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. 2020 Jun 12;2020(6):CD002126. doi: 10.1002/14651858.CD002126.pub4

Herman 2013.

Study characteristics
Methods Randomized controlled trial
Participants
  • Women with HMb

  • Over 34 years

  • Without intracavitary pathology

  • Not planning future pregnancy

Interventions Bipolar endometrial ablation (Novasure®) = 138
LNG‐IUS (Mirena®) = 132
Outcomes
  • PBAC at 24 months

  • Re‐intervention

  • Satisfaction

  • Quality of life

  • Sexual function

Notes Short communication of results; full trial awaiting publication. Authors contacted for further details. This study is funded by The Netherlands Organisation for Health Research and Development (ZonMW) grant. The authors declare that they have no competing interests
Between July 2012 and December 2015
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomisation will be performed by accessing a web‐based randomisation programme; patients will be randomised into two groups in a ratio of 1:1, using permuted block randomizations with a variable block size". (protocol)
Allocation concealment (selection bias) Low risk "Participants will be given a computer generated numeric code. Data handling will be done anonymously, with the patient code only available to the local investigator and the research nurse working in the local centre" (protocol)
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding highly unlikely, lack of blinding likely to influence outcome
Blinding of participants and personnel (performance bias) Haematin alkaline, Haemoglobin
All outcomes Unclear risk Alkaline haematin and haemoglobin were not measured
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding highly unlikely, lack of blinding likely to influence outcome
Blinding of outcome assessment (detection bias) (Haematine alkaline and haemoglobin)
All outcomes Unclear risk Alkaline haematin and haemoglobin were not measured
Incomplete outcome data (attrition bias)
All outcomes High risk 91% completed 24 months' follow‐up
Selective reporting (reporting bias) High risk Some of the outcomes on the protocol are not included on the trial report (complications, sick leave and costs)
Other bias Unclear risk No information about baseline characteristics, conflict of interest or funding