Keywords
Implementation Science, Protocol, Quitline, Scoping Review, Smoking cessation
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Mitchell R, O'Grady KA, Brain D and Tyack Z. Evaluating the implementation of adult smoking cessation programs in community settings: Protocol for a scoping review [version 1; peer review: awaiting peer review]. F1000Research 2023, 12:1110 (https://doi.org/10.12688/f1000research.135736.1)
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Study Protocol
Evaluating the implementation of adult smoking cessation programs in community settings: Protocol for a scoping review
[version 1; peer review: awaiting peer review]
PUBLISHED 06 Sep 2023
OPEN PEER REVIEW
REVIEWER STATUS
Abstract
Corresponding author:
Remai Mitchell
Competing interests:
No competing interests were disclosed.
Grant information:
This scoping review is funded by a Supervisor Scholarship for an evaluation of Quitline Queensland, provided by the Preventive Health Branch, Queensland Health. The funder made no other contributions to the development of the protocol.
No other specific funding for the project has been received.
Copyright:
© 2023 Mitchell R et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Mitchell R, O'Grady KA, Brain D and Tyack Z. Evaluating the implementation of adult smoking cessation programs in community settings: Protocol for a scoping review [version 1; peer review: awaiting peer review]. F1000Research 2023, 12:1110 (https://doi.org/10.12688/f1000research.135736.1)
First published: 06 Sep 2023, 12:1110 (https://doi.org/10.12688/f1000research.135736.1)
Latest published: 06 Sep 2023, 12:1110 (https://doi.org/10.12688/f1000research.135736.1)
No other specific funding for the project has been received.
Introduction
Cigarette smoking is the leading preventable cause of morbidity and mortality in adults worldwide.1 Smoking is also among the prominent risk factors for disability-adjusted life years,2 and strongly associated with poor health-related quality of life.3 The World Health Organization (WHO) estimates that 8.7 million people die prematurely worldwide each year, and tens of millions experience avoidable disease, due to tobacco use and exposure.4 Tobacco-related disease and deaths are predicted to continue to increase globally in coming years.5
Smoking-related harm places substantial strain on healthcare systems internationally,6,7 and in some settings causes more disease and premature mortality than alcohol and illicit drugs combined.8 In countries where tobacco is heavily taxed, smoking also places economic burden on individuals and families due to the high cost of tobacco products,9 through the loss of wage-earning capacity from work absences and healthcare costs due to smoking-related morbidity, and premature death.10
In 2007, the WHO introduced MPOWER measures as a guide to support countries globally to deter smoking.11 The acronym stands for the six measures included in the guide and are as follows: monitor tobacco use and prevention policies (M), protect people from tobacco smoke (P), offer help to quit tobacco smoking (O), warn about the dangers of tobacco (W), enforce bans on tobacco advertising, promotion and sponsorship (E), and raise taxes on tobacco (R).11
Many countries have established Quitlines, which offer telephone-based counselling services to support smokers to quit,12 fulfilling measure “O” of the MPOWER interventions.11 Whilst Quitlines have been shown to be effective and cost-effective internationally,12–23 a preliminary search of the literature revealed heterogeneity between Quitline services by jurisdiction. Although there is evidence that engagement with a Quitline increases the likelihood of successful cessation attempts,12,13,22,23 there is little evidence to support the specific components of Quitline services such as the optimum number, frequency or duration of counselling support calls, or core program components.22 Furthermore, there is conflict regarding the benefit of free nicotine replacement therapy (NRT) provision as an adjunct to Quitline counselling.13,23 The heterogeneity between Quitline services makes it difficult to evaluate the implementation of specific components and strategies used by each service.
Whilst there is ample literature evaluating the effectiveness of smoking cessation programs in community-based services,24–34 the implementation of programs is rarely reported. Reporting core and flexible or adapted components of the smoking cessation programs implemented and implementation strategies applied, implementation outcomes, and contextual factors influencing implementation of the interventions and implementation strategies in included studies will enable identification of the elements delivered that may be responsible for clinical or service outcomes, adaptations that have occurred across services that inform future selection of implementation strategies, and potential research gaps regarding program implementation.
