Standard 5: Selection, Measurement, and Reporting of Outcomes in Clinical Trials in Children

Author:

Sinha Ian P.1,Altman Douglas G.2,Beresford Michael W.1,Boers Maarten3,Clarke Mike4,Craig Jonathan5,Alberighi Ornella Della Casa6,Fernandes Ricardo M.7,Hartling Lisa8,Johnston Bradley C.9,Lux Andrew10,Plint Amy11,Tugwell Peter12,Turner Mark1,van der Lee Johanna H.13,Offringa Martin13,Williamson Paula R.14,Smyth Rosalind L.1

Affiliation:

1. Department of Women’s and Children’s Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom;

2. Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom;

3. Department of Clinical Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, Netherlands;

4. All-Ireland Hub for Trials Methodology Research, Centre for Public Health, Queen's University Belfast, Belfast, Northern Ireland;

5. School of Public Health, University of Sydney, Sydney, Australia;

6. Clinical Pharmacology Unit, G. Gaslini Institute, Genoa, Italy;

7. Department of Pediatrics, Santa Maria Hospital, Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Instituto de Medicina Molecular, Lisboa, Portugal;

8. Department of Pediatrics, Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, Alberta, Canada;

9. Department of Anaesthesia and Pain Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada;

10. Department of Pediatric Neurology, Frenchay Hospital and the Bristol Royal Hospital for Children, Bristol, United Kingdom;

11. Department of Pediatrics and Department of Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada;

12. Department of Medicine, University of Ottawa and Institute of Population Health, Ottawa, Ontario, Canada;

13. Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; and

14. Department of Biostatisics, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom

Publisher

American Academy of Pediatrics (AAP)

Subject

Pediatrics, Perinatology and Child Health

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