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BACKGROUND: Direct-acting antiviral medications have the potential to eliminate the hepatitis C virus (HCV) epidemic among people who inject drugs; yet, suboptimal adherence remains a barrier. Directly observed treatment (DOT), an effective strategy for optimizing adherence, has been frequently implemented in opioid treatment programs but less commonly in community health settings due to the heavy burden of daily visits. An alternative is video-observed therapy (VOT), which uses mobile health technology to monitor adherence. VOT has not been widely studied among people who inject drugs with HCV. OBJECTIVE: This qualitative study, part of a larger implementation evaluation, investigates stakeholder perceptions and experiences with VOT in Project HERO (Hepatitis C Real Outcomes), a multisite pragmatic trial testing treatment delivery models for people who inject drugs with HCV. Our goal was to understand the potential barriers and facilitators to the implementation of the VOT technology. METHODS: Qualitative interviews were conducted with 27 Project HERO study staff and 7 patients. Interviews focused on perceptions and experiences with the VOT app and barriers and facilitators to implementation. Team meeting minutes over the first 2 years of the project were transcribed. A coding system was developed and applied to the data. We summarized thematic data and compared participant perceptions to generate a close understanding of the data. RESULTS: Frequent barriers to VOT included mechanical failure, stolen or lost phones, and a steep learning curve for participants and study staff. In sites with older and less technically skilled participants, staff found it difficult to implement the VOT app. Research staff found that the routine monitoring of app use led to closer engagement with participants. This was both a benefit and a potential threat to the validity of this pragmatic trial. Patient participants reported mixed experiences. CONCLUSIONS: VOT may be a useful alternative to DOT for some patients, but it may not be feasible for all. Significant staff involvement may be required.
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Usuários de Drogas , Hepatite C Crônica , Hepatite C , Abuso de Substâncias por Via Intravenosa , Humanos , Hepacivirus , Preparações Farmacêuticas , Antivirais/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Hepatite C/tratamento farmacológicoRESUMO
BACKGROUND: It is increasingly recognized that policies have played a role in both alleviating and exacerbating the health and economic consequences of the COVID-19 pandemic. There has been limited systematic evaluation of variation in U.S. local COVID-19-related policies. This study introduces the U.S. COVID-19 County Policy (UCCP) Database, whose objective is to systematically gather, characterize, and assess variation in U.S. county-level COVID-19-related policies. METHODS: In January-March 2021, we collected an initial wave of cross-sectional data from government and media websites for 171 counties in 7 states on 22 county-level COVID-19-related policies within 3 policy domains that are likely to affect health: (1) containment/closure, (2) economic support, and (3) public health. We characterized the presence and comprehensiveness of policies using univariate analyses. We also examined the correlation of policies with one another using bivariate Spearman's correlations. Finally, we examined geographical variation in policies across and within states. RESULTS: There was substantial variation in the presence and comprehensiveness of county policies during January-March 2021. For containment and closure policies, the percent of counties with no restrictions ranged from 0% (for public events) to more than half for public transportation (67.8%), hair salons (52.6%), and religious gatherings (52.0%). For economic policies, 76.6% of counties had housing support, while 64.9% had utility relief. For public health policies, most were comprehensive, with 70.8% of counties having coordinated public information campaigns, and 66.7% requiring masks outside the home at all times. Correlations between containment and closure policies tended to be positive and moderate (i.e., coefficients 0.4-0.59). There was variation within and across states in the number and comprehensiveness of policies. CONCLUSIONS: This study introduces the UCCP Database, presenting granular data on local governments' responses to the COVID-19 pandemic. We documented substantial variation within and across states on a wide range of policies at a single point in time. By making these data publicly available, this study supports future research that can leverage this database to examine how policies contributed to and continue to influence pandemic-related health and socioeconomic outcomes and disparities. The UCCP database is available online and will include additional time points for 2020-2021 and additional counties nationwide.
