Development and validation of a disease-specific quality of life questionnaire for patients with peripheral artery disease (QOLPAD)

Ebru-Berrin Arman, Matthias Augustin, Nicole Mohr, Sebastian E Debus, Peter Breuer, Christine Blome, Ebru-Berrin Arman, Matthias Augustin, Nicole Mohr, Sebastian E Debus, Peter Breuer, Christine Blome

Abstract

Background: The aim of this study was to develop and validate a short and feasible questionnaire to measure health-related quality of life (HRQoL) in patients with peripheral artery disease (PAD). The content of the new instrument is intended to correspond with the simultaneously developed instrument Patient Benefit Index for PAD (PBI-PAD), which evaluates treatment goals and benefits in this patient group.

Methods: Fifty patients stated their disease burden on free-text questionnaires, which was used by an interdisciplinary expert panel to develop 12 items for the new instrument, named Quality of Life questionnaire for patients with peripheral artery disease (QOLPAD). The validity of the instrument was tested in patients from Germany with PAD stages I to IV who completed the QOLPAD, EuroQol questionnaire (EQ-5D-3L; EuroQol visual analogue scale (EQ VAS)), and Vascular Quality of Life questionnaire (VascuQoL) before (baseline) and three months after (follow-up) treatment.

Results: One hundred and three patients were included at baseline (mean age: 68.6 years; 68% male), among whom, 57 provided data at follow-up. Most patients (86.4%) rated the completion of QOLPAD as being easy. Internal consistency was satisfactory, with a Cronbach's alpha of 0.74 (baseline) and 0.84 (follow-up). Convergent validity was indicated by significant correlations with the EQ-5D-3L (baseline: - 0.62; follow-up: - 0.81), EQ VAS (baseline: - 0.44, follow-up: - 0.79), VascuQoL global score (baseline: - 0.77; follow-up: - 0.87), global rating of impairment (baseline: 0.64; follow-up: 0.71), and PAD stage (baseline: 0.40; follow-up: 0.67). Sensitivity to change was confirmed by significant correlations of change in the QOLPAD with changes in convergent criteria; however, the high number of dropouts limits the generalizability of this finding.

Conclusion: This study provided evidence that the QOLPAD is internally consistent and valid in patients receiving treatment for PAD in Germany.

Keywords: Health-related quality of life; Patient-reported outcomes; Peripheral artery disease; Questionnaire; Validation.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
British English version of the QOLPAD
Fig. 2
Fig. 2
Flow diagram of study population (phase 2, validation study). n: number of patients; baseline: first measurement; follow-up: second measurement, approximately 3 months after the start of treatment

References

    1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382:1329–1340. doi: 10.1016/S0140-6736(13)61249-0.
    1. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015;116(9):1509–1526. doi: 10.1161/CIRCRESAHA.116.303849.
    1. Fontaine R, Kim M, Kieny R. Surgical treatment of peripheral circulation disorders. Helv Chir Acta. 1954;21:499–533.
    1. McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, et al. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001;286:1599–1606. doi: 10.1001/jama.286.13.1599.
    1. Koller M, Neugebauer EA, Augustin M, Büssing A, Farin E, Klinkhammer-Schalke M, et al. Assessment of quality of life in health services research—conceptual, methodological and structural prerequisites. Gesundheitswesen. 2009;71:864–872. doi: 10.1055/s-0029-1239516.
    1. Pell JP. Impact of intermittent claudication on quality of life. Eur J Vasc Endovasc Surg. 1995;9(4):469–472. doi: 10.1016/S1078-5884(05)80018-8.
    1. de Vries M, Ouwendijk R, Kessels AG, de Haan MW, Flobbe K, Hunink MG, et al. Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease. J Vasc Surg. 2005;41(2):261–268. doi: 10.1016/j.jvs.2004.11.022.
    1. Mehta T, Venkata Subramaniam A, Chetter I, McCollum P. Assessing the validity and responsiveness of disease-specific quality of life instruments in intermittent claudication. Eur J Vasc Endovasc Surg. 2006;31(1):46–52. doi: 10.1016/j.ejvs.2005.08.028.
    1. Aber A, Lumley E, Phillips P, Woods HB, Jones G, Michaels J. Themes that determine quality of life in patients with peripheral arterial disease: a systematic review. Patient. 2018;11:489–502. doi: 10.1007/s40271-018-0307-7.
    1. Morgan MB, Crayford T, Murrin B, Fraser SC. Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg. 2001;33(4):679–687. doi: 10.1067/mva.2001.112326.
    1. Nordanstig J, Wann-Hansson C, Karlsson J, Lundström M, Pettersson M, Morgan M. Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease. J Vasc Surg. 2014;59:700–707. doi: 10.1016/j.jvs.2013.08.099.
    1. Poku E, Duncan R, Keetharuth A, Essat M, Phillips P, Woods HB, et al. Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties. Health Qual Life Outcomes. 2016;14(1):161. doi: 10.1186/s12955-016-0563-y.
    1. Conijn AP, Jens S, Terwee CB, Breek JC, Koelemay MJ. Assessing the quality of available patient reported outcome measures for intermittent claudication: a systematic review using the COSMIN checklist. Eur J Vasc Endovasc Surg. 2015;49(3):316–334. doi: 10.1016/j.ejvs.2014.12.002.
    1. Zander N, Demirel EB, Augustin M, Sommer R, Debus ES, Breuer P, et al. Development and validation of the Patient Benefit Index for peripheral arterial disease. Vasa. 2018;47(3):219–226. doi: 10.1024/0301-1526/a000687.
    1. Blome C, Gosau R, Radtke MA, Reich K, Rustenbach SJ, Spehr C, Thaçi D, Augustin M. Patient-relevant treatment goals in psoriasis. Arch Dermatol Res. 2016;308(2):69–78. doi: 10.1007/s00403-015-1613-8.
    1. Blome C, Augustin M. Measuring change in quality of life: bias in prospective and retrospective evaluation. Value Health. 2015;18:110–115. doi: 10.1016/j.jval.2014.10.007.
    1. The EuroQol Group EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Jeger RV, Rickenbacher P, Pfisterer ME, Hoffmann A. Outpatient rehabilitation in patients with coronary artery and peripheral arterial occlusive disease. Arch Phys Med Rehabil. 2008;89:618–621. doi: 10.1016/j.apmr.2007.09.040.
    1. Augustin M, Baade K, Heyer K, Price PE, Herberger K, Wild T, et al. Quality-of-life evaluation in chronic wounds: comparative analysis of three disease-specific questionnaires. Int Wound J. 2017;14:1299–1304. doi: 10.1111/iwj.12803.

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