Noelle Carlozzi

University of Michigan | U-M · Department of Physical Medicine and Rehabilitation

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 interve...

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 indepen...

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-rat...

Objective: To report on the development and calibration of the new Blood Pressure Dysregulation Measurement System (BPD-MS) item banks that assess the impact 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 Ve...

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.DesignQualitative...

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). Con...

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...

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 interventio...

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 di...

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...

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 t...

PurposeThe 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 i...

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 interve...

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 Center...

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 patient...

Objective To provide reliability and validity data to support the clinical utility of Econ-QOL scores in caregivers of civilians and service members/veterans (SMVs) with TBI. Design Cross-sectional survey study. Setting Three academic medical centers and a VA treatment facility. Participants 376 caregivers of civilians (n=213) and SMVs (n=163) w...

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 o...

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/des...

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 Info...

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 funct...

Objective Although sleep difficulties are common following SCI, little is known about how day-to-day fluctuations in sleep quality affects 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 seven days of...

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 utilized a combination of baseline surveys and 7 end-of-day (EOD) diaries. Setting General communit...

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 exam...

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. Regis...

In recent years, a growing body of research has established that social determinants of health influence the health outcomes of patients, especially those with T2DM. We developed a new patient-reported outcome (PRO) measure of an important social determinant of behavior that is specific to persons with T2DM: illness burden. Qualitative and quantita...

Over 27 million Americans have type 2 diabetes mellitus (T2DM), accounting for >7.7 million hospital admissions. Social determinants of behavior, including medication adherence, play a critical role in their health outcomes. We developed a new patient-reported outcome (PRO) measure to evaluate medication adherence in people with T2DM, using establi...

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 Quali...

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 dis...

PurposeAs 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. There...

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...

Background: Patients with chronic health conditions are at heightened risk for psychiatric disorders; yet, little is known about the occurrence of psychiatric disorders or associations with patient and disease characteristics in glomerular disease. Methods: This study included patients with glomerular disease enrolled in the Kidney Research Network...

Objective: The purpose of this study was to examine perceived sleep-related impairment in caregivers of individuals with traumatic brain injury (TBI). Specifically, we examined the relationship between caregiver-perceived sleep-related impairment and different aspects of health-related quality of life (HRQOL) and explored whether these relationship...

Purpose/Objective: The purpose of this study is to estimate the occurrence of low health literacy among caregivers of people with traumatic brain injury (TBI), and to evaluate associations of health literacy with caregiver health-related quality of life (HRQOL) and perceptions of the caregiving role. Research Method/Design: The TBI-CareQOL measure...

Objective: The goal of this study was to examine the association between characteristics of persons with traumatic brain injury (PwTBI) and perceived sleep-related impairment of the caregivers. Method: Fifty-two dyads (n = 23 civilians, n = 29 service members/veterans [SMVs]) were enrolled. Caregivers completed the Patient-Reported Outcomes Meas...

Purpose Individuals with Huntington disease (HD) experience progressive cognitive decline that may appear years before motor manifestations of the disease. These declines have a profound effect on health-related quality of life (HRQOL) over the disease course, and thus it is important that self-report measures of cognitive function are validated fo...

Objective To understand the factor structure of Health-Related Quality of Life (HRQOL) specific to caregivers of people living with Traumatic Brain Injury (TBI). Design Prospective, cross-sectional data collection. Setting Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. Par...

Objective: Caregivers of individuals with traumatic brain injury (TBI) frequently experience anxiety related to the caregiver role. Often this is due to a caregiver's perceived need to avoid people and situations that might upset or "trigger" the care recipient. There are currently no self-report measures that capture these feelings; thus, this ar...

Purpose/objective: To examine the influence of traumatic brain injury (TBI) severity on the health-related quality of life of caregivers providing care to service members/veterans (SMV) following a TBI. Research Method/Design: Thirty caregivers (90.0% female; 70.0% spouse; age: M = 39.5 years, SD = 10.7) of SMVs who sustained a mild, moderate, sev...

Purpose/objective: Persons with Huntington's disease experience stigma because of their gene status. Whereas perceived stigma has been found to impact quality of life, it is unknown how different health domains (i.e., physical, emotional, cognitive, and social) are associated with feelings of stigma. In addition, stigma research has been limited b...

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...

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...

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 person...

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 me...

Background: Social health is an important concern in persons with Huntington's disease (HD); however, there is little literature examining this construct in this population. Objective: While cross-sectional data supports the clinical utility of two Neuro-QoL social health measures in persons with HD, data is still needed to establish their longi...

Background: Huntington's disease (HD) is a neurological disorder that causes severe motor symptoms that adversely impact health-related quality of life. Patient-reported physical function outcome measures in HD have shown cross-sectional evidence of validity, but responsiveness has not yet been assessed. Objectives: This study evaluates the resp...

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...

Background and purpose Huntington disease (HD) is a progressive neurodegenerative disorder. There are no HD-specific measures to assess for end-of-life (EOL) preferences that have been validated for clinical use. The purpose of this study is to demonstrate reliability and validity of three HD-specific EOL measures for use in and clinical research s...

Purpose: This study examined the relationships between different aspects of motor dysfunction (chorea, dystonia, rigidity, incoordination, oculomotor dysfunction, dysarthria, and gait difficulties) and functional status in persons with Huntington's disease. Methods: A total of 527 persons with Huntington's disease completed the Unified Huntingto...

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 Pittsburg...

Objective: To develop, calibrate, and evaluate the test-retest reliability of a new patient-reported outcome measure of headache pain relevant for individuals with traumatic brain injury (TBI). Setting: Six TBI Model Systems rehabilitation centers in the United States. Participants: Adults with medically confirmed documentation of TBI. Design...

Objective: To develop and calibrate new patient-reported outcome measures of cognitive concerns for individuals with traumatic brain injury (TBI). Setting: Five TBI model systems rehabilitation centers in the United States. Participants: Adults with medically confirmed history of TBI. Design: Cross-sectional survey in interview format. Main...

Objective: To develop a pain interference item bank, computer adaptive test (CAT), and short form for use by individuals with traumatic brain injury (TBI). Design: Cross-sectional survey study. Setting: Five TBI Model Systems rehabilitation hospitals. Participants: Five hundred ninety individuals with TBI. Interventions: Not Applicable. O...

Background: Patient-reported outcomes (PROs) for mental health are important for persons with Huntington disease (HD) who commonly experience symptoms of depression, anxiety, irritability, anger, aggression, and apathy. Given this, there is a need for reliable and valid patient-reported outcomes measures of mental health for use as patient-centere...

Objective Preference-sensitive surgical decisions merit shared decision-making, as decision engagement can reduce decisional conflict and regret. Elective cleft-related procedures are often preference sensitive, and therefore, we sought to better understand decision-making in this population. Design Semistructured interviews were conducted to elic...

Background: Understanding the relationship between clinical and patient-reported outcomes (PROs) will help support clinical care and future clinical trial design of novel therapies for focal segmental glomerulosclerosis (FSGS). Methods: FSGS patients ≥8 years of age enrolled in the Nephrotic Syndrome Study Network completed Patient-Reported Outc...

Objective: To develop an item response theory (IRT)-calibrated, patient-reported outcome measure of subjective independence for individuals with traumatic brain injury (TBI). Design: Large-scale item calibration field testing; confirmatory factor analysis (CFA) and graded response model IRT analyses. Setting: Five TBI Model System centers acro...

Objective: To investigate the relationship of 2 health-related quality-of-life (QOL) item banks (Emotional Suppression and Caregiver Vigilance), developed for caregivers of service members/veterans with traumatic brain injury (TBI), to caregivers' positive and negative affect. Setting: Community. Participants: One hundred sixty-five caregivers...

PURPOSE Patient-reported outcomes after radical prostatectomy have focused on erectile function. To date, no studies have validated the Patient-Reported Outcome Measurement Information System (PROMIS) Sexual Interest and Satisfaction single item measures in patients with prostate cancer, nor have studies examined how these measures relate to erecti...

Purpose Perceived fatigability, reflective of changes in fatigue intensity in the context of activity, has emerged as a potentially important clinical outcome and quality of life indicator. Unfortunately, the nature of perceived fatigability is not well characterized. The aim of this study is to define the characteristics of fatigability through th...

Objective: Nephrotic syndrome (NS) is a kidney disease known to adversely impact health-related quality of life (HRQOL). Patient-reported outcome (PRO) measures are commonly used to characterize HRQOL and the patient disease experience. This study aims to improve the interpretability and clinical utility of the Patient-Reported Outcomes Measuremen...

