Abstract
Acquisition of scientific data required for the rational decisions on health policy has became an important tool in determining the validity of the financing methods of treatment from public funds based on the health technology assessment (HTA). The primary source of scientific evidence for health technology assessment are randomized controlled trials (RCTs), because of their features (e.g. randomization or blindness) reducing methodological bias. These features may become a disadvantage, which markedly reduces the possibility of the transfer of the results and conclusions to the everyday practice. In this situation an important role begin to play pragmatic randomized controlled trials (PRCTs), providing highly reliable information about the effectiveness in contrast to observational studies or registries. However, an important problem is correct design and quality assessment of such trials. A systematic review in Medline through Pubmed using the following queries: “(pragmatic OR practical OR naturalistic OR real world) AND (design OR quality)” was performed till June 2012 to gather and systematize the current information about pragmatic randomized trials to improve the quality of the practical effectiveness evaluation in health technology assessment reports. Using this search strategy nearly 28 000 hits were obtained. Preliminary evaluation of the found publications demonstrated that the best reflection of the conditions of routine practice (generalizability) in PRCTs can be obtained mostly through the development of broader inclusion criteria, minimizing the exclusion criteria or broadening the scope of patients evaluation. We found also suitable tools, which can be used both during the design and evaluation of reliability of PRCTs: PRECIS, PR-tool, Pragmascope tool or CONSORT. Properly assessed PRCTs data in conjunction with information about the efficacy from RCTs will serve as a whole to facilitate business decisions in medical practice, as well as health organizations and rationalization of cost-reimbursement of used or new medical technologies.
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