Division of Health Informatics, Department of Population Health Sciences, Weill Cornell Medicine, 425 East 61st Street, Suite 301, New York, NY 10065, USA.
Division of General Internal Medicine, Department of Medicine, Weill Cornell Medicine, 1300 York Ave, F-2007, New York, NY 10065, USA.
Eur Heart J Qual Care Clin Outcomes. 2022 Aug 17;8(5):510-517. doi: 10.1093/ehjqcco/qcab022.
The objective of the Randomized comparison of the Outcome of single vs. Multiple Arterial grafts: Quality of Life (ROMA:QOL) trial is to evaluate the impact of coronary artery bypass graft surgery (CABG) on quality of life (QOL). The primary hypothesis of ROMA:QOL is that participants in the multiple arterial graft (MAG) will report time-varying changes in QOL that will be lower in the post-operative recovery period and higher after 12 months compared to patients in the single arterial graft (SAG). The secondary hypotheses are that both groups will have improvements in symptoms at 12 months, and that compared to the SAG group, participants in the MAG group will experience better physical functioning and physical and mental health symptoms.
An estimated 2111 participants will be enrolled from the parent ROMA trial from 13 countries. Outcome assessments include the Seattle Angina Questionnaire (SAQ) (primary outcome), Short Form-12v2, EuroQol-5D (EQ-5D)-5L, PROMIS-29, and PROMIS Neuropathic Pain measured at baseline, first post-operative visit, 6, 12, 24, 36, 48, and 60 months. The analysis for the primary outcome, the change in the SAQ from baseline to 12 months, will be compared across all time-points between the two treatment arms.
The ROMA:QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.
随机比较单支与多支动脉旁路移植术结果：生活质量（ROMA：QOL）试验的目的是评估冠状动脉旁路移植术（CABG）对生活质量（QOL）的影响。ROMA：QOL 的主要假设是，多动脉移植（MAG）组的参与者报告 QOL 的时变变化，术后恢复期较低，12 个月后高于单动脉移植（SAG）组。次要假设是两组在 12 个月时症状都会改善，与 SAG 组相比，MAG 组的参与者将体验到更好的身体机能和身心症状。
将从 13 个国家的母 ROMA 试验中招募约 2111 名参与者。结果评估包括西雅图心绞痛问卷（SAQ）（主要结果）、短式健康调查 12 项简表（SF-12v2）、欧洲五维健康量表（EQ-5D）-5L、PROMIS-29 和 PROMIS 神经性疼痛，在基线、第一次术后访视、6、12、24、36、48 和 60 个月进行测量。主要结果，即 SAQ 从基线到 12 个月的变化，将在两个治疗组的所有时间点之间进行比较。
ROMA：QOL 试验将回答通过 MAG 和 SAG 干预臂、性别以及是否有糖尿病患者，在 CABG 方面，QOL、身体和心理健康症状是否存在差异。
