The quality of reporting methods and results of cost-effectiveness analyses in Spain: a methodological systematic review.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.