Stakeholder engagement in health technology assessment: a scoping review protocol

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Despite being considered good practice to engage stakeholders in HTA, there is a lack of standardised methods and limited guidance on how to incorporate stakeholder engagement in the HTA process. This scoping review aims to identify the current practices for stakeholder engagement in HTA internationally. Methods JBI methodology for scoping reviews will be followed and the final review will be reported in accordance with PRISMA-ScR checklist. This scoping review will include both peer review published literature as well as grey literature. This will include guidance documents and webpages describing stakeholder engagement processes in HTA, as well as qualitative, quantitative, and mixed method peer review publications describing and evaluating stakeholder engagement. The search strategy will be developed by a medical librarian using two concepts: “stakeholder engagement” and “health technology assessment”. Two researchers will independently screen, select, and chart data from the identified documents. The quantitative data will be described descriptively while the qualitative data will be analysed using a basic content analysis and reported narratively. Conclusion This scoping review will identify current practices for stakeholder engagement in the HTA process internationally. The review findings will be used to inform updates to the national guideline for stakeholder engagement for HTA in Ireland and can also be used to develop future guidance. 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HRB Open Res 2025, 8 :90 ( https://doi.org/10.12688/hrbopenres.14191.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Stakeholder engagement in health technology assessment: a scoping review protocol [version 1; peer review: 1 approved with reservations] Shibu Shrestha https://orcid.org/0000-0003-1101-0581 1,2 , David Aluga https://orcid.org/0000-0001-8133-3525 3 , Marie Carrigan https://orcid.org/0000-0002-2940-0054 1 , Conor Teljeur https://orcid.org/0000-0002-4494-1000 1 , Barbara Clyne 4 , Mairin Ryan 1,5 Shibu Shrestha https://orcid.org/0000-0003-1101-0581 1,2 , David Aluga https://orcid.org/0000-0001-8133-3525 3 , [...] Marie Carrigan https://orcid.org/0000-0002-2940-0054 1 , Conor Teljeur https://orcid.org/0000-0002-4494-1000 1 , Barbara Clyne 4 , Mairin Ryan 1,5 PUBLISHED 15 Aug 2025 Author details Author details 1 Health Technology Assessment, Health Information and Quality Authority, Dublin, D07 E98Y, Ireland 2 School of Population Health, RCSI University of Medicine and Health Sciences, Dubliln, D02 YN77, Ireland 3 Trinity College Dublin, Department of Public Health and Primary Care, Dublin, Leinster, D24 DH74, Ireland 4 Department of Public Health and Epidemiology, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 YN77, Ireland 5 Department of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, D02 PN40, Ireland Shibu Shrestha Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Validation, Writing – Original Draft Preparation, Writing – Review & Editing David Aluga Roles: Data Curation, Formal Analysis, Investigation, Writing – Original Draft Preparation, Writing – Review & Editing Marie Carrigan Roles: Methodology, Writing – Review & Editing Conor Teljeur Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Barbara Clyne Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Mairin Ryan Roles: Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Public and Patient Involvement collection. Abstract Introduction Stakeholder engagement in the multidisciplinary process of Health Technology Assessment (HTA) ensures consideration of different perspectives and relevant issues during the HTA process. Despite being considered good practice to engage stakeholders in HTA, there is a lack of standardised methods and limited guidance on how to incorporate stakeholder engagement in the HTA process. This scoping review aims to identify the current practices for stakeholder engagement in HTA internationally. Methods JBI methodology for scoping reviews will be followed and the final review will be reported in accordance with PRISMA-ScR checklist. This scoping review will include both peer review published literature as well as grey literature. This will include guidance documents and webpages describing stakeholder engagement processes in HTA, as well as qualitative, quantitative, and mixed method peer review publications describing and evaluating stakeholder engagement. The search strategy will be developed by a medical librarian using two concepts: “stakeholder engagement” and “health technology assessment”. Two researchers will independently screen, select, and chart data from the identified documents. The quantitative data will be described descriptively while the qualitative data will be analysed using a basic content analysis and reported narratively. Conclusion This scoping review will identify current practices for stakeholder engagement in the HTA process internationally. The review findings will be used to inform updates to the national guideline for stakeholder engagement for HTA in Ireland and can also be used to develop future guidance. READ ALL READ LESS Keywords engagement, health technology assessment, stakeholder Corresponding Author(s) Shibu Shrestha ( [email protected] ) Close Corresponding author: Shibu Shrestha Competing interests: SS, MC, CT, and MR are working in the Health Technology Assessment Directorate of the Health Information and Quality Authority and undertake HTA. Grant information: This work is conducted as part of the SPHeRE Programme under Grant No. SPHeRE/2022/001. However, no funding was received for this work. Copyright: © 2025 Shrestha S 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: Shrestha S, Aluga D, Carrigan M et al. Stakeholder engagement in health technology assessment: a scoping review protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :90 ( https://doi.org/10.12688/hrbopenres.14191.1 ) First published: 15 Aug 2025, 8 :90 ( https://doi.org/10.12688/hrbopenres.14191.1 ) Latest published: 15 Aug 2025, 8 :90 ( https://doi.org/10.12688/hrbopenres.14191.1 ) 1 Background Health Technology Assessment (HTA) is “a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle” 1 . HTA typically addresses questions related to different aspects of the technology such as clinical effectiveness and safety, cost effectiveness, organisational and resource aspects, social, ethical, and legal considerations. The HTA process and decisions based on HTA involve and affect different individuals referred to as stakeholders, through an impact on patient outcomes, service provision, income or expenditure 2 . Internationally, there is variation in HTA methods and focus, governance and role, scope and remit, method of assessment, and influence on coverage decisions. Variations also exist based on the income level of country; high-income countries are primarily focused on policy-making and optimal decision-making in HTA, integrating the involved institutions, and increasing the knowledge and skills base in HTA 3 – 5 . In contrast, middle-income countries tend to focus on raising awareness, learning from the experiences of developed countries, optimal resource allocation, and establishment of centralised and integrated institutions for HTA 3 – 5 . While is there is a growing interest for HTA in low income countries, the limited evidence indicates an ongoing lack of HTA being undertaken in these countries 6 . There is also variation in levels of institutional development for HTA and limited application of HTA to making regulatory, coverage/formulary and reimbursement decisions among low income countries 6 . HTAs are conducted by different bodies such as government agencies and ministries, national/regional HTA agencies, and other institutions such as national insurance organisations, academic institutions, drug regulators authorising medicines and/or medical devices with a distinct HTA function 5 , 7 . Stakeholders have been defined as “individuals, organisations or communities that have a direct interest in the process and outcomes of a project, research or policy endeavour” 8 , 9 . With reference to HTA, stakeholders are the individuals or groups who are responsible for or affected by the healthcare-related decisions that are informed by the assessment 2 . There are different frameworks categorising stakeholders. A recent comprehensive categorisation described by Tugwell et al. is the 11Ps framework, which categorises stakeholders into eleven groups: patients/consumers, payers/funders of research, payers and purchasers of health services, publishers, policy-makers, principal investigators, product makers, producers and commissioners of guidelines, programme managers, providers, and public 10 . Deverka et al. defined engagement as “an iterative process of actively soliciting the knowledge, experience, judgment and values of individuals selected to represent a broad range of direct interest in a particular issue, for the dual purpose of: creating a shared understanding; making relevant, transparent and effective decisions” 8 , 9 . Hence, the same definition has been applied to define stakeholder engagement in HTA 2 . Stakeholder engagement allows for critical assessment of the technology from different perspectives, contributes to the legitimacy of the decisions made based on HTA and also helps in consideration of all relevant issues during the HTA process 2 , 11 . There are various approaches for engaging stakeholders in HTA including participation through membership of a HTA committee or expert advisory group, and engagement through public calls (external engagement) 5 . How stakeholders are involved in the HTA process varies across different HTA systems. For example, public engagement is based on multiple factors such as the perceived complexity of the policy-making issue, perceived impact of the decision, as well as time and resource constraints 12 . Engagement of stakeholders in HTA provides a reflection of the HTA process and the ability of the HTA process to incorporate various values and preferences important to different factions of the society 5 . Engagement of stakeholders in HTA is therefore considered good practice by the international HTA community 13 . However, studies have highlighted that there is limited guidance on stakeholder engagement in HTA (for example, for rare diseases and palliative care), a lack of standardised methods for engaging stakeholders, a lack of guidance on usage of terminologies to denote different stakeholder groups in HTA, and also reluctance to engage stakeholders in the HTA process due to concerns about biasing assessments 12 , 14 , 15 . These factors contribute to variation in stakeholder engagement which may result in a lack of or limited public representation in informing HTA supported decision making 15 . A study conducted on 30 HTA agencies found that 30% of them identified developing an effective and efficient mechanism to engage stakeholders in HTA as a major challenge 16 . This issue was more prevalent in the case of conducting rapid HTAs where deadlines were short, and stakeholder engagement consumed more time 16 . Even though high-income countries often have established HTA mechanisms, they also face challenges around increasing stakeholders’ participation in HTA and increasing the transparency of these processes 3 . In Ireland, the Health Information and Quality Authority (HIQA) develops national HTA guidelines to encourage the use of appropriate methodology in HTAs that inform healthcare investment decisions by the Department of Health and Health Service Executive (HSE). In 2014, HIQA developed guidelines for stakeholder engagement in HTA to encourage consistency in stakeholder engagement process across different agencies and other groups, such as academia, undertaking HTA in Ireland 2 . Since these guidelines were developed, there have been advances in stakeholder engagement in other fields of health services research, such as guideline development 17 . A need has also been expressed for more sophisticated approaches to stakeholder engagement in HTA 8 . This scoping review will identify contemporary evidence on stakeholder engagement practices in HTA internationally. The results of this review will be used to inform the update of the national stakeholder engagement guideline developed by HIQA in 2014, titled, ‘Guidelines for Stakeholder Engagement in Health Technology Assessment in Ireland’. 2 Aim of the study The overall aim of the scoping review is to identify the current practices for stakeholder engagement in the HTA process. 3 Methods 3.1 Research question The overall objective of the review is to answer the question “What are the existing international practices for stakeholder engagement in the HTA process?” This question will be addressed through the following specific questions: ▪ What are the reported and perceived purposes of guidance for stakeholder engagement in the HTA process? ▪ What are the reported modes of stakeholder engagement in the HTA process? ▪ What are the reported approaches or processes for stakeholder engagement in the HTA process? ▪ What are the perceived contributions of stakeholders in the HTA process? 3.2 Study design A scoping review is a “type of evidence synthesis that aims to systematically identify and map the breadth of evidence available on a particular topic, field, concept, or issue, often irrespective of source (such as primary research, reviews, non-empirical evidence) within or across particular contexts” 18 . As the research question aims to identify a wide range of practices of stakeholder engagement in HTA, a scoping review design would be best suited for it 18 . The review will be conducted in accordance with the JBI methodology for scoping reviews 19 . The protocol for the review has been registered in Open Science Framework (OSF) and can be accessed through this link: https://doi.org/10.17605/OSF.IO/C3ESF . The completed scoping review will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist 20 . 3.3 Inclusion/exclusion criteria 3.3.1 Study design To be included, peer-reviewed publications and documents (e.g. handbooks/guidance documents) must describe processes or approaches for stakeholder engagement in the HTA process using the definition of the HTA process as described in Section 3.3.4 . The web pages of organisations or agencies undertaking HTA will be considered for inclusion if they describe the process for stakeholder engagement and fulfil all of the inclusion criteria. There will be no restriction on study designs and all qualitative, quantitative and mixed-method studies addressing the research question will be considered and assessed for eligibility. Inclusion will be limited to studies conducted among stakeholders who have conducted or been part of the HTA process. Commentaries, perspective or opinion pieces, and editorials reporting findings of a primary study will be included if it meets other inclusion criteria. Otherwise, commentaries, perspective or opinion pieces, editorials, protocols, and conference abstracts will be excluded. Studies that describe stakeholder engagement in a context other than the HTA process will also be excluded. Studies in a language other than English will be translated into English using DeepL, and assessed for eligibility. 3.3.2 Population Stakeholders have been defined as “individuals, organisations or communities that have a direct interest in the process and outcomes of a project, research or policy endeavour” 8 , 9 . Stakeholders are responsible, or affected by health and healthcare related decisions that can be informed by research evidence 21 . The population for inclusion is therefore broad. We will include studies and documents whose population includes any or all of the stakeholder groups as listed in the 11 ‘P’s framework developed by Tugwell et al. as these categories were designed to be comprehensive and inclusive of all interest groups 10 . However, some stakeholders might fit under different categories and during the process of the review, other groups that meet the definition of HTA stakeholder may also be identified and will be included. Therefore, broad population groups that will be considered for inclusion will be (but not limited to): ▪ Patients/consumers, caregivers, and patient groups. ▪ Payers/funders of research. ▪ Payers and purchasers of health services (for example, those who pay for or reimburse health related interventions, including insurers, individuals with deductibles, others, and those entities responsible for underwriting the cost of care, such as employers and governments). ▪ Publishers (those involved in the knowledge translation of evidence syntheses, for example, peer-review editors, scientific publishers, science writers). ▪ Policy makers (for example, governments and professional associations, those involved in the regulatory processes of drugs and health devices). ▪ Principal investigators (for example, researchers conducting studies that may or may not be relevant to the review). ▪ Product makers (for example, drug, natural products and/or device manufacturers). ▪ Producers and commissioners of guidelines (for example, institutions and organisations that commission, develop, or implement guideline development procedures). ▪ Programme managers (for example, managers/directors/administrators and individuals who plan, lead, oversee, or deliver any programme that provides public health, community services, or clinical care (for example, budgeting, hiring, staffing, organising, coordinating, reporting). These individuals may be health care providers but are not at the point of care delivering health care related to the programme of interest (for example, overseeing an immunisation programme but not delivering vaccinations). ▪ Providers (individuals and/or organisations providing care, such as nurses, physicians, pharmacists, community-based workers). ▪ Public (for example, communities or general members of the population or community, excluding patients, caregivers, and health professionals, living or working with the condition of interest) 10 . 3.3.3 Concept Stakeholder engagement is defined as an iterative process of actively soliciting the knowledge, experience, judgment and values of individuals selected to represent a broad range of direct interest in a particular issue, for the dual purpose of: creating a shared understanding; and making relevant, transparent and effective decisions 9 . The process is multi-directional, resulting in “informed decision-making about the selection, conduct and use of the research” 10 . Terms such as but not limited to “partnerships”, “involvement”, “consultation”, “co-production”, “co-creation”, “co-design” and “patient and public involvement”, are often also used to refer to engagement 10 . For the purpose of this review, any studies/documents using stakeholder engagement or any of these terms in the context of HTA will be considered eligible for inclusion. 3.3.4 Context HTA is defined as a “multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle” 1 . The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system 22 . For the purpose of this review, the HTA process will refer not only to the multidisciplinary assessment process, as defined above, but also to those aspects which occur prior to or after the decision to undertake an HTA has been made. These include: requesting for HTA to be undertaken, topic prioritisation, defining the scope, managing of HTA, and deciding the findings of the HTA 22 . For the purpose of this review, de-novo evidence synthesis for HTA undertaken by bodies conducting HTA, HTA that involves critical appraisal of manufacturer submission only, and HTA that involves critical appraisal of manufacturer submission and de-novo evidence synthesis will be included. Any HTA submitted as part of a dossier or documents for reimbursement will not be included. Inclusion will be limited to stakeholder engagement in the HTA process, as distinct from stakeholder engagement in any of the individual domains conducted outside of a HTA process (e.g. stakeholder engagement in systematic reviews and other evidence synthesis processes). Some agencies that have multiple functions might develop guidance documents applicable to encompassing the wide range of activities they engage in (e.g. HTA development and clinical guideline development). Such documents will only be included if, after assessing the purpose and scope of the document, it is found that they encapsulate the HTA process as defined above. 3.4 Database search A literature search will be conducted in MEDLINE Complete via EBSCO, Embase via Elsevier, CINAHL Complete via EBSCO, PsycInfo via EBSCO and The Cochrane Library via Wiley. The search strategy will be developed by a medical librarian and peer-reviewed by a second librarian. A sample search strategy for Medline has been shown in Table 1 below. Grey literature sources will be searched extensively using a three pronged approach: grey literature database search, hand searching of websites of HTA agencies, and targeted Google search. The grey literature database search will be run in a database such as GreyMatters. The websites of international HTA agencies will be hand searched to identify guidance documents for stakeholder engagement in the HTA process. The countries and agencies conducting HTA will be identified through reviewing members of AFROHTA, Americas RedETSA, HTAsiaLink, HTAR and INAHTA. Additionally, the websites of AFROHTA, Americas RedETSA, HTAsiaLink, HTAi, HTAR, INAHTA and ISPOR will also be hand searched for relevant literature. A targeted domain specific Google search will be run using the keywords “stakeholder”, “public”, “patients”, and “health technology assessment”. This targeted search will limit the Google search to the materials of different HTA agencies websites. The first 10 pages of the search hits will be screened and literature will be identified for full text review. Additionally, forward citation searching of eligible studies and searching reference lists of identified systematic reviews and included studies will also be conducted. Searches will be limited to the period from 2014 to December 2024 to capture the most recent approaches since the development of the HIQA guidelines (2014) 2 . Table 1. Search strategy for Medline. Database Name Medline via Ebscohost Date search was run 17 December 2024 # Query Limiters/Expanders Last Run Via Results S13 S5 AND S11 Limiters - Publication Date: 20140101- 20241231 Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 993 S12 S5 AND S11 Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 1,323 S11 S6 OR S7 OR S8 OR S9 OR S10 Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 20,295 S10 AB technology N1 evaluation OR TI technology N1 evaluation Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 1,322 S9 AB technology N1 appraisal OR TI technology N1 appraisal Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 592 S8 AB ( HTA OR HTAs ) OR TI ( HTA OR HTAs ) Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 4,719 S7 AB health N1 technology N1 assessment* OR TI health N1 technology N1 assessment* Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 7,604 S6 (MH "Technology Assessment, Biomedical+") Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 12,567 S5 S1 OR S2 OR S3 OR S4 Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 290,826 S4 AB ( (stakeholder* or advisor* or reference* or expert* or consultation* or steering) N1 (group* or panel*) ) OR TI ( (stakeholder* or advisor* or reference* or expert* or consultation* or steering) N1 (group* or panel*) ) Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 63,399 S3 AB ( (Stakeholder* OR patient* OR consumer* OR public OR carer OR carers OR caregiver* OR client* OR service-user* or end-user* OR “service provider*” OR policymaker* or policy-maker* or funder* or indust* or pharmaceutical or "interest user*" or "healthcare professional*" OR clinician* OR payer* OR purchaser* OR manufacturer* OR "program* manager*" OR investigator* OR researcher* OR "decision maker*" ) N2 (engag* or involv* or partnership* OR participat*) ) OR TI ( (Stakeholder* OR patient* OR consumer* OR public OR carer OR carers OR caregiver* OR client* OR service-user* or end-user* OR "service provider*" OR policymaker* or policy-maker* or funder* or indust* or pharmaceutical OR "interest user*" or "healthcare professional*" OR clinician* OR payer* OR purchaser* OR manufacturer* OR "program* manager*" OR investigator* OR researcher* OR "decision maker*" ) N2 (engag* or involv* or partnership* OR participat*) ) Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 205,895 S2 (MH "Patient Participation") Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 30,589 S1 (MH "Stakeholder Participation+") Expanders - Apply equivalent subjects Search modes - Proximity Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - MEDLINE Complete 5,073 3.5 Data management For data management purposes, the results of the database search will be exported to Covidence ( www.covidence.org ). Two reviewers will independently review the titles and abstracts and subsequently review the full texts of the identified records. A list of grey literature documents identified through searching of websites will be maintained in a Micosoft Excel spreadsheet and screened by the two reviewers. Those peer-reviewed papers and grey literature documents that meet the inclusion criteria for this scoping review will be included. Any disagreement regarding the eligibility of documents will be resolved through discussion, and using a third reviewer where necessary. 3.6 Data charting Data charting will be performed by one reviewer and cross-checked by another. A data charting tool developed based on the research questions will be piloted, the two reviewers will trial out the data charting form and enter data from 2–3 articles/documents into the charting form. A sample data charting template is shown in Table 2 below. After trialling the data charting form, the reviewers will discuss any uncertainties and if necessary changes will be made to the charting form. Data will be charted for the following headings: ▪ General study characteristics such as study design, year of publication, country under study ▪ Reported and perceived purpose of the guidance for stakeholder engagement in the HTA process ▪ Stakeholder groups engaged in the HTA process ▪ Methods for identifying stakeholders ▪ Methods for recruitment ▪ Methods for balancing stakeholder group representation ▪ Methods for engaging/method of communication ▪ Frequency of engagement ▪ Level of engagement (advisory/feedback or decision-making) ▪ Perceived contribution of stakeholders ▪ Methods for resolving disagreement ▪ Management of conflict of interest ▪ Experience of stakeholders engaged in the HTA process ▪ Barriers and facilitators to stakeholder engagement Table 2. Data charting template. Document characteristics Title Author/ Publishing organisation, Year Country Type of document Options ▪ Peer review article ▪ Guidance document ▪ Webpage Study design Applicable only for primary research studies. Options: ▪ Qualitative ▪ Quantitative ▪ Mixed methods Type of HTA Drop down menu with options ▪ De novo HTA ▪ Appraisal of manufacturer submission ▪ Appraisal of manufacturer submission combined with de novo evidence synthesis Sample size, where applicable Applicable only for primary research studies. Free text to include number of people included in the study. Data collection methods Applicable only for primary research studies. Free text Why are stakeholders engaged? Reported or perceived purpose of the guidance/stakeholder engagement Who are the stakeholders being engaged? Stakeholder groups engaged in the HTA process Stakeholder groups as categorised by Tugwell et al. Drop down menu with options: ▪ Patients/consumers, caregivers, and patient groups ▪ Payers/ funders of research ▪ Payers and purchasers of health services ▪ Publishers ▪ Policy makers ▪ Principal investigators ▪ Product makers ▪ Producers and commissioners of guidelines ▪ Programme managers ▪ Providers ▪ Public ▪ Others Methods for identifying stakeholders Methods for recruitment Methods for balancing stakeholder group representation How are stakeholder engaged? Methods for engaging/method of communication Level of engagement (advisory/feedback or decision-making) Methods for resolving disagreement Management of conflict of interest Evaluation of engagement When are stakeholders engaged with? Frequency of engagement/ At what stage of the HTA are stakeholder engaged with? What do the stakeholders think about the engagement? Perceived contribution of stakeholders Experience of stakeholders engaged in the HTA process As this is a scoping review aiming to provide an overview of a diverse range of outcomes, no quality appraisal will be undertaken. 3.7 Data analysis The quantitative findings will be synthesised using descriptive statistics (frequency, percentage) and described narratively. The qualitative findings will be synthesised using a basic qualitative content analysis approach as recommended by JBI scoping review guidance and will follow the approach described by Pollock et al. 23 , 24 . This is a descriptive approach to analysis and involves an open-coding process whereby concepts or characteristics are allocated into overall categories 23 . The basic qualitative content analysis approach consists of three phases as described by Elo and Kyngäs which has been stated to be applicable to scoping reviews as well 25 . The three phases are: i) preparation, ii) organising, and iii) reporting 25 . The preparation phase involves assessing if a basic qualitative content analysis is needed or not and then using either an inductive or deductive approach to conduct the analysis. This scoping review will follow an inductive approach for qualitative content analysis. The second phase, the organising phase, involves familiarisation with the data followed by open coding of the data, development of a coding framework and organisation of extracted data within the coding framework. The third phase, the reporting phase, involves presentation of the data through tables, heat maps, word clouds, along with a narrative description of the results 23 , 25 . The choice of data visualisation methods will be dependent on the underlying body of evidence identified. 4 Study status At time of publication of this protocol, database and grey literature searches have been carried out and title and abstract screening is underway. 5 Dissemination The findings will be disseminated through publication in a peer-reviewed journal, and conference presentations. The findings will also be presented in a one day workshop. 6 Discussion The scoping review aims to identify the current practices of stakeholder engagement in the HTA process. Considering the limited guidance on stakeholder engagement, it is important to identify practices globally and the perception of stakeholders regarding the current engagement modalities. Understanding this aspect will help to develop guidance for stakeholder engagement in the HTA process that is meaningful and acceptable to the stakeholder groups. 8 Ethical approval Ethical approval is not required as it is a review of studies. 9 Consent to participate The consent to participate is not applicable. 7 Data availability No data are associated with this article. Faculty Opinions recommended References 1. O'Rourke B, Oortwijn W, Schuller T, et al. : The new definition of health technology assessment: a milestone in International Collaboration. Int J Technol Assess Health Care. 2020; 36 (3): 187–90. PubMed Abstract | Publisher Full Text 2. Health Information and Quality Authority: Guidelines for stakeholder engagement in health technology assessment in Ireland. Ireland: 2014; [cited 2024 16 Jul]. Reference Source 3. Ghazinoory S, Majidi B, Nasri S, et al. : Differences between health technology assessment topics in high- and middle-income countries: a scoping review. Arch Public Health. 2021; 79 (1): 225. PubMed Abstract | Publisher Full Text | Free Full Text 4. Cowie MR, Bozkurt B, Butler J, et al. : How can we optimise health technology assessment and reimbursement decisions to accelerate access to new cardiovascular medicines? Int J Cardiol. 2022; 365 : 61–68. PubMed Abstract | Publisher Full Text 5. Fontrier AM, Visintin E, Kanavos P: Similarities and differences in Health Technology Assessment systems and implications for coverage decisions: evidence from 32 countries. Pharmacoecon Open. 2022; 6 (3): 315–28. PubMed Abstract | Publisher Full Text | Free Full Text 6. Babigumira JB, Jenny AM, Bartlein R, et al. : Health Technology Assessment in low-and middle-income countries: a landscape assessment. J Pharm Health Serv Res. 2016; 7 (1): 37–42. Publisher Full Text 7. Babidge WJ: Global HTA. health. 2021; 1 : 2. 8. Boaz A, Hanney S, Borst R, et al. : How to engage stakeholders in research: design principles to support improvement. Health Res Policy Syst. 2018; 16 (1): 60. PubMed Abstract | Publisher Full Text | Free Full Text 9. Deverka PA, Lavallee DC, Desai PJ, et al. : Stakeholder participation in comparative effectiveness research: defining a framework for effective engagement. J Comp Eff Res. 2012; 1 (2): 181–94. PubMed Abstract | Publisher Full Text | Free Full Text 10. Tugwell P, Welch V, Magwood O, et al. : Protocol for the development of guidance for collaborator and partner engagement in health care evidence syntheses. Syst Rev. 2023; 12 (1): 134. PubMed Abstract | Publisher Full Text | Free Full Text 11. Ryan M, Moran PS, Harrington P, et al. : Contribution of stakeholder engagement to the impact of a Health Technology Assessment: an Irish case study. Int J Technol Assess Health Care. 2017; 33 (4): 424–9. PubMed Abstract | Publisher Full Text 12. Wortley S, Street J, Lipworth W, et al. : What factors determine the choice of public engagement undertaken by Health Technology Assessment decision-making organizations? J Health Organ Manag. 2016; 30 (6): 872–90. PubMed Abstract | Publisher Full Text 13. Van Haesendonck L, Ruof J, Desmet T, et al. : The role of stakeholder involvement in the evolving EU HTA process: insights generated through the European Access Academy's multi-stakeholder pre-convention questionnaire . J Mark Access Health Policy. 2023; 11 (1): 2217543. PubMed Abstract | Publisher Full Text | Free Full Text 14. Brereton L, Wahlster P, Mozygemba K, et al. : Stakeholder involvement throughout Health Technology Assessment: an example from palliative care. Int J Technol Assess Health Care. 2017; 33 (5): 552–61. PubMed Abstract | Publisher Full Text 15. Street J, Stafinski T, Lopes E, et al. : Defining the role of the public in Health Technology Assessment (HTA) and HTA-informed decision-making processes. Int J Technol Assess Health Care. 2020; 36 (2): 87–95. PubMed Abstract | Publisher Full Text 16. O'Rourke B, Werkö SS, Merlin T, et al. : The ‘top 10’ challenges for Health Technology Assessment: INAHTA viewpoint. Int J Technol Assess Health Care. 2020; 36 (1): 1–4. PubMed Abstract | Publisher Full Text 17. Petkovic J, Riddle A, Lytvyn L, et al. : Guidance for engagement in health guideline development: a scoping review. Campbell Syst Rev. 2024; 20 (4): e70006. PubMed Abstract | Publisher Full Text | Free Full Text 18. Munn Z, Peters MD, Stern C, et al. : Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Med Res Methodol. 2018; 18 (1): 143. PubMed Abstract | Publisher Full Text | Free Full Text 19. Peters MD, Godfrey C, McInerney P, et al. : Scoping reviews. JBI manual for evidence synthesis. 2020; 10 . Publisher Full Text 20. Tricco AC, Lillie E, Zarin W, et al. : PRISMA extension for Scoping Reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. 2018; 169 (7): 467–73. PubMed Abstract | Publisher Full Text 21. Concannon TW, Meissner P, Grunbaum JA, et al. : A new taxonomy for stakeholder engagement in Patient-Centered Outcomes Research. J Gen Intern Med. 2012; 27 (8): 985–91. PubMed Abstract | Publisher Full Text | Free Full Text 22. Health Information and Quality Authority: A guide to health technology assessment at HIQA. Dublin: Health Information and Quality Authority, 2016; [cited 2024 8 Nov 2024]. Reference Source 23. Pollock D, Peters MDJ, Khalil H, et al. : Recommendations for the extraction, analysis, and presentation of results in scoping reviews. JBI Evid Synth. 2023; 21 (3): 520–32. PubMed Abstract | Publisher Full Text 24. Peters MDJ, Marnie C, Tricco AC, et al. : Updated methodological guidance for the conduct of scoping reviews. JBI Evid Synth. 2020; 18 (10): 2119–26. PubMed Abstract | Publisher Full Text 25. Elo S, Kyngäs H: The qualitative content analysis process. J Adv Nurs. 2008; 62 (1): 107–15. PubMed Abstract | Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 15 Aug 2025 ADD YOUR COMMENT Comment Author details Author details 1 Health Technology Assessment, Health Information and Quality Authority, Dublin, D07 E98Y, Ireland 2 School of Population Health, RCSI University of Medicine and Health Sciences, Dubliln, D02 YN77, Ireland 3 Trinity College Dublin, Department of Public Health and Primary Care, Dublin, Leinster, D24 DH74, Ireland 4 Department of Public Health and Epidemiology, School of Population Health, RCSI University of Medicine and Health Sciences, Dublin, D02 YN77, Ireland 5 Department of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, D02 PN40, Ireland Shibu Shrestha Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Validation, Writing – Original Draft Preparation, Writing – Review & Editing David Aluga Roles: Data Curation, Formal Analysis, Investigation, Writing – Original Draft Preparation, Writing – Review & Editing Marie Carrigan Roles: Methodology, Writing – Review & Editing Conor Teljeur Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Barbara Clyne Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Mairin Ryan Roles: Writing – Review & Editing Competing interests SS, MC, CT, and MR are working in the Health Technology Assessment Directorate of the Health Information and Quality Authority and undertake HTA. Grant information This work is conducted as part of the SPHeRE Programme under Grant No. SPHeRE/2022/001. However, no funding was received for this work. Article Versions (1) version 1 Published: 15 Aug 2025, 8:90 https://doi.org/10.12688/hrbopenres.14191.1 Copyright © 2025 Shrestha S 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. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Shrestha S, Aluga D, Carrigan M et al. Stakeholder engagement in health technology assessment: a scoping review protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :90 ( https://doi.org/10.12688/hrbopenres.14191.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 15 Aug 2025 Views 0 Cite How to cite this report: Nagraj SK. Reviewer Report For: Stakeholder engagement in health technology assessment: a scoping review protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :90 ( https://doi.org/10.21956/hrbopenres.15607.r49681 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-90/v1#referee-response-49681 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 30 Sep 2025 Sumanth Kumbargere Nagraj , Peninsula Dental School, University of Plymouth, Plymouth, England, UK Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15607.r49681 1. If foreign language articles are included based on the DeepL, will you be extracting data based on the DeepL translation? If so, provide the references for the accuracy of translation done by DeepL. 2. "Commentaries, perspective or opinion ... Continue reading READ ALL 1. If foreign language articles are included based on the DeepL, will you be extracting data based on the DeepL translation? If so, provide the references for the accuracy of translation done by DeepL. 2. "Commentaries, perspective or opinion pieces, and editorials reporting findings of a primary study will be included if it meets other inclusion criteria." Please elaborate other inclusion criteria. 3. Please add information on modes, approaches and processes for stakeholder engagement in the background section. This will help the reader to understand your objectives. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Guideline development, Evidence synthesis, Research priority setting I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Nagraj SK. Reviewer Report For: Stakeholder engagement in health technology assessment: a scoping review protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :90 ( https://doi.org/10.21956/hrbopenres.15607.r49681 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-90/v1#referee-response-49681 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 15 Aug 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 15 Aug 25 read Sumanth Kumbargere Nagraj , University of Plymouth, Plymouth, UK Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Nagraj S. This is an open access peer review report 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. 30 Sep 2025 | for Version 1 Sumanth Kumbargere Nagraj , Peninsula Dental School, University of Plymouth, Plymouth, England, UK 0 Views copyright © 2025 Nagraj S. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions 1. If foreign language articles are included based on the DeepL, will you be extracting data based on the DeepL translation? If so, provide the references for the accuracy of translation done by DeepL. 2. "Commentaries, perspective or opinion pieces, and editorials reporting findings of a primary study will be included if it meets other inclusion criteria." Please elaborate other inclusion criteria. 3. Please add information on modes, approaches and processes for stakeholder engagement in the background section. This will help the reader to understand your objectives. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Guideline development, Evidence synthesis, Research priority setting I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Nagraj SK. Peer Review Report For: Stakeholder engagement in health technology assessment: a scoping review protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :90 ( https://doi.org/10.21956/hrbopenres.15607.r49681) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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