Elsevier

Health Policy

Volume 107, Issues 2–3, October 2012, Pages 146-156
Health Policy

Review
Clinical guidelines in the European Union: Mapping the regulatory basis, development, quality control, implementation and evaluation across member states

https://doi.org/10.1016/j.healthpol.2012.08.004Get rights and content

Abstract

Introduction

Clinical guidelines are advocated to improve the quality of care, especially for chronic diseases. However, the regulatory basis of clinical guidelines, their development, quality control, implementation and use as well as evaluation within countries across the European Union is not systematically known.

Methods

Using information collected from key informants in each country by means of a structured questionnaire, this mapping exercise illustrates the varied status of guideline production in European Union countries.

Results

Most European Union countries have an established national, regional or local clinical guideline programme, and a substantial proportion have developed guidelines on the prevention and management of chronic diseases. Several countries have mechanisms in place to ensure the quality of scientific evidence used for the development of guidelines is high and that the process is consistent and transparent. Others are only now taking an interest in guideline development and are taking the first steps towards establishing ways of implementing them. The majority of countries have no legal basis for the development of guidelines and those that have well established systems mostly implement them on a voluntary basis. The process of guideline development varies in its degrees of decentralisation across countries with many different types of organisations taking on this responsibility. There is general acceptance of the value of the instrument developed by the AGREE collaboration for evaluating the methodological robustness of guidelines. However, the extent to which guidelines are implemented in Europe is unknown, as there is no systematic data collection and, in most countries, no structure to enable it. There are few examples of formal evaluations of the development, quality, implementation and use of guidelines.

Conclusions

Our findings call for renewed efforts to respond to the severe lack of standardized guideline terminology and accessibility as well as rigorous studies to evaluate the relationship between different ways to develop guidelines and their methodological quality, between their quality and the actual implementation and usage, and finally between implementation and health outcomes.

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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