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Validation of PROMIS Profile-29 in adults with hemophilia in the Netherlands. / van Balen, Erna C.; Haverman, Lotte; Hassan, Shermarke et al.

In: Journal of thrombosis and haemostasis, Vol. 19, No. 11, 11.2021, p. 2687-2701.

Research output: Contribution to journal › Article › Academic › peer-review

Harvard

van Balen, EC, Haverman, L, Hassan, S, Taal, EM, Smit, C, Driessens, MH, Beckers, EAM, Coppens, M, Eikenboom, J, Hooimeijer, HLL, Leebeek, FWG, van Vulpen, LFD, Schols, SEM, Terwee, CB, Rosendaal, FR, van der Bom, JG & Gouw, SC 2021, 'Validation of PROMIS Profile-29 in adults with hemophilia in the Netherlands', Journal of thrombosis and haemostasis, vol. 19, no. 11, pp. 2687-2701. https://doi.org/10.1111/jth.15454

APA

van Balen, E. C., Haverman, L., Hassan, S., Taal, E. M., Smit, C., Driessens, M. H., Beckers, E. A. M., Coppens, M., Eikenboom, J., Hooimeijer, H. L. L., Leebeek, F. W. G., van Vulpen, L. F. D., Schols, S. E. M., Terwee, C. B., Rosendaal, F. R., van der Bom, J. G., & Gouw, S. C. (2021). Validation of PROMIS Profile-29 in adults with hemophilia in the Netherlands. Journal of thrombosis and haemostasis, 19(11), 2687-2701. https://doi.org/10.1111/jth.15454

Vancouver

van Balen EC, Haverman L, Hassan S, Taal EM, Smit C, Driessens MH et al. Validation of PROMIS Profile-29 in adults with hemophilia in the Netherlands. Journal of thrombosis and haemostasis. 2021 Nov;19(11):2687-2701. Epub 2021. doi: 10.1111/jth.15454

Author

van Balen, Erna C. ; Haverman, Lotte ; Hassan, Shermarke et al. / Validation of PROMIS Profile-29 in adults with hemophilia in the Netherlands. In: Journal of thrombosis and haemostasis. 2021 ; Vol. 19, No. 11. pp. 2687-2701.

