Hemse Health Central, Region Gotland, Visby, Sweden.
Heart and Vascular Theme, Karolinska Universitetssjukhuset, Stockholm, Sweden.
Open Heart. 2019 May 28;6(1):e000954. doi: 10.1136/openhrt-2018-000954. eCollection 2019.
A home-based tool for heart failure (HF) patients, was evaluated in a specialist setting as a randomised controlled trial (RCT) and also in a validation cohort in a primary care setting in a clinical controlled trial (CCT). The tool provides education, symptom monitoring and titration of diuretics. The aim of this study was thus to extend validity of the previous RCT findings in order to describe applicability of the tool in clinical practice.
Data from both trials were analysed separately, as well as a pooled data set (n=172). Data were analysed with respect to HF related in-hospital days, self-care behaviour and system adherence, during a 6-month intervention. The analysis of in-hospital days for the pooled data was adjusted for baseline differences between the two study cohorts, relating to disease state.
In the RCT (n=72) the intervention group (IG) consisted of 32 patients and the control group (CG) of 40 patients. The risk ratio (RR) for in-hospital days was RR: 0.72, 95% CI 0.61 to 0.84, p<0.05 in favour of the IG. In the CCT (n=100) both the IG and the CG consisted of 50 patients and the IG had fewer in-hospitals days, comparable to the RCT findings with RR: 0.67; 95% CI 0.45 to 0.99; p<0.05. For the pooled data set made up of 172 patients, the groups were well balanced but with a higher prevalence of hypertension in the CG. The RR relating to in-hospital days for the pooled data set was 0.71; 95% CI 0.61 to 0.82; p<0.05 in favour of the IG. There was a statistically significant improvement in self-care by 27% and the median system adherence was 94%.
These analyses suggest that the evaluated tool might reduce HF related in-hospital days in the general HF population, which adds to the external validity of previous findings.Clinical Trial Registration NCT03655496.
一种基于家庭的心力衰竭（HF）患者工具，已在专科环境中作为随机对照试验（RCT）进行评估，并且在初级保健环境中的验证队列中作为临床对照试验（CCT）进行评估。该工具提供教育、症状监测和利尿剂滴定。因此，本研究的目的是扩展先前 RCT 研究结果的有效性，以便描述该工具在临床实践中的适用性。
分别分析两项试验的数据，以及合并数据集（n=172）。在 6 个月的干预期间，分析与 HF 相关的住院天数、自我护理行为和系统依从性的数据。对合并数据的住院天数分析进行了调整，以消除两个研究队列之间与疾病状态相关的基线差异。
在 RCT（n=72）中，干预组（IG）由 32 名患者组成，对照组（CG）由 40 名患者组成。住院天数的风险比（RR）为 RR：0.72，95%CI 0.61 至 0.84，p<0.05 对 IG 有利。在 CCT（n=100）中，IG 和 CG 各有 50 名患者，IG 的住院天数较少，与 RCT 发现的结果相似，RR：0.67；95%CI 0.45 至 0.99；p<0.05。对于由 172 名患者组成的合并数据集，两组平衡良好，但 CG 中高血压的患病率较高。与合并数据集相关的住院天数的 RR 为 0.71；95%CI 0.61 至 0.82；p<0.05 对 IG 有利。自我护理改善了 27%，中位数系统依从性为 94%。
这些分析表明，评估的工具可能会减少一般 HF 人群中与 HF 相关的住院天数，这增加了先前研究结果的外部有效性。临床试验注册 NCT03655496。
