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.

Generic PROMIS item banks in adults with hemophilia for patient‐reported outcome assessment: Feasibility, measurement properties, and relevance

“… 21 In addition, strong correlations were reported between the PROMIS‐29 domains depression and anxiety and the RAND‐36 emotional well‐being domain in the HiN‐6 study, with data collected at the same time point. 50 …”

“…This is in contrast with results from other studies that do support the use of PROMIS depression and anxiety domains in patients with hemophilia. 21 , 50 …”

Preliminary evaluation of the Chinese version of the patient-reported outcomes measurement information system 29-item profile in patients with aortic dissection

“…The magnitude of the correlation coefficients was interpreted as high (r ≥ 0.7), moderate (r = 0.5–0.7) and low (r < 0.5) [ 38 ]. Based on published literature, the PROMIS-29 subscales were hypothesized to have high correlations (r ≥ 0.7) [ 17 ] between similar legacy PRO subscales (Table 5 ).…”

“…Discriminant validity was supported through comparing correlations between scores of PROMIS-29 domains and dissimilar constructs of legacy measures; these correlations were expected to be less than 0.60 [ 17 ]. The construct validity of the PROMIS-29 was also assessed by conducting a known-groups analysis.…”

“…This measure is widely practiced worldwide and is already available in more than 40 languages. Due to its brevity and breadth, the PROMIS-29 has been examined in a broad range of general [ 16 ] or patient populations, such as adults with hemophilia [ 17 ], chronic low back pain [ 18 ], chronic pulmonary diseases [ 19 ], burn survivors [ 20 ] and kidney transplant recipients [ 21 ]. Good and robust psychometric properties have been established within these different settings.…”