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1.
PLoS One ; 15(4): e0230749, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32240206

RESUMO

BACKGROUND: The international public health (PH) community is debating the opportunity to incorporate genomic technologies into PH practice. A survey was conducted to assess attitudes of the European Public Health Association (EUPHA) members towards their role in the implementation of public health genomics (PHG), and their knowledge and attitudes towards genetic testing and the delivery of genetic services. METHODS: EUPHA members were invited via monthly newsletter and e-mail to take part in an online survey from February 2017 to January 2018. A descriptive analysis of knowledge and attitudes was conducted, along with a univariate and multivariate analysis of their determinants. RESULTS: Five hundred and two people completed the questionnaire, 17.9% were involved in PHG activities. Only 28.9% correctly identified all medical conditions for which there is (or not) evidence for implementing genetic testing; over 60% thought that investing in genomics may divert economic resources from social and environmental determinants of health. The majority agreed that PH professionals may play different roles in incorporating genomics into their activities. Better knowledge was associated with positive attitudes towards the use of genetic testing and the delivery of genetic services in PH (OR = 1.48; 95% CI 1.01-2.18). CONCLUSIONS: Our study revealed quite positive attitudes, but also a need to increase awareness on genomics among European PH professionals. Those directly involved in PHG activities tend to have a more positive attitude and better knowledge; however, gaps are also evident in this group, suggesting the need to harmonize practice and encourage greater exchange of knowledge among professionals.

2.
J Natl Compr Canc Netw ; 18(1): 36-43, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31910385

RESUMO

BACKGROUND: Many new targeted cancer drugs have received FDA approval based on durable responses in nonrandomized controlled trials (non-RCTs). The goal of this study was to evaluate whether the response rates (RRs) and durations of response (DoRs) of targeted cancer drugs observed in non-RCTs are consistent when these drugs are tested in RCTs. METHODS: We used the FDA's Table of Pharmacogenomic Biomarkers in Drug Labeling to identify cancer drugs that were approved based on changes in biomarker endpoints through December 2017. We then identified the non-RCTs and RCTs for these drugs for the given indications and extracted the RRs and DoRs. We compared the RRs and median DoR in non-RCTs versus RCTs using the ratio of RRs and the ratio of DoRs, defined as the RRs (or DoRs) in non-RCTs divided by the RRs (or DoRs) in RCTs. The ratio of RRs or DoRs was pooled across the trial pairs using random-effects meta-analysis. RESULTS: Of the 21 drug-indication pairs selected, both non-RCTs and RCTs were available for 19. The RRs and DoRs in non-RCTs were greater than those in RCTs in 63% and 87% of cases, respectively. The pooled ratio of RRs was 1.06 (95% CI, 0.95-1.20), and the pooled ratio of DoRs was 1.17 (95% CI, 1.03-1.33). RRs and DoRs derived from non-RCTs were also poor surrogates for overall survival derived from RCTs. CONCLUSIONS: The RRs were not different between non-RCTs and RCTs of cancer drugs approved based on changes to a biomarker, but the DoRs in non-RCTs were significantly higher than in RCTs. Caution must be exercised when approving or prescribing targeted drugs based on data on durable responses derived from non-RCTs, because the responses could be overestimates and poor predictors of survival benefit.

