Evidence map›Paper›PMID 34378406›Full record

ArticleBone & joint open2021

Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis : a qualitative study.

Alba X Realpe, James Blackstone, Damian R Griffin, Andrew J F Bing, Michael Karski, Stephen A Milner, Malik Siddique, Andrew Goldberg

Abstract read
In one paragraph

Article in Bone & joint open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. World journal of orthopedics · 2023
    Review
  5. Patient perspective on the use of carbon fibre plates for extremity fracture fixation.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2023
    Article
  6. Article
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

8 authors.

Alba X RealpeBristol Medical School, University of Bristol, Bristol, UK.ORCID https://orcid.org/0000-0001-9502-3907
James BlackstoneComprehensive Clinical Trials Unit, University College London, London, UK.
Damian R GriffinUniversity of Warwick Warwick Medical School, Coventry, UK.
Andrew J F BingRobert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust, Oswestry, Shropshire, UK.
Michael KarskiFoot and Ankle Surgery, Wrightington Hospital, Wigan, UK.
Stephen A MilnerUniversity Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.
Malik SiddiqueNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, Newcastle upon Tyne, UK.
Andrew GoldbergThe Wellington Hospital, London, UK.ORCID https://orcid.org/0000-0002-8650-4503

Funding

Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

aimsA multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial.

methodsWe collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment.

resultsRecruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm.

conclusionThis study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators' meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article:

Indexed as

ankle arthritisAnkle arthrodesisankle arthroplastyAnkle arthroplastyAnkle fusionAnkle osteoarthritisarthrodesisarthroplastyclinical trialscliniciansOrthopaedicOrthopaedic surgeonsorthopaedic surgical trialsPatient experiencephysiotherapistsRandomized clinical trialsrandomized controlled trialsRecruitment

Identifiers

PMID34378406
PMCPMC8384444

What OpenQuestion holds

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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.