The Programme for Global Paediatric ResearchTM Workshop:
Researching Outcomes for High Risk Newborns and Children
in Developing Countries
May 9, 2007, 8:00 a.m. – 5:00 p.m.
Sheraton Centre, Toronto
The workshop was preceded on May 8 by a PGPR symposium entitled Global Childhood Diseases Which Can Impair Development”. The following issues, presented and discussed in the symposium, were fundamental to the workshop discussions:
Nutrition and economic status has a significant effect, not only on growth, but on the social and intellectual development of children
- Correcting nutritional deficiencies and enhancing caregiver-child interaction can improve child development.
- Diseases of children can be followed by developmental delay. Malaria, and especially malarial encephalopathy, can result in considerable delay. Neonatal hyperbilirubinemia appears to be a major cause of developmental delay in some low income countries.
- Children within programs designed to reduce mortality from neonatal diseases (asphyxia, infections) are a “high risk” group requiring developmental follow up studies.
With these issues in mind, the workshop focused on determining ways that potential or actual developmental failure can be identified early so that corrective measures can be instituted. The workshop also focused on the importance of evaluating treatments of diseases or disabilities in order to ensure that these treatments are least likely to inhibit subsequent development.
The workshop included 55 participants from at least 18 countries. Three presentations were followed by small group discussions and the workshop concluded with a final plenary session at which the small groups presented their deliberations and group discussion took place.
I Plenary Session
Conducting Outcome Studies in Developing Countries: Gary Darmstadt, Associate Professor and Director, International Center for Advancing Neonatal Health, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, U.S.A.
Dr. Darmstadt’s slides are attached as Appendix A. He discussed the pressing need for information about the prevalence of handicapping disorders in low and mid income countries. He emphasized the urgent need for studies of developmental disabilities and indicated that, ideally, such studies should be associated with the provision of services. He pointed out the specific needs for such studies and how they should be integrated into existing health systems.
Dr. Darmstadt also reviewed the existing information on follow up studies of newborn infants treated for asphyxia or infection by community health workers. There were no significant studies available.
Summary of Comments During Open Discussion Following Dr. Darmstadt’s Presentation
The assessment of infants “at risk” should be part of an overall component of the health system, namely the provision of developmental services.
Health services to mothers traditionally include advice about feeding and child care, but usually do not deal specifically with developmental assessment and information and support on child rearing, stimulation etc. That information should be part of health systems and evaluating development could be a component. This initiative would represent a paradigm shift in that child health research would not only recognize and study death and morbidity but also child development.
It was pointed out that the concept of milestones is unknown in many cultures
In Turkey there are programs for child development and for stimulation. Those have included a simple system for evaluating child development which has not yet been published in English. There is a WHO study now underway which is evaluating developmental assessment programs in many countries around the world.
Recently there has been tremendous progress in recognizing and dealing with diseases that are killing and harming children; now there is an opportunity and need to move to the next dimension, follow up and evaluation of survivors.
Four components must be considered in instituting developmental programs:
- Family involvement - to understand the program and to be trained to stimulate
- Community workers - to be trained
- Health systems - to be organized to provide these programs
- An enlightened and committed government policy
Etiology of Developmental Disorders in Developing Countries: Donald Silberberg, Professor, Department of Neurology, University of Pennsylvania, Philadelphia. U.S.A.
Dr. Silberberg’s slides are attached as Appendix B.
Dr. Silberberg showed:
- It is likely that there is a high prevalence of developmental disability in developing countries. However the actual incidence is unknown and available data are inaccurate and/or provide no real information.
- There are many causes of abnormal development and disabilities.
- There are plans for a large scale critical study of neurodevelopmental disabilities of children in 45,000 households in a variety of communities in India. This study is being done in collaboration with INCLEN. A description of the methodology for such studies and the design and time table for implementing the study in India was included in Dr. Silberberg’s presentation.
- Existing screening tools are not adequate. Therefore a new neuro-developmental disability screening tool has been developed and tested (Phase 1) and is to be applied in the upcoming study in India (Phase2).
