Device-specific quality of life: results from the ATLAS trial—avoid transvenous leads in appropriate subjects
Bibliographic record
Abstract
AIMS: Patient-reported outcomes (PROs) provide important insights into patients' acceptance of their medical devices. Avoid Transvenous Leads in Appropriate Subjects (ATLAS), a randomized, multi-centre, open-label clinical trial, recently reported fewer perioperative complications in subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous ICD (TV-ICD) patients. This study reports PROs, including device-specific and generic quality of life (QOL), from the ATLAS trial. METHODS AND RESULTS: Device-specific QOL was the primary PRO using the Florida Patient Acceptance Survey (FPAS) at 1 and 6 months' post-implantation. Secondary outcomes included generic QOL using the Medical Outcomes Survey (SF-36) pre-implant and 6 months' post-implantation. The FPAS and SF-36 were analysed using analysis of covariance. Pain measured using a Numeric Rating Scale, at 1 and 6 months, anaesthetic, body mass index, and within/between differences were analysed using descriptive statistics and mixed-effects linear models. Of the 503 patients randomized in ATLAS, 404 had complete FPAS data to be included in this analysis. Participant characteristics were balanced. There were no significant differences between S-ICD and TV-ICD for the FPAS or SF-36, across time points. Mean total FPAS scores increased from 73.73 (16.09) to 77.05 (16.13) and 74.43 (15.35) to 78.25 (15.88) for S-ICD and TV-ICD, respectively (P < 0.001). Patient-reported outcomes suggested that both devices were associated with good QOL. CONCLUSION: Device-specific and generic QOL were similar between S-ICD and TV-ICD groups up to 6 months' post-implantation, indicating that regardless of device type, both groups reported good device-specific QOL in ATLAS patients. Subcutaneous ICD patients reported higher pain scores at implant, but pain decreased by 6 months. The findings offer evidence that can be included during shared decision-making. The inclusion of patient partners in ATLAS provided an opportunity to measure PROs that were deemed important to patients. REGISTRATION: ClinialTrials.gov: NCT02881255.
Stored with the screening record, where it is evidence for the labels above.
How this classification was reachedexpand
The three-model screen
all 5,600 screened works →All three models called this out of scope.
Patient-reported quality of life outcomes from a defibrillator trial; a clinical result, not a study of trial practice.
This is a clinical trial outcomes analysis, and methodological terms are incidental.
Clinical trial report of ICD device quality of life; object is medical device outcomes, not research methods.
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 | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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 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".