ReviewClinical guidelines in the European Union: Mapping the regulatory basis, development, quality control, implementation and evaluation across member states
Introduction
Clinical guidelines are one of several tools available to health service purchasers and providers for the improvement of the quality of care. The Institute of Medicine (IOM) defines clinical guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” [1].
Clinical guidelines are grounded in the concept of evidence-based medicine and constitute, together with Health Technology Assessment, a crucial link in the translation between clinical research and actual health care [2]. Clinical guidelines may address various aspects of decision making in clinical practice, for example the choice of diagnostic and screening tests, the provision of medical and surgical services, the duration of hospital stay and other aspects of clinical practice [3]. Their aim is to reduce inappropriate variation in clinical practice and improve the quality of healthcare. They also support education and training of health professionals and help patients to make informed decisions.
The clinical guideline development process facilitates the effective translation of evidence into clinical practice [4], [5]. The premise is that the greater the strength of the evidence used, the higher the quality of the guidelines [4], and the greater the potential for rational use of resources and improvement of quality of healthcare [6], [7], [8]. Several methodologies have been developed [5], [9], [10] that allow us to assess critically the quality of clinical guidelines [11], [12]. Another discussion and evaluation strand focused on strategies to disseminate and implement clinical guidelines. The key assumption driving that research was and still is: The more physicians know about guidelines, the more they will use them (and the better quality of care will get).
In the late 1990s, there was a concerted effort among academics and health care practitioners to coordinate guideline development internationally, leading to the formation of the AGREE Collaboration [13], [14]. Their work culminated in the publication of the validated and widely used AGREE tool [14] which identified six domains and 23 specific items for assessing guideline quality [14]. A revised version, AGREE II, has since been developed, with refined terms, improved supporting documentation, and strengthened measurement properties. Its utility has been tested among different stakeholders and the AGREE collaboration continues to develop additional resources to support its use [15].
However, the way guidelines are produced, implemented, used and evaluated within countries – and to which extent this is tied to regulation and organizational set-up – is still not well understood or systematically studied. Therefore, the possibility to learn from other countries or to establish best practice is quite limited. As a first step, this paper therefore seeks to systematically explore how clinical guidelines are being developed, checked for quality (e.g. with the AGREE instrument), implemented and evaluated across the European Union (and Norway and Switzerland), using a conceptual framework with five dimensions.
Section snippets
Methods
This mapping of clinical guidelines across the European Union (and Norway and Switzerland) is based on both published and grey literature as well as information collected from key informants in each country by means of a questionnaire on five key components of clinical guidelines: (a) regulatory basis, (b) development, (c) quality control, (d) implementation and (e) evaluation (see Box 1).
The questionnaire was developed on the basis of literature on the desirable characteristics of guideline
Regulatory basis
The majority of countries have no legal basis for the development of clinical guidelines and those countries that have well established systems mostly implement them on a voluntary basis. Only a few countries have a legal mandate to develop guidelines, as is the case in Latvia (regulation no. 469 “Procedures by which clinical guidelines shall be developed, evaluated, registered and implemented” [17]), where this, however, does not mean that any are actually produced (Table 1).
Development
The process of
Discussion
This mapping exercise illustrates the varied status of clinical guideline production in the European Union. A few countries have well-developed systems in place to develop clinical guidelines while most have only fragmentary initiatives led by enthusiasts, with little more than aspirations to do something more formal at some unspecified time in the future.
Our findings on the value of a legal mandate are inconclusive. Spencer and Walshe suggested that having a legal requirement for quality
Conclusion
This mapping exercise provides, to our knowledge, the most updated and thorough account of how clinical guidelines operate in Europe. A limitation of this exercise is that while we were able to collect information on all the countries, this information is quite general and it does not allow us to ascertain important aspects of clinical guideline development such as the barriers to implementation, their impact and whether those guidelines that are being developed are of good quality.
While a few
Conflict of interest
We are not aware of any relationships or support which might be perceived as conflict of interest.
Funding
This paper is the result of research that was requested by the European Commission's Directorate–General for Health and Consumers and co-funded through the EU's FP7 Cooperation Work Programme: Health (contract number 242058; contract acronym EUCBCC). The European Observatory on Health Systems and Policies is responsible for conducting this work. The European Commission is not responsible for the content of the paper. Responsibility for the facts described in the report and the views expressed
Acknowledgements
We thank all questionnaire respondents who took time to generously provide us with the requested information. We particularly wish to thank Dr. Luisa Pettigrew for all her help in identifying respondents within the WONCA Europe working group.
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