Biostats Chapters 1-6

_________ are types of clinical research that collect data at a single point in time.

Cross-sectional studies

What epidemiologic activity involves in tracking the people afflicted with a particular disease?

Disease Surveillance

What theory explains disease outbreak in terms of relationships and interactions between the host, the agent, and the environment?

Epidemiologic Triad

What terminology is defined as the study of diseases in population and the evaluation of interventions at a population level, as a method of solving the problems of diseases in individuals?

Epidemiology

_____ is a style of research in which the objective is interpretation and description of a cultural or social group or system. The researcher examines the group's observable and learned patterns of behavior, customs, and ways of life. This style of research requires prolonged observation of the group.

Ethnography

What is the process of combining the best available research evidence with your knowledge and skill to make collaborative, patient- or population-centered decisions within the context of a given healthcare situation?

Evidence-based practice

__________ involves selecting subjects at random from a population, separating subjects randomly into experimental and control groups, then measuring differences between them or associations between predictor and response variables while also controlling for one or more variables.

Experimental research

Which of the following statements is true?

External validity allows findings to be generalized back to the population from which the sample was derived.

What variables interfere with the intended purpose of the investigation by introducing error to the study?

Extraneous variable and intervening variable

A predatory online journal exhibits which characteristic?

Follows substandard peer review guidelines for publishing research reports

_________ is the concept of drawing an inference from a sample of subjects that holds true for the population represented by the sample.

Generalizability

_____ is a style of research in which researchers investigate an abstract problem and its processes. The objective of this style of research is to generate an inductive theory about a substantive area.

Grounded theory

Consider a patient who has Type II diabetes. Which of the following is an example of a surrogate outcome for this patient?

HbA1c (hemoglobin A1c) blood test

The _____ provides science-based, 10-year national objectives for improving the health of all Americans. For three decades, the program has established benchmarks and monitored progress over time in order to encourage collaborations across communities and sectors, empower individuals to make informed health conditions, and measure the impact of prevention activities.

Healthy People Initiative

What is used to display the frequencies or proportions of observations in a continuous scale data set?

Histogram

In a normally-shaped distribution, where is the median located?

In the same place as the mean

In a normally-shaped distribution, where is the mean located?

In the same place as the median

Researchers conducting quantitative and qualitative studies need to carefully establish the characteristics of the participants they want to study. Patients must meet these characteristics; otherwise, they are not eligible to participate. This description defines what concept?

Inclusion criteria

______ make predictions about a population based on the data drawn from a sample.

Inferential statistics

Scores on the chronic fatigue instrument were analyzed at baseline, 4 weeks, and 8 weeks using an ANOVA analysis. The score for 4 weeks was carried over to the 8 week time frame when participants did not return for the final measurement. This description is an example of what type of analysis?

Intention-to-treat

Identify the characteristic of research design relating to the degree to which the outcomes of the study can be contributed to the interventions.

Internal validity

Identify the condition of interest element of the following focused clinical question: "What intervention is most effective for treating overweight in a 45-year-old Hispanic male?"

Intervention

A study was conducted by a pharmaceutical company to determine the safety of a medication as well as side effects and the appropriate dosage of the medication. The study was conducted in a controlled environment with a small number (n = 60) of healthy volunteers. Select the correct statement regarding this study.

It was a Phase I trial.

In the following abstract, identify the primary outcome measure. Which of the following statements is true regarding the primary outcome measure? Abstract BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors. DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271). SETTING: A large academic medical center. PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight (kg), cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months, with mean difference in change in total cholesterol being the primary outcome of interest.RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001) than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors.

It was a surrogate outcome.

In the following abstract, identify the primary outcome measure. Which of the following statements is true regarding the primary outcome measure? Abstract BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on cardiovascular risk factors primarily (as represented by the ratio of total-high-density lipoprotein (\[HDL] cholesterol and triglycerides), and body weight secondarily. DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271).SETTING: A large academic medical center. PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight (kg), cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months, with mean difference in change in total cholesterol being the primary outcome of interest. RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in the ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001); and greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors.

It was a surrogate outcome.

_________ are defined as aspects of studies that reduce their generalizability.

Limitations

______ is a field focusing on the interplay of human behavior and the environment related to health outcomes, problems of disease, and disease control. This field addresses the spatial context of health-related issues, specifically the location of disease occurrence and contributing environmental factors.

Medical geography

Identify the type of evidence that combines the statistical analyses of multiple independently conducted studies.

Meta-analysis

In which of a study's major sections do you find information about the research design?

Methods

What item tells us the most frequently occurring value in a distribution?

Mode

What are exposures, attributes, or behaviors associated with (but not the cause of) a given outcome of interest and that can be controlled?

Modifiable Risk Factors

The external validity of a study is influenced by which extraneous variable?

Nonrandom section of the sample from the population

Researchers strive to remain unbiased, honest, and precise when making decisions regarding the planning, conducting, and reporting of a quantitative and qualitative study. The previous statement defines:

Objectivity

_________ quantifies phenomena but does not involve the use of an intervention.

Observational research

Which study design is used when both researchers and participants know to which group the subjects were assigned, meaning they know what treatment is being received by the subjects?