BibTeX

@article{abba7705f72246fc8fa81552933eeefb,
title = "Validation of PROMIS Profile-29 in adults with hemophilia in the Netherlands",
abstract = "Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) Profile-29 questionnaire is widely used worldwide, but it has not yet been validated in the Netherlands, nor in persons with hemophilia. Objective: To validate the Dutch-Flemish version of the PROMIS-29 Profile v2.01 in adults with hemophilia. Methods: Dutch males with hemophilia (all severities) completed questionnaires that contained sociodemographic and clinical characteristics, the PROMIS-29, RAND-36, and the Hemophilia Activities List (HAL). Structural validity of each subscale was assessed with confirmatory factor analysis (CFA). Internal consistency was calculated for each subscale with sufficient model fit in CFA. Construct validity was assessed by testing hypotheses about (1) correlations of each PROMIS-29 subscale with corresponding scales of RAND-36 and domains of HAL, and (2) mean differences in T-scores between subgroups with different hemophilia severities, self-reported joint impairment, and HIV infection status. We considered ≥75% of data in accordance with the hypotheses evidence for construct validity. Results: In total, 770 persons with hemophilia participated in this cross-sectional study. CFA revealed sufficient structural validity for five subscales: Physical Function, Depression, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Internal consistency was high and Cronbach's alpha ranged from 0.79 for Sleep Disturbance to 0.96 for Pain Interference. Differences between clinical subgroups were in the expected direction. Construct validity was confirmed for Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Intensity. Conclusion: This study revealed sufficient evidence for structural validity, internal consistency, and construct validity for most PROMIS Profile-29 subscales among people with hemophilia in the Netherlands.",
keywords = "hemophilia A, hemophilia B, patient reported outcome measures, surveys and questionnaires, validation study",
author = "{van Balen}, {Erna C.} and Lotte Haverman and Shermarke Hassan and Taal, {Elisabeth M.} and Cees Smit and Driessens, {Mari{\"e}tte H.} and Beckers, {Erik A. M.} and Michiel Coppens and Jeroen Eikenboom and Hooimeijer, {H. l{\`e}ne L.} and Leebeek, {Frank W. G.} and {van Vulpen}, {Lize F. D.} and Schols, {Saskia E. M.} and Terwee, {Caroline B.} and Rosendaal, {Frits R.} and {van der Bom}, {Johanna G.} and Gouw, {Samantha C.}",
note = "Funding Information: This study was funded by the Dutch Ministry of Health, Welfare and Sports as part of the Hemophilia in the Netherlands study. Funding Information: E.C. van Balen, L. Haverman, S. Hassan, E.M. Taal, C. Smit, M.H. Driessens, E.A.M. Beckers, H.L. Hooimeijer, S.E.M. Schols, C.B. Terwee, and F.R. Rosendaal have no conflicts of interest to disclose. M. Coppens has received financial support for research from Bayer, CSL Behring, Daiichi Sankyo, Portola/Alexion, Roche, Sanquin Blood Supply, and UniQure and consultancy or lecturing fees from Bayer, CSL Behring, Medcon International, MEDtalks, NovoNordisk, Pfizer, and Sobi. J. Eikenboom received research support from CSL Behring and has been a teacher on educational activities of Roche. F.W.G. Leebeek received unrestricted research grants from CSL Behring, Takeda, UniQure and Sobi, is a consultant for UniQure, Novo Nordisk, Biomarin, and Takeda, of which the fees go to the institution, and has received a travel grant from Sobi. L.F.D. van Vulpen received a research grant form CSL Behring, is a consultant for Sobi and Tremeau; all fees go to the institution. He is also a DSMB member for a study by Roche. J.G. van der Bom has been a teacher on the educational activities of Bayer. S.C. Gouw has received unrestricted research grants from Sobi. Publisher Copyright: {\textcopyright} 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.",
year = "2021",
month = nov,
doi = "10.1111/jth.15454",
language = "English",
volume = "19",
pages = "2687--2701",
journal = "Journal of thrombosis and haemostasis",
issn = "1538-7933",
publisher = "Wiley-Blackwell",
number = "11",

}

RIS

TY - JOUR

T1 - Validation of PROMIS Profile-29 in adults with hemophilia in the Netherlands

AU - van Balen, Erna C.

AU - Haverman, Lotte

AU - Hassan, Shermarke

AU - Taal, Elisabeth M.

AU - Smit, Cees

AU - Driessens, Mariëtte H.

AU - Beckers, Erik A. M.

AU - Coppens, Michiel

AU - Eikenboom, Jeroen

AU - Hooimeijer, H. lène L.

AU - Leebeek, Frank W. G.

AU - van Vulpen, Lize F. D.

AU - Schols, Saskia E. M.

AU - Terwee, Caroline B.

AU - Rosendaal, Frits R.

AU - van der Bom, Johanna G.

AU - Gouw, Samantha C.

N1 - Funding Information: This study was funded by the Dutch Ministry of Health, Welfare and Sports as part of the Hemophilia in the Netherlands study. Funding Information: E.C. van Balen, L. Haverman, S. Hassan, E.M. Taal, C. Smit, M.H. Driessens, E.A.M. Beckers, H.L. Hooimeijer, S.E.M. Schols, C.B. Terwee, and F.R. Rosendaal have no conflicts of interest to disclose. M. Coppens has received financial support for research from Bayer, CSL Behring, Daiichi Sankyo, Portola/Alexion, Roche, Sanquin Blood Supply, and UniQure and consultancy or lecturing fees from Bayer, CSL Behring, Medcon International, MEDtalks, NovoNordisk, Pfizer, and Sobi. J. Eikenboom received research support from CSL Behring and has been a teacher on educational activities of Roche. F.W.G. Leebeek received unrestricted research grants from CSL Behring, Takeda, UniQure and Sobi, is a consultant for UniQure, Novo Nordisk, Biomarin, and Takeda, of which the fees go to the institution, and has received a travel grant from Sobi. L.F.D. van Vulpen received a research grant form CSL Behring, is a consultant for Sobi and Tremeau; all fees go to the institution. He is also a DSMB member for a study by Roche. J.G. van der Bom has been a teacher on the educational activities of Bayer. S.C. Gouw has received unrestricted research grants from Sobi. Publisher Copyright: © 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.

