Patient experience of medication administration and development of a Patient Experience and Preference Questionnaire (PEPQ) for patients with advanced or metastatic cancer.

Introduction: A better understanding of patient experience of intravenous (IV) or subcutaneous (SC) routes of administration is fundamental to providing optimal administration of medical therapies to oncology patients. The objective of this study was to examine patient experiences of IV and SC treatment with nivolumab and confirm the relevance of item concepts in the Patient Experience and Preference Questionnaire (PEPQ). The PEPQ is a clinical outcomes' assessment instrument developed to obtain patient-centric data and understand the experience with IV and SC treatment administration. Methods: Embedded qualitative interviews were conducted with a subset of participants from three treatment cohorts with metastatic non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), unresectable or advanced metastatic melanoma, hepatocellular carcinoma (HCC), or colorectal cancer (CRC) from the CA209-8KX clinical trial. Concept elicitation interviews were conducted within 14 days of the initial treatment cycle and patient experiences with IV and SC treatment administration were assessed. Concepts from interviews were mapped to the PEPQ version 1.0 questions to assess relevance and convergence of concepts. Results: Interviews were conducted with 43 trial participants from clinical sites opting to participate from six countries (Argentina, France, the Netherlands, Poland, Spain, and New Zealand). The mean age of sub-study participants was 66 ± 11.3 years (range 24-80 years), and 67.4% (N = 29) were male. Sub-study participants with experience of SC most frequently reported symptoms or signs of injection-related redness (27.9%), itching (14.0%), and pain (of needle), and described the pain as pricking, stinging, or tingling (11.0% each). The amount of pain and time burden were widely endorsed as important factors for satisfaction and related to the route of medication administration. For 11 sub-study participants with experience with both IV and SC treatments, 10 (90.9%) preferred SC over IV treatment administration. Conclusion: This study summarizes the experience and satisfaction of receiving IV or SC treatment and confirms the relevance of the PEPQ in a subgroup of CA209-8KX clinical trial participants with metastatic NSCLC, RCC, melanoma, HCC, and CRC. Participant treatment experience and satisfaction with the route of medication mapped to the PEPQ question content support the relevance of PEPQ v2.0 in clinical trials as a self-report measure.

The Severity of Chronic Cough Diary (SCCD): development and content validation of a novel patient-reported outcome instrument for evaluating the symptom experience of chronic cough.

BACKGROUND: Refractory chronic cough (RCC), a cough lasting longer than 8 weeks with an unexplained underlying etiology and unresponsive to conventional treatment, can have substantial effects on patients' quality of life. For assessment of the efficacy of antitussive medication in clinical trials in RCC, patient-reported outcome (PRO) instruments should be fit for purpose with appropriate content validity. Here we describe the qualitative testing of a newly developed PRO instrument: the Severity of Chronic Cough Diary (SCCD). METHODS: The SCCD was developed to assess patients' symptom experience of cough in patients with RCC. A preliminary version was tested and refined based on an iterative process in a qualitative study. In total, three rounds of interviews were conducted with adult participants diagnosed with RCC in the USA (n = 19) and UK (n = 10). Rounds 1-3 consisted of hybrid concept elicitation (CE) interviews and cognitive interviews (CIs), with Round 3 also including interviews in a subset of participants (n = 5) about the usability of the SCCD as administered on an electronic handheld device. RESULTS: The CE interviews identified concepts important to patients' experiences related to RCC that were broadly in line with the concepts in the preliminary version of the SCCD. Participants provided positive feedback on the draft SCCD across all CI rounds, reporting the instrument to be relevant and straightforward to complete, and containing a comprehensive set of concepts to evaluate their symptom experience of RCC. Participants demonstrated a good understanding of proposed item wording, response options, and the 24-hour recall period, and thought completion of the SCCD on the electronic device was easy. Following revisions based on results from each interview round, the SCCD at the end of this qualitative research study had 14 items assessing the concepts of: cough symptoms (five items), symptoms related to cough (four items), disruption to activities due to cough (three items), and disruption to sleep due to cough (two items). CONCLUSIONS: The results of this study provide qualitative evidence supporting the content validity of the SCCD as a PRO instrument for evaluating outcomes of therapies for RCC in clinical trials.

