The RESOLVE Trial for people with chronic low back pain: statistical analysis plan

被引：3
作者：
Bagg, Matthew K. [1 ,2 ,3 ]
Lo, Serigne [4 ]
Cashin, Aidan G. [1 ,2 ]
Herbert, Rob D. [1 ]
O'Connell, Neil E. [5 ]
Lee, Hopin [1 ,6 ,7 ]
Hubscher, Markus [1 ]
Wand, Benedict M. [8 ]
O'Hagan, Edel [1 ,2 ]
Rizzo, Rodrigo R. N. [1 ,9 ]
Moseley, G. Lorimer [1 ,10 ]
Stanton, Tasha R. [1 ,10 ]
Maher, Christopher G. [11 ]
Goodall, Stephen [12 ]
Saing, Sopany [12 ]
McAuley, James H. [1 ,9 ]
机构：
[1] Neurosci Res Australia, Ctr Pain IMPACT, 139 Barker St, Sydney, NSW 2031, Australia
[2] Univ New South Wales, Prince Wales Clin Sch, Prince Wales Hosp Campus, Sydney, NSW, Australia
[3] Univ New South Wales, New Coll Village, Sydney, NSW, Australia
[4] Univ Sydney, Melanoma Inst Australia, Sydney, NSW, Australia
[5] Brunel Univ London, Coll Hlth & Life Sci, Dept Clin Sci, Kingston Lane, Uxbridge, Middx, England
[6] Univ Oxford, Nuffield Orthopaed Ctr, Ctr Stat Med, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Windmill Rd, Headington, England
[7] Univ Newcastle, Sch Med & Publ Hlth, Univ Dr, Newcastle, NSW, Australia
[8] Univ Notre Dame Australia Fremantle, Sch Physiotherapy, Perth, WA, Australia
[9] Univ New South Wales, Sch Med Sci, Sydney, NSW, Australia
[10] Univ South Australia, IMPACT Hlth, City East Campus, Adelaide, SA, Australia
[11] Univ Sydney, Fac Med & Hlth, Inst Musculoskeletal Hlth, Sydney, NSW, Australia
[12] Univ Technol Sydney, Ctr Hlth Econ Res & Evaluat, Sydney, NSW, Australia
来源：
BRAZILIAN JOURNAL OF PHYSICAL THERAPY | 2021年 / 25卷 / 01期
基金：
英国医学研究理事会;
关键词：
Back pain; Chronic pain; Statistical data analysis; Clinical trial; SYSTEMATIC ANALYSIS; CLINICAL-TRIALS; GLOBAL BURDEN; BRAIN CHANGES; 195; COUNTRIES; REDUCES PAIN; ABNORMALITIES; TERRITORIES; DISABILITY; PROTOCOL;
D O I：
10.1016/j.bjpt.2020.06.002
中图分类号：
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学（修复外科学）];
学科分类号：
摘要：
Background: Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control. Results: We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results. Conclusion: This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. (C) 2020 Associacao Brasileira de Pesquisa e Pos-Graduacao em Fisioterapia. Published by Elsevier Editora Ltda. All rights reserved.
引用
收藏
页码：103 / 111
页数：9
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