The relentless increase in healthcare costs and the global economic crisis require us to rethink the way research is done. The heterogeneity of patients is a major challenge in designing and coordinating high-quality studies about sepsis. Studies on new treatments and devices, such as polymyxin B hemoperfusion, must be optimized not only for potential benefits for a specific population (i.e. efficacy), but also for their eventual implementation in real-world situations (i.e. effectiveness) and for economic costs (i.e. efficiency). In this regard, theragnosis and newer statistical tools could help us obtain useful information from real-life observational data. In this review, we discuss the basic components required for sustainable research in polymyxin B hemoperfusion.

Keywords:
Effectiveness, Efficacy, Polymyxin B, Hemoperfusion, Theragnosis
1.
Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR: Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001;29:1303-1310.
2.
Rubulotta FM, Ramsay G, Parker MM, Dellinger RP, Levy MM, Poeze M, et al: An international survey: public awareness and perception of sepsis. Crit Care Med 2009;37:167-170.
3.
Haynes RB: What kind of evidence is it that evidence-based medicine advocates want health care providers and consumers to pay attention to? BMC Health Serv Res 2002;2:3.
4.
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS: Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71-72.
5.
Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-1892.
6.
Lauer MS, D'Agostino RB: The Randomized Registry Trial - the next disruptive technology in clinical research? N Engl J Med 2013;369:1579-1581.
7.
Cinel I, Opal SM: Molecular biology of inflammation and sepsis: a primer. Crit Care Med 2009;37:291-304.
8.
Neter E, Gorzynski EA, Westphal O, Luderitz O: The effects of antibiotics on enterobacterial lipopolysaccharides (endotoxins), hemagglutination and hemolysis. J Immunol 1958;80:66-72.
9.
Cohen J, Aslam M, Pusey CD, Ryan CJ: Protection from endotoxemia: a rat model of plasmapheresis and specific adsorption with polymyxin B. J Infect Dis 1987;155:690-695.
10.
Bello G, Di Muzio F, Antonelli M: Endotoxin filtration in Gram-negative sepsis. Clin Pulm Med 2013;20:137-143.
11.
Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, et al: Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA 2009;301:2445-2452.
12.
ClinicalTrials.gov: Safety and efficacy of polymyxin B hemoperfusion (PMX) for septic shock (EUPHRATES). http://clinicaltrials.gov/show/NCT01046669 (accessed September 23, 2013).
13.
Cruz DN, Perazella MA, Bellomo R, de Cal M, Polanco N, Corradi V, et al: Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review. Crit Care 2007;11:R47.
14.
MacMahon S, Collins R: Reliable assessment of the effects of treatment on mortality and major morbidity. II. Observational studies. Lancet 2001;357:455-462.
15.
Ferrer R, Artigas A, Suarez D, Palencia E, Levy MM, Arenzana A, et al: Effectiveness of treatments for severe sepsis: a prospective, multicenter, observational study. Am J Resp Crit Care 2009;180:861-866.
16.
EUPHAS 2. http://www.euphas2.eu (accessed September 23, 2013).
17.
Berto P, Ronco C, Cruz D, Melotti RM, Antonelli M: Cost-effectiveness analysis of polymyxin-B immobilized fiber column and conventional medical therapy in the management of abdominal septic shock in Italy. Blood Purif 2011;32:331-340.
18.
Esteban E, Ferrer R, Alsina L, Artigas A: Immunomodulation in sepsis: the role of endotoxin removal by polymyxin B-immobilized cartridge. Mediators Inflamm 2013;2013:507539.
© 2014 S. Karger AG, Basel
2014
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