Advance care planning in patients with advanced cancer: A 6-country, cluster-randomised clinical trial.

BACKGROUND: Advance care planning (ACP) supports individuals to define, discuss, and record goals and preferences for future medical treatment and care. Despite being internationally recommended, randomised clinical trials of ACP in patients with advanced cancer are scarce. METHODS AND FINDINGS: To test the implementation of ACP in patients with advanced cancer, we conducted a cluster-randomised trial in 23 hospitals across Belgium, Denmark, Italy, Netherlands, Slovenia, and United Kingdom in 2015-2018. Patients with advanced lung (stage III/IV) or colorectal (stage IV) cancer, WHO performance status 0-3, and at least 3 months life expectancy were eligible. The ACTION Respecting Choices ACP intervention as offered to patients in the intervention arm included scripted ACP conversations between patients, family members, and certified facilitators; standardised leaflets; and standardised advance directives. Control patients received care as usual. Main outcome measures were quality of life (operationalised as European Organisation for Research and Treatment of Cancer [EORTC] emotional functioning) and symptoms. Secondary outcomes were coping, patient satisfaction, shared decision-making, patient involvement in decision-making, inclusion of advance directives (ADs) in hospital files, and use of hospital care. In all, 1,117 patients were included (442 intervention; 675 control), and 809 (72%) completed the 12-week questionnaire. Patients' age ranged from 18 to 91 years, with a mean of 66; 39% were female. The mean number of ACP conversations per patient was 1.3. Fidelity was 86%. Sixteen percent of patients found ACP conversations distressing. Mean change in patients' quality of life did not differ between intervention and control groups (T-score -1.8 versus -0.8, p = 0.59), nor did changes in symptoms, coping, patient satisfaction, and shared decision-making. Specialist palliative care (37% versus 27%, p = 0.002) and AD inclusion in hospital files (10% versus 3%, p < 0.001) were more likely in the intervention group. A key limitation of the study is that recruitment rates were lower in intervention than in control hospitals. CONCLUSIONS: Our results show that quality of life effects were not different between patients who had ACP conversations and those who received usual care. The increased use of specialist palliative care and AD inclusion in hospital files of intervention patients is meaningful and requires further study. Our findings suggest that alternative approaches to support patient-centred end-of-life care in this population are needed. TRIAL REGISTRATION: ISRCTN registry ISRCTN63110516.

Population-based strategies to control manufacturing epidemics. / Interventi di popolazione per contrastare l'epidemia di prodotti insalubri.

"The multinational corporations producing tobacco, alcohol, soft drinks, and processed foods have a role of vectors in the increase of chronic diseases, so that one can speak of manufacturing epidemics. The main aim of this paper is to conduct a literature review on different approaches in population-based interventions to stem the rise in consumption of unhealthy products. Different approaches were found: • command-and-control regulations: the route is definitely more advanced for tobacco with the implementation of an international treaty, which requires 180 ratifying states to implement a series of tobacco control policies. Similar regulations have been partially adopted to reduce alcohol use and to increase taxes of sugar-sweetened beverages; • multinational corporations in few Countries can voluntarily adopt recommendations on media campaigns and on labelling of soft drinks and processed foods; • in order to reduce salt in foods, many Countries developed voluntary agreements with industries with monitoring systems to assess compliance. Population-based interventions to try to align the interests of multinational corporations with those of public health are described in literature: • the "Health Footprint" programme; • the performance-based regulation which could oblige industry to take responsibility to reduce the harmful consequences of the use of their unhealthy commodities; • the price-cap regulation, usually applied to the utilities sector, would set a cap on the price of the tobacco industry, raising the tobacco taxes by 500 million euros per year. In order to reduce the burden of chronic disease, one of the objectives of the Italian National Prevention Plan, a working group including non-governmental organizations and experts in communication, social marketing, and lifestyles should be organized by the Ministry of Health in order to identify which population-based interventions could be implemented in Italy in next years to stem the rise of consumption of unhealthy products. ".

[Tobacco farming in Italy receives more funds in comparison to tobacco control]. / La tabacchicoltura in Italia riceve più fondi del controllo del tabagismo.

