Identification of outcomes in clinical studies for pelvic venous disorders

Konstantinos Kavallieros; Tasneem Pope; Matthew Tan; Harmeena Kaur; Sergio Gianesini; Zaza Lazarashvili; Aleksandra Jaworucka-Kaczorowska; Sriram Narayanan; Adam M Gwozdz; Alun H Davies

doi:10.1016/j.jvsv.2024.101865

Identification of outcomes in clinical studies for pelvic venous disorders

J Vasc Surg Venous Lymphat Disord. 2024 Mar 5:101865. doi: 10.1016/j.jvsv.2024.101865. Online ahead of print.

Affiliations

¹ Academic Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
² Section of Vascular Surgery, Department of Surgery and Cancer, London, UK.
³ Department of Translational Medicine, University of Ferrara, Ferrara, Italy; Department of Surgery, Uniformed Services University of Health Sciences, Bethesda, MD.
⁴ Chapdize Cardiovascular Center, Tbilisi, Georgia.
⁵ Center of Phlebology and Aesthetic Medicine, Jaworuccy Surgery Center, Janczewo, Poland.
⁶ Venus Clinic and The Harley Street Heart and Vascular Centre, Singapore, Singapore.
⁷ Academic Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK. Electronic address: a.gwozdz@imperial.ac.uk.

PMID: 38452895
DOI: 10.1016/j.jvsv.2024.101865

Abstract

Objective: There is increasing recognition that health systems need to measure and improve the value of patient care by measuring outcomes. Chronic pelvic pain secondary to pelvic venous insufficiency can have a significant impact on the quality of life (QOL) of women affected. Despite growing recognition, pelvic venous disorders (PeVDs), an important cause of chronic pelvic pain, remain underdiagnosed. Developing a core outcome set (COS) for benchmarking care delivery enhances the standardization of care. However, there is no consensus regarding a standardized minimum set of outcomes for PeVD. We aimed to generate a list of outcomes reported in previous PeVD treatment studies to lay the foundation for developing a COS for PeVD.

Methods: This scoping review was undertaken according to the PRISMA-ScR guidelines. Initially, screening, full-text review and extraction was conducted on studies published between 2018 and 2023. Subsequently, the search was expanded using 1-year intervals, until, over a 1-year interval, no new outcomes were recorded. Closely related outcomes were classified into domains, and domains into three core areas: disease-specific, treatment-related, and QOL-related outcomes.

Results: Of the 1579 records identified, 51 publications were included. From these studies, 108 different outcomes were identified. The median number of outcomes per study was 8 (interquartile range, 6-13). Closely related outcomes were organized into 42 outcome domains, which were then categorized into 3 core outcome areas; 47.6% (20/42) were disease specific, 35.7% (15/42) treatment related, and 16.7% (7/42) were QOL related. Of the 51 included studies, disease-specific outcomes were identified in 96.1% of the studies (49/51), treatment-related outcomes in 94.1% (48/51), and QOL outcomes in only 13.7% (7/51).

Conclusions: There was significant heterogeneity in outcomes reported in PeVD studies. Most PeVD treatment studies evaluated disease-specific and treatment-related outcomes of PeVD, but few reported outcomes that measured the impact on QOL. These findings will inform the next steps in developing a COS for PeVD.

Keywords: Core outcome set; Outcomes; Pelvic venous disease; Pelvic venous insufficiency; Scoping review.

Publication types

Review