Brotons Cuixart C, Permanyer Miralda C
Unidad de Epidemiología Clínica, Hospital General Vall d'Hebron, Barcelona.
Rev Esp Cardiol. 1997 Mar;50(3):192-200. doi: 10.1016/s0300-8932(97)73203-2.
Over the last decade, changes in health care delivery and concern with costs and with dramatic variations in practice between regions, institutions and even physicians at the same institution have led the administrators and health politicians to focus on the outcomes of medical care. The Agency for Health Care Policy and Research was established with the objective of fostering research on the outcomes of medical interventions and on the development of guidelines. The Agency supports studies based not only on standard outcomes such as mortality and morbidity, but also on quality of life and patient satisfaction. The Patient Outcome Research Teams (PORTs) projects are the showcase displays of the Agency, and their goals are to identify and analyze the outcomes and costs of alternative interventions for a given clinical condition, in order to determine the most effective and cost-effective means to prevent, diagnose, treat, or manage it and develop and test methods for reducing inappropriate or unnecessary variations. Three PORTs are focused on the following cardiovascular conditions: acute myocardial infarction, chronic ischemic heart disease and stroke. There are many situations in which randomized clinical trials are not feasible and large-scale observational studies are necessary to generate information about what happens in the real practice. This information deepens the understanding of practical effectiveness as opposed to theoretical efficacy since trials do not always measure all the outcomes of interest to patients and physicians. One way to solve the problem of inaccurate data of observational studies is by establishing a specific registry to measure in an efficient way key patient characteristics, process of care elements and relevant outcomes. The Cardiac Surgery Reporting System is a registry that collects clinical data on all patients undergoing cardiac surgery in New York State. This registry has produced reliable and valid measures of quality and hospitals and cardiac surgery programs throughout New York use this information to improve outcomes for their patients. Health related quality of life can be a useful outcome measure in the assessment of clinical effectiveness. However, there are still many methodological questions regarding the validity and sensitivity of quality of life measurement an optimal study design calls for caution in the interpretation of current results and makes refinement of methodological issues a desirable goal. Nevertheless, apparently valid studies of cardiovascular diseases and interventions using health related quality of life as an outcome measures have been reported where such measures have provided information about undesirable side effects of medications and the impact of the intervention on the health related quality of life. Moreover, some of these studies have identified different patterns of health care as leading to different quality of life outcomes. Thus, quality of life measurement appears as a technology which holds promise for the future assessment of clinical effectiveness.
在过去十年中,医疗服务的变化、对成本的关注以及地区、机构乃至同一机构内医生之间医疗实践的巨大差异,促使管理人员和卫生政策制定者将重点放在医疗保健的结果上。医疗保健政策与研究机构的设立目的是促进对医疗干预结果及指南制定的研究。该机构不仅支持基于死亡率和发病率等标准结果的研究,还支持基于生活质量和患者满意度的研究。患者结果研究团队(PORTs)项目是该机构的典型展示,其目标是识别和分析针对特定临床状况的替代干预措施的结果和成本,以确定预防、诊断、治疗或管理该状况的最有效和最具成本效益的方法,并开发和测试减少不适当或不必要差异的方法。三个PORTs聚焦于以下心血管疾病:急性心肌梗死、慢性缺血性心脏病和中风。在许多情况下,随机临床试验不可行,需要大规模观察性研究来获取实际医疗中发生情况的信息。与理论疗效相对,这些信息加深了对实际有效性的理解,因为试验并不总是能衡量患者和医生感兴趣的所有结果。解决观察性研究数据不准确问题的一种方法是建立特定的登记系统,以有效方式测量关键患者特征、护理过程要素和相关结果。心脏手术报告系统是一个收集纽约州所有接受心脏手术患者临床数据的登记系统。该登记系统产生了可靠且有效的质量衡量指标,纽约州各地的医院和心脏手术项目利用这些信息来改善患者的治疗结果。健康相关生活质量可作为评估临床有效性的有用结果指标。然而,关于生活质量测量的有效性和敏感性仍存在许多方法学问题。最佳研究设计要求在解释当前结果时谨慎,并将完善方法学问题作为一个理想目标。尽管如此,已有关于心血管疾病和干预措施的明显有效的研究报告,这些研究将健康相关生活质量作为结果指标,此类指标提供了有关药物不良副作用以及干预措施对健康相关生活质量影响的信息。此外,其中一些研究确定了不同的医疗模式会导致不同的生活质量结果。因此,生活质量测量似乎是一项对未来临床有效性评估有前景的技术。