Randomized double-blind controlled trials (RCTs) conduct researches in carefully selected populations to ensure results of RCTs are unaffected by external disturbances and provide evidence of safety and efficacy. Real-world researches further help to understand the real world effects of new technologies in different medical environments after-market authorization. RCTs are the evidence foundation of real-world researches, and real-world researches provide valuable complement to RCTs. Medical insurance database is one of the most important database in real-world researches. Now, China's national medical insurance is entering a new era and transits from passive payment and compensation into a value-based strategic purchase mechanism for its insured population to buy the most cost-effective services. It is necessary to establish a mature, well-organized and value-based mechanism. The core of such mechanism is values, which is the price/performance ratio of innovative medicines and technologies rather than looking at the price solely. Demonstrating innovative drug value is an essential part of health care assessment. The authors argue that the assessment of the overall value of innovative technologies or medicines should include and based on the following four dimensions: clinical value, economic value, patient value and society value.
ObjectiveTo compare the effectiveness of haemocoagulase agkistrodon and tranexamic acid and sodium chloride in the prevention and treatment of perioperative bleeding in a real world setting. MethodsA research database was constructed based on the records of inpatient visits using haemocoagulase agkistrodon and tranexamic acid and sodium chloride according to the SuValue? database from January 1, 2016 to December 31, 2020. The patients were divided into two groups according to the different interventions. After matching with a 1∶1 propensity score, the effectiveness of two groups was compared. ResultsA total of 858 patients were included in each of the two groups, and there was no statistically significant difference in baseline characteristics between the two groups (P>0.05). Research results showed that patients using haemocoagulase agkistrodon had significantly reduced length of hospital stay, decrease in hematocrit, average estimated surgical bleeding, and decrease in hemoglobin (P<0.01). ConclusionHaemocoagulase agkistrodon has better effectiveness than tranexamic acid and sodium chloride for reducing perioperative blood loss based on current real world evidence.
As an important source for real-world data, existing health and medical data have gained wide attentions recently. As the first part of the serial technical guidance for real-world data and studies, this report introduced the concepts, features and potential applications of existing medical and health data, proposed recommendations for planning and developing a research database using existing health and medical data, and developed essential indicators for assessing the quality of such research databases. The technical guidance may standardize and improve the development of research database using existing health and medical data in China.
ObjectiveTo construct a comprehensive value evaluation index system for the hospital admission of predicate consumables, providing a reference for the admission evaluation of predicate consumables in hospitals. MethodsAn initial pool of comprehensive value evaluation indexes for the hospital admission of predicate consumables was established through literature research and expert consultation. The evaluation indexes were screened and optimized via two rounds of Delphi expert consultation, and the final admission evaluation index system was determined through an expert consensus meeting, and the analytic hierarchy process was adopted to determine the weights of the indexes. ResultsThe final comprehensive value evaluation index system comprised six first-level indexes: clinical effectiveness (0.372 3), reliability (0.273 3), economic efficiency (0.113 8), hospital management (0.093 1), values and preferences (0.087 2), and enterprise services (0.060 3), along with 14 second-level indexes. Among these, "failure rate" (0.273 3), "safety" (0.215 5), and "effectiveness" (0.156 8) carried relatively higher weights. The effective response rates for the two rounds of expert consultation were 80% and 100%, with expert authority coefficients of 0.86 and 0.92, and Kendall's coefficients of concordance of 0.208 and 0.205, respectively. ConclusionThe hospital admission evaluation system constructed in this study integrates multi-dimensional indexes, which can provide a scientific reference for the admission of predicate consumables in hospitals.
ObjectiveTo establish a hospital admission evaluation process for predicate consumables. MethodsAn initial evaluation process for predicate consumables was constructed through a combination of literature review and expert consultation. Subsequently, two rounds of Delphi expert consultation were conducted with 20 specialists to revise and refine the specific steps of the admission evaluation process. Finally, the definitive version of the process was confirmed via an expert consensus conference. ResultsThe finalized hospital admission evaluation process for predicate consumables consisted of 14 specific steps under three core phases: equivalence evaluation, evidence collection, and comprehensive evaluation of consumables. The two rounds of Delphi expert consultation yielded effective response rates of 80% and 100%, and expert authority coefficients (Cr) of 0.86 and 0.92, respectively. In the final consensus voting, the approval rate for all steps reached 100% except for two steps, which achieved an approval rate of 95%. ConclusionThe admission evaluation process established in this study is detailed, scientifically rigorous, and practically applicable, which can provide a decision-making framework for the standardized admission of predicate consumables.
