Browsing by Author "Reeve, Bryce B"
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Item Open Access A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study.(PloS one, 2018-01) Evon, Donna M; Stewart, Paul W; Amador, Jipcy; Serper, Marina; Lok, Anna S; Sterling, Richard K; Sarkar, Souvik; Golin, Carol E; Reeve, Bryce B; Nelson, David R; Reau, Nancy; Lim, Joseph K; Reddy, K Rajender; Di Bisceglie, Adrian M; Fried, Michael WSymptom burden, medical comorbidities, and functional well-being of patients with chronic hepatitis C virus (HCV) initiating direct acting antiviral (DAA) therapy in real-world clinical settings are not known. We characterized these patient-reported outcomes (PROs) among HCV-infected patients and explored associations with sociodemographic, liver disease, and psychiatric/substance abuse variables.PROP UP is a large US multicenter observational study that enrolled 1,600 patients with chronic HCV in 2016-2017. Data collected prior to initiating DAA therapy assessed the following PROs: number of medical comorbidities; neuropsychiatric, somatic, gastrointestinal symptoms (PROMIS surveys); overall symptom burden (Memorial Symptom Assessment Scale); and functional well-being (HCV-PRO). Candidate predictors included liver disease markers and patient-reported sociodemographic, psychiatric, and alcohol/drug use features. Predictive models were explored using a random selection of 700 participants; models were then validated with data from the remaining 900 participants. The cohort was 55% male, 39% non-white, 48% had cirrhosis (12% with advanced cirrhosis); 52% were disabled or unemployed; 63% were on public health insurance or uninsured; and over 40% had markers of psychiatric illness. The median number of medical comorbidities was 4 (range: 0-15), with sleep disorders, chronic pain, diabetes, joint pain and muscle aches being present in 20-50%. Fatigue, sleep disturbance, pain and neuropsychiatric symptoms were present in over 60% and gastrointestinal symptoms in 40-50%. In multivariable validation models, the strongest and most frequent predictors of worse PROs were disability, unemployment, and use of psychiatric medications, while liver markers generally were not.This large multi-center cohort study provides a comprehensive and contemporary assessment of the symptom burden and comorbid medical conditions in patients with HCV treated in real world settings. Pain, fatigue, and sleep disturbance were common and often severe. Sociodemographic and psychiatric markers were the most robust predictors of PROs. Future research that includes a rapidly changing population of HCV-infected individuals needs to evaluate how DAA therapy affects PROs and elucidate which symptoms resolve with viral eradication.(Clinicaltrial.gov: NCT02601820).Item Open Access A dimensional approach to understanding severity estimates and risk correlates of marijuana abuse and dependence in adults.(International journal of methods in psychiatric research, 2012-06) Wu, Li-Tzy; Woody, George E; Yang, Chongming; Pan, Jeng-Jong; Reeve, Bryce B; Blazer, Dan GWhile item response theory (IRT) research shows a latent severity trait underlying response patterns of substance abuse and dependence symptoms, little is known about IRT-based severity estimates in relation to clinically relevant measures. In response to increased prevalences of marijuana-related treatment admissions, an elevated level of marijuana potency, and the debate on medical marijuana use, we applied dimensional approaches to understand IRT-based severity estimates for marijuana use disorders (MUDs) and their correlates while simultaneously considering gender- and race/ethnicity-related differential item functioning (DIF). Using adult data from the 2008 National Survey on Drug Use and Health (N = 37,897), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for MUDs among past-year marijuana users were examined by IRT, logistic regression, and multiple indicators-multiple causes (MIMIC) approaches. Among 6917 marijuana users, 15% met criteria for a MUD; another 24% exhibited subthreshold dependence. Abuse criteria were highly correlated with dependence criteria (correlation = 0.90), indicating unidimensionality; item information curves revealed redundancy in multiple criteria. MIMIC analyses showed that MUD criteria were positively associated with weekly marijuana use, early marijuana use, other substance use disorders, substance abuse treatment, and serious psychological distress. African Americans and Hispanics showed higher levels of MUDs than Whites, even after adjusting for race/ethnicity-related DIF. The redundancy in multiple criteria suggests an opportunity to improve efficiency in measuring symptom-level manifestations by removing low-informative criteria. Elevated rates of MUDs among African Americans and Hispanics require research to elucidate risk factors and improve assessments of MUDs for different racial/ethnic groups.Item Open Access An item response theory analysis of DSM-IV criteria for hallucinogen abuse and dependence in adolescents.