Clinical and Public Health Guidelines最新文献

Health inequalities are differences in health across the population and between different groups in society that are systematic, unfair and avoidable. They are caused by the conditions in which people are born, live, work and grow. These conditions influence peoples' opportunities for good mental and physical health.¹

Reducing health inequalities is one of NICE's core principles. NICE's guidance supports strategies that improve population health as a whole while offering particular benefits to the most disadvantaged. Adopting NICE's recommendations into practice will ensure the care provided is effective and consistent and makes efficient use of resources. And ultimately, it reduces the impact of health inequalities on people's health.²

Generally, a form called Equality and Health Inequalities Assessment (EHIA) is created when developing each guidance topic. EHIA records the approaches used to identify potential equality and health inequalities issues, identifies inequalities issues and how these were considered and addressed at each stage of the guideline development process. However, the EHIA is largely based on the input from the developers and topic experts as well as the health inequalities raised by committee members. Further information on our process and methods can be found in our guidelines manual.³

NICE is exploring new approaches to addressing health inequalities in guidance development. One approach used, and the focus of this brief research report, is the development of the overarching health inequalities briefing to inform health inequality issues on any breast cancer-related topic update.

The health inequalities briefing for breast cancer was a pragmatic, targeted review of evidence exploring the health inequalities associated with breast cancer. It aimed to support both the NICE development team and the committee during breast cancer guidance development to consider health inequalities issues more systematically and transparently. The findings within the briefing also highlighted key gaps in evidence, potential research questions and research recommendations not only to NICE but to the wider health and care system from a health inequalities perspective.

A small technical team was formed to develop a briefing protocol, conduct searches, review and summarise research, interpret findings and undertake independent quality assurance. In the health inequalities briefing, the King's Fund framework (Table 1) for health inequalities was used to synthesise examples of the key health inequalities faced by populations in England across the four dimensions of inequality and five levels of outcomes for each dimension.

To be pragmatic, the initial search focused on real-world evidence, including routinely available data sources, such as national cancer registry datasets and key published reports on inequalities by charities, nongovernm

Important advances in clinical guideline development have emerged in the three decades since David Eddy first introduced the term ‘evidence-based’ into the medical literature.¹ In the early 2000s, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) initiative introduced rating of evidence quality using a range of considerations, rather than mere study-design criteria.² In 2011, a US Institute of Medicine report defined standards for the trustworthiness of clinical guidelines, which required a systematic review of the literature and called for the incorporation of representative stakeholders into guideline panels.³ A parallel report called for routine consideration of evidence from observational studies and randomized trials,⁴ already a provision of the GRADE system. These advances gained traction,⁵ and over the course of the last 10 years, they raised expectations regarding guideline quality.

Yet, the impact of clinical guidelines on practitioner behaviour and clinical care remains in doubt. A 2003 landmark study⁶ found that only around half of eligible patients in the United States were receiving guideline-recommended care. Surveys continue to demonstrate non-adherence and practitioner reluctance to follow guidelines.^{7, 8} Recently, the experience of the coronavirus disease (COVID) pandemic exposed additional barriers and impediments to the adoption and adherence to guideline recommendations in day-to-day practice. Understanding these barriers in the context of the social processes surrounding healthcare delivery and decision-making could be key to increasing the real-world impact of the clinical guideline enterprise. This is the thesis of this commentary.

COVID-19 exposed rifts, inequities and weaknesses in many aspects of society, including flaws in the linkage between research, guidelines and clinical practice. Foremost was the difference between the timescale of change in clinical practice and that of the production, synthesis and incorporation into guideline recommendations of clinical research. This was particularly evident during the first months of the pandemic when the severity of a still unfamiliar illness was at its height.⁹

An historical mission of the Evidence-Based Medicine movement was to close the research-to-practice gap. In 1993, a widely cited article demonstrated a 10-year gap between the emergence of evidence supporting a specific intervention and its acceptance as standard care.¹⁰ The table illustrates the current existence of a similar time lag between the initial planning of a trial capable of definitively changing the evidence base underpinning a guideline recommendation and the incorporation of its findings into a revision (Table 1). Over this time, clinical prac

Guideline development is easy and efficient. With instant access to all the contributing information—all the relevant evidence, critical appraisal of the evidence by the community, values and preferences of public representatives, judgements by multidisciplinary experts, and re-usable data where others have developed recommendations for similar decisions—….

Wait. It's 2024, not 2042. Let's try that again.

Guideline development is difficult and resource-intensive. Even when the decision-making process works well, there is so much work involved to gather the evidence, assess the certainty of the evidence, determine the relative importance of the outcomes and consider contextual factors. It is sometimes easier if we can adapt from others who have already done it, but their work is not fitting what we need, so we essentially recreate the work, using our development methods anyway.

Some aspects of guideline development are necessarily difficult and should not be oversimplified, but there are many opportunities to reduce the work involved. For example, automating tasks that do not require human cognition, such as identifying direct links to supporting information, can greatly improve work efficiency. To realize this potential, the guideline development content will need to be available in a form the computer can process.

Computers could make guideline development more efficient. They already do, to some degree. We copy and paste instead of retyping when we can. We use autocomplete features to enter data when the machine can guess what we want to express, or dropdown lists when the choices are preset for us. We have come to expect massive increases in efficiency at times, such as rapid responses for targeted searching in large databases. Compare that to literature searching before the Internet.

But the essence of our work—understanding the evidence and judgements sufficiently to select information and use it for informing our decisions—is not grasped by the computer. We may try to apply artificial intelligence (AI) to the challenge and occasionally show a tool helps a step in the process (e.g., highlighting population, intervention, and outcome terms in the text),¹ but we have yet to create an AI that understands evidence and judgements.