Open-label

A Likert scale is an example of which type of data?

Ordinal

_____ are results that patients and providers care about, such as the patient's ability to function, level of pain, or cost of care.

Outcomes that matter

_______________ are clinically relevant outcomes that provide direct measures of disease, including measures as quality of life or mortality.

Outcomes that matter

_______ is when researchers compare treatment groups that include only those patients who completed the treatment originally allocated.

Per-protocol analysis

Use the following abstract to answer the question below. Abstract BACKGROUND: This trial evaluated the maximum tolerated dose (MTD), safety, pharmacokinetics, and activity of volasertib, a selective Polo-like kinase 1 inhibitor that induces mitotic arrest and apoptosis, combined with cisplatin or carboplatin in patients with advanced/metastatic solid tumors. METHODS: Sequential patient cohorts (3 + 3 dose-escalation design) received a single infusion of volasertib (100-350 mg) with cisplatin (60-100 mg/m(2)) or carboplatin (area under the concentration versus time curve [AUC]4-AUC6) on day 1 every 3 weeks for up to six cycles. Sixty-one patients received volasertib/cisplatin (n = 30) or volasertib/carboplatin (n = 31) for a median of 3.5 (range, 1-6) and 2.0 (range, 1-6) treatment cycles, respectively.RESULTS: The most common cycle 1 dose-limiting toxicities (DLTs) were thrombocytopenia, neutropenia, and fatigue. MTDs (based on cycle 1 DLTs) were determined to be volasertib 300 mg plus cisplatin 100 mg/m(2) and volasertib 300 mg plus carboplatin AUC6. Co-administration did not affect the pharmacokinetics of each drug. Partial responses were observed in two patients in each arm. Stable disease was achieved in 11 and 6 patients treated with volasertib/cisplatin and volasertib/carboplatin, respectively. CONCLUSIONS: Volasertib plus cisplatin or carboplatin at full single-agent doses was generally manageable and demonstrated activity in heavily pretreated patients with advanced solid tumors.

Phase I

Read the following description of the Koppos et al study that compared two medications for treating multiple sclerosis: The most common medication for treatment of multiple sclerosis interferon beta-1a. A new medication, daclizumab HYP, has been developed showing a similar efficacy to interferon beta-1a. Both medications have been found to be safe in small studies involving samples sizes ranging from 50 to 70 subjects.1,2,3 Further controlled clinical trials established efficacy of daclizumab HYP, identifying short term side effects and risks of the medications.4,5 It is not known, however, if daclizumab HYP is superior to interferon beta-1a in terms of the frequency and severity of relapse episodes, nor the degree of remission that occurs at the end of relapse periods. PURPOSE: A randomized, double-blind, active-controlled, multi-site, national clinical trial was performed (n = 1,841) to compare daclizumab HYP (administered subcutaneously at a dose of 150 mg every 4 weeks) with interferon beta-1a (administered intramuscularly at a dose of 30 µg once weekly) for up to 144 weeks. The primary end point was the annualized relapse rate. RESULTS: The annualized relapse rate was lower with daclizumab HYP than with interferon beta-1a (0.22 vs. 0.39; 45% lower rate with daclizumab HYP; P<0.001). At week 144, the estimated incidence of disability progression confirmed at 12 weeks was 16% with daclizumab HYP and 20% with interferon beta-1a (P=0.16). Serious adverse events, excluding relapse of multiple sclerosis, were reported in 15% of the patients in the daclizumab HYP group and in 10% of those in the interferon beta-1a group. Infections were more common in the daclizumab HYP group than in the interferon beta-1a group (in 65% vs. 57% of the patients, including serious infection in 4% vs. 2%), as were cutaneous events such as rash or eczema (in 37% vs. 19%, including serious events in 2% vs. <1%) and elevations in liver aminotransferase levels that were more than 5 times the upper limit of the normal range (in 6% vs. 3%). CONCLUSIONS: Among patients with relapsing-remitting multiple sclerosis, daclizumab HYP showed efficacy superior to that of interferon beta-1a with regard to the annualized relapse rate and lesions, as assessed by means of MRI, but was not associated with a significantly lower risk of disability progression confirmed at 12 weeks. The rates of infection, rash, and abnormalities on liver-function testing were higher with daclizumab HYP than with interferon beta-1a. This study is an example of what type of research?

Phase III clinical trial

n which phase of clinical trials are post-marketing studies conducted?

Phase IV

Which of the following terms describes the proportion of the population with a given disease at a single point in time?

Prevalence

After the practitioner determines the trustworthiness of evidence in the EBP process, what decision-making steps follow?

Proceed to inform the client what intervention needs to be completed, incorporate evidence with the practitioner's experience, and consider the clients' needs and preferences.

_________ are studies characterized by their forward orientation in time. They involve establishing a hypothesis or hypotheses, collection of data over a defined period of time, and then analysis of findings.

Prospective studies

What type of evidence is useful for answering PPAARE questions based on the situation of a practitioner understanding a client's experience and perceptions of a disease or condition?

