Reliability and validity of specific quality of life assessment questionnaires related to chronic venous insufficiency: a systematic review

Almeida, Igor Lucas Geraldo Izalino de; Figueiredo, Pedro Henrique Scheidt; Silva, Whesley Tanor; Mendonça, Vanessa Amaral; Lacerda, Ana Cristina Rodrigues; Lima, Vanessa Pereira; Bastone, Alessandra de Carvalho; Costa, Henrique Silveira

doi:10.1590/1677-5449.202102292

Igor Lucas Geraldo Izalino de Almeida

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0001-8883-9692

Pedro Henrique Scheidt Figueiredo

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0002-6748-3081

Whesley Tanor Silva

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0002-5783-1820

Vanessa Amaral Mendonça

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0002-1696-6091

Ana Cristina Rodrigues Lacerda

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0001-5366-3754

Vanessa Pereira Lima

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0002-0349-3248

Alessandra de Carvalho Bastone

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0002-2414-3730

Henrique Silveira Costa

Universidade Federal dos Vales do Jequitinhonha e Mucuri – UFVJM, Diamantina, MG, Brasil.

https://orcid.org/0000-0002-1426-7246

Conflicts of interest: No conflicts of interest declared concerning the publication of this article.

Correspondence Henrique Silveira Costa Rodovia MGT 367, Km 583, 5000 - Alto da Jacuba CEP 39100-000 - Diamantina (MG), Brasil Tel.: +55 (38) 3532-1200 E-mail: henriquesilveira@yahoo.com.br

Author information ILGIA - Physical therapist; MSc in Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM). PHSF, VPL, ACB and HSC - Adjunct professors, Departamento de Fisioterapia; Professor, Programa de Pós-graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM). WTS - Physical therapist; Master’s candidate in Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM). VAM and ACRL - Associate professors, Departamento de Fisioterapia; Professor, Programa de Pós-graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM). ACRL - Associate professor, Departamento de Fisioterapia; Professor, Programa de Pós-Graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM).

Author contributions Conception and design: ILGIA, HSC, VPL, PHSF Analysis and interpretation: ILGIA, WTS, ACB Data collection: ILGIA, WTS Writing the article: ILGIA, WTS Critical revision of the article: VAM, ACRL Final approval of the article*: ILGIA, PHSF, WTS, VAM, ACRL, VPL, ACB, HSC Statistical analysis: N/A. Overall responsibility: HSC *All authors have read and approved of the final version of the article submitted to J Vasc Bras.

