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
| Autor: | 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 |
|---|---|
| Přispěvatelé: | Sterling M., Rebbeck T., Connelly L.B., Leaver A., Ritchie C., Bandong A., Mackey M., Cameron I.D., Mitchell G., Arora M., Armfield N.R. |
| Rok vydání: | 2021 |
| Předmět: |
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 |
| Zdroj: | Braz J Phys Ther |
| ISSN: | 1413-3555 |
| DOI: | 10.1016/j.bjpt.2021.05.004 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect