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BMJ Open logoLink to BMJ Open
. 2025 Jun 12;15(6):e094710. doi: 10.1136/bmjopen-2024-094710

Risk and protective factors associated with teenage pregnancy and intergenerational interventions: a scoping review protocol

Zamasomi Luvuno 1, Wilbroda Hlolosile Chiya 2, Silingene Joyce Ngcobo 2, Deshini Naidoo 3, Serwaa Omowale 4, Tracy Zhandire 2,, Elizabeth Musili Joseph-Shehu 2,5, Busisiwe Purity Ncama 2, Sinegugu E Duma 2
PMCID: PMC12161424  PMID: 40506074

Abstract

Abstract

Introduction

Teenage pregnancy remains a critical global health issue, particularly in low- and middle-income countries. The intergenerational transmission of teenage pregnancy underscores the need for targeted interventions. Existing research on intergenerational approaches is fragmented, with varying methodologies and outcomes. This scoping review seeks to address this gap by answering the following research questions: What are the available intergenerational interventions for teenage pregnancy, and what are the associated risks and protective factors for early and late teenage pregnancy?

Methods and analysis

This study does not involve primary data collection and therefore does not require ethical approval. The review will be conducted in five stages: identifying the research question; identifying relevant studies; study selection; charting the data; and collating, summarising and reporting the results. A comprehensive search of electronic databases, grey literature and relevant organisational websites will be conducted for literature published between 2014 and 2024. Data will be extracted using a standardised form and synthesised narratively. Stakeholder consultation will be conducted to refine findings and ensure relevance. The findings will be reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) extension for Scoping Reviews guidelines. The results will be presented through narrative synthesis, with tables and charts used to summarise key information.

Ethics and dissemination

As the review is based on publicly available data, ethical approval is not required. Ethical clearance will be sought for stakeholder consultations, if necessary. Findings will be disseminated through peer-reviewed publications, conferences, policy briefs and shared openly on the Open Science Framework (OSF). This protocol is registered in the OSF (https://doi.org/10.17605/OSF.IO/CM9WK).

Keywords: Adolescent, Health, Risk Factors, PUBLIC HEALTH


Strengths and limitations of this study.

  • Uses a rigorous methodological framework based on Arksey and O’Malley, with JBI (Joanna Briggs Institute) enhancements.

  • Includes both peer-reviewed and grey literature for comprehensive coverage.

  • Lacks a focused analysis of theoretical frameworks guiding interventions.

  • Limits inclusion to English-language studies, potentially excluding relevant non-English research.

  • Does not assess study quality, as per scoping review methodology.

Introduction

Teenage pregnancy, as defined by the WHO1 as pregnancies occurring in girls aged 10–19 years, poses significant health risks for both mother and child, disrupts education and leads to economic instability.2 3 Within this age group, early teenage pregnancy refers to pregnancies in girls aged 10–14 years, while late teenage pregnancy pertains to those aged 15–19 years.4 Recognising these distinctions is essential for developing targeted interventions and policies that address the specific challenges faced by each subgroup within the adolescent population. In this protocol, we will use the terms teenage pregnancy and adolescent pregnancy interchangeably, aligning with the WHO’s definition of adolescence.3

Despite various initiatives, teenage pregnancy remains a significant concern, especially in low- and middle-income countries (LMICs) where limited resources and educational opportunities prevail.5 Healthcare services in these regions also face obstacles, including shortages of medical personnel and supplies.6 While global rates of teenage pregnancy have declined, disparities persist, often reflecting broader socioeconomic inequalities.3 5 According to the WHO, approximately 21 million girls aged 15–19 years in developing regions become pregnant annually, with about 12 million giving birth.3 5 Several risk factors, including low socioeconomic status, limited access to education and inadequate sexual health knowledge, contribute to the likelihood of teenage pregnancy.7 Conversely, protective factors, such as strong family support and comprehensive sexual education, can mitigate these risks.8

