D. External proposal
Preproposal
The _______________________ was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
Prescription Drug User Fee Act
Testability
Present when the research question includes components that can be measured and examined
The most common way to report results for a cross-sectional survey is simply to report which of the following? A. Incidence rate B. Prevalence rate C. Morbidity rate D. Mortality rate
Prevalence rate
A cross-sectional survey is also known as a(n): A. Ecological study B. Cohort study C. Prevalence study D. Case-control study
Prevalence study
What type of research/study approach is used when data are newly collected and analyzed? A.Primary B.Secondary C.Tertiary D.None of the above
Primary
Defining the study question and identifying partners is the first step in planning what type of analysis?
Primary analysis
Defining the study question and identifying partners is the first step in planning what type of analysis? A. Primary analysis B. Secondary analysis C. Tertiary analysis D. Systematic review
Primary analysis
Which study approach gives the researcher control over items like selection of a source population, and the content and wording of a questionnaire? A.Primary studies B.Secondary studies C.Tertiary studies D.Every type of study
Primary studies
In which type of study will data be collected from individuals?
Primary study
What is defined as the assurance that individuals get to choose what information they reveal about themselves?
Privacy
Which of the following is defined as the assurance that individuals get to choose what information they reveal about themselves? A. Privacy B. Autonomy C. Confidentiality D. Authority
Privacy
Reconciliation
Process of resolving any discrepancies between the researcher's financial records and the reports produced by the institution hosting the researcher's grant/contract accounts
Quota sampling (2)
Proportional stratified sampling is desired but not possible Participants with the characteristic of interest are non-randomly selected until a set quota is met
A ____________ is usually a request for funding or supervisory approval. A. Project B. Protocol C. Proposal D. Program
Proposal
Comparing the rates of new (incident) disease in people with different exposure histories is the goal of what type of study approach? A. Case-control study B. Cross-sectional study C. Prospective Cohort study D. None of the above
Prospective Cohort study
What type of study design should be used to investigate an exposure that is relatively uncommon but a source of exposed individuals is available?
Prospective cohort study
What type of study design should be used to investigate an exposure that is relatively uncommon but a source of exposed individuals is available? A. Time-series study B. Panel study C. Longitudinal cohort study D. Prospective cohort study
Prospective cohort study
The Code of Federal Regulations, 1974, Title 45 Part 46 regulations what?
Protection of Human Subjects
The __________________ explains the exact procedures that will be used for every step of the research process. A. Proposal B. Project C. Protocol D. Program
Protocol
Matching
Protocols for recruiting one or more controls who are demographically similar to each case in a case-control study or recruiting one or more unexposed individuals who are demographically similar to each exposed person in a cohort study
In what ways can businesses and employers address health disparities?
Provide opportunities for workplace prevention activities (preventive screenings) and partner with local resources to enhance employees' ability to identify and use reliable health information.
Food, Drug & Cosmetic ACT (1938)
Provided for three kinds of food standards: 1) standards (definitions) of identity 2) standards of quality 3) standards regulating the fill of container
Committee on Publication Ethics (COPE)
Provides guidance on how to avoid research misconduct during the dissemination phase of a research project.
International Committee of Medical Journal Editors (ICMJE)
Provides guidelines about manuscript formatting and authorship criteria that are widely used in health sciences
Which of the following is the most important, publicly available, health science database? A. PsycINFO B. ISI Web of Science C. PubMed D. CINAHL
PubMed
What type of projects might use data mining and computational linguistics to explore social media events?
Public health informatics
What type of projects might use data mining and computational linguistics to explore social media events? A. Health informatics B. Bioinformatics C. Clinical informatics D. Public health informatics
Public health informatics
All of the following are true statements about publicly available data, EXCEPT: A. Entire data sets might be immediately available to download from an agency's website B. If a screening process is in place, researchers will need to submit a request form to use the data C. Publicly available data set files are always available for free D. Access to some data files might be limited to the citizens or residents of the country in which the data was collected
Publicly available data set files are always available for free
What type of study approach looks for the themes and meanings that emerge from the observation and evaluation of a situation or context? A. Qualitative B. Case-control C. Quantitative D. Experimental
Qualitative
Narrative Inquiry
Qualitative research that examines autobiographies, personal letters, family stories, and other records to understand how people frame their identities and social relationships.
Action Research
Qualitative research that is designed to allow participants to work together to solve a problem.
All of the following are types of evaluative research, EXCEPT: A. Program evaluation B. Needs assessment C. Cost-effectiveness analysis D. Quantitative analysis
Quantitative analysis
All of the following are true statements about questionnaires, EXCEPT: A. Questionnaires must include questions confirming that participants meet the eligibility criteria for the study. B. Questionnaires must be able to place study participants into key categories. C. Questionnaires should not include questions about factors influencing the relationship between exposures and outcomes. D. Length of the questionnaire should be considered
Questionnaires should not include questions about factors influencing the relationship between exposures and outcomes.
All of the following are true statements about paraphrasing information from articles being cited in a research report, EXCEPT: A. Paraphrasing helps ensure that the article being cited has been understood B. Paraphrasing requires citation of the original source C. Quotation marks need to be used when paraphrasing D. An in-text citation must be provided when paraphrasing
Quotation marks need to be used when paraphrasing
Cluster sampling (2)
Random sampling of a population which is similar in characteristics, yet heterogeneous - E.g. : selection of 30 pharmacy schools - E.g.,: selection of 30 pediatrician offices to survey attitudes toward info on immunizations Very effective for narrowing specific research interests
A study in which people are allocated by chance alone to receive one of several clinical interventions. One of these interventions is the standard of comparison or control.
Randomized control study
The highest level of evidence in a clinical study comes from which type of research?
Randomized control study
Confidence Intervals
Range of possible values. 95% sure mean of population will fall within this interval.
