Health e-Research Centre, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Sciences Centre (MAHSC), Oxford Road, Manchester, M13 9PL, UK.
Centre for Pharmacoepidemiology and Drug Safety, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Sci Rep. 2019 Aug 2;9(1):11222. doi: 10.1038/s41598-019-47712-5.
The objective of this study was to assess the reliability of individual risk predictions based on routinely collected data considering the heterogeneity between clinical sites in data and populations. Cardiovascular disease (CVD) risk prediction with QRISK3 was used as exemplar. The study included 3.6 million patients in 392 sites from the Clinical Practice Research Datalink. Cox models with QRISK3 predictors and a frailty (random effect) term for each site were used to incorporate unmeasured site variability. There was considerable variation in data recording between general practices (missingness of body mass index ranged from 18.7% to 60.1%). Incidence rates varied considerably between practices (from 0.4 to 1.3 CVD events per 100 patient-years). Individual CVD risk predictions with the random effect model were inconsistent with the QRISK3 predictions. For patients with QRISK3 predicted risk of 10%, the 95% range of predicted risks were between 7.2% and 13.7% with the random effects model. Random variability only explained a small part of this. The random effects model was equivalent to QRISK3 for discrimination and calibration. Risk prediction models based on routinely collected health data perform well for populations but with great uncertainty for individuals. Clinicians and patients need to understand this uncertainty.
本研究旨在评估基于常规收集数据的个体风险预测的可靠性,同时考虑数据和人群中临床站点之间的异质性。使用 QRISK3 进行心血管疾病 (CVD) 风险预测作为范例。该研究纳入了来自临床实践研究数据链接的 392 个站点的 360 万患者。使用包含每个站点的 QRISK3 预测因子和脆弱性(随机效应)项的 Cox 模型来纳入未测量的站点变异性。一般实践中数据记录存在很大差异(体重指数缺失率范围为 18.7%至 60.1%)。实践之间的发病率差异很大(每 100 名患者年发生 CVD 事件的比例从 0.4 到 1.3 不等)。具有随机效应模型的个体 CVD 风险预测与 QRISK3 预测不一致。对于 QRISK3 预测风险为 10%的患者,随机效应模型预测的风险范围在 7.2%至 13.7%之间。随机变异性仅解释了其中的一小部分。随机效应模型在判别和校准方面与 QRISK3 相当。基于常规收集的健康数据的风险预测模型在人群中表现良好,但对个体而言存在很大的不确定性。临床医生和患者需要了解这种不确定性。