Qualitative evidence

In the following abstract, identify the primary outcome measure reported. What is the data type for the primary outcome measure?Abstract BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors. DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271)SETTING: A large academic medical center.PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight (kg), cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months, with mean difference in change in weight being the primary outcome of interest. RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001) than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors.

Quantitative

Use the following abstract to answer the question below. Abstract BACKGROUND: We previously reported that a randomized controlled trial of antenatal micronutrient supplements in rural Nepal decreased the risk of low birth weight by ~15%. OBJECTIVE: The objective was to examine the effects of micronutrient supplementation on growth and body composition in children of supplemented mothers through school age. DESIGN: Mothers received 1 of 5 micronutrient supplements daily: folic acid, folic acid + iron, folic acid + iron + zinc, multiple micronutrients, or a control. All of the supplements contained vitamin A. Children born during this trial were revisited at age 6-8 y to measure height, weight, mid-upper arm circumference, waist circumference, and triceps and subscapular skinfold thicknesses. Arm fat and muscle area were estimated by using standard formulas, and height-for-age, weight-for-age, and body mass index-for-age z scores were calculated by using the World Health Organization growth standard. RESULTS: Of the 3771 surviving children, 3324 were revisited and consented to anthropometric measurements. Maternal supplementation with folic acid + iron + zinc resulted in an increase in mean height (0.64 cm; 95% CI: 0.04, 1.25) and a reduction in mean triceps skinfold thickness (20.25 mm; 95% CI: 20.44, 20.06), subscapular skinfold thickness (20.20 mm; 95% CI: 20.33, 20.06), and arm fat area (20.18 cm2; 20.34, 20.01). No significant differences were found between groups in mean weight or body mass index-for-age z scores, waist circumference, or arm muscle area. Other micronutrient combinations including a multiple micronutrient formulation failed to show a growth benefit. CONCLUSION: Antenatal supplementation with zinc may benefit child growth, particularly in areas where a deficiency of this nutrient is common. What is the data type for the difference in height between the different micronutrient groups and the control group at 6-8 years?

Quantitative

What procedure is implemented for assigning participants to intervention groups (placebo group, control group, experimental group) to ensure each group's characteristics are equal?

Randomization

Use the following abstract to answer the question below. Abstract BACKGROUND: We previously reported that a randomized controlled trial of antenatal micronutrient supplements in rural Nepal decreased the risk of low birth weight by ~15%. OBJECTIVE: The objective was to examine the effects of micronutrient supplementation on growth and body composition in children of supplemented mothers through school age. DESIGN: Mothers received 1 of 5 micronutrient supplements daily: folic acid, folic acid + iron, folic acid + iron + zinc, multiple micronutrients, or a control. All of the supplements contained vitamin A. Children born during this trial were revisited at age 6-8 y to measure height, weight, mid-upper arm circumference, waist circumference, and triceps and subscapular skinfold thicknesses. Arm fat and muscle area were estimated by using standard formulas, and height-for-age, weight-for-age, and body mass index-for-age z scores were calculated by using the World Health Organization growth standard. RESULTS: Of the 3771 surviving children, 3324 were revisited and consented to anthropometric measurements. Maternal supplementation with folic acid + iron + zinc resulted in an increase in mean height (0.64 cm; 95% CI: 0.04, 1.25) and a reduction in mean triceps skinfold thickness (-0.25 mm; 95% CI: -0.44, -0.06), subscapular skinfold thickness (-0.20 mm; 95% CI: -0.33, -0.06), and arm fat area (-0.18 cm2; 20.34, -0.01). No significant differences were found between groups in mean weight or body mass index-for-age z scores, waist circumference, or arm muscle area. Other micronutrient combinations including a multiple micronutrient formulation failed to show a growth benefit. CONCLUSION: Antenatal supplementation with zinc may benefit child growth, particularly in areas where a deficiency of this nutrient is common. What is the data scale for the difference in height between the different micronutrient groups and the control group at 6-8 years?

Ratio

What biostatistics is the event rate among those exposed to a factor divided by the event rate among those not exposed to the same factor?

Relative Risk

According to the Belmont Report, __________ "incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy." Which basic ethical principle is defined above?

Respect for persons

_____ is a practice of looking for the best available evidence subsequent to a clinical encounter.

Retrospective EBP

____ refers to determining the factors the predispose someone to a specific disease.

Risk identification

Qualatitive data are collected until the data from new participants are the same as the data from previously interviewed patients. This situation is known as:

Saturation

What procedures are used to identify early signs and symptoms of a disease or health problems associated with a population at risk for a specific disease or event.

Screening

Identify the type of research conducted in this abstract. The aim of this study was to develop a valid evaluation instrument for assessing nurses as educators to improve clients' medication management. Focus groups of nurses explored desired nursing behaviors as educators in medication management. Using grounded theory, a list of behaviors was generated and categorized into themes. After the data analysis was completed, the researchers developed a questionnaire based on the list of behaviors from the focus groups. Participants rated the behaviors using Likert scale (0=not important to 7=extremely important) based on their importance to medication management and patient-centered communication.