For what type of questions must decisions be made about how many entries to include on a scale and whether there will be a neutral option? A. Open-ended questions B. Closed-ended questions C. Categorical questions D. Ranked questions
Ranked questions
A scale with a defined distance between points with an absolute zero is called:
Ratio
Variables that are classified to have numeric responses plotted on a scale on which a value of zero stands for 'nothing', is known as: A. Ratio variables B. Interval variables C. Nominal variables D. Ordinal variables
Ratio variables
All of the following are true statements about conducting a systematic review, EXCEPT: A. A systematic review may involve searching two or more databases B. A systematic review may involve looking up every article cited in an included article to try to fully capture the entire published literature C. A system for identifying eligible articles must be in place D. Reading the abstracts alone is sufficient to determine the final eligibility of an article
Reading the abstracts alone is sufficient to determine the final eligibility of an article
When cases and controls systematically have different memories of the past, this is known as: A. Recap bias B. Recall bias C. Response bias D. Misclassification bias
Recall bias
What is the major limitation when using existing clinical records? A. Data are difficult to extract. B. Data are protected by the Health Insurance Portability and Accountability Act. C. Records are often incomplete D. Records require signed release from the patient.
Records are often incomplete
Overmatching
Recruiting challenges and possible statistical bias resulting from matching cases and controls, or exposed and unexposed participants, on too many characteristics
All of the following are options for matching cases and controls in a case-control study, EXCEPT: A. No matching B. Frequency (group) matching C. Matched-pairs (individual) matching D. Recurrent matching
Recurrent matching
All of the following are true statements about articles used as a reference in a research report, EXCEPT: A. References should be carefully selected to support the importance, validity, and conclusion of the study B. References can be used to acknowledge the alternative methodological approaches that could have been used C. References can be used to identify areas in which new findings agree with existing literature D. References could be used to contradict the new study findings
References could be used to contradict the new study findings
Hypothesis (2)
Reflects the general problem under study Restates the general problem in a form that is precise enough to allow testing
The key statistical measure for cohort studies is? A. Relative risk B. Odds ratio C. Prevalence D. Correlation
Relative risk
Retraction
Removal of a published article from the accepted scientific literature due to major errors or author misconduct.
What type of study method is used for many of the largest studies conducted by the U.S. Centers for Disease Control and Prevention? A. KAP survey B. Repeated cross-sectional survey C. Longitudinal cohort survey D. Meta-analytical survey
Repeated cross-sectional survey
What type of study method is used for many of the largest studies conducted by the US Centers for Disease Control and Prevention?
Repeated cross-sectional survey
All of the following are true statements about the information that should be included in the methods section of an article, EXCEPT: A. Methods used to identify, sample, and recruit study participants should be described B. Methods used for data collection should be described, including interviewing techniques C. Identify who collected the original data and how they were collected D. Report a summary of key study findings
Report a summary of key study findings
You must renew your protocol to continue research activities before it expires by submitting a _________.
Report of Progress
To look for a health science abstract in PubMed one can use all of the following search methods EXCEPT: A. Keywords B. MeSH terms C. Boolean operators D. Reprise operators
Reprise operators
All of the following are true statements about revising and resubmitting a manuscript, EXCEPT: A. Responding to reviewer's comments is necessary B. Some journals require a version of the manuscript that highlights the changes made in the document in the resubmission C. Repsonses to reviewers' comments should be prepared in the same file as the manuscript D. A new cover letter should be enclosed with the revised manuscript
Repsonses to reviewers' comments should be prepared in the same file as the manuscript
Kefauver-Harris Amendment (1962)
Required drug manufacturers to prove scientifically that a medication was not only safe, but effective.
Which statements about correlational studies is FALSE? A. Uses population-level data to look for associations between two or more group characteristics. B. It is also known as an ecological study. C. Existing data sources are almost always used for this type of study. D. Requires the collection of data from individual study participants.
Requires the collection of data from individual study participants.
Investigating a new subject to learn more about the world is called:
Research
The process of systematically and carefully investigating a subject in order to learn or discover new information about the world is known as? A. Epidemiology B. Health C. Research D. None of the above
Research
A Gantt chart can be very helpful for visually displaying which of the following? A. Research policy B. Research protocol C. Research timeline D. Research outline
Research timeline
All of the following are true statements about using incentives to increase study participation rate, EXCEPT: A. Researchers may offer a small gift to study participants (i.e. bar of soap) B. Researchers may offer a substantial gift to all study participants (i.e. a new car) C. Researchers may provide treatment for certain conditions examined in the study D. Researchers may enter all questionnaire respondents into a drawing for a more substantial gift (i.e. $100 gift certificate to a local restaurant)
Researchers may offer a substantial gift to all study participants (i.e. a new car)
Which is an example of a type of exposure? A. Socioeconomic status B. Depressive disorders C. Near drowning D. Poisonings
Socioeconomic status
Which of the following typically spells out expectations and procedures for disclosing conflicts of interest, avoiding research misconduct, reporting research ethics or personal violations, and otherwise exhibiting professionalism? A. Advance directives B. Informed consent C. Certificate of confidentiality D. Responsible conduct of research training programs
Responsible conduct of research training programs
Nuremberg Code History (4)
Resulted from the Nuremberg Military Tribunals, 1949 In response to Concentration Camp prisoners Doctors in 1947 argued no difference between legal and illegal experiments Nuremburg code and Declaration of Helsinki basis for Code of Federal Regulations (CFR)
When preparing slides for an oral presentation, the greatest number of slides should be dedicated to which area of content?
Results
When preparing slides for an oral presentation, the greatest number of slides should be dedicated to which area of content? A. Research goal B. Background C. Methods D. Results
Results
Which section of a research article should start with a description of the study population that clearly identifies the sample size and the demographics of the participants? A. Introduction B. Methods C. Results D. Discussion
Results
______________ section should start with a description of the study population that clearly identifies the sample size and the demographics of the study participants. A. Introduction B. Methods C. Results D. Discussion
Results
Investigator Responsibilities - study documents
Retain and make study documentation available to sponsor representatives and FDA inspectors for data verification purposes
What type of cohort study establishes baseline information from birth records, school records, medical files, occupational records, or other sources that may be decades old? A. Prospective cohort study B. Retrospective cohort study C. Longitudinal cohort study D. Generational cohort study
Retrospective cohort study
All of the following are examples of approaches used in qualitative research to gather and interpret data, EXCEPT: A. Phenomenology B. Grounded Theory C. Ethnography D. Retrospectivity
Retrospectivity
A main role of IRBs is to determine the ______________________________ for clinical studies. They must make sure that the physical risk is not disproportionate to the benefits.
