The incorporation of data on pre-analytical and analytical factors in model-based Health Technology Assessments(HTAs) of medical tests: a systematic review protocol

Background: Medical tests are becoming increasingly important in modern health care. As the number of tests coming to the global market continues to rise, Health Technology Assessments (HTAs) will play an increasingly important role in directing test adoption decisions. Assessment of health-economic outcomes within HTAs – most often informed via decision model-based evaluations – have not routinely addressed the impact of pre-analytical and analytical factors on test performance, which can have a significant effect on test outcomes. This systematic review will investigate methods utilised in HTA model-based economic evaluations, to identify if and how data on the impact of pre-analytical and analytical factors on test performance is being assessed. Methods: The Cochrane HTA database and key HTA authority websites will be searched to identify published papers and reports relating to HTAs of in-vitro tests including a model-based economic evaluation. Title and abstract screening will be conducted by a primary reviewer and 10% independently screened by a second reviewer. Full text screening and data extraction will be conducted by the primary reviewer, with 10% of data extraction independently conducted by a second reviewer. For all included studies, basic characteristics of the study, disease area and test technology assessed will be extracted. For studies identified as including an assessment of pre-analytical and analytical factors, additional data on the type of factors assessed, methods utilised, impact on the cost-effectiveness results and study quality will be recorded. Discussion: Understanding the methods used in this area will enable identification of key gaps in current methodology and potential avenues for future research. The findings of this work will be disseminated via a peer-reviewed journal publication and at national and international conferences.