Supplementary Material for: Patient and caregiver perspectives on the design and execution of ACT-GLOBAL, a stroke adaptive platform trial: a focus group study
Bibliographic record
Abstract
Introduction: Adaptive platform trials represent a paradigm shift in stroke research. We examined how patient-partners perceived the design and execution of an international platform trial in acute stroke, ACT-GLOBAL (A multi-faCtorial, mulTi-arm, multi-staGe, randomised, gLOBal Adaptive pLatform trial for stroke), through a series of focus groups with process evaluation methodology. Methods: Participants were recruited from two comprehensive stroke centers one in Calgary, Canada and one in Sydney, Australia. Four virtual focus groups were attended by a total of 21 patient-partners and 11 clinician-researchers. One focus group had repeat attendees to review a draft consent form and patient information sheet, and one presented a video describing platform trials. Physician facilitators presented the platform trial concept followed by a facilitated discussion. Audio recordings were transcribed and combined with field notes. Exemplar quotes and themes were identified separately for each group and subsequently across groups. Results: Patients/caregivers perceived acute stroke-focussed adaptive platform trials such as ACT-GLOBAL as providing potentially beneficial opportunities to be randomized to multiple treatments, with efficiencies and richer data to improve patient care. Emphasis was given to the importance of gatekeeper processes for the addition of future questions posed by the platform to ensure examined questions would not interfere with routine care, and that safety decisions were ultimately made by non-conflicted parties. They appreciated that deferral of consent would be ideal to allow timely randomization/treatment within the adaptive stroke platform, and for patient safety to be prioritized in enrolment-related decisions with family input whenever feasible. The need to have trial information accessible in digestible chunks, multiple languages, and modalities, was emphasized. To facilitate engagement, transparency, trust, and two-way communication was deemed critical to the informed consent process. Conclusion: Patient-partners were supportive of an adaptive platform trial design. However, they expressed important priorities in their execution whilst safeguarding patient autonomy and safety. Oversight, multiple modes of delivering patient information, and having feedback evaluation and transparency with ongoing participation were identified as valued components. Deferral of consent was recognized as a pragmatic way to enrol patients. Similar considerations may apply to adaptive platform trials in other neurological/medical emergencies.
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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 | 0.006 | 0.040 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.678 | 0.109 |
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".