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PWE-229 Assessing patient reported outcome in Crohn's disease

Authors:
  • Galen Research Ltd

Abstract

Introduction Research into the impact of Crohn's Disease (CD) and its treatment on the patient relies on outdated and inappropriate generic questionnaires. These do not address important impacts of the illness and ask questions of limited relevance. As part of a study to develop CD-specific patient-reported outcome measures (PROMS), qualitative interviews were conducted with CD patients. Methods Item generation was based on the International Classification of Functioning, Disability and Health (ICF) and the needs-based quality of life (QoL) models. Interviewees were recruited via out-patient clinics and interviewed in a private room or at the researcher's offices. Interviews covered all aspects of the impact of CD and its treatment and were audio-recorded. Transcripts were content analysed to identify impacts on symptoms, activity limitations and QoL. Results 26 patients (69.2% female; aged 25–68; mean (SD): 46.2 (14.7) years) were interviewed. Participants had a wide range of duration of CD (2–40; mean (SD): 13.0 (12.9) years). 2641 statements relating to the impact of CD were identified. These statements fell into three major categories with a number of sub-themes identified: Symptoms (such as pain, fatigue and emotional impairment), activity limitations (such as difficulties with walking, lifting and jobs around the house) and QoL (including preoccupation with the disease, self-conscious of appearance and reduced socialisation). Conclusion The study was successful in identifying the most important impacts of CD from the patients' perspective. In addition to generating potential items for the new measure the findings of the interviews have implications for clinical practice and clinical trial design. Audit of services and assessment of new interventions for CD should assess whether or not these impacts of CD are improved. Only then will it be possible to determine whether interventions are of true benefit to the patient. Competing interests None declared.
Competing interests None declared.
REFERENCES
1. European Evidence-Based Consensus on the Prevention, Diagnosis and Management
of Opportunistic Infections in iBD, ECCO Guidelines. 2009.
2. Garrett Lawlor MD, Alan C, Moss MD. CMV in IBD: Pathogen or innocent
bystander? Inflamm Bowel Dis 2010;16:1620e7.
PWE-228 AN ASSESSMENT OF THE IMPACT 5ASA DOSE, DOSE
INTERVAL, PREPARATION AND DELIVERY HAVE ON
MAINTAINING REMISSION IN ULCERATIVE COLITIS
doi:10.1136/gutjnl-2012-302514d.228
J R O’Kelly,* I D Arnott. GI Unit, Western General Hospital, Edinburgh, UK
Introduction 5-Aminosalicylic Acid (5ASA) plays a key role in both
induction and maintenance of remission in ulcerative colitis (UC). A
number of questions remain poorly assessed by clinical trials
including the role of dose, dose interval, preparation and delivery
method in maintaining remission. We aimed to assess the value of
preparation, dose, delivery method and dosing interval on the
duration of rst remission in patients with newly diagnosed UC.
Methods We retrospectively assessed an inception cohort of 100
newly diagnosed UC patients diagnosed between 2004 and 2008 and
followed-up for 3 years. 69 patients took oral Pentasa and 11 took
oral Asacol. The diagnosis adhered to the criteria of Lennard-Jones
and clinical details were categorised according to the Montréal
classication. Data were also collected on 5ASA maintenance drug
(Asacol or Pentasa), dose (high dose or low dose), and delivery (oral
or oral and rectal). Relapse was dened as an increase in symptoms
needing an increase in anti-inammatory therapy. Risk of relapse
was evaluated using HR, and by using Cox regression to control for
potential confounders.
Results From induction of remission to the end of our 3 yr follow-
up, 76% of patients relapsed, with a mean time to relapse of
16 months. Mean daily dose taken of Asacol was 2.3 g/day (IQR 0 g/
day) and Pentasa 2.4 g/day (IQR 2e3 g/day). We found no signi-
cant difference in the relapse rates between Asacol and Pentasa.
(Relapse rate 7/11 Asacol vs 53/69 Pentesa, c
2
¼0.574, HR 1.78
(p¼0.19)). We also found no signicant difference between: relapse
rates for patients taking high dose 5ASA vs low dose. (Relapse rate
9/10 high dose vs 42/58 low dose, c
2
¼0.114 HR 0.505 (p¼0.223));
Oral and rectal vs oral alone (Relapse rate 10/12oral + rectal vs 59/
77 oral, c
2
¼0.374, HR 0.49 (p¼0.09)); Twice daily and once daily
(Relapse rate 44/60 TD vs 5/6 OD, c
2
¼0.306, HR 2.12 (p¼0.43)),
and three times daily compared with twice daily (Relapse rate 20/23
TD vs 44/60 BD, c
2
¼0.107, HR 0.82 (p¼0.6)).
Conclusion The duration of rst remission in UC is variable and
although 5ASA are effective the majority of patients will relapse
within 3 years. These data demonstrate that relapse is inuenced
