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1.
Assessment ; 27(5): 941-958, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-29441793

RESUMO

Existing measures of experiences of sexualization and objectification of women focus on behaviors that men do toward women. However, women may also contribute to the objectification of other women. The aim of the present study was to develop the Women's Objectification of Women Scale (WOWS). Through a series of four studies using samples of college women and samples obtained through MTurk, we (a) established that existing measures of objectification focus on behaviors that men perform, (b) gathered qualitative data on women's experiences of objectification by women, (c) developed models of the WOWS using classical test theory methods and item response theory, and (d) subjected the WOWS to confirmatory factor analysis and validity testing. The WOWS is a psychometrically sound, brief assessment of women's experiences of objectification by other women and may help further research on women's interpersonal experiences as they pertain to body image concerns, mental health, and well-being.


Assuntos
Imagem Corporal , Gansos , Animais , Feminino , Humanos , Masculino , Universidades
2.
J Stud Alcohol Drugs ; 77(6): 980-985, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27797701

RESUMO

OBJECTIVE: The purpose of this study was to assess the association between team sport participation and substance use, and racial/ ethnic disparities, among U.S. adolescents. METHOD: Data from 6,721 male and 6,761 female high school students in the 2013 Youth Behavior Risk Survey were used. Logistic regression was used to assess the relationship between team sport participation and substance use across gender and race/ethnicity. RESULTS: Among males, participation in team sports was associated with increased risk for use of smokeless tobacco (odds ratio [OR] = 1.81, 95% CI [1.42, 2.32]), alcohol (OR = 1.30, 95% CI [1.11, 1.52]), and steroids (OR = 1.69, 95% CI [1.26, 2.27]), and decreased risk for use of smoked tobacco (OR = 0.80, 95% CI [0.65, 0.99]) and inhalants (OR = 0.67, 95% CI [0.53, 0.85]). Among females, participation in team sports was associated with increased risk for use of smokeless tobacco (OR = 1.49, 95% CI [1.03, 2.18]) and diet pills (OR = 1.31, 95% CI [1.02, 1.68]), and decreased risk for use of smoked tobacco (OR = 0.60, 95% CI [0.50, 0.72]), cocaine (OR = 0.66, 95% CI [0.46, 0.94]), and prescription drugs (OR = 0.77, 95% CI [0.67, 0.89]). When examined within specific racial/ethnic groups, these patterns were not consistent. CONCLUSIONS: High school athletes are at increased risk for use of smokeless tobacco as well as alcohol, steroids, and diet pills. At the same time, they are at lower risk for use of smoked tobacco, inhalants, and cocaine, compared with non-athlete peers. Specific intersections of race/ethnicity and gender demonstrated deviations from these patterns.


Assuntos
Comportamento do Adolescente , Esportes/estatística & dados numéricos , Estudantes/estatística & dados numéricos , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Adolescente , Etnicidade , Feminino , Humanos , Modelos Logísticos , Masculino , Razão de Chances , Transtornos Relacionados ao Uso de Substâncias/etnologia , Inquéritos e Questionários , Estados Unidos/epidemiologia
3.
JAMA ; 315(23): 2576-94, 2016 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-27305422

