BOX 5-1a An Urgent Case for Clear Messaging

A clinical study conducted in East Africa to evaluate fluid resuscitation in children with severe infections (severe malaria, sepsis, or others) and shock came to a surprising conclusion: the treatment—fluid boluses—which has been the standard around the world, actually decreased survival (Maitland et al., 2011). The trial overturned several decades of pediatric recommendations that are taught in pediatric life-support training and followed worldwide. Six clinical centers in Kenya, Tanzania, and Uganda participated in the clinical study.

This study faced several messaging challenges from its outset. The study required approval to obtain “emergency consent.” A lengthy consent form read to parents holding a critically ill child was neither feasible nor humane. Yet parents needed to understand (and subsequent research shows they did) that they could refuse to participate in the study without jeopardizing their child’s treatment in any way.

As the research was being designed, opportunities to involve the community in discussions about the study might have been desirable, but were somewhat limited, inasmuch as the hospitals involved were regional facilities serving dispersed populations and had no real “community.” To help address this, the research team developed and distributed explanatory brochures about the project.

Once the trial was stopped, it was important that health care providers not misinterpret the results as suggesting that no intravenous fluids should be given. Children who cannot drink for themselves still must receive sufficient fluids intravenously to maintain normal levels.

Dissemination efforts for the trial results include a paper in the New England Journal of Medicine; a YouTube video about the trial and its findings; and in-person presentations as well as distribution of a DVD about the trial to pediatric societies and academic institutions in East Africa. Finally, an ongoing effort is under way to advise the World Health Organization and other health policymaking bodies to develop policies and guidelines that take into account the results of this important study.

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Based on the presentation by Kathryn Maitland, Professor of Medicine, Imperial College.

From: 5, Messages and Methods for Public Engagement

Cover of Public Engagement and Clinical Trials
Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary.
Institute of Medicine (US).
Washington (DC): National Academies Press (US); 2012.
Copyright © 2012, National Academy of Sciences.

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