Study	Version	Sample	Reliability		Validity		Score for quality ^‡ ‡ The stars indicate the quality scores evaluated with the Newcastle-Ottawa scale for cross-sectional studies, ranging from zero to 10 stars. The higher the number of stars, the higher the methodological quality of the study. The maximum score for the “Selection” item is five stars, the maximum score for the “Comparability” item is two stars, and the maximum score for the “Outcome” item is three stars.	Overall quality
Study	Version	Sample	Internal consistency	Repeatability	Hypothesis testing	Criterion/construct validity		Overall quality
CIVIQ-20
Launois et al.³⁵35 Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996;5(6):539-54. http://dx.doi.org/10.1007/BF00439228. PMid:8993100. http://dx.doi.org/10.1007/BF00439228...	Original version, in French	n=2,001 patients (CEAP 0 to 4)	(+) for the psychological (α=0.90), physical (α=0.83), and pain dimensions (α=0.83)	Not by ICC	(+) Differences in the global index between patients with and without arteritis (p<0.001)	(?)	Selection (★★★)	Low quality
			(-) for social dimension (α=0.67)				Comparability (-)
							Outcome (★★)
							Total score: 05/10
Launois et al.³⁴34 Launois R, Mansilha A, Jantet G. International psychometric validation of the Chronic Venous Disease quality of life Questionnaire (CIVIQ-20). Eur J Vasc Endovasc Surg. 2010;40(6):783-9. http://dx.doi.org/10.1016/j.ejvs.2010.03.034. PMid:20920862. http://dx.doi.org/10.1016/j.ejvs.2010.03...	Multicenter study (18 countries) in several languages	n=4,048 patients (CEAP 0 to 4)	(+) for the global index (α=0.94)	Not by ICC	(+) Differences in the global index and in all dimensions among CEAP 0 to 4 (p<0.001)	(?)	Selection (★★★★)	High quality
			(+) for all dimensions (α=0.86 for physical, 0.89 for psychological, 0.83 for pain, and 0.76 for the social dimension)				Comparability (★)
							Outcome (★★)
							Total score: 07/10
Biemans et al.³⁶36 Biemans AA, van der Velden SK, Bruijninckx CM, Buth J, Nijsten T. Validation of the chronic venous insufficiency quality of life questionnaire in Dutch patients treated for varicose veins. Eur J Vasc Endovasc Surg. 2011;42(2):246-53. http://dx.doi.org/10.1016/j.ejvs.2011.04.007. PMid:21531589. http://dx.doi.org/10.1016/j.ejvs.2011.04...	Dutch version	n=159 patients (CEAP 1 to 6, 53±13.13 years, 70.4% females)	(+) for the global index (α=0.94)	Not by ICC	(+) Differences in the global score among CEAP 0 and 1 versus 2 and 3 versus 4 to 6 (p<0.001)	(+) The correlation with the physical component of the SF-36 was adequate (r= -0.64)	Selection (★★★★)	High quality
						(-) The correlation with the mental component of the SF-36 was not adequate (r= -0.42)	Comparability (★)
							Outcome (★★)
							Total score: 07/10
Ozdemir et al.³⁷37 Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016;5(1):381. http://dx.doi.org/10.1186/s40064-016-2039-2. PMid:27066388. http://dx.doi.org/10.1186/s40064-016-203...	Turkish population	n=140 patients (CEAP 3 to 6, 52.3±13.40 years, 61.4% females)	(+) for the global index (α=0.93)	(+) for the global index / inter-rater (ICC=0.80)	(?)	(+) The correlation with VEINES-QoL was adequate (r= -0.57; p < 0.001)	Selection (★★★★)	Low quality
							Comparability (-)
							Outcome (★★)
							Total score: 06/10
Sinozic et al.³⁸38 Sinozic T, Bazdaric K, Sverko D, Ruzic A, Katic M. Validation of the Croatian version of CIVIQ quality of life questionnaire in patients with chronic venous disorders. Croat Med J. 2017;58(4):292-9. http://dx.doi.org/10.3325/cmj.2017.58.292. PMid:28857522. http://dx.doi.org/10.3325/cmj.2017.58.29...	Croatian population	n=428 patients (CEAP 1 to 6, median age of 52 years, 78% females)	(+) for the global index (α=0.94)	(?)	(?)	(?)	Selection (★★)	Low quality
							Comparability (-)
							Outcome (★★)
							Total score: 04/10
CIVIQ-14
Launois et al.³³33 Launois R, Le Moine JG, Lozano FS, Mansilha A. Construction and international validation of CIVIQ-14 (a short form of CIVIQ-20), a new questionnaire with a stable factorial structure. Qual Life Res. 2012;21(6):1051-8. http://dx.doi.org/10.1007/s11136-011-0008-3. PMid:21947689. http://dx.doi.org/10.1007/s11136-011-000...	Original version confirmed in Polish, Czech, Spanish, and French populations	n=3,004 patients in a multicenter study	(?)	(+) for all dimensions / inter-rater (ICC from 0.88 to 0.94)	(?)	(?)	Selection (★★★)	High quality
				(+) for all items / inter-rater (weighted kappa from 0.81 to 0.87)			Comparability (★)
							Outcome (★★)
							Total score: 06/10
Radak et al.³⁹39 Radak DJ, Vlajinac HD, Marinkovic JM, Maksimovic MZ, Maksimovic ZV. Quality of life in chronic venous disease patients measured by short Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) in Serbia. J Vasc Surg. 2013;58(4):1006-13. http://dx.doi.org/10.1016/j.jvs.2011.08.003. PMid:22051876. http://dx.doi.org/10.1016/j.jvs.2011.08....	Serbian version	n=2,660 patients (CEAP 0 to 6, 57.4±12.9 years, 72.5% females)	(+) for the global index (α=0.93) and for all dimensions (α from 0.78 to 0.91)	(?)	(+) Differences in the CIVIQ-14 score among CEAP 0 to 6 (p<0.01).	(?)	Selection (★★★)	High quality
							Comparability (★)
							Outcome (★★★)
							Total score: 08/10
Sinozic et al.³⁸38 Sinozic T, Bazdaric K, Sverko D, Ruzic A, Katic M. Validation of the Croatian version of CIVIQ quality of life questionnaire in patients with chronic venous disorders. Croat Med J. 2017;58(4):292-9. http://dx.doi.org/10.3325/cmj.2017.58.292. PMid:28857522. http://dx.doi.org/10.3325/cmj.2017.58.29...	Croatian version	n=428 patients (CEAP 1 to 6, median age of 52 years, 78% females)	(+) for the global index (α=0.92)	(?)	(+) Differences in the CIVIQ-14 score among CEAP 1 and 2 versus 3 and 4 versus 5 and 6 (p<0.001)	(?)	Selection (★★)	High quality
							Comparability (★)
							Outcome (★★)
							Total score: 05/10