In the European Union almost 300,000 tons of raw tobacco are produced every year, contributing for 4% of the world production. In Italy, tobacco crop produces around 90,000 tons/year and is concentrated in Veneto, Tuscany, Umbria and Campania Regions. In 1970, Common Market Organisation provided a virtually unlimited support for European tobacco production. After 2004, funds progressively has been cut by half, even though the other half has been given for restructuring or reconversion of tobacco farms through the Rural Development Plan. The Framework Convention on Tobacco Control recommends conversion of tobacco crops, although there are no effective measures. Tobacco production requires large quantities of chemicals (pesticides, growth regulators, fertilisers), with significant workers' exposure if applied without personal protective equipments. Pesticides may have genotoxic, teratogenic, immunotoxic, hormonal, and carcinogenic effects. Tobacco itself may cause also a disease called "Green tobacco sickness" syndrome, as a consequence of nicotine dermal absorption due to skin exposure to tobacco leaves. In Italy, financial resources for tobacco production and restructuring/conversion to other crops of previously tobacco planted fields are available. On the contrary, anti-smoking media interventions do not receive funds comparatively relevant as those for tobacco production.

[Even cigarette butts can impact environment and health: preliminary considerations]. / Anche i mozziconi di sigaretta hanno un impatto sull'ambiente e la salute: alcune considerazioni preliminari.

In Italy, every year about 72 billion of cigarette butts are thrown away in the environment. Cigarette butts represent 50% of the wastes of urban areas (parks, roads) in the world, and 40% of Mediterranean Sea wastes. In particular, total polluting load is constituted of 1,872 Bq millions of Polonium-210, assuming 75 mBq per cigarette butt, and 1,800 tons of volatile organic compounds. As a matter of fact, according to several surveys, cigarette butts are considered by smokers and non-smokers as a common and acceptable waste in the environment. In 2008, European Union issued a Directive on wastes considering the «extended producer responsibility¼ (i.e., every industry is liable for costs of collection, transport and disposal of its own products). In October 2012, the Italian Parliament proposed a bill that classifies cigarette butts as special wastes in the frame of this responsibility. It could be interesting in the future to follow the legislative process of that bill in the Italian Parliament in order to show how strong it will be supported.

Motivation, acceptability and attitudes toward lung cancer screening among persons who attend a tobacco cessation program: A multicenter survey in Italy.

This study aimed to evaluate smoking cessation (SC) motivation and the acceptability of a lung cancer screening (LCS) program with low-dose computed tomography (LDCT) among people who attend SC programs. A multicenter survey was conducted in the period January-December 2021 involving 197 people who attended group or individual SC courses in Reggio Emilia and Tuscany. Questionnaires, information sheets, and decision aids about the potential benefits and harms of LCS with LDCT were distributed at different time points during the course. The wish to protect own health (66%) was the most frequent reason given for quitting smoking, followed by cigarette dependence (40.6%) and current health problems (30.5%). Half of the participants (56%) considered periodic health checks including LDCT, as an advantageous activity. The great majority of participants were in favor of LCS (92%), with only 8% being indifferent, and no one was against these programs. Interestingly, those with sufficiently high smoking-related LC risk to be eligible for LCS and those attending the individual course were less in favor of LCS but also less concerned about the possible harms associated with LCS. The type of counseling was a significant predictor for both LCS acceptability and perceived harm of LCS. The favorable perception of LCS in people attending SC courses, despite the considerable preoccupation with potential harms, is an important finding of this study. Introducing a discussion on the benefits and harms of LCS in SC programs may prepare persons who smoke to make informed decisions on utilizing LCS.

Tobacco endgame in the WHO European Region: Feasibility in light of current tobacco control status.

INTRODUCTION: To assess the feasibility of developing World Health Organization (WHO) European Region countries' goals and measures in line with tobacco endgame objectives, information on the current tobacco control context and capacity is needed. The aim of this study was to assess the implementation of the Framework Convention on Tobacco Control (WHO FCTC) and MPOWER measures in the region. METHODS: In this cross-sectional study we used data from the WHO FCTC implementation reports and MPOWER from 2020 in 53 WHO European Region countries. Six domains (i.e. capacity, taxation and price policies, other national key regulations, public awareness raising and communication, tobacco use cessation, and monitoring) were formed. Subsequently, available indicators under these domains were scored and the level of implementation was computed for each country. Mann-Whitney tests were carried out to compare the scores between the group of countries with and without official endgame goals. RESULTS: Overall, implementation of the WHO FCTC with the selected indicators at the country level ranged from 28% to 86%, and of MPOWER from 31% to 96%. Full implementation was achieved by 28% of WHO FCTC Parties in the region in taxation and price policies, 12% in public awareness raising and communication, and 42% in monitoring. In capacity, tobacco use cessation and other national key regulations, none of the Parties in the region reached full implementation. Overall median WHO FCTC scores were significantly higher in countries with official endgame goals than in those without (p<0.001). CONCLUSIONS: There is unequal implementation of both WHO FCTC and MPOWER measures among WHO European Region countries. MPOWER and WHO FCTC provide all the measures for the necessary first steps, followed by innovative measures, to accomplish tobacco endgame goals.

