Dagmar Amtmann

PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions

OBJECTIVEnTo present an overview of a series of studies in which the clinical validity of the National Institutes of Healths Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations.nnnSTUDY DESIGN AND SETTINGnApproximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model.nnnRESULTSnThe results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions.nnnCONCLUSIONnThe cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in real-world clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions.

Resilience, age, and perceived symptoms in persons with long-term physical disabilities

Resilience may mitigate impact of secondary symptoms such as pain and fatigue on quality of life in persons aging with disability. This study examined resilience in a large sample of individuals with disabling medical conditions by validating the Connor–Davidson Resilience Scale, obtaining descriptive information about resilience and evaluating resilience as a mediator among key secondary symptoms and quality of life using structural equation modeling. Results indicated that the measure’s psychometric properties were adequate in this sample. Resilience was lowest among participants who were middle-aged or younger, and participants with depression. Resilience mediated associations between secondary symptoms and quality of life.

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

OBJECTIVEnTo evaluate clinical validity, including responsiveness, of Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PROMIS-PI) and pain behavior (PROMIS-PB) T-scores.nnnSTUDY DESIGN AND SETTINGnData 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.nnnRESULTSnA 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.nnnCONCLUSIONnThis 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.

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.

Construct Validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in Adults With Lower Limb Amputation

OBJECTIVEnTo assess construct validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M), a self-report mobility measure for people with lower limb amputation (LLA).nnnDESIGNnCross-sectional study.nnnSETTINGnPrivate prosthetic clinics (n=37).nnnPARTICIPANTSnCurrent lower limb prosthesis users (N=199; mean age ± SD, 55.4±14.3y; 71.4% men) were assessed before receiving a replacement prosthesis, prosthetic socket, and/or prosthetic knee.nnnINTERVENTIONSnNot applicable.nnnMAIN OUTCOME MEASURESnConvergent construct validity was examined using correlations between participants PLUS-M T-scores and measures of physical function, mobility, and balance, including the Amputee Mobility Predictor (AMP), timed Up and Go (TUG), Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF), Prosthesis Evaluation Questionnaire-Mobility Subscale (PEQ-MS), and Activities-specific Balance Confidence (ABC) Scale. Known-groups construct validity was evaluated by comparing differences in PLUS-M T-scores among participants grouped by Medicare Functional Classification Level (MFCL).nnnRESULTSnPLUS-M T-scores demonstrated a moderate positive relationship with AMP scores (ρ=.54, P<.001) and a moderate negative relationship with TUG times (ρ=-.56, P<.001). The PLUS-M also showed a strong positive relationship with PEQ-MS scores (ρ=.78, P<.001), ABC Scale scores (ρ=.81, P<.001), and PROMIS-PF T-scores (ρ=.81, P<.001). Significant differences (P<.05) in PLUS-M T-scores were found among groups of people classified by different MFCLs.nnnCONCLUSIONSnStudy results support the validity of the PLUS-M as a self-report measure of prosthetic mobility. Correlations between PLUS-M and measures of physical function, mobility, and balance indicate convergent construct validity. Similarly, significant differences in PLUS-M T-scores across MFCL groups provide evidence of known-groups construct validity. In summary, evidence indicates that PLUS-M has good construct validity among people with LLA.

The role of pain acceptance on function in individuals with disabilities: a longitudinal study.

Abstract Having higher levels of pain acceptance has been shown to be associated positively with quality of life in patients with chronic pain, but its role in adjustment to chronic pain among individuals with physical disabilities living in the community is not known. Moreover, issues related to item overlap between measures of pain acceptance and measures of patient function have limited the conclusions that can be drawn from previous research in this area. To better understand the role that pain acceptance plays in patient function, we administered measures of pain acceptance, pain intensity, depressive symptoms, and function to 392 individuals with physical disabilities, and the pain, symptom, and function measures were readministered 3.5 years later. Analyses evaluated the main and interaction effects of initial pain acceptance on subsequent changes in pain and function. Having higher levels of pain acceptance—in particular as reflected by a willingness to engage in activities despite pain—resulted in less increase in pain intensity and more improvements in pain interference, physical function, depressive symptoms, and sleep quality. The findings indicate that previous research supporting the importance of pain acceptance to function in patients from health care settings extends to individuals with chronic pain living in the community. Moreover, they indicate that pain acceptance may have long-lasting (up to 3.5 years) beneficial effects on subsequent pain and function and on the association between change in pain and depression. Research to examine the potential benefits of community-based treatments that increase pain acceptance is warranted.

Characterizing mobility from the prosthetic limb user’s perspective: Use of focus groups to guide development of the Prosthetic Limb Users Survey of Mobility:

Background: Input from target respondents in the development of patient-reported outcome measures is necessary to ensure that the instrument is meaningful. Objectives: To solicit perspectives of prosthetic limb users about their mobility experiences and to inform development of the Prosthetic Limb Users Survey of Mobility. Study design: Qualitative study. Methods: Four focus groups of lower limb prosthesis users were held in different regions of the United States. Focus group transcripts were coded, and themes were identified. Feedback from participants was used to develop a framework for measuring mobility with a lower limb prosthesis. Results: Focus group participants (Nu2009=u200937) described mobility as a confluence of factors that included characteristics of the individual, activity, and environment. Identified themes were defined as individual characteristics, forms of movement, and environmental situations. Prosthetic mobility was conceptualized as movement activities performed in an environmental or situational context. Conclusion: Respondent feedback used to guide development of Prosthetic Limb Users Survey of Mobility established a foundation for a new person-centered measure of mobility with a prosthetic limb. Clinical relevance Perspectives of target respondents are needed to guide development of instruments intended to measure health outcomes. Focus groups of prosthetic limb users were conducted to solicit experiences related to mobility with a lower limb prosthesis. Results were used to inform development of a clinically meaningful, person-centered instrument.

A psychometric examination of multimorbidity and mental health in older adults

Objectives: Multimorbidity, the presence of multiple chronic medical conditions, is particularly prevalent in older adults. We examined the relationship of multimorbidity with mental health, social network and activity limitations in the National Health and Aging Trends Study, a nationally representative, age-stratified sample of older adults. Method: After excluding participants who used a proxy to complete the survey and those who did not answer any of the depressive symptoms, anxiety symptoms and positive and negative affect items, the final sample was 7026. A disease count of 10 conditions (heart disease, hypertension, arthritis, osteoporosis, diabetes, lung disease, stroke, dementia, cancer, fracture) was used. Results: Factor analysis indicated a one factor structure for disease count was tenable, although cancer did not appear to fit the model. Therefore, a count of the nine other diseases was used. Disease count was related to increased depressive symptoms, anxiety symptoms and negative affect and less positive affect. All individual diseases including cancer were related to worse mental health as was having two or more conditions. Disease count, having two or more conditions and several individual diseases (heart disease, hypertension, arthritis, cancer and fracture) were also related to increases in social network size while other individual diseases (osteoporosis, diabetes, lung disease, stroke and dementia) were related to decreases in social network size. All the measures of multimorbidity and individual diseases were associated with the increased odds of activity limitations. Conclusions: Results support a broader focus for older adults with multimorbidity that includes mental health needs.