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COVID-19 , Pandemias , COVID-19/epidemiologia , Estudos Transversais , Humanos , Políticas , Saúde Pública , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: The United States needs to increase access to effective obesity prevention and treatment programming for impoverished youth at risk for health disparities. Although recommended, schools have difficulty consistently implement evidence-based obesity programing. We report on the effectiveness of adding structured nutrition education and minimum physical activity (PA) requirements to standard middle school after-school programming. METHODS: Using a longitudinal pre-post study design, we evaluated program effectiveness at one year on target behaviors on students recruited during three consecutive school years (2016-2018). We used generalized linear (or logistic) mixed-effects modeling to determine: 1) impact on healthy weight and target healthy behavior attainment, and 2) whether target behavior improvement and weight change were associated with after-school program attendance. The seven target behaviors relate to eating healthy, physical activity, and sleep. RESULTS: Over the three years, a total of 76 students enrolled and completed one year of programming (62% Hispanic, 46% girls, 72% with BMI > 85th %ile, 49% with BMI > 95th %ile). Of students with BMI > 85th %ile, 44% maintained or decreased BMI Z-score. There were improvements (non-significant) in BMI Z-score and the adoption of four healthy eating behaviors: fruit, vegetables, sugar-free beverages, and unhealthy snack food. Students with higher after-school attendance (> 75%) had greater improvements (non-significant) in composite behavior scores, BMI Z-score, and in most target behaviors (5/7) than students with lower after-school attendance (< 75%). Sleep improvements were significantly associated with BMI Z-score decrease (Beta = - 0.05, 95% CI (- 0.1,-0.003), p = 0.038.) CONCLUSIONS: Enhancement of existing after-school programming with structured nutrition education and minimum physical activity requirements demonstrates positive improvements in several health behaviors and weight outcomes. Adopting enhanced after-school programming increases access to health activities and may bring us closer to solving obesity in at-risk youth in impoverished communities. TRIAL REGISTRATION: ClinicalTrials.gov identifier (NCT number): NCT03565744 . Registered 21 June 2018 - Retrospectively registered.
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Obesidade Infantil , Serviços de Saúde Escolar , Adolescente , Peso Corporal , Comportamento Alimentar , Feminino , Comportamentos Relacionados com a Saúde , Promoção da Saúde , Humanos , Obesidade Infantil/prevenção & controle , Instituições AcadêmicasRESUMO
This paper reports on a randomized control trial involving children less than 3 years old and their mothers who were regarded at risk of maltreating their children by referral agencies. Mothers' risk status derived from a heavy trauma burden (average exposure over the first 18 years of their lives to 10 possible adverse childhood experiences [ACEs] was >5), mental health challenges (15%-28% had experienced a prior psychiatric hospitalization), and prior removal of a child to foster care (20%). Mothers were randomly assigned to either a widely used parenting class known as Systematic Training for Effective Parenting (STEP) or the Group Attachment-Based Intervention (GABI), a multifamily 26-week treatment. The resulting mother-child pairs available for consideration in this baseline versus end-of-treatment report were 35 families in the STEP arm and 43 families in the GABI arm. The focus of this paper is the outcome measure of observed parent-child relationship assessed with the Coding of Interactive Behavior (Feldman, 1998) collected at baseline and end of treatment. In comparison to STEP, results indicated that GABI was linked to significant improvements in maternal supportive presence and dyadic reciprocity, and significant declines in maternal hostility and dyadic constriction (proxies for risk of child maltreatment). These medium-to large-sized effects remained significant even after controlling for mothers' prior ACEs in analysis of covariance procedures. In addition, two small interaction effects of ACEs by treatment type were found, underlining the need for, and value of, treatments that are sensitive to parents' traumatic histories.
