Evidence map›Paper›PMID 38088137›Full record

ArticleEuropean journal of physical and rehabilitation medicine2024

The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies.

Chiara Arienti, Susan Armijo-Olivo, Giorgio Ferriero, Peter Feys, Thomas Hoogeboom, Carlotte Kiekens, Stefano G Lazzarini, Silvia Minozzi, Stefano Negrini, Aydan Oral and 5 more

Abstract read
In one paragraph

Article in European journal of physical and rehabilitation medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
  2. Interventions that prolong multidimensional healthspan in humans: a systematic review of randomized controlled trials.The journals of gerontology. Series A, Biological sciences and medical sciences · 2026
    Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Review
  7. Review
  8. 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

15 authors.

Chiara ArientiIRCCS Fondazione Don Gnocchi, Milan, Italy.
Susan Armijo-OlivoFaculty of Economics and Social Sciences, University of Applied Sciences of Osnabrück, Osnabrück, Germany.
Giorgio FerrieroDepartment of Biotechnology and Life Sciences, University of Insubria, Varese, Italy.
Peter FeysUhasselt, Faculty of Rehabilitation Sciences, REVAL Rehabilitation Research Center, Hasselt, Belgium.
Thomas HoogeboomIQ Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands.
Carlotte KiekensIRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Stefano G LazzariniIRCCS Fondazione Don Gnocchi, Milan, Italy.
Silvia MinozziDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Stefano NegriniIRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Aydan OralDepartment of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Türkiye.
Elisa PolliniUniversity of Brescia, Brescia, Italy - e.pollini003@studenti.unibs.it.
Livia PuljakCenter for Evidence-Based Medicine and Healthcare, Catholic University of Croatia, Zagreb, Croatia.
Alex Todhunter-BrownGlasgow Caledonian University, Glasgow, UK.
Margaret WalsheDepartment of Clinical Speech and Language Studies, Trinity College, Dublin, Ireland.
Participants in the 5th Cochrane Rehabilitation Methodological Meeting

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aimed to synthesize evidence from studies that addressed the influence of bias domains in randomized controlled trials on rehabilitation intervention effect estimates and discuss how these findings can maximize the trustworthiness of an RCT in rehabilitation. We screened studies about the influence of bias on rehabilitation intervention effect estimates published until June 2023. The characteristics and results of the included studies were categorized based on methodological characteristics and summarized narratively. We included seven studies with data on 227,806 RCT participants. Our findings showed that rehabilitation intervention effect estimates are likely exaggerated in trials with inadequate/unclear sequence generation and allocation concealment when using continuous outcomes. The influence of blinding was inconsistent and different from the rest of medical science, as meta-epidemiological studies showed overestimation, underestimation, or neutral associations for different types of blinding on rehabilitation treatment effect estimates. Still, it showed a more consistent pattern when looking at patient-reported outcomes. The impact of attrition bias and intention to treat has been analyzed only in two studies with inconsistent results. The risk of reporting bias seems to be associated with overestimation of treatment effects. Bias domains can influence rehabilitation treatment effects in different directions. The evidence is mixed and inconclusive due to the poor methodological quality of RCTs and the limited number and quality of studies looking at the influence of bias and treatment effects in rehabilitation. Further studies about the influence of bias in RCTs on rehabilitation intervention effect estimates are needed.

Indexed as

Randomized Controlled Trials as TopicBiasEpidemiologic StudiesHumans

Identifiers

PMID38088137
PMCPMC10938941

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.