Stakeholder Engagement in Planning the Design of a National Needs Assessment for Cardiovascular Disease Prevention and Management in Nepal

lationships that could be construed as a conflict of interest. Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Shrestha Archana*,y, Biraj Man Karmacharya*,z, Maharjan Rashmi*, Vaidya Abhinavx, Dhimal Meghnathjj, Oli Nataliax, Shrestha Rajeev{, Pyakurel Prajjwal, Fitzpatrick Annette**,yy,zz, Citrin Davidzz,xx,jjjj,{{, Bajracharya Swornim*, Xu Dong Roman***, Spiegelman Donnay,##, Koju Rajendrayyy Kavrepalanchwok, Kathmandu, and Dharan, Nepal; Boston, MA, USA; Seattle, WA, USA; New Haven, CT, USA; and Guangzhou, China

A key challenge for health care systems research is to close the gap between research production and research use [1]. Stakeholder engagement is an important pathway to narrow this gap [2]. Stakeholder engagement helps to generate knowledge, increase ownership, reduce conflict, and encourage partnership. Stakeholder engagement also facilitates inclusive decision making and promotes equity on decision making [3]. Stakeholders can be engaged across the stages of research including identifying topics, choosing hypotheses, analyzing data, and disseminating findings [4,5]. The levels of involvement range from consultations, to collaboration in bidirectional partnerships, to collaboratively leading research projects [6].
Although there is growing support for stakeholder engagement, the actual impact of such engagement has not been well established. Systematic reviews have reported that only a few studies actually measure engagement, and there is lack of consensus on reporting stakeholder engagement process and outcomes [7,8]. Although there has been a rapid increase of work on stakeholder engagement as well as recommendations that researchers systematically document and evaluate stakeholder The authors report no relationships that could be construed as a conflict of interest. Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under grant #5U24HL136789-02. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. From the *Department of engagement process and report its impact on individual projects [3], there is limited reporting of the process and even less of evaluation of the engagement process. Here, we describe the stakeholder engagement and evaluation while planning the national needs assessment for cardiovascular disease (CVD) prevention and management in Nepal.

Setting
Project: Translational Research Capacity Building Initiative to address CVD in Nepal. The project aims to build national capacity to lead translational research in CVD by creating and training a multisectoral, multidisciplinary team; building partnership with U.S. and regional institutions; systematically assessing national needs; and developing an actionable translational research plan. CVD are the leading causes of premature deaths in the world with >80% of all CVD-related deaths occurring in lowand middle-income countries [9]. In Nepal, CVD risk factors have increased alarmingly over the past decades, increasing by 45% and 41% in deaths due to ischemic heart disease and stroke, respectively, between 2007 and 2017 [9,10]. Proven cost-effective strategies are available for reducing cardiovascular diseases in low-income settings including both population-wide and individual risk approaches. However, scaling up these interventions is challenging especially in a low-income country such as Nepal. Not only is individual behavior modification complicated by sociocultural and environmental factors, in addition the health care delivery system is not set up to address prevention and treatment, nor have adequate resources been dedicated toward these efforts to address prevention and treatment. Specifically, enormous gaps exist in the following:1) epidemiological understanding of CVD and their risk factors (modifiable and nonmodifiable); 2) national level policies and strategies to address CVD; 3) health care systems infrastructure to provide education and treatment; 4) community-and patient-level support; 5)development and application of national registries for CVD; and 6) human resources to lead and implement the agendas to address the growing burden of CVD in Nepal.
A multifaceted, multisectoral synergistic effort is required for the sustainable uptake of evidence-based interventions into routine clinical and community-based settings. Given the complexities, it is important to train and build the capacity of the Nepali researchers to identify local needs for CVD and develop feasible context-specific implementation strategies to deliver evidence-based interventions. To lay this groundwork, Dhulikhel HospitaleKathmandu University Hospital has built a collaborative team of Nepalese and international experts to build capacity, assess national needs, and develop an actionable translational research plan to address the growing burden of CVD in Nepal. We have also enrolled 16 research fellows from diverse professional backgrounds.
The overall aim of the national needs assessment is to investigate the CVD epidemiology and national capacity to prevent and manage CVD in Nepal. The specific aims are 1) to assess national-level infrastructure and capacity for CVD prevention and management interventions in Nepal on leadership and governance, health service delivery, health financing, human resources, pharmaceuticals and medical products, and health information system and 2) to assess the CVD burden and severity in Nepal using available secondary data. The main outcome of the assessment is to report key findings for each health system function, highlighting important strengths, critical cross-cutting health system weaknesses that limit performance, and recommendations for priority interventions. In addition, the findings, priorities, and recommendations have to be corroborated and validated by key stakeholders at the national level. The results of the assessment will be utilized to prioritize national CVD health needs, design relevant interventions, and develop a translational research plan.