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Maus-Tratos Infantis/prevenção & controle , Relações Mãe-Filho , Apego ao Objeto , Psicoterapia de Grupo/métodos , Experiências Adversas da Infância , Maus-Tratos Infantis/psicologia , Filho de Pais com Deficiência/psicologia , Pré-Escolar , Feminino , Humanos , Masculino , Mães/psicologia , Avaliação de Processos e Resultados em Cuidados de Saúde , Poder Familiar/psicologia , Fatores de RiscoRESUMO
OBJECTIVE: To estimate the cost of delivering a hepatitis C virus care coordination program at 2 New York City health care provider organizations and describe a potential payment model for these currently nonreimbursed services. DESIGN: An economic evaluation of a hepatitis C care coordination program was conducted using micro-costing methods compared with macro-costing methods. A potential payment model was calculated for 3 phases: enrollment to treatment initiation, treatment initiation to treatment completion, and a bonus payment for laboratory evidence of successful treatment outcome (sustained viral response). SETTING: Two New York City health care provider organizations. PARTICIPANTS: Care coordinators and peer educators delivering care coordination services were interviewed about time spent on service provision. De-identified individual-level data on study participant utilization of services were also used. INTERVENTION: Project INSPIRE is an innovative hepatitis C care coordination program developed by the New York City Department of Health and Mental Hygiene. MAIN OUTCOME MEASURES: Average cost per participant per episode of care for 2 provider organizations and a proposed payment model. RESULTS: The average cost per participant at 1 provider organization was $787 ($522 nonoverhead cost, $264 overhead) per episode of care (5.6 months) and $656 ($429 nonoverhead cost, $227 overhead, 5.7 months) at the other one. The first organization had a lower macro-costing estimate ($561 vs $787) whereas the other one had a higher macro-costing estimate ($775 vs $656). In the 3-phased payment model, phase 1 reimbursement would vary between the provider organizations from approximately $280 to $400, but reimbursement for both organizations would be approximately $220 for phase 2 and approximately $185 for phase 3. CONCLUSIONS: The cost of this 5.6-month care coordination intervention was less than $800 including overhead or less than $95 per month. A 3-phase payment model is proposed and requires further evaluation for implementation feasibility. Project INSPIRE's HCV care coordination program provides good value for a cost of less than $95 per participant per month. The payment model provides an incentive for successful cure of hepatitis C with a bonus payment; using the bonus payment to support HCV tele-mentoring expands HCV treatment capacity and empowers more primary care providers to treat their own patients with HCV.
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Hepatite C/terapia , Administração dos Cuidados ao Paciente/economia , Mecanismo de Reembolso , Gerenciamento Clínico , Custos de Cuidados de Saúde/estatística & dados numéricos , Hepacivirus/efeitos dos fármacos , Hepacivirus/patogenicidade , Hepatite C/epidemiologia , Humanos , Cidade de Nova Iorque/epidemiologia , Administração dos Cuidados ao Paciente/métodos , Administração dos Cuidados ao Paciente/tendênciasRESUMO
This article outlines the main premises of an innovative trauma-informed intervention, group attachment-based intervention, specifically developed to target vulnerable families with infants and toddlers, living in one of the poorest urban counties in the nation. It also reports on the trauma-relevant characteristics of 60 families entering a clinical trial to study the effectiveness of Group Attachment-Based Intervention. Initial survey results revealed high levels of neglect, abuse, and household dysfunction in mothers' histories (77% reported ≥4 adverse childhood experiences, with more than 90% reporting 2 or more current toxic stressors, including poverty, obesity, domestic and community violence, and homelessness).
