Development of an Enzyme-Linked Immunosorbent Spot Assay for the Assessment of Adeno-Associated Virus Peptides to Examine Immune Safety.

Adeno-associated virus (AAV)-based gene therapies have shown promise as novel treatments for rare genetic disorders such as hemophilia A and spinal muscular atrophy. However, cellular immune responses mediated by cytotoxic (CD8+) and helper (CD4+) T cells may target vector-transduced cells as well as healthy immune cells, impacting safety and efficacy. In this study, we describe the optimization and reproducibility of interferon-γ (IFNγ)-based and interleukin-2 (IL-2)-based enzyme-linked immunosorbent spot (ELISpot) assays for measuring T cell responses against AAV peptide antigens. For method optimization, peripheral blood mononuclear cells (PBMCs) were isolated from healthy human donors and stimulated with commercially available major histocompatibility complex (MHC) class I or II-specific peptides as positive controls. Peptide pools were designed from published AAV8 and AAV9 capsid protein sequences and then used to assess the presence of AAV-specific T cell responses. Our results demonstrate a measurable increase in IFNγ and IL-2-producing cells after AAV peptide presentation. Furthermore, there was an observed difference in the magnitude and specificity of response to peptide pools based on AAV serotype and donor. Finally, using individual peptides, we identified a region of the AAV9 capsid protein that can elicit an immunogenic response. This work shows the applicability of ELISpot in assessing anti-AAV immune responses and provides insight into how novel recombinant AAV vectors could be designed to reduce immunogenic potential.

Access, Utilization, and Quality of Behavioral Health Integration in Medicaid Managed Care.

Importance: Many states have moved from models that carve out to those that carve in or integrate behavioral health in their Medicaid managed care organizations (MCOs), but little evidence exists about the effect of this change. Objective: To assess the association of the transition to integrated managed care (IMC) in Washington Medicaid with health services use, quality, health-related outcomes, and measures associated with social determinants of health. Design, Setting, and Participants: This cohort study used difference-in-differences analyses of Washington State's 2014 to 2019 staggered rollout of IMC on claims-based measures for enrollees in Washington's Medicaid MCO. It was supplemented with interviews of 24 behavioral health agency leaders, managed care administrators, and individuals who were participating in the IMC transition. The data were analyzed between February 1, 2023, and September 30, 2023. Main Outcomes and Measures: Claims-based measures of utilization (including specialty mental health visits and primary care visits); health-related outcomes (including self-harm events); rates of arrests, employment, and homelessness; and additional quality measures. Results: This cohort study included 1 454 185 individuals ages 13 to 64 years (743 668 female [51.1%]; 14 306 American Indian and Alaska Native [1.0%], 132 804 Asian American and Pacific Islander [9.1%], 112 442 Black [7.7%], 258 389 Hispanic [17.8%], and 810 304 White [55.7%] individuals). Financial integration was not associated with changes in claims-based measures of utilization and quality. Most claims-based measures of outcomes were also unchanged, although enrollees with mild or moderate mental illness experienced a slight decrease in cardiac events (-0.8%; 95% CI, -1.4 to -0.2), while enrollees with serious mental illness experienced small decreases in employment (-1.2%; 95% CI -1.9 to -0.5) and small increases in arrests (0.5%; 95% CI, 0.1 to 1.0). Interviews with key informants suggested that financial integration was perceived as an administrative change and did not have substantial implications for how practices delivered care; behavioral health agencies lacked guidance on how to integrate care in behavioral health settings and struggled with new contracts and regulatory policies that may have inhibited the ability to provide integrated care. Conclusions and Relevance: The results of this cohort study suggest that financial integration at the MCO level was not associated with significant changes in most measures of utilization, quality, outcomes, and social determinants of health. Additional support, including monitoring, training, and funding, may be necessary to drive delivery system changes to improve access, quality, and outcomes.

