Minimally important differences for Patient Reported Outcomes Measurement Information System pain interference for individuals with back pain

Abstract

BackgroundThe minimally important difference (MID) refers to the smallest change that is sufficiently meaningful to carry implications for patients’ care. MIDs are necessary to guide the interpretation of scores. This study estimated MID for the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference (PI).MethodsStudy instruments were administered to 414 people who participated in two studies that included treatment with low back pain (LBP; n=218) or depression (n=196). Participants with LBP received epidural steroid injections and participants with depression received antidepressants, psychotherapy, or both. MIDs were estimated for the changes in LBP. MIDs were included only if a priori criteria were met (ie, sample size ≥10, Spearman correlation ≥0.3 between anchor measures and PROMIS-PI scores, and effect size range =0.2–0.8). The interquartile range (IQR) of MID estimates was calculated.ResultsThe IQR ranged from 3.5 to 5.5 points. The lower bound estimate of the IQR (3.5) was greater than mean of standard error of measurement (SEM) both at time 1 (SEM =2.3) and at time 2 (SEM =2.5), indicating that the estimate of MID exceeded measurement error.ConclusionBased on our results, researchers and clinicians using PROMIS-PI can assume that change of 3.5 to 5.5 points in comparisons of mean PROMIS-PI scores of people with LBP can be considered meaningful.

Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy

“…In particular, patients with MELD > 12 had higher (worse) scores on all symptoms compared to the other two groups, with mean differences ranging from 1.9 to 4.1. While the sample size of those with MELD > 12 was small (n = 37) and provided limited precision, the mean differences were comparable to established PROMIS minimally important differences reported in other medical populations . In the final known‐groups validity analysis, we found positive correlations between a greater number of comorbid health conditions and worse symptom scores, consistent with prior studies .…”

“…Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference within or between groups generally ranges from 2‐5 points …”

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

“…In fact, it may be that the clinical difference between subgroups categorized by cross-sectional cut-points is larger than the minimal amount 79 . This may also explain the slightly larger MID estimates (3.5 to 5.5) recently found among patients with low back pain and depression 4 . Our findings are also concordant with those from our cross-sectional study, which detected ceiling effects in PROMIS Anxiety and supported the cross-sectional construct validity of each PROMIS instrument.…”

“…4,79 These criteria were designed to ensure that the: 1) Legacy anchor is associated with the PROMIS measure (Spearman correlation≥0.3 between change scores 55 ); 2) Important change group has ≥10 participants (i.e. legacy change score greater than or equal to the legacy MID, but no greater than twice the legacy MID); and 3) Effect size (Cohen’s d ) of each MID falls within plausible range (0.2≤ x≤ 0.8) 55,79 .…”

Feasibility and acceptability of telephone‐delivered cognitive‐behavioral‐based physical therapy for patients with traumatic lower extremity injury

“…Various studies support good reliability and validity of PROMIS pain interference in multiple patient populations including those with chronic pain and arthritis (Bartlett et al, ; Broderick, Schneider, Junghaenel, Schwartz, & Stone, ; Cella et al, ; Stone, Broderick, Junghaenel, Schneider, & Schwartz, ). PROMIS pain interference is especially responsive to targeted pain interventions and has an MCID of 5.5 in low back pain patients (Amtmann et al, ; Askew, Cook, Revicki, Cella, & Amtmann, ).…”