TY - JOUR
T1 - Healthcare professionals' views of the use and administration of two salvage therapy drugs for acute ulcerative colitis
T2 - a nest qualitative study within the CONSTRUCT trial
AU - Clement, Clare
AU - Rapport, Frances
AU - Seagrove, Anne C
AU - Alrubaiy, Laith
AU - Williams, John
PY - 2017/2
Y1 - 2017/2
N2 - ObjectivesInsight 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.DesignAn interview-based qualitative study using Framework Analysis embedded within an open-label, pragmatic, randomised trial. SettingNHS Health boards and Trusts, including large teaching and district hospitals in England, Scotland and Wales.ParticipantsPrincipal 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.ResultsInterviews 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.ConclusionsFindings 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.
AB - ObjectivesInsight 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.DesignAn interview-based qualitative study using Framework Analysis embedded within an open-label, pragmatic, randomised trial. SettingNHS Health boards and Trusts, including large teaching and district hospitals in England, Scotland and Wales.ParticipantsPrincipal 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.ResultsInterviews 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.ConclusionsFindings 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.
U2 - 10.1136/bmjopen-2016-014512
DO - 10.1136/bmjopen-2016-014512
M3 - Article (Academic Journal)
C2 - 28399515
SN - 2044-6055
VL - 7
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e014512
ER -