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Maus-Tratos Infantis/prevenção & controle , Serviços de Assistência Domiciliar/organização & administração , Apego ao Objeto , Pais/educação , Áreas de Pobreza , Psicoterapia de Grupo/organização & administração , Terapia Comportamental/métodos , Criança , Maus-Tratos Infantis/estatística & dados numéricos , Pré-Escolar , Violência Doméstica/estatística & dados numéricos , Humanos , Lactente , Masculino , Pais/psicologia , Estados UnidosRESUMO
Background: A minority of American youth meet CDC physical activity (PA) recommendations; children in the Bronx face additional structural barriers to engaging in PA. The B'N Fit Power expansion draws on pilot programming to increase the proportion of middle school students who engage in one hour of daily PA. The COVID-19 pandemic presented additional obstacles, including increased food insecurity and suspension of organized PA programming. This research aimed to evaluate differences in baseline target behavior attainment before and after the start of the COVID-19 pandemic to inform future programming to help children reduce their risk of obesity. Methods: Afterschool program leaders at three Bronx public schools collected demographic and target behavior data at baseline and attendance data throughout the school year. Results: During the 2016-2017 and 2017-2018 school years, 76 students enrolled and completed one year of programming, which was administered at a single site (61 % Hispanic, 46% female). Of these, 76 (100%) completed a baseline target behaviors questionnaire. During the 2021-2022 school year, 417 students enrolled and completed one year of programming at one of the three sites (70% Hispanic, 48% female). 89 (21%) completed a baseline target behaviors questionnaire. Participants surveyed after the start of the COVID-19 pandemic reported drinking more sugar-sweetened beverages (Median=3 daily, IQR 2-5), sleeping less (Median=8 hours daily, IQR 6-9 hours), and consuming fast food more frequently (Median=1 time weekly, IQR 0 times weekly-2 to 3 times weekly) than those surveyed prior to the start of the pandemic. The number of PA hours completed each week trended toward significant decline (Median=3, IQR 2-5, p=0.09) in students tracked after the start of the pandemic. Conclusions: The attainment of several target behaviors among school children linked to the reduction of childhood obesity declined during the COVID-19 pandemic. These findings can be applied to enhancing existing real-world afterschool PA programming.
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Background: Acupuncture and yoga have both been shown to be effective in chronic pain. Underrepresented populations have poorer pain outcomes with less access to effective pain care. Objective: To assess the feasibility of bundling group acupuncture with yoga therapy for chronic neck, back or osteoarthritis pain in safety net settings. Methods: This was a feasibility pilot in Bronx and Harlem primary care community health centers. Participants with chronic neck, back or osteoarthritis pain received acupuncture and yoga therapy over a 10-week period. Participants received 10 weekly acupuncture treatments in group setting; with Yoga therapy sessions beginning immediately following the 3rd session. Primary outcome was pain interference and pain intensity on the Brief Pain Inventory (BPI); Outcomes were measured at baseline, 10-week close of intervention, and 24-week follow-up. Results: 93 patients were determined to be eligible and completed the baseline interview. The majority of participants were non-White and Medicaid recipients. 78 (84%) completed the intervention and 10-week survey, and 58 (62%) completed the 24-week post intervention survey. Participants received an average number of 6.5 acupuncture sessions (out of a possible 10), and 4 yoga sessions (out of a possible 8) over the 10-week intervention. Patients showed statistically significant improvements in pain at the close of the intervention and at a somewhat lesser rate, at 24-weeks post intervention. Challenges included telephone outreach and site coordination integrating acupuncture with yoga therapy. The trial also had to be stopped early due to the COVID-19 pandemic. Conclusions: Bundling acupuncture therapy and yoga therapy is feasible for an underrepresented population with chronic pain in urban community health centers with preliminary indications of acceptability and benefit to participants.
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Despite widespread agreement that stakeholder engagement is needed in patient-centered outcomes research (PCOR), no taxonomy exists to guide researchers and policy makers on how to address this need. We followed an iterative process, including several stages of stakeholder review, to address three questions: (1) Who are the stakeholders in PCOR? (2) What roles and responsibilities can stakeholders have in PCOR? (3) How can researchers start engaging stakeholders? We introduce a flexible taxonomy called the 7Ps of Stakeholder Engagement and Six Stages of Research for identifying stakeholders and developing engagement strategies across the full spectrum of research activities. The path toward engagement will not be uniform across every research program, but this taxonomy offers a common starting point and a flexible approach.
