Quality of Life Questionnaire and Disease Severity Scale for Patients With Chronic Pelvic Venous Disorders: Design and Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- internal consistency score
研究概览
简要总结
There are currently no specific validated patient-centric tools for the clinical evaluation of patients with chronic pelvic venous disorders (CPVD). The study involves the development and validation of a questionnaire for the quality of life and a scale of disease severity for a patient with pelvic venous disease.
详细描述
This retrospective study will include patients with pelvic varicose veins seen between 2018 and 2020.
2 groups of patients will be formed. The main group will be women with verified CPVD, the comparison group - 93 participants without signs of CPVD.
All patients will respond to the previously developed Pelvic Varicose Veins Questionnaire (PVVQ) and Pelvic Venous Clinical Severity Score (PVCSS) as submitted questionnaires.
Validation of the PVVQ questionnaire and the PVCSS scale will be carried out in accordance with the methodology for studying the quality of life and clinical scales in accordance with international standards. The main psychometric properties of both instruments in terms of validity, reliability and sensitivity will be assessed.
The validation protocol will include certain steps: 1) pre-testing, 2) assessing the reliability of the questionnaire, 3) assessing the validity, 4) assessing the sensitivity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •presence of PVV;
- •completed Patient Informed Consent Form;
- •age from 18 to 70 years;
- •ability to understand and answer the questions of the proposed questionnaire.
排除标准
- •absence of confirmed PVV;
- •lack of Patient Informed Consent Form;
- •under the age of 18 or over 70 years old;
- •pregnancy at any stage and 12-month postpartum period;
- •presence of a gynecological or other concomitant (urological, neurological, procto-logical, etc.) significant pathology that has similar clinical symptoms with CPVD and re-quires specific treatment;
- •presence of severe concomitant gastrointestinal or hematopoietic system pathology, terminal stages of cardiovascular, respiratory, renal and hepatic failure, stage IV malignant tumor, obliterating diseases of lower limbs arteries;
- •dementia and other mental disorders that limit the ability to understand the essence of the research, fill out Patient Informed Consent Form and answer the questionnaire
结局指标
主要结局
internal consistency score
时间窗: At baseline and after 14 days
Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.
internal consistency assessment
时间窗: At baseline
To assess the degree of internal consistency, the Cronbach's alpha coefficient will be used, which is calculated by the formula: α = N \* r / (1 + r \* (N - 1)), where N is the number of components under study, r is the average correlation coefficient between the components. The study will assess the reliability of the questionnaire and the scale as a whole, as well as the impact on the overall reliability of each individual domain. Domain correlation will be assessed using Spearman's rank correlation method (r).
discriminant validity evaluation internal consistency score
时间窗: At baseline
To assess discriminant validity, the level of quality of life and disease severity of patients with CPVD will be compared with similar levels of healthy participants.
determination of criterion validity
时间窗: At baseline
To assess the validity, the reliability of the construct will be studied by determining the criterion validity, i.e. identifying the correlation coefficient or relationships between the scales of both questionnaires with some external criterion. The scales of the SF-36 questionnaire will be used as external criteria for assessing the quality of life, and elements of visual analogue scales will be used to assess the severity of the disease.
Sensitivity assessment.
时间窗: At baseline and after 2 months
To assess the sensitivity, a comparison of the indicators of the questionnaire questionnaires at the points before treatment and 2 months after the treatment will be carried out.
次要结局
未报告次要终点
研究者
Rustem V. Akhmetzyanov, MD, PhD.
Associate Professor of the Department of Cardiovascular and Endovascular Surgery
Kazan State Medical University