The ISPOR Good Practices for Quality Improvement of Cost-Effectiveness Research Task Force Report.

OBJECTIVES The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Health Science Policy Council recommended and the ISPOR Board of Directors approved the formation of a Task Force to critically examine the major issues related to Quality Improvement in Cost-effectiveness Research (QICER). The Council's primary recommendation for this Task Force was that it should report on the quality of cost-effectiveness research and make recommendations to facilitate the improvement of pharmacoeconomics and health outcomes research and its use in stimulating better health care and policy. Task force members were knowledgeable and experienced in medicine, pharmacy, biostatistics, health policy and health-care decision-making, biomedical knowledge transfer, health economics, and pharmacoeconomics. They were drawn from industry, academia, consulting organizations, and advisors to governments and came from Japan, the Netherlands, Canada and the United States. METHODS Face-to-face meetings of the Task Force were held at ISPOR North American and European meetings and teleconferences occurred every few months. Literature reviews and surveys were conducted and the first preliminary findings presented at an open forum at the May 2008 ISPOR meeting in Toronto. The final draft report was circulated to the expert reviewer group and then to the entire membership for comment. The draft report was posted on the ISPOR Web site in April 2009. All formal comments received were posted to the association Web site and presented for discussion at the Task Force forum during the ISPOR 14th Annual International Meeting in May 2009. Comments and feedback from the forums, reviewers and membership were considered in the final report. Once Task Force consensus was reached, the article was submitted to Value in Health. CONCLUSIONS The QICER Task Force recommends that ISPOR implement the following: * With respect to CER guidelines, that ISPOR promote harmonization of guidelines, allowing for differences in application, regional needs and politics; evaluate available instruments or promote development of a new one that will allow standardized quantification of the impact of CER guidelines on the quality of CER studies; report periodically on those countries or regions that have developed guidelines; periodically evaluate the quality of published studies (those journals with CER guidances) or those submitted to decision-making bodies (as public transparency increases). * With respect to methodologies, that ISPOR promote publication of methodological guidelines in more applied journals in more easily understandable format to transfer knowledge to researchers who need to apply more rigorous methods; promote full availability of models in electronic format to combat space restrictions in hardcopy publications; promote consistency of methodological review for all CER studies; promote adoption of explicit best practices guidelines among regulatory and reimbursement authorities; periodically update all ISPOR Task Force reports; periodically review use of ISPOR Task Force guidelines; periodically report on statistical and methodological challenges in HE; evaluate periodically whether ISPOR's methodological guidelines lead to improved quality; and support training and knowledge transfer of rigorous CER methodologies to researchers and health care decision-makers. * With respect to publications, that ISPOR develop standard CER guidances to which journals will be able to refer their authors and their reviewers; lobby to establish these guidances within the International Committee for Medical Journal Editors (ICMJE) Requirements to which most journals refer in their Author Instructions; provide support in terms of additional reviewer expertise to those journals lacking appropriate reviewers; periodically report on journals publishing CER research; periodically report on the quality of CER publications; and support training and knowledge transfer of the use of these guidelines to researchers and reviewers. * With respect to evidence-based health-care decision-making, that ISPOR recognize at its annual meetings those countries/agencies/private companies/researchers using CER well, and those practitioners and researchers supporting good patient use of CER in decision-making; and promote public presentation of case studies of applied use of CER concepts or guidelines.