Research Methods, Successful Approaches

What is Integrative Research

-It is intended to encompass research that brings together multiple research studies or extends prior research, such as Meta-analysis -Allows data from many empirical studies that meet the specified inclusion criteria to be united into a larger unit for study -May yield more objective conclusions -Can also evaluate large databases to extend prior data

What are important things to know about monitoring participants

-Must be adequate -Level is a fan of the study design daily, weekly, etc... -Forms can help monitor compliance -Help catch inconsistencies -May need more formal methods in a free-living study (phone calls)

When choosing participants for a study, what is important to know about sample size

-Must offer adequate levels of significance and power -Calculations are ONLY an estimate, -May need multiple sites for adequate diversity in population -ideally a short time between screening & study commencement so participants don't start making behavior changes

What are major issues with RCTs

-Noncompliance and loss of subjects -Follow all participants equally to the same extent regardless of compliance -Reasons for withdrawal may give insight into the treatment (too hard)

With RCTs, measured end points can be either one of two things

-Objective (hard)= lab values -Subjective (soft)= degree of pain or symptoms

What does a systematic review provide

1. A summary of medical reports on a specific clinical question 2. Uses explicitly defined search methods 3. Critically evaluate and synthesize literature

What are the goals of research presentation

1. Communicate logically, clearly, accurately, and ethically 2. Peer review gives clear, constructive direction to the authors 3. Avoid over generalizing research findings 4. Representative of a population only if variables are well controlled

What does the Belmont Report support

1. Full and comprehensible disclosure to subjects 2. Non-coerced consent 3. Confidentiality 4. Protection of privacy 5. Equity in subject selection 6. Autonomous right of free choice 7. Termination of research project if at any point the data warrants such action

What is important to consider when designing a research study

1. Identify a relevant important topic 2. Develop a well-considered question or hypothesis *research should expand current knowledge and enhance the practice of the profession

What are three sources of human error that need to be differentiated

1. Inadvertent (honest mistake) 2. Negligence 3. Intentional deception

What are the 6 essential characteristics of a hypothesis

1. Measurable 2. Specifies the population 3. Identifies the time frame 4. Specifies the type of relationship to be examined 5. Defines the variables 6. States the level of statistical significance

What are the 3 main problems associated with data collection

1. Missing data 2. Incorrect data 3. Excess variability Problems can be prevented with proper organization & training of personnel

What are the domains that should be addressed

1. Quality 2. Quantity 3. Consistency

What are the 4 driving forces of research, according to Monsen, that continue to influence ongoing studies of nutrition

1. Recognizing the unexpected (the "Aha" moment, 1st vit) 2. Extending existing information (go beyond what is known to find the unknown, 2nd vit) 3. Point-counterpoint (actions & reactions, functional foods) 4. Responding to socioeconomic and political environment (WIC)

What are the 3 main principals of the Belmont Report

1. Respect for persons: *Individuals are treated autonomously *Protected even if autonomy is diminished 2. Respect for beneficence *Do no harm, or minimize possible harm 3. Respect for justice *Burdens and benefits be shared equally

What are 4 common research errors that invalidate a study

1. Sampling 2. Non-coverage 3. Non-response 4. Measurement

What should a research question include

1. Who/which- subjects/units to be assessed broad terms 2. What specific factor of interest 3. How assessed Specific outcome to be assessed

What is involved in a systemic review

1. searching 2. selecting 3. critical evaluating 4. synthesizing and grading reports 5. disseminating results

What is an optimal group size for RCTs?

200

At what grade reading level is the informed consent written

5th grade reading level

What type of menu cycle is best for an experimental diet

6-day is the best choice it help with adherence

When considering data analysis, what is ANOVA

A more complicated method of handling repeated measures uses the repeated measures analysis of variance (ANOVA), includes a "time" factor in the model, accounting for the fact that measurements taken on the same participant are not independent

What is Translational Research

A promising type of research whose goal is to translate new science to patient care. Upon this base rests evidence-based practice It takes results from the lab/study to the community It ALWAYS follows ethical procedures and practices

What does AHRQ stand for

Agency for healthcare research and quality report

Observational, and experimental are examples of which category of research

Analytic

Which category of research evaluates hypothesis, and ascertain cause & effect

Analytic

Which classification of research: -Has a hypothesis -Experimental design is the gold standard -Important factors are held constant except those manipulated by investigators

