key: cord-0049031-nmuq2y6d authors: nan title: From the IASLC Tobacco Control Committee date: 2020-08-24 journal: J Thorac Oncol DOI: 10.1016/j.jtho.2020.07.010 sha: fbc1c1205927d16fa6d517d1133fe11d37c2ddbc doc_id: 49031 cord_uid: nmuq2y6d nan The Necessity of Continuing to Ban Tobacco Use in Public Places post-COVID-19 The coronavirus disease 2019 (COVID-19) emerged in late 2019 and has since been declared a pandemic by the World Health Organization (WHO). Millions of cases have been reported globally and in all 22 countries of the WHO's Eastern Mediterranean Region (EMR). In the EMR, 15 countries have temporarily banned waterpipe use in both indoor and outdoor public places in response to the COVID-19 pandemic1. This coincided with the release of the WHO Regional Office for the Eastern Mediterranean (WHO/EMRO) "Questions and Answers on Tobacco, Waterpipe and E-cigarette Use in the context of COVID-19" in March 2020. The prohibition is the first of its kind after years of challenges in adopting and/or enacting such a ban. Countries in other WHO regions have also taken specific tobacco control policy measures related to the pandemic, including the banning of spitting in public places in India due to a potentially higher risk of transmission of the virus. The policy response during the COVID-19 pandemic demonstrates that countries in the EMR have both the political will and technical means to adopt and implement strong tobacco control measures to protect public health. It is hoped that this can continue beyond the COVID-19 pandemic by sustaining these new measures at the national level. Recent advances in mobile health and digital technologies have enabled remote trials to offer a promising alternative to traditional in-person clinical trials. Remote trials afford expedient recruitment of large, demographically representative study samples, without undo burden to a research team. The Coronavirus Disease 2019 (COVID-19) global health pandemic has resulted in rapid requirements to shift ongoing clinical trials to remote delivery and assessment platforms, making methods for the conduct of remote trials even more timely. The present review provides an overview of available methods for the conduct of remote tobacco-focused clinical trials as well as illustrative examples of how these methods have been implemented across recently completed and ongoing tobacco studies. We focus on key aspects of the clinical trial pipeline including remote: 1) study recruitment and screening, 2) informed consent, 3) assessment, 4) biomarker collection, and 5) medication adherence monitoring. Way back in the brief, pre-COVID moment of early 2020, we received some long-awaited news. The NELSON study, investigating lung cancer screening by low dose CT (LDCT) chest, was published after a long wait(1). This study reported the results in over 13,000 male smokers randomly assigned to LDCT or no screening at baseline, then at 1, 3 and 5.5 years. It found a 24% reduction in lung cancer mortality at 10 years of followup. This was headline news for the screening community and confirmed the mortality benefit demonstrated by the NLST (National Lung Screening Trial) published way back in 2011 (2) . Both studies recruited current or former smokers with some differences in the age groups and smoking history. The NLST recruited current or former smokers aged 55-74, with a 30-pack year smoking history; the former smokers had quit less than 15 years prior to recruitment. The NELSON study recruited current or former smokers aged 50-74, with a history of more than 15 cigarettes/d x 25y or more than 10 cigarettes/d x 30y; the former smokers had quit within 10 years of recruitment. The NLST compared LDCT with CXR performed annually x 3. The NELSON study compared LDCT with no screening. The NLST reported a 20% reduction in lung cancer mortality with LDCT in over 50,000 men and women randomly assigned to either LDCT or CXR. The NELSON study reported a 24% reduction in lung cancer mortality in over 13,000 men randomly assigned to either LDCT or no screening. Results in a smaller group of women have been presented (3) although not formally published. They look very promising with a 61% reduction in lung cancer mortality in the LDCT group. Since the publication of the NLST the United States has introduced lung cancer screening with many other jurisdictions considering their own programs. Despite the benefit, the uptake of screening appears low in the United States, with a recent study reporting that only 2% of eligible candidates have LDCT chest, far below that of other cancer-screening programs. This is due to a range of factors, despite improvements in funding (4) . Lung cancer screening studies provide opportunities in smoking cessation, with evidence that screening programs improve quit rates (5) and that quitting improves the results of screening (6) . The link between lung cancer and tobacco underpins LDCT screening, with early detection in asymptomatic current or former smokers a major intervention that improves survival. This week's news, that