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Validation of China Health-Related Outcomes Measures-Cardiovascular Disease
Objectives: China Health -Related Outcomes Measures (CHROME) was an initiative aimed at developing a system of preference -based health -related quality of life instruments for China. CHROME -cardiovascular disease (CVD) is a CVD-specific instrument with 14 items developed under this initiative. This study aimed to test the psychometric properties of CHROME-CVD. Methods: This validation study was conducted using cross-sectional questionnaire survey in China. Eligible patients with CVD were recruited and asked to complete the CHROME-CVD, the EQ-5D-5L, and a CVD-specific nonpreference-based healthrelated quality of life instrument selected according to the confirmed diagnosis of the patients. Item evaluation, internal consistency, measurement invariance, test -retest reliability, structural validity, and construct validity were tested using classic test theory. Item response theory was used to evaluate item -level performance. Results: A total of 444 patients with CVD (coronary artery disease, n = 276, heart failure, n = 104, angina, n = 33, and atrial fibrillation, n =16) from 6 provinces in China were enrolled for the validation. Exploratory factor analysis identified 4 factors: chest pain, other symptoms, physical health, and mental and social health. Cronbach 's alpha and intraclass correlation coefficient were .0.8. A total of 20 of 26 (76.9%), and 90 of 95 (94.7%) predefined hypotheses were met for convergent and discriminant validities, respectively. No important difference was identified between subgroups of gender and residency. Response options of 10 items were found overlapped based on categorical response curves, which led to modification to 4 -level response options. Wording of 3 items were modified by referring wordings of reference instruments. Conclusion: The validation of the CHROME-CVD demonstrated generally good psychometric properties. Further validation on the modified CHROME-CVD is needed.
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Governing cross-border healthcare in mainland China: a scoping review of national policies from 2002 to 2022.
This study reviews national-level policies regulating cross-border healthcare in mainland China after it acceded to the World Trade Organization (WTO). Policy documents from official websites of the State Council and 19 ministries were screened, from which 487 policy documents were analyzed. WTO's five modes of trade and WHO's six building blocks of healthcare system were used to guide the analysis of policymaking patterns, charting of policy evolution process, identification of key policy areas, differentiation of 29 detailed policy themes, and identification of major countries/regions involved in cross-border healthcare. The findings lead to four policy recommendations: (1) to establish a national-level committee to govern cross-border healthcare, (2) to build an information system to comprehensively integrate various information on cross-border healthcare consumption and provision, (3) to take more proactive policy actions in healthcare internationalization, and (4) to carry out reform experiments in key sub-national regions to fully explore various possibilities in developing and regulating cross-border healthcare.
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Prevalence and patterns of multimorbidity in China during 2002-2022: A systematic review and meta-analysis.
Background: Multimorbidity is common, particularly among elderly people. Restructuring health service systems to better manage this public health issue requires knowledge regarding disease prevalence and patterns. We quantified the epidemiology characteristics of multimorbidity among adults in China to inform policy-making and resource allocation. Methods: We searched 10 databases for studies (January 2000-October 2023) reporting primary epidemiological multimorbidity data for adults in China. We included observational studies; we excluded duplicate publications and studies investigating a single comorbidity pattern, focused on specific population categories, using medical insurance reimbursement data, and with unclear/incomplete data. We assessed risk of bias using the STROBE checklist and estimated heterogeneity among studies. The prevalence was pooled using the random-effects method and sample size as weight. Findings: Of 13,998 records retrieved, 67 studies (30 in English, 37 in Chinese) were included. The prevalence (95% confidence interval) of multimorbidity was 25.4% (15.1%, 35.7%) among Chinese adults. Among 42 studies reporting age-specific prevalence, multimorbidity prevalence increased rapidly with age: 3.3% (0%, 15.2%) for age 18-29 years, 5.9% (0%, 12.9%) for 30-44 years, 17.6% (6.1%, 29.1%) for 45-59 years, 32.4% (16.1%, 48.7%) for 60-69 years, 38.5% (23.6%, 53.4%) for 70-79 years, and 40.2% (20.8%, 59.6%) for age ≥ 80 years. Overall prevalence of multimorbidity has increased in recent years, with regional disparity. The most common patterns included hypertension with hearing impairment (10.4% [95% CI: 4.3%, 16.5%]), dyslipidemia (8.9% [4.1%, 13.6%]), and diabetes (8.7% [3.7%, 13.8%]). Conclusion: Multimorbidity was present nearly one in four Chinese adults, with hypertensive diseases and other comorbidities being the most-observed pattern; the prevalence increased rapidly with increased age. There is huge variation in the prevalence of multimorbidity across China. Coordinated, comprehensive strategies are urgently needed to control the ongoing impact of multimorbidity.