The intergenerational cycle of teenage pregnancy is well documented, with daughters of teenage mothers more likely to become teenage mothers themselves.8 9 This cycle highlights the complex interplay of social, economic and cultural factors leading to early childbearing.10 Intergenerational interventions, such as family-based programmes, mentoring initiatives and comprehensive sex education involving both adolescents and their parents or caregivers, aim to disrupt the cycle by addressing sociocultural determinants across generations.11 For instance, the Adolescent Girls Initiative-Kenya (AGI-K) combines economic empowerment with sexual and reproductive health education to delay pregnancies among at-risk youth.12 Similarly, in India, programmes integrating family counselling, educational support and vocational training have effectively reduced teenage pregnancies in rural communities.13 The success of these interventions often hinges on aligning with cultural norms and socioeconomic contexts to effectively engage families and communities.14 15

However, the literature on these interventions remains fragmented, lacking consensus on effective models, target populations and specific outcomes. While previous reviews16,19 have addressed certain aspects of teenage pregnancy prevention, our scoping review aims to provide a holistic synthesis of the available evidence on intergenerational interventions, mapping existing knowledge across multiple contexts and cultures, and identifying the unique effectiveness of multi-generational approaches. By synthesising a broader range of interventions and highlighting cultural and contextual factors, our review seeks to offer comprehensive guidance for the development of future policies and interventions.

Understanding contextual factors is critical for designing and implementing effective intergenerational interventions,8 making them the primary focus of this review. Despite growing interest in intergenerational interventions for teenage pregnancy prevention, existing studies exhibit diverse methodologies, target populations and outcomes.7 A comprehensive understanding of these interventions is essential to inform evidence-based policies.20 This scoping review aims to synthesise existing research on intergenerational approaches in LMICs, mapping current evidence, identifying knowledge gaps and guiding future research and policy development. The review will also explore how cultural contexts influence intervention success and examine risk and protective factors associated with early and late teenage pregnancy. The primary research question is: What intergenerational interventions are available for teenage pregnancy in LMICs, and what are the associated risk and protective factors for early and late teenage pregnancy?

Methods and analysis

This scoping review will be guided by Arksey and O’Malley’s methodological framework, as outlined in the Joanna Briggs Institute (JBI) manual for evidence synthesis.21 The review will follow six key stages: identifying the research question; identifying relevant studies; study selection; charting the data; collating, summarising and reporting the results; and conducting a stakeholder consultation to refine findings and ensure relevance. Each stage is described below. This study protocol was registered and published with the Open Science Framework (OSF). The reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines.21 22 This study started in November 2024 and is expected to be completed by June 2025, including all phases of data collection, analysis and reporting.

Scope of the review

This scoping review aims to explore two key areas: (1) the associated risk and protective factors related to teenage pregnancy within LMICs and (2) the intergenerational interventions at preventing teenage pregnancy. While teenage pregnancy is a global issue, the first part of the review specifically focuses on LMICs due to their distinct socioeconomic, cultural and healthcare challenges. The interventions and influencing factors in LMICs may differ significantly from those in high-income countries, making it essential to focus on these regions to generate contextually relevant insights. By examining both interventions and influencing factors, this review aims to provide a comprehensive understanding of the strategies and determinants that affect teenage pregnancy in LMICs.

Stage 1: identifying the research question

The Population, Concept and Context (PCC) framework was used to identify the main concepts in the primary review question and inform the search strategy (table 1). This review addresses the following research questions and objectives.

Table 1. PCC framework for identifying the main concepts of the scoping review study.

PCC element Definition
Population Teenage aged 10–19 years who are pregnant or at risk of pregnancy.
Concept The associated risk and protective factors influencing early (ages 13–15 years) and late (ages 16–19 years) teenage pregnancies as well as the intergenerational interventions at preventing teenage pregnancy.
Context Studies published between 2014 and 2024. Peer-reviewed articles in English will be included. Relevant grey literature, such as government reports, policy documents and organisational publications, will also be considered. While the primary focus is on English-language sources, non-English documents may be included if translation resources are available.

PCC, Population, Concept and Context.

Primary research questions

  1. What are the risk and protective factors associated with early and late teenage pregnancy in the LMICs?

  2. What intergenerational interventions exists to prevent teenage pregnancy?

Objectives to address these questions

  1. Explore how indentified risk and protective factors influence teenage pregnancy in LMICs to inform future research directions.

  2. Examine and synthesise existing intergenerational interventions targeting teenage pregnancy, focusing on their components and characteristics.

