Open AccessScale for efficacy and safety evidence based on design and methodological quality of treatments and preventive technologies trials
Author(s) -
O. Yu. Rebrova
Publication year - 2018
Publication title -
rossijskij allergologičeskij žurnal
Language(s) - English
Resource type - Journals
eISSN - 2686-682X
pISSN - 1810-8830
DOI - 10.36691/rja147
Subject(s) - scale (ratio) , quality (philosophy) , risk analysis (engineering) , evidence based medicine , clinical study design , research design , psychological intervention , reimbursement , randomized controlled trial , medicine , clinical trial , management science , computer science , health care , alternative medicine , engineering , nursing , mathematics , economics , physics , surgery , epistemology , pathology , quantum mechanics , economic growth , philosophy , statistics
The quality of the evidence on the efficacy and safety of therapeutic and preventive interventions is analyzed in health technology assessment procedure (including the development of reimbursement lists such as the List of Vital and Essential Drugs in Russian Federation) and during development of clinical guidelines. The traditional approach to assess the evidence quality is based on the well-known pyramid of research designs (from meta-analyses to case descriptions), and now it is obsolete. The modern approach is to take into account also the methodological quality of studies. The methodological quality depends on risks of biases and the risk of incorrect data analysis. The article proposes a scale based on combinations of designs and three levels of methodological quality (high, medium, poor) for each of them. The scale differentiates meta-analyses based on randomized controlled trials and comparative studies of other designs. In the scale, the new design of indirect comparisons is envisaged, its’ evidence is lower than for RCT that are used for indirect comparisons. The scale can be used for assessing the absolute and relative effectiveness and safety of medical and preventive medical technologies. At present, the scale is included in the guidelines for the complex assessment of pharmaceuticals.