RESUMO
BACKGROUND: Sustained-release (SR) tapentadol was listed on Australia's Pharmaceutical Benefits Scheme (PBS) in 2014 for chronic severe pain requiring long-term opioid treatment. Dispensings have increased since listing despite declining trends in other PBS-listed opioids. Preferential prescribing of SR opioids may increase the risk of dependence and accidental overdose, particularly when used to treat acute pain. AIMS: To explore the quality use of publicly subsidised tapentadol in Australia. METHODS: We examined annual initiation rates and patterns of use of tapentadol (SR) in the dispensing records of a 10% random sample of PBS-eligible Australians (2014-2021). We used national tapentadol sales data to assess the proportion of sales attributable to the PBS. RESULTS: Tapentadol initiation increased from 2014, peaking at 7.5/1000 adult population in 2019 before declining to 5.3/1000 in 2021. We identified 63 766 new users between 2014 and 2020, of whom 92.8% discontinued in the first year following initiation, 58.0% had only a single dispensing and 34.3% had no other opioids dispensed in the 3 months before or after initiation. 27.8% of new users were dispensed tapentadol on the same day as potentially interacting medicines. There was a sustained drop in the proportion of sales attributable to the PBS from June 2020 onwards, from an average of 69.1%, to 63.9% of pack sales. CONCLUSIONS: Patterns of use suggest tapentadol (SR) is generally used for short duration. Although most tapentadol sold in Australia is subsidised, there is evidence of a shift towards private sales.
Assuntos
Analgésicos Opioides , Tapentadol , Tapentadol/uso terapêutico , Humanos , Austrália/epidemiologia , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/economia , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Adulto , Dor Crônica/tratamento farmacológico , Preparações de Ação Retardada , Padrões de Prática Médica/estatística & dados numéricos , Adulto JovemRESUMO
BACKGROUND: Although immunotherapy has emerged as a therapeutic strategy for many cancers, there are limited studies establishing the safety and efficacy in people living with HIV (PLWH) and cancer. METHODS: PLWH and solid tumors or Kaposi sarcoma (KS) receiving antiretroviral therapy and a suppressed HIV viral load received nivolumab at 3 mg/kg every 2 weeks, in two dose deescalation cohorts stratified by CD4 count (stratum 1: CD4 count > 200/µL and stratum 2: CD4 count 100-199/µL). An expansion cohort of 24 participants with a CD4 count > 200/µL was then enrolled. RESULTS: A total of 36 PLWH received nivolumab, including 15 with KS and 21 with a variety of other solid tumors. None of the first 12 participants had dose-limiting toxicity in both CD4 strata, and five patients (14%) overall had grade 3 or higher immune related adverse events. Objective partial response occurred in nine PLWH and cancer (25%), including in six of 15 with KS (40%; 95% CI, 16.3-64.7). The median duration of response was 9.0 months overall and 12.5 months in KS. Responses were observed regardless of PDL1 expression. There were no significant changes in CD4 count or HIV viral load. CONCLUSIONS: Nivolumab has a safety profile in PLWH similar to HIV-negative subjects with cancer, and also efficacy in KS. Plasma HIV remained suppressed and CD4 counts remained stable during treatment and antiretroviral therapy, indicating no adverse impact on immune function. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02408861.
Assuntos
Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Sarcoma de Kaposi , Humanos , Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Nivolumabe/efeitos adversos , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Sarcoma de Kaposi/tratamento farmacológico , Contagem de Linfócito CD4 , Carga ViralRESUMO
BACKGROUND: Conflicting evidence suggests a possible association between use of prescribed psychostimulants during pregnancy and adverse perinatal outcomes. METHODS: We conducted population-based cohort studies including pregnancies conceived between April 2002 and March 2017 (Ontario, Canada; N = 554â272) and January 2003 to April 2011 [New South Wales (NSW), Australia; N = 139â229]. We evaluated the association between exposure to prescription amphetamine, methylphenidate, dextroamphetamine or lisdexamfetamine during pregnancy and pre-eclampsia, placental abruption, preterm birth, low birthweight, small for gestational age and neonatal intensive care unit admission. We used inverse probability of treatment weighting based on propensity scores to balance measured confounders between exposed and unexposed pregnancies. Additionally, we restricted the Ontario cohort to social security beneficiaries where supplementary confounder information was available. RESULTS: In Ontario and NSW respectively, 1360 (0.25%) and 146 (0.10%) pregnancies were exposed to psychostimulants. Crude analyses indicated associations between exposure and nearly all outcomes [OR range 1.15-2.16 (Ontario); 0.97-2.20 (NSW)]. Nearly all associations were attenuated after weighting. Pre-eclampsia was the exception: odds remained elevated in the weighted analysis of the Ontario cohort (OR 2.02, 95% CI 1.42-2.88), although some attenuation occurred in NSW (weighted OR 1.50, 95% CI 0.77-2.94) and upon restriction to social security beneficiaries (weighted OR 1.24, 95% CI 0.64-2.40), and confidence intervals were wide. CONCLUSIONS: We observed higher rates of outcomes among exposed pregnancies, but the attenuation of associations after adjustment and likelihood of residual confounding suggests psychostimulant exposure is not a major causal factor for most measured outcomes. Our findings for pre-eclampsia were inconclusive; exposed pregnancies may benefit from closer monitoring.