Study	Version	Sample	Reliability		Validity		Score for quality ^‡ ‡ The stars indicate the quality scores evaluated with the Newcastle-Ottawa scale for cross-sectional studies, ranging from zero to 10 stars. The higher the number of stars, the higher the methodological quality of the study. The maximum score for the “Selection” item is five stars, the maximum score for the “Comparability” item is two stars, and the maximum score for the “Outcome” item is three stars.	Overall quality
Study	Version	Sample	Internal consistency	Repeatability	Hypothesis testing	Criterion / construct validity		Overall quality
Lamping et al.⁴⁰40 Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. 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. http://dx.doi.org/10.1067/mva.2003.152. PMid:12563215. http://dx.doi.org/10.1067/mva.2003.152...	Original version (English-speaking sample)	n=88 patients (CEAP 1 to 4, 47.5±12.1 years, 92% females)	(+) for VEINES-QoL (α=0.91)	(+) inter-rater (ICC 14 to 30 days: 0.89)	-	(+) The correlation between the score and the physical component of the SF-36 was adequate (r=0.61)	Selection (★★★★)	High quality
	Original version (English-speaking sample)	n=88 patients (CEAP 1 to 4, 47.5±12.1 years, 92% females)	(+) for VEINES-QoL (α=0.91)	(+) inter-rater (ICC 14 to 30 days: 0.89)	-	(-) The correlation between the score and the mental (r=0.19) component of the SF-36 was not adequate.	Comparability (★)
	Original version (French-speaking sample)	n=305 patients (CEAP 0 to 6, 20 to 75 years, 81% females)	(+) for VEINES-QoL (α=0.88 to 0.92)	(+) inter-rater (ICC 14 to 30 days: 0.89)	-	(+) The correlation between the score and the physical (r=0.52 to 0.69) component of the SF-36 was adequate.	Outcome (★★)
	Original version (French-speaking sample)	n=305 patients (CEAP 0 to 6, 20 to 75 years, 81% females)	(+) for VEINES-QoL (α=0.88 to 0.92)	(+) inter-rater (ICC 14 to 30 days: 0.89)	-	(-) The correlation between the score and mental (r=0.34 to 0.49) component of the SF-36 was not adequate (r=0.34 to 0.49).	Total score: 07/10
	Original version (Italian-speaking sample)	n=143 patients (CEAP 0 to 6, 53.1±12.7 years, 78% females)	(+) for VEINES-QoL (α=0.94)	-	-	(+) The correlations between the VEINES-QoL score and the physical (r=0.73) and mental (r=0.55) components of the SF-36 were adequate.
	Original version (Canadian French -speaking sample)	n=79 patients (CEAP 0 to 6, 45.5±11.8 years, 92% females)	(+) for VEINES-QoL (α=0.90)	-	-	(+) The correlation between the VEINES-QoL score and the physical (r=0.71) component of the SF-36 was adequate
	Original version (Canadian French -speaking sample)	n=79 patients (CEAP 0 to 6, 45.5±11.8 years, 92% females)	(+) for VEINES-QoL (α=0.90)	-	-	(-) The correlation between the VEINES-QoL score and the mental (r=0.26) component of the SF-36 was not adequate
Kutlu et al.⁴¹41 Kutlu A, Yilmaz E, Cecen D, Eser E, Ozbakkaloglu A. The Turkish validity and reliability of the venous insufficiency epidemiological and economic study-quality of life/symptoms scales. Angiology. 2011;62(4):329-37. http://dx.doi.org/10.1177/0003319710394159. PMid:21421620. http://dx.doi.org/10.1177/00033197103941...	Turkish adaptation	n=118 hospitalized patients (CEAP 1 to 5, 44.37±1.71 years, 74.6% females)	(+) for VEINES-QoL (α=0.86)		(+) Differences in VEINES- QoL (p<0.001) between CEAP classes	(+) The correlations between the VEINES-QoL and the SF-36 domains physical functioning (r=0.66), role physical (r=0.57), pain (r=0.60), vitality (r=0.50), social functioning (r=0.56), and role emotional (r=0.50) were adequate	Selection (★★★)	High quality
						(-) The correlations between the VEINES-QoL and the SF-36 domains general health (r=0.48), and mental health (r=0.43) were not adequate	Comparability (★)
