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开展一项多中心回顾性研究。

Performing a Multicenter Retrospective Study.

作者信息

Ramgopal Sriram, Benedetti Jillian, Cotter Jillian M

机构信息

Division of Emergency Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Office of Clinical and Community Trials, Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.

出版信息

Hosp Pediatr. 2025 Feb 1;15(2):e77-e82. doi: 10.1542/hpeds.2024-008020.

Abstract

Multicenter retrospective studies can provide a pragmatic approach to evaluating uncommon pediatric conditions and are less expensive than prospective research. A well-executed retrospective multicenter study, with rigorous study design, systematic data collection, and robust statistical analysis, can produce clinically important and generalizable findings A variety of observational designs can be employed, including cross-sectional, cohort, and case-control studies. Selection bias, ascertainment bias, and confounding are common issues in retrospective research. Key steps include development of a feasible study design, regular contact with site investigators, and detailed data collection and management strategies. Principal investigators must seek to ensure that case ascertainment and data collection are consistent across sites, using manual and/or automated data extraction methods. Operations manuals, training sessions, and regular meetings can be used to ensure data reliability. Ethical considerations include obtaining institutional review board approval and establishing data use agreements. A proactive statistical approach to handling missing data, using techniques like multiple imputation and sensitivity analyses, is necessary. Careful planning, effective collaboration, and embracing technological advancements will enhance the value and accuracy of retrospective multicenter studies. This article discusses important considerations in the performance of a retrospective multicenter study.

摘要

多中心回顾性研究可为评估罕见儿科疾病提供一种实用方法,且比前瞻性研究成本更低。一项执行良好的回顾性多中心研究,具备严谨的研究设计、系统的数据收集和强大的统计分析,能够得出具有临床重要性且可推广的结果。可以采用多种观察性设计,包括横断面研究、队列研究和病例对照研究。选择偏倚、确定偏倚和混杂是回顾性研究中的常见问题。关键步骤包括制定可行的研究设计、与研究点调查人员定期联系以及详细的数据收集和管理策略。主要研究者必须设法确保各研究点的病例确定和数据收集一致,可使用手动和/或自动数据提取方法。操作手册、培训课程和定期会议可用于确保数据可靠性。伦理考量包括获得机构审查委员会的批准和建立数据使用协议。采用多重填补和敏感性分析等技术对缺失数据进行积极的统计处理方法是必要的。精心规划、有效协作并采用技术进步将提高回顾性多中心研究的价值和准确性。本文讨论了进行回顾性多中心研究的重要注意事项。

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