■根据基于社区的健康测量指标选择标准(COSMIN)的指南,总结并评估以中医(TCM)为特征的呼吸系统疾病患者报告结果(PRO)量表的内容并评估其方法学质量和测量特性。
■PubMed,WebofScience,Embase,中国国家知识基础设施(CNKI),万方数据,VIP,从成立之初到2022年12月,都在中国生物医学(CBM)的研究中搜索了中医针对呼吸系统疾病的PRO量表。对PRO量表的特点进行了定性总结。按照COSMIN准则,根据检查表评估偏差的风险,和不同的测量属性(内容效度,结构有效性,内部一致性,可靠性,标准有效性,和反应性)进行了评估。最后,对证据的整体质量进行了评估,建议是使用修改后的等级方法制定的。
■共包括13个量表,6用于慢性阻塞性肺疾病(COPD),3肺癌,2为特发性肺纤维化(IPF),1用于社区获得性肺炎(CAP),1为支气管扩张。所有13种量表均为疾病特异性量表,是根据中国文化背景开发的,用于衡量中医疗效。这项研究没有提供测量误差的信息,跨文化有效性,并对这些措施的结构有效性进行假设检验。没有量表在内容效度和响应性方面被评为足够。两个量表显示出足够的结构效度,而11个量表表现出足够的内部一致性。三个量表证明了足够的可靠性,7个量表显示出足够的标准效度。所有13种量表均具有B的推荐水平。
■13种量表可反映中医临床疗效,适用于中国人群。然而,这些量表的验证不够全面,他们的研究方法质量需要进一步加强。
UNASSIGNED: To summarize the contents and assess the methodological quality and measurement properties of the patient-reported outcome (PRO) scales featured with Traditional Chinese Medicine (TCM) for respiratory diseases based on the guideline of COnsensus-based Standards for the selection of health Measurement INstruments (
COSMIN).
UNASSIGNED: PubMed, Web of Science, Embase,
China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, and
China Biology Medicine (CBM) were searched for studies on PRO scales featured with TCM for respiratory diseases from their inception until December 2022. The characteristics of the PRO scales were qualitatively summarized. Following the
COSMIN guideline, the risk of bias was assessed according to the checklist, and different measurement properties (content validity, structural validity, internal consistency, reliability, criterion validity, and responsiveness) were evaluated. Finally, the evidence\'s overall quality was assessed, and the recommendation was formulated using the modified GRADE approach.
UNASSIGNED: A total of 13 scales were included, with 6 for chronic obstructive pulmonary disease (COPD), 3 for lung cancer, 2 for idiopathic pulmonary fibrosis (IPF), 1 for community-acquired pneumonia (CAP), and 1 for bronchiectasis. All 13 scales are disease-specific scales and were developed based on Chinese cultural background to measure the efficacy of TCM. The study did not provide information on measurement error, cross-cultural validity, and hypothesis testing for the construct validity of these measures. No scale was rated as sufficient in content validity and responsiveness. Two scales showed sufficient structural validity, while 11 scales exhibited sufficient internal consistency. Three scales demonstrated sufficient reliability, and 7 scales showed sufficient criterion validity. All 13 scales have a recommendation level of B.
UNASSIGNED: The 13 scales could reflect the clinical efficacy of TCM and are suitable for the Chinese population. Nevertheless, the validation of these scales was not comprehensive enough, and the methodological quality of their studies needs to be further strengthened.