An observational study in Pelvic Congestion Syndrome, sponsored by Kazan State Medical University. Completed at 1 site in Russian Federation. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Kazan State Medical University · Observational
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.
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.
Reliability assessment. The reliability assessment will be carried out according to three criteria - internal consistency, discriminant validity and internal consistency.
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).
To assess discriminant validity, the level of quality of life and disease severity of patients with VBT will be compared with similar levels of healthy participants.
Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.
Assessment of validity. 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.
To study the degree of representation of the studied psychological construct in the test results, both types of construct validity will be determined: convergent and discriminant.
Based on this examination of the data, objective information on the validity, reliability and sensitivity of PVVQ and PVCSS will be obtained.
Kazan State Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients attending primary care
Exclusion Criteria:
304 patients with verified CPVD
Other: questionnaire responses
93 participants without signs of CPVD.
Other: questionnaire responses
questionnaire responses - Pelvic Varicose Veins Questionnaire (PVVQ) and Pelvic Venous Clinical Severity Score (PVCSS)
internal consistency assessment
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).
Time frame: At baseline
discriminant validity evaluation internal consistency score
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.
Time frame: At baseline
internal consistency score
Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.
Time frame: At baseline and after 14 days
determination of criterion validity
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.
Time frame: At baseline
Sensitivity assessment.
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.
Time frame: At baseline and after 2 months
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Kazan State Medical University