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BACKGROUND: Enrolling children in clinical trials typically requires parental or guardian permission and, when appropriate, child assent. Aligning requirements across jurisdictions would facilitate multisite pediatric trials. Guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the best candidate for a global standard but would benefit from additional specification. METHODS: Ethical analysis of ICH guidance for permission and assent for pediatric trials, with recommendations for clarification. RESULTS: ICH guidance regarding permission and assent would be enhanced by additional detail in the following areas: (1) what information should be provided to parents, guardians, and children considering a trial, and how that information should be provided; (2) the definition of "assent," the criteria for when assent should be required, and the need to include children in discussions even when assent is not mandated; (3) criteria for requiring children's signatures indicating agreement; (4) greater specificity regarding children's right to decline or withdraw; and (5) clarification of when children's wish to decline or withdraw from participation may be overridden and of what the overriding process should entail. CONCLUSION: ICH guidance provides a global standard for decision making regarding children's participation in trials. Several clarifications would facilitate the conduct of multinational pediatric research. IMPACT: Enrolling children in clinical trials requires the permission of a parent/guardian ± the assent of the minor. Differing global regulatory requirements for enrolling children complicate the conduct of multicenter and multinational trials. The authors identify points of ambiguity and/or contradiction in the International Council for Harmonization guidelines and offer recommendations for a common ethical platform for conducting global pediatric research.
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Niño , Consentimiento Informado , Participación del Paciente , Humanos , Participación del Paciente/legislación & jurisprudencia , Ensayos Clínicos como AsuntoRESUMEN
INTRODUCTION: Little is known about whether patients and physicians perceive lung cancer screening (LCS) as a teachable moment to promote smoking cessation or the degree to which physicians in "real world" settings link LCS discussions with smoking cessation counseling. We sought to characterize patient and physician perspectives of discussions about smoking cessation during LCS. METHODS: We conducted a qualitative study (interviews and focus groups) with 21 physicians and 28 smokers screened in four diverse hospitals. Transcripts were analyzed for characteristics of communication about smoking cessation and LCS, the perceived effect on motivation to quit smoking, the degree to which physicians leverage LCS as a teachable moment to promote smoking cessation, and suggestions to improve patient-physician communication about smoking cessation in the context of LCS. RESULTS: Patients reported that LCS made them more cognizant of the health consequences of smoking, priming them for a teachable moment. While physicians and patients both acknowledged that smoking cessation counseling was frequent, they described little connection between their discussions regarding LCS and smoking cessation counseling. Physicians identified several barriers to integrating discussions on smoking cessation and LCS. They volunteered communication strategies by which LCS could be leveraged to promote smoking cessation. CONCLUSIONS: LCS highlights the harms of smoking to patients who are chronic, heavy smokers and thus may serve as a teachable moment for promoting smoking cessation. However, this opportunity is typically missed in clinical practice. IMPLICATIONS: LCS highlights the harms of smoking to heavily addicted smokers. Yet both physicians and patients reported little connection between LCS and tobacco treatment discussions due to multiple barriers. On-site tobacco treatment programs and post-screening messaging tailored to the LCS results are needed to maximize the health outcomes of LCS, including smoking quit rates and longer-term smoking-related morbidity and mortality.
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Detección Precoz del Cáncer/psicología , Neoplasias Pulmonares/diagnóstico , Educación del Paciente como Asunto , Relaciones Médico-Paciente , Fumadores/psicología , Cese del Hábito de Fumar/psicología , Fumar/terapia , Actitud Frente a la Salud , Comunicación , Femenino , Conductas Relacionadas con la Salud , Humanos , Neoplasias Pulmonares/prevención & control , Neoplasias Pulmonares/psicología , Masculino , Persona de Mediana Edad , Motivación , Médicos/psicología , Investigación Cualitativa , Fumar/psicología , Cese del Hábito de Fumar/métodosRESUMEN
BACKGROUND: Guidelines recommend, and Medicare requires, shared decision-making between patients and clinicians before referring individuals at high risk of lung cancer for chest CT screening. However, little is known about the extent to which shared decision-making about lung cancer screening is achieved in real-world settings. OBJECTIVE: To characterize patient and clinician impressions of early experiences with communication and decision-making about lung cancer screening and perceived barriers to achieving shared decision-making. DESIGN: Qualitative study entailing semi-structured interviews and focus groups. PARTICIPANTS: We enrolled 36 clinicians who refer patients for lung cancer screening and 49 patients who had undergone lung cancer screening in the prior year. Participants were recruited from lung cancer screening programs at four hospitals (three Veterans Health Administration, one urban safety net). APPROACH: Using content analysis, we analyzed transcripts to characterize communication and decision-making about lung cancer screening. Our analysis focused on the recommended components of shared decision-making (information sharing, deliberation, and decision aid use) and barriers to achieving shared decision-making. KEY RESULTS: Clinicians varied in the information shared with patients, and did not consistently incorporate decision aids. Clinicians believed they explained the rationale and gave some (often purposely limited) information about the trade-offs of lung cancer screening. By contrast, some patients reported receiving little information about screening or its trade-offs and did not realize the CT was intended as a screening test for lung cancer. Clinicians and patients alike did not perceive that significant deliberation typically occurred. Clinicians perceived insufficient time, competing priorities, difficulty accessing decision aids, limited patient comprehension, and anticipated patient emotions as barriers to realizing shared decision-making. CONCLUSIONS: Due to multiple perceived barriers, patient-clinician conversations about lung cancer screening may fall short of guideline-recommended shared decision-making supported by a decision aid. Consequently, patients may be left uncertain about lung cancer screening's rationale, trade-offs, and process.
