A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan

Adrian Traeger; Ian Skinner; Markus Hubscher; Hopin Lee; Lorimer Moseley; Michael Nicholas; Nicholas Henschke; Kathryn Refshauge; Fiona Blyth; Chris  Main; Julia Hush; Garry Pearce; Serigne Lo; James McAuley

doi:10.1016/j.bjpt.2017.04.005

A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan

Adrian Traeger, Ian Skinner, Markus Hubscher, Hopin Lee, Lorimer Moseley, Michael Nicholas, Nicholas Henschke, Kathryn Refshauge, Fiona Blyth, Chris Main, Julia Hush, Garry Pearce, Serigne Lo, James McAuley

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

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.

Original language	English
Pages (from-to)	219-223
Number of pages	5
Journal	Brazilian Journal of Physical Therapy
Volume	21
Issue number	3
DOIs	https://doi.org/10.1016/j.bjpt.2017.04.005
Publication status	Published - 27 May 2017

Keywords

low back pain
patient education
preventive medicine
primary care
Patient education
Low back pain
Preventive medicine
Primary care

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10.1016/j.bjpt.2017.04.005

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Traeger, A., Skinner, I., Hubscher, M., Lee, H., Moseley, L., Nicholas, M., Henschke, N., Refshauge, K., Blyth, F., Main, C., Hush, J., Pearce, G., Lo, S., & McAuley, J. (2017). A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan. Brazilian Journal of Physical Therapy, 21(3), 219-223. https://doi.org/10.1016/j.bjpt.2017.04.005

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title = "A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan",

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.",

keywords = "low back pain, patient education, preventive medicine, primary care, Patient education, Low back pain, Preventive medicine, Primary care",

author = "Adrian Traeger and Ian Skinner and Markus Hubscher and Hopin Lee and Lorimer Moseley and Michael Nicholas and Nicholas Henschke and Kathryn Refshauge and Fiona Blyth and Chris Main and Julia Hush and Garry Pearce and Serigne Lo and James McAuley",

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Traeger, A, Skinner, I, Hubscher, M, Lee, H, Moseley, L, Nicholas, M, Henschke, N, Refshauge, K, Blyth, F, Main, C, Hush, J, Pearce, G, Lo, S & McAuley, J 2017, 'A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan', Brazilian Journal of Physical Therapy, vol. 21, no. 3, pp. 219-223. https://doi.org/10.1016/j.bjpt.2017.04.005

TY - JOUR

T1 - A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial)

T2 - statistical analysis plan

AU - Traeger, Adrian

AU - Skinner, Ian

AU - Hubscher, Markus

AU - Lee, Hopin

AU - Moseley, Lorimer

AU - Nicholas, Michael

AU - Henschke, Nicholas

AU - Refshauge, Kathryn

AU - Blyth, Fiona

AU - Main, Chris

AU - Hush, Julia

AU - Pearce, Garry

AU - Lo, Serigne

AU - McAuley, James

PY - 2017/5/27

Y1 - 2017/5/27

N2 - 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.

AB - 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.

KW - low back pain

KW - patient education

KW - preventive medicine

KW - primary care

KW - Patient education

KW - Low back pain

KW - Preventive medicine

KW - Primary care

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JO - Brazilian Journal of Physical Therapy

JF - Brazilian Journal of Physical Therapy

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ER -

A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan

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