Estimates of Minimally Important Differences (MIDs) for Two Patient‐Reported Outcomes Measurement Information System (PROMIS) Computer‐Adaptive Tests in Chronic Pain Patients

Abstract

Anchor-and distribution-based methods were combined to evaluate and establish minimally important differences (MIDs) for two Patient-Reported Outcomes Measurement Information System (PROMIS) measures in an outpatient chronic pain population. These included the computer-adaptive test (CAT) versions of two PROMIS measures: Depressive Symptoms and Anxiety-Related Symptoms (PROMIS; Cella, Gershon, Lai & Choi). Participants (n = 170) undergoing a behavioral medicine evaluation in an interdisciplinary pain management clinic completed two PROMIS CATs and multiple clinical anchor measures/ questions. Modeled after similar analyses (Yost, Eton, Garcia, & Cella), three a priori criteria were used to select usable cross-sectional anchor-based MID estimates; these included a minimum Spearman correlation of .3 between the PROMIS measure and anchor item/categories, a minimum comparison group sample size of 10 within each anchor, and an effect size between .2 and .8 for each anchor-based estimate. For each PROMIS measure, the mean standard error of measurement was calculated and incorporated into MID analyses. Using a large sample (n = 170), a number of the cross-sectional T-score anchorbased MID estimates (57%) were not included due to failure to meet a priori criteria. Based on the analyses, the following T-score MID ranges are recommended: Depression CAT (3.5-5.5) and Anxiety CAT (3.0-5.5). The average effect sizes for MID estimates ranged from .32 to .57. This study is among the first to address MIDs for PROMIS measures; it is the first study to establish usable MIDs for psychological symptoms on outpatients with chronic/persistent pain. The results may be used to gauge minimally important clinical difference and/or treatment response for individuals within this patient population. MIDs for PROs are particularly useful when treatment responses are significant to the patient but are difficult to evaluate during the clinical visit.

Loving-Kindness Meditation vs Cognitive Processing Therapy for Posttraumatic Stress Disorder Among Veterans

“… 38 For depression, the noninferiority margin was 4 points on the PROMIS depression measure, which is defined as the minimally important difference and represents a Cohen d effect size of approximately 0.50. 39 , 40 , 41 The proportion with clinically meaningful improvement or worsening of depressive symptoms was assessed using stringent (≥8 points) and less stringent (≥4 points) criteria.…”

United States Population-Based Estimates of Patient-Reported Outcomes Measurement Information System Symptom and Functional Status Reference Values for Individuals With Cancer

“…11 On the basis of prior PROMIS validation studies in cancer, we considered a group score difference of 3 points likely to be clinically meaningful. 12,13 Published symptom cutoff scores for pain interference, fatigue, anxiety, and depression were used to describe symptom severity (none, mild, moderate, or severe). 14…”

Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation

“…23 However, further observational and clinical research has shown minimally important difference (MID) to be much lower, near 3.5. 40,41 In fact, a recent randomized trial showed a MID of 3.0 along the PROMIS depression domain. 42 Our detected change of 4.5 likely conveys a meaningful change.…”

“…Initial theory suggested that half of a SD, a t ‐score change of 5 points, is considered clinically meaningful 23 . However, further observational and clinical research has shown minimally important difference (MID) to be much lower, near 3.5 40,41 . In fact, a recent randomized trial showed a MID of 3.0 along the PROMIS depression domain 42 .…”