A scoping review protocol to map the research foci trends in tobacco ...

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A scoping review of reviews protocol to map the trends in tobacco control research.

Journal:

BMJ Open

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Date Submitted by the Author:

Complete List of Authors:

bmjopen-2014-006643 Protocol 15-Sep-2014

Secondary Subject Heading:

Research methods, Evidence based practice, Health services research PREVENTIVE MEDICINE, Substance misuse < PSYCHIATRY, STATISTICS & RESEARCH METHODS

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Keywords:

Smoking and tobacco

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Primary Subject Heading:

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Halas, Gayle; University of Manitoba, Family Medicine Schultz, Annette; University of Manitoba, Nursing Rothney, Janet; University of Manitoba, Health Sciences Library Goertzen, Leah; University of Manitoba, Kinesiology; University of Manitoba, Family Medicine Wener, Pam; University of Manitoba, College of Rehabilitation Services Katz, Alan; University of Manitoba, Community Health Sciences; University of Manitoba, Family Medicine

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on For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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A SCOPING REVIEW OF REVIEWS PROTOCOL TO MAP THE TRENDS IN TOBACCO CONTROL RESEARCH

Gayle Halas. Department of Family Medicine, College of Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg MB, Canada. Annette SH Schultz. College of Nursing, Faculty of Health Sciences, University of Manitoba, Winnipeg MB, Canada. Janet Rothney. Neil John Maclean Health Sciences Library, University of Manitoba, Winnipeg MB, Canada.

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Leah Goertzen. Faculty of Kinesiology and Department of Family Medicine, College of Medicine, University of Manitoba, Winnipeg MB, Canada. Pam Wener. College of Rehabilitation Sciences, Faculty of Health Sciences, University of Manitoba Research, Winnipeg MB, Canada.

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Alan Katz.* Departments of Community Health Sciences and Family Medicine, College of Medicine, Faculty of Health Sciences, University of Manitoba, P228-770 Bannatyne Ave, Winnipeg MB, Canada. R3E 0W2 [email protected] Ph: 204-789-3442 *Corresponding Author

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Word Count: 2225

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Key Words: Prevention, Tobacco, Smoking, Protocol, Scoping, Review

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For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Abstract Introduction: Tobacco dependence and smoke exposure has been a global epidemic with health consequences recognized by the U.S Surgeon General since the 1960’s and 1970’s respectively. In this time period, a vast body of research evidence has emerged including many reviews of primary research studies targeting various tobacco control strategies.

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Published review studies synthesize primary evidence providing a rich source for mapping the broad range of topics and research foci along with revealing areas of evidence deficits. In this paper, we outline our scoping review protocol to systematically review published

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review articles specific to tobacco control and primary prevention over the last ten years. Methods and analysis: Using Arksey & O’Malley’s scoping review methodology as a guide,

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our scoping review of published reviews begins with searching several databases: PubMed,

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Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature

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(CINAHL), PsycInfo and Educational Resources Information Centre (ERIC). Our multidisciplinary team has formulated search strategies and two reviewers will

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independently screen eligible studies for final study selection. Bibliographic data and

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content of the abstracts will be collected and analyzed using a tool developed iteratively by the research team.

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Ethics and dissemination: A scoping review of published review articles is a novel approach for examining the breadth of literature regarding tobacco control strategies and, as a secondary analysis, does not require ethics approval. We anticipate results will identify research gaps as well as novel ideas for primary prevention research specific to tobacco control strategies concerning intervention, programming and policy. Although this is our


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first step to establishing a foundation for a research agenda, we will be disseminating results through journals and conferences targeting primary care providers and tobacco control.

Strengths and limitations of this study

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Strengths: -

A novel review approach covering a vast volume of literature on a broad topic thus offering a “big picture” or map of research on tobacco control.

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A feasible strategy to identify research foci and knowledge gaps within the last ten

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years of tobacco control research. -

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A practical method for synthesizing research that has used a wide range of methodological approaches, settings, study populations and behaviors.

Limitations

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-

A less detailed analysis of project-specific interventions and research approaches.

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Due to the heterogeneity and breadth of the included studies, the final data extraction framework is still in development.

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In the 1960s, the U.S Surgeon General report recognized that tobacco use was linked to serious health consequences.[1] A decade later, the report announced that tobacco smoke exposure was likewise an underlying contributor to what is now considered a longstanding global health epidemic. Since these public acknowledgements, a vast body of

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research evidence has developed around the health consequences related to tobacco use and a range of tobacco control strategies. In developed countries, tobacco use and smoke exposure rates have fallen since the 1960’s. However, the World Health Organization (WHO) currently reports that nearly six million premature deaths each year are

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attributable to either tobacco use or smoke exposure, which is higher than deaths resulting

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from HIV/AIDS, tuberculosis and malaria collectively.[2, 3] Nearly one third to one half of

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tobacco users will develop a tobacco-related chronic illness leading to death; the most common conditions being cancers, cardiovascular diseases or respiratory alignments.

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Alternatively, evidence suggests that when individuals stop smoking, health benefits are

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realized within one day (pulse and blood pressure), and benefits accumulate the longer a

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person remains smoke-free.[4]. One such long term benefit is the decreasing risk of heart disease comparable to never-smokers within 15 years of quitting smoking. Given this

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evidence, it seems logical to situate tobacco control strategies within the domain of primary prevention where the aim is to prevent illness among the general population. In this paper, we propose a scoping review protocol to systematically review published reviews specific to tobacco control situated within primary prevention.


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Background As a Canadian research team, we first looked at the history of tobacco control in our country, which has had a federal tobacco control strategy since the late 1960s. Although the initial focus was on public awareness, legislation and health promotion approaches, in 2001 Health Canada announced a comprehensive strategy targeting prevention, cessation, protection, and denormalization.[5] The next historical shift was in 2005, when Canada

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signed a World Health Organization [WHO] treaty specific to tobacco control.[6] Given these federal efforts, rates of tobacco use and smoke exposure have significantly diminished. However, the most recent statistics report 16% of Canadians (approximately

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4.6 million people) are current smokers with the majority (11.9%) smoking daily.[7] There

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are an estimated 37,000 premature and preventable tobacco-related deaths annually, and the Canadian health care system is estimated to spend $4.4 billion in direct health costs

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caring for tobacco-related conditions.[8] Although improvement is evident, so is the

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ongoing epidemic, and the reality that tobacco use remains a health priority. While the

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federal government initially allotted millions of dollars toward tobacco control (prevention, cessation, protection and product regulation), recent fiscal restraint has led to

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a focus on specific populations as well as an emphasis on the link between tobacco and serious disease.[9]

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The WHO’s Framework Convention on Tobacco Control (FCTC) was the first evidencebased negotiated treaty within this organization, and developed in response to the global tobacco epidemic.[6] In 2005, the FCTC was ratified by 168 member states, including Canada. In 13 of the 38 articles outlined by the FCTC, numerous national, regional and international evidence-based strategies for diminishing tobacco use and exposure to


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tobacco smoke are addressed. Notably, the FCTC frames tobacco control strategies within two main areas: reducing the demand for and supply of tobacco products. The FCTC has now been in place for nine years. The tobacco control measures endorsed in the Framework are reported to be responsible for dramatic reductions in tobacco use[10] and for increased investments for tobacco control research and surveillance globally.[11] While there is ongoing interest in sustaining FCTC strategies, there is also consideration of

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alternate “end-game” strategies and policies to further reduce the effects of the tobacco epidemic.[10,11] The actual number of tobacco users remains significant and costs to treat and manage health care needs of people living with tobacco-related cancers, cardiovascular

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diseases and respiratory illness suggests it remains an epidemic and a primary prevention priority.[12]

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Our Primary Prevention Research Team is working towards defining a program of research

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in primary prevention. Given the tobacco epidemic reality and globally-embraced strategic

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approaches, tobacco control is an important health-related issue within the domain of

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primary prevention. In this paper, we present a protocol for completing a scoping review of reviews covering the published tobacco control literature over the last decade. The

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objectives are to identify and summarize the tobacco control research, and identify

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challenges to tobacco control strategies and gaps in research evidence. In response to the WHO 2008 challenge to close equity gaps within a generation, we will also incorporate an equity lens within our exploration of the tobacco control literature.[13] Methods/Design We chose to undertake a scoping review of published reviews covering a vast body of tobacco control research. Scoping review methodology is particularly useful when


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examining a broadly covered topic. The aim is to comprehensively and systematically map the literature and identify key concepts, theories, evidence, or research gaps. Unlike systematic reviews or meta-analyses, scoping reviews do not narrow the parameters of the review to research trials or require quality assessment. Nonetheless, this type of review is rigorous and methodical in its approach to examining the extent, range and nature of research activity in a particular field[14] while encompassing both empirical and

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conceptual research on broadly framed questions.[15] In designing the protocol for our scoping review of reviews we drew upon Arksey and O’Malley’s[14] seminal work as well as recent scoping review publications.[16,17] Arksey

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and O’Malley’s scoping review framework outlines a five stage approach with each stage

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discussed below. Adaptations were driven by an intention to develop a feasible approach for reviewing a vast body of literature.[18]

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Stage 1: Identifying the research questions

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Arksey & O’Malley[14] suggest an iterative process for developing one or more guiding

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research questions, where each revision is driven by increasing familiarity with the literature. We first realized the need for an iterative process when initial searches

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produced primarily tobacco cessation articles. Our intention to comprehensively examine

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the tobacco control literature within the domain of primary prevention prompted us to seek a framework encompassing all aspects of tobacco control to guide the search. Turning to the FCTC strategic action terms, we identified five research questions to guide our scoping review of reviews (see Table 1). As well, when we reflected on the inclusion of an equity lens, we turned to the PRISMA-Equity 2013 Extension[19] which identifies multiple components of equity to be addressed in the review.


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Table 1: List of Research Questions and Operational Definitions Research Questions 1. Which tobacco control strategies are being addressed in the tobacco control literature?

Operational Definitions Tobacco Control Strategies:

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2. Who are the target populations being addressed in the tobacco control literature?

•

Marketing, advertising, sponsorship

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Exposure to tobacco smoke and protection

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Regulating content, packaging

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Pricing and taxation

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Education and public awareness

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Cessation

• Illicit sales and sales to minors Target Populations: •

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•

Society

Government

Industry

Community

Health care

Schools

Workplaces

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Family

•

Individual

• Child/Youth Equity:

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3. How is equity situated in the tobacco control literature?

•

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Macro-level determinants (poverty)

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Access barriers

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Stated intention to address

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Strategy to address root structural source Barriers and Facilitators: •

4. What barriers and facilitators to implementing tobacco control strategies are identified in the literature? 5. How is effectiveness situated within the tobacco control literature?

•

As stated by author(s)

Effectiveness: •

As stated by author(s)


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Stage 2: Identifying relevant studies The aim of scoping reviews is to comprehensively address broad research questions; yet, parameters are required to guide the search strategy. At this stage, the team deliberated and decided upon criteria for eligibility, databases to search, and formulated a search strategy and key terms. Eligibility Criteria

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The following inclusion criteria were used to guide the search and will also be used when reviewing articles: •

Published in English language;

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Human subjects;

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January 2003-March 2014;

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All age groups

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Research that targets the general population and only randomly include individuals with an illness, disease, or condition

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•

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Review articles including systematic review; meta-analysis; meta-synthesis; scoping

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review; narrative reviews, rapid review; critical review; integrative review •

Research conducted within Canada, U.S., Europe, United Kingdom, Australia, and New Zealand.

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Explicit exclusion criteria identified are: •

Journal articles that are not rigorous reviews (i.e., outside of those defined in the inclusion list), such as book reviews, opinion articles, commentaries or editorial reviews.


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•

Research targeting a population because of a diagnosed illness or disease or interventions targeting treatment of a specific disease, illness or condition.

Databases The following electronic databases were searched: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and

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Educational Resources Information Centre (ERIC). Search strategy

We drew on the WHO FCTC to operationalize search terms for “tobacco control strategy”,

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which focuses on demand and supply reduction strategies.[6] Our research team

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iteratively developed an extensive list of primary and secondary search terms as well as filtering methods. The primary search terms focused on core tobacco related terms (i.e.,

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tobacco, smoke, nicotine). The secondary search terms included a broader set of keywords

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such as promotion, prevention, interventions as well as tobacco control strategies based on

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the FCTC (such as pricing, regulation, packaging). The filtering methods included the date range (within the last 10 years), English, Human and a search string to further narrow the

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results to review articles. We used the Boolean term “AND” between the core tobacco search strategy and each of the other keywords.

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Publication titles from a preliminary search were reviewed to inform refinement of terms in consultation with our team. Refinement of search parameters can be illustrated in the following two examples. Firstly, marijuana use is not a topic that we chose to include but terms such as, “smoking” did not automatically filter out publications around marijuana use. Using the No Explode option for the main MeSH term “Smoking” eliminated


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“Marijuana Smoking” from search results ("Smoking"[Mesh:NoExp]). Secondly, we need to be mindful of search terms that produce irrelevant outputs but need to be included as they may otherwise eliminate relevant articles. For example, we found many of the search results targeted a particular disease, such as COPD, and are therefore outside the domain of primary prevention. However, if we use Chronic Obstructive Pulmonary Disease or COPD as a search term to filter out such articles, we would miss reviews discussing tobacco use in

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terms of preventing COPD, thus relevant to primary prevention. The librarian on our team played a key role in determining and testing appropriate keywords, MESH terms and filters to maximize sensitivity and specificity within the search.

