The need for pragmatic clinical trials in low and middle income settings – taking essential neonatal interventions delivered as part of inpatient care as an illustrative example

DiscussionA set of basic interventions have been defined, based on available evidence, that could substantially reduce early neonatal deaths if successfully implemented at scale within district and sub-district hospitals in LMIC. However, we illustrate that there remain many gaps in the evidence available to guide delivery of many inpatient neonatal interventions, that existing evidence is often from high income settings and that it frequently indicates uncertainty in the magnitude or even direction of estimates of effect. Furthermore generalizing results to LMIC where conditions include very high patient staff ratios, absence of even basic technologies, and a reliance on largely empiric management is problematic. Where there is such uncertainty over the effectiveness of interventions in different contexts or in the broad populations who might receive the intervention in routine care settings pragmatic trials that preserve internal validity while promoting external validity should be increasingly employed.SummaryMany interventions are introduced without adequate evidence of their effectiveness in the routine settings to which they are introduced. Global efforts are needed to support pragmatic research to establish the effectiveness in routine care of many interventions intended to reduce mortality or morbidity in LMIC. Such research should be seen as complementary to efforts to optimize implementation.

Source: Epidemiologic Perspectives and Innovations - January 18, 2016 Category: Epidemiology Authors: Mike EnglishJamlick KarumbiMichuki MainaJalemba AluvaalaArchna GuptaMerrick ZwarensteinNewton Opiyo Source Type: research