ObjectiveTo comprehensively review the status quo, contents, and problems of health technology assessments (HTAs) on cardiovascular and cerebrovascular diseases in Chinese rural. MethodsThe CNKI, VIP, WanFang Data and CBM databases were searched for the HTAs on cardiovascular and cerebrovascular diseases in Chinese rural up to October 31st, 2013. Two reviewers independently screened literatures and extracted data, and then the qualitative method was used to systematically analyze the literatures' information and results. ResultsA total of 34 studies were included. Of which, 23 were descriptive studies and 11 were experimental studies. The studied populations were patients and ordinary residents who had received the service of cardiovascular and cerebrovascular diseases health technology in rural, as well as the grassroots medical technical personnel and promotion staffs who had developed the health technologies. HTAs on cardiovascular and cerebrovascular diseases in rural mainly included western medicine health technologies and traditional Chinese medicine (TCM) health technologies. The contents of HTA of the included literatures mainly included:effectiveness, acceptability, requirements, economic characteristics, safety and technical specific property. The results of the included literatures showed that the type of diseases involved in cardiovascular and cerebrovascular diseases in rural were not widely enough, the fields involved in assessment contents were single, lack of rigorous and comprehensive study design. ConclusionWe need more HTAs of cardiovascular and cerebrovascular diseases in rural, we also need to strengthen early prevention, promote a wider range of cardiovascular and cerebrovascular diseases health technology, strengthen promotion and application of both TCM health technologies and the combination of TCM and western medicine health technologies in cardiovascular and cerebrovascular diseases.
Objective To investigate the feasibility of health technology permission (HTP) for widely used, high cost and risk technologies based on evidence of health technology assessment (HTA) from the perspective of Ministry of Health (MOH). Method With reference to experiences of HTA and evidence-based health administration in developed countries, four HTA and EBM entities have been established in China, which promoted and disseminated HTA. Three technologies-Bank of Haematopoietic Stem Cell from Umbilical Cord, Assisted Reproductive Technology (ART) and Sperm Bank-were piloted to assess, which provided quality evidence to assist MOH in formulating the Regulation for Permission on Health Technology. Results A set of technologies such as medical equipment, clinical techniques and screening technology for disease prevention and control have been assessed. Several regulations for permission on individual health technologies have been prepared to guide certification of professionals and health institutes. These include Regulation of Bank of Haematopoietic Stem Cell from Umbilical Cord, Regulation of Assisted Repreduction Technology and Management of Human Sperm Bank. Conclusions Although we have possessed a pre-requisite to establish a set of managing system for evidence-based permission of health technologies, an efficient infrastructure to run this system should be established and improved.
Objective According to health technology assessment (HTA) methodology, to assess the efficacy and safety of different doses of metoprolol in the treatment of atrial fibrillation (AF). Methods Based on the principles of HTA, we searched some important medical databases including MEDLINE, EMBASE, The Cochrane Library and CMCC, as well as several national special heart disease databases and side effect centers. We selected eligible studies based on the inclusion and exclusion criteria and critically assessed their quality. Results Intravenous metoprolol 10 mg - 15 mg could control rapid ventricular rate in patients with chronic AF. On either rest or exercise, oral metoprolol 150 mg/d had a better control of rapid ventricular rate than 50 mg/d in patients with chronic AF. For preventing postoperative AF (POAF), the intravenous metoprolol 20 mg group and the 30 mg group could decrease the incidence of POAF compared to the 10 mg group. Oral metoprolol 150 mg/d was more effective than 100 mg/d in preventing POAF. In addition, intravenous metoprolol therapy was well-tolerated and more effective than oral metoprolol therapy in preventing atrial fibrillation after cardiac surgery. Results from several national side effect centers demonstrated that the incidence of adverse reactions associated with metoprolol was low. Conclusion Present evidence showed that high dose of metoprolol was superior to low dose in treating AF, however, the evidence available is insufficient. It is suggested that adequate evidence through further studies are needed. The safety profile of different doses of metoprolol is similar.
ObjectiveTo utilize a rapid health technology assessment to evaluate the efficacy, safety and cost-effectiveness of the MitraClip device for patients with severe mitral regurgitation (MR). MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM and the CRD databases were electronically searched to collect clinical evidence and economic evaluations on the efficacy, safety and cost-effectiveness of the MitraClip device for patients with severe MR from inception to May 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies; then, descriptive analyses and data summaries were performed. ResultsA total of 33 studies, involving 4 HTA reports, 3 RCTs, 16 systematic reviews or meta-analyses, and 10 economic evaluations were included. In the evidence comparing MitraClip and surgery, most of the literature showed that the MitraClip group had higher postoperative residual MR, fewer blood transfusion events, and fewer hospital days. We found no significant treatment effects on 30-day adverse events and mortality, and the 1-year and above survival rate. In the evidence of MitraClip versus medical therapy alone, all included studies showed that MitraClip benefited mid-term and long-term survival and reduced the incidence of subsequent cardiac hospitalizations. Economic evaluations showed that the clinical benefits were cost-effective in the setting of their health service systems. ConclusionThe available high-grade clinical evidence shows that MitraClip is effective and safe to some extent, and has cost-effectiveness compared with traditional treatment in other countries. However, the real-world effectiveness and cost-effectiveness of the MitraClip need to be tested in the Chinese population and health-care setting.
