Respiratory health effects of e-cigarette substitution for tobacco cigarettes: a systematic review.

BACKGROUND: E-cigarettes (electronic nicotine delivery system, ENDS) have been presented as a harm reduction strategy for people who smoke tobacco cigarettes but who cannot achieve abstinence, or for those who wish to continue to enjoy nicotine and the habit of smoking. What are the health effects of the substitution of ENDS for tobacco cigarettes? This systematic review evaluates the evidence of human clinical tests on the respiratory effects of ENDS use in participants who smoke tobacco cigarettes. METHODS: A registered and published protocol was developed conforming to PRISMA 2020 and AMSTAR2 standards. The literature search was conducted in PubMed, Scopus, and the CENTRAL Cochrane Library and updated to May 2022. Three supplementary searches and a grey literature search were performed. Studies were evaluated with the JBI quality tools and the Oxford Catalogue of Bias. Due to the heterogeneity (diversity) of the studies, a narrative data synthesis was performed on the test findings plus three sub-group analyses. RESULTS: The review consists of sixteen studies and twenty publications. Spirometry tests comprised the majority of the data. In total, 66 respiratory test measurements were reported, out of which 43 (65%) were not significant. Statistically significant findings were mixed, with 9 tests showing improvements and 14 measuring declines, none of which was clinically relevant. Ten studies were rated at a high risk of bias, and six had some concerns primarily due to inadequate research designs and the conduct of the studies. Reporting bias was documented in thirteen studies. CONCLUSIONS: Most of the studies showed no difference in respiratory parameters. This indicates that ENDS substitution for smoking likely does not result in additional harm to respiratory health. Due to the low quality of the studies, confidence in the conclusions is rated as low. Robust studies with a longer duration and sufficient power are required to validate any potential benefits or possible harms of ENDS substitution. Registration PROSPERO #CRD42021239094, International Registered Report Identifier (IRRID): DERR1-10.2196/29084.

e-Cigarette Use and the Cessation of Tobacco Cigarette Smoking: Protocol for an Umbrella Review.

BACKGROUND: Electronic nicotine delivery systems (ENDS), commonly called e-cigarettes, have been examined in clinical studies for their effects on tobacco smoking cessation. In the past 2 years, a dozen or more systematic reviews on ENDS and cigarette smoking cessation have been published that present differing conclusions and recommendations on the use of ENDS. OBJECTIVE: Our umbrella review aims to synthesize the findings from current systematic reviews to investigate the quit rates and the percentage of participants abstinent from cigarette smoking using ENDS. Additionally, we will examine the quit rates with ENDS in comparison to other established cessation treatments. METHODS: The search will retrieve systematic reviews that include both clinical trials and experimental studies on the use of ENDS for smoking cessation. We will also include nonrandomized cohort studies that track ENDS use and the subsequent abstinence from smoking. Databases searches will be conducted in Embase, Scopus, PubMed, and 7 additional registries. Secondary searches will include reference checking, citation chasing, and consultations with topic experts. Two reviewers will perform a title and abstract exclusion followed by a full-paper inclusion process. Data extraction will be conducted by 1 reviewer and completely checked by a second reviewer. Each systematic review will be assessed by 2 reviewers for methodological quality using AMSTAR2 (A Measurement Tool to Assess Systematic Reviews, version 2) and for reporting bias using categories from the Centre for Evidence-Based Medicine's Catalogue of Bias. Unreported discrepancies between the protocol and the published review will be identified. RESULTS: The umbrella review started on March 1, 2023. At the time of publication, the study selection was being conducted and the pilot testing of the data extraction and bias assessment forms were in progress. The review is expected to be completed by December 31, 2023, followed by the submission of the review for journal publication. A second-order meta-analysis will calculate the range and average of quit rates for ENDS. A vote counting of the direction of effect, based on quit rates, will be used to present the relative effectiveness of ENDS for smoking cessation compared to other cessation treatments (including no treatment). A citation matrix will list primary studies with their bias ratings from all the systematic reviews. The effect of overlapping studies between the systematic reviews will be calculated using the corrected coverage area analysis. A sensitivity analysis will examine the impact of the intensity of cessation treatment on quit rates. Depending on the availability of data, subgroup analyses will be conducted based on participants' gender, age, prior quit attempts, and nicotine dependence. The strength or weakness of the evidence synthesis will be assessed using a stratification of evidence technique. Reporting bias will be presented with a tabulation of bias indicators. Publication bias will be assessed. CONCLUSIONS: The use of ENDS for smoking cessation is a highly controversial subject. Through an exhaustive synthesis of the available data, we will present the quit rates of cigarette smoking cessation obtained with ENDS and how they compare to quit rates obtained from other established cessation treatments. The critical quality and bias assessment of the systematic reviews will indicate the most reliable sources to inform treatment considerations and policy development. TRIAL REGISTRATION: PROSPERO CRD42023406165; https://tinyurl.com/4ekzpbrj. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47711.

