Background: 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.Methods: PRO-HF 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 12-15 months post-randomization. Secondary outcomes included domains of the KCCQ-12, hospitalization and emergency department visit rates, HF medication therapy, clinic visit frequency, and testing rates.Results: Across 17 clinicians, 1,248 participants were enrolled and randomized to PRO assessment (n=624) or usual care (n=624). The median age was 63.9 (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 [p=0.16]) median OSS scores 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; p=0.85). The results were consistent across pre-specified subgroups. A post hoc analysis demonstrated a significant interaction with greater benefit among participants with baseline KCCQ-12 OSS scores of 60-80 but not in less or more symptomatic participants. No significant differences were found in 1-year mortality, hospitalizations, ED visits, medication therapy, clinic follow-up, or testing rates between arms.Conclusions: 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.

中文翻译：

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心力衰竭诊所患者报告的健康状况常规评估的临床影响

背景：临床常规使用患者报告结果（PRO）测量对心力衰竭（HF）患者临床结果的影响尚未得到充分表征。我们测试了基于临床的使用特定疾病的 PRO 是否可以改善患者报告的 1 年生活质量。方法：PRO-HF 是一项针对常规 PRO 评估或常规护理的开放标签、平行、患者水平随机临床试验2021 年 8 月 30 日至 2022 年 6 月 30 日期间在一家学术心力衰竭诊所进行了为期 1 年的随访。在 PRO 评估组中，参与者在每次心力衰竭诊所就诊时完成了堪萨斯城心肌病问卷 12 (KCCQ-12)，并将结果与​​治疗临床医生分享。常规护理组在随机分组时和 1 年后完成了 KCCQ-12，但未与治疗临床医生分享。主要结局是随机化后 12-15 个月的 KCCQ-12 总体总结评分 (OSS)。次要结果包括 KCCQ-12 的领域、住院和急诊科就诊率、心力衰竭药物治疗、门诊就诊频率和检测率。 结果：在 17 名临床医生中，1,248 名参与者被纳入并随机分配至 PRO 评估 (n=624) 或常规护理 (n=624)。中位年龄为 63.9 岁（四分位距 [IQR] 51.8-72.8），38.9% 为女性，中位基线 KCCQ-12 OSS 为 82.3（IQR 58.3-94.8）。最终 KCCQ-12（PRO 组中 87.9% 的患者可用，常规护理中 85.1% 的患者可用 [p=0.16]）中位 OSS 评分在 PRO 组中为 87.5 (IQR 68.8-96.9)，在 PRO 组中为 87.6 (IQR 69.7-96.9)。常规护理组的基线调整平均差异为 0.2（95% CI：-1.7 至 2.0；p=0.85）。预先指定的亚组的结果是一致的。事后分析表明，基线 KCCQ-12 OSS 分数为 60-80 的参与者之间存在显着的相互作用，且获益更大，但症状较少或较多的参与者则不然。在 1 年死亡率、住院治疗、急诊就诊、药物治疗、临床随访或各组之间的检测率方面没有发现显着差异。结论：心力衰竭门诊就诊时的常规 PRO 评估不会影响患者报告的生活质量或其他质量。临床结果。应测试将 PRO 嵌入常规临床护理的替代策略和设置。