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Elizabeth A Hahn,1,2 Phillip A Ianni,3 Robin A Hanks,4 Jennifer A Miner,3 Jenna Freedman,3 Noelle E Carlozzi3 1Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 2Center for Patient-Centered Outcomes, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 3Center for Clinical Outcomes Development and Application (CODA), Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA; 4Department of Physical Medicine and Rehabilitation, School of Medicine, Wayne State University, Detroit, MI, USA Purpose: Caregivers have expressed interest in survey research, yet there is limited information available about survey response burden, ie, the time, effort, and other demands needed to complete the survey. This may be particularly important for caregivers due to excessive time demands and/or stress associated with caregiving. Method: Survey response burden indicators were collected as part of a study to develop and validate a patient-reported outcome (PRO) measurement system for caregivers of civilians or service members/veterans (SMVs) with traumatic brain injury (TBI). Results: Compared to the group caring for civilians (n=335), the group caring for SMVs (n=123) was comprised of all women, was younger, had fewer racial/ethnic minorities, had more education, and nearly all were the spouse of a person with TBI. All PRO outcomes were poorer for the group caring for SMVs. Although the caregivers of SMVs had poorer PRO outcomes compared to caregivers of civilians, they were more likely to report that they would recommend the study to others. Caregivers with less education and those from racial/ethnic minority groups had more favorable ratings of their study participation experience, even though they needed more help using the computer or answering the questions. Conclusion: The results of this study provide useful information about the acceptability of computer-based survey administration for caregiver PROs. PROs are widely gathered in clinical and health services research and could be particularly useful in TBI care programs. More data are needed to determine the best assessment strategies for individuals with lower education who are likely to require some assistance completing PRO surveys. Studies evaluating PROs administered by multimedia platforms could help researchers and clinicians plan the best strategies for assessing health-related quality of life in TBI caregivers. Keywords: patient-reported outcomes, computer-based survey administration, study participation ratings, military personnel

PurposeHuntington 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.MethodsNew 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.ResultsModerate 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.ConclusionsHDQLIFE encompasses both validated Neuro-QoL/PROMIS measures, as well as five new scales in order to provide a comprehensive assessment of HRQOL in HD.

Objective: To test the efficacy of a randomized control trial low-touch mobile health intervention designed to promote care partner self-awareness and self-care., Design: This randomized controlled trial included a baseline assessment of self-report surveys of health-related quality of life (HRQOL), care partner-specific outcomes, and the functional/mental status of the person with traumatic brain injury (TBI), as well as a 6-month home monitoring period that included 3 daily questions about HRQOL, monthly assessments of 12 HRQOL domains, and the use of a Fitbit to continuously monitor physical activity and sleep. HRQOL surveys were repeated at 3 and 6 months post-home monitoring., Setting: Two academic medical centers., Participants: A total of 254 TBI care partners., Interventions: The CareQOL app, a mobile health app designed to promote care partner self-awareness (through self-monitoring) and self-care (through personalized self-care push notifications)., Results: Care partners were randomly assigned to self-monitoring alone (n=128) or self-monitoring plus self-care push notifications (n=126). Although we neither saw improvements in HRQOL outcomes, nor in physical activity or sleep, we found that across all the different measures, approximately 1/3 of the participants showed clinically meaningful improvements, 1/3 stayed the same, and 1/3 got worse; care partners who reported engagement in the intervention were more likely to show improvements than those who were not engaged. There was preliminary support for factors that being male, caring for a person with posttraumatic stress symptoms, living in the same household as the person with TBI, being a spousal care partner, working, and being diagnosed with COVID-19 during the study were associated with increased risk for negative outcomes., Conclusions: Findings suggest that engagement with the app, even when it is confined to self-monitoring alone, is associated with small improvements in HRQOL., (Copyright © 2025 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Aims: This study aims to improve the interpretability and clinical utility of the COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) by identifying distinct financial toxicity classes in adults with diabetes., Methods: Data included a sample of 600 adults with Type 1 or Type 2 diabetes and high A1c. Latent Class Analysis was used to identify subgroups of patients based on COST-FACIT score patterns., Results: We identified 3 financial toxicity classes (high, medium and low) with strong indicators of membership classification. Multiple indicators of financial stress, maladaptive cost-coping behaviors, more comorbidities, more prescribed medications, more diabetes distress, more depressive symptoms, closer to the federal poverty level, female, having lower educational attainment and being single were all significant predictors of high financial toxicity class membership. A score of 26 on the COST-FACIT was the strongest threshold for sorting high vs. medium/low financial toxicity, with a positive predictive value (PPV) of 76% and negative predictive value (NPV) of 93%., Conclusion: The COST-FACIT can be used to reliably identify people with diabetes that have high financial toxicity. Integrating this new cut-score into clinical practice may help clinical teams identify people in need of additional support due to financial toxicity., Competing Interests: Declarations. Ethics approval and consent to participate: All study procedures were approved by the University of Michigan Institutional Review Board (IRB-MED HUM00149794). Consent for publication: NA. Competing interests: The authors have no competing interests to report., (© 2024. The Author(s).)

Objectives: Limited data exist regarding recovery from surgery from the adolescent's perspective, or data regarding concordance between adolescent and caregiver symptom reports preventing appreciation of adolescent needs and hindering the provision of appropriate care., Methods: We conducted semi-structured interviews with adolescents ages 12 to 17 and a parent caregiver 2 weeks following a variety of outpatient elective surgeries about recovery symptoms. We used latent manifest content analysis to analyze interview data. Caregiver-adolescent response concordance was assessed using Cohen κ., Results: Interviews were conducted with 31 adolescent-caregiver pairs (median age: 15 y). Fifty-eight percent of adolescents and 84% of caregivers were female; 71% of adolescents were White. Twenty-three percent of children reported severe pain, some of which was not expected given the surgery. Severe pain was associated with nausea (71%, P=0.002), pain-related sleep disturbance (86%, P=0.007), and severe anxiety (43%, P=0.008). Fatigue was also common (58%), but not associated with severe pain (P=0.484) or sleep disturbance (P=0.577). Thirty-nine percent reported anxiety; 32% experienced anger/frustration. Caregiver-adolescent concordance was only substantial for severe pain (κ=0.71) and anger/frustration (κ=0.67). Caregiver reports also often included psychological symptoms not reported by their children, with qualitative evidence supporting caregiver accuracy., Discussion: Adolescents may experience significant physical symptoms, such as pain and fatigue, even after minor surgeries. Fatigue symptoms may be unrelated to pain or sleep. Caregiver report of adolescent psychological symptoms may be necessary to gain a complete understanding of those symptoms in this population., Competing Interests: This study was supported by institutional funding from The Department of Anesthesiology at the University of Michigan. The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Ureteral stents are placed by urologists to ensure ureteral patency in the postoperative period following ureteroscopy to treat kidney stones, with the goal to reduce complications. However, ureteral stents themselves cause pain and urinary symptoms in many patients that can lead to morbidity. Professional society guidelines support stent omission after uncomplicated ureteroscopy, which represents most cases. Despite this, ureteral stents are utilized in more than 80% of all ureteroscopy procedures. One reason for guideline discordance is the low level of evidence supporting stent omission recommendations. Studies are inconclusive on whether stents increase pain and complications. A recent Cochrane review concluded higher quality and large trials are needed to inform decision-making. Furthermore, there is a lack of studies evaluating health-related quality of life (HRQOL), patient-reported outcomes (PROs), and unplanned healthcare utilization. Another factor is that prospective clinical trials are hindered by patient reluctance to be randomized to either stent placement or omission. The outcomes of patients who decline randomization have been ignored in trials, limiting the generalizability of the evidence., Methods: Through collaboration with patient partners, we developed a pragmatic multi-center combined randomized and observational cohort study in a quality improvement collaborative. Patients will be prospectively enrolled into a randomized cohort in which assignment to ureteral stent omission (vs. placement) is determined in the operating room using a web-based randomization platform. Patients who decline randomization are invited to take part in an observational (real-world) cohort in which the determination of stent use is at the discretion of the urologist. Patients in both cohorts will complete preoperative and postoperative assessments of PROs including pain, urinary symptoms, interference with usual activities, time taken off work or school, and treatment satisfaction. Unplanned healthcare utilization within 30 days postoperatively will be assessed by review of the electronic health record. Severe adverse events will be recorded. A subgroup of patients and urologists will also participate in qualitative semi-structured interviews focusing on knowledge, preferences, and practice patterns regarding ureteral stenting. Interview transcripts will be thematically analyzed., Discussion: This study is designed to evaluate the HRQOL and 30-day healthcare utilization of patients undergoing ureteral stent omission compared to stent placement following uncomplicated ureteroscopic treatment of upper urinary tract stones. Additionally, patient and urologist opinions and preferences related to ureteral stenting will be explored through qualitative interviews, with the aim of identifying key barriers and facilitators of practice change related to stenting practices., Trial Registration: ClinicalTrials.gov, NCT05866081. Registered on 19 May 2023., Competing Interests: Declarations. Ethics approval and consent to participate {24}: The SOUL study has received IRB approval by WCG (24 May 2023, protocol #20232054), which will serve as the central IRB for all participating performance sites. Written, informed consent to participate will be obtained from all participants. Consent for publication {32}: This manuscript does not contain individual personal data from patients. Competing interests {28}: KRG is a consultant to medical device companies in the field of stone disease: Olympus, Boston Scientific, Ambu, Coloplast. KRG has investigator funding for a clinical trial funded by Coloplast. CAD is a consultant to medical device companies in the field of stone disease: Boston Scientific, Cook Medical. The remaining authors declare that they have no competing interests., (© 2024. The Author(s).)