Objective: To examine the validity of factor analytically based summary scores that were developed using the National Institutes of Health Toolbox Emotion Battery (NIHTB-EB); (ie, psychological well-being, social satisfaction, negative affect) normative sample in individuals with neurologic conditions. Design: Cross-sectional, observational coho...

Background: Positive affect is associated with resiliency and beneficial health outcomes, but little is known about associations between positive affect and health-related quality of life (HRQOL) in Huntington's disease (HD). Objective: This longitudinal study determined the association between positive affect and several HRQOL outcomes in perso...

Chorea, a hallmark symptom of Huntington’s disease (HD), is characterized by jerky involuntary movements affecting the whole body that can interfere with daily functioning and impact health-related quality of life (HRQOL). To characterize chorea’s impact on everyday functioning and HRQOL and identify patterns of perception and experiences of chorea...

Health related quality of life (HRQOL) measures have become increasingly important in the management of glioma patients in both research and clinical practice settings. Functional impairment is common in low-grade and high-grade glioma patients as the disease has both oncological and neurological manifestations. Natural disease history as well as m...

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 respon...

There is scant literature describing the effect of glomerular disease on health-related quality of life (HRQOL). The Cure Glomerulonephropathy study (CureGN) is an international longitudinal cohort study of children and adults with four primary glomerular diseases (minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy,...

Objective: To examine group differences among caregivers of service members or veterans (SMVs) and civilians with traumatic brain injury (TBI). Design: An observational research study examining the group differences between caregivers of SMVs and civilians with TBI. The data presented was collected as part of a larger study that calibrated and v...

Purpose: This study investigated the most efficient means of measuring pain intensity and pain interference comparing ecological momentary assessment (EMA) to end of day (EOD) data, with the highest level of measurement reliability as examined in individuals with spinal cord injury. Methods: EMA (five times throughout the day) and EOD ratings of...

Purpose: Symptom progression in Huntington disease (HD) is associated with cognitive decline which may interfere with the self-report of symptoms. Unfortunately, data to support or refute the psychometric reliability of patient-reported outcomes (PROs) as HD progresses are limited. This is problematic given that PROs are increasingly recognized as...

Objective: To investigate the association of the sociocultural variables race/ethnicity, education, and poverty level to caregivers’ positive and negative appraisals following traumatic brain injury. Design: Survey. Setting: Community. Participants: 344 caregivers (216 White; 69 Black; 39 Hispanic) of persons with complicated mild to severe TBI a...

Objective: To develop a new measurement system, the TBI-CareQOL, that can evaluate both general and caregiving-specific aspects of health-related quality of life (HRQOL) in caregivers of persons with traumatic brain injury (TBI). Design: New item pools were developed and refined using literature reviews, qualitative data from focus groups, and c...

Background: Huntington disease (HD) is associated with increased risk of suicide. Objective: This study compares suicide ideation in HD to the general population, assesses factors associated with increased prevalence of suicidal thoughts, and compares clinician-rated to self-reported assessments of suicidal ideation. Methods: We examined 496 p...

Objective: To develop a new patient-reported outcome measure that captures feelings of being trapped that are commonly experienced by caregivers of individuals with traumatic brain injury (TBI). Design: Cross-sectional SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility...

Objective: To examine the reliability and validity of the short form (SF) and computer adaptive test (CAT) versions of the Patient Reported Outcomes Measurement Information System (PROMIS) measures of social health of caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI). Design: Self-report questionnaires...

Objective: To develop a new measure of caregiver strain for use in caregivers of individuals with TBI, TBI-CareQOL Caregiver Strain. Design: Qualitative data, literature reviews, and cross-sectional survey study. Setting: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. P...

Background: Clinician-rated measures of functioning are often used as primary endpoints in clinical trials and other behavioral research in Huntington disease. As study costs for clinician-rated assessments are not always feasible, there is a question of whether patient self-report of commonly used clinician-rated measures may serve as acceptable...

Objective: To provide important reliability and validity data to support the use of the PROMIS Mental Health measures in caregivers of civilians or service members/veterans with traumatic brain injury (TBI). Design: Patient-reported outcomes surveys administered through an electronic data collection platform. Setting: Three TBI Model Systems r...