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Busse R, Klazinga N, Panteli D, et al., editors. Improving healthcare quality in Europe: Characteristics, effectiveness and implementation of different strategies [Internet]. Copenhagen (Denmark): European Observatory on Health Systems and Policies; 2019. (Health Policy Series, No. 53.)

Improving healthcare quality in Europe: Characteristics, effectiveness and implementation of different strategies [Internet].

9 clinical practice guidelines as a quality strategy.

Dimitra Panteli , Helena Legido-Quigley , Christoph Reichebner , Günter Ollenschläger , Corinna Schäfer , and Reinhard Busse .

What are the characteristics of the strategy?

Clinical guidelines (or “clinical practice 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”. They have the potential to reduce unwarranted practice variation, enhance translation of research into practice, and improve healthcare quality and safety, if developed and implemented according to international standards. They can be used to provide best practice recommendations for the treatment and care of people by health professionals, to develop standards to assess the clinical practice of individual health professionals and healthcare organizations, to help educate and train health professionals and to help patients make informed decisions. A valid guideline has the potential of influencing care outcomes, but for that it needs to be effectively disseminated and implemented (informing processes of care).

What is being done in European countries?

Less than half of European countries surveyed in 2011 reported having an official basis for guidelines, although implementation still mostly took place on a voluntary basis. Across countries guidelines can be developed at national, regional and/or local level; in most cases professional associations are involved in the endeavour. About one third of countries have a central agency developing clinical guidelines in collaboration with professional associations; several countries reported having multiple levels of clinical guideline development, with regional and local bodies as well as several professional organizations contributing to the centrally coordinated process; finally, fewer countries had no central coordination of the guideline development process at all: professional associations or providers often step in to fill the void. Countries with “well established” activities and wide experience in guideline development and implementation include Belgium, England, France, Germany and the Netherlands; many others have introduced some form of guideline production. There is no newer systematically collected evidence along these lines, but varying degrees of progress can be expected among countries depending on recent reform activity.

What do we know about the effectiveness and cost-effectiveness of the strategy?

A systematic review carried out in 2011 found that while significant effects on outcomes have been measured in some studies, others show no or unclear effects of treatment according to guideline recommendations. Newer studies also show mixed results regarding the effect of guidelines on outcomes, but a clear link with implementation modalities. Regarding cost-effectiveness, the scope of evidence is even more limited. Most of the relevant studies only partially accounted for costs incurred in the process of guideline production. Given the vastly differing practices in guideline production across countries and contexts, an overall conclusion on whether the strategy as a whole is cost-effective or not is very difficult to draw.

How can the strategy be implemented?

There is increasing consensus that incorporating implementation considerations already in the guideline development process can have a substantial influence on implementability, and a number of tools have been developed for that purpose. The uptake of clinical guidelines is influenced by factors that fall under two broad aims: the creation of content and the communication of that content. Education for professionals or patients and print material are the most commonly employed strategies for translating guidelines to practice, but practices vary considerably and gaps have been identified both in the scope and follow-up of interventions. Despite the general recognition of the importance of implementation tools, most guidelines have been found to not be accompanied by such applications. One of the most prominent developments in the area of guideline implementation in recent years has been the increased utilization of information technologies to facilitate guideline adherence, such as decision support software, and the use of guidelines at the bedside, such as mobile guideline apps. Guideline formats that support shared decision-making have been gaining focus in recent years, as has the importance of editorial independence and declaration of conflicts of interest.

• Conclusions for policy-makers

The overview of country-specific practices presented in this chapter clearly demonstrates how divergent guideline practices can be, especially when viewed as national strategies for quality improvement. The fact that in several countries practitioners “borrow” recommendations produced abroad combined with existing international initiatives points to a considerable potential for more active knowledge exchange in the future. However, the context-specific nature of produced guidelines must always be taken into account. A lot has already been undertaken in the context of guideline adaptability but earlier, more intensive collaboration might be fruitful, especially on issues such as optimizing guideline development and implementation in the age of multimorbidity. There is currently no discussion about centralizing the dissemination (let alone the development) of guidelines at EU level, but perhaps it is time to consider such a mechanism, especially given the recent suspension of the USA-based clearinghouse that served internationally as a frequently used resource.

9.1. Introduction: the characteristics of clinical practice guidelines

Clinical practice guidelines (in this chapter simply “clinical guidelines”) have been defined by the US Institute of Medicine (IOM, 2011 ) as “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”. They can be used to: inform individual clinical decision-making, provide best practice recommendations for the treatment and care of people by health professionals, develop standards to guide and assess the clinical practice of individual health professionals and healthcare organizations, help educate and train health professionals, and help patients make informed decisions (ESF, 2011 ).

As per their definition, clinical guidelines are part of the armamentarium of evidence-based medicine (EBM). The term “evidence-based” in relation to healthcare practices found its first use in the early 1990s as one of the possible bases for the development of clinical guidelines (Eddy, 2005 ). It subsequently became increasingly well-established in the context of evidence-based medicine, which came to be widely understood as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients” (Sackett et al., 1996 ). The main idea behind this definition, namely relying on scientific evidence with low risk of bias to inform decision-making, increasingly permeated practices beyond the individual patient level, not only in the aforementioned field of clinical guidance development but also in the context of coverage decision-making (Eddy, 2005 ), mainly through the use of Health Technology Assessment (HTA; see Chapter 6 ).

