开发和验证一个新的巴雷特食道患者报告的结果测量 (B-PROM) 的发展和验证
Elizabeth Ratcliffe1,2, James Britton2,3, Sharon Baines3
1Gastroenterology Department, Wrightington Wigan and Leigh NHS Foundation Trust, Wigan, UK.
EClinicalMedicine
|May 15, 2024
概括
开发并验证了一种新的巴雷特食道 (BO) 患者报告的结果测量 (PROM),B-PROM. 该工具有效评估患者关键问题,如癌症的担忧和症状,为临床使用提供可靠的测量方法.
科学领域:
- 胃肠病学和临床研究方法.
- 开发和验证患者报告的结果指标 (PROM).
背景情况:
- 巴雷特食道 (BO) 患者经历了严重的癌症担忧,症状负担,缺乏疾病特异性的知识.
- 目前没有可用于临床实践和研究的经过验证的BO特定PROM.
- 这项研究旨在创建和验证一种新的工具,B-PROM,以解决这些未满足的需求.
研究的目的:
- 开发和验证一种针对巴雷特食道 (Barrett's oesophagus,BO) 的新型患者报告结果测量方法 (PROM).
- 创建一个简洁的工具,解决患者关键问题,包括知识,信任,症状,癌症担忧和监测负担.
- 确保B-PROM具有强大的心理测量特性,可在临床和研究环境中可靠使用.
主要方法:
- 项目生成由文献审查和混合方法研究提供信息.
- 通过修改的Delphi流程 (2021年5月至8月) 改进项目银行.
- 通过认知面试和多中心测试对387名参与者进行验证 (2021年9月至2023年2月).
主要成果:
- B-PROM涵盖疾病知识,临床医生信任,症状负担,癌症担忧和监测负担.
- 验证表明完成率高 (>95%),平均完成时间为5分34秒,内部一致性强 (克朗巴赫α = 0.846).
- 证实了卓越的测试重复测试可靠性,测量没有显著差异.
结论:
- B-PROM是第一个专门针对巴雷特食道的系统评估的PROM.
- 验证结果表明强大的内部一致性,效率,低缺失率和出色的可靠性.
- B-PROM是一个有价值的新工具,用于评估BO护理和研究中患者报告的关键结果.
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