TY - JOUR
T1 - Process for Development of Multicenter Urodynamic Studies
AU - Nager, Charles W.
AU - Albo, Michael E.
AU - FitzGerald, Mary P.
AU - McDermott, Susan M.
AU - Kraus, Stephen
AU - Richter, Holly E.
AU - Zimmern, Philippe
N1 - Funding Information:
The Urinary Incontinence Treatment Network (UITN) is a consortium of investigators from nine continence treatment centers with support from a biostatistical coordinating center. This network is supported by cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development. In 2001, the network implemented the first protocol, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)—a randomized trial of 655 women—to compare the modified Tanagho-Burch procedure with the autologous rectus fascia sling procedure for women with predominant stress urinary incontinence. The primary aim of the SISTEr trial was to compare the efficacy of these two surgical procedures, and the 2-year outcomes are being assessed. One of the secondary aims of the SISTEr protocol has been to determine the prognostic value of UDSs and to identify the urodynamic parameters that predict for treatment success in each surgical procedure.
PY - 2007/1
Y1 - 2007/1
N2 - Objectives: To describe our experiences with a continuous quality improvement process for the standardization of multicenter urodynamic studies (UDSs) in a multi-institutional network. Multicenter UDSs can have considerable variations in testing procedures, training, equipment, and reviewer biases. Methods: A quality control process was developed that included protocol development, certification of urodynamic testers, central review to assess compliance with protocol and quality, protocol modifications, standardization of equipment and signal configuration, development of an electronic signal repository, and the development of UDS Interpretation Guidelines. Results: We describe our experience and process in the development and implementation of a standardized UDS protocol in a multicenter surgical trial for stress urinary incontinence. The process included our protocol development, quality control measures, standardization processes, electronic signal repository, and the need for UDS Interpretation Guidelines. A urodynamic testing procedures protocol was implemented successfully by 20 urodynamic testers at nine continence treatment centers. The protocol provides explicit and detailed guidelines for equipment, calibration, patient position, specific annotations, lay language bladder sensation parameters, visual leak point pressure techniques, modifications for prolapse, and data recording. A UDS Interpretation Guidelines document provides specific suggestions for validity and plausibility determination, expected ranges of urodynamic variables, and reasonable agreement of measuring systems. Both documents are available to urodynamic investigators on the Urinary Incontinence Treatment Network website (http://www.uitn.net/resourcesforphysicians.htm). Conclusions: Multicenter UDSs require a continuous quality improvement process and the development of UDS testing procedures and interpretation guidelines.
AB - Objectives: To describe our experiences with a continuous quality improvement process for the standardization of multicenter urodynamic studies (UDSs) in a multi-institutional network. Multicenter UDSs can have considerable variations in testing procedures, training, equipment, and reviewer biases. Methods: A quality control process was developed that included protocol development, certification of urodynamic testers, central review to assess compliance with protocol and quality, protocol modifications, standardization of equipment and signal configuration, development of an electronic signal repository, and the development of UDS Interpretation Guidelines. Results: We describe our experience and process in the development and implementation of a standardized UDS protocol in a multicenter surgical trial for stress urinary incontinence. The process included our protocol development, quality control measures, standardization processes, electronic signal repository, and the need for UDS Interpretation Guidelines. A urodynamic testing procedures protocol was implemented successfully by 20 urodynamic testers at nine continence treatment centers. The protocol provides explicit and detailed guidelines for equipment, calibration, patient position, specific annotations, lay language bladder sensation parameters, visual leak point pressure techniques, modifications for prolapse, and data recording. A UDS Interpretation Guidelines document provides specific suggestions for validity and plausibility determination, expected ranges of urodynamic variables, and reasonable agreement of measuring systems. Both documents are available to urodynamic investigators on the Urinary Incontinence Treatment Network website (http://www.uitn.net/resourcesforphysicians.htm). Conclusions: Multicenter UDSs require a continuous quality improvement process and the development of UDS testing procedures and interpretation guidelines.
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U2 - 10.1016/j.urology.2006.08.1118
DO - 10.1016/j.urology.2006.08.1118
M3 - Article
C2 - 17270617
AN - SCOPUS:33846527269
SN - 0090-4295
VL - 69
SP - 63
EP - 67
JO - Urology
JF - Urology
IS - 1
ER -