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Availability of essential medicines, progress and regional distribution in China: a systematic review and meta-analysis.
Background: Essential medicines are the backbone of healthcare and meet the priority healthcare needs of the population. However, approximately one-third of the global population does not have access to essential medicines. Although China formulated essential medicine policies in 2009, the progress of availability of essential medicines and regional variations remains unknown. Therefore, this study was conducted to evaluate the availability of essential medicines, their progress, and regional distribution in China in the last decade. Methods: We searched eight databases from their inception to February 2022, relevant websites, and reference lists of included studies. Two reviewers selected studies, extracted data, and evaluated the risk of bias independently. Meta-analyses were performed to quantify the availability of essential medicines, their progress, and regional distribution. Results: Overall 36 cross-sectional studies conducted from 2009 to 2019 were included, with regional data for 14 provinces. The availability of essential medicines in 2015-2019 [28.1%, 95% confidence interval (CI): 26.4-29.9%] was similar to that in 2009-2014 (29.4%, 95% CI: 27.5-31.3%); lower in the Western region (19.8%, 95% CI: 18.1-21.5%) than Eastern (33.8%, 95% CI: 31.6-36.1%) and Central region (34.5%, 95% CI: 30.6-38.5%); very low for 8 Anatomical Therapeutic Chemical (ATC) categories (57.1%), and low for 5 categories (35.7%) among all ATC groups. Conclusion: The availability of essential medicines in China is low compared with the World Health Organization goal, has not changed much in the last decade, is unequal across regions, and lacks data for half of provinces. For policy-making, the monitoring system of the availability of essential medicines is to be strengthened to enable long-term surveillance, especially in provinces where the data has been missing. Meanwhile, Joint efforts from all stakeholders are warranted to improve the availability of essential medicines in China toward the universal health coverage target. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=315267, identifier: PROSPERO CRD42022315267.
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Clinical Epidemiology in China series. Paper 1: Evidence-based medicine in China: An oral history study
Objective: To describe and record the evolution of EBM in China. Study Design and Setting: We conducted the study following the general methodology of oral history. The interviews were done at Lanzhou University, between 18th and 22 nd April 2019 using pre-defined questions. All interviews were videorecorded. Two investigators extracted and analyzed the information from the interviews independently. Results: One international expert and ten Chinese experts participated in the interviews. After the introduction of EBM in China in the mid-1990s, more than 20 EBM centres have been established. According to the interviewees, Gordon Guyatt, David Sackett and lain Chalmers are the international experts who played the most important role in the development of EBM in China. China has contributed to EBM on the international level by conducting systematic reviews, developing reporting checklists, and introducing the principles of EBM into Traditional Medicine. The Chinese Cochrane Centre and the EBM Centre of Lanzhou University were ranked the top two EBM Centres in China by the interviewees. Conclusion: EBM has been developing in China for nearly a quarter of a century. Many achievements have been reached, however, EBM is still facing many challenges in China, including shortages of funding support and personnel, as well as limited local high-quality evidence. (C) 2021 Elsevier Inc. All rights reserved.
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Evidence-based practice implementation in healthcare in China: a living scoping review.
