- Email: [email protected]
The need for collaboration in guidelines
ARTICLE IN PRESS
www.elsevier.de/zefq Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) 103 (2009) 3–4
Editorial
The need for collaboration in guidelines Introduction
Jako S. Burgers, MD, PhD 1. Dutch Institute for Healthcare Improvement CBO Churchilllaan 13 3527 GV Utrecht The Netherlands Tel.: +31 30 2843900 Fax: +31 30 2943644 E-Mail: [email protected] 2. Scientific Institute for Quality of Healthcare Radboud University Nijmegen Medical centre P.O. Box 9101 114 IQ healthcare 6500 HB Nijmegen The Netherlands Tel.: +31 612946103 Fax: +31 243540166
Clinical practice guidelines are being developed in almost all western countries. In the last two decades, the number of guidelines has increased exponentially. In Germany, medical professional societies have been very productive. Mono- and multidisciplinary guidelines have been developed on a variety of topics. Professional societies, even the smaller ones, increasingly feel the need to produce guidelines to meet to the demands from society to transparency and to show up their standards for high performance. Guideline development, however, is not easy and requires special knowledge and expertise. It is particularly challenging to develop a product that is methodologically sound as well as helpful in decision making in clinical practice. Collaboration is needed between academic institutes, professional societies and patient organisations to bridge the gap between research and practice. This issue of the AEZQ journal is devoted to collaboration in guidelines and includes articles describing findings from studies and projects that aim to enhance the quality and effectiveness of guidelines.
Quality criteria for guidelines Clinical practice guidelines aim to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances [1]. The ultimate goal is to improve patient outcomes, but only valid and reliable
Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) doi:10.1016/j.zefq.2009.01.001
guidelines can realise this goal [2]. Therefore, guidelines should be based on the best available evidence [3]. There is a growing international consensus about the method of evidencebased guideline development, including systematic searching of literature, quality appraisal of the selected evidence, and explicit linking of the recommendations and their supporting evidence [4]. The use of quality criteria as reflected in the DELBI instrument (www.versorgungsleitlinien.de/methodik/ delbi), is actively promoted by the Association of the Scientific Medical Associations (AWMF) and the Agency for Quality in Medicine (AEZQ). It is based on the internationally validated AGREE Instrument [4] and includes an additional domain covering the applicability to the German healthcare system to ensure use in local practice.
Focus on implementation Considering the consensus on the method of development, innovation in guidelines should now focus on implementation. Effective guidelines contain specific recommendations that are easy to follow and compatible with existing norms and values [5,6]. The article of Schubert et al. shows the need for exploring the acceptance of guideline recommendations among the target users [7]. However, if this is performed after release of the guideline, it may be coming too late. Instead, it would be helpful to integrate surveys or focus groups among the target users within the process of development, allowing guideline developers to modify the
3
ARTICLE IN PRESS
Clinical guidelines should not only attend to the best available evidence and judgement of clinical experts, but also to the views and preferences of patients [9]. The question is not whether but how to involve patients in guideline development. Several methods can be used, such as patient participation in the guideline development group, surveys or focus groups among patients, and inclusion of patient organisations in the external review process. Effective and representative input from patients, however, demands knowledge, skills and a certain degree of organisation. These are often not available, as shown by Sa¨nger et al. [10]. Special training may be needed to optimize the input from patients. International collaboration within the G-I-N Public and Patient Involvement working group (www.g-i-n.net) can help increase our knowledge and expertise on this topic.
National and international collaboration As the number of guidelines is increasing, there is a risk of duplication and fragmentation. For most chronic conditions (e.g. hypertension, diabetes, asthma) several guidelines are available. This could lead to the paradox that evidence-based guidelines on the same topic contain conflicting recommendations [11–13]. This can confuse and frustrate practitioners and can even harm patients as well [14]. Particularly in large countries, such as United States, Australia, and Germany, national programming is essential to avoid competing guidelines [15]. Independent institutes can help coordinating the efforts in guideline development. Central funding of guideline development is needed to support
4
[8]
[9]
[10]
Moving forward Finally, European collaboration on training in EBM is encouraging [17]. Sharing the principles of EBM is fundamental for harmonizing efforts in guidelines. The Guidelines International Network (G-I-N) strongly supports education and training of professionals in EBM and offers an excellent platform to moving forward in guideline collaboration [18]. The ZEFQ journal will keep you informed!