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Classificação , Avaliação de Resultados em Cuidados de Saúde/classificação , Avaliação de Resultados em Cuidados de Saúde/métodos , Assistência Centrada no Paciente/classificação , Assistência Centrada no Paciente/métodos , Diretrizes para o Planejamento em Saúde , HumanosRESUMO
A neural network (NN)-based method is presented in this paper which allows the identification of parameters for material cards used in Finite Element simulations. Contrary to the conventionally used computationally intensive material parameter identification (MPI) by numerical optimization with internal or commercial software, a machine learning (ML)-based method is time saving when used repeatedly. Within this article, a self-developed ML-based Python framework is presented, which offers advantages, especially in the development of structural components in early development phases. In this procedure, different machine learning methods are used and adapted to the specific MPI problem considered herein. Using the developed NN-based and the common optimization-based method with LS-OPT, the material parameters of the LS-DYNA material card MAT_187_SAMP-1 and the failure model GISSMO were exemplarily calibrated for a virtually generated test dataset. Parameters for the description of elasticity, plasticity, tension-compression asymmetry, variable plastic Poisson's ratio (VPPR), strain rate dependency and failure were taken into account. The focus of this paper is on performing a comparative study of the two different MPI methods with varying settings (algorithms, hyperparameters, etc.). Furthermore, the applicability of the NN-based procedure for the specific usage of both material cards was investigated. The studies reveal the general applicability for the calibration of a complex material card by the example of the used MAT_187_SAMP-1.
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Some individuals' understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.
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Bancos de Espécimes Biológicos , Consentimento Livre e Esclarecido , Termos de Consentimento , Eletrônica , HumanosRESUMO
BACKGROUND: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use. METHODS: We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640. FINDINGS: Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group). INTERPRETATION: In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support. FUNDING: Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.
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Usuários de Drogas , Hepatite C , Abuso de Substâncias por Via Intravenosa , Humanos , Abuso de Substâncias por Via Intravenosa/complicações , Abuso de Substâncias por Via Intravenosa/tratamento farmacológico , Antivirais/efeitos adversos , Sofosbuvir/uso terapêutico , Hepatite C/tratamento farmacológico , Hepatite C/complicações , HepacivirusRESUMO
Social barriers to effective medical care are mandated to be routinely assessed as part of an evaluation for liver transplantation. This study explores how frequently liver transplant programs encounter these barriers in patients undergoing an evaluation and whether programs with higher proportions of Medicaid patients, historically disadvantaged minority patients, and rural patients encounter social barriers more frequently. A survey for assessing patient demographics and social barriers was electronically completed by representatives of 61 of 104 eligible US adult liver transplant programs (59%). Fifty-eight of the 61 programs identified themselves, and their characteristics were similar to those of all 104 US programs according to publicly available data from the Organ Procurement and Transplantation Network. Social barriers were reported to be encountered sometimes (10%-30%) or frequently (>30%) by the 61 programs as follows: inadequate or unstable health insurance (68.9% of the programs), a chaotic social environment (63.9%), a lack of a care partner (60.7%), an inability to obtain transportation (49.2%), a low educational level (36.1%), inadequate housing (23.0%), a language barrier (19.7%), no reliable way of contacting the patient (16.4%), difficulty in obtaining child care (11.5%), and food insecurity (8.2%). The frequencies of perceived social barriers did not differ significantly between programs reporting higher or lower proportions of Medicaid, minority, or rural patients. Our analysis suggests that program-level operational planning for addressing social barriers to transplant listing should be considered regardless of the proportions of Medicaid-insured, racial or ethnic minority, and rural patients in the population.
