Publications by authors named "Yuanxi Jia"

10 Publications

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The Effect of Lutein/Zeaxanthin Intake on Human Macular Pigment Optical Density: A Systematic Review and Meta-Analysis.

Adv Nutr 2021 Jun 22. Epub 2021 Jun 22.

Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Lutein, zeaxanthin, and meso-zeaxanthin are the only carotenoids found in the human macula and may have a role in visual function. These carotenoids are reported to protect the retina, and thus vision, as antioxidants and by acting as a blue light filter. Our objective was to determine a minimum concentration of lutein/zeaxanthin intake that is associated with a statistically significant and/or clinically important change in macular pigment optical density (MPOD) among adults with healthy eyes. We searched Ovid MEDLINE, CENTRAL, and the Commonwealth of Agriculture Bureau for English-language studies through to July 2020. Two reviewers screened results to identify studies that evaluated supplements or dietary sources of lutein/zeaxanthin on MPOD among adults with healthy eyes. One reviewer extracted data and assessed strength of evidence, which was confirmed by a second reviewer. Two independent reviewers assessed the risk of bias. Meta-analyses were stratified by total lutein/zeaxanthin dose. We included 46 studies (N = 3189 participants; mean age = 43 y; 42% male). There was no statistically significant change in MPOD among studies evaluating <5 mg/d of total lutein/zeaxanthin intake which primarily assessed dietary interventions for 3-6 mo (pooled mean difference, 0.02; 95% CI: -0.01 to 0.05). The pooled mean increase in MPOD was 0.04 units (95% CI: 0.02 to 0.07) among studies evaluating 5 to <20 mg/d of lutein/zeaxanthin and was 0.11 units (95% CI: 0.06 to 0.16) among studies evaluating ≥20 mg/d of lutein/zeaxanthin for 3-12 mo. MPOD increased with lutein/zeaxanthin intake, particularly at higher doses, among adults with healthy eyes. The effects of lutein/zeaxanthin intake at doses <5 mg/d or from dietary sources is less clear. Increased lutein/zeaxanthin intake can help with maintaining ocular health. Future research is needed to determine the minimum dose and duration of lutein/zeaxanthin intake that is associated with a clinically important change in MPOD or visual function.
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http://dx.doi.org/10.1093/advances/nmab071DOI Listing
June 2021

Effect of redundant clinical trials from mainland China evaluating statins in patients with coronary artery disease: cross sectional study.

BMJ 2021 02 2;372:n48. Epub 2021 Feb 2.

Department of Medicine, School of Medicine, Johns Hopkins University, 1830 East Monument Street, Suite 8068, Baltimore, MD 21287, USA

Objective: To identify redundant clinical trials evaluating statin treatment in patients with coronary artery disease from mainland China, and to estimate the number of extra major adverse cardiac events (MACEs) experienced by participants not treated with statins in those trials.

Design: Cross sectional study.

Setting: 2577 randomized clinical trials comparing statin treatment with placebo or no treatment in patients with coronary artery disease from mainland China, searched from bibliographic databases to December 2019.

Participants: 250 810 patients with any type of coronary artery disease who were enrolled in the 2577 randomized clinical trials.

Main Outcome Measures: Redundant clinical trials were defined as randomized clinical trials that initiated or continued recruiting after 2008 (ie, one year after statin treatment was strongly recommended by clinical practice guidelines). The primary outcome is the number of extra MACEs that were attributable to the deprivation of statins among patients in the control groups of redundant clinical trials-that is, the number of extra MACEs that could have been prevented if patients were given statins. Cumulative meta-analyses were also conducted to establish the time points when statins were shown to have a statistically significant effect on coronary artery disease.

Results: 2045 redundant clinical trials were identified published between 2008 and 2019, comprising 101 486 patients in the control groups not treated with statins for 24 638 person years. 3470 (95% confidence interval 3230 to 3619) extra MACEs were reported, including 559 (95% confidence interval 506 to 612) deaths, 973 (95% confidence interval 897 to 1052) patients with new or recurrent myocardial infarction, 161 (132 to 190) patients with stroke, 83 (58 to 105) patients requiring revascularization, 398 (352 to 448) patients with heart failure, 1197 (1110 to 1282) patients with recurrent or deteriorated angina pectoris, and 99 (95% confidence interval 69 to 129) unspecified MACEs.