Conceptual framework
We used Ray and Miller's framework [3] for planning, evaluating, and reporting stakeholder engagement. The framework is illustrated in Table 1. As our study is in an early phase, we are only able to report immediate outcomes in this paper.
Context. In the context of an overall research agenda of assessing national needs for the prevention and management of CVD, we planned to engage a wide range of stakeholders from different sectors. There was a high level of commitment from researchers to engage relevant stakeholders in the process. The desired inputs were the jg SCIENCE values, knowledge, and experience of a range of stakeholders. The desired outputs were to incorporate the inputs to improve research objectives, scope, and methods and to guide subsequent research efforts. External funding and dedicated time were available for the stakeholder engagement and evaluation. The purpose of the stakeholder engagement was to incorporate a broad range of experiences in the planning and execution of the needs assessment to enhance interpretability and relevance of findings suited for local context. The stakeholders were consulted specifically for developing the study methods, conceptual framework, and stakeholder engagement process. In the long run, stakeholders are planned to be engaged at different levels: 1) inform-to provide stakeholders with balanced and objective information to help them understand the needs assessment process, results, and recommendations; 2) consult-to obtain inputs from stakeholders on the process, results, and recommendations; 3) involve-to work with stakeholders throughout the process to ensure their feedback is incorporated; 4) collaborate-to partner with stakeholders for conducting the needs assessment by defining objectives, collecting data, analyzing data, and interpreting the results; and 5) empower-to engage in the needs assessment process with shared power in decisionmaking process for conducting the assessment.

Processes
Stakeholder recruitment and composition. We defined a stakeholder as an individual or group affected by CVD or in a position to directly influence CVD prevention and management at a national level in Nepal. We adopted the 7Ps framework (Patients and the Public, Providers, Purchasers, Payers, Public Policy Makers and Policy Advocates, Product Makers and the Principal Investigators) [11] that identifies key groups to consider for engagement. The first group, patients and the public, represents the current and potential consumers of patient-centered health care and population-focused public health services. The second were providers, including individuals and organizations that provide care to patients and populations. Purchasers, the individuals and entities responsible for underwriting the costs of health care, such as employers, made up the third group. The fourth group consisted of payers who were responsible for reimbursement of medical care, such as insurers. The fifth is composed of public policy makers and policy advocates working in the nongovernmental sector. Product makers, representing drug and device manufacturers, composed the sixth group, and principal investigators, or other researchers, made up the seventh. We used personal and professional networks to identify relevant stakeholders within the 7Ps framework. Furthermore, we updated the list after receiving feedback in our first stakeholders' meeting. We received ethical approval to include human subjects (stakeholders) from the Institutional Review Committee of Kathmandu University School of Medical Sciences, an independent body approved by Nepal Health Research Council.
Frequency and duration of engagement. For planning of the needs assessment, we interacted with the stakeholders on 3 separate occasions: during 2 meetings with a smaller group of 15 people and 1 workshop with a group of 37 stakeholders.
Small group meetings: We formed a task force to guide and lead the needs assessment process that was cochaired by the principal investigator of the Translational Research Capacity Building Initiative to address CVD in Nepal and the executive chairperson of the Nepal Health Research Council (NHRC), an apex body for health research in Nepal. There are coinvestigators, a heart patient, a representative from Cardiac Society of Nepal, representatives from the Ministry of Health and Population, and members from NHRC on the task force. The task force aims to meet 4 times a year to plan and oversee the needs assessment process. We conducted 2 1-h task force meetings to discuss the needs assessment proposal and receive feedback.
Stakeholder workshop: We conducted a 3-h workshop with 40 stakeholders to present the needs assessment plan and receive feedback. The stakeholders introduced themselves to the large group. Then, we provided a brief orientation to the preliminary research topic, conceptual framework, and methods using a PowerPoint (Microsoft, Redmond, WA) presentation to promote full participation. We stimulated colearning by ensuring that each stakeholder had at least a 5-min dedicated time to speak and encouraged them to ask questions and share their experiences and expertise. We addressed concerns or queries raised by the stakeholders. Two research team members were dedicated to recording all comments and recommendations in a log.
Setting expectations and decision making. At our first stakeholder workshop, we revisited expectations and invited further dialogue in roles and responsibilities. For the task force, we also prepared a terms of reference document that specified the roles of stakeholders, power dynamics, and decision-making process.
Immediate outcomes. The principal investigator and coinvestigators further discussed the feedback and revised the research questions, scope, and methods.
Evaluation of stakeholder engagement. We approached 37 stakeholders for an interview to receive feedback on the stakeholder engagement process. This explored perspectives of the stakeholders regarding the engagement process and how it could be improved in future.
We asked their feedback in relation to the following themes: 1) expectations from the engagement process; 2) representation of stakeholders; 3) degree of involvement; gSCIENCE j GLOBAL HEART, VOL. 14, NO. 2, 2019 4) engagement channels and methods; 5) future expectations; and 6) benefits and barriers to engagement. The interviews were semistructured and were administered in person or by telephone by a coinvestigator and a research officer. The responses were coded manually and analyzed thematically.

