Catalá-López Ferrán, Ridao Manuel, Alonso-Arroyo Adolfo, García-Altés Anna, Cameron Chris, González-Bermejo Diana, Aleixandre-Benavent Rafael, Bernal-Delgado Enrique, Peiró Salvador, Tabarés-Seisdedos Rafael, Hutton Brian
Fundación Instituto de Investigación en Servicios de Salud, Valencia, Spain.
Department of Medicine, University of Valencia/INCLIVA Health Research Institute and CIBERSAM, Valencia, Spain.
Syst Rev. 2016 Jan 7;5:6. doi: 10.1186/s13643-015-0181-5.
Cost-effectiveness analysis has been recognized as an important tool to determine the efficiency of healthcare interventions and services. There is a need for evaluating the reporting of methods and results of cost-effectiveness analyses and establishing their validity. We describe and examine reporting characteristics of methods and results of cost-effectiveness analyses conducted in Spain during more than two decades.
A methodological systematic review was conducted with the information obtained through an updated literature review in PubMed and complementary databases (e.g. Scopus, ISI Web of Science, National Health Service Economic Evaluation Database (NHS EED) and Health Technology Assessment (HTA) databases from Centre for Reviews and Dissemination (CRD), Índice Médico Español (IME) Índice Bibliográfico Español en Ciencias de la Salud (IBECS)). We identified cost-effectiveness analyses conducted in Spain that used quality-adjusted life years (QALYs) as outcome measures (period 1989-December 2014). Two reviewers independently extracted the data from each paper. The data were analysed descriptively.
In total, 223 studies were included. Very few studies (10; 4.5 %) reported working from a protocol. Most studies (200; 89.7 %) were simulation models and included a median of 1000 patients. Only 105 (47.1 %) studies presented an adequate description of the characteristics of the target population. Most study interventions were categorized as therapeutic (189; 84.8 %) and nearly half (111; 49.8 %) considered an active alternative as the comparator. Effectiveness of data was derived from a single study in 87 (39.0 %) reports, and only few (40; 17.9 %) used evidence synthesis-based estimates. Few studies (42; 18.8 %) reported a full description of methods for QALY calculation. The majority of the studies (147; 65.9 %) reported that the study intervention produced "more costs and more QALYs" than the comparator. Most studies (200; 89.7 %) reported favourable conclusions. Main funding source was the private for-profit sector (135; 60.5 %). Conflicts of interest were not disclosed in 88 (39.5 %) studies.
This methodological review reflects that reporting of several important aspects of methods and results are frequently missing in published cost-effectiveness analyses. Without full and transparent reporting of how studies were designed and conducted, it is difficult to assess the validity of study findings and conclusions.
成本效益分析已被公认为是确定医疗保健干预措施和服务效率的重要工具。有必要评估成本效益分析方法和结果的报告情况并确定其有效性。我们描述并研究了西班牙二十多年来进行的成本效益分析方法和结果的报告特征。
通过在PubMed及补充数据库（如Scopus、ISI科学网、英国国家卫生服务体系经济评估数据库（NHS EED）以及英国约克大学循证医学与卫生保健中心的卫生技术评估（HTA）数据库、西班牙医学索引（IME）、西班牙卫生科学文献索引（IBECS））中进行更新的文献检索获取信息，开展了一项方法学系统评价。我们确定了西班牙进行的以质量调整生命年（QALYs）作为结局指标的成本效益分析（时间段为1989年至2014年12月）。两名评价员独立从每篇论文中提取数据。对数据进行描述性分析。
共纳入223项研究。极少有研究（10项；4.5%）报告是按照方案开展的。大多数研究（200项；89.7%）是模拟模型，纳入患者的中位数为1000例。只有105项（47.1%）研究对目标人群特征进行了充分描述。大多数研究干预措施归类为治疗性（189项；84.8%），近半数（111项；49.8%）将一种积极对照作为比较对象。87份报告（39.0%）的数据有效性源自单项研究，只有少数（40项；17.9%）使用基于证据综合的估计值。极少有研究（42项；18.8%）对QALY计算方法进行了完整描述。大多数研究（147项；65.9%）报告研究干预措施比对照产生“更多成本和更多QALYs”。大多数研究（200项；89.7%）报告了有利结论。主要资金来源是私营营利部门（135项；60.5%）。88项（39.5%）研究未披露利益冲突。
这项方法学评价反映出已发表的成本效益分析中经常缺少方法和结果几个重要方面的报告。如果不全面、透明地报告研究的设计和实施方式，就难以评估研究结果和结论的有效性。