Background: Evidence-based practice (EBP) implementation plays a crucial role in bridging the knowledge-action gaps and reducing health inequities. Little is known about its development in China. This study aims to provide an overview of the EBP implementation research progress in healthcare in China and identify gaps for future studies. Methods: We conducted a scoping review following the Joanna Briggs Institute scoping review methodology and the Cochrane Collaboration's guidance on living reviews. We performed a literature search in four Chinese databases (i.e., China National Knowledge Infrastructure, Wan Fang Database, The VIP Database, and China Biology Medicine) and three English databases (i.e., Ovid MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, and EMBASE), Google scholar, and Baidu scholar from 1996 to 2021. We included EBP implementation studies conducted in healthcare settings in China and were published in Chinese and English literature. The search will be run on a regular basis to monitor the development of new literature and determine when to update the review. Findings: Of the 11,276 records identified, we finally included 309 papers. The publications were on a sharp rise since 2013 and were predominantly from the nursing field (292/309, 94.50%). The commonly researched areas were symptom management (75/309, 24.27%), tube care (46/309, 14.89%), perioperative care (43/309, 13.92%), and fundamental care (43/309, 13.92%). Joanna Briggs Institute model was the most frequently used model to guide the implementation process (92/159, 59.75%). A median number of 8 people often comprised an implementation team, with 113 studies (36.57%) taking a multidisciplinary approach. 204 studies reported utilizing audit criteria to assist evaluation of evidence implementation rate with diversified methods measuring the criteria. Lack of knowledge, skills, and resources, and incomplete procedures or pathways were top barriers impeding EBP implementation. Leadership support was considered the most common facilitator. Education and training were the most frequently described implementation strategies for healthcare professionals and patients. Optimizing workflows and developing evaluation tools were the primary strategies adopted by organizations. 291 studies measured patient outcomes and 174 studies measured healthcare professional outcomes. Interpretation: To our knowledge, this scoping review is the first one to systematically examine the EBP implementation research progress in healthcare in China. Based on this review, we identified contributions that Chinese EBP implementation research made to the global community, and provided eight recommendations for Chinese researchers in conducting implementation studies in the future. Funding: None.
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Clinical Epidemiology in China series. Paper 2: Promoting GRADE at the national level: The experience from China
Objective: To share the experience of promoting GRADE in China. Study design and setting: We designed the study and collected data on the following three aspects of the GRADE in China: the key activities related to GRADE, the main achievements of the GRADE, and potential challenges and future opportunities. Results: Three GRADE centres have been established in China since 2011. Seventeen articles of the GRADE working group have been translated and published in Chinese, and 31 articles have been written by Chinese scientists in Chinese to introduce and interpret the GRADE approach so far. More than 50 GRADE workshops and meetings have been held by GRADE centres in China, covering two-thirds of all provinces and autonomous regions of China. The percentages of societies from the Chinese Medical Association (CMA) and the Chinese Medical Doctor Association (CMDA) that used the GRADE system to develop guidelines were 30% and 18%, respectively. Conclusion: Over the past decade, China has made progress in promoting the GRADE system and Chinese GRADE centres have made a significant contribution.
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Clinical Epidemiology in China series. Paper 3: The methodological and reporting quality of systematic reviews and meta-analyses published by China' researchers in English-language is higher than those published in Chinese-language
Objective: To assess the methodological and reporting quality of Chinese- and English -language systematic reviews and meta-analyses (SRs/MAs) published by Chinese authors between 2016 and 2018. Study design and setting: We searched MEDLINE and Chinese Science Citation Database (CSCD) for SRs/MAs led by Chinese authors published between 2016 and 2018. We used random sampling to select 10% of the eligible SRs/MAs published in each year from CSCD, and then matched the same number of SRs/MAs in MEDLINE. Reporting quality was evaluated using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and methodological quality using the Assessment of Multiple Systematic Reviews (AMSTAR-2) tool. Stratified analyses were conducted to compare the differences of quality between Chinese- and English language SRs/MAs. Results: We identified 336 SRs/MAs (168 in Chinese and 168 in English). The reporting quality in Chinese-language SRs/MAs was slightly lower than English-language SRs/MAs (mean PRISMA scores: 20.58 vs. 21.71 in 2016, 19.87 vs. 21.24 in 2017, and 21.29 vs. 22.38 in 2018). Less than half of both Chinese- and English-language SRs/MAs complied with item 5 (protocol and registration), item 7 (information sources), item 8 (search) and item 27 (funding)). The methodological quality in Chinese -language SRs/MAs was also slightly lower than English -language SRs/MAs (mean AMSTAR-2 scores: 8.07 vs. 9.36 in 2016; 9.21 vs. 10.26 in 2017; 8.86 vs. 9.28 in 2018). Three items (item 2: established a protocol; item 4: use a comprehensive literature search; and item 10: report the sources of funding) were adhered to by less than 10% of both Chinese- and English -language SRs/MAs. Only one (0.6%) Chinese-language SRs/MA and nine (5.4%) English-language SRs/MAs were rated as high methodological quality. Conclusion: The reporting and methodological quality of English-language SRs/MAs conducted by authors from China between 2016 and 2018 were slightly better than those of Chinese -language SRs/MAs.
