title: 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.
abstract: Background In 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. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based 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. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.
authors.affiliation: 1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.|2 Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
authors.forename: Laurent
authors.initials: L
authors.lastname: Billot
authors.affiliation: 1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.|2 Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
authors.forename: Richard I
authors.initials: RI
authors.lastname: Lindley
authors.affiliation: 2 Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Harvey
authors.affiliation: 3 Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India.|4 The George Institute for Global Health, Oxford University, Oxford, UK.
authors.forename: Pallab K
authors.initials: PK
authors.lastname: Maulik
authors.affiliation: 1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.|5 College of Health and Wellbeing, University of Central Lancashire, Preston, UK.
authors.forename: Maree L
authors.initials: ML
authors.lastname: Hackett
authors.affiliation: 6 Indian Institute of Public Health, Hyderabad, India.|7 Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Gudlavalleti Vs
authors.initials: GV
authors.lastname: Murthy
authors.affiliation: 1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.|2 Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
authors.forename: Craig S
authors.initials: CS
authors.lastname: Anderson
authors.affiliation: 8 School of Medical Sciences, University of Hyderabad, Hyderabad, Telangana, India.
authors.forename: Bindiganavale R
authors.initials: BR
authors.lastname: Shamanna
authors.affiliation: 1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
authors.affiliation: 9 School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: Marion
authors.initials: M
authors.lastname: Walker
authors.affiliation: 10 Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, University of Leeds, Leeds, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Forster
authors.affiliation: 11 Academic Section of Geriatric Medicine, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Langhorne
authors.affiliation: 12 Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.
authors.forename: Shweta J
authors.initials: SJ
authors.lastname: Verma
authors.affiliation: 3 Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Felix
authors.affiliation: 3 Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Alim
authors.affiliation: 12 Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.
authors.forename: Dorcas Bc
authors.initials: DB
authors.lastname: Gandhi
authors.affiliation: 12 Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.
authors.forename: Jeyaraj Durai
authors.initials: JD
authors.lastname: Pandian
mesh_terms: D017028:Caregivers; D003627:Data Interpretation, Statistical; D005190:Family; D005500:Follow-Up Studies; D006801:Humans; D007194:India; D018579:Patient Selection; D012720:Severity of Illness Index; D020521:Stroke / Q000628:therapy; D000071939:Stroke Rehabilitation / Q000379:methods*; D016896:Treatment Outcome
keywords: India; Rehabilitation; caregivers; clinical trial; cost factors; developing countries; disability; statistical analysis plan