Objectives
To reach an international expert consensus on the diagnosis, prognosis and management of fetal lower urinary tract obstruction (LUTO) by means of a Delphi procedure, and to use this to define a core outcome set (COS).
Methods
A three-round Delphi procedure was conducted among an international panel of experts in fetal LUTO. The panel was provided with a list of literature-based parameters to consider for the diagnosis, prognosis, management and outcomes of LUTO. A parallel procedure was conducted with patient groups during the development of the COS.
Results
A total of 168 experts were approached, of whom 99 completed the first round and 80/99 (80.8%) completed all three rounds of the study questionnaires. Consensus was reached that, in the first trimester, an objective measurement of longitudinal bladder diameter of =?7?mm should be used to suspect LUTO. In the second trimester, imaging parameters suggestive of LUTO could include enlarged bladder, keyhole sign, bladder wall thickening, bilateral hydronephrosis, bilateral hydroureteronephrosis and male sex. There was 79% agreement that the current prognostic scoring systems in the literature should not be used clinically. However, experts agreed on the value of amniotic fluid volume (at
Conclusion
International consensus on the diagnosis, prognosis and management of fetal LUTO, as well as the COS, should inform clinical care and research to optimize perinatal outcomes. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
H. J. Mustafa, A. Khalil, S. Johnson, S. J. Gordijn, W. Ganzevoort, C. Melling, C. J. Koh, G. T. Mandy, M. D. Kilby, A. Johnson, R. A. Quintero, G. Ryan, A. A. Shamshirsaz, A. A. Nassr, on behalf of the LUTO Working Group
Disease Category: Pregnancy & childbirth
Disease Name: Lower Urinary Tract Obstruction
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Procedure
- Clinical experts
- Families
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
The methods for Development of a core outcome set for studies investigating fetal lower urinary tract obstruction (LUTO-COS) are informed by the recommendations of the COMET initiative and the Core Outcome Set–STAndards (COS-STAD), with adaptations specific to the scope of this project. We will use a step-wise approach, consisting of four stages. Step 1 will be to identify currently reported outcomes in the literature and identify unreported outcomes important to patient/parent stake- holders, through structured interviews. Step 2 will be a modified three-phase online Delphi process to determine the core outcomes important to all stakeholders. Step 3 will be a face-to-face consensus meeting of key stakeholders to agree on the COS, and step 4 will be dissemination and implementation of the developed COS.