Critical decisions: A mixed-methods study of decision-making among diverse gynecologic cancer patients considering therapeutic clinical trial enrollment.

OBJECTIVE: Participation in therapeutic clinical trials does not reflect the diversity of gynecologic cancer patients, limiting access to novel therapeutics and generalizability of results. Reasons for inequities in participation among historically underrepresented populations remain undertheorized, as studies have shown equal willingness to participate among groups. We sought to apply a precarity framework to conceptualize the factors that impact patients' desire to enroll, to improve equity in gynecologic oncology clinical trial participation. METHODS: Gynecologic cancer patients at a single tertiary care facility in the Southwestern United States who discussed participation in therapeutic clinical trial with their oncology provider from 2020 to 2021 were identified. Enrolled participants completed surveys and qualitative interviews regarding treatment experiences and decision-making. Oncology providers completed parallel surveys at the time of their patient's enrollment. Descriptive statistics and thematic coding were used to analyze data. RESULTS: 30 patients were enrolled and participated in surveys and interviews. No differences were found in quantitative data assessing shared decision-making and patient-centered communication between those who enrolled and those who did not. Qualitative data demonstrated that patients who declined trial enrollment expressed concerns regarding uncertainty and loss of control, independence in decision-making, and significant resource challenges and financial toxicity of cancer treatment. CONCLUSIONS: We identified a constellation of factors that contribute to desire to enroll in clinical trials, that we describe using the framework of precarity. Through identification of precarious patients and mitigation of burdens, we anticipate improved enrollment and retention in therapeutic clinical trials among diverse gynecologic oncology patients.

"Care needs to be integrated" Patient and provider perspectives on a cancer shared-care model.

PURPOSE: Current early-stage breast and gynecological cancer care models often begin with a referral from a primary care provider (PCP) or gynecologist (OB/Gyn) and end with a patient being transitioned back to the referring provider at the completion of treatment. There is frequently little communication between oncologists and the referring provider during treatment, and this pattern continues after the patient completes their treatment. METHODS: We convened a diverse Patient Advisory Board (PAB) to identify areas where breast or gynecological cancer patients felt they could benefit from additional support during and after their cancer care. PAB members attended five Zoom meetings and completed four online surveys. Semi-structured interviews were conducted with primary care or OB/Gyn physicians to collect information on current practices. RESULTS: Patients identified multiple areas in which they needed additional support from their PCP. Providers also identified topics on which they could use additional training. However, there was little overlap between patient and provider priority topics. Both patients and providers agreed that there was inadequate communication between the cancer center and PCPs before, during, and after cancer treatment. CONCLUSIONS: A shared-care model that emphasizes communication between primary care providers, the oncology care team, and patients is urgently needed. Patients indicated the need for additional support from their PCP on specific topics, and PCPs were interested in continuing their education to better serve their patients with cancer. IMPLICATIONS FOR CANCER SURVIVORS: The importance of consistent communication among all parties during the entire cancer journey was emphasized as a key area for improvement.

InterMEL: An international biorepository and clinical database to uncover predictors of survival in early-stage melanoma.

