Evidence map›Paper›PMID 31049783›Full record

ArticleInternal and emergency medicine2019

Evaluating the effects of switching from cigarette smoking to using a heated tobacco product on health effect indicators in healthy subjects: study protocol for a randomized controlled trial.

Nik Newland, Frazer John Lowe, Oscar Martin Camacho, Mike McEwan, Nathan Gale, James Ebajemito, George Hardie, James Murphy, Christopher Proctor

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Internal and emergency medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
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  5. Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Nik NewlandGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
Frazer John LoweGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK. frazer_lowe@bat.com.ORCID http://orcid.org/0000-0003-2916-9902
Oscar Martin CamachoGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
Mike McEwanGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
Nathan GaleGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
James EbajemitoGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
George HardieGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
James MurphyGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
Christopher ProctorGroup Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.
British American Tobacco (United Kingdom) · GB

Funding

British American Tobacco (Investments) Ltd. N/A
6 · The paper itself

Abstract

Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in health effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public health impact of THPs.Clinical Trial Registration: https://www.isrctn.com/ISRCTN81075760.

Indexed as

AdultBiomarkersCigarette SmokingFemaleHealthy VolunteersHumansMaleMiddle AgedNicotineTobacco ProductsBiomarkersNicotineAugmentation IndexBiomarkersCardiovascular diseaseNNALOxidative stressPRRPSmoking cessationTobacco heating product

Identifiers

PMID31049783
PMCPMC6722146
OpenAlexW2942670762

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.