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Disparidades em Assistência à Saúde/estatística & dados numéricos , Transplante de Fígado/estatística & dados numéricos , Medicaid/estatística & dados numéricos , Grupos Minoritários/estatística & dados numéricos , População Rural/estatística & dados numéricos , Fatores Socioeconômicos , Populações Vulneráveis/estatística & dados numéricos , Listas de Espera , Adulto , Criança , Cuidado da Criança/estatística & dados numéricos , Pré-Escolar , Barreiras de Comunicação , Escolaridade , Abastecimento de Alimentos/estatística & dados numéricos , Pesquisas sobre Atenção à Saúde , Habitação/estatística & dados numéricos , Humanos , Idioma , Estado Civil/estatística & dados numéricos , Desenvolvimento de Programas , Meio Social , Inquéritos e Questionários , Obtenção de Tecidos e Órgãos/estatística & dados numéricos , Meios de Transporte/estatística & dados numéricos , Estados UnidosRESUMO
Aging, HIV infection, and antiretroviral therapy have been associated with increasing rates of chronic comorbidities in patients with HIV. Urban minority populations in particular are affected by both the HIV/AIDS and chronic disease epidemics. Our objectives were to estimate the prevalence of and risk factors for hypertension, dyslipidemia, and diabetes among HIV-infected adults in the Bronx and describe comorbidity-related treatment outcomes. This was a cross-sectional study of 854 HIV-positive adults receiving care at 11 clinics which provide HIV primary care services; clinics were affiliated with a large urban academic medical center. Data on blood pressure (BP), cholesterol, and glycemic control were collected through standardized chart review of outpatient medical records. We found prevalence rates of 26%, 48%, and 13% for hypertension, dyslipidemia, and diabetes, respectively. Older age, obesity, family history, and current protease inhibitor use were consistently associated with comorbidity. Diabetes treatment goals were achieved less often than BP and lipid goals, and concurrent diabetes was a significant predictor for BP and lipid control. In conclusion, major cardiovascular-related comorbidities are prevalent among HIV-positive adults in the Bronx, especially older and obese individuals. Differences exist in comorbidity-related treatment outcomes, especially for patients with concurrent diabetes. Because cardiovascular risk is modifiable, effective treatment of related comorbidities may improve morbidity and mortality in HIV-infected patients.
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Fármacos Anti-HIV/uso terapêutico , Diabetes Mellitus/epidemiologia , Dislipidemias/epidemiologia , Infecções por HIV/tratamento farmacológico , Hipertensão/epidemiologia , Adulto , Fatores Etários , Comorbidade/tendências , Estudos Transversais , Quimioterapia Combinada , Feminino , Infecções por HIV/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/epidemiologia , Ambulatório Hospitalar , Prevalência , Resultado do TratamentoRESUMO
Objective: To identify factors associated with implementing bundled group acupuncture and yoga therapy (YT) to treat underserved patients with chronic pain in community health center (CHC) settings. This is not an implementation science study, but rather an organized approach for identification of barriers and facilitators to implementing these therapies as a precursor to a future implementation science study. Design: This study was part of a single-arm feasibility trial, which aimed to test the feasibility of bundling GA and YT for chronic pain in CHCs. Treatment outcomes were measured before and after the 10-week intervention period. Implementation feasibility was assessed through weekly research team meetings, weekly yoga provider meetings, monthly acupuncture provider meetings, and weekly provider surveys. Settings: The study was conducted in New York City at two Montefiore Medical Group (MMG) sites in the Bronx, and one Institute for Family Health (IFH) site in Harlem. Subjects: Participants in the feasibility trial were recruited from IFH and MMG sites, and needed to have had lower back, neck, or osteoarthritis pain for >3 months. Implementation stakeholders included the research team, providers of acupuncture and YT, referring providers, and CHC staff. Results: Implementation of these therapies was assessed using the Consolidated Framework for Implementation Research. We identified issues associated with scheduling, treatment fidelity, communication, the three-way disciplinary interaction of acupuncture, yoga, and biomedicine, space adaptation, site-specific logistical and operational requirements, and patient-provider language barriers. Issues varied as to their frequency and resolution difficulty. Conclusions: This feasibility trial identified implementation issues and resolution strategies that could be further explored in future implementation studies. Clinical Trial Registration No.: NCT04296344.
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Terapia por Acupuntura , Dor Crônica/terapia , Serviços de Saúde Comunitária , Acessibilidade aos Serviços de Saúde , Yoga , Estudos de Viabilidade , Humanos , Área Carente de Assistência Médica , Cidade de Nova Iorque , Projetos PilotoRESUMO
To be able to use finite element (FE) simulations in structural component development, experimental investigations for the characterization of the material properties are required to subsequently calibrate suitable material cards. In contrast to the commonly used computational and time-consuming method of parameter identification (PI) by using analytical and numerical optimizations with internal or commercial software, a more time-efficient method based on machine learning (ML) is presented. This method is applied to simulate the material behavior of additively manufactured specimens made of acrylonitrile butadiene styrene (ABS) under uniaxial stress in a structural simulation. By using feedforward artificial neural networks (FFANN) for the ML-based direct inverse PI process, various investigations were carried out on the influence of sampling strategies, data quantity and data preparation on the prediction accuracy of the NN. Furthermore, the results of hyperparameter (HP) search methods are presented and discussed and their influence on the prediction quality of the FFANN are critically evaluated. The investigations show that the NN-based method is applicable to the present use case and results in material parameters that lead to a lower error between experimental and calculated force-displacement curves than the commonly used optimization-based method.
