Evaluating the usefulness and reporting quality of randomized clinical trials for pediatric tonsillectomy pharmacologic interventions: A systematic assessment

Randomized controlled trials (RCTs) underpin evidence-based perioperative and pharmacologic care in pediatric tonsillectomy, yet their real-world usefulness depends on clinically meaningful design and transparent reporting. We applied the van 't Hooft usefulness framework, an eight-criterion, 13-item instrument derived from the features of useful clinical research described by Ioannidis, to appraise the usefulness and reporting quality of contemporary pediatric tonsillectomy pharmacology RCTs.

We systematically identified RCTs of pharmacologic interventions in children undergoing tonsillectomy or adenotonsillectomy, published in English between 2019 and 2025. Records were screened in duplicate (Rayyan) with third-reviewer adjudication. Each trial was scored on 13 items across two domains (core clinical utility and transparency) on a 0-2 scale (0 = not fulfilled, 1 = partial, 2 = full; maximum composite score 26). The problem-base item was adjudicated by an otolaryngology resident physician. We summarized item- and domain-level fulfillment, examined temporal trends, and assessed the correlation between the utility and transparency domains.

Sixty-two RCTs met inclusion criteria. The median composite usefulness score was 11 of 26 (IQR 10-15; mean 11.8 ± 3.8), and only 1 trial (1.6%) exceeded 75% of the maximum. Most trials were conducted in Asia (41; 66%) and published in general medicine (21; 34%) or otolaryngology (19; 31%) journals; the median journal impact factor was 2.00 (IQR 1.30-2.90). Pragmatic design was nearly absent (0 trials fully pragmatic; 60/62 [96.8%] non-pragmatic), no trial included a value-for-money assessment (62/62 [100%] absent), and only 7 trials (11.3%) made raw data available. Utility and transparency domain scores were weakly positively correlated (r = 0.30, p = 0.016). Composite usefulness increased modestly over the study period (+0.75 points/year, p = 0.018), driven by the utility domain; journal impact factor was the only independent predictor of usefulness in multivariable analysis (β = 0.57, p = 0.049).

Contemporary pediatric tonsillectomy pharmacology RCTs show consistent deficits in pragmatism, patient-centered design, economic evaluation, and data transparency. Systematic adoption of the van 't Hooft usefulness criteria and established reporting standards (SPIRIT, CONSORT) at the design stage could help improve the clinical value of future trials in this high-volume surgical population.