Analytic

How often are "living guidelines" updated

Annually

What is it called when blood samples (ex) taken at the time of study and carefully saved for subsequent analysis at a time researchers deem appropriate but that is undetermined when the samples are taken= ethically questionable

Banked samples

What do you call the assumption of consent to tests and analyses not included in the original agreement

Blanket consent

This observational analytic study does not involve intervention (is not experimental) Used to explore etiology by comparing the prevalence of the exposure to factors of interest in person who have a disease with that of a group without the disease. Less expensive & require less time than Cohort

Case-control studies -retrospective -groups with disease= Cases -groups without= Controls Looks at frequency, association (odds ratio), and prevalence of exposure

Principles to guide conduct, commitments, and obligations to self, client, society, and the profession

Code of Ethics -act with objectivity and respect -Avoid discrimination -maintain confidentiality -base practices on scientific principals & current info -Conduct professional affairs with honesty, integrity, and fairness -remain free of conflicts of interest

What are some examples of intentional deception

Concealing data not supporting a certain hypothesis Selective reporting or data cooking Data trimming Blatantly fabricating data Plagiarism

What is the study that is based on data collected at a single point in time

Cross-sectional

This type of research -often precedes other research -Is considered formulative or exploratory studies -Data are collected by observation, interviews (focus groups), and questionnaires

Descriptive

Which category of research cannot test or verify, illustrates a relevant but non qualified topic involving a well-focused research question

Descriptive

Which classification of research: -Has a research objective question -Describes a specific point in time -Provides baseline data -Can monitor change over time -Can help generate a hypothesis

Descriptive

What are two categories of research

Descriptive and Analytic

Which category are epidemiological and qualitative in (data detailing person, place, and time are collected: case reports/series, surveys)

Descriptive,

What is the Belmont Report of 1978

Document supporting the rights of human subjects, issued by the *National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research *In response to 2 scandals of the 1930's: 1.Injection of live, malignant cells into elderly patients in a chronic disease hospital without informed consent 2. Long-term observation of the "natural" course of syphilis in men without informed consent

What study has a range of biological effects in response to different doses of nutrients/dietary constituents

Dose-response study

What is a RCT crossover study

Each participant serves as their own control (participate in both groups)

In the Descriptive category of research, what is the research called that collects data detailing person, place, and time

Epidemiological

Research that involves correlational studies, case reports, case series, surveys surveillance systems, demographics, vital statistics (Govt)

Epidemiological

What resulted from the Nuremberg Code of 1947

Established 10 principals that must be followed in human experimentation *The birth of Informed Voluntary Consent of human subjects (Informed Consent)

How often does evidence-based medicine update reviews

Every 2 years

How often are peer-reviewed publications updated

Every 2-5 years, there is more time between publications

What is a RCT factorial study

Factor- the major independent variable -2 or more levels as a subdivision of each factor 2x2 factorial study has 4 treatment groups 3x4 has 12 treatment groups

With RCTs, what is restricted randomization

Groups are similar in desirable characteristics, such as age

What kind of criteria guide the filtering process for selecting research reports to include

Inclusion and Exclusion criteria -include at least 2 independent reviews of the article

What is it that must be obtained for All Human participants, clearly & accurately describes what the research entails, written at a level all participants can understand and contain lay info

Informed Consent Participants must be given the opportunity to review and ask questions before signing

Experimental research falls into the category of analytic, what types of research is done in this group

Investigates-controlled interventions Clinical Trials Randomized controlled clinical trials (RCT's) (double blind, meds/drugs)

What are important things to know about the research question

It should be a concise, simple, straight forward statement Uncomplicated Use objective measurable, operational terms (ex: Identify, compare, differentiate, assess, describe)

What is the study that is based on data collected at more than one point in time

Longitudinal

What are important things to know about incentives for participants

Low-cost nutrition related (diet analysis, nut counseling..) May need to be gender/age specific Should not be so extravagant to make uninterested participants want to participate Should not be so undesirable that it causes selection bias & poor commitment

What kind of studies must have perfect compliance

Metabolic studies (wt, urine, bio markers) Perfect compliance is the goal for all studies, but will likely not be perfect in human studies

In the analytic category of research, what type of research has: Measures of association Relative risk- Cohort studies Odds ratios- Case-control studies Measures of effect Attributable risk- Public health impact