Conclusions: Of more than 2000 redundant clinical trials on statins in patients with coronary artery disease identified from mainland China, an extra 3000 MACEs, including nearly 600 deaths, were experienced by participants not treated with statins in these trials. The scale of redundancy necessitates urgent reform to protect patients.
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http://dx.doi.org/10.1136/bmj.n48DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7851709PMC
February 2021

Association between switching of primary outcomes and reported trial findings among randomized drug trials from China.

J Clin Epidemiol 2021 Apr 9;132:10-17. Epub 2020 Dec 9.

Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA. Electronic address:

Background And Objective: To evaluate the association between the nature of findings and the switching of registered primary outcomes among randomized controlled trials (RCTs) from mainland China.

Methods: This is a retrospective cohort study. We retrieved RCTs from trial registries and identified the corresponding journal articles from bibliographic databases until August 2019. Trial registries and journal articles were compared to evaluate whether registered primary outcomes with negative findings were more likely to be switched to secondary outcomes in the subsequent journal articles than those with positive findings.

Results: Switching of registered primary outcomes occurred in 131 (45%) of 294 RCTs. A total of 450 registered primary outcomes were matched to 522 (37%) primary outcomes and 871 (63%) secondary outcomes in the journal articles. Among RCTs registered before they started, the odds of switching primary outcomes with negative findings were 2.64 (95% CI: 1.16-6.02) times the odds of switching those with positive findings. Among RCTs registered when they were ongoing, the odds of switching primary outcomes with negative findings were 8.84 (95% CI: 3.62-25.93) times the odds of switching those with positive findings.

Conclusion: The nature of findings may play a role in how likely a prespecified primary outcome is switched subsequently.
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http://dx.doi.org/10.1016/j.jclinepi.2020.11.023DOI Listing
April 2021

Assessment of Duplicate Publication of Chinese-Sponsored Randomized Clinical Trials.

JAMA Netw Open 2020 12 1;3(12):e2027104. Epub 2020 Dec 1.

Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland.

Importance: Duplicate publications of randomized clinical trials are prevalent in the health-related literature. To date, few studies have assessed the interaction between duplicate publication and the language of the original publication.

Objective: To assess the existence of duplicate publication and the extent to which duplicate publication is associated with the language of the original publication.

Design, Setting, And Participants: In this retrospective cohort study, eligible randomized clinical trials were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible randomized clinical trials were for drug interventions from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. The trial registries were either primary registries recognized by the World Health Organization or the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration.

Exposures: Individual randomized clinical trials with positive vs negative results.

Main Outcomes And Measures: Journal articles were classified as main articles (determined by largest sample size and longest follow-up among all journal articles derived from that randomized clinical trial) and duplicates. The duplicates were classified into 4 types: (1) unreferenced subgroup analysis (article did not disclose itself as a subgroup analysis or reference its main article); (2) unreferenced republication (article did not disclose itself as a replicate of the main article or reference it); (3) unreferenced interim analysis (article did not disclose itself as an interim analysis or reference its main article); and (4) partial duplicate (article did not disclose its sharing a subset of participants with other articles or reference them).

Results: Among 470 randomized clinical trials published by August 2019 as journal articles, 55 (11.7%) had 75 duplicates, of which 53 (70.7%) were cross-language duplicates. Of the 75 duplicates, 33 (44.0%) were unreferenced republications, 25 (33.3%) unreferenced subgroup analyses, 15 (20.0%) unreferenced interim analyses, and 2 (2.7%) partial duplicates. When the main article of a randomized clinical trial was published in Chinese, those with positive findings were 2.48 (95% CI, 1.08-5.71) times more likely to have subsequent duplicate publication than those with negative findings.

Conclusions And Relevance: In this study, most duplicates were cross-language duplicates and the most common type was unreferenced republication of the main article. Duplicate publication bias exists when the main articles of randomized clinical trials were published in Chinese, potentially misleading readers and compromising journals and evidence synthesis.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.27104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716193PMC
December 2020

Measures of Adult Shoulder Function.

Arthritis Care Res (Hoboken) 2020 10;72 Suppl 10:250-293

Monash University and Cabrini Institute, Melbourne, Victoria, Australia, and The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.

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http://dx.doi.org/10.1002/acr.24230DOI Listing
October 2020

Prevention of mother-to-child transmission of hepatitis B virus: protocol for a one-arm, open-label intervention study to estimate the optimal timing of tenofovir in pregnancy.

BMJ Open 2020 09 13;10(9):e038123. Epub 2020 Sep 13.

Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Introduction: Hepatitis B virus (HBV) remains a public health threat and the main route of transmission is from mother to child (MTCT). Tenofovir disoproxil fumarate (TDF) treatment can reduce MTCT of HBV although the optimal timing to attain undetectable HBV DNA concentrations at delivery is unknown. This protocol describes the procedures following early initiation of maternal TDF prior to 20 weeks gestation to determine efficacy, safety and feasibility of this approach in a limited-resource setting.

Methods And Analyses: One hundred and seventy pregnant women from the Thailand-Myanmar border between 12 and <20 weeks gestational age will be enrolled into a one-arm, open-label, TDF treatment study with cessation of TDF 1 month after delivery. Sampling occurs monthly prenatal, at birth and at 1, 2, 4 and 6 months post partum. Measurement of tenofovir concentrations in maternal and cord plasma is anticipated in 10-15 women who have detectable HBV DNA at delivery and matched to 20-30 women with no detectable HBV DNA. Infant HBsAg status will be determined at 2 months of age and HBV DNA confirmed in HBsAg positive cases. Adverse events including risk of flare and adherence, based on pill count and questionnaire, will be monitored. Infants will receive HBV vaccinations at birth, 2, 4 and 6 months and hepatitis B immunoglobulin at birth if the mother is hepatitis B e antigen positive. Infant growth and neurodevelopment at 6 months will be compared with established local norms.

Ethics And Dissemination: This study has ethical approval by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University (FTM ECF-019-06), Johns Hopkins University (IRB no: 00007432), Chiang Mai University (FAM-2559-04227), Oxford Tropical Research Ethics Committee (OxTREC Reference: 49-16) and by the local Tak Community Advisory Board (TCAB-02/REV/2016). The article will be published as an open-access publication.

Trial Registration Number: NCT02995005, Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-038123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7488796PMC
September 2020

Assessment of Language and Indexing Biases Among Chinese-Sponsored Randomized Clinical Trials.

JAMA Netw Open 2020 05 1;3(5):e205894. Epub 2020 May 1.

Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland.

Importance: Language and indexing biases may exist among Chinese-sponsored randomized clinical trials (CS-RCTs). Such biases may threaten the validity of systematic reviews.

Objective: To evaluate the existence of language and indexing biases among CS-RCTs on drug interventions.

Design, Setting, And Participants: In this retrospective cohort study, eligible CS-RCTs were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible CS-RCTs were for drug interventions conducted from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. Primary trial registries were recognized by the World Health Organization and the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration.

Exposures: Individual CS-RCTs with positive vs negative results (positive vs negative CS-RCTs).

Main Outcomes And Measures: For assessing language bias, the main outcome was the language of the journal in which CS-RCTs were published (English vs Chinese). For indexing bias, the main outcome was the language of the bibliographic database where the CS-RCTs were indexed (English vs Chinese).

Results: The search identified 891 eligible CS-RCTs. Four hundred seventy CS-RCTs were published by August 31, 2019, of which 368 (78.3%) were published in English. Among CS-RCTs registered in the Chinese Clinical Trial Registry (ChiCTR), positive CS-RCTs were 3.92 (95% CI, 2.20-7.00) times more likely to be published in English than negative CS-RCTs; among CS-RCTs in English-language registries, positive CS-RCTs were 3.22 (95% CI, 1.34-7.78) times more likely to be published in English than negative CS-RCTs. These findings suggest the existence of language bias. Among CS-RCTs registered in ChiCTR, positive CS-RCTs were 2.89 (95% CI, 1.55-5.40) times more likely to be indexed in English bibliographic databases than negative CS-RCTs; among CS-RCTs in English-language registries, positive CS-RCTs were 2.19 (95% CI, 0.82-5.82) times more likely to be indexed in English bibliographic databases than negative CS-RCTs. These findings support the existence of indexing bias.

Conclusions And Relevance: This study suggests the existence of language and indexing biases among registered CS-RCTs on drug interventions. These biases may distort evidence synthesis toward more positive results of drug interventions.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.5894DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256669PMC
May 2020

A systematic review of measurement properties of patient-reported outcome measures for use in patients with foot or ankle diseases.

Qual Life Res 2017 08 17;26(8):1969-2010. Epub 2017 Mar 17.

Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA.

Purpose: To identify currently available patient-reported outcome measures (PROMs) used in patients with foot or ankle diseases; and to critically appraise, compare and synthesize the psychometric evidence for the identified PROMs.

