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Objective: To understand the status of autism spectrum disorder (ASD) cohort studies and explore the feasibility of constructing ASD disease-specific cohorts based on real-world data (RWD). Methods: ASD cohort studies published by December 2022 were collected by literature retrieval from major Chinese and English databases. And the characteristics of the cohort were summarized. Results: A total of 1 702 ASD cohort studies were included, and only 60 (3.53%) were from China. A total of 163 ASD-related cohorts were screened, of which 55.83% were birth cohorts, 28.22% were ASD-specific cohorts, and 4.91% were ASD high-risk cohorts. Most cohorts used RWD such as hospital registries or conducted community-based field surveys to obtain participant information and identified patients with ASD by scales or clinical diagnoses. The contents of the studies included ASD incidence and prognostic risk factors, ASD comorbidity patterns and the impact of ASD on self-health and their offspring's health. Conclusions: ASD cohort studies in developed countries have been in the advanced stage, while the Chinese studies are still in their infancy. RWD provides the data basis for ASD-specific cohort construction and offers new opportunities for research, but work such as case validation is still needed to ensure the scientific nature of cohort construction.
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Humanos , Trastorno del Espectro Autista , Estudios de Cohortes , Bases de Datos FactualesRESUMEN
OBJECTIVE@#To evaluate the association between serum uric acid (SUA) and kidney function decline.@*METHODS@#Data was obtained from the China Health and Retirement Longitudinal Study on the Chinese middle-aged and older population for analysis. The kidney function decline was defined as an annual estimated glomerular filtration rate (eGFR) decrease by > 3 mL/min per 1.73 m 2. Multivariable logistic regression was applied to determine the association between SUA and kidney function decline. The shape of the association was investigated by restricted cubic splines.@*RESULTS@#A total of 7,346 participants were included, of which 1,004 individuals (13.67%) developed kidney function decline during the follow-up of 4 years. A significant dose-response relation was recorded between SUA and the kidney function decline ( OR 1.14, 95% CI 1.03-1.27), as the risk of kidney function decline increased by 14% per 1 mg/dL increase in SUA. In the subgroup analyses, such a relation was only recorded among women ( OR 1.22, 95% CI 1.03-1.45), those aged < 60 years ( OR 1.22, 95% CI 1.05-1.42), and those without hypertension and without diabetes ( OR 1.22, 95% CI 1.06-1.41). Although the dose-response relation was not observed in men, the high level of SUA was related to kidney function decline ( OR 1.83, 95% CI 1.05-3.17). The restricted cubic spline analysis indicated that SUA > 5 mg/dL was associated with a significantly higher risk of kidney function decline.@*CONCLUSION@#The SUA level was associated with kidney function decline. An elevation of SUA should therefore be addressed to prevent possible kidney impairment and dysfunction.
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Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , China/epidemiología , Pueblos del Este de Asia , Tasa de Filtración Glomerular , Riñón/fisiopatología , Estudios Longitudinales , Factores de Riesgo , Ácido Úrico/sangreRESUMEN
From the perspective of data users, ensuring the relevance and reliability of big data in healthcare and medicine via assessments on data appropriateness is a prerequisite for generating high-quality real-world evidence, which could guarantee good representativeness and generalizability of real-world studies. This review summarized the quality dimensions, definitions, evaluation indexes and calculating methods of assessment on the appropriateness of real-world data (RWD) according to guidance from different countries and international organizations, as well as exploring the opportunities and challenges for better assessing RWD appropriateness.
