Xin Sun

• Sichuan University

Sepsis real-time prediction models (SRPMs) provide timely alerts and may improve patient outcomes but face limited clinical adoption due to inconsistent validation methods and potential biases. Comprehensive evaluation, including external full-window validation with model- and outcome-level metrics, is crucial for real-world effectiveness, yet perf...

Machine learning (ML) models have been developed to identify randomised controlled trials (RCTs) to accelerate systematic reviews (SRs). However, their use has been limited due to concerns about their performance and practical benefits. We developed a high-recall ensemble learning model using Cochrane RCT data to enhance the identification of RCTs...

Background Hepatitis B virus (HBV) infection is a common public health problem, and maternal HBV infection can cause adverse outcomes in both mothers and fetuses. However, the influence of hepatitis B e antigen (HBeAg) serostatus on obstetric outcomes is not well established. This study aims to investigate the prevalence trend of maternal HBV infec...

Aim To provide a comprehensive assessment of the efficacy and safety of pharmacological interventions for AP. Methods This was an overview of systematic reviews based on randomized controlled trials comparing pharmacological interventions with placebo or blank control in adults with AP. We searched PubMed, Embase, and the Cochrane Database of Syst...

Promoting the international acceptance of clinical studies about traditional Chinese medicine (TCM) interventions is a key strategy for internationalization of TCM. However, the complexities of TCM interventions—in terms of the theories, practice patterns, and components—pose challenges to the design and implementation of clinical studies that are...

Introduction Although various sham acupuncture techniques have been employed to ensure blinding in randomised controlled trials (RCTs) of acupuncture, the effectiveness of blinding in these trials and its influence on trial effect size estimates remain unclear. The objectives of this study are the following: (1) to investigate the proportion and st...

Background Surgical interventions for spontaneous supratentorial intracerebral haemorrhage (ICH) include conventional craniotomy (CC), decompressive craniectomy (DC), and minimally invasive surgery (MIS), with the latter encompassing endoscopic surgery (ES) and minimally invasive puncture surgery (MIPS). However, the superiority of surgery over con...

Backgrounds Syntheses of non-randomized studies of interventions (NRSIs) and randomized controlled trials (RCTs) are increasingly used in decision-making. This study aimed to summarize when NRSIs are included in evidence syntheses of RCTs, with a particular focus on the methodological issues associated with combining NRSIs and RCTs. Methods We sea...

Routinely collected health data (RCD) are currently accelerating publications that evaluate the effectiveness and safety of medicines and medical devices. One of the fundamental steps in using these data is developing algorithms to identify health status that can be used for observational studies. However, the process and methodologies for identify...

Bayesian meta‐analysis is a promising approach for rare events meta‐analysis. However, the inference of the overall effect in rare events meta‐analysis is sensitive to the choice of prior distribution for the heterogeneity parameter. Therefore, it is crucial to assign a convincing prior specification and ensure that it is both plausible and transpa...

Background With the global push for human papillomavirus (HPV) vaccination, many women of childbearing age may receive this vaccine around the time of conception. Previous studies have clarified the association between Peri-conception HPV vaccination and several adverse pregnancy outcomes (e.g., spontaneous abortion). However, the risk for birth de...

The angioedema risk may vary among stroke patients receiving different thrombolytic agents. This study aimed to investigate the angioedema risk associated with different thrombolytic agents and to identify associated risk factors. We conducted a large-scale retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) d...

Background There is a growing trend to include non-randomised studies of interventions (NRSIs) in rare events meta-analyses of randomised controlled trials (RCTs) to complement the evidence from the latter. An important consideration when combining RCTs and NRSIs is how to address potential bias and down-weighting of NRSIs in the pooled estimates....

An increasing number of observational studies have investigated the risk of using drugs during pregnancy on congenital malformations. However, the credibility of the causal relationships drawn from these studies remains uncertain. This study aims to evaluate the potential methodological issues in existing observational studies. We used a stepwise a...

Background The high recurrence rate after liver resection emphasizes the urgent need for neoadjuvant therapy in hepatocellular carcinoma (HCC) to enhance the overall prognosis for patients. Immune checkpoint inhibitors, camrelizumab combined with an anti-angiogenic tyrosine kinase inhibitor (TKI) apatinib, have emerged as a first-line treatment opt...