ObjectiveCapsule endoscopy (CE) has been widely used in the diagnosis of small bowel disease (SBD) in the world. To bring CE into the national health insurance directory, and intensify its popularization in primary hospitals, the government needs high quality health technology assessment (HTA) evidence for decision making. This study was aimed to comprehensively evaluate the effectiveness, safety, applicability and economics of CE in the diagnosis of SBD based on global review, to providing the best currently-available evidence for decision making. MethodsWe electronically searched The Cochrane Library (Issue 8, September 2013), PubMed, EMbase, INAHTA, VIP, CBM, CNKI and WanFang Data. We screened studies, extracted data, and evaluated quality independently, according to inclusion and exclusion criteria; and then we made final conclusion after comprehensive analysis. ResultsWe finally included 4 HTAs, 11 systematic reviews (SRs)/ Meta-analyses, 2 randomized controlled trials (RCTs), 5 guidelines, and 10 economics studies for assessment. The results of HTAs, SRs/ meta-analyses and RCTs all showed that, the disease detection rate of CE was higher than that of many other traditional technologies, and that the main adverse event for CE was retention (0.7% to 3.0%), which were consistent with those of the guidelines' recommendations. Besides, the comprehensive results of economics studies showed the superiority of CE compared with other technologies. As the first choice, CE could significantly decrease potential costs, especially when used in outpatients. Conclusiona) Compared with similar technologies, CE indeed has advantages in diagnostic yield, safety and potential costs in the diagnosis of SBD. However, its application has certain limitations, which still needs to be verified by more high quality evidence about CE diagnosis accuracy. b) It is sug gested that, when the government approves the introduction of CE to hospitals, many factors must be considered, such as local disease burden, clinical demands, ability to pay, and staff configuration. At the same time, it is necessary to standardize training for medical technicians, to reduce economic loss caused by poor technical abilities of medicaltechnicians.
ObjectiveTo investigate the health technologies on diabetes prevention and management used in rural China and the assessment results of these health technologies, and to provide references for the selection and using of health technologies on diabetes prevention and management in rural China. MethodsWe searched VIP, CNKI, CBM and WanFang Data to collect survey studies and assessment reports of health technologies on diabetes prevention and management in rural China. The search date was up to July 15th, 2014. Two reviewers independently screened literature, and then the qualitative analysis was performed for the included studies. ResultsA total of 15 studies were included. The results of qualitative analysis showed that:the targeted populations were patients and ordinary villagers who had received the service or treatment of diabetes health technology in rural, as well as the grassroots medical technical personnel and promotion staffs who had developed the health technologies. Diabetes health technology studies in rural mainly included medical personnel health technology related knowledge training. The contents of health technology assessment involved effectiveness, acceptability, economic characteristics, requirements and technical specific property. ConclusionThere was limited researches on the investigation and analysis of health technologies on diabetes prevention and management in rural China, and evaluation content remains insufficient.
Health technological innovation has helped to improve health care delivery and patient outcomes. However, the proliferation of health care technology has accompanied burgeoning health care costs and evoked social, ethical, legal, and political concerns. Health technology assessment (HTA) is the systematic evaluation of properties, effects and/or other impacts of health care technology. The main purpose of HTA is to inform persons of technology-related policy making in health care. There is great variation in the scope, selection of methods and level of detail in the practice of HTA. This paper will introduce the basic concepts and methods of HTA in order to help those who are interested in conducting HTA.
Objective To systematically review published methodological guidelines for health technology assessment (HTA) at home and abroad. Methods Common electronic databases, guideline databases, international networks of HTA agencies/organizations, representative national HTA networks and official websites of governmental health departments were extensively searched and screened to identify guidelines for conducting or reporting HTA from inception to April 24, 2023. Basic information on guidelines, HTA processes, assessment indicators, reporting checklists and other information was extracted, analyzed and described using a systematic review methodology. Results A total of 41 guidelines were included in this study, published from January 2002 to January 2023; the publishing institutions involved 23 countries/international organizations, and 6 languages; the assessments were mainly for all health technologies (n=23), pharmaceuticals (n=4), diagnostic/testing technologies (n=4), non-pharmaceutical health technologies (n=3), medical devices/equipment (n=3), hospital health technologies (n=2), medical and surgical interventions (n=1), and screening technologies (n=1); the assessment perspectives were mainly health system perspectives (n=16), societal perspectives (n=12), and hospital perspectives (n=3), while the rest did not provide information on the perspectives; 28 guidelines described the detailed HTA assessment process, involving 11 steps; there were 39 guidelines described the assessment domains and related assessment indicators in detail, ranging from 2 to 9 assessment domains and involving 10 first-level assessment indicators; a checklist for HTA reports listed in 10 guidelines, involving 18 report entries; 17 guidelines reported conflicts of interest, mostly no conflicts of interest (n=10), and 3 of the remaining 7 guidelines did not indicate a specific conflict of interest, while 4 guidelines in which possible sources of conflict of interest were indicated. Conclusion The development of HTA has formed a relatively perfect assessment system, but there is a need to unify the criteria for classification of health technologies and reporting checklist, improve the specificity indicators for different types of health technologies, and clarify the assessment perspectives. Combined with the current situation of HTA development in China, contextualized guidelines for HTA implementation and reporting should be formulated to provide scientific information and methodological basis for decision-making on rational allocation of health resources.
