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PURPOSE: We aimed to validate and, if performance was unsatisfactory, update the previously published prognostic model to predict clinical deterioration in patients hospitalized for COVID-19, using data following vaccine availability. METHODS: Using electronic health records of patients ≥18 years, with laboratory-confirmed COVID-19, from a large care-delivery network in Massachusetts, USA, from March 2020 to November 2021, we tested the performance of the previously developed prediction model and updated the prediction model by incorporating data after availability of COVID-19 vaccines. We randomly divided data into development (70%) and validation (30%) cohorts. We built a model predicting worsening in a published severity scale in 24 h by LASSO regression and evaluated performance by c-statistic and Brier score. RESULTS: Our study cohort consisted of 8185 patients (Development: 5730 patients [mean age: 62; 44% female] and Validation: 2455 patients [mean age: 62; 45% female]). The previously published model had suboptimal performance using data after November 2020 (N = 4973, c-statistic = 0.60. Brier score = 0.11). After retraining with the new data, the updated model included 38 predictors including 18 changing biomarkers. Patients hospitalized after Jun 1st, 2021 (when COVID-19 vaccines became widely available in Massachusetts) were younger and had fewer comorbidities than those hospitalized before. The c-statistic and Brier score were 0.77 and 0.13 in the development cohort, and 0.73 and 0.14 in the validation cohort. CONCLUSION: The characteristics of patients hospitalized for COVID-19 differed substantially over time. We developed a new dynamic model for rapid progression with satisfactory performance in the validation set.
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COVID-19 , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , COVID-19/diagnóstico , Femenino , Masculino , Persona de Mediana Edad , Pronóstico , Anciano , Massachusetts/epidemiología , Registros Electrónicos de Salud/estadística & datos numéricos , Deterioro Clínico , Estudios de Cohortes , Hospitalización/estadística & datos numéricos , Índice de Severidad de la Enfermedad , Vacunas contra la COVID-19/administración & dosificación , Modelos Estadísticos , Adulto , Medición de RiesgoRESUMEN
AIM: To examine trends of second-line glucose-lowering therapies among patients with type 2 diabetes (T2D) initiating first-line metformin in the United States and the United Kingdom, overall and by subgroups of cardiovascular disease (CVD) and calendar time. METHODS: Using the US Optum Clinformatics and the UK Clinical Practice Research Datalink, we identified adults with T2D who initiated first-line metformin or sulphonylurea monotherapy, separately, from 2013 to 2019. Within both cohorts, we identified patterns of second-line medications through June 2021. We stratified patterns by CVD and calendar time to investigate the impact of rapidly evolving treatment guidelines. RESULTS: We identified 148 511 and 169 316 patients initiating treatment with metformin monotherapy in the United States and the United Kingdom, respectively. Throughout the study period, sulphonylureas and dipeptidyl peptidase-4 inhibitors were the most frequently initiated second-line medications in the United States (43.4% and 18.2%, respectively) and the United Kingdom (42.5% and 35.8%, respectively). After 2018, sodium-glucose co-transporter 2 inhibitors and glucagon-like peptide-1 receptor agonists were more commonly used as second-line agents in the United States and the United Kingdom, although these agents were not preferentially prescribed among patients with CVD. Initiation of first-line sulphonylureas was much less common, and most sulphonylurea initiators had metformin added as the second-line agent. CONCLUSIONS: This international cohort study shows that sulphonylureas remain the most common second-line medications prescribed following metformin in both the United States and the United Kingdom. Despite recommendations, the use of newer glucose-lowering therapies with cardiovascular benefits remains low.