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She was instrumental in modifying and applying search terms to comply with the various

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bibliographic databases. The complete and final search strategy for PubMed can be found in Appendix A; further search strategy details across bibliographic databases are available

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upon request from the first author. Upon completion, the searches from each database

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were documented and references were imported into database-specific folders in RefWorks where duplicates were eliminated.

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Stage 3: Study selections

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We designed a two-part study selection process. First, titles will be reviewed by a single

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reviewer to determine eligibility based on the defined inclusion and exclusion criteria. For example, titles that indicate a target population with an existing medical condition or where the research was carried out in an ineligible country will be removed. At this primary stage of the review, any uncertainty with a title will not yet eliminate the citation for consideration in the second stage. The second part of the selection process will include two independent reviews of the titles and abstracts using the eligibility criteria. Where


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differences arise, the reviewers will consult a third reviewer to reach consensus. When consensus is not reached, those articles will be included in the review. While scoping review methodology does not specify a process for evaluating study quality,[14] we will only include abstracts that demonstrate evidence of a systematic approach. Stage 4: Charting the data We will collect and sort key pieces of information from the abstracts of the selected articles.

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As part of the scoping review of reviews approach and the large quantity of published research literature to be covered, we will only be reviewing abstracts and extracting information to the extent that it is available in the abstracts. Some of this information is

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standard in data extraction (such as author, year of publication, study objectives) and

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additional information will be collected in order to address research questions.[14,16] Daudt et al[16] suggest a trial charting exercise and team consultation to ensure

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consistency with the questions and purpose.

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For our review, a priori categories will guide the extraction and charting of data from the

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abstracts however additional categories may emerge during the data collection process. If this occurs, consultation with our research team will guide decisions for additional

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categories.[16] Table 2 includes the a priori categories within the data collection tool. Table 2: Collating and describing review data Abstract Purpose Tobacco Target of study Control Population Intervention Year of Publication

Intervention Descriptor

Country

Objective

Type

Outcome Measure

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WHO FCTC Action Area

Equitybased foci/ results

Effective Interventions

(+) reports positive effects (-) reports negative effects (+/-) reports dual findings


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Stage 5: Collating, summarizing and reporting the results The unique purpose of a scoping review is to aggregate the findings and present an overview rather than a meta-synthesis reporting results on narrowly defined questions. The inherent challenges are in determining a framework for presenting a narrative account.[14] While this approach is still an iterative work in progress, the WHO FCTC strategies are likely to guide our descriptive and visual presentation of results. We will use

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the PRISMA reporting guidelines for systematic reviews[20] including components of equity[19] in order to accurately report the review analysis and summary. Conclusion

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Our protocol for systematically conducting a scoping review of published review articles

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specific to tobacco control and primary prevention over the last ten years has been presented. This scoping review of reviews[18] is a novel approach that offers a feasible

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means for synthesizing a wide-range of research literature specific to tobacco control

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strategies within the domain of primary prevention. As this will be a first scoping review of

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reviews within this topic area, our results will advance the scoping review science and provide unique insights concerning the extent and scope of tobacco control efforts.

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Furthermore, the identification of research gaps may dispel the myth that tobacco control

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is considered done, and reveal new directions for tobacco control research within the domain of primary prevention.


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COMPETING INTERESTS Authors have no competing interests to declare.

FUNDING

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This work was supported by The Manitoba Research Chair in Primary Prevention awarded to Dr Alan Katz by the Manitoba Health Research Council and the Heart and Stroke Foundation of Manitoba.

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CONTRIBUTORSHIP STATEMENT

All authors have made substantive intellectual contributions to the development of this

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protocol. AK conceptualized the review approach and provided general guidance to the

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research team. All authors were involved in developing the review question and the review design. AS identified the framework from which JR and GH developed and tested search

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terms. LH, AK and AS initially developed the data extraction framework which was then

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further developed by input from all team members. GH and AS initiated the first draft of the

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manuscript which was then followed by numerous iterations with substantial input and appraisal from all of the authors. All authors approve the final version of the manuscript.

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References 1 U.S Department of Health and Human Services. The Health Consequences of Smoking - 50 years of progress: A report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for

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Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. 2 World Health Organization. WHO Global Report: Mortality attributable to tobacco. Geneva, WHO: 2012.

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3 Asma S, Song Y, Cohen J, Eriksen M, Pechacek T, Cohen N, Iskander J. CDC Grand Rounds: Global tobacco control centers for disease control and prevention. Morbidity and Mortality

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Weekly Report. Atlanta: Center for Disease Control; April 4, 2014. Report No.: Vol 63, No

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13.

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4 Registered Nurses Association of Ontario. Integrating Smoking Cessation into Daily

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Nursing Practice (best practice guidelines). Toronto, ON: Registered Nurses of Ontario; 2007.

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5 Health Canada. Tobacco Reports and Publications: A national strategy. 1999.

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[http://www.hc-sc.gc.ca.proxy1.lib.umanitoba.ca/hc-ps/pubs/tobac-tabac/ns-sn/indexeng.php] 6 World Health Organization. WHO Framework Convention on Tobacco Control. Geneva: World Health Organization; 2005.


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7 Health Canada. Canadian tobacco use monitoring survey (CTUMS). 2012. [http://www.hc-sc.gc.ca.proxy1.lib.umanitoba.ca/hc-ps/tobac-tabac/researchrecherche/stat/ctums-esutc_2012-eng.php#tab3.;] 8 Health Canada. Looking forward: The future of federal tobacco control. September 12, 2011. [http://www.hc-sc.gc.ca.proxy1.lib.umanitoba.ca/hc-ps/consult/_2011/foward-

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avenir/consult-eng.php;]

9 Health Canada. Strong Foundation, Renewed Focus: An overview of Canada’s federal tobacco control strategy 2012-17. [http://www.hc-sc.gc.ca/hc-ps/pubs/tobac-tabac/fssf/index-eng.php.]

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10 Myers ML. The FCTC's Evidence-based Policies Remain a Key to Ending the Tobacco

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Epidemic. Tob Control. 2013 May;22 Suppl 1:i45-6.

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11 Yach D, Pratt A, Glynn TJ, Reddy KS. Research to Stop Tobacco Deaths. Globalization and Health. 2014; 10(1).

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12 Fiore MC, Jaén CR, Baker TB, on behalf of the Tobacco Use and Dependence Guideline

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Panel, consortium representatives, consultants and staff. Treating Tobacco Use and Dependence: 2008 update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; May 2008.

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13 Canadian Institute for Health Information. Health Region Interventions that Address the Social Determinants of Health: Equity and structural lenses in intervention research. Ottawa: Canadian Institute for Health Information; Feb 2013.


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14 Arksey H, O'Malley L. Scoping Studies: Towards a methodological framework. International Journal of Social Research Methodology: Theory and Practice. 2005; 8(1):1932. 15 Grimshaw J. A Knowledge Synthesis Chapter. Ottawa: Canadian Institute of Health Research; 2010.

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16 Daudt HML, Van Mossel C, Scott SJ. Enhancing the Scoping Study Methodology: A large, inter-professional team's experience with Arksey and O'Malley's framework. BMC Medical Research Methodology. 2013; 13(1).

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17 Levac D, Colquhoun H, O'Brien KK. Scoping Studies: Advancing the Methodology. Implementation Science. 2010; 5(1).

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18 Goertzen L, Schultz A, Halas G, Rothney J, Wener P, Katz A. The Proliferation of Research

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Literature and Capturing the Big Picture: The value of a scoping review of reviews. Submitted for publication. 2014.

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19 Welch V, Petticrew M, Tugwell P, Moher D, O'Neill J, Waters E, White H, the PRISMA-

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Equity Bellagio group. PRISMA-Equity 2012 Extension: Reporting guidelines for systematic reviews with a focus on health equity. PLoS Medicine. 2012;9(10).

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20 Moher D, Liberati A, Tetzlaff J, Altman DG, Altman D, the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Medicine. 2009; 6(7).


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APPENDIX A: SEARCH STRATEGY FOR PUBMED Core Search: (("Tobacco Products"[Mesh] OR "Nicotine"[Mesh] OR

"Smoking"[Mesh:NoExp] OR "Tobacco Use Cessation"[Mesh] OR "Tobacco Use Cessation Products"[Mesh] OR "Tobacco Use Disorder"[Mesh]) NOT ("smoking/adverse effects"[mesh] OR "tobacco products/adverse effects"[mesh] OR "nicotine/adverse effects"[mesh]))

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Combined with each of the following using Boolean term “AND”

1. ((("Health Promotion"[Mesh] OR "School Health Services"[Mesh] OR "Healthy People

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Programs"[Mesh] OR "Preventive Health Services"[Mesh] OR "Public Health"[Mesh] OR "Primary Prevention"[Mesh]) OR ( "Preventive Dentistry"[Mesh] OR "Patient

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Advocacy"[Mesh] OR "Nursing"[Mesh] OR "Health Education"[Mesh] OR "Health

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Fairs"[Mesh] OR "Consumer Advocacy"[Mesh] OR "Child Advocacy"[Mesh] ))) 2. (program OR programs OR programme OR programmes OR programming) 3. (intervention) 4. (Pricing )

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5. ("second hand smoke" OR "second-hand smoke" OR "smoke exposure") 6. (sponsorship) 7. (packaging OR package)

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8. ((label OR labelling) NOT "open-label") 9. ("product regulation") 10. (advertis*) 11. (("smoke free policy") OR "smoke-free policy")

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12. (("Nursing Evaluation Research"[Mesh] OR "Program Evaluation"[Mesh]) OR ( "Health Services Research"[Mesh] OR "Process Assessment (Health Care)"[Mesh] OR "Treatment Outcome"[Mesh] )) OR ( "Quality Assurance, Health Care"[Mesh] OR "Outcome and Process Assessment (Health Care)"[Mesh] OR "Medical Audit"[Mesh] )) 13. ((intervention OR prevention OR program* OR strateg* OR promot*) AND (effective OR efficacy OR successful OR assessment OR evaluation OR "best practice" OR "promising

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practices"))

14. ((intervention OR prevention OR program* OR strateg* OR promot*) AND (barrier* OR determinant* OR polic* OR advoca*)) 15. (campaign)

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16. (strateg*)

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Filters applied to EACH of the above searches: Meta-Analysis; Review; Systematic Reviews;

published in the last 10 years; Humans; English

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Review search string: (“scoping review" OR "scoping study" OR " rapid review" OR

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"systematic review" OR "meta analysis" OR "meta-analysis" "meta synthesis" OR "metasynthesis" OR "critical review" OR "integrative review" )

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BMJ Open 1 PRISMA 2 3 4 5 Section/topic 6 7 TITLE 8 9 Title 10 ABSTRACT 11 12 Structured summary 13 14 15 16 INTRODUCTION 17 18 Rationale 19 Objectives 20 21 22 23 24 METHODS 25 Protocol and registration 26 27 28 29 Eligibility criteria 30 31 32 Information sources 33 34 35 Search 36 37 Study selection 38 39 40 41 Data collection process 42 43 44 Data items 45 46 47 48

2009 Checklist

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Page 1 of 2

Reported on page #

# Checklist item

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Identify the report as a systematic review, meta-analysis, or both. Identified as a Scoping Review of Reviews

2

Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number. Structured according to BMJ Open guidelines for protocol papers.

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Describe the rationale for the review in the context of what is already known.

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Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS). In this scoping review of reviews approach, we do not specify PICO elements as the research aims to broadly examine existing reviews related to tobacco control in the context of primary prevention and not narrowing according to population, interventions or outcomes.

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6

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3

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Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number. This is a scoping review of reviews protocol; registration number not applicable.

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Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale. Eligibility criteria guided the search strategy, with same characteristics employed as search filters where possible.

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Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched. Electronic databases and timeframe identified

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Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated. Full search strategy for PubMed provided.

Appendix

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State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis). Screening and eligibility for selection were primarily determined by whether the studies met the eligibility criteria based on a title review followed by an abstract review by two independent reviewers

11 & 12

Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators. A preliminary data extract form has been developed and is currently being piloted and revised as necessary.

12

10

11

List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

8,9,

Page 21 of 23 1 PRISMA 2009 2 3 4 Risk of bias in individual 12 5 studies 6 7 Summary measures 13 8 9 Synthesis of results 14 10 11 12 # 13 Section/topic 14 15 Risk of bias across studies 15 16 17 16 18 Additional analyses 19 20 RESULTS 21 17 22 Study selection 23 24 Study characteristics 18 25 26 19 27 Risk of bias within studies 28 Results of individual studies 20 29 30 21 31 Synthesis of results 32 33 Risk of bias across studies 22 34 23 35 Additional analysis 36 37 DISCUSSION 38 Summary of evidence 24 39 40 Limitations 25 41 42 43 Conclusions 26 44 45 FUNDING 46 47 48

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Checklist

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Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis. Not applicable as this scoping review of reviews does not assess individual study bias.

