研究参与和经历的患者植入左心室辅助设备之前和之后的机械循环支持措施的调整和生活质量（MCS A-QOL）研究。
Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study.
机构信息
Departments of Psychiatry and Behavioral Sciences and Preventive Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Chicago, IL, 60611, USA.
Departments of Medical Social Sciences and Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
出版信息
Qual Life Res. 2022 Aug;31(8):2457-2470. doi: 10.1007/s11136-022-03111-4. Epub 2022 Mar 8.
PURPOSE
Adults living with mechanical circulatory support (MCS) present with unique challenges (e.g., left ventricular assist device [LVAD]-related self-care, adverse events) to research study enrollment, engagement, and completion. The purpose of this study was to understand the experiences of adults with MCS who were eligible for and enrolled in a study of health-related quality of life (HRQOL).
METHODS
In a secondary analysis of data from the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life study, we used a mixed-methods approach to evaluate research engagement and experiences among adults preparing to undergo or currently living with MCS implant. First, we assessed the cascade of study engagement. Second, we assessed research experiences using a structured interview developed for this study.
RESULTS
Of 1011 participants approached for the study, 86.7% enrolled, 12.7% declined, and 0.6% were ineligible. Of 877 participants enrolled, 272 were pre-implant (of whom 88% completed assessments; "respondents") and 605 were post-implant (of whom 74% completed assessments). Only 14% of respondents reported difficulty completing the questionnaires, 54% had previously used an iPad to complete questionnaires, and 62% reported that their experience was "as expected." Respondents qualitatively described both positive (e.g., value of research) and negative (e.g., too much time) research experiences, difficulties completing questionnaires (e.g., online platform, health literacy issues), and provided recommendations for the questionnaires and delivery.
CONCLUSIONS
Participants enjoyed participating in HRQOL research focused on MCS and had unique perspectives for improving the questionnaires. It is important to minimize the burden of participation and critical to be flexible to meet participant preferences for research engagement.
TRIAL REGISTRATION
NCT03044535 (accessible at https://clinicaltrials.gov/ct2/show/NCT03044535 ), registered February 7, 2017.
目的
患有机械循环支持（MCS）的成年人在研究入组、参与和完成方面存在独特的挑战（例如，左心室辅助装置[LVAD]相关的自我护理、不良事件）。本研究的目的是了解符合条件并参加健康相关生活质量（HRQOL）研究的 MCS 成年人的经验。
方法
在机械循环支持：调整和生活质量研究数据的二次分析中，我们使用混合方法评估了准备接受或正在接受 MCS 植入的成年人的研究参与和经验。首先，我们评估了研究参与的级联。其次，我们使用为本研究开发的结构化访谈评估了研究经验。
结果
在该研究中，1011 名参与者中有 86.7%入组，12.7%拒绝，0.6%不符合条件。在 877 名入组的参与者中，272 名处于植入前（其中 88%完成评估；“应答者”），605 名处于植入后（其中 74%完成评估）。只有 14%的应答者报告说完成问卷有困难，54%以前使用过 iPad 完成问卷，62%表示他们的体验“符合预期”。应答者定性描述了积极的（例如，研究的价值）和消极的（例如，时间太多）研究体验、完成问卷的困难（例如，在线平台、健康素养问题），并为问卷和交付提出了建议。
结论
参与者喜欢参与专注于 MCS 的 HRQOL 研究，并对改善问卷有独特的看法。尽量减少参与负担很重要，灵活满足参与者对研究参与的偏好至关重要。
试验注册
NCT03044535（可在 https://clinicaltrials.gov/ct2/show/NCT03044535 上获得），于 2017 年 2 月 7 日注册。
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