INTRODUCTION: We are conducting a multicenter study to identify classifiers predictive of disease-specific survival in patients with primary melanomas. Here we delineate the unique aspects, challenges, and best practices for optimizing a study of generally small-sized pigmented tumor samples including primary melanomas of at least 1.05mm from AJTCC TNM stage IIA-IIID patients. We also evaluated tissue-derived predictors of extracted nucleic acids' quality and success in downstream testing. This ongoing study will target 1,000 melanomas within the international InterMEL consortium. METHODS: Following a pre-established protocol, participating centers ship formalin-fixed paraffin embedded (FFPE) tissue sections to Memorial Sloan Kettering Cancer Center for the centralized handling, dermatopathology review and histology-guided coextraction of RNA and DNA. Samples are distributed for evaluation of somatic mutations using next gen sequencing (NGS) with the MSK-IMPACTTM assay, methylation-profiling (Infinium MethylationEPIC arrays), and miRNA expression (Nanostring nCounter Human v3 miRNA Expression Assay). RESULTS: Sufficient material was obtained for screening of miRNA expression in 683/685 (99%) eligible melanomas, methylation in 467 (68%), and somatic mutations in 560 (82%). In 446/685 (65%) cases, aliquots of RNA/DNA were sufficient for testing with all three platforms. Among samples evaluated by the time of this analysis, the mean NGS coverage was 249x, 59 (18.6%) samples had coverage below 100x, and 41/414 (10%) failed methylation QC due to low intensity probes or insufficient Meta-Mixed Interquartile (BMIQ)- and single sample (ss)- Noob normalizations. Six of 683 RNAs (1%) failed Nanostring QC due to the low proportion of probes above the minimum threshold. Age of the FFPE tissue blocks (p<0.001) and time elapsed from sectioning to co-extraction (p = 0.002) were associated with methylation screening failures. Melanin reduced the ability to amplify fragments of 200bp or greater (absent/lightly pigmented vs heavily pigmented, p<0.003). Conversely, heavily pigmented tumors rendered greater amounts of RNA (p<0.001), and of RNA above 200 nucleotides (p<0.001). CONCLUSION: Our experience with many archival tissues demonstrates that with careful management of tissue processing and quality control it is possible to conduct multi-omic studies in a complex multi-institutional setting for investigations involving minute quantities of FFPE tumors, as in studies of early-stage melanoma. The study describes, for the first time, the optimal strategy for obtaining archival and limited tumor tissue, the characteristics of the nucleic acids co-extracted from a unique cell lysate, and success rate in downstream applications. In addition, our findings provide an estimate of the anticipated attrition that will guide other large multicenter research and consortia.

Improving Uptake of Cancer Genetic Risk Assessment in a Remote Tailored Risk Communication and Navigation Intervention: Large Effect Size but Room to Grow.

PURPOSE: Cancer genetic risk assessment (CGRA) is recommended for women with ovarian cancer or high-risk breast cancer, yet fewer than 30% receive recommended genetic services, with the lowest rates among underserved populations. We hypothesized that compared with usual care (UC) and mailed targeted print (TP) education, CGRA uptake would be highest among women receiving a phone-based tailored risk counseling and navigation intervention (TCN). METHODS: In this three-arm randomized trial, women with ovarian or high-risk breast cancer were recruited from statewide cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TP received a mailed educational brochure. Participants assigned to TCN received the mailed educational brochure, an initial phone-based psychoeducational session with a health coach, a follow-up letter, and a follow-up navigation phone call. RESULTS: Participants' average age was 61 years, 25.4% identified as Hispanic, 5.9% identified as non-Hispanic Black, and 17.5% lived in rural areas. At 6 months, more women in TCN received CGRA (18.7%) than those in TP (3%; odds ratio, 7.4; 95% CI, 3.0 to 18.3; P < .0001) or UC (2.5%; odds ratio, 8.9; 95% CI, 3.4 to 23.5; P < .0001). There were no significant differences in CGRA uptake between TP and UC. Commonly cited barriers to genetic counseling were lack of provider referral (33.7%) and cost (26.5%), whereas anticipated difficulty coping with test results (14.0%) and cost (41.2%) were barriers for genetic testing. CONCLUSION: TCN increased CGRA uptake in a group of geographically and ethnically diverse high-risk breast and ovarian cancer survivors. Remote personalized interventions that incorporate evidence-based health communication and behavior change strategies may increase CGRA among women recruited from statewide cancer registries.

Understanding cancer genetic risk assessment motivations in a remote tailored risk communication and navigation intervention randomized controlled trial.

Background: National guidelines recommend cancer genetic risk assessment (CGRA) (i.e. genetic counseling prior to genetic testing) for women at increased risk for hereditary breast and ovarian cancer (HBOC). Less than one-half of eligible women obtain CGRA, leaving thousands of women and their family members without access to potentially life-saving cancer prevention interventions. Purpose: The Genetic Risk Assessment for Cancer Education and Empowerment Project (GRACE) addressed this translational gap, testing the efficacy of a tailored counseling and navigation (TCN) intervention vs. a targeted print brochure vs. usual care on CGRA intentions. Selected behavioral variables were theorized to mediate CGRA intentions. Methods: Breast and ovarian cancer survivors meeting criteria for guideline-based CGRA were recruited from three state cancer registries (N = 654), completed a baseline survey, and were randomized. TCN and targeted print arms received the brochure; TCN also participated in a tailored, telephone-based decision coaching and navigation session grounded in the Extended Parallel Process Model and Ottawa Decision Support Framework. Participants completed a one-month assessment. Logistic regression was used to compare the rate of CGRA intentions. CGRA intentions and theorized mediator scores (continuous level variables) were calculated using mixed model analysis. Results: CGRA intentions increased for TCN (53.2%) vs. targeted print (26.7%) (OR = 3.129; 95% CI: 2.028, 4.827, p < .0001) and TCN vs. usual care (23.1%) (OR = 3.778, CI: 2.422, 5.894, p < .0001). Perceived risk (p = 0.023) and self-efficacy (p = 0.035) mediated CGRA intentions in TCN. Conclusions: Improvements in CGRA intentions and theorized mediators support the use of a tailored communication intervention among women at increased HBOC risk. (Clinicaltrials.gov: NCT03326713.)Trial registration: ClinicalTrials.gov identifier: NCT03326713.