Objectives To analyze the costs and medication patterns of patients with chronic kidney disease (CKD) and comorbidities in Xuzhou, China, using a large electronic medical records database. Methods Data were obtained from an electronic medical records database. The annual per-person and per-visit cost of hospitalization, as well as the proportions...

Background Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this s...

Objective To identify subclasses of acute pancreatitis (AP) patients in the intensive care unit (ICU) by analyzing blood urea nitrogen (BUN) trajectories. Methods AP patients in West China Hospital System (development cohort) and three public databases in the United States (validation cohort) were included. Latent class trajectory modelling was us...

The meta‐analysis of rare events presents unique methodological challenges owing to the small number of events. Bayesian methods are often used to combine rare events data to inform decision‐making, as they can incorporate prior information and handle studies with zero events without the need for continuity corrections. However, the comparative per...

The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documented drug uses throughout the pregnancy life course and adverse pregnancy outcomes. The main goal of the study aims to monitor and evaluate the safety of drug use through the pregnancy life course in the Chinese setting. The DEEP cohort is...

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 regu...

Objective Time‐varying treatments are common in observational studies. However, when assessing treatment effects, the methodological framework has not been systematically established for handling time‐varying treatments. This study aimed to examine the current methods for dealing with time‐varying treatments in observational studies and developed p...

Objective Alteplase is the current standard of care for acute ischemic stroke. Tenecteplase is a newer fibrinolytic agent with preferable administration and lower costs; however, its comparative effectiveness to alteplase remains uncertain. We set out to perform a systematic review and meta-analysis to establish the benefits and harms of tenectepla...

Introduction Obstetric care is a highly active area in the development and application of prognostic prediction models. The development and validation of these models often require the utilization of advanced statistical techniques. However, failure to adhere to rigorous methodological standards could greatly undermine the reliability and trustwort...

Background Time‐varying drug treatments are common in studies using routinely collected health data (RCD) for assessing treatment effects. This study aimed to examine how these studies reported, handled, and interpreted time‐varying drug treatments. Methods A systematic search was conducted on PubMed from 2018 to 2020. Eligible studies were those...

Background The clinical characteristics of early-onset type 2 diabetes (T2D) patients are not fully understood. To address this gap, we conducted a cohort study to evaluate clinical characteristics and disease burden in the new-onset T2D population, especially regarding the progression of diseases. Methods This cohort study was conducted using a p...

Background The sedation strategies have not been well established for patients with invasive mechanical ventilation (MV). This study compared alternative sedation strategies – including early deep-to-light sedation (DTLS), continuous deep sedation (CDS) and continuous light sedation (CLS, the currently recommended strategy) – on ventilator, ICU or...

Introduction Although interest in including non-randomised studies of interventions (NRSIs) in meta-analysis of randomised controlled trials (RCTs) is growing, estimates of effectiveness obtained from NRSIs are vulnerable to greater bias than RCTs. The objectives of this study are to: (1) explore how NRSIs can be integrated into a meta-analysis of...

Wen Wang and colleagues discuss the rationale and propose a framework for using real world evidence to support coverage decisions in Chinese setting

Objectives: To systematically appraise the methodologies used for guidelines for positron emission tomography (PET) imaging and to compare the consistency of these recommendations. Methods: We searched PubMed, EMBASE, four guideline databases, and Google Scholar to identify evidence-based clinical practice guidelines pertaining to the use of PET...

Rare events meta-analyses of randomized controlled trials (RCTs) are often underpowered because the outcomes are infrequent. Real-world evidence (RWE) from non-randomized studies may provide valuable complementary evidence about the effects of rare events, and there is growing interest in including such evidence in the decision-making process. Seve...

Background Faced with the high costs and low success rates of clinical trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this study aimed to summarize...

Background Routinely collected health data (RCD) are important resource for exploring drug treatment effects. Adequate reporting of data source profiles may increase the credibility of evidence generated from these data. This study conducted a systematic literature review to evaluate the reporting characteristics of databases used by RCD studies to...

Clinical question Is acupuncture effective in treating knee osteoarthritis (KOA)? Current practice Although increasingly used in the clinical setting, acupuncture is not mentioned or weakly recommended in guidelines for the treatment of KOA. Recommendations We suggest acupuncture rather than no treatment in adult KOA (weak recommendation, moderat...

