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Choice of primary outcomes evaluating treatment for heavy menstrual bleeding
Author(s) -
Herman MC,
Penninx JPM,
Geomini PM,
Mol BW,
Bongers MY
Publication year - 2016
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/1471-0528.14054
Subject(s) - medicine , randomized controlled trial , systematic review , sample size determination , clinical endpoint , medline , meta analysis , surgery , statistics , mathematics , political science , law
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 ( RCT s) and systematic reviews regarding the treatment of HMB . Search strategy Published systematic reviews and RCT s. Selection criteria Full reports of RCT s or systematic reviews. Data collection and analysis For RCT s, 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 RCT s, 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 . Tweetable abstract A standardised collection of outcomes in heavy menstrual bleeding research is urgently needed.