Landscape of mutations in early stage primary cutaneous melanoma: An InterMEL study.

It is unclear why some melanomas aggressively metastasize while others remain indolent. Available studies employing multi-omic profiling of melanomas are based on large primary or metastatic tumors. We examine the genomic landscape of early-stage melanomas diagnosed prior to the modern era of immunological treatments. Untreated cases with Stage II/III cutaneous melanoma were identified from institutions throughout the United States, Australia and Spain. FFPE tumor sections were profiled for mutation, methylation and microRNAs. Preliminary results from mutation profiling and clinical pathologic correlates show the distribution of four driver mutation sub-types: 31% BRAF; 18% NRAS; 21% NF1; 26% Triple Wild Type. BRAF mutant tumors had younger age at diagnosis, more associated nevi, more tumor infiltrating lymphocytes, and fewer thick tumors although at generally more advanced stage. NF1 mutant tumors were frequent on the head/neck in older patients with severe solar elastosis, thicker tumors but in earlier stages. Triple Wild Type tumors were predominantly male, frequently on the leg, with more perineural invasion. Mutations in TERT, TP53, CDKN2A and ARID2 were observed often, with TP53 mutations occurring particularly frequently in the NF1 sub-type. The InterMEL study will provide the most extensive multi-omic profiling of early-stage melanoma to date. Initial results demonstrate a nuanced understanding of the mutational and clinicopathological landscape of these early-stage tumors.

Characterizing Low-Risk Breast and Gynecological Cancer Patients for Transition into an Oncology/Primary Care Coordinated Care Model: Findings from a Survey of Diverse Survivors in a Rural U.S. State.

We conducted a survey to characterize the key attributes of racial/ethnic and geographically diverse low-risk breast and gynecologic cancer patients. We collected data regarding patients' access to primary care (PC); compliance with screening recommendations; treatment for comorbidities; logistical barriers to clinic visits; and receipt of survivorship care documentation (SCD). Survey findings informed the development of an oncology/Primary Care Provider (PCP) care coordination intervention to improve care. We distributed a cross-sectional survey among a convenience sample of 150 cancer survivors. Responses were calculated using descriptive statistics and compared based on the distance participants traveled to their appointments at the cancer center (≤30 vs. >30 miles). Of the 150 respondents, 35% traveled >30 miles for follow-up care and 78% reported having one or more comorbid condition(s). PC utilization was high: 88% reported having a PCP, and 91% indicated ≤1 yearly follow-up visit. Participants traveling >30 miles reported higher rates of logistical challenges associated with cancer center visits compared to those traveling ≤30 miles. Nearly half of respondents (46%) had not received SCD. In conclusion, survey studies such as these allow for the systematic assessment of survivor behaviors and care utilization patterns to inform the development of care coordination interventions for diverse, low-risk cancer patients.

A Population-Based Feasibility Study of Occupation and Thoracic Malignancies in New Mexico.

BACKGROUND: Occupational exposures in mining and oil/gas extraction are known risk factors for thoracic malignancies (TMs). Given the relatively high proportion of these industries in New Mexico (NM), we conducted a feasibility study of adult lifetime occupational history among TM cases. We hypothesized a higher proportion of occupational TM in NM relative to the estimated national average of 10-14%. METHODS: We identified incident TM cases through the population-based New Mexico Tumor Registry (NMTR), from 2017-2018. Cases completed a telephone interview. An adjudication panel reviewed case histories and classified cancers as probable, possible, or non-occupational related, taking into account the presence, duration, and latency of exposures. We characterized recruitment and describe job titles and exposures among those with occupational TMs. We also compared the distributions of industry between those with and without occupational TM. RESULTS: The NMTR identified 400 eligible TM cases, 290 of which were available to be recruited (n=285 lung/bronchial cancer; n=5 mesotheliomas). Of the latter, 60% refused and 18% were deceased, 9% had invalid addresses, 11% were unable to be reached by telephone, and 3% were too ill to participate. The 43 cases who completed an interview held 236 jobs. A total of 33% of cases were classified as probable occupational TM and 5% as possible occupational TM. CONCLUSIONS: High rates of early mortality and refusals were significant barriers to study participation. Nonetheless, the proportion of probable occupational TMs greatly exceeded the estimated national average, highlighting the need for further study of occupational TM in the state.