Principles for Health Information Collection, Sharing, and Use: A Policy Statement From the American Heart Association.

The evolution of the electronic health record, combined with advances in data curation and analytic technologies, increasingly enables data sharing and harmonization. Advances in the analysis of health-related and health-proxy information have already accelerated research discoveries and improved patient care. This American Heart Association policy statement discusses how broad data sharing can be an enabling driver of progress by providing data to develop, test, and benchmark innovative methods, scalable insights, and potential new paradigms for data storage and workflow. Along with these advances come concerns about the sensitive nature of some health data, equity considerations about the involvement of historically excluded communities, and the complex intersection of laws attempting to govern behavior. Data-sharing principles are therefore necessary across a wide swath of entities, including parties who collect health information, funders, researchers, patients, legislatures, commercial companies, and regulatory departments and agencies. This policy statement outlines some of the key equity and legal background relevant to health data sharing and responsible management. It then articulates principles that will guide the American Heart Association's engagement in public policy related to data collection, sharing, and use to continue to inform its work across the research enterprise, as well as specific examples of how these principles might be applied in the policy landscape. The goal of these principles is to improve policy to support the use or reuse of health information in ways that are respectful of patients and research participants, equitable in impact in terms of both risks and potential benefits, and beneficial across broad and demographically diverse communities in the United States.

The effects of behavioral health integration in Medicaid managed care on access to mental health and primary care services-Evidence from early adopters.

OBJECTIVE: To evaluate the impacts of a transition to an "integrated managed care" model, wherein Medicaid managed care organizations moved from a "carve-out" model to a "carve-in" model integrating the financing of behavioral and physical health care. DATA SOURCES/STUDY SETTING: Medicaid claims data from Washington State, 2014-2019, supplemented with structured interviews with key stakeholders. STUDY DESIGN: This mixed-methods study used difference-in-differences models to compare changes in two counties that transitioned to financial integration in 2016 to 10 comparison counties maintaining carve-out models, combined with qualitative analyses of 15 key informant interviews. Quantitative outcomes included binary measures of access to outpatient mental health care, primary care, the emergency department (ED), and inpatient care for mental health conditions. DATA COLLECTION: Medicaid claims were collected administratively, and interviews were recorded, transcribed, and analyzed using a thematic analysis approach. PRINCIPAL FINDINGS: The transition to financially integrated care was initially disruptive for behavioral health providers and was associated with a temporary decline in access to outpatient mental health services among enrollees with serious mental illness (SMI), but there were no statistically significant or sustained differences after the first year. Enrollees with SMI also experienced a slight increase in access to primary care (1.8%, 95% CI 1.0%-2.6%), but no sustained statistically significant changes in the use of ED or inpatient services for mental health care. The transition to financially integrated care had relatively little impact on primary care providers, with few changes for enrollees with mild, moderate, or no mental illness. CONCLUSIONS: Financial integration of behavioral and physical health in Medicaid managed care did not appear to drive clinical transformation and was disruptive to behavioral health providers. States moving towards "carve-in" models may need to incorporate support for practice transformation or financial incentives to achieve the benefits of coordinated mental and physical health care.

Addressing reproductive health needs across the life course: an integrated, community-based model combining contraception and preconception care.

Prevention of pregnancy (contraception) and preparation for pregnancy (preconception care) are services that most people need during their reproductive life course. Despite increased attention, and growing recognition that health before pregnancy is crucial to addressing disparities in maternity outcomes, service provision is far from routine. We bring together evidence from the literature, new quantitative and qualitative data on women's preferences, and case studies of existing practice, to develop an integrated, community-based model that synthesises reproductive life planning, contraception, and preconception care. Our model provides a holistic, life course approach, encompassing school-based education, social media, and national campaigns, and highlights the need for training and system-level support for the range of health-care professionals who can deliver it. This high-level model can be adapted across settings, leading to a step change in the provision of preconception care in the community with consequent improvements in health and wellbeing, and reductions in inequalities at population level.