Cancer screening programmes in Italy during the COVID-19 pandemic: an update of a nationwide survey on activity volumes and delayed diagnoses.

INTRODUCTION: In Italy, regional governments are in charge of implementing cervical, breast and colorectal cancer screening programmes. The 2020 Coronavirus pandemic led to a national lockdown and the temporary suspension of several non-urgent healthcare activities, including cancer screening. This paper aims to describe the results of a national survey carried out by the National Centre for Screening Monitoring (ONS) on cervical, breast and colorectal cancer screening activities in 2020. MATERIALS AND METHODS: A national survey was conducted by ONS in 2020 to assess: the number of screening invitations by Region; the volumes of screening tests and the attitude to attend the screening programme compared to 2019; the number of delayed diagnoses of malignant or pre-malignant lesions caused by the slowing down of screening programmes, based on the average Region-specific screening detection rate for cervical, breast and colorectal cancers. RESULTS: Screening tests for breast, colorectal and cervical cancer decreased by 37.6%, 45.5% and 43.4% in 2020 compared with 2019. In 2020 the estimated numbers of undiagnosed lesions are: 3,324 breast cancers, 1,299 colorectal cancers, 7,474 colorectal advanced adenomas and 2,782 CIN2 or more severe cervical lesions. Participation in cancer screening programmes decreased by 15%, 15% and 20%, for cervical, breast and CRC screening, respectively. DISCUSSION AND CONCLUSIONS: An urgent call to action is needed to prevent further delays and to limit the impact of the pandemic on cancer diagnosis and prevention.

[Harm reduction strategy in tobacco control]. / Esistono sostituti delle sigarette a rischio ridotto per chi non riesce a smettere?

Potentially reduced exposure products (PREPs), already sold in USA and in some European Countries, are low-nitrosamine cigarettes, low-nitrosamine smokeless tobacco (e.g., the Swedish Snus), cigarette-like products, and medicinal nicotine products. Even e-cigarette delivers nicotine. With the exception of snus and medicinal nicotine, studies on the health effects of PREPs have not been carried out, although some PREPs are already sold and promoted as products that effectively reduce health risks. Thus, a second disaster similar to that occurred for light cigarettes could happen in the next years. Only medicinal nicotine and snus could be valid candidates to become PREPs, even if they pose some significant health risks. The World Health Organization, following a precautionary approach, has recently published a list of 9 carcinogens or toxicants recommended for mandated lowering (the tobacco-specific nitrosamines NNN and NNK, acetaldehyde, acrolein, benzene, benzo[a]pyrene, 1-3 butadiene, carbon monoxide, formaldehyde), and 9 carcinogens or toxicants for monitoring in usual cigarettes (not PREPs), underlining that tobacco companies cannot use this reduction strategy as a promotional message, as it occurred for light cigarettes in the 70s and 80s. The present status quo, in which cigarettes are freely available, medicinal nicotine, being a drug, is available under a regulated market, and Snus is prohibited, actually denies smokers the right to choose safer nicotine products. The solution suggested by the UK Royal College of Physicians is to balance the nicotine market, framing tobacco products and medicinal nicotine in the same regulation system; establishing a nicotine and tobacco regulatory authority;making medicinal nicotine more available; evaluating the feasibility of the introduction in the English market of Swedish Snus. California Government remarks that the nicotine maintenance is not a valid strategy, because it could induce smokers not to try to quit.Thus, California Department of Health Services prohibits promotion of snus and medicinal nicotine as a harm reduction strategy. However, the US Federal Family Smoking Prevention and Tobacco Control Act, signed by President Obama in 2009, places tobacco products under FDA jurisdiction: FDA must define criteria for lowering carcinogens and toxicants in tobacco products, making more available medicinal nicotine, evaluating PREPs, creating a federal Tobacco Control Agency.Which approaches is Italy going to follow?