3.
Value Health ; 23(1): 114-126, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31952666

RESUMO

BACKGROUND: Monoclonal antibodies against epidermal growth factor receptor (EGFR) have proved beneficial for the treatment of metastatic colorectal cancer (mCRC), particularly when combined with predictive biomarkers of response. International guidelines recommend anti-EGFR therapy only for RAS (NRAS,KRAS) wild-type tumors because tumors with RAS mutations are unlikely to benefit. OBJECTIVES: We aimed to review the cost-effectiveness of RAS testing in mCRC patients before anti-EGFR therapy and to assess how well economic evaluations adhere to guidelines. METHODS: A systematic review of full economic evaluations comparing RAS testing with no testing was performed for articles published in English between 2000 and 2018. Study quality was assessed using the Quality of Health Economic Studies scale, and the British Medical Journal and the Philips checklists. RESULTS: Six economic evaluations (2 cost-effectiveness analyses, 2 cost-utility analyses, and 2 combined cost-effectiveness and cost-utility analyses) were included. All studies were of good quality and adopted the perspective of the healthcare system/payer; accordingly, only direct medical costs were considered. Four studies presented testing strategies with a favorable incremental cost-effectiveness ratio under the National Institute for Clinical Excellence (£20 000-£30 000/QALY) and the US ($50 000-$100 000/QALY) thresholds. CONCLUSIONS: Testing mCRC patients for RAS status and administering EGFR inhibitors only to patients with RAS wild-type tumors is a more cost-effective strategy than treating all patients without testing. The treatment of mCRC is becoming more personalized, which is essential to avoid inappropriate therapy and unnecessarily high healthcare costs. Future economic assessments should take into account other parameters that reflect the real world (eg, NRAS mutation analysis, toxicity of biological agents, genetic test sensitivity and specificity).

4.
Cancer Med ; 9(2): 824-836, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31777197

RESUMO

Current recommendations of The US Preventive Services Task Force (USPSTF) on colorectal cancer (CRC) screening strategies are based on models that assume 100% adherence. Since adherence can have a large effect on screening outcomes, we aimed to compare the effectiveness of CRC screening strategies under reported adherence rates at the population level. We developed and validated a microsimulation model to assess the effectiveness of colonoscopy (COL), flexible sigmoidoscopy (FS), high-sensitivity guaiac fecal occult blood-test (HS-gFOBT), fecal immunochemical test (FIT), multitarget stool DNA test (FIT-DNA), computed tomography colonography (CTC), and methylated SEPT9 DNA test (SEPT9) in terms of CRC incidence and mortality, incremental life years gained (LYG), number of colonoscopies, and adverse events for men and women 50 years or older over their lifetime. We assessed outcomes under 100% adherence rates and reported adherence rates. We also performed sensitivity analyses to evaluate the impact of varying adherence levels on CRC outcomes. Assuming 100% adherence, FIT-DNA, FIT, HS-gFOBT, and SEPT9 averted 42-45 CRC cases and 25-26 CRC deaths, COL 46 cases and 26 deaths, CTC 39 cases and 23 deaths, FS 32 cases and 19 deaths per 1000 individuals. Assuming reported adherence, SEPT9 averted 37 CRC cases and 23 CRC deaths, COL 34 cases and 20 deaths, FIT-DNA, FIT, CTC and HS-gFOBT 16-25 cases and 10-16 deaths per 1000 individuals. LYG reflected the effectiveness of each strategy in reducing CRC cases and deaths. Adverse events were more common for COL (3.7 per 1000 screened) and annual SEPT9 (3.4 per 1000 screened), and proportional to the number of colonoscopies. Among the screening strategies recommended by USPSTF, colonoscopy results in the largest benefit when we account for adherence. Adherence rates higher than 65%-70% would be required for any stool or blood-based screening modality to match the benefits of colonoscopy.