Risk-to-benefit ratio
Which of the following should always be the top priority when designing and implementing an experimental study? A. Safety B. Efficacy C. Sensitivity D. Specificity
Safety
___________ population is the group of individuals that are asked to participate in research studies. A. Target B. Source C. Sample D. Study
Sample
All of the following are components of a detailed research plan for a researcher collecting new data from individuals, EXCEPT: A. Develop a questionnaire and other data collection tools B. Screen abstracts and full-length articles for eligibility C. Prepare an application for a research ethics review committee D. Identify an appropriate way to recruit participants
Screen abstracts and full-length articles for eligibility
What type of research/study approach is used when existing data are used and analyzed? A.Primary B.Secondary C.Tertiary D.None of the above
Secondary
When studies analyze existing clinical records, survey data, or population data rather than collecting new information from study participants, this is known as: A. Primary analysis B. Secondary analysis C. Tertiary analysis D. None of the above
Secondary analysis
In which type of study will an existing data set be analyzed statistically?
Secondary study
The timeline for what type of study might be very short if an entire data file and the relevant supporting documentation can be downloaded from a website? A. Primary study B. Secondary study C. Tertiary study D. Quaternary study
Secondary study
The goal of a qualitative study is to: A. Synthesize existing knowledge. B. Seek to understand how individuals and communities perceive and make sense of the world and their experiences. C. Compare exposure histories in people with the disease (cases) and people without the disease (controls). D. Describe a group of individuals with a disease.
Seek to understand how individuals and communities perceive and make sense of the world and their experiences.
The systematic review process requires all of the following, EXCEPT: A. Identification of an appropriately narrow study question B. Selection of a semi-structured strategy C. Screening for all potentially relevant articles to determine whether they meet the predefined eligibility criteria D. Extraction of relevant information from all eligible articles
Selection of a semi-structured strategy
Range
Simplest measure of variation Takes into account what the extremes are and not the bulk of observations Difference between highest and lowest scores Usually used as a descriptor (79%-92%)
When the sample size is __________ , the sample mean may be _________ the mean in(to) the total population. A. Small, far from B. Small, close to C. Large, far from D. Large, close to
Small, far from
What is defined as looking up every article cited by eligible articles in order to identify other articles that might be relevant but not indexed in the selected databases?
Snowballing
Which of the following is defined as looking up every article cited by eligible articles in order to identify other articles that might be relevant but not indexed in the selected databases? A. Brainstorming B. Snowballing C. Plagiarizing D. Validating
Snowballing
NULL HYPOTHESIS
States that there is no relationship between the independent and dependent variables under study
Bivariable Analysis
Statistical analyses such as rate ratios, odd ratios, and other comparative statistical tests that examine the relationship between two variables
Univariate Analysis
Statistical analysis that describes one variable in a data set
Survival Analysis
Statistical evaluations of the distributions of the durations of time and individuals in a study population experience from an initial time point (such as the time of enrollment in a study or the time of diagnosis of a particular condition) until some well-defined event, which can be death, discharge from a hospital, or some other outcome
Weighting
Statistical methods used to adjust for sampling methods, for demographic differences between a population and a source population, for varying sample sizes in a meta-analysis, or for other circumstances
Multivariable Analysis
Statistical tests such as multiple regression models that examine the relationships between three or more variables
All of the following are true statements about conducting a meta-analysis, EXCEPT: A. Statistics from similar studies can be pooled even if the studies have different population groups or different interventions B. Pooling several unadjusted (crude) odds ratios may be appropriate C. Before pooling the data, the researcher must show that the results of the studies are comparable D. A random effects model is required when the test of heterogeneity show that the included studies are dissimilar
Statistics from similar studies can be pooled even if the studies have different population groups or different interventions
Which of the following models have inputs that vary according to a probability distribution, so the outcomes differ every time the model is run? A. SIR models B. Compartmental models C. Deterministic models D. Stochastic models
Stochastic models
Which of the following is NOT a step a researcher can take to regain motivation to continue writing the research manuscript? A. Changing habits or scenery when writing the manuscript B. Stop writing for a long period of time to not get bored with the writing process C. Setting a time line for completing small parts of the paper D. Build in rewards that celebrate those intermediate successes on the way to the completed paper
Stop writing for a long period of time to not get bored with the writing process
All of the following are true statements about acquiring/using private data sets, EXCEPT: A. Access to a private data set is most likely to be granted if the new researcher has some connection to the original researcher B. When privately held data are shared with a new investigator, the original researchers usually expect to be coauthors on any resulting publication C. Individual researchers or small research teams may have data available that have not yet been analyzed and therefore could be acquired by a new researcher D. Students are less likely to get privately owned data from their professors to conduct their own research
Students are less likely to get privately owned data from their professors to conduct their own research
Nested Case-Control Study
Study that uses the participants of a large longitudinal cohort study as the source population for both cases and controls in a case-control study.
Randomization
Subjects assigned to active or other treatments based on some random criteria or by chance. This is done to prevent the bias associated with the investigator having a choice in the treatment selected for the subject.
Milgram's Study of Obedience to Authority (5)
Subjects coerced into feeling they had seriously injured somebody Prod 1: Please continue or Please go on. Prod 2: The experiment requires that you continue. Prod 3: It is absolutely essential that you continue. Prod 4: You have no other choice, you must go on.
Sample
Subset of population. Few college students from different schools measures of central tendency.
Self-Administered Surveys
Survey forms that participants complete for themselves, either using a paper-and-pencil version or an online version.
Predictive Validity
Survey instrument validity demonstrated when a new test is correlated with subsequent measures of performance in related domains.
Construct Validity
Survey instrument validity demonstrated when a test measures the theoretical construct the test is intended to assess.