RESUMO

IMPORTANCE: Colorectal cancer (CRC) remains a significant cause of morbidity and mortality in the United States. OBJECTIVE: To systematically review the effectiveness, diagnostic accuracy, and harms of screening for CRC. DATA SOURCES: Searches of MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials for relevant studies published from January 1, 2008, through December 31, 2014, with surveillance through February 23, 2016. STUDY SELECTION: English-language studies conducted in asymptomatic populations at general risk of CRC. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently appraised the articles and extracted relevant study data from fair- or good-quality studies. Random-effects meta-analyses were conducted. MAIN OUTCOMES AND MEASURES: Colorectal cancer incidence and mortality, test accuracy in detecting CRC or adenomas, and serious adverse events. RESULTS: Four pragmatic randomized clinical trials (RCTs) evaluating 1-time or 2-time flexible sigmoidoscopy (n = 458,002) were associated with decreased CRC-specific mortality compared with no screening (incidence rate ratio, 0.73; 95% CI, 0.66-0.82). Five RCTs with multiple rounds of biennial screening with guaiac-based fecal occult blood testing (n = 419,966) showed reduced CRC-specific mortality (relative risk [RR], 0.91; 95% CI, 0.84-0.98, at 19.5 years to RR, 0.78; 95% CI, 0.65-0.93, at 30 years). Seven studies of computed tomographic colonography (CTC) with bowel preparation demonstrated per-person sensitivity and specificity to detect adenomas 6 mm and larger comparable with colonoscopy (sensitivity from 73% [95% CI, 58%-84%] to 98% [95% CI, 91%-100%]; specificity from 89% [95% CI, 84%-93%] to 91% [95% CI, 88%-93%]); variability and imprecision may be due to differences in study designs or CTC protocols. Sensitivity of colonoscopy to detect adenomas 6 mm or larger ranged from 75% (95% CI, 63%-84%) to 93% (95% CI, 88%-96%). On the basis of a single stool specimen, the most commonly evaluated families of fecal immunochemical tests (FITs) demonstrated good sensitivity (range, 73%-88%) and specificity (range, 90%-96%). One study (n = 9989) found that FIT plus stool DNA test had better sensitivity in detecting CRC than FIT alone (92%) but lower specificity (84%). Serious adverse events from colonoscopy in asymptomatic persons included perforations (4/10,000 procedures, 95% CI, 2-5 in 10,000) and major bleeds (8/10,000 procedures, 95% CI, 5-14 in 10,000). Computed tomographic colonography may have harms resulting from low-dose ionizing radiation exposure or identification of extracolonic findings. CONCLUSIONS AND RELEVANCE: Colonoscopy, flexible sigmoidoscopy, CTC, and stool tests have differing levels of evidence to support their use, ability to detect cancer and precursor lesions, and risk of serious adverse events in average-risk adults. Although CRC screening has a large body of supporting evidence, additional research is still needed.


Assuntos
Adenoma/diagnóstico , Comitês Consultivos , Neoplasias Colorretais/diagnóstico , Serviços Preventivos de Saúde , Doenças Assintomáticas , Colonografia Tomográfica Computadorizada/estatística & dados numéricos , Colonoscopia/efeitos adversos , Colonoscopia/estatística & dados numéricos , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/mortalidade , DNA/análise , Confiabilidade dos Dados , Fezes/química , Humanos , Imuno-Histoquímica/estatística & dados numéricos , Achados Incidentais , Sangue Oculto , Ensaios Clínicos Controlados Aleatórios como Assunto , Sensibilidade e Especificidade , Sigmoidoscopia/estatística & dados numéricos , Estados Unidos
4.
Genet Med ; 18(12): 1258-1268, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27124788

RESUMO

PURPOSE: Genome and exome sequencing can identify variants unrelated to the primary goal of sequencing. Detecting pathogenic variants associated with an increased risk of a medical disorder enables clinical interventions to improve future health outcomes in patients and their at-risk relatives. The Clinical Genome Resource, or ClinGen, aims to assess clinical actionability of genes and associated disorders as part of a larger effort to build a central resource of information regarding the clinical relevance of genomic variation for use in precision medicine and research. METHODS: We developed a practical, standardized protocol to identify available evidence and generate qualitative summary reports of actionability for disorders and associated genes. We applied a semiquantitative metric to score actionability. RESULTS: We generated summary reports and actionability scores for the 56 genes and associated disorders recommended by the American College of Medical Genetics and Genomics for return as secondary findings from clinical genome-scale sequencing. We also describe the challenges that arose during the development of the protocol that highlight important issues in characterizing actionability across a range of disorders. CONCLUSION: The ClinGen framework for actionability assessment will assist research and clinical communities in making clear, efficient, and consistent determinations of actionability based on transparent criteria to guide analysis and reporting of findings from clinical genome-scale sequencing.Genet Med 18 12, 1258-1268.


Assuntos
Doenças Genéticas Inatas/diagnóstico , Testes Genéticos , Variação Genética , Genômica , Exoma/genética , Doenças Genéticas Inatas/patologia , Genoma Humano , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Medicina de Precisão
5.
Genet Med ; 18(8): 780-7, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-26633547