Both clinical guidelines and HTA are based on the same foundation, that is the synthesis of available clinical evidence in a manner that is useful to their intended users, particularly in light of the ever-increasing volume of primary research. As such, they are both knowledge translation tools. However, HTA focuses on a particular intervention and mainly addresses policy-makers’ needs and questions whilst clinical guidelines are primarily focused not on a narrow clinical question but on broader and more complex topics (i.e. disease management), as well as on supporting clinical practice. As such, they are part and parcel of structuring the knowledge base underpinning the work of healthcare professionals. However, given their common scientific rationale, clinical guidelines and HTA may inform each other’s development ( see Table 9.1 ).

Evidence-based medicine, clinical guidelines and HTA in context.

For clinical guidelines, another important distinction to make is that from clinical pathways. Despite the fact that the definition of a clinical pathway varies ( see Chapter 12 ), they generally aim to operationalize translated knowledge and transform it into everyday care processes; they tend to focus on the care of patients within one provider institution and ensure flow of information throughout the treatment process. Where guidelines tend to focus on specific physician-patient decisions (what should be done), pathways tend to focus more on the operational and logistical aspects (who should do what, when and where). A similar distinction can be made between clinical practice guidelines and clinical protocols or bundles ( see JCI, 2016 ). The development of clinical pathways and other operationalization tools can be informed by clinical guidelines ( see also Kredo et al., 2016 ).

To reiterate, clinical guidelines focus on how to approach patients with defined healthcare problems either throughout the entire care process or in specific clinical situations. As such they can be considered as a tool to inform healthcare delivery, with a specific focus on the clinical components, considering the practice of medicine as an applied science. However, it is important to understand the difference in terminology used in international literature regarding the different components of transforming evidence-based clinical practice at the provider level. Box 9.1 provides such a disambiguation of relevant terms (Wiles et al., 2017 ). The aim of this chapter is to provide an insight on the role clinical guidelines can and do play as healthcare quality improvement tools in the European context and highlight potential open questions for future research.

Terminology around clinical guidelines.

9.2. Why should clinical guidelines contribute to healthcare quality?

Clinical guidelines have the potential to reduce unwarranted practice variation and enhance translation of research into practice. In the context of Donabedian’s triad (the fourth lens of the five-lens quality framework presented in Chapter 2 ), the overall hypothesis is that a well developed guideline which is also well implemented will help improve patient outcomes by optimizing the process of care (IOM, 2011 ; Qaseem et al., 2012 ; see Fig. 9.1 ). However, cross-fertilization with other knowledge translation tools, such as HTA, could in theory extend their influence to structural elements as well.

Influence of clinical guidelines on process and outcomes of care. Source: Grimshaw et al., 2012

For clinical guidelines to have an actual impact on processes and ultimately outcomes of care, they need to be well developed and based on scientific evidence. Efforts to identify the attributes of high-quality clinical guidelines prompted extensive debates on which criteria are most important. Desirable attributes of clinical guidelines were defined by the IOM in 1990 ( Box 9.2 ). The Council of Europe ( 2001 ) endorsed both the use of guidelines themselves and the importance of developing them based on a sound methodology and reliable scientific evidence so as to support best practice. With the increasing interest in the implications of guideline use, methodologies for their development, critical assessment, dissemination and implementation, as well as their adaptation and updating, have been developed and several studies on their appropriateness and usefulness have been carried out ( see below).

Desirable attributes of clinical guidelines.

Regarding guideline development, a number of guidebooks in different formats are available from different actors in different contexts (“guidelines for guidelines”; see , for example, Shekelle et al., 1999 ; Woolf et al., 2012 ; and Schünemann et al., 2014 ). Increasingly since its inception in 2003, guideline development tools include the GRADE approach (Guyatt et al., 2011 ; Neumann et al., 2016 ; Khodambashi & Nytrø, 2017 ). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was created by the synonymous working group, 1 which is a collaborative consisting mainly of methodologists and clinicians. It provides a framework for assessing the quality (or “certainty”) of the evidence supporting, inter alia, guideline recommendations and therefore their resulting strength (GRADE Working Group, 2004 ). Essentially, GRADE classifies recommendations as strong when a recommended intervention or management strategy would presumably be chosen by a majority of patients, clinicians or policy-makers in all care scenarios, and as weak when different choices could be made (reflecting limited evidence quality, uncertain benefit-harm ratios, uncertainty regarding treatment effects, questionable cost-effectiveness, or variability in values and preferences ( see , for example, Vandvik et al., 2013 )). The GRADE evidence-to-decision framework further helps guideline developers in structuring their process and evaluation of available evidence (Neumann et al., 2016 ).

On the user side, several tools to evaluate (“appraise”) the methodological quality of clinical guidelines exist (for example, Lohr, 1994 ; Vlayen et al., 2005 , Siering et al., 2013 ; Semlitsch et al., 2015 ). The most commonly used instrument to assess the quality of a guideline is that developed by the AGREE (Appraisal of Guidelines for Research and Evaluation) Collaboration, initially funded through an EU research grant. The instrument comprises 23 criteria grouped in the following six domains of guideline development addressed by the AGREE instrument in its second iteration (AGREE II): scope and purpose; stakeholder involvement; rigour of development; clarity and presentation; applicability; and editorial independence (Brouwers et al., 2010 ). To facilitate the consideration of AGREE II elements already in the guideline development process, a reporting checklist was created in 2016 (Brouwers et al., 2016 ). There have been calls for more content-focused guideline appraisal tools, as existing options were considered by some to be mainly looking at the documentation of the guideline development process (Eikermann et al., 2014 ). At the same time, there is recognition that the development of good clinical guidelines often requires trade-offs between methodological rigour and pragmatism (Browman et al., 2015 ; Richter Sundberg, Garvare & Nyström, 2017 ). Several studies have evaluated the overall quality of guidelines produced in certain contexts, invariably demonstrating that there is considerable variation in how guidelines score on the various AGREE domains (for example, Knai et al., 2012 ). However, there seems to be an overall improvement in quality over time (Armstrong et al., 2017 ). Research shows that while guideline appraisals often use arbitrarily set AGREE cut-off scores to categorize guidelines as being of good or bad quality (Hoffmann-Eßer et al., 2018b ), the scoring of specific criteria, such as rigour of development and editorial independence, seems to be the major influencer of final scores (Hoffman-Eßer et al., 2018a ).

