1. A randomised controlled trial of implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT): Statistical analysis plan
- Author
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Ian D. Cameron, Geoffrey Mitchell, Nigel R Armfield, Carrie Ritchie, Michele Sterling, Trudy Rebbeck, Martin Mackey, Aila Nica Bandong, Andrew Leaver, Luke B. Connelly, Mohit Arora, Sterling M., Rebbeck T., Connelly L.B., Leaver A., Ritchie C., Bandong A., Mackey M., Cameron I.D., Mitchell G., Arora M., and Armfield N.R.
- Subjects
medicine.medical_specialty ,Clinical Trial Protocol ,Cost-Benefit Analysis ,Physical Therapy, Sports Therapy and Rehabilitation ,Randomised clinical trial ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Clinical pathway ,Statistical Analysis Plan ,Randomized controlled trial ,law ,Outcome Assessment, Health Care ,Whiplash ,medicine ,Humans ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,Whiplash Injuries ,Pain Measurement ,Intention-to-treat analysis ,business.industry ,Rehabilitation ,Guideline ,medicine.disease ,Missing data ,Clinical trial ,Critical Pathways ,Physical therapy ,Whiplash associated disorders ,business ,human activities ,030217 neurology & neurosurgery - Abstract
Background Statistical analysis plans describe the processes of data handling and analysis in clinical trials; by doing so they increase the transparency of the analysis and reporting of studies. This paper reports the planned statistical analysis plan for the Whiplash ImPaCT study. For individuals with whiplash injury, Whiplash ImPaCT aims to assess the effectiveness of a guidelines-based clinical pathway of care compared with usual care. Methods We report the planned procedures, methods, and reporting for the primary and secondary analyses of the Whiplash ImPaCT study. The primary outcomes are Global Recovery and Neck Disability Index at 3 months post-randomisation. Outcomes will be analysed according to the intention to treat principle using linear mixed models. A cost-utility analysis will be conducted to compute the incremental cost-effectiveness of the intervention to usual care. We describe data handling, our analytical approach, assumptions about missing data, and our planned methods of reporting. Discussion This paper will provide a detailed description of the planned analyses for the Whiplash ImPaCT trial.
- Published
- 2021
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