Kostuj Tanja, Rehart Stefan, Matta-Hurtado Ronald, Biehl Christoph, Willburger Roland E, Schmidt Klaus
Department of Orthopedics and Traumatology, Catholic Hospital Bochum, St. Josefs Hospital, University Hospital of Ruhr University Bochum, Bochum, Germany.
Institute for Medical Biometry and Epidemiology, University of Witten/Herdecke, Witten, Germany.
BMJ Open. 2017 Oct 10;7(10):e015987. doi: 10.1136/bmjopen-2017-015987.
Most patients suffering with rheumatic diseases who undergo surgical treatment are receiving immune-modulating therapy. To determine whether these medications affect their outcomes a national registry was established in Germany by the German Society of Surgery (DGORh). Data from the first 1000 patients were used in a pilot study to identify relevant corisk factors and to determine whether such a registry is suitable for developing accurate and relevant recommendations.
Data were collected from patients undergoing surgical treatments with their written consent. A second consent form was used, if complications occurred. During this pilot study, in order to obtain a quicker overview, risk factors were considered only in patients with complications. Only descriptive statistical analysis was employed in this pilot study due to limited number of observed complications and inhomogeneous data regarding the surgery and the medications the patients received. Analytical statistics will be performed to confirm the results in a future outcome study.
Complications occurred in 26 patients and were distributed equally among the different types of surgeries. Twenty one of these patients were receiving immune-modulating therapy at the time, while five were not. Infections were observed in 2.3% of patients receiving and in 5.1% not receiving immunosuppression.
Due to the low number of cases, inhomogeneity in the diseases and the treatments received by the patients in this pilot study, it is not possible to develop standardised best-practice recommendations to optimise their care. Based on this observation we conclude that in order to be suitable to develop accurate and relevant recommendations a national registry must include the most important and relevant variables that impact the care and outcomes of these patients.
大多数接受外科治疗的风湿性疾病患者正在接受免疫调节治疗。为了确定这些药物是否会影响治疗结果，德国外科学会（DGORh）在德国建立了一个全国性登记处。在一项试点研究中使用了前1000名患者的数据，以识别相关的共同风险因素，并确定这样一个登记处是否适合制定准确且相关的建议。
在患者书面同意的情况下收集接受外科治疗患者的数据。如果发生并发症，则使用第二份同意书。在这项试点研究中，为了更快地获得总体情况，仅在发生并发症的患者中考虑风险因素。由于观察到的并发症数量有限，以及患者接受的手术和药物数据不均匀，本试点研究仅采用了描述性统计分析。未来将进行分析统计以在结果研究中确认结果。
26名患者发生了并发症，且在不同类型的手术中分布均匀。其中21名患者当时正在接受免疫调节治疗，而5名未接受。接受免疫抑制治疗的患者中有2.3%发生感染，未接受免疫抑制治疗的患者中有5.1%发生感染。
由于本试点研究中的病例数较少，患者所患疾病和接受的治疗存在异质性，因此无法制定标准化的最佳实践建议以优化他们的护理。基于这一观察结果，我们得出结论，为了适合制定准确且相关的建议，全国性登记处必须纳入影响这些患者护理和治疗结果的最重要和相关的变量。