Tackling second-hand exposure to tobacco smoke and aerosols of electronic cigarettes: the TackSHS project protocol.

OBJECTIVE: The TackSHS project aims to comprehensively elucidate the impact that exposure to second-hand smoke (SHS) from cigarettes and second-hand aerosols (SHA) from electronic cigarettes have on the respiratory health of the European population according to socioeconomic characteristics and other determinants. METHOD: The TackSHS project involves a series of coordinated studies carried out by 11 academic and public health organisations from six European countries. The project will investigate: a) the determinants of SHS and SHA exposure assessed at the individual level (surveys on representative general population samples) and in common environments (environmental sampling in specific settings); b) the overall disease burden, mortality and morbidity attributable to such exposure; and c) its economic impact in terms of direct health care costs. The project will also examine specific acute respiratory health changes in healthy individuals and patients with respiratory diseases exposed to SHS and SHA. In addition, the project will examine the effectiveness of a novel intervention to reduce SHS exposure in households where smoking is permitted. All these studies are inter-related and involve collaborative coordination among the participant organisations. CONCLUSION: The comprehensive, integrated approach of the TackSHS project will enable a significant step forward from the current status quo in the understanding of the impact of SHS and SHA exposure on health and provide the basis for health policy recommendations to help European countries to further reduce the harm caused by SHS and SHA exposure.

Measuring for change: A multi-centre pre-post trial of an air quality feedback intervention to promote smoke-free homes.

INTRODUCTION: Second-hand smoke exposure in the home is a serious cause of ill-health for children. Behaviour change interventions have been developed to encourage parents to keep homes smoke-free. This study evaluates a novel air quality feedback intervention using remote air quality monitoring with SMS and email messaging to promote smoke-free homes among families from deprived areas. METHODS: This paper presents a pre-post study of this intervention. Using internet connected monitors developed with the Dylos DC1700, daily SMS and weekly email feedback provided for 16 days to participants recruited in four European countries. Participants were recruited based on their stage of change, in order to target those most able to achieve smoke-free homes. The primary outcome measure was median change in mean fine particulate matter (PM2.5) concentration between baseline and follow-up periods, while secondary outcome measures included change in time over the World Health Organisation (WHO) guideline limit for PM2.5 exposure over 24 h (25 µg/m3) in those periods and the number of homes where PM2.5 concentrations reduced. Telephone interviews were conducted with participants in Scotland post-intervention to explore intervention experience and perceived effectiveness. RESULTS: Of 86 homes that completed the intervention study, 57 (66%) experienced pre-post reductions in measured PM2.5. The median reduction experienced was 4.1 µg/m3 (a reduction of 19% from baseline, p = 0.008). Eight homes where concentrations were higher than the WHO guideline limit at baseline fell below that level at follow-up. In follow-up interviews, participants expressed positive views on the usefulness of air quality feedback. DISCUSSION: Household air quality monitoring with SMS and email feedback can lead to behaviour change and consequent reductions in SHS in homes, but within the context of our study few homes became totally smoke-free.

[Second-hand smoke exposure in Florence and Belluno before and after the Italian smoke-free legislation]. / Esposizione a fumo o passivo a Firenze e a Belluno prima e dopo l'entrata in vigore del divicto di fumo in Italia.

INTRODUCTION: a law banning smoking in enclosed public places entered into force in Italy on January 10th 2005. OBJECTIVE: to compare the SHS exposure before and after the coming into force of the new anti-smoking law, with direct measurements in public venues and workplaces. METHODS: vapour-phase nicotine was measured using passive samplers, with personal and environmental sampling. SETTING: samples were collected in 10 municipality offices, 10 industry buildings and 11 public venues (4 discos and 7 pubs) in two towns (Florence and Belluno) from november 2004 to march 2005. RESULTS: during the pre-ban period a wide range of nicotine concentrations was observed. Offices and industry sector exhibited very low concentrations, 0,47 e 0,40 microg/m3 in median, respectively. Highest concentrations were measured in pubs and discos (35,59 and 127,16 microg/m3). After the smoking ban, a noteworthy reduction in nicotine concentrations was found with a stronger effect in pubs and discos (95% of decrease). DISCUSSION: the introduction of a national smoking ban led to a clear reduction in SHS exposure, with stronger results in environments less protected by previous regulations.

