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开发和验证 COPD 药物依从性指数。

Development and validation of a drug adherence index for COPD.

机构信息

Health Economics and Outcomes Research, Optum, Eden Prairie, MN.

Life Sciences Medication Adherence, Optum, Eden Prairie, MN.

出版信息

J Manag Care Spec Pharm. 2021 Feb;27(2):198-209. doi: 10.18553/jmcp.2021.27.2.198.

Abstract

Inhaled medications are the mainstay of treatment for chronic obstructive pulmonary disease (COPD). Despite their importance, adherence to these medications is low. Low adherence is linked to increased exacerbation rates, mortality rates, health care utilization, and, ultimately, increased costs. A drug adherence index (DAI) is a predictive modeling tool that identifies patients most likely to change adherence status so that they can be targeted for support programs. Optum has previously developed DAI tools for diabetes, hypertension, and high cholesterol. In this study, a COPD-specific DAI was developed. This DAI tool could be used to better target medication adherence support in patients with COPD, aiming to increase adherence. To develop a COPD-specific DAI using (a) enrollment, medical, and pharmacy variables and (b) only enrollment and pharmacy variables for potential application to pharmacy benefit managers and pharmacy plans. This was a retrospective observational study using health care claims among Medicare Advantage with Part D beneficiaries with COPD in the United States. Potential predictors of adherence were measured during a 1-year baseline period. The adherence outcome was measured during a subsequent 1-year at-risk period. Adherence to long-acting bronchodilators was defined as a proportion of days covered (PDC) ≥80%. Nonadherence was defined as a PDC of <80%. Patients were stratified according to their adherence status at baseline, and logistic regression models were developed separately for each set of patients. Separate models were also developed using enrollment, medical, and pharmacy variables (primary objective) or using enrollment and pharmacy variables only (secondary objective). A total of 61,507 patients met all inclusion and exclusion criteria. For the primary objective, at baseline, 31,142 patients were adherent and 30,365 patients were nonadherent. The final DAI model used to predict future nonadherence included 30 covariates, with 7 predictors from medical claims. The validated model c-statistic was 0.752. The final DAI model used to predict future adherence included 29 covariates; only 4 predictors were from medical claims. The validated model c-statistic was 0.691. Findings were similar for the secondary objective using only enrollment and pharmacy variables. This DAI was developed and validated specifically to predict future adherence status to long-acting bronchodilator medications among patients with COPD. The DAI models performed better for predicting nonadherence than predicting adherence. Both organizations with medical and pharmacy data and organizations with only pharmacy data could utilize the DAI tool to target patients for adherence programs, as results were similar with and without the use of medical variables. This study was sponsored and funded by GlaxoSmithKline (HO-16-17938). The study sponsor participated in the conception and design of the study, analysis and interpretation of the data, and drafting and critical revision of the report and approved submission of the manuscript. All authors had access to the results of the analyses, reviewed and edited the manuscript, approved the final draft, and were involved in the decision to submit the manuscript for publication. The data contained in the Optum database contain proprietary elements owned by Optum and, therefore, cannot be broadly disclosed or made publicly available at this time. The disclosure of these data to third parties assumes certain data security and privacy protocols are in place and that the third party has executed a license agreement that includes restrictive agreements governing the use of the data. Bengtson, Buikema, and Bankcroft are employees at Optum, and Schilling is a former employee of Optum; their employment was not contingent on this work. Optum was funded by GlaxoSmithKline to conduct the study. Stanford was an employee of GlaxoSmithKline at the time of this study and holds stock in GlaxoSmithKline.

摘要

吸入药物是治疗慢性阻塞性肺疾病(COPD)的主要方法。尽管它们很重要,但患者对这些药物的依从性很低。低依从性与加重率、死亡率、医疗保健利用率的增加有关,最终导致成本增加。药物依从性指数(DAI)是一种预测模型工具,可识别最有可能改变依从性状态的患者,以便为他们提供支持计划。Optum 之前已经为糖尿病、高血压和高胆固醇开发了 DAI 工具。在这项研究中,开发了一种 COPD 特异性 DAI。该 DAI 工具可用于更好地针对 COPD 患者的药物依从性支持,旨在提高依从性。

使用 (a) 登记、医疗和药房变量和 (b) 仅登记和药房变量来开发 COPD 特异性 DAI,以便潜在地应用于药房福利经理和药房计划。

这是一项使用美国医疗保险优势与 Part D 受益人的 COPD 患者的医疗保健索赔进行的回顾性观察性研究。在为期 1 年的基线期内测量了依从性的潜在预测因素。在随后的 1 年风险期内测量了依从性结果。长效支气管扩张剂的依从性定义为比例天数覆盖(PDC)≥80%。不依从性定义为 PDC<80%。根据患者在基线时的依从性状态对患者进行分层,并为每组患者分别开发逻辑回归模型。还分别使用登记、医疗和药房变量(主要目标)或仅使用登记和药房变量(次要目标)开发了单独的模型。

共有 61,507 名患者符合所有纳入和排除标准。对于主要目标,在基线时,31,142 名患者是依从的,30,365 名患者是不依从的。用于预测未来不依从性的最终 DAI 模型包括 30 个协变量,其中 7 个来自医疗索赔。验证后的模型 c 统计量为 0.752。用于预测未来依从性的最终 DAI 模型包括 29 个协变量;只有 4 个预测因子来自医疗索赔。验证后的模型 c 统计量为 0.691。次要目标仅使用登记和药房变量,结果相似。

该 DAI 是专门为预测 COPD 患者长效支气管扩张剂药物未来依从性状态而开发和验证的。DAI 模型在预测不依从性方面的表现优于预测依从性。具有医疗和药房数据的组织以及仅具有药房数据的组织都可以使用 DAI 工具来为依从性计划定位患者,因为使用和不使用医疗变量的结果相似。

这项研究由葛兰素史克(HO-16-17938)赞助和资助。研究赞助商参与了研究的构思和设计、数据分析和解释、报告的起草和关键修订以及批准提交手稿。所有作者都可以访问分析结果、审查和编辑手稿、批准最终草案,并参与决定提交手稿进行出版。Optum 数据库中包含的专有元素属于 Optum 所有,因此目前不能广泛披露或公开提供这些数据。将这些数据披露给第三方需要满足某些数据安全和隐私协议,并且第三方必须签署许可协议,其中包括有关使用数据的限制性协议。Bengtson、Buikema 和 Bankcroft 是 Optum 的员工,Schilling 曾是 Optum 的员工;他们的雇佣与这项工作无关。Optum 受 GlaxoSmithKline 委托进行这项研究。斯坦福大学在进行这项研究时是 GlaxoSmithKline 的员工,拥有 GlaxoSmithKline 的股票。

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引用本文的文献

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Methods to assess COPD medications adherence in healthcare databases: a systematic review.
Eur Respir Rev. 2023 Sep 27;32(169). doi: 10.1183/16000617.0103-2023. Print 2023 Sep 30.

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