5.
Int J Cancer ; 146(3): 781-790, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30977121

RESUMO

Bronchoscopy is the safest procedure for lung cancer diagnosis when an invasive evaluation is required after imaging procedures. However, its sensitivity is relatively low, especially for small and peripheral lesions. We assessed benefits and costs of introducing a bronchial gene-expression classifier (BGC) to improve the performance of bronchoscopy and the overall diagnostic process for early detection of lung cancer. We used discrete-event simulation to compare clinical and economic outcomes of two different strategies with the standard practice in former and current smokers with indeterminate nodules: (i) location-based strategy-integrated the BGC to the bronchoscopy indication; (ii) simplified strategy-extended use of bronchoscopy plus BGC also on small and peripheral lesions. Outcomes modeled were rate of invasive procedures, quality-adjusted-life-years (QALYs), costs and incremental cost-effectiveness ratios. Compared to the standard practice, the location-based strategy (i) reduced absolute rate of invasive procedures by 3.3% without increasing costs at the current BGC market price. It resulted in savings when the BGC price was less than $3,000. The simplified strategy (ii) reduced absolute rate of invasive procedures by 10% and improved quality-adjusted life expectancy, producing an incremental cost-effectiveness ratio of $10,109 per QALY. In patients with indeterminate nodules, both BGC strategies reduced unnecessary invasive procedures at high risk of adverse events. Moreover, compared to the standard practice, the simplified use of BGC for central and peripheral lesions resulted in larger QALYs gains at acceptable cost. The location-based is cost-saving if the price of classifier declines.


Assuntos
Análise Custo-Benefício , Detecção Precoce de Câncer/normas , Neoplasias Pulmonares/diagnóstico , Idoso , Biomarcadores Tumorais/genética , Biópsia/efeitos adversos , Biópsia/economia , Biópsia/normas , Brônquios/diagnóstico por imagem , Brônquios/patologia , Broncoscopia/efeitos adversos , Broncoscopia/economia , Broncoscopia/normas , Simulação por Computador , Redução de Custos , Detecção Precoce de Câncer/economia , Detecção Precoce de Câncer/métodos , Feminino , Seguimentos , Perfilação da Expressão Gênica/economia , Perfilação da Expressão Gênica/normas , Humanos , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/cirurgia , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade , Padrão de Cuidado/economia , Tomografia Computadorizada por Raios X/efeitos adversos , Tomografia Computadorizada por Raios X/economia , Tomografia Computadorizada por Raios X/normas
6.
J Natl Cancer Inst ; 2019 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-31651981

RESUMO

BACKGROUND: The FDA's accelerated approval and later withdrawal for bevacizumab in patients with metastatic breast cancer (mBC) is a seminal case for ongoing debates about the validity of using progression-free survival (PFS) as a surrogate measure for overall survival (OS) in cancer drug approvals. We systematically reviewed and meta-analyzed the evidence around bevacizumab's regulatory approval and withdrawal in mBC. METHODS: We searched for all published phase 2 or 3 clinical trials testing bevacizumab in first-line mBC. Data was extracted on trial demographics, interventions, and outcomes. Descriptive analysis was stratified by whether the trial was initiated prior to, during, or after the accelerated approval. We used a cumulative random effects meta-analysis to assess the evolution of evidence of the effect of bevacizumab on PFS and OS. We estimated the association between the trial-level PFS and OS effect using a non-linear mixed regression model. RESULTS: Fifty-two studies were included. Trial activity dramatically dropped after the accelerated approval was withdrawn. Eight clinical trials reported hazard ratios (HRs) and were meta-analyzed. The cumulative HR for PFS was 0.72 (95%CI 0.65-0.79), and the cumulative HR for OS was 0.90 (95%CI 0.80-1.01). The regression model showed a statistically non-significant association between PFS benefit and OS benefit (ß = 0.43, SE = 0.81). CONCLUSION: The FDA's decision-making in this case was consistent with the evolving state of evidence. However, the fact that 7 clinical trials is insufficient to conclude validity (or lack thereof) for a trial-level surrogate suggests that it would be more efficient to conduct trials using the more clinically meaningful endpoints.

7.
J Law Med Ethics ; 47(3): 357-361, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31560620

RESUMO

Biomarkers can be powerful tools to guide diagnosis, treatment, and research. However, prudent use of bio-markers requires formal validation efforts. Although the data needed for biomarker validation has traditionally been hard to access, new research initiatives can ease this process.

