1 INTRODUCTION

Health guidelines produce arguably the most influential scientific publications, often cited thousands or tens of thousands of times.^1-3 Furthermore, guidelines are some of the most wanted products of health professionals who organize in professional societies and are the source of widely used products such as UpToDate and DynaMed, thereby having an important effect on practice. However, there is ongoing concern about guideline quality and health guideline development is not regulated universally.^4-6 Without regulation, anyone can develop a health guideline. Indeed, most people involved in guideline development, for example, through membership on a guideline development group or guideline panel, are not specifically trained to create guidelines. Yet, health guidelines should meet quality standards and their development requires a combination of clinical, public health or other content skills, research methodology training, and social and management skills.

Authorization requirements to conduct activity in the health field exist for nearly any health profession through licensing or certification, but health guideline development does not require specific certification. This creates a conundrum. Usually, highly regulated professions create guidelines, while the skills for creating them, that is, guideline science and practical aspects, are not taught in the vast majority of health professional or university programmes. The conundrum is understandable because of the highly packed curricula and the science about health recommendations in guidelines is very specialized. However, the lack of formalized training and certification is concerning, because individual health professionals may treat hundreds or perhaps thousands of people, but guideline recommendations affect most health professions and millions of people. For instance, global World Health Organization (WHO) infectious disease guidelines on tuberculosis or malaria or guidelines for cardiac or respiratory diseases developed by major professional societies or governmental organizations affect millions at a time.

Training about guideline development was typically restricted to single introductory lectures or minimal preparation. As faculty members at McMasters University working in guideline sciences, we began to think that this was a problem. We teamed up to create - with and under the auspice of the Guideline International Network (GIN)—the International Guideline Training and Certification Programme (INGUIDE) (INGUIDE.org). This commentary describes INGUIDE's background, purpose, structure, and significance after approximately 3 years of operation. Additional articles will describe the methods to create the programme, how it was piloted, its detailed training and certification methods, the learners' demographics including country of origin, performance, feedback and evaluation, and other aspects of the programme.

2 RATIONALE FOR INGUIDE

Numerous organizations have provided standards for guideline development.^7-11 While tools to plan, report and critically appraise guidelines according to these standards exist, a globally accepted certified training for guidelines as a health profession did not exist before INGUIDE.^{12, 13} We obtained agreement on the benefit of professional training with the GIN Board of Trustees (BoT) in 2016, and during subsequent BoT meetings our proposals were discussed and finally accepted by the GIN BoT. Following this decision, we created INGUIDE to provide standardization where possible, quality improvement and global capacity building in guideline development and implementation. Because of the available scientific and financial backing from investigator-initiated research funding, we initiated this programme at the McMaster GRADE Center in collaboration with GIN that provided a minority investment (see below for organization and leadership of the programme). We believed that GIN was the ideal partner and umbrella organization to host such a programme because of its vision (Trustworthy and accessible guidance for better health) and mission ‘to lead, strengthen and support collaboration and work within the guideline development, adaptation, and implementation community’.

3 OVERVIEW, MISSION AND GOALS OF INGUIDE

Thus, INGUIDE was created to elevate the quality, effectiveness, and global reach of health guideline development, providing comprehensive resources, training, and certification to those involved in the guidelines.

4 INGUIDE's STRUCTURE AND CERTIFICATION LEVELS

The programme covers the full lifecycle of guideline development, including planning, implementation, evaluation and updating of practice guidelines. Courses are structured according to the GIN-McMaster Guideline Development Checklist tool and can be tailored to suit the needs of various organizations and trainees.¹⁵ It provides methodological skills, such as applying or understanding systematic reviews and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach in the context of guidelines, and focuses on practical aspects, such as using the guideline participant tool and chair's checklist.^16-18 The evidence-to-decision approach presents a major component of methods-focused training.^{7, 19, 20}

The INGUIDE team tracks learners' progress and keeps certified individuals in a database. We previously labelled the courses as levels 1 through 4, but while advancement to the next level requires certification in the prior, we removed the numbering for at least two reasons. First, most learners, intentionally, will only complete the guideline group or member certification course because that is where their involvement with guidelines stays. Second, INGUIDE also has special focus modules. As of late 2023, these include a quality assurance and a GRADE adolopment module.^{21, 22} A specific certification course for clinical and content chairs that will focus on the group leadership part of the lead methodologist and chair certification is nearly completed and future modules will include more specialized training, including on testing and diagnosis and more specific GRADE modules. To create these modules and training opportunities as well as ISO:9001 certification requires time and effort, but we have ambitious timelines. Through an increasing number of certified instructors, our goal is to increase the global capacity in creating these quality-assured training opportunities. The figure provides an overview of the organization, oversight, training courses, certification approach and contributors to the INGUIDE programme (Figure 1).