  3. Identify and analyse challenges in the implementation of these interventions and explore context-specific solutions.

  4. Examine regional variations in intergenerational interventions and derive lessons from successful cases.

Stage 2: identifying the relevant studies

Consultation with a librarian will inform the development of search strategies. Comprehensive searches will use keywords related to the interventions (‘teenage pregnancy,’ ‘intergenerational interventions,’ ‘risk and protective factors associated with early and late teenage pregnancy’) irrespective of the type of studies and study designs. Appropriate Boolean operators AND/OR will also be used to identify relevant articles. The following electronic databases: PubMed/MEDLINE, PsycINFO, Scopus, Web of Science, EBSCOhost Web and Google Scholar, while acknowledging its limitations, will be used to identify grey literature and additional studies not indexed in the primary databases. We have implemented specific search filters to manage the volume of results and enhance relevance. All peer-reviewed studies and grey literature that addresses the research questions will be selected in the study. Only articles published in English between 2014 to date will be used. While the primary focus will be on English-language publications, non-English grey literature will also be considered, using translation support as needed. The literature search results will be uploaded to EndNote V.21. The EndNote V.21 software will be used to find and remove duplicates. A manual check will also be conducted to ensure accuracy. The full initial search strategy is provided in table 2.

Table 2. Initial search terms and limitations.

Database Search terms Limitations
PubMed/MEDLINE ‘Teenage pregnancy’ OR ‘adolescent pregnancy’ OR ‘teen pregnancy’ OR ‘teenage parent’” OR ‘teenage mothers’ AND ‘Intergenerational interventions’ OR ‘intergenerational approaches’ OR ‘family-based interventions’ AND ‘Risk factors’ OR ‘protective factors’ AND ‘Early teenage pregnancy’ OR ‘late teenage pregnancy’ Human subjectsEnglish language2014–2024 publications year
EBSCOhost Web ‘Teenage pregnancy’ OR ‘adolescent pregnancy’ OR ‘teen pregnancy’ OR ‘teenage mothers’ AND ‘Intergenerational interventions’ OR ‘family-based interventions’ AND ‘Risk factors’ OR ‘protective factors’ AND ‘Early adolescent pregnancy’ OR ‘late adolescent pregnancy’ Human subjectsEnglish language2014–2024 publications year
Google Scholar ‘Teenage pregnancy’ OR ‘adolescent pregnancy’ OR ‘teen pregnancy’ AND ‘Intergenerational interventions’ OR ‘family-based interventions’ AND ‘Risk factors’ OR ‘protective factors’ AND ‘Early teenage pregnancy’ OR ‘late teenage pregnancy’ Human subjectsEnglish language2014–2024 publications
Web of Science ‘Teenage pregnancy’ OR ‘adolescent pregnancy’ OR ‘teen pregnancy’ OR ‘teen mothers’ AND ‘Intergenerational interventions’ OR ‘family-based interventions’ AND ‘Risk factors’ OR ‘protective factors’ AND ‘Early teenage pregnancy’ OR ‘late teenage pregnancy’ Human subjectsEnglish language2014–2024 publications
PsycINFO ‘Teenage pregnancy’ OR ‘adolescent pregnancy’ OR ‘teen pregnancy’ OR ‘teenage mothers’ AND ‘Intergenerational interventions’ OR ‘family-based interventions’ AND ‘Protective factors’ OR ‘risk factors’ AND ‘Early adolescent pregnancy’ OR ‘late adolescent pregnancy’ Human subjectsEnglish language2014–2024 publications
Scopus ‘Teenage pregnancy’ OR ‘adolescent pregnancy’ OR ‘teen pregnancy’ AND ‘Intergenerational interventions’ OR ‘family interventions’ OR ‘intergenerational support’ AND ‘Risk factors’ OR ‘protective factor’ AND ‘Early teenage pregnancy’ OR ‘late teenage pregnancy’ Human subjectsEnglish language2014–2024 publications
Grey literature sources Government reports, policy documents and organisational websites will be searched using the terms: (‘Teenage pregnancy’ OR ‘adolescent pregnancy’ OR ‘teen pregnancy’) AND (‘intergenerational interventions’ OR ‘family-based programmes’ OR ‘parent-adolescent interventions’) AND (‘risk factors’ OR ‘protective factors’).