							Outcome (★★)
							Total score: 06/10
Tuygun et al.⁴²42 Tuygun AK, Ketenci B, Gunay R, et al. Validity and reliability of VEINES-QOL/Sym questionnaire in chronic venous disorders. J Cardiovasc Surg. 2012;53(3):355-61. PMid:22269893.	Turkish adaptation	n=100 patients (CEAP not reported, 41.9±12.5 years, 68% females)	(+) for the global index (α=0.91)	(+) inter-rater (ICC=0.99; n=30)	-	(+) The correlations between the VEINES-QoL score and the physical (r=0.78) and mental (r=0.65) components of the SF-36 were adequate	Selection (★★★)	High quality
							Comparability (★)
							Outcome (★★)
							Total score: 06/10
van der Velden et al.⁴³43 van der Velden SK, Biemans AA, Nijsten T, Sommer A. Translation and validation of the Dutch VEINES-QOL/Sym in varicose vein patients. Phlebology. 2014;29(4):227-35. http://dx.doi.org/10.1177/0268355513476279. PMid:23559592. http://dx.doi.org/10.1177/02683555134762...	Dutch adaptation	n=66 patients (CEAP 1 to 6, 54.9±13.1 years, 73% females)	(+) for VEINES-QoL (α=0.88)	-	(-) No differences in VEINES-QoL between classes C1 versus C2 versus C3 to C6 (p=0.41)	(+) The correlation between the VEINES-QoL score and the physical component of the SF-36 was adequate (r=0.6)	Selection (★)	Low quality
						(-) The correlation between the VEINES-QoL score and the mental component of SF-36 was not adequate (r=0.2)	Comparability (-)
							Outcome (★★)
							Total score: 03/10
Bland et al.⁴⁴44 Bland JM, Dumville JC, Ashby RL, et al. Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial. BMC Cardiovasc Disord. 2015;15(1):85. http://dx.doi.org/10.1186/s12872-015-0080-7. PMid:26260973. http://dx.doi.org/10.1186/s12872-015-008...	Patients with venous leg ulcers	n=450 patients with venous leg ulcers (68.6±14.5 years, 49.3% females)	(+) for VEINES-QoL (α=0.88)	(+) inter-rater (ICC=0.80)	-	(+) The correlations between the VEINES-QoL score and the physical (r=0.58, p<0.001) and mental (r=0.58, p<0.001) components of the SF12 were adequate	Selection (★★★)	High quality
							Comparability (★)
							Outcome (★★)
							Total score: 06/10
Sinabulya et al.⁴⁵45 Sinabulya H, Bergstrom G, Hagberg J, Johansson G, Blomgren L. Cultural adaptation and validation of the Swedish VEINES-QOL/Sym in patients with venous insufficiency. Phlebology. 2018;33(8):540-6. http://dx.doi.org/10.1177/0268355517733406. PMid:28954585. http://dx.doi.org/10.1177/02683555177334...	Swedish adaptation	n=112 patients (CEAP 1 to 6, a majority at CEAP 2, 54.5±15.2 years, 75% females)	(+) for VEINES-QoL (α=0.93)	-	(-) No differences in VEINES-QoL (p=0.22) between CEAP classes	(+) The correlations between the VEINES-QoL and the SF-36 domains bodily pain (r=0.82), general health (r=0.55), physical functioning (r=0.70), role emotion (r=0.57), role physical (r=0.61), social functioning (r=0.54) and vitality (r=0.54) were adequate	Selection (★★★)	High quality
						(-) The correlation between the VEINES-QoL and the SF-36 domain mental health (r=0.45) was not adequate	Comparability (★)
							Outcome (★★)
							Total score: 06/10
Ribeiro-Samora et al.⁴⁶46 Ribeiro-Samora GA, Carvalho MLV, Moura RMF, Pereira DAG. Limitations of VEINES QOL/SYM for discriminating chronic venous insufficiency severity. J Vasc Bras. 2019;19:e20180096. http://dx.doi.org/10.1590/1677-5449.180096. PMid:31839797. http://dx.doi.org/10.1590/1677-5449.1800...	Brazilian adaptation	n=98 patients (CEAP 1 to 6, 60.73±14.11 years, 88.8% females)	-	-	(-) No differences in VEINES-Sym (p=0.70) or VEINES-QoL (p=0.40) between CEAP 1, 2, and 3 versus 4, 5, and 6.	-	Selection (★★★)	High quality
							Comparability (★)
							Outcome (★★)
							Total score: 06/10

