Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews
Bibliographic record
Abstract
BACKGROUND: Complete and transparent reporting of clinical trial protocols and reports ensures that these documents are useful to all stakeholders, that bias is minimized, and that the research is not wasted. However, current studies repeatedly conclude that pediatric trial protocols and reports are not appropriately reported. Guidelines like SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) may improve reporting, but do not offer guidance on issues unique to pediatric trials. This paper reports two systematic reviews conducted to build the evidence base for the development of pediatric reporting guideline extensions: 1) SPIRIT-Children (SPIRIT-C) for pediatric trial protocols, and 2) CONSORT-Children (CONSORT-C) for pediatric trial reports. METHOD: MEDLINE, the Cochrane Methodology Register, and reference lists of included studies were searched. Publications of any type were eligible if they included explicit recommendations or empirical evidence for the reporting of potential items in a pediatric protocol (SPIRIT-C systematic review) or trial report (CONSORT-C systematic review). Study characteristics, recommendations and evidence for pediatric extension items were extracted. Recurrent themes in the recommendations and evidence were identified and synthesized. All steps were conducted by two reviewers. RESULTS: For the SPIRIT-C and CONSORT-C systematic reviews 366 and 429 publications were included, respectively. Recommendations were identified for 48 of 50 original reporting items and sub-items from SPIRIT, 15 of 20 potential SPIRIT-C reporting items, all 37 original CONSORT items and sub-items, and 16 of 22 potential CONSORT-C reporting items. The following overarching themes of evidence to support or refute the utility of reporting items were identified: transparency; reproducibility; interpretability; usefulness; internal validity; external validity; reporting bias; publication bias; accountability; scientific soundness; and research ethics. CONCLUSION: These systematic reviews are the first to systematically gather evidence and recommendations for the reporting of specific items in pediatric protocols and trials. They provide useful and translatable evidence on which to build pediatric extensions to the SPIRIT and CONSORT reporting guidelines. The resulting SPIRIT-C and CONSORT-C will provide guidance to the authors of pediatric protocols and reports, respectively, helping to alleviate concerns of inappropriate and inconsistent reporting, and reduce research waste.
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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 | 0.476 | 0.775 |
| Meta-epidemiology (narrow) | 0.006 | 0.008 |
| Meta-epidemiology (broad) | 0.018 | 0.031 |
| Bibliometrics | 0.046 | 0.040 |
| Science and technology studies | 0.006 | 0.010 |
| Scholarly communication | 0.018 | 0.021 |
| Open science | 0.012 | 0.014 |
| Research integrity | 0.020 | 0.017 |
| Insufficient payload (model declined to judge) | 0.010 | 0.005 |
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".