Evidence map›Paper›PMID 26338841›Full record

ReviewBMJ open2015

What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study.

Susan Armijo-Olivo, Humam Saltaji, Bruno R da Costa, Jorge Fuentes, Christine Ha, Greta G Cummings

Abstract readMulticenter StudyReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 20 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

39 citing papers in PubMed, 20 syntheses or guidelines pooled it.

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  8. Effect of home-based exercise prehabilitation on postoperative outcomes in colorectal cancer surgery: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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  13. Effectiveness of exercise training on cancer-related fatigue in colorectal cancer survivors: a systematic review and meta-analysis of randomized controlled trials.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
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  17. Exercise interventions for cerebral palsy.The Cochrane database of systematic reviews · 2017
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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

6 authors.

Susan Armijo-OlivoCLEAR Outcomes (Connecting Leadership, Education and Research) Research Program, University of Alberta, Edmonton Clinic Health Academy (ECHA), Edmonton, Alberta, Canada Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada Faculty of Rehabilitation Medicine, Rehabilitation Research Center, University of Alberta, Edmonton, Alberta, Canada.
Humam SaltajiOrthodontic Graduate Clinic, School of Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Bruno R da CostaUniversitat Bern, Institute of Primary Health Care, Bern, Switzerland.
Jorge FuentesFaculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada Department of Physical Therapy, Catholic University of Maule, Talca, Chile.
Christine HaFaculty of Rehabilitation Medicine, Rehabilitation Research Center, University of Alberta, Edmonton, Alberta, Canada.
Greta G CummingsFaculty of Nursing, CLEAR Outcomes (Connecting Leadership Education & Research) Research Program, University of Alberta, Edmonton Clinic Health Academy|University of Alberta, Edmonton, Alberta, Canada.

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

objectiveTo determine if adequacy of randomisation and allocation concealment is associated with changes in effect sizes (ES) when comparing physical therapy (PT) trials with and without these methodological characteristics.

designMeta-epidemiological study.

participantsA random sample of randomised controlled trials (RCTs) included in meta-analyses in the PT discipline were identified.

interventionData extraction including assessments of random sequence generation and allocation concealment was conducted independently by two reviewers. To determine the association between sequence generation, and allocation concealment and ES, a two-level analysis was conducted using a meta-meta-analytic approach. PRIMARY AND SECONDARY OUTCOME MEASURES: association between random sequence generation and allocation concealment and ES in PT trials.

results393 trials included in 43 meta-analyses, analysing 44,622 patients contributed to this study. Adequate random sequence generation and appropriate allocation concealment were accomplished in only 39.7% and 11.5% of PT trials, respectively. Although trials with inappropriate allocation concealment tended to have an overestimate treatment effect when compared with trials with adequate concealment of allocation, the difference was non-statistically significant (ES=0.12; 95% CI -0.06 to 0.30). When pooling our results with those of Nuesch et al, we obtained a pooled statistically significant value (ES=0.14; 95% CI 0.02 to 0.26). There was no difference in ES in trials with appropriate or inappropriate random sequence generation (ES=0.02; 95% CI -0.12 to 0.15).

conclusionsOur results suggest that when evaluating risk of bias of primary RCTs in PT area, systematic reviewers and clinicians implementing research into practice should pay attention to these biases since they could exaggerate treatment effects. Systematic reviewers should perform sensitivity analysis including trials with low risk of bias in these domains as primary analysis and/or in combination with less restrictive analyses. Authors and editors should make sure that allocation concealment and random sequence generation are properly reported in trial reports.

Indexed as

BiasEpidemiologic StudiesHumansPhysical Therapy ModalitiesRandomized Controlled Trials as TopicRisk Assessmentallocation concealmentmeta-epidemiologicalphysical therapyrisk of biassequence generation

Identifiers

PMID26338841
PMCPMC4563231

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.