Evidence based medicine and research activities in the developing world

Sascha Meyer, Lead Consultant,
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Other Contributors:

June 10, 2014

Dear Sir, We read with interest the work by Duke et Fuller (1) demonstrating an increase in the publication of randomized controlled trial (RCT); total: 1553) in 76 low- and middle income countries (LMIC) over a 11-year period. Of note, studies of nutrition (366 publications, 23.6%) and malaria (336 publications, 21%) predominated. Trials of infectious diseases - most importantly malaria involved a comprehensive range of both treatment and preventive strategies with the implementation of new interventions as routine health strategies, and reductions in malaria. The authors demonstrated that there have been a relatively small number of trials of interventions for treatment or prevention of acute respiratory infection (98 publications, 6.3%), neonatal health (64 publications, 4.1%) and tuberculosis in children (26 publications, 1.7%). Interestingly, in the last 5 years there has been increasing focus on non-communicable diseases such as asthma and allergy, obesity, diabetes and cardiac disease, and behavioural-developmental disorders while mental health conditions have received little attention (21 publications, 1.4% of publications) (1).

While Duke et Fuller. (1) are to be congratulated for their systematic analysis, there is an ongoing lack of up-to-date, systematic reviews that critically assess the role and potential limitations of evidence-based medicine (EBM) and systematic Cochrane reviews in particular originating in LMIC. Undoubtedly, EBM has contributed substantially to improving the quality of medicine in general, and in neonatology and pediatrics in particular (2). Cochrane reviews are systematic reviews/meta-analyses of primary research in the medical and health policy fields. They are considered the highest standard in EBM. Thus, the Cochrane database may prove particularly beneficial for LMIC with limited resources. However, most published clinical research has been conducted in highly industrialised Western countries, and it remains unclear how the results gained from these RCTs will translate into changes in medical care in the developing world. Thus, it is important that LMIC themselves get involved in research activities based on their specific medical problems and needs - as demonstrated by Duke et Fuller ?1? - but also in the process of generating of Cochrane reviews as well.

Hence, we would like to share our data analysis on this topic (3). We performed a systematic literature review of all Cochrane reviews published between 1996 and 2010 by the Cochrane Neonatal Review Group (CNRG) and in the field of neuropediatrics. The main outcome parameter of our review was the assessment of the percentage of reviews that originated in developing countries and the number of reviews that provided conclusive/ inconclusive data. In total, 262 reviews were performed in the field of neonatology and 112 in the field of neuropediatrics. Only a small fraction (15/262 (5.7%) in neonatology and 16/112 (14.3%) in neuropediatrics) originated in developing countries. Only seven of those 15 reviews in the field of neonatology provided conclusive recommendations (six negative, one positive) while in neuropediatrics 9 reviews provided conclusive recommendations (five negative and four positive), while six were inconclusive. One report provided conditional recommendations.

This is of concern, for worldwide the vast majority of neonates and children are born and raised in these countries. Moreover, the recommendations issued in Cochrane reviews performed in highly industrialised countries are largely applicable to the fields of neonatology and neuropediatrics as practised in industrialised countries and will potentially exclude the majority of neonates, infants, and children being born and cared for in the developing world. However, recently, efforts (through initiatives such as the Effective Health Care Alliance and the SEA-orchid consortium) have been undertaken to disseminate knowledge from the CNRG to low- and middle-income countries to ensure that care practices are evidence-based and that scarce resources will be used and allocated appropriately (2, 4). These programs target generators as well as users and teachers of evidence in order to ultimately ensure the implementation of effective interventions (2, 4). Moreover, and of note, our study also demonstrated that a substantial percentage of systematic Cochrane reviews from developing countries were inconclusive and failed to provide any recommendation with regard to a specific intervention.

Based on our findings and the work by Duke et Fuller (1), we conclude that there is an ongoing need for high-quality research that addresses specific issues that are most relevant to the medical care of children in developing countries. Funding and research agencies will play a pivotal role in selecting the most appropriate research programs for the developing world. Given the limited financial and human resources that are available in the medical arena in the developing world, future emphasis must be on long-term outcomes that are vital to infants and children and their families, as well as to healthcare workers. Importantly, in the future the effects of interventions not only on survival, but also on long -term morbidity, must be considered (5). This change in paradigm is particularly important in perinatal medicine. In doing so, the realization and implementation of the Millennium Development Goals as defined in 2000 will become realistic, thus reducing child mortality rates worldwide (6, 7). In the future, it will be important to assess effectiveness of interventions that will have been put in place following the publication of high quality RCTs - as shown by Duke et Fuller (1) - and systematic reviews in LMIC.

References 1. Duke T, Fuller D. Randomised controlled trials in child health in developing countries: trends and lessons over 11 years. Arch Dis Child. 2014 Mar 10. doi: 10.1136/archdischild-2013-305702. [Epub ahead of print] 2. Davis, P.G. 2006. "Cochrane Reviews in Neonatology: Past, Present and Future." Seminars in Fetal & Neonatal Medicine 11: 111-16 3. Meyer S, Willhelm C, Girisch W, Gottschling S, Gr?ber S, Gortner L. The role of developing countries in generating Cochrane meta-analyses in the field of pediatrics (neonatology and neuropediatrics): a systematic analysis. World Health Popul. 2013;14(2):24-32 4. Henderson-Smart, D.J., P. Lumbiganon, M.R. Festin, J.J. Ho, H. Mohammad, S.J. McDonald et al. 2007. "Optimising Reproductive and Child Health Outcomes by Building Evidence-Based Research and Practice in South East Asia (SEA-Orchid): Study Protocol." BMC Medical Research Methodology 7: 43;doi: 10.1186/1471- 2288-7-43 5. Liu L, Johnson HL, Cousens S, et al. Global, regional, and national causes of child mortality: an updated systematic review for 2010 with time trends since 2000. Lancet 2012;379(June 9):2151-61. 6. UNICEF. Committing to child survival: a promise renewed. New York: United Nations Children's Fund, 2012. Ref Type: Report 7. Willhelm, C., W. Girisch, L. Gortner and S. Meyer. 2012. "Role of Cochrane Reviews in Pediatric Neurology." Acta Paediatrica 101(4): 352-3. d

Conflict of Interest:

None declared

Conflict of Interest

None declared