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PURPOSE: Little is known about whether gene expression profile (GEP) testing and specific recurrence scores (e.g., medium risk) improve women's confidence in their chemotherapy decision or perceived recurrence risk. We evaluate the relationship between these outcomes and GEP testing. METHODS: We surveyed women eligible for GEP testing (stage I or II, Gr1-2, ER+, HER2-) identified through the Surveillance, Epidemiology, and End Results (SEER) Registry of Washington or Kaiser Permanente Northern California from 2012 to 2016, approximately 0-4 years from diagnosis (N = 904, RR = 45.4%). Confidence in chemotherapy was measured as confident (Very, completely) versus Not Confident (Somewhat, A little, Not At All); perceived risk recurrence was recorded numerically (0-100%). Women reported their GEP test receipt (Yes, No, Unknown) and risk recurrence score (High, Intermediate, Low, Unknown). In our analytic sample (N = 833), we propensity score weighted the three test receipt cohorts and used propensity weighted multivariable regressions to examine associations between the outcomes and the three test receipt cohorts, with receipt stratified by score. RESULTS: 29.5% reported an unknown GEP test receipt; 86% being confident. Compared to no test receipt, an intermediate score (aOR 0.34; 95% CI 0.20-0.58), unknown score (aOR 0.09; 95% CI 0.05-0.18), and unknown test receipt (aOR 0.37; 95% CI 0.24-0.57) were less likely to report confidence. Most women greatly overestimated their recurrence risk regardless of their test receipt or score. CONCLUSIONS: GEP testing was not associated with greater confidence in chemotherapy decisions. Better communication about GEP testing and the implications for recurrence risk may improve women's decisional confidence.
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Neoplasias da Mama/patologia , Tomada de Decisão Clínica , Perfilação da Expressão Gênica , Recidiva Local de Neoplasia/diagnóstico , Participação do Paciente/psicologia , Adulto , Idoso , Mama/patologia , Mama/cirurgia , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/terapia , Sobreviventes de Câncer/estatística & dados numéricos , Quimioterapia Adjuvante/psicologia , Quimioterapia Adjuvante/estatística & dados numéricos , Feminino , Humanos , Mastectomia , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/prevenção & controle , Participação do Paciente/estatística & dados numéricos , Prognóstico , Pontuação de Propensão , Programa de SEER/estatística & dados numéricos , Autorrelato/estatística & dados numéricosRESUMO
Health systems today have increasing opportunities and imperatives to conduct delivery science, which is applied research that evaluates clinical or organizational practices that systems can implement or encourage. Examples include research on eliminating racial/ethnic disparities in hypertension management and on identifying the types of patients who can successfully use video visits. Clinical leaders and researchers often face barriers to delivery science, including limited funding, insufficient leadership support, lack of engagement between operational and research leaders, limited pools of research expertise, and lack of pathways to identify and develop ideas. We describe five key strategies we employed to address these barriers and develop a portfolio of delivery science programs in Kaiser Permanente Northern California. This portfolio now includes small and medium-sized grant programs, training programs for postdoctoral research fellows and experienced physician researchers, and a dedicated team that partners with clinicians to develop high-priority ideas and conduct small projects. Most of our approaches are consistent with frameworks used to develop delivery science by other health systems; some are innovative. Most of these strategies are adaptable by other health systems prepared to make long-range organizational commitments to mechanisms that foster partnerships between clinical leaders and researchers.
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Prestação Integrada de Cuidados de Saúde/métodos , Prestação Integrada de Cuidados de Saúde/tendências , Pessoal de Saúde/tendências , Liderança , HumanosRESUMO
OBJECTIVE: Black and Latino children experience significantly worse asthma morbidity than their white peers for multifactorial reasons. This study investigated differences in family-provider interactions for pediatric asthma, based on race/ethnicity. METHODS: This was a cross-sectional study of parent surveys of asthmatic children within the Population-Based Effectiveness in Asthma and Lung Diseases Network. Our study population comprised 647 parents with survey response data. Data on self-reported race/ethnicity of the child were collected from parents of the children with asthma. Outcomes studied were responses to the questions about family-provider interactions in the previous 12 months: (1) number of visits with asthma provider; (2) number of times provider reviewed asthma medications with patient/family; (3) review of a written asthma treatment plan with provider; and (4) preferences about making asthma decisions. RESULTS: In multivariate adjusted analyses controlling for asthma control and other co-morbidities, black children had fewer visits in the previous 12 months for asthma than white children: OR 0.63 (95% CI 0.40, 0.99). Additionally, black children were less likely to have a written asthma treatment plan given/reviewed by a provider than their white peers, OR 0.44 (95% CI 0.26, 0.75). There were no significant differences by race in preferences about asthma decision-making nor in the frequency of asthma medication review. CONCLUSION: Black children with asthma have fewer visits with their providers and are less likely to have a written asthma treatment plan than white children. Asthma providers could focus on improving these specific family-provider interactions in minority children.