Objective To assess whether the use of Tanreqing (TRQ) Injection could show improvements in time to extubation, intensive care unit (ICU) mortality, ventilator-associated events (VAEs) and infection-related ventilator associated complication (IVAC) among patients receiving mechanical ventilation (MV).MethodsA time-dependent cox-regression analysis...

Objectives This study aims to explore whether maternal hepatitis B carrier status is associated with an increased risk of congenital abnormalities. Design A systematic review and meta-analysis of observational studies. Data sources PubMed, Embase (Ovid), Scopus, the China National Knowledge Infrastructure (CNKI) and the Wanfang databases. Study...

Background: Many rare events meta-analyses of randomized controlled trials (RCTs) have lower statistical power, and real-world evidence (RWE) is becoming widely recognized as a valuable source of evidence. The purpose of this study is to investigate methods for including RWE in a rare events meta-analysis of RCTs and the impact on the level of unc...

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...

Background To investigate the reporting of prognostic prediction model studies in obstetric care through a cross-sectional survey design. Methods PubMed was searched to identify prognostic prediction model studies in obstetric care published from January 2011 to December 2020. The quality of reporting was assessed by the TRIPOD checklist. The over...

Background: Stroke is the leading cause of death in China, and predicting the stroke burden could provide essential information guiding the setting of medium- and long-term health policies and priorities. The study aimed to project trends associated with stroke burden in China through 2050, not only in terms of incidence and mortality but also for...

Background The acupoint selections impact the effects of acupuncture, and preliminary evidence showed potential connection between pain threshold (PT) and acupuncture response. This study examined whether acupuncture at acupoints with lower PT versus higher PT would yield different effects in patients with knee osteoarthritis (KOA). Methods In thi...

Objective To examine whether appropriate statistical methods were used in acupuncture randomized controlled trials (RCTs). Study Design and Setting We searched PubMed to identify acupuncture RCTs with continuous outcome as primary outcome published in the core clinical journals and complementary and alternative medicine (CAM) journals between Janu...

Objective Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among...

Background: Danhong injection is widely used for treating ischemic stroke in China. However, its effects on ischemic stroke patients when given along with Western medicines (i.e., the add-on effect) were not well-established. Methods: We searched PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and three Chinese databases f...

Background: The effect of thromboembolism prophylaxis on clinical outcomes, such as ventilator-associated events (VAEs), ICU stays, and mortality, remains controversial. This study was conducted to evaluate the effect of pharmacological thromboprophylaxis on VAEs, ICU stays, and ICU mortality among patients receiving mechanical ventilation (MV). Ma...

Background The value of ¹⁸F-fluorodeoxyglucose positron emission tomography (¹⁸F-FDG PET) in the diagnostic assessment of pediatric fever of unknown origin is not known, and evidence from adults is not applicable. Objective To quantify the contribution of ¹⁸F-FDG PET to pediatric fever of unknown origin, considering its diagnostic limitations. Ma...

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 Mar...

Purpose To evaluate the association between biparental hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] seropositivity) and pregnancy outcomes in patients undergoing assisted reproductive technology (ART) treatment, including clinical pregnancy rate (CPR) and live birth rate (LBR). Methods We searched various literature datab...

Background The acupoint selections impact the effects of acupuncture, and preliminary evidence showed potential connection between pain threshold (PT) and acupuncture response. This study examined whether acupuncture at acupoints with lower PT versus higher PT would yield different effects in patients with knee osteoarthritis (KOA). Methods In this...

Objectives Missing data are common in randomized controlled trials (RCTs) involving repeatedly measured continuous outcomes. Evidence on the reporting and handling of such outcome data is lacking, which has prevented further improvement in methods and reporting of RCTs. Study Design and Setting We searched PubMed to identify RCTs published in the...

Objectives: Subject to ethical constraints, real-world data are an important resource for evaluating treatment effects of medication use during pregnancy and the postpartum period. This study investigated whether motherwort injection, a traditional Chinese medicine preparation, was more effective than intramuscular (IM) oxytocin for preventing post...

Real-world data study evidence, as an important part of evaluating the safety and effectiveness of drugs and devices, has attracted increasing attention from regulatory agencies and scholars both at home and abroad, and has become an essential source of evidence to support the development and review of drugs and devices. This paper systematically d...