5 OTHER CORE COMPONENTS

We developed a guideline-matching service to facilitate the alignment of training and resources with the needs of individuals and organizations (https://inguide.org/panel-matching/). This service allows both trained individuals and organizations seeking INGUIDE-trained individuals to connect. We felt that obtaining ISO:9001 Certification demonstrates the programme's commitment to international quality standards in health guideline development, that is, the quality of our programme is monitored independently.

6 GLOBAL IMPACT, COLLABORATIONS AND TRANSLATIONS

Since the launch of the INGUIDE programme, over 1500 learners have been trained across its various certification levels. Specifically, the programme has seen more than 1,200 learners enroled in the ‘Guideline Group or Panel Member Certification’ since its inception in September 2020. Additionally, the ‘Guideline Methodologist Certification’ has enroled over 300 learners since its launch in May 2021, over 60 individuals have been trained for “Lead methodologist, guideline developer and chair certification” since its launch in September 2022, and 10 individuals have been trained as guideline development instructor since September 2023. A separate publication will describe the experience, feedback, and demographics of these global learners. We specifically partnered with the European Commission to develop the quality assurance and improvement module and with the WHO to support guideline adolopment through a dedicated module. Furthermore, we have a partnership with the Canadian Royal College of Physicians and Surgeons and offer continuing medical education credits. In addition, we have translated material into Chinese, French and Spanish and are conducting translation efforts in several other languages to create global capacity of certified guideline developers.

7 SUCCESS STORIES AND TESTIMONIALS

We already have numerous success stories and learnings. One of our early partners, the Endocrine Society trained their methodologists and guideline panel members through INGUIDE.²³ Furthermore, because of their commitment to quality guideline development group members of major organizations have been trained, such as the European Commission, the WHO, the Public Health Agency of Canada, the Endocrine Society and the European Academy of Allergy & Clinical Immunology (EAACI) to name a few. Testimonials from trainees or organizations that have benefited from the programme are listed on our website (https://inguide.org/testimonials/). These success stories will be described in more detail in future articles. We also have learned that the developments in the guideline science will require updating of courses—something we have already done—and that language translations require careful attention to keep material consistent between different courses. We also created an international advisory board to ensure we keep the programme aligned with global developments.

8 ORGANIZATION AND LEADERSHIP OF THE PROGRAMME

9 FUTURE DIRECTIONS AND ASPIRATIONS

Operation of the programme is costly and time-consuming. Our vision for the future impact of INGUIDE on global health guidelines and recommendation development is that we are seeking independent funders to support us in offering capacity building globally at no or minimal cost to participants in low- and middle-income countries and settings. In addition, accessibility is enhanced by offering courses in various languages, which requires careful coordination and resources. Furthermore, we are looking at developing additional modules to cover the breadth of guidelines development. Readers are encouraged to connect with us and suggest priorities to help us create that strategy (https://inguide.org/contact/).

10 CONCLUSION

In summary, INGUIDE was created to elevate the quality, effectiveness, and global reach of healthcare guideline development, providing comprehensive resources, training, and certification to guideline creators under the auspices of GIN, a Scottish registered charity.

AUTHOR CONTRIBUTIONS

Holger J. Schünemann: Conceptualization; funding acquisition; writing—original draft; resources; writing—review and editing; methodology; visualization; project administration. Robby Nieuwlaat: Writing—review and editing; conceptualization; methodology; resources; visualization; project administration.

CONFLICT OF INTEREST STATEMENT

This commentary was invited. Holger J. Schünemann (HJS) is member of the Editorial Board of Clinical and Public Health Guidelines, but he did not participate in the editorial process of this paper and had no influence on the editorial decisions related to it. HJS and Robby Nieuwlaat (RN) are creators of INGUIDE, members of the steering committee and programme directors of the INGUIDE programme. HJS is chair of the steering committee and co-chair of the GRADE Working Group. HJS and RN conducted the work until now while being at McMaster University. HJS now maintains an emeritus appointment at McMaster University but his primary appointment is at Humanitas University, Milan, Italy. Coincidentally, HJS is the current chair of the Guidelines International Network (GIN) and is recused from decisions about INGUIDE at GIN board of trustees meetings. They have not received direct payments through the INGUIDE programme.

ETHICS STATEMENT

The authors did not seek ethics board review for this invited commentary.