title: Choice of primary outcomes evaluating treatment for heavy menstrual bleeding.
abstract: BACKGROUND
  Heavy menstrual bleeding (HMB) is a common problem with a variety of treatment options and many studies have been performed evaluating treatment effects. Consistency in the choice and definition of primary and secondary outcomes is important for the interpretation of data and for the synthesis of data in systematic reviews or individual patient data meta-analysis (IPDMA).
  
  
  OBJECTIVE
  To give insight into the primary endpoints and outcome measures chosen in randomised controlled trials (RCTs) and systematic reviews regarding the treatment of HMB.
  
  
  METHODS
  Published systematic reviews and RCTs.
  
  
  METHODS
  Full reports of RCTs or systematic reviews.
  
  
  METHODS
  For RCTs, we used the primary outcomes, as they were used for the sample size calculation. For systematic reviews, all outcomes listed as primary were included. Four authors selected the studies.
  
  
  RESULTS
  Twelve different primary outcomes were reported by 66 RCTs, most blood loss- related (44/66 studies). Amenorrhoea was the most common blood loss primary outcome (16/44 studies) and the Pictorial Blood Loss Assessment Chart (PBAC) was the most used measurement tool (27/44 studies). Satisfaction was the second most prevalent primary outcome measure (13/66 studies). In all, 14/26 (54%) systematic reviews prespecified a single primary outcome, whereas all other reviews used composite primary outcomes. Blood loss was the most studied outcome (12/26 reviews).
  
  
  CONCLUSIONS
  The most used primary outcomes in HMB studies relate to blood loss but there is no consistency regarding the endpoints chosen or measurement tools used to describe blood loss. Standardising outcomes will aid valid comparison and interpretation of data pertaining to the treatment of HMB.
  
  
  CONCLUSIONS
  A standardised collection of outcomes in heavy menstrual bleeding research is urgently needed.
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: M C
authors.initials: MC
authors.lastname: Herman
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: Jpm
authors.initials: J
authors.lastname: Penninx
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: P M
authors.initials: PM
authors.lastname: Geomini
authors.affiliation: School of Paediatrics and Reproductive Health, The Robinson Institute, University of Adelaide, Adelaide, SA, Australia.
authors.forename: B W
authors.initials: BW
authors.lastname: Mol
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.|Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: M Y
authors.initials: MY
authors.lastname: Bongers
mesh_terms: D000568:Amenorrhea / Q000209:etiology; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008595:Menorrhagia / Q000150:complications / Q000517:prevention & control / Q000628:therapy*; D015201:Meta-Analysis as Topic; D016032:Randomized Controlled Trials as Topic
keywords: Core outcome sets; heavy menstrual bleeding; outcomes; randomised controlled trial; systematic review