Prevalence and Methodological Characteristics of Subgroup Analyses in Stepped Wedge Cluster Randomised Trials: Protocol for a Systematic Review
Bibliographic record
Abstract
Abstract Background: The stepped wedge cluster randomised trial is an increasingly common trial design. The design can be useful for informing real-world clinical decision-making, including decisions about the effectiveness of interventions in particular subgroups. However, there is little existing guidance about how to perform subgroup analyses in the stepped wedge design. We aim to determine the prevalence of subgroup analyses and describe statistical methods used to perform them in stepped wedge cluster randomised trials.Methods: We will conduct a systematic review following the methodology recommended in the Cochrane Handbook for Systematic Reviews of Interventions. We report this protocol according to the PRISMA-P checklist. The protocol has been registered in the Open Science Framework. We will search for terms related to ‘stepped wedge’. Sources will be PubMed, Embase, PsycINFO, Web of Science, CINAHL, Cochrane Library, and Current Controlled Trials Register up to 16 October 2020. Studies will be eligible if they are written in English, involve human participants and are primary or secondary reports of planned or completed stepped wedge cluster randomised trials. Two reviewers will first screen the titles and abstracts, then full texts, to select studies that should be included in the review. Disagreements will be solved by consensus through discussion with a third reviewer. We will extract data related to study characteristics including presence or absence of subgroup analyses, characteristics of subgroup variables examined, statistical methods used to perform subgroup analyses, and adherence to the most consistently recommendations suggested for subgroup analyses in general including in clinical trials. We will perform a qualitative synthesis of the extracted data.Discussion: This protocol offers a reproducible and transparent procedure for a systematic review of the literature. It will provide a portrait of the frequency and types of subgroup analyses performed in stepped wedge cluster randomised trials. These results will inform the development of recommendations for subgroup analyses in such trials.Systematic review registration: This protocol has been registered on Open Science Framework, Registration ID: https://osf.io/2kwrz.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | Metaresearch Domain: Methods · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Systematic review | high |
| gpt | Metaresearch Domain: Methods · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Systematic review | medium |
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 | 0.259 | 0.444 |
| Meta-epidemiology (narrow) | 0.007 | 0.007 |
| Meta-epidemiology (broad) | 0.021 | 0.027 |
| Bibliometrics | 0.017 | 0.019 |
| Science and technology studies | 0.004 | 0.009 |
| Scholarly communication | 0.009 | 0.012 |
| Open science | 0.006 | 0.008 |
| Research integrity | 0.012 | 0.012 |
| Insufficient payload (model declined to judge) | 0.044 | 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, unvalidatedLabeled directly by 2 models reading the full record.
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".