Healthcare professionals' views of the use and administration of two salvage therapy drugs for acute ulcerative colitis:a nest qualitative study within the CONSTRUCT trial

OBJECTIVES: Insight into healthcare professionals’ views and experiences of the use of ciclosporin and infliximab as salvage therapies for acute ulcerative colitis (UC) and how this may affect participation in a comparison trial is lacking. The study aimed to capture views and opinions of healthcare professionals about the two drugs within the CONSTRUCT trial. DESIGN: An interview-based qualitative study using Framework Analysis embedded within an open-label, pragmatic randomised trial. SETTING: National Health Service Health Boards and Trusts, including large teaching and district hospitals in England, Scotland and Wales. PARTICIPANTS: Principal Investigators (PIs) for trial sites (who were all consultant gastroenterologists) and nurses responsible for administering and monitoring the salvage therapy drugs across trial sites. 15 PIs and 8 nurses recruited from a range of sites stratified by site recruitment rates were interviewed. RESULTS: Interviews revealed that professionals made judgements regarding the salvage therapies largely based on experience of giving the two drugs and perceptions of effectiveness and adverse side effects. A clear preference for infliximab among nurses was revealed, largely based on experiences of administration and drug handling, with some doctors strongly favouring infliximab based on experience of prescribing the drug as well as patient views and the existing evidence base. Most doctors were more equivocal, and all were prepared to suspend preferences and wait for evidence of effectiveness and safety from the CONSTRUCT trial. PIs also questioned guidelines around drug use and restrictions placed on personal autonomy in delivering best patient care. CONCLUSIONS: Findings highlight healthcare professionals’ preference for the salvage treatment, infliximab in treating steroid-resistant UC, largely based on resource intensive nursing requirements of intravenous administration of ciclosporin. Not all doctors expressed this preference, being more equivocal, and all professionals were content to suspend preferences within the CONSTRUCT trial and recognised the importance of establishing relative effectiveness and safety. TRIAL REGISTRATION NUMBER: ISRCTN 22663589