(Addictive behaviors, 2010-03) Wu, Li-Tzy; Pan, Jeng-Jong; Yang, Chongming; Reeve, Bryce B; Blazer, Dan GAIM:This study applied both item response theory (IRT) and multiple indicators-multiple causes (MIMIC) methods to evaluate item-level psychometric properties of diagnostic questions for hallucinogen use disorders (HUDs), differential item functioning (DIF), and predictors of latent HUD. METHODS:Data were drawn from 2004-2006 National Surveys on Drug Use and Health. Analyses were based on 1548 past-year hallucinogen users aged 12-17 years. Substance use and symptoms were assessed by audio computer-assisted self-interviewing methods. RESULTS:Abuse and dependence criteria empirically were arrayed along a single continuum of severity. All abuse criteria indicated middle-to-high severity on the IRT-defined HUD continuum, while dependence criteria captured a wider range from the lowest (tolerance and time spent) to the highest (taking larger amounts and inability to cut down) severity levels. There was indication of DIF by hallucinogen users' age, gender, race/ethnicity, and ecstasy use status. Adjusting for DIF, ecstasy users (vs. non-ecstasy hallucinogen users), females (vs. males), and whites (vs. Hispanics) exhibited increased odds of HUD. CONCLUSIONS:Symptoms of hallucinogen abuse and dependence empirically do not reflect two discrete conditions in adolescents. Trends and problems related to hallucinogen use among girls and whites should be examined further to inform the designs of effective gender-appropriate and culturally sensitive prevention programs.Item Open Access Co-occurring reasons for medication nonadherence within subgroups of patients with hyperlipidemia.(Journal of behavioral medicine, 2019-04) Blalock, Dan V; Bosworth, Hayden B; Reeve, Bryce B; Voils, Corrine IMedication nonadherence is a significant clinical problem among individuals taking statins. Poor adherence is often attributable to several reasons, yet most adherence interventions target a single reason. Baseline data were examined from a randomized clinical trial of 236 patients with hyperlipidemia. A latent class analysis was then performed on patients reporting any nonadherence (n = 109). A 4-class solution provided the most optimal fit and differentiation of classes. Class 1 (N = 59, 54%) included patients who reported occasionally forgetting. Class 2 (N = 16, 14%) represented patients who were concerned about side effects. Class 3 (N = 17, 16%) represented patients who reported out-of-routine life events as contributing to nonadherence. Class 4 (N = 17, 16%) represented patients who endorsed a large number reasons indiscriminately. Class membership was almost uniformly unrelated to any patient demographic factors or treatment arm. Each cluster of reasons defining these patients may be best addressed through different intervention strategies.Item Open Access Congruence of patient- and clinician-reported toxicity in women receiving chemotherapy for early breast cancer.(Cancer, 2020-04-21) Nyrop, Kirsten A; Deal, Allison M; Reeve, Bryce B; Basch, Ethan; Chen, Yi Tang; Park, Ji Hye; Shachar, Shlomit S; Carey, Lisa A; Reeder-Hayes, Katherine E; Dees, Elizabeth C; Jolly, Trevor A; Kimmick, Gretchen G; Karuturi, Meghan S; Reinbolt, Raquel E; Speca, JoEllen C; Lee, Jordan T; Wood, William A; Muss, Hyman BBACKGROUND:The National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, collected alongside the clinician-reported Common Terminology Criteria for Adverse Events, enables comparisons of patient and clinician reports on treatment toxicity. METHODS:In a multisite study of women receiving chemotherapy for early-stage breast cancer, symptom reports were collected on the same day from patients and their clinicians for 17 symptoms; their data were not shared