Assuntos
Pré-Eclâmpsia , Complicações na Gravidez , Nascimento Prematuro , Gravidez , Feminino , Recém-Nascido , Humanos , Pré-Eclâmpsia/epidemiologia , Nascimento Prematuro/epidemiologia , Placenta , Complicações na Gravidez/tratamento farmacológico , Complicações na Gravidez/epidemiologia , Ontário/epidemiologia , Resultado da Gravidez/epidemiologiaRESUMO
PURPOSE: Guidelines recommend primary prophylactic (PP) granulocyte colony stimulating factor (G-CSF) for prevention of febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy with high risk (HR: > 20%), or intermediate risk (IR:10-20%) of FN and ≥ 1 patient risk factor (e.g., age ≥ 65y). The current retrospective cohort study describes patterns of PP-G-CSF in older Medicare patients undergoing myelosuppressive chemotherapy with HR/IR of FN. METHODS: Patients aged ≥ 66y initiating chemotherapy regimens with HR/IR of FN to treat breast, colorectal, lung, or ovarian cancer, or Non-Hodgkin's Lymphoma were selected using Medicare 20% sample (2013-2015) and 100% cancer patient (2014-2017) data. PP-G-CSF use was identified in the first cycle. Timing of pegfilgrastim pre-filled syringe (PFS) administration, proportion of patients completing all cycles (adherence) with pegfilgrastim PFS or on-body injector (OBI), and duration of short-acting G-CSF (sG-CSF) was described across all cycles. RESULTS: Of 64,893 patients receiving HR/IR for FN, 71% received HR and 29% IR regimens. Overall, PP-G-CSF use in the first cycle was 53% (HR: 74%; IR: 44%) and varied across cancers. Adherence with pegfilgrastim was slightly higher among OBI initiators (78%) than PFS (74%). Number of PP-sG-CSF administrations (mean [SD]) per cycle was 5.1 (SD: 2.7) overall, 5.4 (2.6) for HR, and 4.9 (2.7) for IR. CONCLUSION: Despite cancer treatment guidelines recommending PP-G-CSF use to reduce risk of FN associated with HR and IR (with ≥ 1 patient risk-factor) regimens, PP-G-CSF remains underutilized in older patients, across cancer types and regimens. Opportunities exist for improvement in use of PP-G-CSF.
Assuntos
Linfoma não Hodgkin , Neoplasias , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Filgrastim/uso terapêutico , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Linfoma não Hodgkin/tratamento farmacológico , Medicare , Neoplasias/tratamento farmacológico , Neoplasias/etiologia , Polietilenoglicóis/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Estudos Retrospectivos , Estados UnidosRESUMO
PURPOSE: The purpose of this in vitro prospective nonrandomized study is to compare the toxicity and strength of cyanoacrylate and hydrogel adhesives on human retinal pigment epithelium (RPE) cells and porcine retina, respectively. METHODS: The toxicity of cyanoacrylate (histoacryl, dermabond, superglue), ReSure PEG, and Tisseel fibrin glue on human RPE cells was determined by growing RPE cells in vitro, applying the different adhesives to the cells, and monitoring for disruption of growth over 3 days. The relative strength of these adhesives was tested by gluing a 3 mm piece of foam to a porcine retina and determining the amount of force needed to break the attachment. RESULTS: 0.085 N of force was required to break the porcine retinal tissue (p = .913). Histoacryl adhesive exhibited high strength (0.247 N) and high RPE toxicity (0.55 mm inhibition zone after 24 hrs). The strength of Tisseel fibrin glue was 0.078 N while that of ReSure was only 0.053 N. Both Tisseel and ReSure were nontoxic to the RPE cells. CONCLUSIONS: Tisseel VH fibrin sealant may provide the best option for sealing retinal breaks because of its high strength and low retinal toxicity.