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State the principal summary measures (e.g., risk ratio, difference in means). Descriptive statistics where possible

13

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Describe the methods of handling data and combining results of studies, if done, including measures of consistency 2 (e.g., I ) for each meta-analysis. Mainly narrative presentation of results

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13 Reported on page #

Checklist item

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Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).

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Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.

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Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.

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For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations. Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12).

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For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot.

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Present the main results of the review. If meta-analyses are done, include for each, confidence intervals and measures of consistency Present results of any assessment of risk of bias across studies (see Item 15).

Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]).

Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users, and policy makers). Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias). To be determined during the review process Provide a general interpretation of the results in the context of other evidence, and implications for future research.


na TBD 13

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1 PRISMA 2009 Checklist Page 1 of 2 2 3 4 Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the 14 5 systematic review. 6 7 From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. 8 doi:10.1371/journal.pmed1000097 9 For more information, visit: www.prisma-statement.org. 10 Page 2 of 2 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 47 48

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Identification

PRISMA 2009 Flow Diagram

Records identified through database searching (n = 12,227 )

Additional records identified through other sources (n = 0 )

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Screening

Records after duplicates removed (n =5060 )

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Records screened (n = 5060 )

Records excluded (n = 3035 )

Full-text articles assessed for eligibility (n =tbd )

Full-text articles excluded, with reasons (n =tbd )

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Eligibility

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Studies included in quantitative synthesis (meta-analysis) (n =0 )

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Included

Studies included in qualitative synthesis (n =tbd )

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From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and MetaAnalyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097

For more information, visit www.prisma-statement.org.


BMJ Open

A SCOPING REVIEW PROTOCOL TO MAP THE RESEARCH FOCI TRENDS IN TOBACCO CONTROL OVER THE LAST DECADE

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Manuscript ID: Article Type:



BMJ Open bmjopen-2014-006643.R1 Protocol 05-Nov-2014


Smoking and tobacco

Research methods, Evidence based practice, Health services research

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Keywords:

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PREVENTIVE MEDICINE, Substance misuse < PSYCHIATRY, STATISTICS & RESEARCH METHODS, PRIMARY CARE, PUBLIC HEALTH

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A SCOPING REVIEW PROTOCOL TO MAP THE RESEARCH FOCI TRENDS IN TOBACCO CONTROL OVER THE LAST DECADE.


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Leah Goertzen. Faculty of Kinesiology and Department of Family Medicine, College of Medicine, University of Manitoba, Winnipeg MB, Canada. Pamela Wener. College of Rehabilitation Sciences, Faculty of Health Sciences, University of Manitoba Research, Winnipeg MB, Canada.

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Word Count: 2253

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Published review studies synthesize primary evidence providing a rich source for mapping the broad range of topics and research foci along with revealing areas of evidence deficits. In this paper, we outline our scoping review protocol to systematically review published review articles specific to tobacco control and primary prevention over the last ten years.

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Methods and analysis: Using Arksey & O’Malley’s scoping review methodology as a guide,

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our scoping review of published reviews begins with searching several databases: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature

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(CINAHL), PsycInfo and Educational Resources Information Centre (ERIC). Our

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multidisciplinary team has formulated search strategies and two reviewers will

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independently screen eligible studies for final study selection. Bibliographic data and content of the abstracts will be collected and analyzed using a tool developed iteratively by the research team.

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Ethics and dissemination: A scoping review of published review articles is a novel approach for examining the breadth of literature regarding tobacco control strategies and, as a secondary analysis, does not require ethics approval. We anticipate results will identify research gaps as well as novel ideas for primary prevention research specific to tobacco control strategies concerning intervention, programming and policy. Although this is our first step to establishing a foundation for a research agenda, we will be disseminating


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results through journals and conferences targeting primary care providers and tobacco control.

Strengths and limitations of this study Strengths: -

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A novel review approach covering a vast volume of literature on a broad topic thus offering a “big picture” or map of research on tobacco control within the context of primary prevention.

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A practical method for synthesizing research that has used a wide range of

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methodological approaches, settings, study populations and behaviors.

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Limitations

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Due to the heterogeneity and breadth of the included studies, the final data

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extraction framework will not be complete until the review is concluded. -

The synthesis of data will be limited to peer-reviewed published work.


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In the 1960s, the U.S Surgeon General report recognized that tobacco use was linked to serious health consequences [1]. A decade later, the report announced that tobacco smoke exposure was likewise an underlying contributor to what is now considered a longstanding global health epidemic. Since these public acknowledgements, a vast body of

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research evidence has developed around the health consequences related to tobacco use and a range of tobacco control strategies. Although improvement is evident, so is the reality that tobacco use remains significant, and treatments and management costs of

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people with tobacco-related health conditionsare astronomical [2]. As the aim of primary

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prevention strategies is to prevent illness among the general population, it seems logical that tobacco control strategies fit within this domain of prevention. Given the large corpus

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of research literature covering tobacco control and our interests in primary prevention, we

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describe a protocol for a scoping review of published reviews specific to tobacco control situated within primary prevention.

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Background

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In developed countries, tobacco use and smoke exposure rates have fallen since the 1960’s.

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However, the World Health Organization (WHO) currently reports that nearly six million premature deaths each year are attributable to either tobacco use or smoke exposure, which is higher than deaths resulting from HIV/AIDS, tuberculosis and malaria collectively [3, 4]. Nearly one third to one half of tobacco users will develop a tobacco-related chronic illness leading to death; the most common conditions being cancers, cardiovascular diseases or respiratory alignments.


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In response to this ongoing global tobacco epidemic, the WHO developed the Framework Convention on Tobacco Control (FCTC), which was the first evidence-based negotiated treaty within this organization [5]. In 2005, the FCTC was ratified by 168 member states, including Canada. In 13 of the 38 articles outlined by the FCTC, numerous evidence-based strategies for diminishing tobacco use and exposure to tobacco smoke are addressed and have been adopted globally by the member states. Notably, the FCTC frames tobacco

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control strategies within two main areas: reducing the demand for and supply of tobacco products.

The FCTC has now been in place for nine years. The tobacco control measures endorsed in

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the Framework are reported to be responsible for dramatic reductions in tobacco use [6]

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and for increased investments for tobacco control research and surveillance globally [7]. While there is ongoing interest in sustaining FCTC strategies, there is also consideration of

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alternate “end-game” strategies and policies to further reduce the effects of the tobacco

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epidemic [6, 7]. Several decades of tobacco control strategies along with evidence of the

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health consequences of tobacco use have emerged, but has the reflective step of looking broadly across this vast corpus of research been taken? Since few studies have examined

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the published tobacco research as a whole, Cohen et al [8] undertook a bibliometric

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analysis to examine the shift in tobacco research foci between two decades. Our scoping review will contribute a long overdue review of the breadth of research and research foci trends since the introduction of the FCTC, specifically strategies within the domain of primary prevention. This means our focus will be on strategies for intercepting the cause of disease among healthy populations rather than tobacco control strategies targeting populations demonstrating initial signs of disease (secondary prevention) or strategies


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focusing on the reduction of complications among populations with various stages of incurable conditions (tertiary prevention) [9]. We have also chosen to respond to the WHO 2008 challenge to close equity gaps within a generation by incorporating an equity lens into our analysis [10]. Our Primary Prevention Research Team is working towards defining a program of research in primary prevention and here, we present a protocol for completing a scoping review of reviews covering the published tobacco control literature

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over the last decade. Methods/Design

We chose to undertake a scoping review of published reviews covering a vast body of

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tobacco control research. Scoping review methodology is particularly useful when

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examining a broadly covered topic. The aim is to comprehensively and systematically map the literature and identify key concepts, theories, evidence, or research gaps. Unlike

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systematic reviews or meta-analyses, scoping reviews do not narrow the parameters of the

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review to research trials or require quality assessment. Nonetheless, this type of review is

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rigorous and methodical in its approach to examining the extent, range and nature of research activity in a particular field [11] while encompassing both empirical and conceptual research on broadly framed questions [12].

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In designing the protocol for our scoping review of reviews we drew upon Arksey and O’Malley’s [11] seminal work as well as recent scoping review publications [13, 14]. Arksey and O’Malley’s scoping review framework outlines a five stage approach with each stage discussed below. Adaptations were driven by an intention to develop a feasible approach for reviewing a vast body of literature [15].


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Stage 1: Identifying the research questions Arksey & O’Malley [11] suggest an iterative process for developing one or more guiding research questions, where each revision is driven by increasing familiarity with the literature. We first realized the need for an iterative process when initial searches primarily resulted in tobacco cessation articles, rather than articles addressing other tobacco control strategies. Our intention to comprehensively examine the tobacco control

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literature within the domain of primary prevention prompted us to seek a framework encompassing all aspects of tobacco control to guide the search. Turning to the FCTC strategic action terms, we identified five research questions to guide our scoping review of

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reviews (see table 1). As well, when we reflected on the inclusion of an equity lens, we

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turned to the PRISMA-Equity 2013 Extension [16], which identifies multiple components of equity to be addressed in the review.

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Table 1: List of Research Questions and Operational Definitions Operational Definitions Tobacco Control Strategies based on FCTC(6) • Price and tax measures • Protection from exposure • Regulation of contents and product disclosures • Packaging/labelling • Education and awareness • Advertising, promotion, sponsorship • Cessation • Illicit trade • Sales to minors Target Populations: • Society Government

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Research Questions 1. Which tobacco control strategies are being addressed in the tobacco control literature?

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3. How is equity addressed in the tobacco control literature?

Industry • Community Health care Schools Workplaces • Family • Individual • Child/Youth Equity categories based on PRISMA extension [19] • Population characteristics including gender, age, ethnicity access barriers • Assumptions and rationale related to equity are stated • Intention to address equity as the focus of review, the research question or within the analysis • Strategy to address root structural source is stated. Barriers and Facilitators: • As stated by author(s)

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4. What barriers and facilitators to implementing tobacco control strategies are identified in the literature? 5. Is intervention effectiveness evident within the tobacco control literature?

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Effectiveness: • Intervention outcomes presented by author(s) • Authors’ suggestions for future research

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Stage 2: Identifying relevant studies

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The aim of scoping reviews is to comprehensively address broad research questions; yet, parameters are required to guide the search strategy. At this stage, the team deliberated and decided upon criteria for eligibility, databases to search, and formulated a search strategy and key terms.


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Eligibility Criteria The following inclusion criteria were used to guide the search and will also be used when reviewing articles: •


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Human subjects;

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All age groups

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Research that targets the general population and only randomly include individuals

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with an illness, disease, or condition •

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•

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Explicit exclusion criteria identified are:

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•

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Databases The following electronic databases were searched: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and Educational Resources Information Centre (ERIC).


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Search strategy We drew on the WHO FCTC to operationalize search terms for “tobacco control strategy”, which focuses on demand and supply reduction strategies [5]. Our research team iteratively developed an extensive list of primary and secondary search terms as well as filtering methods. The primary search terms focused on core tobacco related terms (i.e., tobacco, smoke, nicotine). The secondary search terms included a broader set of keywords

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such as promotion, prevention, interventions as well as tobacco control strategies based on the FCTC (such as pricing, regulation, packaging). The filtering methods included the date range (within the last 10 years), English, Human and a search string to further narrow the

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results to review articles. We used the Boolean term “AND” between the core tobacco

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search strategy and each of the other keywords. Publication titles from a preliminary search were reviewed to inform refinement of terms

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in consultation with our team. Refinement of search parameters can be illustrated in the

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following two examples. Firstly, marijuana use is not a topic that we chose to include but

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terms such as, “smoking” did not automatically filter out publications around marijuana use. Using the No Explode option for the main MeSH term “Smoking” eliminated

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“Marijuana Smoking” from search results ("Smoking"[Mesh:NoExp]). Secondly, we need to

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be mindful of search terms that produce irrelevant outputs but need to be included as they may otherwise eliminate relevant articles. For example, we found many of the search results targeted a particular disease, such as COPD, and are therefore outside the domain of primary prevention. However, if we use COPD as a search term to filter out such articles, we would miss reviews discussing tobacco use in terms of preventing COPD, thus relevant to primary prevention.


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The librarian on our team played a key role in determining and testing appropriate keywords, MESH terms and filters to maximize sensitivity and specificity within the search. She was instrumental in modifying and applying search terms to comply with the various bibliographic databases. The complete and final search strategy for PubMed can be found in Appendix A; further search strategy details across bibliographic databases are available upon request from the first author. Upon completion, the searches from each database

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were documented and references were imported into database-specific folders in RefWorks where duplicates were eliminated. Stage 3: Study selection

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reviewer to determine eligibility based on the defined inclusion and exclusion criteria. For example, titles that indicate a target population with an existing medical condition or

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where the research was carried out in an ineligible country will be removed. At this

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primary stage of the review, any uncertainty with a title will not yet eliminate the citation

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for consideration in the second stage. The second part of the selection process will include two independent reviews of the titles and abstracts using the eligibility criteria. At this

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point, the two reviewers will also assess the systematic approach reported in the abstract.

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Given that abstracts commonly contain less specific details, we developed criteria (Table 2) to determine acceptable level of rigour based on a preliminary review of the abstracts and an inductive approach drawing on Gough et al’s observations of varied review methods. [17, 18] A PRISMA Flow diagram [19] (Figure 1.0 in Appendix B) will report final numbers once the review is completed.