relatively little by high dose or bi-directional therapies and there
were no differences in the preparations studied. This would indicate
that concordance with therapy is a vital aspect of 5ASA efcacy and
clinicians should reinforce this point when discussing therapy.
Competing interests None declared.
PWE-229 ASSESSING PATIENT REPORTED OUTCOME IN CROHN’S
DISEASE
doi:10.1136/gutjnl-2012-302514d.229
1
J Wilburn,*
1
S R Crawford,
1
S P McKennna,
1
J Twiss,
1
M Ben-L’amri,
2
K Kemp,
2
S Campbell.
1
Galen Research Ltd, Manchester Royal Infirmary, Manchester, UK;
2
Department of Gastroenterology, Manchester Royal Infirmary, Manchester, UK
Introduction Research into the impact of Crohns Disease (CD) and
its treatment on the patient relies on outdated and inappropriate
generic questionnaires. These do not address important impacts of
the illness and ask questions of limited relevance. As part of a study
to develop CD-specic patient-reported outcome measures
(PROMS), qualitative interviews were conducted with CD patients.
Methods Item generation was based on the International Classi-
cation of Functioning, Disability and Health (ICF) and the needs-
based quality of life (QoL) models. Interviewees were recruited via
out-patient clinics and interviewed in a private room or at the
researchersofces. Interviews covered all aspects of the impact of
CD and its treatment and were audio-recorded. Transcripts
were content analysed to identify impacts on symptoms, activity
limitations and QoL.
Results 26 patients (69.2% female; aged 25e68; mean (SD): 46.2
(14.7) years) were interviewed. Participants had a wide range of
duration of CD (2e40; mean (SD): 13.0 (12.9) years). 2641 state-
ments relating to the impact of CD were identied. These state-
ments fell into three major categories with a number of sub-themes
identied: Symptoms (such as pain, fatigue and emotional impair-
ment), activity limitations (such as difculties with walking, lifting
and jobs around the house) and QoL (including preoccupation with
the disease, self-conscious of appearance and reduced socialisation).
Conclusion The study was successful in identifying the most
important impacts of CD from the patientsperspective. In addition
to generating potential items for the new measure the ndings of
the interviews have implications for clinical practice and clinical
trial design. Audit of services and assessment of new interventions
for CD should assess whether or not these impacts of CD are
improved. Only then will it be possible to determine whether
interventions are of true benet to the patient.
Competing interests None declared.
PWE-230 AN IRON-RESPONSIVE PROBIOTIC TO TREAT
INFLAMMATORY BOWEL DISEASE
doi:10.1136/gutjnl-2012-302514d.230
1
J Bailey,*
2
C Probert,
1
T Cogan.
1
School of Veterinary Science, University of Bristol,
Bristol, UK;
2
Department of Gastroenterology, Institute for Translational Medicine,
University of Liverpool, Liverpool, UK
Introduction Iron is an essential cofactor in most biological systems.
Lactic acid bacteria (LAB), frequently employed as probiotics, are
unusual in having little or no requirement for iron. In the intestine
of inammatory bowel disease (IBD) patients increased availability
of iron following oral iron supplementation or intestinal bleeding
enhances growth and virulence of many pathogens against which
LAB cannot compete. We have previously identied an iron-
responsive LAB, Streptococcus thermophilus NCIMB 41856, with
probiotic potential based on functionality in in vitro models which
could be competitive during active disease. In order for this strain to
be used as a probiotic treatment in IBD patients it must be safe, able
to survive gastrointestinal transit and preferentially adhere to
epithelial cells and colonise.
Methods Adhesion to the human epithelial cell lines, T84 and Caco-
2, was investigated and the ability of S thermophilus NCIMB 41856
to abrogate binding of potential pathogens, in particular adherent-
invasive Escherichia coli examined in vitro. The strain was also was
subjected to in vitro safety tests which included the production of
ammonia, indole, phenols, amines, hydrogen peroxide and D-lactate.
Antibiotic resistance was examined, including detection of trans-
missible antibiotic resistance. Ability to survive within a low pH
environment was determined, as was enzyme activity and metab-
olism of carbohydrates.
Results The strain was found to be capable of binding to epithelial
cells and reduce the binding of potential pathogens, while not
causing cellular damage itself. It produced no harmful metabolites
Gut July 2012 Vol 61 Suppl 2 A391
Posters
ResearchGate has not been able to resolve any citations for this publication.
CMV in IBD: Pathogen or innocent bystander?
  • Garrett Lawlor
  • Alan C Moss
Garrett Lawlor MD, Alan C, Moss MD. CMV in IBD: Pathogen or innocent bystander? Inflamm Bowel Dis 2010;16:1620e7.