Buchanan Paula M, Schnitzler Mark A, Brennan Daniel C, Dzebisashvili Nino, Willoughby Lisa M, Axelrod David, Salvalaggio Paolo R, Abbott Kevin C, Burroughs Thomas E, Lentine Krista L
Center for Outcomes Research, St. Louis University School of Medicine, St. Louis, Missouri, USA.
Clin J Am Soc Nephrol. 2008 Jan;3(1):117-24. doi: 10.2215/CJN.02790707. Epub 2007 Dec 12.
Accurate assessment of the use of immunosuppressive medications is vital for observational analyses that are widely used in transplantation research. This study assessed the accuracy of three potential sources of maintenance immunosuppression data.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This study investigated the agreement of immunosuppression information in directly linked electronic medical records for Medicare beneficiaries who received a kidney transplant at one center in 1998 through 2001, Organ Procurement and Transplantation Network (OPTN) survey data, and Medicare pharmacy claims. Pair-wise, interdata concordance (kappa) and percentage agreement statistics were used to compare immunosuppression regimens reported at discharge, and at 6 mo and 1 yr after transplantation in each data source.
Among 181 eligible participants, agreement between data sources for nonsteroid immunosuppression increased with time after transplantation. By 1-yr, concordance was excellent for calcineurin inhibitors and mycophenolate mofetil (kappa = 0.79 to 1.00), and very good for azathioprine (kappa = 0.73 to 0.85). Similarly, percentage agreement at 1 yr was 94.9 to 100% for calcineurin inhibitors, 91.1 to 95.7% for mycophenolate mofetil, and 87.5 to 92.8% for azathioprine. Widening the comparison time window resolved 33.6% of cases with discordant indications of calcineurin inhibitor and/or antimetabolite use in claims compared with other data sources.
This analysis supports the accuracy of the three sources of data for description of nonsteroid immunosuppression after kidney transplantation. Given the current strategic focus on reducing collection of data, use of alternative measures of immunosuppression exposure is appropriate and will assume greater importance.
准确评估免疫抑制药物的使用情况对于移植研究中广泛使用的观察性分析至关重要。本研究评估了维持免疫抑制数据的三个潜在来源的准确性。
设计、地点、参与者与测量:本研究调查了1998年至2001年在一个中心接受肾移植的医疗保险受益人的直接关联电子病历、器官获取与移植网络(OPTN)调查数据以及医疗保险药房报销记录中的免疫抑制信息的一致性。采用两两数据间的一致性(kappa)和百分比一致性统计来比较各数据源中移植出院时、移植后6个月和1年报告的免疫抑制方案。
在181名符合条件的参与者中,非甾体免疫抑制的数据来源之间的一致性随移植后时间增加。到1年时,钙调神经磷酸酶抑制剂和霉酚酸酯的一致性极佳(kappa = 0.79至1.00),硫唑嘌呤的一致性非常好(kappa = 0.73至0.85)。同样,1年时钙调神经磷酸酶抑制剂的百分比一致性为94.9%至100%,霉酚酸酯为91.1%至95.7%,硫唑嘌呤为87.5%至92.8%。与其他数据源相比,扩大比较时间窗口解决了33.6%的报销记录中钙调神经磷酸酶抑制剂和/或抗代谢物使用指征不一致的病例。
该分析支持了这三个数据源用于描述肾移植后非甾体免疫抑制情况的准确性。鉴于当前对减少数据收集的战略重点,使用免疫抑制暴露的替代测量方法是合适的,并且将变得更加重要。