Study protocol of EUREST-PLUS - European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Disease

Flavored tobacco products appeal to youth, and jurisdictions have implemented policy interventions to reduce youth tobacco initiation. This study reviews the process, challenges, and compliance monitoring of a flavored tobacco sales restriction. New York City (NYC) passed a policy restricting the sale of flavored non-cigarette tobacco products in 2009. To describe the policy’s passage, legal defense, implementation, and enforcement, we conducted stakeholder interviews, reviewed legislative and legal records, and analyzed administrative data on retailer inspections and violations. Extensive public and policy maker education efforts preceded this policy. Barriers included opposition to the policy’s passage and a tobacco manufacturer’s lawsuit that sought to halt the law’s implementation and to establish that NYC lacked the authority to restrict the sale of flavored products. The city implemented the flavored tobacco policy as intended and it withstood legal challenges. NYC integrated enforcement into the city’s retailer compliance monitoring infrastructure, and the violation rate is low. Our investigation of NYC’s experience with flavored tobacco policy implementation and enforcement can provide policy makers and health professionals with insights relevant to policy implementation, expand understanding of the potential impact of these kinds of policies, and inform compliance monitoring efforts.

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Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-017-1912-9 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 12

Author(s):

Dina Visca ◽

Vicky Tsipouri ◽

Letizia Mori ◽

Ashi Firouzi ◽

Sharon Fleming ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Lung Disease ◽

Study Protocol ◽

Controlled Trial ◽

Randomised Controlled ◽

Fibrotic Lung Disease

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ICE COLD ERIC – International collaborative effort on chronic obstructive lung disease: exacerbation risk index cohorts – Study protocol for an international COPD cohort study

BMC Pulmonary Medicine ◽

10.1186/1471-2466-9-15 ◽

2009 ◽

Vol 9 (1) ◽

Cited By ~ 20

Author(s):

Lara Siebeling ◽

Gerben ter Riet ◽

Willem M van der Wal ◽

Ronald B Geskus ◽

Marco Zoller ◽

...

Keyword(s):

Cohort Study ◽

Lung Disease ◽

Study Protocol ◽

Obstructive Lung Disease ◽

Risk Index ◽

Chronic Obstructive Lung Disease ◽

Chronic Obstructive ◽

Collaborative Effort ◽

Disease Exacerbation ◽

Exacerbation Risk

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Study protocol: the ear–nose–throat (ENT) prospective international cohort of patients with primary ciliary dyskinesia (EPIC-PCD)

BMJ Open ◽

10.1136/bmjopen-2021-051433 ◽

2021 ◽

Vol 11 (10) ◽

pp. e051433

Author(s):

Myrofora Goutaki ◽

Yin Ting Lam ◽

Mihaela Alexandru ◽

Andreas Anagiotos ◽

Miguel Armengot ◽

...

Keyword(s):

Lung Disease ◽

Study Protocol ◽

Primary Ciliary Dyskinesia ◽

Clinical Symptoms ◽

Ethics Committees ◽

Human Research Ethics ◽

Patient Organisations ◽

Patient Reported ◽

Reported Data ◽

Ciliary Dyskinesia

IntroductionPrimary ciliary dyskinesia (PCD) is a rare, genetic, multiorgan disease with an estimated prevalence of 1 in 10 000. It affects mainly the upper and lower airways due to impaired mucociliary clearance. Almost all patients have sinonasal or otologic (ear–nose–throat, ENT) problems, although the ENT clinical phenotype may present great variability. Despite that, data on PCD ENT manifestations are scarce and based on small single-centre studies. To date, we know little about the spectrum and severity of PCD ENT disease, its association with lung disease, its course over life and its determinants of prognosis.This study protocol describes the aims and methods of the first prospective, observational, multinational cohort study focusing on ENT disease in patients with PCD.Methods and analysisThe ENT prospective international cohort of patients with PCD (EPIC-PCD) is a prospective standardised observational clinical cohort set up as a multinational multicentre study, embedded into routine patient care. It aims to longitudinally characterise ENT disease in patients with PCD and its association with lung disease, and to identify determinants of its prognosis. Patients of all ages, diagnosed with PCD who undergo an ENT clinical assessment at least once a year at one of the participating centres will be invited to participate. Collected data include diagnostic test results, results of ENT examinations, lung function measurements, information on management of ENT disease and patient-reported data on clinical symptoms and health-related quality of life (QoL). Data are collected using the standardised PCD-specific FOLLOW-PCD form and the validated QoL-PCD questionnaire.Ethics and disseminationThe study has been reviewed and approved by the Human Research Ethics Committees at all participating centres, based on local legislation. The results of the study will be published in scientific journals, presented at scientific conferences and disseminated to participants and national patient organisations.Trial registrationNCT04611516.

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