Sequential mixed methods

_____ is the theory, procedures and methodology by which data are summarized.

Statistics

__________ means using one outcome to reflect another.

Surrogate outcome

_____ are results that are based on the association of a physiologic or biologic measure with a known clinical end point, such as blood pressure, as a measure for heart disease.

Surrogate outcomes

_____ was a medication prescribed to pregnant women in the 1950s and 1960s as a treatment for morning sickness.

Thalidomide

Based on the study abstract below, select the descriptive statistic from the following answers. Abstract OBJECTIVES: To examine change in urinary incontinence before and after bariatric surgery and to identify factors associated with improvement and remission among women and men in the first 3 years after bariatric surgery. MAIN OUTCOMES AND MEASURES: The frequency and type of urinary incontinence episodes in the past 3 months were assessed using a validated questionnaire. Prevalent urinary incontinence was defined as at least weekly urinary incontinence episodes, and remission was defined as change from prevalent urinary incontinence at baseline to less than weekly urinary incontinence episodes at follow-up. RESULTS: Of 2458 participants, 1987 (80.8%) completed baseline and follow-up assessments. At baseline, the median age was 47 years (age range, 18-78 years), the median body mass index was 46 kg/m2 (range, 34-94 kg/m2), and 1565 of 1987 (78.8%) were women. Urinary incontinence was more prevalent among women (49.3%; 95% CI, 46.9%-51.9%) than men (21.8%; 95% CI, 18.2%-26.1%) (P?CONCLUSIONS AND RELEVANCE: Among women and men with severe obesity, bariatric surgery was associated with substantially reduced urinary incontinence over 3 years. Improvement in urinary incontinence may be an important benefit of bariatric surgery. From this study, which of the following is a descriptive statistic?

The 3-year urinary incontinence prevalence was 24.8%.

What regulating body was created by the U.S. government in the 1970s in response to the Tuskegee Syphilis Study?

The Food and Drug Administration

Read the following abstract, paying close attention to the methods; determine which of the following statements is true with regard to the outcome measures. Abstract BACKGROUND: Barium enema (BE) is widely available for diagnosis of colorectal cancer despite concerns about its accuracy and acceptability. Computed tomographic colonography (CTC) might be a more sensitive and acceptable alternative. We aimed to compare CTC and BE for diagnosis of colorectal cancer or large polyps in symptomatic patients in clinical practice. METHODS: This pragmatic multicentre randomised trial recruited patients with symptoms suggestive of colorectal cancer from 21 UK hospitals. Eligible patients were aged 55 years or older and regarded by their referring clinician as suitable for radiological investigation of the colon. Patients were randomly assigned (2:1) to BE or CTC by computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome - diagnosis of colorectal cancer, or large (=10 mm) polyps - by intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621. FINDINGS: 3838 patients were randomly assigned to receive either BE (n=2553) or CTC (n=1285). Thirty-four patients withdrew consent, leaving for analysis 2527 assigned to BE and 1277 assigned to CTC). The detection rate of colorectal cancer or large polyps was significantly higher in patients assigned to CTC than in those assigned to BE (93 [7.3%] of 1277 vs 141 [5.6%] of 2527, relative risk 1.31, 95% CI 1.01-1.68; p=0.0390). CTC missed 3 of 45 colorectal cancers, and BE missed 12 of 85. The rate of additional colonic investigation was higher after CTC than after BE (283 [23.5%] of 1206 CTC patients had additional investigation vs 422 [18.3%] of 2300 BE patients; p=0.0003), due mainly to a higher polyp detection rate. Serious adverse events were rare. INTERPRETATION: CTC is a more sensitive test than BE. Our results suggest that CTC should be the preferred radiological test for patients with symptoms suggestive of colorectal cancer. FUNDING: NIHR Health Technology Assessment Programme, NIHR Biomedical Research Centres funding scheme, Cancer Research UK, EPSRC Multidisciplinary Assessment of Technology Centre for Healthcare, and NIHR Collaborations for Leadership in Applied Health Research and Care.

The primary outcome measure was the presence of large polyps (=10 mm) or colorectal cancer diagnosis.

Read the following abstract and select the statement that is true regarding where it belongs in the evidence pyramid. Abstract BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors. DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271)SETTING: A large academic medical center. PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight (kg), cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months, with mean difference in change in weight being the primary outcome of interest.RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001) than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors.

The study belongs in Level III of the evidence pyramid.

