[关键词]
[摘要]
【目的】 采用国际公认的研究方法,构建维吾尔医(维医)治疗银屑病临床研究核心指标集,帮助研究者规范选择结局 指标,提高研究结果的证据质量。【方法】 系统检索中英文数据库,收集维医治疗银屑病的临床研究、系统评价及注册方案 中包含的结局指标,构建结局指标条目池,并通过患者和医生定性调查对条目池进行补充,形成初始指标池清单。以此清 单为基础进行两轮德尔菲(Delphi)调查,获得不同利益群体对结局指标重要性的Likert评分,然后通过共识会议,最终确定 维医治疗银屑病临床研究核心指标集。【结果】 维医治疗银屑病临床研究核心指标集包含6个指标域,共14个结局指标:银 屑病症状(银屑病面积和严重程度)、皮损严重程度(红斑、鳞屑、浸润度等)、医生整体评估、患者总体评估、治疗满意度、 健康相关生活质量、复发率、不良事件、药物不良反应、血常规、尿常规、肝肾功能、维吾尔医证候症状评价、体液变化。 【结论】 构建的维医治疗银屑病临床研究核心指标集,可为相关研究疗效评价指标的选择及报告提供参考依据。
[Key word]
[Abstract]
Objective To construct the core outcome set (COS) for clinical research on Uyghur medicine in treating psoriasis by using internationally-recognized research methods, thus to aid the researchers in choosing the standardized outcomes and to enhance the quality of evidence from research findings. Methods A systematic retrieval of Chinese and English databases was conducted to collect outcomes from clinical studies, systematic reviews,and registered protocols of Uyghur medicine for treating psoriasis. An outcome pool was constructed based on the results of literature review. The outcomes were supplemented after qualitative surveys of patients and physicians,and then an initial list of outcomes was formed. Two rounds of Delphi surveys on the initial list were conducted for obtaining Likert scale ratings from different stakeholder groups to evaluate the importance of outcomes. After that,a consensus meeting was held to finalize the COS for clinical research on Uyghur medicine in treating psoriasis. Results The COS for clinical research on Uyghur medicine in treating psoriasis comprises six domains,totaling 14 outcomes. The 14 outcomes were psoriasis symptoms (psoriasis area and area severity index),skin manifestations(erythema, scaling, infiltration, etc.), investigator global assessment, patient global assessment,treatment satisfaction,health-related quality of life,recurrence rate,adverse events,drug adverse reactions,blood routine,urine routine,liver and kidney function,Uyghur medicine symptom assessment,and fluid changes. Conclusion The COS for clinical research on Uyghur medicine in treating psoriasis has been constructed,and will provide a reference for the selection of efficacy-evaluation outcomes and for the reporting of outcomes in related studies.
[中图分类号]
R291.5
[基金项目]
新疆维吾尔自治区重点研发计划项目 (编号:2022B03012-1)