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Asma/etnologia , Hispânico ou Latino/estatística & dados numéricos , Visita a Consultório Médico/estatística & dados numéricos , Médicos de Família/estatística & dados numéricos , Grupos Raciais/estatística & dados numéricos , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Reconciliação de Medicamentos , Pais , Satisfação do Paciente , Inquéritos e QuestionáriosRESUMO
BACKGROUND: International postlicensure studies have identified an increased risk of intussusception after vaccination with the second-generation rotavirus vaccines RotaTeq (RV5, a pentavalent vaccine) and Rotarix (RV1, a monovalent vaccine). We studied this association among infants in the United States. METHODS: The study included data from infants 5.0 to 36.9 weeks of age who were enrolled in three U.S. health plans that participate in the Mini-Sentinel program sponsored by the Food and Drug Administration. Potential cases of intussusception and vaccine exposures from 2004 through mid-2011 were identified through procedural and diagnostic codes. Medical records were reviewed to confirm the occurrence of intussusception and the status with respect to rotavirus vaccination. The primary analysis used a self-controlled risk-interval design that included only vaccinated children. The secondary analysis used a cohort design that included exposed and unexposed person-time. RESULTS: The analyses included 507,874 first doses and 1,277,556 total doses of RV5 and 53,638 first doses and 103,098 total doses of RV1. The statistical power for the analysis of RV1 was lower than that for the analysis of RV5. The number of excess cases of intussusception per 100,000 recipients of the first dose of RV5 was significantly elevated, both in the primary analysis (attributable risk, 1.1 [95% confidence interval, 0.3 to 2.7] for the 7-day risk window and 1.5 [95% CI, 0.2 to 3.2] for the 21-day risk window) and in the secondary analysis (attributable risk, 1.2 [95% CI, 0.2 to 3.2] for the 21-day risk window). No significant increase in risk was seen after dose 2 or 3. The results with respect to the primary analysis of RV1 were not significant, but the secondary analysis showed a significant risk after dose 2. CONCLUSIONS: RV5 was associated with approximately 1.5 (95% CI, 0.2 to 3.2) excess cases of intussusception per 100,000 recipients of the first dose. The secondary analysis of RV1 suggested a potential risk, although the study of RV1 was underpowered. These risks must be considered in light of the demonstrated benefits of rotavirus vaccination. (Funded by the Food and Drug Administration.).
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Intussuscepção/etiologia , Vacinas contra Rotavirus/efeitos adversos , Estudos de Coortes , Humanos , Imunização Secundária , Lactente , Intussuscepção/epidemiologia , Risco , Vacinas contra Rotavirus/administração & dosagem , Estados Unidos/epidemiologia , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/efeitos adversosRESUMO
PURPOSE: Multigene testing for breast cancer recurrence risk became available in 2007, yet many eligible patients remain untested. This study evaluated variation in testing rates, and oncologist and organizational factors associated with variation, in a setting without financial influences on testing. METHODS: We conducted a retrospective cohort study using electronic data and oncologist surveys within Kaiser Permanente Northern California, a large integrated health care system. Analyses included all 2974 test eligible patients from 2013 to 2015, 113 oncologists, and 15 practice groups. Receipt of multigene testing was evaluated with generalized linear mixed models. RESULTS: Overall, 39% of eligible patients had multigene testing, but rates varied widely among practice groups, ranging from 24 to 48% after case mix adjustment. This 24% difference among practices was greater than the variation associated with most patient characteristics, including comorbidities and race/ethnicity, and similar to that associated with tumor size. Practice group and oncologist factors were statistically significant contributors to the variation in testing after adjusting for patient factors. Patients were more likely to be tested if they had a female oncologist (aOR 1.60, 95% CI 1.21-2.12) or were in a practice whose chief had a high testing rate (aOR 1.20, 95% CI 1.12-1.29 per 10% increase in the percent tested). CONCLUSIONS: Oncologist and leadership practices play a key role in the variation in genomic test use for cancer recurrence risk even in a healthcare system without financial barriers to testing and could be a leverage point for implementing desired practice changes for new genomic advances.