Identifying spin bias of nonsignificant findings in biomedical studies.

OBJECTIVE: The purpose of this research note is to share a technique for the identification of spin bias that we developed as part of a living systematic review on the cardiovascular testing of e-cigarette substitution for cigarette smoking. While some researchers have remarked on the subjective nature of ascertaining spin bias, our technique objectively documents forms of spin bias arising from the misrepresentation of nonsignificant findings and from the omission of data. RESULTS: We offer a two-step process for the identification of spin bias consisting of tracking data and findings and recording of data discrepancies by describing how the spin bias was produced in the text. In this research note, we give an example of the documentation of spin bias from our systematic review. Our experience was that nonsignificant results were presented as causal or even as significant in the Discussion of studies. Spin bias distorts scientific research and misleads readers; therefore it behooves peer reviewers and journal editors to make the effort to detect and correct it.

Clinical testing of the cardiovascular effects of e-cigarette substitution for smoking: a living systematic review.

Some persons who smoke have substituted e-cigarettes for tobacco cigarettes, either completely or partially. What effect does this have on cardiovascular functioning? We conducted a living systematic review on human clinical studies measuring the cardiovascular effects of e-cigarette substitution for smoking. The Scopus, PubMed, and CENTRAL Cochrane Library databases were searched on January 31 and April 29, 2021. Three secondary searches and a grey literature search were conducted. Included study designs were randomized controlled trials, quasi-experimental clinical trials, and cohort studies. Risk of bias and study quality were evaluated with the JBI Critical Appraisal tools and the Oxford Catalogue of Bias. The systematic review covered 25 studies comprising 1810 participants who smoked. Twenty studies were rated at high risk of bias, and five as some concerns. A tabular synthesis by direction of effect was conducted due to heterogeneity in the data. Nearly two-thirds of the test analyses indicated that e-cigarette use had no significance difference compared with tobacco cigarettes on heart rate, blood pressure, and in other cardiovascular tests. In two studies, participants with hypertension experienced a clinically relevant reduction in systolic blood pressure after 1 year of e-cigarette use. E-cigarette substitution incurs no additional cardiovascular risks, and some possible benefits may be obtained, but the evidence is of low to very low certainty. An update search on May 30, 2022 retrieved five studies that did not alter our conclusion.Registration PROSPERO #CRD42021239094.

Health impact of e-cigarettes and heated tobacco products in chronic obstructive pulmonary disease: current and emerging evidence.

INTRODUCTION: Quitting is the only proven method to attenuate the progression of chronic obstructive pulmonary disease (COPD). However, most COPD smokers do not seem to respond to smoking cessation interventions and may benefit by lessening the negative health effects of long-term cigarette smoke exposure by switching to non-combustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and e-cigarettes (ECs). AREAS COVERED: Compared with conventional cigarettes, HTPs and ECs offer substantial reduction in exposure to toxic chemicals and have the potential to reduce harm from cigarette smoke when used as tobacco cigarette substitutes. In this review, we examine the available clinical studies and population surveys on the respiratory health effects of ECs and HTPs in COPD patients. EXPERT OPINION: The current research on the impact of ECs and HTPs on COPD patients' health is limited, and more high-quality studies are needed to draw definitive conclusions. However, this review provides a comprehensive overview of the available literature for health professionals looking to advise COPD patients on the use of these products. While ECs and HTPs may offer some benefits in reducing harm from cigarette smoke, their long-term effects on COPD patients' health are still unclear.

