Robert L. Askew

Comparing CESD-10, PHQ-9, and PROMIS depression instruments in individuals with multiple sclerosis.

PURPOSE This study evaluated psychometric properties of the Patient Health Questionnaire-9 (PHQ-9), the Center for Epidemiological Studies Depression Scale-10 (CESD-10), and the 8-item PROMIS Depression Short Form (PROMIS-D-8; 8b short form) in a sample of individuals living with multiple sclerosis (MS). RESEARCH METHOD Data were collected by a self-reported mailed survey of a community sample of people living with MS (n = 455). Factor structure, interitem reliability, convergent/discriminant validity and assignment to categories of depression severity were examined. RESULTS A 1-factor, confirmatory factor analytic model had adequate fit for all instruments. Scores on the depression scales were more highly correlated with one another than with scores on measures of pain, sleep disturbance, and fatigue. The CESD-10 categorized about 37% of participants as having significant depressive symptoms. At least moderate depression was indicated for 24% of participants by PHQ-9. PROMIS-D-8 identified 19% of participants as having at least moderate depressive symptoms and about 7% having at least moderately severe depression. None of the examined scales had ceiling effects, but the PROMIS-D-8 had a floor effect. CONCLUSIONS Overall, scores on all 3 scales demonstrated essential unidimensionality and had acceptable interitem reliability and convergent/discriminant validity. Researchers and clinicians can choose any of these scales to measure depressive symptoms in individuals living with MS. The PHQ-9 offers validated cutoff scores for diagnosing clinical depression. The PROMIS-D-8 measure minimizes the impact of somatic features on the assessment of depression and allows for flexible administration, including Computerize Adaptive Testing (CAT). The CESD-10 measures 2 aspects of depression, depressed mood and lack of positive affect, while still providing an interpretable total score.

University of Washington Self-Efficacy Scale: A New Self-Efficacy Scale for People With Disabilities

OBJECTIVE To develop a self-efficacy scale for people living with multiple sclerosis (MS) and spinal cord injury (SCI) that can be used across diagnostic conditions. DESIGN The scale was developed using modern psychometric methods including item response theory. Items were administered at 3 time-points of a longitudinal survey of individuals with MS and SCI. SETTING Survey participants with MS were recruited from the National MS Society, and participants with SCI were recruited from the Northwest Regional Spinal Cord Injury Model System and the Shepherd Center at the Virginia Crawford Research Institute in Atlanta, GA. PARTICIPANTS Adults aged 18 years and older reporting a definitive diagnosis of MS (N=473) or SCI (N=253). INTERVENTIONS None. MAIN OUTCOME MEASURES Evaluation of the new self-efficacy measure called the University of Washington Self-Efficacy Scale (UW-SES) included comparisons with the Chronic Disease Self-Efficacy Scale and other patient-reported outcome measures. RESULTS UW-SES has excellent psychometric properties including well-functioning response categories, no floor effects, and low ceiling effects. A long form (17 items) and a short form (6 items) are available. The correlation between the score on the newly developed scale and the Chronic Disease Self-Efficacy Scale was high (.83), providing support for convergent validity. Higher self-efficacy scores were statistically significantly associated with better mental health, better physical health, less fatigue, less stress, less pain interference, less pain, fewer sleep problems, and lower depressive symptoms. CONCLUSIONS The UW-SES is a psychometrically sound instrument for measuring self-efficacy, validated in MS and SCI, and can be used across both conditions. Both the long form and the short form are available free of charge.

Pain affects depression through anxiety, fatigue, and sleep in multiple sclerosis.