Development and content validation of the Satisfaction and Experience Questionnaire for Granulocyte Colony-Stimulating Factor (SEQ-G-CSF).

BACKGROUND: Several options for granulocyte colony-stimulating factor (G-CSF) prophylaxis of chemotherapy-induced febrile neutropenia are available to patients worldwide. We have developed a novel patient-reported outcome measure, the Satisfaction and Experience Questionnaire for G-CSF (SEQ-G-CSF), to help understand patients' perspectives of and satisfaction with different G-CSF options. RESULTS: Three oncology nurses and 40 adult oncology patients in the United States were enrolled and participated in focus group discussions to develop and refine the SEQ-G-CSF. Nurses had ≥ 5 years of experience treating oncology patients and were currently involved in the management of oncology patients receiving G-CSF prophylaxis. The patients had breast cancer, lung cancer, non-Hodgkin lymphoma, or prostate cancer (10 patients in each group) and were receiving G-CSF prophylaxis via injection or the on-body injector (OBI) device. The preliminary SEQ-G-CSF contained an item relevance questionnaire and three SEQ modules (sociodemographic, medical history, and G-CSF-related healthcare characteristics questionnaires). Twenty-one patients (53% of total sample size) discussed their experience and satisfaction with G-CSF. Their most common experiences were G-CSF effectiveness, convenience and benefits of the OBI, and relationships with healthcare providers. Side effects and having to undergo additional treatment were also reported. Satisfaction with aspects of G-CSF included the OBI and effectiveness of G-CSF treatment; dissatisfaction included inconvenience (having to return to the clinic the next day and administration of the injection) and the insurance approval process. The SEQ-G-CSF was finalized after three rounds of cognitive interviews and includes five domains related to general satisfaction (one item), treatment burden (four items), travel burden (two items), time burden (four items), and treatment compliance (two items). CONCLUSIONS: The SEQ-G-CSF is a novel instrument that quantifies a patient's experience and satisfaction with different G-CSF options using 13 easy-to-understand items. This study provides evidence for the content validity of SEQ-G-CSF. Although further psychometric testing is required, the SEQ-G-CSF may be a useful addition to clinical trials, observational studies, and clinical practice.

Challenges of developing a district child welfare plan in South Africa: lessons from a community-engaged HIV/AIDS research project.

The Amajuba Child Health and Wellbeing Research Project measured the impact of orphaning due to HIV/AIDS on South African households between 2004 and 2007. Community engagement was a central component of the project and extended through 2010. We describe researcher engagement with the community to recruit participants, build local buy-in, stimulate interest in study findings, and promote integration of government social welfare services for families and children affected by HIV/AIDS. This narrative documents the experience of researchers, drawing also on project reports, public documents, and published articles, with the objective of documenting lessons learned in this collaboration between researchers from two universities and a community in South Africa during a period that spanned seven years. This experience is then analyzed within the context of an applied research, community-engagement framework.

Exploring the implementation of patient-reported outcome measures in cancer care: need for more real-world evidence results in the peer reviewed literature.

BACKGROUND: To explore the existing evidence of the real-world implementation of patient-reported outcomes (PROs) in oncology clinical practice and address two aims: (1) summarize available evidence of PRO use in clinical practice using a framework based on the International Society for Quality of Life Research (ISOQOL) PRO Implementation Guide; and (2) describe reports of real-world, standardized PRO administration in oncology conducted outside of scope of a research study. METHODS: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was developed to guide the systematic literature review (SLR) that was conducted in MEDLINE and Embase databases. A two step search strategy was implemented including two searches based on previously completed reviews. Studies published from 2006 to 2017 were synthesized using a framework based on the ISOQOL PRO Implementation Guide. RESULTS: After screening 4427 abstracts, 36 studies met the eligibility criteria. Most elements of the ISOQOL PRO Implementation Guide were followed. Two notable exceptions were found: 1) providing PRO score interpretation guidelines (39% of studies); and 2) providing patient-management guidance for addressing issues identified by PROs (25% of studies). Of the 22 studies with an intervention component, 19 (86%) reported intervention effects on study outcomes. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) was the most commonly used PRO (n = 10, 28%); use of 38 other PRO measures was also reported. Only three studies (8%) reported real-world PRO implementation. CONCLUSION: Reports of real-world PRO implementation are limited. Reports from studies conducted in clinical settings suggest gaps in information on PRO score interpretation and the use of PRO results to inform patient management. Before the promise of practice-based PRO assessment in oncology can be truly realized, investigators need to advance the state-of-the-art of real-time PRO score interpretation as well as developing guidance on how to use PRO insights to drive clinically-meaningful patient-management strategies.