RESUMO

PURPOSE: Enthusiasm for molecular diagnostic (MDx) testing in oncology is constrained by the gaps in required evidence regarding its impact on patient outcomes (clinical utility (CU)). This effectiveness guidance document proposes recommendations for the design and evaluation of studies intended to reflect the evidence expectations of payers, while also reflecting information needs of patients and clinicians. METHODS: Our process included literature reviews and key informant interviews followed by iterative virtual and in-person consultation with an expert technical working group and an advisory group comprising life-sciences industry experts, public and private payers, patients, clinicians, regulators, researchers, and other stakeholders. RESULTS: Treatment decisions in oncology represent high-risk clinical decision making, and therefore the recommendations give preference to randomized controlled trials (RCTs) for demonstrating CU. The guidance also describes circumstances under which alternatives to RCTs could be considered, specifying conditions under which test developers could use prospective-retrospective studies with banked biospecimens, single-arm studies, prospective observational studies, or decision-analytic modeling techniques that make a reasonable case for CU. CONCLUSION: Using a process driven by multiple stakeholders, we developed a common framework for designing and evaluating studies of the clinical validity and CU of MDx tests, achieving a balance between internal validity of the studies and the relevance, feasibility, and timeliness of generating the desired evidence.Genet Med 18 8, 780-787.


Assuntos
Técnicas de Diagnóstico Molecular/métodos , Neoplasias/genética , Pesquisa Biomédica , Tomada de Decisão Clínica , Estudos de Avaliação como Assunto , Medicina Baseada em Evidências , Guias como Assunto , Humanos
6.
Genet Med ; 17(9): 702-12, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25590981

RESUMO

PURPOSE: Family history of colorectal cancer (CRC) is a known risk factor for CRC and encompasses both genetic and shared environmental risks. METHODS: We conducted a systematic review to estimate the impact of family history on the natural history of CRC and adherence to screening. RESULTS: We found high heterogeneity in family-history definitions, the most common definition being one or more first-degree relatives. The prevalence of family history may be lower than the commonly cited 10%, and confirms evidence for increasing levels of risk associated with increasing family-history burden. There is evidence for higher prevalence of adenomas and of multiple adenomas in people with family history of CRC but no evidence for differential adenoma location or adenoma progression by family history. Limited data regarding the natural history of CRC by family history suggest a differential age or stage at cancer diagnosis and mixed evidence with respect to tumor location. Adherence to recommended colonoscopy screening was higher in people with a family history of CRC. CONCLUSION: Stratification based on polygenic and/or multifactorial risk assessment may mature to the point of displacing family history-based approaches, but for the foreseeable future, family history may remain a valuable clinical tool for identifying individuals at increased risk for CRC.


Assuntos
Neoplasias Colorretais/genética , Neoplasias Colorretais/patologia , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer , Saúde da Família , Predisposição Genética para Doença , Humanos , Prevalência , Fatores de Risco
7.
Ann Intern Med ; 162(3): 192-204, 2015 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-25531400

RESUMO

BACKGROUND: Elevated blood pressure (BP) is the largest contributing risk factor to all-cause and cardiovascular mortality. PURPOSE: To update a systematic review on the benefits and harms of screening for high BP in adults and to summarize evidence on rescreening intervals and diagnostic and predictive accuracy of different BP methods for cardiovascular events. DATA SOURCES: Selected databases searched through 24 February 2014. STUDY SELECTION: Fair- and good-quality trials and diagnostic accuracy and cohort studies conducted in adults and published in English. DATA EXTRACTION: One investigator abstracted data, and a second checked for accuracy. Study quality was dual-reviewed. DATA SYNTHESIS: Ambulatory BP monitoring (ABPM) predicted long-term cardiovascular outcomes independently of office BP (hazard ratio range, 1.28 to 1.40, in 11 studies). Across 27 studies, 35% to 95% of persons with an elevated BP at screening remained hypertensive after nonoffice confirmatory testing. Cardiovascular outcomes in persons who were normotensive after confirmatory testing (isolated clinic hypertension) were similar to outcomes in those who were normotensive at screening. In 40 studies, hypertension incidence after rescreening varied considerably at each yearly interval up to 6 years. Intrastudy comparisons showed at least 2-fold higher incidence in older adults, those with high-normal BP, overweight and obese persons, and African Americans. LIMITATION: Few diagnostic accuracy studies of office BP methods and protocols in untreated adults. CONCLUSION: Evidence supports ABPM as the reference standard for confirming elevated office BP screening results to avoid misdiagnosis and overtreatment of persons with isolated clinic hypertension. Persons with BP in the high-normal range, older persons, those with an above-normal body mass index, and African Americans are at higher risk for hypertension on rescreening within 6 years than are persons without these risk factors. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.


