Skip to main content
Top
Gepubliceerd in: Quality of Life Research 6/2020

04-02-2020

Qualitative study of patients with venous malformations: symptom experiences and content validity of patient-reported outcome measures

Auteurs: Ryan W. England, Christopher R. Bailey, Milena D. Anatchkova, Anne M. Skalicky, Mark H. Meissner, Melvin Rosenblatt, Heather L. Gelhorn, Clifford R. Weiss

Gepubliceerd in: Quality of Life Research | Uitgave 6/2020

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

Purpose

To determine important symptoms and functional effects of venous malformations (VMs) to assess the content validity of commonly used patient-reported outcome (PRO) measures for use with VM patients.

Methods

This cross-sectional, qualitative study involved cognitive interviews with participants with VM aged ≥ 14 years. From February to June 2016, 11 participants (8 female) with a mean (± standard deviation) age of 31 ± 15 years were recruited from three clinical sites. The following subgroups were evaluated: 5 adults (aged ≥ 18) with trunk/extremity VMs; 3 adolescents (aged 14–17) with trunk/extremity VMs; and 3 adults with head/neck VMs. We evaluated the content validity of the Worst Pain Numeric Rating Scale (NRS), Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference 8-item short form, and PROMIS Physical Function 8-item short form.

Results

The most common participant-reported VM symptoms were swelling (n = 10), skin discoloration (n = 8), acute episodic pain (n = 8), chronic pain (n = 7), numbness (n = 7), and tingling/burning (n = 6). Participants reported that VMs affected their physical function (n = 10), appearance (n = 10), relationships/social activities (n = 7), and emotional health (n = 3). The Worst Pain NRS and PROMIS Pain Interference measures were relevant to all participants’ VM experience. Only adults with head/neck VMs found the PROMIS Physical Function measure to be irrelevant. The assessed PRO measures did not address several symptoms commonly reported by VM patients (swelling, skin discoloration, numbness, and appearance).

