背景:最近开发的骨折相关感染(FRI)共识定义,这是基于特定的诊断标准,尚未在临床研究中得到充分验证。我们旨在确定FRI共识定义标准的诊断性能,并评估某些暗示性和确认性标准的组合对诊断性能的影响。
方法:多中心,多国,进行了回顾性队列研究.患者被细分为FRI或对照组,根据他们接受的治疗和多学科小组的建议(“意向治疗”)。排除标准是在研究期间外诊断为FRI的患者,年龄小于18岁的患者,病理性骨折患者或颅骨骨折患者,子宫颈,胸椎和腰椎。所有患者的最小随访时间为18个月。
结果:总体而言,637例患者因怀疑FRI而接受了翻修手术。其中,480例患者被诊断为FRI,相应处理,并包括在FRI组中。其他157例患者纳入对照组。至少一个确认体征的存在与97.5%的敏感性相关,特异性为100%和高鉴别值(AUROC0.99,p<0.001)。存在临床确认标准或,如果不存在,至少一种阳性培养与最高的诊断性能相关(灵敏度:98.6%,特异性:100%,AUROC:0.99(p<0.001))。在出现时没有临床确认体征的患者亚组中,至少95%的特异性被发现为发热的临床症状,伤口引流,当地的温暖和红色。
结论:至少一个确认标准的存在可以识别绝大多数FRI患者,并具有良好的诊断鉴别价值。因此,我们的研究验证了FRI共识定义的确认标准.在存在具有毒性病原体的单个阳性培养物的情况下,很可能感染。当某些临床暗示体征(例如,伤口引流)被观察到(单独或组合,甚至没有确认标准),它更有可能,存在感染。
BACKGROUND: The recently developed fracture-related infection (FRI)
consensus definition, which is based on specific diagnostic criteria, has not been fully validated in clinical studies. We aimed to determine the diagnostic performance of the criteria of the FRI
consensus definition and evaluated the effect of the combination of certain suggestive and confirmatory criteria on the diagnostic performance.
METHODS: A multicenter, multi-national, retrospective cohort study was performed. Patients were subdivided into an FRI or a control group, according to the treatment they received and the recommendations from a multidisciplinary team (\'intention to treat\'). Exclusion criteria were patients with an FRI diagnosed outside the study period, patients younger than 18 years of age, patients with pathological fractures or patients with fractures of the skull, cervical, thoracic and lumbar spine. Minimum follow up for all patients was 18 months.
RESULTS: Overall, 637 patients underwent revision surgery for suspicion of FRI. Of these, 480 patients were diagnosed with FRI, treated accordingly, and included in the FRI group. The other 157 patients were included in the control group. The presence of at least one confirmatory sign was associated with a sensitivity of 97.5%, a specificity of 100% and a high discriminatory value (AUROC 0.99, p < 0.001). The presence of a clinical confirmatory criterion or, if not present, at least one positive culture was associated with the highest diagnostic performance (sensitivity: 98.6%, specificity: 100%, AUROC: 0.99 (p < 0.001)). In the subgroup of patients without clinical confirmatory signs at presentation, specificities of at least 95% were found for the clinical suggestive signs of fever, wound drainage, local warmth and redness.
CONCLUSIONS: The presence of at least one confirmatory criterion identifies the vast majority of patients with an FRI and was associated with an excellent diagnostic discriminatory value. Therefore, our study validates the confirmatory criteria of the FRI
consensus definition. Infection is highly likely in case of the presence of a single positive culture with a virulent pathogen. When certain clinical suggestive signs (e.g., wound drainage) are observed (individually or in combination and even without a confirmatory criterion), it is more likely than not, that an infection is present.