with each other. The proportions of moderate, severe, or very severe patient-reported symptom severity were compared with the proportions of clinician-rated grade 2, 3, or 4 toxicity. Patient-clinician agreement was assessed via κ statistics. Chi-square tests investigated whether patient characteristics were associated with patient-clinician agreement. RESULTS:Among 267 women, the median age was 58 years (range, 24-83 years), and 26% were nonwhite. There was moderate scoring agreement (κ = 0.413-0.570) for 53% of symptoms, fair agreement for 41% (κ = 0.220-0.378), and slight agreement for 6% (κ = 0.188). For example, patient-reported and clinician-rated percentages were 22% and 8% for severe or very severe fatigue, 41% and 46% for moderate fatigue, 32% and 39% for mild fatigue, and 6% and 7% for none. Clinician severity scores were lower for nonwhite patients in comparison with white patients for peripheral neuropathy, nausea, arthralgia, and dyspnea. CONCLUSIONS:Although clinician reporting of symptoms is common practice in oncology, there is suboptimal agreement with the gold standard of patient self-reporting. These data provide further evidence supporting the integration of patient-reported outcomes into oncological clinical research and clinical practice to improve monitoring of symptoms as well as timely interventions for symptoms.Item Open Access Construct and differential item functioning in the assessment of prescription opioid use disorders among American adolescents.(Journal of the American Academy of Child and Adolescent Psychiatry, 2009-05) Wu, Li-Tzy; Ringwalt, Christopher L; Yang, Chongming; Reeve, Bryce B; Pan, Jeng-Jong; Blazer, Dan GOBJECTIVE:To examine the psychometric properties of diagnostic criteria for prescription analgesic opioid use disorders (OUDs) and to identify background predictors of a latent continuum for OUD liability. METHOD:Data were drawn from the adolescent sample of the 2006 National Survey of Drug Use and Health. Item response theory (IRT) and multiple indicators-multiple causes methods were used to examine DSM-IV criteria for OUDs in a subsample of adolescents who reported nonmedical prescription opioid use in the past year (N = 1,290). RESULTS:Among nonmedical users of prescription opioids, the criteria of OUDs were arrayed along a single continuum of severity. All abuse criteria were endorsed at a severity level higher than D1 (tolerance) and D5 (time spent) but lower than D3 (taking larger amounts) and D4 (inability to cut down). Differential item functioning in reports of dependence symptoms across adolescents' sex and race/ethnicity were identified: withdrawal, time spent, and continued use despite medical or psychological problems. Adjusting for the effects of differential item functioning and the demographic variables examined, female subjects were more likely than male subjects to exhibit a higher level of OUD liability. CONCLUSIONS:Study findings do not support the DSM-IV's current hierarchical distinction between abuse of and dependence on prescription opioids. Abuse symptoms in adolescents are not necessarily less severe than those of dependence. There is evidence of some differential item functioning in the assessment of OUDs.Item Open Access Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).(Journal of comparative effectiveness research, 2015-01) Chen, Ronald C; Carpenter, William R; Kim, Mimi; Hendrix, Laura H; Agans, Robert P; Meyer, Anne-Marie; Hoffmeyer, Anna; Reeve, Bryce B; Nielsen, Matthew E; Usinger, Deborah S; Strigo, Tara S; Jackman, Anne M; Anderson, Mary; Godley, Paul AThe North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.Item Open Access Exploring Communication Ability in Individuals With Angelman Syndrome: Findings From Qualitative Interviews With Caregivers.