Conclusion

These results suggest that several VM symptoms are not assessed fully by commonly used PRO measures, and that the relevance of functional limitation questions may vary by VM location.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
go back to reference Wassef, M., Blei, F., Adams, D., Alomari, A., Baselga, E., Berenstein, A., et al. (2015). Vascular anomalies classification: Recommendations from the International Society for the Study of Vascular Anomalies. Pediatrics,136(1), e203–214.CrossRef Wassef, M., Blei, F., Adams, D., Alomari, A., Baselga, E., Berenstein, A., et al. (2015). Vascular anomalies classification: Recommendations from the International Society for the Study of Vascular Anomalies. Pediatrics,136(1), e203–214.CrossRef
2.
go back to reference Behravesh, S., Yakes, W., Gupta, N., Naidu, S., Chong, B. W., Khademhosseini, A., et al. (2016). Venous malformations: Clinical diagnosis and treatment. Cardiovascular Diagnosis and Therapy,6(6), 557–569.CrossRef Behravesh, S., Yakes, W., Gupta, N., Naidu, S., Chong, B. W., Khademhosseini, A., et al. (2016). Venous malformations: Clinical diagnosis and treatment. Cardiovascular Diagnosis and Therapy,6(6), 557–569.CrossRef
3.
go back to reference Nguyen, H. L., Bonadurer, G. F., 3rd, & Tollefson, M. M. (2018). Vascular malformations and health-related quality of life: A systematic review and meta-analysis. JAMA Dermatology,154(6), 661–669.CrossRef Nguyen, H. L., Bonadurer, G. F., 3rd, & Tollefson, M. M. (2018). Vascular malformations and health-related quality of life: A systematic review and meta-analysis. JAMA Dermatology,154(6), 661–669.CrossRef
4.
go back to reference Marler, J. J., & Mulliken, J. B. (2005). Current management of hemangiomas and vascular malformations. Clinics in Plastic Surgery,32(1), 99–116.CrossRef Marler, J. J., & Mulliken, J. B. (2005). Current management of hemangiomas and vascular malformations. Clinics in Plastic Surgery,32(1), 99–116.CrossRef
5.
go back to reference van der Vleuten, C. J., Kater, A., Wijnen, M. H., Schultze Kool, L. J., & Rovers, M. M. (2014). Effectiveness of sclerotherapy, surgery, and laser therapy in patients with venous malformations: A systematic review. Cardiovascular and Interventional Radiology,37(4), 977–989.PubMed van der Vleuten, C. J., Kater, A., Wijnen, M. H., Schultze Kool, L. J., & Rovers, M. M. (2014). Effectiveness of sclerotherapy, surgery, and laser therapy in patients with venous malformations: A systematic review. Cardiovascular and Interventional Radiology,37(4), 977–989.PubMed
6.
go back to reference Hage, A. N., Chick, J. F. B., Srinivasa, R. N., Bundy, J. J., Chauhan, N. R., Acord, M., et al. (2018). Treatment of venous malformations: The data, where we are, and how it is done. Techniques in Vascular and Interventional Radiology,21(2), 45–54.CrossRef Hage, A. N., Chick, J. F. B., Srinivasa, R. N., Bundy, J. J., Chauhan, N. R., Acord, M., et al. (2018). Treatment of venous malformations: The data, where we are, and how it is done. Techniques in Vascular and Interventional Radiology,21(2), 45–54.CrossRef
8.
go back to reference Asdahl, K. R., Hedelund, L., Keller, J., Baad-Hansen, T., & Damsgaard, T. (2018). Outcome measures after sclerotherapy of venous malformations: A systematic review. Cardiovascular and Interventional Radiology,41(8), 1141–1151.CrossRef Asdahl, K. R., Hedelund, L., Keller, J., Baad-Hansen, T., & Damsgaard, T. (2018). Outcome measures after sclerotherapy of venous malformations: A systematic review. Cardiovascular and Interventional Radiology,41(8), 1141–1151.CrossRef
9.
go back to reference Horbach, S. E. R., van de Ven, J. S., Nieuwkerk, P. T., Spuls, P. I., van der Horst, C., & Reekers, J. A. (2018). Patient-reported outcomes of bleomycin sclerotherapy for low-flow vascular malformations and predictors of improvement. Cardiovascular and Interventional Radiology,41(10), 1494–1504.CrossRef Horbach, S. E. R., van de Ven, J. S., Nieuwkerk, P. T., Spuls, P. I., van der Horst, C., & Reekers, J. A. (2018). Patient-reported outcomes of bleomycin sclerotherapy for low-flow vascular malformations and predictors of improvement. Cardiovascular and Interventional Radiology,41(10), 1494–1504.CrossRef
10.
go back to reference Horbach, S. E., Lokhorst, M. M., Saeed, P., de Gouyon Matignon de Pontouraude, C. M., Rothova, A., & van der Horst, C. M. (2016). Sclerotherapy for low-flow vascular malformations of the head and neck: A systematic review of sclerosing agents. Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS,69(3), 295–304.CrossRef Horbach, S. E., Lokhorst, M. M., Saeed, P., de Gouyon Matignon de Pontouraude, C. M., Rothova, A., & van der Horst, C. M. (2016). Sclerotherapy for low-flow vascular malformations of the head and neck: A systematic review of sclerosing agents. Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS,69(3), 295–304.CrossRef
11.
go back to reference Horbach, S. E., Rigter, I. M., Smitt, J. H., Reekers, J. A., Spuls, P. I., & van der Horst, C. M. (2016). Intralesional bleomycin injections for vascular malformations: A systematic review and meta-analysis. Plastic and Reconstructive Surgery,137(1), 244–256.CrossRef Horbach, S. E., Rigter, I. M., Smitt, J. H., Reekers, J. A., Spuls, P. I., & van der Horst, C. M. (2016). Intralesional bleomycin injections for vascular malformations: A systematic review and meta-analysis. Plastic and Reconstructive Surgery,137(1), 244–256.CrossRef