Background: The management of type 2 diabetes mellitus (T2DM) includes mastery of complex care activities, self-management skills, and routine health care encounters to optimize glucose control and achieve good health. Given the lifelong course of T2DM, patients are faced with navigating complex medical and disease-specific information. This health-seeking behavior is a driver of health disparities and is associated with hospitalization and readmission. Given that health-seeking behavior is a potentially intervenable social determinant of health, a better understanding of how people navigate these complex systems is warranted., Objective: To address this need, we aimed to develop new patient-reported outcome (PRO) measures that evaluate health-seeking behavior in persons with T2DM. These new PROs were designed to be included in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system, which includes several other PROs that capture the importance of social determinants of health., Methods: Overall, 225 participants with T2DM completed 56 self-report items that examined health-seeking behaviors. Classical Test Theory and Item Response Theory were used for measurement development. Exploratory factor analysis (EFA; criterion ratio of eigenvalue 1 to eigenvalue 2 being >4; variance for eigenvalue 1 ≥40%) and confirmatory factor analysis (CFA; criterion 1-factor CFA loading <.50; 1-factor CFA residual correlation >.20; comparative fit index ≥0.90; Tucker-Lewis index ≥0.90; root mean square error of approximation <0.15) were used to determine unidimensional sets of items. Items with sparse responses, low-adjusted total score correlations, nonmonotonicity, low factor loading, and high residual correlations of high error modification indices were candidates for exclusion. A constrained graded response model was used to examine item misfit, and differential item functioning was examined to identify item bias. Cronbach α was used to examine internal consistency reliability for the new PROs (criterion ≥0.70), and floor and ceiling effects were examined (criterion ≤20%)., Results: Four unidimensional sets of items were supported by EFA (all EFA eigenvalue ratios >4; variance for eigenvalue 1=41.4%-67.3%) and CFA (fit statistics all exceeded criterion values). This included (1) "Health-Seeking Behavior: PCP-Specific" (6 items); (2) "Health-Seeking Behavior: General Beliefs" (13 items); (3) "Health-Seeking Behavior: Family or Friends-Specific" (5 items); and (4) "Health-Seeking Behavior: Internet-Specific" (4 items). All items were devoid of differential item functioning for age, sex, education, or socioeconomic status factors. "Health-Seeking Behavior: General Beliefs" was developed to include both a computer adaptive test and a 6-item short form version; all other PROs were developed as static short forms. The psychometric reliability of these new PROs was supported; internal consistency ranged from acceptable to excellent (Cronbach α=.78-.91), and measures were free of significant floor or ceiling effects (floor effects range: 0%-8.9%; ceiling effects range: 0%-8.4%)., Conclusions: The new REDD-CAT Health-Seeking Behavior PROs provide reliable assessments of health-seeking behaviors among those with T2DM., (©Suzanne E Mitchell, Michael A Kallen, Jonathan P Troost, Barbara A De La Cruz, Alexa Bragg, Jessica Martin-Howard, Ioana Moldovan, Jennifer A Miner, Brian W Jack, Noelle E Carlozzi. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 22.11.2024.)

Introduction: Fluid overload is a source of substantial morbidity for adults and children with nephrotic syndrome (NS). Preparation and Rationale for a Fluid Overload in Nephrotic Syndrome Clinical Outcomes Assessment Set for Drug Development (Prepare-NS, 5UG3FD007308) was funded by the US Food and Drug Administration to develop a core set of patient-reported and observer-reported (for young children) outcome measures of fluid overload for use in pharmaceutical trials across the lifespan., Methods: The Prepare-NS study team developed the proposed context of use with input from stakeholders. We conducted a scoping review to assess the available literature on relevant patient- and observer-reported measures and performed secondary analyses of existing qualitative and quantitative data., Results: The outcome set will aim to serve individuals 2 years of age and older with primary NS conditions (specifically focal segmental glomerulosclerosis, minimal change disease, IgM nephropathy, membranous nephropathy, and childhood-onset NS not biopsied). The existing literature describing patient-reported outcomes in NS largely relies on nonspecific measures of health-related quality of life; fluid overload has been associated with lower scores on these measures., Conclusion: To address the gap in measure availability and fluid overload content, the Prepare-NS team has launched a set of qualitative studies for concept elicitation from the population of interest to inform development of new measures. The resulting measures subsequently will undergo psychometric evaluation and validation in a survey study., Competing Interests: Eloise Salmon, Noelle E. Carlozzi, Jin-Shei Lai, Catherine Spino, Yujie Wang, Emily Capellari, Rebecca Scherr, Kayla Sifre, Shawn Sullivan, Courtney Hurt, Tina Creguer, Kelly Helm, Richard Lafayette, Patrick H. Nachman, David T. Selewski, and John Devin Peipert report no conflicts of interest., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Background: Direct-to-participant online reporting facilitates the conduct of clinical research by increasing access and clinically meaningful patient engagement., Objective: We assessed feasibility of online data collection from adults with diagnosed Huntington's disease (HD) who directly reported their problems and impact in their own words., Methods: Data were collected online from consenting United States residents who self-identified as 1) having been diagnosed with Huntington's disease, 2) able to ambulate independently, and 3) self-sufficient for most daily needs. Data for this pilot study were collected using the Huntington Study Group myHDstory online research platform. The Huntington Disease Patient Report of Problems (HD-PROP), an open-ended questionnaire, was used to capture verbatim bothersome problems and functional impact. Natural language processing, human-in-the-loop curation of verbatim reports involving clinical and experience experts, and machine learning classified verbatim-reports into clinically meaningful symptoms., Results: All 8 questionnaires in the online pilot study were completed by 345 participants who were 60.9% men, 34.5±9.9 (mean±SD) years old, and 9.5±8.4 years since HD diagnosis. Racial self-identification was 46.4% Caucasian, 28.7% African American, 15.4% American Indian/Alaska Native, and 9.5% other. Accuracy of verbatim classification was 99%. Non-motor problems were the most frequently reported symptoms; depression and cognitive impairment were the most common., Conclusions: Online research participation was feasible for a diverse cohort of adults who self-reported an HD diagnosis and predominantly non-motor symptoms related to mood and cognition. Online research tools can help inform what bothers HD patients, identify clinically meaningful outcomes, and facilitate participation by diverse and under-represented populations.

Purpose: To develop and validate a novel patient-reported outcome (PRO) measure to assess vision-related functioning in individuals with severe peripheral field loss (PFL)., Design: Prospective outcome measure development/validation study., Methods: A 127-item questionnaire was developed based on a prior qualitative interview study. A total of 116 participants with severe PFL due to retinitis pigmentosa (RP) or glaucoma were recruited at the Kellogg Eye Center and completed the Likert-scaled telephone-administered questionnaire. Included participants had a horizontal extent of their visual field <20 degrees (RP) or a mixed or generalized stage 4 to 5 defect using the Enhanced Glaucoma Staging System (glaucoma) in the better seeing eye (or in 1 eye if the fellow eye visual acuity was <20/200). Response data were analyzed using exploratory factor analysis and Rasch modeling. Poorly functioning items were eliminated, confirmatory factor analysis was used to ensure scale unidimensionality, and the model was refit to produce the final instrument., Results: The final Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire contains 53 items across 6 domains: mobility, object localization, object recognition, reading, social functioning, and technology. There were 74 items removed because of high missingness, poor factor loadings, low internal consistency, high local dependency, low item information, item redundancy, or differential item functioning. Using Rasch item calibrations, person ability scores could be calculated for each of the 6 unidimensional LV-SCOPE domains with good test-retest stability., Conclusions: The LV-SCOPE Questionnaire provides a valid and reliable measure of vision-related functioning across 6 key domains relevant to individuals with severe PFL. Findings support the clinical utility of this psychometrically valid instrument., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To report on the development and calibration of the new Blood Pressure Dysregulation Measurement System (BPD-MS) item banks that assess the effect of BPD on health-related quality of life (HRQOL) and the daily activities of Veterans and non-Veterans with spinal cord injury (SCI)., Design: Cross-sectional survey study., Setting: Two Veteran Affairs medical centers and a SCI model system site., Participants: 454 respondents with SCI (n=262 American Veterans and n=192 non-Veterans; N=454)., Interventions: Not applicable MAIN OUTCOME MEASURES: The BPD-MS item banks., Results: BPD item pools were developed and refined using literature reviews, qualitative data from focus groups, and cognitive debriefing of persons with SCI and professional caregivers. The item banks then underwent expert review, reading level assessment, and translatability review prior to field testing. The items pools consisted of 180 unique questions (items). Exploratory and confirmatory factor analyses, item response theory modeling, and differential item function investigations resulted in item banks that included a total of 150 items: 75 describing the effect of autonomic dysreflexia on HRQOL, 55 describing the effect of low blood pressure (LBP) on HRQOL, and 20 describing the effect of LBP on daily activities. In addition, 10-item short forms were constructed based on item response theory-derived item information values and the clinical relevance of item content., Conclusions: The new BPD-MS item banks and corresponding 10-item short forms were developed using established rigorous measurement development standards, which represents the first BPD-specific patient-reported outcomes measurement system unique for use in the SCI population., (Copyright © 2023 American Congress of Rehabilitation Medicine. All rights reserved.)

Background: Caregivers of people with chronic illnesses often face negative stress-related health outcomes and are unavailable for traditional face-to-face interventions due to the intensity and constraints of their caregiver role. Just-in-time adaptive interventions (JITAIs) have emerged as a design framework that is particularly suited for interventional mobile health studies that deliver in-the-moment prompts that aim to promote healthy behavioral and psychological changes while minimizing user burden and expense. While JITAIs have the potential to improve caregivers' health-related quality of life (HRQOL), their effectiveness for caregivers remains poorly understood., Objective: The primary objective of this study is to evaluate the dose-response relationship of a fully automated JITAI-based self-management intervention involving personalized mobile app notifications targeted at decreasing the level of caregiver strain, anxiety, and depression. The secondary objective is to investigate whether the effectiveness of this mobile health intervention was moderated by the caregiver group. We also explored whether the effectiveness of this intervention was moderated by (1) previous HRQOL measures, (2) the number of weeks in the study, (3) step count, and (4) minutes of sleep., Methods: We examined 36 caregivers from 3 disease groups (10 from spinal cord injury, 11 from Huntington disease, and 25 from allogeneic hematopoietic cell transplantation) in the intervention arm of a larger randomized controlled trial (subjects in the other arm received no prompts from the mobile app) designed to examine the acceptability and feasibility of this intensive type of trial design. A series of multivariate linear models implementing a weighted and centered least squares estimator were used to assess the JITAI efficacy and effect., Results: We found preliminary support for a positive dose-response relationship between the number of administered JITAI messages and JITAI efficacy in improving caregiver strain, anxiety, and depression; while most of these associations did not meet conventional levels of significance, there was a significant association between high-frequency JITAI and caregiver strain. Specifically, administering 5-6 messages per week as opposed to no messages resulted in a significant decrease in the HRQOL score of caregiver strain with an estimate of -6.31 (95% CI -11.76 to -0.12; P=.046). In addition, we found that the caregiver groups and the participants' levels of depression in the previous week moderated JITAI efficacy., Conclusions: This study provides preliminary evidence to support the effectiveness of the self-management JITAI and offers practical guidance for designing future personalized JITAI strategies for diverse caregiver groups., Trial Registration: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591., (©Jitao Wang, Zhenke Wu, Sung Won Choi, Srijan Sen, Xinghui Yan, Jennifer A Miner, Angelle M Sander, Angela K Lyden, Jonathan P Troost, Noelle E Carlozzi. Originally published in JMIR Formative Research (https://formative.jmir.org), 14.09.2023.)

