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PURPOSE: This study quantifies the impact on budget and cost per health benefit of implementing digital breast tomosynthesis (DBT) in place of digital mammography (DM) for breast cancer screening among asymptomatic women in Italy. METHODS: A budget impact analysis and a cost consequence analysis were conducted using parameters from the MAITA project and literature. The study considered four scenarios for DBT implementation, i.e., DBT for all women, DBT for women aged 45-49 years, DBT based on breast density (BI-RADS C + D or D only), and compared these to the current DM screening. Healthcare provider's perspective was adopted, including screening, diagnosis, and cancer treatment costs. RESULTS: Introducing DBT for all women would increase overall screening costs by 20%. Targeting DBT to women aged 45-49 years or with dense breasts would result in smaller cost increases (3.2% for age-based and 1.4-10.7% for density-based scenarios). The cost per avoided interval cancer was significantly higher when DBT was applied to all women compared to targeted approaches. The cost per gained early-detected cancer slightly increases in targeted approaches, while the assumptions on the clinical significance and overdiagnosis of cancers detected by DBT and not by DM have a strong impact. CONCLUSIONS: Implementing DBT as a primary breast cancer test in screening programs in Italy would lead to a substantial increase in costs. Tailoring DBT use to women aged 45-49 or with dense breasts could enhance the feasibility and sustainability of the intervention. Further research is needed to clarify the impact of DBT on overdiagnosis and the long-term outcomes.
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PURPOSE: We present a comprehensive investigation into the organizational, social, and ethical impact of implementing digital breast tomosynthesis (DBT) as a primary test for breast cancer screening in Italy. The analyses aimed to assess the feasibility of DBT specifically for all women aged 45-74, women aged 45-49 only, or those with dense breasts only. METHODS: Questions were framed according to the European Network of Health Technology Assessment (EuNetHTA) Screening Core Model to produce evidence for the resources, equity, acceptability, and feasibility domains of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) decision framework. The study integrated evidence from the literature, the MAITA DBT trials, and Italian pilot programs. Structured interviews, surveys, and systematic reviews were conducted to gather data on organizational impact, acceptability among women, reading and acquisition times, and the technical requirements of DBT in screening. RESULTS: Implementing DBT could significantly affect the screening program, primarily due to increased reading times and the need for additional human resources (radiologists and radiographers). Participation rates in DBT screening were similar, if not better, to those observed with standard digital mammography, indicating good acceptability among women. The study also highlighted the necessity for specific training for radiographers. The interviewed key persons unanimously considered feasible tailored screening strategies based on breast density or age, but they require effective communication with the target population. CONCLUSIONS: An increase in radiologists' and radiographers' workload limits the feasibility of DBT screening. Tailored screening strategies may maximize the benefits of DBT while mitigating potential challenges.
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Neoplasias de la Mama , Detección Precoz del Cáncer , Mamografía , Humanos , Femenino , Neoplasias de la Mama/diagnóstico por imagen , Italia , Mamografía/métodos , Persona de Mediana Edad , Anciano , Detección Precoz del Cáncer/métodos , Estudios de FactibilidadRESUMEN
OBJECTIVES: Cardiovascular disease (CVD), lung cancer (LC), and respiratory diseases are main causes of death in smokers and former smokers undergoing low-dose computed tomography (LDCT) for LC screening. We assessed whether quantification of pulmonary emphysematous changes at baseline LDCT has a predictive value concerning long-term mortality. METHODS: In this longitudinal study, we assessed pulmonary emphysematous changes with densitometry (volume corrected relative area below - 950 Hounsfield units) and coronary artery calcifications (CAC) with a 0-3 visual scale in baseline LDCT of 524 participants in the ITALUNG trial and analyzed their association with mortality after 13.6 years of follow-up using conventional statistics and a machine learning approach. RESULTS: Pulmonary emphysematous changes were present in 32.3% of subjects and were mild (6% ≤ RA950 ≤ 9%) in 14.9% and moderate-severe (RA950 > 9%) in 17.4%. CAC were present in 67% of subjects (mild in 34.7%, moderate-severe in 32.2%). In the follow-up, 81 (15.4%) subjects died (20 of LC, 28 of other cancers, 15 of CVD, 4 of respiratory disease, and 14 of other conditions). After adjusting for age, sex, smoking history, and CAC, moderate-severe emphysema was significantly associated with overall (OR 2.22; 95CI 1.34-3.70) and CVD (OR 3.66; 95CI 1.21-11.04) mortality. Machine learning showed that RA950 was the best single feature predictive of overall and CVD mortality. CONCLUSIONS: Moderate-severe pulmonary emphysematous changes are an independent predictor of long-term overall and CVD mortality in subjects participating in LC screening and should be incorporated in the post-test calculation of the individual mortality risk profile. KEY POINTS: ⢠Densitometry allows quantification of pulmonary emphysematous changes in low-dose CT examinations for lung cancer screening. ⢠Emphysematous lung density changes are an independent predictor of long-term overall and cardio-vascular disease mortality in smokers and former smokers undergoing screening. ⢠Emphysematous changes quantification should be included in the post-test calculation of the individual mortality risk profile.