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Inhibidores de la Dipeptidil-Peptidasa IV , Metformina , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Adulto , Humanos , Estados Unidos/epidemiología , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/inducido químicamente , Hipoglucemiantes/efectos adversos , Estudios de Cohortes , Compuestos de Sulfonilurea/efectos adversos , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Reino Unido/epidemiología , Enfermedades Cardiovasculares/inducido químicamente , Glucosa/uso terapéuticoRESUMEN
BACKGROUND: We sought to develop and prospectively validate a dynamic model that incorporates changes in biomarkers to predict rapid clinical deterioration in patients hospitalized for COVID-19. METHODS: We established a retrospective cohort of hospitalized patients aged ≥18 years with laboratory-confirmed COVID-19 using electronic health records (EHR) from a large integrated care delivery network in Massachusetts including >40 facilities from March to November 2020. A total of 71 factors, including time-varying vital signs and laboratory findings during hospitalization were screened. We used elastic net regression and tree-based scan statistics for variable selection to predict rapid deterioration, defined as progression by two levels of a published severity scale in the next 24 h. The development cohort included the first 70% of patients identified chronologically in calendar time; the latter 30% served as the validation cohort. A cut-off point was estimated to alert clinicians of high risk of imminent clinical deterioration. RESULTS: Overall, 3706 patients (2587 in the development and 1119 in the validation cohort) met the eligibility criteria with a median of 6 days of follow-up. Twenty-four variables were selected in the final model, including 16 dynamic changes of laboratory results or vital signs. Area under the ROC curve was 0.81 (95% CI, 0.79-0.82) in the development set and 0.74 (95% CI, 0.71-0.78) in the validation set. The model was well calibrated (slope = 0.84 and intercept = -0.07 on the calibration plot in the validation set). The estimated cut-off point, with a positive predictive value of 83%, was 0.78. CONCLUSIONS: Our prospectively validated dynamic prognostic model demonstrated temporal generalizability in a rapidly evolving pandemic and can be used to inform day-to-day treatment and resource allocation decisions based on dynamic changes in biophysiological factors.
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COVID-19 , Deterioro Clínico , Humanos , Adolescente , Adulto , COVID-19/epidemiología , Pronóstico , Estudios Retrospectivos , HospitalizaciónRESUMEN
Importance: Nonrandomized studies using insurance claims databases can be analyzed to produce real-world evidence on the effectiveness of medical products. Given the lack of baseline randomization and measurement issues, concerns exist about whether such studies produce unbiased treatment effect estimates. Objective: To emulate the design of 30 completed and 2 ongoing randomized clinical trials (RCTs) of medications with database studies using observational analogues of the RCT design parameters (population, intervention, comparator, outcome, time [PICOT]) and to quantify agreement in RCT-database study pairs. Design, Setting, and Participants: New-user cohort studies with propensity score matching using 3 US claims databases (Optum Clinformatics, MarketScan, and Medicare). Inclusion-exclusion criteria for each database study were prespecified to emulate the corresponding RCT. RCTs were explicitly selected based on feasibility, including power, key confounders, and end points more likely to be emulated with real-world data. All 32 protocols were registered on ClinicalTrials.gov before conducting analyses. Emulations were conducted from 2017 through 2022. Exposures: Therapies for multiple clinical conditions were included. Main Outcomes and Measures: Database study emulations focused on the primary outcome of the corresponding RCT. Findings of database studies were compared with RCTs using predefined metrics, including Pearson correlation coefficients and binary metrics based on statistical significance agreement, estimate agreement, and standardized difference. Results: In these highly selected RCTs, the overall observed agreement between the RCT and the database emulation results was a Pearson correlation of 0.82 (95% CI, 0.64-0.91), with 75% meeting statistical significance, 66% estimate agreement, and 75% standardized difference agreement. In a post hoc analysis limited to 16 RCTs with closer emulation of trial design and measurements, concordance was higher (Pearson r, 0.93; 95% CI, 0.79-0.97; 94% meeting statistical significance, 88% estimate agreement, 88% standardized difference agreement). Weaker concordance occurred among 16 RCTs for which close emulation of certain design elements that define the research question (PICOT) with data from insurance claims was not possible (Pearson r, 0.53; 95% CI, 0.00-0.83; 56% meeting statistical significance, 50% estimate agreement, 69% standardized difference agreement). Conclusions and Relevance: Real-world evidence studies can reach similar conclusions as RCTs when design and measurements can be closely emulated, but this may be difficult to achieve. Concordance in results varied depending on the agreement metric. Emulation differences, chance, and residual confounding can contribute to divergence in results and are difficult to disentangle.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Proyectos de Investigación , Estudios Observacionales como AsuntoRESUMEN
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.
