A researcher gathered all vitamin E studies from the past ten years. Vitamin E was used for a variety of conditions using a pre-specified search strategy. He compared the incidences of cardiovascular-related mortality in those taking vitamin E supplements versus those that did not by re-analyzing all of the data collectively. Describe this type of study: Group of answer choices Meta-analysis Cohort Study Case-control Cross-sectional study Pre-post observational 2) Please explain why you chose that answer. 3)A pharmacy intern has been asked by his preceptor to gather 200 discharged patient charts from the chart room, identify patients who had a nosocomial infection vs those that didn't. The pharmacy intern is to go back through patient history and determine what medications they were on during the stay. Describe this type of study. Case-control Cohort Meta-analysis Pre-post observational Cross-sectional 4)Please explain why you chose that answer. 5)Over 35,000 nurses were studied in a longitudinal study. Each year, the nurses were followed up and asked to report on any incidence of heart disease. The researchers wanted to prospectively study the incidence of heart disease in the subjects and factors precipitating it. Describe this type of study. Group of answer choices Cohort study Case-control Meta-analysis Pre-post observational Cross-sectional 6)Please explain why you chose that answer. 7)Please define a case series, provide an example, and list 2 advantages and 2 limitations. 8)Please define a time series, provide an example, and list 2 advantages and 2 limitations. 9)A researcher believes that blood pressure management by a team that includes collaborative care or independent management by a pharmacist is more effective. They recruit patients with high blood pressure, 50-50 split of males and females in an assisted living center. They randomly assign them to team-based care with a pharmacist (Group A) and without a pharmacist (Group B). They assess blood pressure at baseline, and at every 3 months of care. Their primary outcome is to move patients from Stage 2 Hypertension (per the JNC 8 guidelines) to Stage 1 HTN. During the course of the study, new guidelines come out about blood pressure management that have new staging for blood pressure and new medication recommendations. The researchers found that teams that include a pharmacist significantly improved blood pressure staging and would be valuable for outpatient hypertension care. What are the internal and external threats to validity? Please list the threats and your rationale. 10)Please describe each of the following threats to validity and provide an example for each. Multiple Treatments Selection Bias 11)BACKGROUND Uncontrolled hypertension is a major problem among non-Hispanic black men, who are underrepresented in pharmacist intervention trials in traditional health care settings. METHODS We enrolled a cohort of 319 black male patrons with systolic blood pressure of 140 mm Hg or more from 52 black-owned barbershops (nontraditional health care setting) in a cluster-randomized trial in which barbershops were assigned to a pharmacist-led intervention (in which barbers encouraged meetings in barbershops with specialty-trained pharmacists who prescribed drug therapy under a collaborative practice agreement with the participants’ doctors) or to an active control approach (in which barbers encouraged lifestyle modification and doctor appointments). The primary outcome was reduction in systolic blood pressure at 6 months. RESULTS At baseline, the mean systolic blood pressure was 152.8 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 6 months, the mean systolic blood pressure fell by 27.0 mm Hg (to 125.8 mm Hg) in the intervention group and by 9.3 mm Hg (to 145.4 mm Hg) in the control group; the mean reduction was 21.6 mm Hg greater with the intervention (95% confidence interval, 14.7 to 28.4). A blood-pressure level of less than 130/80 mm Hg was achieved among 63.6% of the participants in the intervention group versus 11.7% of the participants in the control group (P<0.001). In the intervention group, the rate of cohort retention was 95%, and there were few adverse events (three cases of acute kidney injury). CONCLUSIONS Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in larger blood-pressure reduction when coupled with medication management in barbershops by specialty-trained pharmacists. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number) What is the interpretation of the primary outcome? Group of answer choices The intervention was effective in lowering blood pressure (p<0.05). The intervention was effective in lowering blood pressure (p<0.01). The intervention was NOT effective in lowering blood pressure (p>0.05) 12)Please explain your answer - why you chose that interpretation. BACKGROUND Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known. METHODS We randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes. RESULTS The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; number needed to treat to prevent one primary outcome event, 19 [95% CI, 15 to 27]). The hazard ratio for the composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and the hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P=0.009). Death occurred in 101 participants (4.7%) in the dapagliflozin group and 146 participants (6.8%) in the placebo group (hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P=0.004). The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes. The known safety profile of dapagliflozin was confirmed. CONCLUSIONS Among patients with chronic kidney disease, regardless of the presence or absence of diabetes, the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes was significantly lower with dapagliflozin than with placebo. (Funded by AstraZeneca; DAPA-CKD ClinicalTrials.gov number) What is the interpretation of the primary outcome? Group of answer choices Dapagliflozin reduced events vs placebo (p<0.05) Dapagliflozin reduced events vs placebo (p<0.01) Dapagliflozin did not reduce events vs placebo (p>0.05) 14)Please explain your answer - why you chose that interpretation.