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Enfermedades Cardiovasculares , Enfermedad de la Arteria Coronaria , Enfisema , Neoplasias Pulmonares , Enfisema Pulmonar , Humanos , Enfisema Pulmonar/diagnóstico por imagen , Fumadores , Estudios Longitudinales , Detección Precoz del Cáncer , Neoplasias Pulmonares/diagnóstico por imagen , Tomografía Computarizada por Rayos X/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
The new EU Council Recommendation on cancer screening extends organized mammography screening to the 45-74-year age group. Mammography screening in young women has been the subject of discussion since its inception almost forty years ago. Starting from the recent publication of the survival data for breast cancer of the regional programme for women aged 45-49 years, activated in the Emilia-Romagna Region (Northern Italy), it is here proposed to test, with a research and innovation practice, a new screening offer for the 45-54-year age group with a tailored approach, i.e., based on the risk level and breast density.
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Neoplasias de la Mama , Detección Precoz del Cáncer , Mamografía , Anciano , Femenino , Humanos , Persona de Mediana Edad , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/epidemiología , Italia/epidemiología , Tamizaje MasivoRESUMEN
The generation of rapid information has been an important novelty in the COVID-19 pandemic and a challenge for epidemiology. The methodological frailty and uncertainty of rapid data use has been a consequence. We are talking about an 'intermezzo' epidemiology between the event and the production of consolidated data that opens up great opportunities to the use epidemiology for rapid public health decisions, provided a careful work to be done before emergencies. In Italy, an ad hoc national COVID-19 information system producing daily data that quickly became essential for public decision-making. Total and all-cause mortality data are derived from the traditional information system of the Italian National Institute of Statistics (Istat), which, at the onset of the pandemic, was unable to provide rapid total and all-causes mortality data at the national level and still produces them with a one- to two-month delay. National cause and place mortality data referred to the first epidemic wave (March and April 2020) was in May 2021 and recently updated (October 2022) for the whole year 2020. Nearly three years after the onset of the epidemic, we have no nationwide rapid information on the distribution of deaths by place of death (hospitals, nursing homes and other care facilities, home) neither on their breakdown in 'by COVID-19', 'with COVID-19', and 'non-COVID-19' deaths. The pandemic being still in progress, new problems arise (the long-term impact of COVID-19, the impact of lockdown policies, etcetera), whose solution cannot be postponed until peer reviewed papers are available. A fine-tuning of the rapid processing of interim data certainly requires the development of national and regional information systems, but first of all a methodologically robust 'intermezzo' epidemiology.
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COVID-19 , Humanos , COVID-19/epidemiología , SARS-CoV-2 , Pandemias , Italia/epidemiología , Control de Enfermedades TransmisiblesRESUMEN
BACKGROUND: Despite recommendations, mammography screening is often insufficiently integrated into specialist breast centres. A national, cross-sectional, voluntary, online survey on this issue was carried out among the Italian breast centres associated with Senonetwork, the Italian network of breast cancer services. METHODS: A 73-item questionnaire was created, pre-tested and piloted. Centres integrating and not integrating a screening programme were compared using the unified theory of acceptance and use of technology (UTAUT) model. Centres' clustering was performed using the Gower's distance metric. Groups and clusters were compared with the equality-of-means test. RESULTS: The response rate was 82/128 (65%). Overall, 84% (69/82) breast centres reported a collaboration with a screening programme in performing and/or reading mammograms and in the diagnostic work-up of women with abnormal screening results. The same proportion was observed among those centres responding to all questions (62/74). Performance expectancies (or the perceived usefulness of integration in terms of clinical quality, patient convenience, ease of job, and professional growth), satisfaction and motivation were higher in those centres collaborating with the screening programme. Effort expectancy indicators (or the degree to which the respondents believe that the integration is easy to implement) and those concerning the existence of facilitating conditions were lower both in centres collaborating and not collaborating with the screening programme. Among the former, six clusters of centres, distributed from 'no integration' to 'high', were identified. In cluster analysis, the highest level of integration was associated with higher agreement that integration eases the job, offers better opportunities for professional growth, and makes the working environment more satisfactory. The least integrated cluster assigned the lowest score to the statement that local health authority made available the resources needed. CONCLUSIONS: While confirming the positive effects of integrating screening programmes into breast centres, this survey has brought to light specific difficulties that must be faced. The results provide insights into the importance of integration focusing on the perspectives of professional career and motivation. The deficiency of facilitating conditions to integration is modifiable. Screening professionals' societies may have a role as initiators of the integration. Other supporting actions may be included in health laws at the national and regional level.
