Financial burden for caregivers of adolescents and young adults with cancer.

OBJECTIVE: Adolescent and young adult (AYA) cancer survivors are vulnerable to cancer-related financial burden, which is likely shared by their caregivers. This study aims to enhance an existing conceptual model of financial burden by conducting concept elicitation interviews with caregivers to generate knowledge that can be translated to inform instrumental and psychosocial support in cancer care. METHODS: Qualitative concept elicitation interviews were conducted with 24 caregivers of AYA cancer survivors (caregivers of adolescents, n = 12; caregivers of emerging adults, n = 12) recruited from four sites. Constant comparative methods were used to identify themes, and results were interpreted and organized into domains of the conceptual model. We also explored COVID-19 related financial impacts among a subset (n = 12) of caregivers. RESULTS: Seven themes emerged, which varied by age group and strengthened the conceptualization of the model. Themes centered on: (1) direct and indirect costs of cancer; (2) impact of socioeconomic status on financial burden; (3) caregiver desire to shield AYAs from distress due to financial burden; (4) strategies to manage cancer-related costs; (5) worries about AYAs' financial future; (6) seeking and receiving financial support; and (7) navigating the healthcare system. Findings also revealed that COVID-19 exacerbates financial burden for some caregivers. CONCLUSIONS: Building upon our prior work, we have adapted the conceptual model of financial burden to reflect perspectives of AYAs, oncology providers, and now, caregivers. An important next step is to develop a reliable and valid self-report measure of financial burden among caregivers of AYA cancer survivors.

Cancer Survivors' Disability Experiences and Identities: A Qualitative Exploration to Advance Cancer Equity.

Eliminating cancer-related disparities is a global public health priority. Approximately 40% of cancer survivors experience long-term effects of cancer which can lead to activity limitations and participation restrictions; yet discussions of disability are largely absent from clinical and research cancer health equity agendas. The purpose of this study was to explore how cancer survivors experience and make sense of the long-term disabling effects of cancer and its treatments. In this qualitative study, data were collected via in-depth semi-structured interviews with survivors of breast cancer, head and neck cancer, and sarcoma (n = 30). Data were analyzed thematically using a 2-phase iterative process proceeding from descriptive to conceptual coding. Survivors experienced a wide range of long-term physical, sensory, cognitive, and emotional effects, that intertwined to restrict their participation in self-care, work, leisure, and social roles. While the interaction between impairments and participation restrictions meets the definition of disability; participants articulated a range of responses when asked about their disability identity, including (1) rejecting, (2) othering, (3) acknowledging, and (4) affirming. Findings may be indicative of structural and internalized ableism which can impede cancer care and survivorship. To support cancer survivors' transition to post-treatment life, cancer care providers should implement anti-ableist practices and engage in frank discussions about cancer's long-term impacts.

The association of baseline sarcoidosis measurements with 6-month outcomes that are of interest to patients: Results from the On-line Sarcoidosis Assessment Platform Study (OSAP).

INTRODUCTION: The impact of common measures to assess sarcoidosis have not been compared longitudinally to outcomes that are meaningful to patients. We prospectively examined the relationship of baseline measurements of sarcoidosis status to outcomes of interest to patients longitudinally over 6 months. METHODS: Sarcoidosis patients cared for at 6 US medical centers were "phenotyped" at baseline with measurements of pulmonary function, organ involvement, health related quality of life (HRQoL) instruments, and their anti-sarcoidosis treatment history. These patients were followed for 6 months by monitoring outcomes of interest to patients (OIPs) including steps walked, calories expended, sleep, HRQoL measures, workdays missed and health care utilization. For each baseline phenotypic measurement, patients were dichotomized into two groups above and below a specified cutoff value. The area under the OIP versus time curve was compared between these two groups. RESULTS: The cutoff values for many baseline phenotypic measures distinguished the patients into groups with significantly different 6-month OIPs. The chosen cutoff for the patient global estimate of health status distinguished the most OIPs (13/15). The 6-min walk distance cutoff was associated with more OIPs than spirometric measures. All of the HRQOL measure cutoffs were associated with many OIPs, although most of them were other HRQOL measures. INTERPRETATION: Cutoffs for most of the phenotypic measures used to assess sarcoidosis distinguished groups of sarcoidosis patients with differing OIPs over the subsequent 6 months. The patients' global assessment of their disease was the most accurate of these measures. CLINICAL TRIAL REGISTRATION NUMBER: NCT04342403.