Implementation Science facilitates the incorporation of evidence-based practices into routine healthcare by bridging the knowledge gap between research and practice.35 Implementation outcomes are activities that are intentionally and strategically applied to routinise evidence-based interventions into treatment, care provision, and service structure.36,37 Acceptability, cost, fidelity, scalability, health equity, adoption, and maintenance are examples of implementation outcomes described in the literature and used in implementation evaluation frameworks, for example RE-AIM.36,38–40
Interventions applied in controlled settings may demonstrate effectiveness. However, effectiveness is often not evaluated in real-world conditions prior to being integrated at the population level.41,42 Evaluation of real-world implementation of interventions beyond the controlled research setting will demonstrate whether an intervention is effective when delivered to the intended populations and in different contexts.43 Real-world conditions refer to the context in which interventions are delivered by service providers to service users during usual care provision.44 In real-world implementation evaluations, factors that would be considered confounders within the research context, are considered part of the practical context in which the intervention takes place.42
Scoping reviews are a valuable tool for synthesising evidence, providing a broad map of existing literature and identifying gaps in current research.45 Scoping reviews are particularly valuable where the area of research is emergent, complex or poorly understood.46,47 Utilising an existing scoping review framework,48 this study aims to systematically map the evidence including the effectiveness or perceived effectiveness of implementation, and any research gaps surrounding the implementation of smoking cessation programs.
Objectives
The objective of this study is to systematically map the implementation of smoking cessation programs including evaluating how implementation influences service user outcomes.
Research questions
This review aims to elucidate what is known, and not known regarding the implementation of adult smoking cessation programs in the community. This review will explore the following questions:
• What interventions and implementation strategies, or components are utilised by smoking cessation programs to facilitate quit success and how are they applied?
• What implementation outcomes are reported by smoking cessation programs?
• What interventions, characteristics of smoking cessation programs and implementation strategies do service users and service providers perceive to be effective?
• What are the contextual factors influencing implementation of smoking cessation programs in the community?
Selection criteria
The criteria for included studies is based on the Joanna Briggs Institute (JBI) Population Concept Context (PCC) mnemonic for scoping reviews49 (Table 1), in addition to the type of study.
Table 1. Inclusion criteria.
| JBI Population Context Concept mnemonic for scoping reviews used to report the implementation of smoking cessation programs49 | |
|---|---|
| PCC element | Inclusion criteria |
| Population | Adult daily smokers aged 18 years or older |
| Concepts | Interventions and implementation strategies utilised by smoking cessation programs |
| Implementation outcomes | |
| Context | Community-based smoking cessation programs |
Concept/Phenomena of interest
Interventions utilised by smoking cessation programs to be included in the review will include telephone or in-person counselling, behavioural support and advice; NRT; non-nicotine pharmacotherapies; multi-modal programs such as counselling and NRT; peer support programs; computer and mobile phone-based communications and applications; and integrative medicine. The implementation outcomes of interest will be as defined by the authors but will be structured using implementation outcomes defined by Proctor et al.,36 RE-AIM,40 Milat et al.,39 and Brownson et al.38 or by highlighting other implementation outcomes that do not fit within these definitions (see Table 2). Inconsistency in terminology is common in the reporting of implementation outcomes throughout the literature.51 Until there is a standardised lexicon, a challenge for researchers is developing a taxonomy of implementation outcomes to eliminate conceptual overlap in terms.51
Table 2. Definitions of terms used to report the implementation of smoking cessation programs.