8.
J Law Med Ethics ; 47(3): 381-387, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31560631

RESUMO

The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

9.
PLoS One ; 14(8): e0219755, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31381569

RESUMO

BACKGROUND: The existing frameworks for the evaluation of genetic and genomic applications clearly address the technical and clinical value of a test, but are less concerned with the way genetic services are delivered and organized. We therefore aimed to develop a comprehensive new framework that includes an assessment of service delivery. METHODS: A new framework was built on the evaluation dimensions identified through a systematic review of the existing frameworks and a Delphi survey of Italian experts in public health genomics. RESULTS: Our framework has four sections. The first two sections, respectively, guide the evidence collection process for the genetic test (analytic validity; clinical validity; clinical utility; personal utility) and its delivery models (organizational aspects; economic evaluation; ethical, legal and social implications; patient perspective). The third section guides the formulation of the research priorities to be addressed in future research. Finally, the fourth section suggests three criteria to summarize the collected evidence (net benefit, cost-effectiveness, feasibility). CONCLUSION: We have successfully developed an evaluation framework for the evaluation of genetic tests that includes an assessment of service delivery. It also introduces some neglected evaluation dimensions such as personal utility and patient perspective.

10.
JAMA Netw Open ; 2(4): e192224, 2019 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-30977858

RESUMO

Importance: Niacin remains a therapeutic option for patients with cardiovascular disease, but recent studies have called into question the effectiveness of other drugs that increase high-density lipoprotein cholesterol levels. Objective: To systematically review and evaluate the evidence supporting current US Food and Drug Administration-approved uses of niacin in cardiovascular disease prevention settings. Data Sources: MEDLINE, Embase, Cochrane Controlled Clinical Trial Register (Central), ClinicalTrials.gov, and TrialResults-center, from database inception to October 2017. Study Selection: The systematic review included clinical trials involving niacin as a treatment for cardiovascular disease. The meta-analysis included randomized clinical trials reporting niacin's effect, as exposure, on at least 1 long-term cardiovascular disease outcome. Data Extraction and Synthesis: Aggregate study-level data were extracted between November 2017 and January 2018 by 3 independent reviewers, and the analysis was performed in February 2018. Inverse-variance weighted methods were used to produce pooled risk ratios using random-effects models for between-study heterogeneity. Random effects-weighted metaregression analysis was used to assess the association of change in high-density lipoprotein cholesterol levels with the log risk ratio of the pooled results. Main Outcomes and Measures: Cardiovascular disease, coronary heart disease mortality, and other cardiovascular events, including acute coronary syndrome, fatal and nonfatal stroke, revascularization, and major adverse cardiac events. Results: Of 119 clinical trials, 17 documented niacin's effect on at least 1 cardiovascular disease outcome. The meta-analysis included 35 760 patients with histories of cardiovascular disease or dyslipidemia. Cumulative evidence found no preventive association of niacin with cardiovascular outcomes in secondary prevention. Stratified meta-analysis showed an association of niacin monotherapy with reduction of some cardiovascular events among patients without statin treatment (acute coronary syndrome: relative risk, 0.74; 95% CI, 0.58-0.96; stroke: relative risk, 0.74; 95% CI, 0.59-0.94; revascularization: relative risk, 0.51; 95% CI, 0.37-0.72). These results were mainly derived from 2 trials conducted in the 1970s and 1980s. Conclusions and Relevance: Niacin may have some use in lipid control for secondary prevention as monotherapy, perhaps in patients intolerant to statins, but evidence is from older studies on a population potentially not representative of current-day patients.


Assuntos
Doenças Cardiovasculares/tratamento farmacológico , Hipolipemiantes/uso terapêutico , Niacina/uso terapêutico , Adulto , Idoso , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Feminino , Humanos , Lipoproteínas HDL/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Prevenção Secundária , Resultado do Tratamento , Estados Unidos
13.
Eur J Hum Genet ; 26(9): 1398, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29980747

RESUMO

This article was originally published under an incorrect license. This has now been amended and is available under a CC BY-NC-ND 4.0 license. The PDF and HTML versions of the paper have been modified accordingly.