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Análisis Costo-Beneficio , Detección Precoz del Cáncer/normas , Neoplasias Pulmonares/diagnóstico , Anciano , Biomarcadores de Tumor/genética , Biopsia/efectos adversos , Biopsia/economía , Biopsia/normas , Bronquios/diagnóstico por imagen , Bronquios/patología , Broncoscopía/efectos adversos , Broncoscopía/economía , Broncoscopía/normas , Simulación por Computador , Ahorro de Costo , Detección Precoz del Cáncer/economía , Detección Precoz del Cáncer/métodos , Femenino , Estudios de Seguimiento , Perfilación de la Expresión Génica/economía , Perfilación de la Expresión Génica/normas , Humanos , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/cirugía , Masculino , Persona de Mediana Edad , Modelos Económicos , Años de Vida Ajustados por Calidad de Vida , Sensibilidad y Especificidad , Nivel de Atención/economía , Tomografía Computarizada por Rayos X/efectos adversos , Tomografía Computarizada por Rayos X/economía , Tomografía Computarizada por Rayos X/normasRESUMEN
BACKGROUND: We explored whether clinically relevant baseline characteristics of patients with type 2 diabetes can modify the effect of glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium-glucose cotransporter-2 inhibitors (SGLT-2i) on the risk of major adverse cardiovascular events (MACE). METHODS: We investigated Medline and EMBASE through June 2019. We included randomized clinical trials reporting the effect of GLP-1 RA or SGLT-2i on MACE in subgroups of patients with type 2 diabetes, identified through key baseline factors: established cardiovascular disease; heart failure; chronic kidney disease; uncontrolled diabetes; duration of diabetes; hypertension; obesity; age; gender and race. Hazard ratios (HRs) and 95% confidence intervals (CIs) from trials were meta-analyzed using random-effects models. RESULTS: Ten trials enrolling 89,790 patients were included in the analyses. Subgroup meta-analyses showed a 14% risk reduction of MACE in patients with established cardiovascular disease [GLP1-RA: HR, 0.86 (95% CI, 0.80-0.93); SGLT-2i: 0.86 (0.80-0.93)], and no effect in at-risk patients without history of cardiovascular events [GLP1-RA: 0.94 (0.82-1.07); SGLT-2i: 1.00 (0.87-1.16)]. We observed a trend toward larger treatment benefits with SGLT-2i among patients with chronic kidney disease [0.82 (0.69-0.97)], and patients with uncontrolled diabetes for both GLP1-RA or SGLT-2i [GLP1-RA: 0.82 (0.71-0.95); SGLT-2i: 0.84 (0.75-0.95)]. Uncontrolled hypertension, obesity, gender, age and race did not appear to modify the effect of these drugs. CONCLUSIONS: In this exploratory analysis, history of cardiovascular disease appeared to modify the treatment effect of SGLT2i or GLP1-RA on MACE. Chronic kidney disease and uncontrolled diabetes should be further investigated as potential effect modifiers.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Receptor del Péptido 1 Similar al Glucagón/agonistas , Hipoglucemiantes/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Factores de Edad , Glucemia/metabolismo , Comorbilidad , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/metabolismo , Etnicidad , Insuficiencia Cardíaca/epidemiología , Humanos , Hipertensión/epidemiología , Análisis de Mediación , Obesidad/epidemiología , Modelos de Riesgos Proporcionales , Insuficiencia Renal Crónica/epidemiología , Factores Sexuales , Factores de TiempoRESUMEN
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.
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Antineoplásicos/uso terapéutico , Biomarcadores de Tumor/análisis , Neoplasias/tratamiento farmacológico , Medicina de Precisión/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Antineoplásicos/farmacología , Biomarcadores de Tumor/antagonistas & inhibidores , Biomarcadores de Tumor/genética , Humanos , Neoplasias/diagnóstico , Neoplasias/genética , Reproducibilidad de los Resultados , Factores de Tiempo , Resultado del TratamientoRESUMEN
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).