Assuntos
Embucrilato , Adesivos Teciduais , Animais , Cianoacrilatos , Adesivo Tecidual de Fibrina/toxicidade , Estudos Prospectivos , Suínos , Adesivos Teciduais/toxicidadeRESUMO
Intravenous (IV) iron is the therapy of choice when oral iron is ineffective or poorly tolerated, yet use has been limited by fears of hypersensitivity reactions (HSRs). Newer formulations that bind iron more tightly and release it more slowly have made the risk of serious or severe HSRs very low. One such formulation, ferric derisomaltose, has been approved in the United States for delivery of 1000 mg iron in a single IV infusion. Ferric derisomaltose rapidly repletes iron parameters with low rates of serious or severe HSRs. Single-infusion iron repletion offers convenience, eliminates adherence concerns, and reduces healthcare resource utilization.
Assuntos
Anemia Ferropriva/tratamento farmacológico , Dissacarídeos/uso terapêutico , Compostos Férricos/uso terapêutico , Biomarcadores , Doenças Cardiovasculares/induzido quimicamente , Diagnóstico Diferencial , Dissacarídeos/administração & dosagem , Dissacarídeos/efeitos adversos , Dissacarídeos/química , Custos de Medicamentos , Hipersensibilidade a Drogas/diagnóstico , Hipersensibilidade a Drogas/etiologia , Fadiga/induzido quimicamente , Feminino , Compostos Férricos/administração & dosagem , Compostos Férricos/efeitos adversos , Compostos Férricos/química , Rubor/induzido quimicamente , Rubor/diagnóstico , Previsões , Hemoglobinas/análise , Humanos , Hipofosfatemia/sangue , Hipofosfatemia/induzido quimicamente , Infusões Intravenosas , Masculino , Estudos Multicêntricos como Assunto , Gravidez , Complicações Hematológicas na Gravidez/tratamento farmacológico , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos , United States Food and Drug AdministrationRESUMO
OBJECTIVE: To assess variations in hospitalizations, emergency department/observational (ED/OB) stays not resulting in hospitalization, reasons for hospitalization, and hospitalization discharge destinations after chemotherapy, information not provided as part of Oncology Care Model (OCM) baseline data. METHODS: OCM methodology was applied to the Medicare 20% sample data to identify 6-month patient episodes triggered by chemotherapy in 2012-2015. Proportions of episodes with hospitalization or ED/OB stays, reasons for hospitalization, and discharge destinations were summarized. RESULTS: Of 485,186 6-month episodes for 255,229 patients in 13,823 practices, 25% of episodes led to ≥1 hospitalization (from 14% in breast cancer to 56% in acute leukemia), and 23% to ED/OB stays (from 18% in breast cancer to 36% in liver cancer). In 2995 practices with ≥20 total episodes, practice-level proportions of episodes with hospitalization ranged from 14% to 31% (20th-80th percentile) and with ED/OB stays from 17% to 29%. For all cancers combined, the most frequent reasons for hospitalization were infection (13%), anemia (7%), dehydration (5%), and congestive heart failure (3%); the most common discharge destinations were home (71%) followed by a skilled nursing facility (13%), death (6%), and hospice (5%). Reasons for hospitalization and discharge destinations varied by cancer type; acute leukemia episodes led to the highest rates of infection and anemia, and central nervous system tumor episodes to the highest proportions of death or hospice discharge. CONCLUSION: The variations in frequency of and reasons for hospitalization, ED/OB stays, and hospitalization discharge destinations across cancer types should be considered when evaluating OCM practice performance.
Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Medicare , Neoplasias/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Estudos Retrospectivos , Estados UnidosRESUMO
OBJECTIVES: Health region differences in immigration patterns and premature mortality rates exist in Ontario, Canada. This study used linked population-based databases to describe the regional proportion of immigrants in the context of provincial health region variation in premature mortality. METHODS: We analyzed all adult premature deaths in Ontario from 1992 to 2012 using linked population files, Canadian census, and death registry databases. Geographic boundaries were analyzed according to 14 health service regions, known as Local Health Integration Networks (LHINs). We assessed the role of immigrant status and regional proportion of immigrants in the context of these health region variations and assessed the contribution using sex-specific multilevel negative binomial models, accounting for age, individual- and area-level immigration, and area-level material deprivation. RESULTS: We observed significant premature mortality variation among health service regions in Ontario between 1992 and 2012. Average annual rates ranged across LHINs from 3.03 to 6.40 per 1000 among males and 2.04 to 3.98 per 1000 among females. The median rate ratio (RR) decreased for men from 1.14 (95% CI 1.06, 1.19) to 1.07 (95% CI 1.00, 1.11) after adjusting for year, age, area-based material deprivation, and individual- and area-level immigration, and among females reduced from 1.13 (95% CI 1.05, 1.18) to 1.04 (95% CI 1.00, 1.05). These adjustments explained 84.1% and 94.4% of the LHIN-level variation in males and females respectively. Reduced premature mortality rates were associated with immigrants compared with those for long-term residents in the fully adjusted models for both males 0.43 (95% CI 0.42, 0.44) and females 0.45 (0.44, 0.46). CONCLUSION: The findings demonstrate that health region differences in premature mortality in Ontario are in part explained by individual-level effects associated with the health advantage of immigrants, as well as contextual area-level effects that are associated with regional differences in the immigrant population. These factors should be considered in addition to health system factors when looking at health region variation in premature deaths.
Assuntos
Emigrantes e Imigrantes/estatística & dados numéricos , Disparidades nos Níveis de Saúde , Mortalidade Prematura/tendências , Adolescente , Adulto , Idoso , Bases de Dados Factuais , Feminino , Geografia , Humanos , Masculino , Pessoa de Meia-Idade , Ontário/epidemiologia , Adulto JovemRESUMO
Background: Smoking, unhealthy alcohol consumption, poor diet and physical inactivity are leading risk factors for morbidity and mortality, and contribute substantially to overall healthcare costs. The availability of health surveys linked to health care provides population-based estimates of direct healthcare costs. We estimated health behaviour and socioeconomic-attribute healthcare costs, and how these have changed during a period when government policies have aimed to reduce their burden. Methods: The Ontario samples of the Canadian Community Health Surveys (conducted in 2003, 2005, and 2007-2008) were linked at the individual level to all records of health care use of publicly funded healthcare. Generalized linear models were estimated with a negative binomial distribution to ascertain the relationship of health behaviours and socioeconomic risk factors on health care costs. The multivariable cost model was applied to unlinked, Ontario CCHS samples for each year from 2004 to 2013 to examine the evolution of health behaviour and socioeconomic-attributable direct health care expenditures over a 10-year period. Results: We included 80,749 respondents, aged 25 years and older, and 312,952 person-years of follow-up. The cost model was applied to 200,324 respondents aged 25 years and older (CCHS 2004 to 2013). During the 10-year period from 2004 to 2013, smoking, unhealthy alcohol consumption, poor diet and physical inactivity attributed to 22% of Ontario's direct health care costs. Ontarians in the most disadvantaged socioeconomic position contributed to 15% of the province's direct health care costs. Combined, these health behaviour and socioeconomic risk factors were associated with 34% ($134 billion) of direct health care costs (2004 to 2013). Over this time period, we estimated a 1.9% reduction in health care expenditure ($5.0 billion) attributable to improvements in some health behaviours, most importantly reduced rates of smoking. Conclusions: Adverse health behaviours and socioeconomic position cause a large direct health care system cost burden.
