Discussion
cancer
DCIS, CANCER, RECRUITMENT
From the outset of the LORIS study, it was anticipated that recruitment might be difficult because the two arms (conventional treatment and active monitoring with annual mammography) could be perceived as comparing ‘something’ with ‘nothing’ [Since the LORIS trial opened to recruitment, a Cochrane review highlighting factors that impact recruitment to health care RCTs has been published [The Cochrane review also emphasised the importance of tailoring the invitation to participate in a trial to each individual. This was reflected in the findings for LORIS: some women described reading everything very carefully and doing additional research, whilst others skimmed through the written materials; some wanted more detailed information whilst some wanted shorter, less technical information. Strategies for providing trial information in a more flexible way should be considered in the future to try to meet the needs of potential participants who have different preferences and different levels of health literacy. As well as providing information in different modalities, the provision of information with different levels of detail should be considered and this could be facilitated by digital information provision. A recent systematic review of digital tools in the informed consent process found that whilst there was no evidence of negative outcomes, more research was required to confirm benefit [As well as allowing individuals to tailor information provision, digital tools also have the potential to reduce the risk of researcher bias, i.e. the researcher influencing the patient’s decision on participation. This is important for a study like LORIS: about half of site staff reported that, if they were eligible for LORIS, they would either not take part or were unsure. Although the assumption of clinical equipoise underpins RCTs, these findings indicate that many site staff had a preconceived preference for a treatment arm, and this may have impacted recruitment. Although digital tools may benefit the informed consent process, it is important to consider the needs of potential participants with a low level of digital literacy and ensure they have sufficient support to use these tools.Whilst the LORIS patient information materials were well received, many women did not think these had influenced their decision about whether to accept randomisation. Nor did most women feel that their decision had been influenced by discussions with HCPs. Of those who were registered in LORIS and remained eligible following central review, 81% agreed to be randomised, even though randomisation was a concern for nearly half of those women. The major drivers for participation were the belief that the trial offered the best treatment and altruism. The women who withdrew after randomisation did so because they did not want surgery and had been hoping to be randomised to the active monitoring arm. Most of the women who declined randomisation were clear that they wanted surgery, either because of their own concerns or concerns of others. Clear individual patient preference for how DCIS is managed was the reason that the trial design for the LORD study was amended from an RCT to a patient preference design [Communication workshops for site staff improved knowledge about LORIS and confidence to discuss the trial, but it was not possible to explore whether this improved recruitment rates, given other variables, e.g. staffing levels, which affect recruitment. Site staff suggested that low recruitment was due to the stringent inclusion criteria, meaning there were low numbers of eligible patients, and where applicable, the need for a second biopsy, as well as women’s own preferences. Some staff suggested that providing education to the public about DCIS and presenting it outside the cancer context could influence patient decision making.