the United States Preventive Services Task Force (USPSTF), is considering a change to the eligibility criteria for lung cancer screening, will have some impact. As reported by the American College of Radiology, the USPSTF may expand the eligibility criteria for LDCT chest by lowering the starting age to 50, reducing the pack-years required (to 20 py) and extending the quit smoking requirements (from 15 to 20 years) (7) . The USPSTF website (8) presents a draft recommendation calling for public comment (at the time of writing). Likely benefits of the expanded criteria include greater eligibility for particular ethnic groups and women, who may have higher risk of lung cancer at lower levels of smoking intensity. The USPSTF will need research into increasing the uptake of lung cancer screening. Other countries that have yet to establish programs will watch this with intense focus. For the tobacco control community, this development emphasizes the role of tobacco in lung cancer and the certain need for successful smoking cessation. Lung cancer is hard to treat. Although the American Lung Association has reported some improvements over the last 10 years(9) we can still do better. We know that even after lung cancer has been diagnosed that smoking cessation can improve survival (10) . We also know that ongoing smoking may diminish the effects of cancer therapy and that this may cost a lot in subsequent treatments (11) . We know that smoking cessation is hard and that high levels of dependence on tobacco lead to poorer lung cancer outcomes (12) . And we know that many oncologists may prefer that others manage the smoking cessation needs of their patients (13) . The Cancer Network reports on a recent study into the role of pharmacotherapy in smoking cessation in cancer survivors (14) . This draws upon information from national survey data that evaluates the smoking status, quit attempts and cancer diagnosis of respondents. The paper itself reports on over 500 adult cancer survivors with recent quit attempts and breaks down the methods used to quit (15) . Methods included nothing (unassisted), approved medication, e-cigarettes and counselling. Out of the group, 45 people had successfully quit and the most effective measure, through adjusted analysis, turned out to be the approved medications. The paper acknowledges its limitations including the cross-sectional design, the self-reported nature of the data and the sample size. However, it adds to our knowledge. To treat lung cancer, we know a lot about three strategies e surgery, radiotherapy and systemic therapy. We now have a fourth. A small report caught the eyes of this committee. Spain is now warning against smoking and vaping in public, due to the hand-to-face nature of the activity that carries a risk of viral transmission. A local English-language publication summarizes the recommendations that include hand hygiene and cleaning of devices used (16) . Smoking and vaping should not be undertaken in communal settings and only considered in open spaces. We found the health department publication and (with some help in translation) read it through. The Position Paper of the Sistema Nacional de Salud(17) outlines the risks of smoking due to: -Manipulation of protective masks and repetitive contact between mouth and smoking device with fomite transmission -Droplet transmission through smoking -Relaxation of social distancing measures The paper also raises concerns about water pipes, which have been banned during the more restrictive phases of Spanish lockdown. The recommendations highlight our new thinking about masks, about social life and about our habits. Nueva Normalidad indeed. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial Reduced lung-cancer mortality with low-dose computed tomographic screening Nelson Lung Cancer Screening Study Confirms NLST Results Lung Cancer Screening Registry Reveals Low-dose CT Screening Remains Heavily Underutilized. Clin Lung Cancer Impact of low-dose CT screening on smoking cessation among high-risk participants in the UK Lung Cancer Screening Trial The Association between Smoking Abstinence and Mortality in the National Lung Screening Trial Cancer Screening Guidelines Would Help Save Lives United States Preventive Services Taskforce Draft Recommendation Statement Lung Cancer Screening Key Findings j State of Lung Cancer j American Lung Association Tobacco Cessation May Improve Lung Cancer Patient Survival Attributable Failure of First-line Cancer Treatment and Incremental Costs Associated With Smoking by Patients With Cancer Tobacco Dependence Predicts Higher Lung Cancer and Mortality Rates and Lower Rates of Smoking Cessation in the National Lung Screening Trial Oncologist provision of smoking cessation support: A national survey of Australian medical and radiation oncologists Pharmacotherapy Leads to Successful Smoking Cessation in Cancer Survivors j Cancer Network Smoking-Cessation Methods and Outcomes Among Cancer Survivors Spain warns against smoking and vaping in public to avoid Covid infections -The Local