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JMIR Preprints Pandey et al
Effect of E-cigarette in Harm Reduction among the
Adolescents - A Protocol for a Systemic Review
Ashok Pandey, Johurul Islam Jewel, Narayan Bahadur Mahotra, Ayuska Parajuli
Submitted to: JMIR Research Protocols
on: September 25, 2018
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expressively prohibit redistribution of this draft paper other than for review purposes.
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Table of Contents
Original Manuscript ............................................................................................................................................................................. 5
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Effect of E-cigarette in Harm Reduction among the Adolescents - A
Protocol for a Systemic Review
Ashok Pandey1, M.P.H.; Johurul Islam Jewel2, M.P.H.; Narayan Bahadur Mahotra3, M.B.B.S., M.D; Ayuska Parajuli1,
M.P.H.
1 Public Health Research Society Nepal, , , Kathmandu, Nepal.
2 CSF Global, , , Dhaka, Bangladesh.
3 Department of Clinical physiology, Maharajgunj medical campus, Institute of medicine, , , Kathmandu, Nepal.
Corresponding Author:
Ashok Pandey, M.P.H.
Public Health Research Society Nepal
Chabahil, 07, Kathmandu, Nepal
Kathmandu
Nepal
Phone: 977 9849160605
Email: pandeyg7@gmail.com
Abstract
Background: E-cigarettes present an opportunity to increase the tobacco cessation rates, and thereby suppress the largest cause
of global death significantly. Though E-cigarettes are perceived as less harmful than conventional cigarettes still their
effectiveness as a tobacco cessation tool, their difference with other prescribed tobacco cessation methods and their long term
effects are yet to be synthesized precisely.
Objective: The aim of this review is to provide evidence of existing literature in case of harm reduction by e-cigarettes among
adolescent.
Methods: To explore the available evidence on the effect of electronic cigarettes in harm reduction among the adolescents, we
followed the Standard method of Cochrane for conducting a systematic review. Total 13 bibliographic and impact evaluation
database will be searched using a comprehensive search strategy. RCTs and quasi experimental studies on e-cigarettes usability
which has been published scientific journals will be included. Timeframe for searching relevant articles for the review were
limited between January 2003 and June 2018. The intervention provided to the adult population (population aged 19 years and
above), adolescents with pregnancy and adolescents having an other diseased condition will be excluded. Any trial, which is
ongoing, published protocol of trials, traditional reviews and systematic reviews will be excluded. Letter to editor, editorial
comments and conference proceedings were excluded as well. Articles published only in English language will be included.
Results: Narrative synthesis of included articles will be provided, including the quality assessment using standard tools. Pooled
estimation will be provided regarding harm reduction and smoking cessation where applicable.
Conclusions: Not applicable
ClinicalTrial: PROSPERO registration of the systematic review is CRD42018106691
(JMIR Preprints 25/09/2018:12313) DOI: https://doi.org/10.2196/preprints.12313
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Original Manuscript
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Title: Effect of E-cigarette in Harm Reduction among the Adolescents - A Systemic Review
Authors: K.M. Saif-Ur-Rahman1, Razib Mamun1, Mehnaaz Altaf2, Md Johurul islam Jewel2,
Narayan Bahadur Mahotra3, Ayuska Parajuli4, Ashok Pandey2,5.
Affiliations:
1. Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh
2. CSF Global Dhaka, Bangladesh
3. Department of Clinical Physiology, Maharajgunj Medical Campus, Institute of Medicine,
Kathmandu, Nepal
4. Public Health Research Society Nepal (PHRSN), Kathmandu, Nepal
5. Nepal Health Research Council (NHRC), Kathmandu, Nepal
Author Details:
1. Dr. K.M. Saif-Ur-Rahman
Assistant Scientist
Health Systems and Population Studies Division
icddr,b
Email: su.rahman@icddrb.org
2. Mr. Razib Mamun
Research Investigator
Health Systems and Population Studies Division
icddr,b
Email: razib.mamun@icddrb.org
3. Dr Mehnaaz Altaf
Research Officer
CSF Global
Email:dr.mehnaazaltaf@gmail.com
4. Md Johurul islam Jewel
Senior Programme Manager
CSF Global Bangladesh
Email: johurul@hotmail.com
5. Dr Narayan Bahadur Mahotra, MD
Assistant Professor
Department of Clinical physiology, Maharajgunj medical campus, Institute of
medicine, Kathmandu Nepal
Email: narayanmahotra@gmail.com
6. Ayuska Parajuli, MPH
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Research Director
Public Health Research Society Nepal (PHRSN), Nepal
Email: ayusiparajuli@gmail.com
7. Ashok Pandey, MPH/BPH, DGH
Principal Investigator, Harm reduction research study
CSF Global, Dhaka, Bangladesh, Nepal Health Research Council (NHRC),
Kathmandu, Nepal.
