Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL) - Rationale and Study Protocol.
Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL) - Rationale and Study Protocol.
复制标题
单动脉移植与多动脉移植的临床结果的随机比较：生活质量 (ROMA:QOL) - 基本原理和研究方案。
DOI：
10.1093/ehjqcco/qcab022
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Gaudino,Mario
中科院分区：
文献类型：
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作者：
MastersonCreber,Ruth;Safford,Monika;Ballman,Karla;Myers,Annie;Fremes,Stephen;Gaudino,Mario
目的：随机比较单动脉和多动脉移植的结果：生活质量（ROMA:QOL）试验的目的是评估冠状动脉搭桥手术（CABG）对生活质量（QOL）的影响。ROMA:QOL的主要假设是，与单动脉移植（SAG）患者相比，多动脉移植（MAG）的参与者报告的生活质量随时间变化，在术后恢复期较低，12个月后较高。第二种假设是，两组在12个月时症状都会有所改善，与SAG组相比，MAG组的参与者会有更好的身体功能和身心健康症状。方法和结果估计将从13个国家的母ROMA试验中招募2111名参与者。结果评估包括西雅图心绞痛问卷（SAQ）（主要结果）、Short表格-12v2、EuroQol-5D (EQ-5D)-5L、promisi -29和PROMIS神经性疼痛在基线、术后首次就诊、6、12、24、36、48和60个月时测量。对主要结局的分析，即从基线到12个月SAQ的变化，将在两个治疗组之间的所有时间点进行比较。结论：罗马：生活质量试验将回答CABG、MAG和SAG干预组、性别、糖尿病患者和非糖尿病患者在总体生活质量、身心健康症状方面是否存在差异。
AimsThe 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.Methods and ResultsAn 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.ConclusionThe 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.