Nogaro Marie-Caroline, Hartshorn Stuart, Brady Mariea, Offiah Amaka, Faust Saul, Firth Gregory, Ma Jie, Dhiman Paula, O'Mahoney Joanna, Davies Loretta, Spowart Catherine, Moscrop Amy, Young Bridget, Tudur-Smith Catrin, Collins Gary, Perry Daniel C, Theologis Tim
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Bone Jt Open. 2025 Jun 10;6(6):677-684. doi: 10.1302/2633-1462.66.BJO-2024-0277.
Bone and joint infections (BJI) in children are rare but can be serious. Differentiating BJI from other conditions with similar symptoms is critical. Advanced imaging (ultrasound scans (USS) and MRI) is often required to confirm the diagnosis. The differing merits of imaging type and regional variation in access to advanced imaging can lead to diagnostic uncertainty and treatment variation. The aim of this study is to evaluate the diagnostic accuracy of MRI and USS for the investigation of BJI in children, and develop and validate prediction models to aid the diagnosis of BJI in children. A nested qualitative sub-study will explore acceptability of the imaging to children, parents, and health practitioners.
A multicentre retrospective cohort of children (aged < 16 years) with suspected diagnosis of BJI will be used to estimate the diagnostic accuracy of the two imaging methods and develop the prediction models. The models will be evaluated in a second cohort of prospectively recruited children. Diagnostic test accuracy will be estimated overall, and separately for children aged under and over five years. The prediction models will be fit using logistic regression, with candidate predictors chosen based on clinical plausibility and from a review of the literature. Continuous predictors will be examined for non-linearity with confirmed BJI using fractional polynomials. Multiple imputation will be used to replace missing values. Internal validation will be carried out using bootstrapping. Model performance will be assessed with discrimination and calibration.
Ethical approval for this study (registration: ISRCTN15471635) was granted (REC reference 23/WM/0027). Informed consent is being obtained from participants in the prospective cohort and the qualitative sub-study. Study findings will be published in an open access journal and presented at relevant national and international conferences. Relevant charities and associations are being engaged to promote awareness of the project.
儿童骨与关节感染（BJI）虽罕见但可能很严重。将BJI与具有相似症状的其他病症区分开来至关重要。通常需要先进的影像学检查（超声扫描（USS）和MRI）来确诊。成像类型的不同优点以及获取先进成像的区域差异可能导致诊断不确定性和治疗差异。本研究的目的是评估MRI和USS对儿童BJI检查的诊断准确性，并开发和验证预测模型以辅助儿童BJI的诊断。一项嵌套的定性子研究将探讨儿童、家长和医疗从业者对这些成像检查的可接受性。
将使用一个多中心回顾性队列研究，纳入疑似诊断为BJI的16岁以下儿童，以估计两种成像方法的诊断准确性并开发预测模型。这些模型将在前瞻性招募的另一组儿童中进行评估。将总体估计诊断试验准确性，并分别对五岁以下和五岁以上儿童进行估计。预测模型将使用逻辑回归进行拟合，候选预测因子根据临床合理性和文献综述来选择。将使用分数多项式检查连续预测因子与确诊BJI之间的非线性关系。将使用多重填补法来替换缺失值。将使用自举法进行内部验证。将通过区分度和校准来评估模型性能。
本研究已获得伦理批准（注册号：ISRCTN15471635）（REC参考号23/WM/0027）。正在向前瞻性队列研究和定性子研究的参与者获取知情同意书。研究结果将发表在开放获取期刊上，并在相关的国内和国际会议上展示。正在与相关慈善机构和协会合作，以提高对该项目的认识。
