A New Era of National Guideline Development in Saudi Arabia

Saudi Arabia’s ambitious Vision 2030 project was launched in 2016 as a strategy for economic development and national growth, with 11 Vision Realization Programs put in charge of its implementation. The backbone of its Transformation Program for the Health Sector has been the definition of a new Model of Care aiming to deliver 42 coordinated interventions across 6 Systems of Care, with the development of clinical guidelines identified as a key cross-cutting intervention to foster the use of national, evidence-based practices across KSA, reduce care variation, and promote accountable care. This article provides an overview of the history, progress to date, and future outlook of the recently initiated National Guidelines Center in Saudi Arabia, established in collaboration between the Health Holding Company and the Saudi Health Council represented by its National Center for Evidence-based Medicine. The lessons learnt from previous guideline initiatives are grouped under the Center’s design principles of high quality, relevance, practical implementation, and sustainability. Aspects setting the project apart from previous endeavors have been its focus on extensive engagement with key stakeholders in the Saudi guideline ecosystem, the co-development of evidence-based recommendations with aligned key performance measures, and the implementation of guideline recommendations in the clinical workflow via integrated electronic order sets. Nine activity streams aim to enable the Center to take its place among the leading regional and global guideline developing organizations and to optimally support clinicians and patients, Saudi Arabia’s health sector transformation, and the work of guideline communities worldwide.


Introduction
Saudi Arabia (KSA) has one of the highest healthcare expenditures in Gulf Cooperation Council countries (GCC), as well as one of the highest densities of medical professionals per thousand residents [1]. This allows KSA Ministry of Health to provide wide health coverage to both Saudi citizens and expatriates through its widely distributed network of hospitals and primary healthcare centers. Health services in Saudi Arabia (KSA) are provided free of charge to all Saudi citizens and expatriates working in the public sector. All expatriates' workers living in KSA are required to have private health insurance covered by their employers. Health services for this population are provided through the rapidly flourishing private sector.
However, non-communicable diseases, particularly diabetes and obesity, continue to burden the kingdom, and are a major target of preventive care screening policies. It has been estimated that the obese population will reach 73% by 2025 [1]. Conversely, communicable diseases, particularly maternal, and neonatal-associated diseases, have observed a steep decline according to data from 2019 compared to 1990 [2].
In response to this situation in 2016, Saudi Arabia launched the ambitious Vision 2030 project as a strategy for economic development and national growth. Eleven Vision Realization Programs (VRPs) have been put in charge of its implementation, including a dedicated VRP and Transformation Program for the Health Sector [3,4].
The backbone to healthcare transformation is the definition of a new Model of Care that, among other objectives, aims to deliver 42 coordinated interventions across 6 Systems of Care (Keeping well; Planned procedure; Women & children; Urgent problems; Chronic conditions; and Last phase of life) responsible for the delivery of all health services ( Fig. 1) [5]. The development of clinical guidelines had been identified as a key cross-cutting intervention.
Key to achieving the healthcare transformation within the kingdom's Vision 2030 program was to promote the use of national, evidence-based practices across KSA to reduce care variation and promote accountable care, through regular adaptation/development, alignment, training, and dissemination of localized clinical practice guidelines.
In close collaboration with the Saudi Health Council (SHC) represented by its National Center for Evidence-based Medicine, the Health Holding Company (HHC)-established by the Saudi Ministry of Health to drive its Model of Care Health Sector Transformation strategy-has initiated a National Guidelines Center to guide clinical practice and be the advocate for evidence-based medicine, thereby improving the wellbeing of its nation in a sustainable, standardized, and accountable manner.  (SCHS) and other ministries like the Ministry of Economy and Planning, the Ministry of Labor and Social Development and the Ministry of Finance. Key among its many tasks of the SHC was to prepare the healthcare strategy in KSA, issue appropriate regulations to ensure that hospitals run by the Ministry of Health and other government agencies are operated in adherence to the principles of economic management as well as performance and quality standards and development and approval of policies for the coordination and integration between all healthcare providing authorities.
Over the last few decades, numerous organizations across Saudi Arabia have independently undertaken the task to create documents aimed at guiding clinical decisions, such as guidelines, consensus documents, pathways, and protocols [6]. Despite the dedication and hard work of the involved experts, these largely disjointed efforts have been hampered by numerous factors, which have resulted in a lack of reliable, clinically credible, accessible, locally applicable, and nationally adopted guidelines, ultimately impacting on the overall healthcare objectives of the Saudi Vision 2030 project. In response, HHC and SHC developed a strategic plan to address these limitations aligned with the six guiding principles for the project: (i) promote evidence-based medicine; (ii) drive value-based care; (iii) enhance patient and health outcomes; (iv) leverage local and international data-driven clinical guidance; (v) operate in an inclusive and collaborative manner within the ecosystem; and (vi) focus on both curative and preventive health. Table 1 lists the lessons learnt from previous guideline initiatives, reflecting the Center's design principles of high quality, relevance, practical implementation, and sustainability.
Important aspects setting our project apart from previous endeavors and aiming to inform similar endeavors worldwide include its focus on extensive engagement with key stakeholders in the Saudi guideline ecosystem, the co-development of evidence-based recommendations with aligned key performance measures, and the implementation of national guideline recommendations in the clinical workflow at the point of care via integrated electronic order sets.

