Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior.

TitleEvidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior.
Publication TypeJournal Article
Year of Publication2016
AuthorsAskew RL, Cook KF, Revicki DA, Cella D, Amtmann D
JournalJ Clin Epidemiol
Volume73
Pagination103-11
Date Published2016 May
ISSN1878-5921
KeywordsActivities of Daily Living, Adolescent, Adult, Aged, Chronic Disease, Chronic Pain, Comorbidity, Comparative Effectiveness Research, Female, Follow-Up Studies, Humans, Longitudinal Studies, Male, Middle Aged, National Institutes of Health (U.S.), Pain Measurement, Psychometrics, Reproducibility of Results, Self Report, Social Behavior, Surveys and Questionnaires, United States, Young Adult
Abstract

OBJECTIVE: To evaluate clinical validity, including responsiveness, of Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PROMIS-PI) and pain behavior (PROMIS-PB) T-scores.
STUDY DESIGN AND SETTING: Data were aggregated from longitudinal studies of cancer, chronic low back pain (cLBP), rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), and major depressive disorder (MDD). Linear mixed-effects models were used to compare baseline score differences and score changes over time. We calculated standardized response means (SRMs) for subgroups defined by self-reported change in general health and pain.
RESULTS: A total of 1,357 individuals participated at baseline and 1,225 at follow-up. Hypotheses of significant change in PROMIS-PI and PROMIS-PB scores were supported in the intervention groups (cLBP and MDD). Differences in baseline scores for COPD exacerbators compared to stable COPD patients were in the hypothesized direction but were not statistically significant. Subgroups reporting better health showed corresponding negative SRM values supporting responsiveness of T-scores to improvement. Responsiveness to decrements was supported in some but not all clinical groups and varied by anchor. More congruent values were obtained when using a pain-specific anchor.
CONCLUSION: This study provides evidence that PROMIS-PI and PROMIS-PB scores are sensitive to changes in pain in studies of interventions expected to impact pain. The results inform estimation of meaningful change and support power analyses for comparative effectiveness research.

DOI10.1016/j.jclinepi.2015.08.035
Alternate JournalJ Clin Epidemiol
PubMed ID26931296
PubMed Central IDPMC4957699
Grant ListU01 AR052170 / AR / NIAMS NIH HHS / United States
U01 AR057929 / AR / NIAMS NIH HHS / United States
U01 AR052181 / AR / NIAMS NIH HHS / United States
U01 AR057954 / AR / NIAMS NIH HHS / United States
U01 AR057940 / AR / NIAMS NIH HHS / United States
U01 AR052177 / AR / NIAMS NIH HHS / United States
R01 CA060068 / CA / NCI NIH HHS / United States
U01 AR057948 / AR / NIAMS NIH HHS / United States
U01 AR057956 / AR / NIAMS NIH HHS / United States
U01 AR052158 / AR / NIAMS NIH HHS / United States
U01 AR057971 / AR / NIAMS NIH HHS / United States
P30 CA060553 / CA / NCI NIH HHS / United States
U01 AR057967 / AR / NIAMS NIH HHS / United States
U01 AR052155 / AR / NIAMS NIH HHS / United States
U54 AR057943 / AR / NIAMS NIH HHS / United States
U01 AR052171 / AR / NIAMS NIH HHS / United States
U01 AR057936 / AR / NIAMS NIH HHS / United States
U01 AR052186 / AR / NIAMS NIH HHS / United States
U54 AR057951 / AR / NIAMS NIH HHS / United States
U54 AR057926 / AR / NIAMS NIH HHS / United States