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Neoplasias da Mama/genética , Testes Genéticos/métodos , Recidiva Local de Neoplasia/genética , Idoso , California , Prestação Integrada de Cuidados de Saúde , Feminino , Humanos , Pessoa de Meia-Idade , Oncologistas , Padrões de Prática Médica , Estudos RetrospectivosRESUMO
The recent acceleration of scientific discovery has led to greater choices in health care. New technologies, diagnostic tests, and pharmaceuticals have widely varying impact on patients and populations in terms of benefits, toxicities, and costs, stimulating a resurgence of interest in the creation of frameworks intended to measure value in health. Many of these are offered by providers and/or advocacy organizations with expertise and interest in specific diseases (e.g., cancer and heart disease). To help assess the utility of and the potential biases embedded in these frameworks, we created an evaluation taxonomy with seven basic components: 1) define the purpose; 2) detail the conceptual approach, including perspectives, methods for obtaining preferences of decision makers (e.g., patients), and ability to incorporate multiple dimensions of value; 3) discuss inclusions and exclusions of elements included in the framework, and whether the framework assumes clinical intervention or offers alternatives such as palliative care or watchful waiting; 4) evaluate data sources and their scientific validity; 5) assess the intervention's effect on total costs of treating a defined population; 6) analyze how uncertainty is incorporated; and 7) illuminate possible conflicts of interest among those creating the framework. We apply the taxonomy to four representative value frameworks recently published by professional organizations focused on treatment of cancer and heart disease and on vaccine use. We conclude that each of these efforts has strengths and weaknesses when evaluated using our taxonomy, and suggest pathways to enhance the utility of value-assessing frameworks for policy and clinical decision making.
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Técnicas de Apoio para a Decisão , Atenção à Saúde/normas , Indicadores de Qualidade em Assistência à Saúde , Aquisição Baseada em Valor , Cardiologia , Conflito de Interesses , Análise Custo-Benefício , Atenção à Saúde/economia , Oncologia , VacinasRESUMO
The Postlicensure Rapid Immunization Safety Monitoring Program, the vaccination safety monitoring component of the US Food and Drug Administration's Mini-Sentinel project, is currently the largest cohort in the US general population for vaccine safety surveillance. We developed a study design selection framework to provide a roadmap and description of methods that may be utilized to evaluate potential associations between vaccines and health outcomes of interest in the Postlicensure Rapid Immunization Safety Monitoring Program and other systems using administrative data. The strengths and weaknesses of designs for vaccine safety monitoring, including the cohort design, the case-centered design, the risk interval design, the case-control design, the self-controlled risk interval design, the self-controlled case series method, and the case-crossover design, are described and summarized in tabular form. A structured decision table is provided to aid in planning of future vaccine safety monitoring activities, and the data components comprising the structured decision table are delineated. The study design selection framework provides a starting point for planning vaccine safety evaluations using claims-based data sources.
