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.

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.

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.

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.

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.

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.

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.

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.

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.

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.