Protocol for the process evaluation of the GOAL trial: investigating how comprehensive geriatric assessment (CGA) improves patient-centred goal attainment in older adults with chronic kidney disease in the outpatient setting
Bibliographic record
Abstract
INTRODUCTION: The GOAL Cluster Randomised Controlled Trial (NCT04538157) is now underway, investigating the impact of comprehensive geriatric assessment (CGA) for frail older people with chronic kidney disease (CKD). The primary outcome is the attainment of patient-identified goals at 3 months, assessed using the goal attainment scaling process. The protocol requires a dedicated process evaluation that will occur alongside the main trial, to investigate issues of implementation, mechanisms of impact and contextual factors that may influence intervention success. This process evaluation will offer novel insights into how and why CGA might be beneficial for frail older adults with CKD and provide guidance when considering how to implement this complex intervention into clinical practice. METHODS AND ANALYSIS: This process evaluation protocol follows guidance from the Medical Research Council and published guidance specific for the evaluation of cluster-randomised trials. A mixed methodological approach will be taken using data collected as part of the main trial and data collected specifically for the process evaluation. Recruitment and process data will include site feasibility surveys, screening logs and site issues registers from all sites, and minutes of meetings with intervention and control sites. Redacted CGA letters will be analysed both descriptively and qualitatively. Approximately 60 semistructured interviews will be analysed with a qualitative approach using a reflexive thematic analysis, with both inductive and deductive approaches underpinned by an interpretivist perspective. Qualitative analyses will be reported according to the Consolidated criteria for Reporting Qualitative research guidelines. The Standards for Quality Improvement Reporting Excellence guidelines will also be followed. ETHICS AND DISSEMINATION: Ethics approval has been granted through Metro South Human Research Ethics Committee (HREC/2020/QMS/62883). Dissemination will occur through peer-reviewed journals and feedback to trial participants will be facilitated through the central coordinating centre. TRIAL REGISTRATION NUMBER: NCT04538157.
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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 | 0.227 | 0.323 |
| Meta-epidemiology (narrow) | 0.008 | 0.007 |
| Meta-epidemiology (broad) | 0.012 | 0.009 |
| Bibliometrics | 0.006 | 0.009 |
| Science and technology studies | 0.009 | 0.009 |
| Scholarly communication | 0.014 | 0.009 |
| Open science | 0.007 | 0.006 |
| Research integrity | 0.015 | 0.020 |
| Insufficient payload (model declined to judge) | 0.170 | 0.050 |
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".