An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial
Bibliographic record
Abstract
Abstract Background While the rates of total knee arthroplasty (TKA) continue to rise worldwide, there are concerns about whether all surgeries are appropriate. Guidelines for appropriateness suggest that patients should have realistic expectations for total knee arthroplasty (TKA), and that the patient and their surgeon should agree that the potential benefits outweigh the potential harms. The objective of this study is to evaluate whether routinely collected pre- and post-TKA patient-reported outcome measures (PROMs) could be integrated into a patient decision aid to better inform these appropriateness criteria. This randomised trial will evaluate the preliminary efficacy of a tailored PROM-based patient decision aid and surgeon report (compared to usual care) for patients considering TKA on decision quality. Methods This is a pragmatic, randomised controlled trial conducted at one site in Alberta, Canada. Adults over the age of 30 years, who have been scheduled for a TKA consultation at the Edmonton Bone and Joint Centre with a participating surgeon, who understand, speak, and read English, and can provide informed consent, are eligible to participate. Participants will be randomised to receive a PROM-based patient decision aid and surgeon report before their surgical consultation or usual care. The decision aid will provide patients with information on their expected outcomes based on the EQ-5D-5L PROM, and these estimates are individualized based on clinical and demographic characteristics. The primary outcome of this trial is decision quality. Analysis will consider outcomes intention to treat, and feasibility outcomes for implementing the trial to routine practise. Discussion This patient decision aid and surgeon report intervention could contribute to improved treatment decision-making for patients considering total knee arthroplasty. Trial registration (registry and number) ClinicalTrials.gov : NCT03240913. Registered on August 1, 2017.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.068 | 0.085 |
| Meta-epidemiology (narrow) | 0.008 | 0.004 |
| Meta-epidemiology (broad) | 0.013 | 0.008 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.003 | 0.005 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.010 | 0.010 |
| Insufficient payload (model declined to judge) | 0.059 | 0.010 |
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 source (direct Gemma or distilled Codex), 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".