(American journal on intellectual and developmental disabilities, 2023-05) Zigler, Christina K; Lucas, Nicole; McFatrich, Molly; Gordon, Kelly L; Jones, Harrison N; Berent, Allyson; Panagoulias, Jennifer; Evans, Paula; Reeve, Bryce BCommunication deficits have a substantial impact on quality of life for individuals with Angelman syndrome (AS) and their families, but limited qualitative work exists to support the necessary content of measures aiming to assess communication for these individuals. Following best practices for concept elicitation studies, we conducted individual qualitative interviews with caregivers and clinicians to elicit meaningful aspects of communication for individuals with AS. Caregivers were able to discuss their child's specific communication behaviors within a large number of expressive, receptive, and pragmatic functions via numerous symbolic and non-symbolic modalities. These results aligned well with published literature on communication in AS and will be used to inform the design of a novel caregiver-reported measure. Future studies on communication in individuals with AS should focus on gathering quantitative data from large samples of diverse caregivers, which would allow for estimations of the frequency of specific behaviors across the population.Item Open Access Facets of physical function assessed by patient-reported outcome measures in oncology research.(Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2024-04) Coles, Theresa; Fillipo, Rebecca; Plyler, Kate; Hernandez, Alexy; Henke, Debra M; Arizmendi, Cara; Cantrell, Sarah; Lagoo-Deenadayalan, Sandhya; Rory Goodwin, C; LeBlanc, Thomas W; Horodniceanu, Erica G; Bhatnagar, Vishal; Reeve, Bryce B; Weinfurt, KevinPurpose
The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure.Methods
As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a "card sort" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item.Results
The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation.Conclusion
Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.Item Open Access Helping the Demand Find the Supply: Messaging the Value of Specialty Palliative Care Directly to Those With Serious Illnesses.(Journal of pain and symptom management, 2019-06) Kamal, Arif H; Docherty, Sharron L; Reeve, Bryce B; Samsa, Gregory P; Bosworth, Hayden B; Pollak, Kathryn IItem Open Access Patients' Experiences With Staphylococcus aureus and Gram-Negative Bacterial Bloodstream Infections: Results From Cognitive Interviews to Inform Assessment of Health-Related Quality of Life.(Open forum infectious diseases, 2022-02) King, Heather A; Doernberg, Sarah B; Grover, Kiran; Miller, Julie; Oakes, Megan; Wang, Tsai-Wei; McFatrich, Molly; Ruffin, Felicia; Staman, Karen; Lane, Hannah G; Rader, Abigail; Sund, Zoë; Bosworth, Hayden B; Reeve, Bryce B; Fowler, Vance G; Holland, Thomas LBackground
We previously conducted a concept elicitation study on the impact of Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient's perspective and found significant impacts on HRQoL, particularly in the physical and functional domains. Using this information and following guidance on the development of patient-reported outcome (PRO) measures, we determined which combination of measures and items (ie, specific questions) would be most appropriate in a survey assessing HRQoL in bloodstream infections.Methods
We selected a variety of measures/items from the Patient-Reported Outcomes Measurement Information System (PROMIS) representing different domains. We purposefully sampled patients ~6-12 weeks post-SAB/GNB and conducted 2 rounds of cognitive interviews to refine the survey by exploring patients' understanding of items and answer selection as well as relevance for capturing HRQoL.Results
We interviewed 17 SAB/GNB patients. Based on the first round of cognitive interviews (n = 10), we revised the survey. After round 2 of cognitive interviewing (n = 7), we finalized the survey to include 10 different PROMIS short forms/measures of the most salient HRQoL domains and 2 adapted questions (41 items total) that were found to adequately capture HRQoL.Conclusions
We developed a survey from well-established PRO measures that captures what matters most to SAB/GNB patients as they recover. This survey, uniquely tailored to bloodstream infections, can be used to assess these meaningful, important HRQoL outcomes in clinical trials and in patient care. Engaging patients is crucial to developing treatments for bloodstream infections.Item Open Access Relationship between sleep and exercise as colorectal cancer survivors transition off treatment.(Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2018-08) Coles, Theresa; Bennett, Antonia V; Tan, Xianming; Battaglini, Claudio L; Sanoff, Hanna K; Basch, Ethan; Jensen, Roxanne E; Reeve, Bryce BThe primary objective of this study was to evaluate the relationship between exercise and sleep disturbance in a sample of individuals diagnosed with stage I, II, and III colorectal cancer (CRC) as patients transitioned off first-line treatment. We also sought to identify heterogeneity in the relationship between sleep disturbance and exercise.Data were obtained from the MY-Health study, a community-based observational study of adults diagnosed with cancer. Patient-Reported Outcomes Measurement Information System® (PROMIS) measures (e.g., PROMIS Sleep) were administered, and participants self-reported demographics, comorbidities, cancer treatment, and exercise. Regression mixture and multiple regression models were used to evaluate the relationship between sleep disturbance and exercise cross-sectionally at an average of 10 months after diagnosis, and the change in sleep disturbance over a 7-month period, from approximately 10 to 17 months post-diagnosis.Patients whose exercise was categorized as likely at or above American College of Sports Medicine's guidelines did not report statistically better sleep quality compared to patients who were classified as not active. However, retirement (B = - 2.4), anxiety (B = 0.21), and fatigue (B = 0.24) had statistically significant relationships with sleep disturbance (p < 0.05). Increase in exercise was not significantly associated with a decrease in sleep disturbance. No statistical heterogeneity was revealed in the relationship between sleep and exercise.Further prospective research using an objective measure of exercise is warranted to confirm or refute the nature of the relationship between exercise and sleep disturbance in individuals diagnosed with CRC transitioning off first-line treatment.Item Open Access Reporting and utilization of Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures in orthopedic research and practice: a systematic review.(Journal of orthopaedic surgery and research, 2020-11-23) Horn, Maggie E; Reinke, Emily K; Couce, Logan J; Reeve, Bryce B; Ledbetter, Leila; George, Steven ZBACKGROUND:The Patient-Reported Outcomes Measurement Information SystemⓇ (PROMISⓇ) is a dynamic system of psychometrically sound patient-reported outcome (PRO) measures. There has been a recent increase in the use of PROMIS measures, yet little has been written about the reporting of these measures in the field of orthopedics. The purpose of this study was to conduct a systematic review to determine the uptake of PROMIS measures across orthopedics and to identify the type of PROMIS measures and domains that are most commonly used in orthopedic research and practice. METHODS:We searched PubMed, Embase, and Scopus using keywords and database-specific subject headings to capture orthopedic studies reporting PROMIS measures through November 2018. Our inclusion criteria were use of PROMIS measures as an outcome or used to describe a population of patients in an orthopedic setting in patients ≥ 18 years of age. We excluded non-quantitative studies, reviews, and case reports. RESULTS:Our final search yielded 88 studies published from 2013 through 2018, with 57% (50 studies) published in 2018 alone. By body region, 28% (25 studies) reported PROMIS measures in the upper extremity (shoulder, elbow, hand), 36% (32 studies) reported PROMIS measures in the lower extremity (hip, knee, ankle, foot), 19% (17 studies) reported PROMIS measures in the spine, 10% (9 studies) reported PROMIS measures in trauma patients, and 6% (5 studies) reported PROMIS measures in general orthopedic patients. The majority of studies reported between one and three PROMIS domains (82%, 73 studies). The PROMIS Computerized Adaptive Test (CAT) approach was most commonly used (81%, 72 studies). The most frequently reported PROMIS domains were physical function (81%, 71 studies) and pain interference (61%, 54 studies). CONCLUSION:Our review found an increase in the reporting of PROMIS measures over the recent years. Utilization of PROMIS measures in orthopedic populations is clinically appropriate and can facilitate communication of outcomes across different provider types and with reduced respondent burden. REGISTRATION:The protocol for this systematic review was designed in accordance with the PRISMA guidelines and is registered with the PROSPERO database (CRD42018088260).Item Open Access Responsiveness of the PROMIS® measures to changes in disease status among pediatric nephrotic syndrome patients: a Midwest pediatric nephrology consortium study.