Respiratory and Cardiovascular Health Effects of e-Cigarette Substitution: Protocol for Two Living Systematic Reviews.

BACKGROUND: Despite the clear risks of tobacco use, millions of people continue to smoke. Electronic nicotine delivery systems (ENDS), commonly called e-cigarettes, have been proposed as a substitute for those who are unwilling or unable to quit. Current systematic and narrative reviews on the health effects of ENDS use, particularly respiratory and cardiovascular effects, have come to differing conclusions. OBJECTIVE: We conducted two systematic reviews to critically assess and synthesize available human studies on the respiratory and cardiovascular health effects of ENDS substitution for people who smoke. The primary goal is to provide clinicians with evidence on the health effects of ENDS substitution to inform their treatment recommendations and plans. The twin goal of the reviews is to promote health literacy in ENDS users with facts on the health effects of ENDS. METHODS: These two reviews will be living systematic reviews. The systematic reviews will be initiated through a baseline review. Studies will be evaluated using the JBI quality assessment tools and a checklist of biases drawn from the Centre for Evidence Based Medicine Catalogue of Bias. A narrative synthesis is planned because of the heterogeneity of data. A search for recently published studies will be conducted every 3 months, and an updated review will be published every 6 months for the duration of the project or possibly longer. RESULTS: The baseline and updated reviews will be published in a peer-reviewed journal. The findings of the reviews will be reported in a white paper for clinicians and a fact sheet for people who use ENDS. CONCLUSIONS: The substitution of ENDS for cigarettes is one way to potentially reduce the risks of smoking. Clinicians and their patients need to understand the potential benefits and possible risks of substituting ENDS for cigarettes. Our living systematic reviews seek to highlight the best and most up-to-date evidence in this highly contentious and fast-moving field of research. TRIAL REGISTRATION: PROSPERO CRD42021239094; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=239094. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29084.

Critical appraisal of the European Union Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) Preliminary Opinion on electronic cigarettes.

BACKGROUND: In preparation for the 2021 revision of the European Union Tobacco Products Directive, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has posted its Preliminary Opinion on Electronic Cigarettes. They concluded that e-cigarettes only achieve a sub-optimal level of protection of human health. In this paper, we provide evidence that the Opinion's conclusions are not adequately backed up by scientific evidence and did not discuss the potential health benefits of using alternative combustion-free nicotine-containing products as substitute for tobacco cigarettes. METHODS: Searches for articles were conducted in PubMed and by citation chasing in Google Scholar. Articles were also retrieved with a review of references in major publications. Primary data from World Health Organization surveys, the conclusions of reviews, and peer-reviewed non-industry studies were cited to address errors and omissions identified in the Opinion. RESULTS: The Opinion omitted reporting on the individual and population health benefits of the substitution of e-cigarettes (ENDS) for cigarette smoking. Alternative hypotheses to the gateway theory were not evaluated. Its assessment of cardiovascular risk is contradicted by numerous reviews. It cites ever-use data that do not represent current patterns of use. It did not report non-nicotine use. It presented erroneous statements on trends in ENDS prevalence. It over-emphasized the role of flavours in youth ENDS initiation. It did not discuss cessation in sufficient length. CONCLUSIONS: For the delivery of a robust and comprehensive final report, the members of the Working Group of the Scientific Committee on Health, Environmental and Emerging Risks will need to consider (1) the potential health benefits of ENDS substitution for cigarette smoking, (2) alternative hypotheses and contradictory studies on the gateway effect, (3) its assessment of cardiovascular risk, (4) the measurements of frequency of use, (5) non-nicotine use, (6) the role of flavours, and (7) a fulsome discussion of cessation.