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Neoplasias Colorrectales/economía , Neoplasias Colorrectales/genética , Análisis Mutacional de ADN/economía , Genes ras , Costos de la Atención en Salud , Mutación , Pruebas de Farmacogenómica/economía , Variantes Farmacogenómicas , Medicina de Precisión/economía , Antineoplásicos Inmunológicos/economía , Antineoplásicos Inmunológicos/uso terapéutico , Toma de Decisiones Clínicas , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Análisis Costo-Beneficio , Costos de los Medicamentos , Receptores ErbB/antagonistas & inhibidores , Predisposición Genética a la Enfermedad , Humanos , Metástasis de la Neoplasia , Selección de Paciente , Fenotipo , Valor Predictivo de las Pruebas , Años de Vida Ajustados por Calidad de VidaRESUMEN
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.
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Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias de la Mama/economía , Análisis Costo-Beneficio , Neoplasias Ováricas/economía , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/genética , Femenino , Predisposición Genética a la Enfermedad , Pruebas Genéticas/economía , Humanos , Judíos/genética , Tamizaje Masivo/economía , Mutación , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/genética , Medición de RiesgoRESUMEN
BACKGROUND: Health promotion and prevention activities should tackle health inequalities to reduce disparities in health among disadvantaged populations. This study aimed to assess the extent to which the Italian Regions considered health inequalities during the planning of prevention activities, to detect geographical differences and to identify the possible determinants of differences in attention to health inequalities. METHODS: The 19 Regional Prevention Plans (RPPs) developed by Italian Regions within the National Prevention Plan (NPP) 2010-2013 were assessed using a specific tool to address the level of attention to health inequalities. Univariate and multivariate analyses were performed to identify regional characteristics associated with a higher level of attention to health inequalities. RESULTS: Of the 702 projects included in the 19 RPPs, only 56 (8.0 %) specifically addressed issues related to health inequalities. The results of the multivariate analysis showed that a higher level of attention was associated with the macroarea of intervention 'prevention in high-risk groups', with the higher quality of the Strategic Plan Section of the RPP and with the higher percentage of migrants in the Region in 2010. Moreover, projects that addressed the topic of health inequalities were more likely to be developed in the Northern Regions, in Regions with a lower level of 'linking social capital' and with a Higher Regional Health Care Expenditure (RHCE) as a percentage of Regional Gross Domestic Product (RGDP) in 2010. CONCLUSIONS: The level of attention to health inequalities in the regional planning process of prevention activities 2010-2013 in Italy is low. The results of this study supported the new round of prevention planning in Italy, and highlight the urgent need to increase the number of policies and interventions able to reduce health inequalities.
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Etnicidad/estadística & datos numéricos , Promoción de la Salud/normas , Disparidades en Atención de Salud/tendencias , Salud Pública/métodos , Promoción de la Salud/estadística & datos numéricos , Disparidades en Atención de Salud/estadística & datos numéricos , Humanos , ItaliaRESUMEN
This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.
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Fármacos Cardiovasculares/uso terapéutico , Enfermedades Cardiovasculares/tratamiento farmacológico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Medicamentos Genéricos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Equivalencia TerapéuticaRESUMEN
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.
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Competencia Clínica , Curriculum , Higiene/educación , Internado y Residencia , Medicina Preventiva/educación , Humanos , Ciudad de RomaRESUMEN
This study was aimed to assess the association between regional financial deficits and Recovery Plans and the quality of the 702 projects developed by the Italian Regions within the National Prevention Plan 2010-13. Multivariate analyses showed significant associations between Recovery Plans and low quality of projects, possibly due to weak regional public health capacities. Regions with Recovery Plans are likely to focus mainly on short-term issues with a high impact on health care costs, leaving few resources available for prevention. A different approach to financial deficit focused on long-term strategies, including those for health promotion and disease prevention, is needed.
