Pharmacy Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Heart Failure and Heart Transplant Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain.
JMIR Mhealth Uhealth. 2020 Feb 4;8(2):e15957. doi: 10.2196/15957.
Medication nonadherence in heart transplant recipients (HTxR) is related to graft loss and death. mHeart is a mobile app that uses electronic patient-reported outcome measures (ePROMs) to identify and manage medication nonadherence in the outpatient heart transplant (HTx) population.
The study primarily aimed to validate mHeart to measure medication nonadherence in early stage HTxR by assessing the psychometric properties of ePROMs. The secondary aims were to (1) measure patient satisfaction with the mHeart tool and its usability and (2) explore the impact of a theory-based treatment on medication nonadherence rates to determine its scalability to larger research.
A prospective study was conducted in the outpatient clinic of a tertiary hospital. All consecutive early stage HTxR (<1.5 years from HTx) were included. The ePROM psychometric properties assessed were validity, reliability, responsiveness, interpretability, and burden. ePROMs comprised the 4-item Morisky-Green-Levine questionnaire and an adapted version of the Haynes-Sackett questionnaire. The Simplified Medication Adherence Questionnaire (SMAQ) was also applied on-site. Three consecutive medication nonadherence assessments were performed by a transplant pharmacist. To improve medication nonadherence, theory-based interventions were delivered in a 1-month period. Patient satisfaction was assessed by a semiquantitative Web-based survey at the end of the study.
We included 31 early stage HTxR (age: mean 54 years, SD 12 years), and 71% (22/31) of them were men. The HTxR were taking a mean 13 (SD 4; range 7-18) drugs per day. A total of 42% (13/31) of patients were unaware of the consequences of medication nonadherence, and 39% (12/31) of patients were nonadherent to immunosuppressive treatment. The content validity measure showed excellent levels of expert panel agreement for the Haynes-Sacket (14/14, 100%) and Morisky-Green-Levine (13/14, 93%) questionnaires. SMAQ and Morisky-Green-Levine ePROMs showed similar measurement domains (convergent validity, phi=0.6, P<.001), which, as expected, differed from Haynes-Sackett ePROMs (divergent validity, phi=0.3, P=.12). Reliability assessment revealed a very strong association between ePROM and on-site PROMs (phi>0.7, P<.001). Reproducibility was moderate (Haynes-Sackett κ=0.6, P<.002) or poor (Morisky-Green-Levine κ=0.3, P=.11) because of unexpected improved medication adherence rates during the test-retest period. According to responsiveness, the theory-based multifaceted intervention program improved medication nonadherence by 16% to 26% (P<.05). A burden analysis showed that ePROMs could potentially overcome traditional on-site limitations (eg, automatic recording of ePROM responses in the hospital information system). The mean score for overall patient satisfaction with the mHeart approach was 9 (SD 2; score range: 0-10). All 100% (29/29) of patients surveyed reported that they would recommend the mHeart platform to other HTxR.
ePROMs adhered to the quality standards and successfully identified medication nonadherence in the HTx population, supporting their widespread use. The theory-based intervention program showed a promising improvement in medication adherence rates and produced excellent patient satisfaction and usability scores in HTxR.
心脏移植受者（HTxR）的药物依从性与移植物丢失和死亡有关。mHeart 是一款使用电子患者报告结局测量（ePROMs）的移动应用程序，用于识别和管理门诊心脏移植（HTx）人群中的药物不依从性。
本研究旨在通过评估 ePROMs 的心理测量特性，验证 mHeart 用于测量早期 HTxR 患者的药物不依从性。次要目的是（1）测量患者对 mHeart 工具及其可用性的满意度，（2）探索基于理论的治疗对药物不依从率的影响，以确定其在更大规模研究中的可扩展性。
在一家三级医院的门诊进行了一项前瞻性研究。所有连续的早期 HTxR（HTx 后<1.5 年）均纳入研究。评估的 ePROM 心理测量特性包括有效性、可靠性、反应性、可解释性和负担。ePROMs 包括 Morisky-Green-Levine 问卷的 4 项和 Haynes-Sackett 问卷的改编版。还在现场应用简化药物依从性问卷（SMAQ）。由一名移植药剂师进行了三次连续的药物不依从性评估。为了改善药物不依从性，在 1 个月的时间内提供了基于理论的干预措施。在研究结束时，通过半定量网络调查评估患者满意度。
我们纳入了 31 名早期 HTxR（年龄：平均 54 岁，标准差 12 岁），其中 71%（22/31）为男性。HTxR 每天平均服用 13（标准差 4；范围 7-18）种药物。共有 42%（13/31）的患者不知道药物不依从的后果，39%（12/31）的患者不依从免疫抑制治疗。内容效度测量显示，Haynes-Sackett（14/14，100%）和 Morisky-Green-Levine（13/14，93%）问卷的专家小组具有出色的一致性水平。SMAQ 和 Morisky-Green-Levine ePROMs 显示出相似的测量领域（convergent validity，phi=0.6，P<.001），这与预期的 Haynes-Sackett ePROMs 不同（divergent validity，phi=0.3，P=.12）。可靠性评估显示 ePROM 与现场 PROM 之间存在非常强的关联（phi>0.7，P<.001）。由于在测试-重测期间药物依从性率意外提高，重现性为中度（Haynes-Sackett κ=0.6，P<.002）或较差（Morisky-Green-Levine κ=0.3，P=.11）。根据反应性，基于理论的多方面干预方案将药物不依从率提高了 16%至 26%（P<.05）。负担分析表明，ePROMs 可能克服传统现场的局限性（例如，在医院信息系统中自动记录 ePROM 响应）。患者对 mHeart 方法总体满意度的平均得分为 9（标准差 2；得分范围：0-10）。接受调查的所有患者（29/29）均表示他们将向其他 HTxR 推荐 mHeart 平台。
ePROMs 符合质量标准，并成功识别出 HTx 人群中的药物不依从性，支持其广泛应用。基于理论的干预方案显示出改善药物依从性率的有希望的效果，并在 HTxR 中产生了出色的患者满意度和可用性评分。