14.
Eur J Hum Genet ; 26(5): 605-615, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29422659

RESUMO

Given the rapid development of genetic tests, an assessment of their benefits, risks, and limitations is crucial for public health practice. We performed a systematic review aimed at identifying and comparing the existing evaluation frameworks for genetic tests. We searched PUBMED, SCOPUS, ISI Web of Knowledge, Google Scholar, Google, and gray literature sources for any documents describing such frameworks. We identified 29 evaluation frameworks published between 2000 and 2017, mostly based on the ACCE Framework (n = 13 models), or on the HTA process (n = 6), or both (n = 2). Others refer to the Wilson and Jungner screening criteria (n = 3) or to a mixture of different criteria (n = 5). Due to the widespread use of the ACCE Framework, the most frequently used evaluation criteria are analytic and clinical validity, clinical utility and ethical, legal and social implications. Less attention is given to the context of implementation. An economic dimension is always considered, but not in great detail. Consideration of delivery models, organizational aspects, and consumer viewpoint is often lacking. A deeper analysis of such context-related evaluation dimensions may strengthen a comprehensive evaluation of genetic tests and support the decision-making process.


Assuntos
Testes Genéticos/tendências , Genética Médica/tendências , Tomada de Decisões , Humanos , PubMed
15.
Eur J Hum Genet ; 26(4): 518-526, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29374276

RESUMO

We evaluated whether genetic tests with evidence of clinical and personal utility (i.e. APC and BRCA1/2 tests) are associated with higher satisfaction and a more positive perception of care experience than those with undefined utility (i.e. tests for thrombophilia). A cross-sectional survey was performed through telephone interviews to patients tested for deleterious variants in APC or BRCA1/2 genes, or for inherited thrombophilia (FV Leiden and/or FIIG20210A) during a 5-year period (2008-2012). Three aspects of patient experience were assessed: effective communication through pre- and post-test genetic counselling; collaboration between caregivers on the management of patient care; and impact of genetic testing on quality of life. Overall 237 patients had telephone interviews. Multivariate logistic regression analyses showed that patients tested for APC or BRCA1/2 variants were more likely to be satisfied with both pre- and post-test counselling than those tested for inherited thrombophilia (APC vs. thrombophilia, p = 0.039 and 0.005; BRCA1/2 vs. thrombophilia, p = 0.030 and <0.001). Patients tested for APC were more likely to report an improvement in quality of life than those for thrombophilia (OR = 2.97, 95%CI 1.14, 7.72; p = 0.025). A positive association was observed between patients who underwent BRCA1/2 testing, and self-perceived improvement in quality of life (OR = 1.41, 95%CI 0.74, 2.69; p = 0.294). Tests of undefined clinical and personal utility are associated with a lower degree of patient satisfaction with genetic counselling and no clear opinions on changes in quality of life compared with those with well-defined utility.


Assuntos
Atitude , Aconselhamento Genético/psicologia , Predisposição Genética para Doença/psicologia , Neoplasias/psicologia , Trombofilia/psicologia , Adolescente , Adulto , Idoso , Feminino , Aconselhamento Genético/métodos , Testes Genéticos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/genética , Pacientes/psicologia , Trombofilia/genética
16.
Front Public Health ; 5: 252, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28993804

