Cognitive Behavioural Therapy to Optimize Post-Operative Recovery (COPE): a randomized controlled feasibility trial in extremity fracture patients
Bibliographic record
Abstract
BACKGROUND: Outcomes following surgery to operatively manage extremity fractures are variable, and up to two-thirds of patients report chronic post-surgical pain. Preliminary evidence suggests that psychotherapy directed at improving coping skills and reducing somatic vigilance may improve outcomes among fracture patients. The objective of this pilot study was to test the feasibility and acceptability of a randomized controlled trial comparing an online cognitive behavioural therapy (CBT) program versus usual care in patients with an operatively managed open or closed extremity fracture. METHODS: We conducted a single-centre internal pilot study over a 10-month period in patients with at least one operatively managed open or closed fracture of the appendicular skeleton. Participants were randomized to an online CBT program or usual care and followed for 12 months. The goals of our pilot study were to determine an acceptable rate of recruitment, the degree to which participants randomized to CBT were compliant with treatment, the site investigator's ability to adhere to study protocol and data collection procedures, and our ability to achieve high follow-up rates. Feasibility criteria were evaluated using a graded "traffic light" approach, in which "green light" indicates moving forward with the definitive trial, "yellow light" indicates proceeding with modifications to the protocol and trial procedures, and "red light" indicates a definitive trial is not feasible without significant protocol and trial procedure modifications. RESULTS: We enrolled 94 participants over 10 months, which resulted in a "yellow light" for recruitment. Participant compliance with completion of the online CBT program received a "yellow light", with 60% of participants who were randomized to CBT completing all seven modules. However, 40% of participants in the CBT-arm withdrew from the program, resulting in a "red light". Adherence with the study protocol activities at baseline was relatively high (88%) which resulted in a "yellow light". Follow-up was 85% (80 of 94) at 12 months, resulting in a "yellow light". CONCLUSIONS: These results suggest feasibility of a definitive, multi-centre trial to compare CBT versus usual care in the management of persistent post-operative pain in fracture patients despite the pilot phase identifying some challenges with enrollment timelines, compliance with the CBT program, and participant follow-up. For the definitive trial, we will expand participant recruitment to additional centres and implement strategies to optimize participant engagement and compliance with the CBT program and follow-up. TRIAL REGISTRATION: ClincialTrials.gov (NCT04274530). Registered February 18, 2020, https://classic. CLINICALTRIALS: gov/ct2/show/NCT04274530 .
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.012 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".