The Bolivian trauma patient's experience: A qualitative needs assessment.

BACKGROUND: Despite a significant burden of injury-related deaths, the Plurinational State of Bolivia (Bolivia), a lower- middle-income country in South America, lacks a formalized trauma system. This study sought to examine Bolivian trauma care from the patient perspective in order to determine barriers to care and targets for improvement. METHODS: Investigators conducted 15 semi-structured interviews with trauma patients admitted at four hospitals in Santa Cruz de la Sierra, Bolivia in June and July of 2016. Interviews were transcribed, translated, and analyzed through content and discourse analysis to identify key themes and perceptions of trauma care. RESULTS: Participants primarily presented with orthopedic injuries due to road traffic incidents and falls. Only one participant reported receiving first aid from a layperson at the scene of injury. Of the 15 participants, 12 did not know any number to contact emergency medical services (EMS). Participants expressed negative views of EMS as well as concerns for slow response times and inadequate personnel and training. Two thirds of participants were initially brought to a hospital without adequate resources to care for their injuries. Participants generally expressed positive views regarding healthcare workers involved in their hospital-based medical care. CONCLUSIONS: This region of Bolivia has a disorganized, underutilized, and distrusted trauma system. In order to increase survival, interventions should focus on improving prehospital trauma care. Potential interventions include the implementation of layperson trauma first responder courses, the establishment of a medical emergency hotline, the unification of EMS, the implementation of basic training requirements for EMS personnel, and public education campaigns to increase trust in EMS.

Recruiting and Retaining People With Disabilities for Qualitative Health Research: Challenges and Solutions.

There are 56.7 million people with disabilities (PWD) living in the United States; yet, PWD are significantly underrepresented in health research. Even when researchers purposively seek to include PWD in studies, challenges emerge related to recruitment and retention, leading to inadequate representation and surface understandings of this population. This in turn contributes to the perpetuation of implicit and explicit health disparities that are already experienced by this population. Grounded within a qualitative, community-based participatory health research framework, we highlight challenges associated with recruiting and retaining PWD in health research, including a critical analysis of the research enterprise structure, how this disables accessible research practices for PWD, and leads to continued skepticism among PWD regarding the value of participating in research. Finally, we propose solutions to create and maintain a culture of access and inclusion as well as long-term collaborative and equity-focused partnerships.

Institutional Alliances to Reduce Cancer Disparities in Chicago.

A partnership formed between Northeastern Illinois University (NEIU) and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University sought to address well-documented cancer health disparities in Chicago by developing a collaborative research, training, and educational infrastructure between a minority-serving institution and a National Cancer Institute designated comprehensive cancer center. With a critical examination of partnership documentation and outputs, we describe the partnership's community-engaged approaches, challenges, and lessons learned. Northeastern Illinois University and the Lurie Cancer Center engaged in a yearlong partnership-building phase, identified interdisciplinary research teams, formed a governance structure, and identified collective aims. Partnership outcomes included funded inter-institutional research projects, new curriculum, and an annual research trainee program. Significant challenges faced included uncertain fiscal climate, widespread turnover, and dissimilar institutional demands. Lessons learned from this minority serving institution and comprehensive cancer center partnership may be useful for bridging distinct academic communities in the pursuit of ameliorating health disparities.

Measuring psychological trauma after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Psychological Trauma item bank and short form.

OBJECTIVE: To describe the development and psychometric properties of the SCI-QOL Psychological Trauma item bank and short form. DESIGN: Using a mixed-methods design, we developed and tested a Psychological Trauma item bank with patient and provider focus groups, cognitive interviews, and item response theory based analytic approaches, including tests of model fit, differential item functioning (DIF) and precision. SETTING: We tested a 31-item pool at several medical institutions across the United States, including the University of Michigan, Kessler Foundation, Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital and the James J. Peters/Bronx Veterans Administration hospital. PARTICIPANTS: A total of 716 individuals with SCI completed the trauma items RESULTS: The 31 items fit a unidimensional model (CFI=0.952; RMSEA=0.061) and demonstrated good precision (theta range between 0.6 and 2.5). Nine items demonstrated negligible DIF with little impact on score estimates. The final calibrated item bank contains 19 items CONCLUSION: The SCI-QOL Psychological Trauma item bank is a psychometrically robust measurement tool from which a short form and a computer adaptive test (CAT) version are available.

Validation and important differences for the Sarcoidosis Assessment Tool. A new patient-reported outcome measure.