Criterion Validity, Concrete Validity
Survey instrument validity demonstrated when an established test is used as a standard for confirming the utility of a new test that examines a similar theoretical construct.
Face Validity
Survey instrument validity demonstrated when content experts and users agree that a survey instrument will be easy for study participants to understand and correctly complete.
Concurrent Validity
Survey instrument validity demonstrated when participants in a pilot study complete both an existing test and a new test and the correlation between the test results is strong.
Content Validity, Logical Validity
Survey instrument validity demonstrated when subject matter experts agree that a set of survey items captures the most relevant information about the study domain.
Discriminant Validity
Survey instrument validity demonstrated when two indicators that the construct says should not be related are shown not to be associated.
Convergent Validity
Survey instrument validity demonstrated when two indicators that the underlying theory says should be related are shown to be correlated.
Open-Ended (Free Response) Questions
Survey or interview questions that allow an unlimited number of possible answers
Which of the following is NOT an example of an additional assessment that can be conducted as a way to supplement self-reported information during the data collection process? A. Vital signs B. Test of physiological function C. Physical fitness tests D. Surveys
Surveys
Which of the following examines the distribution of the durations of time that individuals in a study population experience from an initial time point until some well-defined event, which can be death, discharge from a hospital, or some other outcome? A. Path analysis B. Structural equation modeling C. Survival analysis D. Analysis of covariance
Survival analysis
______________ examines the distribution of the durations of time that individuals in a study population experience from an initial time point until some well-defined event. A. Spatial analysis B. Survival analysis C. Regression D. Confounder
Survival analysis
Writer's Block
Sustained struggles with writing that an author might experience due to fear of failure or other barriers to productivity.
Advance Access
The availability of a research manuscript on a journal's website prior to the assignment of that article to a particular issue of the journal.
Narrative Review
Tell a story about a topic using evidence from the literature to support the "plot"
Ordinary Differential Equations (ODE)
Term used to described the flows between compartments in mathematical models
Role of the Clinical Research Associate (CRA)
Terms used interchangeably: CRA, monitor and Site Manager. Generally works for, employed by the sponsor or CRO. Roles may be in-house or field based. Designated by the sponsor to monitor the progress of a clinical investigation. Encompasses much more than the actual process of "monitoring" partnering with sites to complete the study accurately, on time, and efficiently.
Systematic reviews and meta-analyses are considered to be what type of study: A. Primary B. Secondary C. Tertiary D. None of the above
Tertiary
In which type of study will existing literature be reviewed?
Tertiary study
What type of study revolves around a thorough review of existing literature?
Tertiary study
What type of study revolves around a thorough review of existing literature? A. Primary study B. Secondary study C. Tertiary study D. Quaternary study
Tertiary study
What is the 2nd phase to clinical trials?
Tests efficacy and safety profile with small numbers.
Sensitivity Analysis
Tests with robustness of statistical methods and results
Stratified Sampling (3)
That people in the population differ systematically along some characteristic? And this characteristic relates to the factors being studied? Then stratified sampling is one solution
Who are CRAs?
The FDA requires that a CRA be qualified by training and experience. They may be nurses, scientists, engineers, pharmacists, etc. (medical or non-medical backgrounds). They need not be a person qualified to diagnose and treat the disease or condition for which the IP is under investigation.
Central Tendency
The average value for numeric variables, such as a mean or median
Denominator
The bottom number in a ratio; that is, the "B" in the ratio "A/B"
Target Population
The broader population to which the results of a study should be applicable.
___________ was the first international code of research ethics established in 1947.
The Nuremberg code
African Americans are reluctant to participate in clinical trials because of:
The Tuskegee experiment
Discrimination
The ability of a statistical model to distinguish between independent groups
Power (statistical)
The ability of a statistical test to detect significant differences in a population when differences really do exist; ___ is increased when the number of participants included in the analysis is large.
Excess Risk (Attributable Risk) (AR)
The absolute difference between the incidence rates in two independent populations
Endmatter
The acknowledgments of funders, disclosures about possible conflicts of interest, author and contributor information, and other details that some journals place between the end of the main text of an article and the start of the reference list
Secondary Study
The analysis of an existing data set or existing health records
All of the following are required steps when completing a review article EXCEPT: A.An extensive search of the literature B.The extraction of key information from relevant articles C.The clear and concise presentation of information D.The analysis of data
The analysis of data
Health Informatics
The application of advanced techniques from information science and computer science to the compilation and analysis of health data.
A codebook should specify all of the following, EXCEPT: A. The name of each variable B. The wording of the question that was asked C. The appropriate answer for each question D. The variable type
The appropriate answer for each question
Originality
The aspects of a new research project that are novel and will allow it to make a unique contribution to the health science literature
Privacy
The assurance that research participants get to choose what information they reveal about themselves.
All of the following information should be included in the cover letter that accompanies the manuscript being submitted for review, EXCEPT: A. The importance of the research B. The author's and coauthor's work experience C. The validity of the research D. The fit of the manuscript to the journal
The author's and coauthor's work experience
Generalizability
The external validity of a study that allows its results to be considered applicable to a target audience
Discussion Section
The final section of a typical four-part scientific report, which compares the new finding to the prior literature on the topic, acknowledges the limitations of the study, and summarizes the implications and conclusions of the study
Introduction Section
The first section of a scientific report, which presents foundational theories, provides critical definitions, and spells out the study goals; also called a background section
FDA Major Program Centers
The five divisions of the FDA responsible for reviewing and approving new products.
The most important consideration(s) when deciding which data collection approach to use in a primary study is(are)? A. Cost B. The goals of the study and expectations of the sample population members C. Time D. Potential barriers to participation for study participants
The goals of the study and expectations of the sample population members
Maximum
The greatest (highest) numeric value for a variable in a data set
Literature Review Parts (4)
The importance of the question asked The current status of the topic The relationship between the literature and problem statement Summary
Anonymity
The inability of the identity of a participant to be identified from his/her responses to a survey instrument or records in a database
Ecological Fallacy
The incorrect assumption that individuals follow the trends observed in population-level data.
Study Population
The individuals who participate in a study.