Study	Version	Sample	Reliability		Validity		Score for quality ^‡ ‡ The stars indicate the quality scores evaluated with the Newcastle-Ottawa scale for cross-sectional studies, ranging from zero to 10 stars. The higher the number of stars, the higher the methodological quality of the study. The maximum score for the “Selection” item is five stars, the maximum score for the “Comparability” item is two stars, and the maximum score for the “Outcome” item is three stars.	Overall quality
Study	Version	Sample	Internal consistency	Repeatability	Hypothesis testing	Criterion / construct validity		Overall quality
Garrat et al.⁵¹51 Garratt AM, Macdonald LM, Ruta DA, Russell IT, Buckingham JK, Krukowski ZH. Towards measurement of outcome for patients with varicose veins. Qual Health Care. 1993;2(1):5-10. http://dx.doi.org/10.1136/qshc.2.1.5. PMid:10132081. http://dx.doi.org/10.1136/qshc.2.1.5...	Original version, in English	n=281 patients with varicose veins (45±8 years, 76% females)	(+) for the global index (α=0.72)	(?)	(?)	(-) The correlations with the SF-36 domains were not adequate [physical functioning (r= -0.49), role physical (r= -0.35), social functioning (r= -0.44), role emotional (r= -0.41), mental health (r= - 0.31), vitality (r= -0.38), pain (r= -0.44), and general health (r= -0.25)]	Selection (★★★★)	High quality
							Comparability (★)
							Outcome (★★)
							Total score:07/10
Smith et al.⁴⁷47 Smith JJ, Garratt AM, Guest M, Greenhalgh RM, Davies AH. Evaluating and improving health-related quality of life in patients with varicose veins. J Vasc Surg. 1999;30(4):710-9. http://dx.doi.org/10.1016/S0741-5214(99)70110-2. PMid:10514210. http://dx.doi.org/10.1016/S0741-5214(99)...	In English	n=137 patients with varicose veins without ulcerations (median age of 46 years, ranging from 22 to 82, 71% females)	(+) for the global index (α=0.74)	(?)	(?)	(-) The correlations with the SF-36 domains were not adequate [physical functioning (r= -0.39), role physical (r= -0.41), social functioning (r= -0.39), and pain (r= -0.39)]	Selection (★★★★)	Low quality
							Comparability (-)
							Outcome (★★)
							Total score:06/10
Klem et al.⁴⁸48 Klem TM, Sybrandy JE, Wittens CH. Measurement of health-related quality of life with the Dutch translated Aberdeen Varicose Vein Questionnaire before and after treatment. Eur J Vasc Endovasc Surg. 2009;37(4):470-6. http://dx.doi.org/10.1016/j.ejvs.2008.11.036. PMid:19117775. http://dx.doi.org/10.1016/j.ejvs.2008.11...	Dutch population	n=143 patients (CEAP 1 to 6, 54±13 years, 69% females)	(+) for the global index (α=0.76)	-	(+) The score was significantly different (p<0.01) among CEAP classes (CEAP 1 and 2 versus 3 and 4 versus 5 and 6)	(?)	Selection (★★★★)	High quality
							Comparability (★)
							Outcome (★★)
							Total score:07/10
Leal et al.⁵⁰50 Leal FJ, Couto RC, Pitta GBB. Validação no Brasil de Questionário de Qualidade de Vida na Doença Venosa Crônica (Questionário Aberdeen para Veias Varicosas no Brasil/AVVQ-Brasil). J Vasc Bras. 2015;14(3):241-7. http://dx.doi.org/10.1590/1677-5449.0025. http://dx.doi.org/10.1590/1677-5449.0025...	Brazilian population	n=107 patients (CEAP 1 to 6, 50.1±12,7 years, 87.9% females)	(+) for dysfunction (α=0.77), and esthetic appearance (α=0.73)	(+) inter-rater (ICC=0.95)	(+) The score was significantly different (p=0.012) between CEAP 1, 2, and 3 versus 4, 5, and 6).	(+) The correlations with the SF-36 domains physical functioning (r= -0.51), role physical (r= -0.52), and pain (r= -0.55) were adequate	Selection (★★★★)	High quality
			(-) for the global index (α=0.54), for varicose extension (α=0.64), and for complications (α=0.29)	(+) intra-rater (ICC=0.85)		(-) The correlations with the SF-36 domains social functioning (r= -0.48), role emotional (r= -0.41), mental health (r= - 0.31), vitality (r= -0.28), and general health (r= - 0.32) were not adequate	Comparability (★)
							Outcome (★★)
							Total score:07/10
Klem et al.⁴⁹49 Klem TM, Sybrandy JE, Wittens CH, Bot MLE. Reliability and validity of the Dutch translated Aberdeen Varicose Vein Questionnaire. Eur J Vasc Endovasc Surg. 2009;37(2):232-8. http://dx.doi.org/10.1016/j.ejvs.2008.08.025. PMid:18993090. http://dx.doi.org/10.1016/j.ejvs.2008.08...	Dutch population	n=143 patients (CEAP 1 to 6, 54±13 years, 69% females)	(?)	Not by ICC	(+) The score was significantly different (p<0.01) among CEAP classes (CEAP 1 and 2 versus 3 and 4 versus 5 and 6)	(+) The correlation with the SF-36 physical functioning domain (r= -0.54) was adequate	Selection (★★★★)	High quality
						(-) The correlations with the SF-36 domains role physical (r= -0.45), social functioning (r= -0.41), and pain (r= -0.44) were not adequate.	Comparability (★)
							Outcome (★★)
							Total score:07/10

