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- Title
Core Outcome Sets in Child Health: A Systematic Review.
- Authors
Lei, Ruobing; Shen, Quan; Yang, Bo; Hou, Tianchun; Liu, Hui; Luo, Xufei; Li, Yuehuan; Zhang, Junhua; Norris, Susan L.; Chen, Yaolong
- Abstract
Key Points: Question: What core outcome sets have been developed in child health, and how was the development process? Findings: In this systematic review including 77 core outcome sets, nearly half of outcomes presented were not classified in any coherent manner, and the recommended standard, the Core Outcome Measures in Effectiveness Trials outcome classification, did not adequately address pediatric core outcome sets. A variety of different methods were used, although none of the core outcome sets involved all 6 types of stakeholders in the development process. Meaning: Both the quantity and quality of pediatric core outcome sets have improved over time, but there is still significant room for improvement. This systematic review identifies core outcome sets in child health, describes the methods used for development and stakeholder participation, and evaluates the methodological quality of existing core outcome sets. Importance: Developing core outcome sets is essential to ensure that results of clinical trials are comparable and useful. A number of core outcome sets in pediatrics have been published, but a comprehensive in-depth understanding of core outcome sets in this field is lacking. Objective: To systematically identify core outcome sets in child health, collate the diseases to which core outcome sets have been applied, describe the methods used for development and stakeholder participation, and evaluate the methodological quality of existing core outcome sets. Evidence Review: MEDLINE, SCOPUS, Cochrane Library, and CINAHL were searched using relevant search terms, such as clinical trials, core outcome, and children, along with relevant websites, such as Core Outcome Measures in Effectiveness Trials (COMET). Four researchers worked in teams of 2, performed literature screening and data extraction, and evaluated the methodological quality of core outcome sets using the Core Outcome Set–Standards for Development (COS-STAD). Findings: A total of 77 pediatric core outcome sets were identified, mainly developed by organizations or researchers in Europe, North America, and Australia and mostly from the UK (22 [29%]) and the US (22 [29%]). A total of 77 conditions were addressed; the most frequent International Classification of Diseases, 11th Revision category was diseases of the digestive system (14 [18%]). Most of the outcomes in pediatric core outcome sets were unordered (34 [44%]) or presented in custom classifications (29 [38%]). Core outcome sets used 1 or more of 8 development methods; the most frequent combination of methods was systematic review/literature review/scoping review, together with the Delphi approach and consensus for decision-making (10 [14%]). Among the 6 main types of stakeholders, clinical experts were the most frequently involved (74 [100%]), while industry representatives were rarely involved (4 [5%]). Only 6 core outcome sets (8%) met the 12 criteria of COS-STAD. Conclusions and Relevance: Future quality of pediatric core outcome sets should be improved based on the standards proposed by the COMET initiative, while core outcome sets methodology and reporting standards should be extended to pediatric populations to help improve the quality of core outcome sets in child health. In addition, the COMET outcome taxonomy should also add items applicable to children.
- Subjects
MEDICAL databases; CINAHL database; CONSENSUS (Social sciences); EVALUATION of medical care; NOSOLOGY; DIGESTIVE system diseases; SYSTEMATIC reviews; STAKEHOLDER analysis; HEALTH outcome assessment; PEDIATRICS; CHILDREN'S health; DECISION making; DESCRIPTIVE statistics; MEDLINE; DELPHI method
- Publication
JAMA Pediatrics, 2022, Vol 176, Issue 11, p1131
- ISSN
2168-6203
- Publication type
Article
- DOI
10.1001/jamapediatrics.2022.3181