Summary of Comments During Open Discussion Following Dr. Silberberg’s Presentation
The comprehensive planning in the Silberberg/INCLEN research proposal is consistent with the rigor needed to assess the problem of childhood disability in developing countries.
The research protocol could be applied in other countries; this would be done in collaboration with the Silberberg/INCLEN research team.
Concern was expressed about the ethics of investigating developmental delays and disorders without providing needed services. In many villages over 50% of children are stunted and presumably many of those have delayed development. What would be achieved by “counting the numbers”? Furthermore, what about “stigmatizing”, while not providing services to assist affected children and their families? All of this illustrates the potential that such surveys would do more harm than good.
Dr. Silberberg’s response to these concerns was that he and his colleagues hope that there would be services offered. By bringing the problems to the attention of the health system more service would be made available. As to stigmatization he could not conceive that “ignorance would be preferable to knowledge”. He followed that by saying that there had been evidence, at least in Bangladesh, that studies leading to identification of problems in a community, lead to community action and eventual provision of additional services.
These issues were discussed at greater length during and following the small group sessions (see below).
Methodology for Evaluating Cognitive/Intellectual Development in Low and Mid Income Countries: Robert Armstrong, Professor and Chairman, Department of Paediatrics, University of British Columbia; and Chief, Paediatric Medicine, BC Children’s Hospital, Vancouver, Canada
Dr. Armstrong’s slides are attached as Appendix C.
Dr. Armstrong reviewed the existing information on studies of child development in low and mid income countries. He stated that uniform evaluation techniques are needed and he described the possible approaches that might be taken to reach this goal.
There was no formal discussion after Dr. Armstrong’s presentation however the issues he discussed were further explored by group 3 and subsequently presented by Dr. Armstrong (see below).
II Small Group Sessions
Workshop participants were divided into four small groups to determine clear recommendations on specific issues.
Chairs: Zulfiqar A. Bhutta The Aga Khan University, Karachi, Pakistan; and Gary L. Darmstadt, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, U.S.A.Topic: How can follow up studies best be incorporated into research protocols designed to study the effect of community health workers treating neonatal asphyxia and infectious diseases?
After the breakout sessions ended, Group 1 presented a summary of its discussions. This summary is attached as Appendix D. This presentation was followed by plenary group discussion during which Group 1 further encouraged including developmental follow-up programs in existing studies of newborns or prospective studies of pregnant mothers. Ideally, these programs would be linked both to appropriate services and referral support.
It was felt that there is an urgent need to identify all those studies in which developmental follow up could be included. A member of Group 1 was willing to lead this initiative and a small group was willing to help. The group will identify potential existing studies into which developmental follow up can be added and then circulate that list to the other workshop attendees. This will lead to a definitive plan (a concept paper) which might be used to secure funding for actually adding developmental follow up to the studies. PGPR could assume a coordinating/supportive role.
It was pointed out that the Child Health Epi Reference Group (CHERG) is an expert group linked to WHO and UNICEF which is charged with the responsibility of redoing the neonatal aspect of the Global Burden of Disease. It is possible that developmental assessment could be included therein.
It was suggested that programs designed to assess development could be summarized in a “road to developmental health” as a simple graphic display of how a child should be developing -- not unlike a growth chart. Such a graph could be developed as a pictorial display for caregivers and would help in assessing development and thereby help identify developmental support needs.
It was felt that training community health workers in developmental follow up would be a very new and important endeavor. Its importance could and should be evaluated even along lines of cost - benefit.
Chairs: Waldemar A. Carlo, University of Alabama, Birmingham, U.S.A.; and Reeta Rasaily, Indian Council of Medical Research, New Delhi, India
Topic: How should community health workers be trained in order to best conduct follow up studies of survivors of neonatal and childhood diseases?
After the breakout sessions ended, Group 2 presented a summary of its discussions. They advised they had broadened their mandate by considering the training of community health workers, not only for follow up of survivors of disease, but also in identifying those at risk (eg. because of social problems).