RATIONALE: Patient-reported outcome (PRO) measures have been developed to measure symptoms and other aspects of health-related quality of life. OBJECTIVES: The Sarcoidosis Assessment Tool (SAT), a sarcoidosis-specific PRO, was administered in a lung and skin sarcoidosis treatment trial. We explored SAT performance characteristics and correlation with standard clinical measurements to validate it as a useful clinical sarcoidosis-specific PRO. METHODS: The SAT analyses focused on baseline and Week 16 assessments. Besides the SAT, participants underwent clinical and physician assessments plus additional PROs that were used as anchor variables and were compared with the SAT. Reliability was evaluated by using Cronbach α coefficient. Spearman correlation coefficients were used to evaluate the association between SAT scores with clinical and other PRO measures. Changes between assessments in the clinical and PRO "anchor" variables were classified as improved, stable, or worsened. Mean differences between adjacent categories of the known groups and mean changes from the ability to detect change analyses were reviewed for appropriate clinically important difference estimates. MEASUREMENTS AND MAIN RESULTS: Results from 173 patients were analyzed. Each SAT module reflected appropriate anchor variables at baseline and in terms of change. The Cronbach α for each of these modules was at least 0.87. In addition, we successfully established a clinically important difference range for each SAT module. CONCLUSIONS: We demonstrated that the SAT is a reliable and consistent sarcoidosis-specific PRO. It has excellent internal consistency and reliability. A range of clinically important differences has been established for the SAT modules. Clinical trial registered with www.clinicaltrials.gov (NCT 00955279).

Myotonic Dystrophy Health Index: initial evaluation of a disease-specific outcome measure.

INTRODUCTION: In preparation for clinical trials we examine the validity, reliability, and patient understanding of the Myotonic Dystrophy Health Index (MDHI). METHODS: Initially we partnered with 278 myotonic dystrophy type-1 (DM1) patients and identified the most relevant questions for the MDHI. Next, we used factor analysis, patient interviews, and test-retest reliability assessments to refine and evaluate the instrument. Lastly, we determined the capability of the MDHI to differentiate between known groups of DM1 participants. RESULTS: Questions in the final MDHI represent 17 areas of DM1 health. The internal consistency was acceptable in all subscales. The MDHI had a high test-retest reliability (ICC = 0.95) and differentiated between DM1 patient groups with different disease severities. CONCLUSIONS: Initial evaluation of the MDHI provides evidence that it is valid and reliable as an outcome measure for assessing patient-reported health. These results suggest that important aspects of DM1 health may be measured effectively using the MDHI.

Ensuring comprehensive assessment of urinary problems in prostate cancer through patient-physician concordance.

OBJECTIVES: To examine the concordance between clinicians and men diagnosed with prostate cancer on a clinician-derived pathophysiological classification of the following self-reported urinary complications: storage (irritative), voiding (obstructive), and leakage/incontinence. MATERIALS AND METHODS: Fourteen urology experts classified 37 urinary function questionnaire items into 3 primary conceptual dimensions (e.g., storage [irritative], voiding [obstructive] and urinary leakage/incontinence) that would best reflect each item's content. In addition, 218 patient participants provided responses to the 37 items. Using classifications by experts to develop the conceptual framework, the structure was tested using confirmatory factor analyses with patient data. RESULTS: Expert consensus was achieved in the classification of 31 out of 37 items. Using the 3-factor conceptual framework and patient data, the fit indices for the overall correlated factor model suggested an acceptable overall model fit. The analyses of the separate domains showed acceptable fit for the storage/irritative domain and the leaking/incontinence domain. The dimensionality of the voiding/obstructive domain was too difficult to estimate. CONCLUSIONS: Our analysis found items that conceptually and psychometrically support 2 constructs (leaking/incontinence and storage/irritative). The consistency of this support between the groups suggests a clinical relevance that is useful in treating patients. We have conceptual support for a third hypothesis (voiding/obstructive), although there were too few items to assess this psychometrically. Relative motivating factors of bother and urinary complaints were not addressed and remain an unmet need in this field.

Patient-reported outcome measures for sleep disorders and related problems: clinical and research applications.

Patients with sleep disorders are most concerned with the impact of these diseases on their quality of life. Patient-reported outcome (PRO) measurement tools, which assess aspects of a patient's health status that come directly from the patient, are well suited to evaluate quality of life related to sleep disorders. Although PRO data are subjective, they can be quantified, evaluated for reliability and reproducibility, and used to answer questions of clinical and research importance. This article reviews various PRO measure tools used for sleep disorders in clinical and research settings. These instruments may play a role in screening, diagnosis, and monitoring of various sleep disorders.