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Neoplasias de la Mama , Mamografía , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/prevención & control , Estudios Transversales , Detección Precoz del Cáncer , Femenino , Humanos , ItaliaRESUMEN
BACKGROUND: There are few studies demonstrating how the effectiveness of various extents of non-pharmaceutical interventions (NPIs) before and after vaccination periods. The study aimed to demonstrate such an effectiveness in the alteration of the epidemic curves from theory to practice. METHODS: The empirical data on the daily reported COVID-19 cases were extracted from open source. A computer simulation design in conjunction with the susceptible-exposed-infected-recovered (SEIR) type model was applied to evaluating confinement measures in Italy with adjustment for underreported cases; isolation and quarantine in Taiwan; and NPIs and vaccination in Israel. RESULTS: In Italy scenario, the extents of confinement measures were 34% before the end of March and then scaled up to 70% after then. Both figures were reduced to 22-69% after adjusting for underreported cases. Approximately 44% of confinement measures were implemented in the second surge of pandemic in Italy. Fitting the observational data on Taiwan assuming the initial outbreak similar to Wuhan, China, 44% of isolation and quarantine were estimated before March 23rd, 2020. Isolation and quarantine were scaled up to 90% and at least 60% to contain community-acquired outbreaks from March 24th, 2020 onwards. Given 15% monthly vaccination rate from December 2020 in Israel, the effectiveness estimates of reducing the infected toll were 36%, 56%, and 85% for NPIs alone, vaccination alone, and both combined, respectively. CONCLUSION: We demonstrated how various NPIs stamp out and delay the epidemic curve of COVID-19. The optimal implementation of these NPIs has to be planned before wide vaccine uptake worldwide.
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Vacunas contra la COVID-19/uso terapéutico , COVID-19 , COVID-19/prevención & control , COVID-19/terapia , China/epidemiología , Simulación por Computador , Humanos , Israel/epidemiología , Italia/epidemiología , Taiwán/epidemiología , VacunaciónRESUMEN
The decision aid "Donnainformata-mammografia" (https://www.donnainformata-mammografia.it/en/) has been developed with the aim of providing clear information on the benefits and harms of breast cancer screening, and the controversies on the relationship between mortality reduction and overdiagnosis. It was evaluated in a randomized clinical trial showing it increases informed choice and does not decrease participation in screening.This article describes the framework, the guiding principles, and the operational phases of the tool development.The project was developed within the national screening programme. The promoters decided to state their placement, to start from the information needs of women and what is already known, and to balance spontaneous navigation with "nudging" to key contents. Three focus groups with 18 women and 4 interviews were organized. Participants expressed a favourable attitude towards screening, and no knowledge of the debate on screening efficacy and overdiagnosis. A literature review and a comparison of decision aids were conducted. The online tool included the results of these steps. The home page presents key information with links to relevant topics, so that the person can decide to stop there having an overview or to continue. The «ready to decide¼ button, which leads to the section of decision support, can be clicked on every page. Here, the person can evaluate a list of key points on the basis of her values, in order to decide to participate in screening or not.
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Neoplasias de la Mama , Técnicas de Apoyo para la Decisión , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Toma de Decisiones , Detección Precoz del Cáncer , Femenino , Humanos , Italia/epidemiología , Tamizaje MasivoRESUMEN
BACKGROUND: Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA). METHODS: A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA. RESULTS: Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%). CONCLUSION: DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT03097653.