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Evaluation of quality of pharmacoeconomic studies involved in traditional Chinese medicine in China
Objectives The pharmacoeconomic studies of traditional Chinese medicine (TCM) are still in its infancy. Assessing the quality of pharmacoeconomic studies of TCM to improve the efficiency of health resource allocation and guide the rational use of medicine. Methods Four databases were searched from inception to January 2018. The Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) and the Quality of Health Economic Studies (QHES) were used to assess the reporting quality and methodological quality. STATA 12.0 and Meta analyst 3.13 were used to analyze the related data. Results A total of 178 studies were included. The methodological evaluation of the study found that the total score of QHES was 47.85 +/- 8.09. The report quality evaluation results found that many studies did not report comprehensive information, such as lack of detailed reports on abstracts, study perspectives, time frames, discount rates, model selection, but the titles, study background and location, and health results, resource and cost estimates, analysis methods, and heterogeneity analysis are reported in more detail. Six of the ten stratification factors have statistically significant differences. Conclusion The overall quality of pharmacoeconomic studies of TCM is low, and further standardization and improvement are needed to obtain reliable study results.
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[Priority setting in scaled-up cancer screening in China: an systematic review of economic evaluation evidences].
Objective: The existed economic evaluations of cancer screening in Chinese population are almost all single-cancer focused, evidence on parallel comparison among multiple cancers is lacking. Thus, the aim of this study was, from a priority setting perspective, to compare the cost-effectiveness of six common cancers(colorectal cancer, breast cancer, liver cancer, lung cancer, esophageal cancer and stomach cancer) to facilitate policy making in future scaled-up screening in populations in China. Methods: Partially based on our previous single-cancer systematic reviews (colorectal cancer, breast cancer, liver cancer, and lung cancer), evidence of economic evaluations of cancer screening in populations in mainland China were systematically updated and integrated. The main updates include: 1) Stomach cancer and esophageal cancer were newly added to the current analysis. 2) The literature searching was extended to 8 literature databases, including PubMed, EMbase, The Cochrane Library, Web of Science, CBM, CNKI, Wanfang Data, and VIP. 3) The period of publication year was updated to the recent 10 years: January 1, 2009 to December 31, 2018. 4) The study focused on populations in mainland China. Following the standard processes of literature searching, inclusion and exclusion from previous systematic reviews, the basic characteristics, evaluation indicators and main results of the included studies were extracted. All the costs were discounted to 2017 value using the by-year consumer price index of medical and health care residents in China and presented in the Chinese Yuan (CNY). The ratios of incremental cost-effectiveness ratio (ICER) to China's per capita GDP in 2017 were calculated (3 means not cost-effective). Given a specific indicator, the median value among all reported screening strategies for each cancer was calculated, based on which priority ranking was then conducted among all cancers when data available. Results: A total of 45 studies were included, 22 for breast cancer, 12 for colorectal cancer, 6 for stomach cancer, 4 for esophageal cancer (all conducted in high-risk areas), 1 for liver cancer and none for lung cancer (was not then considered for next ranking due to limited numbers of studies). When based on the indicator, the median ratio of cost per life-year saved to China's per capita GDP (reported in 12 studies), the lowest ratio (-0.015) was observed in esophageal cancer among 16 strategies of 2 studies (N=2, n=16), followed by 0.297 for colorectal cancer (N=3, n=12), 0.356 for stomach cancer (N=1, n=4) and 0.896 for breast cancer (N=6, n=52, P(75)=3.602). When based on another commonly used ICER indicator, the median ratio of cost per quality-adjusted life-year gained to China's per capita GDP (reported in 13 studies), the least cost was found in stomach cancer (0.495, N=3, n=8, P(75)=3.126), followed by esophageal cancer (0.960, N=1, n=4, P(75)=1.762) and breast cancer (2.056, N=9, n=64, P(75)=4.217). Data was not found for colorectal cancer. In addition, cost per cancer case detected was the most adopted indicator (32 studies). The median cost among all screening strategies for each cancer was 14 759 CNY for stomach cancer (N=5, n=7), 49 680 CNY for colorectal cancer (N=12, n=25) and 171 930 CNY for breast cancer (N=13, n=24), respectively. Data was not available for esophageal cancer and rare for precancer cases detected. Evidence related to cost per disability-adjusted life-year gained was not available. Conclusions: At China's national level and limited to the six cancers covered by the current study, the preliminary analysis suggests that stomach cancer and colorectal cancer were the most cost-effective target cancers and could be given priority in the future scaled-up screening in general populations. Esophageal cancer screening should be prioritized in high-risk areas. Breast cancer was also cost-effective in general but some of the intensive screening strategies were marginal. Data on liver cancer and lung cancer were too limited to conclude, and more well-designed studies and high-quality research evidence should be required. This priority ranking might be changed if other common cancers were involved analyses.