Burden of renal angiomyolipomas associated with tuberous sclerosis complex: results of a patient and caregiver survey.

BACKGROUND: Tuberous sclerosis complex (TSC) is a rare genetic disorder characterized by benign tumors in multiple organs, including non-cancerous kidney lesions known as renal angiomyolipomas. This study's objective is to describe the age-stratified morbidity, treatment patterns, and health-related quality of life of TSC patients with renal angiomyolipomas in the United States. A cross-sectional, anonymous web-based survey was conducted with a convenience sample of TSC patients and caregivers identified through a patient advocacy organization. RESULTS: Out of the total sample of 676, 182 respondents reported having kidney complications with 33% of the pediatric group and 25% of the adult group with TSC reporting them. Of those with kidney complications, 110 (60%) reported a diagnosis of renal angiomyolipomas, of which 79 (72%) were adult patients and 31 (28%) were pediatric age patients. Eighty-four percent of the pediatric group and 76% of the adult group reported lesions on both kidneys. Of the patients experiencing involvement of only one kidney, 60% of the pediatric group and 21% of the adult group reported having multiple tumors within the affected kidney. Almost all of the sample (99%) reported seeing a physician and having a procedure or test for TSC in the past year. Less than half the respondents (44%) reported being hospitalized in the past year. Thirty-nine percent reported an emergency room visit as well. Compared to scores for patients with kidney disease, the angiomyolipoma adult patients reported significantly lower Mental Component Summary scores on the SF-12. CONCLUSIONS: Renal angiomyolipomas burden leads to frequent healthcare resource use including hospitalization, invasive treatments, and surgical procedures, which result in an impaired mental health related quality of life.

Bullying and health-related quality of life in children and adolescent Mexican students / "Bullying" e qualidade de vida relacionada com a saúde de crianças e adolescentes escolares mexicanos

Abstract Previous studies have reported a relationship between being a victim of bullying, but no studies have been carried out with Mexican students; notwithstanding the high scores of bullying in Mexico in international rankings. The objective of this study was to analyze the association between being a victim of bullying and lower HRQoL among schoolchildren and adolescents in Mexico. This cross-sectional and correlational study involved 2225 students from 22 elementary, middle and high schools. HRQoL was assessed with the KIDSCREEN-10 questionnaire and bullying with the social adaptation dimension of KIDSCREEN-52. Bivariate associations were evaluated, and a multivariate logistic regression was utilized. The prevalence of victims of bullying was 17.3%. Being a victim of bullying was double the risk of having a lower HRQoL than not being a victim after adjusting for health perception, gender and age, OR 2.3 (1.7-3.1). As the Wilson and Cleary Model of Quality of Life explains, individual characteristics, such as, being a victim of bullying are associated with quality of life. Similar findings in the existing literature imply that bullying is a global phenomenon that impacts the victimized child or adolescent's life in different ways.