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Neoplasias de la Mama/diagnóstico , Técnicas de Apoyo para la Decisión , Internet , Neoplasias de la Mama/diagnóstico por imagen , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Italia , Mamografía/métodos , Persona de Mediana Edad , Evaluación de Programas y Proyectos de Salud , Factores SocioeconómicosRESUMEN
BACKGROUND: Changes in smoking habits and predictors of smoking cessation were examined in the randomized ITALUNG lung cancer screening trial. METHODS: In three centers, eligible smokers or ex-smokers (55-69 years, ≥20 pack-years in the last 10 years) were randomized to receive annual invitation for low-dose computed tomography for 4 years or usual care. At invitation, subjects received written information for a free smoking cessation program. Quitting outcome was assessed at year 4. RESULTS: Among participants who completed baseline assessments and year 4 screening, higher quitting (20.8% vs. 16.7%, p = .029) and lower relapse (6.41% vs. 7.56%, p = .50) rates were observed in the active screening group as compared to the usual-care control group. Corresponding figures in the intention-to-treat analysis were as follows: 16.04% versus 14.64% (p = .059) and 4.88% versus 6.43% (p = .26). Quitting smoking was significantly associated to male gender, lower pack-years, and having pulmonary nodules at baseline. Center-specific analyses showed a threefold statistically significant higher probability to quit associated with participating in the smoking cessation program. A subsample of smokers of the scan group from one center showed higher quitting rates over 12-month follow-up as compared to matched controls from the general population who underwent the same smoking cessation program. CONCLUSIONS: Consistently with previous reports, in the ITALUNG trial, screened subjects showed significantly higher quit rates than controls, and higher quit rates were associated with both the presence of pulmonary nodules and participating in a smoking cessation program. Maximal effect on quitting outcome was observed with the participation in the smoking cessation program. IMPLICATIONS: Participating in lung cancer screening promotes smoking cessation. An effective "teachable moment" may be achieved when the smoking cessation intervention is structured as integral part of the screening clinical visits and conducted by a dedicated team of health care professionals. Standardized guidelines for smoking cessation interventions in lung cancer screening are needed.
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Fumar Cigarrillos/efectos adversos , Detección Precoz del Cáncer/psicología , Neoplasias Pulmonares/diagnóstico , Educación del Paciente como Asunto/métodos , Fumadores/psicología , Cese del Hábito de Fumar/psicología , Anciano , Femenino , Humanos , Italia/epidemiología , Neoplasias Pulmonares/epidemiología , Neoplasias Pulmonares/prevención & control , Masculino , Persona de Mediana Edad , Motivación , Cese del Hábito de Fumar/estadística & datos numéricos , Tomografía Computarizada por Rayos XRESUMEN
Overdiagnosis estimates have varied substantially, causing confusion. The discussions have been complicated by the fact that population and study design have varied substantially between studies. To help assess the impact of study design choices on the estimates, we compared them on a single population. A cohort study from Funen County, Denmark, recently suggested little (â¼1%) overdiagnosis. It followed previously screened women for up to 14 years after screening had ended. Using publically available data from Funen, we recreated the designs from five high-estimate, highly cited studies from various countries. Selected studies estimated overdiagnosis to be 25-54%. Their designs were adapted only to the extent that they reflect the start of screening in Funen in 1993. The reanalysis of the Funen data resulted in overdiagnosis estimates that were remarkably similar to those from the original high-estimate age-period studies, 21-55%. In additional analyses, undertaken to elucidate the effect of the individual components of the study designs, overdiagnosis estimates were more than halved after the most likely changes in the background risk were accounted for and decreased additionally when never-screened birth cohorts were excluded from the analysis. The same data give both low and high estimates of overdiagnosis, it all depends on the study design. This stresses the need for a careful scrutiny of the validity of the assumptions underpinning the estimates. Age-period analyses of breast cancer overdiagnosis suggesting very high frequencies of overdiagnosis rested on unmet assumptions. This study showed that overdiagnosis estimates should in the future be requested to adequately control for the background risk and include an informative selection of the studied population to achieve valid and comparable estimates of overdiagnosis.
