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Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument.
Patient. 2016 08; 9(4):335-48.P

Abstract

OBJECTIVE

To evaluate the psychometric properties of the VVSymQ(®) instrument, a new 5-item patient-reported outcome (PRO) measure for symptoms of varicose veins.

METHOD

The VVSymQ(®) electronic daily diary was administered to outpatients who received routine treatment for varicose veins (N = 40). Compliance with diary administration and item score variability, reliability, construct validity, sensitivity to change, and clinically meaningful change were evaluated.

RESULTS

Patients completed >97 % of scheduled diary assessments (at screening, baseline, and week 8). The VVSymQ(®) instrument captured patients' pre-treatment symptoms (all VVSymQ(®) symptoms were endorsed by ≥75 % of patients at baseline), and the change post-treatment (mean change in score -6.1), with a large Cohen effect size (1.6). Test-retest reliability was high (intraclass correlation coefficient 0.96); internal consistency was good (Cronbach's alpha ≥0.76; baseline, week 8). VVSymQ(®) scores were more strongly associated with PRO scores that reflect symptoms and symptom impact (the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms [VEINES-QOL/Sym] instrument and the Chronic Venous Insufficiency Quality-of-Life Questionnaire [CIVIQ-20]) than with PRO scores that reflect appearance (the Patient Self-Assessment of Appearance of Visible Varicose Veins [PA-V(3)]) or clinician-reported outcome scores (the Clinical-Etiology-Anatomy-Pathophysiology [CEAP] Classification of Venous Disorders and Venous Clinical Severity Score [VCSS]), demonstrating construct validity. Patients reporting that symptoms were "moderately" or "much improved" on the Patient Global Impression of Change (PGIC) anchor (i.e., >97 % of patients) had mean improvements of -6.3 VVSymQ(®) points, while a cumulative distribution curve showed that 50 % of patients improved by ≥-5.8 points; thus, a score change of approximately -6 demonstrated a clinically meaningful change in this study. The clinically meaningful change in the VVSymQ(®) score was greater in patients with a greater baseline VVSymQ(®) symptom burden, and the VVSymQ(®) instrument captured clinically meaningful treatment benefit even in patients with a low baseline symptom burden.

CONCLUSION

The 5-item VVSymQ(®) instrument is a brief, psychometrically sound, useful tool for evaluating patient-reported varicose veins symptoms.

Authors+Show Affiliations

BTG International, Ltd., Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK. david.wright@btgplc.com.ERT, Pittsburgh, PA, USA.ERT, Pittsburgh, PA, USA.University of Birmingham, Heart of England NHS Foundation Trust, Birmingham, UK.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27016239

Citation

Wright, David D I., et al. "Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument." The Patient, vol. 9, no. 4, 2016, pp. 335-48.
Wright DD, Paty J, Turner-Bowker DM, et al. Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument. Patient. 2016;9(4):335-48.
Wright, D. D., Paty, J., Turner-Bowker, D. M., & Bradbury, A. (2016). Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument. The Patient, 9(4), 335-48. https://doi.org/10.1007/s40271-015-0159-3
Wright DD, et al. Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument. Patient. 2016;9(4):335-48. PubMed PMID: 27016239.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument. AU - Wright,David D I, AU - Paty,Jean, AU - Turner-Bowker,Diane M, AU - Bradbury,Andrew, PY - 2016/3/27/entrez PY - 2016/3/27/pubmed PY - 2017/3/10/medline SP - 335 EP - 48 JF - The patient JO - Patient VL - 9 IS - 4 N2 - OBJECTIVE: To evaluate the psychometric properties of the VVSymQ(®) instrument, a new 5-item patient-reported outcome (PRO) measure for symptoms of varicose veins. METHOD: The VVSymQ(®) electronic daily diary was administered to outpatients who received routine treatment for varicose veins (N = 40). Compliance with diary administration and item score variability, reliability, construct validity, sensitivity to change, and clinically meaningful change were evaluated. RESULTS: Patients completed >97 % of scheduled diary assessments (at screening, baseline, and week 8). The VVSymQ(®) instrument captured patients' pre-treatment symptoms (all VVSymQ(®) symptoms were endorsed by ≥75 % of patients at baseline), and the change post-treatment (mean change in score -6.1), with a large Cohen effect size (1.6). Test-retest reliability was high (intraclass correlation coefficient 0.96); internal consistency was good (Cronbach's alpha ≥0.76; baseline, week 8). VVSymQ(®) scores were more strongly associated with PRO scores that reflect symptoms and symptom impact (the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms [VEINES-QOL/Sym] instrument and the Chronic Venous Insufficiency Quality-of-Life Questionnaire [CIVIQ-20]) than with PRO scores that reflect appearance (the Patient Self-Assessment of Appearance of Visible Varicose Veins [PA-V(3)]) or clinician-reported outcome scores (the Clinical-Etiology-Anatomy-Pathophysiology [CEAP] Classification of Venous Disorders and Venous Clinical Severity Score [VCSS]), demonstrating construct validity. Patients reporting that symptoms were "moderately" or "much improved" on the Patient Global Impression of Change (PGIC) anchor (i.e., >97 % of patients) had mean improvements of -6.3 VVSymQ(®) points, while a cumulative distribution curve showed that 50 % of patients improved by ≥-5.8 points; thus, a score change of approximately -6 demonstrated a clinically meaningful change in this study. The clinically meaningful change in the VVSymQ(®) score was greater in patients with a greater baseline VVSymQ(®) symptom burden, and the VVSymQ(®) instrument captured clinically meaningful treatment benefit even in patients with a low baseline symptom burden. CONCLUSION: The 5-item VVSymQ(®) instrument is a brief, psychometrically sound, useful tool for evaluating patient-reported varicose veins symptoms. SN - 1178-1661 UR - https://www.unboundmedicine.com/medline/citation/27016239/Psychometric_Evaluation_of_a_New_Patient_Reported_Outcome__PRO__Symptom_Diary_for_Varicose_Veins:_VVSymQ_®__Instrument_ L2 - https://dx.doi.org/10.1007/s40271-015-0159-3 DB - PRIME DP - Unbound Medicine ER -