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Larry A Green, Washington, DC The Robert Graham Center
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Professor van Weel ups the ante for family physician researchers, and for good reasons, including the United States' National Institute of Health's "Roadmap" initiative, now seeking to enhance clinical research by establishing research networks in various fields. Standardized ethical review processes for such networks, as mentioned by Dr. van Weel, would be an example of help in reducing barriers to more practice-based research involving people in different states and countries. I remain optimistic that careful observational research in primary care research networks will emerge as a valid source of knowledge, especially about the EFFECTIVENESS (vs mere efficacy)of interventions in primary care. It is conceivable that populations receiving care (not just a sample) can be incorporated into primary care network research. When one knows whether the population cared for was better or worse after intervention A, and the favorable experience is reduced or absent when intervention A is not done, and the favorable experience is replicated in another population exposed to intervention A --what would we clinicians be prepared to conclude? Would we prefer to rely on and wait for an RCT involving a few randomly chosen but selected patients to define evidence- based care for our patients? Is there something beyond the RCT that is needed to complete medical knowledge? Could these questions be part of the agenda for the next WONCA research conference? Competing interests: None declared |
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Chris van Weel, Nijmegen, The Netherlands professor of family medicine
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Unless primary care will disappear overnight from the international research agenda, the otitis media study [1] will in all likelihood for later generations be looked upon as a landmark event. International variation in primary care performance has been analyzed extensively and in depth before. But here for one of the first times, the international setting of primary care with all its variations, was used to analyze treatment and outcome of a common condition in primary care. Due to this international setting it was possible to overcome restricted treatment options imposed by national standard setting. Given the fact that the potential of international primary care research is thriving [2] the analysis of the otitis media study experience presents valuable ‘behind-the-scenes’ experience. This is experience the international primary care research community could learn from and build upon and for that reason I would like to pursue the implications of this paper from an international perspective. The first point is directed at methodology: it is an interesting model that an international framework presented a natural experiment – through variation of treatment routines for otitis media – that could serve as an alternative for a randomized controlled trial (RCT). This was interesting and welcome in this case, but more methodological evidence is needed on the value of this methodological concept in general terms and to what extent international variation in care can replace RCTs. In fact, the international otitis media study [1] was a parallel series of observational studies, and recently the reliability of observational research has been challenged in an in-depth epidemiological debate on the effectiveness and safety of hormone replacement [3]. The concerns of practitioner-prescriber bias in the light of expected treatment outcomes that were raised in that context [4] should not be discarded lightly, and international meta-analysis of study collaborations might be helpful to explore more in-depth their strengths and weakness. Technology and lack of international standardization of practice and research equipment came forward as restrictive factors in the otitis media study. Although family medicine has come a long way in standardizing most of its key terms and information [5, 6], such data have to be collected under prevailing health care conditions and this will inevitably account for international variation. Yet, it might be helpful for primary care, to tap into the experiences in other fields of medicine. Cardiology, with its long reputation of large-scale international studies, would come foreword as an interesting party in an analysis of international research experience and research in that field must have encountered some of the challenges of the otitis media study group. . It is obvious that there are discipline-specific driving factors towards international collaboration in research: in primary care the importance to include the rich variation of practitioners’ performance and (national) practice routines, while in other specialties – see the cardiology mega-trials – it is the need of sufficient numbers. The most interesting aspect of the otitis media study, though, is in the different ethical appreciations of treatments. It is logical that family physicians’ preference, in case of otitis media, for antibiotics in the US and UK and for the ‘wait-and-see’ approach in Netherlands is grounded in the ethical valuation of their respective national review panel. But it remains difficult to accept, in ethical terms, that national preferences dictate that antibiotics is what patients will get even when wait-and-see is equally good, or patients are put on a wait-and-see approach when antibiotics have added benefits. In other words, the national (or even regional [1]) borders with their ethical views might impede the effectiveness of medical care. For that reason international research advocacy should challenge this and address considerations of ethical review panels in the light of international primary care. In summary, the international study on otitis media heralds an urgent need for a review of primary care research in an international perspective, including experiences of other medical disciplines and taking into account the broad medical and ethical implications. Would this be the theme of a next [2] Wonca-invitational conference? Chris van Weel Professor of family medicine Radboud University Medical Centre References 1.Froom J, Culpepper L, Grob P, et al. Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. Br Med J 1990; 300: 582-586. 2.van Weel C, Rosser WW. Improving health care globally: A critical review of the necessity of family medicine research and recommendations to build research capacity. Ann Fam Med 2004; 2 (suppl. 2): 5s-16s. 3.Lowlor DA, Davey Smith G, Ebrahim S. Commentary: the hormone replacement-coronary heart disease conondrum: is this the death of observational epidemiology? Int J Epidemiol 2004; 33: 464-467. 4.Vandenbroucke J. The HRT story: vindication of old epidemiological theory. Int J Epidemiol 2004; 33: 456-457 5.Wonca International Classification Committee. Internatioal Classification of Primary Care, ICPC-2 . 2nd ed. Oxford: Oxford University Press, 1998. 6.Bentzen N. (ed) Wonca Dictionary of General/Family Practice. Copenhagen: Maanedsskrift for Praktisk Laegegering, 2003. Also: http://www.globalfamilydoctor.com Competing interests: None declared |
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Jonathan P Graffy, Cambridge, UK Senior Clinical Research Associate, University of Cambridge
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Green et al tell a good story but fail to answer a key question, “Was it worth the effort?” in their account of international collaboration on otitis media research. Perhaps the more we put into our research, the harder it is to admit defeat. Was their finding that there was little difference in the time children took to recover from otitis media, regardless of the antibiotic regime used in their country, worth the effort? If this was the whole story, one might be tempted to dismiss study as a grand but foolhardy mission. But they report lessons that we can all learn from. - Different countries really are different, so collaborative projects need to fit the local context. - Although eWorld, their data transmission system let them down, the Internet now offers an economical way to transmit data from collaborative studies. - Research often takes longer than we anticipate, and we need to build margins of error into our funding bids. - This paper also reminds us that researchers must engage in debates about when the regulation of research only serves to stifle it. Despite the difficulties that Green et al encountered, globalisation is making it easier to communicate across national boundaries. Both doctors and patients turn to the Internet for information from around the world. As we communicate more it becomes easier to see the differences between the ways in which we work. Indeed opinion leaders often find ideas from abroad more attractive than locally developed solutions when they face up to long-standing problems in the delivery of health services. So there is a strong case for more cross-border research. Hopefully this paper will help those embarking on this avoid some of the pitfalls that Green et al encountered. Competing interests: None declared |
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Ann C. Macaulay, Montreal, Canada Professor, Department of Family Medicine, McGill University
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Thank you for writing this article outlining how you overcame the complexities of international research involving several countries. All researchers should keep this gem close at hand; however many hurdles have arisen in your current research this article will remind you how much worse it could be! Competing interests: None declared |
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