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Prevención Primaria/economía , Salud Pública/economía , Asignación de Recursos para la Atención de Salud/economía , Humanos , Italia , Calidad de la Atención de Salud/economíaRESUMEN
OBJECTIVES: To identify those studies in which economic analysis of predictive genetic and pharmacogenetic testing programs have been carried out. Since the Italian National Prevention Plan 2014-2018 foresees the implementation of genetic testing for inherited breast cancer, special attention was given to the cost-effectiveness of BRCA1/2 testing programs. METHODS: A systematic review of primary economic evaluations (EEs) of predictive genetic and pharmacogenetic testing programs and an overview of previously published systematic reviews of economic evaluations (ERs) was performed. RESULTS: Overall 128 EEs and 11 ERs were identified. The methodological quality of both EEs and ERs was good on average. Both predictive genetic and pharmacogenetic testing programs were mainly concerned with oncological diseases. Seventeen percent of genetic testing programs are cost-saving, while a further 44% of cost/QALY ratios fall under the commonly used threshold of 37,000 per QALY. For BRCA1/2 testing, only cascade genetic screening programs, targeted to close relatives of carriers, show clear evidence of cost-effectiveness. CONCLUSION: Despite some limitations, EEs and ERs are powerful tools that provide indications to policy-makers on which genetic testing programs might be introduced into health care systems and public health practice.
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Pruebas Genéticas/economía , Pruebas de Farmacogenómica/economía , Neoplasias de la Mama/economía , Neoplasias de la Mama/genética , Neoplasias de la Mama/prevención & control , Análisis Costo-Beneficio , Atención a la Salud/economía , Detección Precoz del Cáncer/economía , Femenino , Genes BRCA1 , Genes BRCA2 , Enfermedades Genéticas Congénitas/economía , Enfermedades Genéticas Congénitas/genética , Predisposición Genética a la Enfermedad , Salud Global , Costos de la Atención en Salud , Humanos , Reembolso de Seguro de Salud , Esperanza de Vida , Neoplasias Ováricas/economía , Neoplasias Ováricas/genética , Neoplasias Ováricas/prevención & control , Años de Vida Ajustados por Calidad de VidaRESUMEN
BACKGROUND: Public health genomics is an emerging multidisciplinary approach, which aims to integrate genome-based knowledge in a responsible and effective way into public health. Despite several surveys performed to evaluate knowledge, attitudes and professional behaviors of physicians towards predictive genetic testing, similar surveys have not been carried out for public health practitioners. This study is the first to assess knowledge, attitudes and training needs of public health professionals in the field of predictive genetic testing for chronic diseases. METHODS: A self-administered questionnaire was used to carry out a cross-sectional survey of a random sample of Italian public health professionals. RESULTS: A response rate of 67.4% (797 questionnaires) was achieved. Italian public health professionals have the necessary attitudinal background to contribute to the proper use of predictive genetic testing for chronic diseases, but they need additional training to increase their methodological knowledge. Knowledge significantly increases with exposure to predictive genetic testing during postgraduate training (odds ratio (OR) = 1.74, 95% confidence interval (CI) = 1.05-2.88), time dedicated to continuing medical education (OR = 1.53, 95% CI = 1.14-2.04) and level of English language knowledge (OR = 1.36, 95% CI = 1.07-1.72). Adequate knowledge is the strongest predictor of positive attitudes from a public health perspective (OR = 3.98, 95% CI = 2.44-6.50). Physicians show a lower level of knowledge and more public health attitudes than other public health professionals do. About 80% of public health professionals considered their knowledge inadequate and 86.0% believed that it should be improved through specific postgraduate training courses. CONCLUSIONS: Specific and targeted training initiatives are needed to develop a skilled public health workforce competent in identifying genomic technology that is ready for use in population health and in modeling public health genomic programs and primary care services that need to be developed, implemented and evaluated.