Predicting Breast Reduction Resection Weights and Attainment of Insurance-Mandated Minimums.

BACKGROUND: Despite evidence that reduction mammaplasty alleviates macromastia symptoms independent of resection weights, resection minimums are commonly used to grant insurance coverage. Multiple formulas have been published to predict resection weights, but very few have evaluated predictive performance relative to attaining common insurance minimums. METHODS: This was a retrospective single-center review of 268 patients from 2007 to 2020. Multiple linear regression and exponential models were created to predict resection weights and attainment of the Schnur, 350-g, and 500-g minimums. Accuracy was compared against published Appel, Descamps, and Galveston equations. Body mass index subgroup analyses were performed. RESULTS: The exponential model possessed the lowest resection weight prediction error overall (172.8 ± 211.5 g). All equations performed significantly better than surgeons in predicting attainment of the 500-g minimum. None performed better than the surgeons' predictive accuracy in attaining a 350-g minimum. Multiple linear regression and exponential models performed significantly better than surgeons in predicting attainment of the Schnur minimum. Only the exponential model performed significantly better than surgeons for both the Schnur (82% versus 71%; P < 0.01) and the 500-g minimums (89% versus 68%; P < 0.01). On body mass index subgroup analyses, all three minimums were biased in favor of obese women-the least egregious of these was the 350-g minimum. CONCLUSIONS: All minimums were biased against nonobese women. Our exponential model equation based on preoperative sternal notch-to-nipple and nipple-to-inframammary fold distances accurately predicts resection weights and improves on our surgeons' predictive accuracy in attaining the Schnur or 500-g minimums. This may prove useful in the preoperative setting to better counsel patients.

Emotional experiences of women who access early pregnancy assessment units: a qualitative investigation.

Purpose: Early pregnancy complications are common and often result in pregnancy loss, which can be emotionally challenging for women. Research on the emotional experiences of those attending Early Pregnancy Assessment Units [EPAUs] is scarce. This analysis explored the emotions which women spontaneously reported when being interviewed about their experiences of using EPAU services.Materials and methods: Semi-structured telephone interviews were conducted with a purposive sample of 38 women. Using Thematic Framework Analysis, we identified six unique emotional typologies which mapped onto women's clinical journeys.Results: Women with ongoing pregnancies were characterized as having: "Anxious Presentation" or "Sustained Anxiety due to Diagnostic Uncertainty", dependent on whether their initial scan result was inconclusive. Women with pregnancy loss had one of four emotional typologies, varying by diagnostic timing and required interventions: "Anxious-Upset"; "Anxious-Upset after Diagnostic Uncertainty"; "Anxious-Upset with Procedural Uncertainty"; "Anxious with Sustained Uncertainty".Conclusions: We provide insights into the distinct emotions associated with different clinical pathways through EPAU services. Our findings could be used to facilitate wider recognition of women's emotional journeys through early pregnancy complications and stimulate research into how best to support women and their partners, in these difficult times.

Patient and caregiver socioeconomic burden of first-line systemic therapy for advanced gastroesophageal adenocarcinoma.

Aim: This study assessed the work productivity and financial impact of advanced gastroesophageal adenocarcinomas, comprising gastric, esophageal and gastroesophageal junction cancers, on patients of working age and their caregivers. Patients & methods: A multicenter medical chart review and surveys of patients with advanced gastroesophageal adenocarcinoma and their caregivers was conducted in France, Germany, the UK, China, Japan and the USA. Results: Across differing regions, the study highlighted the impact of cancer on patients' ability to work, to function normally and on their wellbeing, as well as the economic burden placed on patients and their caregivers. Conclusion: Advanced gastroesophageal adenocarcinomas have a significant impact on patients' and caregivers' well-being and are associated with reduced work productivity, and income loss.

