Evidence map›Paper›PMID 39820627›Full record

ArticlePloS one2025

Reasons for declining to participate in a trial of online cognitive behavioural therapy following orthopaedic trauma: A mixed methods study.

Sheila Sprague, Jodi L Gallant, Natalie Fleming, Sofia Bzovsky, Sarah MacRae, Mavis Lyons, Jose Manuel De Maria Prieto, Herman Johal, Paula McKay, Jason W Busse and 1 more

Abstract read
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Sheila SpragueDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0003-1466-8063
Jodi L GallantDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Natalie FlemingDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Sofia BzovskyDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0003-3505-1396
Sarah MacRaeDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Mavis LyonsDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Jose Manuel De Maria PrietoDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0002-1861-9245
Herman JohalDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Paula McKayDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Jason W BusseDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0002-0178-8712
COPE Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The timely enrollment of study participants is critical to the success of clinical trials. Understanding factors that contribute to patients' decision to participate in trials involving online cognitive behavioural therapy for pain management should prove helpful to optimize the design of study protocols. Fracture patients from an orthopaedic clinic who declined to participate in the Cognitive behavioural therapy to Optimize Post-operative rEcovery (COPE) trial were asked to complete a Research Participation Questionnaire that asked them about their previous experiences with clinical research and mental health therapy and their reasons for declining to participate in the COPE trial. At the end of the questionnaire, a subset of participants was offered the opportunity to participate in a telephone interview to further discuss why they declined to participate in the COPE trial. Sixty-four patients who declined to participate in the COPE trial completed the questionnaire and twenty of these participants agreed to take part in a telephone interview (31%). Twenty-two participants (34%) had previous experience with clinical research and six participants (9%) had received cognitive behavioural therapy (CBT) in the past. Excessive time commitment (41%) was the most commonly selected reason for not participating in the COPE trial, followed by a disinclination to participate in clinical research (19%). Four themes emerged from the interviews with participants: 1) belief that they could overcome mental health challenges after their fracture without external help; 2) belief that CBT might be helpful for some fracture patients, but not for themselves; 3) preference for online or in-person CBT; and 4) concerns regarding time commitment. To maximize enrollment, trials exploring the role of psychotherapy in recovery from orthopedic trauma should optimize time commitment of psychotherapy. Providing information in the patient consent process regarding evidence for psychotherapy and recovery from orthopedic trauma may also prove helpful in promoting patient enrollment.

Indexed as

Cognitive Behavioral TherapyFractures, BonePatient ParticipationAdultAgedFemaleHumansMaleMiddle AgedSurveys and Questionnaires

Identifiers

PMID39820627
PMCPMC11737714

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.