Remote Assessment of Functional Mobility and Strength in Older Cancer Survivors: Protocol for a Validity and Reliability Study.

BACKGROUND: Older cancer survivors, faced with both age- and treatment-related morbidity, are at increased and premature risk for physical function limitations. Physical performance is an important predictor of disability, quality of life, and premature mortality, and thus is considered an important target of interventions designed to prevent, delay, or attenuate the physical functional decline. Currently, low-cost, valid, and reliable methods to remotely assess physical performance tests that are self-administered by older adults in the home-setting do not exist, thus limiting the reach, scalability, and dissemination of interventions. OBJECTIVE: This paper will describe the rationale and design for a study to evaluate the accuracy, reliability, safety, and acceptability of videoconferencing and self-administered tests of functional mobility and strength by older cancer survivors in their own homes. METHODS: To enable remote assessment, participants receive a toolkit and instructions for setting up their test course and communicating with the investigator. Two standard gerontologic performance tests are being evaluated: the Timed Up and Go test and the 30-second chair stand test. Phase 1 of the study evaluates proof-of-concept that older cancer survivors (age ≥60 years) can follow the testing protocol and use a tablet PC to communicate with the study investigator. Phase 2 evaluates the criterion validity of videoconference compared to direct observation of the two physical performance tests. Phase 3 evaluates reliability by enrolling 5-10 participants who agree to repeat the remote assessment (without direct observation). Phase 4 enrolls 5-10 new study participants to complete the remote assessment test protocol. Feedback from participants in each phase is used to refine the test protocol and instructions. RESULTS: Enrollment began in December 2019. Ten participants completed the Phase 1 proof-of-concept. The study was paused in mid-March 2020 due to the COVID-19 pandemic. The study is expected to be completed by the end of 2020. CONCLUSIONS: This validity and reliability study will provide important information on the acceptability and safety of using videoconferencing to remotely assess two tests of functional mobility and strength, self-administered by older adults in their homes. Videoconferencing has the potential to expand the reach, scalability, and dissemination of interventions to older cancer survivors, and potentially other older adults, especially in rural areas. TRIAL REGISTRATION: ClinicalTrials.gov NCT04339959; https://clinicaltrials.gov/ct2/show/NCT04339959. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20834.

Biobehavioral effects of Tai Chi Qigong in men with prostate cancer: Study design of a three-arm randomized clinical trial.

Fatigue is often one of the most commonly reported symptoms in prostate cancer survivors, but it is also one of the least understood cancer-related symptoms. Fatigue is associated with psychological distress, disruptions in sleep quality, and impairments in health-related quality of life. Moreover, inflammatory processes and changes related to the hypothalamic-pituitary-adrenal (HPA) axis and/or autonomic nervous system may also play a role in cancer-related fatigue. Thus, effective treatments for fatigue in prostate cancer survivors represent a current unmet need. Prior research has shown that Tai Chi Qigong, a mind-body exercise intervention, can improve physical and emotional health. Herein, we describe the protocol of the ongoing 3-arm randomized controlled Health Empowerment & Recovery Outcomes (HERO) clincal trial. One hundred sixty-six prostate cancer survivors with fatigue are randomized to a modified Tai Chi Qigong intervention (TCQ), intensity-matched body training intervention (BT), or usual care (UC) condition. Guided by biopsychosocial and psychoneuroimmunology models, we propose that TCQ, as compared to BT or UC will: i) reduce fatigue (primary outcome) in prostate cancer survivors; ii) reduce inflammation; and iii) regulate the expression of genes from two major functional clusters: a) inflammation, vasodilation and metabolite sensing and b) energy and adrenergic activation. Assessments are conducted at baseline, the 6-week midpoint of the intervention, and 1 week, 3 months, and 12 months post-intervention. If our findings show that TCQ promotes recovery from prostate cancer and its treatment, this type of intervention can be integrated into survivorship care plans as the standard of care. The study's findings will also provide novel information about underlying biobehavioral mechanisms of cancer-related fatigue. TRIAL REGISTRATION NUMBER: NCT03326713; clinicaltrials.gov.

