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A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya

Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot’ studies to investigate interventions already proven efficacious, offered free of charge to government, but confined by the government to a small part of the population, may...

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Autores principales: Oduwo, Elizabeth, Edwards, Sarah JL
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4223386/
https://www.ncbi.nlm.nih.gov/pubmed/25027410
http://dx.doi.org/10.1186/1745-6215-15-287
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author Oduwo, Elizabeth
Edwards, Sarah JL
author_facet Oduwo, Elizabeth
Edwards, Sarah JL
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description Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot’ studies to investigate interventions already proven efficacious, offered free of charge to government, but confined by the government to a small part of the population, may violate children’s right to health, and the negative duty on governments not to prevent access to treatment. The applicants challenged a government decision to offer Nevirapine in a few pilot sites when evidence showed Nevirapine significantly reduced HIV transmission rates and despite donor offers of a free supply. The government refused to expand access, arguing they needed to collect more information, and citing concerns about long-term hazards, side effects, resistance and inadequate infrastructure. The court ruled this violated children’s right to health and asked the government to immediately expand access. Cluster randomized trials involving children are increasingly popular, and are often used to reduce 'contamination’: the possibility that members of a cluster adopt behavior of other clusters. However, they raise unique issues insufficiently addressed in literature and ethical guidelines. This case provides additional crucial guidance, based on a common human rights framework, for the Kenyan government and other involved stakeholders. Children possess special rights, often represent a 'captive’ group, and so motivate extra consideration. In a systematic review, we therefore investigated whether cluster trial designs are used to prevent or delay children’s access to treatment in Kenya or otherwise inconsistently with children’s right to health as outlined in the above case. Although we did not find state sponsored cluster trials, most had significant public sector involvement. Core obligations under children’s right to health were inadequately addressed across trials. Few cluster trials reported rationale for cluster randomization, offered post- trial access or planned to implement successful interventions. A small number of trials may have unnecessarily evaluated proven interventions, offered their control arm trial conditions worse than local standards of care or evaluated interventions ostensibly worse than local standards of care. Further research is required to establish if children’s right to health in cluster trials is well understood and to explain why some obligations are unmet.
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spelling pubmed-42233862014-11-08 A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya Oduwo, Elizabeth Edwards, Sarah JL Trials Review Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot’ studies to investigate interventions already proven efficacious, offered free of charge to government, but confined by the government to a small part of the population, may violate children’s right to health, and the negative duty on governments not to prevent access to treatment. The applicants challenged a government decision to offer Nevirapine in a few pilot sites when evidence showed Nevirapine significantly reduced HIV transmission rates and despite donor offers of a free supply. The government refused to expand access, arguing they needed to collect more information, and citing concerns about long-term hazards, side effects, resistance and inadequate infrastructure. The court ruled this violated children’s right to health and asked the government to immediately expand access. Cluster randomized trials involving children are increasingly popular, and are often used to reduce 'contamination’: the possibility that members of a cluster adopt behavior of other clusters. However, they raise unique issues insufficiently addressed in literature and ethical guidelines. This case provides additional crucial guidance, based on a common human rights framework, for the Kenyan government and other involved stakeholders. Children possess special rights, often represent a 'captive’ group, and so motivate extra consideration. In a systematic review, we therefore investigated whether cluster trial designs are used to prevent or delay children’s access to treatment in Kenya or otherwise inconsistently with children’s right to health as outlined in the above case. Although we did not find state sponsored cluster trials, most had significant public sector involvement. Core obligations under children’s right to health were inadequately addressed across trials. Few cluster trials reported rationale for cluster randomization, offered post- trial access or planned to implement successful interventions. A small number of trials may have unnecessarily evaluated proven interventions, offered their control arm trial conditions worse than local standards of care or evaluated interventions ostensibly worse than local standards of care. Further research is required to establish if children’s right to health in cluster trials is well understood and to explain why some obligations are unmet. BioMed Central 2014-07-16 /pmc/articles/PMC4223386/ /pubmed/25027410 http://dx.doi.org/10.1186/1745-6215-15-287 Text en Copyright © 2014 Oduwo and Edwards; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Review
Oduwo, Elizabeth
Edwards, Sarah JL
A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya
title A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya
title_full A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya
title_fullStr A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya
title_full_unstemmed A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya
title_short A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya
title_sort systematic review of factors affecting children’s right to health in cluster randomized trials in kenya
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4223386/
https://www.ncbi.nlm.nih.gov/pubmed/25027410
http://dx.doi.org/10.1186/1745-6215-15-287
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