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Population coverage and location of hospitals at the end of 2018 in Xiamen city. Shading represents the population coverage of permanent residents in each district (10 000), circles represent the location of tertiary hospitals, and triangles represent the location of secondary hospitals
Context in source publication
Context 1
... city comprises 6 administrative districts, 38 subdistrict units, 364 residential communities and 147 villages. Xiamen currently maintains 15 tertiary hospitals (defined as those with >500 beds), 2 secondary hospitals (between 100 and 499 beds), 39 primary healthcare facilities and 281 health stations (Figure 1). Since 2006, the government of Xiamen has developed four major healthcare data platforms (Figure 2): (i) Residents Healthcare Management Platform, which integrates data from the other three platforms and serves for making appointments and checking electronic health files by residents (Supplementary Appendix 1A, available as Supplementary data at IJE online); (ii) Primary Healthcare Management Platform, which collects healthcare data from 39 primary healthcare facilities and 272 (of the 281) health stations (Supplementary Appendix 1B, available as Supplementary data at IJE online); (iii) Electronic Healthcare Records (EHR) Platform, which collects EHR data from 15 tertiary and 2 secondary hospitals (Supplementary Appendix 1C, available as Supplementary data at IJE online); and (iv) Maternal and Child Health Management Platform, which collects healthcare data from pregnant women and their offspring across all maternity departments in Xiamen. ...
Citations
... The risk of bleeding among treated patients was 4.2%.30 Analysis of prescription data from 804 sample hospitals suggested that use of NRDL drugs increased by25.7% from 2015 to 2021. ...
Wen Wang and colleagues discuss the rationale and propose a framework for using real world evidence to support coverage decisions in Chinese setting
... Considering the particularities of assisted conception (i.e., cause of subfertility and ART procedure) and higher incidence of GDM following ART [20], we aimed to evaluate if the impact of maternal bodyweight on GDM incidence following ART was similar to that describe in spontaneous conceptions, since this subject has been insufficiently investigated [18]. In order to provide evidence for future interventions in maternal body weight before ART treatment, we conducted a dose-response analysis to explore the impact of maternal pre-pregnancy body weight on GDM following ART treatment, using data from REPRESENT [21]. ...
... This study was conducted using data from REPRESENT, a population-based pregnancy registration database in China, which is described elsewhere [21]. Briefly, REPRE-SENT collected healthcare data from pregnant women and their offspring across all maternity departments in Xiamen city, Fujian Province, China, which has a permanent population of more than 4 million. ...
Background
The impact of maternal pre-pregnancy bodyweight on gestational diabetes mellitus (GDM) following assisted reproductive technology (ART) treatment has been insufficiently investigated. The aim of this study was to investigate the association between maternal pre-pregnancy bodyweight and GDM following ART.
Methods
From January 2014 to March 2019, this population-based retrospective cohort study included pregnancies achieved by ART treatment in a pregnancy registration database in China. Multivariate regression analysis and restricted cubic splines were used to explore the association between bodyweight and GDM.
Results
A total of 6,598 pregnancies were included. The incidence of GDM was 26.0% (1715/6598). A total of 868 (13.2%) pregnant women were underweight, 665 (10.8%) were overweight, and 145 (2.20%) were obesity. We found a linear dose–response relation between maternal body mass index and GDM by restricted cubic splines, where one unit body mass index increase was associated with the 15% elevated risk of GDM (adjusted odds ratio [OR] 1.15, 95% CI 1.08–1.22). Compared to the normal weight group, maternal underweight was associated with lower risk of GDM (adjusted OR 0.68, 95% CI 0.57–0.82), while increased risk was found for overweight (adjusted OR 1.54 95% CI 1.29–1.84) and obesity (adjusted OR 1.74, 95% CI 1.23–2.47).
Conclusions
Our study found a linear dose–effect relationship between pre-pregnancy bodyweight and GDM following ART treatment. The findings in this study support the clinical recommendation of advising women with overweight or obesity to lose weight prior to ART treatment.
