Which type of PROMs to use in MS routine clinical care: The validity of PROMIS CAT questionnaires

Multiple sclerosis (MS) healthcare aims to shift towards patient-centered care, in which empowered patients contribute their values in life and needs in clinical encounters. Patient-reported outcome measures (PROMs) do support the development of person-centered treatment goals and enable communication of patient's needs with healthcare providers.

To evaluate the construct validity of seven Patient-Reported Outcomes Measurement Information System® Computer Adaptive Tests (PROMIS CATs) that assess the domains Anxiety, Depression, Pain Interference, Fatigue, Sleep Disturbance, Physical Function, and the Ability to Participate in Social Roles and Activities in MS outpatients, and to compare the average number of items needed to obtain a PROMIS CAT domain score with the number of items in the corresponding regularly used PROMs in MS healthcare and research.

In this cross-sectional study PROMIS CATs and PROMs data from adult people with MS consulting the outpatient clinics of neurology or rehabilitation medicine of the MS Center Amsterdam were analysed. Construct validity of PROMIS CATs was evaluated with hypotheses testing based on predefined Spearman correlations ( ≥0.70 for corresponding and ≥0.50 for related but dissimilar constructs) with HADS anxiety and depression, MSWS-12, MSIS29, EQ5D, CIS20r fatigue, AMSQ-sf. Construct validity was considered adequate when more than 75% of the formulated hypotheses were confirmed.

Outcome data from 498 MS outpatients (median age 47.2 years [IQ 37.4-55.2]; 69% females) were available. All correlations with corresponding constructs, except for depression (Spearman's rho = 0.68), were ≥0.70. All correlations with related, but dissimilar constructs were ≥0.50. In total 94% (17/18) of our hypotheses were confirmed. Four personalized PROMIS CAT items were on average needed to complete each PROMIS questionnaire. The traditional PROMs had a fixed number of 78 items in total.

All seven PROMIS CATs demonstrated evidence for sufficient construct validity in MS outpatients. In addition, completion of PROMIS CATs required far less items than the commonly used PROMs in MS health care and research.