Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set
Metadatos
Mostrar el registro completo del ítemEditorial
Wyley
Materia
AUB Core outcome set Heavy menstrual bleeding
Fecha
2023-04Referencia bibliográfica
Cooper, N. A. M., Rivas, C., Munro, M. G., Critchley, H. O. D., Clark, T. J., Matteson, K. A., ... & Khan, K. (2023). Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set. BJOG: An International Journal of Obstetrics & Gynaecology.[DOI: 10.1111/1471-0528.17473]
Patrocinador
Academy of Medical Sciences (AMS); National Institute for Health Research (NIHR); Beatriz Galindo (senior modality) Programme GrantResumen
Objective: To develop a core outcome set for heavy menstrual bleeding (HMB).
Design: Core outcome set (COS) development methodology described by the
COMET initiative.
Setting: University hospital gynaecology department, online international survey
and web-based
international consensus meetings.
Population or sample: An international collaboration of stakeholders (clinicians,
patients, academics, guideline developers) from 20 countries and 6 continents.
Methods: 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.
Main outcome measures: Outcome importance was assessed in the Delphi survey
on a 9-point
scale.
Results: 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.
Conclusions: 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.