http://wso.sagepub.com/content/early/2016/10/19/1747493016674956.abstract
- Laurent Billot1,2
- Richard I Lindley1,2⇑
- Lisa A Harvey2
- Pallab K Maulik3,4
- Maree L Hackett1,5
- Gudlavalleti VS Murthy6,7
- Craig S Anderson1,2
- Bindiganavale R Shamanna8
- Stephen Jan1
- Marion Walker9
- Anne Forster10
- Peter Langhorne11
- Shweta J Verma12
- Cynthia Felix3
- Mohammed Alim3
- Dorcas BC Gandhi12
- Jeyaraj Durai Pandian12
- 1The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia
- 2Sydney Medical School, University of Sydney, Sydney, NSW, Australia
- 3Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India
- 4The George Institute for Global Health, Oxford University, Oxford, UK
- 5College of Health and Wellbeing, University of Central Lancashire, Preston, UK
- 6Indian Institute of Public Health, Hyderabad, India
- 7Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK
- 8School of Medical Sciences, University of Hyderabad, Hyderabad, Telangana, India
- 9School of Medicine, University of Nottingham, Nottingham, UK
- 10Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, University of Leeds, Leeds, UK
- 11Academic Section of Geriatric Medicine, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK
- 12Department of Neurology, Christian Medical College, Ludhiana, Punjab, India
- 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.
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