Study	Version	Sample	Reliability		Validity		Score for quality ^‡ ‡ The stars indicate the quality scores evaluated with the Newcastle-Ottawa scale for cross-sectional studies, ranging from zero to 10 stars. The higher the number of stars, the higher the methodological quality of the study. The maximum score for the “Selection” item is five stars, the maximum score for the “Comparability” item is two stars, and the maximum score for the “Outcome” item is three stars.	Overall quality
Study	Version	Sample	Internal consistency	Repeatability	Hypothesis testing	Criterion / construct validity		Overall quality
CCVUQ
Smith et al.⁵⁵55 Smith JJ, Guest MG, Greenhalgh RM, Davies AH. Measuring the quality of life in patients with venous ulcers. J Vasc Surg. 2000;31(4):642-9. http://dx.doi.org/10.1067/mva.2000.104103. PMid:10753271. http://dx.doi.org/10.1067/mva.2000.10410...	Original version, in English	n=98 patients with venous leg ulcers (median age was 76 years, 60% females)	(+) for the global index (α=0.93)	(+) intra-rater (ICC=0.84, sample subset)		(+) The correlations with the SF-36 domains were adequate [physical functioning (r= -0.60), role physical (r = -0.55), pain (r = -0.57), general health (r =-0.56), vitality (r = -0.55), social functioning (r = –0.71), role emotional (r = -0.52), and mental health (r = -0.57)]	Selection (★★)	Low quality
							Comparability (-)
							Outcome (★★)
							Total score:04/10
Wong et al.⁵⁶56 Wong IK, Lee DT, Thompson DR. Translation and validation of the Chinese version of the Charing Cross Venous Ulcer Questionnaire. J Clin Nurs. 2006;15(3):356-7. http://dx.doi.org/10.1111/j.1365-2702.2006.01307.x. PMid:16466486. http://dx.doi.org/10.1111/j.1365-2702.20...	Chinese adaptation	n=100 patients with venous leg ulcers (70±10.7 years, 30% females)	(+) for the global index (α=0.95) and for all domains (α>0.90)	(+) ICC (6 weeks)=0.94	(?)	(?)	Selection (★★★)	High quality
							Comparability (-)
							Outcome (★★)
							Total score:05/10
Couto et al.⁵⁷57 Couto RC, Leal FJ, Pitta GBB. Validação do questionário de qualidade de vida na úlcera venosa crônica em língua portuguesa. J Vasc Bras. 2016;15(1):4-10. http://dx.doi.org/10.1590/1677-5449.003015. http://dx.doi.org/10.1590/1677-5449.0030...	Brazilian adaptation	n=50 patients with venous leg ulcers (CEAP C5 to C6, 63.2±11.74 years, 80% females)	(+) for the global index (α=0.92)	(+) inter-rater / ICC (30 minutes) = 0.95	(?)	(+) The correlation with the SF-36 domains physical functioning (r= -0.58), pain (r = -0.60), general health (r =-0.66), vitality (r = -0.72), and social functioning (r = –0.54) were adequate	Selection (★★)	Low quality
				(+) intra-rater / ICC (7 to 15 days) = 0.95		(-) The correlations with the domains role physical (r = -0.41), role emotional (r = -0.42), and mental health (r = -0.48) of the SF-36 were not adequate	Comparability (-)
							Outcome (★★)
							Total score:04/10