Stakeholders and purpose of engagement
Based on the 7Ps framework, we present stakeholders and the purpose of engagement in Table 1. A total of 50 stakeholders were identified, 40 of which accepted our invitation and were engaged. Of the 10 who were not engaged, 6 had other conflicting time commitments and 4 cited personal reasons for not attending any interaction programs. We achieved a balanced composition of our stakeholder group, with 5 representatives from patients and public; 5 representatives from providers, 3 purchasers, 4 payers, 5 policy makers, 4 product makers, and 14 research team members, including investigators and research assistants. Stakeholder mapping has been illustrated in Table 2. jg SCIENCE Immediate outcomes Discussion during task force meetings and influence on the needs assessment plan. The recommendations and their effects on the need assessment plan are summarized in Table 3. All 5 recommendations made during the task force meetings were incorporated into the needs assessment plan. Three of the recommendations focused on improving the stakeholder engagement process, whereas 2 recommendations were aimed at improving or modifying methods to align with stakeholder priorities.
Discussion during stakeholder workshop and influence on the needs assessment plan. During the discussion session in the workshop, we received a total of 28 recommendations. Of these, 16 recommendations were incorporated. Eleven helped to improve research methods, 4 to improve stakeholder engagement, and 2 to expand the scope of dissemination. The recommendations and affects that were incorporated are summarized in Table 4. Seven recommendations were beyond the scope of this study, and 5 were relevant but could not be incorporated due to resource limitations. The recommendations that were not incorporated with the reasons why are summarized in Table 5.
Intermediate and long-term outcomes As our research and engagement process is in the early phase, we are not able to assess and report intermediate and long-term outcomes.

Evaluation of stakeholder engagement
Eighty-nine percent of the stakeholders who attended the workshop responded to our interview calls (n ¼33).
Expectations from the engagement process. Only about one-half of the participants mentioned that they were aware of the purpose of the meeting and their specific roles prior to attending the event. Several participants underscored the need of pre-meeting information sharing and preparation before the workshop. One participant said, "I came because my friend couldn't come and she asked me to participate on her behalf. I didn't have any idea of what the program was about." "Role and expectation from all the stakeholders must be clarified earlier. Since there are different levels of stakeholders, clarity is required beforehand" (a participant from principal investigator group of 7Ps framework).

