Your browser doesn't support javascript.
loading
A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan.
Traeger, Adrian C; Skinner, Ian W; Hübscher, Markus; Lee, Hopin; Moseley, G Lorimer; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; Lo, Serigne; McAuley, James H.
Afiliación
  • Traeger AC; Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia. Electronic address: a.traeger@neura.edu.au.
  • Skinner IW; Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
  • Hübscher M; Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
  • Lee H; Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
  • Moseley GL; Neuroscience Research Australia, Sydney, New South Wales, Australia; Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
  • Nicholas MK; Pain Management Research Institute, University of Sydney at Royal North Shore Hospital, Sydney, New South Wales, Australia.
  • Henschke N; Institute of Public Health, University of Heidelberg, Heidelberg, Germany.
  • Refshauge KM; Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.
  • Blyth FM; Centre for Education and Research on Ageing, University of Sydney, Sydney, New South Wales, Australia.
  • Main CJ; Arthritis Care UK National Primary Care Centre, Keele University, North Staffordshire, UK.
  • Hush JM; Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.
  • Pearce G; Department of Rehabilitation Medicine, Greenwich Hospital, Sydney, New South Wales, Australia.
  • Lo S; Melanoma Institute Australia, Sydney, New South Wales, Australia.
  • McAuley JH; Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
Braz J Phys Ther ; 21(3): 219-223, 2017.
Article en En | MEDLINE | ID: mdl-28545779
ABSTRACT

BACKGROUND:

Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain.

RESULTS:

We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures.

CONCLUSIONS:

Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results. TRIAL REGISTRATION ACTRN12612001180808 (https//www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808).
Asunto(s)
Palabras clave
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Dolor de la Región Lumbar Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Braz J Phys Ther Asunto de la revista: MEDICINA FISICA / REABILITACAO Año: 2017 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Dolor de la Región Lumbar Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Braz J Phys Ther Asunto de la revista: MEDICINA FISICA / REABILITACAO Año: 2017 Tipo del documento: Article