We evaluated the adequacy of randomization and concealment, blinding, reporting of outcomes, sample size calculation, and disclosure of funding sources.
The qualitative study sample will be a subset of the outcomes sample.
However, the qualitative data sample is expected to be a subset of the outcomes sample.
Retention trials were often poorly reported without consort diagrams, clear primary outcomes, sample size, sociodemographic composition or power calculations.
Based on this study's primary feasibility and preliminary efficacy outcomes, sample size was based on resources available.
Poor reporting existed in terms of "outcomes", "sample size", "outcomes and estimation", "ancillary analyses" with positive rate of less than 30% (Table 1).
To increase the power for other secondary outcomes including the patient-reported outcomes, sample size was set at a minimum of 128 and maximum of 150 subjects.
The fourth study will be a prospective cohort study of the changes in outcomes from baseline to one year for all patients in the outcomes sample.
Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered.
Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings.
