Page 41 - EVALUATION OF TREATMENT FOR HEAVY MENSTRUAL BLEEDING by Herman, Malou

The variety of interventions in combination with a large number of different outcomes has resulted in a diversity of studies performed in the field of HMB. 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). To give insight into the primary endpoints and outcome measures chosen in RCTs and systematic reviews regarding the treatment of HMB we performed a systematic review in Chapter 8. We included full reports of RCTs or systematic reviews regarding the treatment of HMB. The studies had to report on the treatment of HMB and had to have a predefined primary outcome, underpinned by a sample size calculation. In the end, 66 RCTs and 26 reviews were included for analysis.
Twelve different primary outcomes were reported by 66 RCTs, of which the most frequently reported were blood-loss related (44/66). Amenorrhoea was the most common blood-loss related primary outcome (16/44). PBAC was the tool most frequently used to measure blood loss (27/44). Satisfaction was the second largest primary outcome (13/66), but there was no consistency in how this was measured. Fourteen (54%) reviews pre-specified a single primary outcome, while all other reviews used composite primary outcomes. Blood loss was the most frequently studied outcome among all reviews (12/26).
In conclusion, our findings show that there is large heterogeneity in the primary outcomes used in studies evaluating the treatment of HMB. Blood-loss related outcomes are most frequently used in HMB studies. Nevertheless, there is lack of consensus on how to define and measure these blood-loss outcomes. We also found huge variation regarding the measurement tools used. Our study increases awareness of HMB studies globally and draws attention specifically to the fact that consensus on primary outcomes is lacking in HMB research.
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Summary
Chapter 10 provides a general discussion and implementation suggestions for further research.
Chapter 11 contains the valorisation addendum and explains why my research is important.
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