Tafernaberry et al.⁵⁸58 Tafernaberry G, Otero G, Agorio C, Dapueto JJ. Adaptación y evaluación inicial del Charing Cross Venous Ulcer Questionnaire en pacientes con úlceras venosas crónicas en Uruguay. Rev Med Chil. 2016;144(1):55-65. http://dx.doi.org/10.4067/S0034-98872016000100008. PMid:26998983. http://dx.doi.org/10.4067/S0034-98872016...	Uruguayan adaptation	n=50 patients with venous leg ulcers (63.4 years, ranging from 34 to 84, 52% females)	(+) for the global index (α=0.83)	(?)	(?)	(?)	Selection (★★★★)	High quality
							Comparability (★)
							Outcome (★★)
							Total score:07/10
Amaral et al.⁵⁹59 Amaral KVA, Melo PG, Alves GR, et al. Charing Cross Venous Ulcer Questionnaire - Brasil: estudo bicêntrico de confiabilidade. Acta Paul Enferm. 2019;32(2):147-52. http://dx.doi.org/10.1590/1982-0194201900021. http://dx.doi.org/10.1590/1982-019420190...	Brazilian adaptation	n=112 patients with venous leg ulcer (61.39±11.86 years, 50% females)	(+) for the global index (α=0.92)	(+) ICC (30 min) = 0.96	(?)	(?)	Selection (★★★★)	Low quality
							Comparability (-)
							Outcome (★★)
							Total score:06/10
VLU-QoL
Hareendran et al.⁵³53 Hareendran A, Doll H, Wild DJ, et al. The venous leg ulcer quality of life (VLU-QoL) questionnaire: development and psychometric validation. Wound Repair Regen. 2007;15(4):465-73. http://dx.doi.org/10.1111/j.1524-475X.2007.00253.x. PMid:17650089. http://dx.doi.org/10.1111/j.1524-475X.20...	Original version, in English	n=70 patients with venous leg ulcers (74±12 years old, 69% females)	(+) for all domains (α>0.8)	(+) ICC for all domains (48 to 73h): ranging from 0.83 to 0.86	(+) Patients who reported exudate, edema, and ulcer smell had lower scores on the VLU-QoL	(+) The correlation between the activities domain of VLU-QoL and the physical component of the SF-36 was adequate (r= -0.58; p<0.001)	Selection (★★)	High quality
					(-) There was no significant association between VLU-QoL and hyperpigmentation	(-) The correlation between the activities domain of VLU-QoL and the mental component of the SF-36 was not adequate (r= -0.29; p<0.001)	Comparability (★)
						(-) The correlations between the psychological domain of VLU-QoL and physical (r= -0.39) and mental (r= -0.46) component of SF-36 were not adequate (p<0.001 for both)	Outcome (★★)
						(-) The correlations between the symptoms distress domain of VLU-QoL and physical (r= -0.41) and mental (r= -0.40) components of SF-36 were not adequate (p<0.001 for both)	Total score:05/10
Araújo et al.⁵⁴54 Araújo RB, Fortes MR, Abbade LP, Miot HA. Translation, cultural adaptation to Brazil and validation of the venous leg ulcer quality of life questionnaire (VLU-QoL-Br). Rev Assoc Med Bras. 2014;60(3):249-54. http://dx.doi.org/10.1590/1806-9282.60.03.014. PMid:25004271. http://dx.doi.org/10.1590/1806-9282.60.0...	Brazilian adaptation	n=82 patients with healed and active venous leg ulcer (CEAP 5 to 6, 67.3±13.9 years, 68% females)	(+) for the global index (α=0.94), and for all domains (α>0.91)	(+) ICC=0.90 in 30 days	(?)	(?)	Selection (★★)	Low quality
				(+) ICC=0.78 in 60 days			Comparability (-)
							Outcome (★★)
							Total score:04/10