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Toma de Decisiones , Detección Precoz del Cáncer/psicología , Neoplasias Pulmonares/psicología , Participación del Paciente/psicología , Rol del Médico/psicología , Investigación Cualitativa , Femenino , Humanos , Neoplasias Pulmonares/diagnóstico , Masculino , Participación del Paciente/métodos , Relaciones Médico-Paciente , Distribución AleatoriaRESUMEN
PURPOSE: Understanding differences between patients who accept and decline HIV testing is important for developing methods to reduce decliner rates among patients at risk for undiagnosed HIV. The objectives of this study were to determine the rates of acceptance and reasons for declining, and to determine if differences exist in patient or visit characteristics between those who accept and decline testing. BASIC PROCEDURES: This was a retrospective medical record review of all patients offered an emergency department (ED) HIV test from 11/1/11 to 10/31/12. Patient demographic characteristics, health characteristics, and ED visit characteristics were compared to assess differences between those who accept and those who decline testing. FINDINGS: Of 4510 ED patients offered an HIV test, 3470 accepted for an acceptance rate of 77%. The most common reasons for declining were "no perceived risk" and "tested in the last 3 months." Those who accepted testing were more likely to be unmarried, less than age 35, Hispanic or African American, Spanish speaking, foreign born, have no primary care provider, report no pain at triage, have a daytime ED visit, and be discharged from the ED compared to admitted. Sex, employment status, and ED length of stay did not affect whether patients accepted testing. PRINCIPAL CONCLUSIONS: Acceptance of ED-based rapid HIV testing is not universal, and there are both patient and visit characteristics consistently associated with declining testing. This detracts from the goal of using the ED to screen a large number of at-risk patients who do not have access to testing elsewhere.
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Serodiagnóstico del SIDA/estadística & datos numéricos , Servicio de Urgencia en Hospital/estadística & datos numéricos , Aceptación de la Atención de Salud/estadística & datos numéricos , Negativa del Paciente al Tratamiento/estadística & datos numéricos , Adolescente , Adulto , Factores de Edad , Anciano , Femenino , Humanos , Masculino , Estado Civil , Persona de Mediana Edad , Estudios Retrospectivos , Adulto JovenRESUMEN
High utilizers of acute care in nonurban settings are at risk for poor health outcomes. Much of Massachusetts is nonurban, with many residents experiencing limited access to health care providers, fragmented health care services, inadequate housing, and low health literacy. This study examines patient perspectives on the Community Hospital Acceleration, Revitalization, and Transformation (CHART) investment program, a state-based grant program focused on advancing community hospitals toward value-based care. We found that CHART staff engaged patients in care coordination and patient advocacy, promoted patient agency and health literacy, and provided socioemotional support. These findings may help inform future program development around meeting the medical and social needs of high utilizers of health care services.