A qualitative study of sedentary behaviours in stroke survivors: non-participant observations and interviews with stroke service staff in stroke units and community services.

PURPOSE: Sedentary behaviour (SB) is associated with negative health outcomes and is prevalent post-stroke. This study explored SB after stroke from the perspective of stroke service staff. METHODS: Qualitative mixed-methods study. Non-participant observations in two stroke services (England/Scotland) and semi-structured interviews with staff underpinned by the COM-B model of behaviour change. Observations were analysed thematically; interviews were analysed using the Framework approach. RESULTS: One hundred and thirty-two observation hours (October - December 2017), and 31 staff interviewed (January -June 2018). Four themes were identified: (1) Opportunities for staff to support stroke survivors to reduce SB; (2) Physical and psychological capability of staff to support stroke survivors to reduce SB; (3) Motivating factors influencing staff behaviour to support stroke survivors to reduce SB; (4) Staff suggestions for a future intervention to support stroke survivors to reduce SB. CONCLUSIONS: Staff are aware of the consequences of prolonged sitting but did not relate to SB. Explicit knowledge of SB was limited. Staff need training to support stroke survivors to reduce SB. Sedentary behaviour in the community was not reported to change markedly, highlighting the need to engage stroke survivors in movement from when capable in hospital, following through to home.Implications for rehabilitationStroke survivor sedentary behaviour is influenced, directly and indirectly, by the actions and instructions of stroke service staff in the inpatient and community setting.The built and social environment, both in the inpatient and community settings, may limit opportunities for safe movement and can result in stroke survivors spending more time sedentary.Stroke service staff appreciate the benefit of encouraging stroke survivors to stand and move more, if it is safe for them to do so.Staff would be amenable to encourage stroke survivors to reduce sedentary behaviour, provided they have the knowledge and resources to equip them to support this.

Community-Level Economic Distress, Race, and Risk of Adverse Outcomes After Heart Failure Hospitalization Among Medicare Beneficiaries.

BACKGROUND: Socioeconomic disadvantage is a strong determinant of adverse outcomes in patients with heart failure. However, the contribution of community-level economic distress to adverse outcomes in heart failure may differ across races and ethnicities. METHODS: Patients of self-reported Black, White, and Hispanic race and ethnicity hospitalized with heart failure between 2014 and 2019 were identified from the Medicare MedPAR Part A 100% Files. We used patient-level residential ZIP code to quantify community-level economic distress on the basis of the Distressed Community Index (quintile 5: economically distressed versus quintiles 1-4: nondistressed). The association of continuous and categorical measures (distressed versus nondistressed) of Distressed Community Index with 30-day, 6-month, and 1-year risk-adjusted mortality, readmission burden, and home time were assessed separately by race and ethnicity groups. RESULTS: The study included 1 611 586 White (13.2% economically distressed), 205 840 Black (50.6% economically distressed), and 89 199 Hispanic (27.3% economically distressed) patients. Among White patients, living in economically distressed (versus nondistressed) communities was significantly associated with a higher risk of adverse outcomes at 30-day and 1-year follow-up. Among Black and Hispanic patients, the risk of adverse outcomes associated with living in distressed versus nondistressed communities was not meaningfully different at 30 days and became more prominent by 1-year follow-up. Similarly, in the restricted cubic spline analysis, a stronger and more graded association was observed between Distressed Community Index score and risk of adverse outcomes in White patients (versus Black and Hispanic patients). Furthermore, the association between community-level economic distress and risk of adverse outcomes for Black patients differed in rural versus urban areas. Living in economically distressed communities was significantly associated with a higher risk of mortality and lower home time at 1-year follow-up in rural areas but not urban areas. CONCLUSIONS: The association between community-level economic distress and risk of adverse outcomes differs across race and ethnic groups, with a stronger association noted in White patients at short- and long-term follow-up. Among Black patients, the association of community-level economic distress with a higher risk of adverse outcomes is less evident in the short term and is more robust and significant in the long-term follow-up and rural areas.

