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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as a cessation treatment instead of relying on professional guidelines that are often based on inadequate and out of date information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
For healthcare policy makers, the reviews will provide data for evidence-informed decisions for treatment protocols and programs, and guidance for research programs.
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.

Google Scholar Link

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

Identifying spin bias of nonsignificant findings in biomedical studies

May 3, 2023 |

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...

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

Link

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

Thinking critically about reviews and tobacco harm reduction

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If it is not a systematic review, then the reviewers chose the studies they wanted to include, also known as “cherry picking.”
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Peer review is not a guarantee of accurate evidence. A retracted e-cigarette study published by the American Heart Association had already been cited as “fact” in 38 publications, including a US Surgeon General report. The Lancet and the New England Journal of Medicine retracted major articles on coronavirus that had passed peer review.
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In vitro (cell) studies are not conducted with standardized testing techniques and are subject to high levels of false positives.
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In vivo (animal) studies on e-cigarettes often use tests that do not replicate vaping, such as cutting open the animals’ tracheas and injecting e-liquid, or squirting e-liquid into the animals’ noses. Also, consider the ethical issues about animal testing.
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The dominant position against tobacco harm reduction is evidenced in how negative reviews and studies on e-cigarettes are cited far more frequently than those with neutral or positive conclusions.
Taken from Catania Conversation, May 30, 2020

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