Clinical and Public Health Guidelines最新文献

The Society of Obstetric Medicine Australia and New Zealand (SOMANZ) Hypertension in Pregnancy Guideline 2023 is the first evidence-based guideline for hypertensive disorders of pregnancy that has been developed to the standards of the Australian National Health and Medical Research Council (NHMRC). This article describes the methodology, challenges and considerations in developing the guideline and includes details on group composition, literature search, evidence synthesis and development of recommendations. We also discuss several practical considerations and challenges related to contextual issues, topics of interest and resources available for guideline developers working with similar jurisdictions or topics.

A core outcome set (COS) is ‘an agreed standard set of outcomes that should be measured and reported, as a minimum in trials for a specific health condition’,¹ developed via consensus with stakeholders. Although the focus on COS originated on randomised trials, their use in systematic reviews, routine care, audit and, importantly, in clinical guidelines, is being increasingly recognised. The core outcome measures in effectiveness trials (COMET) initiative is an organisation for anyone interested in the development and application of COS and they host a database of studies relating to COS (https://comet-initiative.org/Resources/Database).

There are at least three main reasons why we would advocate the use of a relevant COS when developing a clinical guideline. First, there is the desire to have a research ecosystem where this minimum set of outcomes considered and reported in trials, combined in systematic reviews and used for clinical decision-making and monitoring patient progress are the same. Consistency will reduce bias and increase efficiency, and COS are a means to facilitating this. Second, it reduces duplication of effort. COS developers go through a rigorous, transparent process and involve all relevant parties including patients and members of the public in determining the outcomes of critical importance;^{1, 2} guideline authors commonly repeat an almost identical procedure. Third, using COS in guidelines would encourage researchers to consider using them when designing trials.

The International Guideline Development Credentialing and Certification Programme (https://inguide.org/) mentions COS and some guideline organisations, including National Institute for Clinical Excellence (NICE) in the United Kingdom (https://www.nice.org.uk/), recommend the use of COS in their manual. However, to date, very little is known about the consideration and use of COS by guideline authors. We conducted a piece of research to examine whether or not COS were being referenced in guidelines and the extent to which the guideline outcomes selected agreed with outcomes listed in a relevant COS.³ We focussed on 10 disease areas with a published high-quality COS and 38 guidelines with matching scope. What we found is that none of those guidelines explicitly mentioned or referenced the COS, and the agreement between the guideline outcomes and COS outcomes was variable. Although limited in terms of disease groups and geographical coverage, this exercise tells us that guideline authors are not yet routinely considering COS when choosing outcomes for their PICO statements (PICO is a framework to construct clinical questions and stands for Population, Intervention, Comparator and Outcome).

These findings were presented at the 2023 GIN conference in Glasgow and the response from the guideline community was very encouraging. We ran a workshop introducing the COMET database and d

Established at the Guidelines International Network (GIN) annual conference in 2013 in San Francisco, the GIN Multimorbidity Working Group has existed for 10 years. Its aim was and is to explore the questions of how and to what extent multimorbidity and its related constructs can be reflected in guideline development. A major methodological challenge is to find a balance between not getting lost in the thousands of different disease combinations and formulating recommendations that are useful in everyday clinical practice.

Cynthia Boyd, founding member and first chair of the GIN multimorbidity working group, published a frequently cited article on the accumulation of guideline recommendations for an individual 72-year-old patient with multimorbidity. She described the complexity of the patient's condition and the number of diagnoses that can affect the number of guideline recommendations and thus maximize the treatment burden for those involved.¹ Today, 18 years later, the topic of multimorbidity, with its associated phenomena such as polypharmacy, is well established and a topic of several guidelines.^2-5

There are a variety of definitions of multimorbidity, from the simple counting of diagnoses to the use of complex indices that account for disease severity and drug therapy, biopsychosocial and somatic risk factors.^{6, 7} They all have in common that multimorbidity is defined as the simultaneous presence of several chronic diseases, with no one disease initially taking priority.⁸ In contrast, if one disease is dominant (called index disease), the term co-morbidity is often used.⁹

In recent years, it has been recognized that ‘too much medicine’ is being practiced overall and that many diagnostic and therapeutic measures are either superfluous at best or often even harmful.¹⁰ Since too much medicine is a widespread problem across all medical disciplines, it is obvious that the overwhelming number of symptoms and problems associated with multimorbidity can lead to an abundance of diagnostic and therapeutic measures. Moreover, too much medicine means an increase in treatment burden and potential harm for the multimorbid patient.

A key issue for the GIN Multimorbidity Working Group is how guidelines for multimorbidity can address this problem. How can we ensure that the necessary is done and the unnecessary avoided for people with multimorbidity? Last but not least, how can the ‘less-is-more approach’ to multimorbidity be implemented?

At the GIN Annual Congress 2023 in Glasgow, the working group discussed the scope and purpose of guidelines, healthcare system issues and guideline developers' challenges.

The working group cited the hamster wheel phenomenon as a major system-related flaw. Across healthcare systems and countries, every medical discipline suffers from a seemin

Living evidence methods, such as those used to produce living guidelines, can evolve over time as the context or evidence changes. In Australia, the National Clinical Evidence Taskforce has been developing living guidelines for the management and care of people with coronavirus disease 2019 (COVID-19) since March 2020, undertaking daily searches, and producing over 130 updates of more than 200 recommendations. Over the 3 years of the guidelines, the methods have also been ‘living’. In this paper, we describe why, how and with what impact changes to our methods have been made. When changes were required to the methods, the Taskforce Evidence Team developed a ‘Methods Brief’ outlining the proposed changes, rationale and any risks. This was presented to the Guidelines Leadership Group for approval and to the Steering Committee for noting. Changes were then reflected in the online, publicly available description of our methods. Methods to develop the living guidelines evolved through five phases, reflecting changes in the availability of evidence, the degree and nature of clinical uncertainty and resource availability. Largely these changes were to the criteria we used to select evidence for inclusion, and our expected level of responsiveness to new evidence. In the initial phases, inclusion criteria were very broad, and as the evidence base stabilised our focus narrowed to areas of high clinical importance and evidence certainty. The rapidly evolving nature of the pandemic, understanding of the illness, clinical questions and evidence base during development of the living COVID-19 guidelines, necessitated multiple changes to the methods used to produce the guidelines. In this context, the ongoing revision of the methods for living guideline production was a necessity and a strength of the living approach. Questions remain about how best to ensure rigour is maintained while methods evolve.

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