Impact of the SARS-CoV-2 pandemic on access to contraception and pregnancy intentions: a national prospective cohort study of the UK population.

OBJECTIVE: Evaluate the impact of the COVID-19 pandemic on access to contraception and pregnancy intentions. DESIGN: Nationwide prospective cohort study. SETTING: United Kingdom. PARTICIPANTS: Women in the UK who were pregnant between 24 May and 31 December 2020. MAIN OUTCOME MEASURES: Access to contraception and level of pregnancy intentions, using the London Measure of Unplanned Pregnancy (LMUP) in women whose last menstrual period was before or after 1 April 2020. While the official date of the first UK lockdown was 23 March, we used 1 April to ensure that those in the post-lockdown group would have faced restrictions in the month that they conceived. RESULTS: A total of 9784 women enrolled in the cohort: 4114 (42.0%) conceived pre-lockdown and 5670 (58.0%) conceived post-lockdown. The proportion of women reporting difficulties accessing contraception was higher in those who conceived after lockdown (n=366, 6.5% vs n=25, 0.6%, p<0.001) and continued to rise from March to September 2020. After adjusting for confounders, women were nine times more likely to report difficulty accessing contraception after lockdown (adjusted odds ratio (aOR) 8.96, 95% CI 5.89 to 13.63, p<0.001). There is a significant difference in the levels of pregnancy planning, with higher proportions of unplanned (n=119, 2.1% vs n=55, 1.3%) and ambivalent pregnancies (n=1163, 20.5% vs n=663, 16.1%) and lower proportions of planned pregnancies (n=4388, 77.4% vs n=3396, 82.5%) in the post-lockdown group (p<0.001). After adjusting for confounders, women who conceived after lockdown were still significantly less likely to have a planned pregnancy (aOR 0.88, 95% CI 0.79 to 0.98, p=0.025). CONCLUSIONS: Access to contraception in the UK has become harder during the COVID-19 pandemic and the proportion of unplanned pregnancies has almost doubled.

Real-world symptoms, disease burden, resource use and quality of life in US patients with advanced renal cell cancer.

Aim: To assess symptoms, healthcare resource utilization and health-related quality of life in advanced renal cell carcinoma (aRCC) clinical practice. Materials & methods: The USA point-in-time survey of physicians and patients was conducted between February and September 2019. Results: Data were available for 227 patients. Mean (standard deviation) number of symptoms was 3.4 (3.2); differences were observed across International Metastatic RCC Database Consortium risk categories (p < 0.001), with fewer symptoms in favorable-risk patients. Disease burden, measured by greater healthcare resource utilization and worse health-related quality of life, was high, particularly in International Metastatic RCC Database Consortium intermediate- or poor- versus favorable-risk patients. In total, 45 patients (21.6%) were hospitalized due to aRCC within a 6-month period, 35 (16.8%) had one hospitalization and ten (4.8%) experienced ≥2 hospitalizations due to aRCC. Mean (standard deviation) 19-Item Functional Assessment of Cancer Therapy Kidney Symptom Index score was 53.6 (13.2) for this population, significantly lower than the reference value (59.8; p < 0.001). Conclusion: A clear need exists for improved disease management in patients with aRCC.

Lay abstract Late-stage/advanced renal cell carcinoma (aRCC) is kidney cancer that has spread to other body parts. aRCC is expensive to treat and affects patients in many ways. New treatments have become available, including tyrosine kinase inhibitors and immuno-oncology therapies. The type of treatment recommended depends on the patient's International Metastatic RCC Database Consortium risk score. This is a way of classifying patients as having a good, intermediate or poor survival risk. We asked physicians questions about their patients such as their age, how long they had aRCC, their treatment and symptoms, and asked patients how aRCC affected their lives, including how often they visited doctors and hospitals. aRCC had the greatest effect on patients with poor-risk scores. Those patients had more symptoms and worse quality of life than patients with intermediate or good risk scores. Treatment also affected patients' lives, although not as much as risk score. Patients with aRCC need better treatment options to help improve their quality of life.