Resumo Pesquisas prévias informaram que ser vítima de "bullying" se associa à menor Qualidade de Vida Relacionada com a Saúde (QVRS); mas nenhuma foi realizada em estudantes Mexicanos apesar dos altos índices de "bullying" mostrados para o México nos rankings internacionais. O objetivo deste estudo foi analisar a associação entre ser vítima de "bullying" e QVRS. Este estudo transversal e de correlação incluiu 2225 crianças e adolescentes de 22 escolas de nível básico, médio básico e médio superior. A QVRS foi avaliada com o questionário KIDSCREEN-10 e o "bullying" com a dimensão de aceitação social do KIDSCREEN-52. Analisaram-se as associações bivariadas, verificou-se confusão e interação, e utilizou-se regressão logística multivariável. A prevalência de vítimas de "bullying" foi de 17.3%. Ser vítima de "bullying" obteve um risco de mais do dobro de QVRS inferior que não ser vítima, depois de ajustar pela percepção de saúde, gênero e idade, OR 2.3 (1.7-3.1). No mesmo sentido que o referido pelo Modelo de Wilson e Cleary, em estudantes mexicanos com características individuais como ser vítima de "bullying", associam-se à QVRS, descoberta similar ao encontrado na literatura existente o que implica que o "bullying" é um fenômeno global que se reflete em diferentes aspectos da vida em crianças e adolescentes vitimizados.

Economic burden, work, and school productivity in individuals with tuberous sclerosis and their families.

AIMS: Tuberous sclerosis complex (TSC) is a multi-organ autosomal-dominant, genetic disorder with incomplete penetrance. The multiple manifestations of TSC and impacts to numerous organ systems represent significant disease, healthcare, and treatment burden. The economic and employment burden of the disease on individuals and their families is poorly understood. This study assessed the cost of illness and work and school productivity burden associated with TSC in a cross-sectional web-survey sample. MATERIALS AND METHODS: Eligible TSC individuals and caregivers were invited through the Tuberous Sclerosis Alliance advocacy group to complete a web-based survey about illness characteristics, treatment, disease burden, direct and indirect healthcare costs, work and school impairment. RESULTS: Data from 609 TSC adults or caregiver respondents with no cognitive impairments were analyzed. TSC adults (>18 years of age) had significantly higher direct out-of-pocket costs for ER visits, expenses for medical tests and procedures, alternative treatments, medications and lifetime cost of surgeries compared to TSC pediatric individuals. Both TSC adults and TSC caregivers reported work and school absenteeism and presenteeism; however, adults reported significantly higher absenteeism and presenteeism and overall activity impairment due to TSC, as might be expected, compared to TSC caregivers. TSC adults had significantly higher absenteeism and presenteeism rates compared to adults with moderate-to-severe plaque psoriasis and muscular sclerosis. CONCLUSIONS: TSC results in considerable direct out-of-pocket medical costs and impairment to work productivity, especially for adults. Future studies should include the comparator group and examine direct cost burden in the US using electronic medical records and insurance databases.

Content validity and electronic PRO (ePRO) usability of the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) in mesothelioma patients.

PURPOSE: Obtaining qualitative data directly from the patient perspective enhances the content validity of patient-reported outcome (PRO) instruments. The objective of this qualitative study was to evaluate the content validity of the Lung Cancer Symptom Scale for Mesothelioma (LCSS-Meso) and its usability on an electronic device. METHODS: A cross-sectional methodological study, using a qualitative approach, was conducted among patients recruited from four clinical sites. The primary target population included patients with pleural mesothelioma; data were also collected from patients with peritoneal mesothelioma on an exploratory basis. Semi-structured interviews were conducted consisting of concept elicitation, cognitive interviewing, and evaluation of electronic patient-reported outcome (ePRO) usability. RESULTS: Participants (n = 21) were interviewed in person (n = 9) or by telephone (n = 12); 71% were male with a mean age of 69 years (SD = 14). The most common signs and symptoms experienced by participants with pleural mesothelioma (n = 18) were shortness of breath, fluid build-up, pain, fatigue, coughing, and appetite loss. The most commonly described symptoms for those with peritoneal mesothelioma (n = 4) were bloating, changes in appetite, fatigue, fluid build-up, shortness of breath, and pain. Participants with pleural mesothelioma commonly described symptoms assessed by the LCSS-Meso in language consistent with the questionnaire and a majority understood and easily completed each of the items. The ePRO version was easy to use, and there was no evidence that the electronic formatting changed the way participants responded to the questions. CONCLUSIONS: Results support the content validity of the LCSS-Meso and the usability of the electronic format for use in assessing symptoms among patients with pleural mesothelioma.

