Translational medicine as implementation science in the field of monitoring HIV and TB. New concepts emanating from resource‐poor countries

Abstract

In the last decade, there has been generous support by Western nations to deal with the HIV/AIDS epidemic and accompanying plethora of infections, a significant portion of the aid is extended to resource-restricted countries (1). The wave of support has contributed to the development of a branch of biomedical activity, referred to as translational medicine. This new field covers two areas: (i) the ‘‘translational medicine proper’’ (T-1) to establish proofs of concepts mostly in animal models that lead to pilot studies in humans, and (ii) ‘‘the translational medicine-2’’ (T-2, also referred to as ‘‘implementation science’’) for optimizing already established medical concepts in rich and poor countries alike, for wider applications in communities (2). Fledgling journals which carry the ‘‘translational’’ title clearly favor T-1 publications; by contrast, on the pages of Clinical Cytometry mostly T-2 topics are featured as clinical implementations of diagnostically relevant developments. For two reasons, the T-2 field is subject to political scrutiny. First, In 2008, US $ 15.6 billion was spent on AIDS programs in low and middle income countries. Currently, a very high proportion (50%) of these are coming from external, including generous North American, sources and these may not be sustainable. Furthermore, the calculated trends reveal that this expenditure is to shoot up to 2–3 times higher levels, and that a major epidemic will still be with us in 2031 without a change in approach (3). Second, medical care in the West is, by tradition, expensive (4). The health care practiced in the US appears to be in the 37th position with respect to cost efficiency (5). Consequently, when suggesting that from now on the resource-restricted partners must contribute more to their HIV care/prevention (3), the possibilities of modifying diagnostics according to the local needs using local implementation science must be considered. This field in Africa has been revitalized since generic antiretroviral therapy (ART) became affordable. During the last decade requirements for simplifying diagnostics has frequently been advocated in the pages on Clinical Cytometry (6,7). When African health care workers are faced with acute crisis, they are often proven to be inventive. Evidence is gathering that the technologists in resource-poor regions are capable of developing and/or modifying methods in order that these are elegantly simplified for more affordable large scale testing formats. Some of these efforts represent improvements of precision, accuracy, quality assessment, and training (8–10). In his recent book, Nigel Crisp, the former Chief Executive of the National Health Service of the United Kingdom (11) explains that ‘‘poor countries do not need a diluted version of what rich countries have now, and may have an easier time building a better system from little.’’ Inspired by his approach, in this editorial, we would like to briefly review five recent papers (12–16). But first we need to consider two significant changes in the global outlook which influence the use of diagnostics. In 2006, the WHO recommended that all HIV positive patients start ART when their CD4 T-cell count fell to 200 cells/mm. In patients with CD4 counts between 200 and 350 cells/mm, the initiation of ART was optional on the basis of these patients showing some symptoms (Grade 2–4) or were still asymptomatic (Grade 1). However, in countries with poor resources this guideline was frequently interpreted as to start ART at 200/mm, reaching many patients too late (17,18) even at levels as low as 50–150 CD4 T-cells/mm. Recently, it has also been shown that earlier start of ART at higher CD4 T-cell counts reduces mortality and morbidity rates (17,18). Therefore WHO, in unison with other regulatory bodies, now recommends ART to be