Assuntos
Determinação da Pressão Arterial/normas , Monitorização Ambulatorial da Pressão Arterial/normas , Hipertensão/diagnóstico , Programas de Rastreamento/métodos , Programas de Rastreamento/normas , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Erros de Diagnóstico , Humanos , Hipertensão/complicações , Hipertensão/epidemiologia , Incidência , Programas de Rastreamento/efeitos adversos , Padrões de Referência , Fatores de Risco , Fatores de Tempo , Estados Unidos/epidemiologia , Procedimentos Desnecessários , Hipertensão do Jaleco Branco/diagnóstico , Hipertensão do Jaleco Branco/epidemiologia
8.
Clin Cancer Res ; 20(6): 1428-44, 2014 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-24634466

RESUMO

This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond analytical and clinical validation, successful demonstration of clinical utility involves developing sufficient evidence to demonstrate that a diagnostic test results in an improvement in patient outcomes. This discussion is complementary to theoretical frameworks described in previously published guidance and literature reports by the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, Institute of Medicine, and Center for Medical Technology Policy, among others. These reports are comprehensive and specifically clarify appropriate clinical use, adoption, and payer reimbursement for assay manufacturers, as well as Clinical Laboratory Improvement Amendments-certified laboratories, including those that develop assays (laboratory developed tests). Practical criteria and steps for establishing clinical utility are crucial to subsequent decisions for reimbursement without which high-performing molecular diagnostics will have limited availability to patients with cancer and fail to translate scientific advances into high-quality and cost-effective cancer care. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development."


Assuntos
Aprovação de Teste para Diagnóstico , Técnicas de Diagnóstico Molecular , Neoplasias/diagnóstico , Guias de Prática Clínica como Assunto , Aprovação de Teste para Diagnóstico/normas , Aprovação de Teste para Diagnóstico/tendências , Humanos , Técnicas de Diagnóstico Molecular/normas , Técnicas de Diagnóstico Molecular/tendências , Terapia de Alvo Molecular/métodos , Neoplasias/terapia , Guias de Prática Clínica como Assunto/normas , Estados Unidos
9.
Genet Med ; 15(1): 14-24, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22955111

RESUMO

To provide an update on recent revisions to Evaluation of Genomic Applications in Practice and Prevention (EGAPP) methods designed to improve efficiency, and an assessment of the implications of whole genome sequencing for evidence-based recommendation development. Improvements to the EGAPP approach include automated searches for horizon scanning, a quantitative ranking process for topic prioritization, and the development of a staged evidence review and evaluation process. The staged process entails (i) triaging tests with minimal evidence of clinical validity, (ii) using and updating existing reviews, (iii) evaluating clinical validity prior to analytic validity or clinical utility, (iv) using decision modeling to assess potential clinical utility when direct evidence is not available. EGAPP experience to date suggests the following approaches will be critical for the development of evidence based recommendations in the whole genome sequencing era: (i) use of triage approaches and frameworks to improve efficiency, (ii) development of evidence thresholds that consider the value of further research, (iii) incorporation of patient preferences, and (iv) engagement of diverse stakeholders. The rapid advances in genomics present a significant challenge to traditional evidence based medicine, but also an opportunity for innovative approaches to recommendation development.


Assuntos
Medicina Baseada em Evidências , Genoma Humano , Genômica , Sequenciamento de Nucleotídeos em Larga Escala , Testes Genéticos , Humanos , Revisão por Pares , Garantia da Qualidade dos Cuidados de Saúde
10.
BMC Med Inform Decis Mak ; 12: 117, 2012 Oct 19.
Artigo em Inglês | MEDLINE | ID: mdl-23078403

RESUMO

The development of genomic tests is one of the most significant technological advances in medical testing in recent decades. As these tests become increasingly available, so does the need for a pragmatic framework to evaluate the evidence base and evidence gaps in order to facilitate informed decision-making. In this article we describe such a framework that can provide a common language and benchmarks for different stakeholders of genomic testing. Each stakeholder can use this framework to specify their respective thresholds for decision-making, depending on their perspective and particular needs. This framework is applicable across a broad range of test applications and can be helpful in the application and communication of a regulatory science for genomic testing. Our framework builds upon existing work and incorporates principles familiar to researchers involved in medical testing (both diagnostic and prognostic) generally, as well as those involved in genomic testing. This framework is organized around six phases in the development of genomic tests beginning with marker identification and ending with population impact, and highlights the important knowledge gaps that need to be filled in establishing the clinical relevance of a test. Our framework focuses on the clinical appropriateness of the four main dimensions of test research questions (population/setting, intervention/index test, comparators/reference test, and outcomes) rather than prescribing a hierarchy of study designs that should be used to address each phase.


