Gynecological Cancer Complications Management Questionnaire: A National Consensus Study Design Using Modified Delphi Process

Summary: Intracavitary and interstitial brachytherapy are established methods in the management of gynecological cancers. Although brachytherapy has evolved over the past several decades, complications persist. Instances of vascular injury are reported in up to 5.2%. In the post-CT era, complete and partial uterine perforation occurrences have been reported as 1.38% and 6.46%, respectively. In cases where evidence-based medicine is not applicable, the reliance on expert provider’s interpretation of any limited data and their subsequent recommendations is crucial for medical decision making. The Modified Delphi process presents a means of addressing these gaps in knowledge and data through synthesis of isolated anecdotal approaches into cohesive clinic practice guidelines that are central to providing safe and effective patient care. A steering committee will be established from the Cancer Centers at the University of Oklahoma, Virginia Commonwealth University, Dartmouth College, and Emory University. The group will be comprised of physician brachytherapists who specialize in gynecologic malignancies and resident physicians who will primarily be involved in study design and execution. Academic institutes and private practice groups will be invited to nominate representatives to join a consensus panel. The nominees will be required to be actively practicing gynecologic brachytherapy and must be willing to complete all rounds of an Online Modified Delphi process that will be delivered digitally via the Qualtrics online survey platform. The survey will include three main sections to cover vaginal cylinder, tandem and ring/compound implants, and interstitial implants. Questions will be selected by the steering committee and amended iteratively over each subsequent round. Particularly nuanced topics that may require further expansion in the form of new questions which will be introduced at the beginning of each new round. Each survey round will be open for answer submission for 14 days with a reminder email being sent to participants three days before the deadline for submission. Data will be collected, collated, and analyzed following the conclusion of each round. Predetermined criteria for agreement, extrapolated from the RAND method, will be applied. These criteria will consist of a consensus greater than or equal to 80% to indicate strong agreement in favor of a statement, 67-79% to indicate agreement, 21-66% to indicate no agreement, and less than or equal to 20% to indicate strong rejection of a statement. Complications arising from gynecologic brachytherapy have the potential for devastating outcomes. While not as commonly lethal, they none-the-less often lead to drastic changes in patient quality of life with potentially lifelong consequences. To date, there is scant data to establish guidelines of therapy for these complications. The Online Modified Delphi process presents an avenue to realistically provide insight into these shortcomings with the goal of giving prompt treatment to patients and avoiding permanent or more serious sequelae. Aous Jarrouj (he/him/his), MD, MBA, MHM (Presenting Author) - University of Oklahoma; Wade McLanahan, MD (Co-Author) - University of Oklahoma; Danushka Senevirantne, MD, PhD (Co-Author) - University of Oklahoma; Andrea Johnston, MD (Co-Author) - University of Oklahoma