Methodology standards associated with quality reporting in clinical studies in pediatric surgery journals

Background/Purpose: Reports of clinical trials often lack adequate descript ions of design and analysis; recent attention has focused on improving this omission so readers can properly assess the strength of the findings and d raw their own conclusions. Similar analysis of study design and methodologi c standards associated with quality reporting has not been carried out for pediatric surgery journals. Methods: All studies (n = 642) published in 1998 in Journal of Pediatric Su rgery (JPS) and Pediatric Surgery International (PSI), were reviewed for de mographic data and study design. The frequency of reporting of 11 basic ele ments of design and analysis was evaluated in randomized clinical trials (R CT), nonrandomized clinical trials (NRCT), and retrospective cohorts (RC) f rom JPS by consensus of 2 assessors. Results: Of the 642 studies, 17% of articles (111 of 642) were classified a s clinical studies. Sixty-three were comparative studies and consisted of R C (n = 48), NRCT (n = 12), and RCT (n = 3). Two-thirds of articles publishe d were either case reports or case series (431 of 642), and 16% were basic science articles. Demographic analysis showed a wide range of topics addres sed, 4 authors per article, and multiple country of origin of authors. More than 66% of all RCT in JPS reported on eligibility criteria, admission bef ore allocation, random allocation, method of randomization, patients' blind ness to treatment, treatment complications, statistical analyses, statistic al methods, loss to follow-up, and statistical methods; 2 elements of desig n and analysis, however, were poorly reported: blind assessment of outcome (33%) and power (17%). Conclusions: There were few randomized, controlled trials in pediatric surg ery journals, and further attention should be given to evaluate the causal factors. Nine elements of quality reporting were well reported; however, 2 others were poorly reported; this may improve if editors of pediatric surgi cal journals provide authors with guidelines on how to report clinical tria l design and analysis. J Pediatr Surg 36:1160-1164. Copyright (C) 2001 by W .B. Saunders Company.