Representation of stakeholders.
Almost all of the participants (32 of 33) said that relevant people were invited. Some suggested to include the following stakeholders in subsequent meetings: 1) caretakers of heart patients; 2) representatives of Female Community Health Volunteers from other areas (in the first meeting, Female Community Health Volunteers from only 1 district were invited); 3) government representatives from local levels; 4) representatives from the Ministry of Finance; 5) consumers' groups; 6) health providers working in rural areas; 7) gender experts; 8) representatives from other ministries; and 9) health economists. Participants from the Ministry of Health and Population suggested that more government representation was required not just in the assessment process but also as researchers or research fellows. One government representative said, "If we aim for changes at the national level, there has to be active participation of government representatives in the research." Degree of involvement. More than one-half of the participants (n ¼ 16) said that they actively participated in the stakeholder workshop and felt that their inputs were accepted and addressed in the discussion. Research team members who were involved in developing the preliminary needs assessment plan chose not to speak much in order to provide more time and space for other stakeholders. All participants unanimously agreed that they were included well in the discussions.
Engagement channels and methods. None of the participants said that the further engagement plan of the stakeholders (4 workshops with similar intensity and activity in 2 years) would be too much. In fact, almost onethird of them said that might not be enough time (n ¼ 11). Participants were also willing to share their views and opinions in the future through phone calls (n ¼ 17), e-mails and letters (n ¼ 21), and in-person meetings (n ¼ 14). More than one-half of the participants believed their task was to inform or consult the project team (n ¼ 15) and about one-third thought that they had to be involved in the process as well (n ¼ 11).  Tables 2 and 3.

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Many participants highlighted that the interactive sessions with smaller groups can be more informative. As 1 participant said, "Rather than long discussions on different topics, it would have been better to have multiple short presentations, followed by interactions among smaller groups on different topics." There was also a concern regarding the heterogeneity of the group, potentially affecting the understandability of the discussions. One participant mentioned, "Patients and caretakers might not be able to grasp the technical details of the presentations and the discussions." Benefits of stakeholder engagement. Almost all participants said that the workshop provided an open platform for a multisectoral group to colearn from each other and share ideas. It helped to enhance the research design process by incorporating expertise and ideas from different perspectives early on. Other benefits that were noted were the following: 1) commitments from policy level; 2) awareness of all relevant professionals on what to expect from CVD prevention and management needs assessment; 3) identification of the gaps in the assessment plan; 4) team building; and 5) enhanced ownership. Some participants stated that participation at the planning phase can lead to the improved implementation of the assessment process, validation of findings, and ownership of the results.
Challenges of stakeholder engagement. About onethird of the participants (n ¼ 10) mentioned that it is challenging to commit time for conducting research. Some mentioned that engaging the same government officials throughout the research process will be difficult because of their frequent transfer. Other major challenges that were noted include the following: 1) difficulties around comprehending and incorporating feedback from such a diverse group of people; 2) varying levels of pre-existing knowledge and expertise, which makes it challenging to discuss with all of them together in a single forum; and 3) challenges around professional or personal aspirations Collect primary data to map the situation of CVD in Nepal Resource limitation Develop and evaluate treatment guidelines for managing hypertension, myocardial infarction, stroke, and other CVD Resource limitation Quantify the health literacy, particularly CVD knowledge in the general population Resource limitation Establish a nationwide surveillance of myocardial infarction, stroke, and rheumatic heart disease Resource limitation Estimate death and disability rates due to CVD using a population-based survey Resource limitation Conduct clinical trials to test effectiveness of various interventions on CVD management Beyond the scope of the study Assess the quality of medicines available in the market Beyond the scope of the study Quantify the antibacterial resistance at the population level Beyond the scope of the study Assess influence of fast food and high sugar beverage consumption on CVD rates Beyond the scope of the study Assess school environments to develop CVD prevention strategy at an early age Beyond the scope of the study Register and monitor tonsillitis among children to prevent rheumatic heart disease Beyond the scope of the study Prepare a lifestyle modification protocol to prevent and manage CVDs Beyond the scope of the study CVD, cardiovascular disease. among stakeholders that may not be relevant to the research process. We have summarized the major challenges, barriers, and the proposed ways to address them for stakeholder engagement in Table 6.

