Hlatky Mark A
Stanford University School of Medicine, Stanford, CA, USA.
Value Health. 2016 Jul-Aug;19(5):516-9. doi: 10.1016/j.jval.2016.04.019.
Since the 1980s, when the American College of Cardiology (ACC) and the American Heart Association (AHA) established a joint task force to examine the use of cardiovascular procedures and therapies, cardiologists have been leaders in the development of clinical practice guidelines. The ACC/AHA guidelines development process has evolved considerably over the last 30 or more years. Guidelines now focus on clinical conditions, such as angina, instead of procedures, such as bypass surgery. There is a formal organizational structure, with dedicated staff, a standing committee on practice guidelines, and specific panels of volunteer experts on each topic. This process tightly manages conflicts of interest and strives for evidence-based, as opposed to opinion-based, guidelines, with a clear citation of the supporting evidence. Traditional clinical guidelines consider only what is best for the individual patient, and have explicitly not considered the cost to society. Nevertheless, in many guidelines development meetings, high cost was implicitly considered: if a procedure was extremely costly, the evidence needed to be very strong. The Guidelines Committee recognized that cost considerations ought to be made more transparent, and that the evidence on economic value should be explicitly cited when available. These considerations were formalized by a recent white paper on incorporating economic considerations into ACC/AHA guidelines. In considering value, it is necessary to assess the quality of the evidence as well as to define levels of value. The next ACC/AHA guideline will incorporate value as a part of its recommendations. This will be an evidence-based process in which published economic assessments relating to key questions will be reviewed.
自20世纪80年代美国心脏病学会(ACC)和美国心脏协会(AHA)成立联合特别工作组以审查心血管手术和治疗方法的使用以来,心脏病专家一直是临床实践指南制定的领导者。在过去30多年里,ACC/AHA指南的制定过程有了很大发展。如今,指南关注的是心绞痛等临床病症,而非搭桥手术等手术。它有一个正式的组织结构,配备了专职人员、一个实践指南常务委员会以及针对每个主题的志愿者专家特定小组。这个过程严格管理利益冲突,力求制定基于证据而非基于意见的指南,并明确引用支持证据。传统临床指南只考虑对个体患者最有利的情况,并未明确考虑对社会的成本。然而,在许多指南制定会议中,高成本被隐含地考虑在内:如果一种手术成本极高,那么所需证据就必须非常有力。指南委员会认识到成本考量应更加透明,并且在有可用的经济价值证据时应明确引用。最近一份关于将经济考量纳入ACC/AHA指南的白皮书使这些考量正式化。在考虑价值时,有必要评估证据质量并界定价值水平。下一份ACC/AHA指南将把价值纳入其建议之中。这将是一个基于证据的过程,在此过程中,将对与关键问题相关的已发表经济评估进行审查。