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

Will be useless unless we finally get a database of stroke rehab protocols with efficacy ratings.
http://wso.sagepub.com/content/early/2016/10/19/1747493016674956.abstract

1. Laurent Billot1,2
2. Richard I Lindley1,2⇑
3. Lisa A Harvey2
4. Pallab K Maulik3,4
5. Maree L Hackett1,5
6. Gudlavalleti VS Murthy6,7
7. Craig S Anderson1,2
8. Bindiganavale R Shamanna8
9. Stephen Jan1
10. Marion Walker9
11. Anne Forster10
12. Peter Langhorne11
13. Shweta J Verma12
14. Cynthia Felix3
15. Mohammed Alim3
16. Dorcas BC Gandhi12
17. Jeyaraj Durai Pandian12

1. ¹The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia
2. ²Sydney Medical School, University of Sydney, Sydney, NSW, Australia
3. ³Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India
4. ⁴The George Institute for Global Health, Oxford University, Oxford, UK
5. ⁵College of Health and Wellbeing, University of Central Lancashire, Preston, UK
6. ⁶Indian Institute of Public Health, Hyderabad, India
7. ⁷Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK
8. ⁸School of Medical Sciences, University of Hyderabad, Hyderabad, Telangana, India
9. ⁹School of Medicine, University of Nottingham, Nottingham, UK
10. ¹⁰Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, University of Leeds, Leeds, UK
11. ¹¹Academic Section of Geriatric Medicine, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK
12. ¹²Department of Neurology, Christian Medical College, Ludhiana, Punjab, India

1. Richard I Lindley, The George Institute for Global Health, University of Sydney, Level 3, 50 Bridge St., Sydney, NSW 2000, Australia. Email: richard.lindley@sydney.edu.au

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.