Greater Odds for Angina in Uranium Miners Than Nonuranium Miners in New Mexico.

OBJECTIVE: The aim of this study was to test the hypothesis that uranium miners in New Mexico (NM) have a greater prevalence of cardiovascular disease than miners who extracted the nonuranium ore. METHODS: NM-based current and former uranium miners were compared with nonuranium miners by using cross-sectional standardized questionnaire data from the Mining Dust in the United States (MiDUS) study from 1989 to 2016. RESULTS: Of the 7215 eligible miners, most were men (96.3%). Uranium miners (n = 3151, 43.7%) were older and diabetic, but less likely to currently smoke or use snuff (P ≤ 0.001 for all). After adjustment for covariates, uranium miners were more likely to report angina (odds ratio 1.51, 95% confidence interval 1.23 to 1.85) than nonuranium miners. CONCLUSION: Our data suggest that along with screening for pulmonary diseases, uranium industry workers should be screened for cardiovascular diseases.

Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial.

BACKGROUND: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. METHODS: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. DISCUSSION: The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. TRIAL REGISTRATION NUMBER: NCT03326713; clinicaltrials.gov.

Accuracy of Self-Reported Weight Among Adolescent and Young Adults Following Bariatric Surgery.

PURPOSE: This study evaluates accuracy of self-reported weight in adolescent bariatric surgery patients. MATERIALS AND METHODS: During follow-up visits, participants self-reported weight and had weight measured. The differences between self-reported and measured weights were analyzed from 60 participants. RESULTS: Participants were 70% (n = 42) female, 72% (n = 43) white, mean age of 20.8 years and a median body mass index of 36.6 kg/m2. At an average of 3.5 years following surgery, females underestimated weight (0.5 kg, range: -18.7 to 5.6 kg), while males overestimated (1.1 kg, range: -7.8 to 15.2 kg). Most (80%, n = 48) reported within 5 kg of measured weight. The majority of adolescents who previously underwent bariatric surgery reported reasonably accurate weights, but direction of misreporting varied by gender. CONCLUSION: Self-reported weights could be utilized when measured values are unavailable without markedly biasing the interpretation of outcomes.

An Innovative Approach to Enhancing Access to Medical Screening for Miners using a Mobile Clinic with Telemedicine Capability.

Inadequate access to medical care in underserved and geographically isolated rural communities may limit the delivery of quality screening care to miners. Use of mobile screening clinics, manned by a physician assistant or nurse practitioner, is one way to improve their access. Miners demonstrate a high level of satisfaction with services provided by the mobile screening clinic. The addition of telemedicine to mobile screening clinics allows miners to have access to university-based specialist care and provides an opportunity to specialists to tele-mentor other providers. Although inadequately studied, limited data suggest that miners accept telemedicine consultation. We expect that the innovative use of mobile screening clinics with telemedicine technology might allow efficient utilization of resources to meet the medical screening needs of a large number of miners in geographically remote locations in the United States.

Uranium Workers Demonstrate Lower Lobe Predominant Irregular Pneumoconiotic Opacities on Chest Radiographs.

BACKGROUND: There is a paucity of literature on the chest radiographic findings in uranium workers. OBJECTIVE: To characterize the chest radiographic findings of pneumoconiosis in a New Mexican cohort of uranium workers. METHODS: The most recent results from chest radiographs were abstracted in this cross-sectional study. RESULTS: Radiographs showed small pneumoconiotic opacities of profusion score of ≥ 1/0 in 155/429 (36.1%) uranium workers. The most common shape/size of the primary and secondary opacities was s (90.3%) and t (83.7%) types, respectively. Lower lung zones were the most affected. American Indians were the population group at greatest odds for having profusion score ≥ 1/0 (O.R. 2.65, 95% C.I. 1.61, 4.36). CONCLUSIONS: Uranium workers' pneumoconiosis is associated with predominantly lower lobe, irregular, and small opacities. Clinical providers and policymakers must consider uranium workers' pneumoconiosis in the differential diagnosis for lower lobe-predominant interstitial lung disease, in the appropriate exposure setting.

