Objective To evaluate the clinical effectiveness, safety, cost-effectiveness of eight angiotensin converting enzyme inhibitors (ACEIs) in order to provide evidence for adjustment of Essential Drug List in China. Method Collecting all clinical trials by searching Medline, Cochrane Library, Embase and Chinese Biomedical Database and conducting critical appraisal. High quality randomized controlled trials and systematic reviews were included to assess the effectiveness of ACEIs. Non-randomized controlled trials were also included to evaluate the safety and cost-effectiveness. Results New generation of ACEIs are better than enalapril and captopril in antihypertension and endurance. Meta-analysis showed that T/P ratio was less than 50% in prindopril, benazepril and captopril. Enalapril and captopril had the most adequate evidence in the treatment of chronic heart failure. The effects of lisinopril, prindopril, benazepril and cilazapril positive influence on heart failure were assessed by surrogates. Captopril, lisinopril could reduce the total death rate of acute period (during 36 hours of AMI). Enalapril, captopril, ramipril and prindopril had the effect of heart protection in late period of AMI (3 days after AMI). Only ramipril, lisinopril and prindopril had evidence to support the protective effect on cerebral vessels. The available evidence, though not adequate, showed all the ACEIs except benazepril could diminish proteinuria and delay the renal failure. The new generations of ACEIs were similar in adverse reactions to enalapril and captopril, while incidences were lower than enalapril and captopril. Few evidence on cost-effectiveness of ACEIs were identified. The available evidence showed enalapril was cost-effective in treating heart failure. However, it compromised to lisinopril. The studies on ethics were not available. Conclusions It was difficult to generally rank the eight ACEIs according to available evidence. Not all eight ACEIs had adequate evidence in organs protection. It was suggested that clinicians should select ACEIs with adequate evidence to treat patients on states.
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.
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.
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.
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.
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.
ObjectivesTo explore the using status of psychological assessment instruments including checklists, questionnaires and scales after earthquake, so as to provide baseline data for establishing a standard method and process in developing earthquake-related population psychological screening and assessment instruments in future. MethodsWe searched WanFang Data, CNKI, VIP, PubMed, EMbase, The Cochrane Library and CiNii databases, as well as special websites about earthquake and disaster management from inception to July 30th, 2014 to collect studies evaluating the population psychological health conditions with assessment instruments after earthquakes. The earthquake countries/regions, the main assessment institutions, the time of assessment, the objects of assessment, and the instruments used were analyzed. ResultsA total of 794 studies were included, of which 87.4% were from mainland China, and 78.0% were related to the Wenchuan earthquake. Most of assessments were conducted by universities (47.9%) and hospitals (46.9%) in Sichuan, Beijing and Guangdong provinces of China. The psychological assessments conducted in the first year after quake were found in 537 studies (67.6%), of which 244 studies (45.4%) reported the psychological assessments results in the first month after quake. The top five assessment objects were children/teenagers, survivors, wounded, military rescuers, and medical staff. In the 794 included studies, a total of 217 instruments were used. In the 244 studies reported the assessment results in the first month after quake, a total of 73 instruments were used. 122 of the 244 studies reported only one instrument was used, and the other 122 of the 244 studies reported two or more instruments were used. Most of the instruments were translation versions and developed for mental disorders. The top 5 instruments were Symptom Checklist 90, Self-Rating Depression Scale, Self-Rating Anxiety Scale, PTSD Checklist-Civilian Version and Impact of Event Scale Revised, respectively. ConclusionAll the psychological assessment instruments are not developed for assessing earthquake-related psychological health problem, so a simple, economic, feasible and specialized instrument for earthquake-related population should be developed. It's needed to organize professionals to design a local guideline and training material for earthquake survivors and rescuers, and to establish a standardized, sustainable normal training base and trainer's team, so as to standardize the psychological aid work.
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.
Objectives To evaluate the effectiveness, safety, applicability and economy of psychological assessment instruments including checklists, questionnaires and scales used in population exposed to earthquake. MethodsWe searched PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP, WanFang Data, and CiNii databases, as well as special websites about earthquake and disaster management from inception to July 30th, 2014 to collect studies related to psychological assessment of population exposed to earthquake in the first month after quake. A descriptive analysis was conducted to analyze the positive detection rate of psychological problems, rate of informed consent, and effective response rate in population exposed to earthquake, as well as the cost of psychological assessment. ResultsA total of 67 studies were included which involved 4 instruments including Symptom Checklist 90 (SCL-90), Self-Reporting Questionnaire-20 (SRQ-20), Chinese Psychosomatic Health Scale-134 (CPSHS-134) and 12-item General Health Questionnaire (GHQ-12). SCL-90 was the most commonly used scale. Forty-five studies reported the positive detection rate of psychological problems in population exposed to earthquake. The positive detection rates by using SCL-90, GHQ-12 and SRQ-20 were 8.6% to 77.8%, 65.6% to 89.9% and 65.6% to 89.9%, respectively. Informed consent was reported in 27 studies, and effective response rate was reported in 20 studies with the highest one 99.56% for CPSHS-134. No study reported the cost of psychological assessment. ConclusionSCL-90, RQ-20, CPSHS-134 and GHQ-12 are mainly used instruments for assessing psychological problems in population exposed to earthquake in the first month after quake. The reporting of important information related to effectiveness, safety, applicability and economy of psychological assessment instruments is insufficient and not standardized. A concise and authoritative psychological assessment instrument for population exposed to earthquake is warranted.
ObjectivesThe primary objectives of this rapid health technology assessment (RHTA) were to assess the safety and effectiveness of Da Vinci surgical system compared with traditional e surgeries, so as to provide the currently-available best evidence for health decision makers and clinical workers. MethodsA comprehensive search of electronic databases (EMbase, PubMed, The Cochrane Library, Web of Science, CNKI, VIP, CBM and WanFang Data) and relevant professional HTA websites were conducted from inceptionto October 9, 2012. Two reviews independently screen literature according to the inclusion and exclusion criteria, extracted data, and assess the quality of included studies. The data based on secondary studies were reported, and a final recommendation and its level was made based on assessment outcome. ResultsA total of 21 studies were included, encompassing 7 HTAs and 14 systematic reviews/metaanalyses. The included studies involved radical prostatectomy, hysterectomy, nephrectomy, coronary artery bypass graft, and gastric fundoplication. Though the included HTAs and systematic reviews/meta-analyses focus on different diseases, the outcomes showed significant differences existed between Da Vinci surgical system and other routine surgery in clinical effectiveness and safety of different diseases. Compared with routine surgery, Da Vinci surgical system shortened hospital stay; decreased operation conversion rates, blood loss and blood transfusion rates during surgery; but it increased operative time. Besides, compared with traditional laparoscopic surgery, Da Vinci surgical system shortened operation time and hospital stay, and decreased operation conversion rates, blood loss and blood transfusion rates during surgery. ConclusionCurrent evidence shows that the clinical effectiveness and safety outcomes of Da Vinci surgical system differ in diseases. Currently, most included HTAs and systematic reviews/meta-analyses are based on observational studies, relevant prospective randomized controlled trials lack, and the evidence is graded as low quality, health decision makers are suggested to apply this evidence with caution on the basis of comprehensive consideration.