- Questions to Evaluate a Study Whose Primary Objective is to Evaluate a Therapy (continued)
Methods Evaluation (continued)
- Were the subjects and investigators *blinded to the fullest extent possible?
- Were all patients who entered the trial accounted for at the end of the trial? If not, what would happen to the study's conclusions if all the patients lost to the treatment group were added as failures?
- Were each of the groups treated exactly the same in all respects except for the intervention being studied?
- Did the investigators enroll enough patients in the study to ensure that a negative result was not due to too few subjects?
- Were subgroups and outcomes specified beforehand and did the authors stick to those outcomes and subgroups in their analysis?
- Who funded the research?
Outcomes Evaluation
- Do these results apply to your patient? How similar to your patient were the patients in this study?
- Was the outcome a truly meaningful outcome? For example, did the medication just lower cholesterol or did it actually lower total cardiac mortality or total mortality?
- Could your patient actually comply with the therapy?
- Does the result apply to all subgroups in the study which were predetermined or only to subgroups which were identified after the results were collected?
- If you are satisfied that the statistical significance is real, are you satisfied with the clinical significance? What are the absolute risk reduction and the number needed to treat for this therapy?