Email: pandeyg7@gmail.com
Corresponding Author:
Ashok Pandey, MPH/BPH, DGH
Principal Investigator
CSF Global, Dhaka, Bangladesh, Nepal Health Research Council (NHRC),
Kathmandu, Nepal.
Email: pandeyg7@gmail.com Alternative Email: phrsnepal@gmail.com
Abstract
Background:
E-cigarettes present an opportunity to increase the tobacco cessation rates, and thereby suppress the
largest cause of global death significantly. Though E-cigarettes are perceived as less harmful than
conventional cigarettes still their effectiveness as a tobacco cessation tool, their difference with other
prescribed tobacco cessation methods and their long term effects are yet to be synthesized precisely.
The aim of this review is to provide evidence of existing literature in case of harm reduction by e-
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cigarettes among adolescent.
Method:
To explore the available evidence on effect of electronic cigarette in harm reduction among the
adolescents, we followed the Standard method of Cochrane for conducting a systemic review. Total
13 bibliographic and impact evaluation database will be searched using a comprehensive search
strategy. RCTs and quasi experimental studies on e-cigarettes usability which has been published
scientific journals will be included. Timeframe for searching relevant articles for the review were
limited between January 2003 and June 2018. Intervention provided on adult population (population
aged 19 years and above), adolescents with pregnancy and adolescents having other diseased
condition will be excluded. Any trial which is ongoing, published protocol of trials, traditional
reviews and systematic reviews will be excluded. Letter to editor, editorials comments and
conference proceedings were excluded as well. Articles published only in English language will be
included.
Results: Narrative synthesis of included articles will be provided including the quality assessment
using standard tools. Pooled estimation will be provided regarding harm reduction and smoking
cessation where applicable.
Trial registration: PROSPERO registration of the systematic review is CRD42018106691.
Key words: Adolescent; E-cigarettes; Harm-reduction; Review; Smoking; Tobacco control.
Background:
Smoking tobacco is considered a public health threat which causes 7 million global death per year
(1, 2). Direct tobacco use kills more than 6 million people and second hand smoking is responsible
for approximately 890 000 global deaths per year (1, 2). Data shows that this epidemic is changing
its path and moving from higher economic countries to lower economic countries (1, 3). The
numbers of smokers are decreasing in high-income countries but in low and middle income countries
(LMICs) where the population is more denser, the smoking is increasing in an alarming rate which
predicts the death from tobacco in LMICs is going to be double between 2002 to 2030 (1, 3). At
present 80% of the total 1.1 billion global smokers are dwelling in the developing countries (2) and
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approximately 60% of these smokers are living in Asia (4). In China alone people are smoking one -
third of all cigarettes (1, 5). Thus smoking cessation is a public health priority and to assist the world
to fight the epidemic, different smoking cessation tools are developed and are already in the market
to assist the world to fight the epidemic of smoking. Among them, ane-cigarette is the latest one and
is demanding the most attention due to its potentiality of becoming a promising tobacco cessation
tool (6-10).