Project Progress to Date
As of October 2022, several milestones have been reached including: (i) documentation of the Center's vision and mission, charter, goals, processes, and policies; (ii) extensive stakeholder engagement with organizations active in the Saudi guideline ecosystem; (iii) confirmation of the SHC National Center for Evidence-Based Medicine as the most suitable entity to host the center following consultation among 19 stakeholder organizations using a RACI (Responsible/Accountable/Consulted/Informed) framework; (iv) based on a data-driven impact/effort analysis, selection of the initial 12 guideline topics as follows: Chronic kidney disease, Dental caries, Community-acquired pneumonia, Cesarean section, Stroke, Sepsis, Acute gastroenteritis in children, Low back pain in adults, Mechanical ventilation, Chronic obstructive pulmonary disease, and Depression; (v) Recruitment of Clinical Leads and multidisciplinary Task Forces for all topics; and (vi) Development of a multi-component dissemination and implementation strategy.

Future Outlook
Over the upcoming months, work will focus on (i) completing the Center's first 12 guidelines; (ii) approving the guidelines by the National Center for Evidence-Based Medicine's Scientific Committee; (iii) disseminating the guidelines via multiple channels including a website, mobile apps, and educational events; (iv) implementing national guideline recommendations at the point of care through localized order sets embedded in the electronic health record at selected pilot sites; (v) finalizing the Center's internal team and infrastructure; (vi) disseminating guidance on the GIN criteria for giving a seal of approval as national guidelines to those developed by other guideline organizations [7]; (vii) developing certified learning modules for a national training program for guideline development; (viii) fostering partnerships and collaborations with key stakeholders in the guideline ecosystem within Saudi Arabia as well as across the Middle East and worldwide; and (ix) establishing its strategic objectives for the upcoming years. This will enable the National Guidelines Center to realize its ambitious plans for extensive topic coverage, to take its place among the leading regional and global guideline developing organizations, and to optimally support clinicians and patients, Saudi Arabia's healthcare transformation strategy, and the work of guideline communities worldwide. In line with global best practice, stakeholder buy-in and ownership has been sought from the earliest stage of the project via extensive stakeholder consultation in the form of 3 workshops, 2 surveys, and 10 post-survey interviews for alignment with over 60 key stakeholders during formulation of foundational Guidelines Center documents, policies and processes (Vision, Mission, Charter, Design principles, Guideline Development Processes, Conflict of Interest Policies, Governance Structure, Guideline Topic Selection etc.) [12] End users and representatives of key stakeholder organizations involved in the healthcare process or guideline implementation are invited to participate in peer review Utilize local expertise Guideline development is undertaken (with the help of a methodology and administrative support team) by multidisciplinary panels ("Task Forces") of around ten people each, comprised of local healthcare professionals across the specialties relevant to the guideline The selection of clinical questions by guideline task forces is informed by local clinical priorities and needs for each topic and usually covers several settings and/or areas across the care continuum such as prevention, diagnosis, treatment, discharge, and follow-up Focus on local needs and value The selection and prioritization of guideline topics is based a multicomponent framework comprised of guideline impact indicators (such as local or regional epidemiology and disease burden) and effort parameters (e.g. availability and maturity of local care pathways, national guideline centers or teams) Value is built into the very fabric of the project and the Center, for example through Close involvement of the Center for Improving Value in Health (https:// cvalue. sa) Input on topic selection and other strategic decisions from insurer and payer organizations Systematic consideration of cost as one of the contextual factors when formulating guideline recommendations Acknowledgements All Health Holding Company and Saudi Health Council leadership and staff involved in the guideline development and all the guideline task forces leads and team members Author Contributions All authors contributed equally.
Funding No funding was granted.
Data Availability Not applicable.

Design principle 3: practical implementation Develop a varied and timely dissemination and implementation strategy
The guidelines produced by the Guidelines Center will be disseminated to end users through online and offline channels including a website, mobile apps, publications, and educational events Order sets in electronic patient record systems at selected pilot sites are being aligned with the new national guidelines, enabling automated monitoring of clinical adoption and impact Key performance indicators are being co-developed for selected recommendations to provide starting points for local audits and quality improvement initiatives to drive guideline use and adherence Design principle 4: sustainability Identify the optimal long-term host for the National Guidelines Center HHC has conducted interviews with 18 stakeholder organizations across the Saudi guideline landscape to establish the most effective future governance model for the Center that resulted in consensus for a National Guidelines Center to move to the SHC and its National

Consent for Publication Not applicable.
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