... 4 In recent years, routinely collected health care data (RCD), such as electronic medical records (EMRs), have become an irreplaceable source of information for assessing the real-world treatment effects of CHIs, especially in exploring the optimal treatment patterns and the timing of CHIs among heterogeneously treated populations. [5][6][7] Although RCD share apparent advantages in sample sizes, representative population, and high-dimensional variables, these data are, in their nature, observational. 8 Consequently, the resulting treatment effects of CHIs are usually threatened by a diversity of potential biases. ...
Aim
In the context of integrative medicine, whether Chinese herbal injections are effective in routine practice has become a question of broad interest. However, confounding by indication (i.e., indication bias) is a prevalent and highly challenging methodological issue when using routinely collected health care data to assess the real‐world effectiveness of Chinese herbal injections.
Methods and results
We proposed a methodological approach to tackling confounding by indication in assessing the real‐world effectiveness of Chinese herbal injections, incorporating empirical experiences, a literature review and interactive discussions, and a panel of external experts to finally achieve a consensus. This approach consisted of three cohesive steps, including a full understanding of treatment patterns, construction of fair comparisons by identifying appropriate combination treatments and comparators, and using statistical methods to further control for confounding. In the investigation of treatment patterns, we proposed five domains to identify treatment patterns with Chinese herbal injections, and we offered five patterns of combination treatments to characterize how Chinese herbal injections are used in conjunction with other treatments. In constructing fair comparisons, we suggested the use of both nonuse and active comparators; given the diverse combination treatments, we developed six scenarios that may form fair comparisons. In the statistical analysis, we discussed five statistical models for controlling confounding by indication, including their pros and cons. We also included a practical example to illustrate the usefulness of the methodological approach.
Conclusion
The proposed approach may serve as an effective tool to guide researchers to reliably assess the effectiveness of Chinese herbal injections in the context of integrative medicine.
... First, the proposed dynamic risk scores require integrated EHR systems to capture the healthcare activities of individuals, and such systems might not always be available at the population level. Nevertheless, recent studies using big data resources could facilitate the development of EHR-based systems, such as that in Xiamen (Fujian Province) [27] , Yichang (Hubei Province) and Minhang District (Shanghai) [28] in China and Ontario in Canada (the CANHEART study) [29] . Second, the study was conducted only in a developed area of China. ...
Risk prediction tools are crucial for population-based management of cardiovascular disease (CVD). However, most prediction models are currently used to assess long-term risk instead of the risk of short-term CVD onset. We developed a Dynamic Risk-based Early wArning Monitoring (DREAM) system using large-scale, real-time electronic health record (EHR) data from 2010 to 2020 from the CHinese Electronic health Records Research in Yinzhou (CHERRY) study. The dynamic risk scores were derived from a 1:5 matched nested case–control set comprising 70,470 individuals (11,745 CVD events) and then validated in a cohort of 81,205 individuals (5950 CVD events). The individuals were Chinese adults aged 40–79 years without a history of CVD at baseline. Eleven predictors related to vital signs, laboratory tests, and health service utilization were selected to establish the dynamic scores. The proposed scores were significantly associated with the subsequent CVD onset (adjusted odds ratio, 1.21; 95% confidence interval, 1.20–1.23). The area under the receiver operating characteristic curves (AUCs) was 0.6010 (0.5929–0.6092) and 0.6021 (0.5937–0.6105) for the long-term 10-year CVD risk <10% and ≥10% groups in the derivation set, respectively. In the long-term 10-year CVD risk ≥10% group in the validation set, the change in AUC in addition to the long-term risk was 0.0235 (0.0155–0.0315). By increasing the risk threshold from 7 to 16 points, the proportion of true subsequent CVD cases among those given alerts increased from 40.61% to 85.31%. In terms of management efficiency, the number needed to manage per CVD case ranged from 2.46 to 1.17 using the risk scores. With the increasing popularity and integration of EHR systems with wearable technology, the DREAM scores can be incorporated into an early-warning system and applied in dynamic, real-time, EHR-based, automated management to support healthcare decision making for individuals, general practitioners, and policymakers.
