Archna Gupta

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

BackgroundPragmatic randomized trials aim to examine the effects of interventions in the full spectrum of patients seen by clinicians who receive routine care. Such trials should be employed in parallel with efforts to implement many interventions which appear promising but where evidence of effectiveness is limited. We illustrate this need taking the case of essential interventions to reduce inpatient neonatal mortality in low and middle income countries (LMIC) but suggest the arguments are applicable in most clinical areas.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.

Promoting development and uptake of health innovations: The Nose to Tail Tool

Introduction Health sector management is increasingly complex as new health technologies, treatments, and innovative service delivery strategies are developed. Many of these innovations are implemented prematurely, or fail to be implemented at scale, resulting in substantial wasted resources. Methods A scoping review was conducted to identify articles that described the scale up process conceptually or that described an instance in which a healthcare innovation was scaled up. We define scale up as the expansion and extension of delivery or access to an innovation for all end users in a jurisdiction who will benefit from it. Results Sixty nine articles were eligible for review. Frequently described stages in the innovation process and contextual issues that influence progress through each stage were mapped. 16 stages were identified: 12 deliberation and 4 action stages. Included papers suggest that innovations progress through stages of maturity and the uptake of innovation depends on the innovation aligning with the interests of 3 critical stakeholder groups (innovators, end users and the decision makers) and is also influenced by 3 broader contexts (social and physical environment, the health system, and the regulatory, political and economic environment). The 16 stages form the rows of the Nose to Tail Tool (NTT) grid and the 6 contingency factors form columns. The resulting stage-by-issue grid consists of 72 cells, each populated with cell-specific questions, prompts and considerations from the reviewed literature. Conclusion We offer a tool that helps stakeholders identify the stage of maturity of their innovation, helps facilitate deliberative discussions on the key considerations for each major stakeholder group and the major contextual barriers that the innovation faces. We believe the NTT will help to identify potential problems that the innovation will face and facilitates early modification, before large investments are made in a potentially flawed solution.