Beyond the methodological quality of the guideline itself, however, the issue of applicability is also of great importance ( see also Box 9.2 ). Heffner noted that as guidelines were rarely tested in patient care settings prior to publication (as would a drug before being approved), the quality of clinical guidelines is defined narrowly by an analysis of how closely recommendations are linked to scientific and clinical evidence (Heffner, 1998 ). This concern remains today, though it is now more explicitly addressed ( see , for example, Steel et al., 2014 ; Li et al., 2018 ), raising the question of whether guidelines should be systematically pilot-tested in care delivery settings before being finalized. Furthermore, local contextual considerations often influence how guideline recommendations can be used. The science of guideline adaptation aims to balance the need for tailored recommendations with the inefficiency of replicating work already carried out elsewhere. Here as well, a number of frameworks have been developed to guide adaptation efforts (Wang, Norris & Bero, 2018 ).

Finally, considering the speed with which medical knowledge progresses and the pace of knowledge production at primary research level, it is to be expected that guideline recommendations need to be kept up-to-date. A comprehensive review on the issue concluded that one in five recommendations is outdated three years post-launch of the guideline and concluded that longer updating intervals are potentially too long (Martínez García et al., 2014 ). In light of the considerable resources required for both the development and the updating of clinical guidelines, approaches for efficient, potentially “real time” updating of (individual) guideline recommendations as new evidence emerges are being discussed (“living guidelines” – see Akl et al., 2017 , as well as Elliott et al., 2014 , for the concept of “living” systematic reviews; se e also Vernooij, 2014 ; Martínez García et al., 2015 ). However, their usefulness needs to be balanced against the potential of updating recommendations too soon, i.e. without a sufficiently mature evidence base, and running the risk of encouraging the use of as-yet-unproven options in the delivery of care. Furthermore, continuous updating is in itself resource-intensive.

For clinical guidelines to have an actual impact on processes and ultimately outcomes of care they need to be not only well developed and based on scientific evidence but also disseminated and implemented in ways that ensure they are actually used by clinicians. So-called guideline clearinghouses, such as the one operated by the US Agency for Healthcare Research and Quality, 2 which was defunded in the summer of 2018, as well as online repositories hosted by large guideline-producing institutions (such as the National Institute for Health and Care Excellence in the UK) or professional associations and/or their umbrella organizations serve as passive dissemination tools. The work of the Guidelines International Network 3 further promotes the dissemination of guideline-related content and provides an exchange platform for guideline developers and users. Tools to assist with the implementation of guideline recommendations (such as point-of-care mobile applications or checklists for clinicians, patient self-management tools and evaluation tools for managers) have progressed along with other developments around clinical practice guidelines in recent years. However, it seems that there is still considerable variation in the availability of such tools by condition, country and the organization responsible for issuing the guidelines (Gagliardi & Brouwers, 2015 ; Liang et al., 2017 ).

We discuss the above issues in more detail later in the chapter. At this juncture it is important to note that the points raised so far implicitly focus on improving the effectiveness and safety of patient care. However, as discussed in Chapter 2 , the dimension of patient-centredness – i.e. the importance of considering patients’ needs and preferences, as well as those of their caregivers – is important not only for the delivery of care but also for its outcomes (Hewitt-Taylor, 2006 ; May, Montori & Mair, 2009 ; Gupta, 2011 ). This issue constitutes a more recent focus of discussion around guideline development and utilization processes, with guidelines ideally not only facilitating patient education but also endorsing engagement and fostering shared decision-making, thus assuring that individual patient values are balanced against the “desired” outcomes embedded in the trials that form the basis of the recommendations in the guidelines (see, for example, van der Weijden et al., 2013 ). Ideally, guidelines should help in determining the treatment plan and individual treatment goals before each intervention, particularly for chronic patients. Different modalities of patient involvement exist in different contexts: patient group representatives are sometimes included in the guideline development process and guideline documents are increasingly produced in different formats for practitioners and patients ( see , for example, G-I-N, 2015 ; as well as Elwyn et al., 2015 ; Fearns et al., 2016 ; Schipper et al., 2016 ; Zhang et al., 2017 ; Cronin et al, 2018 ).

In summary, clinical guidelines have the potential to influence mainly processes and ultimately outcomes of care, targeting primarily professionals and dealing with the effectiveness, safety and increasingly also patient-centredness of care. To fulfill this potential, they need to be:

• based on the best available scientific evidence;
• developed by a balanced, multidisciplinary panel following formal, robust consensus techniques;
• well disseminated, and implemented in a context and user-specific manner; and
• kept up-to-date.

The following sections look at how these aspects are addressed in European countries, and how the potential contribution of clinical guidelines to quality of care can be understood and optimized.

9.3. What is being done in Europe?

9.3.1. extent of formalization of guidelines.

There is no recent comprehensive comparison of practices around the development and use of clinical guidelines in European countries. The most systematic effort to approach this issue remains the survey carried out by Legido-Quigley et al. in 2011. The survey included 80 respondents from 29 European countries and looked at a number of issues including the regulatory basis underpinning guidelines in each health system, the guideline development process, mechanisms of quality control, implementation modalities, and evaluation of produced recommendations (Legido-Quigley et al., 2012 ).