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Imunização/efeitos adversos , Segurança do Paciente , Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , Estudos de Casos e Controles , Estudos de Coortes , Humanos , Projetos de PesquisaRESUMO
Introduction: Learning health systems require a workforce of researchers trained in the methods of identifying and overcoming barriers to effective, evidence-based care. Most existing postdoctoral training programs, such as NIH-funded postdoctoral T32 awards, support basic and epidemiological science with very limited focus on rigorous delivery science methods for improving care. In this report, we present the 10-year experience of developing and implementing a Delivery Science postdoctoral fellowship embedded within an integrated health care delivery system. Methods: In 2012, the Kaiser Permanente Northern California Division of Research designed and implemented a 2-year postdoctoral Delivery Science Fellowship research training program to foster research expertise in identifying and addressing barriers to evidence-based care within health care delivery systems. Results: Since 2014, 20 fellows have completed the program. Ten fellows had PhD-level scientific training, and 10 fellows had clinical doctorates (eg, MD, RN/PhD, PharmD). Fellowship alumni have graduated to faculty research positions at academic institutions (9), and research or clinical organizations (4). Seven alumni now hold positions in Kaiser Permanente's clinical operations or medical group (7). Conclusions: This delivery science fellowship program has succeeded in training graduates to address delivery science problems from both research and operational perspectives. In the next 10 years, additional goals of the program will be to expand its reach (eg, by developing joint research training models in collaboration with clinical fellowships) and strengthen mechanisms to support transition from fellowship to the workforce, especially for researchers from underrepresented groups.
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PURPOSE: An association between the influenza antiviral medication oseltamivir and neuropsychiatric events has been suggested by post-marketing case reports in Japan. This possible association was not supported by cohort studies in the U.S. conducted prior to the 2009 influenza A (H1N1) pandemic, when usage rates were comparatively low. We assessed oseltamivir safety before and during the pandemic using biologically plausible risk intervals, particularly focusing on psychiatric events. METHODS: Outpatients with influenza episodes from January 2007 through June 2010 were identified using diagnosis codes and positive tests at eight health care systems (sites) in the Vaccine Safety Datalink Project. Oseltamivir-treated and untreated patients were matched according to calendar week, age, sex, site, and propensity for treatment. Within this matched cohort, conditional logistic regression models were used to estimate the risk of four neuropsychiatric and five other adverse events (AEs) during pre-specified risk intervals. RESULTS: Among 27,684 matched pairs, no associations were identified between oseltamivir treatment and any pre-defined AE. The absolute risks of incident psychiatric events in the 1-7 day risk interval were 0.126% for oseltamivir-treated and 0.105% for untreated patients (odds ratio = 1.21, 95% confidence interval [CI]: 0.74, 1.97; risk difference = 0.022%, 95% CI: -0.035%, 0.078%); the most common diagnosis was unspecified anxiety state. Results were similar for 1-14 and 1-2 day risk intervals and for pediatric/adolescent subgroups. CONCLUSIONS: Consistent with prior U.S. cohort studies, no evidence was identified for an increased risk of neuropsychiatric or other AEs following oseltamivir treatment. Safety should be prospectively monitored to inform antiviral medication usage recommendations.
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Antivirais/efeitos adversos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Oseltamivir/efeitos adversos , Humanos , Transtornos Mentais/induzido quimicamente , RiscoRESUMO
The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system is a cohort-based active surveillance network initiated by the US Department of Health and Human Services to supplement preexisting and other vaccine safety monitoring systems in tracking the safety of monovalent pandemic 2009 H1N1 influenza vaccine in the United States during 2009-2010. PRISM investigators conducted retrospective analysis to determine whether 2009 H1N1 vaccination was associated with increased risk of any of 14 prespecified outcomes. Five health insurance and associated companies with 38 million members and 9 state/city immunization registries contributed records on more than 2.6 million doses of 2009 H1N1 vaccine. Data on outcomes came from insurance claims. Complementary designs (self-controlled risk interval, case-centered, and current-vs.-historical comparison) were used to optimize control for confounding and statistical power. The self-controlled risk interval analysis of chart-confirmed Guillain-Barré syndrome found an elevated but not statistically significant incidence rate ratio following receipt of inactivated 2009 H1N1 vaccine (incidence rate ratio = 2.50, 95% confidence interval: 0.42, 15.0) and no cases following live attenuated 2009 H1N1 vaccine. The study did not control for infection prior to Guillain-Barré syndrome, which may have been a confounder. The risks of other health outcomes of interest were generally not significantly elevated after 2009 H1N1 vaccination.