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Table 2. Inclusion and Exclusion Criteria Determining Acceptable Reviews Criteria for inclusion:

Criteria for exclusion:

(required the presence of at least one of the following in the abstract) Used explicit methods to identify reviews:

A review of literature or documents that

Databases searched

were not primary research, for example a

Search terms used

review of websites or industry documents Cataloguing various policies across jurisdictions rather than reporting on

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Date range

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evaluation of a policy

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An analysis of various methodological

Number of articles retrieved

approaches

Literature review – is a term or label to

describe the article rather than reporting as

OR “comprehensive search” OR “systematic

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review” OR “systematic search”

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Used terms such as “comprehensive review”

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a verb: “to review….”

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Where differences arise, the reviewers will consult a third reviewer to reach consensus. When consensus is not reached, those articles will be included in the review. While scoping review methodology does not specify a process for evaluating study quality [11], we will only include abstracts that demonstrate evidence of a systematic approach.


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Stage 4: Charting the data We will collect and sort key pieces of information from the abstracts of the selected articles. As part of the scoping review of reviews approach and the large quantity of published research literature to be covered, we will only be reviewing abstracts and extracting information to the extent that it is available in the abstracts. Some of this information is standard in data extraction (such as author, year of publication, study objectives) and

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additional information will be collected in order to address research questions [11, 13]. Daudt et al [13] suggest a trial charting exercise and team consultation to ensure consistency with the questions and purpose.

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categories [13]. Table 3 includes the a priori categories within the data collection tool. Table 3: Data Extraction Framework

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Bibliometrics Authors Title Source Year of Pub Country Language

Characteristics of the Review Objective(s)

Type of review

Primary = focus on tobacco control Multi= addressing multiple risk behaviours

Coding the Characteristics Action Areas: - price and tax - protection - product regulation - packaging, labeling - education, communication, training - advert and promo - cessation (all programming) - illicit trade -sales to minors Equity Lens Such as, SES gender, race, ethnicity, religion, age, residence, sexual orientation, disability, Other (specify)

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Number of included studies Time-frame

Intervention Descriptors Outcome Measures: -Process, -Impact (incl behavior change) -Outcome (incl health events/ measures) Target Population -Individual (specify - youth, child, adult) -Family -Community -Students/ School -Employees/ Workplace -Health Care -Society - Other (specify)

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Effectiveness: - Intervention outcomes presented by author(s) - Future research directions offered by author(s)

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Stage 5: Collating, summarizing and reporting the results

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The unique purpose of a scoping review is to aggregate the findings and present an overview rather than a meta-synthesis reporting results on narrowly defined questions.

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The inherent challenges are in determining a framework for presenting a narrative account [11]. While this approach is still an iterative work in progress, the WHO FCTC strategies are likely to guide our descriptive and visual presentation of results. We will use the PRISMA reporting guidelines for systematic reviews [19] including components of equity [16] in order to accurately report the review analysis and summary.


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Conclusion Our protocol for systematically conducting a scoping review of published review articles specific to tobacco control and primary prevention over the last ten years has been presented. This scoping review of reviews [15] is a novel approach that offers a feasible means for synthesizing a wide-range of research literature specific to tobacco control strategies within the domain of primary prevention. As this will be a first scoping review of

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reviews within this topic area, our results will advance the scoping review methodology. Results will provide unique insights concerning the extent and scope of tobacco control research foci useful for research and end-user communities. Against the backdrop of a

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decade of FCTC strategies, we will identify research foci trends and potential gaps specific

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to the domain of primary prevention. A reflective analysis of this large corpus of published tobacco control research as a whole may reveal new upstream and downstream directions

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for tobacco control research to prevent tobacco related morbidity.

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Abbreviations WHO - The World Health Organization

FCTC - Framework Convention on Tobacco Control (from WHO)

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CINAHL - The Cumulative Index to Nursing and Allied Health Literature ERIC - Educational Resources Information Centre COPD - Chronic Obstructive Pulmonary Disease


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Competing interests The authors declare that they have no competing interests. This work was supported by The Manitoba Research Chair in Primary Prevention awarded to Dr Alan Katz by the Manitoba Health Research Council and the Heart and Stroke Foundation of Manitoba. Contributorship Statement

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All authors have made substantive intellectual contributions to the development of this protocol. AK conceptualized the review approach and provided general guidance to the research team. All authors were involved in developing the review question and the review

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design. AS identified the framework from which JR and GH developed and tested search

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terms. LH, AK and AS initially developed the data extraction framework which was then further developed by input from all team members. GH and AS initiated the first draft of

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the manuscript which was then followed by numerous iterations with substantial input and

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appraisal from all of the authors. All authors approved the final version of the manuscript

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submitted as well as the revised October 30. 2014 version. Funding

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Manitoba Research Chair in Primary Prevention awarded to Dr Alan Katz by the Manitoba

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Health Research Council and the Heart and Stroke Foundation of Manitoba.


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References 1 US Department of Health and Human Services. The health consequences of smoking - 50 years of progress: A report of the surgeon general. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.

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2 Fiore MC, Jaén CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. clinical practice guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.; May 2008.

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3 World Health Organization. WHO global report: Mortality attributable to tobacco. Geneva, WHO: 2012.

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4 Asma S, Song Y, Cohen J, Eriksen M, Pechacek T, Cohen N, et al. CDC grand rounds: Global

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tobacco control centers for disease control and prevention morbidity and mortality weekly

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report Atlanta: Center for Disease Control; April 4, 2014. Report No.: Vol 63, No 13.

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5 World Health Organization. WHO framework convention on tobacco control. Geneva: World Health Organization; 2005.

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6 Myers ML. The FCTC's evidence-based policies remain a key to ending the tobacco epidemic. Tob Control. 2013 May;22 Suppl 1:i45-6.

7 Yach D, Pratt A, Glynn TJ, Reddy KS. Research to stop tobacco deaths. Globalization and Health. 2014;10(1).


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8 Cohen JE, Chaiton MO, Planinac LC. Taking stock: A bibliometric analysis of the focus of tobacco research from the 1980s to the 2000s. Am J Prev Med. 2010;39(4):352-6. 9 Cohen L, Chavez V, Chehimi S(. Prevention is primary: Strategies for community wellbeing. Second ed. San Francisco: Jossey-Bass; 2010. 10 Canadian Institute for Health Information. Health region interventions that address the

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social determinants of health: Equity and structural lenses in intervention research Ottawa: Canadian Institute for Health Information; Feb 2013. 11 Arksey H, O'Malley L. Scoping studies: Towards a methodological framework.

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International Journal of Social Research Methodology: Theory and Practice. 2005;8(1):1932.

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12 Grimshaw J. A knowledge synthesis chapter. Ottawa: Canadian Institute of Health Research; 2010.

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13 Daudt HML, Van Mossel C, Scott SJ. Enhancing the scoping study methodology: A large,

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inter-professional team's experience with arksey and O'malley's framework. BMC Medical Research Methodology. 2013;13(1).

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14 Levac D, Colquhoun H, O'Brien KK. Scoping studies: Advancing the methodology. Implementation Science. 2010;5(1). 15 Goertzen L, Schultz A, Halas G, Rothney J, Wener P, Katz A. The proliferation of research literature and capturing the big picture: The value of a scoping review of reviews. . Submitted for Publication. 2014.


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16 Welch V, Petticrew M, Tugwell P, Moher D, O'Neill J, Waters E, et al. PRISMA-equity 2012 extension: Reporting guidelines for systematic reviews with a focus on health equity. PLoS Medicine. 2012;9(10). 17 Gough D, Thomas J, Oliver S. Clarifying differences between review designs and methods. Systematic Reviews. 2012;1(1).

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18 Gough D. Meta-narrative and realist reviews: Guidance, rules, publication standards and quality appraisal. BMC Medicine. 2013;11(1). 19 Moher D, Liberati A, Tetzlaff J, Altman DG, Altman D, the PRISMA Group. Preferred

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reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Medicine. 2009;6(7).

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Leah Goertzen. Faculty of Kinesiology and Department of Family Medicine, College of Medicine, University of Manitoba, Winnipeg MB, Canada. Pamela Wener. College of Rehabilitation Sciences, Faculty of Health Sciences, University of Manitoba Research, Winnipeg MB, Canada.

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A novel review approach covering a vast volume of literature on a broad topic thus offering a “big picture” or map of research on tobacco control within the context of primary prevention.

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A practical method for synthesizing research that has used a wide range of

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research evidence has developed around the health consequences related to tobacco use and a range of tobacco control strategies. Although improvement is evident, so is the reality that tobacco use remains significant, and treatments and management costs of

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people with tobacco-related health conditionsare astronomical [2]. As the aim of primary

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prevention strategies is to prevent illness among the general population, it seems logical that tobacco control strategies fit within this domain of prevention. Given the large corpus

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of research literature covering tobacco control and our interests in primary prevention, we

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describe a protocol for a scoping review of published reviews specific to tobacco control situated within primary prevention.

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Background

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However, the World Health Organization (WHO) currently reports that nearly six million premature deaths each year are attributable to either tobacco use or smoke exposure, which is higher than deaths resulting from HIV/AIDS, tuberculosis and malaria collectively [3, 4]. Nearly one third to one half of tobacco users will develop a tobacco-related chronic illness leading to death; the most common conditions being cancers, cardiovascular diseases or respiratory alignments.


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focusing on the reduction of complications among populations with various stages of incurable conditions (tertiary prevention) [9]. We have also chosen to respond to the WHO 2008 challenge to close equity gaps within a generation by incorporating an equity lens into our analysis [10]. Our Primary Prevention Research Team is working towards defining a program of research in primary prevention and here, we present a protocol for completing a scoping review of reviews covering the published tobacco control literature

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over the last decade. Methods/Design

We chose to undertake a scoping review of published reviews covering a vast body of

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tobacco control research. Scoping review methodology is particularly useful when

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examining a broadly covered topic. The aim is to comprehensively and systematically map the literature and identify key concepts, theories, evidence, or research gaps. Unlike

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systematic reviews or meta-analyses, scoping reviews do not narrow the parameters of the

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review to research trials or require quality assessment. Nonetheless, this type of review is

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rigorous and methodical in its approach to examining the extent, range and nature of research activity in a particular field [11] while encompassing both empirical and conceptual research on broadly framed questions [12].

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3. How is equity addressed in the tobacco control literature?


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Human subjects;

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All age groups

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Explicit exclusion criteria identified are:

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Databases The following electronic databases were searched: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and Educational Resources Information Centre (ERIC).


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Search strategy We drew on the WHO FCTC to operationalize search terms for “tobacco control strategy”, which focuses on demand and supply reduction strategies [5]. Our research team iteratively developed an extensive list of primary and secondary search terms as well as filtering methods. The primary search terms focused on core tobacco related terms (i.e., tobacco, smoke, nicotine). The secondary search terms included a broader set of keywords

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such as promotion, prevention, interventions as well as tobacco control strategies based on the FCTC (such as pricing, regulation, packaging). The filtering methods included the date range (within the last 10 years), English, Human and a search string to further narrow the

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results to review articles. We used the Boolean term “AND” between the core tobacco

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search strategy and each of the other keywords. Publication titles from a preliminary search were reviewed to inform refinement of terms

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following two examples. Firstly, marijuana use is not a topic that we chose to include but

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terms such as, “smoking” did not automatically filter out publications around marijuana use. Using the No Explode option for the main MeSH term “Smoking” eliminated

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“Marijuana Smoking” from search results ("Smoking"[Mesh:NoExp]). Secondly, we need to

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be mindful of search terms that produce irrelevant outputs but need to be included as they may otherwise eliminate relevant articles. For example, we found many of the search results targeted a particular disease, such as COPD, and are therefore outside the domain of primary prevention. However, if we use COPD as a search term to filter out such articles, we would miss reviews discussing tobacco use in terms of preventing COPD, thus relevant to primary prevention.


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The librarian on our team played a key role in determining and testing appropriate keywords, MESH terms and filters to maximize sensitivity and specificity within the search. She was instrumental in modifying and applying search terms to comply with the various bibliographic databases. The complete and final search strategy for PubMed can be found in Appendix A; further search strategy details across bibliographic databases are available upon request from the first author. Upon completion, the searches from each database

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for consideration in the second stage. The second part of the selection process will include two independent reviews of the titles and abstracts using the eligibility criteria. At this

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Given that abstracts commonly contain less specific details, we developed criteria (Table 2) to determine acceptable level of rigour based on a preliminary review of the abstracts and an inductive approach drawing on Gough et al’s observations of varied review methods. [17, 18] A PRISMA Flow diagram [19] (Figure 1.0 in Appendix B) will report final numbers once the review is completed.


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Table 2. Inclusion and Exclusion Criteria Determining Acceptable Reviews Criteria for inclusion:


(required the presence of at least one of the following in the abstract) Used explicit methods to identify reviews:

A review of literature or documents that

Databases searched

were not primary research, for example a

Search terms used

review of websites or industry documents Cataloguing various policies across jurisdictions rather than reporting on

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Date range

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describe the article rather than reporting as

OR “comprehensive search” OR “systematic

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review” OR “systematic search”

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Used terms such as “comprehensive review”

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Stage 4: Charting the data We will collect and sort key pieces of information from the abstracts of the selected articles. As part of the scoping review of reviews approach and the large quantity of published research literature to be covered, we will only be reviewing abstracts and extracting information to the extent that it is available in the abstracts. Some of this information is standard in data extraction (such as author, year of publication, study objectives) and

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additional information will be collected in order to address research questions [11, 13]. Daudt et al [13] suggest a trial charting exercise and team consultation to ensure consistency with the questions and purpose.

