A protocol for developing a core outcome set for ectopic pregnancy.
Consensus study
Core outcome set
Ectopic pregnancy
Modified Delphi method
Randomised controlled trials
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
17 Nov 2021
17 Nov 2021
Historique:
received:
08
04
2021
accepted:
29
10
2021
entrez:
18
11
2021
pubmed:
19
11
2021
medline:
20
11
2021
Statut:
epublish
Résumé
Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. To develop and implement a core outcome set to guide future research in ectopic pregnancy. We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus 'core' outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. COMET 1492 . Registered in November 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy.
STUDY AIM
OBJECTIVE
To develop and implement a core outcome set to guide future research in ectopic pregnancy.
METHODS AND ANALYSIS
METHODS
We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus 'core' outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes.
TRIAL REGISTRATION
BACKGROUND
COMET 1492 . Registered in November 2019.
Identifiants
pubmed: 34789295
doi: 10.1186/s13063-021-05772-x
pii: 10.1186/s13063-021-05772-x
pmc: PMC8596090
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
813Subventions
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Informations de copyright
© 2021. The Author(s).
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