Observational

It what type of situation might a Free-Living study be used

Often used for weight loss trials

When is the "contract" of informed consent concluded

Once the data is collected -further testing is prohibited -samples should be destroyed after specified time -records maintained securely

What is an instrument science uses to monitor itself, Decline to participate if conflict of interest, Maintain confidentiality of the study, esp before it is published

Peer Review

What kind of study evaluates the acute effects of a specific nutrient, food, or mixed meal on an end point of interest

Postprandial study -can build on the effects of in vitro studies or in vivo studies of longer duration

What is the study that starts with the examination of a presumed cause or exposure, and then goes forward in time to an observed presumed effect or outcome

Prospective

This observational analytic study mimics an RCT, but does not involve investigator manipulation. Uses "Cohort", often looks at disease & useful for determining the frequency of newly diagnoses diseases Takes a lot of time & needs large #s

Prospective studies -prospective (concurrent) follow-up: generate data on disease occurrence -retrospective (non concurrent) follow-up: existing records yield data on disease occurrence

Name 3 research reports

QUOROM- Meta or RCTs CONSORT- clinical trials STROBE- observation studies MOOSE- meta-analysis of observational studies STARD- studies of diagnostic accuracy

In the Descriptive category of research, what is the research called that generates data described with words instead of numbers

Qualitative

Research that involves observation, in-depth individual interviews, focus groups, nominal group process, Delphi technique...

Qualitative

What is the gold standard under controlled study

Randomized controlled trial (RCT) -participants randomly assigned to a treatment group and remain on this treatment throughout study

The gold standard in experimental design where both subjects and investigators are unaware of assignment

Randomized controlled trials (RCTs)

What are the forces (benefits) for research

Research advances our profession Future research is born from current research Improved health through better nutrition: -higher quality of life -Lower health care costs

What is the Nuremberg Code of 1947

Resulted from actions of German physicians toward Nazi concentration camp inmates during World War II

What is the study that begins with manifestations of an outcome and goes back in time to uncover relationships

Retrospective

What is important to do before beginning research

Review published literature like Medline or Pubmed

What are some types of research errors

Sampling, non coverage, nonresponse, measurement, errors or data distortion & overgeneralization, errors of misrepresentation to human subjects

What tool is designed to describe and quantify characteristics of a defined population? -usually employs an objective -obtain a descriptive profile of the population Uses: -Provides baseline data -Useful for establishing associations among variables -Can provide clues to direct further study *DOES NOT ALLOW CONCLUSIONS ABOUT CAUSAL RELATIONSHIPS

Surveys collected by: questionnaires Interviews physical exams (anthropometrics, lab evils, or direct obser)

What is the Declaration of Helsinki (1964)

The 2nd major international code of ethics, adopted by the World Medical Assoc. -12 basic principles regarding the process of submitting experimental protocols Also: counseled researchers to exercise caution in conducting research that could affect the environment and to respect the welfare of animals used for research

What is the name of an international nonprofit and independent organization, that produces and disseminates systematic reviews of health care interventions and addresses the effectiveness of these interventions?

The Cochrane Collaboration, the major product of the collaboration is the Cochrane Database of Systematic Reviews, which is published quarterly as part of the Cochrane Library

Which method of estimating energy requirements has predicted energy needs most accurately

The Mifflin St. Jeor Equation

Each research project should have a dependent and independent variable. Which one is the outcome variable of interest

The dependent variable The independent variable is the factor that is thought to influence the dependent variable -the exposure -the presumed causal factor

What determines the experimental design, methods to be implemented, and subsequent statistical analyses

The hypotheses

What is the selection of participants guided by

The hypothesis Specific inclusion & exclusion criteria Must be outside normal range for factor tone measured at the beginning of the study Diverse inclusion better allows results to be generalized to a larger proportion of the population

What drives the study design, subject population and methods to employ

The research question -EAL provides summaries of best avail research -FDA website has recent petitions for health claims that have been filed

What is the basis for research design

The scientific method

How many steps are in a systematic review, which one is the 1st step

There are 7 steps 1. Identify a specific problem/area of uncertainty 2. Formulate that problem as a question 3. Find and select relevant evidence 4. Evaluate research reports 5. Synthesize and grade the evidence 6. Form recommendations based on the best available evidence 7. Publish the findings

What does the Academy's grading reflect

Types of research in the hierarchy of evidence Quality of the studies Consistency of the magnitude of effect

With RCTs, what is crossover design

Uses one person for both the control and intervention group