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The effects of diagnosis-related groups payment on hospital healthcare in China: a systematic review.
Background: There has been a growing interest in using diagnosis-related groups (DRGs) payment to reimburse inpatient care worldwide. But its effects on healthcare and health outcomes are controversial, and the evidence from low- and middle- income countries (LMICs) is especially scarce. The objective of this study is to evaluate the effects of DRGs payment on healthcare and health outcomes in China. Method: A systematic review was conducted. We searched literature databases of PubMed, Cochrane Library, EMBASE, Web of Science, Chinese National Knowledge Infrastructure and SinoMed for empirical studies examining the effects of DRGs payment on healthcare in mainland China. We performed a narrative synthesis of outcomes regarding expenditure, efficiency, quality and equity of healthcare, and assessed the quality of evidence. Results: Twenty-three publications representing thirteen DRGs payment studies were included, including six controlled before after studies, two interrupted time series studies and five uncontrolled before-after studies. All studies compared DRGs payment to fee-for-service, with or without an overall budget, in settings of tertiary (7), secondary (7) and primary care (1). The involved participants varied from specific groups to all inpatients. DRGs payment mildly reduced the length of stay. Impairment of equity of healthcare was consistently reported, especially for patients exempted from DRGs payment, including: patient selection, cost-shifting and inferior quality of healthcare. However, findings on total expenditure, out of pocket payment (OOP) and quality of healthcare were inconsistent. The quality of the evidence was generally low or very low due to the study design and potential risk of bias of included studies. Conclusion: DRGs payment may mildly improve the efficiency but impair the equity and quality of healthcare, especially for patients exempted from this payment scheme, and may cause up-coding of medical records. However, DRGs payment may or may not contain the total expenditure or OOP, depending on the components design of the payment. Policymakers should very carefully consider each component of DRGs payment design against policy goals. Well-designed randomised trials or comparative studies are warranted to consolidate the evidence of the effects of DRGs payment on healthcare and health outcomes in LMICs to inform policymaking.
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Quality of life of empty-nest elderly in China: a systematic review and meta-analysis
We performed a systematic review and meta-analysis to evaluate the quality of life (QoL) of the empty-nest elderly in China. We searched five databases up to 20 November 2018, to identify all studies on the QoL of empty-nest elderly in China. Twenty-nine were included in the final review. Compared with the control group, the physiological function, psychological function, social function and total score of QoL of empty nests were lower than those of non-empty nests. In addition, meta-analysis showed that the empty nesters were lower than the non-empty nesters in General Health, Role Physical, Bodily Pain, Role Emotional and Vitality. The existing evidence showed that the QoL of the empty-nest elderly in China was to some extent lower than that of the non-empty nest elderly.
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Barriers and enablers of the prevention of mother-to-child transmission of HIV/AIDS program in China: a systematic review and policy implications
Objective: To identify the barriers to and enablers of the prevention of mother-to-child transmission (PMTCT) of HIV program in China. Methods: A systematic review of the existing literature regarding barriers to and enablers of the implementation of the PMTCT program in China was performed. The checklist from the SURE guidelines (Supporting the Use of Research Evidence) was used to synthesize the barriers and enablers (supporting strategies) and to analyze their relationships. The HIV testing rate, vertical transmission rate, and antiretroviral treatment (ART) acceptance rate among HIV-infected women and their infants was also extracted from the included studies to assess the effectiveness of the enablers. Results: Initially 794 publications were identified, and ultimately 14 articles were included. Eighteen types of barrier and nine types of supportive strategy were identified, mainly at the level of social and political issues, healthcare recipients, healthcare providers, and the healthcare system. Based on government-oriented multi-sector cooperation, enablers in China have included community-hospital-family promotion, comprehensive financial support for service recipients, free HIV testing at marriage registration, the opt-out model, and the one-to-one service model. Conclusions: Experience in China suggests that the government's role in coordination and the acceptability and accessibility of the service should be the primary concerns in regard to the PMTCT project. (C) 2017 The Author(s).
