Evidence map›Paper›PMID 28545779›Full record

ArticleBrazilian journal of physical therapy

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

Adrian C Traeger, Ian W Skinner, Markus Hübscher, Hopin Lee, G Lorimer Moseley, Michael K Nicholas, Nicholas Henschke, Kathryn M Refshauge, Fiona M Blyth, Chris J Main and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Brazilian journal of physical therapy. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Adrian C TraegerPrince 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.
Ian W SkinnerPrince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
Markus HübscherPrince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
Hopin LeePrince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
G Lorimer MoseleyNeuroscience Research Australia, Sydney, New South Wales, Australia; Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
Michael K NicholasPain Management Research Institute, University of Sydney at Royal North Shore Hospital, Sydney, New South Wales, Australia.
Nicholas HenschkeInstitute of Public Health, University of Heidelberg, Heidelberg, Germany.
Kathryn M RefshaugeFaculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.
Fiona M BlythCentre for Education and Research on Ageing, University of Sydney, Sydney, New South Wales, Australia.
Chris J MainArthritis Care UK National Primary Care Centre, Keele University, North Staffordshire, UK.
Julia M HushDepartment of Health Professions, Macquarie University, Sydney, New South Wales, Australia.
Garry PearceDepartment of Rehabilitation Medicine, Greenwich Hospital, Sydney, New South Wales, Australia.
Serigne LoMelanoma Institute Australia, Sydney, New South Wales, Australia.
James H McAuleyPrince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStatistical 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.

resultsWe 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.

conclusionsMaking 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 registrationACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808).

Indexed as

Data Interpretation, StatisticalHumansLow Back PainPatient Education as TopicResearch DesignLow back painPatient educationPreventive medicinePrimary care

Identifiers

PMID28545779
PMCPMC5537460

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.