Imagine if we could make the evidence and judgements computable (i.e., machine-interpretable) so that the computer could create derivative concepts through calculations and logical operations. Searches would be even more efficient. Compare the precision searching for a nearby restaurant when you are travelling to finding evidence for a specific clinical outcome. You can find not only the restaurant's name but also its location, hours of operation and a link to its menu. However, if you find an article that mentions the clinical outcome in the abstract, you still need to obtain the full text, read it to extract the data and make many judgements to determine t

Health guidelines impact clinical, public health and policy practice, but there is no regulation for their development, often leading to variability in quality and trustworthiness. The International Guideline Training and Certification Programme (INGUIDE), established by faculty at McMaster University in partnership and under the auspice of the Guidelines International Network (GIN), addresses this shortcoming by offering structured, evidence-based training and certification for those involved in guidelines (inguide.org). This commentary describes INGUIDE's background, purpose, structure and significance after approximately 3 years of operation. INGUIDE's mission is to enhance the quality of health guidelines globally. It provides comprehensive training to ensure the systematic development of guidelines based on the best evidence and adherence to international quality standards, as reflected in its ISO:9001 certification. The programme also emphasizes capacity building, filling educational gaps, and ensuring the global inclusivity of its courses. INGUIDE's certification covers the entire lifecycle of guideline development and includes several levels of certification, ranging from panel member to methodologist, lead methodologist, developer, chair and instructor certification. The programme already has had a global impact, training over 1500 learners since its launch. INGUIDE is led by a steering committee with input from an international advisory board and operational staff, supported by certified instructors. The programme's vision for the future includes expanding accessibility and creating additional training modules, with a commitment to continuous improvement and adaptation to diverse healthcare contexts, in particular low- and middle-income countries and settings.

The first traceable guidelines in the literature were consensus statements (i.e., recommendations formulated during specialties conferences in the United States) developed by professional associations and based on the participants' experience and opinions. This methodology has been called GOBSAT (Good Old Boys Sat Around the Table), namely, the process by which mainly self-selected experts discuss their (often subjective) opinions and provide recommendations.¹ During the early 1990s, the evidence-based medicine (EBM) movement was born. Clinical practice guidelines gradually started implementing this approach and shifted from the expert-based approach to a process based on systematic reviews to answer clinically relevant questions.² As a result, ‘systematic review’ was incorporated in the definition by, formerly, the United States Institute of Medicine (currently, the National Academy of Health) in 2011: guidelines are ‘statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’.³ This newer generation of evidence-based guidelines quickly became the ideal methodological approach to develop more transparent recommendations. However, the evolution of guidelines was far from ending.

Additional factors were also identified as key to informing the development of recommendations. The consideration of patients' values and preferences, costs and use of resources, the impact on health equity and the feasibility and applicability of the recommended actions have been identified as critical in the recommendation process. In short, guidelines need to provide recommendations supported by evidence but also feasible, affordable, usable and acceptable to users and patients. Therefore, guidelines evolved from consensus-based statements to recommendations that use evidence-based methods to work with research evidence and, later, to systematically consider patients' values and preferences, costs and resources used and the feasibility of the recommendations.⁴

This exciting evolution of guidelines has been possible thanks to the work of many guidelines developers, researchers and users who have contributed for decades to improve guidelines in different ways. It is impossible to list all the key actors that have contributed, but perhaps the most significant milestones in this journey are the emergence of the EBM movement, the development and expansion of systematic review methods, the development of the AGREE tool,⁵ the establishment of the Guidelines International Network (GIN)⁶ and the constitution of the Grading of Recommendations, Assessment, Development and Evaluations working group.⁷

As a paediatrician, I am a guidelines user. However, my

I was not the first person to consider starting a journal dedicated to guidelines. In reality, by the time I presented a proposal formally to the Guidelines International Network (GIN) board in September 2021, the idea to establish a journal (in this digital information age) was far from a novel one. However, it always struck me as odd that although there are tens of thousands of journals with new ones being launched every year, there were no dedicated peer-reviewed scholarly journals focusing on guideline methods or research, or journals publishing solely guidelines. From my perspective as an evidence synthesiser, implementation scientist and guideline methodologist, this seemed incongruous given there are multiple journals dedicated to systematic reviews (both methods and/or the reviews themselves), health technology assessment and implementation science. While these other fields had their scholarly homes for scientific output, guideline development and methods articles remained scattered in the wind.

GIN is a network of organisations and individuals interested in evidence-based guidelines and has one of the world's largest international guideline library and registry. Founded in November 2002 and formally incorporated as a company and a Scottish Charity in February 2003, GIN seeks to improve the quality of health care by promoting systematic development of clinical practice guidelines and their application into practice, through supporting international collaboration. With the benefit of hindsight, perhaps an ideal time to have established a journal for the guideline community would have been during the establishment of GIN—although it is fair to say the original founders had more than enough to focus on. As the old saying goes, ‘the best time to plant a tree was 20 years ago, the second best time is now’—and we believe that now, as the guideline field continues to evolve, the soil is ready for the planting.

In November 2021, the GIN board agreed that an expression of interest for a publishing partner should be drafted. During 2022, this was distributed externally and the board sought feedback and input from the broader GIN community, publishers and others interested in the idea of a journal dedicated to guidelines. After considerable feedback and interest, we were proud to announce Wiley as the publisher for this journal. Once an agreement was put in place, we undertook our next task—identifying the inaugural editor in chief for this journal. It was with great pleasure (and some relief after tough competition for the role) that we were able to recruit Dr Ivan Florez to this role. With his enthusiastic nature, passion for guideline methods, comprehensive understanding of the field along with a keen eye for detail, we know he is the perfect candidate for this critical appointment.

We see this dedicated journal for guidelines (and guideline science) having a number of benefits for both GIN as an organisation and also our mem