Spreadsheet
The interactive computer application that organizes and stores data in table form
Target Journal
The journal a researcher intends to submit a manuscript to first.
Minimum
The least (lowest) numeric value for a variable in a data set
External Validity
The likelihood that the results of the study with internal validity can be generalized to other populations, places, and times
Study Goal
The main research question that a research project seeks to answer
Efficacy
The measure of the success of an intervention that calculates the proportion of individuals in the control group who experienced an unfavorable outcome but could have been expected to have a favorable outcome if they had been in the active group instead
Outcome
The measured endpoint in an experimental study or an observed event such as the onset of incident disease in a cohort study
Anthropometry
The measurement of the human body, such as the measurement of height, weight, waist circumference, and hip circumference.
Mode
The most common answer given by respondents to a particular question
Incidence Rate Ratio (IRR)
The most common measure of association for cohort studies, this ratio comparison incidence rate among the exposed true the incidence rate in the unexposed
Significant Figures
The number of digits in a number that are presented after a decimal point
Incidence Rate
The number of new cases of disease in a population during a specified period of time divided by the total number of persons in the population who are at risk during the period
Number Needed to Harm (NNH)
The number of people who would need to receive a particular treatment in order to expect that one of them would have a particular adverse outcome
During the manuscript's submission process to a journal, some journals will require all of the following information, EXCEPT: A. The number of tables included in the manuscript B. Statements about ethics approval, funding, conflict of interest, and authors contributions C. The word count of the manuscript D. The number of words on the title page
The number of words on the title page
test value
The numerical value obtained from a statistical test
Secondary Analysis
The researcher conducting the statistical analysis does not have any contact with the individuals whose data is being examined
Primary Investigator (PI)
The researcher who accepts principal responsibility for a research project, guaranteeing that the protocol is being followed, the budget is properly managed, and any adverse outcomes are immediately reported to the institution's research ethics committee.
An OR = 1 means: A. The odds of exposure is higher in cases B. The odds of exposure is higher in controls C. The odds of exposure is the same for cases and controls D. None of the above
The odds of exposure is the same for cases and controls
DEPENDENT VARIABLES (5)
The outcomes of a research study Depend on the experimental treatment The variable that is predicted to The outcome variable (consequent) Influenced by the independent variable
Diagnostic Accuracy
The percent of participants who were either true positives or true negatives
Prevalence Rate
The percentage of the population with a given trait at the time of the study
First Author (Lead Author)
The person who was the most involved in writing a manuscript
Demography
The scientific study of population characteristics.
Methods Section
The second section of a scientific report, which presents details about the processes used for data collection and analysis
Direct Costs
The specific monetary expenses associated with a particular research project
Protocol
The plan for conducting the trial. Includes the objectives, design, procedures, and statistical methods to be used. Includes: -type of trial design -duration of the subject participation -discontinuation criteria -description of the investigational product -justification for the dose and route of administration -trial population -inclusion, exclusion, and withdraw criteria -all procedures related to the trial -the safety and efficacy assessment parameters -procedures for recording and reporting adverse events -statistical methods
The person accepting the responsibility for guaranteeing that the protocol is followed, adverse outcomes are immediately reported to the ethics committee, and the budget is properly managed is known as: A. The primary investigator B. The investigator in charge C. The boss D. The senior researcher
The primary investigator
Conditional Probability
The probability of an event (B) occuring given that some prior event (A) has already occurred; for example, the probability of surviving to age 95 (B) given that one has already survived to age 90 (A)
Cumulative Probability
The probability of an event occurring by the end of a particular observation period
Introduction Parts (6)
The problem statement A rationale for the research Statement of the research objectives Hypothesis or Hypotheses Definition of terms Summary
Closeout
The process by which it is determined that all applicable administrative actions and all required work for an award have been completed by the grantee
Interviews
The process of a researcher verbally asking a participant questions and recording the person's responses.
Data Cleaning
The process of correcting any typographical or other errors in data files
Data Mining
The process of examining big data sets to identify patterns and new knowledge.
Brainstorming
The process of gathering long lists of spontaneous ideas about possible research questions
Data Security
The process of protecting computer files with passwords and other mechanisms for restricting unauthorized access and use
Research
The process of systematically and carefully investigating a subject in order to discover new insights about the world
Recoding
The process of using one or more variable in a database to create a new derived variable
Proportionate Mortality Rate
The proportion of deceased members of a population whose death was attributable to a particular cause
Attributable Risk Percent (AR%)
The proportion of incident cases among the exposed people in a cohort study that are due to the exposure
Mortality Rate
The proportion of members of a population who die of any condition during a specified time period
Sensitivity
The proportion of people who actually have the disease who test positive using the new test
Specificity
The proportion of people who do not have the disease who test negative with the new test
Case Fatality Rate
The proportion of persons diagnosed with a specific disease who die from that disease
Negative Predictive Value (NPV)
The proportion of those who test negative who actually do not have the disease
Positive Predictive Value (PPV)
The proportion of those who test positive with the new test who actually have the disease
Confidentiality
The protection of personal information provided to researchers.
Interquartile Range (IQR)
The range for the 25th to 75th percentiles, which captures the middle 50% of responses
Hazard Ratio
The ratio of two hazard functions, such as comparison of the durations of time to an event (such as death) in two populations
Desk/Bench Rejection
The rejection of a manuscript from a journal without external peer review.
Causality
The relationship in which an exposure directly causes an outcomes; presence of it is usually determined with both quantitative analysis and a qualitative consideration of causal theory using the Bradford Hill criteria
Institutional Review Boards (IRBs)
The research ethics committees responsible for protecting human subjects who participate in research studies.
Project Narrative
The research goals and methods spelled out in a research plan or proposal
Tuskegee Experiments
The study initially involved 600 black men - 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients' informed consent. Researchers told the men they were being treated for "bad blood," a local term used to describe several ailments, including syphilis, anemia, and fatigue. In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.
Epistemology
The study of knowledge and the nature of how an investigator knows what is real and true.
Epidemiology
The study of the distribution and determinants of health and disease in human populations
Ontology
The study of the nature of being, becoming, existence, reality, or truth.
