StaR Child Health: Developing Evidence-Based Guidance for the Design, Conduct, and Reporting of Pediatric Trials

Hartling, Lisa; Wittmeier, Kristy; Lee, J H van der; Klassen, Terry P.; Craig, Jonathan C.; Offringa, Martin

doi:10.1038/clpt.2011.212

Cited by 19 publications

(18 citation statements)

References 33 publications

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“…3,4 This discrepancy has led to a growing recognition of the need to increase the number and quality of pediatric trials to improve the evidence base and the need for practical, appropriate, and clear information for children and families participating in studies. [5][6][7][8] In emergency pediatric settings specifically, there is a conflict between the requirement for prospective informed consent, which may not be practicable in emergencies, and the need for better evidence. First, there is uncertainty about the validity of informed consent obtained in such a stressful environment.…”

Section: What This Study Addsmentioning

confidence: 99%

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

et al. 2015

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BACKGROUND: There is limited experience in using deferred consent for studies involving children, which was legalized in the United Kingdom in 2008. We aimed to inform future studies by evaluating consent rates and reasons for nonconsent in a large randomized controlled trial in pediatric intensive care. METHODS:In the CATCH trial, eligible children from 14 PICUs in England and Wales were randomly assigned to 3 types of central venous catheters. To avoid delay in treatment, children admitted on an emergency basis were first randomly assigned to a trial central venous catheter, and we deferred seeking consent to use already collected data and blood samples until after stabilization.RESULTS: Consent was obtained for 984/1358 (72%) of children admitted on an emergency basis. Failure to obtain consent resulted mainly from a lack of opportunity (early discharge or transfer) for survivors and difficulties in seeking consent for children who died. For admissions where there was an opportunity to approach (n = 1298), inclusion rates differed according to survival status: 93/984 (9%) of consented patients died, compared with 58/314 (18%) of nonconsented patients. For children admitted on an emergency basis whose families were approached, 984/1178 (84%) provided deferred consent (n = 15 sites), compared with 441/641 (69%) of children admitted on an elective basis who were approached for prospective consent (n = 9 sites).CONCLUSIONS: Design of emergency randomized controlled trials should balance the potential burden that seeking consent in difficult situations may cause against risk of bias by disproportionately excluding children who die or are transferred. Ethics committees could consider approving the use of already collected data when best efforts to obtain deferred consent are unsuccessful.WHAT'S KNOWN ON THIS SUBJECT: Deferral of consent avoids delaying emergency interventions while ensuring consent to ongoing participation and use of data. Deferred consent is particularly important for enabling trials in pediatric settings, where many medicines and devices are unlicensed and untested for use. WHAT THIS STUDY ADDS:Approaches for seeking deferred consent should balance the potential burden of obtaining consent against risk of bias due to outcome-related attrition. Ethics committees could consider approving data use when best efforts to obtain deferred consent are met with no response.

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Section: What This Study Addsmentioning

confidence: 99%

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

et al. 2015

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“…More clinical trials should be conducted in African settings, and work should continue as initiated by WHO on the development of a framework for support and management of such trials. The training of highly qualified personnel able to participate in clinical pediatric trials in low-and middle-income countries is a mandatory component of any such effort [31,32].…”

Section: Relevant Clinical Researchmentioning

confidence: 99%

“…Beginning with an initial meeting in 2009, StaR Child Health has already focused on the needs of clinical trialists in low-and middle-income settings [31,32], and this emphasis has been maintained through subsequent meetings in 2010 and 2012 [33] and by the publication of an initial set of six research standards in 2012 [34][35][36][37][38][39].…”

Section: Relevant Clinical Researchmentioning

confidence: 99%

Better Drug Therapy for the Children of Africa: Current Impediments to Success and Potential Strategies for Improvement

et al. 2013

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A commentary is presented on the urgent need for a comprehensive effort to improve the practice of pediatric therapeutics in Africa. A call for action is addressed to a variety of practitioners internationally, many of whom possess skills that could be fruitfully applied to the improvement of health outcomes for African children. Successful engagement with the many challenges requires the complementary effort of researchers in basic and clinical pharmacology and toxicology, nurses, pharmacists, physicians, clinical pharmacologists, clinical pharmacists, and political leaders and civil servants. While a comprehensive or systematic review of the relevant literature has not been attempted, the authors have highlighted promising initiatives driven by international agencies and academic networks. Two African perspectives are presented to reinforce the prospect of child health gains that can be achieved through consistent pursuit of optimal therapy for conditions such as respiratory infection, diarrhea, malaria, and HIV/AIDS. There is an imperative for development of north-south and south-south partnerships that will amplify current research efforts and mobilize existing knowledge concerning pediatric drugs. The overall goal is a multidisciplinary commitment to making essential medicines available at the right time, the right place, and in the right formulation for African children from infancy to adolescence.

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“…No es casual que incluso haya una iniciativa internacional para establecer guías para la investigación en pediatría (StaR Child Health) que permitan mejorar esta situación. 6 Por ello, toda orientación que permita un mejor desarrollo y presentación de resultados de investigaciones es de particular importancia para quienes nos dedicamos a la salud infantil.…”

Section: Editorialunclassified

Nuevas recomendaciones para sostener antiguos valores de responsabilidad y transparencia en publicaciones de revistas médicas

Serra¹

2013

Arch Argent Pediat

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StaR Child Health: Developing Evidence-Based Guidance for the Design, Conduct, and Reporting of Pediatric Trials

Cited by 19 publications

References 33 publications

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

Better Drug Therapy for the Children of Africa: Current Impediments to Success and Potential Strategies for Improvement

Nuevas recomendaciones para sostener antiguos valores de responsabilidad y transparencia en publicaciones de revistas médicas

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