Implementing Risk Stratification in Primary Care: Challenges and Strategies.

INTRODUCTION: Primary care risk stratification (RS) has been shown to help practices better understand their patient populations' needs and may improve health outcomes and reduce expenditures by targeting and tailoring care to high-need patients. This study aims to understand key considerations practices faced and practice experiences as they began to implement RS models. METHODS: We conducted semistructured interviews about experiences in RS with 34 stakeholders from 15 primary care practices in Oregon and Colorado and qualitatively analyzed the data. RESULTS: Three decisions were important in shaping practices' experiences with RS: choosing established versus self-created algorithms or heuristics, clinical intuition, or a combination; selecting mechanisms for assigning risk scores; determining how to integrate RS approaches into care delivery. Practices using clinical intuition found stratification time-consuming and difficult to incorporate into existing workflows, but trusted risk scores more than those using algorithms. Trust in risk scores was influenced by data extraction capabilities; practices often lacked sufficient data to calculate their perceived optimal risk score. Displaying the scores to the care team was a major issue. Finally, obtaining buy-in from care team members was challenging, requiring repeated cycles of improvement and workflow integration. DISCUSSION: Practices used iterative approaches to RS implementation. As a result, procedural and algorithmic changes were introduced and were influenced by practices' health IT, staffing, and resource capacities. Practices were most successful when able to make iterative changes to their approaches, incorporated both automation and human process in RS, educated staff on the importance of RS, and had readily accessible risk scores.

Preconception health in England: a proposal for annual reporting with core metrics.

There is growing interest in preconception health as a crucial period for influencing not only pregnancy outcomes, but also future maternal and child health, and prevention of long-term medical conditions. Successive national and international policy documents emphasise the need to improve preconception health, but resources and action have not followed through with these goals. We argue for a dual intervention strategy at both the public health level (eg, by improving the food environment) and at the individual level (eg, by better identification of those planning a pregnancy who would benefit from support to optimise health before conception) in order to raise awareness of preconception health and to normalise the notion of planning and preparing for pregnancy. Existing strategies that target common risks factors, such as obesity and smoking, should recognise the preconception period as one that offers special opportunity for intervention, based on evidence from life-course epidemiology, developmental (embryo) programming around the time of conception, and maternal motivation. To describe and monitor preconception health in England, we propose an annual report card using metrics from multiple routine data sources. Such a report card should serve to hold governments and other relevant agencies to account for delivering interventions to improve preconception health.

The Role of Government in Precision Medicine, Precision Public Health and the Intersection With Healthy Living.

This paper focuses on the significant role of government in promoting precision medicine and public health and the potential intersection with healthy living (HL) and population health. Recent research has highlighted the interplay between genes, environments and different exposures individuals and populations experience over a lifetime. These interactions between longitudinal behaviors, epigenetics, and expression of the human genome have the potential to transform health and well-being, even within a single generation. Precision medicine can elucidate these longitudinal interactions with a granularity that has not been previously possible across the exposome. Understanding the interactions between genes, epigenetics, proteins, metabolites, and the exposome may inform more evidence-based, effective policy, system, and environmental change to optimize individual and population health. Government has an important role in helping to fund primary research in precision medicine and precision public health, as well as creating and enforcing standards related to food systems, air quality, and access to health care, defining and optimizing measures of health care quality and safety, and ensuring data privacy standards and protections, interoperability, and integration with surveillance systems. Government partnership and collaboration with the non-profit and private sectors can optimize precision medicine and precision public health for the benefit of the United States and global population.

Comparing the order of the London Measure of Unplanned Pregnancy and the Demographic and Health Survey question on pregnancy intention in a single group of postnatal women in Malawi - the effect of question order on assessment of pregnancy intention.

