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, Mariette H.
AU - Beckers, Erik A. M.
AU - Coppens, Michiel
AU - Eikenboom, Jeroen
AU - Hooimeijer, Helene 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.
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
KW - QUALITY-OF-LIFE
KW - MINIMALLY IMPORTANT DIFFERENCES
KW - REPORTED OUTCOME INSTRUMENTS
KW - SYSTEM SHORT FORMS
KW - FUNCTIONAL IMPAIRMENT
KW - US ADULTS
KW - PAIN
KW - RESPONSIVENESS
KW - QUESTIONNAIRE
KW - INDIVIDUALS
U2 - 10.1111/jth.15454
DO - 10.1111/jth.15454
M3 - Article
SN - 1538-7933
VL - 19
SP - 2687
EP - 2701
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
IS - 11
ER -