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categories [13]. Table 3 includes the a priori categories within the data collection tool. Table 3: Data Extraction Framework

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Type of review

Primary = focus on tobacco control Multi= addressing multiple risk behaviours

Coding the Characteristics Action Areas: - price and tax - protection - product regulation - packaging, labeling - education, communication, training - advert and promo - cessation (all programming) - illicit trade -sales to minors Equity Lens Such as, SES gender, race, ethnicity, religion, age, residence, sexual orientation, disability, Other (specify)

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The unique purpose of a scoping review is to aggregate the findings and present an overview rather than a meta-synthesis reporting results on narrowly defined questions.

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The inherent challenges are in determining a framework for presenting a narrative account [11]. While this approach is still an iterative work in progress, the WHO FCTC strategies are likely to guide our descriptive and visual presentation of results. We will use the PRISMA reporting guidelines for systematic reviews [19] including components of equity [16] in order to accurately report the review analysis and summary.


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Conclusion Our protocol for systematically conducting a scoping review of published review articles specific to tobacco control and primary prevention over the last ten years has been presented. This scoping review of reviews [15] is a novel approach that offers a feasible means for synthesizing a wide-range of research literature specific to tobacco control strategies within the domain of primary prevention. As this will be a first scoping review of

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reviews within this topic area, our results will advance the scoping review methodology. Results will provide unique insights concerning the extent and scope of tobacco control research foci useful for research and end-user communities. Against the backdrop of a

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decade of FCTC strategies, we will identify research foci trends and potential gaps specific

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to the domain of primary prevention. A reflective analysis of this large corpus of published tobacco control research as a whole may reveal new upstream and downstream directions

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for tobacco control research to prevent tobacco related morbidity.

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Abbreviations WHO - The World Health Organization

FCTC - Framework Convention on Tobacco Control (from WHO)

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CINAHL - The Cumulative Index to Nursing and Allied Health Literature ERIC - Educational Resources Information Centre COPD - Chronic Obstructive Pulmonary Disease


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Competing interests The authors declare that they have no competing interests. This work was supported by The Manitoba Research Chair in Primary Prevention awarded to Dr Alan Katz by the Manitoba Health Research Council and the Heart and Stroke Foundation of Manitoba.

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2 Fiore MC, Jaén CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. clinical practice guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.; May 2008.

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4 Asma S, Song Y, Cohen J, Eriksen M, Pechacek T, Cohen N, et al. CDC grand rounds: Global

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tobacco control centers for disease control and prevention morbidity and mortality weekly

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report Atlanta: Center for Disease Control; April 4, 2014. Report No.: Vol 63, No 13.

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8 Cohen JE, Chaiton MO, Planinac LC. Taking stock: A bibliometric analysis of the focus of tobacco research from the 1980s to the 2000s. Am J Prev Med. 2010;39(4):352-6. 9 Cohen L, Chavez V, Chehimi S(. Prevention is primary: Strategies for community wellbeing. Second ed. San Francisco: Jossey-Bass; 2010. 10 Canadian Institute for Health Information. Health region interventions that address the

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International Journal of Social Research Methodology: Theory and Practice. 2005;8(1):1932.

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inter-professional team's experience with arksey and O'malley's framework. BMC Medical Research Methodology. 2013;13(1).

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14 Levac D, Colquhoun H, O'Brien KK. Scoping studies: Advancing the methodology. Implementation Science. 2010;5(1). 15 Goertzen L, Schultz A, Halas G, Rothney J, Wener P, Katz A. The proliferation of research literature and capturing the big picture: The value of a scoping review of reviews. . Submitted for Publication. 2014.


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16 Welch V, Petticrew M, Tugwell P, Moher D, O'Neill J, Waters E, et al. PRISMA-equity 2012 extension: Reporting guidelines for systematic reviews with a focus on health equity. PLoS Medicine. 2012;9(10). 17 Gough D, Thomas J, Oliver S. Clarifying differences between review designs and methods. Systematic Reviews. 2012;1(1).

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1. ((("Health Promotion"[Mesh] OR "School Health Services"[Mesh] OR "Healthy People Programs"[Mesh] OR "Preventive Health Services"[Mesh] OR "Public Health"[Mesh] OR

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"Primary Prevention"[Mesh]) OR ( "Preventive Dentistry"[Mesh] OR "Patient

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Fairs"[Mesh] OR "Consumer Advocacy"[Mesh] OR "Child Advocacy"[Mesh] ))) 2. (program OR programs OR programme OR programmes OR programming)

4. (Pricing )

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3. (intervention)

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practices"))

14. ((intervention OR prevention OR program* OR strateg* OR promot*) AND (barrier* OR determinant* OR polic* OR advoca*)) 15. (campaign) 16. (strateg*)

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17. (“point-of-purchase” OR “point-of-sale” OR “point of purchase” OR “point of sale” OR “power wall” OR “retail”)

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18. (“tv” OR “television” OR “radio” OR “broadcast” OR “mass media” OR “marketing” OR “countermarketing”)

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BMJ Open 1 PRISMA 2 3 4 5 Section/topic 6 7 TITLE 8 9 Title 10 ABSTRACT 11 12 Structured summary 13 14 15 16 INTRODUCTION 17 18 Rationale 19 Objectives 20 21 22 23 24 METHODS 25 Protocol and registration 26 27 28 29 Eligibility criteria 30 31 32 Information sources 33 34 35 Search 36 37 Study selection 38 39 40 41 Data collection process 42 43 44 Data items 45 46 47 48

2009 Checklist

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Response to Reviewers re bmjopen-2014-006643 Reviewer comments Editors Comments: 1. Please include the study design in your title

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Authors’ response

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1. We had originally stated the design in the title as it is “a scoping review of reviews”. However, we have revised the title also in response to Reviewer 3’s suggestion to simplify.

The title was revised and if we have misunderstood the request please let us know

Reviewer 1: A/Prof Sharon Lawn Flinders University, Australia

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2. This protocol describes a well thought out process. The authors have paid particular attention to the potentially nuanced nature of the literature in their planned search.

2. Thank you for this acknowledgement and recognition of our ambitious scoping review project.

3. It is unfortunate that their planned process excludes specific populations (eg. people with mental illness who smoke); although I understand that the literature for such populations is worthy of its own protocol.

3. While this is unfortunate, given our aim of focusing on tobacco control within the domain of primary prevention, excluding certain populations makes sense. That is not to say the other populations are not important but as stated, really worthy of a separate protocol; we had removed over 1800 citations regarding populations with particular conditions or illnesses to meet our scoping review parameters. .

No additional action taken

4. We appreciate this suggestion and have consulted these articles. One very helpful aspect was with search terms. The inclusion of additional terms have resulted in new review articles not previously found. Thankyou!

Revised search strategy Appendix A

5. We chose to do a scoping review of

While we have not reframed

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Reviewer 2: Janet Hoek, University of Otago, New Zealand 4. First, several studies have already reviewed specific tobacco control strategies. For example, Hammond reviewed warning labels; Edwards and Paynter and, more recently, Robertson et al. reviewed point-of-sale display restrictions, and Wakefield and her team have reviewed mass media advertising.(1-4) The authors may plan to draw on these reviews as they progress their work, but I think they could acknowledge them earlier as they could learn from both the approaches taken and the search terms used. 5. As well as drawing on earlier studies, the authors need to demonstrate

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Response to Reviewers re bmjopen-2014-006643 that their work will extend what is already documented. They may achieve this goal by updating earlier reviews (as Robertson et al did) but they might also want to consider reframing their overall objective, which (if I have understood it correctly) is to identify priority areas for research. I think it would be helpful to researchers if the authors could report on progress since earlier reviews and consider whether the recommendations made in these still apply.

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reviews in order to have a more global perspective of the last decade of research regarding tobacco control. Focusing on a specific strategy notable in the three references indicated lies in contrast to our interest, which is to map “the big picture” regarding tobacco control reviews that have been published and are most relevant to primary prevention. Cohen, Chaiton and Planinac (2010)1 recognized the vast body of tobacco control literature including existing reviews and stated that there is a need for a more comprehensive meta-review to examine the tobacco control research corpus.

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6. Further, it would be helpful to have some indication of where preventive and policy priorities should lie. For example, could the authors recommend best practice marketing measures so countries with these in place might be guided to focus on the next priority? In other words, could the authors outline both priority areas and what best practice represents in each of these?

6. We appreciate this point regarding identification of priorities, which may well be part of our results paper discussion. These kinds of statements would be premature in a protocol paper.

7. Suggestions regarding the search terms. Marketing activities often include retailing and there is good evidence of a dose-response relationship between exposure to in-store displays and risk of experimentation among adolescents. I suggest extending the proposed search terms to include “retailing” (and relevant synonyms) and

7. As per point #4 above re: search terms.

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our goals nor aligned with the articles mentioned, we have brought in the Cohen et al1 article as this one more closely aligns with our goals.

No action

See point #4

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Cohen JE, Chaiton MO, Planinac LC. (2010). Taking Stock: A bibliometric analysis of the focus of tobacco research from the 1980s to the 2000s. American Journal of Preventive Medicine 39(4):352-356.


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Response to Reviewers re bmjopen-2014-006643 8. further suggest grouping retailing with advertising, marketing and sponsorship. I also suggest moving packaging to consider this as a marketing term (packaging has little obvious link to product content, where it is currently located in Table 1).

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9. Regulating content could arguably be a little more specific to ensure it covers removal of flavours and additives that enhance palatability as well as progressive removal of nicotine, to reduce addictiveness. Both areas have been somewhat neglected (at least to the best of my knowledge) and the authors really could extend our understanding if they present a review of work on these topics.

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10. As far as the target population groups are concerned, I wondered about identifying groups of higher priority. These might include indigenous peoples (important given the review includes New Zealand, the US and Australia, where smoking prevalence among indigenous peoples is at least double that of other population groups). Other priority groups where smoking presence is known to be higher are young adults and members of LGBTQ communities and women who are pregnant and smoking are also an important priority group that might be considered.

8. Grouping these categories was based on the FCTC. However, we’ve revisited the way we presented FCTC in Table 1 and revised.

Table 1 Operational Definitions of Tobacco Control Strategies was revised.

9. This is an interesting angle and prompted a search of the literature to include search terms “flavour or flavors or additive” however the few reviews that emerged did not examine removal of flavours or additives to influence tobacco dependence and treatment.

No further action.

10. In our search, we didn’t use terms to identify or target any specific population. While our intention was to focus on a general population (i.e., do not have a specific health condition), reviews that include various groups or special populations will not be excluded. In particular, reporting of our findings will identify many of the populations you mention and will be noted through the inclusion of an equity lens. In Table 1 we now provide greater detail concerning the equity lens.

Table 1 revised, with more details concerning the equity lens.

11. Thank you for this recommendation. We have revised the introductory section, based on these comments. The most notable change is the removal of the Canadian perspective.

Significant revisions to condense the intro and background pp. 4-6.

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11. Finally, I suggest clarifying and condensing the introductory section, which could be tighter and less repetitive. Perhaps begin by noting the serious health effects caused by tobacco (I suggest using caused rather than associated or related); refer to “smoke exposure” as second-hand smoke exposure (SHS exposure) – perhaps use US SG reports to document growing evidence of smoking’s harmful effects. Page 4 could be reduced to one paragraph. The next para could outline the FCTC as a comprehensive

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Response to Reviewers re bmjopen-2014-006643 response to these problems and could outline the key measures proposed; I suggest differentiating between “public awareness” (education), legislation (policy or regulation) and health promotion (is this different from education)? I am not sure the Canadian data is really relevant and suggest using the FCTC approach as a reason why a review examining the effects of different measures could inform future approaches.

Reviewer #3 Peter Bragge

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12. At the moment your overarching aim lacks focus: It would be good to be a bit clearer on what your scoping review is going to add to the field i.e. what gap is your overview itself is filling? Is the overall aim to drive a research agenda in this area, or to better understand intervention, programming and policy? Or put another way, is your audience researchers, interventionists or policymakers? This could influence both your data extraction and your overall approach to writing and presenting the results.

12. Good point! We have revised the introduction/background in response to review point # 11, which more clearly situates the overall gap we are filling by conducting this work in extending the work completed by Cohen et al1 who first identified the need for this type of review. In addition, we make a comment about audience in the conclusions.

