1420
four
cases (not "non-life-threatening" as Joslin describes it) when given to otherwise healthy, node-negative women with a possible life expectancy well over ten years-when increased mortality can be seen in patients treated with radiotherapy from causes other than
breast cancer. The patient sub-groups referred to above have increased since the inception of this trial, since it has since been reported! that DCIS shows remarkable radiological, histological, and biological diversity. This fact, combined with the slow rate of patient accrual to these DCIS trials, will result in data with very low statistical power. Since heterogeneity and diversity are evident, requiring ever larger numbers of trial participants to achieve useful data, the reluctance of both physicians and patients to enter these trials should be given serious scrutiny. Some reasons for the unacceptability to the patient of this UK DCIS trial have been proffered,3but it is obviously important to look for all reasons why this flawed trial is unacceptable (due for 2-year review in May, 1992) if progress towards finding the best treatment for this condition and indeed to the acceptability of trials in general are not to be
compromised.
Reaction time in block 1 (random choice) before (.)rapid-rate TMS.
(0)
and after
Reaction time expressed as mean (SD) for all 18 subjects in sets of ten trials. *Sets with significantly (p
four
cases (not "non-life-threatening" as Joslin describes it) when given to otherwise healthy, node-negative women with a possible life expectancy well over ten years-when increased mortality can be seen in patients treated with radiotherapy from causes other than
breast cancer. The patient sub-groups referred to above have increased since the inception of this trial, since it has since been reported! that DCIS shows remarkable radiological, histological, and biological diversity. This fact, combined with the slow rate of patient accrual to these DCIS trials, will result in data with very low statistical power. Since heterogeneity and diversity are evident, requiring ever larger numbers of trial participants to achieve useful data, the reluctance of both physicians and patients to enter these trials should be given serious scrutiny. Some reasons for the unacceptability to the patient of this UK DCIS trial have been proffered,3but it is obviously important to look for all reasons why this flawed trial is unacceptable (due for 2-year review in May, 1992) if progress towards finding the best treatment for this condition and indeed to the acceptability of trials in general are not to be
compromised.
Reaction time in block 1 (random choice) before (.)rapid-rate TMS.
(0)
and after
Reaction time expressed as mean (SD) for all 18 subjects in sets of ten trials. *Sets with significantly (p
