On 2016 Jun 17, Timothy M Krahn commented:

It is important to emphasize that our study is about documented disclosure of information that should be provided to patients in accordance with minimum ethics standards for consent to IVF. Most of the critical points made by Hilde Bastian are openly avowed in the limitations section of the paper. We explicitly acknowledged the declining participation rate over time and the fact that fewer of the participating Canadian IVF clinics provided us with information sheets. To be clear, the documents we very specifically requested and the documents we reviewed (as stated in the article) were ‘consent documents’ comprised of both consent forms and accompanying information sheets.

As regards our content analysis, disclosure elements were deemed present if mentioned anywhere in the consent documents reviewed. Mere mention of a keyword (or keywords) for an information element was sufficient for that element to be deemed present as part of documented disclosure. We used this strategy to remove any subjectivity as regards the quality of disclosure, and to be as generous as possible (from a clinic perspective) as regards any conclusions that might be drawn. In practice, this meant that if a consent form indicated that information about a disclosure element was in an accompanying information sheet, that element would have been judged as present just on the basis of the keyword and/or a rudimentary description alone.

Thus, while Bastian is correct that information elements might have been present in the information sheets known to exist but not provided to us, reasonable efforts were made to minimize this possibility. We could do no better given that we could only work with the consent documents that the clinics provided. For the 2014 data set, all clinics were sent an initial request by email followed by a posted letter. If there was no response, those remaining were contacted at least once by telephone. In our estimation, there is nothing more we could have done to generate better and more comprehensive information without increased collaboration by Canadian IVF clinics.

We stand behind our conclusion that “the disclosure of information relevant to the interests of those undergoing IVF and those who are born as a result of IVF appears to be decreasing. Furthermore, the information that increasingly is being disclosed in consent documents appears to be directing the orientation and content of these documents away from the primary interests of the relevant women, couples, and children.” [emphasis added] This general and avowedly tentative conclusion is consistent with the limited representativeness of the data and this we openly acknowledged.

On 2016 Jun 11, Hilda Bastian commented:

This is a vitally important issue to address, but the data presented in this study do not support the authors' conclusion that disclosure of information is decreasing.

The study is characterized by a steeply declining availability of data for comparison - in both the response rate and amount of data provided by those clinics responding. From the first to the last year studied:

• The response rate dropped from 65% to 31%.
• The percentage of consent forms referring to other information sheets as the vehicles for informing women/couples rose from 55% to 100%.
• The percentage of those information sheets available for the study dropped from 82% to 18%.

This suggests that a principal finding, based on a minority of clinics in 2014, is a shift towards providing supplementary information to consent forms, rather than consent forms as the sole formal vehicle of disclosure. If those information sheets were available - and 82% were not in 2014 - the conclusion of this study could be very different.

It would be useful to know if the consent forms indicated that the person signing had been provided with the supplementary information, as part of the formal disclosure. Clarification from the authors would also be useful on whether data from information sheets was included in the results Table, or whether only consent forms themselves were the source.

If both types of consent documents are included, then for 2014, complete consent documents were available for only 2 of 35 clinics (6%), compared with 9 of 17 clinics in 1991 (53%). And the increased coverage of items in the earlier years could be attributable to the enlarged scope of materials assessed.

On 2016 Jun 11, Hilda Bastian commented:

This is a vitally important issue to address, but the data presented in this study do not support the authors' conclusion that disclosure of information is decreasing.

The study is characterized by a steeply declining availability of data for comparison - in both the response rate and amount of data provided by those clinics responding. From the first to the last year studied:

• The response rate dropped from 65% to 31%.
• The percentage of consent forms referring to other information sheets as the vehicles for informing women/couples rose from 55% to 100%.
• The percentage of those information sheets available for the study dropped from 82% to 18%.

This suggests that a principal finding, based on a minority of clinics in 2014, is a shift towards providing supplementary information to consent forms, rather than consent forms as the sole formal vehicle of disclosure. If those information sheets were available - and 82% were not in 2014 - the conclusion of this study could be very different.

It would be useful to know if the consent forms indicated that the person signing had been provided with the supplementary information, as part of the formal disclosure. Clarification from the authors would also be useful on whether data from information sheets was included in the results Table, or whether only consent forms themselves were the source.

If both types of consent documents are included, then for 2014, complete consent documents were available for only 2 of 35 clinics (6%), compared with 9 of 17 clinics in 1991 (53%). And the increased coverage of items in the earlier years could be attributable to the enlarged scope of materials assessed.

On 2016 Jun 17, Timothy M Krahn commented:

It is important to emphasize that our study is about documented disclosure of information that should be provided to patients in accordance with minimum ethics standards for consent to IVF. Most of the critical points made by Hilde Bastian are openly avowed in the limitations section of the paper. We explicitly acknowledged the declining participation rate over time and the fact that fewer of the participating Canadian IVF clinics provided us with information sheets. To be clear, the documents we very specifically requested and the documents we reviewed (as stated in the article) were ‘consent documents’ comprised of both consent forms and accompanying information sheets.

As regards our content analysis, disclosure elements were deemed present if mentioned anywhere in the consent documents reviewed. Mere mention of a keyword (or keywords) for an information element was sufficient for that element to be deemed present as part of documented disclosure. We used this strategy to remove any subjectivity as regards the quality of disclosure, and to be as generous as possible (from a clinic perspective) as regards any conclusions that might be drawn. In practice, this meant that if a consent form indicated that information about a disclosure element was in an accompanying information sheet, that element would have been judged as present just on the basis of the keyword and/or a rudimentary description alone.

Thus, while Bastian is correct that information elements might have been present in the information sheets known to exist but not provided to us, reasonable efforts were made to minimize this possibility. We could do no better given that we could only work with the consent documents that the clinics provided. For the 2014 data set, all clinics were sent an initial request by email followed by a posted letter. If there was no response, those remaining were contacted at least once by telephone. In our estimation, there is nothing more we could have done to generate better and more comprehensive information without increased collaboration by Canadian IVF clinics.

We stand behind our conclusion that “the disclosure of information relevant to the interests of those undergoing IVF and those who are born as a result of IVF appears to be decreasing. Furthermore, the information that increasingly is being disclosed in consent documents appears to be directing the orientation and content of these documents away from the primary interests of the relevant women, couples, and children.” [emphasis added] This general and avowedly tentative conclusion is consistent with the limited representativeness of the data and this we openly acknowledged.