Assuntos
Comportamentos Relacionados com a Saúde , Gastos em Saúde , Obesidade Mórbida , Adulto , Feminino , Humanos , Masculino , Ontário , Fatores SocioeconômicosRESUMO
El objetivo de este artículo es hacer una aproximación fenomenológica al denominado Mejoramiento Deportivo Postconvencional, encaminado a la prolongación del máximo performance; es decir, hacia la posibilidad de mantener un óptimo desempeño por más tiempo, superando el declive fisiológico natural y coartando, de cierta manera, el derecho de los atletas en formación de disfrutar de las ventajas que representa pertenecer a esta élite, en términos de honor, estatus, y de los crecientes estímulos económicos que ofrece el deporte profesional. Para ello, se hace una aproximación teórica al Mejoramiento Deportivo Postconvencional, definido como el uso de aditamentos biotecnológicos con capacidad de producir transformaciones corporales para aumentar el desempeño. Luego, se indagan los conceptos de límite y riesgo desde una perspectiva psicológica, dirigida a la idiosincrasia del deportista, y se analiza cómo se originan y sustentan las preferencias individuales y su evolución. Más adelante, se hace referencia a la participación de los beneficios, idea original del campo de la investigación biomédica y vinculada al deporte de rendimiento, dado que una parte de sus avances se aprovechan allí. Por último, se retoma el concepto de justicia para comprender la relación entre el deporte profesional, sus beneficios y la noción de frugalidad.
The objective of this article is to make a phenomenological approach to the so-called Postconventional Sports Improvement, aimed at prolonging the maximum performance; that is, towards the possibility of maintaining optimal performance for longer, overcoming the natural physiological decline and affecting, in a certain way, the right of athletes in training to enjoy the advantages of belonging to this elite, in terms of honor, status, and the growing economic stimuli offered by professional sport. To do this, a theoretical approach is made to post-conventional Sports Improvement, defined as the use of biotechnological attachments with the ability to produce bodily transformations to increase performance. Then, the concepts of limit and risk are investigated from a psychological perspective, aimed at the idiosyncrasies of the athlete, and analyzed how individual preferences and their evolution originate and sustain. Later, reference is made to profit sharing, the original idea of the field of biomedical research and linked to performance sport, as some of its advances are exploited there. Finally, the concept of justice is retaken to understand the relationship between professional sport, its benefits and the notion of frugality.
O objetivo deste artigo é o de abordagem fenomenológica o chamado Melhoria Sports pós-convencional, que visa alargar o máximo de desempenho; isto é, a possibilidade de manter um ótimo desempenho por mais tempo, superando o declínio fisiológico natural e limitando, de certa forma, o direito de atletas em formação para aproveitar as vantagens de pertencer a esta elite, em termos de honra, status, e aumentando os incentivos econômicos oferecidos pelo desporto profissional. Para isso, uma abordagem teórica para a Melhoria Sports pós-convencional, definida como o uso de adjuntos biotecnológicos capazes de produzir transformações corporais para aumentar o desempenho é. Em seguida, os conceitos de limites e de risco são investigados a partir de um ponto de vista psicológico, conduziu às idiossincrasias do atleta, e analisados como se originam e sustentar preferências e evolução individuais. Mais tarde, ele está se referindo à partilha de benefícios, ideia original do campo da pesquisa biomédica e associada ao desempenho esporte, como parte de seu progresso presa lá. Finalmente, o conceito de justiça é retomada para compreender a relação entre o desporto profissional, seus benefícios e a noção de frugalidade.
Assuntos
Desempenho Atlético , Esportes , Bioética , EficiênciaRESUMO
BACKGROUND: Irrational use of medicines is widespread in the South-East Asia Region (SEAR), where policy implementation to encourage quality use of medicines (QUM) is often low. The aim was to determine whether public-sector QUM is better in SEAR countries implementing essential medicines (EM) policies than in those not implementing them. METHODS: Data on six QUM indicators and 25 EM policies were extracted from situational analysis reports of 20 country (2-week) visits made during 2010-2015. The average difference (as percent) for the QUM indicators between countries implementing versus not implementing specific policies was calculated. Policies associated with better (> 1%) QUM were included in regression of a composite QUM score versus total number of policies implemented. RESULTS: Twenty-two policies were associated with better (> 1%) QUM. Twelve policies were associated with 3.6-9.5% significantly better use (p < 0.05), namely: standard treatment guidelines; formulary; a government unit to promote QUM; continuing health worker education on prescribing by government; limiting over-the-counter (OTC) availability of systemic antibiotics; disallowing public-sector prescriber revenue from medicines sales; not charging fees at the point of care; monitoring advertisements of OTC medicines; public education on QUM; and a good drug supply system. There was significant correlation between the number of policies implemented out of 22 and the composite QUM score (r = 0.71, r2 = 0.50, p < 0.05). CONCLUSIONS: Country situational analyses allowed rapid data collection that showed EM policies are associated with better QUM. SEAR countries should implement all such policies.