DISCUSSION
We describe the experience of stakeholder engagement in planning the national level needs assessment for CVD prevention and management in Nepal and evaluation of the engagement process. We specifically investigated how the stakeholder engagement affected our needs assessment plan and their feedback to improve the stakeholder engagement process in future. We were able to engage 80% of the targeted stakeholders identified using the 7Ps framework [11], representing different groups of service users, providers and policy makers, patients and public, providers, purchasers, payers, policy makers, product makers, and principal investigators. The recommendations from the stakeholder engagement process led to modifications in our needs assessment plans aimed at improving design, dissemination plan, and further stakeholder engagement.
A core element of stakeholder engagement is the identification and prioritization of stakeholders [9]. The 7Ps framework [11] helped us identify a comprehensive list of relevant stakeholders that are directly affected by CVD or can influence CVD prevention and management. The discussion during the workshop and the post-workshop survey reaffirmed that the list was comprehensive; only a few additions were suggested. We updated our list, and the additional members will be invited in subsequent meetings.
Our stakeholder engagement did not just aim to gather inputs, but it also worked to foster a long-term a relationship throughout the subsequent steps of the needs assessment implementation and uptake of results. Stakeholder engagement is a complex and dynamic process. It is a fundamental step not just prior to any major policy formulation but also necessary throughout the process of program implementation, monitoring, and evaluation [11,12]. We, therefore, sought to involve different stakeholders at different levels. We forged a formal partnership between Kathmandu University School of Medical Sciences (the host institution of the principal investigator) and the NHRC through a Memorandum of Understanding and the creation of the needs assessment task force cochaired by the principal investigator and the executive director of NHRC. This was aimed at creating an equitable relationship between stakeholders and decision makers.
Of 33 total recommendations, 21 contributed to improving the research plan. Other investigators have also reported to have improved research methods and processes through stakeholder engagement [7]. Furthermore, engaging a diverse group led to covering a wide range of recommendations. For example, government representatives highlighted the need to be mindful of the ongoing changes in the national health system due to the ongoing transition to the federal system and around aligning the assessment with continuously shifting government priorities. Representatives from academic institutions underscored the need of academia-policy linkages and suggested sharing research results via policy briefs. The patients emphasized the need for a referral system, improved health information system, and broader access to health services. The pharmaceutical organizations emphasized the need to explore cost analyses of generic drugs and involving quacks (nonlicensed providers) as respondents in assessing the health utilization pattern at the community level.
Almost one-half of the stakeholders were not clear about the purpose of the meeting before attending. Despite this, stakeholders described satisfaction and some expressed willingness to participate more frequently than planned. Almost all participants said that the workshop provided an open platform for the multisectoral group to colearn from one another and share ideas. It helped to enhance research by incorporating expertise and ideas from a different perspective. Stakeholder engagement has been reported to empower stakeholders in other settings [7].
Many participants mentioned that it is challenging to commit time for contributing to the research. Some mentioned that continued engagement of the government officials would be difficult because they are transferred from one place to another within a short time. The challenge of time management has been reported previously. Snape et al. [13] found significant disagreement between stakeholders on the purpose of engagement in research as well as its justification for ethical and patient empowerment grounds.
We have engaged the stakeholders in an early phase of our research. It has been argued that stakeholder partner engagement in early stages of the research process aids in the translation and interpretation of the findings, which ultimately increases the "actionability" of research results [4e11]. By incorporating patients and other stakeholders as partners throughout the research process, they can effectively serve as early ambassadors of research efforts and subsequent findings, which may help to extend to audiences beyond peer-reviewed journals and may facilitate increased uptake of results into the community and health care setting, thereby accelerating its adoption into practice [14e16].
Our study has 3 major strengths. First, it provides a unique perspective on the national health system assessment (for CVD prevention and management) through stakeholder engagement in a low-income setting. Second, we report the process, immediate output, and evaluation of an early stage stakeholder engagement. Third, we have used evidence-informed frameworks to identify the relevant stakeholders and to plan, implement, and evaluate the engagement process, which has facilitated transparency and quality of stakeholder engagement in planning a research. This can facilitate understanding of the best practices of stakeholder engagement.

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This study has some limitations. We were not able to assess the intermediate-level and long-term influence of the research because we are at an early stage of our research. In the future, we plan to evaluate the intermediate-and longterm outcomes using a standard framework. Another limitation is that we used a semistructured questionnaire to evaluate the engagement process. It corroborates with other studies that have described the lack of robust tools available for evaluation of engaged research [7,8].

CONCLUSIONS
Our study reaffirms that stakeholder engagement can positively affect the design of a research process. We received invaluable recommendations from stakeholders, which were incorporated to improve the needs assessment plan. We recommend that a structured evaluation of stakeholder engagement be developed and implemented in the future to accurately examine the intended success of stakeholder engagement. Although this study was small, it provides important insights for future researchers that aim to engage stakeholders in national-level assessment programs in health.