On 2014 Jul 17, Adam Jacobs commented:

There are a number of problems with this study, and I fail to see how the authors conclusions of "no major problems of feasibility or acceptability of randomisation were found" can be supported.

First, there is the question of feasibility. This study attempted to use 6 breast screening units. These units apparently volunteered for the study, so might be considered to be less likely to have feasibility problems than sites in general. Despite that, 1 of the 6 sites was unable to participate.

There were clearly also resource implications in managing the study, but only an informal description was given of increases in workload. With no attempt made by the authors to quantify the increased workload, it is hard to judge how it might impact on feasibility.

As for acceptability, it is not surprising that the authors found no problems, as they did not look for them. I could not find any mention of the study participants having been asked questions about acceptability.

While women who were invited to screening could have spontaneously reported concerns about acceptability if they felt sufficiently strongly (though it is hardly realistic to expect that more than a tiny minority would do so if not specifically asked), women who were not invited, who would still be included in the study in the control group in the main age extension trial, were given no such opportunity.

This study has therefore told us nothing about how acceptable the study participants found it to be included in a randomised trial without their consent.

On 2014 Jul 17, Adam Jacobs commented:

There are a number of problems with this study, and I fail to see how the authors conclusions of "no major problems of feasibility or acceptability of randomisation were found" can be supported.

First, there is the question of feasibility. This study attempted to use 6 breast screening units. These units apparently volunteered for the study, so might be considered to be less likely to have feasibility problems than sites in general. Despite that, 1 of the 6 sites was unable to participate.

There were clearly also resource implications in managing the study, but only an informal description was given of increases in workload. With no attempt made by the authors to quantify the increased workload, it is hard to judge how it might impact on feasibility.

As for acceptability, it is not surprising that the authors found no problems, as they did not look for them. I could not find any mention of the study participants having been asked questions about acceptability.

While women who were invited to screening could have spontaneously reported concerns about acceptability if they felt sufficiently strongly (though it is hardly realistic to expect that more than a tiny minority would do so if not specifically asked), women who were not invited, who would still be included in the study in the control group in the main age extension trial, were given no such opportunity.

This study has therefore told us nothing about how acceptable the study participants found it to be included in a randomised trial without their consent.