They thought the focus should be on normal development with appreciation of milestones that are appropriate not only for age but also for country and that local variations should be recognized. Further they thought that there is a need in planning programs to determine the assets and potential of individual countries and communities. They emphasized that for any such program to work the community and the country should be involved.
It should be recognized that a new system must be proven and cannot simply be accepted as effective without such proof.
Group 2 then considered who should be the people responsible for assessment. They felt they could be community health workers, nurses, or midwives, however many of these people are already working full time. It was agreed that, ideally, the person conducting the follow up should be part of the community and should be incorporated into the existing health care system e.g. IMCI or essential neonatal care programs.
Also the training program should be incorporated into other training programs for community workers. Resources and local “master trainers”, available to the trainees as they gather experience, will be needed.
The training will require validation of a tool that is appropriate for the community. Decisions will have to be made regarding the complexity or simplicity of the tool. This tool would be a screening tool and therefore there must be back up for validation. The group reaffirmed that the tool, like the entire program, should be part of the existing health system thereby strengthening the system rather than potentially undermining it.
Referring again to incorporation in the health system the group felt that evaluation should be carried out at times of other health system contacts such as immunization. They felt that this process could be of help to families by facilitating early identification of problems. Also, the evaluation should be installed to enhance development rather than simply to identify defects (which, on its own, could stigmatize the child and family).
For this to be effective programs should be explained to families and to the community. Such communication in instituting and operating these programs is essential, especially because it is clear that in many communities the concept of “child development” - both normal and abnormal - is not known.
After Group 2 presented this summary of its breakout session discussions, plenary group discussion took place. Much of the discussion emphasized the need for a family-centered program. Also, the evaluation of development should be part of the community’s health system. Those involved in developmental evaluation could include school teachers, social workers, physiotherapists, public health workers, community workers, etc.
Chairs: Robert Armstrong, British Columbia Children’s and Women’s Hospital, Vancouver, Canada; and Chifumbe Chintu, University of Zambia, Lusaka, Zambia
Topic: What methods for follow up studies of child development are applicable in low and mid-income countries?
After the breakout sessions ended, Group 3 presented a summary of its discussions. This summary is attached as Appendix E. This presentation was followed by plenary group discussion during which a question was posed:
Since there is now an initiative (see discussion after group 1 presentation) to use existing cohorts for follow up studies, are there some existing tools that could be applied immediately?
Although the workshop attendees were eager to move ahead it was felt that there are currently no accepted tests; rather, there is much variability and no consensus. However, it was recognized that something will have to be applied and perhaps in doing so an evaluation of the technique should also be applied.
Some of the members of Group 3 will be organizing to study available techniques for conducting follow up studies of child development, with the goal of determining ideal techniques which could be uniformly applied in many studies. As the Group 1 sub-group moves ahead to identify studies in which developmental follow up can be included, they should consult with this Group 3 sub-group studying available study techniques.
It was stated that in India there have been studies using the 10 question approach. This approach is applicable for children 2 years old and older, but not for the 0-2 age range. There is an urgent need for acceptable, uniform developmental assessment tools, for the 0-2 age, which would be applicable in developing countries.
It was mentioned that the NICHD may have an IRB global data base on childhood studies including development. PGPR will attempt to obtain further information about that.
PGPR will remain available to assist in the implementation of the proposed initiatives; however PGPR is not a funding agency and is not be able to financially support research studies.
Chairs: William Feldman, University of Toronto, Toronto, Canada; and Margaret Nakakeeto, Milago Hospital, Kampala, Uganda
Topic: How can political and social issues best be navigated when conducting follow up studies of survivors of childhood diseases?
After the breakout sessions ended, Group 4 presented a summary of its discussions. This summary is attached as Appendix F. This presentation was followed by plenary group discussion during which there was emphasis on the need to stress health benefits of programs. This would be an important component of approaches to governments. Governments will listen to ideas about programs that will save money (by, for example, preventing disabilities). It was emphasized that Ministries of Finance may find many of these programs appealing.
Once again there was discussion of the danger of “parachuting” and the need to develop local capacity by training professionals and community workers on site. These individuals would stay with the programs as they develop.