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. 2016 Apr 25;2016(4):CD003455. doi: 10.1002/14651858.CD003455.pub2

Jensen 1997.

Methods RCT. Duration of study: not reported
Follow‐up, days (mean): 770 versus 704. However, major outcomes were compared at 12 months after randomisation
Participants 21 people with CRP, RT 2 years ago, failed medical treatment, and per rectum bleeds at least 3 times a week
Sex (M/F): 18/3
Similar groups with respect to demographic and clinical characteristics
Dropouts: none
Interventions Intervention: Heater probe (9)
Comparator: Bipolar electrocoagulation probe (12)
 Treatment with the same probe till the bleeding stopped, mean 4 treatments
Outcomes Sigmoidoscopies 4 to 6 weekly till bleeds stopped and follow‐up requirements
 Fall in severe bleeds and the need for follow‐up in both groups. Significant decrease in both groups
Notes No side effects reported. QoL informally assessed with participant responses, which improved with treatment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation method not described
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding (performance bias and detection bias) Low risk Unclear whether participants had been blinded, but as both arms received a similar active intervention it seems unlikely that this would have introduced performance bias
Blinding of outcome assessment subjective Low risk Unclear whether participants had been blinded, but as both arms received a similar active intervention it seems unlikely that this would have introduced bias for subjective outcomes
Blinding of outcome assessment objective Unclear risk Managing physician was blinded to treatment, however, it was not clearly described whether the research nurse who evaluated and followed all participants was blinded.
Incomplete outcome data: subjective outcomes Low risk No loss to follow‐up
Incomplete outcome data: objective outcomes Low risk No loss to follow‐up
Selective reporting (reporting bias) Unclear risk Study was published in 1997, so no study protocol available. However, all outcomes prespecified in the methods section were reported in the results section
Other bias Low risk No indications of other bias