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A PRISMA-compliant systematic review and meta-analysis of the relationship between thyroid disease and different levels of iodine intake in mainland China.
Background: Low-iodine intake has historically been an issue in China, causing widespread iodine deficiency diseases (IDD). China started to introduce universal salt iodization in 1995, but reports of increased thyroid disease are a concern and appropriate levels of iodine intake must be considered. Objective: To assess the prevalence of thyroid disease with different urinary iodine concentrations (UICs) in the general population of those residing in mainland China. Furthermore, we aimed to analyze the relationship between thyroid disease and UIC, to provide guidance in establishing effective health policies regarding iodine intake. Methods: PubMed, Cochrane, Embase, CNKI, Wan fang, and CQVIP databases were searched for random community-based relevant studies with UIC published before January 2016 in mainland China. Two independent reviewers extracted data from eligible citations, and obtained prevalence of thyroid disease for different UICs, as well as the intergroup interaction P values. Results: Forty-three articles were included. The prevalence of thyroid nodules was 22.3% (95% confidence interval [CI]: 20.6%-24.1%) for the low-iodine group, 25.4% (95% CI: 20.8%-28.8%) for the medium-iodine group, and 6.8% (95% CI: 2.8%-11.5%) for the high-iodine group. In the high-iodine group, the prevalence of thyroid nodules was lower than the other groups. The prevalence of 8.3% (95% CI: 3.8%-17.3%) for subclinical hypothyroidism in the high-iodine group was significantly higher than the low- and medium-iodine groups (P < .01). The prevalence of hypothyroidism in the medium-iodine group was 0.2% (95% CI: 0.1%-0.4%), and was lower than the prevalence of the other 2 groups (P < .01). There was no difference in prevalence of hyperthyroidism in each group. Conclusions: Thyroid nodules are the most easily detectable thyroid disease. These have a lower prevalence in the high-iodine group. The prevalence of most thyroid diseases is lowest for a UIC ranging from 100 to 299 μg/L. This serves as a reference for health policy-making with respect to iodine levels. Further studies on this topic should be carried out according to sufficient thyroid cancer data.
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Barriers and enablers of the prevention of mother-to-child transmission of HIV/AIDS program in China: a systematic review and policy implications.
Objective: To identify the barriers to and enablers of the prevention of mother-to-child transmission (PMTCT) of HIV program in China. Methods: A systematic review of the existing literature regarding barriers to and enablers of the implementation of the PMTCT program in China was performed. The checklist from the SURE guidelines (Supporting the Use of Research Evidence) was used to synthesize the barriers and enablers (supporting strategies) and to analyze their relationships. The HIV testing rate, vertical transmission rate, and antiretroviral treatment (ART) acceptance rate among HIV-infected women and their infants was also extracted from the included studies to assess the effectiveness of the enablers. Results: Initially 794 publications were identified, and ultimately 14 articles were included. Eighteen types of barrier and nine types of supportive strategy were identified, mainly at the level of social and political issues, healthcare recipients, healthcare providers, and the healthcare system. Based on government-oriented multi-sector cooperation, enablers in China have included community-hospital-family promotion, comprehensive financial support for service recipients, free HIV testing at marriage registration, the opt-out model, and the one-to-one service model. Conclusions: Experience in China suggests that the government's role in coordination and the acceptability and accessibility of the service should be the primary concerns in regard to the PMTCT project.
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Assessing new developments in the pre-market regulatory process of medical devices in the People's Republic of China.
The objective of this paper is to provide a systematic overview of the Chinese medical device registration processes, identify challenges and suggest how these can be addressed. In addition, the paper will outline the impact of new policies and regulations since the restructuring of the China FDA. A systematic review was performed for journal articles between the year of 2009 and 2013 in the following databases: PubMed, ScienceDirect and Zhongguozhiwang. The review has identified 184 papers which were potentially relevant. Seventeen articles were included in the review, which highlights the challenges and opportunities related to the medical device registration process. In order to understand the actual impact of the regulation environment and its policies including the lack of regulatory guidance regular assessment updates are crucial. The results of this paper are aimed at informing regulatory bodies, health policy decision makers, national and international Health Technology Assessment networks as well as medical devices manufacturers.
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