Overall, the study identified three broad categories of engagement in clinical guideline development among participating European countries:

• The first category included those with “well established” activities and wide experience in guideline development and implementation. This category comprised the leaders in guideline development (Belgium, England, France, Germany and the Netherlands) and other countries that had, and have, well established programmes (Denmark, Finland, Italy, Norway and Sweden).
• The second category comprised countries that had introduced some form of guideline production and were therefore “making progress” towards having adequate systems in place (for example, Luxembourg).
• The third category involved cases where clinical guidelines had either been “recently adopted” or were “in the planning stage” at the time of investigation.

The majority of countries had no legal basis for the development and implementation of clinical guidelines. Only 13 reported having an officially established basis for guidelines, although implementation still mostly took place on a voluntary basis. Such examples are the French Health Authority ( Haute Authorité de Santé , HAS) and the National Disease Management Guidelines Programme in Germany ( Programm für Nationale Versorgung s leitlinien , NVL), which develop clinical guidelines, disseminate them and evaluate their implementation within their respective healthcare system. In France, while clinical guidelines are established by national regulations, their use by practitioners is not mandatory and an initial phase of financial penalties for non-compliance was soon abandoned. In Germany, the NVL programme is run by the highest authorities in the self-governance of physicians, the German Medical Association ( Bunde särztekammer ), the National Association of Statutory Health Insurance Physicians ( Kassenärztliche Bundesvereinigung ), and the Association of the Scientific Medical Societies in Germany ( Arbeitsgemeinschaft der Wi s senschaftlichen Medizinischen Fachgesellsch aften , AWMF). NVL guidelines follow a defined methodology (Bundesärztekammer, 2017 ) and usually inform the content of national disease management programmes (DMPs). Physicians who are voluntarily enrolled in these programmes sign an obligation to rely on the DMP standards and to document their (non)-compliance ( see also Stock et al., 2011 ); however, the mission statement of the NVL programme clearly highlights that guidelines are recommendations and practitioners “can – and sometimes must” deviate from them in justified cases.

9.3.2. Systems and structures of guideline development

The same survey showed that across countries guidelines can be developed at national, regional and/or local level; in most cases professional associations are involved in the endeavour. Three main modalities could be discerned:

• about one third of countries had a central agency developing clinical guidelines in collaboration with professional associations;
• several countries reported having multiple levels of clinical guideline development, with regional and local bodies as well as several professional organizations contributing to a centrally coordinated process; and
• finally, fewer countries had no central coordination of the guideline development process at all: professional associations or providers often stepped in to fill the void following personal initiative.

An example of a national agency entirely in charge of a top-down endorsement of recommendations is the National Institute for Health and Care Excellence (NICE) in England, a government-funded organization responsible for providing national guidance and setting quality standards on the promotion of good health and the prevention and treatment of ill-health. Although NICE guidance is developed for the context of England and Wales, it is often used by institutions and health professionals in other countries ( see below). The Scottish Intercollegiate Guidelines Network (SIGN) is part of the Evidence Directorate of Healthcare Improvement Scotland, a public body within the Scottish National Health Service. It develops and disseminates national clinical guidelines containing recommendations for effective practice based on current evidence and has established itself as one of the go-to instances for guideline best practice in Europe. In Norway the development of official national guidelines falls under the responsibility of the Directorate of Health, although professional associations produce their own guidance in parallel (central and decentralized development). In Belgium several institutions have emerged and are involved in the production and dissemination of clinical guidelines, such as the Colleges of Physicians, the Belgian Health Care Knowledge Centre (KCE), the Belgian Centre for Evidence-Based Medicine (CEBAM), the EBPracticeNet and the Federal Council for the Quality of Nursing. In Germany the AWMF – the umbrella organization of more than 160 scientific medical associations – is responsible for maintaining an online guideline repository and determining the methodology for guideline development across medical societies (AWMF, 2012 ); the methodology for the previously described NVL programme is defined separately. The inclusion of all developed guidelines in the online repository of the AWMF necessitates certain minimum standards and guidelines are categorized according to their evidence base and mode of development ( see Fig. 9.2 ).

AWMF criteria for guideline categorization. Source: Nothacker et al., 2016

At the other end of the spectrum in the study by Legido-Quigley et al. ( 2012 ), practitioners in countries such as Greece and Slovenia had to rely on their own efforts to obtain evidence usually produced abroad; at the time of investigation, professional associations had begun to show interest in the field and both countries have made progress since then (Albreht et al., 2016 ; Economou & Panteli, 2019 ).

9.3.3. Use of quality appraisal tools

Legido-Quigley et al. ( 2012 ) confirmed that the general acceptance and use of the AGREE II instrument ( see above) applies to practices in European countries as well: nine countries reported that the instrument was widely used and three more reported not having a formal quality appraisal requirement but working with AGREE if guideline quality was assessed. Some countries employed either adapted versions of the AGREE II instruments or their own appraisal tools. Respondents from twelve countries indicated that no processes to appraise the quality of guidelines were in place. For example, the NICE Guidelines Manual explicitly states that its provisions are based on AGREE II (NICE, 2014 ). In Germany guidelines in the AWMF system are checked for quality before being listed, using the German Instrument for Methodological Guideline Appraisal ( Deutsches Instrument zur Bewertung der methodischen Le itlinienqualität , DELBI) checklist, which is based on the AGREE I instrument and adapted to the German context ( see Semlitsch et al., 2015 ).

9.3.4. Formal pathways for guideline implementation and stimulation of their usage

Ascertaining the extent to which guidelines are actually being implemented – and used – is difficult in most cases; in general there is only very limited systematic data collection of this type of information (we return to this issue in the section on optimizing implementation, below). However, Legido-Quigley et al. ( 2012 ) did investigate if underlying conditions for guideline implementation were enforced in European countries, including mandatory nature of utilization, official dissemination practices and financial incentives.

