Abstract
Objectives
Insight into healthcare professionals’ views and experiences of the use of ciclosporin and infliximab as salvage therapies for acute ulcerative colitis 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
NHS 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. Fifteen 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 amongst 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 but also 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.
Insight into healthcare professionals’ views and experiences of the use of ciclosporin and infliximab as salvage therapies for acute ulcerative colitis 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
NHS 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. Fifteen 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 amongst 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 but also 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.
| Original language | English |
|---|---|
| Article number | e014512 |
| Number of pages | 9 |
| Journal | BMJ Open |
| Volume | 7 |
| Issue number | 2 |
| Early online date | 22 Feb 2017 |
| DOIs | |
| Publication status | Published - Feb 2017 |
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Dive into the research topics of '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'. Together they form a unique fingerprint.Research output
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Comparison Of iNfliximab and ciclosporin in Steroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)
Williams, J., Alam, M. F., Alrubaiy, L., Clement, C., Cohen, D., Grey, M., Hilton, M., Hutchings, H. A., Longo, M., Morgan, J., Rapport, F., Seagrove, A. C. & Watkins, A., Jun 2016, In: Health Technology Assessment. 20, 44, 352 p.Research output: Contribution to journal › Article (Academic Journal) › peer-review
Open AccessFile52 Citations (Scopus)835 Downloads (Pure) -
Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial
Williams, J., Alrubaiy, L., Arnott, I., Clement, C., Cohen, D., Gordon, J., Hawthorn, B., Hilton, M., Hutchings, H., Jawhari, A., Longo, M., Mansfield, J., Morgan, J., Rapport, F., Seagrove, A., Sebastian, S., Shaw, I., Travis, S. & Wakins, A., Sept 2016, In: Lancet Gastroenterology and Hepatology. 1, 1, p. 15-24 10 p.Research output: Contribution to journal › Article (Academic Journal) › peer-review
Open AccessFile245 Citations (Scopus)318 Downloads (Pure) -
Patient and health professionals’ perspectives on the use of ciclosporin and infliximab when treating acute severe ulcerative colitis: an added dimension to the construct trial
Clement, C. & Rapport, F., 16 Nov 2015, Trials. BioMed Central, 1 p. P72. (Trials; vol. 16(Suppl 2)).Research output: Chapter in Book/Report/Conference proceeding › Conference Contribution (Conference Proceeding)
Open AccessFile290 Downloads (Pure)
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