1 GlaxoSmithKline, Research Triangle Park, North Carolina.
2 Comprehensive Health Insights, Humana, Louisville, Kentucky.
J Manag Care Spec Pharm. 2019 Jan;25(1):58-69. doi: 10.18553/jmcp.2019.25.1.058.
Chronic obstructive pulmonary disease (COPD) exacerbations can accelerate disease progression and lead to higher health care costs. To improve patient survival and reduce cost, risk assessment measures should be developed to identify patients at risk for exacerbations and prevent future exacerbations.
To (a) externally validate the COPD treatment ratio (CTR) as a measure of COPD exacerbation risk based on predictive models previously tested and (b) assess the measure's capability to assess risk using only pharmacy claims for use in Medicare Part D programs.
This was a retrospective observational study conducted using the Humana research datasets. Separate assessments were performed using pharmacy-only models that excluded risk factors derived from medical claims. Patients were aged ≥ 40 years, with ≥ 1 inpatient hospitalization or ≥ 2 physician's office, emergency department, or urgent care visits with a COPD diagnosis. Using logistic regression models, risk factors (age, exacerbation history, COPD and concomitant medication use, and comorbidities) were assessed during the baseline period (year 1) and were used to predict the risk of exacerbation during year 2. Continuous and dichotomized CTRs were analyzed. A cut-point of 0.3 was initially used for dichotomizing CTR, and subsequently receiver operating characteristics (ROC) analysis was used to determine the optimal cut-point for CTR.
A total of 92,496 patients were identified, the majority of which (96.2%) were Medicare members with a mean age of 69 years. During the baseline period, 14.0% and 11.2% of patients had ≥ 1 moderate or severe exacerbation, respectively. Overall, the CTR performed well in predicting future COPD exacerbations, especially severe exacerbations. ROC analysis suggested that 0.7 was the optimal cut-point for dichotomizing CTR. Patients with a CTR ≥ 0.7 had a 7.9% (OR = 0.921; 95% CI = 0.852-0.995) lower risk of a severe exacerbation, compared with those with a CTR < 0.7. Stronger effects were seen in pharmacy-only models, with patients 17% less likely to experience a severe exacerbation with a CTR ≥ 0.7 compared with patients with a CTR < 0.7.
This study validated the use of CTR as a modifiable measure of risk of COPD exacerbation in a large commercial and Medicare population and remained a robust predictor when pharmacy-only claims data were available. A CTR of ≥ 0.7 may be a useful target to help reduce the risk of severe exacerbations, and its use by payer or quality organizations has the potential to improve COPD management.
This study was funded by GlaxoSmithKline (GSK; study number HO-15-16651). GSK had a role in the study design, collection, analysis, and interpretation of data and in the writing of the study report but did not place any restrictions on access to the data or on the statements made in the manuscript. The authors were in full editorial control of publication target journal and content and conclusions, accepted full responsibility for final approval of a manuscript describing this GSK-sponsored research, and had final responsibility for the decision to submit for publication. Stanford and Lau are employees of GSK and hold GSK stocks/shares. Li and Stemkowski are employees of Comprehensive Health Insights, which was contracted to conduct the study but did not receive funding for manuscript development. This manuscript was presented in part at the American Thoracic Society 2017 International Conference; May 19-24, 2017; Washington, DC.
慢性阻塞性肺疾病(COPD)加重会加速疾病进展,并导致更高的医疗保健费用。为了提高患者生存率并降低成本,应开发风险评估措施,以识别有加重风险的患者,并预防未来的加重。
(a)根据先前经过测试的预测模型,外部验证 COPD 治疗比(CTR)作为 COPD 加重风险的衡量标准;(b)评估仅使用医疗保险 D 部分计划的药房索赔评估风险的能力。
这是一项使用 Humana 研究数据集进行的回顾性观察性研究。使用排除了来自医疗索赔的风险因素的仅药房模型进行了单独评估。患者年龄≥40 岁,有≥1 次住院或≥2 次医生办公室、急诊部或紧急护理就诊,诊断为 COPD。使用逻辑回归模型,在基线期(第 1 年)评估风险因素(年龄、加重史、COPD 和伴随药物使用以及合并症),并用于预测第 2 年的加重风险。分析了连续和二分类 CTR。最初使用 0.3 作为二分类 CTR 的截断值,随后使用接收者操作特征(ROC)分析确定 CTR 的最佳截断值。
共确定了 92496 名患者,其中大多数(96.2%)是医疗保险会员,平均年龄为 69 岁。在基线期内,分别有 14.0%和 11.2%的患者有≥1 次中度或重度加重。总体而言,CTR 在预测未来 COPD 加重方面表现良好,尤其是严重加重。ROC 分析表明,0.7 是二分类 CTR 的最佳截断值。CTR≥0.7 的患者发生严重加重的风险降低 7.9%(OR=0.921;95%CI=0.852-0.995),与 CTR<0.7 的患者相比。在仅药房模型中观察到更强的效果,CTR≥0.7 的患者发生严重加重的可能性比 CTR<0.7 的患者低 17%。
这项研究验证了 CTR 作为 COPD 加重风险的可修改衡量标准在大型商业和医疗保险人群中的使用,并且当仅使用药房索赔数据时,它仍然是一个强大的预测指标。CTR≥0.7 可能是一个有用的目标,有助于降低严重加重的风险,并且支付者或质量组织使用它有潜力改善 COPD 管理。
这项研究由葛兰素史克(GSK;研究编号 HO-15-16651)资助。GSK 参与了研究设计、数据收集、分析和解释以及研究报告的撰写,但对数据的访问或对报告中陈述的限制没有任何限制。作者对目标期刊和内容的编辑完全负责,对描述这项 GSK 赞助研究的手稿的最终批准承担全部责任,并对提交出版的最终决定负责。斯坦福和劳是 GSK 的员工,持有 GSK 的股票/股份。李和斯特姆科夫斯基是 Comprehensive Health Insights 的员工,该公司受雇进行研究,但没有为此开发手稿提供资金。本文部分内容在 2017 年 5 月 19 日至 24 日在美国胸科学会 2017 年国际会议上发表;华盛顿特区。