Background: Housing security is a key social determinant of behavior related to health outcomes., Objective: The purpose of this study was to develop a new patient-reported outcome measure that evaluates aspects of housing security for use in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system., Design: Qualitative data, literature reviews, and cross-sectional survey study., Participants: A total of 225 people with T2DM provided responses to the items in this item pool., Main Measures: A new item pool that evaluates important aspects of housing security was developed using stakeholder data from focus groups of persons with T2DM., Key Results: For the Housing Affordability scale, factor analysis (both exploratory and confirmatory) supported the retention of six items. Of these items, none exhibited sparse cells or problems with monotonicity; no items were deleted due to low item-adjusted total score correlations. For the six affordability items, a constrained graded response model indicated no items exhibited misfit; thus, all were retained. No items indicated differential item functioning (examined for age, sex, education, race, and socioeconomic status). Thus, the final Affordability item bank comprised six items. A Housing Safety index (three items) and a Home Features index (eight items) were also developed. Reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measures were also supported., Conclusions: The REDD-CAT Housing Security Measure provides a reliable and valid assessment of housing affordability, safety, and home features in people with type 2 diabetes mellitus. Future work is needed to establish the clinical utility of this measure in other clinical populations., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Objective: Death anxiety, represented by the HDQLIFE™ Concern with Death and Dying (CwDD) patient-reported outcome (PRO) questionnaire, captures a person's worry about the death and dying process. Previous work suggests that death anxiety remains an unremitting burden throughout all stages of Huntington disease (HD). Although palliative interventions have lessened death anxiety among people with advanced cancer, none has yet to undergo testing in the HD population. An account of how death anxiety is associated with longitudinal changes to aspects of health-related quality of life (HRQoL) would help optimize neuropalliative interventions for people with HD. Methods: HDQLIFE collected PROs concerning physical, mental, social, and cognitive HRQoL domains and clinician-rated assessments from people with HD at baseline and 12 and 24 months. Linear mixed-effects models were created to determine how baseline death anxiety was associated with follow-up changes in HRQoL PROs after controlling for baseline death anxiety and other disease and sociodemographic covariates. Results: Higher baseline HDQLIFE CwDD is associated with 12- and 24-month declines in HDQLIFE Speech Difficulties, neurology quality of life (NeuroQoL) Depression, Suicidality, HDQLIFE Meaning and Purpose, and NeuroQoL Positive Affect and Well-being. Interpretation: Death anxiety may be a risk factor for worsening mental health and speech difficulty. A further prospective study is required to evaluate whether interventions on death anxiety or mental health generally can reduce declines in HRQoL for people with HD over time.

Purpose: Establishing the psychometric reliability and validity of new measures is an ongoing process. More work is needed in to confirm the clinical utility of the TBI-CareQOL measurement development system in both an independent cohort of caregivers of traumatic brain injury (TBI), as well as in additional caregiver groups., Methods: An independent cohort of caregivers of people with TBI (n = 139), as well as three new diverse caregiver cohorts (n = 19 caregivers of persons with spinal cord injury, n = 21 caregivers for persons with Huntington disease, and n = 30 caregivers for persons with cancer), completed 11 TBI-CareQOL measures (caregiver strain; caregiver-specific anxiety; anxiety; depression; anger; self-efficacy; positive affect and well-being; perceived stress; satisfaction with social roles and activities; fatigue; sleep-related impairment), as well as two additional measures to examine convergent and discriminant validity (PROMIS Global Health; the Caregiver Appraisal Scale)., Results: Findings support the internal consistency reliability (all alphas > 0.70 with the vast majority being > 0.80 across the different cohorts) of the TBI-CareQOL measures. All measures were free of ceiling effects, and the vast majority were also free of floor effects. Convergent validity was supported by moderate to high correlations between the TBI-CareQOL and related measures, while discriminant validity was supported by low correlations between the TBI-CareQOL measures and unrelated constructs., Conclusion: Findings indicate that the TBI-CareQOL measures have clinical utility in caregivers of people with TBI, as well as in other caregiver groups. As such, these measures should be considered as important outcome measures for clinical trials aiming to improve caregiver outcomes., (© 2023. The Author(s).)

Introduction: Edema is a common manifestation of proteinuric kidney diseases, but there is no consensus approach for reliably evaluating edema. The objective of this study was to develop an edema clinician-reported outcome measure for use in patients with nephrotic syndrome., Methods: A literature review was conducted to assess existing clinician-rated measures of edema. Clinical experts were recruited from internal medicine, nephrology, and pediatric nephrology practices to participate in concept elicitation using semi-structured interviews and cognitive debriefing. Qualitative analysis methods were used to collate expert input and inform measurement development. In addition, training and assessment modules were developed using an iterative process that also utilized expert input and cognitive debriefing to ensure interrater reliability., Results: While several clinician-rated measures of edema have been proposed, our literature review did not identify any studies to support the reliability or validity of these measures. Fourteen clinician experts participated in the concept elicitation interviews, and twelve participated in cognitive debriefing. A clinician-reported outcome measure for edema was developed. The measure assesses edema severity in multiple individual body parts. An online training module and assessment tool were generated and refined using additional clinician input and investigative team expertise., Conclusion: The Edema ClinRO (V1) measure is developed specifically to measure edema in nephrotic syndrome. The tool assesses edema across multiple body parts, and it includes a training module to ensure standardized administration across raters. Future examination of this measure is ongoing to establish its reliability and validity., Competing Interests: Joshua Thurman receives royalties from Alexion Pharmaceuticals, Inc. He is a consultant for, will receive royalty income from, and holds stock in Q32 Bio Inc. He is also on the data review team for Goldfinch Bio. Michelle O’Shaughnessy is a consultant for Chinook Pharmaceuticals. Noelle Carlozzi, through the University of Michigan, received research funding for the design and conduct of this study. Laura Mariani, through the University of Michigan, has received research funding from the NIH, DOD, Nephcure Kidney International, and Boehringer Ingelheim unrelated to this work. She also receives personal consulting fees from Reata Pharmaceuticals, Calliditas Therapeutics, and Travere Therapeutics. Howard Trachtman is a consultant to Travere, Goldfinch Bio, Roche, and Walden and receives research funding from the NIH, DOD, and Natera. He is also Chair of DMC for pediatric studies conducted by Otsuka and is on the editorial board of Scientific Reports, Glomerular Diseases, Pediatric Nephrology, and Kidney360. Debbie Gipson, through the University of Michigan, received research funding for the design and conduct of this study from Goldfinch Bio and, through the University of Michigan, receives funding for research or consulting from Goldfinch Bio, Genentech, Roche, Boehringer Ingelheim, Travere, AstraZeneca, Novartis, Pfizer, Vertex, Reata, NIH, CDC, and FDA. Youssef Farag is a past employee of Goldfinch Bio. Liron Walsh is a past employee of Goldfinch Bio. All other authors report no conflicts of interest., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Objective: With Huntington disease (HD), a fatal neurodegenerative disease where the prevalence of suicidal thoughts and behavior (STB) remains elevated as compared to other neurological disorders, it is unknown whether STB and health-related quality of life (HRQoL) affect plans for the end of life or more broadly, advance care planning (ACP). Conversely, it is unknown whether ACP would provoke future changes to STB and HRQoL. Therefore, we sought to evaluate whether STB and HRQoL patient-reported outcomes (PROs) contribute to ACP and whether ACP relates to changes in STB and HRQoL at 24 months., Methods: HD-validated clinician- and patient-assessments (i.e., HRQoL PROs) were obtained at baseline enrollment, 12 and 24 months through our multi-center study (HDQLIFE™) throughout the United States among people with premanifest, early-stage, and late-stage manifest HD. We used linear mixed-effects models to determine the relationships between STB and HRQoL at baseline and HDQLIFE End of Life Planning at follow-up. Separate linear mixed-effects models were used to assess the relationship between HDQLIFE End of Life Planning at baseline, and HRQoL and STB at 12 and 24 months. False discovery rate adjustments were used to account for multiple comparisons., Results: At baseline enrollment, STB and HRQoL were not related to HDQLIFE End of Life Planning at 12 or 24 months. Similarly, at baseline, HDQLIFE End of Life Planning demonstrated no association with STB or HRQoL at 12 or 24 months., Interpretation: STB and HRQoL PROs do not significantly affect patient engagement with ACP. Most importantly, engaging in ACP does not cause untoward effects on HRQoL or STB for this rare neurodegenerative disease where the lifetime prevalence of STB approaches 30%., Competing Interests: L.L.S. receives financial support as a paid consultant from the HDSA, American Film Institute, University of Texas Houston (McGovern School), and Tikvah for Parkinson; he has received research support from the Memorial Sloan Kettering Meaning Centered Psychotherapy (MCP) National Cancer Institute (NCI) R25 Training, and Northwestern Physician Scientist Training program. J.P.T. owns stocks in Procter and Gamble and General Electric, and has received research funding through the University of Michigan with Complexa Inc., Retrophin Inc., and Goldfinch Bio, and the University of Michigan with Vertex Pharmaceuticals and Pfizer Inc. D.B. has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Speaker: Teva Pharmaceuticals, Acorda Therapeutics, Neurocrine Biosciences, Adamas Pharmaceuticals Consulting: Biogen Pharmaceuticals, Amgen Pharmaceuticals, Acadia Pharmaceuticals, Genentech, Inc., GE Healthcare, Gerson Lehrman Group, Guidepoint, L.E.K. C., and has received personal compensation in an editorial capacity for Editor: Annals of Clinical and Translational Neurology. B.M.K. received research grant support from the National Institute of Aging (NIA), National Institute of Nursing Research, and Patient-Centered Outcomes Research Institute; he has received speaker honoraria from the Parkinson's Foundation. H.G.P. receives funding from the NIH (CA197730; AG049666; MH121886; NR018693; CA218313). M.N. has received personal compensation in the range of $5,000–$9,999 for serving as a Consultant for Voyager. M.N. has received personal compensation in the range of $500–$4,999 for serving as a Consultant for Roche. M.N. has received personal compensation in the range of $5,000–$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. M.N. has received personal compensation in the range of $500–$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Uniqure. An immediate family member of M.N. has received stock or an ownership interest from Fresca. The institution of M.N. has received research support from HDSA. The institution of M.N. has received research support from Parkinson Foundation. M.N. has received research support from Parkinson Foundation. The institution of M.N. has received research support from Neuraly. M.N. has received personal compensation in the range of $500–$4,999 for serving as a speaker with American Academy of Neurology (AAN). S.F. has received personal compensation in the range of $500–$4,999 for serving as a Consultant for Oscine Therapeutics. S.F. has received personal compensation in the range of $500–$4,999 for serving as a Consultant for uniQure. S.F. has received personal compensation in the range of $500–$4,999 for serving as a Consultant for MCG Health. The institution of S.F. has received research support from HDSA. The institution of S.F. has received research support from Michael J Fox Foundation. The institution of S.F. has received research support from Roche/Genentech. The institution of Dr. Frank has received research support from CHDI Foundation. The institution of S.F. has received research support from Huntington Study Group (HSG). The institution of S.F. has received research support from Triplet Therapeutics. J{has received research funding from the NIH (NS075321, NS103957, NS107281, NS092865, U10NS077384, NS097437, U54NS116025, U19 NS110456, AG050263, AG-64937, NS097799, NS075527, ES029524, NS109487, R61 AT010753 [NCATS, NINDS, NIA], RO1NS118146, R01AG065214), Department of Defense (W81XWH-217-1-0393), Michael J Fox Foundation, Barnes-Jewish Hospital Foundation (Elliot Stein Family Fund and Parkinson disease research fund), American Parkinson Disease Association (APDA) Advanced Research Center at Washington University, Greater St. Louis Chapter of the APDA, Paula and Rodger Riney Fund, Jo Oertli Fund, HDSA, Murphy Fund, and CHDI; has received honoraria from CHDI, Huntington Disease Study Group, Parkinson Study Group, Beth Israel Hospital (Harvard group), University of Pennsylvania, and Stanford University; is co-director for the Dystonia Coalition, which has received the majority of its support through the NIH (grants NS116025, NS065701 from the NINDS and TR 001456 from the Office of Rare Diseases Research at the NCATS); serves as Director of Medical and Scientific Advisory Committee of the Dystonia Medical Research Foundation, Chair of the Scientific Advisory Committee of the Parkinson Study Group, Chair of the Interim Executive Membership Committee of the HSG, Chair of the Nominating Committee of the HSG; Chair of the Standards Committee of the HSG, member of the Scientific Advisory Board of the APDA, Chair of the Scientific and Publication Committee for ENROLL-HD, and member of the Education Committee of the HSG; and has provided medical legal consultation to Wood, Cooper and Peterson, LLC, and Simmons and Simmons LLP. P.D. reports receiving funding from Vaccinex, Inc., Neurocrine Biosciences Inc., and UniQure, for his role as Site Investigator for clinical trials in Huntington Disease. D.C. reports consultant fees from AbbVie, Bristol Myers Squibb (BMS), Exelixis, Merck, Novartis, and Pfizer; reports licensing fees from FACIT.org; research grants (institutional) from AbbVie, Astellas, Aveo, BMS, GlaxoSmithKline, Merck, Novartis, and Pfizer; and is an officer of FACIT.org. N.E.C. reports research grants from the NIH, the Neilsen Foundation, and CHDI, as well as a contract from Teva Pharmaceuticals. She is also supported by research funding from the Alzheimer's Association, the Food and Drug Administration (FDA), as well as the Department of Health and Human Services—Centers for Medicare and Medicaid Services. She receives honoraria for her role on the CHDI scientific advisory board and is a consultant on the Traumatic Brain Injury (TBI) Congressionally mandated study., (© Leonard L. Sokol et al., 2023; Published by Mary Ann Liebert, Inc.)

