Clinically meaningful classes of financial toxicity for patients with diabetes.

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.

A Qualitative Assessment of Adolescent Symptom Report and Caregiver Concordance Following Outpatient Surgery.

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.

A Digital Biomarker Dataset in Hematopoietic Cell Transplantation: A Longitudinal Study of Caregiver-Patient Dyads (dHCT).

Background: Hematopoietic stem cell transplantation (HCT) is a potentially life-saving therapy for individuals with blood diseases, but involves a challenging recovery process that requires dedicated caregivers. The complex interplay between emotional distress, care partner (or unpaid caregiver) burden, and treatment outcomes necessitates comprehensive physiological and psychological measurements to fully understand these dynamics.

Findings: We collected longitudinal data from 166 HCT caregiver-patient dyads over 120 days post-transplant as part of a randomized controlled trial ( NCT04094844 ).

Four New Patient-Reported Outcome Measures Examining Health-Seeking Behavior in Persons With Type 2 Diabetes Mellitus (REDD-CAT): Instrument Development Study.

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.

Preparation and Rationale for a Patient-Centered Clinical Outcome Assessment Set of Fluid Overload for Drug Development in Nephrotic Syndrome.

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.

Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP): study protocol for a multicenter, randomized, adaptive allocation clinical trial to identify the optimal duration of induced hypothermia for neuroprotection in comatose, adult survivors of after out-of-hospital cardiac arrest.

Background: Cardiac arrest is a common and devastating emergency of both the heart and brain. More than 380,000 patients suffer out-of-hospital cardiac arrest annually in the USA. Induced cooling of comatose patients markedly improved neurological and functional outcomes in pivotal randomized clinical trials, but the optimal duration of therapeutic hypothermia has not yet been established.

Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP): study protocol for a multicenter, randomized, adaptive allocation clinical trial to identify the optimal duration of induced hypothermia for neuroprotection in comatose, adult survivors of after out-of-hospital cardiac arrest.

Background: Cardiac arrest is a common and devastating emergency of both the heart and brain. More than 380,000 patients suffer out-of-hospital cardiac arrest annually in the United States. Induced cooling of comatose patients markedly improved neurological and functional outcomes in pivotal randomized clinical trials, but the optimal duration of therapeutic hypothermia has not yet been established.

What Huntington's Disease Patients Say About Their Illness: An Online Direct-to-Participant Pilot Study.

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.

Developing an Edema Clinician-Reported Outcome Measure for Nephrotic Syndrome.

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.

Identifying Design Opportunities for Adaptive mHealth Interventions That Target General Well-Being: Interview Study With Informal Care Partners.

Background: Mobile health (mHealth) interventions can deliver personalized behavioral support to users in daily contexts. These interventions have been increasingly adopted to support individuals who require low-cost and low-burden support. Prior research has demonstrated the feasibility and acceptability of an mHealth intervention app (CareQOL) designed for use with informal care partners.

Development and Validation of the Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire.

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.

The reliability and validity of the TBI-CareQOL system in four diverse caregiver groups.

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).

Item Banks for Measuring the Effect of Blood Pressure Dysregulation on Health-Related Quality of Life in Persons With Spinal Cord Injury.

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.

Development of a New Measure of Housing Security: The REDD-CAT Housing Security Measure.

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.

A pilot intervention of using a mobile health app (ONC Roadmap) to enhance health-related quality of life in family caregivers of pediatric patients with cancer.

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 and engaged with it at least twice weekly for at least 50% of the 120-day study duration.

Death Anxiety in Huntington Disease: Longitudinal Heath-Related Quality-of-Life Outcomes.

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.

Impact-Tardive Dyskinesia (Impact-TD) Scale: A Clinical Tool to Assess the Impact of Tardive Dyskinesia.

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.

An app-based just-in-time-adaptive self-management intervention for care partners: The CareQOL feasibility pilot study.

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.

Development and calibration data for the Healthcare Access Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

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.

Development and calibration data for the Medication Adherence Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

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.

Development and calibration data for the Illness Burden item bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

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.

Barriers and Facilitators to Accessing Rehabilitation Health Care: A Veterans Affairs Traumatic Brain Injury Model Systems Qualitative Study.

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.