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临床试验/NCT04224454
NCT04224454已完成不适用

Influenza, Pneumococcal and Diphtheria-tetanus-poliomyelitis Vaccine Coverage in Patients With Primary Sjögren's Syndrome: a Cross-sectional Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Rate of patients with Sjögren's syndrome vaccinated against DTP

研究概览

简要总结

Evaluation of vaccination coverage for influenza, pneumococcus and DTP in patients with pSS and investigated the reasons for non-vaccination.

详细描述

A cross-sectional study was performed in pSS patients from two different French tertiary referral centers for autoimmune diseases (Paris-Bicêtre and Montpellier). From January 2016 to November 2017, questionnaires were randomly delivered to patients with pSS according to European-American Diagnostic Criteria (2002). Before completing the questionnaire, patients gave their consent to participate. This questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow (HL) to limit missing data.

Data collected in the questionnaire included previous vaccinations, reasons for non-vaccination, sources of vaccine proposition, and sociodemographic data including education level (Bachelor degree, and post-Bachelor degree education) and presence of young child(ren) (inferior 10 years old) at home. The following data was collected from the medical file: European-American Diagnostic Criteria (2002) for pSS, the most recent EULAR Sjögren's syndrome disease activity index (ESSDAI), comorbidities (chronic lung diseases, diabetes, chronic kidney diseases, chronic liver diseases, chronic heart diseases, cardiovascular comorbidities [coronary or cerebral ischemia] and severe neurological or muscle diseases), history of severe A cross-sectional study was performed in pSS patients from two different French tertiary referral centers for autoimmune diseases (Paris-Bicêtre and Montpellier). From January 2016 to November 2017, questionnaires were randomly delivered to patients with pSS according to European-American Diagnostic Criteria (2002). Before completing the questionnaire, patients gave their consent to participate. This questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow (HL) to limit missing data. Data collected in the questionnaire included previous vaccinations, reasons for non-vaccination, sources of vaccine proposition, and sociodemographic data including education level (Bachelor degree, and post-Bachelor degree education) and presence of young child(ren) (inferior 10 years old) at home. The following data was collected from the medical file: European-American Diagnostic Criteria (2002) for pSS, the most recent EULAR Sjögren's syndrome disease activity index (ESSDAI), comorbidities (chronic lung diseases, diabetes, chronic kidney diseases, chronic liver diseases, chronic heart diseases, cardiovascular comorbidities [coronary or cerebral ischemia] and severe neurological or muscle diseases), history of severe infection (requiring intravenous antibiotics or hospital admission), current smoking status, treatments used for pSS including hydroxychloroquine, immunosuppressive drugs (methotrexate, leflunomide, ciclosporine, azathioprine, mycophenolate mofetil) and biological disease-modifying anti-rheumatic drugs (bDMARDs).

For descriptive statistical analysis, mean more or less SD were used for continuous variables and frequencies (percentage) for categorical variables. To evaluate factors associated with up-to-date vaccination, the investigators compared categorical variables between patients with updated and non-updated influenza, pneumococcal or DTP vaccines by using the Fisher exact test or chi-square test as appropriate. Continuous variables (age, ESSDAI) were compared by Student t test. A binary logistic regression model was used for multivariate analysis to estimate the odds ratio (OR) of being vaccinated with the 95% confidence interval (CI). p< 0.05 was considered statistically significant. All statistical analyses were performed with IBM SPSS 15 software.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Rate of patients with Sjögren's syndrome vaccinated against DTP

时间窗: 10 years

Rate of patients with Sjögren's syndrome vaccinated against DTP : number of patients vaccinated for DTP within 10 years divided to the number of patients not vaccinated for DTP within 10 years

Rate of patients with Sjögren's syndrome vaccinated against influenzae virus

时间窗: 1 year

Rate of patients with Sjögren's syndrome vaccinated against influenzae virus: number of patients vaccinated against influenzae virus within 1 year divided to the number of patients not vaccinated against influenzae virus within 1 year

Rate of patients with Sjögren's syndrome vaccinated against streptococcus pneumoniae

时间窗: 5 years

Rate of patients with Sjögren's syndrome vaccinated against streptococcus pneumoniae: number of patients vaccinated against streptococcus pneumoniae within 5 years divided to the number of patients not vaccinated against streptococcus pneumoniae within 5 years

次要结局

  • Evaluate the reasons for non-vaccination(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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