Purpose: The purpose of this study was to develop a new measure, the Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) Illness Burden item bank, to evaluate the impact that a chronic condition has on independent living, the ability to work (including working at home), social activities, and relationships., Methods: Semi-structured interviews were used to inform the development of an item pool (47 items) that captured patients' beliefs about how a diagnosis of type 2 diabetes interferes with different aspects of their lives. The Illness Burden item bank was developed and tested in 225 people with type 2 diabetes mellitus., Results: No items had sparse response option cells or problems with monotonicity; two items were deleted due to low item-rest correlations. Factor analyses supported the retention of 29 items. With those 29 remaining items, a constrained (common slope) graded response model fit assessment indicated that two items had misfit; they were excluded. No items displayed differential item functioning by age, sex, education, or socio-economic status. The final item bank is comprised of 27 items. Preliminary data supported the reliability (internal consistency and test-retest reliability) and validity (convergent, discriminant, and known-groups) of the new bank., Conclusion: The Illness Burden item bank can be administered as a computer adaptive test or a 6-item short form. This new measure captures patients' perceptions of the impact that having type 2 diabetes has on their daily lives; it can be used in conjunction with the REDD-CAT measurement system to evaluate important social determinants of health in persons with type 2 diabetes mellitus., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: The purpose of this study was to develop a new measure to evaluate the ability to receive medical services when needed among persons with type 2 diabetes mellitus., Methods: The Healthcare Access measure was developed using data from 225 persons with type 2 diabetes mellitus who completed an item pool comprised of 54 questions pertaining to their experience accessing healthcare services., Results: Exploratory and confirmatory factor analyses supported the retention of 45 items. In addition, a constrained graded response model (GRM), as well as analyses that examined item misfit and differential item functioning (investigated for age, sex, education, race, and socioeconomic status), supported the retention of 44 items in the final item bank. Expert review and GRM item calibration products were used to inform the selection of a 6-item static short form and to program the Healthcare Access computer adaptive test (CAT). Preliminary data supported the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measure., Conclusions: The new Healthcare Access item bank can be used to examine the experiences that persons with type 2 diabetes mellitus have with healthcare access, to better target treatment improvements and mitigate disparities; it will be available as a part of the Neuro-Qol measurement system through healthmeasures.net and the PROMIS Application Programmable Interface (API) in early 2023., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: To provide reliability and validity data to support the clinical utility of Economic Quality of Life Measure (Econ-QOL) scores in caregivers of civilians and service members/veterans with traumatic brain injury (TBI)., Design: Cross-sectional survey study., Setting: Three academic medical centers and a Veterans Affairs treatment facility., Participants: 376 caregivers of civilians (n=213) and service members/veterans (n=163) with TBI (N=376)., Interventions: N/A., Main Outcome Measures: Econ-QOL and several patient-reported outcome measures (Traumatic Brain Injury Caregiver Quality of Life Caregiver-Specific Anxiety and Caregiver Strain, Patient-Reported Outcomes Measurement Information System sleep-related impairment, Neurological Quality of Life Measurement System positive affect and well-being) and measures of financial status (self-reported income)., Results: Internal consistency reliability of the Econ-QOL Short Form scores were excellent (all Cronbach's alphas ≥.92). There were no floor or ceiling effects for scores. There was evidence of convergent and discriminant validity, with the Econ-QOL scores having the strongest relationships with self-reported income (convergent validity evidence) and weak relationships with the other measures (discriminant validity evidence). Individuals with scores that were "below or possibly below" the poverty line (according to 2016 federal government poverty level thresholds) reported worse economic quality of life relative to those individuals who were definitely above the poverty line, supporting known-groups validity., Conclusions: This article establishes the clinical utility of scores on the Econ-QOL Short Form in caregivers of persons with TBI and provides evidence that it is valid and appropriate to use such scores not only in a variety of different disability populations (eg, spinal cord injury, stroke) but also in caregivers., (Copyright © 2022 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: To develop a new computer adaptive test that evaluates important aspects of medication adherence for persons with type 2 diabetes mellitus., Methods: Two hundred and twenty-five people with type 2 diabetes mellitus completed 41 items related to medication adherence., Results: Exploratory analysis supported the essential unidimensionality of the initial item pool. Five items were deleted due to low item-adjusted total score correlations (resulting in 36 items). Confirmatory factor analysis supported the retention of 27 items. A graded response model identified no items for exclusion, based on misfit. No items were flagged for meaningful differential item functioning (DIF). The final item bank is comprised of 27 items; an associated 6-item short form was constructed that balanced both psychometric factors (e.g., item information values) and clinical input. Initial analysis of the simulated CAT and static short form supported both the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known groups) of both administration formats., Conclusions: The new medication adherence item bank provides a reliable and valid assessment of the ability to take medications accurately among people with T2DM; it will be available in early 2023 through healthmeasures.net., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: To compare barriers and facilitators to accessing health care services among service members and veterans (SMVs) by traumatic brain injury (TBI) severity groups., Design: Qualitative descriptive study guided by an access to health care services conceptual framework., Setting: Five Veterans Affairs (VA) polytrauma rehabilitation centers., Participants: SMVs (N=55, including 10 caregivers as proxies) ≥2 years post-TBI recruited from the VA TBI Model Systems and grouped by TBI severity (mild/moderate, severe)., Main Outcome Measures: Barriers and facilitators accessing care., Results: The main facilitators included ease of communicating with providers to help SMVs identify and utilize appropriate health care, family advocates who promoted engagement in health care, ability to use government and community facilities, and online resources or equipment. Distance to services was uniformly identified as a main barrier for both patient groups. However, facilitators and barriers to health care access differed by TBI severity. SMVs with severe TBI highlighted the role of nonprofit organizations in promoting health care engagement and the availability of VA specialty residential programs in meeting health care needs. Having unrecognized health care needs in chronic stages and communication difficulties with providers were more commonplace for those with greater TBI severity and affected quality of care. Those with mild/moderate TBI highlighted challenges associated with paying for services in the community and scheduling of services., Conclusions: Barriers and facilitators exist across multiple dimensions of a health care access framework and vary by TBI severity. Results suggest possible mechanistic links between health care access and SMV health outcomes. Findings support current policy and practice efforts to facilitate health care access for SMVs with TBI but highlight the need for tailored approaches for those with greater disability., (Published by Elsevier Inc.)