12.
go back to reference Benjamin, K., Vernon, M. K., Patrick, D. L., Perfetto, E., Nestler-Parr, S., & Burke, L. (2017). Patient-reported outcome and observer-reported outcome assessment in rare disease clinical trials: An ISPOR COA Emerging Good Practices Task Force Report. Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research,20(7), 838–855.CrossRef Benjamin, K., Vernon, M. K., Patrick, D. L., Perfetto, E., Nestler-Parr, S., & Burke, L. (2017). Patient-reported outcome and observer-reported outcome assessment in rare disease clinical trials: An ISPOR COA Emerging Good Practices Task Force Report. Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research,20(7), 838–855.CrossRef
13.
go back to reference Jensen, M. P., Karoly, P., O'Riordan, E. F., Bland, F., Jr., & Burns, R. S. (1989). The subjective experience of acute pain. An assessment of the utility of 10 indices. The Clinical Journal of Pain,5(2), 153–159.CrossRef Jensen, M. P., Karoly, P., O'Riordan, E. F., Bland, F., Jr., & Burns, R. S. (1989). The subjective experience of acute pain. An assessment of the utility of 10 indices. The Clinical Journal of Pain,5(2), 153–159.CrossRef
14.
go back to reference Cella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., et al. (2010). The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Journal of Clinical Epidemiology,63(11), 1179–1194.CrossRef Cella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., et al. (2010). The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Journal of Clinical Epidemiology,63(11), 1179–1194.CrossRef
15.
go back to reference Bowman, J., Johnson, J., McKusick, M., Gloviczki, P., & Driscoll, D. (2013). Outcomes of sclerotherapy and embolization for arteriovenous and venous malformations. Seminars in Vascular Surgery,26(1), 48–54.CrossRef Bowman, J., Johnson, J., McKusick, M., Gloviczki, P., & Driscoll, D. (2013). Outcomes of sclerotherapy and embolization for arteriovenous and venous malformations. Seminars in Vascular Surgery,26(1), 48–54.CrossRef
16.
go back to reference Breugem, C. C., Merkus, M. P., Smitt, J. H., Legemate, D. A., & van der Horst, C. M. (2004). Quality of life in patients with vascular malformations of the lower extremity. British Journal of Plastic Surgery,57(8), 754–763.CrossRef Breugem, C. C., Merkus, M. P., Smitt, J. H., Legemate, D. A., & van der Horst, C. M. (2004). Quality of life in patients with vascular malformations of the lower extremity. British Journal of Plastic Surgery,57(8), 754–763.CrossRef
17.
go back to reference Delgado, J., Bedoya, M. A., Gaballah, M., Low, D. W., & Cahill, A. M. (2014). Percutaneous sclerotherapy of foot venous malformations: Evaluation of clinical response. Clinical Radiology,69(9), 931–938.CrossRef Delgado, J., Bedoya, M. A., Gaballah, M., Low, D. W., & Cahill, A. M. (2014). Percutaneous sclerotherapy of foot venous malformations: Evaluation of clinical response. Clinical Radiology,69(9), 931–938.CrossRef
18.
go back to reference Fahrni, J. O., Cho, E. Y., Engelberger, R. P., Baumgartner, I., & von Kanel, R. (2014). Quality of life in patients with congenital vascular malformations. Journal of Vascular Surgery. Venous and Lymphatic Disorders,2(1), 46–51.CrossRef Fahrni, J. O., Cho, E. Y., Engelberger, R. P., Baumgartner, I., & von Kanel, R. (2014). Quality of life in patients with congenital vascular malformations. Journal of Vascular Surgery. Venous and Lymphatic Disorders,2(1), 46–51.CrossRef
19.
go back to reference Kubiena, H. F., Hack, T., Roka, J., Frey, E., Plank, C., Lammer, J., et al. (2012). Vascular malformations in infancy and young adulthood: Signs and symptoms signaling progression. European Surgery,44(1), 54–59.CrossRef Kubiena, H. F., Hack, T., Roka, J., Frey, E., Plank, C., Lammer, J., et al. (2012). Vascular malformations in infancy and young adulthood: Signs and symptoms signaling progression. European Surgery,44(1), 54–59.CrossRef
20.
go back to reference Lu, X., Ye, K., Shi, H., Li, W., Huang, Y., Huang, X., et al. (2011). Percutaneous endovenous treatment of congenital extratruncular venous malformations with an ultrasound-guided and 810-nm diode laser. Journal of Vascular Surgery,54(1), 139–145.CrossRef Lu, X., Ye, K., Shi, H., Li, W., Huang, Y., Huang, X., et al. (2011). Percutaneous endovenous treatment of congenital extratruncular venous malformations with an ultrasound-guided and 810-nm diode laser. Journal of Vascular Surgery,54(1), 139–145.CrossRef
21.
go back to reference Markovic, J. N., Kim, C. Y., Lidsky, M. E., & Shortell, C. K. (2012). A 6-year experience treating vascular malformations with foam sclerotherapy. Perspectives in Vascular Surgery and Endovascular Therapy,24(2), 70–79.CrossRef Markovic, J. N., Kim, C. Y., Lidsky, M. E., & Shortell, C. K. (2012). A 6-year experience treating vascular malformations with foam sclerotherapy. Perspectives in Vascular Surgery and Endovascular Therapy,24(2), 70–79.CrossRef
22.