An e-cigarette contains refined nicotine which is dissolved in propylene glycol, glycerin or other
humectants and gets vaporized by heating and gets delivered into the airways (7). As smokers are
getting direct nicotine without other harmful ingredients of tobacco thus e-cigarette is considered
less harmful than traditional cigarettes (11, 12).The e-cigarette can also reduce the craving and
smoking withdrawal symptoms (6). Though the popularity of e-cigarettes is increasing as an
effective tobacco quitting aid but the evidence of its efficacy are yet to be synthesized more
accurately due to its controversial status (9). Few studies found e-cigarette as an effective quitting
method (7, 9, 10) and it is significantly associated with an increase in the rate of tobacco cessation
(9, 10) while few studies couldn’t conclude the same (9, 13). One study found nicotine patches and
e-cigarette, both have similar achievements in case of assisting smokers to quit smoking by
supplying nicotine demand (14). But another study is showing smokers who used e-cigarette are
more likely n quitting smoking than smokers who used prescribed nicotinic replacement therapy (6).
One study claiming second hand vaping from e-cigarettes pushes the bystanders, including children
and young people towards risk of Cardiovascular diseases as it emits different toxic chemicals (12).
But another study failing to conclude the same by saying that e-cigarettes causes exposure to nicotine
only but not to any tobacco specific toxic chemicals (15). While another study found e-cigarettes
contain a very low amount of toxins compared to cigarettes and supported the idea of using e-
cigarettes to reduce the exposure of tobacco toxins (16).
Adult smoking usually starts in adolescence (17). According to a study almost 88% of smokers who
smoke daily started smoking at the age of 18 (18). If e-cigarette can play a major role in smoking
cessation among the adolescents, it will significantly change the global tobacco cessation rate. There
are several ongoing studies providing information regarding the efficiency of e-cigarettes in reducing
harm among adults but there is limited information to determine the harm reducing properties of e-
cigarettes among the adolescents. In order to conclude with clarification if e-cigarette can really play
as a public health tool among the adolescents in tobacco harm reduction by quitting or switching,
more studies and trials are required to be conducted. This systematic review will focus on available
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evidence of the existing literature in case of harm reduction by e-cigarette among the adolescents.
METHODS:
PROTOCOL
To explore the available evidence on effect of electronic cigarette in harm reduction among the
adolescents, a protocol for systematic review and meta analysis has been developed following the
guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols
(PRISMA-P) which is a reporting standard for systematic reviews considering interventions for
improvement of health care (19, 20). PRISMA-P checklist of reporting standard for this protocol has
been provided as Additional file 1.
CRITERIA FOR ELIGIBILITY
Studies will be included based on the predefined sets of criteria for inclusion and exclusion. A set of
codes will be developed to include the articles for full text review and further synthesis.
PARTICIPANTS
Adolescent people (between the ages of 10 and 19 years) inclusive of all geographic location, sex,
socio-economic groups will be considered including marginalized population, slum-dwellers,
displaced, migrants and others.
INTERVENTIONS
Interventions that use e-cigarette aimed to increase cigarette smoking cessation and to switching
smoking habit from cigarette to e-cigarette. Interventions will be considered at different levels such
as individual intervention, peer intervention, group intervention etc.
COMPARATORS
Comparison between baseline and end line, pre-test, and post-test, presence or absence of
intervention, an intervention compared with a control arm or an intervention with a different intensity
will be considered.
OUTCOMES
Harm reduction will be included as outcome including smoking cessation, switching smoking habit
from cigarette to e-cigarette.
Primary outcomes
Smoking cessation, switching of smoking habit
Secondary outcomes
Reduction in use of cigarette; any adverse event including physical illness such as respiratory
distress, cough, nausea, vomiting, pneumonia will be considered as the secondary outcome.
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SETTING
This systematic review will include all sorts of intervention using e-cigarettes in all available
settings. There will be no restrictions regarding individual or group intervention.
STUDY DESIGNS
All interventional studies including randomized controlled trials (RCTs), clustered RCTs and quasi
experimental designs will be considered to explore the effect of e-cigarette in harm reduction among
the adolescents. Non interventional studies such as prospective studies, analytic studies incorporating
cohort and case-control design and cross-sectional studies will not be included. Any study using
qualitative design will also be excluded.
INCLUSION AND EXCLUSION CRITERIA
RCTs and quasi experimental studies on e-cigarettes usability which has been published in scientific
journals will be included. Articles published in different languages other than English will not be
considered. The invention of currently available e-cigarettes was in 2003. Therefore, the timeframe
for searching relevant articles for the review will be limited between January 2003 and June 2018.