High Prevalence of Nonalcoholic Fatty Liver Disease in Adolescents Undergoing Bariatric Surgery.

BACKGROUND & AIMS: Little is known about the prevalence of nonalcoholic fatty liver disease (NAFLD) among severely obese adolescents or factors that determine its development. We investigated the prevalence of NAFLD in a multicenter cohort of adolescents undergoing bariatric surgery and the factors associated with it. METHODS: We enrolled 242 adolescents undergoing bariatric surgery between March 2007 and February 2012 at 5 tertiary care centers into a multicenter, prospective observational cohort study. Intraoperative core liver biopsies were collected from 165 subjects; 17 were excluded because of insufficient liver tissue or use of hepatotoxic medications, so 148 remained in the study (mean age, 16.8 ± 1.6 years; median body mass index = 52 kg/m(2)). Liver tissues were analyzed by histology using validated criteria. Hepatic gene expression was analyzed in 67 samples. RESULTS: NAFLD was present in 59% of this predominantly female (72%), white (68%), non-Hispanic (91%) cohort. Of subjects with NAFLD, 24% had borderline and 10% had definite nonalcoholic steatohepatitis (NASH). Mild fibrosis (stage 2 or lower) was observed in 18% of liver biopsies and stage 3 was observed in 0.7%, but cirrhosis was not detected. Dyslipidemia was present in 78% of subjects, hypertension in 44%, and diabetes in 14%. More severe NAFLD was associated with increasing levels of alanine aminotransferase, fasting glucose level, hypertension (each P < .01), and white blood cell count (P = .04). Only diabetes was associated with detection of fibrosis (odds ratio = 3.56; 95% confidence interval: 1.93-6.56). Microarray analysis associated presence of NASH with altered expression of genes that regulate macrophage chemotaxis, cholesterol absorption, and fatty acid binding. CONCLUSIONS: More than half of adolescents undergoing bariatric surgery in this cohort had NAFLD, yet the prevalence of severe or fibrotic NASH was low. Increasing severity of NAFLD was associated with level of alanine aminotransferase and cardiometabolic risk factors, but not body mass index. Based on gene expression analysis, borderline and definite NASH were associated with abnormal immune function, intestinal cholesterol absorption, and lipid metabolism.

Access to care for adolescents seeking weight loss surgery.

OBJECTIVE: Adolescents seeking weight loss surgery (WLS) frequently encounter obstacles obtaining treatment authorization from insurance carriers. This study identified factors influencing authorization for adolescents with clinical indications for WLS. METHODS: A retrospective review was conducted for adolescents with clinical indications for WLS at five adolescent centers. This cohort represented a consecutive series of adolescents with insurance benefits for WLS for whom insurance authorization was sought between 2009 and 2011. Outcomes included number and timing of insurance authorizations for surgery, denials, and appeals. RESULTS: Records from 57 adolescents (74% female; mean age 16 (range: 12-17) years; mean BMI 51.3 kg/m(2) ) were reviewed. Of these, only 47% were approved with the original request. Eighty percent of those denied were approved on appeal, while 11% never obtained authorization for surgery. Age less than 18 years and proposed procedure were the most common reasons for denial. CONCLUSIONS: Less than half of adolescents with clinical indications for surgery received approval for the procedure on the first request. The appeal process typically resulted in overturning of denials, so that surgical care could be delivered.

Evaluation of a Teleform-based data collection system: a multi-center obesity research case study.

Utilizing electronic data capture (EDC) systems in data collection and management allows automated validation programs to preemptively identify and correct data errors. For our multi-center, prospective study we chose to use TeleForm, a paper-based data capture software that uses recognition technology to create case report forms (CRFs) with similar functionality to EDC, including custom scripts to identify entry errors. We quantified the accuracy of the optimized system through a data audit of CRFs and the study database, examining selected critical variables for all subjects in the study, as well as an audit of all variables for 25 randomly selected subjects. Overall we found 6.7 errors per 10,000 fields, with similar estimates for critical (6.9/10,000) and non-critical (6.5/10,000) variables-values that fall below the acceptable quality threshold of 50 errors per 10,000 established by the Society for Clinical Data Management. However, error rates were found to widely vary by type of data field, with the highest rate observed with open text fields.