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Humanos , Macrodatos , Atención a la Salud , Reproducibilidad de los ResultadosRESUMEN
Objective: To systematically summarize and analyze the clinical research progress of therapeutic vaccines for cervical cancer or precancerous lesions. Methods: English databases (PubMed, Embase, Web of Science, Cochrane library, Proquest, and ClinicalTrails.gov) and Chinese databases (SinoMed, CNKI, WanFang, and VIP Database) were systematically searched to collect literature on therapeutic vaccines for cervical cancer or precancerous lesions from inception to February 18, 2021. After screening, we evaluated the risk of bias of included studies, and combed the basic information of the literature, research designs, information of vaccines, study patients, outcome indicators and so on, qualitatively summarized the clinical research progress. Results: A total of 71 studies were included in this systematic review, including 14 random controlled trials, 15 quasi-random controlled trials, 4 cohort studies, 1 case-control study, 34 case series studies and 3 case reports. The study patients included women aged 15~79 with cervical cancer or precancerous lesions in 18 countries from 1989 to 2021. On the one hand, there were 40 studies on therapeutic vaccines for cervical precancerous lesions (22 867 participants), involving 21 kinds of vaccines in 6 categories. Results showed 3 marketed vaccines (Cervarix, Gardasil, Gardasil 9) as adjuvant immunotherapies were significant effective in preventing the recurrence of precancerous lesions compared with the conization only. In addition, MVA E2 vaccine had been in phase Ⅲ clinical trials as a specific therapeutic vaccine, with relative literature showing it could eliminate most high-grade precancerous lesions. Therapeutic vaccines for precancerous lesions all showed good safety. On the other hand, there were 31 studies on therapeutic vaccines for cervical cancer (781 participants), involving 19 kinds of vaccines in 7categories, with none had been marketed. 25 studies were with no control group, showing the vaccines could effectively eliminate solid tumors, prevent recurrence, and prolong the median survival time. However, the vaccines effectiveness couldn't be statistically calculated due to the lack of a control group. As for the safety of therapeutic vaccines for cervical cancer, 9 studies showed that patients experienced serious adverse events after treatments, where 7 studies reported that serious adverse events occurred in patients couldn't be ruled out as the results of therapeutic vaccines. Conclusions: The literature review shows that the literature evidence for the therapeutic vaccines for cervical precancerous lesions is relatively mature compared with the therapeutic vaccines for cervical cancer. The four kinds of vaccines on the market are all therapeutic vaccines for precancerous lesions, but they are generally used as vaginal infection treatments or adjuvant immunotherapies for cervical precancerous lesions, not used for the specific treatments of cervical precancerous lesions. Other specific therapeutic vaccines are in the early stage of clinical trials, mainly phase Ⅰ/Ⅱ clinical trials with small sample size. The effectiveness and safety data are limited, and further research is still needed.
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Femenino , Humanos , Vacunas contra el Cáncer/uso terapéutico , Displasia del Cuello del Útero/prevención & control , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/uso terapéutico , Lesiones Precancerosas/terapia , Neoplasias del Cuello Uterino/prevención & controlRESUMEN
To compare the differences on current ethical issues in the areas of epidemiological practice between China and America,to identify the major ethical problems existing in the epidemiological studies in China.Through searching and reviewing papers published on Chinese Journal of Epidemiology and American Journal of Epidemiology from Jan.2006 to Dec.2010,we made a comparison on ethical issues involved in the original studies that focusing on human beings.In total,749 Chinese articles and 1221 American articles were recruited,with the following findings: (1)The proportion with announcements of “Informed consent by the subjects” was 29.24% in Chinese literature and 38.08% in the Americans (x2=16.02,P<0.001 ).The proportion with “having had approvals from the ethic committees” was 29.24% in Chinese,while 38.08% in American ( x2=604.40,P< 0.0001 ).(2) Both in China and America,there had been an increase of ethical issues in the last 5 years.(3)Articles derived from trial studies had better involvement on ethics than those from observational studies.(4) The level on ethical issues in the American Research Institutes exceeded those in China (5)American studies also had showed better ideas on Ethic issues on biological specimens collection and privacy protection,than those in Chinese studies.Among the studies on Chinese Journal of Epidemiology,the proportion of ‘informed consent' was higher than in ethical review,but both ethical review and awareness on ‘informed consent' had left far behind than the American Journal of Epidemiology.This could be seen at the institution level of the writers,during specimen collection and privacy protection,as well as at the overall level.The results reminded us that the Departments of Technology Management should spend more efforts on the improvement of public education regarding ethics for researchers and to update the process of edition for Journals as well as to reinforce the rules of ethics in epidemiological research.
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Objective To investigate the number and distribution of un-repaired cleft lip/palate patients in Gansu province. Methods A census was conducted by staff members of the health system and Population and Family Planning Committee (PFPC) in Gansu province. Standardized -Questionnaires were administered to collect demographic, domestic and diagnosis-related information. Results In 2008, the total number of un-repaired cleft lip/palate patients was 4675,with a detection rate of 1.84/10 000 in Gansu province. Rates of detection were higher in males (2.11/10 000), young age group(4.86/10 000), rural areas(2.23/10 000),poor counties(2.19/10 000)than in females(1.43/10 000), medium (0,97/10 000)/old age group(0.68/10 000), township areas (0.62/10 000), or richer counties (1.35/10 000). Among all the cities and prefectures of Gansu,Baiyin city (2.7/10 000) had the highest while Jinchang city (0.7/10 000) had the lowest prevalence rates. Conclusion Un-repaired cleft lip/palate had been a disease burden to Gansu province,especially in the rural area and poorer counties.