There is a growing demand for the use of high-quality real-world evidence (RWE) to support regulatory decision-making worldwide and in China, which highlights the need for conducting literature reviews to evaluate the available data and evidence. This study aims to review the use of RWE in Chinese regulatory decisions and to summarize relevant regulatory and methodological considerations to inform the future use of RWE in China. We identified policy documents, technical guidance documents, and cases on official Chinese government websites and extracted their contents separately. We consulted experts from the National Medical Products Administration (NMPA) and academic institutes and searched case-related articles for enrichment. We also searched and included articles related to the use of RWE/Real-world data in Chinese regulatory decisions. Six trial versions of technical guidance documents, 7 case studies, and 40 articles related to the Chinese regulatory decisions were included in this study. Based on the technical guidance, data quality, and appropriate study design and statistical analysis are the main concerns for RWE generation. The cases and articles related to regulatory decisions revealed 9 main concerns, including data sources and applicability, data quality, strength of existing evidence, appropriate study design and statistical analysis, regulated and transparent process for analysis and evidence generation, product safety and efficacy, product characteristics and clinical needs, ethical considerations and data security, and communicate adequately with regulatory authorities. Among these concerns, data issues are central. Preliminary attempts have been made by the NMPA to promote the use of RWE, but substantial challenges still remain.
Background
After the implementation of 2- and 3-child policies, the rising proportion of high-age and high-risk pregnancies put enormous pressure on maternal and child health (MCH) services for China. This populous nation with an increasing population flow imperatively required the support of large-scale information systems for management. Municipal MCH information systems were commonly applied in developed cities of eastern provinces in China. However, implementation of provincial MCH information systems in relatively low-income areas is lacking. In 2020, the implementation of a regional maternal and child information system (RMCIS) in Inner Mongolia filled this gap.
Objective
This paper aimed to demonstrate the construction process and evaluate the implementation effect of an RMCIS in improving the regional MCH in Inner Mongolia.
Methods
We conducted a descriptive study for the implementation of an RMCIS in Inner Mongolia. Based on the role analysis and information reporting process, the system architecture design had 10 modules, supporting basic health care services, special case management, health support, and administration and supervision. Five-color management was applied for pregnancy risk stratification. We collected data on the construction cost, key characteristics of patients, and use count of the main services from January 1, 2020, to October 31, 2022, in Inner Mongolia. Descriptive analysis was used to demonstrate the implementation effects of the RMCIS.
Results
The construction and implementation of the RMCIS cost CNY 8 million (US $1.1 million), with a duration of 13 months. Between 2020 and 2022, the system recorded 221,772 registered pregnant women, with a 44.75% early pregnancy registry rate and 147,264 newborns, covering 278 hospitals and 225 community health care centers in 12 cities. Five-color management of high-risk pregnancies resulted in 76,975 (45.45%) pregnancies stratified as yellow (general risk), 36,627 (21.63%) as orange (relatively high risk), 156 (0.09%) as red (high risk), and 3888 (2.30%) as purple (infectious disease). A scarred uterus (n=28,159, 36.58%), BMI≥28 (n=14,164, 38.67%), aggressive placenta praevia (n=32, 20.51%), and viral hepatitis (n=1787, 45.96%) were the top factors of high-risk pregnancies (yellow, orange, red, and purple). In addition, 132,079 pregnancies, including 65,018 (49.23%) high-risk pregnancies, were registered in 2022 compared to 32,466 pregnancies, including 21,849 (67.30%) high-risk pregnancies, registered in 2020.
Conclusions
The implementation of an RMCIS in Inner Mongolia achieved the provincial MCH data interconnection for basic services and obtained both social and economic benefits, which could provide valuable experience to medical administration departments, practitioners, and medical informatics constructors worldwide.
Background:
Chinese herbal medicines (CHM) have been long used among pregnant populations in China. However, despite the high susceptibility of this population to drug exposure, it continued to remain unclear about how often they were used, to what extent they were used at different pregnancy stages, and whether their use was based on sound safety profiles particularly when used in combination with pharmaceutical drugs.
Objective:
The aim of this descriptive cohort study was to systematically investigate the use of CHM throughout the pregnancy and their safety profiles.
