Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, School of Biological Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
Health eResearch Centre, Centre for Health Informatics, School of Health Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
Pharmacoepidemiol Drug Saf. 2019 Feb;28(2):179-186. doi: 10.1002/pds.4649. Epub 2018 Sep 28.
To quantify misclassification in glucocorticoid (GC) exposure defined using UK primary care prescription data.
A cross-sectional study including patients with rheumatoid arthritis prescribed oral GCs in the past 2 years. Glucocorticoid exposure based on electronic prescription records was compared with participant-reported GC use captured using a paper diary. Prescription data (containing information about prescriptions issued but no dispensing information) was provided by the Clinical Practice Research Datalink. The following variables were defined: current use and dose of oral GCs and if (and when) participants had received a GC injection. For oral GCs, self-reported use was taken to represent "true" exposure. A dataset representing a hypothetical population was generated to assess the impact of the misclassification found for current use.
A total of 67 of 78 study participants (86%) were correctly classified as currently on/off oral GCs; 32/38 (84.2%) participants reporting current GC use and 35/40 (87.5%) participants not reporting current use were correctly classified. Estimated values of current dose were imprecise (correlation coefficient 0.46). Concordance between reported and prescribed GC injections was poor (kappa statistic 0.14). Misclassification bias was demonstrated in the hypothetical population: For "true" relative risks of 1.5, 4, and 9, the "observed" relative risks were 1.33, 2.48, and 3.58, respectively.
Misclassification of current use of oral GCs was low but sufficient to lead to significant bias. Researchers should take care to assess the likely impact of exposure misclassification on their analyses.
定量评估使用英国初级保健处方数据定义的糖皮质激素(GC)暴露的分类错误。
这是一项横断面研究,纳入了过去 2 年内接受口服 GC 治疗的类风湿关节炎患者。通过电子处方记录确定的 GC 暴露情况与使用纸质日记记录的参与者报告的 GC 使用情况进行比较。处方数据(包含处方开具但无配药信息)由临床实践研究数据链接提供。定义了以下变量:目前使用的口服 GC 剂量和是否(以及何时)接受过 GC 注射。对于口服 GC,报告的使用情况被视为“真实”暴露。生成了一个代表假想人群的数据集,以评估当前使用情况分类错误的影响。
在 78 名研究参与者中,共有 67 名(86%)被正确分类为目前正在使用/停用口服 GC;报告目前正在使用 GC 的 38 名参与者中有 32 名(84.2%)和未报告目前正在使用 GC 的 40 名参与者中有 35 名(87.5%)被正确分类。目前剂量的估计值不精确(相关系数 0.46)。报告和处方 GC 注射之间的一致性较差(kappa 统计量 0.14)。在假想人群中证明了分类错误偏差:对于“真实”相对风险为 1.5、4 和 9,“观察”相对风险分别为 1.33、2.48 和 3.58。
目前口服 GC 使用情况的分类错误率较低,但足以导致显著的偏倚。研究人员应注意评估暴露分类错误对其分析的可能影响。