OBJECTIVE Over a quarter million individuals in the United States have multiple sclerosis (MS). Chronic pain and depression are disproportionately high in this population. The purpose of this study was to examine the relationship between chronic pain and depression in MS and to examine potentially meditational effects of anxiety, fatigue, and sleep. METHOD We used cross-sectional data from self-reported instruments measuring multiple symptoms and quality of life indicators in this study. We used structural equation modeling to model direct and indirect effects of pain on depression in a sample of 1,245 community-dwelling individuals with MS. Pain interference, depression, fatigue, and sleep disturbance were modeled as latent variables with 2 to 3 indicators each. The model controlled for age, sex, disability status (Expanded Disability Status Scale), and social support. RESULTS A model with indirect effects of pain on depression had adequate fit and accounted for nearly 80% of the variance in depression. The effects of chronic pain on depression were almost completely mediated by fatigue, anxiety, and sleep disturbance. Higher pain was associated with greater fatigue, anxiety, and sleep disturbance, which in turn were associated with higher levels of depression. The largest mediating effect was through fatigue. Additional analyses excluded items with common content and suggested that the meditational effects observed were not attributable to content overlap across scales. CONCLUSION Individuals living with MS who report high levels of chronic pain and depressive symptoms may benefit from treatment approaches that can address sleep, fatigue, and anxiety.

Effects of non-pharmacological pain treatments on brain states

OBJECTIVE To (1) evaluate the effects of a single session of four non-pharmacological pain interventions, relative to a sham tDCS procedure, on pain and electroencephalogram- (EEG-) assessed brain oscillations, and (2) determine the extent to which procedure-related changes in pain intensity are associated with changes in brain oscillations. METHODS 30 individuals with spinal cord injury and chronic pain were given an EEG and administered measures of pain before and after five procedures (hypnosis, meditation, transcranial direct current stimulation [tDCS], neurofeedback, and a control sham tDCS procedure). RESULTS Each procedure was associated with a different pattern of changes in brain activity, and all active procedures were significantly different from the control procedure in at least three bandwidths. Very weak and mostly non-significant associations were found between changes in EEG-assessed brain activity and pain. CONCLUSIONS Different non-pharmacological pain treatments have distinctive effects on brain oscillation patterns. However, changes in EEG-assessed brain oscillations are not significantly associated with changes in pain, and therefore such changes do not appear useful for explaining the benefits of these treatments. SIGNIFICANCE The results provide new findings regarding the unique effects of four non-pharmacological treatments on pain and brain activity.

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

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.

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

Background The 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). Methods Study 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. Results The 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. Conclusion Based 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.

Pain intensity rating training: results from an exploratory study of the ACTTION PROTECCT system.

Abstract Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public–private partnership developed a training system with specific, standardized guidance regarding daily average pain intensity ratings. A 3-week exploratory study among participants with low-back pain, osteoarthritis of the knee or hip, and painful diabetic peripheral neuropathy was conducted, randomly assigning participants to 1 of 3 groups: training with human pain assessment (T+); training with automated pain assessment (T); or no training with automated pain assessment (C). Although most measures of validity and reliability did not reveal significant differences between groups, some benefit was observed in discriminant validity, amount of missing data, and ranking order of least, worst, and average pain intensity ratings for participants in Group T+ compared with the other groups. Prediction of greater reliability in average pain intensity ratings in Group T+ compared with the other groups was not supported, which might indicate that training produces ratings that reflect the reality of temporal pain fluctuations. Results of this novel study suggest the need to test the training system in a prospective analgesic treatment trial.

Quality of life in patients with TIA and minor ischemic stroke.

