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Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life.
J Vasc Surg 2003; 37(2):410-9JV

Abstract

OBJECTIVE

The purpose of this study was to develop a practical and scientifically rigorous, patient-reported outcome measure to evaluate quality of life and symptoms across the range of conditions (eg, telangiectasias, varicose veins, edema, skin changes, leg ulcers) in chronic venous disorders of the leg (CVDL).

METHODS

This study was a psychometric study within the VEnous INsufficiency Epidemiological and Economic Study (VEINES), an international, prospective cohort study to evaluate clinical outcomes, quality of life, costs, and use of health services in CVDL. The study was set in the 166 general practices and 116 specialist clinics in Belgium, France, Italy, and Canada (Quebec) that participated in the VEINES study plus in additional specialist clinics in Ottawa and Montreal. Field testing was carried out in three samples of patients in four countries (Belgium, France, Italy, Canada), including participants in the VEINES study (n dagger 1531) and patients recruited in additional samples of 88 English-speaking patients (Canada) and 53 French-speaking patients (Belgium, France). The reliability and validity sample (n = 615) included 527 VEINES patients and 88 patients from the supplementary English-speaking sample. The test-retest sample (n = 135) included 53 French-speaking and 82 English-speaking patients from the supplementary samples. The responsiveness sample included 1516 VEINES patients. The 26-item VEINES-QOL/Sym is a new, patient-reported questionnaire to evaluate symptoms and quality of life and is available in four language versions (English, French, Italian, French Canadian).

RESULTS

Standard psychometric tests confirmed the acceptability (missing data, item endorsement frequencies, floor and ceiling effects), reliability (internal consistency, item-total, inter-item correlations) and validity (content, construct, convergent, discriminant, known groups) of the four language versions of the VEINES-QOL/Sym and the test-retest reliability of the English and French versions and provided preliminary evidence of responsiveness in a pooled language sample.

CONCLUSION

The VEINES-QOL/Sym is a practical and scientifically sound, patient-reported measure of outcomes in CVDL that has been developed with rigorous methods. As the only fully validated measure of quality of life and symptoms that is appropriate for use across the full spectrum of CVDL-related conditions, that is quick and easy to administer, and that is available in four languages, the VEINES-QOL/Sym provides a rigorous tool for improving the evaluation of outcomes in clinical trials, epidemiologic studies, and audit.

Authors+Show Affiliations

Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom. donna.lamping@lshtm.ac.uk

Pub Type(s)

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

Language

eng

PubMed ID

12563215

Citation

Lamping, Donna L., et al. "Evaluation of Outcomes in Chronic Venous Disorders of the Leg: Development of a Scientifically Rigorous, Patient-reported Measure of Symptoms and Quality of Life." Journal of Vascular Surgery, vol. 37, no. 2, 2003, pp. 410-9.
Lamping DL, Schroter S, Kurz X, et al. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg. 2003;37(2):410-9.
Lamping, D. L., Schroter, S., Kurz, X., Kahn, S. R., & Abenhaim, L. (2003). Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. Journal of Vascular Surgery, 37(2), pp. 410-9.
Lamping DL, et al. Evaluation of Outcomes in Chronic Venous Disorders of the Leg: Development of a Scientifically Rigorous, Patient-reported Measure of Symptoms and Quality of Life. J Vasc Surg. 2003;37(2):410-9. PubMed PMID: 12563215.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. AU - Lamping,Donna L, AU - Schroter,Sara, AU - Kurz,Xavier, AU - Kahn,Susan R, AU - Abenhaim,Lucien, PY - 2003/2/4/pubmed PY - 2003/2/26/medline PY - 2003/2/4/entrez SP - 410 EP - 9 JF - Journal of vascular surgery JO - J. Vasc. Surg. VL - 37 IS - 2 N2 - OBJECTIVE: The purpose of this study was to develop a practical and scientifically rigorous, patient-reported outcome measure to evaluate quality of life and symptoms across the range of conditions (eg, telangiectasias, varicose veins, edema, skin changes, leg ulcers) in chronic venous disorders of the leg (CVDL). METHODS: This study was a psychometric study within the VEnous INsufficiency Epidemiological and Economic Study (VEINES), an international, prospective cohort study to evaluate clinical outcomes, quality of life, costs, and use of health services in CVDL. The study was set in the 166 general practices and 116 specialist clinics in Belgium, France, Italy, and Canada (Quebec) that participated in the VEINES study plus in additional specialist clinics in Ottawa and Montreal. Field testing was carried out in three samples of patients in four countries (Belgium, France, Italy, Canada), including participants in the VEINES study (n dagger 1531) and patients recruited in additional samples of 88 English-speaking patients (Canada) and 53 French-speaking patients (Belgium, France). The reliability and validity sample (n = 615) included 527 VEINES patients and 88 patients from the supplementary English-speaking sample. The test-retest sample (n = 135) included 53 French-speaking and 82 English-speaking patients from the supplementary samples. The responsiveness sample included 1516 VEINES patients. The 26-item VEINES-QOL/Sym is a new, patient-reported questionnaire to evaluate symptoms and quality of life and is available in four language versions (English, French, Italian, French Canadian). RESULTS: Standard psychometric tests confirmed the acceptability (missing data, item endorsement frequencies, floor and ceiling effects), reliability (internal consistency, item-total, inter-item correlations) and validity (content, construct, convergent, discriminant, known groups) of the four language versions of the VEINES-QOL/Sym and the test-retest reliability of the English and French versions and provided preliminary evidence of responsiveness in a pooled language sample. CONCLUSION: The VEINES-QOL/Sym is a practical and scientifically sound, patient-reported measure of outcomes in CVDL that has been developed with rigorous methods. As the only fully validated measure of quality of life and symptoms that is appropriate for use across the full spectrum of CVDL-related conditions, that is quick and easy to administer, and that is available in four languages, the VEINES-QOL/Sym provides a rigorous tool for improving the evaluation of outcomes in clinical trials, epidemiologic studies, and audit. SN - 0741-5214 UR - https://www.unboundmedicine.com/medline/citation/12563215/Evaluation_of_outcomes_in_chronic_venous_disorders_of_the_leg:_development_of_a_scientifically_rigorous_patient_reported_measure_of_symptoms_and_quality_of_life_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0741521402752932 DB - PRIME DP - Unbound Medicine ER -