How often are patient-important outcomes represented in neonatal randomized controlled trials? an analysis of cochrane neonatal reviews

Nai Ming Lai, Denise Yin Xian Leom, Wen Li Chow, Kee Hsin Chen, Pu Hong Lin, Nathorn Chaiyakunapruk, Colleen Ovelman, Roger Soll

研究成果: 雜誌貢獻回顧型文獻

摘要

Background: Research findings based on patient-important outcomes (PIOs) provide more useful conclusions than those that are based on surrogate outcomes. It is unclear to what extent PIOs are represented in neonatal randomized controlled trials (RCTs). Objectives: We determined the proportion of PIOs in neonatal RCTs included in Cochrane Neonatal reviews. Methods: We extracted up to 5 outcomes from each RCT included in Cochrane Neonatal reviews published until January 2018, with independent determination of PIOs among authors followed by a discussion leading to a consensus. We defined PIOs as outcomes that matter to patient care, such as clinical events or physiological or laboratory parameters that are widely used to guide management. Results: Among 6,832 outcomes extracted from 1,874 RCTs included in 276 reviews, 5,349 (78.3%) were considered PIOs; 461 studies (24.5%) included 5 or more PIOs, 1,278 (68.2%) included 1-4 PIOs, while 135 (7.2%) had no PIO included. PIOs were observed more often among dichotomous than among continuous outcomes (94.9 vs. 61.5%; RR: 1.54; 95% CI: 1.50-1.58), and more among subjective than among objective outcomes (95.9 vs. 76.8%; RR: 1.25; 95% CI: 1.22-1.28). Newer studies were more likely to have a greater number of PIOs (adjusted OR: 1.033 [95% CI: 1.025-1.041] with each publication year). Conclusions: The large and increasing representation of PIOs over the years suggests an improving awareness by neonatal trialists of the need to incorporate important outcomes in order to justify the utilization of resources. Further research should explore the reasons for non-inclusion or non-reporting of PIOs in a small proportion of RCTs.

原文英語
頁數8
期刊Neonatology
DOIs
出版狀態接受/付印 - 一月 1 2020

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Developmental Biology

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  • 引用此

    Lai, N. M., Leom, D. Y. X., Chow, W. L., Chen, K. H., Lin, P. H., Chaiyakunapruk, N., Ovelman, C., & Soll, R. (認可的出版社/出版中). How often are patient-important outcomes represented in neonatal randomized controlled trials? an analysis of cochrane neonatal reviews. Neonatology. https://doi.org/10.1159/000506703