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EVALUATING A STUDY This outlinewill be used for discussion of the papersin the small groups and the exam. Summary of the findings 1. What is the problem and what is known about it so far? (Background) 2. Why did researchers do this particular study? (State thehypothesis.) 3. Who was studied? (Describe the population including size.) 4. How was the study done? (Describe the studydesign and duration, outcomes and risk factors/treatments and how they weremeasured.) 5. What did the researchers find? (Present the major resultsof the study referring totables and figures. Report the measure(s) of effect/association (comparison ofrisks) between risk factor/treatment and disease/outcome (RR, OR, AR.) Interpretation of the findingsand limitations of the study Are the findingsbelievable (not the result of chance,bias or confounding)? Are the findings useful (generalizable and practical)? 6. How may chance (randomerror) have affected the results? (Describe the methods used to evaluatethe probability of Type 1 error (confidence intervals, hypothesis testing) or Type 2 error (power).) 7. How may bias (systematicerror) have affected the results? (Name the strategies used to minimizeinformation bias (blinding, objective measures of riskfactors and outcomes) or selection bias (randomization, complete follow up).Note the size and direction of any bias.) 8. How may confounding(association with other risk factors) have affected the results? (Note the provisions made to minimizeconfounding (randomization,matching, stratification, multivariate analysis). Note also the size anddirection of any confounding effects.) 9. What is the generalizability of the study findings? (Discuss the individuals or groups that may or may not benefit from the findings.) 10. Are the findings practical? (Discuss the applicabilityof the findings to non study individuals or groups with reference to effect size, acceptability, availability, cost and obsolescence of thetreatment.)
Check list for specificstudy designs(see Dr Levine’sLecture notes and Chapter 5 High-yield Biostatistics) Case control 1. Were the caseschosen from a population that was in all ways similar to thecases except for the disease or outcome being studied? 2. Was the exposure/risk factor/intervention present beforethe outcome? Cohort study 1. Did the cohort exclude those already with the disorder?(i.e. an inceptioncohort) 2. Was there completefollow up? 3. Was the population representative 4. Were there an adequate numberof events? 5. Was there adequatetime between exposureand event? 6. Was there appropriate control for confounding factors? Controlled trial 1. Was there randomization? 2. Was there completefollow up? 3. Was the analysisby “intention to treat”? Evidence that an association reflectscause and effect 1. Temporality: cause precedeseffect 2. Strength of the association: large relative risk 3. Dose response: increasing risk results in increasing disease 4. Biological plausibility: consistent with biological knowledge of the time 5. Consistency: similar to other studiesin different persons,places and times 6. Reversibility: decreasing or removing risk reduces disease
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