Assuntos
Tomada de Decisões , Testes Genéticos/normas , Medicina Baseada em Evidências , Genômica , Humanos , Reprodutibilidade dos Testes
12.
Cochrane Database Syst Rev ; (3): CD007303, 2009 Jul 08.
Artigo em Inglês | MEDLINE | ID: mdl-19588423

RESUMO

BACKGROUND: Erythropoiesis-stimulating agents (ESAs) reduce anemia in cancer patients and may improve quality of life, but there are concerns that ESAs might increase mortality. OBJECTIVES: Our objectives were to examine the effect of ESAs and identify factors that modify the effects of ESAs on overall survival, progression free survival, thromboembolic and cardiovascular events as well as need for transfusions and other important safety and efficacy outcomes in cancer patients. SEARCH STRATEGY: We searched the Cochrane Library, Medline, Embase and conference proceedings for eligible trials. Manufacturers of ESAs were contacted to identify additional trials. SELECTION CRITERIA: We included randomized controlled trials comparing epoetin or darbepoetin plus red blood cell transfusions (as necessary) versus red blood cell transfusions (as necessary) alone, to prevent or treat anemia in adult or pediatric cancer patients with or without concurrent antineoplastic therapy. DATA COLLECTION AND ANALYSIS: We performed a meta-analysis of randomized controlled trials comparing epoetin alpha, epoetin beta or darbepoetin alpha plus red blood cell transfusions versus transfusion alone, for prophylaxis or therapy of anemia while or after receiving anti-cancer treatment. Patient-level data were obtained and analyzed by independent statisticians at two academic departments, using fixed-effects and random-effects meta-analysis. Analyses were according to the intention-to-treat principle. Primary endpoints were on study mortality and overall survival during the longest available follow-up, regardless of anticancer treatment, and in patients receiving chemotherapy. Tests for interactions were used to identify differences in effects of ESAs on mortality across pre-specified subgroups. The present review reports only the results for the primary endpoint. MAIN RESULTS: A total of 13933 cancer patients from 53 trials were analyzed, 1530 patients died on-study and 4993 overall. ESAs increased on study mortality (combined hazard ratio [cHR] 1.17; 95% CI 1.06-1.30) and worsened overall survival (cHR 1.06; 95% CI 1.00-1.12), with little heterogeneity between trials (I(2) 0%, p=0.87 and I(2) 7.1%, p=0.33, respectively). Thirty-eight trials enrolled 10441 patients receiving chemotherapy. The cHR for on study mortality was 1.10 (95% CI 0.98-1.24) and 1.04; 95% CI 0.97-1.11) for overall survival. There was little evidence for a difference between trials of patients receiving different cancer treatments (P for interaction=0.42). AUTHORS' CONCLUSIONS: ESA treatment in cancer patients increased on study mortality and worsened overall survival. For patients undergoing chemotherapy the increase was less pronounced, but an adverse effect could not be excluded.


Assuntos
Anemia/mortalidade , Transfusão de Eritrócitos , Hematínicos/efeitos adversos , Neoplasias/mortalidade , Adulto , Anemia/complicações , Anemia/terapia , Criança , Darbepoetina alfa , Intervalo Livre de Doença , Epoetina alfa , Eritropoetina/efeitos adversos , Eritropoetina/análogos & derivados , Feminino , Humanos , Masculino , Neoplasias/complicações , Neoplasias/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes
13.
Lancet ; 373(9674): 1532-42, 2009 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-19410717