Using the NIH Toolbox in special populations: considerations for assessment of pediatric, geriatric, culturally diverse, non-English-speaking, and disabled individuals.

BACKGROUND: In order to develop health outcomes measures that are relevant and applicable to the general population, it is essential to consider the needs and requirements of special subgroups, such as the young, elderly, disabled, and people of different ethnic and cultural backgrounds, within that population. METHODS: The NIH Toolbox project convened several working groups to address assessment issues for the following subgroups: pediatric, geriatric, cultural, non-English-speaking, and disabled. Each group reviewed all NIH Toolbox instruments in their entirety. RESULTS: Each working group provided recommendations to the scientific study teams regarding instrument content, presentation, and administration. When feasible and appropriate, instruments and administration procedures have been modified in accordance with these recommendations. CONCLUSION: Health outcome measurement can benefit from expert input regarding assessment considerations for special subgroups.

Gustation assessment using the NIH Toolbox.

The NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox) is a set of brief measures for the assessment of cognitive function, emotional health, motor function, and sensory function for use in clinical trials and in epidemiologic and longitudinal studies. Gustatory perception is assessed as 1 of 6 areas of sensory function. A team of 11 scientists with expertise in taste perception selected 2 gustatory measures, 1 of which can be used in young pediatric populations. The measure selected for young pediatric populations assesses sucrose (sweet) taste preference and can also be used across the age span of 5 to 85 years. For adult populations, the selected measure is a regional test, which assesses variability in perceived intensity of quinine hydrochloride (bitter) when applied to the tongue tip as well as perceived with the whole mouth. The team also recommends the regional test for assessing other tastants, such as sodium chloride (salty). Validation studies have demonstrated that the measures modified for the NIH Toolbox correlate with more traditional assessments, and can identify known population differences in gustation.

Somatosensation assessment using the NIH Toolbox.

Touch sensation is one element of sensory function. As such, somatosensation is one of the sensory domains included in the NIH Toolbox, which is an assessment battery for measuring a range of human functions including emotional health, sensation, cognition, and motor function. We evaluated a variety of methods for inclusion in the NIH Toolbox main battery. In a convenience sample of 409 participants, we evaluated aspects of kinesthesia, pain, and tactile discrimination. We present results on these measures across the lifespan and discuss implications for future studies that use the NIH Toolbox and these measures.

Audition assessment using the NIH Toolbox.

The NIH Toolbox project has assembled measurement tools to assess a wide range of human perception and ability across the lifespan. As part of this initiative, a small but comprehensive battery of auditory tests has been assembled. The main tool of this battery, pure-tone thresholds, measures the ability of people to hear at specific frequencies. Pure-tone thresholds have long been considered the "gold standard" of auditory testing, and are normally obtained in a clinical setting by highly trained audiologists. For the purposes of the Toolbox project, an automated procedure (NIH Toolbox Threshold Hearing Test) was developed that allows nonspecialists to administer the test reliably. Three supplemental auditory tests are also included in the Toolbox auditory test battery: assessment of middle-ear function (tympanometry), speech perception in noise (the NIH Toolbox Words-in-Noise Test), and self-assessment of hearing impairment (the NIH Toolbox Hearing Handicap Inventory Ages 18-64 and the NIH Toolbox Hearing Handicap Inventory Ages 64+). Tympanometry can help differentiate conductive from sensorineural pathology. The NIH Toolbox Words-in-Noise Test measures a listener's ability to perceive words in noisy situations. This ability is not necessarily predicted by a person's pure-tone thresholds; some people with normal hearing have difficulty extracting meaning from speech sounds heard in a noisy context. The NIH Toolbox Hearing Handicap Inventory focuses on how a person's perceived hearing status affects daily life. The test was constructed to include emotional and social/situational subscales, with specific questions about how hearing impairment may affect one's emotional state or limit participation in specific activities. The 4 auditory tests included in the Toolbox auditory test battery cover a range of auditory abilities and provide a snapshot of a participant's auditory capacity.

Pain assessment using the NIH Toolbox.