Assuntos
Medicamentos Essenciais/uso terapêutico , Política de Saúde , Setor Público , Sudeste Asiático , Confiabilidade dos Dados , Coleta de Dados , Honorários e Preços , Humanos , Qualidade da Assistência à SaúdeRESUMO
Although all-cause mortality rates have fallen in many countries in the last 40 years, the well-off and city dwellers have experienced the greatest gains. In this paper, we report on socio-economic and regional variations in premature mortality in Ontario. Premature mortality rates were highest in areas with the greatest degrees of social deprivation. While premature mortality continued to fall in the least deprived group, they flattened in the other groups and rose between 2000-2007 and 2008-2015 in the most deprived group. There were substantial variations in premature mortality rates across the Local Health Integration Networks, with the greatest disadvantage being seen in the southeast, northwest and northeast regions of Ontario. These data present a major challenge to policy makers. Health, social and economic policies need to be directed toward narrowing the gaps we have identified here. We have excellent metrics with which to measure their success.
Assuntos
Mortalidade Prematura/tendências , Programas Médicos Regionais/tendências , Fatores Socioeconômicos , Feminino , Política de Saúde , Disparidades em Assistência à Saúde , Humanos , Masculino , OntárioRESUMO
Indigenous data governance principles assert that Indigenous communities have a right to data that identifies their people or communities, and a right to determine the use of that data in ways that support Indigenous health and self-determination. Indigenous-driven use of the databases held at the Institute for Clinical Evaluative Sciences (ICES) has resulted in ongoing partnerships between ICES and diverse Indigenous organizations and communities. To respond to this emerging and complex landscape, ICES has established a team whose goal is to support the infrastructure for responding to community-initiated research priorities. ICES works closely with Indigenous partners to develop unique data governance agreements and supports processes, which ensure that ICES scientists must work with Indigenous organizations when conducting research that involves Indigenous peoples.
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Academias e Institutos/organização & administração , Indígena Americano ou Nativo do Alasca , Bases de Dados Factuais , Participação da Comunidade , Curadoria de Dados/ética , Serviços de Saúde do Indígena , Humanos , OntárioRESUMO
Importance: Follow-up of participants in randomized trials may be limited by logistic and financial factors. Some important randomized trials have been extended well beyond their original follow-up period by linkage of individual participant information to routinely collected data held in administrative records and registries. Objective: To perform a scoping review of randomized clinical trials extended by record linkage to characterize this literature and explore any additional insights into treatment effectiveness provided by long-term follow-up using record linkage. Data Sources: A literature search in Embase, CINAHL, MEDLINE, and the Cochrane Register of Controlled Trials was performed for the period January 1, 1945, through November 25, 2016. Study Selection: Various combinations of search terms were used, as there is no accepted terminology. Determination of study eligibility and extraction of information about trial characteristics and outcomes, for both original and extended trial reports, were performed in duplicate. Data Extraction and Synthesis: Assessment of study eligibility and data extraction were performed independently by 2 reviewers. All analyses were descriptive. Main Outcomes and Measures: Outcomes in the pairs of original and extended trials were categorized according to whether any benefits or harms from interventions were sustained, were lost, or emerged during long-term follow-up. Results: A total of 113 extended trials were included in the study. Linkage to administrative and registry data extended follow-up by between 1 and 55 years. The most common interventions were pharmaceuticals (47 [41.6%]), surgery (19 [16.8%]), and disease screening (19 [16.8%]). End points most frequently studied through record linkage included mortality (88 [77.9%]), cancer (41 [36.3%]), and cardiovascular events (37 [32.7%]). One hundred four trial extensions (92.0%) were analyzed according to the original trial randomization. The reports provided details of 155 analyses of study outcomes. Seventy-four analyses (47.7%) identified statistically significant benefits in the trial extension phase. In 21 of these (28.4%), benefits were significant only in this period. Null results in both the original and extended trials were seen in 34 of the analyses (21.9%). Loss of significant benefits of an intervention were seen in 12 analyses (7.7%). Statistically significant harms were seen in 16 trial extension analyses (10.3%), and in 14 of these (87.5%), the harms were significant only in the trial extension phase. Conclusions and Relevance: Trial extension by linkage to routinely collected data is a versatile underused approach that may add critical insights beyond those of the original trial. Some beneficial and harmful outcomes of interventions are captured only in the extension phase of randomized trials.
