In Silico Science
In Silico Science is training researchers on innovative methods for living systematic reviews and umbrella reviews applied to the research on tobacco harm reduction, with particular reference to the health effects on cardiovascular and respiratory systems, weight management, COPD, asthma, and smoking cessation
The new highly innovative research project by CoEHAR
This project will produce systematic reviews and umbrella reviews that critically assess the quality of studies and produce living reviews and reports in plain language on high quality studies. These reviews will provide policy makers, healthcare professionals and consumers with reliable and up-to-date data from high-standards studies to shape their decisions on policies and practices to reduce the harm caused by smoking
What is “In Silico Science”? What benefits will it bring?
Healthcare providers and consumers need sound facts and the latest research to inform their decisions about vaping as a substitute for smoking. Unfortunately in the fraught debate over e-cigs, many assertions on the health effects of vaping are based on low quality studies. This project will produce living systematic reviews and umbrella reviews, together with a plain language summaries of the top quality studies to provide information on the health effects of vaping as a substitution for smoking. The living systematic reviews and umbrella reviews, along with plan language summaries, will provide evidence to guide consumers, healthcare professionals, policy makers and regulators.
Consumers
For consumers, the summaries will inform them about the potential benefits and risks of trying substitution.
Healthcare Professionals
For healthcare professionals, the reviews will provide open access to research findings about the health effects of vaping that they may observe in their patients. The reviews will support healthcare providers to make their own determination about substitution as a cessation treatment instead of relying on professional guidelines that are often based on inadequate and out of date information
Healthcare policy makers
Regulators
For regulators, executive summaries can inform policy decisions on graduated regulations based on the potential benefits of vaping, instead of relying on the precautionary principle and defaulting to tobacco control legislation.
Renée O' Leary
Renée O’Leary, PhD found her interest in tobacco research in 2006 with the simple observation that tobacco use was the world’s leading cause of death. Since that time, she has focused her research efforts on reducing the harms of cigarette smoking and has specialized in literature review methodologies.
Her Doctorate
She obtained her doctorate in 2018 at the University of Victoria (Canada). Her dissertation, Vapour Products/E-cigarettes: Claims and Evidence encompasses an analysis of e-cigarette regulation, a review of reviews on e-cigarettes and cessation, and a systematic evidence review of youth vaping. A chapter is published as “Claims in Vapour Device Regulation: A Narrative Policy Framework Analysis” (2017, International Journal of Drug Policy). During her doctoral program she led a research project and produced a monograph for the Canadian Institutes of Health Research, Clearing the Air: A Systematic Review on the Harms and Benefits of E-Cigarettes and Vapour Devices.
Her Master's Thesis and other Research
Her Master’s thesis examined the tobacco industry, The Cigarette Commodity Chain and National Tobacco Control in China and Brazil. She is co-author on eight published articles on smoking cessation and on outdoor smoking bans. As well, she has been involved in health-related literature searches on health equity, post-cardiac care, women’s health indicators, domestic violence interventions, and alcohol studies.
Recent Works
Most recently she is a co-author of “The effect of e-cigarette aerosol emissions on respiratory health: a narrative review” (Expert Review of Respiratory Medicine, 2019). Her commentary “Tobacco Harm Reduction in the 21st Century” with co-author Dr. Polosa is currently in press at Drugs and Alcohol Today.
She is the Project Leader at CoEHAR for a series of literature reviews on tobacco harm reduction for smokers through e-cigarette substitution and its effects on respiratory, cardiovascular, and metabolic (weight) health.
In February 2019 the European Commission designated the Scientific Committee for Health, the Environment, and Emerging Risks (SCHEER)for the draft of a paper as a “scientific opinion on e-cigarettes2. A preliminary report stated electronic cigarettes are only partially effective as an alternative and less harmful than traditional cigarette. According to Riccardo Polosa, Founder of CoEHAR, together with Giovanni Li Volti, Director of CoEHAR and Renèe O’Leary, project leader of In Silico Science, the conclusions by the Commission did not take into account the individual health benefits of using electronic cigarettes compared to conventional ones
Living Systematic Reviews
While cessation is the ideal outcome for people who smoke, many smokers experience multiple treatment failures, particularly those who have been smoking for decades. Substitution is easier to achieve than abstinence, as demonstrated by decades of research on harm reduction. What health benefits may accrue to people who smoke by switching to vapour products (vaping)? The research challenges with vapour product substitution is that many studies are biased by inadequate research designs, selective reporting, and other critical flaws, and there are an accelerating number of studies being published. Healthcare providers, policy-makers, and consumers need sound facts and the latest research to inform their decisions about vaping as a substitute for smoking.
Methodology for Living Systematic Reviews
A detailed protocol is developed and registered for the reviews. For each review, we formalize rigorous quality standards for inclusion of studies with a Critical Interpretive Synthesis, a method developed in 2006 that critically questions the research problems, study assumptions, factors influencing recommendations, and taken-for-granted concepts found in the literature. With these criteria, the review will progress into a standard systematic review, with one addition: a pre-designed process to keep the review up to date. This emergent systematic review method has been named the Living Systematic Review. These reviews are conducted to PRISMA standards and contain an executive summary and a plain language report. After each review is published, an evidence gap map is charted to produce targeted recommendations for future research.
Primary objective
Publish 3 living systematic reviews and plain language summaries of the top quality studies to provide information on the health effects of vaping as a substitution for smoking in the areas of cardiovascular effects, respiratory effects, and weight management.