RESUMO

BACKGROUND: Erythropoiesis-stimulating agents reduce anaemia in patients with cancer and could improve their quality of life, but these drugs might increase mortality. We therefore did a meta-analysis of randomised controlled trials in which these drugs plus red blood cell transfusions were compared with transfusion alone for prophylaxis or treatment of anaemia in patients with cancer. METHODS: Data for patients treated with epoetin alfa, epoetin beta, or darbepoetin alfa were obtained and analysed by independent statisticians using fixed-effects and random-effects meta-analysis. Analyses were by intention to treat. Primary endpoints were mortality during the active study period and overall survival during the longest available follow-up, irrespective of anticancer treatment, and in patients given chemotherapy. Tests for interactions were used to identify differences in effects of erythropoiesis-stimulating agents on mortality across prespecified subgroups. FINDINGS: Data from a total of 13 933 patients with cancer in 53 trials were analysed. 1530 patients died during the active study period and 4993 overall. Erythropoiesis-stimulating agents increased mortality during the active study period (combined hazard ratio [cHR] 1.17, 95% CI 1.06-1.30) and worsened overall survival (1.06, 1.00-1.12), with little heterogeneity between trials (I(2) 0%, p=0.87 for mortality during the active study period, and I(2) 7.1%, p=0.33 for overall survival). 10 441 patients on chemotherapy were enrolled in 38 trials. The cHR for mortality during the active study period was 1.10 (0.98-1.24), and 1.04 (0.97-1.11) for overall survival. There was little evidence for a difference between trials of patients given different anticancer treatments (p for interaction=0.42). INTERPRETATION: Treatment with erythropoiesis-stimulating agents in patients with cancer increased mortality during active study periods and worsened overall survival. The increased risk of death associated with treatment with these drugs should be balanced against their benefits. FUNDING: German Federal Ministry of Education and Research, Medical Faculty of University of Cologne, and Oncosuisse (Switzerland).


Assuntos
Anemia/tratamento farmacológico , Transfusão de Eritrócitos , Hematínicos/efeitos adversos , Neoplasias/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Adolescente , Adulto , Idoso , Anemia/etiologia , Antineoplásicos/uso terapêutico , Modificador do Efeito Epidemiológico , Eritropoetina/efeitos adversos , Feminino , Hematínicos/uso terapêutico , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Modelos de Riscos Proporcionais , Proteínas Recombinantes , Projetos de Pesquisa , Taxa de Sobrevida , Resultado do Tratamento , Adulto Jovem
14.
Public Health Genomics ; 12(4): 233-44, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19367091

RESUMO

BACKGROUND: In recent decades, extensive resources have been invested to develop cellular, molecular and genomic technologies with clinical applications that span the continuum of cancer care. METHODS: In December 2006, the National Cancer Institute sponsored the first workshop to uniquely examine the state of health services research on cancer-related cellular, molecular and genomic technologies and identify challenges and priorities for expanding the evidence base on their effectiveness in routine care. RESULTS: This article summarizes the workshop outcomes, which included development of a comprehensive research agenda that incorporates health and safety endpoints, utilization patterns, patient and provider preferences, quality of care and access, disparities, economics and decision modeling, trends in cancer outcomes, and health-related quality of life among target populations. CONCLUSIONS: Ultimately, the successful adoption of useful technologies will depend on understanding and influencing the patient, provider, health care system and societal factors that contribute to their uptake and effectiveness in 'real-world' settings.


Assuntos
Genômica , Pesquisa sobre Serviços de Saúde/organização & administração , Neoplasias/terapia , Continuidade da Assistência ao Paciente , Acessibilidade aos Serviços de Saúde , Humanos , Neoplasias/genética , Qualidade da Assistência à Saúde , Justiça Social
15.
Genet Med ; 11(1): 3-14, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18813139

RESUMO

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Initiative, established by the National Office of Public Health Genomics at the Centers for Disease Control and Prevention, supports the development and implementation of a rigorous, evidence-based process for evaluating genetic tests and other genomic applications for clinical and public health practice in the United States. An independent, non-federal EGAPP Working Group (EWG), a multidisciplinary expert panel selects topics, oversees the systematic review of evidence, and makes recommendations based on that evidence. This article describes the EGAPP processes and details the specific methods and approaches used by the EWG.


Assuntos
Medicina Baseada em Evidências/métodos , Genética Médica/métodos , Genômica/métodos , Centers for Disease Control and Prevention, U.S. , Estudos de Avaliação como Assunto , Técnicas Genéticas/normas , Genética Médica/tendências , Humanos , Estados Unidos
16.
Genet Med ; 10(2): 89-98, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18281915