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Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Errores Diagnósticos/estadística & datos numéricos , Detección Precoz del Cáncer/métodos , Mamografía/métodos , Uso Excesivo de los Servicios de Salud/estadística & datos numéricos , Proyectos de Investigación , Anciano , Dinamarca/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , PronósticoRESUMEN
Lung cancer screening with low-dose CT can save lives. This European Union (EU) position statement presents the available evidence and the major issues that need to be addressed to ensure the successful implementation of low-dose CT lung cancer screening in Europe. This statement identified specific actions required by the European lung cancer screening community to adopt before the implementation of low-dose CT lung cancer screening. This position statement recommends the following actions: a risk stratification approach should be used for future lung cancer low-dose CT programmes; that individuals who enter screening programmes should be provided with information on the benefits and harms of screening, and smoking cessation should be offered to all current smokers; that management of detected solid nodules should use semi-automatically measured volume and volume-doubling time; that national quality assurance boards should be set up to oversee technical standards; that a lung nodule management pathway should be established and incorporated into clinical practice with a tailored screening approach; that non-calcified baseline lung nodules greater than 300 mm3, and new lung nodules greater than 200 mm3, should be managed in multidisciplinary teams according to this EU position statement recommendations to ensure that patients receive the most appropriate treatment; and planning for implementation of low-dose CT screening should start throughout Europe as soon as possible. European countries need to set a timeline for implementing lung cancer screening.
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Detección Precoz del Cáncer/normas , Neoplasias Pulmonares/diagnóstico , Tamizaje Masivo/normas , Guías de Práctica Clínica como Asunto , Tomografía Computarizada por Rayos X/métodos , Europa (Continente) , Femenino , Humanos , Incidencia , Neoplasias Pulmonares/epidemiología , MasculinoRESUMEN
Asymptomatic high-risk subjects, randomized in the intervention arm of the ITALUNG trial (1,406 screened for lung cancer), were enrolled for the ITALUNG biomarker study (n = 1,356), in which samples of blood and sputum were analyzed for plasma DNA quantification (cut off 5 ng/ml), loss of heterozygosity and microsatellite instability. The ITALUNG biomarker panel (IBP) was considered positive if at least one of the two biomarkers included in the panel was positive. Subjects with and without lung cancer diagnosis at the end of the screening cycle with LDCT (n = 517) were evaluated. Out of 18 baseline screen detected lung cancer cases, 17 were IBP positive (94%). Repeat screen-detected lung cancer cases were 18 and 12 of them positive at baseline IBP test (66%). Interval cancer cases (2-years) and biomarker tests after a suspect Non Calcific Nodule follow-up were investigated. The single test versus multimodal screening measures of accuracy were compared in a simulation within the screened ITALUNG intervention arm, considering screen-detected and interval cancer cases. Sensitivity was 90% at baseline screening. Specificity was 71 and 61% for LDCT and IBP as baseline single test, and improved at 89% with multimodal, combined screening. The positive predictive value was 4.3% for LDCT at baseline and 10.6% for multimodal screening. Multimodal screening could improve the screening efficiency at baseline and strategies for future implementation are discussed. If IBP was used as primary screening test, the LDCT burden might decrease of about 60%.
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Biomarcadores de Tumor/sangre , Detección Precoz del Cáncer , Neoplasias Pulmonares/sangre , Neoplasias Pulmonares/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Anciano , ADN de Neoplasias/sangre , Femenino , Humanos , Italia , Pérdida de Heterocigocidad/genética , Pulmón/diagnóstico por imagen , Pulmón/patología , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología , Masculino , Tamizaje Masivo , Inestabilidad de Microsatélites , Persona de Mediana Edad , Imagen Multimodal , Fumar , Esputo/metabolismoRESUMEN
BACKGROUND: ITALUNG is contributing to the European evaluation of low-dose CT (LDCT) screening for lung cancer (LC). METHODS: Eligible subjects aged 55-69â years, smokers or ex-smokers (at least 20 pack-years in the last 10â years), were randomised to receive an annual invitation for LDCT screening for 4â years (active group) or to usual care (control group). All participants were followed up for vital status and cause of death (at the end of 2014) and LC incidence (at the end of 2013). Pathological and clinical information was collected from the Tuscan Cancer Registry data. RESULTS: 1613 subjects were randomly assigned to the active group and 1593 to the control group. At the end of the follow-up period 67 LC cases were diagnosed in the active group and 71 in the control group (rate ratio (RR)=0.93; 95% CI 0.67 to 1.30). A greater proportion of stage I LC was observed in the active group (36% vs 11%, p<0.001). Non-significant reductions of 17% (RR=0.83; 95% CI 0.67 to 1.03) for overall mortality and 30% (RR=0.70; 95% CI 0.47 to 1.03) for LC-specific mortality were estimated. CONCLUSIONS: Despite the lack of statistical significance, the ITALUNG trial outcomes suggest that LDCT screening could reduce LC and overall mortality. Moreover, the comparison of the number of LC cases diagnosed in the two groups does not show overdiagnosis after an adequate follow-up period. A pooled analysis of all European screening trials is advocated to assess the benefit-to-harm ratio of LDCT screening and its implementation in public health settings. TRIAL REGISTRATION NUMBER: Results, NCT02777996.