PY - 2021/11

Y1 - 2021/11

N2 - Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) Profile-29 questionnaire is widely used worldwide, but it has not yet been validated in the Netherlands, nor in persons with hemophilia. Objective: To validate the Dutch-Flemish version of the PROMIS-29 Profile v2.01 in adults with hemophilia. Methods: Dutch males with hemophilia (all severities) completed questionnaires that contained sociodemographic and clinical characteristics, the PROMIS-29, RAND-36, and the Hemophilia Activities List (HAL). Structural validity of each subscale was assessed with confirmatory factor analysis (CFA). Internal consistency was calculated for each subscale with sufficient model fit in CFA. Construct validity was assessed by testing hypotheses about (1) correlations of each PROMIS-29 subscale with corresponding scales of RAND-36 and domains of HAL, and (2) mean differences in T-scores between subgroups with different hemophilia severities, self-reported joint impairment, and HIV infection status. We considered ≥75% of data in accordance with the hypotheses evidence for construct validity. Results: In total, 770 persons with hemophilia participated in this cross-sectional study. CFA revealed sufficient structural validity for five subscales: Physical Function, Depression, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Internal consistency was high and Cronbach's alpha ranged from 0.79 for Sleep Disturbance to 0.96 for Pain Interference. Differences between clinical subgroups were in the expected direction. Construct validity was confirmed for Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Intensity. Conclusion: This study revealed sufficient evidence for structural validity, internal consistency, and construct validity for most PROMIS Profile-29 subscales among people with hemophilia in the Netherlands.

AB - Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) Profile-29 questionnaire is widely used worldwide, but it has not yet been validated in the Netherlands, nor in persons with hemophilia. Objective: To validate the Dutch-Flemish version of the PROMIS-29 Profile v2.01 in adults with hemophilia. Methods: Dutch males with hemophilia (all severities) completed questionnaires that contained sociodemographic and clinical characteristics, the PROMIS-29, RAND-36, and the Hemophilia Activities List (HAL). Structural validity of each subscale was assessed with confirmatory factor analysis (CFA). Internal consistency was calculated for each subscale with sufficient model fit in CFA. Construct validity was assessed by testing hypotheses about (1) correlations of each PROMIS-29 subscale with corresponding scales of RAND-36 and domains of HAL, and (2) mean differences in T-scores between subgroups with different hemophilia severities, self-reported joint impairment, and HIV infection status. We considered ≥75% of data in accordance with the hypotheses evidence for construct validity. Results: In total, 770 persons with hemophilia participated in this cross-sectional study. CFA revealed sufficient structural validity for five subscales: Physical Function, Depression, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Internal consistency was high and Cronbach's alpha ranged from 0.79 for Sleep Disturbance to 0.96 for Pain Interference. Differences between clinical subgroups were in the expected direction. Construct validity was confirmed for Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Intensity. Conclusion: This study revealed sufficient evidence for structural validity, internal consistency, and construct validity for most PROMIS Profile-29 subscales among people with hemophilia in the Netherlands.

KW - hemophilia A

KW - hemophilia B

KW - patient reported outcome measures

KW - surveys and questionnaires

KW - validation study

UR - http://www.scopus.com/inward/record.url?scp=85111838773&partnerID=8YFLogxK

U2 - 10.1111/jth.15454

DO - 10.1111/jth.15454

M3 - Article

C2 - 34245088

VL - 19

SP - 2687

EP - 2701

JO - Journal of thrombosis and haemostasis

JF - Journal of thrombosis and haemostasis

SN - 1538-7933

IS - 11

ER -

ID: 19264731