Department of Cardiology, The 1St Hospital of Shanxi Medical University, 85 South Jiefang Road, Taiyuan, 030001, Shanxi Province, China.
Shanxi Provincial Key Laboratory of Major Diseases Risk Assessment, 56 South XinJian Road, Taiyuan, 030001, Shanxi Province, China.
BMC Cardiovasc Disord. 2021 Jan 30;21(1):58. doi: 10.1186/s12872-021-01872-3.
The minimal clinically important difference (MCID) of a patient-reported outcome (PRO) represents the threshold value of the change in the score for that PRO. It is deemed to have an important implication in clinical management. This study was performed to evaluate the clinical significance of chronic disease self-management (CDSM) for patients with chronic heart failure based on the MCID of the chronic heart failure-PRO measure (CHF-PROM).
A multicenter, prospective cohort study of 555 patients with heart failure were enrolled from July 2018. Advice of CDSM was provided in written form at discharge to all patients. Information regarding CHF-PROM and CDSM were collected during follow-up. Multilevel models were applied to dynamically evaluate the effects of CDSM for CHF-PROM scores, as well as its physical and psychological domains. MCID changes of the PRO were introduced and compared with β values of CDSM obtained from the multi-level models to further evaluate the clinical significance. The STROBE checklist is shown in Additional file 1.
Scores for CHF-PROM improved significantly after discharge. The multilevel models showed that a regular schedule, avoidance of over-eating, a low-sodium diet and exercise increased scores on CHF-PROM. Compared with the MCID, avoidance of over-eating (12.39 vs. 9.75) and maintenance of a regular schedule often (10.98 vs. 9.75), and exercise almost every day (11.36 vs. 9.75) reached clinical significance for the overall summary. Avoidance of over-eating (5.88 vs. 4.79) and a regular schedule almost every day (4.96 vs. 4.79) reached clinical significance for the physical scores. Avoidance of over-eating half of the time (5.26 vs. 4.87) and a regular schedule almost every day (5.84 vs. 4.87) demonstrated clinical significance for the psychological scores.
This study observed an association of avoidance of over-eating and maintenance of a regular schedule with the improvement of CHF-PROM. It provides further evidence for management of heart failure.
Current Prospective Trials NCT02878811; registered August 25, 2016; https://clinicaltrials.gov/ct2/show/NCT02878811?term=NCT02878811&draw=2&rank=1 .
患者报告结局（PRO）的最小临床重要差异（MCID）代表该 PRO 评分变化的阈值。它被认为对临床管理具有重要意义。本研究旨在基于慢性心力衰竭-PRO 量表（CHF-PROM）的 MCID，评估慢性疾病自我管理（CDSM）对慢性心力衰竭患者的临床意义。
2018 年 7 月，对 555 例心力衰竭患者进行了一项多中心前瞻性队列研究。所有患者在出院时均以书面形式提供 CDSM 建议。在随访期间收集了有关 CHF-PROM 和 CDSM 的信息。应用多水平模型动态评估 CDSM 对 CHF-PROM 评分及其生理和心理领域的影响。引入 PRO 的 MCID 变化，并与多水平模型获得的 CDSMβ 值进行比较，以进一步评估临床意义。STROBE 清单见附加文件 1。
出院后 CHF-PROM 评分明显提高。多水平模型显示，规律作息、避免暴饮暴食、低钠饮食和运动可提高 CHF-PROM 评分。与 MCID 相比，避免暴饮暴食（12.39 与 9.75）和经常保持规律作息（10.98 与 9.75）以及几乎每天运动（11.36 与 9.75）在总体总结中达到临床意义。避免暴饮暴食（5.88 与 4.79）和几乎每天保持规律作息（4.96 与 4.79）在生理评分中达到临床意义。避免暴饮暴食一半时间（5.26 与 4.87）和几乎每天保持规律作息（5.84 与 4.87）在心理评分中达到临床意义。
本研究观察到避免暴饮暴食和保持规律作息与 CHF-PROM 改善之间存在关联。为心力衰竭的管理提供了进一步的证据。
当前前瞻性试验 NCT02878811；注册于 2016 年 8 月 25 日；https://clinicaltrials.gov/ct2/show/NCT02878811？term=NCT02878811&draw=2&rank=1。