[11]
[12]
[13]
References [1] Institute of Medicine. Clinical Practice Guidelines: Directions for a new program. Washington DC: National Academy Press; 1990. [2] Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993;342:1317–22. [3] Woolf SH. Practice guidelines, a new reality in medicine. II. Methods of developing guidelines. Arch Intern Med 1992;152: 946–52. [4] The AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Safe Health Care 2003;12: 18–23. [5] Grol R, Dalhuijsen J, Thomas S, Veld C, Rutten G, Mokkink H. Attributes of clinical guidelines that influence use of guidelines in general practice: observational study. BMJ 1998;317:858–61. [6] Burgers JS, Grol RPTM, Zaat JOM, Spies TH, Van der Bij AK, Mokkink HGA. Characteristics of effective clinical guidelines for general practice. Br J Gen Pract 2003;53: 15–9. [7] Schubert I, Egen-Lappe V, Heymans L, Ihle P, Feßler J. Gelesen ist noch nicht getan: Hinweise zur Akzeptanz von hausa¨rztlichen Leitlinien. Eine Befragung in Zirkeln
[14]
[15]
[16]
[17]
der Hausarztzentrierten Versorgung (HZV). Z Arztl Fortbild Qualitatssich 2009;103: 5–12. Schra¨der P, Reiter A, Boy O, Fischer B, Do¨bler K. Qualita¨tsindikatoren der BQS als Monitoring-Instrument zur Leitlinienimplementierung am Beispiel ausgewa¨hlter Qualita¨tsindikatoren bei Mammakarzinom und Schenkelhalsfraktur. Z Arztl Fortbild Qualitatssich 2009;103:17–25. Krahn M, Naglie G. The next step in guideline development: incorporating patient preferences. JAMA 2008;300: 436–8. Sa¨nger S, Englert G, Brunsmann F, Quadder B, Villarroell D, Ollenschla¨ger G. Patientenbeteiligung an der Leitlinienentwicklung – sind die Patientenorganisationen fu¨r diese Aufgabe geru¨stet? Kurzbericht zum Vortrag. Z Arztl Fortbild Qualitatssich 2009;103:13–6. Burgers JS, Bailey JV, Klazinga NS, Van der Bij AK, Grol R, Feder G, for the AGREE Collaboration. Inside guidelines: comparative analysis of recommendations and evidence in diabetes guidelines from 13 countries. Diab Care 2002;25:1933–9. Watine J, Friedberg B, Nagy E, Onody R, Oosterhuis W, Bunting PS, et al. Conflict between guideline methodologic quality and recommendation validity: a potential problem for practitioners. Clin Chem 2006; 52:65–72. Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among international pharyngitis guidelines: not just academic. Ann Fam Med 2007;5:436–43. Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines. BMJ 1999;318:527–30. Institute of Medicine. Knowing what works in health care: a roadmap for the nation. Washington DC: National Academies Press; 2008. Rabady S. Praxisempfehlungen EbM’’ Guidelines fu¨r Allgemeinmedizin : Erste Erfahrungen mit Implementierung und Akzeptanz. Z Arztl Fortbild Qualitatssich 2009;103:27–33. Weinbrenner S, Meyerrose B, Vega-Perez A, Kulier R, Coppus SFPJ, Kunz R. fu¨r die EUebm-Gruppe. EUebm – Integration ’’ einer europaweit harmonisierten Ausund Fortbildung zu Evidenzbasierter Medizin (EbM) in die Krankenversorgung. Z Arztl Fortbild Qualitatssich 2009;103:35–9. Ollenschla¨ger G, Marshall C, Qureshi S, Rosenbrand K, Slutsky J, Burgers J, et al. Improving the quality of health care: using international collaboration to inform guideline programmes – by founding the Guidelines International Network G-I-N. Qual Safe Health Care 2004;13:455–60. ’’
Collaboration with patients
national collaboration and to avoid duplication of efforts. Smaller countries, such as Austria, could benefit from products developed elsewhere. Rabady describes the example of the adaptation and use of the Finnish ‘EBM Guidelines’ [16]. Collaboration with the guideline authors and providing them feedback data on the use and acceptance of the recommendations, could further raise the quality and effectiveness of these guidelines.
’’
recommendations before final publication. This may also apply to the development of quality indicators for monitoring the use of guidelines [8].
