Evidence map›Paper›PMID 27565304›Full record

Trial reportThe journal of pain2016

Exploring What Factors Mediate Treatment Effect: Example of the STarT Back Study High-Risk Intervention.

Gemma Mansell, Jonathan C Hill, Chris Main, Kevin E Vowles, Daniëlle van der Windt

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

5 authors.

Gemma MansellResearch Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, United Kingdom. Electronic address: g.mansell@keele.ac.uk.
Jonathan C HillResearch Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, United Kingdom.
Chris MainResearch Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, United Kingdom.
Kevin E VowlesDepartment of Psychology, University of New Mexico, Albuquerque, New Mexico.
Daniëlle van der WindtResearch Institute for Primary Care and Health Sciences, Keele University, Keele, Staffordshire, United Kingdom.

Funding

Arthritis Research UK 20202
6 · The paper itself

Abstract

Interventions developed to improve disability outcomes for low back pain (LBP) often show only small effects. Mediation analysis was used to investigate what led to the effectiveness of the STarT Back trial, a large primary care-based trial that treated patients consulting with LBP according to their risk of a poor outcome. The high-risk subgroup, randomized to receive either psychologically-informed physiotherapy (n = 93) or current best care (n = 45), was investigated to explore pain-related distress and pain intensity as potential mediators of the relationship between treatment allocation and change in disability. Structural equation modeling was used to generate latent variables of pain-related distress and pain intensity from measures used to identify patients at high risk (fear-avoidance beliefs, depression, anxiety, and catastrophizing thoughts). Outcome was measured using the Roland-Morris Disability Questionnaire. Change in pain-related distress and pain intensity were found to have a significant mediating effect of .25 (standardized estimate, bootstrapped 95% confidence interval, .09-.39) on the relationship between treatment group allocation and change in disability outcome. This study adds to the evidence base of treatment mediation studies in pain research and the role of distress in influencing disability outcome in those with complex LBP. PERSPECTIVE: Mediation analysis using structural equation modeling found that change in pain-related distress and pain intensity mediated treatment effect in the STarT Back trial. This type of analysis can be used to gain further insight into how interventions work, and lead to the design of more effective interventions in future.

Indexed as

NegotiatingTreatment OutcomeAdultAgedCatastrophizationDisability EvaluationFactor Analysis, StatisticalFemaleFollow-Up StudiesHumansLow Back PainMaleMiddle AgedMood DisordersPain ManagementPain Measurementlow back painMediation analysispsychological intervention

Identifiers

PMID27565304
PMCPMC5123895

What OpenQuestion holds

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Registered trials

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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.