Assuntos
Seguimentos , Registro Médico Coordenado , Ensaios Clínicos Controlados Aleatórios como Assunto , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Mineração de Dados/métodos , Mineração de Dados/normas , HumanosRESUMO
Suicide and alcohol use disorders are primary determinants of health disparity among Alaska Native people in contrast to the US general population. Qungasvik, a Yup'ik word for toolbox, is a strengths-based, multi-level, community/cultural intervention for rural Yup'ik youth ages 12-18. The intervention uses "culture as intervention" to promote reasons for life and sobriety in young people using local expertise, high levels of community direction, and community based staff. The intervention is grounded in local practices and adaptive to local cultural differences distinctive to rural Yup'ik communities. The current study compares the effectiveness of high-intensity intervention in one community (treatment), operationalized as a high number of intervention activities, or modules, implemented and attended by youth, contrasted to a lower intensity intervention in a second community (comparison) that implemented fewer modules. A Yup'ik Indigenous theory of change developed through previous qualitative and quantitative work guides intervention. In the model, direct intervention effects on proximal or intermediate variables constituting protective factors at the individual, family, community, and peer influences levels lead to later change on the ultimate prevention outcome variables of Reasons for Life protective from suicide risk and Reflective Processes about alcohol use consequences protective from alcohol risk. Mixed effects regression models contrasted treatment and comparison arms, and identified significant intervention effects on Reasons for Life (d = 0.27, p < .05) but not Reflective Processes.
Assuntos
/psicologia , Prevenção do Suicídio , Consumo de Álcool por Menores/prevenção & controle , Adolescente , Alaska , Criança , Redes Comunitárias , Pesquisa Participativa Baseada na Comunidade , Feminino , Humanos , Masculino , Psicometria , Inquéritos e QuestionáriosRESUMO
PURPOSE: Evaluate changes in use of erythropoiesis-stimulating agents (ESAs) and red blood cell transfusion in cancer patients receiving myelosuppressive chemotherapy following regulatory and reimbursement actions. METHODS: Calendar year patient cohorts (2005-2013) with breast, colorectal, lung, multiple myeloma, non-Hodgkin lymphoma, ovarian, or prostate cancer and receiving myelosuppressive chemotherapy were identified within the Marketscan database. Incidence of ESA treatment and transfusion were estimated in each year, as was median number of ESA administrations. Clinical characteristics associated with ESA administration and transfusions were evaluated by using multivariable logistic regression. Additionally, annual new ESA user cohorts within the Oncology Services Comprehensive Electronic Records database (2011-2014) were examined to assess hemoglobin levels at ESA initiation. RESULTS: Across all tumor types, ESA use decreased substantially (breast cancer: 53.7 to 3.2%; lung cancer: 66.0 to 13.3%, non-Hodgkin lymphoma: 39.8 to 3.8%), transfusion use increased (2 to 5.5%, 5.5 to 18.2%, and 4.5 to 9.1%, respectively), and median number of ESA administrations declined. Across all tumor types, proportion of patients initiating an ESA with hemoglobin >10 g/dL was <10% from 2011 onward. In recent years, cancer patients who are older, female, and have chronic kidney disease or moderate or severe liver disease were most likely to receive ESAs. CONCLUSION: Subsequent to important regulatory and reimbursement ESA-related actions, total ESA exposure among cancer patients receiving myelosuppressive chemotherapy declined substantially. Today, fewer patients receive ESA therapy, and among those treated, more are initiated at hemoglobin levels <10 g/dL and are exposed for a shorter duration, consistent with current product labeling.