House Style
The style sheet or guide used by a particular journal or publisher to dictate the requirements for spelling, citation style, and other formatting details.
Program Evaluation
The systematic collection and analysis of information to answer questions about the effectiveness and efficiency of a project, program, or policy.
Ethnography
The systematic study of people and cultures.
Results Section
The third section of a typical four-part scientific report, which contains key finds with text as well tables and/or figures
Cutpoint
The threshold for recording a numeric variable into categories
Numerator
The top number in a ratio; that is, the "A" in the ratio "A/B"
Simple Randomization
The use of a coin toss, a random number generator, or some other simple mechanism to randomly assign each individual in an experimental study to one of the exposure groups
Mixed Methods
The use of both qualitative and quantitative techniques in one research study.
Bioinformatics
The use of computer technologies to manage biological information.
Plagiarism
The use of other people's ideas, words, or images without proper attribution.
Coding (of qualitative data)
The use of words or short phrases to briefly summarize the contents, attitudes, processes, or other aspects of each item in a transcript or other qualitative document.
Point Estimate
The value of a statistic in a study population, which is typically presented along with a corresponding 95% confidence interval that provides additional information about the likely value of the statistic in the source population
What is the first point of the Nuremberg code?
The voluntary consent of the human subject is absolutely essential.
Informed Consent
The voluntary decision of an individual to participate in a research study after reviewing essential information about the project.
Participants in a case-control study are selected based on: A. Their disease status B. Their exposure status C. Both exposure and disease status D. None of the above
Their disease status
In a retrospective cohort study, study participants are recruited based on: A. Their exposure status B. Their disease status C. Their disease and exposure status D. Their disease history
Their exposure status
Which of the following is NOT a characteristic of formal scientific reports? A. They are published in a popular magazine, newspaper or website B. They describe the study design and explain why it was appropriate for the objectives of the study C. They explain how exposures and outcomes were defined and assessed D. They discuss the limitations of the study
They are published in a popular magazine, newspaper or website
Purpose of inferential statistics
To infer to a larger population to make comparisons between data Random sampling is CRITICAL
The purpose of the IRB (2)
To protect the rights and welfare of individuals who serve as participants of research conducted by researchers. To ensure institutional compliance with those ethical considerations contained in the Code of Federal Regulations (45 CFR 46).
Data collection includes all of the following except: -Voice recordings -Video recordings -Notetaking/data entry -Transmission/note storage
Transmission/note storage
All of the following are methods to analyze experimental studies, EXCEPT: A. Number needed to treat (NNT) B. Efficacy C. Number needed to harm (NNH) D. Treatment-given approach
Treatment-given approach
INDEPENDENT VARIABLES (5)
Treatments or conditions under control of the researcher (indirect or direct control) Levels—at least two different values of the independent variable must be present Also called the predictor variable A condition, intervention, or characteristic that will predict or cause a given outcome It is manipulated by the researcher
VARIABLES
Variables are a class of outcomes that can take on more than one value The more precisely a variable is measured, the more useful the measurement is
Ordinal Variables (Ranked Variables)
Variables for which responses are ranked from best to worst, most to least, or other scales
Moderator Variable
Variables related to independent or dependent variables, and hiding the true relationship between independent and dependent variables
Between-group variance
Variance between JMU and ODU
Within-group variance
Variance within JMU itself
Standard Deviation/Variance
Variance: The average distance from the mean in squared units Standard Deviation is the square root of the variance (brings variance to regular units) Increased variance/SD, increases variability
The Nuremburg Code (3)
Voluntary consent of the human subject is absolutely essential Results should be for good of society Results should be based on the results of animal experimentation
Informal Sources
Websites, fact sheets, newspapers, and other source of information that are not peer-reviewed and should generally not be cited in formal research reports
Total-group variance
What ANOVA takes into account
A needs assessment answers what question?
What is the health status of this population?
A needs assessment answers which of the following questions? A. What is the health status of this population? B. What are the threats to health in this population? C. How good are we at preventing, diagnosing, and treating health concerns in the populations in which we serve? D. Was this intervention successful at improving the health status in this population?
What is the health status of this population?
What is the primary study question to ask when conducting a cross-sectional survey? A. What are the key characteristics of the cases in this study population? B. What is the prevalence of the exposure and/or disease in the population? C. Do cases and controls have different exposure history? D. None of the above
What is the prevalence of the exposure and/or disease in the population?
All of the following are true statements about data entry, EXCEPT: A. Data can be entered into a database program like Microsoft Access B. When entering data on Microsoft Excel each variable data should be entered on a row C. Database and spreadsheet files can be uploaded into standard statistical software programs for analysis D. It may be worth doing double-entry of at least 10% of the completed surveys to check the accuracy of data entry
When entering data on Microsoft Excel each variable data should be entered on a row
When should the present tense be used in reports, papers, and presentations?
When referencing established knowledge and when referencing work you are currently reporting
When should the Narrative Review approach be used? A. When the goal is to describe a new perspective on a topic that can be supported by the existing literature. B. When the goal is to compare the findings of previous studies on a well-defined topic. C. When the goal is to summarize previous findings using pooled statistics. D. When the goal is to write a report on the information found.
When the goal is to describe a new perspective on a topic that can be supported by the existing literature.
All of the following are ways a researcher can begin writing a research report if s/he is not sure where to begin, EXCEPT: A. Include relevant information about the methods used in the research from the study's protocol in the working document B. Fill the names of the people to thank in the acknowledgement section C. Include a working title for the paper at the beginning of the document D. Write the entire manuscript in one sitting
Write the entire manuscript in one sitting
What can create a negative thought cycle that can be difficult to break?