Background: As the first-line treatment for mechanically ventilated patients with critical illness, fentanyl and its analogs (e.g., sufentanil and remifentanil) are commonly used in the intensive care unit (ICU). However, the pharmacokinetics, metabolism, and potency of these agents differed. Their effects on clinical outcomes have not been well-un...

Rapid recommendation is a novel methodological framework for developing clinical practice guidelines and this framework shares the basic features of classical guidelines but differs from classical clinical practice guidelines in its `rapid’ development process (typically within 90 days) with an aim of translating practice-changing studies to recomm...

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 effect...

Background: Danhong injection is widely used for treating ischemic stroke in China. However, its effects on ischemic stroke patients when adding to western medicines (i.e., the add-on effect) were not well established. Methods: We searched PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL) and three Chinese databases from ince...

Background In recent years, studies that used routinely collected data (RCD), such as electronic medical records and administrative claims, for exploring drug treatment effects, including effectiveness and safety, have been increasingly published. Abstracts of such studies represent a highly attended source for busy clinicians or policy-makers, and...

Objectives : Systematic understanding is lacking regarding how current trials handle repeated measure data and the extent to which appropriate statistical methods are used for such data set. This study investigated the current practice of analyzing the repeated measure data among randomized controlled trials (RCTs). Study Design and Setting : We s...

Background. Acupoint sensitization is considered an important factor in the efficacy of acupoint therapy. This study aimed to evaluate the efficacy of acupressure in the prevention of stable angina pectoris using acupoints with different pressure-pain sensitivities. Methods. A total of 202 patients were enrolled and randomly assigned to a high-sens...

Background: Specification of interventions and selection of control are two methodological determinants for a successful acupuncture trial. However, it is not fully understood about the current practice of these two determinants. We thus conduced a cross-sectional study to examine specification of interventions and selection of control among curren...

Background The controlling nutritional status (CONUT) score has been widely used to evaluate the nutritional and immunological status. Clinical value of postoperative CONUT (PoCONUT) score in hepatocellular carcinoma (HCC) remains unknown. This study assessed whether PoCONUT score could serve as a useful predictor of survival for patients with smal...

2020 was an unprecedented year, with rapid and drastic changes in human mobility due to the COVID-19 pandemic. To understand the variation in commuting patterns among the Chinese population across stable and unstable periods, we used nationwide mobility data from 318 million mobile phone users in China to examine the extreme fluctuations of populat...

Background: Human migration is one of the driving forces for amplifying localized infectious disease outbreaks into widespread epidemics. During the outbreak of COVID-19 in China, the travels of the population from Wuhan have furthered the spread of the virus as the period coincided with the world's largest population movement to celebrate the Chi...

This systematic review investigated dose–response relationship between maternal prepregnancy body mass index (BMI) and pregnancy outcomes following assisted reproductive technology, including clinical pregnancy rate (CPR), miscarriage rate (MR), and live birth rate (LBR). We searched four major databases and finally included 105 studies involving m...

Objectives: To examine whether the use of natural language processing (NLP) technology is effective in assisting rapid title and abstract screening when updating a systematic review. Study Design: Using the searched literature from a published systematic review, we trained and tested an NLP model that enables rapid title and abstract screening when...

Background: Although previous clinical studies suggest possible benefits of acupuncture for knee osteoarthritis (KOA), the value of acupuncture at sensitized points is uncertain. We aimed to preliminarily assess the feasibility of performing a definitive randomized controlled trial to explore the effectiveness of acupuncture for KOA with highly se...

Background: Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies by another variable (e.g., age or disease severity). Assessing the credibility of an apparent effect modification presents challenges; therefore, we...

Objective To systematically review the efficacy of a combination of recombinant follicle‐stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) protocol versus human menopausal gonadotropin (hMG) protocol in controlled ovarian stimulation (COS). Methods PubMed, EMbase, The Cochrane Central Register of Controlled Trials, China Nationa...

Aims: To assess the effects of Sodium glucose co-transporter-2 (SGLT2) inhibitors on diabetic ketoacidosis (DKA) in patients with type 2 diabetes. Materials and methods: We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to June 13, 2019 for Randomized controlled trials (RCT...

Objectives Classical meta-analyses routinely treated studies with no events in both arms non-informative and excluded them from analyses. This study assessed whether such studies contain information and have influence on the conclusions of meta-analyses. Design and setting: We collected meta-analyses of binary outcomes with at least one study havi...