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Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials.

ABSTRACT: Minimally important difference (MID) refers to the smallest meaningful difference that carries implications for patient care. Minimally important differences are necessary to help interpret patient-reported pain outcomes in research and clinical practice. The PROMIS pain interference scales were validated across diverse samples; however, more information about their MIDs could improve their interpretability. The purpose of this study was to estimate MIDs for 4 fixed-length PROMIS pain interference scales, including the 6-item Pain Short Form and the 4-, 6-, and 8-item pain interference scales used in the PROMIS profile instruments. Data were analyzed from 3 randomized controlled trials (N = 759). The 3 samples, respectively, consisted of patients with chronic low back pain (n = 261), chronic back pain or hip/knee osteoarthritis pain (n = 240), and a history of stroke (n = 258). For each sample, anchor- and distribution-based approaches were used to estimate MIDs. Standard error of measurement and effect sizes were used as distribution-based MID estimates. Anchor-based MID estimates were established by mapping PROMIS pain interference scores onto established anchor measures, including the Brief Pain Inventory, and retrospective and prospective global ratings of change. The distribution- and anchor-based MID estimates showed convergence. For the pain samples, MID estimates ranged from 2 to 3 T-score points. For the nonpain sample, MID estimates ranged from 3.5 to 4.5 T-score points. The MID estimates were comparable across the 4 fixed-length scales. These MIDs can be used to evaluate treatment effects in research and clinical care and to calculate estimates for powering clinical trials.

SUBMITTER: Chen CX

PROVIDER: S-EPMC5860950 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials.

Chen Chen X CX Kroenke Kurt K Stump Timothy E TE Kean Jacob J Carpenter Janet S JS Krebs Erin E EE Bair Matthew J MJ Damush Teresa M TM Monahan Patrick O PO

Pain 20180401 4

Minimally important difference (MID) refers to the smallest meaningful difference that carries implications for patient care. Minimally important differences are necessary to help interpret patient-reported pain outcomes in research and clinical practice. The PROMIS pain interference scales were validated across diverse samples; however, more information about their MIDs could improve their interpretability. The purpose of this study was to estimate MIDs for 4 fixed-length PROMIS pain interferen ...[more]

PMID: 29200181

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Project description: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.

Project description:Background contextWhen different health care providers use different patient-reported outcome (PRO) instruments, it is challenging to integrate findings that describe particular patient groups or to establish treatment effectiveness across studies. It is therefore critical to develop accurate ways to convert scores between various instruments for clinicians and researchers to make comparisons across health outcomes.PurposeTo develop a common metric so that scores on the Oswestry Disability Index (ODI) and scores on the PROMIS Physical Function can be converted interchangeably.Study design/settingData were collected from a prospective study. A single-group linking design was used.Patient sampleThe study population included 9020 patients presented to an orthopedic spine clinic from November 2013 to March 2019.Outcome measuresPatients completed the ODI and the PROMIS Pain Interference scale delivered by Computerized Adaptive Testing (CAT) at the same time prior to their visit with a spine clinician.MethodsEquipercentile linking methods based on log-linear smoothing approach and non-smoothing approach were used to establish a common metric across the two measures.ResultsThe two measures assess the similar contruct of pain. The correlation between the scores of the ODI and the PROMIS PI was 0.81. The standardized Root Expected Mean Square Difference (REMSD) values for gender, ethnic, and racial groups ranged from 3.55% to 4.81%. Hence, the assumptions for the equipercentile linking method were met. The crosswalk derived linked scores based on the log-linear smoothing method yielded small deviations (Δ = 0.09) from the observed scores. We then identified linked PROMIS-PI scores corresponding to the benchmark ODI scores for the five disability levels and for various categories of patients.ConclusionsThis study is the first to create crosswalks to interchangeably convert scores between the ODI to the PROMIS-PI in a large population of spine patients using the equipercentile linking method. The results of this study provide confidence in the validity and usefulness of the derived crosswalks based on the equipercentile linking approach. The crosswalks are helpful for comparing new and old studies on the two measures and identifying benchmark scores for various diseases and disability levels.

Dataset Information

Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials.

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Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials.

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