Read the following abstract and select the statement that is true regarding where it belongs in the evidence pyramid. Abstract OBJECTIVE: To examine the effect of supplemental prenatal folic acid, folic acid-iron, folic acid-iron-zinc, and multiple micronutrients on maternal morbidity in rural Nepal. METHODS: A cluster-randomized double-masked controlled trial of pregnant women who received daily supplements from early pregnancy through 3 months postpartum as per the treatment allocation. Women were interviewed at birth about labor and delivery complications and for 9 days postpartum to obtain 24-hour histories of morbidity. RESULTS: A total of 3986 (97.3%) women completed an interview regarding labor and delivery; morbidity history was available for 3564 (87.0%) women. Folic acid-iron reduced the risk of postpartum hemorrhage (relative risk [RR] 0.59; 95% confidence interval [CI] 0.35-0.98). Risk of dysfunctional labor increased with multiple micronutrient supplementation (RR 1.28; 95% CI, 1.01-1.60), although preterm premature rupture of membrane decreased (RR 0.40; 95% CI, 0.21-0.79). Puerperal sepsis was lower in those receiving folic acid-iron, folic acid-iron-zinc, and multiple micronutrients compared with controls (P<0.05). CONCLUSION: Prenatal folic acid-iron supplementation reduced the risk of obstetric complications in this South Asian setting.

The study belongs in Level III of the evidence pyramid.

Read the following abstract and select the statement that is correct. Abstract: This critical ethnography explored the experiences of battered, immigrant, Spanish-speaking Latinas in the Midwest of the United States. It relied on Chicana and Mujerista frameworks for understanding help-seeking. Although there has been progress in documenting intimate partner violence in the United States, there is less knowledge concerning this issue with undocumented Latinas. The methodology implemented two stages: (a) observations and informal interviews and (b) formal interviews. The findings reveal multiple sides of ""el silencio."" Maintaining the silence, or breaking it, is surrounded by exchanges with the internal voice parallel to personal experiences with violence at different points in life. It is also affected by cultural expectations in home and host country.

The study is qualitative.

Read the following abstract and select the statement that is correct. Abstract BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors .DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271) SETTING: A large academic medical center. PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight (kg), cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months, with mean difference in change in weight being the primary outcome of interest. RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001) than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors.

The study represents the positivistic paradigm

Read the following abstract and select the statement that is correct. Abstract BACKGROUND: The effectiveness of helmets at preventing cycling fatalities, a leading cause of death among young adults worldwide, is controversial, and safety regulations for cycling vary by jurisdiction. We sought to determine whether nonuse of helmets is associated with an increased risk of fatal head injury. METHODS: We used a case-control design involving 129 fatalities using data from a coroner's review of cycling deaths in Ontario, Canada, between 2006 and 2010. We defined cases as cyclists who died as a result of head injuries; we defined controls as cyclists who died as a result of other injuries. The exposure variable was nonuse of a bicycle helmet. RESULTS: Not wearing a helmet while cycling was associated with an increased risk of dying as a result of sustaining a head injury (adjusted odds ratio [OR] 3.1, 95% confidence interval [CI] 1.3-7.3). We saw the same relationship when we excluded people younger than 18 years from the analysis (adjusted OR 3.5, 95% CI 1.4-8.5) and when we used a more stringent case definition (i.e., only a head injury with no other substantial injuries; adjusted OR 3.6, 95% CI 1.2-10.2). INTERPRETATION: Not wearing a helmet while cycling is associated with an increased risk of sustaining a fatal head injury. Policy changes and educational programs that increase the use of helmets while cycling may prevent deaths.

The study uses a quantitative approach.

Select the characteristic(s) that would be associated with a positivistic study. Select all that apply.

The style is experimental.

Read the following abstract, paying close attention to the methods, and determine which of the following statements is true with regard to the outcome measures. Abstract BACKGROUND: Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy. OBJECTIVE: To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD,?10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit. INTERVENTIONS: All participants received education. Early physical therapy (n?=?108) consisted of 4 physical therapy sessions. Usual care (n?=?112) involved no additional interventions during the first 4 weeks. MAIN OUTCOMES AND MEASURES: Primary outcome was change in the ODI score (range: 0-100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up.RESULTS: One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, -3.2 [95% CI, -5.9 to -0.47], P?=?.02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, -3.5 [95% CI, -6.8 to -0.08], P?=?.045]), but not at 1-year follow-up (between-group difference, -2.0 [95% CI, -5.0 to 1.0], P?=?.19). There was no improvement in pain intensity at 4-week, 3-month, or 1-year follow-up (between-group difference, -0.42 [95% CI, -0.90 to 0.02] at 4-week follow-up; -0.38 [95% CI, -0.84 to 0.09] at 3-month follow-up; and -0.17 [95% CI, -0.62 to 0.27] at 1-year follow-up). The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up (between-group difference, -2.7 [95% CI, -4.6 to -0.85] at 4-week follow-up; -2.2 [95% CI, -3.9 to -0.49] at 3-month follow-up; and -0.92 [95% CI, -2.7 to 0.61] at 1-year follow-up). There were no differences in health care utilization at any point. CONCLUSIONS AND RELEVANCE: Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care.

There were no primary outcome measures reported in the abstract.

In the following example of a search string, identify the results that will be derived from the Boolean operator ""not."" ""Diabetes Mellitus, Type 2"" AND exercise NOT (nutrition OR diet)

This search would exclude results that include the term ""nutrition"" as well as the term ""diet"" in the title or keywords.

What is the name of the method used to avoid bias of knowing whether participants are assigned to the intervention or comparison group, when this information is withheld from the participants themselves, the researchers administering the intervention or placebo, and the researchers collecting the data?