Methods: Literature searches were performed in Medline and EMBASE from their inception to January 25th, 2016. Methodological quality was evaluated using the COSMIN checklist. The final rating of the methodological quality of each study for each property was the lowest rating among the items within that property. The psychometric evidence of the properties investigated in the included articles was assessed using the quality criteria established by Terwee et al. The methodological quality ratings and psychometric evidence assessments were synthesized using the method first proposed by Schellingerhout et al.

Results: In total, 3077 articles were identified by the literature search, from which 115 studies investigating 50 PRO instruments were included in the review process. The Foot Function Index (FFI) was the most explored instrument, while the Manchester-Oxford Foot Questionnaire (MOXFQ) demonstrated the best properties.

Conclusion: Most PROMs on foot and ankle diseases have limited evidence for their psychometric properties. The MOXFQ, with the highest overall ratings, could be a useful PROM for evaluating patients with foot or ankle diseases, based on current available evidence. More research is needed to improve the quality of the standards used to assess PROMs and the studies making these assessments.
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http://dx.doi.org/10.1007/s11136-017-1542-4DOI Listing
August 2017

Effectiveness of prevention of mother-to-child transmission practice in three provinces of Southern China.

Hum Vaccin Immunother 2015 ;11(8):2061-7

a Chinese Center for Disease Control and Prevention ; Beijing , China.

Vaccination in prevention mother-to-child transmission (PMTCT) of hepatitis B has been recommended since plasma-derived hepatitis B vaccines became available in China in 1986; however, less study evaluated practice effectiveness of PMTCT systematically. We conducted a prospective survey to evaluate the effectiveness of PMTCT practices in 3 provinces of southern China. We selected prefectures with low timely birth dose coverage in Yunnan, Guangxi, and Hunan provinces. Infants born to HBsAg positive mothers were evaluated at 7-12 months of age. We tested hepatitis B virus (HBV) surface antigen (HBsAg) and HBV e antigen (HBeAg) of mothers and tested HBsAg of infants born to HBsAg positive mothers using Enzyme-linked Immunosorbent Assay (ELISA) at provincial CDC laboratories. We used logistic regression analysis to analyze the risk factors for HBV infection. Among 3,094 infants born to HBsAg positive mothers, 172 were positive for HBsAg (5.6%). HBeAg status of pregnant women, timely birth dose (TBD) of hepatitis B vaccine were major predictors for HBV infection of infants. PMTCT practices greatly reduced the prevalence of HBsAg among infants born to HBsAg positive mothers China. However, the effectiveness of strategies used in PMTCT varied. HBsAg screening for pregnant women, monitoring of infants born to HBsAg positive mother should be enhanced to evaluate the effectiveness of program.
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http://dx.doi.org/10.1080/21645515.2015.1023972DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4635870PMC
May 2016

Cost-effectiveness analysis of a hepatitis B vaccination catch-up program among children in Shandong Province, China.

Hum Vaccin Immunother 2014 ;10(10):2983-91

a Chinese Center for Disease Control and Prevention ; Beijing , China.

Objective: The aim of the study was to estimate long-term cost‑effectiveness of a hepatitis B vaccination catch-up program among children born between 1994 and 2001 (when they were 8‑15 y old) in Shandong province, China, to provide information for nationwide evaluation and future policy making.

Methods: We determined the cost-effectiveness of the catch-up program compared with the status quo (no catch-up program). We combined a Decision Tree model and a Markov model to simulate vaccination and clinical progression after hepatitis B virus (HBV) infection. Parameters in the models were from the literature, a field survey, program files, and the National Notifiable Disease Reporting System (NNDRS). The incremental cost‑effectiveness ratio (ICER) was used to compare the 2 alternative strategies. One-way sensitivity analysis, 2-way sensitivity analysis, and probability sensitivity analysis were used to assess parameter uncertainties.

Results: The catch-up program was dominant compared with the status quo. Using a total of 5.53 million doses of vaccines, the catch-up program could prevent 21,865 cases of symptomatic acute hepatitis B, 3,088 carrier states with positive hepatitis B surface antigen (HBsAg), and 812 deaths due to HBV infection. The catch-up program could add 28,888 quality-adjusted life years (QALYs) and save $192.01 million in the targeted population in the future. The models were robust, considering parameter uncertainties.

Conclusion: The catch-up program in Shandong province among children born between 1994 and 2001 was 'very cost-saving.' It could save life years and reduce total future costs. Our study supported the desirability and impact of such a catch-up program throughout China.
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http://dx.doi.org/10.4161/hv.29944DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443099PMC
September 2015
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