Development and challenges in setting up an international bone infection registry
Development and challenges in setting up an international bone infection registry
复制标题
DOI：
10.1007/s00402-019-03303-7
复制
发表时间：
2019-11-07
影响因子：
2.3
通讯作者：
Chen, Maio S.
中科院分区：
文献类型：
--
作者：
Kates, Stephen L.;Hurni, Severine;Chen, Maio S.
前言骨髓炎是一种日益加重的社会负担，尤其是由于多重耐药菌的出现。缺乏前瞻性地收集关于患者风险因素、实验室测试结果、治疗方式、血清学分析结果和结果的数据的中央登记机构的缺乏，阻碍了本可以改善和提供骨感染治疗指南的研究努力。目前的手稿描述了在建立多大洲登记册方面吸取的经验教训。材料和方法这项多中心的国际登记旨在前瞻性地收集重要的患者、临床和外科数据，并进行为期一年的随访期。18岁或以上的患者通过骨折固定或关节成形术确诊为金黄色葡萄球菌长骨感染，他们同意参与研究。在基线、1个月、6个月和12个月时，使用简明36健康调查问卷(版本2)、Parker活动评分和Katz日常生活能力独立指数来评估结果。在随访时收集血清学样本。结果与大量研究地点进行合同谈判是困难的；获得伦理批准是耗时但直接的。最初的患者招募速度很慢，导致目标患者数量从400人减少到300人，并延长了招生期限。最后，18个研究地点(在亚洲、北美和南美洲以及中欧的10个国家)招募了292名符合条件的患者。通过雇用信使服务和当地监测人员，克服了后勤和语言障碍。结论多中心登记有助于收集大量病例进行分析。明确的数据收集做法对数据质量很重要，但要与大量研究地点协调起来具有挑战性。
Introduction Osteomyelitis is an increasing burden on the society especially due to the emergence of multiple drug-resistant organisms. The lack of a central registry that prospectively collects data on patient risk factors, laboratory test results, treatment modalities, serological analysis results, and outcomes has hampered the research effort that could have improved and provided guidelines for treatments of bone infections. The current manuscript describes the lessons learned in setting up a multi-continent registry. Materials and methods This multicenter, international registry was conducted to prospectively collect essential patient, clinical, and surgical data with a 1-year follow-up period. Patients 18 years or older with confirmed S. aureus long bone infection through fracture fixation or arthroplasty who consented to participate in the study were included. The outcomes using the Short Form 36 Health Survey Questionnaire (version 2), Parker Mobility Score, and Katz Index of Independence in Activities of Daily Living were assessed at baseline and at 1 month, 6 months, and 12 months. Serological samples were collected at follow-ups. Results Contract negotiation with a large number of study sites was difficult; obtaining ethics approvals were time-consuming but straightforward. The initial patient recruitment was slow, leading to a reduction of target patient number from 400 to 300 and extension of enrollment period. Finally, 292 eligible patients were recruited by 18 study sites (in 10 countries of 4 continents, Asia, North and South America, and Central Europe). Logistical and language barriers were overcome by employing courier service and local monitoring personnel. Conclusions Multicenter registry is useful for collecting a large number of cases for analysis. A well-defined data collection practice is important for data quality but challenging to coordinate with the large number of study sites.