Implementation of clinical guidelines was found generally to not be mandatory. Only Hungary, Lithuania, the Netherlands and Sweden reported some type of general legal requirement but no penalties for non-compliance seemed to be in place. For instance, in the Netherlands clinical guidelines use was mandatory only in certain cases, such as in end-of-life care. Respondents from Hungary indicated that guidelines formulated by single providers (for example, hospitals) were binding within the establishment in question.

In Germany National Disease Management Guidelines are used as a basis to define mandatory standards for disease management programmes. Furthermore, the German Guideline Programme in Oncology, launched in 2008 to foster the development, implementation and evaluation of evidence-based clinical practice guidelines in oncology, regularly derives quality indicators during the guideline development process ( see Chapter 3 for more information on quality indicators in general). These then flow directly into the certification of oncology centres, which are the cornerstone of healthcare delivery for cancer in Germany. Data on the indicators are collected and fed back to the guideline developers to aid with the updating process.

In some countries and contexts clinical guidelines were not mandatory but clinicians were expected to follow them. For example, in the English NHS healthcare professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement and they are required to record their reasons for not following guideline recommendations. In Germany whether or not treatment was carried out according to official guidelines has been used as an argument during malpractice cases (Legido-Quigley et al., 2012 ).

In terms of dissemination practices, in most countries guidelines were published on the websites of the agencies responsible for producing and disseminating them and are thus made accessible to a wide audience, albeit in a passive manner. In Germany guidelines are collected and made available by the German guideline repository (see above and Figure 9.2 ). 4 Among the countries surveyed by Legido-Quigley et al. ( 2012 ) a number of more proactive approaches to dissemination could be observed, including tailored versions for different target groups and newsletters. In Sweden, for example, updated clinical guidelines were sent to each registered practitioner and a short version was compiled for the lay public. Regarding implementation support tools, some countries reported concrete measures, including checklists and how-to guides accompanying new guidelines, as well as IT tools (websites, apps, etc., see below).

Most notably, NICE has a team of implementation consultants that work nationally to encourage a supportive environment and locally to share knowledge and support education and training; additionally, it has developed generic implementation tools (for example, an overall “how-to” guide) and specific tools for every guideline (for example, a costing template and a PowerPoint presentation for use within institutions). Interestingly, NICE’s smartphone app, which allowed users to download guidance and use it offline during practice was retired at the end of 2018 and users are now encouraged to use the revamped NICE website. This decision reflects developments in IT infrastructures, personal mobile connectivity (i.e. data) limits and NICE’s recognition of the importance of ensuring clinicians’ access to up-to-date recommendations (NICE, 2018 ).

In the Netherlands the use of clinical guidelines is promoted through electronic web pages, some developed with interactive learning. A national website contains a series of implementation tools 5 and certain guideline content is integrated in electronic patient record systems. The latter was reported as being the cornerstone of guideline implementation in Finland as well: guidelines are integrated with the Evidence-Based Medicine electronic Decision Support (EBMeDS) system, allowing clinicians to open them from within the electronic patient record. Moreover, summaries, patient versions, PowerPoint slide series and online courses are developed. In Germany indicator-based approaches are used to monitor and endorse implementation ( see below), while additional tools include IT-applications in hospitals and the use of guideline-based clinical pathways. At the time of Legido-Quigley et al.’s investigation in 2011, smartphone applications to further simplify guideline implementation had also started to appear (for example, García-Lehuz, Munoz Guajarado & Arguis Molina, 2012 ). In the intervening years many developers have produced implementation apps (ranging from content repositories to interactive operationalization tools) and guideline repositories have their own app-based platforms for guideline-based decision support (we return to this in the section on good implementation practice, below).

Financial incentives seem not to be a particularly frequently used tool to encourage the use of clinical guidelines. Legido-Quigley et al. ( 2012 ) found that Romanian health units which developed and implemented treatment protocols based on national clinical guidelines received additional funding. In Portugal financial incentives for doctors, nurses and staff were given, based on their score in the annual audit of family physician performance, which also includes clinical guidelines. In the Netherlands some insurers provided financial incentives to support clinical guidelines implementation but largely as a secondary mechanism.

9.3.5. Systematic evaluation of guideline programmes

Overall, there are few examples of systematic formal evaluation of the development, quality, implementation and use of clinical guidelines. NICE produces implementation reports which measure the uptake of specific recommendations taken from selected pieces of guidance by means of routine data analysis. Researchers assess the uptake and effectiveness of guidance on an ad hoc basis. In Sweden the development, quality control, implementation and use of guidelines are regularly evaluated by the National Board of Health and Welfare as well as by county councils or universities on request. Finally, in Germany the development and quality of guidelines are regularly evaluated by AWMF; the quality of the National Guideline Programme is surveyed and closely controlled by the Medical Centre for Quality in Health Care ( Ärztliches Zentrum für Qualität in der Medizin , ÄZQ) and the AWMF, while the Institute for Quality and Efficiency in Health Care ( Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen , IQWiG) is responsible for systematically researching and evaluating current guidelines (German and international) to determine necessity for updating DMP standards (Legido-Quigley et al., 2012 ).

9.4. The effectiveness and cost-effectiveness of clinical guidelines as a quality strategy

As mentioned earlier in this chapter, the main components of evaluating the usefulness of clinical guidelines as a quality strategy target their implementation and validity: do they reach their target (are clinicians and patients aware of them) and affect the way clinicians treat their patients (influence on process of care) and do they actually support better healthcare (if implemented, do health outcomes actually improve)? ( See also Fig. 9.1 .)

