"Health inequities in the diagnosis and outcome of sepsis in Argentina: a prospective cohort study" en el journal Critical Care. La Doctora Estenssoro es una destacada investigadora y miembro de LIVEN. Felicitaciones a Elisa y su equipo.
Globalization of clinical research is a growing phenomenon1. Research is necessary to make progress in health care and is usually funded by governmental, private or pharmaceutical institutions, each of them having their own interests and restraints.
Research is more difficult in resource-limited settings, such as low and middle-income countries (LMICs). These resource-limited contexts have become more important actors in the effort to identify novel solutions to major health care issues. Unfortunately, healthcare systems in those contexts are frequently low-resilient and not widely available for the general population2. Additionally, regional, political, and socioeconomic disparities, alongside with limited hospitals capacity, inadequate human resources, lack of experience on conducting large and prospective studies, and insufficient implementation science research, hinder clinical research in LMICs2.
Critical care is one of the most demanding fields in requirements for high-quality, cost-effective treatments. Sepsis is a significant health burden worldwide and if not recognized early and managed promptly, can evolve to sepsis-related tissue hypoperfusion or septic shock, multiple organ failure and death3. Regrettably, over 19 million sepsis cases with 5 million related deaths are estimated to occur annually in LMICs4.
Nonetheless, our recent ANDROMEDA-SHOCK study recently published in JAMA5 seems to us a good example of doing research on a significant health problem, in a resource-limited setting. In fact, Latin America is globally a region of LMICs although some of them, by a slight margin, exceed the defining threshold.
In our study, we compared two strategies for septic shock resuscitation, attempting to integrate the best evidence in a step-by-step algorithm. Recruitment of patients and researcher participation relayed on clinical interest and a high individual commitment only, since the study was conducted without funding.
We believe that ANDROMEDA-SHOCK study design and execution may be useful as a model to follow for doing research in similar scenarios. So, if willing to face the challenge to setup a research effort, our suggestions to current and future investigators from comparably restricted settings, would be:
1. To choose a health care problem with global recognition that also presents a significant problem in the participating countries and centers.
2. To test a high yield, cost-effective, ethically-clean intervention, that is available in all-resource settings and able to be implemented and benefit the patients in the participating countries.
3. To have, at least, one academic institution providing a strong logistic support.
4. To have a shared innovative attitude for taking advantage of the team’s equipoise, coupled with a strong commitment of clinicians motivated and passionate with the possibility to contribute significantly to the field.
5. To setup a multicenter supporting network of committed colleagues, in partnership with experienced investigators and (external) advisors.
Finally, having a strong leadership that supports the previous points is key to engage teams in the participating centers and thus maintain high recruitment and quality despite the lack of financial incentives.
The authors, on behalf of the ANDROMEDA-SHOCK Investigators and the Latin America Intensive Care Network (LIVEN).
1. Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and Scientific Implications of the Globalization of Clinical Research. New Engl J Medicine. 2009;360(8):816-823. doi:10.1056/nejmsb0803929
2. Rudd KE, Kissoon N, Limmathurotsakul D, et al. The global burden of sepsis: barriers and potential solutions. Crit Care. 2018;22(1):232. doi:10.1186/s13054-018-2157-z
3. Singer M, Deutschman CS, Seymour C, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Jama. 2016;315(8):801-810. doi:10.1001/jama.2016.0287
4. Fleischmann C, Scherag A, Adhikari NK, et al. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Resp Crit Care. 2016;193(3):259-272. doi:10.1164/rccm.201504-0781oc
5. Hernández G, Ospina-Tascón GA, Damiani L, et al. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock. Jama. 2019;321(7):654-664. doi:10.1001/jama.2019.0071