VIEWpoint www.nature.com/clinicalpractice/gasthep
Are global guidelines desirable, feasible and necessary? M Fried*, EMM Quigley, RH Hunt, G Guyatt, BO Anderson, DJ Bjorkman, MJG Farthing, SS Fedail, R Green-Thompson, J Hampton, J Krabshuis, L Laine and R Horton For details of the authors’ affiliations and biographies go to the article online.
Correspondence *Division of Gastroenterology and Hepatology University Hospital Zürich Raemistrasse 100 CH-8091 Zürich Switzerland
[email protected] Received 2 March 2007 Accepted 26 September 2007 Published online 13 November 2007 www.nature.com/clinicalpractice doi:10.1038/ncpgasthep0994
Guidelines matter.1 The medical literature is awash with guidelines and the field of gastroenterology is no exception. Medical organizations that create guidelines face difficult challenges and guidance is needed.2 Firstly, if guidelines are to be truly evidence-based, all recommendations should be supported by up-to-date systematic reviews. Such reviews can, however, be very costly if adherence to strict standards is maintained. Secondly, the impact of such guidelines on medical practice, or on such outcomes as mortality or morbidity, has been scarcely documented. Thirdly, are guidelines developed in large part in Western countries really useful and relevant to resource-poor, lessdeveloped countries? This last issue is of particular relevance to the World Gastroenterology Organization (WGO) given its special interest in training and education in gastroenterology and the care of digestive disorders in developing nations. The WGO has attempted, when developing guidelines, to place emphasis on topics of importance to the developing world and to tailor its recommendations to the capabilities of poorer health-care systems. The WGO established a task force early in 2005 to identify the key issues in the development and implementation of global guidelines.3 This task force laid the framework for cascades. A cascade is a collection of related diagnostic and treatment options arranged hierarchically in terms of conditions and available resources. For guidelines to work, cascades need to be built into them. Guidelines without cascades are resource-blind and will not work in most of the world.4 Global guidelines are desirable because they serve at least four functions. Firstly, guidelines have an advocacy function. They draw attention to neglected areas of medical practice and public health. Secondly, guidelines can set standards. They consider variations in practice and therefore reveal inequities of care. Ample evidence for the potential value of guidelines for the developing world is provided in the area of child health. A team of investigators and public health experts concluded that the application of 23 proven interventions in the 42 countries where
nature clinical practice GASTROENTEROLOGY & HEPATOLOGY
90% of child deaths occur under the age of 5 years could prevent 6 million premature deaths. These guidelines would cost 5 billion US dollars to implement—~25% of what is currently spent on HIV and AIDS, and ~25% of what developing countries currently spend on military equipment.5 Thirdly, guidelines encourage a critical scrutiny of the research literature. For example, it has been estimated that the authors of ~50% of all clinical trials published in leading medical journals provide inadequate documentation of their methods.3 Consequently, guidelines developed on the basis of such incomplete evidence might well be flawed. Finally, guidelines also provide a platform to debate the quality and meaning of evidence. Such scrutiny could help to avoid the adoption of therapies, such as the administration of hormone replacement therapy to menopausal and postmenopausal women, on the basis of the findings of observational studies, only to be subsequently proved misleading when appropriate studies are performed.3 Guideline development involves many steps. A topic must be identified and refined and a guideline panel convened. This panel should consider all reasonable management strategies for dealing with the problem. The next step is to perform a systematic review to identify and appraise the available evidence. A critical appraisal of this evidence must be then translated into a guideline. The guideline must then be disseminated to the relevant audience and implemented. Finally, the impact of the guideline should be prospectively assessed using meaningful and measurable outcomes. Difficulties might occur during each step: it would be nearly impossible to choose topics that are appropriate for the entire world, convene a panel representing all stakeholders and synthesize recommendations from evidence that, in the case of those disorders that afflict developing countries, might well be scanty. The greatest challenges will be encountered at the implementation phase; the expectation that a guideline can be disseminated and implemented in developing countries in a manner that would be considered january 2008 vol 5 no 1
VIEWpoint www.nature.com/clinicalpractice/gasthep