Results of a Qualitative Study to Develop a Patient Reported Outcome Measure for Patients with 4 Subtypes of Soft Tissue Sarcoma.

OBJECTIVE: The objective of this research was to develop a disease-specific symptom inventory for soft tissue sarcoma. METHODS: Literature review and clinical expert and patient interviews were conducted to determine disease-specific symptoms important to patients with one of the four STS subtypes. Clinical experts identified the most relevant STS symptom items from the item pool developed from literature review. Concept elicitation interviews were conducted with patients to elicit their STS symptom experiences followed by a completion of the draft symptom list via web survey. A cognitive interview was conducted on the comprehension and importance of the symptom items. RESULTS: Eighty-three symptom items were compiled and discussed with three clinical experts who identified 26 symptoms specific to the four STS subtypes. A total sample of 27 STS participants with self-reported leiomyosarcoma (74%), undifferentiated sarcoma (15%), synovial sarcoma (7%), or liposarcoma (4%) diagnosis completed the web survey and 10 were interviewed. The draft 12-item STS-specific symptom inventory includes abdominal pain, pressure in abdomen, early satiety, bloating, gastrointestinal pain, muscle pain, bone pain, heavy menstrual flow, shortness of breath, chest pain, cough, and painful menstruation. CONCLUSION: A number of symptoms are common across STS subtypes and may form a single STS symptom inventory.

Content validity and ePRO usability of the BPI-sf and "worst pain" item with pleural and peritoneal mesothelioma.

BACKGROUND: The Brief Pain Inventory-short form (BPI-sf) is widely used in self-reported pain assessment, incorporates pain numeric rating scales (NRS) and is commonly utilized in electronic format in clinical trials, however, there is no published information about its usability as an electronic patient-reported outcome (ePRO) measure. The objective of this qualitative study was threefold: 1) to better understand pain experiences among patients with pleural or peritoneal mesothelioma; 2) to assess the interpretability of the instructions, item stem, recall period, and response option of the "worst pain" item of the BPI-sf; and 3) to examine the usability of the TrialMax Touch™ (CRF Health, Inc., Plymouth Meeting, PA) screen-based handheld device and the electronic format of the BPI-sf in a sub-sample of pleural mesothelioma patients. METHODS: A cross-sectional qualitative study was conducted among participants with pleural and peritoneal mesothelioma recruited from 4 clinical sites in the US. Semi-structured telephone or in-person interviews were conducted consisting of concept elicitation, cognitive interviewing of the 11-item BPI-sf, and in-person interview evaluation of ePRO assessment usability in pleural mesothelioma patients. RESULTS: Twenty-one participants recruited from 4 clinical sites in the US were interviewed in-person (n = 9) and by telephone (n = 12); 71% male; mean age 68.7 ± 13.6 years. Pleural and peritoneal patients described pain as ranging from discomfort to intense pain and reported being able to distinguish tumor pain from treatment pain. The BPI-sf "worst pain" item was relevant to, and easily understood by, study participants with pleural and peritoneal mesothelioma. The ePRO version was found to be easy to use, but readability of small font may be an issue. Participants reported minimal differences between their responses on the paper and ePRO version for all of the pain severity and pain interference items. CONCLUSIONS: Results support the relevance and ease of understanding of the "worst pain" item and provide support for its content validity in patients with pleural and peritoneal mesothelioma. Usability of the ePRO format of the BPI-sf was confirmed for use in clinical trials among patients with pleural mesothelioma.

Caring for Children With Tuberous Sclerosis Complex: What Is the Physical and Mental Health Impact on Caregivers?

Disease burden associated with tuberous sclerosis complex, a genetic disorder characterized by benign tumor growth including lesions in multiple organs, puts tremendous demands on families. This analysis examines the physical and mental health burden of tuberous sclerosis complex caregivers in the United States. An institutional review board-approved web-based survey of tuberous sclerosis complex caregivers collected information; descriptive analyses were conducted on age-based subgroups. A total of 275 caregivers of tuberous sclerosis complex patients responded. Mean patient age ≤ 18 years was 6.9 (±4.4) and 42.3 (±18.2) for patients >18 years of age. Caregivers reported multiple tuberous sclerosis complex manifestations and high health care utilization for patients. Caregivers spending more time on doctor visits or researching tuberous sclerosis complex had lower physical and mental health-related quality of life scores and more depressive symptoms. Tuberous sclerosis complex caregivers had significantly lower physical and mental health-related quality of life scores and more depressive symptomatology compared to US healthy adult population norms.