Background: The Roadmap mobile health (mHealth) app was developed to provide health-related quality of life (HRQOL) support for family caregivers of patients with cancer., Methods: Eligibility included: family caregivers (age ≥18 years) who self-reported as the primary caregiver of their pediatric patient with cancer; patients (age ≥5 years) who were receiving cancer care at the University of Michigan. Feasibility was calculated as the percentage of caregivers who logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the 120-day study duration. Feasibility and acceptability was also assessed through a Feasibility and Acceptability questionnaire and the Mobile App Rating Scale to specifically assess app-quality. Exploratory analyses were also conducted to assess HRQOL self- or parent proxy assessments and physiological data capture., Results: Between September 2020-September 2021, 100 participants (or 50 caregiver-patient dyads) consented and enrolled in the ONC Roadmap study for 120-days. Feasibility of the study was met, wherein the majority of caregivers (N=32; 65%) logged into ONC Roadmap and engaged with it at least twice weekly for at least 50% of the study duration (defined a priori in the Protocol). The Feasibility and Acceptability questionnaire responses indicated that the study was feasible and acceptable with the majority (>50%) reporting Agree or Strongly Agree with positive Net Favorability [( Agree + Strongly Agree ) - ( Disagree + Totally Disagree )] in each of the domains (e.g., Fitbit use, ONC Roadmap use, completing longitudinal assessments, engaging in similar future study, study expectations). Improvements were seen across the majority of the mental HRQOL domains across all groups; even though underpowered, there were significant improvements in caregiver-specific aspects of HRQOL and anxiety and in depression and fatigue for children (ages 8-17 years), and a trend toward improvement in depression for children ages 8-17 years and in fatigue for adult patients., Conclusions: This study supports that mHealth technology may be a promising platform to provide HRQOL support for caregivers of pediatric patients with cancer. Importantly, the findings suggest that the study protocol was feasible, and participants were favorable to participate in future studies of this intervention alongside routine cancer care delivery., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-22-24/coif). CNN is supported by an NIH/NCI T32 Training Grant (T32CA236621). JPT reports that the analytic work for this study was supported by the National Center for Advancing Translational Sciences (NCATS Grant Number: UL1TR002240) for the Michigan Institute for Clinical and Health Research. JAM is supported as a research staff member on HL146354 (Roadmap mHealth Study). AH, NEC, DLB, DAH report that being Co-I of National Institute of Health/National Heart, Lung, and Blood Institute grant (1R01HL146354). SWC reports that this work was supported by an American Society of Hematology Bridge Grant and National Institute of Health/National Heart, Lung, and Blood Institute grant (1R01HL146354) and the Edith S. Briskin and Shirley K Schlafer Foundation (SWC). SWC is supported by grants 1R01HL146354 and K24HL156896. The other authors have no conflicts of interest to declare., (2023 mHealth. All rights reserved.)

Objective: Tardive dyskinesia (TD) is a movement disorder that can negatively affect health-related quality of life. However, the impact of TD is not necessarily dependent solely on the objective severity of TD movements. There is currently no easy-to-use, standardized, clinician-rated assessment of the impact of TD on functioning. The aim of this consensus panel was to develop a scale (Impact-TD scale) to assess the impact of TD on patients' daily functioning in practice settings., Participants: Nine health care professionals with expertise in TD and clinical scale development met to discuss how TD negatively impacts the functional activities of patients., Evidence: This panel comprised 7 individuals from a previous panel that developed recommendations on the importance of optimally assessing the functional impact of TD. The previous panel published a narrative literature review that summarized the existing approaches to assess the impact of TD in clinical research and practice., Consensus Process: A modified Delphi process was used to assess agreement on the format and content of the Impact-TD scale. The panel discussed key features of the Impact-TD scale (ie, simplicity, usability, assessment of frequency of impact versus interference/distress). The scale aimed to describe specific consequences of TD symptoms with which patients may have difficulty., Conclusions: Consensus was reached on a list of consequences of TD symptoms that have a functional impact and were categorized in 4 functional domains: social, psychological/psychiatric, physical, and vocational/educational/recreational. The Impact-TD scale offers an easy-to-use clinical scale to measure the functional impact of TD in practice settings., (© Copyright 2022 Physicians Postgraduate Press, Inc.)

Purpose/objective: The primary objective of this study was to establish the feasibility and acceptability of an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention (JITAI) in three distinct groups of care partners (care partners of persons with spinal cord injury [SCI], Huntington's disease [HD], or hematopoietic cell transplantation [HCT])., Research Method/design: Seventy care partners were enrolled in this study (n = 19 SCI; n = 21 HD, n = 30 HCT). This three-month (90 day) randomized control trial involved wearing a Fitbit to track sleep and steps, providing daily reports of health-related quality of life (HRQOL), and completing end of month HRQOL surveys. Care partners in the JITAI group also received personalized pushes (i.e., text-based phone notifications that include brief tips or suggestions for improving self-care). At the end of three-months, care partners in both groups completed a feasibility and acceptability questionnaire., Results: Most (98.6%) care partners completed the study, average compliance was 88% for daily HRQOL surveys, 96% for daily steps, and 85% for daily sleep (from wearing the Fitbit), and all monthly surveys were completed with the exception of one missed 3-month assessment. The acceptability of the protocol was high; ratings exceeded 80% agreement for the different elements of the study. Improvements were seen for the majority of the HRQOL measures. There was no evidence of measurement reactivity., Conclusions/implications: Findings provide strong support for the acceptability and feasibility of an intensive data collection protocol that involved the administration of a JITAI. Although this trial was not powered to establish efficacy, findings indicated improvements across a variety of different HRQOL measures (~1/3 of which were statistically significant). (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Introduction: Although perioperative anxiety is common, its trajectory and influence on postoperative pain and opioid use are not well understood. We sought to examine the association and trajectory of perioperative anxiety, pain and opioid use following common surgical procedures., Methods: We conducted a prospective cohort study of 1771 patients undergoing elective surgical procedures. Self-reported opioid use, pain (Brief Pain Inventory) and anxiety (Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety) were recorded on the day of surgery and at 1 month, 3 months and 6 months postsurgery. Clinically significant anxiety was defined as a PROMIS Anxiety T-score ≥55. We examined postoperative opioid use in the context of surgical site pain and anxiety using mixed-effects regression models adjusted for covariates, and examined anxiety as a mediator between pain and opioid use., Results: In this cohort, 65% of participants completed all follow-ups and 30% reported clinically significant anxiety at baseline. Anxiety and surgical site pain were highest on the day of surgery (anxiety: mean=49.3, SD=9.0; pain: mean=4.3, SD=3.3) and declined in the follow-up period. Those with anxiety reported higher opioid use (OR=1.40; 95% CI 1.0, 1.9) and 1.14-point increase in patient-reported surgical pain (95% CI 1.0, 1.3) compared with those without anxiety. Anxiety had no significant mediation effect on the relationship of pain and opioid use., Discussion: Anxiety is an independent risk factor for increased pain and opioid use after surgery. Future studies examining targeted behavioral therapies to reduce anxiety during the perioperative period may positively impact postoperative pain and opioid use., Competing Interests: Competing interests: The authors declare no conflicts of interest. Dr. Bicket reports past service as consultant for Axial Healthcare and Alosa Health, a non-profit organization focusing on academic detailing, outside the submitted work. Dr. Brummett reports consulting activities with Heron Therapeutics, Vertex Pharmaceuticals, Alosa Health, and the Benter Foundation, as well as expert medical testimony., (© American Society of Regional Anesthesia & Pain Medicine 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose/objective: While there is evidence in other clinical groups to suggest that sleep problems can negatively impact cognitive performance, this relationship has not yet been examined in people with spinal cord injury (SCI). Thus, we sought to examine the association between sleep and cognitive function in people with SCI., Research Method/design: Over the course of 7 days, 167 individuals with SCI completed daily subjective ratings of sleep (sleep quality, number of hours slept per night, and bedtime variability) and wore a wrist-worn device that continuously monitored autonomic nervous system (ANS) activity (i.e., blood volume pulse [BVP] signal and electrodermal activity [EDA] signal). At the end of this home monitoring period, participants completed a subjective rating of cognition and six objective cognitive tests. A series of multivariable linear regressions were used to examine associations between eight measures of sleep/ANS activity during sleep and eight cognitive variables., Results: Subjective ratings of sleep were not related to either objective cognitive performance or self-reported cognitive function. However, there were some relationships between ANS activity during sleep and objective cognitive performance: lower BVP signal was associated with poorer performance on measures of processing speed, working memory, learning and long-term memory, and EDA signals were associated with poorer performance on a measure of executive function., Conclusions/implications: Future work is needed to better understand the relationship of sleep, especially sleep physiology, and cognitive functioning for individuals with SCI, and how that may be similar or different to relationships in the general population. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Informal family care partners of persons with traumatic brain injury (TBI) often experience intense stress resulting from their caregiver role. As such, there is a need for low burden, and easy to engage in interventions to improve health-related quality of life (HRQOL) for these care partners. This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners. Participants are randomized either to a control group, where they wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback), or the JITAI group, where they wear the Fitbit®, provide daily reports of HRQOL and receive personalized self-management pushes for 6 months. 240 participants will be enrolled (n = 120 control group; n = 120 JITAI group). Outcomes are collected at baseline, 1-, 2-, 3-, 4-, 5- & 6-months, as well as 3- and 6-months post intervention. We hypothesize that the care partners who receive the intervention (JITAI group) will show improvements in caregiver strain (primary outcome) and mental health (depression and anxiety) after the 6-month (180 day) home monitoring period. Participant recruitment for this study started in November 2020. Data collection efforts should be completed by spring 2025; results are expected by winter 2025. At the conclusion of this randomized control trial, we will be able to identify care partners at greatest risk for negative physical and mental health outcomes, and will have demonstrated the efficacy of this JITAI intervention to improve HRQOL for these care partners. Trial registration: ClinicalTrial.gov NCT04570930; https://clinicaltrials.gov/ct2/show/NCT04570930., Competing Interests: The authors have declared that no competing interests exist.