RESUMO

PURPOSE: Summarize evidence regarding genetic testing in adults to inform warfarin dosing to reduce adverse drug events such as serious bleeding. METHODS: Review published (and selected gray) literature using the Rapid-ACCE structure that addresses analytic validity, clinical validity, clinical utility, and ethical, legal, and social implications. RESULTS: Preliminary data suggest overall analytic sensitivity and specificity will be 98% or higher for CYP2C9 genotyping, but strength of evidence for analytic validity is low, especially for VKORC1 testing. Strength of evidence is high for the clinical validity of both genes in predicting stable warfarin dose, an intermediate outcome, but is low for the association between CYP2C9 testing and severe bleeding events (clinical sensitivity 46% (95% CI 32-60%); specificity 69% (95% CI 62-75%) and absent for bleeding events associated with VKORC1 testing. No data are available to document clinical utility of genotyping before warfarin dosing. CONCLUSIONS: The most important gaps identified are: which variants should be included in a testing panel, lack of data from external proficiency testing, lack of validated dosing algorithm incorporating genetic and nongenetic factors, evidence of clinical utility, reliable economic analyses, and methods to address several ethical, legal, and social implications issues.


Assuntos
Alelos , Anticoagulantes/efeitos adversos , Hidrocarboneto de Aril Hidroxilases/genética , Hemorragia/induzido quimicamente , Oxigenases de Função Mista/genética , Varfarina/efeitos adversos , Citocromo P-450 CYP2C9 , Relação Dose-Resposta a Droga , Genótipo , Hemorragia/genética , Humanos , Medição de Risco , Sensibilidade e Especificidade , Vitamina K Epóxido Redutases , Varfarina/administração & dosagem
17.
J Natl Cancer Inst ; 98(10): 708-14, 2006 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-16705125

RESUMO

This is an updated systematic review of 57 trials and 9353 cancer patients from articles, abstracts, and reports published between January 1, 1985, and April 30, 2005, on the effects of epoetin alfa and beta (i.e., epoetin) and darbepoetin alfa (i.e., darbepoetin). We included randomized controlled trials comparing epoetin or darbepoetin plus red blood cell transfusion with red blood cell transfusion alone for prophylaxis or treatment of anemia in cancer patients with or without concurrent antineoplastic therapy. The Cochrane Library, MEDLINE, EMBASE, and conference proceedings were searched. Effect estimates and 95% confidence intervals (CIs) were calculated with fixed-effects models. Treatment with epoetin or darbepoetin statistically significantly reduced the risk for red blood cell transfusions (relative risk [RR] = 0.64, 95% CI = 0.60 to 0.68; 42 trials and 6510 patients) and improved hematologic response (RR = 3.43, 95% CI = 3.07 to 3.84; 22 trials and 4307 patients). Treatment with epoetin or darbepoetin increased the risk of thrombo-embolic events (RR = 1.67, 95% CI = 1.35 to 2.06; 35 trials and 6769 patients). Uncertainties remain as to whether and how epoetin or darbepoetin affects overall survival (hazard ratio = 1.08, 95% CI = 0.99 to 1.18; 42 trials and 8167 patients). Caution is advised when using epoetin or darbepoetin in combination with thrombogenic chemotherapeutic agents or for cancer patients who are at high risk for thrombo-embolic events.


Assuntos
Anemia Hipocrômica/tratamento farmacológico , Anemia Hipocrômica/prevenção & controle , Antineoplásicos/efeitos adversos , Eritropoetina/uso terapêutico , Neoplasias/tratamento farmacológico , Tromboembolia/induzido quimicamente , Anemia Hipocrômica/induzido quimicamente , Anemia Hipocrômica/terapia , Antineoplásicos/administração & dosagem , Darbepoetina alfa , Epoetina alfa , Transfusão de Eritrócitos , Eritropoetina/análogos & derivados , Hematínicos/uso terapêutico , Humanos , Incidência , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes , Projetos de Pesquisa , Medição de Risco , Tromboembolia/epidemiologia , Resultado do Tratamento
18.
Clin Leadersh Manag Rev ; 19(5): E2, 2005 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-16188159

RESUMO

CLMA volunteered to conduct an online pilot survey of its membership to help the Institute for Quality in Laboratory Medicine (IQLM) determine quality management activities in laboratories. Among the hospital-based members who were surveyed, approximately 25 percent responded. The data they volunteered provide a snapshot of the current state of laboratory quality management. The pilot survey is part of a larger IQLM plan to develop networks of laboratories to monitor and evaluate laboratory practices and services to enhance laboratory medicine. This pilot survey will be used by IQLM as a model to establish quality and patient safety networks, applicable to laboratories of all sizes and types. Performance comparisons and best practices may then be shared to reduce laboratory errors and improve patient safety.