[The smoke free movies initiative in the United States]. / Le iniziative smoke free movies negli Stati Uniti e la battaglia per liberare il cinema dal fumo.

Movies influence fashion, lifestyles, and represent smoking as an acceptable behaviour. In fact the greatest tobacco companies built relationships with Hollywood's actors and producers, in order to show smoking and cigarette brands in films. All over the world laws have been developed, in order to restrict smoking and tobacco advertising. Films showing tobacco do not violate these laws, even in those states where tobacco advertising is restricted. Moreover, films are better than any other commercial advertisements because the audience is total unconscious of the sponsor's involvement. Stanton Glantz, Medicine Professor at San Francisco University, is the voice of the movement for smoke-free movies. A lot of studies show that cigarette smoking is more frequently in '90s movies than in 60's and 70's movies. The smoking actors seem to be attractive, strong, healthy and successful. Films showing smoking influence tomorrow's customers: adolescents. Teenagers watching "smoking films" are the most exposed to start smoking. Hence the need to educate Hollywood industry, in order to have smoke-free movies.

Exposure to secondhand smoke in terraces and other outdoor areas of hospitality venues in eight European countries.

BACKGROUND: Outdoor secondhand smoke (SHS) concentrations are usually lower than indoor concentrations, yet some studies have shown that outdoor SHS levels could be comparable to indoor levels under specific conditions. The main objectives of this study were to assess levels of SHS exposure in terraces and other outdoor areas of hospitality venues and to evaluate their potential displacement to adjacent indoor areas. METHODS: Nicotine and respirable particles (PM2.5) were measured in outdoor and indoor areas of hospitality venues of 8 European countries. Hospitality venues of the study included night bars, restaurants and bars. The fieldwork was carried out between March 2009 and March 2011. RESULTS: We gathered 170 nicotine and 142 PM2.5 measurements during the study. The median indoor SHS concentration was significantly higher in venues where smoking was allowed (nicotine 3.69 µg/m3, PM2.5: 120.51 µg/m3) than in those where smoking was banned (nicotine: 0.48 µg/m3, PM2.5: 36.90 µg/m3). The median outdoor nicotine concentration was higher in places where indoor smoking was banned (1.56 µg/m3) than in venues where smoking was allowed (0.31 µg/m3). Among the different types of outdoor areas, the highest median outdoor SHS levels (nicotine: 4.23 µg/m3, PM2.5: 43.64 µg/m3) were found in the semi-closed outdoor areas of venues where indoor smoking was banned. CONCLUSIONS: Banning indoor smoking seems to displace SHS exposure to adjacent outdoor areas. Furthermore, indoor settings where smoking is banned but which have a semi-closed outdoor area have higher levels of SHS than those with open outdoor areas, possibly indicating that SHS also drifts from outdoors to indoors. Current legislation restricting indoor SHS levels seems to be insufficient to protect hospitality workers--and patrons--from SHS exposure. Tobacco-free legislation should take these results into account and consider restrictions in the terraces of some hospitality venues to ensure effective protection.

Smoke-free policy development in Italy through the legislative process of the ban 2000-2005, and press media review 1998-2008.

The objective of this article is to describe the process of approval of the Italian smoking ban, enacted in 2005. The method is to conduct a review of proposed and approved legislation 2000- 2005, and of articles published in Italian newspapers, 1998-2008. Enabling factors in the process were: the leadership of two consecutive Health Ministers, both physicians, who introduced the bill four times between 2000-2002; the repeated presentation and final approval of the bill as an amendment within a bill on public administration which enabled timely approval of the ban; and the stringent air quality standards in the 2003 regulation that made building smoking rooms impracticable and prohibitively expensive. Limiting factors in the process were: the 6-month delay in approving the regulation on smoking rooms; the 1.5-year delay in approving the regulation establishing owners' responsibility for enforcing the ban in hospitality premises and the legal action in August 2005, which shifted responsibility for enforcement to police. Eighty-three percent of the 808 articles published on smoking in 1998-2008 were released between 2000-2005, during the policy process. While the press devoted considerable attention to the issues raised by the hospitality sector, the long legislative process of the bill and its regulations also stimulated coverage on tobacco control issues.