Abstract
Purpose
To create a prospective, multicenter coordinated registry network (CRN) of robust “real world” data for benign prostatic hyperplasia (BPH) that links surgical practices to objective and subjective outcomes of patients who undergo surgery for the improvement in lower urinary tract symptoms (LUTS) secondary to BPH.
Methods
We gathered a group of BPH experts from various institutions to identify the minimum core data elements needed to assess BPH procedures. To achieve consensus on the data elements, we used a Delphi method adaptation, in which a series of surveys were answered by the expert panel individually and anonymously. Survey results were collected and analyzed. Questions for the following round were based on response analysis from the prior survey. This process was repeated until consensus was achieved.
Results
Participation rates in the first and second rounds were 100% and 90%, respectively. The expert panel reached consensus on 148 data elements out of the 182 proposed, capturing patient medical and surgical history, procedure, discharge, short- and long-term follow-up, device factors, surgery, and surgeon factors.
Conclusion
We have successfully developed a set of core data elements to support the study of BPH surgical therapies by gathering an expert panel on BPH and using the Delphi method. These data elements influence provider decisions about treatment and include important outcomes related to efficacy and safety.
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Contributions
SMD: protocol/project development, data collection, data analysis, manuscript writing/editing. NB: data collection, manuscript writing/editing. DE: data collection, manuscript writing/editing. KZ: data collection, manuscript writing/editing. SAK: data collection, manuscript writing/editing. TSK: data collection, manuscript writing/editing. LBL: data collection, manuscript writing/editing. KTM: data collection, manuscript writing/editing. MPR: data collection, manuscript writing/editing. CW: data collection, manuscript writing/editing. AT: protocol/project development, manuscript writing/editing. AS: protocol/project development, manuscript writing/editing. BC: protocol/project development, data collection, manuscript writing/editing.
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Conflict of interest
Naeem Bhojani is a consultant for Olympus, Boston Scientific, and Procept BioRobotics. Dean Elterman is a consultant for Olympus, Boston Scientific, and Procept BioRobotics. Matthew Rutman is a consultant for Boston Scientific. Charles Welliver is compensated for Continuing Medical Education (CME) content from Oakstone publishing and Medscape. Alexis Te is a consultant for PROCEPT BioRobotics, Urotronic, and Zenflow. Bilal Chughtai is a consultant for Olympus, Boston Scientific, Medeon Bio, and Allergan. The other authors declare that they have no known competing interests.
Informed consent/ethical approval
Study was approved by the WCM Institutional Review Board (IRB #1601016896) and was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.
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Martinez Diaz, S., Bhojani, N., Elterman, D. et al. Development of a North American coordinated registry network for surgical treatment of benign prostatic hyperplasia. World J Urol 40, 2991–2999 (2022). https://doi.org/10.1007/s00345-022-04164-3
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DOI: https://doi.org/10.1007/s00345-022-04164-3