Intervention provided on adult population (population aged 19 years and above), adolescents with
pregnancy and adolescents having other diseased condition will not be included. Any trial which is
ongoing, published protocol of trials, traditional reviews and systematic reviews will be excluded.
Letter to the editor, editorials comments and conference proceedings will be excluded as well.
Studies focusing on outcomes other than the primary and secondary outcome mentioned in this
protocol will also be excluded.
INFORMATION SOURCES
A comprehensive search strategy will be applied systematically to search the relevant electronic
bibliographic databases and impact evaluation database. The bibliographic databases are: Pubmed
through MEDLINE, Web of Science, Embase, CINAHAL, Scopus, Centers for Disease Control and
Prevention Tobacco Information and Prevention Source (TIPS), PsycINFO, Smoking and Health
Database (Institute for Science and Health) and the Cochrane Tobacco Addiction Group Trials
Register. Impact evaluation databases including the Cochrane Central Register of Controlled Trials
(CENTRAL), WICTRP (International Clinical Trials Registry Platform), Clinical Trials. gov, 3ie
Impact Evaluation repository and Cochrane tobacco addiction group specialized register. The
comprehensive search strategy will be developed including key terms which are related to and
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demonstrating the target population, e-cigarette as an intervention and outcome in terms of harm
reduction.
In addition to the bibliographic databases, citation tracking and selective snow balling will be
conducted to include relevant articles.
SEARCH STRATEGY
Combining the key search terms, a search strategy with adequate comprehensiveness will be
prepared for MEDLINE. Searching keywords will be used for other bibliographic databases adapting
the database specific filters for study design. Major search terms for the target population, proposed
intervention and estimated outcome has been outlined in tabulated form (Table 1).
Table 1: Keywords and search terms used in the comprehensive search strategy
Population (P) Intervention (I) Outcome (O)
Adolescent
Youth
Teen
School
Student
Child
Pupil
“Electronic cigarette”
“e-cigarette”
“electronic nicotine”
- Smoking cessation
- Smoking reduction
- Switching of smoking habit
- Harm reduction
- Risk reduction
- Reduce tobacco harm
- Tobacco use cessation
DATA MANAGEMENT
Management of references will be conducted using the software EndNote to organize the retrieved
articles as an outcome of the comprehensive literature search. An Endnote library will be created
incorporating all the available articles found as an outcome of the extensive search of different
bibliographic database. Duplicate articles will be removed. Following the inclusion criteria, a set of
codes will be prepared for the inclusion of eligible articles during the screening process.
SELECTION PROCESS
Standard methods of two stage screening will be applied during the selection for inclusion. Initially,
the reviewers will include the articles considering title and abstract screening only. Firstly, two
reviewers will check the eligibility of each article independently. Included articles will be screened
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by going through the full text at the second phase for final consideration. Screening for full text will
be carried out by two independent reviewers as well. In both stages, any dispute between the
reviewers while taking a decision regarding inclusion will be discussed with a third reviewer and
resolved. Screening in both stages will be performed based on predefined inclusion and exclusion
criteria. A sequence of exclusion criteria will be applied to reduce the chance of subjectivity in
prioritizing exclusion criteria. Proper recording of reasons for excluding any article will be
maintained. More than one article from a single study will also be reported. A brief description of
included and excluded studies will be graphically presented using the Preferred Reporting Items for
Systematic Reviews and Meta-analyses (PRISMA) flow-diagram (21). The proposed flow diagram
of the selection process of the review is demonstrated in Figure 1.
Figure 1: Flow diagram of the inclusion process.
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DATA EXTRACTION
Information will be extracted including target population of the study, setting of the study, socio-
demographic characteristics of the participants, study design, description of the intervention using
electronic cigarette for smoking cessation or switching and harm reduction, enrollment details,
attrition related information, measurement of outcome and relevant information to assess the risk of
bias.
QUALITY ASSESSMENT
The Critical Appraisal Skills Program (CASP) checklist for randomized controlled trials and quasi
experimental studies will be used to appraise the articles critically. The quality of the included
articles will be assessed by two reviewers separately and any confusion or dispute in decision
between the independent reviewers will be finalized by a third reviewer.
