bcacp - stats/ DI/ study design exam questions and answers 2024

Con of tertiary literature? lag time for updates; interpretation is dependent on author opinion; often incomplete Tertiary literature works that summarize, discuss, criticize, etc., the primary literature - guidelines, texts, ACCESS pharmacy Secondary literature index of abstract primary and teriary literature found in journals, provides a rapid method to search for primary literature - Medline, PubMed Evidence-based medicine? The conscientious explicity and judicious use of current best evidence in making decisions about the care of individual pts while integrating clinical experience with the best available evidence from a systemic search Criticisms of EBM? cookbook - reduced clinician autonomy; too dificult to apply to individuals; limited data to suggest improved care Quality improvement vs research definitions if the results of a project are presented outside an organization, it is defined as research, if only used internally, and not meant to contribute to generalized knowledge, then QI Nuremberg code? 1948 Germany, subjects need to give informed consent and benefits must outweight risks Helsinki Code? Governs research ethics, defines rules, basis for good clinical practices used today Tuskegee syphilis study? increased pt risks, heightened awareness of the need to protect human subjects and to ensure their informed voluntary consent Belmont report? summarized basic ethical principles identified in deliberations Code of federal regulations (CFR) DHHS title 45 part 46 protection of human subjects none When would you get expedited IRB review? minimal risk to participant, minor change to previously approved study, minimal risk to subjects Title II preventing health care fraud and abuse; admin simplification; medical liability reform privacy rules, transaction and code set rules, security rules, enforcment rules, unique identifier rule (NPI) Can you use share pt information? work-related: trmt, payment, healthcare operations, authorized by the pt mean average very sensitive to outliers median midpoint (50th percentile) good for skewed populations mode most common value standard deviation variability about the mean Applied to continuous data that are normally or near-normally distributed 68% of the sample values are within ±1 SD, 95% are within ±2 SD, and 99% are within ±3 SD. parametric normally distributed data Internal validity Is study design legit to come to its conclusions? External validity Can you generalize the study results outside the study setting? Benefit of a case report/case series allows hypothesis generation (FQ QTc) Observational study design? Drawback of this method? Does not involve investigator intervention, only observation; these studies investigate associations, not causes Case-control study (or retrospective study) Study the exposure or what happened in a grp that has the outcome of interest (Ex. lung cancer, did they work in oil fields) Minimize bias in case control study? Cases and controls are selected in the same way Measure of association in a case-control study? OR - odds of exposure to a factor in those with a condition or disease compared to those who do not have condition 1 indicates no difference in risk, and if the CI includes 1, there is no statistical difference. Cohort (another observational design) definition? Determine association between exposure/factors and a disease/condition. Have study sample, some have a risk factor and others don't, some have the outcome being looked at and some don't in each grp Cross-sectional study? Prevalence study, identify prevalence or characteristics of a condition in a grp of individuals (how many pregnant women are using headache medication) Incidence? Measure of the probability of developing a disease Number of new cases per population in specified time (divide number of individuals who develop a disease during a time period by the number of individuals who were at risk) Prevalence? number of individuals who have condition/disease at any given time Null hypothesis (H0) No difference between grps Hypothesis testing determine whether the data are consistent with H0 (no difference). Alternative hypothesis (Ha) states that there is a difference level of significance level of acceptable error caused by a false positive - α usually 0.05. Paarametric tests - student t-test - ANOVA - Linear regression Student t-test - One-sample test: Grp 1 vs known population mean - Two-sample, independent samples, or unpaired test: Grp 1 vs Grp 2 - Paired test: Measure 1 vs 2 in grp 1 ANOVA generalized version of the t-test that can apply to 2 grps Non-parametric tests Used for continuous data that do not meet the assumptions of the t-test or ANOVA. - Wilcoxon rank sum + Mann-Whitney Nominal data - Chi-square test - 2+ grps