Seminal work by Grimshaw & Russel ( 1993 ) looked into the influence of clinical guidelines on medical practice in the early nineties and found that although interest in guidelines was increasing, their utilization and effectiveness remained unclear. It is known that important barriers for guideline implementation rest with lack of awareness (Cabana et al., 1999 ) and the reluctance of physicians to change their approach to the management of disease (Michie & Johnston, 2004 ). A public survey on NICE guidelines discovered that awareness of a guideline did not necessarily imply that respondents understood or knew how to use it (McFarlane et al., 2012 ). A related study carried out in the German primary care context found awareness of clinical guidelines to be relatively low and the inclination to treat according to guidelines not to be higher – and occasionally even lower – in those practitioners who were aware of their existence compared to those who were not (Karbach et al., 2011 ). Similarly, a study in the French primary care context concluded that, while a favourable disposition towards guidelines in general meant a higher likelihood of awareness of specific guidelines, it did not have a significant effect on the actual application of guideline recommendations in practice (Clerc et al., 2011 ). Cook et al. ( 2018 ) showed that while clinicians believed practice variation should be reduced, they were less certain that this can be achieved. In the Swiss context, despite a generally favourable disposition towards guidelines, barriers to adherence comprised lack of guideline awareness and familiarity, applicability of existing guidelines to multimorbid patients, unfavourable guideline factors and lack of time, as well as inertia towards changing previous practice (Birrenbach et al., 2016 ). In a scoping review capturing evidence published up to the end of 2015, Fischer et al. ( 2016 ) found that barriers to guideline implementation can be differentiated into personal factors, guideline-related factors and external factors, and that structured implementation can improve guideline adherence.

Regarding drivers towards guideline awareness and utilization, Francke et al. ( 2008 ) showed that the simpler a guideline is to follow, the more likely it is to be accepted by practitioners. Work by Brusamento et al. ( 2012 ) supports the conclusions already drawn by Grimshaw et al. ( 2004 ) that the effect of different implementation strategies on care processes varies but spans from non-existence to moderate, with no clear advantage of multifaceted or single interventions. The latter finding was confirmed by a review of reviews in 2014 (Squires et al., 2014 ), as well as for specific areas of care (for example, Suman et al., 2016 ). Looking at the issue of guideline adherence over time, recent work found that it decreased about half of the time after more than one year following implementation interventions but the evidence was generally too heterogeneous for really robust conclusions (Ament et al., 2015 ). A number of studies have tackled the concept of guideline “implementability” in the past few years and are discussed more closely in the next section.

Early work investigating the effects of guidelines on outcomes in primary care found little evidence of effect, citing methodological limitations of the evidence body (Worral, Chaulk & Freake, 1997 ). Evidence from the Netherlands also suggests that while clinical guidelines can be effective in improving the process and structure of care, their effects on patient health outcomes were studied far less and data are less convincing (Lugtenberg, Burgers & Westert, 2009 ). This was substantiated by further work in the area (Grimshaw et al., 2012 ). The systematic review by Brusamento et al. ( 2012 ) confirmed the lack of conclusive evidence: while significant effects had been measured, for example regarding the percentage of patients who achieved strict hypertension control through guideline compliant treatment, other studies showed no or unclear effects of guideline-concordant treatment. Newer studies also show mixed results regarding the effect of guidelines on outcomes, but a clear link with implementation modalities (Roberts et al., 2016 ; Cook et al., 2018 ; Kovacs et al., 2018 ; Shanbhag et al., 2018 ).

Regarding cost-effectiveness, the scope of evidence is even more limited. A comprehensive analysis should include the costs of the development phase, the dissemination/implementation and the change determined in the health service by putting the guideline into practice. However, in practice data on the cost of guideline development are scarce and – given the vast variability of settings and practices – likely not generalizable (Köpp et al., 2012 ; Jensen et al., 2016 ). A systematic review by Vale et al. ( 2007 ) pointed out that among 200 studies on guideline implementation strategies (only 11 from Europe), only 27% had some data on cost and only four provided data on development and implementation. Most of the relevant studies only partially accounted for costs incurred in the process of guideline production. Having said that, NICE has developed methods to assess the resource impact of its guidelines; for a subset of cost-saving guidelines, savings ranged from £31 500 to £690 per 100 000 population. An investigation of one component of guideline use, namely that of active implementation in comparison to general dissemination practices, found that while the former requires a substantial upfront investment, results regarding optimized processes of care and improved patient outcomes may not be sufficient to render it cost-effective (Mortimer et al., 2013 ). A related but separate issue is the use of cost-effectiveness analyses in clinical guidelines; challenges and opportunities have been identified in the international literature (Drummond, 2016 ; Garrison, 2016 ).

9.5. How can clinical guidelines be implemented to improve quality of care?

The previous section touched on the variability of evidence (both in terms of demonstrated effect and strength) regarding the success of different guideline implementation strategies. In this section we look at recent insights on how the implementation of clinical guidelines can be optimized to further facilitate their contribution to good-quality care. This timeframe also reflects the recent increased attention to implementation science in healthcare in general.

There is increasing consensus that incorporating implementation considerations already in the guideline development process can have a substantial influence on implementability. This is reflected in the checklist for implementation planning developed by Gagliardi et al. ( 2015 ), which provides a set of concrete actionable items, based on the premise that “implementation should be considered at the beginning, and throughout the guideline development process” (Gagliardi et al., 2015 ; see also Richter-Sundberg et al., 2015 for an example from Sweden). A tool to assist guideline developers with ensuring context-specific implementability elements throughout the guideline process has also been developed (GUIDE-M; see Brouwers et al., 2015 ). Other work into good implementation practice for clinical guidelines has identified specific implementability domains that influence the uptake of clinical guidelines, differentiating between components that fall under two broad aims: the creation of content and the communication of that content (Kastner et al., 2015 ; Box 9.3 ).