Objective: This study aimed to examine same-day associations of pain, fatigue, depressed mood, anxiety, and perceived cognitive function with social participation in the daily lives of adults with spinal cord injury (SCI)., Design: Observational study used a combination of baseline surveys and 7 end-of-day (EOD) diaries., Setting: General community., Participants: Individuals with SCI (N=168; mean age, 49.8y; 63% male, 37% female)., Main Outcome Measures: Patient-Reported Outcomes Measurement Information System short form measures (Ability to Participate in Social Roles and Activities, Pain Intensity, Depression, Anxiety, Cognitive Function Abilities) were adapted for daily administrations as EOD diaries., Result: Results of multivariable model showed that daily increases in fatigue (B=-0.10; P=.004) and depressive symptoms (B=-0.25; P=<.001) and decreases in perceived cognitive function (B=0.11; P=<.001) were significantly related to worse same-day social participation. Daily fluctuations in anxiety and pain were unrelated to same-day social participation., Conclusions: This is the first study that shows within-person associations of common SCI symptoms with social participation in the daily lives of adults with SCI. Results from the current study may help to develop more effective individualized treatments of symptoms and symptom effect aimed at improving social participation., (Published by Elsevier Inc.)

Introduction: An outstanding question in kidney transplantation is how to prepare candidates and their social supports for optimal posttransplant outcomes. Project Aims: This program evaluation assessed whether a pretransplant quality improvement clinic improved clinical outcomes in the year posttransplant compared to recipients receiving standard of care. Design: The Countdown to Transplant Clinic was implemented with kidney transplant candidates expected to receive a transplant within the next few months. The clinic included an enhanced education session on posttransplant lifestyle management, confirmation of support (≥2 adults), and evaluations by transplant social work, psychology, and nephrology. Results: Seventy-five patients participated in the clinic and underwent a transplant. A retrospective chart review of posttransplant laboratory values, rehospitalizations (within 3-months posttransplant), biopsy-confirmed graft failure, and mortality (within 1-year posttransplant) were collected from both groups. Univariate and multivariate propensity score-weighted linear or logistic regression models were used to evaluate the association between clinic participation and outcomes. In models adjusting for relevant covariates, participation in The Countdown to Transplant Clinic (vs standard care) was associated with a lower coefficient of variation of serum tacrolimus (all values collected 3-12 months posttransplant), 30-day posttransplant white blood cell counts (but not 90-day), 90-day posttransplant potassium, and 30 and 31 to 90 days rehospitalizations. Clinic participation did not predict serum glucose levels at 30- or 90-days posttransplant. Due to low rates of rejection and mortality, meaningful comparisons were not possible. Conclusion: Participation in a pretransplant, multicomponent clinic may improve certain outcomes of interest posttransplantation. Pilot testing for feasibility for randomized controlled trials is a necessary next step.

Objective: Although sleep difficulties are common after spinal cord injury (SCI), little is known about how day-to-day fluctuations in sleep quality affects health-related quality of life (HRQOL) among these individuals. We examined the effect of sleep quality on same-day HRQOL using ecological momentary assessment methods over a 7-day period., Design: Repeated-measures study involving 7 days of home monitoring; participants completed HRQOL measures each night and ecological momentary assessment ratings 3 times throughout the day; multilevel models were used to analyze data., Setting: Two academic medical centers., Participants: A total of 170 individuals with SCI (N=170)., Interventions: Not applicable., Main Outcome Measures: Daily sleep quality was rated on a scale of 0 (worst) to 10 (best) each morning. Participants completed end-of-day diaries each night that included several HRQOL measures (Sleep Disturbance, Sleep-related Impairment, Fatigue, Cognitive Abilities, Pain Intensity, Pain Interference, Ability to Participate in Social Roles and Activities, Depression, Anxiety) and ecological momentary assessment ratings of HRQOL (pain, fatigue, subjective thinking) 3 times throughout each day., Results: Multilevel models indicated that fluctuations in sleep quality (as determined by end-of-day ratings) were significantly related to next-day ratings of HRQOL; sleep quality was related to other reports of sleep (Sleep Disturbance; Sleep-related Impairment; Fatigue) but not to other aspects of HRQOL. For ecological momentary assessment ratings, nights of poor sleep were related to worse pain, fatigue, and thinking. Generally, sleep quality showed consistent associations with fatigue and thinking across the day, but the association between sleep quality and these ecological momentary assessment ratings weakened over the course of the day., Conclusions: Findings highlight the important association between sleep and HRQOL for people with SCI. Future work targeting sleep quality improvement may have positive downstream effects for improving HRQOL in people with SCI., (Copyright © 2021 The American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Care partners (ie, informal family caregivers) of individuals with health problems face considerable physical and emotional stress, often with a substantial negative impact on the health-related quality of life (HRQOL) of both care partners and care recipients. Given that these individuals are often overwhelmed by their caregiving responsibilities, low-burden self-management interventions are needed to support care partners to ensure better patient outcomes., Objective: The primary objective of this study is to describe an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention that incorporates passive mobile sensor data feedback (sleep and activity data from a Fitbit [Fitbit LLC]) and real time self-reporting of HRQOL via a study-specific app called CareQOL (University of Michigan) to provide personalized feedback via app alerts., Methods: Participants from 3 diverse care partner groups will be enrolled (care partners of persons with spinal cord injury, care partners of persons with Huntington disease, and care partners of persons with hematopoietic cell transplantation). Participants will be randomized to either a control group, where they will wear the Fitbit and provide daily reports of HRQOL over a 3-month (ie, 90 days) period (without personalized feedback), or the just-in-time adaptive intervention group, where they will wear the Fitbit, provide daily reports of HRQOL, and receive personalized push notifications for 3 months. At the end of the study, participants will complete a feasibility and acceptability questionnaire, and metrics regarding adherence and attrition will be calculated., Results: This trial opened for recruitment in November 2020. Data collection was completed in June 2021, and the primary results are expected to be published in 2022., Conclusions: This trial will determine the feasibility and acceptability of an intensive app-based intervention in 3 distinct care partner groups: care partners for persons with a chronic condition that was caused by a traumatic event (ie, spinal cord injury); care partners for persons with a progressive, fatal neurodegenerative disease (ie, Huntington disease); and care partners for persons with episodic cancer conditions that require intense, prolonged inpatient and outpatient treatment (persons with hematopoietic cell transplantation)., Trial Registration: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591., International Registered Report Identifier (irrid): DERR1-10.2196/32842., (©Noelle E Carlozzi, Sung Won Choi, Zhenke Wu, Jennifer A Miner, Angela K Lyden, Christopher Graves, Jitao Wang, Srijan Sen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.12.2021.)

Purpose/objective: To examine the association between physical and mental symptoms and cognition in people with spinal cord injury. Research Method/Design: One hundred seventy-four community-dwelling adults with spinal cord injury completed several self-reported measures of health-related quality of life (Patient-Reported Outcomes Measurement Information System [PROMIS] Cognitive Abilities, Anxiety, Depression, Fatigue, and Pain Intensity) as well as a traditional neuropsychological assessment (six tests that included assessments of processing speed, working memory, memory, executive function, and attention). A series of multivariable linear regressions were used to test for associations between physical and mental symptoms and the seven ratings of cognition (i.e., scores on PROMIS Cognitive Abilities, as well as the six scores from the neuropsychological tests) after controlling for age, gender, education, and injury classification., Results: There was generally no association between symptom measures and neuropsychological test performance with one exception: Greater pain was associated with poorer performance on attention. However, anxiety and fatigue were associated with lower self-perceived cognitive function. Among those individuals with evidence of cognitive impairment in at least one cognitive domain, anxiety was also associated with lower working memory score, and fatigue was associated with lower delayed memory performance., Conclusions/implications: While the associations between pain and cognitive performance are consistent with general literature, the absence of a relationship between other symptoms (i.e., depression and fatigue) and cognitive performance was somewhat more surprising. Similarly, the associations between anxiety and fatigue with perceived cognitive function are consistent with the general literature, yet the absence of a relationship with depression was somewhat more surprising. Future work is needed to replicate these findings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Purpose/objective: Polypharmacy is common in people with spinal cord injury (SCI). Given the high rates of medication use, and the complicated side effect profile of many of the medications that are regularly prescribed in people with SCI, we were interested in the association between the use of different classes of medications and cognitive function in these individuals. Research Method/Design: One-hundred and 73 people with SCI participated in an observational study. Self-reported medications were provided by participants. Participants also completed several cognitive tests designed to capture multiple aspects of cognition (processing speed, attention, working memory, learning, free-recall memory, delayed free recall memory, executive function), as well as a self-report measure that captures participant perceptions of cognitive function. A series of multivariable linear regressions were used to test for associations between medications and the seven measures of cognition., Results: In general, there was not a robust relationship between medication use and cognitive function; the sole exception was an association between opioid use and subjective cognitive function. There was some preliminary support for an association between medication use, especially benzodiazepine and opioid analgesic use, and poorer cognitive performance. Specifically: Opioid analgesic use was associated with slowed processing speed, worse attention, poorer working memory, poorer executive function and more subjective cognitive complaints; benzodiazepine use was associated with slower processing speed, poorer working memory, and worse executive function; anticonvulsant use was related to worse delayed free recall memory; and the number of medication categories a person with SCI was taking was related to slower processing speed, and worse subjective cognitive function. Antidepressant, cannabis, skeletal muscle relaxant, sedative and stimulant use were not significantly related to cognitive performance, nor to subjective reports of cognitive function., Conclusions/implications: Findings did not support a strong relationship between medication use and cognitive function in people with SCI. There is some preliminary support for an association between benzodiazepine use and cognitive performance, but this needs to be confirmed in future research. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Health benefits of physical activity are well recognized in the general population for reducing the risk of chronic health conditions. Less is known about the effects of physical activity on people currently using or who may use wheeled mobility devices in the future, specifically individuals with multiple sclerosis, cerebral palsy, and spinal cord injury who are at increased likelihood for use of a wheeled mobility device. On December 1-3, 2020, the National Institutes of Health convened the Pathways to Prevention workshop: "Can Physical Activity Improve the Health of Wheelchair Users?" to consider the available scientific evidence on the clinical benefits and harms of physical activity for people currently using or who may use wheeled mobility devices in the future, with the aim of developing recommendations to fill gaps in the evidence base. A multidisciplinary team of content area experts developed the agenda and an evidence-based practice center prepared the evidence report. An independent panel, selected by the National Institutes of Health, attended the workshop; convened to develop recommendations on the basis of the systematic review, presentations, and public comments received during the workshop; and revised recommendations based on public comments received. This final report summarizes the panel's findings and identifies current gaps in knowledge. The panel made recommendations for new research efforts, including novel methods and new research infrastructure to improve the evidence base about the effects of physical activity on people currently using or who may use wheeled mobility devices in the future., (© 2021 The Authors.)