OBJECTIVE: Pain is an important component of health and function, and chronic pain can be a problem in its own right. The purpose of this report is to review the considerations surrounding pain measurement in the NIH Toolbox, as well as to describe the measurement tools that were adopted for inclusion in the NIH Toolbox assessment battery. METHODS: Instruments to measure pain in the NIH Toolbox were selected on the basis of scholarly input from a diverse group of experts, as well as review of existing instruments, which include verbal rating scales, numerical rating scales, and graphical scales. RESULTS: Brief self-report measures of pain intensity and pain interference were selected for inclusion in the core NIH Toolbox for use with adults. A 0 to 10 numerical rating scale was recommended for measuring pain intensity, and a 6-item Patient Reported Outcome Measurement Information System (PROMIS) short form for measuring pain interference. The 8-item PROMIS Pediatric Pain Interference measure was recommended as a supplemental measure. No specific measure was recommended for measuring pain intensity in children. CONCLUSIONS: Core and supplemental measures were recommended for the NIH Toolbox. Additional measures were reviewed for investigators who seek tools for measuring pain intensity in pediatric samples.

Efficient assessment of the most important symptoms in advanced prostate cancer: the NCCN/FACT-P Symptom Index.

BACKGROUND: Owing to the spectrum of symptoms, side effects, and concerns in clinically advanced prostate cancer (PC), effective symptom assessment is imperative. In line with recent regulatory guidance on the development of patient-reported outcomes, we undertook a multistep/multistudy approach to develop and test a new symptom index (NCCN FACT-Prostate Symptom Index-17 that can be used to examine the effectiveness of noncurative treatments in advanced PC. METHODS: This included significant input from two waves of expert medical providers (n=66 and 11, respectively) and two waves of patient engagement and testing (n=50 and 24, respectively). The resulting 17-item symptom index for advanced PC was then divided into sets or categories based on whether the symptoms are predominantly disease or treatment related. RESULTS: Preliminary reliability estimates suggest good internal consistency (α=0.86) and relationships with expected outside validity criteria are moderate to strong. CONCLUSIONS: This new tool may help clinicians and researchers quickly target and measure important symptoms and concerns in advanced PC, leading to increased knowledge of treatment effectiveness of noncurative therapies and improvements in the quality of patient care. Copyright © 2010 John Wiley & Sons, Ltd.

Reliability across studies from the functional assessment of cancer therapy-general (FACT-G) and its subscales: a reliability generalization.

PURPOSE: The aim of this study was to conduct a reliability generalization of the Functional Assessment of Cancer Therapy-General (FACT-G) and its subscales to examine variation in score reliability across all published studies. METHODS: We reviewed 344 publications based on predetermined criteria. About 78 published studies reported Cronbach's Alpha reliability coefficients from their study in which data were collected. Sample size based weights were applied, and studies were coded on several scale and demographic characteristics. Using independent samples t tests, we examined associations between study characteristics and internal consistency variability. RESULTS: Average FACT-G score reliability was .88 (subscales ranged between .71-.83). Three variables produced small, statistically significant (P < or = .05) eta squared effects (ranging between .06-.21) due to different sources of variation in the FACT-G and subscales: ethnicity, cancer type, and study type-all of which appeared to be related to disproportionate representation of studies with the majority including Caucasian samples, mixed cancer samples, and validation type studies. CONCLUSIONS: The FACT-G and its subscales demonstrated acceptable reliability evidence across observed studies, without substantial variability due to scale or demographic characteristics.

Assessment is not enough: a randomized controlled trial of the effects of HRQL assessment on quality of life and satisfaction in oncology clinical practice.

The potential benefits of health-related quality of life (HRQL) assessment in oncology clinical practice include better detection of problems, enhanced disease and treatment monitoring and improved care. However, few empirical studies have investigated the effects of incorporating such assessments into routine clinical care. Recent randomized studies have reported improved detection of and communication about patients' concerns, but few have found effects on patient HRQL or satisfaction. This study examined whether offering interpretive assistance of HRQL results would improve these patient outcomes. Two hundred and thirteen participants with metastatic breast, lung or colorectal cancer were randomly assigned to one of three conditions: usual care; HRQL assessment or HRQL assessment followed by a structured interview and discussion. Interviews about patients' assessment responses were conducted by a research nurse, who then presented HRQL information to the treating nurse. HRQL and treatment satisfaction outcomes were assessed at 3 and 6 months. No significant differences were found between study conditions in HRQL or satisfaction. Results suggest that routine HRQL assessment, even with description of results, is insufficient to improve patient HRQL and satisfaction. It is suggested that positive effects may require supplementing assessment results with specific suggestions for clinical management changes.