RESUMO

BACKGROUND: Familial hypercholesterolemia (FH) is an autosomal-dominant hereditary disorder of lipid metabolism that causes lifelong exposure to increased LDL levels resulting in premature coronary heart disease and, if untreated, death. Recent studies have shown its prevalence to be higher than previously considered, which has important implications for the mortality and morbidity of associated cardiovascular disease (CVD). Several clinical tools are used worldwide to help physicians diagnose FH, but nevertheless most patients remain undetected. This systematic review of guidelines aims to assess the role of genetic testing in the screening, diagnosis, and management of patients affected by heterozygous or homozygous FH and to identify related health-care pathways. METHODS: We performed a systematic review of the literature; inclusion criteria were English or Italian guidelines focusing on genetic testing. The guidelines were included and evaluated for their content and development process using the Appraisal of Guidelines for Research and Evaluation II instrument. RESULTS: Ten guidelines were considered eligible, and all were judged to be of good quality, with slight differences among them. The most common indications for performing genetic tests were high levels of cholesterol, or physical findings consistent with lipid disorder, in the subject or in the family history. Subsequent screening of family members was indicated when a mutation had been identified in the index patient. Regarding patient management, the various guidelines agreed that intensive treatment with lipid-lowering medications should begin as quickly as possible and that lifestyle modifications should be an integral part of the therapy. CONCLUSION: Since the early detection of affected patients is beneficial for effective prevention of CVD, genetic testing is particularly useful for identifying family members via cascade screening and for distinguishing between heterozygous and homozygous individuals, the latter of which require more extreme therapeutic intervention.

17.
Front Public Health ; 5: 223, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28879178

RESUMO

INTRODUCTION: The appropriate application of genomic technologies in healthcare is surrounded by many concerns. In particular, there is a lack of evidence on what constitutes an optimal genetic service delivery model, which depends on the type of genetic test and healthcare context considered. The present project aims to identify, classify, and evaluate delivery models for the provision of predictive genetic testing in Europe and in selected Anglophone extra-European countries (the USA, Canada, Australia, and New Zealand). It also sets out to survey the European public health community's readiness to incorporate public health genomics into their practice. MATERIALS AND EQUIPMENT: The project consists of (i) a systematic review of published literature and selected country websites, (ii) structured interviews with health experts on the genetic service delivery models in their respective countries, and (iii) a survey of European Public Health Association (EUPHA) members' knowledge and attitudes toward genomics applications in clinical practice. The inclusion criteria for the systematic review are that articles be published in the period 2000-2015; be in English or Italian; and be from European countries or from Canada, the USA, Australia, or New Zealand. Additional policy documents will be retrieved from represented countries' government-affiliated websites. The results of the research will be disseminated through the EUPHA network, the Italian Network for Genomics in Public Health (GENISAP), and seminars and workshops. EXPECTED IMPACT OF THE STUDY ON PUBLIC HEALTH: The transfer of genomic technologies from research to clinical application is influenced not only by several factors inherent to research goals and delivery of healthcare but also by external and commercial interests that may cause the premature introduction of genetic tests in the public and private sectors. Furthermore, current genetic services are delivered without a standardized set of process and outcome measures, which makes the evaluation of healthcare services difficult. The present study will identify and classify delivery models and, subsequently, establish which are appropriate for the provision of predictive genetic testing in Europe by comparing sets of process and outcome measures. In this way, the study will provide a basis for future recommendations to decision makers involved in the financing, delivery, and consumption of genetic services.

18.
Nurse Educ Today ; 53: 54-60, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28445791

RESUMO

BACKGROUND: Advanced education in nursing is essential to provide safe, high quality and efficient health services in line with population needs. However, there is an almost complete lack of studies on how nurses view the usefulness of post-graduate education for their current employment and for professional advancement. OBJECTIVES: To evaluate how nurse graduates view the quality, relevance and applicability of the knowledge and skills acquired during the Master of Science in Nursing (MSN) degree. DESIGN: Multicentre cross-sectional study. METHODS: A multicenter cross-sectional study was carried out through an online questionnaire mailed (July 2014-June 2015) to 560 nurses who obtained the MSN degree from 23 Italian universities in the academic year 2010-2011. DISCUSSION: A total of 426 nurses completed the survey (response rate 76.1%), 80% of whom believed they had acquired knowledge and skills useful in their professional life after graduation. A multiple logistic regression model highlighted the characteristics of nurse graduates who judged the master's course relevant for their present role. In brief, they are expert nurses (OR=3.41, 95% CI=1.54-7.54) who achieved professional growth after the course (OR=5.25, 95% CI=2.67-10.33) and who judged the course very good or excellent (OR=2.16, 95% CI=1.04-4.52). Only 8% of the respondents achieved a full professional growth after the course. CONCLUSION: In Italy, MSN courses are able to provide a high level of skills and competencies. However, given the low rate of professional growth after the course, specific policies should increase the employment rates of new master's graduate nurses.