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Síndrome de Guillain-Barré/etiologia , Vírus da Influenza A Subtipo H1N1/imunologia , Vacinas contra Influenza/efeitos adversos , Vigilância da População , Vigilância de Produtos Comercializados , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Análise por Conglomerados , Estudos de Coortes , Feminino , Síndrome de Guillain-Barré/epidemiologia , Humanos , Incidência , Lactente , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Estados Unidos/epidemiologia , United States Dept. of Health and Human Services , Vacinas Atenuadas/efeitos adversos , Vacinas de Produtos Inativados/efeitos adversos , Adulto JovemRESUMO
An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted.
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Síndrome de Guillain-Barré/etiologia , Vírus da Influenza A Subtipo H1N1/imunologia , Vacinas contra Influenza/efeitos adversos , Vigilância de Produtos Comercializados , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Feminino , Síndrome de Guillain-Barré/epidemiologia , Humanos , Lactente , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Medição de Risco , Estações do Ano , Fatores de Tempo , Estados Unidos/epidemiologia , Vacinas de Produtos Inativados/efeitos adversos , Adulto JovemRESUMO
OBJECTIVE: To evaluate how adolescents with or at risk for type 2 diabetes mellitus (T2DM) and their parent/guardians (parents) perceive adolescents' health-related quality of life. STUDY DESIGN: We interviewed overweight/obese, 12- to 18-year-old youth with T2DM, prediabetes, or insulin resistance and one parent from 5 US sites. Assessments included Pediatric Quality of Life Inventory (PedsQL), Health Utilities Index, family conflict, and diabetes burden. RESULTS: In 108 adolescents, diagnoses included 40.7% with T2DM, 25.0% with prediabetes, and 34.3% with insulin resistance. PedsQL summary score (SS) was higher in adolescents than parents (P=.02). Parents rated physical functioning lower than adolescents (P<.0001), but there were no differences in psychosocial health. Adolescent PedsQL SS did not differ with diagnosis, but was inversely associated with adolescent body mass index z-score (P=.0004) and family conflict (P<.0001) and associated with race/ethnicity (P<.0001). Number of adolescent co-morbidities (P=.007) and burden of diabetes care (P<.05) were inversely associated with parent PedsQL SS. There were no differences in the Health Utilities Index-Mark 3 multi-attribute utility score. CONCLUSIONS: Parents perceive their adolescents' physical functioning as more impaired than adolescents themselves. Contextual factors including severity of obesity, race/ethnicity, family conflict, and burden of diabetes care influence health-related quality of life. Family-based approaches to treatment and prevention of T2DM may benefit from increased attention to the biopsychosocial context.
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Diabetes Mellitus Tipo 2/psicologia , Nível de Saúde , Qualidade de Vida , Medição de Risco/métodos , Adolescente , Adulto , Atitude Frente a Saúde , Criança , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Humanos , Incidência , Masculino , Prognóstico , Psicometria/métodos , Fatores de Risco , Inquéritos e Questionários , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Advances in health information technology and widespread use of electronic health data offer new opportunities for development of large scale multisite disease-specific patient registries. Such registries use existing data, can be constructed at relatively low cost, include large numbers of patients, and once created can be used to address many issues with a short time between posing a question and obtaining an answer. Potential applications include comparative effectiveness research, public health surveillance, mapping and improving quality of clinical care, and others. OBJECTIVE AND DISCUSSION: This paper describes selected conceptual and practical challenges related to development of multisite diabetes and asthma registries, including development of case definitions, validation of case identification methods, variation in electronic health data sources; representativeness of registry populations, including the impact of attrition. Specific challenges are illustrated with data from actual registries.