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Pruebas Genéticas , Genómica , Competencia Profesional , Salud Pública , Adulto , Actitud del Personal de Salud , Enfermedad Crónica , Estudios Transversales , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Italia , Modelos Logísticos , Masculino , Persona de Mediana Edad , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To evaluate the concordance of results between the HORIZON-Pivotal Fracture Trial (PFT) and a non-randomized database study designed to emulate the trial. METHODS: HORIZON-PFT evaluated the efficacy of zoledronic acid vs placebo in reducing the risk of hip fractures and found a 41% risk reduction over a 3-year treatment period (HR = 0.59; 95% CI 0.42 to 0.83). Using two U.S. claims databases from 08/2007 to 12/2020 or 06/2021 we applied eligibility criteria from HORIZON-PFT and identified women with osteoporosis who initiated zoledronic acid or raloxifene as a proxy for placebo. The study protocol was registered on ClinicalTrials.gov (NCT04736693) before inferential analyses. We compared HORIZON-PFT and database study results using prespecified metrics. RESULTS: Due to low adherence in clinical practice, on-treatment follow up was truncated at 18 months in the database study. The hip fracture risk after 18 months was 9.3/1000 in the trial and 8.3/1000 in the database analysis. In the database study, zoledronic acid was associated with a 28% reduction in hip fractures risk compared to raloxifene (HR = 0.72; 95% CI 0.51 to 0.92). The attenuated effect of zoledronic acid in the database study may be explained by its shorter follow-up, as the interpolated estimate of the effect in HORIZON-PFT at 18 months was HRRCT 0.74, nearly identical to the observational estimate HRdatabase 0.72. CONCLUSION: Real-world emulation of the HORIZON-PFT found that zoledronic acid reduced hip fractures risk over an 18-month follow-up period. Limited adherence in clinical practice diminished the magnitude of its preventive effect and precluded long-term estimation of effectiveness in this setting.
RESUMEN
BACKGROUND: Genetic testing for cancer susceptibility is an emerging technology in medicine. This study assessed the knowledge, attitudes and professional behavior of Italian physicians regarding the use of predictive genetic tests for breast and colorectal cancer, including the BRCA1/2 and APC tests. METHODS: A cross-sectional survey of a random sample of Italian physicians was performed in 2010 through a self-administered questionnaire. RESULTS: A response rate of 69.6% (1079 questionnaires) was achieved. A significant lack of knowledge was detected, particularly for APC testing. Less than half of the physicians agreed on the importance of efficacy and cost-effectiveness evidence in the selection of predictive genetic tests to be offered to the patients. Multiple logistic regression analyses showed that education had a positive influence on knowledge, attitudes and, to a lesser extent, professional use. The factor most strongly related to the physicians' use of genetic testing was patients requests for breast (odds ratio=12.65; 95% confidence interval 7.77-20.59) or colorectal cancer tests (odds ratio=7.02; 95% confidence interval 3.61-13.64). A high level of interest for specific training was reported by almost all physicians surveyed. CONCLUSIONS: Targeted educational programs are needed to improve the expertise of physicians, and, ultimately, to enhance the appropriate use of genetic tests in clinical practice.
Asunto(s)
Actitud del Personal de Salud , Neoplasias de la Mama/genética , Neoplasias de la Mama/prevención & control , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/prevención & control , Pruebas Genéticas/estadística & datos numéricos , Proteína de la Poliposis Adenomatosa del Colon/genética , Adulto , Proteína BRCA1/genética , Proteína BRCA2/genética , Estudios Transversales , Femenino , Predisposición Genética a la Enfermedad/genética , Política de Salud , Humanos , Italia , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Revisión de Utilización de RecursosRESUMEN
(1) Influenza causes a significant health and socio-economic burden every year, and health personnel (HP) are at higher risk of exposure to respiratory pathogens than the general population. (2) The study's purpose was to describe and compare influenza vaccine uptake and its prognostic factors among Medical Doctors (MDs) and Non-Medical Health Personnel (NMHP) vs. Non-HP (NHP). We analyzed 2014-2018 data (n = 105,608) from the Italian Behavioral Risk Factor Surveillance System PASSI that, since 2008, has been collecting health-related information continuously in sampled adults. (3) MDs and NMHP represented, respectively, 1.1% and 4.6% of the sample. Among HP, 22.8% (CI 19.8-26.1%) of MDs and 8.5% (CI 7.5-9.5%) of NMHP reported to have been vaccinated vs. 6.3% (CI 6.1-6.5%) in NHP. This difference is confirmed in the three categories (MDs, NMHP, NHP), even more across age groups: in 18-34 yy, respectively, 9.9%, 4.4%, 3.4% vs. 28.4%, 13.9%, 10.6% in 50-64 yy. PASSI surveillance shows an increasing influenza vaccination uptake over time, especially among MDs (22.2% in 2014 vs. 30.5% in 2018). (4) Despite such an increase, especially among younger HP, influenza vaccination uptake is low. Even more under pandemic scenarios, these figures represent key information to address effective strategies for disease prevention and health promotion.