OBJECTIVE: To investigate the effect of question order on women's responses to the London Measure of Unplanned Pregnancy (LMUP) or the pregnancy intention question of the Demographic and Health Survey (DHS) when both are asked in the same survey. We collected data on pregnancy intention from a cohort of 4244 pregnant women in Malawi who were re-interviewed at 1, 6 and 12 months postnatally. Women in Zone 1 were asked the LMUP, then antenatal questions, then the DHS pregnancy intention question, women in Zone 2 were asked the DHS pregnancy intention question, then antenatal questions, then the LMUP; women in Zone 3 were only asked the DHS pregnancy intention question. We used linear regression to compare the LMUP score and ordinal regression to compare DHS categorisations of pregnancy intention across Zones, adjusting for baseline socioeconomic differences between the Zones. RESULTS: We found no effect of question order on the assessment of pregnancy intention by the LMUP. There were differences in the assessment of pregnancy intention when the pregnancy intention question in the DHS was used, however this seemed to be due to baseline sociodemographic differences between the groups of pregnant women being compared, and not due to question order.

Electronic health record tools to assist with children's insurance coverage: a mixed methods study.

BACKGROUND: Children with health insurance have increased access to healthcare and receive higher quality care. However, despite recent initiatives expanding children's coverage, many remain uninsured. New technologies present opportunities for helping clinics provide enrollment support for patients. We developed and tested electronic health record (EHR)-based tools to help clinics provide children's insurance assistance. METHODS: We used mixed methods to understand tool adoption, and to assess impact of tool use on insurance coverage, healthcare utilization, and receipt of recommended care. We conducted intent-to-treat (ITT) analyses comparing pediatric patients in 4 intervention clinics (n = 15,024) to those at 4 matched control clinics (n = 12,227). We conducted effect-of-treatment-on-the-treated (ETOT) analyses comparing intervention clinic patients with tool use (n = 2240) to intervention clinic patients without tool use (n = 12,784). RESULTS: Tools were used for only 15% of eligible patients. Qualitative data indicated that tool adoption was limited by: (1) concurrent initiatives that duplicated the work associated with the tools, and (2) inability to obtain accurate insurance coverage data and end dates. The ITT analyses showed that intervention clinic patients had higher odds of gaining insurance coverage (adjusted odds ratio [aOR] = 1.32, 95% confidence interval [95%CI] 1.14-1.51) and lower odds of losing coverage (aOR = 0.77, 95%CI 0.68-0.88), compared to control clinic patients. Similarly, ETOT findings showed that intervention clinic patients with tool use had higher odds of gaining insurance (aOR = 1.83, 95%CI 1.64-2.04) and lower odds of losing coverage (aOR = 0.70, 95%CI 0.53-0.91), compared to patients without tool use. The ETOT analyses also showed higher rates of receipt of return visits, well-child visits, and several immunizations among patients for whom the tools were used. CONCLUSIONS: This pragmatic trial, the first to evaluate EHR-based insurance assistance tools, suggests that it is feasible to create and implement tools that help clinics provide insurance enrollment support to pediatric patients. While ITT findings were limited by low rates of tool use, ITT and ETOT findings suggest tool use was associated with better odds of gaining and keeping coverage. Further, ETOT findings suggest that use of such tools may positively impact healthcare utilization and quality of pediatric care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02298361 ; retrospectively registered on November 5, 2014.

Initial development and validation of a fecal incontinence-specific quality of life measure.