12. Revisions to the opening and conclusion.

13. There is a limitation in identifying research gaps: One limitation to keep in mind regarding identification of research gaps is that by definition, you won’t find potentially important research questions that have not been addressed at all in the literature. To identify these gaps, a predetermined set of specific research questions, generated by key stakeholders, needs to be searched against. I understand this is outside of the scope of your review, but it is worth acknowledging that research gaps where there is no published research at all cannot be identified by searching published research. Another strategy (which I strongly suggest below) is that you report the conclusions of the identified reviews with respect to research gaps (FYI, we’ve discussed this in our evidence mapping paper, which you may find of interest: http://www.biomedcentral.com/1471-2288/11/92 ) The concept of ‘research gaps’ appears pivotal to your conclusion so this should be addressed

13. We read your evidence mapping paper with great interest. This is an interesting approach – using consultation with key stakeholders to create the comparators, which then offer the means for identifying gaps. Comparatively, we used the FCTC as a framework against which to determine action areas addressed in the literature and alternately, action areas receiving minimal attention. Also and following our initial use of the data extraction framework, we have added another column to capture the authors’ suggestions regarding future research

13. The FCTC backdrop is discussed in the conclusion. Also, see changes to data extraction table, which now includes a column about “Future research directions offered by authors”

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Response to Reviewers re bmjopen-2014-006643 directions. 14. The data extraction protocol should be revisited: The major limitation in this protocol is that data extraction is only at the abstract level. I strongly recommend that this be revisited, because your stated aims on page 2 are to ‘identify research gaps as well as novel ideas for primary prevention research.’ This information is unlikely to be fully covered by the abstract. Based on our experience of overviews of reviews, much of this information is likely to be contained in the discussion section of the review, in which the results of the review are considered in the context of related work and research gaps / future research directions are articulated. I realise there are limitations in processing large volumes of evidence in scoping reviews, but I think that not reviewing the discussion (at a minimum – ideally, scan the whole review) is a missed opportunity to gather rich information that directly addresses your aims.

14. Our original intention was to review full articles however due to volume of tobacco control research; we had at least two options: refine/narrow our focus to decrease the number of articles to review or keep our intention of mapping the “big picture” by developing a scoping review of published review methodology. We realize both approaches come with benefits and limitations, but adhere to our original objective of remaining broad and inclusive. Once this SRR is complete, we have talked about completing a more in depth review of specific areas and indeed seek the rich information that may be missed.

14. No action

15. What is the rationale for the geographic restriction? Wouldn’t it make more sense to restrict to English language?

15. There are publications written in English that report on developing countries. While important, these countries come with different resources and influences. Since this review is large, we decided to limit our inclusion to both English reviews and then geographically to developed countries.

15. Described within the eligibility criteria on page 9.

16. The emphasis in this review is the intersection of primary prevention and tobacco control. We were targeting a general population, which might include people with various illness/conditions but to exclude articles that targeted specific health conditions as this falls outside of the domain of primary prevention, which aims to

16. Revisions to pp 5- 6 regarding the primary prevention focus.

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16. What is the rationale for not including populations with a specific illness? I understand you are not seeking information about treating illnesses, but people with illness could still be the target of anti-smoking interventions? (or is this ‘secondary prevention’? – if so, need to explicitly define ‘primary intervention’

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Response to Reviewers re bmjopen-2014-006643 prevent disease. 17. Have you searched to see if there are any existing overviews of reviews in this field?

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18. Consider the limitations of scoping reviews / overviews of reviews only – essentially the sacrifice of depth for breadth. Some of these concepts are covered in Arksey etc. , but also described quite well in Khangura et al. 2012: http://www.systematicreviewsjournal.com/content/1/1/10

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17. J Cohen et al have done a bibliometric analysis.

17. Reference to Cohen et al review is included on p 5.

18. These suggestions were considered. The challenge we have is in the different objectives for these reviews. A scoping review has a broader focus and is not limited to the approach taken by a systematic review (as per Khangura et al).

19. Have you thought about undertaking this work as a Cochrane overview of reviews?: http://handbook.cochrane.org/chapter_22/22_2_preparing_a_cochrane_ove rview_of_reviews.htm

19. Different process – overview of Cochrane reviews and once again limited scope/narrower question.

19. No action

20. E-cigarettes appear to be the next frontier in tobacco marketing. If resources allow, it would be very interesting to do a small scale search on this term, limited to the last 3 years, and identify any emerging research or research protocols in this area. This (or at least, a comment on this emerging area) will future-proof your overview.

20. This would indeed be interesting. We reviewed our search strategy and determined it will retrieve published reviews on e-cigarettes. At this point, we have found only one review on this topic eligible for our scoping review.

21. The title is a bit of a mouthful, maybe a colon after the word ‘reviews’?

21. Title revised based on comment 1 and this point.

21. Title has been changed.

22. Because you have already performed some searching, there is a mix of past and future tenses in the methods section, which should be addressed

22. We have reviewed the verb tense. Our intention is to reflect our actions, i.e., past tense reflecting work that had been done up to and including the search. Thereafter, future tense reflects work that is to occur.

22. We would be happy to change and would like further feedback from the editor regarding the appropriate manner for presenting tense for this type of manuscript.

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Response to Reviewers re bmjopen-2014-006643 23. Heading for Stage 3 – study selection (not selections)

23. Corrected

23. Corrected subheading (p.11)

24. The search strategy and overarching review framework is well thought out 24. Thank you for acknowledging the and comprehensive breadth of the searching strategy and the comprehensive review framework.

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25. Table 1, Q3 – what do you mean by ‘how is equity situated’? How will you find and extract information on equity from published reviews?

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26. Table 1, Q5 – what do you mean by ‘how is effectiveness situated’? do you mean how is it measured? ‘Situated’ seems difficult to find and extract from a review

25. We have revised the wording in Table 1, Q3. The information extracted will be based on the authors reporting the items of the Extension for Equity-Focused Reviews2

25. More detail around Equity considerations in Table 1, Q3

26. We are not intending to evaluate nor 26. Revision to table 1 Q5, make concluding statements about the page 9. And revision to last effectiveness of interventions covered in the column of Table 3. reviews; however, we are interested in noted how and when authors make comments about effectiveness. This has been a struggle for us, hence really what we intend to do is present a narrative representing the discourse. Thus, we will be noting effectiveness of interventions as it is presented by author(s) as well as where they feel there is insufficient evidence and call for further research.

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27. Table 2 (original) – conclusions may not fit positive / negative or a mix…may be inconclusive. Also, this data extraction example does not meet your stated aim of identifying research gaps (see comment above). Suggest you pilot and finalise the data extraction protocol before published the

Table 2 has been updated; at this time data extraction is finalized and yes, the original (what was in the submission) has been revised by the team.

27. Revision to table 1 Q5, page 8. And revision to last column of Table 3.

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Welch, V., Petticrew, M., Tugwell, P., Moher, D., O'Neill, J., Waters, E., . . . White, H. (2012). PRISMA-equity 2012 extension: Reporting guidelines for systematic reviews with a focus on health equity. PLoS Medicine, 9(10)


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Response to Reviewers re bmjopen-2014-006643 overall review protocol (so that any refinements from hereon are minor only) 28. How are you defining ‘rigorous reviews’ and ‘systematic approach’ – advise you reference an accepted definition of systematic review e.g. Greenhalgh et al. 1997 : http://www.bmj.com/content/315/7109/672

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29. Regarding PRISMA: a) Item 4: I think you could specify a PICOS or at least some PICOS elements, even though the terms will be broad (e.g. population = smokers, intervention = harm reduction)

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b) Item 5: Have you considered registering on PROSPERO? http://www.crd.york.ac.uk/PROSPERO/

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28. We Provide more details of our criteria for a “rigorous review” and “systematic approach” on p 11. 29 a) No action

b) PROSPERO does not register scoping reviews.

b) No action

c) We had decided to include the first draft of our data extraction tool in this submission. As data extraction is basically complete and requests from reviewers, we have now included a refined version of our data extraction guide. This was refined based on piloting extraction processes.

c)Please see revised Table 3.0 on page 13

d) A scoping review does not appraise quality. Rather, we developed a set of criteria to judge the rigor of the systematic approach used by the authors. These details are not included in the manuscript as noted above under point #28

d) See page 11 as noted above under point #28

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c) Item 10: Consider finalising the data extraction based upon a small sample and publish this, rather than a draft (given the suggestions made on data extraction above)

d) Item 12, 15: Could consider quality appraisal of included reviews using AMSTAR: http://amstar.ca/ if capacity. If not, acknowledge this as a limitation

28. Thank you for the reference to Greenhalgh et al however this covers systematic reviews and is not suitable for our purpose. 29 a) Thanks for this suggestion, which would narrow our focus and diminish the breadth of our scoping review; both are not aligned with our goals. For example defining our population as “smokers” would narrow the search and eliminate exposure or marketing/industry focused strategies. As well, the interventions include all FCTC strategies, which mean interventions are vast.

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A SCOPING REVIEW PROTOCOL TO MAP THE RESEARCH FOCI TRENDS IN TOBACCO CONTROL OVER THE LAST DECADE

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Manuscript ID: Article Type:



BMJ Open bmjopen-2014-006643.R2 Protocol 02-Dec-2014


Smoking and tobacco

Research methods, Evidence based practice, Health services research

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Keywords:

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PREVENTIVE MEDICINE, Substance misuse < PSYCHIATRY, STATISTICS & RESEARCH METHODS, PRIMARY CARE, PUBLIC HEALTH

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Leah Goertzen. Faculty of Kinesiology and Recreation Management; Department of Family Medicine, College of Medicine, University of Manitoba, Winnipeg MB, Canada. Pamela Wener. Department of Occupational Therapy, College of Rehabilitation Sciences, Faculty of Health Sciences, University of Manitoba, Winnipeg MB, Canada.

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Word Count: 2272

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A novel review approach to cover a vast volume of literature on a broad topic thus offering a “big picture” or map of research on tobacco control within the context of primary prevention.

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A practical method to synthesize research that has used a wide range of

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Limitations

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research evidence has developed around the health consequences related to tobacco use and a range of tobacco control strategies. Although improvement is evident, so is the reality that tobacco use remains significant, and treatment costs of people with tobacco-

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related health conditions are astronomical [2]. As the aim of primary prevention strategies

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is to prevent illness among the general population, it seems logical that tobacco control strategies fit within this domain of prevention. Given the large corpus of research literature

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covering tobacco control and our interests in primary prevention, we describe a protocol

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for a scoping review of published reviews specific to tobacco control situated within primary prevention.

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Background

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However, the World Health Organization (WHO) currently reports that nearly six million premature deaths each year are attributable to either tobacco use or smoke exposure, which is higher than deaths resulting from HIV/AIDS, tuberculosis and malaria collectively [3, 4]. Nearly one third to one half of tobacco users will develop a tobacco-related chronic illness leading to death; the most common conditions being cancers, cardiovascular diseases or respiratory alignments [3].


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focusing on the reduction of complications among populations with various stages of incurable conditions (tertiary prevention) [9]. We have also chosen to respond to the WHO 2008 challenge to close equity gaps within a generation by proposing use of an equity lens in our analysis [10]. Our Primary Prevention Research Team is working towards defining a program of research in primary prevention and here, we present a protocol for a scoping review of reviews covering the published tobacco control literature over the last decade.

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Methods/Design

We considered the various systematic approaches available to review published literature and chose to undertake a scoping review of published reviews as the best method to map

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the tobacco control research trends over the last decade. Scoping review methodology is

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particularly useful to examine a broadly covered topic to comprehensively and systematically map the literature and identify key concepts, theories, evidence, or research

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gaps. Unlike systematic reviews or meta-analyses, scoping reviews do not narrow the

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parameters of the review to research trials or require quality assessment. Nonetheless, this

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type of review is rigorous and methodical in its approach to examining the extent, range and nature of research activity in a particular field [11] while encompassing both empirical

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and conceptual research on broadly framed questions [12].

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3. How often is equity addressed in the tobacco control literature and how is equity being integrated into published reviews?


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Human subjects;

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All age groups

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Research reviews are limited to English speaking, developed countries including

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Canada, U.S., Europe, United Kingdom, Australia, and New Zealand, where rates of

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smoking, income, standard of living and infrastructures may be comparable and

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influence response trends to tobacco control strategies. Explicit exclusion criteria identified are: •

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Journal articles that are not rigorous reviews (i.e., outside of those defined in the

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inclusion list), such as book reviews, opinion articles, commentaries or editorial reviews. •



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Databases The following electronic databases were searched: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and Educational Resources Information Centre (ERIC). Search strategy We drew on the WHO FCTC to operationalize search terms for “tobacco control strategy”,

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which focuses on demand and supply reduction strategies [5]. Our research team iteratively developed an extensive list of primary and secondary search terms as well as filtering methods. The primary search terms focused on core tobacco related terms (i.e.,

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tobacco, smoke, nicotine). The secondary search terms included a broader set of keywords

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such as promotion, prevention, interventions as well as tobacco control strategies based on the FCTC (such as pricing, regulation, packaging). The filtering methods included the date

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range (within the last 10 years), English, Human and a search string to further narrow the

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results to review articles. We used the Boolean term “AND” between the core tobacco search strategy and each of the other keywords.

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Publication titles from a preliminary search were reviewed to inform refinement of terms

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following two examples. Firstly, marijuana use is not a topic that we chose to include but terms such as, “smoking” did not automatically filter out publications around marijuana use. Using the No Explode option for the main MeSH term “Smoking” eliminated “Marijuana Smoking” from search results ("Smoking"[Mesh:NoExp]). Secondly, we need to be mindful of search terms that produce irrelevant outputs but need to be included as they may otherwise eliminate relevant articles. For example, we found many of the search


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results targeted a particular disease, such as COPD, and are therefore outside the domain of primary prevention. However, if we use COPD as a search term to filter out such articles, we would miss reviews discussing tobacco use in terms of preventing COPD, thus relevant to primary prevention. The librarian on our team played a key role in determining and testing appropriate keywords, MESH terms and filters to maximize sensitivity and specificity within the search.