desirable and optimal in the developed world is, regrettably, unrealistic. The most practical way to overcome these hurdles might be to have a number of smaller panels who develop recommendations for different communities under the auspices of a central sponsoring group. Stakeholders from a variety of regions would provide initial input related to the choice of topics and the framing of the questions around which the guideline would be developed. Once an appropriate topic had been identified, a systematic review could be performed centrally. Each group, consisting of local stakeholders and experts in the topic, would then translate the evidence from the systematic review into recommendations for their communities. Sponsoring groups could work with local stakeholders to develop effective strategies for the dissemination, implementation and monitoring of guidelines in different locations. One could argue that guidelines for the management of disease are, if anything, more necessary in the developing world. Compared with their counterparts in the developed world, patients in developing countries participate less in the management of their health problems. It is critical, therefore, that doctors and other health-care providers be fully apprised—through authoritative and relevant guidelines—of the most appropriate management strategies. Guidelines might also help to set preferred patterns of medical practice. As levels of training and clinical expertise vary considerably among developing countries, access to global guidelines can promote a common and uniform approach to patient care. Furthermore, the implementation and ongoing review of global guidelines can constitute an important tool for the practical delivery of continuous medical education and serve as a benchmark for the appraisal of practice standards. Global guidelines are also needed as a counterweight to guidelines produced by special interest groups. For example, some pharmaceutical companies have sponsored guidelines that scarcely veil their objective to promote a particular product. The blind application of guidelines from the developed world, advanced by special interest groups, which advocate the use of expensive technologies and interventions can, therefore, be especially inappropriate in developing countries. The absence of local or global guidelines renders this occurrence inevitable. Unfortunately, the databases, the know-how and the financial resources january 2008 vol 5 no 1
needed for the development, testing and monitoring of high-quality guidelines are costly and not available in the majority of developing countries. Global guidelines must, therefore, identify realistic diagnostic and treatment alternatives and take account of the local context. For example, a number of effective modalities exist for the management of bleeding esophageal varices, an important cause of morbidity and mortality in the developing world. Good results can be obtained with sclerotherapy alone—a cheap and effective approach that might prove more appropriate than more costly treatments such as variceal band ligation, octreotide or Glypressin® (Ferring B.V., Hoofddop, The Netherlands), which are advocated by North American and European guidelines. In this case and in others, application of a less expensive approach might be more beneficial. Global guidelines are desirable and can have an impact on health throughout the world. In developing global guidelines one must be mindful of the challenges and limitations of the process. A ‘one size fits all’ approach is neither desirable nor feasible. A centralized approach can certainly provide efficiencies by generating systematic literature reviews, developing general recommendations and providing oversight and logistical support to the process. This approach can be complemented by searching regional data sets from Africa,6 South-East Asia,7 Latin America8 and the Eastern Mediterranean.9 To be of real value, it is mandatory that guidelines have local input in the selection of topics and the production of final recommendations. Organizations, such as WGO can, and should, play a leading role in this process.
Competing interests The authors declared no competing interests.
References 1 Kornbluth A et al. (2006) Do guidelines matter? Implementation of the ACG and AGA osteoporosis screening guidelines in inflammatory bowel disease (IBD) patients who meet the guidelines’ criteria. Am J Gastroenterol 101: 1546–1550 2 Steinbrook R (2007) Guidance for guidelines. N Engl J Med 356: 331–333 3 OMGE Montreal September 2005 Symposium: Can Guidelines Span the Globe? Live audio [http://omge.org/ ?cc_program] (accessed 17 October 2007) 4 Quigley EM et al. (2007) Use of evidence in WHO recommendations. Lancet 370: 824 5 Bryce J et al. (2005) Can the world afford to save the lives of 6 million children each year? Lancet 365: 2193–2200. 6 African Index Medicus (AIM) [http://indexmedicus.afro.who.int/] 7 Index Medicus for South East Asia (IMSEAR) [http:// www.who.int/library/databases/searo/en/index.html] 8 Latin American & Caribbean Health Sciences (LILACS) [http://www3.bireme.br/abd/I/ililacs.htm] 9 Eastern Mediterranean Index Medicus [http:// www.who.int/library/databases/emro/en/index.html]
nature clinical practice GASTROENTEROLOGY & HEPATOLOGY
