Browsing by Subject "PROMIS"

Now showing 1 - 7 of 7
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    Association of Chronic Pancreatitis Pain Features With Physical, Mental, and Social Health
    (Elsevier, 2023) Yadav, Dhiraj; Askew, Robert L.; Palermo, Tonya; Li, Liang; Andersen, Dana K.; Chen, Minxing; Fisher, William E.; Fogel, Evan L.; Forsmark, Christopher E.; Hart, Phil A.; Othman, Mohamed O.; Pandol, Stephen J.; Park, Walter G.; Topazian, Mark D.; Van Den Eeden, Stephen K.; Swaroop Vege, Santhi; Yang, Yunlong; Serrano, Jose; Conwell, Darwin L.; Consortium for the Study of Chronic Pancreatitis; Diabetes, and Pancreatic Cancer (CPDPC); Medicine, School of Medicine
    Background and aims: Pain is a cardinal symptom of chronic pancreatitis (CP). Using Patient-Reported Outcomes Measurement Information System (PROMIS) measures, we characterized physical and mental health and symptom profiles of a well-defined cohort of individuals with CP and compared them with control subjects. Among patients with CP, we also examined associations between pain (intensity, temporal nature) and PROMIS symptom profiles and the prevalence of clinically significant psychological comorbidities. Methods: We analyzed baseline data in 488 CP patients and 254 control subjects enrolled in PROCEED (Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies), an ongoing longitudinal cohort study. Participants completed the PROMIS-Global Health, which captures global physical and mental health, and the PROMIS-29 profile, which captures 7 symptom domains. Self-reported pain was categorized by severity (none, mild-moderate, severe) and temporal nature (none, intermittent, constant). Demographic and clinical data were obtained from the PROCEED database. Results: Pain was significantly associated with impairments in physical and mental health. Compared with participants with no pain, CP participants with severe pain (but not mild-moderate pain) had more decrements in each PROMIS domain in multivariable models (effect sizes, 2.54-7.03) and had a higher prevalence of clinically significant depression, anxiety, sleep disturbance, and physical disability (odds ratios, 2.11-4.74). Similar results were noted for constant pain (but not intermittent pain) for PROMIS domains (effect sizes, 4.08-10.37) and clinically significant depression, anxiety, sleep disturbance and physical disability (odds ratios, 2.80-5.38). Conclusions: Severe and constant pain are major drivers for poor psychological and physical health in CP. Systematic evaluation and management of psychiatric comorbidities and sleep disturbance should be incorporated into routine management of patients with CP.
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    Comparative Responsiveness of the PROMIS Pain Interference Short Forms with Legacy Pain Measures: Results from Three Randomized Clinical Trials
    (Elsevier, 2019) Chen, Chen X.; Kroenke, Kurt; Stump, Timothy; Kean, Jacob; Krebs, Erin E.; Bair, Matthew J.; Damush, Teresa; Monahan, Patrick O.; School of Nursing
    The PROMIS Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares to legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from three clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n= 261), chronic back or osteoarthritis pain (n = 240), and a history of stroke (n= 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale, Pain/Enjoyment/General Activity (PEG) scale, SF-36 Bodily Pain scale, and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference scale and PEG. The four PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened.
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    Enduring Uncertainty Through the Lens of Osteoporosis: A Mixed Methods Study
    (2024-06) Vlaeminck, Caitlin Mae; Miller, Wendy Trueblood; Carter, Gregory; Crowder, Sharron J.; Otte, Julie; Longtin, Krista
    Osteoporosis is a chronic illness that is underdiagnosed and often poorly managed. Uncertainty is a phenomenon experienced by individuals diagnosed with chronic illness. There are no published American studies describing whether women diagnosed with osteoporosis experience uncertainty. Experiencing uncertainty can lead to decreased quality of life (QOL), delays in decision-making, and negative impacts on relationships. A mixed methods approach was used using descriptive statistics and two scales, The Mishel Uncertainty in Illness Scale-Community Form (MUIS-C) and the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health scale, and Interpretative Phenomenological Analysis (IPA). Significant negative correlations were found between levels of uncertainty and physical health status and between physical and mental health. The qualitative study focused on describing the experience individuals had with the diagnosis of osteoporosis. Data were collected through semi-structured interviews with fourteen Caucasian women who all had a diagnosis of osteopenia or osteoporosis. Thematic analysis revealed five themes that could be chronologically processed: The Sentinel Event, Adapting to Chronic Disease, Navigating Uncertainty, Being Less Than, and What the Future Holds. The findings of this study have implications for how healthcare providers share knowledge and education about the disease of osteoporosis with individuals. Future research should include women and men from diverse racial and ethnic backgrounds. This inclusive approach is crucial for ensuring that preventive measures and management strategies are tailored to the diverse needs of all individuals, fostering equity and efficacy in osteoporosis care.