Objective: Previous work in Huntington's disease (HD) has shown that a sense of meaning and purpose (M&P) is positively associated with positive affect and well-being (PAW); however, it was unknown whether HD-validated patient-reported outcomes (PROs) influence this association and how M&P impacts PROs in the future. Our study was designed to examine if HD-validated PROs moderate the relationship between M&P and PAW and to evaluate if baseline M&P predicts 12- and 24-month changes in HD-validated PROs., Methods: This was a longitudinal, multicenter study to develop several PROs (e.g., specific for the physical, emotional, cognitive, and social domains) for people with HD (HDQLIFE). The sample consisted of 322 people with HD (n = 50 prodromal, n = 171 early-stage manifest, and n = 101 late-stage manifest HD). A single, multivariate linear mixed-effects model was performed with PAW as the outcome predicted by main effects for M&P and several moderators (i.e., an HD-validated PRO) and interactions between M&P and a given PRO. Linear-mixed models were also used to assess if baseline M&P predicted HD-validated PROs at 12 and 24 months., Results: Higher M&P was positively associated with higher PAW regardless of the magnitude of symptom burden, as represented by HD-validated PROs, and independent of disease stage. In our primary analysis, baseline M&P predicted increased PAW and decreased depression, anxiety, anger, emotional/behavioral disruptions, and cognitive decline at 12 and 24 months across all disease stages., Interpretation: These findings parallel those seen in the oncology population and have implications for adapting and developing psychotherapeutic and palliative HD interventions., (© 2021 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association.)

The aim of this study was to validate the Pittsburgh Fatigability Scale in three different groups: adults with multiple sclerosis ( n = 65), fibromyalgia ( n = 64), and healthy adults ( n = 86). Participants completed the Pittsburgh Fatigability Scale and other self-report measures. While findings supported the internal consistency of the Pittsburgh Fatigability Scale (all Cronbach's alpha ⩾ 0.85), standard error of measurement estimates were larger than hypothesized. In addition, while item-level reliability was generally supported, item-total correlations for two items were lower than expected. Convergent and discriminant validity were supported, and the Pittsburgh Fatigability Scale was able to distinguish between individuals with and without chronic disease. Overall, the Pittsburgh Fatigability Scale exhibited acceptable psychometric properties.

Introduction: Patients with chronic health conditions, particularly chronic kidney disease, are at heightened risk for psychiatric disorders; yet, there are limited data on those with primary glomerular disease., Methods: This study included patients with glomerular disease enrolled in the kidney research network multisite patient registry. Registry data include encounter, diagnoses, medication, laboratory, and vital signs data extracted from participants' electronic health records. ICD-9/10 diagnosis codes were used to identify a subset of psychiatric disorders focused on anxiety, mood, and behavioral disorders. Time-varying Cox proportional hazard models were used to analyze time from the onset of kidney disease to diagnosis of psychiatric disorder. Adjusted models retained significant covariates from the full list of potential confounders, including age, sex, race, ethnicity, time-varying treatment, the estimated glomerular filtration rate, and proteinuria (urine protein-to-creatinine ratio [UPCR]). Analogous models examined diagnosis of psychiatric disorder as a predictor of time to end-stage kidney disease (ESKD)., Results: Data were available for 950 participants, with a median of 58 months of follow-up. 110 (12%) participants were diagnosed with psychiatric disorder during the follow-up. The estimated rate of psychiatric diagnosis after kidney disease was 14.7 cases per 1,000 person-years and was highest among those of adolescent age at the time of kidney disease diagnosis. Adjusted analyses found adolescent age (vs. adult, hazard ratio [HR] = 3.11, 95% confidence interval [CI] 1.87-5.17) and Asian race (vs. white, HR = 0.34, 95% CI 0.16-0.71) were associated with psychiatric diagnosis. A higher UPCR per 1 log unit (HR 1.13, 95% CI 1.01-1.27) and a higher total number of oral medications were associated with psychiatric disorder ( p < 0.001). Psychiatric diagnosis was also associated with progression to ESKD (HR = 2.45, 95% CI 1.53-3.92) in adjusted models., Discussion/conclusion: Psychiatric disorders were documented in approximately one-eighth of patients with glomerular disease and correlated with clinical disease characteristics such as age, race, proteinuria, and oral medication burden. These findings suggest mental health screening is warranted in patients of all ages with glomerular disease., Competing Interests: Though there are no conflicts of interest or disclosures related to these data, the authors would like to report the following financial relationships: J.P.T. has research funding through the University of Michigan (UM) with Retrophin Inc., Goldfinch Bio, Vertex Pharmaceuticals, and Pfizer Inc. D.S.G. has research funding through the UM with Retrophin Inc., Goldfinch Bio, Novartis, and Reata Pharmaceuticals, and consults through UM with Vertex and AstraZeneca. E.S.K. has research funding from Pfizer, has served as a one-time consultant for Mallinckrodt, and serves on the Board of NephCure Kidney International. S.F.M. serves on the Retrophin Advisory Board., (Copyright © 2021 by The Author(s) Published by S. Karger AG, Basel.)

Rationale & Objective: Assessment of how patients feel and function is needed for clinical care and research for focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). The objective of this study was to develop a patient-reported outcome assessment appropriate for use in children and adults with FSGS and MCD., Study Design: Qualitative study using semi-structured interviews., Setting & Participants: 48 semi-structured interviews with children aged 8 to 17 years (n = 11) and adults (n = 10) with FSGS and children aged 8 to 17 (n = 11) and adults (n = 16) with MCD recruited from 3 academic medical centers., Analytical Approach: Latent content analysis., Results: FSGS and MCD have a pervasive and comparable impact on physical, social, and mental health-related quality of life regardless of age or diagnosis. Physical symptoms of swelling, fatigue, and pain were articulated by most participants. Disease management was also a frequent topic of discussion; participants described their experiences with medication and associated side effects, as well as lifestyle changes made to manage their disease (ie, dietary changes and frequent medical appointments). These discussions often identified a profound impact on physical abilities and life participation. In many instances, participants described the negative impact these symptoms had on their mood and sense of self, with most participants reporting feelings of anxiety., Limitations: Participants were primarily non-Hispanic White and English speaking, which may limit generalizability., Conclusions: Our results suggest that there are commonalities to the FSGS-MCD patient experience of health-related quality of life that will enable the generation of a disease-specific FSGS-MCD patient-reported outcomes instrument for use in children and adults. The development of this tool is intended to facilitate better care and support clinical research for these individuals., (© 2021 The Authors.)

Background: Promising disease modifying therapies for Huntington's disease are now entering pivotal trials, raising questions of what patients and families consider successful outcomes. Consistent with an ongoing movement to incorporate patient preferences into the development of new therapies, we conducted a pilot study to assess Huntington's disease community views on emerging DMTs to assist in planning large-scale studies of patient preferences., Methods: Semi-structured interviews were conducted with members of the Huntington's community (manifest disease, at-risk, and family/caregivers). Participants were asked which symptoms they believed should be targeted with novel treatments, as well as potential benefits and tradeoffs of delaying symptom onset versus prolonging late-stage disease., Results: Participants (N = 14) emphasized the need for treatments improving cognitive and/or behavioral symptoms. Many wanted treatments that delayed symptom onset up to 5-10 years, though some considered shorter delays acceptable due to potential value in advancing research to help future generations. Concern regarding potential for prolonging later-stage disease was variable, with some participants uncertain if they would want a treatment that delayed onset but prolonged later-stage disease. Others stated that any delay in onset would be desirable, regardless of potential prolongation of later stage disease., Discussion: This study demonstrates a breadth of opinions among the Huntington's disease community surrounding both the benefits and complex tradeoffs that might occur with disease modifying treatments. These preliminary findings will inform future large-scale studies of attitudes toward disease modifying treatments, which may ultimately guide the design and outcome measure selection for clinical trials., Highlights: In-depth interviews with the Huntington's disease community were used to explore patient and family preferences regarding potential disease modifying therapies. Many wanted symptom delay of 5-10 years, though some considered shorter delays acceptable for altruistic reasons. Opinions on trade-offs varied, suggesting larger preference studies are needed to inform trial design., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2021 The Author(s).)

Background: Existing patient-reported outcome (PRO) measures may not be relevant to the full range of functional and vision-related quality of life (VR-QOL) concerns of individuals with vision impairment due to severe peripheral field loss (PFL). Measurement of VR-QOL in severe PFL is important in order to determine the effectiveness of vision rehabilitation interventions for this population. The purpose of this study was to characterize the impact of severe PFL due to retinitis pigmentosa (RP) and glaucoma on VR-QOL as the initial phase in the development of a novel PRO measure., Methods: Individuals with severe PFL due to RP or glaucoma were recruited from the Kellogg Eye Center and the Association for the Blind and Visually Impaired. Participants completed semi-structured qualitative interviews, the Impact of Vision Impairment (IVI) questionnaire and the RAND 36-Item Health Survey. Interviews were analyzed by two coders using thematic analysis. A matrix analysis was conducted to compare VR-QOL by cause of severe PFL. Sample size was determined by thematic saturation., Results: The study included 37 participants (19 RP, 18 glaucoma). Median best-corrected visual acuity for those with RP and glaucoma was 20/40 and 20/27.5, while Pelli-Robson contrast sensitivity was 1.2 log contrast sensitivity (logCS) and 1.1 logCS, respectively. Median domain scores on the IVI (reading, mobility, well-being) ranged from a low of - 0.2 to a high of 0.7 logits in those with RP and from 0.5 to 1.2 logits in those with glaucoma. Qualitative interviews identified six VR-QOL themes relevant across participants with both RP and glaucoma, including activity limitations, driving, emotional well-being, reading, mobility, and social function. VR-QOL concerns were largely consistent among those with severe PFL due to RP and glaucoma. These overarching themes contained content relevant to specific challenges related to severe PFL., Conclusions: There are commonly occurring VR-QOL concerns among individuals with severe PFL due to RP and glaucoma. The outlined themes will serve as the basis for development of the Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire.

Purpose: As Huntington disease (HD) progresses, speech and swallowing difficulties become more profound. These difficulties have an adverse effect on health-related quality of life (HRQOL), thus psychometrically robust measures of speech and swallowing are needed to better understand the impact of these domains across the course of the disease. Therefore, the purpose of this study is to establish the clinical utility of two new patient-reported outcome measures (PROs), HDQLIFE Speech Difficulties and HDQLIFE Swallowing Difficulties., Methods: Thirty-one participants with premanifest or manifest HD, and 31 age- and sex-matched healthy control participants were recruited for this study. Participants completed several PROs [HDQLIFE Speech Difficulties, HDQLIFE Swallowing Difficulties, Communication Participation Item Bank (CPIB)], as well as several clinician-rated assessments of speech and functioning. A computational algorithm designed to detect features of spoken discourse was also examined. Analyses were focused on establishing the reliability and validity of these new measures., Results: Internal consistency was good for Swallowing (Cronbach's alpha = 0.89) and excellent for Speech and the CPIB (both Cronbach's alpha ≥ 0.94), and convergent/discriminant validity was supported. Known groups validity for the PROs was supported by significant group differences among control participants and persons with different stages of HD (all p < 0.0001). All PROs were able to distinguish those with and without clinician-rated dysarthria (likelihood ratios far exceeded the threshold for clinical decision making [all ≥ 3.28])., Conclusions: Findings support the clinical utility of the HDQLIFE Speech and Swallowing PROs and the CPIB for use across the HD disease spectrum. These PROs also have the potential to be clinically useful in other populations.

Background: The majority of persons with Huntington disease (HD) experience mental health symptoms. Patient-reported outcome (PRO) measures are capable of capturing unobservable behaviors and feelings relating to mental health. The current study aimed to test the reliability and responsiveness to self-reported and clinician-rated change over time of Neuro-QoL and PROMIS mental health PROs over the course of a 24-month period., Methods: At baseline, 12-months, and 24-months, 362 participants with premanifest or manifest HD completed the Neuro-QoL Depression computer adaptive test (CAT), PROMIS Depression short form (SF), Neuro-QoL Anxiety CAT, PROMIS Anxiety SF, PROMIS Anger CAT and SF, Neuro-QoL Emotional/Behavioral Dyscontrol CAT and SF, Neuro-QoL Positive Affect and Well-Being CAT and SF, and Neuro-QoL Stigma CAT and SF. Participants completed several clinician-administered measures at each time point, as well as several global ratings of change at 12- and 24-months. Reliability (test-retest reliability and measurement error) and responsiveness (using standardized response means and general linear models) were assessed., Results: Test-retest reliability and measurement error were excellent for all PROs (all ICC ≥ .90 for test-retest reliability and all SEM percentages ≤ 6.82%). In addition, 12- and 24-month responsiveness were generally supported for the Neuro-QoL and PROMIS mental health PROs; findings relative to clinician-rated anchors of change (e.g., SRMs for the group with declines ranged from .38 to .91 for 24-month change and .09 to .45, with the majority above .25 for 12-month change) were generally more robust than those relative to self-reported anchors of change (e.g., SRMs for the group with declines ranged from .02 to .75, with the majority above .39 for 24-month change and .09 to .45, with the majority above .16 for 12-month change)., Conclusions: The Neuro-QoL and PROMIS mental health PROs demonstrated strong psychometric reliability, as well as responsiveness to self-reported and clinician-rated change over time in people with HD.

Purpose: Family disruption is often an indirect consequence of providing care for a person with traumatic brain injury (TBI). This article describes the development and preliminary validation of a Family Disruption scale designed for inclusion within the TBI-CareQOL measurement system., Method/design: Five hundred thirty-four caregivers of persons with TBI (service member/veteran n = 316; civilian n = 218) completed the Family Disruption scale, alongside several other measures of caregiver strain and health-related quality of life. Classical test theory and item response theory (IRT)-based analyses were conducted to develop, and establish reliability and validity of, this scale., Results: Exploratory and confirmatory factor analysis, as well as Samejima's graded response model-related IRT fit analyses, supported the development of a 3-item scale. This final scale is scored on a T score metric ( M = 50; SD = 10); higher scores are indicative of more family disruption. Reliability (internal consistency; test-retest stability) was supported for both caregiver groups, and average administration times were under 10 s. Convergent and discriminant validity were supported by strong correlations between Family Disruption and measures of caregiver burden, and smaller correlations with positive aspects of caregiving. As evidence of known-groups validity, caregivers of lower-functioning persons with TBI experienced more family disruption than caregivers of higher functioning individuals., Conclusions: The TBI-CareQOL Family Disruption scale is a brief, reliable, and valid assessment of caregiver perceptions of how caring for an individual with a TBI interferes with family life. This measure is well-suited for inclusion in studies seeking to support family functioning in persons with TBI. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Objective: Caregivers of individuals with traumatic brain injury (TBI) often feel pressure to maintain the appearance that they are emotionally well adjusted, despite feelings to the contrary. Because there are currently no measures examining this construct, this article focuses on the development of a new measure that is specific to caregivers of people with TBI., Design: A total of 533 caregivers of civilians with TBI ( n = 218) or service members/veterans (SMVs) with TBI ( n = 315) completed 43 emotional suppression items, as well as other patient-reported outcomes and an estimate of the functional ability of the person with TBI., Results: Exploratory and confirmatory factor analyses supported the retention of 25 items. Graded response model (GRM) analyses and differential item functioning (DIF) studies supported the retention of 21 items in the final measure. Expert review and GRM calibration data were used to develop a 6-item static short form (SF) and program a computer adaptive test (CAT). Internal consistency was excellent for both the CAT and SF (reliabilities ≥ 0.91); 3-week test-retest stability was good (all intraclass correlations ≥ 0.89). Convergent validity was supported by moderate associations between TBI-CareQOL Emotional Suppression and related measures ( r s from 0.47 to 0.59); discriminant validity was supported by small correlations between Emotional Suppression and positive aspects of caregiving and physical health ( r s from 0.14 to 0.28). Known-groups validity was also supported., Conclusions: The new TBI-CareQOL Emotional Suppression CAT and 6-item short form is the first self-report measure of this construct in this population. Our findings suggest this new measure has strong psychometric properties. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Objective: The Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) is a patient-reported outcome measurement system that is specific to caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI). This measurement system includes 26 item banks that represent both generic (i.e., borrowed from existing measurement systems) and caregiver-specific components of health-related quality of life (HRQOL). This report provides reliability and validity data for measures within the TBI-CareQOL that have not previously been reported (i.e., 4 caregiver-specific and 7 generic measures of HRQOL)., Design: Three hundred eighty-five caregivers of persons with TBI completed caregiver-specific computer adaptive tests (CATs) for Feelings of Loss-Self, Caregiver Strain, Caregiver-Specific Anxiety, and Feeling Trapped, as well as generic measures of HRQOL from complementary measurement systems (i.e., Neuro-QoL Positive Affect and Well-Being; PROMIS Sleep-Related Impairment; NIH Toolbox Perceived Stress, General Life Satisfaction, and Self Efficacy; TBI-QOL Resilience and Grief/Loss). Caregivers also completed several additional measures to establish convergent and discriminant validity, as well as the Mayo Portland Adaptability Index, 4th ed., Results: Findings support the internal consistency reliability (all alphas > .85) and test-retest stability (all alphas >.73) of the TBI-CareQOL measures. Convergent validity was supported by moderate to high correlations between the TBI-CareQOL measures and related measures, whereas discriminant validity was supported by low correlations between the TBI-CareQOL measures and unrelated constructs. Known-groups validity was also supported., Conclusions: Findings support the reliability and validity of the item banks that comprise the TBI-CareQOL Measurement System. These measures should be considered for any standardized assessment of HRQOL in caregivers of civilians and SMVs with TBI. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Purpose: Caregivers of service members/veterans (SMVs) encounter a number of barriers when navigating the military health care system. The purpose of this study was to develop a new measure to assess potential caregiver frustration with the systems of care and benefits in the United States Departments of Defense and Veterans Affairs., Method: The TBI-CareQOL Military Health Care Frustration measure was developed using data from 317 caregivers of SMVs with TBI who completed an item pool comprised of 64 questions pertaining to anger or frustration with accessing military health care services., Results: Exploratory and confirmatory factor analyses supported the retention of 58 items. Constrained graded response model (GRM) overall fit and item fit analyses and differential item functioning investigations of age and education factors supported the retention of 43 items in the final measure. Expert review and GRM item calibration products were used to inform the selection of two 6-item static short forms (TBI-CareQOL Military Health Care Frustration-Self; TBI-CareQOL Military Health Care Frustration-Person with TBI) and to program the TBI-CareQOL Military Health Care Frustration computer adaptive test (CAT). Preliminary data supported the reliability (i.e., internal consistency and test-retest reliability) as well as the validity (i.e., convergent, discriminant, and known-groups) of the new measure., Conclusions: The new TBI-CareQOL Military Health Care Frustration measure can be used to examine caregiver perceptions of and experience with the military health care system, to target improvements. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Purpose/objective: Spiritual well-being has been associated with better quality of life outcomes in caregivers, but the associations among the care recipient's functional status, the caregiver's spiritual well-being, and the caregiver's health-related quality of life (HRQOL) is unknown. Research Method/Design: The study examined the Spiritual Well-Being Scale in caregivers of persons with traumatic brain injury (TBI; n = 335). Participants completed measures from the Patient-Reported Outcomes Measurement Information System, the Quality of Life in Caregivers of TBI, and the Caregiver Appraisal Scale. The Mayo-Portland Adaptability Inventory-4 (MPAI-4) measured care recipient's functional status. The association between religious well-being and existential well-being and HRQOL were examined with Pearson correlation coefficients. Multiple linear regressions examined the interaction between caregiver well-being and care recipient functional status on HRQOL outcomes accounting for demographic variables., Results: Less favorable caregiver HRQOL was associated with military affiliation, male status, spousal caregiver relationship, and White race. MPAI-4 was moderately associated with all HRQOL subdomains. For spiritual well-being, existential well-being was moderately correlated with 9 of 16 HRQOL subdomains in comparison to religious well-being that demonstrated small correlations with 3 of 16 subdomains. MPAI-4 had negative effects on HRQOL regardless of spiritual well-being with higher existential well-being reducing the negative impact of the care recipient's functional impairment on HRQOL for significant HRQOL interactions., Conclusions/implications: Interventions that encourage development and maintenance of life purpose and meaning in caregivers of persons with TBI, and less so, spirituality, might have beneficial effects on HRQOL when the person with injury has more functional limitations. (PsycInfo Database Record (c) 2020 APA, all rights reserved).