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Pesquisa Comparativa da Efetividade , Registro Médico Coordenado , Sistemas Computadorizados de Registros Médicos/organização & administração , Sistema de Registros , Asma/epidemiologia , Diabetes Mellitus/epidemiologia , Humanos , Estados Unidos , Estudos de Validação como AssuntoRESUMO
BACKGROUND: High-deductible health plans (HDHPs) are an increasingly common strategy to contain health care costs. Individuals with chronic conditions are at particular risk for increased out-of-pocket costs in HDHPs and resulting cost-related underuse of essential health care. OBJECTIVE: To evaluate whether families with chronic conditions in HDHPs have higher rates of delayed or forgone care due to cost, compared with those in traditional health insurance plans. DESIGN: This mail and phone survey used multiple logistic regression to compare family-level rates of reporting delayed/forgone care in HDHPs vs. traditional plans. PARTICIPANTS: We selected families with children that had at least one member with a chronic condition. Families had employer-sponsored insurance in a Massachusetts health plan and >12 months of enrollment in an HDHP or a traditional plan. MAIN MEASURES: The primary outcome was report of any delayed or forgone care due to cost (acute care, emergency department visits, chronic care, checkups, or tests) for adults or children during the prior 12 months. RESULTS: Respondents included 208 families in HDHPs and 370 in traditional plans. Membership in an HDHP and lower income were each independently associated with higher probability of delayed/forgone care due to cost. For adult family members, the predicted probability of delayed/forgone care due to cost was higher in HDHPs than in traditional plans [40.0% vs 15.1% among families with incomes <400% of the federal poverty level (FPL) and 16.0% vs 4.8% among those with incomes ≥400% FPL]. Similar associations were observed for children. CONCLUSIONS: Among families with chronic conditions, reporting of delayed/forgone care due to cost is higher for both adults and children in HDHPs than in traditional plans. Families with lower incomes are also at higher risk for delayed/forgone care.
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Doença Crônica/economia , Dedutíveis e Cosseguros/economia , Saúde da Família/economia , Planos de Assistência de Saúde para Empregados/economia , Adulto , Criança , Doença Crônica/terapia , Estudos Transversais , Dedutíveis e Cosseguros/tendências , Saúde da Família/tendências , Feminino , Planos de Assistência de Saúde para Empregados/tendências , Humanos , Masculino , Fatores de TempoRESUMO
In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. PRISM has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, PRISM monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, PRISM links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support PRISM are updated quarterly, and PRISM can conduct medical record review for validation of computerized data. The FDA has structured PRISM as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from PRISM's large cohort size. The PRISM program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among PRISM and other surveillance systems, offering potential synergies. FDA and PRISM will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.
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Bases de Dados Factuais/estatística & dados numéricos , Vacinas contra Influenza/efeitos adversos , Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , Humanos , Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Registro Médico Coordenado , Modelos Estatísticos , Projetos Piloto , Desenvolvimento de Programas , Sistema de Registros/estatística & dados numéricos , Estados Unidos , United States Food and Drug Administration , Vacinas/administração & dosagem , Estudos de Validação como AssuntoRESUMO
The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed.
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Pesquisa Comparativa da Efetividade/organização & administração , Pneumopatias/terapia , Transtornos do Sono-Vigília/terapia , Participação da Comunidade , Pesquisa Comparativa da Efetividade/métodos , Implementação de Plano de Saúde , Humanos , National Heart, Lung, and Blood Institute (U.S.) , Observação , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Apoio à Pesquisa como Assunto , Estados UnidosRESUMO
Introduction COVID-19 vaccination rates remain suboptimal in the United States. Clinicians and policymakers need to better understand how likely vaccine-hesitant individuals are to ultimately accept vaccination and what is associated with such changes. This study's aims were to 1) describe changes between vaccine intentions and actual uptake from June 2021 through February 2022, and 2) identify modifiable factors associated with vaccine uptake among those with initial hesitancy. Methods This cohort study included a stratified random sample of adults aged 65 years and older in an integrated health care system. The survey, conducted June through August 2021, elicited intent and perceptions regarding COVID-19 vaccination. Subsequent vaccine uptake through February 2022 was analyzed using electronic health records. Results Of 1195 individuals surveyed, 66% responded; 213 reported not yet having received a COVID-19 vaccine and were further analyzed. At baseline, most individuals said they would definitely not (42%) or probably not (5%) get the COVID-19 vaccine or were not sure (26%). During follow-up, 61 individuals (29%) were vaccinated, including 19% of those who initially said they would definitely not be vaccinated. Among vaccine-hesitant individuals, the rate of vaccination was highest for those who initially considered COVID-19 less dangerous than the vaccine (46%) or named short-term side effects (36%) as their most important concern. Conclusions COVID-19 vaccine intent among older adults was malleable during the pandemic's second year, even among those who initially said they would definitely not be vaccinated. Vaccine uptake could be enhanced by increasing awareness of COVID-19 risks and by addressing vaccine side effects.