Triple-blind

In PubMed, the search strategy can be narrowed by using strategies to gain more relevant results. Identify the strategy that does not narrow the search results.

Using the Clipboard to save relevant citations

Which of the following lists of products, besides food and drugs, must all be registered with the FDA prior to marketing?

Vaccines, blood products, biologics, and radiation-emitting products

What theory posits that there is no singular reason for the occurrence of a disease and a compendium of factors predisposes an individual to meet criteria for a particular case definition?

Web of Causation

What does a RR of 10.5 mean?

What does a RR of 10.5 mean?

A Systematic review (SR) and meta-analysis (MA) located in the Cochrane Library are considered the "gold standard" because:

a methodical process is used to locate evidence from published and unpublished sources and specific predetermined criteria for the selection of studies to include in the SR or MA.

A study performed in a laboratory to determine if the treatment is reasonably safe to allow human clinical trials is referred to as:

a pre-clinical trial.

The advantage of using point-of-care resources is that the information is:

already synthesized from multiple forms of evidence and used chair-side or bedside during patient care.

In a data set with an even number of observations, the median is the:

average of the two observations at the center of the ordered observations.

Typhoid fever was contracted by individuals exposed to Salmonella typhi from Mary Mallon who was employed as a cook. This situation is an example of:

common source outbreak

When the researchers in a study are paid by the company that manufactures the drug being studied, it is important they report a potential:

conflict of interest.

By definition, a/an ___________ is a set of subjects in a trial that is used as the comparison for the treatment group.

control group

A power analysis is calculated to:

ensure the sample size was large enough to detect differences in the treatment and comparison group after data collection.

A __________ is formulated around a clinical information need, including three major elements: (1) a specific condition or outcome; (2) patient demographics; and (3) patient risk factors.

focused clinical question

The advantage of using Clinical Queries in PubMed for evidence-based practice is that it retrieves the:

highest levels of evidence.

The data for a study on blood pressure are collected by four health care practitioners. The researchers established consistent data collection methods among the four nurses related to:

inter-rater availibility

Open access evidence is important for healthcare professionals to be able to:

locate high level evidence at no cost. read full-text research reports on a 24/7 basis. share scientific information on a global basis. locate high level evidence at no cost and read full-text research reports on a 24/7 basis.

In the late 1950s, the drug ________ was commonly prescribed to treat morning sickness and insomnia among pregnant women. The drug was later found to cause phocomelia.

lysergic acid diethylamide

The trustworthiness of a research report is important to establish for:

making evidence-based decisions.

In a study on an insomnia medication, the researchers used a device that was later found not to be an accurate method for detecting sleep. This is an example of:

measurement error.

Once the qualitative data are analyzed, the analysis is verified by the participants to ensure the researcher correctly interpreted their experiences. This process is known as:

member checks.

City dwellers live in run down high-rise apartment buildings where the water is of questionable quality and heat is sparse during the winter months. The high crime rate in the area has caused local businesses to close or relocate to another part of the city, including the local grocery store. People who live in this area cannot afford to have cars and rely on bus transportation. City parks are miles away, and the neighborhood is not safe to walk. The social determinants of health in the scenario are examples of:

modifiable risk factors.

Qualitative researchers engage in reflexivity to raise their awareness of personal perspectives and viewpoints that might influence data collection and analysis. This procedure is important to establish:

objectivity.

Incidence of three types of cardiovascular events (including nonfatal myocardial infarction, nonfatal stroke, and death) was used in the ACCORD trial as the primary measures of effectiveness. These measures are examples of:

outcomes that matter.

Which of the following terms refers to when and epidemic is widespread over several countries or continents?

pandemic

The nursery rhyme, Ring Around the Rosie, is said to be about the plague, which killed up to a half of the population of Europe and Asia over four years. The plague is an example of a/an:

pandemic.

In the late 1950s, the drug thalidomide was commonly prescribed to treat morning sickness and insomnia among pregnant women. The drug was later found to cause:

phocomelia

A ______ inactive substance or treatment that looks the same as, and is given in the same way as, and active drug or intervention/treatment being studied.

placebo

A _____ is a single number, such as a sample mean or incidence rate, that is associated with an outcome measure reported in a study. It is one of the set of reported values for the outcome measure. It tells us what the value for the outcome was among the sample and cannot tell us precisely what the value will be in the population because it is only a single value, rather than a range of values.

point estimate

The highest level of evidence on the positivistic evidence pyramid is found in:

point-of-care resources.

The P=Problem in the PPAARE question related to a public or community health situation focuses on the:

population's prevalence or incidence of diseases or conditions.

Original research publications written by the authors who conducted the research are referred to as:

primary literature

A meta-synthesis is used to combine results of multiple:

qualitative studies on one phenomenon to create a higher level interpretation of the phenomenon.

Clinical practice guidelines are trustworthy when the guidelines are:

rated on the quality of evidence used to create the guideline and rated on the strength of the recommendation.

The total number of subjects in a study is referred to as:

sample size

In a study on an insomnia medication, the researchers selected subjects who did not have insomnia. This is an example of:

sampling bias.