RISK OF BIAS ASSESSMENT
The guidelines from Cochrane assessment of the risk of bias (ROB) for randomized controlled trials
(22) will be followed to evaluate the ROB of the included articles. The assessment will be
independently conducted by two reviewers. According to the guideline, specific six domains namely
selection bias, detection bias, performance bias, reporting bias, attrition bias and other bias are
considered. Judgments of the reviewers on ROB and grading as low risk, unclear and high risk will
be provided. For assessing the selection bias, two identical criteria will be considered which are
allocation concealment and random generation of the sequence. Performance bias and detection bias
will be assessed considering blinding at the level of participants, blinding at the level of
implementers and outcome assessors. Attrition bias will be assessed by extracting information
regarding lost to follow up. Selective reporting of the studies and selective presentation of assessed
outcome will also be reported. Reviewers will explore any other bias such as contamination that may
influence the outcome of the study. Similar to the previous steps, a third reviewer will be engaged to
resolve the disagreement aroused between the reviewers while assessing the ROB.
STRATEGY FOR DATA SYNTHESIS
The analysis will be data driven. A narrative synthesis will be provided describing the key
characteristics of the population of the studies, details of the intervention and assessment of the
Studies identified through search
(N=XX)
Duplicated records (N=XX)
Studies after removing duplicates
(N=XX)
Studies after screening on Title &
Abstract (N=XX)
Studies excluded after screening
on Title &Abstract (N=XX)
Studies after screening on full text
(N=XX)
Studies excluded after screening
on full text (N=XX)
Studies included for review (N=XX)
Studies from citation
tracking/Snow balling (N=XX)
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outcome. Intervention effects for individual studies will be provided by calculating risk ratios or
odds ratio or standardized mean differences for dichotomous outcomes such as smoking cessation,
harm reduction, switching to electronic cigarettes etc. Studies with the same interventions for
smoking cessation, homogenous comparators and similar outcome measurement, will be considered
for pooled synthesis using the fixed effect model meta-analysis. At the same time, 95% confidence
intervals and P values will be estimated for the measured outcomes. Both the Chi-squared test and
the I-squared statistic will be demonstrated for the measurement of the heterogeneity of effect
measures. Substantial heterogeneity will be indicated if the I-squared value reveals greater than 50%.
Sensitivity analyses will be performed based on study characteristics and where applicable.
Moreover, a funnel plot will be generated to describe the potential risk of publication bias using the
software review manager (RevMan).
PUBLICATION PLAN
The protocol of this systematic review is registered with the International Prospective Register of
Systematic Reviews (PROSPERO). PROSPERO registration of the systematic review is
CRD42018106691. Synthesized findings of the systematic review will be described in the form of a
manuscript to publish in a peer reviewed journal.
DECLARATIONS
FUNDING
'Produced with the help of a grant from the Foundation for a Smoke- Free World, lnc. The contents,
selection and presentation of facts, as well as any opinions expressed herein are the sole
responsibility of the authors and under no circumstances shall be regarded as reflecting the positions
of the Foundation for a Smoke-Free World, lnc;
ACKNOWLEDGEMENTS
We acknowledge CSF Global, PHRSN Nepal and icddr,b for providing support to the authors.
AVAILABILITY OF DATA AND MATERIALS
All the relevant information including dataset will be available from the corresponding author.
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AUTHOR CONTRIBUTIONS
AP, KMSUR, RM and MA conceived the systematic review with substantial input from the co-
authors. AP and MA developed the background and rationale of the systematic review. KMSUR and
RM wrote the methodology, screening, data extraction plan, critical appraisal plan and data synthesis
plan of this protocol. RM and KMSUR developed the comprehensive search strategy. All authors
provided potential input after reviewing the manuscript for finalization. The corresponding author is
the guarantor of the systematic review.
COMPETING INTERESTS
The authors declared no competing interests.
ETHICS AND DISSEMINATION
This systematic review is based on published articles; therefore, informed consent and ethical
approval are not required. Findings of the systematic review will be summarized as a manuscript to
publish in international peer reviewed journal for dissemination.
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