Jacquier Isabelle, Boutron Isabelle, Moher David, Roy Carine, Ravaud Philippe
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.
Ann Surg. 2006 Nov;244(5):677-83. doi: 10.1097/01.sla.0000242707.44007.80.
To assess the reporting of surgical interventions, care providers, and number of centers in randomized clinical trials.
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.
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).
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.
评估随机临床试验中手术干预、护理人员及中心数量的报告情况。
进行系统评价以评估2004年发表的评估手术程序的随机对照试验报告。使用标准化的摘要表格提取数据。
共纳入158篇文章。138篇（87.3%）文章报告了预期干预的详细信息，如手术程序；56篇（35.4%）报告了麻醉管理；34篇（15.2%）报告了术前护理；78篇（49.4%）报告了术后护理。64篇文章（40.5%）报告了实验性手术干预的实施方式。大多数试验在单一中心进行（n = 109，69.0%）。仅11篇文章报告了研究背景，仅5篇报告了所实施干预的数量。64篇文章（40.5%）报告了护理人员的选择标准。51篇文章（32.2%）报告了实施干预的护理人员数量。根据CLEAR NPT（专门为评估评估非药物治疗的随机对照试验的报告质量而制定的10项清单）评估，报告质量较低。
手术程序管理、护理人员及手术中心的报告不足可能会在手术干预的随机对照试验中引入偏倚，使其结果存疑。我们建议将CONSORT声明扩展至手术干预。
