Department of Medicine, Section of Neurology, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, GF 543- 820 Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1R9.
Manitoba Centre for Health Policy, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, 408-727 McDermot Ave, Winnipeg, Manitoba, Canada R3E 3P5.
Mult Scler Relat Disord. 2018 Jan;19:134-139. doi: 10.1016/j.msard.2017.11.022. Epub 2017 Dec 2.
Severe relapses that required treatment were important outcomes in the sentinel trials of disease-modifying therapy (DMT). Identifying such relapses in administrative data would allow comparative-effectiveness studies of DMTs to be conducted in real-world clinical settings.
All relapsing-remitting (RRMS) and secondary-progressive (SPMS) patients living in Manitoba between 1999 and 2015 were identified using a validated case definition and linkage to the Manitoba MS Clinic database. All healthcare interactions potentially due to relapses were extracted from population-based administrative (hospital, physician claims and prescription) databases. These "relapse markers" included varying thresholds of outpatient prednisone scripts, day hospital or emergency room (ER) codes for intravenous (IV) methylprednisolone therapy, family physician, neurologist or ER physician billing codes and hospital admissions due to MS. Algorithms using combinations of these markers were compared with a reference standard of neurologist-defined relapses. The most useful algorithms were also examined on a biannual basis over the study period to assess for trends in the sensitivity of relapse detection.
1131 participants with RRMS or SPMS were linked to administrative databases. Analysis of potential relapse markers over the whole 1999-2015 time period was limited by inconsistent coding of same day or ER admissions for IV methylprednisolone administration. Widespread adoption of high-dose oral outpatient prednisone for relapses since 2009 resulted in a progressive improvement in relapse marker sensitivity. The best algorithm consisted of oral prednisone prescriptions >50mg/day for 3-60 days and same day hospital or ER assessment codes with MS as the most responsible diagnosis (sensitivity 70%, specificity 100%, PPV 100%, NPV 96%, kappa 0.8 in 2013-2015).
Severe relapses can be identified from administrative datasets with reasonable accuracy. The trend since 2009 toward outpatient relapse treatment will improve the sensitivity of relapse detection with longitudinal follow-up of this cohort and will allow comparison of severe relapse rates between different DMTs, supporting future comparative effectiveness studies.
在疾病修饰疗法(DMT)的监测试验中,需要治疗的严重复发是重要的结局。在行政数据中识别这些复发可以在真实临床环境中进行 DMT 的比较效果研究。
使用验证后的病例定义并与曼尼托巴省多发性硬化症诊所数据库进行链接,确定了 1999 年至 2015 年间居住在曼尼托巴省的所有缓解复发型(RRMS)和继发进展型(SPMS)患者。从基于人群的行政(医院、医生索赔和处方)数据库中提取所有可能因复发而发生的医疗保健交互。这些“复发标志物”包括门诊泼尼松处方、静脉注射甲基强的松龙治疗的日间医院或急诊室(ER)代码、家庭医生、神经科医生或 ER 医生计费代码以及因 MS 导致的住院治疗的不同阈值。使用这些标志物组合的算法与神经病学家定义的复发的参考标准进行了比较。在研究期间还每两年对最有用的算法进行一次检查,以评估复发检测敏感性的趋势。
1131 名 RRMS 或 SPMS 患者与行政数据库相关联。在整个 1999-2015 年期间,对潜在复发标志物的分析受到同一天或 ER 进行 IV 甲基强的松龙给药的入院编码不一致的限制。自 2009 年以来,广泛采用高剂量口服门诊泼尼松治疗复发导致复发标志物敏感性逐渐提高。最佳算法包括 3-60 天内每天口服泼尼松剂量>50mg 和同一天的医院或 ER 评估代码,其中 MS 是最主要的诊断(敏感性 70%,特异性 100%,PPV 100%,NPV 96%,2013-2015 年kappa 值为 0.8)。
可以从行政数据集中以合理的准确性识别严重复发。自 2009 年以来,门诊治疗复发的趋势将随着对该队列的纵向随访提高复发检测的敏感性,并将允许在不同 DMT 之间比较严重复发率,从而支持未来的比较效果研究。