Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial
Why this work is in the frame
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Bibliographic record
Abstract
BACKGROUND: Patient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibrillator (ICD)-specific PtDA to new ICD candidates and examining preliminary estimates of differences in outcomes. METHODS: Prior to recruitment, ICD candidacy was determined. Consented patients were randomized to (1) usual care or (2) PtDA intervention. Feasibility outcomes included referral and recruitment rates, successful PtDA delivery, and completion of measures. The PtDA intervention was administered prior to specialist consultation and baseline demographics, and measures of decision quality including decisional conflict (DCS), SURE test (Sure of myself, Understand information, Risk-benefit ratio, Encouragement), patient's ICD specific values, ICD knowledge, and health-related quality of life were recorded. Post-consultation, participant's DCS was repeated and decisions to proceed, decline, or defer ICD implantation were collected. Feasibility data was determined using descriptive statistics (continuous and categorical). Preliminary estimates of differences in outcomes were assessed using mean differences. Concordance between values and decision choice was assessed using logistic regression of the intervention group. RESULTS: = 41). Feasibility outcome results were (1) referral rate at approximately 20/month, (2) recruitment rate 61%, and (3) successful delivery of PtDA and study management. Pre-consultation, PtDA patients scored lower on the DCS scale (mean, standard deviation [SD] 27.3 (18.4) compared to usual care, 49.4 (18.6); the between-group difference in means [95% confidence interval (CI)] was - 22.1[- 30.23, - 13.97]. A difference remained post-implantation 21.2 (11.7), PtDA intervention 29.9 (13.3), and usual care - 8.7 [- 14.61, - 2.86]. SURE test results supported DCS differences. The PtDA group scored higher on the ICD-related knowledge questions, with 47.50% scoring greater than 3/5 of the knowledge questions correct, compared to 23.09% receiving usual care. The mean [SD] number of correct knowledge responses out of 5 was 3.33(1.19) in the PtDA group and 2.62 (1.16) in usual care pre-implant. Concordance between values and decision choice found a strong association between predicted and actual ICD implant status in the intervention group. CONCLUSION: Our results suggest that a future definitive trial is feasible. The ICD-specific PtDA shows promise with respect to preliminary estimates of differences in outcomes. TRIAL REGISTRATION: NCT01876173.
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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 | 0.015 | 0.073 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.004 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| 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 it