| Term | Definition |
|---|---|
| Acceptability | The perception that the intervention is satisfactory or agreeable to the subject.36 |
| Adoption | The willingness to initiate and employ the intervention into practice, at both the individual or service provider level, and the service or organisation level.36,40 |
| Adult | A person aged 18 years, or older. |
| Appropriateness | The perception that the intervention is relevant and compatible for supporting smoking cessation, at the individual level for both service users and service providers, and the service or organisation level.36 |
| Child | A person aged 17 years, or younger. |
| Community-based service | A service delivered to a population that does not take place in a hospital and includes physical clinics or offices; outreach centres; home visiting, digital or telephone-based services; or public buildings such as schools or places of worship to deliver the service. The service may be privately and/ or publicly funded and may include paid and/or voluntary workforce to deliver the service. |
| Cost | The monetary cost of implementing the intervention.36 |
| Effectiveness | The efficacy of the intervention to achieve the intended outcome at the individual service user level.40 |
| Feasibility | The ability and scope to successfully implement the intervention at the individual or service level.36 |
| Fidelity | The extent to which the implementation of the intervention conformed to the original service implementation protocol.36 |
| Health equity | Strategies to improve health outcomes for at-risk populations with a focus on solutions, rather than disparities.38 |
| Hospital | A healthcare facility with specialised and auxiliary staff providing acute or long-term, inpatient or outpatient treatment, which is not the office or surgery of a general practitioner for the provision of examination, evaluation, referral, or treatment of a minor ailment to the general population. |
| Implementation | The fidelity and cost of the components of the intervention at the organisation level. The uptake and utilisation of the intervention at the individual service user level.40 |
| Implementation cost | The direct and indirect monetary costs of implementing the intervention.36 |
| Integrative medicine | May also be referred to as “complementary medicine” and includes practices and treatments that are not generally considered a component of conventional medicine. Examples may include hypnosis, acupuncture, and herbal remedies, and will be as defined by the authors. |
| Maintenance | The sustainability of the intervention at the organisation level. The effect of the intervention on outcomes 6 months or more after the last interventional contact at the service user level.40 |
| Penetration | The extent to which the intervention is integrated into service implementation.36 |
| Quitline | A telephone-based service dedicated to support quitting smoking combustible tobacco provided by either a trained counsellor, psychologist, or other allied health professional relevantly qualified to provide such a service, that is provided free of charge to service users. |
| Reach | Service user willingness to engage with the intervention.40 |
| Scalability | The ability of an intervention under small-scale trial conditions, to be replicated on a larger scale, and with a greater reach, in a real-world environment to the greater population.39 |
| Smoker | A person who has smoked 100 cigarettes in their lifetime, and who currently smokes tobacco cigarettes.50 |
| Smoking cessation program | Any service to support cessation of smoking combustible tobacco by a provider qualified within their profession to provide such service. |
| Sustainability | The ongoing utilisation and implementation of the intervention in service delivery.36 |
Context
Studies will take place in high-income countries as defined by The World Bank,52 and compliant with the “O” of the WHO MPOWER measures (i.e., offer help to quit tobacco smoking).11
Types of studies to be included
Original studies of either qualitative, quantitative, or mixed methods will be included in this scoping review. Quantitative study designs for inclusion will include, but not be limited to, randomised controlled trials (RCTs), quasi-RCTs, and matched cohort designs. In addition, qualitative studies of all designs will be considered for inclusion. Non-original studies, such as reviews, including systematic reviews, editorials, opinion pieces, protocols, and individual case studies will not be considered. Studies published from June 1997 until the search date will be considered for the review, consistent with the date of inception of the first Quitline in the world in Victoria, Australia.33 Included studies will be limited to human participants. English language abstracts for which the full text is unavailable will be included and reported separately. Abstracts and full-texts not available in English will not be included as the research team do not have the capacity for translation.
Exclusion criteria
Non-original studies such as reviews, opinion pieces, editorials, protocols, and individual case studies will be excluded. Additionally, studies will be excluded if the following are included:
• Only participants under 18 years of age.
• Only participants using electronic nicotine delivery systems (ENDS) as a quit mechanism.
• Only participants who are not current smokers (e.g., evaluation of uptake prevention or relapse prevention)
• Hospital inpatient programs without any community-based implementation.
• Participants did not engage a formal smoking cessation service (i.e., self-directed smoking cessation plans).
• Programs of cessation of substances other than cigarettes (e.g., ENDS, illicit substances, alcohol) where no other eligible program elements are included.