Dimensions of guideline implementability.

An investigation into trends in guideline implementation found that education for professionals or patients and print material were the most commonly employed strategies for translating guidelines into practice, but practices vary considerably and gaps have been identified both in the scope and follow-up of interventions (Gagliardi & Alhabib, 2015 ). In fact, despite the general recognition that implementation tools are important for ensuring guideline recommendations reach their intended goal, most guidelines were found not to be accompanied by such applications (Gagliardi & Brouwers, 2015 ; Liang et al., 2017 ).

What is more, conclusive evidence supporting the superiority of certain implementation modalities is generally lacking. Fischer et al. ( 2016 ) found that the following aspects are central elements of successful implementation approaches: target-oriented dissemination, education and training, social interaction, decision support systems and standing orders; and tailoring implementation strategies to settings and target groups. At the same time, a comprehensive review of dissemination and implementation practices commissioned by the German Federal Ministry of Health (Althaus et al., 2016 ) investigated the effects of a number of approaches (distribution of educational materials; educational meetings; educational outreach visits; influence of local opinion leaders; audit and feedback; reminder systems; interventions tailored to local circumstances; organizational interventions; and ensuring continuity of care by means of guideline-based clinical pathways) and found that the systematically collected evidence base was inconclusive for all of them. Against this backdrop, the report recommended a number of steps for strengthening guideline implementation in the German context. Next to endorsing further work into developing appropriate and effective implementation approaches, it supported the creation of legal requirements for guidelines and highlighted the importance of developing guidelines of high methodological quality and relevance to practice (in line with internationally acknowledged criteria of guideline good practice: see introduction).

A different systematic review conducted by the National Heart, Lung, and Blood Institute (NHLBI) in the United States a year later, aiming to synthesize evidence from published implementation science literature to identify effective or promising strategies for the adoption and implementation of clinical guidelines, found that audit and feedback as well as educational outreach visits were generally effective in improving both process of care and clinical outcomes, while the respective effectiveness of provider incentives was mixed. Reminders only sometimes improved process of care and were generally ineffective for clinical outcomes. The study also identified barriers and facilitators for clinician adoption or adherence to guidelines. Barriers included time constraints, limited staffing resources, clinician scepticism, clinician knowledge of guidelines and higher age of the clinician. Guideline characteristics, such as format, resources and end-user involvement were identified as facilitators, along with stakeholder involvement, leadership support, organizational culture (for example, multidisciplinary teams) and electronic guidelines systems. The review confirmed the substantial gaps in the evidence on effectiveness of implementation interventions, especially regarding clinical outcomes, cost-effectiveness and contributory contextual issues (Chan et al., 2017 ).

One of the most prominent developments in the area of guideline implementation in recent years has been the increased utilization of information technologies to facilitate (a) push mechanisms for guideline adherence, such as decision support components integrated into clinical management software (for example, alerts, reminders or standing orders; see , for example, Wright et al., 2010 ); (b) the use of guidelines at the bedside (for example, mobile guideline apps); and (c) the faster, potentially “real time” updating of (individual) guideline recommendations as new evidence emerges (for example, with “living guidelines”; see , Akl et al., 2017 and Thomas et al., 2017 , and caveat on this issue earlier in this chapter).

The MAGIC (“Making GRADE the Irresistible Choice”) project was established to facilitate the “authoring, dissemination, and dynamic updating of trustworthy guidelines” (Vandvik et al., 2013 ) and combines the use of all these aspects. It draws on the GRADE principles ( see introduction to this chapter) as well as the work of the DECIDE project, which aims to optimize communication modalities for evidence-based recommendations targeting healthcare professionals and providers, patients and citizens, and policy-makers. 6 Its approach to solving identified issues with traditional guideline practices is shown in Table 9.2 . As mentioned in the introduction, these new approaches still need to be evaluated to ensure that the right balance between benefit and potential harm and/or loss of resources is achieved.

Challenges in guideline practice and MAGIC solutions.

The need for rapid responses in emergency situations (for example, epidemics) has prompted research into so-called “rapid guidelines”, which approach the balance between expedience of process, methodological rigour and implementability in a systematic manner (Florez et al., 2018 ; Kowalski et al., 2018 ; Morgan et al., 2018 ). Another consideration in this direction is the potential of observational data for updating guideline recommendations. The “living guideline” concept relies on the quick identification of clinical trial results, but there are examples of registry data flowing into the development or updating of clinical practice guidelines (OECD, 2015 ). Observational data is necessary to describe current health provision (and its quality), pinpoint potential patient groups that are adequately covered by guideline recommendations, and identify gaps and issues to be resolved by clinical research. They are also vital for identifying late onset treatment harms and drug safety issues. However, they are not first choice when deciding about the benefits of treatment recommendations. A review of NICE guidance found that the uptake of such data in guidelines was slow (Oyinlola, Campbell & Kousoulis, 2016 ).

Performance measurement is another area that lends itself to synergy between clinical guidelines and healthcare data. More and more guideline groups develop quality indicators along with the recommendation sets (Blozik et al., 2012 ). While these are usually primarily intended as general performance measures (i.e. the guideline, as a summary of best knowledge, informs the choice of indicator), a closer look at measurement results can provide insights on the extent to which practice reflects guideline recommendations (i.e. the indicators inform guideline adherence surveillance). Few countries use guideline-based quality indicators for nationwide quality assurance, such as the hospital benchmarking system in Germany (Szecsenyi et al., 2012 ) and the German Guideline Programme in Oncology described earlier in the chapter. In the UK a guidelines-based indicator framework was recently developed to monitor primary care practice (Willis et al., 2017 ). The Guidelines International Network provides reporting guidance for guideline-based performance measurement tools (Nothacker et al., 2016 ).