(Health Qual Life Outcomes, 2017-08-23) Selewski, David T; Troost, Jonathan P; Cummings, Danyelle; Massengill, Susan F; Gbadegesin, Rasheed A; Greenbaum, Larry A; Shatat, Ibrahim F; Cai, Yi; Kapur, Gaurav; Hebert, Diane; Somers, Michael J; Trachtman, Howard; Pais, Priya; Seifert, Michael E; Goebel, Jens; Sethna, Christine B; Mahan, John D; Gross, Heather E; Herreshoff, Emily; Liu, Yang; Carlozzi, Noelle E; Reeve, Bryce B; DeWalt, Darren A; Gipson, Debbie SBACKGROUND: Nephrotic syndrome represents a condition in pediatric nephrology typified by a relapsing and remitting course, proteinuria and the presence of edema. The PROMIS measures have previously been studied and validated in cross-sectional studies of children with nephrotic syndrome. This study was designed to longitudinally validate the PROMIS measures in pediatric nephrotic syndrome. METHODS: One hundred twenty seven children with nephrotic syndrome between the ages of 8 and 17 years participated in this prospective cohort study. Patients completed a baseline assessment while their nephrotic syndrome was active, a follow-up assessment at the time of their first complete proteinuria remission or study month 3 if no remission occurred, and a final assessment at study month 12. Participants completed six PROMIS measures (Mobility, Fatigue, Pain Interference, Depressive Symptoms, Anxiety, and Peer Relationships), the PedsQL version 4.0, and two global assessment of change items. RESULTS: Disease status was classified at each assessment: nephrotic syndrome active in 100% at baseline, 33% at month 3, and 46% at month 12. The PROMIS domains of Mobility, Fatigue, Pain Interference, Depressive Symptoms, and Anxiety each showed a significant overall improvement over time (p < 0.001). When the PROMIS measures were compared to the patients' global assessment of change, the domains of Mobility, Fatigue, Pain Interference, and Anxiety consistently changed in an expected fashion. With the exception of Pain Interference, change in PROMIS domain scores did not correlate with changes in disease activity. PROMIS domain scores were moderately correlated with analogous PedsQL domain scores. CONCLUSION: This study demonstrates that the PROMIS Mobility, Fatigue, Pain Interference, and Anxiety domains are sensitive to self-reported changes in disease and overall health status over time in children with nephrotic syndrome. The lack of significant anchoring to clinically defined nephrotic syndrome disease active and remission status may highlight an opportunity to improve the measurement of HRQOL in children with nephrotic syndrome through the development of a nephrotic syndrome disease-specific HRQOL measure.Item Open Access State of the psychometric methods: patient-reported outcome measure development and refinement using item response theory.(Journal of patient-reported outcomes, 2019-07-30) Stover, Angela M; McLeod, Lori D; Langer, Michelle M; Chen, Wen-Hung; Reeve, Bryce BBACKGROUND:This paper is part of a series comparing different psychometric approaches to evaluate patient-reported outcome (PRO) measures using the same items and dataset. We provide an overview and example application to demonstrate 1) using item response theory (IRT) to identify poor and well performing items; 2) testing if items perform differently based on demographic characteristics (differential item functioning, DIF); and 3) balancing IRT and content validity considerations to select items for short forms. METHODS:Model fit, local dependence, and DIF were examined for 51 items initially considered for the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Depression item bank. Samejima's graded response model was used to examine how well each item measured severity levels of depression and how well it distinguished between individuals with high and low levels of depression. Two short forms were constructed based on psychometric properties and consensus discussions with instrument developers, including psychometricians and content experts. Calibrations presented here are for didactic purposes and are not intended to replace official PROMIS parameters or to be used for research. RESULTS:Of the 51 depression items, 14 exhibited local dependence, 3 exhibited DIF for gender, and 9 exhibited misfit, and these items were removed from consideration for short forms. Short form 1 prioritized content, and thus items were chosen to meet DSM-V criteria rather than being discarded for lower discrimination parameters. Short form 2 prioritized well performing items, and thus fewer DSM-V criteria were satisfied. Short forms 