Methods
The proposed scoping review will follow the Arksey and O’Malley48 methodological framework for scoping reviews. This methodological framework follows five key stages including firstly identifying the research question, followed by a literature search for studies that appear relevant to the research question, selection of studies for inclusion in the review through a literature screening process, extracting and charting data from the included studies, and finally, collating the results, summarising, and reporting the findings of the review.48
Implementation outcomes considered in this review include acceptability, adoption, appropriateness, cost, feasibility, fidelity, penetration, sustainability,36 scalability,39 and health equity,38 in addition to reach, effectiveness, adoption, implementation and maintenance as described in the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework.40
A preliminary search of PROSPERO, MEDLINE (EBSCOhost), Embase (Elsevier), Cochrane Central Register of Controlled Trials (CENTRAL), and JBI Evidence Synthesis (Ovid) performed on 23 January 2023 identified no existing or intended reviews on this topic.
Search strategy
We will search for studies reporting the following: any implementation outcome for a smoking cessation service. The search strategy will be organised and adapted to each database to capture key concepts using Boolean operators. Keywords and MeSH terms will be used to search key concepts including smoking cessation, smoking cessation services and interventions, and implementation evaluations. Search terms were developed and refined through discussion with the author team and in consultation with a research librarian. The search strategy to be used for the databases of MEDLINE, Embase, Cochrane CENTRAL, and Web of Science is provided in Table 3.
Table 3. Search terms and filters.
Information sources
The search will take place from 21 February 2023 and will include the following databases: MEDLINE (EBSCOhost), Embase (Elsevier), the Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science (Clarivate). The search for unpublished studies and grey literature will include clinical trial registers, Open Grey, Google Advanced, and Google Scholar (first 200 results).53 Additionally, we will perform forward and backward citation searches of included articles, and of any literature reviews on this topic that are identified to locate further articles not identified during the search.
Study selection
All identified citations retrieved from the search will be loaded into EndNote 20.0.1 2021 (Clarivate Analytics, PA, USA) citation management system, and duplicates removed. The titles and abstracts of all articles identified in the search will be independently screened via the online application, Rayyan54 by at least two reviewers, based on the inclusion and exclusion criteria. Conflicts will be resolved via discussion or with an additional independent reviewer. Articles selected during the screening process will be retrieved in full and undergo full text assessment against the inclusion criteria described above by two members of the review team. Reasons for exclusion of full-text screened studies which do not meet inclusion criteria will be recorded and reported in the scoping review. Articles included in the full text selection process will be hand searched for potential citation inclusion. Search results will be reported in a flow diagram according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Review (PRISMA-ScR) flow diagram55 (Figure 1).
Figure 1. PRISMA 2020 flow diagram for new systematic reviews which included searches of databases, registers and other sources, adapted from Page et al.55
Data extraction
A data extraction form will be developed and piloted by two authors using a Microsoft Excel spreadsheet. Extracted data will be structured using a matrix consisting of the scoping review predetermined reporting framework fields based on the areas of focus and conceptual frameworks; and data, themes or subthemes that fall outside of the framework. Example fields are reported in Table 1 but may be modified iteratively as the scoping review progresses in alignment with scoping review methods.48,56 The matrix will include items adapted from the Template for Intervention Description and Replication (TIDieR) checklist57 (Table 4). Conflicts that arise during the data extraction and charting process will be resolved either by discussion or with an additional independent reviewer.
Table 4. TIDieR checklist adapted from Hoffman et al.57
| Item number | Item | Where located** | |
|---|---|---|---|
| Primary paper (Page or appendix number) | Other (details) | ||
| BRIEF NAME | |||
| 1. | Word or sentence to describe the intervention. | ||
| WHY | |||
| 2. | Document theoretical basis behind key components of the intervention. | ||
| WHAT | |||
| 3. | Document the intervention materials (e.g., participant documents, training materials) and physical access (URL or appendix). | ||
| 4. | Document activities and processes engaged to administer the intervention. | ||
| WHO PROVIDED | |||
| 5. | Document intervention providers and relevant qualifications, experience, and intervention-specific training. | ||
| HOW | |||
| 6. | Document mechanisms and contexts of delivering the intervention (e.g., face-to-face focus groups). | ||
| WHERE | |||
| 7. | Document specific details of the intervention locations and any relevant organisational characteristics. | ||
| WHEN and HOW MUCH | |||
| 8. | Document the number, frequency, intensity, and duration of the intervention delivered. | ||
| TAILORING | |||
| 9. | Document characteristics of any tailoring or adaptation to the intervention, and rationale for doing so. | ||
| MODIFICATIONS | |||
| 10. | Document characteristics of any modifications to the intervention, and rationale for doing so. | ||
| HOW WELL | |||
| 11. | Planned: Document characteristics of any strategies that were used to support and improve intervention adherence. Document how intervention adherence was assessed. | ||
| 12. | Actual: Document the extent of intervention adherence (if assessed). | ||
The final data extraction will be performed by the first author, with at least 20 percent verified by a second reviewer, according to the study objectives and the extraction template developed and refined during the pilot phase49 (Table 5). Authors of papers will be contacted to request missing or additional data for clarification where papers have been published in the last five years, if required.58
Table 5. Example of extraction template fields for data extraction.