While traditionally the development and implementation of clinical guidelines (and other summaries of evidence) has been geared towards meeting the needs of clinicians, formats that support shared decision-making have been gaining focus in recent years (Agoritsas et al., 2015 ; Härter et al. 2017 ). Guideline-based decision support tools to facilitate clinician-patient interactions and shared decision-making are a standard accompaniment of the German NVL programme ( see above), and are among the activities in MAGIC ( see also Table 9.2 and the SHARE IT project).

Finally, an issue that has been garnering attention in the past few years is that of editorial independence in clinical guideline development. Implementing guideline recommendations that have been created under unclear influence conditions is not only ethically questionable but may also endanger quality of care, as the content may not actually reflect best available evidence. An international survey of 29 institutions involved in clinical guideline development found variability in the content and accessibility of conflict of interest policies; some institutions did not have publicly available policies and of the available policies several did not clearly report critical steps in obtaining, managing and communicating disclosure of relationships of interest (Morciano et al., 2016 ). Recent work from Germany indicates that while financial conflicts of interest seem to be adequately disclosed in the most rigorously developed guidelines, active management of existing conflicts of interest is lagging behind (Napierala et al., 2018 ); this is also reflected in work from Canada, which discovered frequent relations between guideline producing institutions and, for example, the pharmaceutical industry and no clear management strategy (Campsall et al., 2016 ; Shnier et al., 2016 ). This type of issue was also identified in Australia, with one in four guideline authors without disclosed ties to pharmaceutical companies showing potential for undisclosed relevant ties (Moynihan et al., 2019 ). To foster trust and implementation, it is clear that institutions involved in guideline development should invest resources in explicitly collecting all relevant information and establish clear management criteria; the structure of disclosure formats also has a role to play here (Lu et al., 2017 ).

Box 9.4 shows the conflicts of interest management principles defined by the Guidelines International Network (Schünemann et al., 2015 ). In Germany the website Leitlinienwatch.de (“guideline watch”) uses an explicit evaluation matrix to appraise how new German guidelines address the issue of financial conflicts of interest. Beyond measures for direct financial conflicts of interest, the management of indirect conflicts of interest (for example, issues related to academic advancement, clinical revenue streams, community standing and engagement in academic activities that foster an attachment to a specific point of view, cf . Schünemann et al., 2015 ) is also important in guideline development. Ensuring that guidelines are developed based on robust consensus processes by a multidisciplinary panel can contribute to mitigating the effect of such conflicts ( see , for instance, Ioannidis, 2018 ).

G-I-N principles for dealing with conflicts of interests in guideline development.

9.6. Conclusions for policy-makers

Systematically developed, evidence-based clinical guidelines are being used in many countries as a quality strategy. Their usefulness in knowledge translation, particularly in the context of ever-growing volumes of primary research, is not contested. However, their rigour of development, mode of implementation and evaluation of impact can be improved in many settings to enable their goal of achieving “best practice” in healthcare. One of the most important knowledge gaps in this direction is the extent to which guidelines affect patient outcomes and how this effect can be enhanced to ensure better care. For that purpose, both quantitatively measured parameters and service user experience should be taken into account. The latter is already attempted to varying degrees by means of stakeholder involvement, but the practice should be enhanced and expanded to ensure representative and acceptable results. New developments that aim to ensure that guideline recommendations are based on best available evidence, are easily accessible to clinicians and patients, and stay up-to-date should be further explored and evaluated.

The overview of country-specific practices presented in this chapter clearly demonstrates how divergent guideline practices can be, especially when viewed as national strategies for quality improvement. The fact that in several countries practitioners “borrow” recommendations produced abroad combined with existing international initiatives point to a considerable potential for more active knowledge exchange in the future. However, the context-specific nature of produced guidelines must always be taken into account. A lot has already been undertaken in the context of guideline adaptability but earlier, more intensive collaboration might be fruitful, especially on issues such as optimizing guideline development and implementation in the age of multimorbidity. Indeed, this chapter did not focus on the issue of guideline applicability in light of ageing and multimorbidity; implementing guideline recommendations based on evidence derived from young(er) populations without comorbidities does not reflect best practice and can endanger good quality of care for older, multimorbid patients.

In contrast to Health Technology Assessment (HTA; see Chapter 6 ), there is currently no discussion about centralizing the dissemination (let alone the development) of guidelines at EU level, although umbrella organizations of different professional associations produce European guidelines for their specialties. Perhaps it is time to consider such a mechanism, especially given the recent suspension of the USA-based clearinghouse that served internationally as a frequently used resource.

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• Cite this Page Panteli D, Legido-Quigley H, Reichebner C, et al. Clinical Practice Guidelines as a quality strategy. In: Busse R, Klazinga N, Panteli D, et al., editors. Improving healthcare quality in Europe: Characteristics, effectiveness and implementation of different strategies [Internet]. Copenhagen (Denmark): European Observatory on Health Systems and Policies; 2019. (Health Policy Series, No. 53.) 9.
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In this Page

• Introduction: the characteristics of clinical practice guidelines
• Why should clinical guidelines contribute to healthcare quality?
• What is being done in Europe?
• The effectiveness and cost-effectiveness of clinical guidelines as a quality strategy
• How can clinical guidelines be implemented to improve quality of care?

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• European Observatory Health Policy Series

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