Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set.
AUB
core outcome set
heavy menstrual bleeding
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
revised:
20
02
2023
received:
16
09
2022
accepted:
22
02
2023
medline:
4
9
2023
pubmed:
14
4
2023
entrez:
13
4
2023
Statut:
ppublish
Résumé
To develop a core outcome set for heavy menstrual bleeding (HMB). Core outcome set (COS) development methodology described by the COMET initiative. University hospital gynaecology department, online international survey and web-based international consensus meetings. An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents. Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. Outcome importance was assessed in the Delphi survey on a 9-point scale. From the 'long list' of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level. The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy.
Identifiants
pubmed: 37055716
doi: 10.1111/1471-0528.17473
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1337-1345Subventions
Organisme : Academy of Medical Sciences
Pays : United Kingdom
Informations de copyright
© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.
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