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10.1136/bmjopen-2023-080538
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Protocol
Health Policy
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E-participation in policy-making for health: a scoping review protocol
Esmailzadeh Hamid 12esmailzad@gmail.com

Mafimoradi Shiva 3mafimoradis@yahoo.com

Gholami Masoumeh 4masoomeh.gholami1976@gmail.com

http://orcid.org/0000-0002-0666-7928
Mansourzadeh Mohammad Javad 5mj.mansourzadeh@gmail.com

Rajabi Fatemeh 6frajabi@tums.ac.ir

1 Health Information Management Research Center, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
2 University Research and Development Center, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
3 Secretariat of Supreme Council of Health and Food Security, Iran Ministry of Health and Medical Education, Tehran, Iran (the Islamic Republic of)
4 School of Public Health, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
5 Osteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
6 Community Based Participatory Research Center, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)
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None declared.

Dr; mafimoradis@yahoo.com
2024
16 9 2024
14 9 e08053804 10 2023
04 9 2024
Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Abstract

Introduction

For the general public, e-participation represents a potential solution to the challenges associated with in-person participation in health policy-making processes. By fostering democratic engagement, e-participation can enhance civic legitimacy and trust in public institutions. However, despite its importance, there is currently a gap in the literature regarding a comprehensive synthesis of studies on various aspects of e-participation in the health policy domain. These aspects include levels of participation, underlying mechanisms, barriers, facilitators, values and outcomes. To address this gap, our proposed scoping review aims to systematically investigate and classify the available literature related to e-participation in policy-making for health.

Methods and analysis

We will employ the Population, Concept and Context framework developed by Arksey and O’Malley (2005). Our population of interest will consist of participants involved in policy-making for health, including both government organisers of e-participation and participating citizens (the governed). To identify relevant studies, we will systematically search databases such as CINAHL (EBSCO), Academic Search Premier (EBSCO), Social Services Abstracts (ProQuest), Scopus (Elsevier), EMBASE (Elsevier), The Cochrane Database of Systematic Reviews, Campbell Collaboration, JBI Evidence Synthesis and PubMed using a predefined search strategy. Two independent reviewers will conduct a three-tiered screening process for identified articles, with a third reviewer resolving any discrepancies. Data extraction will follow a predefined yet flexible form. The results will be summarised in a narrative format, presented either in tabular or diagrammatic form.

Ethics and dissemination

The National Institute of Health Research of the Islamic Republic of Iran’s ethics committee has approved this review study. Our findings will be disseminated through peer-reviewed publications, conference presentations and targeted knowledge-sharing sessions with relevant stakeholders.

Health policy
Social Interaction
Clinical governance
PUBLIC HEALTH
http://dx.doi.org/10.13039/501100004484 Tehran University of Medical Sciences and Health Services 1400-3-126-56722
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pmcSTRENGTHS AND LIMITATIONS OF THIS STUDY

A robust design has been established for this protocol, incorporating a well-established review framework. The design includes defining a comprehensive search strategy, developed in consultation with an information specialist and adopting an inductive approach for data collection and charting.

In the context of this study, knowledge users—comprising representatives from public administrations, health policy-making bodies and community-based organisations—will actively participate. Their engagement aims to significantly enhance the scoping review processes and contribute to more robust outcomes.

This review will not incorporate any quality assessment or grading of evidence, as it falls outside the chosen methodology.

The review will be restricted to English-language publications, potentially resulting in relevant studies being overlooked due to language bias.

The inclusion criteria will focus solely on peer-reviewed published literature and international reports, which may limit the comprehensiveness of our findings.

Introduction

Public participation is a concept frequently associated with democratic ideals and empowerment. Within the context of health policy, it represents a deliberate process through which governments actively seek input from the public. This engagement aims to gather diverse perspectives on decisions related to health policy formulation. For civil society, the primary objective of public participation is to hold the government accountable for fulfilling its obligations toward the population.Conversely, governments view participation as a means to enhance stakeholder ownership and responsiveness, particularly during critical situations such as the COVID-19 pandemic Conversely, governments view participation as a means to enhance stakeholder ownership and responsiveness, particularly during critical situations such as the COVID-19 pandemic.1 2

Public participation in the policy-making process occurs across multiple levels, each corresponding to the degree of citizens’ influence in shaping the final outcomes. These levels encompass manipulation, therapy, informing, consultation, placation, partnership, delegated power and citizen control.3 The nature, mechanisms and purpose of participation vary significantly among these levels. At the passive end of the spectrum, citizens provide input through mechanisms2 such as in-person forums, open-for-all consultations, policy dialogues, focus groups and citizen panels.4 Moving towards more active engagement, citizens participate directly in decision-making processes5 6—for instance, through health councils, assemblies or representation on steering committees.1 The International Association for Public Participation (IAPP) outlines a five-step framework for participation: information sharing, consultation, collaboration, involvement and empowerment.7

In the context of participation dynamics, manipulation and therapy (often referred to as non-participation) are employed as substitutes for authentic engagement. Rather than facilitating genuine involvement in programme planning and execution, the primary aim is to empower those in positions of authority to educate or address the needs of participants. As the process unfolds, information sharing and consultation may reach levels of tokenism, granting individuals a nominal voice while lacking the influence necessary to sway decision-makers. Placation represents a more advanced form of tokenism, wherein individuals are allowed to provide advice but ultimate decision-making authority remains with those in power. In contrast, partnership models enable negotiation and trade-offs between participants and decision-makers. Finally, in systems of delegated power and citizen control, citizens hold the majority of decision-making seats or even full managerial authority.3 8

In the realm of health policy, public participation plays a pivotal role. Its significance has drawn the attention of health planners, policy-makers and activists, gaining prominence in mainstream health discourse following the 1978 Alma Ata declaration.9 Originally introduced as an international mandate within the context of primary healthcare, public participation has evolved.10 Civil society organisations and community engagement are now recognised as potent tools for enhancing health services worldwide.9 Notably, community engagement interventions, as highlighted by O’Mara-Eves et al, yield positive effects across a spectrum of health outcomes—ranging from health behaviours and consequences to self-efficacy, perceived social support and community well-being.11 These impacts are particularly pronounced at local levels and among marginalised populations.12

Public e-participation, a subset of broader public participation, emerged as a distinct field of study and practice during the early stages of e-government transformation. It refers to the process of involving the public in (health) policy formulation, decision-making and service design and delivery through information and communication technologies (ICTs) or digital media. The overarching goal is to create a participatory, inclusive and deliberative environment.1 7 Notably, the adoption of public e-participation has followed different trajectories in developing vs developed countries. By 2005, the term had gained widespread usage, and numerous public e-participation initiatives—such as multifunction local e-participation platforms, I Paid A Bribe, Change.org, and citizens-to-citizens platforms—in different sectors including health had been established worldwide. These initiatives leverage various technologies, including geographic information systems integrated with web or mobile functions, as well as gamification strategies.13 14

Despite the rapid proliferation of online service and participation platforms, the demand for public e-participation among citizens exhibits considerable variability across contexts, including countries and sectors. This variation is influenced by the institutional features of nation-states, particularly the nature of the relationship between society and the state. Such features significantly impact the policy process and outcomes, affecting the scope and quality of public participation. In general, optimistic expectations placed on public e-participation two decades ago have not been fully realised, even within the health sector.7 15 16

Several challenges and barriers must be addressed by governments and health authorities seeking to promote public e-participation. These include token participation, the capture of participatory processes by elites and the lack of voice for marginalised groups. Additionally, ‘participation fatigue’ arises from the proliferation of participatory processes that yield little meaningful impact. The high but low-visibility costs of maintaining participation processes, coupled with insufficient resources, further complicate efforts. There is also a lack of capacity within public administration to effectively manage these processes, exacerbated by the digital divide. Clear objectives for e-participation are often absent, and there is inconsistency in stakeholders’ expectations and motivations to participate. Trust issues in government, the internet and participation platforms are prevalent, as is a lack of transparency regarding the relationship between participation mechanisms and the policy-making process. Furthermore, there is often a lack of systematic evaluation, insufficient attention to the legal and regulatory framework and a failure to understand the values of public administration and the political system within a country.1 7 10 15

While public e-participation platforms leveraging new technologies have proliferated globally since 2000, it remains unclear whether this multiplication has translated into broader or deeper citizen engagement.3 Existing review studies suggest that electronic platforms designed to support (health) policy-making have often fallen short of achieving meaningful public participation.17 18

Furthermore, measuring the benefits of e-participation is challenging due to unclear objectives and hard-to-measure outcomes related to citizen education, increased civic engagement and trust in public institutions.1 7 19 This lack of information hinders a comprehensive understanding of the conditions under which increased investment in specific participatory mechanisms makes sense for governments.7

Overall, public e-participation research spans multiple disciplines, including public administration, organisation studies, communication and media studies, political science, and information systems research.19

Despite the existence of various synthesised evidence articles on e-services, such as consultation, health assessment and triage, as well as e-participation in policy and decision-making—including systematic reviews on the diffusion of e-participation in public administrations,19 the challenges of social media for citizen e-participation,20 participation tools in urban design,21 barriers and facilitators of e-consultation/services in healthcare,2225 digital shared decision-making in healthcare,26 systematic mapping on the gamification of e-participation27 and scoping reviews on patient engagement activities during the COVID-19 pandemic28—there is no comprehensive review that investigates and scopes the body of literature on e-participation in policy-making for health by charting and classifying the available literature. Indeed, with the exception of synthesis reviews on e-participation in non-health fields, the synthesis reviews on e-participation in the health field have primarily focused on e-services and patient involvement in treatment plan design. Consequently, it remains challenging for researchers and policy-makers to fully comprehend the current body of knowledge on e-participation in policy-making for health, beyond just e-services.

Given the ambiguous and inconsistent information on various aspects of e-participation, particularly its benefits, costs and outcomes—largely due to the ‘deliberation-to-policy gap’ in the health sector4—and the multidisciplinary and fragmented nature of its research,19 there is insufficient rigorous evidence to offer health authorities practical recommendations. This is especially true regarding the use of e-participation with a focus on specific communities, participation mechanisms and models of engagement.

In this context, our scoping review is both timely and essential, aiming to provide a comprehensive overview of the current status of the field across various levels and approaches. Specifically, we seek to elucidate the stages of policy-making that have been studied, including agenda setting, formulation, adoption, implementation, monitoring and evaluation. Additionally, we aim to clarify the levels of policy-making, encompassing microlevel, mesolevel and macrolevel. In detailing these stages, we also intend to identify the e-mechanisms through which public participation has occurred, ranging from in-person to group-based and representative methods.

As previously described, the demand for public e-participation from citizens appears to be highly variable and less optimistic than anticipated. Additionally, the outcomes and values of public e-participation, particularly direct forms, have not received sufficient attention due to unclear objectives and performance indicators. This scoping review aims to identify the challenges, barriers, facilitators and the direct outcomes and values of public e-participation in the health sector.

In addressing these questions, this scoping review ultimately aims to provide a concept map of public e-participation in policy-making for health. The goal is to guide future national and international research on public e-participation, particularly in the context of developing countries where the diffusion of e-participation in policy-making for health is still in its infancy compared with developed nations.

A preliminary search of Google Scholar, PubMed, PROSPERO, the Cochrane Database of Systematic Reviews and the JBI Evidence Synthesis did not reveal any published or ongoing scoping reviews that address this topic in the manner proposed by our current protocol.

Methods and analysis

Review question(s)

What is the current state of knowledge in the literature regarding public e-participation in policy-making for health, particularly concerning the stakeholders involved (including policy-makers, organisers and the general population)?

Subquestions include:

How is public e-participation defined in the literature within the context of policy-making for health?

What levels of public e-participation (information, consultation, collaboration, involvement and empowerment) have been examined in the context of policy-making for health?

Which ICT-based participatory spaces and mechanisms are used for public e-participation in policy-making for health, and for what purposes and approaches?

At which stages (agenda setting, formulation, adoption, implementation, monitoring and evaluation) and levels of analysis (micro, meso and macro) has public e-participation in policy-making for health been most frequently employed?

What barriers and facilitators to public e-participation are reported in the policy-making for health literature?

What benefits and costs (values) of public e-participation are documented in the policy-making for health literature?

What outcomes (eg, quality of policies or decisions made, improvements in public service quality) of public e-participation are reported in the policy-making for health literature and based on what criteria are these successes measured?

Inclusion criteria

The inclusion criteria, developed using the Participants, Concept and Context framework,29 are outlined below:

Participants

This review will consider studies examining participants involved in policy-making for health, either as organisers of e-participation (government) or as participating citizens (the governed). Relevant participants include civil society, societal organisations, non-governmental organisations (NGOs), communities, community-based organisations (CBOs), vulnerable groups, patients, politicians, public administrations (including but not limited to parliaments, the cabinet, supreme councils and commissions), healthcare professionals, bureaucrats and civil servants.

Concept

The concept to be explored in this mapping activity is public e-participation in policy-making for health. Generally, public e-participation is a social activity mediated by ICT, involving interaction or informed dialogue between citizens, public administration, and politicians in policy-making, or even in service design and delivery. This process encourages participants to share ideas or options and engage in collaborative policy-making.7 This will serve as our working definition. Public participation is typically described as a spectrum, and we have chosen to use the IAPP framework (inform, consult, involve, collaborate and empower) to determine what qualifies as a public e-participation study. Although the literature presents various levels of public involvement, it is not guaranteed that these levels are applied consistently across different studies. Consequently, a study’s use of the term public e-participation can refer to a range of ICT-based initiatives with diverse purposes. This scoping review aims to clarify what is being studied in the public e-participation literature within the context of policy-making for health.

By ICT, we refer to any communication device, including but not limited to radio, television, cell phones, computer and network hardware, emails, robots, social media, and satellite systems, as well as the various services and applications associated with them, such as video conferencing and distance learning. This scoping review aims to identify the range of ICT-based participatory mechanisms within the field of policy-making for health.

The concept of policy-making for health also requires a clear definition and common language for this scoping review. For the purposes of this review, we will define public policy as a web of decisions, plans, actions or practices adopted and pursued by a government, party, ruler or statesman to achieve specific health or health-related goals within a society. We will define health according to the WHO as ‘a state of complete physical, mental and social well-being, rather than merely the absence of disease or infirmity’. To delineate the scope of our term ‘health’, we will encompass all types of health policies, including public health, mental health and healthcare while excluding aspects of medical care that focus on individual outcomes and the patient–physician relationship. We will include studies in health public policy at any stage of the policy-making cycle, commonly described as agenda setting, formulation, adoption, implementation, monitoring and evaluation. Another important aspect related to this concept is the level of policy-making for health, which in this review includes three specific levels: micro (front-line clinician), meso (regional, eg, district/county, or institutional, eg, hospital) and macro (national).

For the purposes of this review, a barrier to policy-making for health will be defined as any factor that might impede the formation of participation among politicians, public administrations and citizens. Conversely, facilitators are any factors that might enhance participation or aid in the distribution of power.

The concept of the value of public e-participation will be defined as the overall costs and benefits to the organisers of any initiative aimed at involving people in policy-making for health.

Finally, the ambiguous concept of public e-participation outcomes, which addresses the deliberation-to-policy gap, will be defined as the extent to which the desired goals of public e-participation organisers are realised once the participatory mechanisms are concluded.

Context

This review aims to capture public e-participation in policy-making for health across various participatory spaces where health policies and decisions are made with public involvement. By participatory spaces, we refer to any physical or virtual venues where individuals come together to interact.4 In these spaces, organisers employ various mechanisms, including ICT-based ones, to engage the public.

For the purposes of this review, we will consider a broad array of participatory spaces, regardless of the policy issue or intervention level. These include national sectoral or intersectoral councils, committees, workgroups, parliaments, cabinets, government technical commissions, health ministry managerial councils, health ministry technical deputies, national or provincial health assemblies, policy networks or communities, health CBOs and other existing or designed venues for policy-making for health. These spaces may aim to attract public participation or the participation of all key stakeholders, including the public.

Additionally, we will include all countries with various power structures (democratic, monarchical and autocratic regimes) where public e-participation has taken place. However, we will exclude places where healthcare occurs, such as acute care hospitals, urgent care centres, rehabilitation centres, nursing homes and other long-term care facilities.

Types of sources

This scoping review will consider peer-reviewed academic journal articles, excluding opinion pieces, and will include studies employing qualitative, quantitative and mixed methods of data collection. Additionally, grey literature will be limited to reports from international organisations. Table 1 outlines our inclusion and exclusion criteria.

Table 1 Screening inclusionary and exclusionary criteria

Inclusion criteria	Exclusion criteria	
Peer-reviewed articles including qualitative, quantitative and mix methods of data collection	Opinions articles	
Available in full text	Available only in abstract	
Published in English	Not published in English	
Published from 2000 to the search date	Published before 2000	
Relevance at least to one of the research questionsAddressing the health policy domain, including public health, mental health, healthcare, health equity, environmental health, global health, health technology and health workforce	Addressing digital or electronic-related topics but not e-participation (eg, e-services, e-information)Addressing another policy domain or a healthcare aspect of the health policy domain that focus on individual outcome or the patient–physician relationship.	
Occurring in existing or designed venues for health policy-making, whether with the specific aim of attracting public participation or the participation of all key stakeholders, including the public	Occurring in locations where healthcare services are provided.	

Patient and public involvement

To enhance the conceptualisation of this review and actively involve knowledge users, we established a consultative committee. Comprising nine individuals from public administrations, two representatives from health policy-making bodies and two members from CBOs, this committee played a crucial role in shaping the review’s purpose and research questions. Their input was instrumental in refining and approving the review protocol, ensuring alignment with their specific needs and concerns. Throughout the review process, the committee will continue to be consulted by the reviewers. The practice and impact of these consultation exercises, which challenge conventional perspectives and existing knowledge, will be thoroughly documented in the final scoping review. The details of the committee members are provided in table 2.

Table 2 Summary of stakeholder consultants

Groups	Number	
Public administrations	
HealthCare Network Management Centre in Ministry of Health and Medical Education (MOHME)

Department of Charitable Affairs and Charities within MOHME

Deputy of Parliament Affairs at MOHME

Social Health Workgroup at the Iranian Academy of Medical Sciences

Artificial Intelligence Workgroup in the Presidential Deputy of Scientific Technology and Knowledge-Based Economy

Research and Development Centre at Tehran University of Medical Sciences (TUMS)

Urumiyeh University of Medical Science

IT Centre at TUMS

Knowledge Utilisation Research Centre at TUMS

	9	
Policy-making and decision-making bodies for health	
Secretariat of Supreme Council of Health and Food Security within MOHME

Islamic Parliament Research Center

	2	
Community and community-based organisations	
Pioneer Institute of Transparency and Progress (transparency think tank for Iran)

Head of Governance and Community Empowerment Centre

	2	

Search strategy

The search strategy aims to identify peer-reviewed sources. In collaboration with a research librarian (MJM), we conducted an initial search of databases including Embase (Elsevier), PubMed, Scopus (Elsevier) and Web of Science (Clarivate) to develop the search strategy. We (SM and FR) used primary keywords related to our population, context and relevant concepts. Subsequently, we compiled a list of text words found in the titles and abstracts of relevant articles, along with index terms describing those words. This compilation formed the basis for our comprehensive search strategy (see online supplemental file 1: search strategy). After finalising the search strategy (SM and MG), we (MG) subjected it to a Peer Review of Electronic Search Strategy (PRESS) (see online supplemental file 2: PRESS checklist) before adapting it for each relevant database and information source. Additionally, we will screen the reference lists of selected articles for further relevant papers. The study reviewers will contact study authors if information relevant to our planned data extraction is missing. If necessary, we will also search Google and Google Scholar to identify reports produced by international organisations such as the WHO, NGOs and industry.

If necessary, we will also search Google and Google Scholar to identify reports produced by international organizationsorganisationssuch as the World Health Organization (WHO)WHO, non-governmental organizationsorganisations, and industry.Given the absence of translation services, our study will exclusively incorporate research published in English. However, to mitigate language bias, our initial search will encompass articles written in any language. This approach allows us to assess the extent of non-English literature excluded from our analysis. Furthermore, we will include studies published from 2000 up to the search date.