1-2 performed similarly for model fit statistics, but short form 2 provided greater item precision. CONCLUSIONS:IRT is a family of flexible models providing item- and scale-level information, making it a powerful tool for scale construction and refinement. Strengths of IRT models include placing respondents and items on the same metric, testing DIF across demographic or clinical subgroups, and facilitating creation of targeted short forms. Limitations include large sample sizes to obtain stable item parameters, and necessary familiarity with measurement methods to interpret results. Combining psychometric data with stakeholder input (including people with lived experiences of the health condition and clinicians) is highly recommended for scale development and evaluation.Item Open Access The need for a Serious Illness Digital Ecosystem (SIDE) to improve outcomes for patients receiving palliative and hospice care.(The American journal of managed care, 2020-04) Nicolla, Jonathan; Bosworth, Hayden B; Docherty, Sharron L; Pollak, Kathryn I; Powell, Jeremy; Sellers, Nichole; Reeve, Bryce B; Samsa, Greg; Sutton, Linda; Kamal, Arif HPalliative and hospice care services produce immense benefits for patients living with serious illness and for their families. Due to the national shift toward value-based payment models, health systems and payers share a heightened awareness of the need to incorporate palliative and hospice services into their service mix for seriously ill patient populations. During the last decade, a tremendous amount of capital has been invested to better integrate information technology into healthcare. This includes development of technologies to promote utilization of palliative and hospice services. However, no coordinated strategy exists to link such efforts together to create a cohesive strategy that transitions from identification of patients through receipt of services. A Serious Illness Digital Ecosystem (SIDE) is the intentional aggregation of disparate digital and mobile health technologies into a single system that connects all of the actors involved in serious illness patient care. A SIDE leverages deployed health technologies across disease continuums and geographic locations of care to facilitate the flow of information among patients, providers, health systems, and payers. Five pillars constitute a SIDE, and each one is critical to the success of the system. The 5 pillars of a SIDE are: Identification, Education, Engagement, Service Delivery, and Remote Monitoring. As information technology continues to evolve and becomes a part of the care delivery landscape, it is necessary to develop cohesive ecosystems that inform all parts of the serious illness patient experience and identifies patients for the right services, at the right time.Item Open Access Use of item response theory and latent class analysis to link poly-substance use disorders with addiction severity, HIV risk, and quality of life among opioid-dependent patients in the Clinical Trials Network.(Drug and alcohol dependence, 2011-11) Wu, Li-Tzy; Ling, Walter; Burchett, Bruce; Blazer, Dan G; Yang, Chongming; Pan, Jeng-Jong; Reeve, Bryce B; Woody, George EBACKGROUND:This study applied item response theory (IRT) and latent class analysis (LCA) procedures to examine the dimensionality and heterogeneity of comorbid substance use disorders (SUDs) and explored their utility for standard clinical assessments, including the Addiction Severity Index (ASI), HIV Risk Behavior Scale (HRBS), and SF-36 quality-of-life measures. METHODS:The sample included 343 opioid-dependent patients enrolled in two national multisite studies of the U.S. National Drug Abuse Treatment Clinical Trials Network (CTN001-002). Patients were recruited from inpatient and outpatient addiction treatment settings at 12 programs. Data were analyzed by factor analysis, IRT, LCA, and latent regression procedures. RESULTS:A two-class LCA model fit dichotomous SUD data empirically better than one-parameter and two-parameter IRT models. LCA distinguished 10% of severe comorbid opioid-dependent individuals who had high rates of all SUDs examined-especially amphetamine and sedative abuse/dependence-from the remaining 90% who had SUDs other than amphetamine and sedative abuse/dependence (entropy=0.99). Item-level results from both one-parameter and two-parameter IRT models also found that amphetamine and sedative abuse/dependence