Objective: We investigated health-related quality of life (HRQOL) in patients with TIA and minor ischemic stroke (MIS) using Neuro-QOL, a validated, patient-reported outcome measurement system. Methods: Consecutive patients with TIA or MIS who had (1) modified Rankin Scale (mRS) score of 0 or 1 at baseline, (2) initial NIH Stroke Scale score of ≤5, (3) no acute reperfusion treatment, and (4) 3-month follow-up, were recruited. Recurrent stroke, disability by mRS and Barthel Index, and Neuro-QOL scores in 5 prespecified domains were prospectively recorded. We assessed the proportion of patients with impaired HRQOL, defined as T scores more than 0.5 SD worse than the general population average, and identified predictors of impaired HRQOL using logistic regression. Results: Among 332 patients who met study criteria (mean age 65.7 years, 52.4% male), 47 (14.2%) had recurrent stroke within 90 days and 41 (12.3%) were disabled (mRS >1 or Barthel Index <95) at 3 months. Any HRQOL impairment was noted in 119 patients (35.8%). In multivariate analysis, age (adjusted odds ratio [OR] 1.02, 95% confidence interval [CI] 1.01–1.04), initial NIH Stroke Scale score (adjusted OR 1.39, 95% CI 1.17–1.64), recurrent stroke (adjusted OR 2.10, 95% CI 1.06–4.13), and proxy reporting (adjusted OR 3.94, 95% CI 1.54–10.10) were independent predictors of impaired HRQOL at 3 months. Conclusions: Impairment in HRQOL is common at 3 months after MIS and TIA. Predictors of impaired HRQOL include age, index stroke severity, and recurrent stroke. Future studies should include HRQOL measures in outcome assessment, as these may be more sensitive to mild deficits than traditional disability scales.

Symptoms and quality of life indicators among children with chronic medical conditions

BACKGROUND Children with chronic conditions often experience numerous symptoms, but few research studies examine patterns of symptoms and quality of life (QoL) indicators. OBJECTIVE To examine if reliable latent classes of children with chronic medical conditions can be identified based on the clustering of symptoms and QoL indicators. METHODS Structured interviews were conducted with children ages 9-21 living with chronic medical conditions (N = 90). Multiple symptoms (e.g., pain, sleep, fatigue, and depression) and QoL indicators (e.g., life satisfaction and social support) were measured. Physical health and emotional, social, and school functioning were measured using the Pediatric Quality of Life Inventory (PedsQL). Latent class analysis was used to classify each child into a latent class whose members report similar patterns of responses. RESULTS A three-class solution had the best model fit. Class 1 (high-symptom group; n = 15, 16.7%) reported the most problems with symptoms and the lowest scores on the QoL indicators. Class 2 (moderate-symptom group; n = 39, 43.3%) reported moderate levels of both symptoms and QoL indicators. Class 3 (low-symptom group; n = 36, 40.0%) reported the lowest levels of symptoms and the highest scores on the QoL indicators. CONCLUSIONS The three latent classes identified in this study were distributed along the severity continuum. All symptoms and QoL indicators appeared to move in the same direction (e.g., worse symptoms with lower QoL). The PedsQL psychosocial health summary score (combining emotional, social, and school functioning scores) discriminated well between children with different levels of disease burden.

Translating CESD-20 and PHQ-9 Scores to PROMIS Depression.

This study examined the accuracy of depression cross-walk tables in a sample of people with multiple sclerosis (MS). The tables link scores of two commonly used depression measures to the Patient Reported Outcome Measurement Information System Depression (PROMIS-D) scale metric. We administered the 8-item PROMIS-D (Short-Form 8b; PROMIS-D-8), the 20-item Center for Epidemiologic Studies Depression Scale (CESD-20), and the 9-item Patient Health Questionnaire (PHQ-9) to 459 survey participants with MS. We examined correlations between actual PROMIS-D-8 scores and the scores predicted by cross-walks based on PHQ-9 and CESD-20 scores. Intraclass correlation coefficients were used to assess correspondence. Consistency in severity classification was also calculated. Finally, we used Bland–Altman plots to graphically examine the levels of agreement. The correlations between actual and cross-walked PROMIS-D-8 scores were strong (CESD-20 = .82; PHQ-9 = .74). The intraclass correlation was moderate (.77). Participants were consistently classified as having or not having at least moderate depressive symptoms by both actual and cross-walked scores derived from the CESD-20 (90%) and PHQ-9 (85%). Bland–Altman plots suggested the smaller differences between actual and cross-walked scores with greater-than-average depression severity. PROMIS cross-walk tables can be used to translate depression scores of people with MS to the PROMIS-D metric, promoting continuity with previous research.