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    HDQLIFE: development and assessment of health-related quality of life in Huntington disease (HD)
    (Springer, 2016-10) Carlozzi, N. E.; Schilling, S. G.; Lai, J.-S.; Paulsen, J. S.; Hahn, E. A.; Perlmutter, J. S.; Ross, C. A.; Downing, N. R.; Kratz, A. L.; McCormack, M. K.; Nance, M. A.; Quaid, Kimberly A.; Stout, J. C.; Gershon, R. C.; Ready, R. E.; Miner, J. A.; Barton, S. K.; Perlman, S. L.; Rao, S. M.; Frank, S.; Shoulson, I.; Marin, H.; Geschwind, M. D.; Dayalu, P.; Goodnight, S. M.; Cella, D.; Department of Medicine, IU School of Medicine
    Purpose Huntington disease (HD) is a chronic, debilitating genetic disease that affects physical, emotional, cognitive, and social health. Existing patient-reported outcomes (PROs) of health-related quality of life (HRQOL) used in HD are neither comprehensive, nor do they adequately account for clinically meaningful changes in function. While new PROs examining HRQOL (i.e., Neuro-QoL—Quality of Life in Neurological Disorders and PROMIS—Patient-Reported Outcomes Measurement Information System) offer solutions to many of these shortcomings, they do not include HD-specific content, nor have they been validated in HD. HDQLIFE addresses this by validating 12 PROMIS/Neuro-QoL domains in individuals with HD and by using established PROMIS methodology to develop new, HD-specific content. Methods New item pools were developed using cognitive debriefing with individuals with HD, and expert, literacy, and translatability reviews. Existing item banks and new item pools were field tested in 536 individuals with prodromal, early-, or late-stage HD. Results Moderate to strong relationships between Neuro-QoL/PROMIS measures and generic self-report measures of HRQOL, and moderate relationships between Neuro-QoL/PROMIS and clinician-rated measures of similar constructs supported the validity of Neuro-QoL/PROMIS in individuals with HD. Exploratory and confirmatory factor analysis, item response theory, and differential item functioning analyses were utilized to develop new item banks for Chorea, Speech Difficulties, Swallowing Difficulties, and Concern with Death and Dying, with corresponding six-item short forms. A four-item short form was developed for Meaning and Purpose. Conclusions HDQLIFE encompasses both validated Neuro-QoL/PROMIS measures, as well as five new scales in order to provide a comprehensive assessment of HRQOL in HD.
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    Minimally Important Differences and Severity Thresholds are Estimated for the PROMIS Depression Scales from Three Randomized Clinical Trials
    (Elsevier, 2020-04-01) Kroenke, Kurt; Stump, Timothy E.; Chen, Chen X.; Kean, Jacob; Bair, Matthew J.; Damush, Teresa M.; Krebs, Erin E.; Monahan, Patrick O.
    BACKGROUND: Patient Reported Outcomes Measurement Information Systems (PROMIS) scales are increasingly being used to measure symptoms in research and practice. The purpose of this study was to determine the minimally important difference (MID) and severity thresholds (cut-points) for the four fixed-length PROMIS depression scales. METHODS: The study sample was adult participants in three randomized clinical trials (N=651). MID was estimated using multiple distribution- and anchor-based approaches including assessing correspondence between Patient Health Questionnaire (PHQ-9) and PROMIS depression scores. RESULTS: The best MID estimate was a PROMIS depression T-score of 3.5 points with most methods producing an MID in the 3 to 4 point range across all three samples. MID estimates were similar for all four PROMIS scales. A PHQ-9 1-point change equated to a PROMIS 1.25-point T-score change. PROMIS T-scores of 55, 60, 65, and 70 appeared to be reasonable thresholds for mild, moderate, moderately severe, and severe depression, respectively. LIMITATIONS: The study sample was predominantly male veterans with either chronic pain (2 trials) or previous stroke (1 trial). The severity of depression was mild to moderate. CONCLUSION: A T-score of 3 to 4 points is a reasonable MID for PROMIS depression scales and can be used to assess treatment effects in both practice and research as well to calculate sample sizes for clinical trials. Severity cut-points can help interpret the meaning of scores and action thresholds for treatment decisions.
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    Operating characteristics of PROMIS four-item depression and anxiety scales in primary care patients with chronic pain
    (Oxford University Press, 2014-11) Kroenke, Kurt; Yu, Zhangsheng; Wu, Jingwei; Kean, Jacob; Monahan, Patrick O.; Medicine, School of Medicine
    OBJECTIVE: Depression and anxiety are prevalent in patients with chronic pain and adversely affect pain, quality of life, and treatment response. The purpose of this psychometric study was to determine the reliability and validity of the four-item Patient Reported Outcomes Measurement Information System (PROMIS) depression and anxiety scales in patients with chronic pain. DESIGN: Secondary analysis of data from the Stepped Care to Optimize Pain care Effectiveness study, a randomized clinical trial of optimized analgesic therapy. SETTING: Five primary care clinics at the Roudebush VA Medical Center (RVAMC) in Indianapolis, Indiana. SUBJECTS: Two hundred forty-four primary care patients with chronic musculoskeletal pain. METHODS: All patients completed the four-item depression and anxiety scales from the PROMIS 29-item profile, as well as several other validated psychological measures. The minimally important difference (MID) using the standard error of measurement (SEM) was calculated for each scale, and convergent validity was assessed by interscale correlations at baseline and 3 months. Operating characteristics of the PROMIS measures for detecting patients who had probable major depression or were anxiety-disorder screen-positive were calculated. RESULTS: The PROMIS scales had good internal reliability, and the MID (as represented by two SEMs) was 2 points for the depression scale and 2.5 points for the anxiety scale. Convergent validity was supported by strong interscale correlations. The optimal screening cutpoint on the 4- to 20-point PROMIS scales appeared to be 8 for both the depression and anxiety scales. CONCLUSIONS: The PROMIS four-item depression and anxiety scales are reasonable options as ultra-brief measures for screening in patients with chronic pain.
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    Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials
    (BMC, 2021-02-02) Kroenke, Kurt; Stump, Timothy E.; Chen, Chen X.; Kean, Jacob; Damush, Teresa M.; Bair, Matthew J.; Krebs, Erin E.; Monahan, Patrick O.
    The PROMIS depression scales are reliable and valid measures that have extensive normative data in general population samples. However, less is known about how responsive they are to detect change in clinical settings and how their responsiveness compares to legacy measures. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples.