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Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation.

ABSTRACT: BACKGROUND:Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. METHODS:This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. DISCUSSION:We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health.

SUBMITTER: Petkovic J

PROVIDER: S-EPMC6995157 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation.

Petkovic Jennifer J Riddle Alison A Akl Elie A EA Khabsa Joanne J Lytvyn Lyubov L Atwere Pearl P Campbell Pauline P Chalkidou Kalipso K Chang Stephanie M SM Crowe Sally S Dans Leonila L Jardali Fadi El FE Ghersi Davina D Graham Ian D ID Grant Sean S Greer-Smith Regina R Guise Jeanne-Marie JM Hazlewood Glen G Jull Janet J Katikireddi S Vittal SV Langlois Etienne V EV Lyddiatt Anne A Maxwell Lara L Morley Richard R Mustafa Reem A RA Nonino Francesco F Pardo Jordi Pardo JP Pollock Alex A Pottie Kevin K Riva John J Schünemann Holger H Simeon Rosiane R Smith Maureen M Stein Airton T AT Synnot Anneliese A Tufte Janice J White Howard H Welch Vivian V Concannon Thomas W TW Tugwell Peter P

Systematic reviews 20200201 1

<h4>Background</h4>Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for ...[more]

PMID: 32007104

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Project description:BackgroundThe implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation-STakeholder Engagement Model (I-STEM) in the context of an international, large-scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I-STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process.MethodsIn-depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet-based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first- and third-generation Grounded Theory, including constant comparative method.ResultsWe conducted 55 interviews and observed 19 implementation-related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I-STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes.ConclusionThe I-STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I-STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities.Patient or public contributionPatient contribution to ImpleMentAll trial was facilitated by GAMIAN-Europe at all stages-from grant development to dissemination. GAMIAN-Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN-Europe was involved in pilot testing the ItFits-toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits-toolkit.Trial registrationClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018.

Project description:IntroductionChimeric antigen receptor T-cell (CAR-T) therapy is a class of immunotherapy. An economic evaluation conducted at an early stage of development of CAR-T therapy for treatment of adult relapsed or refractory acute lymphoblastic leukaemia could provide insight into factors contributing to the cost of treatment, the potential clinical benefits, and what the health system can afford. Traditionally, stakeholders are engaged in certain parts of health technology assessment processes, such as in the identification and selection of technologies, formulation of recommendations, and implementation of recommendations; however, little is known about processes for stakeholder engagement during the conduct of the assessment. This is especially the case for economic evaluations. Stakeholders, such as clinicians, policy-makers, patients, and their support networks, have insight into factors that can enhance the validity of an economic evaluation model. This research outlines a specific methodology for stakeholder engagement and represents an avenue to enhance health economic evaluations and support the use of these models to inform decision making for resource allocation. This protocol may inform a tailored framework for stakeholder engagement processes in future economic evaluation model development.Methods and analysisWe will involve clinicians, healthcare researchers, payers, and policy-makers, as well as patients and their support networks in the conduct and verification of an early economic evaluation of a novel health technology to incorporate stakeholder-generated knowledge. Three stakeholder-specific focus groups will be conducted using an online adaptation of the nominal group technique to elicit considerations from each. This study will use CAR-T therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia as a basis for investigating broader stakeholder engagement processes.Ethics and disseminationThis study received ethics approval from the Ottawa Hospital Research Institute Research Ethics Board (REB 20200320-01HT) and the results will be shared via conference presentations, peer-reviewed publications, and ongoing stakeholder engagement.

Project description:BackgroundGuideline adaptation is an emerging field to provide more appropriate recommendations for local clinical practice quality and to promote global health equity. However, its utilization status, adaptation procedures, and related materials remain to be studied.MethodsThis study developed a quality improvement protocol for a study as the Development, Evaluation, and impLemenTation for guideline Adaptation (DELTA) study. Current adapted clinical practice guidelines (CPGs) will be systematically searched. Their characteristics, utilization status, and adaptation procedures will be extracted, compared, and analyzed. Whether these adapted CPGs rigorously followed the instruments and steps of adaptation frameworks will also be appraised. In addition, the advantages and limitations of current adaptation methods and their suitable application situations will be analyzed. In addition, future perspectives as DELTA series and DELTA system, aiming for comprehensively evaluating current needs for guideline adaptation and developing a unified framework and related materials were proposed to improve the acceptability, applicability, and implementation of guideline adaptation in clinical practice. The DELTA series are divided into four phases: phase I in analyzing status, characteristics, and procedures and completeness of adapted CPGs; phase II in analyzing differences, heterogeneity, and implementation between adapted and original CPGs; and phase III in collecting, analyzing, and comparing all available adaptation materials. With these research bases, an international working group will be established in phase IV and will develop unified guideline adaptation materials after Delphi consensus, including adaptation frameworks, appraisal tools and checklists, registries, and databases.DiscussionGuideline adaptation has been advanced as an efficient way to guide local clinical practice. However, it still faces several major challenges. The proposed DELTA study, series, and system will further contribute to this emerging topic.Trial registration This study has been registered by the PROSPERO international database. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=400170 .

Project description:ObjectiveThis evaluation captures the perspectives of multiple stakeholders within a salaried dental care delivery organization (dentists, dental assistants, dental hygienists, and dental management) on the implementation of a pit-and-fissure sealant guideline in the Kaiser Permanente Dental Program. Also assessed is the role of formal processes and structures in providing a framework for guideline implementation.MethodsWe collected qualitative data through field observations, stakeholder interviews (n = 6), and focus groups (30 participants in 5 focus groups). Field observation notes captured summaries of conversations and other activities. Interviews and focus groups were recorded and transcribed. We analyzed transcripts and field notes using a template analysis with NVivo 12 software to identify themes related to the existing implementation process of clinical guidelines and stakeholder perspectives on the strengths and weaknesses of this process.ResultsStakeholders perceived 2 main barriers for achieving implementation of the pit-and-fissure sealant guideline: 1) shortcomings in the implementation infrastructure resulting in lack of clarity about the roles and responsibilities in the guideline implementation process and lack of effective mechanisms to disseminate guideline content and 2) resource constraints, such as limited human, space, and material resources. Perceived opportunities for the dissemination and implementation of guidelines included recognition of the importance of guidelines in dental practice and well-functioning workflows within dental specialties.ConclusionOur research points to the importance of developing and maintaining an infrastructure to ensure standardized, predictable mechanisms for implementation of guidelines and thereby promoting practice change. While addressing resource constraints may not be possible in all circumstances, an important step for improving guideline implementation-wherever feasible-would be the development of a robust implementation infrastructure that captures and delineates roles and responsibilities of different clinical actors in the guideline implementation process.Knowledge transfer statementThe results of this study can be used by health care leadership and administrators to understand possible reasons for a lack of guideline implementation and provide suggestions for establishing sustainable infrastructure to promote the adoption of clinical guidelines in salaried dental clinics.

Project description:BackgroundThis article provides a generalizable method, rooted in co-design and stakeholder engagement, to identify, specify, and prioritize implementation strategies. To illustrate this method, we present a case example focused on identifying strategies to promote pediatric hypertension (pHTN) Clinical Practice Guideline (CPG) implementation in community health center-based primary care practices that involved meaningful engagement of pediatric clinicians, clinic staff, and patients/caregivers. This example was chosen based on the difficulty clinicians and organizations experience in implementing the pHTN CPG, as evidenced by low rates of guideline-adherent pHTN diagnosis and treatment.MethodsWe convened a Stakeholder Advisory Panel (SAP), comprising 6 pediatricians and 5 academic partners, for 8 meetings (~12 h total) to rigorously identify determinants of pHTN CPG adherence and to ultimately develop a testable multilevel, multicomponent implementation strategy. Our approach expanded upon the Expert Recommendations for Implementation Change (ERIC) protocol by incorporating a modified Delphi approach, user-centered design methods, and the Implementation Research Logic Model (IRLM). At the recommendation of our SAP, we gathered further input from youth with or at-risk for pHTN and their caregivers, as well as clinic staff who would be responsible for carrying out facets of the implementation strategy.ResultsFirst, the SAP identified 17 determinants, and 18 discrete strategies were prioritized for inclusion. The strategies primarily targeted determinants in the domains of intervention characteristics, inner setting, and characteristics of the implementers. Based on SAP ratings of strategy effectiveness, feasibility, and priority, three tiers of strategies emerged, with 7 strategies comprising the top tier implementation strategy package. Next, input from caregivers and clinic staff confirmed the feasibility and acceptability of the implementation strategies and provided further detail in the definition and specification of those strategies.ConclusionsThis method-an adaptation of the ERIC protocol-provided a pragmatic structure to work with stakeholders to efficiently identify implementation strategies, particularly when supplemented with user-centered design activities and the intuitive organizing framework of the IRLM. This generalizable method can help researchers identify and prioritize strategies that align with the implementation context with an increased likelihood of adoption and sustained use.

Project description:IntroductionAs the world continues to grapple with the COVID-19 pandemic, emerging evidence suggests that individuals from ethnic minority backgrounds may be disproportionately affected. The United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers (UK-REACH) project has been initiated to generate rapid evidence on whether and why ethnicity affects COVID-19 diagnosis and clinical outcomes in healthcare workers (HCWs) in the UK, through five interlinked work packages/work streams, three of which form the basis of this protocol. The ethico-legal work (Work Package 3) aims to understand and address legal, ethical and acceptability issues around big data research; the HCWs' experiences study (Work Package 4) explores their work and personal experiences, perceptions of risk, support and coping mechanisms; the stakeholder engagement work (Work Package 5) aims to provide feedback and support with the formulation and dissemination of the project recommendations.Methods and analysisWork Package 3 has two different research strands: (A) desk-based doctrinal research; and (B) empirical qualitative research with key opinion leaders. For the empirical research, in-depth interviews will be conducted digitally and recorded with participants' permission. Recordings will be transcribed, coded and analysed using thematic analysis. In Work Package 4, online in-depth interviews and focus groups will be conducted with approximately 150 HCWs, from across the UK, and these will be recorded with participants' consent. The recordings will be transcribed and coded and data will be analysed using thematic analysis. Work Package 5 will achieve its objectives through regular group meetings and in-group discussions.Ethics and disseminationEthical approval has been received from the London-Brighton & Sussex Research Ethics Committee of the Health Research Authority (Ref No 20/HRA/4718). Results of the study will be published in open-access journals, and disseminated through conference presentations, project website, stakeholder organisations, media and scientific advisory groups.Trial registration numberISRCTN11811602.

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Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation.

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Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation.

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