Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials

Abstract

 The PROMIS Pain Interference short forms are responsive to change. Their responsiveness are comparable to legacy pain measures. Responsiveness may vary based on the sample and the direction of change. ABSTRACTThe PROMIS Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares to legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from three clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n= 261), chronic back or osteoarthritis pain (n ACCEPTED MANUSCRIPT A C C E P T E D M A N U S C R I P T 2 = 240), and a history of stroke (n= 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale, Pain/Enjoyment/General Activity (PEG) scale, SF-36 Bodily Pain scale, and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference scale and PEG. The four PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened. Perspective: This paper presents (1) how responsive the PROMIS Pain Interference scales were to detect change over time in the context of three clinical trials and (2) how their responsiveness compared to legacy pain measures. The findings can help researchers and clinicians choose between different patient-reported pain outcome measures.

Comparison of patient-reported outcomes measurement information system and legacy instruments in multiple domains among older veterans with chronic back pain

“…To our knowledge, this is the first study that validates the psychometric properties and feasibility of applying these PROMIS and legacy instruments in an older Veteran population with cLBP. Our results are consistent with literature focused on patients with chronic back pain, where PROMIS instruments correlated well with legacy measures [37][38][39][40]. In a retrospective review of an outcomes database, PROMIS Pain Interference, Physical Function, and Pain Intensity instruments correlated strongly with traditional disability measures in patients with back and neck pain [41].…”

Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials

“…Also, the 3 to 6 point improvement in PROMIS depression T-scores was above the minimally important difference. This greater sensitivity of symptom scales for detecting improvement has been previously reported for depression [5,16,24], pain [20,22,[25][26][27][28] and anxiety [24].…”

“…The retrospective global rating of change assesses overall clinical response from the participant's perspective [20]. At follow-up, participants were asked to rate their mood change compared to their mood at baseline assessment.…”

“…For the prospective anchor, we evaluated each measure's ability to detect any improvement (+ 1 to + 4) as well as moderate improvement (+ 2 to + 4). To determine if depression scales differed in their ability to detect improvement, we also statistically compared AUC values between measures [20,23].…”

Clinical outcome assessment in clinical trials of chronic pain treatments

“…The reliability and validity of PROMIS physical functioning and pain interference measures have been established in several pain populations, 1 , 2 , 4 , 5 , 24 , 51 and emerging studies are demonstrating the responsiveness of the short-form versions of these measures. 16 , 17 , 84 Furthermore, there is now a crosswalk table available to transform the BPI pain interference scores to PROMIS pain interference short-form scores 5 (crosswalks for scores from other PROMIS and legacy measures are available at http://www.prosettastone.org/Pages/default.aspx .)…”