G Ital Cardiol. 1997 Sep;27(9):865-76.
Quality of life is increasingly being incorporated into clinical trials as an end-point that can complement the traditional end-points of mortality and morbidity. This study presents the results of a multicenter survey on the evaluation of health-related quality of life (HRQL) of acute myocardial infarction (AMI) patients. The survey, a companion study of the GISSI-3 trial, involved nurses from 66 italian coronary care units (CCU).
A specific questionnaire, based on a multidimensional concept of health, was developed and validated. The questionnaires, which explored the HRQL of the patients during the month before the questionnaires were handed out, were administered during the hospital stay, at 6 weeks and again at 6 months from the AMI.
1941 patients (64% of the patients initially given the questionnaire) answered the three questionnaires. The AMI has an impact on most aspects of the HRQL at 6 weeks, but at 6 months the major impact continues to involve functional status. Apparently, the overall evaluation of quality of life and health is not affected by the AMI. Women show a lower quality of life compared to men, even at baseline. Elderly patients and patients who suffer from severe left ventricular dysfunction have a worse quality of life compared to younger patients and patients without complications.
A simple questionnaire, delivered to patients during everyday practice, made it possible to obtain a profile of the HRQL of AMI patients. The domain most negatively affected 6 months after the AMI is the functional status.
生活质量越来越多地被纳入临床试验，作为一种可以补充死亡率和发病率等传统终点的终点指标。本研究展示了一项关于急性心肌梗死（AMI）患者健康相关生活质量（HRQL）评估的多中心调查结果。该调查是GISSI - 3试验的一项配套研究，涉及来自66个意大利冠心病监护病房（CCU）的护士。
基于健康的多维概念开发并验证了一份特定问卷。这些问卷探讨了患者在问卷发放前一个月的HRQL，在住院期间、AMI后6周以及6个月时进行发放。
1941名患者（最初发放问卷患者的64%）回答了这三份问卷。AMI在6周时对HRQL的大多数方面有影响，但在6个月时，主要影响仍涉及功能状态。显然，生活质量和健康的总体评估不受AMI影响。即使在基线时，女性的生活质量也低于男性。老年患者和患有严重左心室功能障碍的患者与年轻患者和无并发症的患者相比，生活质量更差。
在日常实践中向患者发放一份简单问卷，就有可能获得AMI患者HRQL的概况。AMI后6个月受负面影响最大的领域是功能状态。