go back to reference Mimura, H., Fujiwara, H., Hiraki, T., Gobara, H., Mukai, T., Hyodo, T., et al. (2009). Polidocanol sclerotherapy for painful venous malformations: Evaluation of safety and efficacy in pain relief. European Radiology,19(10), 2474–2480.CrossRef Mimura, H., Fujiwara, H., Hiraki, T., Gobara, H., Mukai, T., Hyodo, T., et al. (2009). Polidocanol sclerotherapy for painful venous malformations: Evaluation of safety and efficacy in pain relief. European Radiology,19(10), 2474–2480.CrossRef
23.
go back to reference Nakamura, M., Osuga, K., Maeda, N., Higashihara, H., Hamada, K., Hashimoto, N., et al. (2014). Percutaneous sclerotherapy for venous malformations in the extremities: Clinical outcomes and predictors of patient satisfaction. SpringerPlus,3, 520.CrossRef Nakamura, M., Osuga, K., Maeda, N., Higashihara, H., Hamada, K., Hashimoto, N., et al. (2014). Percutaneous sclerotherapy for venous malformations in the extremities: Clinical outcomes and predictors of patient satisfaction. SpringerPlus,3, 520.CrossRef
24.
go back to reference Nguyen, J. T., Koerper, M. A., Hess, C. P., Dowd, C. F., Hoffman, W. Y., Dickman, M., et al. (2014). Aspirin therapy in venous malformation: A retrospective cohort study of benefits, side effects, and patient experiences. Pediatric Dermatology,31(5), 556–560.CrossRef Nguyen, J. T., Koerper, M. A., Hess, C. P., Dowd, C. F., Hoffman, W. Y., Dickman, M., et al. (2014). Aspirin therapy in venous malformation: A retrospective cohort study of benefits, side effects, and patient experiences. Pediatric Dermatology,31(5), 556–560.CrossRef
25.
go back to reference Rautio, R., Laranne, J., Kahara, V., Saarinen, J., & Keski-Nisula, L. (2004). Long-term results and quality of life after endovascular treatment of venous malformations in the face and neck. Acta Radiologica (Stockholm, Sweden: 1987),45(7), 738–745.CrossRef Rautio, R., Laranne, J., Kahara, V., Saarinen, J., & Keski-Nisula, L. (2004). Long-term results and quality of life after endovascular treatment of venous malformations in the face and neck. Acta Radiologica (Stockholm, Sweden: 1987),45(7), 738–745.CrossRef
26.
go back to reference Rautio, R., Saarinen, J., Laranne, J., Salenius, J. P., & Keski-Nisula, L. (2004). Endovascular treatment of venous malformations in extremities: Results of sclerotherapy and the quality of life after treatment. Acta Radiologica (Stockholm, Sweden: 1987),45(4), 397–403.CrossRef Rautio, R., Saarinen, J., Laranne, J., Salenius, J. P., & Keski-Nisula, L. (2004). Endovascular treatment of venous malformations in extremities: Results of sclerotherapy and the quality of life after treatment. Acta Radiologica (Stockholm, Sweden: 1987),45(4), 397–403.CrossRef
27.
go back to reference Sannier, K., Dompmartin, A., Theron, J., Labbe, D., Barrellier, M. T., Leroyer, R., et al. (2004). A new sclerosing agent in the treatment of venous malformations. Study on 23 cases. Interventional Neuroradiology: Journal of Peritherapeutic Neuroradiology, Surgical Procedures and Related Neurosciences,10(2), 113–127.CrossRef Sannier, K., Dompmartin, A., Theron, J., Labbe, D., Barrellier, M. T., Leroyer, R., et al. (2004). A new sclerosing agent in the treatment of venous malformations. Study on 23 cases. Interventional Neuroradiology: Journal of Peritherapeutic Neuroradiology, Surgical Procedures and Related Neurosciences,10(2), 113–127.CrossRef
28.
go back to reference Steiner, F., FitzJohn, T., & Tan, S. T. (2013). Surgical treatment for venous malformation. Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS,66(12), 1741–1749.CrossRef Steiner, F., FitzJohn, T., & Tan, S. T. (2013). Surgical treatment for venous malformation. Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS,66(12), 1741–1749.CrossRef
29.
go back to reference Steiner, F., FitzJohn, T., & Tan, S. T. (2016). Ethanol sclerotherapy for venous malformation. ANZ Journal of Surgery,86(10), 790–795.CrossRef Steiner, F., FitzJohn, T., & Tan, S. T. (2016). Ethanol sclerotherapy for venous malformation. ANZ Journal of Surgery,86(10), 790–795.CrossRef
30.
go back to reference Yun, W. S., Kim, Y. W., Lee, K. B., Kim, D. I., Park, K. B., Kim, K. H., et al. (2009). Predictors of response to percutaneous ethanol sclerotherapy (PES) in patients with venous malformations: Analysis of patient self-assessment and imaging. Journal of Vascular Surgery,50(3), 581–589.CrossRef Yun, W. S., Kim, Y. W., Lee, K. B., Kim, D. I., Park, K. B., Kim, K. H., et al. (2009). Predictors of response to percutaneous ethanol sclerotherapy (PES) in patients with venous malformations: Analysis of patient self-assessment and imaging. Journal of Vascular Surgery,50(3), 581–589.CrossRef
Metagegevens
Titel
Qualitative study of patients with venous malformations: symptom experiences and content validity of patient-reported outcome measures
Auteurs
Ryan W. England
Christopher R. Bailey
Milena D. Anatchkova
Anne M. Skalicky
Mark H. Meissner
Melvin Rosenblatt
Heather L. Gelhorn
Clifford R. Weiss
Publicatiedatum
04-02-2020
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 6/2020
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-020-02435-3

Andere artikelen Uitgave 6/2020

Quality of Life Research 6/2020 Naar de uitgave