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Learning Health Systems (LHS) iteratively implement and evaluate health improvement projects. Dissemination and implementation (D&I) science is the study of evidence-based practices in real-world settings, a critical tool for LHS. This paper explores intersections between LHS and D&I science in Clinical and Translational Science Awards (CTSAs) institutions and identifies critical components of collaboration. We conducted website scans of 34 CTSAs and their home institutions that had Dissemination, Implementation, and Knowledge Translation (DIKT) Workgroup members. We identified linkages between CTSAs and their institutions' LHS. We interviewed six CTSA leaders experienced in LHS and D&I sciences. Nearly half of CTSAs identified an LHS structure on their websites, but only one-third indicates CTSA involvement in these efforts. Interviewees identified key components for successful integration of LHS and D&I sciences: leadership, infrastructure, balance between rigor and efficiency, and aligned incentives. The need for research integration in LHS, to improve evaluation and increase knowledge, is an emerging opportunity for D&I scientists and CTSAs. CTSAs that are engaged in D&I science can introduce and/or expand the role of D&I science in LHS. Collaboration between CTSAs and clinical leaders could result in strengthened relationships between clinical and research enterprises, effective and efficient health care delivery, and improved health.
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Stakeholder engagement is acknowledged as central to dissemination and implementation (D&I) of research that generates and answers new clinical and health service research questions. There is both benefit and risk in conducting stakeholder engagement. Done wrong, it can damage trust and adversely impact study results, outcomes, and reputations. Done correctly with sensitivity, inclusion, and respect, it can significantly facilitate improvements in research prioritization, communication, design, recruitment strategies, and ultimately provide results useful to improve population and individual health. There is a recognized science of stakeholder engagement, but a general lack of knowledge that matches its strategies and approaches to particular populations of interest based on history and characteristics. This article reviews stakeholder engagement, provides several examples of its application across the range of translational research, and recommends that Clinical Translational Science Awards, with their unique geographical, systems, and historical characteristics, actively participate in deepening our understanding of stakeholder engagement science and methods within implementation and dissemination research. These recommendations include (a) development of an inventory of successful stakeholder engagement strategies; (b) coordination and intentionally testing a variety of stakeholder engagement strategies; (c) tool kit development; and (d) identification of fundamental motivators and logic models for stakeholder engagement to help align stakeholders and researchers.
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INTRODUCTION: Dissemination and implementation (D&I) science is not a formal element of the Clinical Translational Science Award (CTSA) Program, and D&I science activities across the CTSA Consortium are largely unknown. METHODS: The CTSA Dissemination, Implementation, and Knowledge Translation Working Group surveyed CTSA leaders to explore D&I science-related activities, barriers, and needed supports, then conducted univariate and qualitative analyses of the data. RESULTS: Out of 67 CTSA leaders, 55.2% responded. CTSAs reported directly funding D&I programs (54.1%), training (51.4%), and projects (59.5%). Indirect support (e.g., promoted by CTSA without direct funding) for D&I activities was higher - programs (70.3%), training (64.9%), and projects (54.1%). Top barriers included funding (39.4%), limited D&I science faculty (30.3%), and lack of D&I science understanding (27.3%). Respondents (63.4%) noted the importance of D&I training and recommended coordination of D&I activities across CTSAs hubs (33.3%). CONCLUSION: These findings should guide CTSA leadership in efforts to raise awareness and advance the role of D&I science in improving population health.
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Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.