Writer's block
Which of the following can create a negative thought cycle that can be difficult to break? A. Reviews of peers B. Flaws in the study C. Writer's block D. Language barriers
Writer's block
A way for an investigator to become an expert in the literature on a well-defined topic is by: A. Writing a review article B. Describing the goals of the study C. Identifying a research question D. None of the above
Writing a review article
Most topics in population based research can be expressed in terms of which formula? A. [disease/outcome] and [exposure] in [population] B. [exposure] and [population] in [disease/outcome] C. [exposure] and [disease/outcome] in [populations] D. None of the above
[exposure] and [disease/outcome] in [populations]
Master Action Plan (MAP)
a living document containing all the current information about the conduct of a study. defines how the project will be run and defines trial conduct
Sample
a representative subset of the population
Null Hypothesis
a statement describing the expected result of a statistical test if there is no difference between two or more values being compared
Assumptions
a thing that is accepted as true or as certain to happen, without proof
The researcher's hypothesis is called the ________.
alternative hypothesis
Skewness
an asymmetric distribution in which a histogram extends farther from the peak on one side than the other, exhibiting left-skewness or right-skewness
ICH-E6 Good Clinical Practice (GCP) (1997)
an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
The objectives of population health research include all of the following except: -create a new disease -identify new health problems -determine risk factors -evaluate health policies
create a new disease
between subjects
comparison of independent groups of subjects tested
w/in subjects
comparison of the same subjects repeated measures one group of people tested multiple times
If there is a confidentiality risk you must have a documentation of ______.
consent
Pre- Clinical Testing (non- clinical testing)
consists of laboratory testing in tubes and animals to determine the compound's expected safety, activity, and pharmacological properties.
Multivariate Analysis of Covariance (MANCOVA)
controls for potential confounders when comparing multiple dependent variables
A measure of the strength or linear relationship between two variables is the ___________.
correlation coefficient
All of the following are examples of comparative statistical tests, EXCEPT: A. Rate ratios B. Odds ratios C. d-tests D. All of the above are example of comparative statistical tests
d-tests
Dummy Variables
derived variables created by recoding a variable with n categorical responses into a series n-1 dichotomous (0/1) variables
purposes
description analysis of relationships analysis of differences
sample size
determined by how big an effect you expect to see based on prior studies (stats) expectation of error willing to accept (bigger= better) larger sizes tend to be more representative of the population
ASU researchers examined the genes of the Havasupai people for _______, __________, _______, and ________.
diabetes, schizophrenia, metabolic disorders, and alcoholism: No genetic connections were found.
cohort cons
differential loss to follow-up (attrition bias) takes longer to do study need more subjects expensive
Uniform Distribution
distribution of responses to a variable in which approximately equal numbers of people provided each allowable answer
New Drug Application (NDA)
document filed to the FDA requesting approval to market the drug or device
Which is NOT an example of a type of disease/outcome? A. Bone fractures B. Depressive disorders C. Drinking water D. Schizophrenia
drinking water
single factor
effect of 1 variable in experimental design 1 independent variable= single intervention
two factor
effect of 2 variables & their interaction w/ one another 2 independent variables= 2 interventions
Clinical Data Management (CDM)
enters the information that is required by the protocol and captured on the Case Report Form to create a database that matches
The study of a disease exposure in a community is best referred to as _________.
epidemiology
Oral health _______ implies the existence of equal oral health attributes among different groups.
equality
Participant selection must be ______ to avoid overburdening or stigmatizing one group.
equitable: Also obtaining the needed number of participants must be feasible and inclusion and exclusion criteria must be described.
Oral health______ is the absence of unacceptable and unjust differences preventing certain groups of the population from reaching their full oral health potential.
equity
Inferential Statistics
evidence-based assumptions in which generalizations are made about a population based a study population that is a subset of the larger group
Clinical trial software packages for budgeting should be all of the following except: -accurate -uniform -expensive -flexible
expensive
Which of the following is not a basic principle of ethics? -autonomy -beneficence/non-maleficence -finance -justice
finance
Null Result
finding that there was no statistically significant difference
Fabrication
form of research misconduct involving the creation of fake data, such as creating fictitious data in a spreadsheet for people who have never completed a questionnaire or participated in an experiment
cohort pros
get true incidence rate good for common diagnosis
primary goal
goal of assignment of subjects create groups that are equally representative of the entire sample
secondary goal
goal of assignment of subjects to groups create groups of equal size
Heteroscedasticity
heterogeneity of variance among the variables in a linear regression model that is demonstrated when the distribution of residuals from a regression model across the length of the best-fit line is uneven
Homoscedasticity
homogeneity of variance among the variables in a linear regression model that is demonstrated by the even distribution of residuals from a regression model across the length of the best-fit line
A living individual about whom and investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information is referred to as the ________.
human subject
Population based studies are conducted using:
humans
threats
inadequate sample selection differences in settings differences in circumstances d/t passage of time
level of significance
is the maximum probability of committing a type I error. This probability is symbolized by α (Greek letter alpha). That is, P(type I error)=α. P(type II error) = β (Greek letter beta).
cross sectional cons
lack info on timing of exposure & outcome relationships unable to show causation
To meet these obligations, the IRB (4)
maintains guiding principles and operating policies demanding the highest professional standards in dealing with human participants, reviews all research projects involving human participants Ensures that appropriate standards are met Ensures that research procedures are safe
non-probability sampling
may not accurately represent the population b/c it is NOT random may result in over/under representation of population subgroups w/in sample may increase sampling error
Standard Error
measure of narrowness or wideness of a normal distribution, which is calculated by dividing the variance by the sample size and then taking the square root of the resulting number
sampling
methods that influence characteristics of a sample influence generalizability of the research
Falsification
misrepresentation of research results, such as modifying extreme data values to improve the results of statistical tests, manipulating photographs or other images collected during laboratory work, or intentionally misreporting a study's methods to make the study look more rigorous than it was
Simple Linear Regression
model that examines whether there is a linear relationship between one predictor variable and an outcome variable
Simultaneous Multiple Regression
model that includes all predictor variables in the model rather than fitting the model using a stepwise approach
Stepwise Multiple Regression
model that systematically adds or removes predictor variables to regression model to find the model that provides the best fit
type II error
occurs if one does not reject the null hypothesis when it is false.
type I error
occurs if one rejects the null hypothesis when it is true.