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She was instrumental in modifying and applying search terms to comply with the various bibliographic databases. The complete and final search strategy for PubMed can be found in Appendix A; further search strategy details across bibliographic databases are available

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upon request from the first author. Upon completion, the searches from each database

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primary stage of the review, any uncertainty with a title will not yet eliminate the citation for consideration in the second stage. The second part of the selection process will include two independent reviews of the titles and abstracts using the eligibility criteria. At this point, the two reviewers will also assess the systematic approach reported in the abstract. Given that abstracts commonly contain less specific details, we developed criteria (Table 2) to determine acceptable level of rigour based on a preliminary review of the abstracts and


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an inductive approach drawing on Gough et al’s observations of varied review methods. [17, 18] A PRISMA Flow diagram [19] (Figure 1.0 in Appendix B) will report final numbers once the review is completed. Table 2. Inclusion and Exclusion Criteria Determining Acceptable Reviews Criteria for inclusion:


At least one of the following minimum criterion required in the abstract:

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A review of literature or documents that were not primary research, for

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Date range

example a review of websites or

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Databases searched

industry documents

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Search terms used

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“systematic review” OR “systematic search”

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review” OR “comprehensive search” OR

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as a verb: “to review….”

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describe the article rather than reporting

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Cataloguing various policies across

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Combined with one of the following criterion:

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Stage 4: Charting the data We will collect and sort key pieces of information from the abstracts of the selected articles. Data to be extracted from the large quantity of published research literature reviews will include some standard information (such as author, year of publication, study objectives) and additional information to examine tobacco control strategies and target populations. Daudt et al [13] suggest a trial charting exercise and team consultation to ensure

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consistency with the questions and purpose. Based on a preliminary exercise, we developed a priori categories which will guide the extraction and charting of data from the abstracts (Table 3). The abstracts provide the data necessary for addressing the main

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objective of this scoping review of reviews i.e., mapping the action areas and target

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populations covered in the tobacco control literature. However, additional categories may emerge during the data collection process and we may also find some eligible abstracts

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with missing data. If additional data extraction categories are needed or if missing data

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emerges, consultation with our research team will guide decisions and will be reported

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with the findings. Table 3: Data Extraction Framework Characteristics of the Review Objective(s)

Type of review

Primary = focus on tobacco control

Coding the Characteristics Action Areas: - price and tax - protection - product regulation - packaging, labeling - education, communication, training - advert and promo - cessation (all programming) - illicit trade -sales to minors Equity Lens

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Multi= addressing multiple risk behaviours

Specified intention or objective related to equity Identified target groups or structural influences related to SES gender, race, ethnicity, religion, age, residence, sexual orientation, disability, Other (specify)

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Stage 5: Collating, summarizing and reporting the results The unique purpose of a scoping review is to aggregate the findings and present an overview rather than a meta-synthesis reporting results on narrowly defined questions. The inherent challenges are in determining a framework for presenting a narrative account


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[11]. While this approach is still an iterative work in progress, the WHO FCTC strategies are likely to guide our descriptive and visual presentation of results. Additionally, we will be able to identify gaps in the research targeting specific populations and actions areas and determine where more in-depth analysis is required. We propose using the PRISMA reporting guidelines for systematic reviews [19] including components of equity [16] to accurately report the review search results and analysis summary. Conclusion

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Our protocol for systematically conducting a scoping review of published review articles specific to tobacco control and primary prevention over the last ten years has been

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presented. This scoping review of reviews [15] is a novel approach that offers a feasible

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means for synthesizing a wide-range of research literature specific to tobacco control strategies within the domain of primary prevention. As this will be a first scoping review of

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reviews within this topic area, our results will advance the scoping review methodology.

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Results will provide unique insights concerning the extent and scope of tobacco control

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research foci useful for research and end-user communities. Against the backdrop of a decade of FCTC strategies, we will identify research foci trends and potential gaps specific

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to the domain of primary prevention. A reflective analysis of this large corpus of published

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tobacco control research as a whole may reveal new upstream and downstream directions for tobacco control research to prevent tobacco related morbidity.


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Abbreviations WHO - The World Health Organization FCTC - Framework Convention on Tobacco Control (from WHO) CINAHL - The Cumulative Index to Nursing and Allied Health Literature ERIC - Educational Resources Information Centre COPD - Chronic Obstructive Pulmonary Disease

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Competing interests

The authors declare that they have no competing interests. This work was supported by The Manitoba Research Chair in Primary Prevention awarded

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to Dr Alan Katz by the Manitoba Health Research Council and the Heart and Stroke Foundation of Manitoba.

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Contributorship Statement

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All authors have made substantive intellectual contributions to the development of this

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protocol. AK conceptualized the review approach and provided general guidance to the

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research team. All authors were involved in developing the review question and the review design. AS identified the framework from which GH and JR developed and tested search

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further developed by input from team members. GH and AS initiated the first draft of the manuscript which was then followed by numerous iterations with substantial input and appraisal from all of the authors. All authors approve the final version of the manuscript. Funding This work was supported by the Manitoba Research Chair in Primary Prevention awarded to Dr Alan Katz by the Manitoba Health Research Council and the Heart and Stroke


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Foundation of Manitoba.

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2 Fiore MC, Jaén CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Clinical practice guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; May 2008.

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4 Asma S, Song Y, Cohen J, et al. CDC grand rounds: Global tobacco control centers for

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disease control and prevention morbidity and mortality weekly report Atlanta: Center for

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Disease Control; April 4, 2014. Report No.: Vol 63, No 13.

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8 Cohen JE, Chaiton MO, Planinac LC. Taking stock: A bibliometric analysis of the focus of tobacco research from the 1980s to the 2000s. Am J Prev Med. 2010;39(4):352-6. 9 Cohen L, Chavez V, Chehimi S. Prevention is primary: Strategies for community wellbeing. Second ed. San Francisco: Jossey-Bass; 2010. 10 Canadian Institute for Health Information. Health region interventions that address the

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International Journal of Social Research Methodology: Theory and Practice. 2005;8(1):19-32.

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13 Daudt HML, Van Mossel C, Scott SJ. Enhancing the scoping study methodology: A large, inter-professional team's experience with Arksey and O'Malley's framework. BMC Medical Research Methodology. 2013;13(1).

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14 Levac D, Colquhoun H, O'Brien KK. Scoping studies: Advancing the methodology. Implementation Science. 2010;5(1).

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15 Goertzen L, Schultz A, Halas G, Rothney J, Wener P, Katz A. The proliferation of research literature and capturing the big picture: The value of a scoping review of reviews. . Submitted for Publication. 2014.


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16 Welch V, Petticrew M, Tugwell P, et al. PRISMA-equity 2012 extension: Reporting guidelines for systematic reviews with a focus on health equity. PLoS Medicine. 2012;9(10). 17 Gough D, Thomas J, Oliver S. Clarifying differences between review designs and methods. Systematic Reviews. 2012;1(1). 18 Gough D. Meta-narrative and realist reviews: Guidance, rules, publication standards and

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quality appraisal. BMC Medicine. 2013;11(1). 19 Moher D, Liberati A, Tetzlaff J, Altman DG, Altman D, the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Medicine. 2009;6(7).

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Gayle Halas. Department of Family Medicine, College of Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg MB, Canada.

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Annette SH Schultz. College of Nursing, Faculty of Health Sciences, University of Manitoba, Winnipeg MB, Canada. Janet Rothney. Neil John Maclean Health Sciences Library, University of Manitoba, Winnipeg MB, Canada. Leah Goertzen. Faculty of Kinesiology and Recreation Management; Department of Family Medicine, College of Medicine, University of Manitoba, Winnipeg MB, Canada. Pamela Wener. Department of Occupational Therapy, College of Rehabilitation Sciences, Faculty of Health Sciences, University of Manitoba, Research, Winnipeg MB, Canada.

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Alan Katz.* Departments of Community Health Sciences and Family Medicine, College of Medicine, Faculty of Health Sciences, University of Manitoba, P228-770 Bannatyne Ave, Winnipeg MB, Canada. R3E 0W2 [email protected] Ph: 204-789-3442

Word Count: 2272

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*Corresponding Author

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Abstract Introduction: Tobacco dependence and smoke exposure has been a global epidemic with health consequences recognized by the U.S Surgeon General since the 1960’s and 1970’s respectively. In this time period, a vast body of research evidence has emerged including

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many reviews of primary research studies targeting various tobacco control strategies. Published review studies synthesize primary evidence providing a rich source for mapping the broad range of topics and research foci along with revealing areas of evidence deficits. In this paper, we outline our scoping review protocol to systematically review published

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review articles specific to tobacco control and primary prevention over the last ten years. Methods and analysis: Using Arksey & O’Malley’s scoping review methodology as a guide,

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our scoping review of published reviews begins with searching several databases: PubMed,

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Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and Educational Resources Information Centre (ERIC). Our

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multidisciplinary team has formulated search strategies and two reviewers will independently screen eligible studies for final study selection. Bibliographic data and

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content of the abstracts will be collected and analyzed using a tool developed iteratively by the research team.

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Ethics and dissemination: A scoping review of published review articles is a novel approach for examining the breadth of literature regarding tobacco control strategies and, as a

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secondary analysis, does not require ethics approval. We anticipate results will identify

research gaps as well as novel ideas for primary prevention research specific to tobacco control strategies concerning intervention, programming and policy. Although this is our first step to establishing a foundation for a research agenda, we will be disseminating


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A novel review approach to covering a vast volume of literature on a broad topic thus offering a “big picture” or map of research on tobacco control within the context of primary prevention.

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A feasible strategy to identify research foci and knowledge gaps within the last ten years of tobacco control research.

A practical method for synthesizingto synthesize research that has used a wide

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range of methodological approaches, settings, study populations and behaviors. Limitations

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In the 1960s, the U.S Surgeon General report recognized that tobacco use was linked to serious health consequences [1]. A decade later, the report announced that tobacco smoke

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exposure was likewise an underlying contributor to what is now considered a longstanding global health epidemic. Since these public acknowledgements, a vast body of research evidence has developed around the health consequences related to tobacco use and a range of tobacco control strategies. Although improvement is evident, so is the

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reality that tobacco use remains significant, and treatment costs of people with tobaccorelated health conditions are astronomical [2]. As the aim of primary prevention strategies

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is to prevent illness among the general population, it seems logical that tobacco control strategies fit within this domain of prevention. Given the large corpus of research literature

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covering tobacco control and our interests in primary prevention, we describe a protocol for a scoping review of published reviews specific to tobacco control situated within primary prevention.

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Background


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However, the World Health Organization (WHO) currently reports that nearly six million premature deaths each year are attributable to either tobacco use or smoke exposure,

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which is higher than deaths resulting from HIV/AIDS, tuberculosis and malaria collectively [3, 4]. Nearly one third to one half of tobacco users will develop a tobacco-related chronic illness leading to death; the most common conditions being cancers, cardiovascular diseases or respiratory alignments [3].


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In response to this ongoing global tobacco epidemic, the WHO developed the Framework Convention on Tobacco Control (FCTC), which was the first evidence-based negotiated treaty within this organization [5]. In 2005, the FCTC was ratified by 168 member states, including Canada. In 13 of the 38 articles outlined by the FCTC, numerous evidence-based

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strategies for diminishing tobacco use and exposure to tobacco smoke are addressed and have been adopted globally by the member states. Notably, the FCTC frames tobacco control strategies within two main areas: reducing the demand for and supply of tobacco products.

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The FCTC has now been in place for nine years. The tobacco control measures endorsed in the Framework are reported to be responsible for dramatic reductions in tobacco use [6]

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alternate “end-game” strategies and policies to further reduce the effects of the tobacco epidemic [6, 7]. Several decades of tobacco control strategies along with evidence of the

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health consequences of tobacco use have emerged, but has the reflective step of looking

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broadly across this vast corpus of research been taken? Since few studies have examined the published tobacco research as a whole, Cohen et al [8] undertook a bibliometric

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analysis to examine the shift in tobacco research foci between two decades. Our scoping

review will contribute a long overdue review of the breadth of research and research foci trends since the introduction of the FCTC, specifically strategies within the domain of

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primary prevention. This means our focus will be on strategies for intercepting the cause of disease among healthy populations rather than tobacco control strategies targeting populations demonstrating initial signs of disease (secondary prevention) or strategies


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focusing on the reduction of complications among populations with various stages of incurable conditions (tertiary prevention) [9]. We have also chosen to respond to the WHO 2008 challenge to close equity gaps within a generation by proposing use of an equity lens in our analysis [10]. Our Primary Prevention Research Team is working towards defining a

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program of research in primary prevention and here, we present a protocol for a scoping review of reviews covering the published tobacco control literature over the last decade. Methods/Design

We considered the various systematic approaches available to review published literature

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and chose to undertake a scoping review of published reviews as the best method to map the tobacco control research trends over the last decade. Scoping review methodology is

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particularly useful to examine a broadly covered topic to comprehensively and systematically map the literature and identify key concepts, theories, evidence, or research

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gaps. Unlike systematic reviews or meta-analyses, scoping reviews do not narrow the parameters of the review to research trials or require quality assessment. Nonetheless, this

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type of review is rigorous and methodical in its approach to examining the extent, range

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and nature of research activity in a particular field [11] while encompassing both empirical and conceptual research on broadly framed questions [12].