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Detección Precoz del Cáncer/métodos , Neoplasias Pulmonares/diagnóstico por imagen , Anciano , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Italia/epidemiología , Estimación de Kaplan-Meier , Neoplasias Pulmonares/epidemiología , Neoplasias Pulmonares/etiología , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/cirugía , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Sistema de Registros , Fumar/efectos adversos , Fumar/epidemiología , Tomografía Computarizada por Rayos X/métodosRESUMEN
BACKGROUND: In Italy women aged 50-69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patients associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health. This trial aims to assess women's informed choices, according to their health literacy and values, on participating or not in BC screening for the first time. Benefits, harms and controversies are presented. METHODS/DESIGN: The impact of the DA will be evaluated in a randomized controlled trial with a two-week follow-up. Women will be randomized via web to DA or a standard brochure. We will invite 8160 women, to obtain a final sample of 816 women. The primary outcome will be informed choice, measured on the basis of knowledge, attitudes and intentions on BC screening. Secondary outcomes are participation rate, satisfaction on information and decisional conflict. DISCUSSION: The web DA will be open-source and implemented on BC screenings and its efficacy for increasing informed choice will be tested. This model could be applied to other healthcare settings, cancer screenings, and public health programs. TRIAL REGISTRATION: The protocol for this trial was registered with the Clinicaltrials.gov registry on March 16, 2017: NCT03097653 .
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Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Protocolos Clínicos , Toma de Decisiones , Detección Precoz del Cáncer , Consentimiento Informado , Mamografía , Adulto , Anciano , Neoplasias de la Mama/prevención & control , Técnicas de Apoyo para la Decisión , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Mamografía/métodos , Tamizaje Masivo , Persona de Mediana Edad , Proyectos de InvestigaciónRESUMEN
BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control, and improve their quality of life. METHODS/DESIGN: We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised. In the intervention sites, patients will be offered interviews with a trained facilitator. In the control sites, patients will receive care as usual. In total, 1360 patients will be included. All participating patients will be asked to complete questionnaires at inclusion, and again after 2.5 and 4.5 months. If a patient dies within a year after inclusion, a relative will be asked to complete a questionnaire on end-of-life care. Use of medical care will be assessed by checking medical files. The primary endpoint is patients' quality of life at 2.5 months post-inclusion. Secondary endpoints are the extent to which care as received is aligned with patients' preferences, patients' evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. DISCUSSION: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014.
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Planificación Anticipada de Atención , Neoplasias Colorrectales/terapia , Neoplasias Pulmonares/terapia , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias Colorrectales/epidemiología , Neoplasias Colorrectales/patología , Comunicación , Toma de Decisiones , Femenino , Personal de Salud , Humanos , Neoplasias Pulmonares/epidemiología , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Atención Dirigida al Paciente , Calidad de Vida , Encuestas y Cuestionarios , Cuidado TerminalRESUMEN
Lung cancer is the first cancer mortality cause in Italy. In last decades, incidence rates have been falling down, but the annual number of deaths is stable because of population ageing. Survival rates for population-based lung cancer cases were at maximum 17% in the last decades. In 2011, the National Lung Screening Trial (NLST) has published the results of the evaluation of efficacy of low-dose CT scan screening compared with chest X-ray showing a 20%cause-specific mortality reduction, based on the randomization, screening, and follow-up of about 53,000 subjects in USA. In Europe, 7 randomized studies are ongoing: the Nelson study, with about 16,000 people enrolled, is the largest one and its results are expected to be published soon. The US Preventive Service Task Force recommended screening for lung cancer. CT Scan screening will be made available within Medicare to high-risk subjects until 74 years or 80 years of age. In Europe, recommendations continue to discourage screening for lung cancer in all member Countries. The implementation of organised screening in Europe is conditioned by an health technology assessment aimed to the identification of the risk profile, performance of screening (false positive rates), and overdiagnosis harm. All the potential harms of screening must be balanced with expected benefits and evaluated in a formal cost-benefits analysis. Better strategies aimed to selective lung cancer screening of high risk subjects, including asbestos workers, must be evaluated in prospective studies.