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

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Abstract

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.

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Most cited references 14

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The pattern and outcome of acute severe colitis.

Lotte C Dinesen, Alissa Walsh, Marijana Protic … (2010)

The prognosis of acute severe ulcerative colitis (ASC) influences therapeutic decisions, but data on prevalence or long-term outcome are few.

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Is Open Access

Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial

John Williams, M Alam, Laith Alrubaiy … (2016)

Summary Background Infliximab and ciclosporin are of similar efficacy in treating acute severe ulcerative colitis, but there has been no comparative evaluation of their relative clinical effectiveness and cost-effectiveness. Methods In this mixed methods, open-label, pragmatic randomised trial, we recruited consenting patients aged 18 years or older at 52 district general and teaching hospitals in England, Scotland, and Wales who had been admitted, unscheduled, with severe ulcerative colitis and failed to respond to intravenous hydrocortisone within about 5 days. Patients were randomly allocated (1:1) to receive either infliximab (5 mg/kg intravenous infusion given over 2 h at baseline, and again at 2 weeks and 6 weeks after the first infusion) or ciclosporin (2 mg/kg per day by continuous infusion for up to 7 days, followed by twice-daily tablets delivering 5·5 mg/kg per day for 12 weeks). Randomisation used a web-based password-protected site, with a dynamic algorithm to generate allocations on request, thus protecting against investigator preference or other subversion, while ensuring that each trial group was balanced by centre, which was the only stratification used. Local investigators and participants were aware of the treatment allocated, but the chief investigator and analysts were masked. Analysis was by treatment allocated. The primary outcome was quality-adjusted survival—ie, the area under the curve (AUC) of scores from the Crohn's and Ulcerative Colitis Questionnaire (CUCQ) completed by participants at baseline, 3 months, and 6 months, then every 6 months from 1 year to 3 years. This trial is registered with the ISRCTN Registry, number ISRCTN22663589. Findings Between June 17, 2010, and Feb 26, 2013, 270 patients were recruited. 135 patients were allocated to the infliximab group and 135 to the ciclosporin group. 121 (90%) patients in each group were included in the analysis of the primary outcome. There was no significant difference between groups in quality-adjusted survival (mean AUC 564·0 [SD 241·9] in the infliximab group vs 587·0 [226·2] in the ciclosporin group; mean adjusted difference 7·9 [95% CI −22·0 to 37·8]; p=0·603). Likewise, there were no significant differences between groups in the secondary outcomes of CUCQ scores, EQ-5D, or SF-6D scores; frequency of colectomy (55 [41%] of 135 patients in the infliximab group vs 65 [48%] of 135 patients in the ciclosporin group; p=0·223); or mean time to colectomy (811 [95% CI 707–912] days in the infliximab group vs 744 [638–850] days in the ciclosporin group; p=0·251). There were no differences in serious adverse reactions (16 reactions in 14 participants receiving infliximab vs ten in nine patients receiving ciclosporin); serious adverse events (21 in 16 patients vs 25 in 17 patients); or deaths (three in the infliximab group vs none in the ciclosporin group). Interpretation There was no significant difference between ciclosporin and infliximab in clinical effectiveness. Funding NIHR Health Technology Assessment programme.

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Influences on GPs' decision to prescribe new drugs-the importance of who says what.

H. Prosser (2003)

The aim of this study was to understand the range of factors that influence GPs' uptake of new drugs A total of 107 GPs selected purposively from high, medium and low new drug prescribing practices in two health authorities in the north west of England were interviewed using the critical incident technique with semi-structured interviews. Interview topics included reasons for prescribing new drugs launched between January 1998 and May 1999; reasons for prescribing the new drug rather than alternatives; and sources of information used for each prescribed drug. Important biomedical influences were the failure of current therapy and adverse effect profile. More influential than these, however, was the pharmaceutical representative. Hospital consultants and observation of hospital prescribing was cited next most frequently. Patient request for a drug, and patient convenience and acceptability were also likely to influence new drug uptake. Written information was of limited importance except for local guidelines. GPs were largely reactive and opportunistic recipients of new drug information, rarely reporting an active information search. The decision to initiate a new drug is heavily influenced by 'who says what', in particular the pharmaceutical industry, hospital consultants and patients. The decision to 'adopt' a new drug is clinched by subsequent personal clinical experience. Prescribing of new drugs is not simply related to biomedical evaluation and critical appraisal but, more importantly, to the mode of exposure to pharmacological information and social influences on decision making. Viewed within this broad context, prescribing variation becomes more understandable. Findings have implications for the implementation of evidence-based medicine, which requires a multifaceted approach.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2017

Publication date (Electronic): 20 February 2017

Volume: 7

Issue: 2

Electronic Location Identifier: e014512

Affiliations

[1 ]School of Social and Community Medicine, University of Bristol , Bristol, UK

[2 ]Centre for Healthcare Resilience and Implementation Science, Macquarie University , Sydney, Australia

[3 ]Swansea University Medical School, Swansea University , Swansea, UK

Author notes

[Correspondence to ] Clare Clement, School of Social and Community Medicine, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK; c.clement@ 123456bristol.ac.uk

Article

Publisher ID: bmjopen-2016-014512

DOI: 10.1136/bmjopen-2016-014512

PMC ID: 5337666

PubMed ID: 28399515

SO-VID: d42bf80b-9f90-49cc-a419-a60f11977b86

Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

License:

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

History

Date received : 28 September 2016

Date accepted : 15 November 2016

Funding

Funded by: Health Technology Assessment Programme, http://dx.doi.org/10.13039/501100000664;

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

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Abstract

Objectives

Design

Setting

Participants

Results

Conclusions

Trial registration number

Related collections

Karger: Gastroenterology

Most cited references 14

The pattern and outcome of acute severe colitis.

Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial

Influences on GPs' decision to prescribe new drugs-the importance of who says what.

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