Sharon A. Gutman; Reporting Standards for Intervention Effectiveness Studies. Am J Occup Ther 2010;64(4):523-527. doi: 10.5014/ajot.2010.09644.
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Large, randomized controlled trial (RCT)
Two-group, nonrandomized controlled trial
Uncontrolled, one-group pretest–posttest
Prospective cohort study
Retrospective cohort study
Random assignment sequence: What method was used to generate the random assignment sequence (include restrictions such as blocking and stratification)?
Random assignment concealment: Was random assignment concealed from the person enrolling participants (thereby reducing potential assignment bias) and from the outcome assessor (reducing potential assessment bias)?
Random assignment implementation: Who generated the assignment sequence, who enrolled participants, and who assigned participants to group conditions? To reduce bias, investigators responsible for creating the assignment sequence should be different from those enrolling and assigning participants to groups.
Intervention: Briefly describe the intervention, and indicate whether it was manualized or based on a written set of practice guidelines. State how many interveners (or therapists) were used.
Intervention administration schedule: Describe the administration schedule for each group, including specific time periods for each study phase (e.g., baseline, intervention, postintervention, follow-up).
Use of multiple interveners: If multiple interveners were used, describe the procedures used to train the interveners to administer intervention. What procedures were used to ensure that interveners provided intervention uniformly?
Blinding of interveners and participants: Were interveners and participants blinded to group assignment? What were the procedures for blinding, and how were they assessed?
Data collection schedule: Describe how and when each type of data was collected in each study phase.
Data collector training and rater reliability: Describe how data collectors were trained to collect data uniformly. If multiple raters were used to measure participant performance, was interrater reliability established for all raters?
Blinding of data collectors: Were data collectors blinded to participant group assignment?
Separation of data collectors and interveners: To reduce bias, were data collectors different from interveners?
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