The effect of e-cigarette aerosol emissions on respiratory health: a narrative review.

Introduction: Due to the uptake in the use of e-cigarettes (ECs), evidence on their health effects is needed to inform health care and policy. Some regulators and health professionals have raised concerns that the respirable aerosols generated by ECs contain several constituents of potential toxicological and biological relevance to respiratory health. Areas covered: We critically assess published research on the respiratory system investigating the effects of ECs in preclinical models, clinical studies of people who switched to ECs from tobacco cigarettes, and population surveys. We assess the studies for the quality of their methodology and accuracy of their interpretation. To adequately assess the impact of EC use on human health, addressing common mistakes and developing robust and realistic methodological recommendations is an urgent priority. The findings of this review indicate that ECs under normal conditions of use demonstrate far fewer respiratory risks than combustible tobacco cigarettes. EC users and smokers considering ECs have the right to be informed about the relative risks of EC use, and to be made aware that findings of studies published by the media are not always reliable. Expert opinion: Growing evidence supports the relative safety of EC emission aerosols for the respiratory tract compared to tobacco smoke.

Claims in vapour device (e-cigarette) regulation: A Narrative Policy Framework analysis.

BACKGROUND: The electronic cigarette or e-cigarette (vapour device) is a consumer product undergoing rapid growth, and governments have been adopting regulations on the sale of the devices and their nicotine liquids. Competing claims about vapour devices have ignited a contentious debate in the public health community. What claims have been taken up in the state arena, and how have they possibly influenced regulatory outcomes? METHODS: This study utilized Narrative Policy Framework to analyze the claims made about vapour devices in legislation recommendation reports from Queensland Australia, Canada, and the European Union, and the 2016 deeming rule legislation from the United States, and examined the claims and the regulatory outcomes in these jurisdictions. RESULTS: The vast majority of claims in the policy documents represented vapour devices as a threat: an unsafe product harming the health of vapour device users, a gateway product promoting youth tobacco uptake, and a quasi-tobacco product impeding tobacco control. The opportunity for vapour devices to promote cessation or reduce exposure to toxins was very rarely presented, and these positive claims were not discussed at all in two of the four documents studied. CONCLUSION: The dominant claims of vapour devices as a public health threat have supported regulations that have limited their potential as a harm reduction strategy. Future policy debates should evaluate the opportunities for vapour devices to decrease the health and social burdens of the tobacco epidemic.

Smoking on the margins: a comprehensive analysis of a municipal outdoor smoke-free policy.

BACKGROUND: This study examined the formulation, adoption, and implementation of a ban on smoking in the parks and beaches in Vancouver, Canada. METHODS: Informed by Critical Multiplism, we explored the policy adoption process, support for and compliance with a local bylaw prohibiting smoking in parks and on beaches, experiences with enforcement, and potential health equity issues through a series of qualitative and quantitative studies. RESULTS: Findings suggest that there was unanimous support for the introduction of the bylaw among policy makers, as well as a high degree of positive public support. We observed that smoking initially declined following the ban's implementation, but that smoking practices vary in parks by location. We also found evidence of different levels of enforcement and compliance between settings, and between different populations of park and beach users. CONCLUSIONS: Overall success with the implementation of the bylaw is tempered by potential increases in health inequities because of variable enforcement of the ban; greatest levels of smoking appear to continue to occur in the least advantaged areas of the city. Jurisdictions developing such policies need to consider how to allocate sufficient resources to enhance voluntary compliance and ensure that such bylaws do not contribute to health inequities.

Clearing the air: protocol for a systematic meta-narrative review on the harms and benefits of e-cigarettes and vapour devices.