Secondary objective(s)
Provide specific recommendations for future research and offer criteria for study design to promote robust evidence on the potential benefits of substitution for tobacco harm reduction.
The Umbrella Reviews
Many clinical studies have investigated vaping and other electronic nicotine-delivery systems (ENDS) for cessation. The 2021 Cochrane review on cessation with ENDS included 61 studies. Consequently, there has been an explosion of systematic reviews on this topic, with 16 published from 2020 to 2022. With so many systematic reviews available, individuals can cherry-pick among the diverging conclusions that support their own position on ENDS.
Objectives
The overarching goal of the Umbrella Review project is to situate the current systematic reviews in the wider discussion of ENDS for cessation in two ways: the quality of the reviews and the clinical data on cessation.
Illuminate the Path
Publish 2 umbrella reviews on high quality scientific journals to show the findings of all the systematic reviews on ENDS for smoking cessation, COPD and asthma
Quality Benchmarking
Recommend, based on an objective and extensive assessment, the best quality systematic reviews and flag substandard reviews.
Quit-rate data
Provide data for ENDS use in smoking cessation and demonstrate the comparative effectiveness to other tools and therapies
Health effects data
Display and synthesize the findings of clinical studies on the effects of ENDS use on COPD and asthma.
Methodology
AMSTAR2 Quality Assessment
Our reviews are assessed with AMSTAR2, one of the most popular measurement instruments and scoring tools for systematic review quality assessment, ensuring trust in our findings.
Bias Mitigation
We proactively identify protocol deviations, data discrepancies, and reporting biases to uphold scientific integrity
Meta-Analytic Strategy
For the clinical data on cessation, the Umbrella Review will perform a meta-analysis of quit rates and a meta-analysis of ENDS effectiveness compared to other cessation treatments. The result of these analyses is a tertiary synthesis of the data available in the systematic reviews.
The umbrella review will synthesize findings from human clinical trials, RCTs, and longitudinal cohort studies. Analysis methods will be selected based on the available datasets. The result of these analyses is a tertiary synthesis of the data available in the systematic reviews. The large number of narrative reviews will be summarized and analyzed for publication bias.
Publications
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...
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...
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...
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...
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...
A Critical Interpretive Synthesis to Develop Quality Assessment Tools for E-Cigarette Reviews: Scope and Protocol
One component of a systematic review is the quality assessment of studies to determine their inclusion or exclusion. Studies on e-cigarettes are conducted in the contentious atmosphere surrounding tobacco harm reduction, which has resulted at times in research bias....
Education and Training
Hundred-fifty participants from all over the world took part in the first webinar on “Living systematic reviews: a new standard for medical research questions” to learn the cutting-edge methodologies in developing a Living Systematic Review.
The seminar, held on 16 November 2021 by In Silico Science project leader Dr Renée O’Leary, underlined that LSR provides the up-to-date evidence on medical topics, including THR, that merit consideration for clinical practice
Renée O’Leary, project leader of “In Silico Science”, explains how to integrate the concept of harm reduction in project management: having the wherewithal to use funds correctly, to think the project through is the key to be able to look at possible contingencies and to to assess the value of the project
Daily meetings, technical skills such as quality assessment and bias evaluation and a very specific methodology regarding the field of systematic reviews: Giusy Rita Maria la Rosa talks about her experience during the first year of fellowship under the In Silico Science project at CoEHAR, held from 2020 to 2021.
Working in an highly professional work environment, thanks to the coordination of Dr. O’Leary, gave to dr. La Rosa the possibility to develop new skills, learning how to deal with an international research project and giving a boost to her career.
Press
CoEHAR: NO HEALTH RESPIRATORY EFFECTS REPORTED WITH ECIG SUBSTITUTION FOR SMOKING
A new review conducted on the available scientific literature showed no difference in respiratory parameters in human clinical tests on the respiratory effects of ENDS use in participants who smoke tobacco cigarettes Catania, 8 November, 2023 – The substitution of...
In Silico Science and Replica PI will attend the 6th THR summit, Athens
CoEHAR Director and the PI of the In Silico Science project will join experts, scientists and THR advocates at the 6th Summit on Tobacco Harm Reduction: Novel products, Research & Policy ( 25-26 September, Athens) by SCHORE The 6th Summit on Tobacco Harm...
6th Scientific Summit: latest findings by CoEHAR presented in Athens
Dr. Renée O’Leary, prof. Giovanni Li Volti and dr.Konstantinos Partsinevelos, CoEHAR researchers, attended the 6th Summit on THR in Athens, presenting evidence on the use of ENDS as cessation aid and data from the latest studies on the effect of modified...
ENDS for smoking cessation: CoEHAR published the umbrella review protocol
As part of the work of the In Silico Science project, dr. Renee O’Leary has recently published the protocol for an umbrella review to provide the widest overview of the clinical evidence on ENDS and cigarette smoking abstinence to an audience of researchers and...
CoEHAR researchers’ “guidebook”: how to identify data misinterpretations in ecig studies
Researchers from CoEHAR’s In Silico Science project have developed a two-step technique to identify spin bias, research reporting that results in an intentional or unintentional misinterpretation of research results Catania, 3 May 2023 – The results of scientific...
In Silico review: ecig add no additional cardiovascular health risks
The In Silico Science team analyzed 25 studies comprising 1810 smokers on the possible cardiovascular effects of cigarette substitution: the findings gave no indications that e-cigarette use is more harmful than smoking. Moreover, switching may lead to some possible...