Core outcome set for studies on pregnant women with vasa previa (COVasP) : A study protocol

Journal article


D'Souza, Rohan, Villani, Linda, Hall, Chelsea, Seyoum, Meron, Kingdom, John, Krznaric, Michael, Donnolley, Natasha and Zamani Javid, Nasrin. (2020). Core outcome set for studies on pregnant women with vasa previa (COVasP) : A study protocol. BMJ Open. 10(7), pp. 1-7. https://doi.org/10.1136/bmjopen-2019-034018
AuthorsD'Souza, Rohan, Villani, Linda, Hall, Chelsea, Seyoum, Meron, Kingdom, John, Krznaric, Michael, Donnolley, Natasha and Zamani Javid, Nasrin
Abstract

Introduction: Vasa previa is a condition where fetal blood vessels run unprotected in the membranes, outside the umbilical cord, and cross the internal opening of the cervix. During rupture of membranes, these vessels can rupture and put the baby at serious risk of severe blood loss and death. Numerous studies are being conducted to improve diagnostic modalities and establish clear management plans to improve pregnancy outcomes. However, the lack of a standardised set of outcomes for studies on vasa previa makes it difficult to compare study findings and draw meaningful conclusions. Through this project, we will be developing a core outcome set for studies on pregnant women with vasa previa (COVasP).

Methods and analysis: The development of COVasP will involve five steps. The first will be a systematic review, in which we will generate a long list of outcomes based on published studies in pregnancies complicated with vasa previa. The second will involve in-depth interviews with current and former patients, their family members and healthcare providers who care for these patients. This will be followed by a two-round Delphi survey, which will aim to narrow down the long list of outcomes into those considered important by four groups of ‘stakeholders’: (1) patients, family members and patient advocates/representatives, (2) healthcare providers, (3) researchers, epidemiologists and methodologists and (4) other stakeholders directly or indirectly involved in the management of these pregnancies such as administrators, guideline developers and policymakers. The fourth step will involve a face-to-face consensus meeting using a nominal group approach to establish a finalised core outcome set. The final step will involve measuring and defining the identified outcomes using a combination of systematic reviews and Delphi surveys.

Keywordsvasa previa; management plan; Delphi Survey; clinical outcome; pregnancy ; fetal development
Year01 Jan 2020
JournalBMJ Open
Journal citation10 (7), pp. 1-7
PublisherBMJ GROUP
ISSN2044-6055
Digital Object Identifier (DOI)https://doi.org/10.1136/bmjopen-2019-034018
Web address (URL)https://bmjopen.bmj.com/content/10/7/e034018
Open accessPublished as ‘gold’ (paid) open access
Research or scholarlyResearch
Page range1-7
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online19 Jul 2020
Publication process dates
Accepted10 Jun 2020
Deposited17 Oct 2024
Additional information

© Author(s) (or their employer(s)) 2020.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.

Place of publicationUnited Kingdom
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