Rationale for study period

The search is limited to studies published in the last 10 years (2014–2024) to ensure the review captures the most recent and relevant evidence on intergenerational interventions and factors influencing teenage pregnancy. Given the evolving nature of public health policies, social norms and intervention strategies over the past decade, focusing on this timeframe allows for the inclusion of contemporary practices, emerging models and recent evidence that better reflect current contexts and challenges. As this study started in 2024, this period was selected to align with the most up-to-date literature available at the time of review. This approach enhances the applicability of findings to present-day programme development and policy-making.

Screening and data management

For the screening and management of articles, EndNote V.21 will be used to store, organise and remove duplicate records. Following this, the screening process will be conducted using Google Forms for initial eligibility assessment and Microsoft Excel 2024 for data extraction and charting. Non-English grey literature selected for inclusion will undergo translation, and pertinent data will be extracted systematically. This combination ensures efficient management, transparent documentation and systematic tracking of study selection.

Stage 3: study selection

Inclusion criteria

In addition to the parameters of the search strategy table 2, studies will be included if they addressed the study PCC (table 1). Meta-analyses and systematic reviews type of studies will be included.

Exclusion criteria

  1. Studies focusing solely on individual-level interventions or medical treatments without considering intergenerational factors.

  2. Interventions targeting older age groups exclusively, without a specific focus on teenagers.

  3. Studies with inadequate methodological rigour or insufficient data to draw meaningful conclusions about the effectiveness of intergenerational interventions.

  4. Literature reviews (those that are not systematic reviews), book chapters, commentaries, editorials and opinion pieces that do not present original research findings.

  5. Studies that primarily focus on descriptive data or theoretical frameworks without empirical evidence on intervention outcomes.

  6. Interventions primarily focused on pregnancy outcomes without addressing preventive measures or intergenerational aspects.

  7. Studies where no abstract or full-text articles are not available.

  8. Non-English publications or studies published before 2010 to maintain relevance to current practices and interventions.

Geographical focus

This review will focus exclusively on studies from LMICs, as these regions face unique challenges related to teenage pregnancy and often experience different socioeconomic barriers to intervention. Studies conducted in high-income countries will be excluded from this review, as the factors influencing teenage pregnancy and the effectiveness of interventions may not be directly applicable to LMIC contexts.

Screening process

The study will undergo three stages of screening: title screening, abstract screening and full-text screening. In accordance with standard review practices, discrepancies in study selection will be resolved through discussion and consensus among reviewers. The primary reviewers (EMJ-S and TZ) will independently conduct title and abstract screening of identified publications using the inclusion criteria. In case of disagreements during title/abstract screening, a third reviewer (WHC) will be consulted to resolve the conflict.

For the full-text screening, the primary reviewers (EMJ-S and TZ) will independently assess the full-text articles of the included abstracts. To ensure the reliability and validity of the inclusion process, a third reviewer (SJN) will randomly select 10% of the full-text articles for independent evaluation and validation of the final inclusion decision. Any discrepancies will be resolved by discussion and consensus, with a third reviewer (SJN) involved when consensus cannot be reached.

To ensure reliability, all reviewers will adhere to a strict screening protocol and predefined inclusion/exclusion criteria. Any discrepancies will be resolved through open discussions among the review team. Additionally, we will seek support from a librarian to enhance the search and screening process.

Stage 4: charting the data

The data charting process

This will be conducted systematically to ensure consistency and accuracy. We will develop calibrated data extraction forms or pretested templates tailored to our review’s objectives, aligning with established guidelines for scoping reviews. Prior to full-scale data extraction, we will pilot these forms on a subset of included studies. This pilot testing aims to refine the forms, clarify any ambiguities and ensure that all relevant data are captured effectively. Adjustments will be made based on feedback and observations from the pilot phase to enhance the reliability of the data extraction process. Data extraction will be performed independently by multiple reviewers to minimise bias and errors. Each reviewer will extract data from the same set of studies, and any discrepancies will be resolved through discussion and consensus. If consensus cannot be reached, a third reviewer will be consulted to make the final decision. This dual-review approach is recommended to increase accuracy and reliability in data extraction.23 By implementing these strategies, we aim to uphold the methodological rigour of our scoping review, ensuring that the extracted data accurately inform our research questions.