A ________________ for a statistical test is used to decide whether the results observed are likely to reflect real differences between groups. A. Null hypothesis B. Proportion C. p-value D. None of the above
p-value
P-Value (Probability Value)
probability value that indicates the likelihood that a test statistics as extreme as or more extreme than the one observed would occur by chance if the null hypothesis was true, a very small ____ means that observed test results is highly unlikely to have occurred by chance
Two-Sided P-Value
probability value that is used for a statistical test when a direction is not specified in the alternative hypothesis
One-Sided P-Value
probability value that is used for a statistical test when a direction is specified in the alternative hypothesis
Multicollinearity (Autocorrelation)
problem that occurs when two or more predictor variables in a multiple regression model are highly correlated, and that redundancy means that the coefficients for one or more of those variables are highly inaccurate
assignment
random assignment preferred to reduce bias from researchers (threat to internal validity) by individual by block systematic matched consecutive
probability sampling
random sampling to obtain subjects that represent a population
case control pros
rare conditions fewer subjects needed cheaper
A statistical method for predicting values of dependent variable on the basis of the values of one or more independent variables is a ___________.
regression analysis
Logistic Regression Models (Logit Regression Models)
regression model used when the outcome variable is dichotomous
Z-Score
score that indicates how many standard deviations away from the sample mean an individual participant's response is
case control cons
selection bias recall bias
Having patients in a study where one measures positive for the disease that has the disease leads to the concept of _______.
sensitivity
non-experimental
simply observing & collecting data observational studies no manipulation of subjects non-random assignment of groups
Which of the following is a type of exposure (not a type of disease)? -poisoning -socioeconomic status -cardiovascular disease -depressive disorder
socioeconomic status
Examples of Systematic and Generalizable Investigations (7)
surveys and questionnaires interviews and focus groups analysis of existing data or biological specimens epidemiological studies evaluations of social or educational programs cognitive and perceptual experiments medical chart review studies
Alternative Hypothesis
statement describing the expected result if there is a difference between populations being compared
Phi Coefficient
statistical measure of the degree to which changes in the value of one binomial variable predict changes in the value of another binomial variable
Cramer's V
statistical measure of the degree to which changes in the value of one categorical variable predict changes in the value of another categorical variable
Kendall's Tau
statistical measure of the degree to which changes in the value of one rank/order variable predict changes in the value of another rank/order variable
Multiple Linear Regression Models
statistical method that examines the relationships between several ratio/interval and/or nominal predictor variables on the value of one nominal outcome variable
Regression Models
statistical model that seeks to understand the relationship between one or more independent (predictor) variables and one dependent (outcome) variable
Goodness-Of-Fit
statistical test for how well real data match the values predicted by a model
Levene's Test
statistical test of the homogeneity of the variances across different groups
One-Sample T-Test
statistical test used to compare the mean value of a ratio/interval variable to a selected value
Independent-Samples T-Test (2-Sample T-Test)
statistical test used to compare the mean values of a ratio/interval variable in two independent populations
Chi-Square Test
statistical test used to compare the value of a nominal variable in two or more independent populations
McNemar's Test
statistical test used to compare the values of a binomial or nominal variable in one population measured twice or in two
Fisher's Exact Test
statistical test used to compare the values of a binomial variable in two independent populations
Matched-Pairs T-Test
statistical test used to compare the values of an interval/ratio variable in one population measured twice or in two paired groups
Nonparametric Tests
statistical tests that do not make assumptions about the distributions of responses
Descriptive Statistics
statistics that describe the basic characteristics of quantitative data, such as means and proportions
Kefauver-Harris Amendment
strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated.
inclusion data
subject eligibility for an experiment broad enough to max sample size narrow enough to minimize extraneous influence
exclusion data
subject ineligibility specific extraneous factors that are anticipated to influence the outcome can confound data
Purposive sampling (3)
targets a particular group of people. When the desired population for the study is rare or very difficult to locate and recruit for a study, purposive sampling may be the only option. E.g. HIV Infected respondents
Variance Inflation Factor (VIF)
test for whether the independent variables in a regression model have reasonably independent errors and are not too intercorrelated
Two-Way ANOVA
test that compares the mean values of a continuous variable among independent groups across two factors (such as both sex and smoking sex)
ANOVA (Analysis of Variance)
test that compares the mean values of a continuous variable among three or more independent populations
Parametric Tests
tests that assume variables being examined have particular distributions, often requiring the variables to have normal or approximately normal distributions
Comparative Statistics
tests that categorize study participants into two or more groups and then compare the characteristics of those groups
IRBs reviewing research in the U.S. must register with
the Department of Health and Human Services
Generalizability
the ability to infer population characteristics based on the sample
The Investigational New Drug Application (IND)
the document filed with the FDA requesting permission to begin testing the investigational product in humans. required when drug is new and unapproved
Population
the entire set of participants of interest
Degrees of Freedom (df)
the number of values in the final calculation of a statistic that are free to vary
Significance Level
the p-value (usually p=0.05) at which the null hypothesis is rejected and a statistical result is considered statistically significant
If a study participant began a lawsuit over HIPAA infractions, who would be responsible?
the researcher and the facility
Confounder
third variable that may make the association between an exposure variable and an outcome variable appear more or less significant than it truly is
Effect Modifier (Interaction Term)
third variable that represents biologically distinct groups of individuals who might experience different responses to various exposures
Case Report Form (CRF)
tool used to collect and capture the subject data required to fulfill the objectives of the trial, such as: -eligibility criteria -medical history -the results of all protocol mandated procedures -adverse events -concomitant medications Gives an accurate and complete picture of the subject's experience in the trial
True or False: Researchers should never deviate from the procedures in their approved protocol because it may threaten the safety and welfare of the study participants.
true
Residual
vertical distance of a data point in a linear regression model to the best-fit line
Mantel-Haenszel
weighting method used to adjust measures of association
double-blind study
when subjects & researchers don't know the groups
blinded study
when subjects don't know which group they're in
A clinical trial protocol should always include a section about protection of vulnerable subjects, which includes all of the following except: -children pregnant women -prisoners -white males -cognitively impaired individuals
white males
