Information provision
DCIS, SHOCKED
For 83/89 (93%) acceptors who were interviewed, the trial had been discussed with more than one HCP, including research nurses (82/89, 92%), surgeons (75/89, 84%), radiologists (11/89, 12%), and an oncologist (1/89, 1%). Most acceptors (83/89, 93%) did not feel that their decision to take part had been influenced by their discussion with an HCP. Similarly, all but one of the decliners had discussed the trial with more than one HCP. Two out of the nine women in this group felt their decision had been influenced at least to some extent by an HCP: one because the surgeon had made it clear that the patient had to be content with both options on offer before entering the trial and one because the surgeon had mentioned surgery before anything else.All the women who were interviewed remembered receiving and reading at least one of the three written information documents: 89/100 (89%) reported reading the PIL, 91/100 (91%) reported reading PIS-A and 97/100 (97%) reported reading PIS-B. Some women talked about reading everything very carefully, and even going online to find out more about both DCIS and the LORIS study or sharing the information with friends who were HCPs. Others described skimming the leaflets or just reading what they considered to be important. One woman explained how she had been too fearful to read the trial sheets initially but had felt comforted about the whole process after a nurse went through everything verbally. Another individual initially found the information too much but followed a friend’s advice to read each PIS bit by bit.Further interview questions focussed specifically on PIS-B, which explained randomisation. Most of the women (73/100, 73%) shared this leaflet with someone else, usually family members but also friends and colleagues. Some who chose not to share PIS-B talked about it being a private matter or not wanting to worry anyone. Most found PIS-B either very or somewhat useful (97/100, 97%) and either very or somewhat clear (98/100, 98%). Two participants talked about finding the concept of randomisation very difficult to understand. Some wanted more information, e.g. about extra tissue being taken, the risks and side effects of surgery, personal benefits of joining LORIS, whilst two women thought there was too much information or that it was too technical. Despite PIS-B being generally perceived as useful and clear, 39/89 (44%) of acceptors did not think it had helped them make a decision, most commonly because they had already decided to join the trial.Most of those interviewed (70/100, 70%) had watched the patient information film and often shared it with a family member, friend or colleague (45/70, 64%). Many who did not watch the film had already made their decision or did not have a DVD player and/or access to the internet. All film viewers found it either very or somewhat clear and useful. The part of the film which was most commonly cited as being particularly useful (37/70, 53%) was the Q&A section. Very few, 4/70 (6%), identified aspects of the film as being unhelpful. Two were concerned about terminology, one woman noted she already knew some of the information from the PISs and one felt some of the questions in the Q&A session were poor. Despite positive opinions from the film viewers, there was a 50:50 split in terms of whether the film helped them decide whether to join the trial; most who did not feel the film had helped with decision making had already decided what to do before viewing it. Nevertheless, many described feeling reassured that they had made the right decision having watched the film, e.g. “I’d already decided to take part at that point. DVD was really important for me to see the doctors’ faces, who are doing the study, Good that the DVD is very short, but really helpful. Made me feel part of something.” (P88)Three additional questions were included in the final 65 interviews, if relevant. One asked about the timing of the PIL: one woman felt it had been given too early but all the other women who remembered receiving it felt it was about right. Some talked about finding the PIL useful because they had been shocked after receiving their mammogram results but appreciated having written information to take away and digest. The other two questions related to whether the women were aware that their biopsy results could make them ineligible for LORIS and how clear they felt this information was in the PIL. Most of the women who answered these questions knew that their eligibility for LORIS depended on their biopsy results (56/61, 92%) and felt that information explaining this in the PIL was either very or somewhat clear (47/51, 92%). Some highlighted how helpful it had been for an HCP to also explain everything orally.