Assuntos
Transfusão de Eritrócitos/estatística & dados numéricos , Eritropoese/efeitos dos fármacos , Hematínicos/uso terapêutico , Reembolso de Seguro de Saúde/estatística & dados numéricos , Legislação de Medicamentos/tendências , Neoplasias/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia/tratamento farmacológico , Anemia/prevenção & controle , Anemia/terapia , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Estudos de Coortes , Bases de Dados Factuais , Feminino , Hemoglobinas/análise , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estimulação Química , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Homicide - a lethal expression of violence - has garnered little attention from public health researchers and health policy makers, despite the fact that homicides are a cause of preventable and premature death. Identifying populations at risk and the upstream determinants of homicide are important for addressing inequalities that hinder population health. This population-based study investigates the public health significance of homicides in Ontario, Canada, over the period of 1999-2012. We quantified the relative burden of homicides by comparing the socioeconomic gradient in homicides with the leading causes of death, cardiovascular disease (CVD) and neoplasm, and estimated the potential years of life lost (PYLL) due to homicide. METHODS: We linked vital statistics from the Office of the Registrar General Deaths register (ORG-D) with Census and administrative data for all Ontario residents. We extracted all homicide, neoplasm, and cardiovascular deaths from 1999 to 2012, using International Classification of Diseases codes. For socioeconomic status (SES), we used two dimensions of the Ontario Marginalization Index (ON-Marg): material deprivation and residential instability. Trends were summarized across deprivation indices using age-specific rates, rate ratios, and PYLL. RESULTS: Young males, 15-29 years old, were the main victims of homicide with a rate of 3.85 [IC 95%: 3.56; 4.13] per 100,000 population and experienced an upward trend over the study period. The socioeconomic neighbourhood gradient was substantial and higher than the gradient for both cardiovascular and neoplasms. Finally, the PYLL due to homicide were 63,512 and 24,066 years for males and females, respectively. CONCLUSIONS: Homicides are an important cause of death among young males, and populations living in disadvantaged neighbourhoods. Our findings raise concerns about the burden of homicides in the Canadian population and the importance of addressing social determinants to address these premature deaths.
Assuntos
Homicídio/estatística & dados numéricos , Adolescente , Adulto , Idoso , Doenças Cardiovasculares/mortalidade , Criança , Pré-Escolar , Atestado de Óbito , Feminino , Humanos , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Ontário/epidemiologia , Características de Residência/estatística & dados numéricos , Fatores de Risco , Classe Social , Adulto JovemRESUMO
We are at the dawn of a data deluge in health that carries extraordinary promise for improving the health of populations. However, current associated efforts, which generally center on the 'precision medicine' agenda, may well fall short in terms of its overall impact. The main challenges, it is argued, are less technical than the following: (1) identifying the data that matter most; (2) ensuring that we make better use of existing data; and (3) extending our efforts from the individual to the population by exploiting new, complex, and sometimes unstructured, data sources. Advances in Epidemiology have shown that policies, features of institutions, characteristics of communities, living and environmental conditions, and social relationships all contribute, together with individual behaviors and factors such as poverty and race, to the production of health. Examples are discussed, leading to recommendations that focus on core priorities for data linkage, including those relating to marginalized populations, better data on socioeconomic status, micro- and macro-environments, collaborating with researchers in the fields of education, environment, and social sciences to ensure the validity and accuracy of multilevel data, aligning research aims with policy decisions that must be made, and heightening efforts to protect privacy.
Assuntos
Meio Ambiente , Saúde da População , Classe Social , Meio Social , Coleta de Dados , Economia , Política de Saúde , Humanos , Armazenamento e Recuperação da Informação , Pobreza , Grupos Raciais , PesquisaRESUMO
BACKGROUND: Immigrants have been shown to possess a health advantage, yet are also more likely to reside in arduous economic conditions. Little is known about if and how the socioeconomic gradient for all-cause, premature and avoidable mortality differs according to immigration status. METHODS: Using several linked population-based vital and demographic databases from Ontario, we examined a cohort of all deaths in the province between 2002 and 2012. We constructed count models, adjusted for relevant covariates, to attain age-adjusted mortality rates and rate ratios for all-cause, premature and avoidable mortality across income quintile in immigrants and long-term residents, stratified by sex. RESULTS: A downward gradient in age-adjusted all-cause mortality was observed with increasing income quintile, in immigrants (males: Q5: 13.32, Q1: 20.18; females: Q5: 9.88, Q1: 12.51) and long-term residents (males: Q5: 33.25, Q1: 57.67; females: Q5: 22.31, Q1: 36.76). Comparing the lowest and highest income quintiles, male and female immigrants had a 56% and 28% lower all-cause mortality rate, respectively. Similar trends were observed for premature and avoidable mortality. Although immigrants had consistently lower mortality rates compared with long-term residents, trends only differed statistically across immigration status for females (p<0.05). CONCLUSIONS: This study illustrated the presence of income disparities as it pertains to all-cause, premature, and avoidable mortality, irrespective of immigration status. Additionally, the immigrant health advantage was observed and income disparities were less pronounced in immigrants compared with long-term residents. These findings support the need to examine the factors that drive inequalities in mortality within and across immigration status.