This underlines the importance of adopting the principle of "process consent", which requires confirmation of consent at each appointment and within each appointment of the study allowing for changes in participant preferences and changes in capacity [ 4].
The first author approached eligible women at their 6-month postpartum research appointment for the ROLO study at the National Maternity Hospital, Dublin, about taking part in the qualitative study.
The potential prognostic factors recorded at the initial physiotherapy appointment for this study will reflect this.
The lead time between the diagnosis of the disease and the first appointment for the present study was considered as the duration of DM.
We decided to use a letter with a fixed appointment date for the three study arms because it has been endorsed by different studies [ 12], and we could compare this intervention with other screening strategies as well as with the control group.
Subjects fulfilling the participation criteria were scheduled for an appointment at the study center where they gave their informed consent and answered an extensive self-administered questionnaire.
Two patients completed the baseline assessment but refused the 2nd assessment (one felt that the questions were not relevant and the other was too ill to continue) and four did not attend for another clinic appointment during the study period due to changes in treatment plans.
Participants either completed follow-up DL, cancelled their appointment, refused follow-up DL, or had not received follow-up DL at the time of the current analysis for another reason (had yet to be scheduled, missed follow-up appointment, left the study, or became ineligible for follow-up DL due to partial mastectomy, diagnosis of breast cancer, or pregnancy).
Therefore, the amount of time spent on consultations in this study is not unusual and compatible with the time allocated for appointments at the study site.
They then had an additional appointment with the study midwife when attending for their 36 weeks gestation antenatal visit, to create their individualised plan of postnatal care.