Assuntos
Mobilidade Ocupacional , Emprego , Tocologia/educação , Competência Profissional , Estudantes de Enfermagem , Adulto , Atitude do Pessoal de Saúde , Estudos Transversais , Educação de Pós-Graduação em Enfermagem , Feminino , Humanos , Itália , Pesquisa em Educação de Enfermagem , Inquéritos e Questionários
19.
Genet Med ; 18(12): 1171-1180, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27906166

RESUMO

PURPOSE: There is considerable evidence regarding the efficacy and effectiveness of BRCA genetic testing programs, but whether they represent good use of financial resources is not clear. Therefore, we aimed to identify the main health-care programs for BRCA testing and to evaluate their cost-effectiveness. METHODS: We performed a systematic review of full economic evaluations of health-care programs involving BRCA testing. RESULTS: Nine economic evaluations were included, and four main categories of BRCA testing programs were identified: (i) population-based genetic screening of individuals without cancer, either comprehensive or targeted based on ancestry; (ii) family history (FH)-based genetic screening, i.e., testing individuals without cancer but with FH suggestive of BRCA mutation; (iii) familial mutation (FM)-based genetic screening, i.e., testing individuals without cancer but with known familial BRCA mutation; and (iv) cancer-based genetic screening, i.e., testing individuals with BRCA-related cancers. CONCLUSIONS: Currently BRCA1/2 population-based screening represents good value for the money among Ashkenazi Jews only. FH-based screening is potentially very cost-effective, although further studies that include costs of identifying high-risk women are needed. There is no evidence of cost-effectiveness for BRCA screening of all newly diagnosed cases of breast/ovarian cancers followed by cascade testing of relatives, but programs that include tools for identifying affected women at higher risk for inherited forms are promising. Cost-effectiveness is highly sensitive to the cost of BRCA1/2 testing.Genet Med 18 12, 1171-1180.


Assuntos
Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias da Mama/economia , Análise Custo-Benefício , Neoplasias Ovarianas/economia , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/genética , Feminino , Predisposição Genética para Doença , Testes Genéticos/economia , Humanos , Judeus/genética , Programas de Rastreamento/economia , Mutação , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/genética , Medição de Risco
20.
Ig Sanita Pubbl ; 72(2): 107-17, 2016.
Artigo em Italiano | MEDLINE | ID: mdl-27336955

RESUMO

To acquire essential knowledge and skills for Public Health practice, residents in Hygiene and Preventive Medicine programs should be provided with excellent training. On behalf of the Roman Public Health Academy (ARSP), the authors, representing the three Hygiene and Preventive Medicine residency training programs in Rome (Italy) aimed to propose a training program to be shared by the above three schools. Firstly, they performed a scientific literature review to identify the core competencies that a public health specialist should have acquired at the end of training. Ten areas (macro-areas or domains) relevant to Public Health practice were defined. The authors then identified the main characteristics that the proposed training program should have, which include: enhancement of community healthcare services and optimization of local resources to create/strengthen exchange and cooperation networks; possibility to adapt the training proposal to an international setting; adoption of a training approach that can respond effectively to a changing health system; customization of training on the basis of residents' individual abilities and motivations, so that their individual strengths can be enhanced; achievement of educational excellence, in compliance with ethical requirements.


Assuntos
Competência Clínica , Currículo , Higiene/educação , Internato e Residência , Medicina Preventiva/educação , Humanos , Roma
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