tapped the more severe end of the latent poly-SUD trait. Regardless of whether SUDs were defined as a continuous trait or categorically, individuals characterized by a high level of poly-SUD demonstrated more psychiatric problems and HIV risk behaviors. CONCLUSIONS:A combined application of categorical and dimensional latent approaches may improve the understanding of comorbid SUDs and their associations with other clinical indicators. Abuse of sedatives and methamphetamine may serve as a useful marker for identifying subsets of opioid-dependent individuals with needs for more intensive interventions.Item Open Access Use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures to characterise health status for patients seeking care from an orthopaedic provider: a retrospective cohort study.(BMJ open, 2021-09-02) Horn, Maggie E; Reinke, Emily K; Yan, Xiaofang; Luo, Sheng; Bolognesi, Michael; Reeve, Bryce B; George, Steven Z; Comprehensive Outcomes in Orthopaedics and Rehabilitation Data System (COORDS) groupObjectives
Characterise the health status of patients newly consulting an orthopaedic specialist across eight clinical subspecialties.Design
Retrospective cohort.Setting
18 orthopaedic clinics, including 8 subspecialties (14 ambulatory and 4 hospital based) within an academic health system.Participants
14 910 patients consulting an orthopaedic specialist for a new patient consultation who completed baseline Patient-Reported Outcomes Measurement Information System (PROMIS) measures associated with their appointment from 17 November 2017 to 13 May 2019. Patients were aged 55.72±5.8 years old, and 61.3% were female and 79.3% were Caucasian and 13.4% were black or African American. Patients who did not complete PROMIS measures or cancelled their appointment were excluded from the study.Primary outcome
PROMIS domains of physical function, pain interference, pain intensity, depression, anxiety, fatigue, sleep disturbance and the ability to participate in social roles.Results
Mean PROMIS scores for physical function were (38.1±9.2), pain interference (58.9±8.1), pain intensity (4.6±2.5), depression (47.9±8.9), anxiety (49.9±9.5), fatigue (50.5±10.3), sleep disturbance (51.1±9.8) and ability to participate in social roles (49.1±10.3) for the entire cohort. Across the clinical subspecialties, neurosurgery, spine and trauma patients were most profoundly affected across almost all domains and patients consulting with a hand specialist reported the least limitations or symptoms across domains. There was a moderate, negative correlation between pain interference and physical functioning (r=-0.59) and low correlations between pain interference with anxiety (r=0.36), depression (r=0.39) as well as physical function and anxiety (r=-0.32) and depression(r=-0.30) and sleep (r=-0.31).Conclusions
We directly compared clinically meaningful PROMIS domains across eight orthopaedic subspecialties, which would not have been possible with legacy measures alone. These results support PROMIS's utility as a common metric to assess and compare patient health status across multiple orthopaedic subspecialties.Item Open Access Validation of the Observer-Reported Communication Ability (ORCA) Measure for Individuals With Angelman Syndrome.(American journal on intellectual and developmental disabilities, 2023-05) Zigler, Christina K; Lin, Li; McFatrich, Molly; Lucas, Nicole; Gordon, Kelly L; Jones, Harrison N; Berent, Allyson; Panagoulias, Jennifer; Evans, Paula; Reeve, Bryce BThere is a critical need for high-quality clinical outcome assessments to capture the important aspects of communication ability of individuals with Angelman syndrome (AS). To center the perspective of caregivers, our team developed the novel Observer-Reported Communication Ability (ORCA) measure using best practice guidelines, with the goal of developing a measure that could be administered to caregivers directly without the need for a certified administrator for use in clinical trials. To refine the draft measure, we conducted two rounds of cognitive interviews with 24 caregivers and a quantitative study including 249 caregivers. The results from both studies support the overall content validity, construct validity, and the reliability of the ORCA measure for individuals with AS > 2 years old for use in research contexts. Future work should explore the responsiveness of ORCA measures to changes over time in a diverse sample.