ABSTRACT: Although most pelvic floor disorders (PFDs) are not life-threatening, they are associated with significant morbidity and impairment in quality of life. Surgical intervention is usually planned and elective. It is difficult to compare results from surgical interventions for these disorders as there are no standard validated definitions for PFDs or outcomes following intervention. In 2001, the US National Institutes of Health convened a consensus panel composed of researchers in studies of PFDs in an effort to standardize terminology and definitions as well as criteria used for reporting research study outcomes. Despite this effort and the subsequent recommendations on standardization developed by several organizations and numerous studies, there is no consensus of opinion on the most appropriate method of outcome assessment for PFDs.
The aim of this report was to review the many types of outcome measures available and to help clinician/researchers choose the most appropriate outcome measures for a surgical intervention that reflect their clinical or project goal. The article discusses the evolution of objective and subjective outcome assessment measures, the increasing use of composite outcomes, and role of patient perspective and their expectations in defining success of surgical intervention.
In the choice of outcome measures in clinical practice and research, the definition of the primary desired outcome must be clear, and validated measurement instruments must be used. Objective outcome measures determine the presence and severity of a pelvic floor condition independent of patient or physician perception of the surgical result. In the past, objective test-based measures were the primary outcome variable in research studies of PFDs. Because most outcomes in intervention studies are now aimed at improving the quality of life, subjective outcomes based on patient expectations and their perspective are being increasingly used to evaluate success of therapy. A large number of validated subjective outcome measures are available; these include symptom diaries and questionnaires (symptom-specific and health-related quality of life).
Research outcomes should be measured as a composite accounting for anatomical changes, and improvement or deterioration in function and symptoms, as well as the overall impression of patients of changes in their quality of life. Outcome assessments must be measured both before and after the intervention. Perception of improvement (success or cure) by patients or clinicians may not correlate with the anatomical outcome. Patient goals and satisfaction may be the most accurate reflection of success of therapy.
Division of Urogynecology and Pelvic Reconstructive Surgery (C.Y.P.-A., H.E.R.), Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL; Center for Urogynecology and Pelvic Reconstructive Surgery (M.D.B.), Obstetrics and Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, OH; and Division of Female Pelvic Medicine & Reconstructive Surgery (K.K.), Department of Obstetrics and Gynecology & Urology, Loyola University, Maywood, IL