Consideration of study quality

In this scoping review, we will include various study designs—randomised controlled trials (RCTs), observational studies and qualitative research—to capture a comprehensive range of evidence. Each design contributes uniquely: RCTs assess intervention efficacy, observational studies provide real-world insights and qualitative studies explore contextual factors. We will consider variations in sample sizes and population characteristics, as these can influence study findings and their applicability. While formal quality assessments are not typical in scoping reviews, we will evaluate the clarity and completeness of reporting in included studies. This approach allows for a nuanced understanding of the evidence, acknowledging the strengths and limitations of diverse study designs.

Reporting standards

To enhance transparency and reproducibility, our scoping review protocol and final report will adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist, which outlines 20 essential and 2 optional reporting items. We will maintain detailed records of all decisions made throughout the review process, including the criteria for study inclusion and exclusion, as well as the methods used for data extraction. This documentation will support the robustness of our findings and facilitate future updates to the review.

The extracted data will include:

  1. Author(s) and year of publication: Identifying the source of the study.

  2. Study title and aim(s)/objective(s): Understanding the purpose and scope of the research.

  3. Study methodology: Details on study design and data collection methods to assess methodological rigour.

  4. Risk and protective factors influencing teenage pregnancy.

  5. Intergenerational intervention details: Specifics of the intergenerational interventions implemented.

  6. Outcomes measured: Key variables and metrics used to evaluate intervention effectiveness.

  7. Significant findings and conclusions: Main results and interpretations drawn by the authors.

To validate the accuracy and consistency of the data charting form, two reviewers (different from the primary reviewers) will randomly select 10% of the final full-text publications. All reviewers will discuss and resolve any discrepancies. Then, one of the primary reviewers (TZ) will complete the data extraction for the remaining full-text articles. Once data charting is completed, the extracted information will undergo thematic analysis and further classification to enhance the synthesis of findings.

Data extraction and synthesis

Data will be extracted using a standardised charting form, capturing key study characteristics, intervention details, outcomes and relevant findings. Specific attention will be given to identifying and categorising risk and protective factors associated with teenage pregnancy within intergenerational interventions.

These factors will be categorised at multiple levels, including individual, family, community and structural factors. We will employ an inductive categorisation approach to allow for the identification of additional factors emerging from the data.

Findings will be presented using narrative synthesis and tabulation to highlight key themes and facilitate comparisons. Where applicable, conceptual mapping will be employed to visually illustrate relationships between themes, interventions and contextual influences. This multilayered approach ensures a comprehensive integration of findings beyond thematic analysis.

Stage 5: collating, summarising and reporting the results

The study selection process will be presented using a PRISMA-ScR flowchart24 to ensure transparency. A narrative synthesis approach will be employed to summarise and analyse the extracted data, incorporating both global and regional perspectives on intergenerational interventions. The extracted data will include details such as author(s) names, year of publication, study design, study population, intervention(s), study setting, aims, geographical location and outcomes, providing a structured overview of the existing evidence base.

Findings will be organised thematically and classified according to types of intergenerational interventions and their effectiveness. The review will further categorise risk and protective factors associated with early and late teenage pregnancy at multiple levelsindividual, family, community and structural, drawing on existing theoretical frameworks, such as an inductive categorisation approach to accommodate emerging factors from the data. Additionally, the review will highlight successful interventions from diverse geographical regions, allowing for a comparative analysis of regional variations in intervention effectiveness and identifying best practices that could be adapted to different settings.

Descriptive statistics may be used to summarise key characteristics of the included studies. Findings will be presented using tables, charts, maps, conceptual frameworks and narrative summaries to facilitate clear interpretation and cross-regional comparisons. Conceptual mapping will be employed where applicable to visually illustrate relationships between intervention types, risk and protective factors, and contextual influences.