BACKGROUND/PURPOSE: Fecal incontinence is a prevalent pediatric condition with psychosocial impacts on both children and their caregivers. We sought to develop and validate the Cincinnati Fecal Incontinence Scale (CINCY-FIS) as a psychometrically valid measure to assess the quality of life and caregiver impacts of pediatric fecal incontinence. METHODS: Items were generated through review of previous measures, expert consensus, and pilot testing with feedback from 8 families. Initial study measures were completed by 222 caregivers. Following item reduction, 18 items were subjected to confirmatory factor analysis. Convergent and criterion validity were assessed using correlation. Reliability was established using internal consistency statistics and test-retest reliability at baseline and 2-week follow-up. RESULTS: A five factor first-order structure with two higher-order factors demonstrated acceptable fit to the data, was consistent with a priori hypotheses, and was more parsimonious than the alternative model. Convergent validity and criterion-related validity were established for all of the CINCY-FIS scales. Reliability was high and consistent across both measurement occasions. CONCLUSIONS: The CINCY-FIS is a reliable and valid assessment of pediatric fecal incontinence-specific quality of life and parenting stress. The score is highly sensitive to patient changes making it suitable for both clinical and research purposes. TYPE OF STUDY: Prospective observational. LEVEL OF EVIDENCE: Study of Diagnostic Test Level II.

Family Health-related Quality of Life in Pediatric Cyclic Vomiting Syndrome.

OBJECTIVE: The aim of the study was to evaluate the relationship of disease characteristics and child anxiety symptoms to family health-related quality of life (FHRQoL) in youth with cyclic vomiting syndrome (CVS). METHODS: Forty-two parents of youth ages 8 to 18 years diagnosed with CVS completed the Family Impact Module of the PedsQL, a measure of the impact of the child's illness on the family. We evaluated the relationship of disease characteristics and child and parent proxy reports of anxiety symptoms on the Screen for Childhood Anxiety and Related Emotional Disorders to FHRQoL. RESULTS: Parent report of child anxiety symptoms and missed school days (mean = 11.93, standard deviation = 14.62) were the strongest predictors of FHRQoL (r = 0.33, df = 1.39, F = 8.51, P = 0.006). Other disease characteristics, including frequency, duration, chronicity of CVS episodes, and delay in initial CVS diagnosis were not significantly associated with the FHRQoL total score. Child anxiety symptoms by either parent and/or child report were associated with subscales of the FHRQoL, including family physical functioning, family communication, and family daily activities. CONCLUSIONS: HRQoL for the families assessed in this study was associated with anxiety symptoms to a greater extent than disease characteristics, indexing the importance of a biopsychosocial approach to CVS management. Screening for anxiety symptoms and support for school absences due to illness are indicated to help lessen the impact of CVS on the family as a whole.

Integrating behavioral health under an ACO global budget: barriers and progress in Oregon.

OBJECTIVES: This study describes challenges that coordinated care organizations (CCOs), a version of accountable care organizations, experienced when attempting to finance integrated care for Medicaid recipients in Oregon and the strategies they developed to address these barriers. STUDY DESIGN: Cross-case comparative study. METHODS: We conducted a cross-case comparative study of 5 diverse CCOs in Oregon. We interviewed key stakeholders: CCO leaders, practice leaders, and primary care and behavioral health clinicians. A multidisciplinary team analyzed data using an immersion-crystallization approach. Financial barriers to integrating care and strategies to address them emerged from this analysis. Findings were member-checked with a CCO integration workgroup to ensure wider applicability. RESULTS: State legislation that initiated CCOs promoted integration expansion. CCOs, however, struggled to create sustainable funding mechanisms to support integration. This was due to regulatory and financial silos that persisted despite CCO global budget formation; concerns about actuarial soundness that limited reasonable, yet creative, uses of federal funds to support integration; and billing difficulties connected to licensing and documentation requirements for behavioral and mental health providers. Despite these barriers, CCOs, with the help of the state, supported expanding integrated care in primary care by using state funds to pilot test integration models and to promote alternative payment methodologies. CONCLUSIONS: Oregon's CCO mandate included a focus on better integrating medical and behavioral healthcare for Medicaid recipients. Despite this intention, challenges exist in the financing of integration, many of which state and federal leaders can address through payment and regulatory reform.