Health technology assessment is a systematic assessment of the nature and impact of health technology. It is a science that solves the problems of health intervention or health technology on society, economy, organization and ethics. Aiming at the current issues of availability, accessibility, affordability, rationality and safety in the field of medical devices, health technology assessment can systematically evaluate the characteristics, effects and impact of medical devices, and provide evidence-based basis for scientific decision-making. Starting from the current status and challenges of medical device management, this paper introduces the origin and development, basic scope, assessment process and main assessment content of health technology assessment, and introduces the application of health technology assessment in medical device management through case studies, so as to promote development of health technology assessment in the field of medical device management and make medical device management more scientific and standardized.
ObjectivesThis study aimed to evaluate the validity and reliability of the clinical practice guidelines (CPGs) applicability evaluation tool, a preliminary revised tool, by using it to appraise specific clinical guidelines.MethodsMedical staffs were sampled from relevant departments in domestic medical institutions to use tool to evaluate the two guidelines. Spearman-Brown coefficient of odd-even split-half method and Cronbach's alpha coefficient were used to evaluate the split-half reliability and internal consistency reliability. The convergent and discriminant validity were evaluated by correlation analysis and correlation coefficient comparison hypothesis test, and the structural validity was investigated by confirmatory factor analysis based on structural equation.ResultsThe split-half reliability of the evaluation tool was 0.86, and the Cronbach's coefficient of the whole tool and each dimension were greater than 0.7 for two guidelines. The success rates of tool convergent and discriminant validity calibration were 100%. In the second-order confirmatory factor analysis model, the χ2 and df were 3.38 and 2.46, the comparative fit index (CFI) were 0.872 and 0.974, the goodness of fit index (GFI) were 0.954 and 0.983, and the adjusted goodness of fit index (AGFI) were 0.846 and 0.959 for two guidelines respectively. Both standard root mean square residual (SRMR) and root mean square error of approximation (RMSEA) were less than 0.09. Both P values of RMSEA hypothesis test were greater than 0.05.ConclusionsThe evaluation scale is a valid and reliable instrument for assessing the applicability of CPGs, which should be further evaluated in practical applications in the future.