Division of Cardiovascular Medicine (A.T.S., J.C., M.S., N.K., J.S., P.A.H.), Stanford University, CA.
Stanford Prevention Research Center (A.T.S.), Stanford University, CA.
Circulation. 2024 May 28;149(22):1717-1728. doi: 10.1161/CIRCULATIONAHA.124.069624. Epub 2024 Apr 7.
The impact of routine clinic use of patient-reported outcome (PRO) measures on clinical outcomes in patients with heart failure (HF) has not been well-characterized. We tested if clinic-based use of a disease-specific PRO improves patient-reported quality of life at 1 year.
The PRO-HF trial (Patient-Reported Outcome Measurement in Heart Failure Clinic) was an open-label, parallel, patient-level randomized clinical trial of routine PRO assessment or usual care at an academic HF clinic between August 30, 2021, and June 30, 2022, with 1 year of follow-up. In the PRO assessment arm, participants completed the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at each HF clinic visit, and results were shared with their treating clinician. The usual care arm completed the KCCQ-12 at randomization and 1 year later, which was not shared with the treating clinician. The primary outcome was the KCCQ-12 overall summary score (OSS) between 12 and 15 months after randomization. Secondary outcomes included domains of the KCCQ-12, hospitalization and emergency department visit rates, HF medication therapy, clinic visit frequency, and testing rates.
Across 17 clinicians, 1248 participants were enrolled and randomized to PRO assessment (n=624) or usual care (n=624). The median age was 63.9 years (interquartile range [IQR], 51.8-72.8), 38.9% were women, and the median baseline KCCQ-12 OSS was 82.3 (IQR, 58.3-94.8). Final KCCQ-12 (available in 87.9% of the PRO arm and 85.1% in usual care; =0.16) median OSS were 87.5 (IQR, 68.8-96.9) in the PRO arm and 87.6 (IQR, 69.7-96.9) in the usual care arm with a baseline-adjusted mean difference of 0.2 ([95% CI, -1.7 to 2.0]; =0.85). The results were consistent across prespecified subgroups. A post hoc analysis demonstrated a significant interaction with greater benefit among participants with a baseline KCCQ-12 OSS of 60 to 80 but not in less or more symptomatic participants. No significant differences were found in 1-year mortality, hospitalizations, emergency department visits, medication therapy, clinic follow-up, or testing rates between arms.
Routine PRO assessment in HF clinic visits did not impact patient-reported quality of life or other clinical outcomes. Alternate strategies and settings for embedding PROs into routine clinical care should be tested.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04164004.
常规临床使用患者报告结局（PRO）测量对心力衰竭（HF）患者的临床结局的影响尚未得到很好的描述。我们检验了基于诊所的特定于疾病的 PRO 是否可以改善患者在 1 年内报告的生活质量。
PRO-HF 试验（心力衰竭诊所的患者报告结局测量）是一项开放标签、平行、患者水平的随机临床试验，于 2021 年 8 月 30 日至 2022 年 6 月 30 日在学术 HF 诊所进行常规 PRO 评估或常规护理，随访 1 年。在 PRO 评估臂中，参与者在每次 HF 诊所就诊时完成堪萨斯城心肌病问卷-12（KCCQ-12），结果与他们的治疗医生分享。常规护理臂在随机化和 1 年后完成 KCCQ-12，结果不与治疗医生分享。主要结局是随机化后 12 至 15 个月的 KCCQ-12 总体总结评分（OSS）。次要结局包括 KCCQ-12 的各个领域、住院和急诊就诊率、HF 药物治疗、诊所就诊频率和检查率。
在 17 位临床医生中，共有 1248 名参与者被纳入并随机分为 PRO 评估（n=624）或常规护理（n=624）组。中位年龄为 63.9 岁（四分位距 [IQR]，51.8-72.8），38.9%为女性，基线 KCCQ-12 OSS 中位数为 82.3（IQR，58.3-94.8）。最终 KCCQ-12（PRO 臂中 87.9%可用，常规护理中 85.1%可用；=0.16）中位 OSS 在 PRO 臂中为 87.5（IQR，68.8-96.9），在常规护理臂中为 87.6（IQR，69.7-96.9），基线调整后的平均差异为 0.2（[95%CI，-1.7 至 2.0]；=0.85）。这些结果在所有预先指定的亚组中都是一致的。一项事后分析表明，在基线 KCCQ-12 OSS 为 60 至 80 的患者中，干预效果存在显著的交互作用，但在症状更轻或更严重的患者中没有显著差异。两组之间在 1 年死亡率、住院、急诊就诊、药物治疗、门诊随访或检查率方面没有发现显著差异。
HF 诊所就诊中的常规 PRO 评估并未影响患者报告的生活质量或其他临床结局。应测试将 PRO 纳入常规临床护理的其他策略和环境。