Tuberous sclerosis complex: a survey of health care resource use and health burden.

PURPOSE: Tuberous sclerosis complex (TSC) is a multiorgan, autosomal-dominant genetic disorder with incomplete penetrance. METHODS: This analysis of a web-based survey focuses on the clinical presentation, management, and associated burden of patients with TSC in the United States. RESULTS: A total of 676 TSC patients or caregivers responded. Both pediatric and adult patient groups experienced skin lesions (77% and 44%), seizures (77% and 24%), and kidney complications (33% and 25%) as well as other manifestations. Patient groups averaged 22 visits to a physician, nine procedures/tests, two emergency room visits, and two hospital admissions in the past year. Standardized tests were administered for health-related quality of life and TSC patients reported significantly worse mental health scores and better physical health scores compared to a normative sample of cancer patients. CONCLUSION: Results demonstrate that TSC is associated with significant clinical burden, resource utilization, and decreased mental health well-being.

The burden of subependymal giant cell astrocytomas associated with tuberous sclerosis complex: results of a patient and caregiver survey.

Tuberous sclerosis complex is a genetic disorder characterized by benign tumor growth including lesions in the ventricular system of the brain known as subependymal giant cell astrocytomas. This analysis focuses on the clinical presentation, management, and associated burden of subependymal giant cell astrocytomas in patients with tuberous sclerosis complex in the United States. An institutional review board-approved web-based survey of tuberous sclerosis complex patients and caregivers collected information, and descriptive analyses were conducted on age-based subgroups. A total of 116 tuberous sclerosis complex-subependymal giant cell astrocytoma patients or caregivers responded (17% of the total tuberous sclerosis complex sample). Mean and median patient ages were 25.5 and 23.5 years. Besides subependymal giant cell astrocytomas, patients also experienced skin lesions (72%), seizures (65%), and cognitive concerns (60%). Forty-five percent reported having brain surgery (22% for subependymal giant cell astrocytoma). In the past year, 42% of patients were admitted at least once to the hospital whereas 39% went to the emergency department. Results demonstrate that tuberous sclerosis complex-subependymal giant cell astrocytoma is associated with significant clinical burden, resource utilization, and decreased well-being.

Quality of life in youth with severe to profound sensorineural hearing loss.

IMPORTANCE: Adolescence is a life stage with rapid and major developmental changes, yet little is known about how these changes influence the quality of life of young people who are deaf or hard of hearing (DHH). OBJECTIVE: To determine differences in the 3 domains of a hearing-specific quality-of-life instrument between youth who had severe to profound sensorineural hearing loss based on whether they used no technology, hearing aids, or cochlear implants. DESIGN AND SETTING: A multi-institutional prospective cohort study. PARTICIPANTS: A convenience sample of 11- to 18-year-old youths with severe to profound sensorineural hearing loss recruited between January 1 and December 31, 2008. MAIN OUTCOME MEASURES: Youth Quality of Life-Research Instrument and Youth Quality of Life Instrument-Deaf and Hard of Hearing (YQoL-DHH) scores. The YQoL-DHH was composed of 3 domains: participation, self-acceptance/advocacy, and stigma-related quality of life. RESULTS: A total of 157 individuals participated. Overall mean (SD) age was 14.1 (2.3) years, and the female-male ratio was 82:75. Forty-nine individuals (31.2%) were not using any technology, 45 (28.7%) were using hearing aids, and 63 (40.1%) were using cochlear implants. Mean age of unilateral or first cochlear implant was 62.9 months. Thirty-eight individuals (24.2%) attended schools with DHH programs, 55 (35.0%) attended schools without DHH programs, and 58 (36.9%) attended schools for the deaf. Statistically significant differences were noted in YQoL-DHH participation and perceived stigma scores between the groups when stratified by technology used and school setting. CONCLUSIONS: These data suggest that the domains of quality of life as measured by our instrument differ significantly among youth based on technology used and school setting. Youth using no technology or cochlear implants tended to score higher than those using hearing aids in mainstream schools with or without DHH programs and in schools for the deaf. The YQoL-DHH instrument is able to detect differences in quality of life within a group of youth with severe to profound hearing loss.