BACKGROUND: Under the shadow of the tobacco epidemic, the sale and use of e-cigarettes and other vapour devices is increasing dramatically. A contentious debate has risen within public health over the harms and benefits of these devices. Clearing the Air seeks to clarify the issues with a systematic review that informs the pressing regulatory and public health decisions to be made regarding these new products. METHODS/DESIGN: Using an integrated knowledge translation approach, public health researchers and knowledge users will work collaboratively throughout the project. Our research questions are the following: (1) What are the health risks and benefits of vapour devices, and how do these compare to cigarettes? (2) What is the harm reduction potential of vapour devices for individuals, the environment, and society? (3) Does youth vapour device experimentation lead to cigarette use? (4) Can vapour devices be effective aids for tobacco cessation? and (5) What is the potential toxicity of second-hand vapour? We are using meta-narrative review to synthesize studies from diverse research traditions because of its capacity to address contestations around a topic. The project has six phases. In the planning phase, we finalized the research questions. In the search phase, we are locating academic publications and grey literature aided by a research librarian. The mapping phase involves categorizing these papers into research traditions to understand different perspectives on the evidence for each research question. In the appraisal phase, we will select and evaluate the relevant papers. Finally, in the synthesis phase, using analytic techniques unique to meta-narrative methodology, we will compare and contrast the evidence from different research traditions to answer our research questions, identifying overarching meta-narratives. In the final stage, the full team will draft recommendations to be disseminated through a variety of knowledge translation strategies. DISCUSSION: Meta-narrative synthesis has the unique capacity to expose the debates that are influencing the interpretation of empirical studies on vapour devices. We seek to "clear the air" with an even-handed review of the evidence and an understanding of the tensions within public health so that we can offer clear-headed recommendations for policy, regulation, and future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015025267.

Partner support for smoking cessation during pregnancy: a systematic review.

INTRODUCTION: Pregnancy is a key time to leverage receptivity to smoking reduction or cessation in both pregnant women and their partners. A partner's smoking status and support for the pregnant/postpartum woman's efforts to reduce or quit smoking may impact her smoking behavior. METHODS: A systematic literature review of interventions to enhance partner support for pregnant/postpartum women's smoking reduction or cessation and cessation treatments for the partners themselves identified 855 unique references, which were examined for relevance, yielding 9 intervention studies. RESULTS: This narrative review analyzed a range of interventions including mass media campaigns, ultrasound scans, video, self-help manuals, counselling, and nicotine replacement therapies (NRTs) aimed at pregnant women and/or their partners. One randomized controlled trial (RCT) showed significant results for an intervention, which included a partner-targeted component in which pregnant women received health counselling, video and printed information, while partners received a booklet explaining the importance of quitting together. Three studies (1 RCT cluster, 1 pre-post test, 1 RCT) demonstrated no effect in improving smoking cessation among pregnant women. Two RCTs included free NRTs, telephone counselling, and multiple contacts as components of effective intervention for male partners, but impact on overall quit rates may not be sustainable postpartum. Seven studies (4 pre-post test, 2 RCT, 1 RCT cluster) found no effect of the intervention on partner smoking cessation. CONCLUSIONS: Despite the importance of partner smoking, there are very few effective smoking cessation interventions for pregnant/postpartum women that include or target male partners, suggesting the need for further intervention development and research to establish the utility of this approach.

Surviving Medicare's IPPS changes: what you need to know.

To prepare for the full impact of MS-DRG implementation, providers should: educate and communicate; ensure coding accuracy and thoroughness; assess productivity; analyze and evaluate; reassess current procedures; stay current.

The future of APCs: a look at Medicare's 2005 changes and industry trends.

As the healthcare industry continues to struggle with an ever-evolving APC-based hospital outpatient PPS, it's important to be aware of some of the latest changes affecting providers and to recognize areas that may present particular challenges for private payers.

Time for a three-year APC checkup.

As hospitals near the end of their third year with APCs and the Medicare outpatient PPS, it's important to reflect on past successes and prepare for the management strategies that will be needed for tomorrow. Particularly important will be reinforcing the importance of interdepartmental cooperation, especially as it relates to new documentation and coding requirements, observation and emergency department protocols, E/M classifications, registration processes, and medical staff involvement.