Isabelle Jacquier1, Isabelle Boutron, David Moher, Carine Roy, Philippe Ravaud. 1. INSERM U738, Paris France [corrected] Assistance Publique Hôpitaux de Paris (APHP), Groupe Hospitalier Bichat-Claude Bernard, Département d'Epidémiologie Biostatistique et Recherche Clinique, Paris, France.
Abstract
OBJECTIVE: To assess the reporting of surgical interventions, care providers, and number of centers in randomized clinical trials. METHODS: Systematic review was performed to assess reports of randomized controlled trials assessing surgical procedure published in 2004. A standardized abstraction form was used to extract data. RESULTS: A total of 158 articles were included. Details on the intervention intended, such as the surgical procedure, were reported in 138 (87.3%) articles, anesthetic management in 56 (35.4%), preoperative care in 34 (15.2%), and postoperative care in 78 (49.4%). How the experimental surgical intervention was carried out was reported in 64 articles (40.5%). Most trials were conducted in single centers (n = 109, 69.0%). The setting was reported in only 11 articles, and the volume of interventions performed was only reported in 5. Selection criteria were reported for care providers in 64 articles (40.5%). The number of care providers performing the intervention was reported in 51 articles (32.2%). The quality of reporting was low as assessed by CLEAR NPT (a 10-items checklist specifically developed to assess the reporting quality of RCTs assessing nonpharmacologic treatment). CONCLUSIONS: 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.
OBJECTIVE: To assess the reporting of surgical interventions, care providers, and number of centers in randomized clinical trials. METHODS: Systematic review was performed to assess reports of randomized controlled trials assessing surgical procedure published in 2004. A standardized abstraction form was used to extract data. RESULTS: A total of 158 articles were included. Details on the intervention intended, such as the surgical procedure, were reported in 138 (87.3%) articles, anesthetic management in 56 (35.4%), preoperative care in 34 (15.2%), and postoperative care in 78 (49.4%). How the experimental surgical intervention was carried out was reported in 64 articles (40.5%). Most trials were conducted in single centers (n = 109, 69.0%). The setting was reported in only 11 articles, and the volume of interventions performed was only reported in 5. Selection criteria were reported for care providers in 64 articles (40.5%). The number of care providers performing the intervention was reported in 51 articles (32.2%). The quality of reporting was low as assessed by CLEAR NPT (a 10-items checklist specifically developed to assess the reporting quality of RCTs assessing nonpharmacologic treatment). CONCLUSIONS: 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.
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