Study/source of evidence selection

All identified records will be compiled and uploaded into the Zotero reference managerAll identified records will be compiled and uploaded into the Zotero reference manager (https://www.zotero.org/). Duplicate entries will be systematically removed. Subsequently, two primary reviewers will independently assess all articles across three stages: title screening, abstract screening and full-text screening. We will apply predefined inclusion criteria to identify potentially relevant papers. These relevant papers will be retrieved in full and imported into EndNote. The full text of selected citations will undergo a detailed assessment against the inclusion criteria by two independent reviewers. Any sources that do not meet the inclusion criteria at the full-text stage will be excluded, and the reasons for exclusion will be documented and reported in the scoping review. In cases of disagreement between the reviewers (SM and NR) during the selection process, resolution will occur through discussion or consultation with a third reviewer (HE or FR). Articles meeting the following criteria will be included in our analysis: relevance to e-participation in policy-making for health, association with a full-text peer-reviewed study (excluding abstract-only search results and opinions), and publication in English from 2000 onward.

Our search will focus on studies published from the year 2000 onward, aligning with the proliferation of e-participation platforms that use new technologies. This trend emerged in developed countries during the first decade of the 2000s and in developing countries over the past 10 years.This trend emerged in developed countries during the first decade of the 2000sand in developing countries over the past 10years7

The comprehensive results of our search and the study inclusion process will be fully documented in the final scoping review. Additionally, we will present these findings using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram.30 Throughout the review process, we will adhere to the guidance provided by the PRISMA extension for Scoping Reviews.31

Data extraction

‘Data extraction from materials and papers included in the scoping review will be conducted by two independent reviewers (SM and NR). They will use a data extraction form in Microsoft Excel, employing an inductive approach (refer to online supplemental file 3: draft of data extraction form). Initially, two interdependent reviewers will pilot the form using the first 10 papers. Subsequently, a consultative committee discussion will address any issues, and the form will be iteratively revised during the data extraction process for each included paper. Detailed modifications will be documented in the full scoping review.

The extracted data will encompass specific details related to the population, e-participation definition, levels, mechanisms, barriers, facilitators, values and outcomes, as well as contextual information. Additionally, we will collect author details, publication year, publication type, country of origin, study objectives, methodology and key findings. In cases of reviewer disagreements, resolution will occur through discussion or consultation with a third reviewer (HE or FR).Furthermore, we will proactively contact authors to request any missing or additional data, as needed Furthermore, we will proactively contact authors to request any missing or additional data, as needed.

Data analysis and presentation

The analysis for this scoping review will primarily adopt a summative approach, focusing on the data extracted from the literature. We will present the extracted data in diagrammatic or tabular formats, aligning with the scoping review’s objectives and research questions. Additionally, a descriptive summary will accompany the tabulated and/or charted results, providing context on how these findings relate to the review’s objectives.

To disseminate the review results, we plan to engage with various key stakeholders through workshops, reports and academic publications. Prior to submitting the final review, we will seek input from members of the consultative committee.

Ethics and dissemination

The National Institute of Health Research of the Islamic Republic of Iran ethics committee approved this review study (ethics code number IR.TUMS.NIHR.REC.1400.019). We will disseminate the findings through peer-reviewed publications, conference presentations and practical recommendations to relevant knowledge users (eg, politicians, policy-makers and managers) at general or private meetings at the national level. Additionally, we will integrate the findings into the future research plans of the relevant research centres at TUMS to guide future research endeavours.

supplementary material

10.1136/bmjopen-2023-080538 online supplemental file 1

Acknowledgements

This review is the protocol of a research study entitled 'Investigating the application of information and communication technology to involve people in the policy-making for health: a scoping review', funded and supported by Tehran University of Medical Sciences grant No 1400-3-126-56722 with ethics code No. IR.TUMS.NIHR.REC.1400.019.

We thank our consultative committee members, Dr Reza Majdzadeh, Dr Habibullah Farid, Dr Ali Akhavan, Dr Azadeh Sayarifard, Dr Maryam Rahbari, Dr Narges Rostamigooran, Dr Mostafa Rezaee, Dr Bohlol Rahimi, Dr Ahmad Rezaee, Dr Hossein Bozarjomehri, Dr Saeed Harasani, Dr S.Mahdi Shariatzadeh, Dr Davoud Pirani for their contribution that greatly improved the protocol. We would also like to show our gratitude to Dr Mohamad-Ismaeel Motlagh the head of the Secretariat of supreme council of health and food security for support during this study.

Review Process File
16 09 2024

Funding: This work was supported by Tehran University of Medical Sciences (TUMS) grant number 1400-3-126-56722.

Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2023-080538).

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

Patient consent for publication: Not applicable.

Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
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