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Hospitales Comunitarios , Humanos , Massachusetts , Femenino , Masculino , Persona de Mediana Edad , Adulto , Anciano , Alfabetización en SaludRESUMEN
OBJECTIVES: We evaluated an intervention designed to identify patients at risk for hepatitis C virus (HCV) through a risk screener used by primary care providers. METHODS: A clinical reminder sticker prompted physicians at 3 urban clinics to screen patients for 12 risk factors and order HCV testing if any risks were present. Risk factor data were collected from the sticker; demographic and testing data were extracted from electronic medical records. We used the t test, χ(2) test, and rank-sum test to compare patients who had and had not been screened and developed an analytic model to identify the incremental value of each element of the screener. RESULTS: Among screened patients, 27.8% (n = 902) were identified as having at least 1 risk factor. Of screened patients with risk factors, 55.4% (n = 500) were tested for HCV. Our analysis showed that 7 elements (injection drug use, intranasal drug use, elevated alanine aminotransferase, transfusions before 1992, ≥ 20 lifetime sex partners, maternal HCV, existing liver disease) accounted for all HCV infections identified. CONCLUSIONS: A brief risk screener with a paper-based clinical reminder was effective in increasing HCV testing in a primary care setting.
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Hepatitis C/diagnóstico , Atención Primaria de Salud/métodos , Sistemas Recordatorios , Adulto , Alanina Transaminasa/sangre , Femenino , Humanos , Cobertura del Seguro/estadística & datos numéricos , Seguro de Salud/estadística & datos numéricos , Masculino , Grupos Raciales/estadística & datos numéricos , Factores de RiesgoRESUMEN
OBJECTIVE: To investigate challenges in care coordination between US Department of Veterans Affairs (VA) clinics and community providers serving rural veterans. METHODS: We completed qualitative interviews in 2017-2018 with a geographically diverse sample of 57 VA and community staff. Interviews were audio-recorded and transcribed verbatim. We used Rapid Qualitative Inquiry (RQI) to guide analyses. RESULTS: Results suggested 5 pivotal domains related to interorganizational care coordination at these sites: organizational mechanisms; organizational culture; relational coordination; contextual factors; and the role of the third party administrators charged with management of scheduling and reimbursement of community services through recent legislation. Across these domains, strategies to bridge gaps between organizations (eg, contracts with third party administrators, development of VA-based community care offices, provision of boundary-spanning staff) at times exacerbated coordination challenges. CONCLUSIONS: Steps taken to improve interorganizational care coordination between VA and community clinics may inadvertently complicate an already complex process. Our findings emphasize the importance of attending to key contextual barriers in coordinating care for rural veterans, and they illustrate the value of fundamental structural and relational approaches to enhancing such care coordination.
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Veteranos , Humanos , Cultura Organizacional , Investigación Cualitativa , Población Rural , Estados Unidos , United States Department of Veterans AffairsRESUMEN
BACKGROUND: In the incidental pulmonary nodule and breast cancer screening settings, high-quality patient-centered communication can improve adherence to evaluation and mitigate patient distress. Although guidelines emphasize shared decision-making before lung cancer screening, little is known about patient-clinician communication after lung cancer screening. RESEARCH QUESTION: How do patients and clinicians perceive communication and results notification after lung cancer screening, and are there approaches that may mitigate or exacerbate distress? STUDY DESIGN AND METHODS: We conducted interviews and focus groups with 49 patients who underwent lung cancer screening in the prior year and 36 clinicians who communicate screening results (primary care providers, pulmonologists, nurses), recruited from lung cancer screening programs at 4 hospitals. We analyzed transcripts using conventional content analysis. RESULTS: Clinicians and patients diverged in their impressions of the quality of communication after lung cancer screening. Clinicians recognized the potential for patient distress and tailored their approach to disclosure based on how clinically concerning they perceived results to be. Disclosure of normal or low-risk findings usually occurred by letter; clinicians believed this process was efficient and well received by patients. Yet many patients were dissatisfied: several could not recall receiving results at all, and others reported that receiving results by letter left them confused and concerned, with little opportunity to ask questions. By contrast, patients with larger nodules typically received results during an immediate phone call or clinic visit, and both patients and clinicians agreed that these conversations represented high-quality communication that met patient needs. Regardless of their cancer risk, patients who learned their results in a conversation appreciated the opportunity to discuss both the meaning of the nodule and the evaluation plan, and to have their concerns addressed, preempting distress. INTERPRETATION: Tension exists between clinicians' interest in efficiency of results notification by letter in low-risk cases and patients' need to understand and be reassured about screening results, their implications, and the plan for subsequent screening or nodule evaluation-even when clinicians did not perceive results as concerning. Brief conversations to discuss lung cancer screening results may improve patient understanding and satisfaction while reducing distress.
