循证初步构建老年肌少症营养功能性食品临床试验指标池

Initiative evidence-based establishment of an indicator pool for clinical evaluation of nutritional and functional food for the elderly with sarcopenia

摘要:

目的 构建老年肌少症营养功能性食品临床试验指标池,为后续确定核心指标集提供依据。方法 检索中国知网、维普、万方、Ovid-Embase、Cochrane Library和PubMed数据库中老年肌少症营养功能性食品干预相关随机对照研究,提取其结局指标集合(A)；检索中、美临床试验注册平台相关试验方案,提取其结局指标集合(B)；采用便利抽样法,以半开放式问卷对全国17家该领域影响力较大的三甲医院的临床医师及患者进行调查,收集医师所关注的结局指标集合(C)和患者所关注的结局指标集合(D)。综合A、B、C、D共4个指标集合,初步构建5个维度、共64个末级指标的指标池。结果 共纳入16篇随机对照研究和15个临床试验方案,经过结局指标提取,获得A集合结局指标95个,B集合结局指标86个；共调研86名医师和85例患者意见,收集到C集合结局指标38个、D集合结局指标35个。按照既定的指标纳入排除方法,经过工作组讨论,确定含有末级指标64个的指标池。结论 本研究建立了老年肌少症营养功能性食品临床试验指标池,并发现该领域临床试验结局指标存在异质性及不一致等问题,对后续构建老年肌少症营养功能性食品临床试验核心指标集具有重要意义。

Abstract:

Objective To establish an indicator pool for clinical trials on nutritional and functional food interventions for the elderly with sarcopenia as the basis of subsequent core outcome set. Methods CNKI, VIP, WANFANG DATA, Ovid-Embase, Cochrane Library and PubMed databases were electronically searched to collect randomized control trials on nutritional and functional food interventions for the elderly with sarcopenia. The outcome indicators were extracted as set A. Chi-CTR and the Clinical Trials were then searched to collect the related registration schemes, and the outcome indicators were extracted to form set B. Using the convenience sampling, a semi-open questionnaire survey was conducted among the clinicians and patients in 17 first-class tertiary hospitals with great influence in this field to collect the set (C) of outcome indicators concerned by the doctors and the set (D) of outcome indicators concerned by the patient. A 5-dimension indicators pool of 64 end-class indicators was initially constructed by integrating the sets A, B, C and D. Results A total of 16 randomized control studies and 15 clinical trial protocols were included, yielding 95 outcomes in set A and 86 in set B. A total of 86 doctors and 85 patients′ opinions were investigated, and 38 and 35 outcome indicators were collected in set C and set D. According to inclusion and exclusion standard of indicators, a final pool of 64 terminal indicators was established. Conclusion This study established an indicator pool for the elderly patients with sarcopenia and found heterogeneity and inconsistencies in the outcome indicators of clinical trials in this field. It is of great significance to continue constructing the core outcome set on nutritional and functional food interventions for those patients.