Table 4.

Factors to Consider in the Design and Analysis of Randomized Controlled Trials

Factor	Yes	No	Uncertain
Have sufficient data been generated from observational studies to justify conducting a randomized controlled trial?	□	□	□
Have the investigators sufficiently described the trial’s inclusion and exclusion criteria and how consideration of these criteria might affect the generalizability of the trial’s findings?	□	□	□
Was the randomization of study subjects to treatment or exposure status done appropriately?	□	□	□
Were potentially confounding factors adequately measured and were they equally distributed between experimental and control groups?	□	□	□
Was the trial single, double, or triple blinded?	□	□	□
Did the trial utilize a run-in phase which may affect the questions being asked?	□	□	□
Were the treatment regimens adequately described and are they generalizable to actual clinical practice?	□	□	□
Was adherence to the treatment under study assessed and adequately described?	□	□	□
Did an adequate placebo exist to the active therapy being tested or was the new therapeutic approach being compared with standard medical practice?	□	□	□
If competing interventions were being used as either adjunctive or standard therapy, were these interventions similarly distributed between the respective comparison groups and/or have they been controlled for analytically?	□	□	□
Were the data analyzed according to the principles of intention to treat?	□	□	□
Was the sample size large enough to adequately examine differences in the principal study outcome(s) between intervention and comparison groups?	□	□	□
Was follow-up of the respective study groups adequate and of sufficient duration?	□	□	□
Were the study strengths and limitations clearly acknowledged?	□	□	□