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Detección Precoz del Cáncer , Comunicación en Salud , Neoplasias Pulmonares/diagnóstico , Atención Dirigida al Paciente/métodos , Relaciones Médico-Paciente , Adulto , Anciano , Femenino , Grupos Focales , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Investigación CualitativaRESUMEN
BACKGROUND: Guidelines recommend lung cancer screening (LCS), and it is currently being adopted nationwide. The American College of Chest Physicians advises inclusion of specific programmatic components to ensure high-quality screening. However, little is known about how LCS has been implemented in practice. We sought to evaluate the experience of early-adopting programs, characterize barriers faced, and identify strategies to achieve successful implementation. METHODS: We performed qualitative evaluations of LCS implementation at three Veterans Administration facilities, conducting semistructured interviews with key staff (n = 29). Guided by the Promoting Action on Research Implementation in Health Services framework, we analyzed transcripts using principals of grounded theory. RESULTS: Programs successfully incorporated most recommended elements of LCS, although varying in approaches to patient selection, tobacco treatment, and quality audits. Barriers to implementation included managing workload to ensure appropriate evaluation of pulmonary nodules detected by screening and difficulty obtaining primary care "buy-in." To manage workload, programs used nurse coordinators to actively maintain screening registries, held multidisciplinary conferences that generated explicit management recommendations, and rolled out implementation in a staged fashion. Successful strategies to engage primary care providers included educational sessions, audit and feedback of local outcomes, and assisting with and assigning clear responsibility for nodule evaluation. Capitalizing on pre-existing relationships and including a designated program champion helped facilitate intradisciplinary communication. CONCLUSIONS: Lung cancer screening implementation is a complex undertaking requiring coordination at many levels. The insight gained from evaluation of these early-adopting programs may inform subsequent design and implementation of LCS programs.
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Detección Precoz del Cáncer , Neoplasias Pulmonares , Atención Primaria de Salud , Salud de los Veteranos/normas , Actitud del Personal de Salud , Barreras de Comunicación , Detección Precoz del Cáncer/métodos , Detección Precoz del Cáncer/normas , Humanos , Colaboración Intersectorial , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/terapia , Selección de Paciente , Atención Primaria de Salud/métodos , Atención Primaria de Salud/organización & administración , Evaluación de Programas y Proyectos de Salud , Mejoramiento de la Calidad , Estados UnidosRESUMEN
BACKGROUND: The increase in opioid overdose deaths has become a national public health crisis. Naloxone is an important tool in opioid overdose prevention. Distribution of nasal naloxone has been found to be a feasible, and effective intervention in community settings and may have potential high applicability in the emergency department, which is often the initial point of care for persons at high risk of overdose. One safety net hospital introduced an innovative policy to offer take-home nasal naloxone via a standing order to ensure distribution to patients at risk for overdose. The aims of this study were to examine acceptance and uptake of the policy and assess facilitators and barriers to implementation. METHODS: After obtaining pre-post data on naloxone distribution, we conducted a qualitative study. The PARiHS framework steered development of the qualitative guide. We used theoretical sampling in order to include the range of types of emergency department staff (50 total). The constant comparative method was initially used to code the transcripts and identify themes; the themes that emerged from the coding were then mapped back to the evidence, context and facilitation constructs of the PARiHS framework. RESULTS: Acceptance of the policy was good but uptake was low. Primary themes related to facilitators included: real-world driven intervention with philosophical, clinician and leadership support; basic education and training efforts; availability of resources; and ability to leave the ED with the naloxone kit in hand. Barriers fell into five general categories: protocol and policy; workflow and logistical; patient-related; staff roles and responsibilities; and education and training. CONCLUSIONS: The actual implementation of a new innovation in healthcare delivery is largely driven by factors beyond acceptance. Despite support and resources, implementation was challenging, with low uptake. While the potential of this innovation is unknown, understanding the experience is important to improve uptake in this setting and offer possible solutions for other facilities to address the opioid overdose crisis. Use of the PARiHS framework allowed us to recognize and understand key evidence, contextual and facilitation barriers to the successful implementation of the policy and to identify areas for improvement.