A traditional literature review that summarizes original research publications is an example of:

secondary literature.

In diabetes, concentrations of glycated hemoglobin (HbA1c) are used as a marker for outcomes such as blindness or amputation. Other markers, such as blood pressure, lipids, albumin excretion rates, and C reactive protein have been used to predict outcomes of cardiovascular disease and to guide clinical practice in people with or without diabetes. HbA1c, blood pressure, lipids, albumin excretion rates, and C reactive protein are examples of:

surrogate outcomes.

A _________ is a type of research in which all previous studies on a specified question are brought together and analyzed collectively.

systematic review or meta-analysis

EBP is defined as:

the process of combining the best available research evidence with your knowledge and skill to make collaborative, patient- or population-centered decisions within the context of a given healthcare situation.

Distilled collections of primary and secondary sources, such as text-books, dictionaries, or encyclopedias, are referred to as:

topical EBP

A qualitative research report provides rich detailed description of quotations from the participants to ensure the reader:

transfers the findings to his/her own context or personal situation.

Formulating a PPAARE question before searching for evidence helps the practitioner identify the:

word or phrases and synonyms to use in the search for evidence.

In an RCT on weight loss, comparing low-carbohydrate diet (<40 g/d) with low-fat diet (<30% of daily energy intake from fat [<7% saturated fat]), the researchers determined that low-carbohydrate diet resulted in greater weight loss: mean difference in change, -3.5 kg (95% CI, -5.6 to -1.4 kg) Based on the confidence interval provided, what is the lowest amount of mean difference in weight change expected among the population if the population followed the low-carbohydrate diet?

-1.4 kg

Identify the primary outcome measure in the following abstract. For the primary outcome measure, select the value that represents the point estimate. Abstract BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors. DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271) SETTING: A large academic medical center. PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight (kg), cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months, with mean difference in change in weight being the primary outcome of interest. RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001) than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors.

-3.5kg

Use the following abstract to answer the question below. Abstract BACKGROUND: We previously reported that a randomized controlled trial of antenatal micronutrient supplements in rural Nepal decreased the risk of low birth weight by ~15%. OBJECTIVE: The objective was to examine the effects of micronutrient supplementation on growth and body composition in children of supplemented mothers through school age. DESIGN: Mothers received 1 of 5 micronutrient supplements daily: folic acid, folic acid + iron, folic acid + iron + zinc, multiple micronutrients, or a control. All of the supplements contained vitamin A) Children born during this trial were revisited at age 6-8 y to measure height, weight, mid-upper arm circumference, waist circumference, and triceps and subscapular skinfold thicknesses. Arm fat and muscle area were estimated by using standard formulas, and height-for-age, weight-for-age, and body mass index-for-age z scores were calculated by using the World Health Organization growth standard. RESULTS: Of the 3771 surviving children, 3324 were revisited and consented to anthropometric measurements. Maternal supplementation with folic acid + iron + zinc resulted in an increase in mean height (0.64 cm; 95% CI: 0.04, 1.25) and a reduction in mean triceps skinfold thickness (-0.25 mm; 95% CI: -0.44, -0.06), subscapular skinfold thickness (-0.20 mm; 95% CI: -0.33, -0.06), and arm fat area (-0.18 cm2; 20.34, -0.01). No significant differences were found between groups in mean weight or body mass index-for-age z scores, waist circumference, or arm muscle area. Other micronutrient combinations including a multiple micronutrient formulation failed to show a growth benefit. CONCLUSION: Antenatal supplementation with zinc may benefit child growth, particularly in areas where a deficiency of this nutrient is common. Based on the confidence interval provided, what is the lowest amount of difference in height at 6-8 years expected between the folic acid + iron + zinc and the control group?

0.04

Use the following abstract to answer the question below. Abstract BACKGROUND: We previously reported that a randomized controlled trial of antenatal micronutrient supplements in rural Nepal decreased the risk of low birth weight by ~15%. OBJECTIVE: The objective was to examine the effects of micronutrient supplementation on growth and body composition in children of supplemented mothers through school age. DESIGN: Mothers received 1 of 5 micronutrient supplements daily: folic acid, folic acid + iron, folic acid + iron + zinc, multiple micronutrients, or a control. All of the supplements contained vitamin A. Children born during this trial were revisited at age 6-8 y to measure height, weight, mid-upper arm circumference, waist circumference, and triceps and subscapular skinfold thicknesses. Arm fat and muscle area were estimated by using standard formulas, and height-for-age, weight-for-age, and body mass index-for-age z scores were calculated by using the World Health Organization growth standard. RESULTS: Of the 3771 surviving children, 3324 were revisited and consented to anthropometric measurements. Maternal supplementation with folic acid + iron + zinc resulted in an increase in mean height (0.64 cm; 95% CI: 0.04, 1.25) and a reduction in mean triceps skinfold thickness (-0.25 mm; 95% CI: -0.44, -0.06), subscapular skinfold thickness (-0.20 mm; 95% CI: -0.33, -0.06), and arm fat area (-0.18 cm2; 20.34, -0.01). No significant differences were found between groups in mean weight or body mass index-for-age z scores, waist circumference, or arm muscle area. Other micronutrient combinations including a multiple micronutrient formulation failed to show a growth benefit. CONCLUSION: Antenatal supplementation with zinc may benefit child growth, particularly in areas where a deficiency of this nutrient is common.Identify the point estimate for the difference in height between the folic acid + iron + zinc and the control group at 6-8 years?