Data analysis and reporting of findings
Quantitative and qualitative data will be analysed separately and presented narratively, graphically and with the aid of tables and figures where appropriate. Reported findings will include: (i) implementation outcomes including cost and consequence evaluation, reported using Proctor,36 RE-AIM,40 Milat et al.,39 or Brownson et al.,38 implementation outcome definitions where applicable;51 (ii) intervention components, reported using adapted TIDieR items;57 (iii) implementation strategies, reported using Expert Recommendations for Implementing Change (ERIC) strategy clusters;59 and (iv) contextual factors influencing the implementation, reported using constructs for external context as described by Watson et al.60 Inner contextual factors will be reported using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework61 (see Figure 2). Qualitative data that does not fit within the predetermined reporting framework will be analysed via an inductive approach62 and reported separately.
Figure 2. Findings and frameworks for reporting outcomes.
Discussion
This protocol outlines the methods for a scoping review evaluating the implementation of smoking cessation services in the community setting. The interventions included in this review were selected based on the smoking cessation interventions evaluated in contemporaneous literature.32,63–68 Proctor et al.36 argue that implementation outcomes should be clearly distinguished from service system and clinical outcomes, to better evaluate the effectiveness of the implementation of services. The authors assert that this distinction between service and clinical outcomes, and implementation, is critical to understanding whether service failures are the result of ineffective interventions, or ineffective implementation.36 Milat et al.39 emphasise the importance of considering the implementation of interventions that historically, public health research has largely ignored. Implementation is an important consideration in research, as public health interventions may be effective within discrete, small-scale studies, but may not translate well in large scale to the general population. Glasgow et al.40 reiterate that implementation has frequently been ignored in public health literature, asserting that integrating the RE-AIM framework into research would enhance the application and equity of intervention delivery to target populations.
This proposed scoping review will present an evidence map describing what is currently known, and what is not known regarding the implementation of smoking cessation programs. A taxonomy of implementation outcomes utilised by smoking cessation programs will be produced, which may form the basis of future systematic reviews of the effectiveness of implementing smoking cessation programs. The outcomes of this scoping review may provide data to help inform the design of future smoking cessation studies. In addition, the results of this scoping review have the potential to contribute to smoking cessation service delivery and uptake.
Limitations
This review does not consider smoking cessation services in low- and middle-income countries (LMIC’s) where approximately 80% of the worlds smokers reside,69 therefore results may not be applicable in LMIC’s. Furthermore, studies where participants were children younger than 18 years of age were excluded. Future reviews to evaluate smoking cessation service implementation to youth are necessary to identify the unique needs of younger smokers. As this review considers studies within community contexts, the findings are not likely to be generalisable to hospital settings. Existing reviews in hospital settings provide insight into the implementation of smoking cessation programs in those settings.70 Limiting contextual analysis to specific categories may restrict the ability to capture certain themes, however our mapping permits adding additional data outside of the analytical framework to capture this data.
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how to cite this article
Mitchell R, O'Grady KA, Brain D and Tyack Z. Evaluating the implementation of adult smoking cessation programs in community settings: Protocol for a scoping review [version 1; peer review: awaiting peer review]. F1000Research 2023, 12:1110 (https://doi.org/10.12688/f1000research.135736.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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