Objective To assess the effectiveness and safety of nine lipid-lowing agents in the national essential drug list (2000) and provide evidence for the adjustment and selection of essential drugs. Methods Based on principles of health technology assessment (HTA) and evidence-based medicine, we searched for all published clinical studies about these drugs from the following databases: MEDLINE (1966-2002.8), The Cochrane Library, EMBASE (1974-2002), CBMdisk (1979-2002.8) and VIP (1989-2002.8), the database of National Center for Adverse Drug Reaction(ADR) Monitoring of China and the database of WHO Uppsala drug monitoring center. Included studies were appraised, analyzed and compared for the reduction of triglyceride (TC) or low density lipoprotein (LDL-C), the prevention for the coronary events and the incidence of ADR. Results The results from comparative trials for lipid-lowing agents showed that the equivalent dose of statins for 25% reduction of LDL-C was atorvastatin 10 mg/d, simvastatin 20 mg/d, pravastatin 40mg/d, lovastatin 40 mg/d, cerivastatin 0.3 mg/d and fluvastatin 80 mg/d. It was difficult to compare fenofibrate with gemfibrozil, acipimox with statins or fibrates based on available data. The study on the primary and secondary prevention of cardiovascular events showed that pravastatin and lovastatin were effective in primary prevention, and long-term use could reduce the incidence of cardiovascular disease.Gemfibrozil could reduce the mortality from coronary heart disease (CHD) but the overall mortality was not changed. Pravastatin, simvastatin, atorvastatin, fluvastatin, gemfibrozil and fenofibrate had a confirmed effect in secondary prevention. Data from large-scale clinical trials and the reports from ADR monitoring center of England, America, Canada and Australia suggested that the statins which had rare ADR were safe and tolerated. Rhabdomyolysis was rare but had a serious adverse reaction associated with statins. The rate of fatal rhabdomyolysis related to cerivastatin was the highest among 6 statins. The safety of simvastatin, lovastatin and atorvastatin was lower than cerivastatin but higher than simvastatin and atorvastatin. The number of ADR reports of fenofibrate was fewer than that of gemfibrozil. Conclusions At present, the best evidence focused on pravastatin, simvastatin and lovastatin are widely used and have a confirmed safety and efficacy. Atorvastatin, fluvastatin and fenofibrate still need more data to confirm their effects on coronary heart disease prevention. The drugs which were shown to be inferior or insufficient evidence are cerivastatin, gemfibrozil and acipimox.
ObjectiveTo investigate the construction strategy of a knowledge base for health technology assessment (HTA) indicators based on a multi-granularity knowledge representation model, in order to meet the users' diverse demands for HTA knowledge services. MethodsFirstly, we constructed a multi-granularity HTA indicator knowledge representation model based on systematically analyzing the content and structure of the HTA indicator system in literature. Secondly, we extracted multi-granularity HTA indicator knowledge from literature and conduct subject indexing in a human-computer collaborative way. Finally, based on the HTA knowledge service requirements, a prototype of the HTA indicator knowledge base-HTA Indicators was designed and developed. ResultsA multi-granularity HTA indicator knowledge representation model was constructed, covering 5 core knowledge units (indicator systems, indicator items, formulas, measurement variables, and subjects), 20 types of attributes, and 12 types of relationships. This model represented the intrinsic characteristics and connections between multi-granularity indicator knowledge units. Knowledge extraction and subject indexing of multi-grain HTA indicators were conducted based on 227 HTA indicator documents, forming instance data. Finally, a prototype of the HTA indicator knowledge base, named HTA Indicators, was developed. HTA Indicators provides services such as multi-granularity HTA indicator knowledge retrieval, navigation, and linking. ConclusionThe construction strategy of the HTA indicator knowledge base based on the multi-granularity knowledge representation model is feasible. The indicator knowledge base can achieve multi-dimensional semantic organization of indicator knowledge, provide multi-level and multi-dimensional indicator knowledge retrieval and discovery services, and meet the users' demand for precise HTA knowledge. In the future, we will explore the use of cutting-edge technologies such as large language models to achieve the automated construction of large-scale HTA knowledge, thereby enhancing the efficiency and intelligence level of knowledge base construction.