Curtis Lesley H, Greiner Melissa A, Hammill Bradley G, DiMartino Lisa D, Shea Alisa M, Hernandez Adrian F, Fonarow Gregg C
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Circ Cardiovasc Qual Outcomes. 2009 Jul;2(4):377-84. doi: 10.1161/CIRCOUTCOMES.108.822692. Epub 2009 Jun 9.
Participation in clinical registries is nonrandom, so participants may differ in important ways from nonparticipants. The extent to which findings from clinical registries can be generalized to broader populations is unclear.
We linked data from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF) registry with 100% inpatient Medicare fee-for-service claims to identify matched and unmatched patients with heart failure. We evaluated differences in baseline characteristics and mortality, all-cause readmission, and cardiovascular readmission rates. We used Cox proportional hazards models to examine relationships between registry enrollment and outcomes, controlling for baseline characteristics. There were 25,245 OPTIMIZE-HF patients in the Medicare claims data and 929,161 Medicare beneficiaries with heart failure who were not enrolled in OPTIMIZE-HF. Although hospital characteristics differed, patient demographic characteristics and comorbid conditions were similar. In-hospital mortality for OPTIMIZE-HF and non-OPTIMIZE-HF patients was not significantly different (4.7% versus 4.5%; P=0.37); however, OPTIMIZE-HF patients had slightly higher 30-day (11.9% versus 11.2%; P<0.001) and 1-year unadjusted mortality (37.2% versus 35.7%; P<0.001). Controlling for other variables, OPTIMIZE-HF patients were similar to non-OPTIMIZE-HF patients for the hazard of mortality (hazard ratio, 1.02; 95% confidence interval, 0.98 to 1.06). There were small but significant decreases in all-cause (hazard ratio, 0.94; 95% CI, 0.92 to 0.97) and cardiovascular readmission (hazard ratio, 0.94; 95% CI, 0.91 to 0.98).
Characteristics and outcomes of Medicare beneficiaries enrolled in OPTIMIZE-HF are similar to the broader Medicare population with heart failure, suggesting that findings from this clinical registry may be generalized.
参与临床登记是非随机的，因此参与者在重要方面可能与未参与者不同。临床登记的研究结果能在多大程度上推广到更广泛人群尚不清楚。
我们将来自“住院心力衰竭患者启动挽救生命治疗组织项目”（OPTIMIZE-HF）登记的数据与100%的住院医疗保险按服务收费索赔数据相链接，以识别匹配和不匹配的心力衰竭患者。我们评估了基线特征、死亡率、全因再入院率和心血管再入院率的差异。我们使用Cox比例风险模型来研究登记入组与结局之间的关系，并对基线特征进行控制。医疗保险索赔数据中有25245名OPTIMIZE-HF患者，以及929161名未参加OPTIMIZE-HF的心力衰竭医疗保险受益人。虽然医院特征不同，但患者人口统计学特征和合并症相似。OPTIMIZE-HF患者和非OPTIMIZE-HF患者的住院死亡率无显著差异（4.7%对4.5%；P=0.37）；然而，OPTIMIZE-HF患者的30天未调整死亡率略高（11.9%对11.2%；P<0.001），1年未调整死亡率也略高（37.2%对35.7%；P<0.001）。在控制其他变量后，OPTIMIZE-HF患者与非OPTIMIZE-HF患者的死亡风险相似（风险比，1.02；95%置信区间，0.98至1.06）。全因再入院率（风险比，0.94；95%CI，0.92至0.97）和心血管再入院率（风险比，0.94；95%CI，0.91至0.98）有小幅但显著的下降。
参加OPTIMIZE-HF的医疗保险受益人的特征和结局与更广泛的心力衰竭医疗保险人群相似，这表明该临床登记的研究结果可能具有普遍性。
