Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery.
The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance.
The WG outlined standardization in four major areas: (1) study design, (2) pretreatment demographics and characterization of the study population, (3) intraoperative events, and (4) posttreatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD-must be included; ADDITIONAL-may be included for a specific study and is inclusive of the Standard items; OPTIMAL-may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY-not relevant.
A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI.
Neurourology and urodynamics. 2024 Jun 05 [Epub ahead of print]
Eric Rovner, Christopher Chermansky, Elisabetta Costantini, Roger Dmochowski, Ekene Enemchukwu, David A Ginsberg, John Heesakkers, Shawn Menefee, Geneviève Nadeau, Charles Rardin, Philippe Zimmern
Department of Urology, Medical University of South Carolina, Charleston, South Carolina, USA., Department of Urology, UPMC Magee Womens Hospital, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA., Department of Medicine and Surgery, University of Perugia, Perugia, Italy., Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Department of Urology, Stanford University School of Medicine, Stanford, California, USA., Department of Urology, Keck School of Medicine of USC, Los Angeles, California, USA., Department of Urology, Maastricht UMC+, Maastricht, The Netherlands., Division of Urogynecology & Reconstructive Pelvic Surgery, Kaiser Permanente San Diego, University of California, San Diego, California, USA., Department of Urology, CHU de Québec - Université Laval, Quebec, Canada., Department of Obstetrics and Gynecology, Alpert School of Medicine, Brown University, Providence, Rhode Island, USA., Department of Urology, UT Southwestern Medical Center, Dallas, Texas, USA.