Validation of a quality-of-life measure for deaf or hard of hearing youth.

OBJECTIVE: Quality-of-life (QOL) measures targeting youth with hearing loss are useful in population needs assessment, educational placement, and program design and evaluation. This study assesses the cross-sectional validity of the Youth Quality of Life Instrument-Deaf and Hard of Hearing Module (YQOL-DHH). STUDY DESIGN. Instrument development and cross-sectional survey. SETTING: Recruitment through schools, professional organizations, clinics, and programs for youth who are deaf or hard of hearing. SUBJECTS AND METHODS. Thirty-five candidate items were administered to 230 adolescents aged 11 to 18 years: 49% female, 61% white, 11% mild hearing loss, 20% moderate/moderate-severe, 41% severe/profound, and 28% with cochlear implants. Participants completed individual or group-administered questionnaires by paper and pencil (58%), Web-based English (29%), American Sign Language (ASL) or Pidgin Signed English (PSE) (9%) on DVD, or interviewer-supervised ASL or PSE DVD (4%). The Children's Depression Inventory (CDI-S) was also completed. Factor structure, reliability, construct validity, and respondent burden were assessed. RESULTS: Thirty-two items were retained in the final instrument covering 3 domains: self-acceptance/advocacy (14 items, Cronbach α = 0.84), perceived stigma (8 items, Cronbach α = 0.85), and participation (10 items, Cronbach α = 0.86). QOL was not significantly associated with hearing level. One-week test-retest coefficients were acceptable: self-acceptance/ advocacy (0.70), perceived stigma (0.78), and participation 0.92). As predicted, the total CDI-S score was associated in the appropriate direction (P < .0001) with all YQOL-DHH domains. Time to complete the paper-and-pencil version was 12 minutes. CONCLUSION: The YQOL-DHH shows good reliability and validity for assessing hearing-specific QOL in adolescents.

Child food insecurity and iron deficiency anemia in low-income infants and toddlers in the United States.

OBJECTIVE: Examine the association between child-level food insecurity and iron status in young children utilizing community-based data from the Children's Sentinel Nutrition Assessment Program (C-SNAP). METHODS: A cross-sectional sample of caregivers of children < or =36 months of age utilizing emergency department (ED) services were interviewed between 6/96-5/01. Caregiver interviews, which included questions on child-level food security, were linked to a primary clinic database containing hemoglobin, red blood cell distribution width, mean corpuscular volume, free erythrocyte protoporphyrin and lead values. Children a priori at-risk for anemia: birthweight < or =2500 g, with HIV/AIDS, sickle cell disease, or lead values > or =10.0 ug/dL, and children < or =6 months of age were excluded from the analysis. Only laboratory tests 365 days prior or 90 days after interview were examined. Iron status was classified in four mutually exclusive categories: 1) Iron Sufficient-No Anemia (ISNA), 2) Anemia (without iron deficiency), 3) Iron Deficient-No Anemia (IDNA), 4) Iron Deficient with Anemia (IDA). RESULTS: 626 ED interviews linked to laboratory data met the inclusion criteria. Food insecure children were significantly more likely to have IDA compared to food secure children [Adjusted Odds Ratio = 2.4, 95% CI (1.1-5.2), p = 0.02]. There was no association between child food insecurity and anemia without iron deficiency or iron deficiency without anemia. CONCLUSION: These findings suggest an association between child level food insecurity and iron deficiency anemia, a clinically important health indicator with known negative cognitive, behavioral and health consequences. Cuts in spending on food assistance programs that address children's food insecurity may lead to adverse health consequences.