Assuntos
Laboratórios Hospitalares/normas , Garantia da Qualidade dos Cuidados de Saúde/métodos , Coleta de Dados , Projetos Piloto , Garantia da Qualidade dos Cuidados de Saúde/estatística & dados numéricos , Estados Unidos
19.
J Natl Cancer Inst ; 97(7): 489-98, 2005 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-15812074

RESUMO

BACKGROUND: Anemia associated with cancer and cancer therapy is an important clinical and economic factor in the treatment of malignant diseases. METHODS: We conducted a systematic literature review to assess the efficacy of erythropoietin to prevent or treat anemia in cancer patients with regard to red blood cell transfusions, hematologic response, adverse events, and overall survival. We searched the Cochrane Library, Medline, EMBASE, and other databases for relevant articles published from January 1985 to December 2001. We included all randomized controlled trials that compared the use of recombinant human erythropoietin (plus transfusion, if needed) with no erythropoietin treatment (plus transfusion, if needed). Relative risks (RRs) and 95% confidence intervals (CIs) were calculated under a fixed-effects model. Clinical and statistical heterogeneity were examined with sensitivity analyses and meta-regression. Statistical tests for effect estimates were two-sided. RESULTS: We identified 27 trials involving 3287 adult patients. Patients treated with erythropoietin had a lower relative risk of having a blood transfusion than untreated patients (RR = 0.67, 95% CI = 0.62 to 0.73). Erythropoietin-treated patients with baseline hemoglobin levels lower than 10 g/dL were more likely to have a hematologic response than untreated patients (RR = 3.60, 95% CI = 3.07 to 4.23). The relative risk for thromboembolic complications after erythropoietin treatment was not statistically significantly increased (RR = 1.58, 95% CI = 0.94 to 2.66) compared with that of untreated patients. There is suggestive but inconclusive evidence that erythropoietin may improve overall survival (adjusted data: hazard ratio [HR] = 0.81, 95% CI = 0.67 to 0.99; unadjusted data: HR = 0.84, 95% CI = 0.69 to 1.02). CONCLUSIONS: Erythropoietin treatment may reduce the risk for blood transfusions and improve hematologic response in cancer patients. However, our favorable survival outcome is in contrast to two large (N = 351 and 939) recently published randomized controlled trials in which erythropoietin-treated patients had statistically significantly worse survival than untreated patients. Possible reasons for the disparity with our results include differences in study population and design, higher target hemoglobin levels and higher risk of thromboembolic complications, and concerns that erythropoietin may stimulate tumor growth.


Assuntos
Anemia/prevenção & controle , Eritropoetina/uso terapêutico , Hematínicos/uso terapêutico , Neoplasias/terapia , Anemia/etiologia , Anemia/terapia , Transfusão de Sangue/estatística & dados numéricos , Eritropoetina/administração & dosagem , Eritropoetina/efeitos adversos , Hematínicos/administração & dosagem , Hematínicos/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes , Medição de Risco , Análise de Sobrevida , Resultado do Tratamento
20.
Public Health Nurs ; 22(1): 36-44, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-15670323

RESUMO

This study sought to develop and test a set of criteria to distinguish elders at high risk of an untoward medication event within community nursing caseloads. A descriptive correlational design was used to identify relevant risk factors for elders. Data on medication knowledge, regime, management abilities, and adherence were obtained from 111 elders receiving community nursing care. Four predictors--12 or more doses of medications per day, more than one prescriber, caregiver available, and sometimes forgetting to take medications--of complexity (R2 explaining 39% of the variance) and adherence (R2 explaining 49% of the variance) were identified as potential factors that subsequently confirmed a discrete group of high risk elders. The use of these four risk factors or screening criteria is recommended for older people within community nursing caseloads.


Assuntos
Enfermagem em Saúde Comunitária/métodos , Enfermagem em Saúde Comunitária/estatística & dados numéricos , Enfermagem Geriátrica/métodos , Enfermagem Geriátrica/estatística & dados numéricos , Erros de Medicação/prevenção & controle , Erros de Medicação/estatística & dados numéricos , Idoso , Austrália , Feminino , Humanos , Masculino , Modelos de Enfermagem , Medicamentos sem Prescrição/uso terapêutico , Cooperação do Paciente/estatística & dados numéricos , Polimedicação , Análise de Regressão , Medição de Risco/métodos , Fatores de Risco , Estatística como Assunto
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