Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889000
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2023-05-24
Brief Title:
Quality of Life Questionnaire and Disease Severity Scale
Sponsor:
Kazan State Medical University
Organization:
Kazan State Medical University
Study Overview
Official Title:
Quality of Life Questionnaire and Disease Severity Scale for Patients With Chronic Pelvic Venous Disorders Design and Validation
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
1 Preliminary testing For preliminary testing patients will fill out questionnaires followed by finding out how clear the questions asked are how accurate and ethical the formulations are in their opinion The convenience of working with the questionnaire from the point of view of the research doctor will also be assessed
2 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 Cronbachs 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 Spearmans 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 Cronbachs alpha
3 Assessment of validity To assess the validity the reliability of the construct will be studied by determining the criterion validity ie 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
4 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
Based on this examination of the data objective information on the validity reliability and sensitivity of PVVQ and PVCSS will be obtained
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
1 Preliminary testing For preliminary testing patients will fill out questionnaires followed by finding out how clear the questions asked are how accurate and ethical the formulations are in their opinion The convenience of working with the questionnaire from the point of view of the research doctor will also be assessed
2 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 Cronbachs 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 Spearmans 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 Cronbachs alpha
3 Assessment of validity To assess the validity the reliability of the construct will be studied by determining the criterion validity ie 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
4 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
Based on this examination of the data objective information on the validity reliability and sensitivity of PVVQ and PVCSS will be obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None