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document
Including a 'no active intervention ' arm in surgical trials is possible : evidence from the CLasP randomised trial . OBJECTIVES To examine the impact of including a 'no active intervention ' arm ( called 'conservative management ' ) in a randomised controlled trial comparing treatments ( including surgery ) for men with lower urinary tract symptoms related to benign prostatic enlargement . METHODS Outcomes 7.5 months after randomisation were acceptability of randomisation , overall acceptability of and satisfaction with conservative management , impact on quality of life , perceived need for further treatment and treatment failure ( defined a priori ) . RESULTS In total , 177 ( out of 755 ) patients refused randomisation , including 31 % who did not want surgery and 22 % who wanted surgery . Most men randomised to conservative management were willing to undertake it as part of a trial but at the end of the trial they were divided between those who wanted to continue with it and those who expected surgery . At follow-up , 39 % of conservative management patients requested surgery , and interference of symptoms with life and an unsuccessful outcome were more commonly reported in this arm . There were no appreciable differences between treatment groups in terms of treatment failures . CONCLUSIONS Including a 'no active intervention ' arm did not appear to have a detrimental effect on patient recruitment or the completion of this trial in the short-term ; overall , conservative management was successfully completed by the majority of patients during the trial period , suggesting that researchers need not avoid including a no-intervention arm in surgical trials as long as they take care with its presentation .
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Intervention_Educational
a 'no active intervention ' arm ( called 'conservative management ' )
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Intervention_Surgical
surgery )
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Intervention_Other
'no active intervention ' arm
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Outcome_Other
acceptability of randomisation , overall acceptability of and satisfaction with conservative management
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Outcome_Other
quality of life , perceived need for further treatment
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Outcome_Other
treatment failure ( defined a priori ) .
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Outcome_Other
interference of symptoms with life
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Outcome_Mental
unsuccessful outcome
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Outcome_Other
treatment failures
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Outcome_Mental
patient recruitment
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Participant_Sex
men
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Participant_Condition
benign prostatic enlargement .
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Participant_Sample-size
177
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Participant_Sample-size
755