Vach Werner, Saxer Franziska, Holsgaard-Larsen Anders, Overgaard Soeren, Farin-Glattacker Erik, Bless Nicolas, Bucher Heiner C, Jakob Marcel
Department of Orthopaedics and Traumatology, University Hospital Basel, Switzerland.
Orthopaedic Research Unit, Department of Clinical Research, University of Southern Denmark and Department of Orthopaedics and Traumatology, Odense University, Odense C, Denmark.
Swiss Med Wkly. 2018 Nov 18;148:w14680. doi: 10.4414/smw.2018.14680. eCollection 2018 Nov 5.
BACKGROUND Surgical registries are becoming increasingly popular. In addition, Swiss legislation requires data on therapeutic outcome quality. The Swiss Association of Surgeons (Schweizerische Gesellschaft Chirurgie, SGC-SCC) has already agreed on a first minimum data set. However, in the long run the scope and content of the registry should be evidence-based and not only accepted by professional stakeholders. The MIDAS study aims at providing such evidence for the example population of patients undergoing emergency or elective hip surgery. Five relevant aspects are considered: (1) choice of instruments for assessing health related quality of life (HRQoL); (2) optimal time-point for assessment; (3) use of proxy assessments; (4) choice of pre-surgery risk factors; and (5) assessment of peri- and postoperative variables. METHODS MIDAS is a longitudinal observational multicentre study. All patients suffering from a femoral neck fracture or from arthritis of the hip joint with an indication for prosthetic joint replacement surgery will be offered participation. The study is based on a combination of routine data from clinical standard practice with specifically documented data to be reported by the treating clinician and data to be collected in cooperation with the patient – in particular patient-reported outcome measures (PROMs). The latter include the Health Utility Index Mark 3 (HUI3) and Euro-Qol-5D (EQ-5D) as generic instruments, Hip Disability and Osteoarthritis Outcome Score (HOOS) as a disease specific instrument for the assessment of HRQoL, and two performance-based functional tests. Data will be collected at baseline, during hospitalisation/at discharge and at three routine follow-up visits. All patients will be asked to name a person for assessing proxy-perceived HRQoL. DISCUSSION To the best of our knowledge, this is the first study explicitly addressing questions about the design of a national surgical registry in an empirical manner. The study aims at providing a scientific base for decisions regarding scope and content of a potential national Swiss surgical registry. We designed a pragmatic study to envision data collection in a national registry with the option of specifying isolated research questions of interest. One focus of the study is the use of PROMs, and we hope that our study and their results will inspire also other surgical registries to take this important step forward. Trial registration Registered at the “Deutsches Register Klinischer Studien (DRKS)”, the German Clinical Trials Registry, since this registry meets the scope and methodology of the proposed study. Registration no.: DRKS00012991
背景 手术登记正变得越来越普遍。此外，瑞士法律要求提供治疗结果质量的数据。瑞士外科医生协会（Schweizerische Gesellschaft Chirurgie，SGC-SCC）已经就首个最小数据集达成一致。然而，从长远来看，登记的范围和内容应以证据为基础，而不仅仅是得到专业利益相关者的认可。MIDAS研究旨在为接受急诊或择期髋关节手术的患者群体提供此类证据。考虑了五个相关方面：（1）评估健康相关生活质量（HRQoL）的工具选择；（2）评估的最佳时间点；（3）代理评估的使用；（4）术前危险因素的选择；以及（5）围手术期和术后变量的评估。
方法 MIDAS是一项纵向观察性多中心研究。所有患有股骨颈骨折或髋关节关节炎且有假体关节置换手术指征的患者都将被邀请参与。该研究基于临床标准实践中的常规数据、治疗医生需专门记录报告的数据以及与患者合作收集的数据（特别是患者报告结局测量，PROMs）的组合。后者包括作为通用工具的健康效用指数Mark 3（HUI3）和欧洲五维度健康量表（EQ-5D）、作为评估HRQoL的疾病特异性工具的髋关节残疾和骨关节炎结果评分（HOOS）以及两项基于表现的功能测试。数据将在基线、住院期间/出院时以及三次常规随访时收集。所有患者都将被要求指定一个人来评估代理感知的HRQoL。
讨论 据我们所知，这是第一项以实证方式明确解决有关国家手术登记设计问题的研究。该研究旨在为有关潜在的瑞士国家手术登记的范围和内容的决策提供科学依据。我们设计了一项务实的研究，以设想在国家登记中进行数据收集，并可选择指定感兴趣的单独研究问题。该研究的一个重点是PROMs的使用，我们希望我们的研究及其结果也能激励其他手术登记向前迈出这重要的一步。
试验注册 自德国临床试验注册中心“Deutsches Register Klinischer Studien (DRKS)”符合拟议研究的范围和方法以来，该研究已在该中心注册。注册号：DRKS00012991