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Sobredosis de Droga/prevención & control , Naloxona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Aceptación de la Atención de Salud , Personal de Hospital/psicología , Administración Intranasal , Adulto , Anciano , Servicio de Urgencia en Hospital , Femenino , Humanos , Masculino , Persona de Mediana Edad , Naloxona/administración & dosificación , Naloxona/provisión & distribución , Antagonistas de Narcóticos/administración & dosificación , Antagonistas de Narcóticos/provisión & distribuciónRESUMEN
The national rise in opioid overdose deaths signifies a need to integrate overdose prevention within healthcare delivery settings. The emergency department (ED) is an opportune location for such interventions. To effectively integrate prevention services, the target population must be clearly defined. We used ICD-9 discharge codes to establish and apply overdose risk categories to ED patients seen from January 1, 2013 to December 31, 2014 at an urban safety-net hospital in Massachusetts with the goal of informing ED-based naloxone rescue kit distribution programs. Of 96,419 patients, 4,468 (4.6%) were at increased risk of opioid overdose, defined by prior opioid overdose, misuse, or polysubstance misuse. A small proportion of those at risk were prescribed opioids on a separate occasion. Use of risk categories defined by ICD-9 codes identified a notable proportion of ED patients at risk for overdose, and provides a systematic means to prioritize and direct clinical overdose prevention efforts.
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Sobredosis de Droga/prevención & control , Servicio de Urgencia en Hospital/organización & administración , Naloxona/provisión & distribución , Antagonistas de Narcóticos/provisión & distribución , Trastornos Relacionados con Opioides/diagnóstico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Sobredosis de Droga/epidemiología , Femenino , Humanos , Clasificación Internacional de Enfermedades , Masculino , Massachusetts , Persona de Mediana Edad , Naloxona/administración & dosificación , Antagonistas de Narcóticos/administración & dosificación , Medición de Riesgo , Proveedores de Redes de Seguridad/organización & administración , Factores Socioeconómicos , Adulto JovenRESUMEN
BACKGROUND: Testing for patients at risk for hepatitis C virus (HCV) infection is recommended, but it is unclear whether providers adhere to testing guidelines. We aimed to measure adherence to an HCV screening protocol during a multifaceted continuous intervention. SUBJECTS AND METHODS: Prospective cohort design to examine the associations between patient-level, physician-level, and visit-level characteristics and adherence to an HCV screening protocol. Study participants included all patients with a visit to 1 of the 3 study clinics and the physicians who cared for them. Adherence to the HCV screening protocol and patient-level, physician-level, and visit-level predictors of adherence were measured. RESULTS: A total of 8981 patients and 154 physicians were examined. Overall protocol adherence rate was 36.1%. In multivariate analysis, patient male sex (odds ratio [OR] = 1.18), new patient (OR = 1.23), morning visit (OR = 1.32), and patients' preferred language being non-English (OR = 0.87) were significantly associated with screening adherence. There was a wide variation in overall adherence among physicians (range, 0%-92.4%). Screening adherence continuously declined from 59.1% in week 1 of the study to 13.7% in week 15 (final week). When implementing complex clinical practice guidelines, planners should address physician attitudinal barriers as well as gaps in knowledge to maximize adherence.
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Adhesión a Directriz/estadística & datos numéricos , Hepatitis C/epidemiología , Tamizaje Masivo/organización & administración , Pautas de la Práctica en Medicina/normas , Adulto , Anciano , Instituciones de Atención Ambulatoria , Análisis de Varianza , Estudios de Cohortes , Femenino , Humanos , Incidencia , Modelos Logísticos , Masculino , Persona de Mediana Edad , Cooperación del Paciente/estadística & datos numéricos , Valor Predictivo de las Pruebas , Atención Primaria de Salud/normas , Atención Primaria de Salud/tendencias , Evaluación de Programas y Proyectos de Salud , Estudios Prospectivos , Medición de Riesgo , Adulto JovenRESUMEN
BACKGROUND: An estimated 3.2 million persons are chronically infected with the hepatitis C virus (HCV) in the U.S. Effective treatment is available, but approximately 50% of patients are not aware that they are infected. Optimal testing strategies have not been described. METHODS: The Hepatitis C Assessment and Testing Project (HepCAT) was a serial cross-sectional evaluation of two community-based interventions designed to increase HCV testing in urban primary care clinics in comparison with a baseline period. The first intervention (risk-based screener) prompted physicians to order HCV tests based on the presence of HCV-related risks. The second intervention (birth cohort) prompted physicians to order HCV tests on all patients born within a high-prevalence birth cohort (1945-1964). The study was conducted at three primary care clinics in the Bronx, New York. RESULTS: Both interventions were associated with an increased proportion of patients tested for HCV from 6.0% at baseline to 13.1% during the risk-based screener period (P<0.001) and 9.9% during the birth cohort period (P<0.001). CONCLUSIONS: Two simple clinical reminder interventions were associated with significantly increased HCV testing rates. Our findings suggest that HCV screening programs, using either a risk-based or birth cohort strategy, should be adopted in primary care settings so that HCV-infected patients may benefit from antiviral treatment.