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In designing the protocol for our scoping review of reviews we drew upon Arksey and O’Malley’s [11] seminal work as well as recent scoping review publications [13, 14].

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Arksey and O’Malley’s scoping review framework outlines a five stage approach with each stage discussed below. Adaptations were driven by an intention to develop a feasible approach for reviewing a vast body of literature [15].


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Stage 1: Identifying the research questions Arksey & O’Malley [11] suggest an iterative process for developing one or more guiding research questions, where each revision is driven by increasing familiarity with the literature. We first realized the need for an iterative process when initial searches

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primarily resulted in tobacco cessation articles, rather than articles addressing other tobacco control strategies. Our intention to comprehensively examine the tobacco control literature within the domain of primary prevention prompted us to seek a framework encompassing all aspects of tobacco control to guide the search. Turning to the FCTC

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strategic action terms, we identified five research questions to guide our scoping review of reviews (see table 1). As well, when we reflected on the inclusion of an equity lens, we

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Table 1: List of Research Questions and Operational Definitions

Operational Definitions Tobacco Control Strategies based on FCTC(6) • Price and tax measures • Protection from exposure • Regulation of contents and product disclosures • Packaging/labelling • Education and awareness • Advertising, promotion, sponsorship • Cessation • Illicit trade • Sales to minors Target Populations: • Society Government

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3. How often is equity addressed in the tobacco control literature and how is equity being integrated into published reviews?


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The aim of scoping reviews is to comprehensively address broad research questions; yet, parameters are required to guide the search strategy. At this stage, the team deliberated and decided upon criteria for eligibility, databases to search, and formulated a search

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strategy and key terms.


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Human subjects;

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All age groups

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Research reviews are limited to English speaking, developed countries including

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Canada, U.S., Europe, United Kingdom, Australia, and New Zealand, where rates of

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smoking, income, standard of living and infrastructures may be comparable and influence response trends to tobacco control strategies. Explicit exclusion criteria identified are:

Journal articles that are not rigorous reviews (i.e., outside of those defined in the

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inclusion list), such as book reviews, opinion articles, commentaries or editorial reviews. •

Research targeting a population because of a diagnosed illness or disease or

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interventions targeting treatment of a specific disease, illness or condition.


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Databases The following electronic databases were searched: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and Educational Resources Information Centre (ERIC). Search strategy

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We drew on the WHO FCTC to operationalize search terms for “tobacco control strategy”, which focuses on demand and supply reduction strategies [5]. Our research team iteratively developed an extensive list of primary and secondary search terms as well as

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filtering methods. The primary search terms focused on core tobacco related terms (i.e., tobacco, smoke, nicotine). The secondary search terms included a broader set of keywords

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such as promotion, prevention, interventions as well as tobacco control strategies based on the FCTC (such as pricing, regulation, packaging). The filtering methods included the date

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range (within the last 10 years), English, Human and a search string to further narrow the results to review articles. We used the Boolean term “AND” between the core tobacco search strategy and each of the other keywords.

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Publication titles from a preliminary search were reviewed to inform refinement of terms in consultation with our team. Refinement of search parameters can be illustrated in the

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following two examples. Firstly, marijuana use is not a topic that we chose to include but terms such as, “smoking” did not automatically filter out publications around marijuana use. Using the No Explode option for the main MeSH term “Smoking” eliminated

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“Marijuana Smoking” from search results ("Smoking"[Mesh:NoExp]). Secondly, we need to be mindful of search terms that produce irrelevant outputs but need to be included as they may otherwise eliminate relevant articles. For example, we found many of the search


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results targeted a particular disease, such as COPD, and are therefore outside the domain of primary prevention. However, if we use COPD as a search term to filter out such articles, we would miss reviews discussing tobacco use in terms of preventing COPD, thus relevant to primary prevention.

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The librarian on our team played a key role in determining and testing appropriate keywords, MESH terms and filters to maximize sensitivity and specificity within the search. She was instrumental in modifying and applying search terms to comply with the various bibliographic databases. The complete and final search strategy for PubMed can be found

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in Appendix A; further search strategy details across bibliographic databases are available upon request from the first author. Upon completion, the searches from each database

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reviewer to determine eligibility based on the defined inclusion and exclusion criteria. For

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example, titles that indicate a target population with an existing medical condition or where the research was carried out in an ineligible country will be removed. At this

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for consideration in the second stage. The second part of the selection process will include

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two independent reviews of the titles and abstracts using the eligibility criteria. At this

point, the two reviewers will also assess the systematic approach reported in the abstract. Given that abstracts commonly contain less specific details, we developed criteria (Table 2) to determine acceptable level of rigour based on a preliminary review of the abstracts and


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an inductive approach drawing on Gough et al’s observations of varied review methods. [17, 18] A PRISMA Flow diagram [19] (Figure 1.0 in Appendix B) will report final numbers once the review is completed. Table 2. Inclusion and Exclusion Criteria Determining Acceptable Reviews

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Criteria for inclusion:


At least one of the following minimum criterion required in the abstract:

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Date range

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Databases searched

Comment [GH1]: REFORMATTED TABLE

A review of literature or documents that were not primary research, for example a review of websites or

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industry documents

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Combined with one of the following criterion:

Cataloguing various policies across

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jurisdictions rather than reporting on

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Search terms used

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Literature review – is a term or label to describe the article rather than reporting

Used terms such as “comprehensive review” OR “comprehensive search” OR

An analysis of various methodological approaches

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as a verb: “to review….”


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“systematic review” OR “systematic search”

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Where differences arise, the reviewers will consult a third reviewer to reach consensus.

When consensus is not reached, those articles will be included in the review. While scoping review methodology does not specify a process for evaluating study quality [11], we will only include abstracts that demonstrate evidence of a systematic approach.


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Stage 4: Charting the data We will collect and sort key pieces of information from the abstracts of the selected articles. Data to be extracted from the large quantity of published research literature reviews will include some standard information (such as author, year of publication, study objectives)

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and additional information to examine tobacco control strategies and target populations. Daudt et al [13] suggest a trial charting exercise and team consultation to ensure consistency with the questions and purpose. Based on a preliminary exercise, we developed a priori categories which will guide the extraction and charting of data from the

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abstracts (Table 3). The abstracts provide the data necessary for addressing the main objective of this scoping review of reviews i.e., mapping the action areas and target

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populations covered in the tobacco control literature. However, additional categories may emerge during the data collection process and we may also find some eligible abstracts

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with missing data. If additional data extraction categories are needed or if missing data emerges, consultation with our research team will guide decisions and will be reported with the findings. Table 3: Data Extraction Framework

Type of review

Primary = focus on tobacco control

Coding the Characteristics Action Areas: - price and tax - protection - product regulation - packaging, labeling - education, communication, training - advert and promo - cessation (all programming) - illicit trade -sales to minors Equity Lens

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Multi= addressing multiple risk behaviours


Specified intention or objective related to equity Identified target groups or structural influences related to SES gender, race, ethnicity, religion, age, residence, sexual orientation, disability, Other (specify)

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Intervention Descriptors

Outcome Measures: -Process, -Impact (incl behavior change) -Outcome (incl health events/ measures) Target Population -Individual (specify - youth, child, adult) -Family -Community -Students/ School -Employees/ Workplace -Health Care -Society - Other (specify)

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The unique purpose of a scoping review is to aggregate the findings and present an overview rather than a meta-synthesis reporting results on narrowly defined questions. The inherent challenges are in determining a framework for presenting a narrative account


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[11]. While this approach is still an iterative work in progress, the WHO FCTC strategies are likely to guide our descriptive and visual presentation of results. Additionally, we will be able to identify gaps in the research targeting specific populations and actions areas and determine where more in-depth analysis is required. We propose using the PRISMA

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reporting guidelines for systematic reviews [19] including components of equity [16] to accurately report the review search results and analysis summary. Conclusion

Our protocol for systematically conducting a scoping review of published review articles

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specific to tobacco control and primary prevention over the last ten years has been presented. This scoping review of reviews [15] is a novel approach that offers a feasible

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means for synthesizing a wide-range of research literature specific to tobacco control strategies within the domain of primary prevention. As this will be a first scoping review of

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reviews within this topic area, our results will advance the scoping review methodology. Results will provide unique insights concerning the extent and scope of tobacco control

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research foci useful for research and end-user communities. Against the backdrop of a

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decade of FCTC strategies, we will identify research foci trends and potential gaps specific to the domain of primary prevention. A reflective analysis of this large corpus of published

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tobacco control research as a whole may reveal new upstream and downstream directions for tobacco control research to prevent tobacco related morbidity.

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Abbreviations WHO - The World Health Organization FCTC - Framework Convention on Tobacco Control (from WHO) CINAHL - The Cumulative Index to Nursing and Allied Health Literature

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ERIC - Educational Resources Information Centre COPD - Chronic Obstructive Pulmonary Disease

Competing interests

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The authors declare that they have no competing interests.

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This work was supported by The Manitoba Research Chair in Primary Prevention awarded to Dr Alan Katz by the Manitoba Health Research Council and the Heart and Stroke Foundation of Manitoba.

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References 1 US Department of Health and Human Services. The health consequences of smoking - 50 years of progress: A report of the surgeon general. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for

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Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. 2 Fiore MC, Jaén CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Clinical practice guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; May 2008.

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3 World Health Organization. WHO global report: Mortality attributable to tobacco. Geneva,

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WHO: 2012.

4 Asma S, Song Y, Cohen J, et al. CDC grand rounds: Global tobacco control centers for

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disease control and prevention morbidity and mortality weekly report Atlanta: Center for Disease Control; April 4, 2014. Report No.: Vol 63, No 13.

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8 Cohen JE, Chaiton MO, Planinac LC. Taking stock: A bibliometric analysis of the focus of tobacco research from the 1980s to the 2000s. Am J Prev Med. 2010;39(4):352-6. 9 Cohen L, Chavez V, Chehimi S. Prevention is primary: Strategies for community wellbeing. Second ed. San Francisco: Jossey-Bass; 2010.

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10 Canadian Institute for Health Information. Health region interventions that address the social determinants of health: Equity and structural lenses in intervention research Ottawa: Canadian Institute for Health Information; Feb 2013.

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11 Arksey H, O'Malley L. Scoping studies: Towards a methodological framework. International Journal of Social Research Methodology: Theory and Practice. 2005;8(1):19-32.

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12 Grimshaw J. A knowledge synthesis chapter. Ottawa: Canadian Institute of Health

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Research; 2010.


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inter-professional team's experience with Arksey and O'Malley's framework. BMC Medical Research Methodology. 2013;13(1).

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14 Levac D, Colquhoun H, O'Brien KK. Scoping studies: Advancing the methodology. Implementation Science. 2010;5(1).

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15 Goertzen L, Schultz A, Halas G, Rothney J, Wener P, Katz A. The proliferation of research literature and capturing the big picture: The value of a scoping review of reviews. . Submitted for Publication. 2014.


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16 Welch V, Petticrew M, Tugwell P, et al. PRISMA-equity 2012 extension: Reporting guidelines for systematic reviews with a focus on health equity. PLoS Medicine. 2012;9(10). 17 Gough D, Thomas J, Oliver S. Clarifying differences between review designs and methods. Systematic Reviews. 2012;1(1).

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1. ((("Health Promotion"[Mesh] OR "School Health Services"[Mesh] OR "Healthy People Programs"[Mesh] OR "Preventive Health Services"[Mesh] OR "Public Health"[Mesh] OR

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"Primary Prevention"[Mesh]) OR ( "Preventive Dentistry"[Mesh] OR "Patient

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Fairs"[Mesh] OR "Consumer Advocacy"[Mesh] OR "Child Advocacy"[Mesh] ))) 2. (program OR programs OR programme OR programmes OR programming)

4. (Pricing )

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3. (intervention)

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practices"))

14. ((intervention OR prevention OR program* OR strateg* OR promot*) AND (barrier* OR determinant* OR polic* OR advoca*)) 15. (campaign) 16. (strateg*)

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17. (“point-of-purchase” OR “point-of-sale” OR “point of purchase” OR “point of sale” OR “power wall” OR “retail”)

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18. (“tv” OR “television” OR “radio” OR “broadcast” OR “mass media” OR “marketing” OR “countermarketing”)

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Page 43 of 45 1 PRISMA 2 3 4 5 Section/topic 6 7 TITLE 8 9 Title 10 ABSTRACT 11 12 Structured summary 13 14 15 16 INTRODUCTION 17 18 Rationale 19 Objectives 20 21 22 23 24 METHODS 25 Protocol and registration 26 27 28 29 Eligibility criteria 30 31 32 Information sources 33 34 35 Search 36 37 Study selection 38 39 40 41 Data collection process 42 43 44 Data items 45 46 47 48

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2009 Checklist

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