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Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis - 30/08/17

Doi : 10.1016/j.jpain.2017.05.001 
Augustine C. Lee , Jeffrey B. Driban , Lori Lyn Price , , William F. Harvey , Angie Mae Rodday , Chenchen Wang
 Center for Complementary and Integrative Medicine, Division of Rheumatology, Tufts Medical Center, Boston, Massachusetts 
 Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts 
 Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts 

Address reprint requests to Chenchen Wang, MD, MSc, Center for Complementary and Integrative Medicine, Division of Rheumatology, Tufts Medical Center, 800 Washington Street, Box 406, Boston, MA 02111.Center for Complementary and Integrative MedicineDivision of RheumatologyTufts Medical Center800 Washington StreetBox 406BostonMA02111

Abstract

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments can provide valid, interpretable measures of health status among adults with osteoarthritis (OA). However, their ability to detect meaningful change over time is unknown. We evaluated the responsiveness and minimally important differences (MIDs) for 4 PROMIS Short Forms: Physical Function, Pain Interference, Depression, and Anxiety. We analyzed adults with symptomatic knee OA from our randomized trial comparing Tai Chi and physical therapy. Using baseline and 12-week scores, responsiveness was evaluated according to consensus standards by testing 6 a priori hypotheses of the correlations between PROMIS and legacy change scores. Responsiveness was considered high if ≥5 hypotheses were confirmed, and moderate if 3 or 4 were confirmed. MIDs were evaluated according to prospective change for people achieving previously-established MID on legacy comparators. The lowest and highest MIDs meeting a priori quality criteria formed a MID range for each PROMIS Short Form. Among 165 predominantly female (70%) and white (57%) participants, mean age was 61 years and body mass index was 33. PROMIS Physical Function had 5 confirmed hypotheses and Pain Interference, Depression, and Anxiety had 3 or 4. MID ranges were: Depression = 3.0 to 3.1; Anxiety = 2.3 to 3.4; Physical Function = 1.9 to 2.2; and Pain Interference = 2.35 to 2.4. PROMIS Physical Function has high responsiveness, and Depression, Anxiety, and Pain Interference have moderate responsiveness among adults with knee OA. We established the first MIDs for PROMIS in this population, and provided an important standard of reference to better apply or interpret PROMIS in future trials or clinical practice.

Perspective

This study examined whether PROMIS Short Form instruments (Physical Function, Pain Interference, Depression, and Anxiety) were able to detect change over time among adults with knee OA, and provided minimally important change estimates for each measure. This standard of reference can help apply or interpret these instruments in the future.

Le texte complet de cet article est disponible en PDF.

Highlights

4 Patient-Reported Outcomes Measurement Information System measures were responsive in osteoarthritis.
Physical Function had high responsiveness.
Pain Interference, Depression, and Anxiety had moderate responsiveness.
Minimally important difference estimates ranged from 1.9 to 3.4.
This standard of reference can help apply or interpret these instruments in the future.

Le texte complet de cet article est disponible en PDF.

Key words : Osteoarthritis, patient-reported outcomes, responsiveness, minimally important difference, Patient-Reported Outcomes Measurement Information System


Plan


 This study was supported by the National Institutes of Health (R01AT005521, K24AT007323, and UL1TR001064). The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. The investigators are solely responsible for the content of the report and the decision to submit for publication. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the report.
 Patient-Reported Outcomes Measurement Information System (PROMIS) was funded with cooperative agreements from the National Institutes of Health Common Fund Initiative (U54AR057951, U01AR052177, U54AR057943, U54AR057926, U01AR057948, U01AR052170, U01AR057954, U01AR052171, U01AR052181, U01AR057956, U01AR052158, U01AR057929, U01AR057936, U01AR052155, U01AR057971, U01AR057940, U01AR057967, U01AR052186). The contents of this article used data developed under PROMIS. These contents do not necessarily represent an endorsement by the US federal government or PROMIS. See www.nihpromis.org for additional information on the PROMIS initiative.
 The authors have no conflicts of interest to declare.
 This trial is registered at Clinicaltrials.gov: NCT01258985; registration date: December 10, 2010.
 Supplementary data accompanying this article are available online at www.jpain.org and www.sciencedirect.com.


© 2017  Publié par Elsevier Masson SAS.
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Vol 18 - N° 9

P. 1096-1110 - septembre 2017 Retour au numéro
Article précédent Article précédent
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