Design, analysis, and reporting of pilot and feasibility trials in anesthesiology: a methodological study
Bibliographic record
Abstract
BACKGROUND: Pilot and feasibility studies are effective tools for assessing the feasibility of performing larger-scale studies. These are particularly useful in anesthesiology, where the research overlaps with several other medical and surgical fields. The objective of this meta-epidemiological study is to assess the design and methodology of pilot and feasibility randomized controlled trials (RCTs) in anesthesiology. METHODS: We searched for pilot and feasibility RCTs in anesthesiology indexed in PubMed during a 5-year span between January 1, 2018, and December 31, 2022. We extracted bibliographic information, field of study, type of intervention, trial duration, trial design, use of qualitative data, use of progression criteria, whether the primary objective and primary outcome were related to feasibility, reported feasibility outcomes, and sample size justification. We conducted logistic regression to determine the factors associated with using progression criteria, having primary feasibility outcomes, and using feasibility outcomes to justify the sample size. We controlled for publication year, journal impact factor, source of funding, intervention type, and region. RESULTS: Our search retrieved 3015 trials, of which 248 were ultimately included and analyzed. Less than a third of studies stated feasibility as the primary objective (n = 77, 31.0%). Feasibility was a primary outcome in 46 (18.6%) studies, progression criteria were used in 27 (10.9%) studies, a sample size justification was listed in 134 (54.0%) studies, and 24 (9.7%) studies used qualitative data. We did not find any statistically significant association between progression criteria and any of the selected variables. Recently published trials had higher odds of having primary feasibility outcomes (odds ratio [OR] 1.39; 95% CI 1.06-1.83). Studies of pharmacological interventions had lower odds primary feasibility outcomes (OR 0.41; 95% CI 0.19-0.90). Recent studies also had higher odds of having a sample size justification based on a feasibility outcome rather than a clinical outcome or similar studies (OR 1.51; 95% CI 1.06-2.15). CONCLUSIONS: More recently published pilot RCTs were significantly associated with having a primary feasibility outcome and determining sample size based on feasibility, while pharmacological studies were significantly associated with less reporting of primary feasibility outcomes. Future research addressing the factors limiting adherence to current guidelines is warranted.
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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 | 0.745 | 0.873 |
| Meta-epidemiology (narrow) | 0.004 | 0.005 |
| Meta-epidemiology (broad) | 0.012 | 0.021 |
| Bibliometrics | 0.028 | 0.027 |
| Science and technology studies | 0.004 | 0.008 |
| Scholarly communication | 0.011 | 0.018 |
| Open science | 0.007 | 0.008 |
| Research integrity | 0.007 | 0.004 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".