[18]
Z. Evid. Fortbild. Qual. Gesundh. wesen 103 (2009) 3–4 www.elsevier.de/zefq
www.elsevier.de/zefq Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) 103 (2009) 3–4
Editorial
The need for collaboration in guidelines Introduction
Jako S. Burgers, MD, PhD 1. Dutch Institute for Healthcare Improvement CBO Churchilllaan 13 3527 GV Utrecht The Netherlands Tel.: +31 30 2843900 Fax: +31 30 2943644 E-Mail: [email protected] 2. Scientific Institute for Quality of Healthcare Radboud University Nijmegen Medical centre P.O. Box 9101 114 IQ healthcare 6500 HB Nijmegen The Netherlands Tel.: +31 612946103 Fax: +31 243540166
Clinical practice guidelines are being developed in almost all western countries. In the last two decades, the number of guidelines has increased exponentially. In Germany, medical professional societies have been very productive. Mono- and multidisciplinary guidelines have been developed on a variety of topics. Professional societies, even the smaller ones, increasingly feel the need to produce guidelines to meet to the demands from society to transparency and to show up their standards for high performance. Guideline development, however, is not easy and requires special knowledge and expertise. It is particularly challenging to develop a product that is methodologically sound as well as helpful in decision making in clinical practice. Collaboration is needed between academic institutes, professional societies and patient organisations to bridge the gap between research and practice. This issue of the AEZQ journal is devoted to collaboration in guidelines and includes articles describing findings from studies and projects that aim to enhance the quality and effectiveness of guidelines.
Quality criteria for guidelines Clinical practice guidelines aim to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances [1]. The ultimate goal is to improve patient outcomes, but only valid and reliable
Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) doi:10.1016/j.zefq.2009.01.001
guidelines can realise this goal [2]. Therefore, guidelines should be based on the best available evidence [3]. There is a growing international consensus about the method of evidencebased guideline development, including systematic searching of literature, quality appraisal of the selected evidence, and explicit linking of the recommendations and their supporting evidence [4]. The use of quality criteria as reflected in the DELBI instrument (www.versorgungsleitlinien.de/methodik/ delbi), is actively promoted by the Association of the Scientific Medical Associations (AWMF) and the Agency for Quality in Medicine (AEZQ). It is based on the internationally validated AGREE Instrument [4] and includes an additional domain covering the applicability to the German healthcare system to ensure use in local practice.
Focus on implementation Considering the consensus on the method of development, innovation in guidelines should now focus on implementation. Effective guidelines contain specific recommendations that are easy to follow and compatible with existing norms and values [5,6]. The article of Schubert et al. shows the need for exploring the acceptance of guideline recommendations among the target users [7]. However, if this is performed after release of the guideline, it may be coming too late. Instead, it would be helpful to integrate surveys or focus groups among the target users within the process of development, allowing guideline developers to modify the
3
ARTICLE IN PRESS
Clinical guidelines should not only attend to the best available evidence and judgement of clinical experts, but also to the views and preferences of patients [9]. The question is not whether but how to involve patients in guideline development. Several methods can be used, such as patient participation in the guideline development group, surveys or focus groups among patients, and inclusion of patient organisations in the external review process. Effective and representative input from patients, however, demands knowledge, skills and a certain degree of organisation. These are often not available, as shown by Sa¨nger et al. [10]. Special training may be needed to optimize the input from patients. International collaboration within the G-I-N Public and Patient Involvement working group (www.g-i-n.net) can help increase our knowledge and expertise on this topic.
National and international collaboration As the number of guidelines is increasing, there is a risk of duplication and fragmentation. For most chronic conditions (e.g. hypertension, diabetes, asthma) several guidelines are available. This could lead to the paradox that evidence-based guidelines on the same topic contain conflicting recommendations [11–13]. This can confuse and frustrate practitioners and can even harm patients as well [14]. Particularly in large countries, such as United States, Australia, and Germany, national programming is essential to avoid competing guidelines [15]. Independent institutes can help coordinating the efforts in guideline development. Central funding of guideline development is needed to support
4
[8]
[9]
[10]
Moving forward Finally, European collaboration on training in EBM is encouraging [17]. Sharing the principles of EBM is fundamental for harmonizing efforts in guidelines. The Guidelines International Network (G-I-N) strongly supports education and training of professionals in EBM and offers an excellent platform to moving forward in guideline collaboration [18]. The ZEFQ journal will keep you informed!