HRQoL questionnaire	Reliability	Validity
CIVIQ-20	Internal consistency: α = from 0.93 to 0.94	Hypothesis testing: There were differences in the CIVIQ-20 global index between patients with and without arteritis (p<0.001), and in all dimensions among CEAP 0 to 4 (p<0.001).
CIVIQ-20	Inter-rater reproducibility: ICC = 0.80	Construct validity: The coefficient for the correlation between the CIVIQ-20 score and: (1) the physical component of the SF-36 was r= -0.64; (2) the mental component of SF-36 was r= -0.42, and (3) the VEINES-QoL score was r= -0.57.
CIVIQ-14	Internal consistency: α = from 0.92 to 0.93	Hypothesis testing: There were differences in the CIVIQ-14 score among CEAP 0 to 6 (p<0.01).
CIVIQ-14	Inter-rater reproducibility: ICC = from 0.88 to 0.94
VEINES-QoL	Internal consistency: α = from 0.86 to 0.94	Hypothesis testing: There were no differences in VEINES-QoL scores among CEAP classes in three studies. There were differences in VEINES-QoL scores among CEAP classes in one study.
	Inter-rater reproducibility: ICC = from 0.80 to 0.99	Construct validity:
		- The coefficients for the correlation between the VEINES-QoL score and the physical component of the SF-36 ranged from 0.52 to 0.78. The coefficient for the correlation between the VEINES-QoL score and the mental component of the SF-36 ranged from 0.19 to 0.65.
		- The coefficients for the correlation between the VEINES-QoL score and physical and mental component of the SF-12 were both 0.58.
		- The coefficients for the correlations between the VEINES-QoL and the SF-36 domains were: (1) physical functioning: from 0.66 to 0.70; (2) role physical: from 0.57 to 0.61; (3) pain: from 0.60 to 0.82; (4) general health status: from 0.48 to 0.55; (5) vitality: from 0.50 to 0.54; (6) social functioning: from 0.54 to 0.56; (7) role emotional: from 0.50 to 0.57; and (8) mental health: from 0.43 to 0.45.
AVVQ	Internal consistency: α = 0.54 to 0.76	Hypotheses testing: The score was significantly different (p<0.012) among CEAP classes.
	Inter-rater reproducibility: ICC = 0.95	Construct validity: The coefficients for the correlations between the AVVQ and the SF-36 domains were: (1) physical functioning: from -0.39 to -0.54 (2) role physical: from -0.35 to -0.52; (3) pain: from -0.39 to -0.55; (4) general health status: from -0.25 to -0.32; (5) vitality: from -0.28 to -0.38; (6) social functioning: from -0.39 to -0.48; (7) role emotional: -0.41; and (8) mental health: -0.31.
	Intra-rater reproducibility: ICC = 0.85
VARIShort	Internal consistency: α=0.93	Construct validity: The correlation coefficient between the VARIShort score and the VEINES-QoL score was -0.819.
VARIShort	Intra-rater reproducibility: ICC = 0.93
CCVUQ	Internal consistency: α = 0.83 to 0.95	Construct validity: The coefficients for the correlations between the CCVUQ and the SF-36 domains were: (1) physical functioning: from -0.58 to -0.60; (2) role physical: from -0.41 to -0.55; (3) pain: from -0.57 to -0.60; (4) general health status: from -0.56 to -0.66; (5) vitality: from -0.55 to -0.72; (6) social functioning: from -0.54 to -0.71; (7) emotional role: from -0.42 to -0.52; and (8) mental health: from -0.48 to -0.57.
VLU-QoL	Internal consistency: α > 0.8	Hypothesis testing: Patients who reported exudate, edema and ulcer smell had lower VLU-QoL scores but there was no significant association between VLU-QoL and hyperpigmentation.
	Intra-rater reproducibility: ICC from 0.78 to 0.90	Construct validity:
		- The coefficients for the correlations between the activities domain of the VLU-QoL and the physical and mental components of the SF-36 were -0.58 and -0.29, respectively.
		- The coefficients for the correlations between the psychological domain of the VLU-QoL and the physical and mental components of the SF-36 were -0.39 and -0.46, respectively.
		- The coefficients for the correlations between the symptoms distress domain of the VLU-QoL and physical and mental components of the SF-36 were -0.41 and -0.40, respectively.

[1] Conflicts of interest: No conflicts of interest declared concerning the publication of this article.

Brasil

Brasil

Reliability and validity of specific quality of life assessment questionnaires related to chronic venous insufficiency: a systematic review

Confiabilidade e validade dos questionários específicos de avaliação da qualidade de vida relacionada à insuficiência venosa crônica: uma revisão sistemática

Abstract