Herman 2013.
Study characteristics | ||
Methods | Randomized controlled trial | |
Participants |
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Interventions | Bipolar endometrial ablation (Novasure®) = 138 LNG‐IUS (Mirena®) = 132 |
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Outcomes |
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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 |
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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 |