Development of an internet-based protocol to facilitate randomized clinical trials in pediatric surgery☆☆☆

Abstract 

Background/Purpose: Randomized clinical trials (RCTs) perhaps are the best method available for the comparison of therapeutic interventions, yet these studies remain scarce in the pediatric surgery literature. The infrequency of surgical conditions, parents' refusal to participate, and difficulty with standardizing operative technique are potential obstacles to conducting multicenter randomized trials. Novel applications of information technology can potentially overcome these obstacles and facilitate randomized trials in pediatric surgery. Methods: Through collaboration with our Biostatistics Department, an Internet-based protocol was developed to facilitate our own multicenter trial for the surgical treatment of necrotizing enterocolitis. A secure, on-line data entry system was developed to manage all aspects of patient care data. Data are validated during the entry phase and directly uploaded into a clinical database for safety monitoring and analysis. Multimedia resources available online were developed to encourage standardization of surgical and nonoperative therapy. Comprehensive informed consent, educational and other support resources are available on line for the parents and family members of patients. These include an 8-minute video detailing pathophysiology, treatment options, and important informed consent issues surrounding the trial. The website also provides administrative support to study centers and periodic updates on trial progress to the medical community at large. Conclusions: Internet-based protocols may facilitate trials in pediatric surgery by reducing administrative costs, improving standardization of surgical technique, and potentially increasing enrollment success rates. Future investigation will examine the impact of this protocol on the education, knowledge base, and attitudes of parents, as well as determine the efficiency and overall cost effectiveness of this data management strategy. J Pediatr Surg 37:990-994. Copyright 2002, Elsevier Science (USA). All rights reserved.

Keywords:  Randomized controlled trials, clinical trials, evidence-based medicine, research design and methods, internet, worldwide web, computers, informed consent, patient education, standardization, data collection and management