The Reporting of Randomized Clinical Trials Using a Surgical Intervention Is in Need of Immediate Improvement
Annals of SurgeryPublished 20 October 2006Open access
Isabelle Jacquier, Isabelle Boutron, David Moher, Carine Roy, Philippe Ravaud
Citations141
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TL;DR
Inadequate reporting on the management of the surgical procedure, care providers, and surgery center may introduce bias in RCTs of surgical interventions, making their results questionable.
Abstract
Inadequate reporting on the management of the surgical procedure, care providers, and surgery center may introduce bias in RCTs of surgical interventions, making their results questionable. We recommend extending the CONSORT Statement to surgical interventions.
Keywords
Decision SciencesMedicine
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