0.64

Based on the following contingency table, which value is the correct result for NPV?

0.744

Based on the following contingency table, which value is the correct result for sensitivity?

0.766

In an isolated community of 23,000 people, there was an outbreak of E. Coli associated with a vegetable grown at a farm in the area. Health statistics for the community showed that at any time, approximately 2 residents in the community were living with an E. Coli infection. During the outbreak, 202 new cases of E. Coli infection were documented. Based on these data, what was the incidence rate of E. Coli infection in the community during the outbreak?

0.88%

In a study on the effects of cognitive behavioral therapy (CBT) as a treatment for insomnia, the researchers utilized the Pittsburgh Sleep Quality Index (PSQI) as their primary outcome measure. The study included a sample of 480 adults, 278 female (57.9%). With the PSQI, a reduction in score indicates improvement in sleep quality. Prior research has shown that a 5% change on the PSQI is a clinically important outcome that matters. In the group that received no intervention (the control group), there was a 2% reduction in PSQI score. In the CBT group, there was a 10.5% reduction in PSQI score.The authors reported: ""the intervention (CBT) was associated with a significant improvement in sleep quality. With alpha < 0.05 the percent difference between groups (7.5%) was statistically significant (p-value=0.001; 95% CI: 7.0%-8.0%).""From this study, which of the following is a descriptive statistic?

2% reduction in PSQI in the control group

Based on the following contingency table, if the study were retrospective, what would be the OR for these data?

4.6

Epidemiology studies determine the:

All of these are correct

Using a research design with a control group helps control for the effects of the:

All of these are correct.

Which statement of the following types of data are true?

All three are quantitive data

In a study on insomnia, the researchers focused on patients' quality of life using a validated instrument. What type of outcome was this?

An outcome that matters

What is used to display the frequencies or proportions of observations in a categorical scale data set?

Bar graph

Which of the following is an ethical principle included in the Belmont Report?

Beneficence

_____ is a style of research in which an individual is studied. His or her experiences are told to the researcher and/or investigated through documentation and archival material.

Biography

_________ is when patients and/or providers are not informed as to the allocation of which subjects are assigned either to treatment or control groups.

Blinding

City dwellers live in run down high-rise apartment buildings where the water is of questionable quality and heat is sparse during the winter months. The high crime rate in the area has caused local businesses to close or relocate to another part of the city, including the local grocery store. People who live in this area cannot afford to have cars and rely on bus transportation. City parks are miles away, and the neighborhood is not safe to walk. What categories of social determinants of health are represented in this scenario?

Built environment

A ______ displays the progress of research participants through the study, beginning with recruitment and ending with the last data element collected from them in a positivistic study.

CONSORT diagram

Researchers develop a set of standard criteria for classifying whether a person has a particular disease, syndrome or health condition. It is a working definition that researchers have agreed upon as the basic unit of study.

Case Definition

In PubMed, what do you use to locate the highest level of positivistic evidence?

Change Article type to Guideline

Read the following description of the Framingham Heart Study (which is a famous, longitudinal study): Cardiovascular disease (CVD) is the leading cause of death and serious illness in the United States. In 1948, the Framingham Heart Study - under the direction of the National Heart Institute (now known as the National Heart, Lung, and Blood Institute or NHLBI) - embarked on an ambitious project in health research. At the time, little was known about the general causes of heart disease and stroke, but the death rates for CVD had been increasing steadily since the beginning of the century and had become an American epidemic. The Framingham Heart Study became a joint project of the National Heart, Lung and Blood Institute and Boston University. The objective of the Framingham Heart Study is to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. The researchers recruited 5,209 men and women between the ages of 30 and 62 from the town of Framingham, Massachusetts, and began the first round of extensive physical examinations and lifestyle interviews that they would later analyze for common patterns related to CVD development. Since 1948, the subjects have continued to return to the study every two years for a detailed medical history, physical examination, and laboratory tests, and in 1971, the Study enrolled a second generation - 5,124 of the original participants' adult children and their spouses - to participate in similar examinations. -quoted from: http://www.framinghamheartstudy.org/ This study is an example of what type of research?

Cohort study

Which of the following is a key element of EBP?

Collaborative patient- or population-centered decisions

In the following abstract, identify the primary outcome measure reported. What is the data scale for the primary outcome measure?Abstract BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors .DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271) SETTING: A large academic medical center. PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight (kg), cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months, with mean difference in change in weight being the primary outcome of interest. RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001) than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors.

Continuous

______ data have the following characteristics: data are ordered, the distance between each unit is equal, a definable zero point, values can be added, subtracted, or or divided and can take on any value within their intervals.

Continuous

_____ is when researchers base the sampling frame on individuals to whom they have easy access.

Convenience sampling