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 construct rapid health technology assessment (RHTA) reporting norms, with a view to providing methodological references for RHTA research and reporting. MethodsBased on the preliminary pool of entries constructed by the literature research results, and taking into account the characteristics of RHTA, a Delphi expert correspondence questionnaire was designed, and 25 experts in the field of HTA were selected to conduct multiple rounds of expert correspondence. By calculating the expert authority coefficient and opinion coordination coefficient, combined with the average value of the entry score, coefficient of variation and full score ratio, the entries were selected to form the list of RHTA report specifications. ResultsThe positive coefficient of experts in both rounds of investigation was 100%, the expert authority coefficient in the first round was 0.858, and the expert authority coefficient in the second round was 0.838. The Kendall coordination coefficient in the first round was 0.169, and in the second round it was 0.081. According to the correspondence of 2 rounds of investigation, the final formation included 8 aspects, 26 first-level entries and 18 second-level entries in the list of RHTA report specifications. ConclusionThis study constructed the RHTA report specification, which is both scientific and operable, providing a reference for RHTA report writing.
The reporting checklist of health technology assessment (HTA) was a tool developed by the International Network of Agencies for Health Technology Assessment (INAHTA) to be used to guide the reporting of HTA. Experiential evidence showed that the tool was effective to improve the reporting quality of HTA and also could be used as a reference in performing HTA and translating the research evidence into decision-making. This paper introduced the background, developing process and main contents of the checklist, so as to improve the reporting quality of HTA in China.
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 analyze the research status and hot spots of health technology assessment (HTA). MethodsDatabases including China National Knowledge Infrastructure (CNKI) and PubMed were searched to collect published studies on HTA. The software of BICOMS-2 and VOSviewer 1.6.10 was used to draw the network diagram and to conduct cluster analysis of keywords. ResultsA total of 1170 studies in Chinese and 8584 studies in English were included. The number of HTA-related publications increased annually, among which countries with the most publications were the United States, the United Kingdom, and Canada. Fudan University had the largest number of studies published in Chinese and York University had the largest number of studies published in English. The research topics mainly focused on hospital HTA, HTA decision transformation research, pharmacoeconomic evaluation, etc. The most frequent diseases were cancer and depression. Emerging keywords were real-word evidence, randomized controlled trials, cost-benefit analysis, etc. ConclusionHTA-related studies increase annually. Many HTA-related studies are performed in developed countries, such as the United States and the United Kingdom. The relevant research topics involve hospital HTA, HTA decision-making transformation research, and pharmacoeconomic evaluation. Current research focus is on the evaluation of health economics in the field of cancer based on the evidence of real-world research and randomized controlled trials.
Hospital-based health technology assessment (HB-HTA) refers to the practice of health technology assessment for hospital management decision-making based on the actual situations in hospitals. It includes processes and methods of health technology assessment carried out in and for hospitals. Under the background of comprehensively promoting the reform of public hospitals in China, HB-HTA is undoubtedly an important scientific method to enhance the fine management of public hospitals and implement the policy of medical reform. This paper introduced the concept, the international and domestic development status, the characteristics of HB-HTA, and put forward the scheme of development of HB-HTA macroscopically, so as to promote the popularization and applications of HB-HTA in China.
Health Technology Assessment International (HTAi), in conjunction with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), initiated a joint Task Force and published guideline and a checklist for deliberative processes for health technology assessment (HTA). Currently, there is a lack of guidance for designing and implementing deliberative processes of HTA in China, so this paper performs a detailed interpretation of the guideline and checklist, with a view to providing a reference for China's HTA and deliberative process, in order to promote the dissemination and application of the HTA methodology, and advance the construction of domestic HTA deliberative processes capacity and institutional mechanism.
Objective To investigate present status of health care in peri-brain-death and analyze its effectiveness and health economic characteristics. Method Retrospective analysis of case series was conducted and a total of 940 patients from surgical intensive care unit (SICU) were reviewed on treatment and part of direct medical expenditure. The patients admitted from Jun. 1999 to Dec. 2000 and Nov. 2001 to Jun. 2002 were included in this study. Data were processed by SPSS 10.0. Results Patients were included if they had two of the three symptoms for at least one hour: deep coma, pupillar light reflex disappear, and no autonomic respiratory. Ultimately 115 patients were included, with a total cost of ￥2 515.9 per day for each case, whereas mortality was 99.10%. Mortality increased with the state of peri-brain-death prolonged. Eighty percent of patients included were dead within 72 hours after admission. Conclusions Attempts to resuscitate patients of peri-brain-death have been the most widely applied in China, however, it resulted in great unnecessary consumption of health resources. It is of great importance to promote legislation of brain death in China.
As a methodological tool, evidence-based management can assess the technological advantages and economical value of medical consumables scientifically, and select the most cost-effective products into the hospital access directory with guarantees of the development of clinical disciplines. Now this method has been widely used for consumable access management in our hospital. Policies and processes have been established to normalize the assess, allocation, and usage, and the management mode is transformed from experience-based management into evidence-based management. With clinical nominalism being changed, the method of evidence-based management can be used for every link of comsumble management, to reduce the costs and ensure the safety and quality of medical consumables at the same time, so as to promote the rational cost of medical consumables.
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.