The implications of the findings will be examined with respect to research, practice and policy formulation, ensuring that the review contributes to evidence-based decision-making. Given the exploratory nature of scoping reviews, which aim to provide an overview of existing literature on a concept/intervention,24 formal quality appraisal of included studies may not be conducted. However, methodological rigour and trustworthiness will be considered during data synthesis and interpretation to ensure a comprehensive and contextually relevant analysis.

Stakeholder consultation

Consultation is a core component of Arksey and O’Malley’s scoping review framework, ensuring that findings are relevant, comprehensive and applicable. As part of this scoping review, a stakeholder consultation will be conducted to refine the results and enhance their practical utility. Key stakeholders will include public health practitioners, policymakers, researchers and representatives from organisations working in adolescent health and sexual and reproductive health. These individuals will be identified based on their expertise in teenage pregnancy prevention, intergenerational interventions, and related policy and programmatic efforts.

Consultations will be conducted through virtual or in-person meetings, depending on availability and logistical considerations. Engagement methods will include structured discussions, surveys or focus groups to gather insights on the applicability and implications of the findings. Stakeholder input will contribute to validating the results, identifying potential gaps and refining key themes. This process will take place during the final stages of data synthesis, allowing stakeholders to inform the interpretation of results and shape recommendations. Their feedback will be systematically integrated into the discussion and conclusion sections to ensure that the review’s findings align with real-world needs and decision-making.

Ethics and dissemination

This scoping review will rely exclusively on publicly available data and will not involve human or animal participants; therefore, formal ethical approval for the literature review component is not required. However, as the review includes consultations with stakeholders to validate findings and enhance contextual relevance, ethical considerations will be observed in line with institutional guidelines. Where necessary, ethical clearance will be sought for stakeholder engagement activities.

The review findings will be disseminated through peer-reviewed journal publications, national and international conference presentations, and policy briefs for relevant stakeholders. Additionally, data will be shared via the OSF25 to ensure transparency and support further research.

Study limitations

Language limitation

To ensure consistency and feasibility in data extraction and analysis, this scoping review will include only literature published in English. This decision is based on the research team’s language proficiency and practical constraints. While this may exclude valuable studies in other languages, efforts will be made to incorporate grey literature such as government reports and organisational publications available in English or with accessible translations. If relevant non-English documents are identified, translation services may be considered. However, the exclusion of non-English literature could affect the comprehensiveness of the review by omitting studies from non-English-speaking countries. This limitation may impact the overall scope of the review. It is important to note that excluding non-English studies in systematic reviews can lead to biases and affect the validity of conclusions. A study found that systematic reviews with language restrictions and no author contact for missing data had lower overall credibility.26 Therefore, while practical constraints necessitate language limitations, acknowledging this potential bias is crucial for transparency.

Discussion

This review underscores the persistent challenge of teenage pregnancy, particularly in LMICs, where it remains a critical public health issue.27 The intergenerational transmission of teenage pregnancy highlights the need for interventions that address not just individual cases, but also the broader social, economic and cultural factors at play.9

Intergenerational interventions offer a promising approach to breaking this cycle,8 yet the current landscape is fragmented, with diverse methodologies and outcomes. This fragmentation underscores the need for comprehensive syntheses of existing research to inform evidence-based policies and identify effective multigenerational strategies.10 This scoping review aims to map the existing literature, providing a comprehensive overview that will inform future research and guide evidence-based policy development. By examining both the interventions and the associated risk and protective factors, this review seeks to provide valuable insights into the complexities of teenage pregnancy.

The necessity for a thorough scoping review is clear. By synthesising the literature on intergenerational interventions and exploring the risk and protective factors associated with teenage pregnancy, this review will contribute to a deeper understanding of the issue. The findings are expected to guide future research and support the development of effective, evidence-based policies and practices to address the multifaceted dynamics of teenage pregnancy.

Acknowledgements

We thank the University of KwaZulu-Natal for their assistance with the literature search strategy, facilitated through their library services.

Footnotes

Funding: Professor Serwaa Omawele would like to thank the National Institute on Minority Health and Health Disparities for travel support to South Africa for this project provided through Training Award Number T37MD014218.Professor Serwaa Omawele would like to thank the National Institute on Minority Health and Health Disparities for travel support to South Africa for this project provided through Training Award Number T37MD014218.

Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-094710).

Patient consent for publication: Not applicable.

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

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