维生素 D 补充对膝骨关节炎（OA）患者疼痛和身体功能的影响：OA 试验库系统评价和个体患者数据（IPD）荟萃分析方案。
Effect of vitamin D supplementation on pain and physical function in patients with knee osteoarthritis (OA): an OA Trial Bank protocol for a systematic review and individual patient data (IPD) meta-analysis.
机构信息
Zhujiang Hospital, Southern Medical University, Guangzhou, China
Centre for Big Data Research in Health, University of New South Wales, Sydney, New South Wales, Australia.
出版信息
BMJ Open. 2020 Apr 23;10(4):e035302. doi: 10.1136/bmjopen-2019-035302.
INTRODUCTION
Observational data suggest that vitamin D deficiency is associated with the onset and progression of knee osteoarthritis (OA). However, randomised controlled trials (RCTs) to date investigating the efficacy of vitamin D supplementation in knee OA have reported conflicting results. Further research is needed to clarify the effects of vitamin D on patient-reported outcomes and determine whether there are patient subgroups who may benefit from the supplementation. The aim of this individual patient data (IPD) meta-analysis is to identify patient-level predictors of treatment response to vitamin D supplementation on pain and physical function.
METHODS AND ANALYSIS
A systematic literature search will be conducted for RCTs of vitamin D supplementation on knee OA. Authors of original RCTs will be contacted to obtain the IPD. The primary outcomes will include long-term (≥12 months) pain and physical function. Secondary outcomes will include medium-term (≥6 months and <12 months) and short-term (<6 months) pain and physical function, as well as patient global assessment, quality of life and adverse events. Potential treatment effect modifiers to be examined in the subgroup analyses include age, gender, body mass index, baseline knee pain severity and physical function, baseline vitamin D level, radiographic stage, presence of bone marrow lesions on MRI, presence of clinical signs of local inflammation and concomitant depressive symptoms. Both one-step and two-step modelling methods will be used to determine the possible modifiable effect of each subgroup of interest.
ETHICS AND DISSEMINATION
Research ethical or governance approval is exempt for this study as no new data are being collected. This study will be the first IPD meta-analysis to clarify the effect of vitamin D supplementation on clinical symptoms in different subgroups of patients with knee OA. The findings will be disseminated through peer-review publications and conference presentations.
PROSPERO REGISTRATION NUMBER
CRD42018107740.
简介
观察性数据表明，维生素 D 缺乏与膝关节骨关节炎（OA）的发病和进展有关。然而，迄今为止，针对维生素 D 补充剂治疗膝骨关节炎疗效的随机对照试验（RCT）报告的结果相互矛盾。需要进一步的研究来阐明维生素 D 对患者报告的结局的影响，并确定是否有特定的患者亚组可能从补充剂中获益。本项个体患者数据（IPD）荟萃分析的目的是确定维生素 D 补充治疗对膝关节 OA 患者疼痛和身体功能的治疗反应的患者个体预测因素。
方法和分析
将对维生素 D 补充治疗膝关节 OA 的 RCT 进行系统文献检索。将联系原始 RCT 的作者以获取 IPD。主要结局包括长期（≥12 个月）疼痛和身体功能。次要结局包括中期（≥6 个月且<12 个月）和短期（<6 个月）疼痛和身体功能，以及患者总体评估、生活质量和不良事件。亚组分析中检查的潜在治疗效应修饰因子包括年龄、性别、体重指数、基线膝关节疼痛严重程度和身体功能、基线维生素 D 水平、放射学分期、MRI 上骨髓病变的存在、局部炎症的临床体征和并存的抑郁症状。将使用一步法和两步法模型来确定每个感兴趣的亚组的可能可修饰效应。
伦理和传播
本研究无需研究伦理或治理批准，因为不会收集新数据。这将是第一项阐明维生素 D 补充剂对不同膝关节 OA 患者亚组临床症状影响的 IPD 荟萃分析。研究结果将通过同行评审出版物和会议演讲进行传播。
前瞻性注册编号
CRD42018107740。
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