Study design:
We developed a large medication use cohort by linking a population-based pregnancy registry and a population-based pharmacy database, which documented all prescriptions both at outpatients and inpatients from conception to 7 days after delivery, including pharmaceutical drugs and processed CHM formula that were approved by regulatory authority and prepared under the guidance of national quality standards. We investigated the prevalence of CHM formula use, prescription pattern and combination use of pharmaceutical drugs throughout the pregnancy life course. Multivariable log-binomial regression was conducted to assess temporal trend, and further explore the potential characteristics associated with the CHM use. Two authors independently conducted a qualitative systematic review of patient package inserts (PPI) of top 100 CHM formula use to identify their safety profiles.
Results:
Our study included 199,710 pregnancies; of those, 65.71% (131,235/199,710) were administered with CHM formula, including 26.13% during pregnancy (corresponding to 14.00%, 8.91% and 8.26% in the first, second, and third trimesters), and 55.63% at post-delivery. The peak uses of CHM occurred between the 5th and 10th weeks. The use of CHM significantly increased over the years (63.28% in 2014 to 69.59% in 2018, adjusted relative risk [aRR]: 1.11, 95% CI: 1.10-1.13), which was particularly great during pregnancy (18.47% to 32.46%, 1.84, 95% CI: 1.77-1.90). Our study observed 291,836 prescriptions involving 469 CHM formula, and the 100 mostly used CHM accounted for 98.28% of the total prescriptions. Of those, a third (33.39%) were dispensed at outpatient visits; 6.79% were external use and 0.29% were injections. However, CHM were very often prescribed in combination with pharmaceutical drugs (overall 94.96%), involving 1,175 pharmaceutical drugs with 1,667,459 prescriptions. A median of 10 (IQR: 5-18) pharmaceutical drugs was prescribed in combination with CHM per pregnancy. The systematic review of drug patient package inserts found that the 100 most frequently prescribed CHM contained a total of 240 herb constituents (median 4.5); 7% were explicitly indicated for pregnancy or postpartum conditions; 43.00% were reported with efficacy or safety data from randomized controlled trials. Information was lacking about whether the medication has any reproductive toxicity, is excreted in human milk or may cross the placenta.
Conclusion:
The use of CHM was prevalent throughout the pregnancy and increased over years. The CHM use peaked at the first trimester and was very often used in combination with pharmaceutical drugs. However, their safety profiles were mostly unclear or incomplete, warranting a strong need for post-approval surveillance for CHM use during pregnancy life course.
Objective
To investigate the impact of maternal hepatitis B virus (HBV) status on pregnancy complications and neonatal outcomes for women undergoing assisted reproductive technology (ART).
Materials and methods
A total of 7,011 pregnancies achieved by ART were included from a population‐based database involving 523,111 pregnancies. Exposures of hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) among pregnant women, were routinely tested at the first antenatal visit for all pregnancies. We collected pregnancy complications (e.g., gestational diabetes mellitus [GDM], intrahepatic cholestasis of pregnancy [ICP]), neonatal outcomes and confounding variables from the same database. Univariate and multivariate analyses by adjusting confounders were conducted to evaluate the impact of maternal HBV infection.
Results
Prevalence of HBsAg seropositivity (HBsAg+) was 11.34% (95% CI 10.6–12.1) and that of HBsAg and HBeAg co‐seropositivity (HBsAg+HBeAg+) was 2.55% (2.1–3.0) among included population. Compared with HBsAg− group, ICP risk in the HBsAg+ group was higher (4.03% vs. 1.79%; adjusted odds ratio [aOR] 2.49, 1.65−3.77). Similarly, ICP prevalence in the HBsAg+HBeAg+ group was higher than that in the HBsAg−HBeAg− group (6.47% vs. 1.61%; aOR 4.78, 2.28–9.98). No associations were found between maternal HBV infection (i.e., HBsAg+, HBsAg+HBeAg+, or HBsAg+HBeAg−) and other adverse outcomes for women undergoing ART (i.e., GDM, pre‐eclampsia, placental previa, premature separation of placenta, premature rupture of membranes, preterm birth, and low birthweight) in this study.
Conclusions
Maternal HBV infection (HBsAg+ or HBsAg+HBeAg+) probably increase ICP risk, but may not associate with other pregnancy complications or neonatal outcomes for pregnant women who underwent ART.
