Evidence map›Paper›PMID 28963300›Full record

ReviewBMJ open2017

Influence of allocation concealment and intention-to-treat analysis on treatment effects of physical therapy interventions in low back pain randomised controlled trials: a protocol of a meta-epidemiological study.

Matheus Oliveira Almeida, Bruno T Saragiotto, Chris G Maher, Leonardo Oliveira Pena Costa

Abstract readReview
In one paragraph

Review in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 3 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

5 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
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

4 authors.

Matheus Oliveira AlmeidaMasters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, São Paulo, Brazil.ORCID http://orcid.org/0000-0002-5488-3350
Bruno T SaragiottoMusculoskeletal Health Sydney, School of Public Health, Sydney Medical School, The University of Sidney, Sydney, Australia.
Chris G MaherMusculoskeletal Health Sydney, School of Public Health, Sydney Medical School, The University of Sidney, Sydney, Australia.
Leonardo Oliveira Pena CostaMasters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, São Paulo, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMeta-epidemiological studies examining the influence of methodological characteristics, such as allocation concealment and intention-to-treat analysis have been performed in a large number of healthcare areas. However, there are no studies investigating these characteristics in physical therapy interventions for patients with low back pain. The aim of this study is to investigate the influence of allocation concealment and the use of intention-to-treat analysis on estimates of treatment effects of physical therapy interventions in low back pain clinical trials. METHODS AND ANALYSIS: Searches on PubMed, Embase, Cochrane Database of Systematic Reviews, Physiotherapy Evidence Database (PEDro) and CINAHL databases will be performed. We will search for systematic reviews that include a meta-analysis of randomised controlled trials that compared physical therapy interventions in patients with low back pain with placebo or no intervention, and have pain intensity or disability as the primary outcomes. Information about selection (allocation concealment) and attrition bias (intention-to-treat analysis) will be extracted from the PEDro database for each included trial. Information about bibliographic data, study characteristics, participants' characteristics and study results will be extracted. A random-effects model will be used to provide separate estimates of treatment effects for trials with and without allocation concealment and with and without intention-to-treat analysis (eg, four estimates). A meta-regression will be performed to measure the association between methodological features and treatment effects from each trial. The dependent variable will be the treatment effect (the mean between-group differences) for the primary outcomes (pain or disability), while the independent variables will be the methodological features of interest (allocation concealment and intention-to-treat analysis). Other covariates will include sample size and sequence generation. ETHICS AND DISSEMINATION: No ethical approval will be required for this study. The study findings will be published in a peer-reviewed journal and presented at international conferences. REGISTRATION NUMBER: International Prospective Register of Systematic Reviews (CRD42016052347).

Indexed as

Epidemiologic StudiesIntention to Treat AnalysisBiasHumansLow Back PainMeta-Analysis as TopicPhysical Therapy ModalitiesRandomized Controlled Trials as TopicResearch Designepidemiologic research designlow back painphysical therapy modalities

Identifiers

PMID28963300
PMCPMC5623523

What OpenQuestion holds

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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.