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 journalArticlepeer-review

    3 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 languageEnglish
    Pages (from-to)219-223
    Number of pages5
    JournalBrazilian Journal of Physical Therapy
    Volume21
    Issue number3
    DOIs
    Publication statusPublished - 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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