Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.

BackgroundIn low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke.ObjectiveTo publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding.MethodsBased upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data.ResultsThe resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting.ConclusionsPublication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly o...