Recognising the importance of the research nurse and study coordinators in enhancing retention of people with haemophilia in clinical trials
Issued Date
2023-01-01
Resource Type
eISSN
20553390
Scopus ID
2-s2.0-86000375339
Journal Title
Journal of Haemophilia Practice
Volume
10
Issue
1
Start Page
128
End Page
137
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Haemophilia Practice Vol.10 No.1 (2023) , 128-137
Suggested Citation
Khair K., Thykjaer H., Barazani-Brutman T., Vanderbilt K.B., Benjamin C., Wakefield C., Williams N., Wongwerawattanakoon P., Zhong H., Mulders G. Recognising the importance of the research nurse and study coordinators in enhancing retention of people with haemophilia in clinical trials. Journal of Haemophilia Practice Vol.10 No.1 (2023) , 128-137. 137. doi:10.2478/jhp-2023-0017 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/106736
Title
Recognising the importance of the research nurse and study coordinators in enhancing retention of people with haemophilia in clinical trials
Corresponding Author(s)
Other Contributor(s)
Abstract
Introduction: For retention in clinical trials of investigational medical products (CTIMPS), the strategy and tactics to keep enrolled participants from discontinuing participation (dropouts) are important. Haemophilia trials often have extended follow-up and require motivated participants who commit for theto support it. Methods: We conducted a 12-question online survey at registration for a virtual research study update summit. The survey investigated the thoughts of RNs/SCs about retention in CTIMPS, their experiences and challenges, and interventions to prevent attrition. Results: Eighty-seven RNs and SCs from 24 countries (Asia, Australia, Europe, the Middle East and North America) participated. The majority (62/75 responses) reported having 1-5 or 6-10 clinical trial participants (46.6% and 36% respectively); the remainder reported 11-40 trial participants. The majority reported no or few participants dropping out of haemophilia clinical trials in the preceding three years (42.8% and 33.7% respectively). RNs/SCs believed participants dropped out because of 'loss of interest' (50%), 'study going on too long' (39%), 'too many visits' (virtual or at centre) (37.5%), 'visits are too time-consuming' (34%) and a 'lack of time' (32.8%). Over half of RNs/SCs believed 'dropouts' would be higher if they did not make extra efforts in retention. The top interventions to retain participants were: keeping an open dialogue, organising visits to fit participant schedules, discussing adverse events, understanding the protocol, and allowing participants time to ask questions. Retention is achieved through flexibility, timeliness, combining trial activities with routine care, shared decision making and effective communication, including via contemporary technology. Conclusion: This study investigating the retention role of RNs/SCs revealed low dropout rates in haemophilia trials. RNs/SCs are able to offer flexibility to trial procedures by, for example, scheduling visits within trial timing 'windows' to support and facilitate individualised follow-up. Patient-centred care and attention, including trust, attitude and expectations, aid successful retention and trial outcomes. This often unrecognised role is important in supporting people with haemophilia in clinical trials to promote good study outcomes.