[11]
[12]
[13]
References [1] Institute of Medicine. Clinical Practice Guidelines: Directions for a new program. Washington DC: National Academy Press; 1990. [2] Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993;342:1317–22. [3] Woolf SH. Practice guidelines, a new reality in medicine. II. Methods of developing guidelines. Arch Intern Med 1992;152: 946–52. [4] The AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Safe Health Care 2003;12: 18–23. [5] Grol R, Dalhuijsen J, Thomas S, Veld C, Rutten G, Mokkink H. Attributes of clinical guidelines that influence use of guidelines in general practice: observational study. BMJ 1998;317:858–61. [6] Burgers JS, Grol RPTM, Zaat JOM, Spies TH, Van der Bij AK, Mokkink HGA. Characteristics of effective clinical guidelines for general practice. Br J Gen Pract 2003;53: 15–9. [7] Schubert I, Egen-Lappe V, Heymans L, Ihle P, Feßler J. Gelesen ist noch nicht getan: Hinweise zur Akzeptanz von hausa¨rztlichen Leitlinien. Eine Befragung in Zirkeln
[14]
[15]
[16]
[17]
der Hausarztzentrierten Versorgung (HZV). Z Arztl Fortbild Qualitatssich 2009;103: 5–12. Schra¨der P, Reiter A, Boy O, Fischer B, Do¨bler K. Qualita¨tsindikatoren der BQS als Monitoring-Instrument zur Leitlinienimplementierung am Beispiel ausgewa¨hlter Qualita¨tsindikatoren bei Mammakarzinom und Schenkelhalsfraktur. Z Arztl Fortbild Qualitatssich 2009;103:17–25. Krahn M, Naglie G. The next step in guideline development: incorporating patient preferences. JAMA 2008;300: 436–8. Sa¨nger S, Englert G, Brunsmann F, Quadder B, Villarroell D, Ollenschla¨ger G. Patientenbeteiligung an der Leitlinienentwicklung – sind die Patientenorganisationen fu¨r diese Aufgabe geru¨stet? Kurzbericht zum Vortrag. Z Arztl Fortbild Qualitatssich 2009;103:13–6. Burgers JS, Bailey JV, Klazinga NS, Van der Bij AK, Grol R, Feder G, for the AGREE Collaboration. Inside guidelines: comparative analysis of recommendations and evidence in diabetes guidelines from 13 countries. Diab Care 2002;25:1933–9. Watine J, Friedberg B, Nagy E, Onody R, Oosterhuis W, Bunting PS, et al. Conflict between guideline methodologic quality and recommendation validity: a potential problem for practitioners. Clin Chem 2006; 52:65–72. Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among international pharyngitis guidelines: not just academic. Ann Fam Med 2007;5:436–43. Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines. BMJ 1999;318:527–30. Institute of Medicine. Knowing what works in health care: a roadmap for the nation. Washington DC: National Academies Press; 2008. Rabady S. Praxisempfehlungen EbM’’ Guidelines fu¨r Allgemeinmedizin : Erste Erfahrungen mit Implementierung und Akzeptanz. Z Arztl Fortbild Qualitatssich 2009;103:27–33. Weinbrenner S, Meyerrose B, Vega-Perez A, Kulier R, Coppus SFPJ, Kunz R. fu¨r die EUebm-Gruppe. EUebm – Integration ’’ einer europaweit harmonisierten Ausund Fortbildung zu Evidenzbasierter Medizin (EbM) in die Krankenversorgung. Z Arztl Fortbild Qualitatssich 2009;103:35–9. Ollenschla¨ger G, Marshall C, Qureshi S, Rosenbrand K, Slutsky J, Burgers J, et al. Improving the quality of health care: using international collaboration to inform guideline programmes – by founding the Guidelines International Network G-I-N. Qual Safe Health Care 2004;13:455–60. ’’
Collaboration with patients
national collaboration and to avoid duplication of efforts. Smaller countries, such as Austria, could benefit from products developed elsewhere. Rabady describes the example of the adaptation and use of the Finnish ‘EBM Guidelines’ [16]. Collaboration with the guideline authors and providing them feedback data on the use and acceptance of the recommendations, could further raise the quality and effectiveness of these guidelines.
’’
recommendations before final publication. This may also apply to the development of quality indicators for monitoring the use of guidelines [8].
[18]
Z. Evid. Fortbild. Qual. Gesundh. wesen 103 (2009) 3–4 www.elsevier.de/zefq