Protocol for a prospective multicentre cohort study to develop and validate two new outcome measures for patients with inflammatory bowel disease

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Abstract

Introduction

Most of the health-related quality of life (HRQoL) measures for patients with inflammatory bowel disease (IBD) were designed to be used in outpatient settings and are therefore not suitable for use in acute inpatient settings. None of the currently used clinical severity indices for patients with IBD have been properly validated. The aim of this study was to describe the development of a new HRQoL questionnaire and a clinical severity index for patients with ulcerative colitis or Crohn's disease that were short, valid and suitable at any stage of their disease. The new HRQoL and disease severity index will be easily used at the point of care, and invaluable monitoring tools for clinical care, audit and research.

Methods and analysis

This is a prospective multisite validation study of two new outcome measures, the Crohn's and Colitis quality of life (CCQ) questionnaire and the Clinical IBD severity score (CISS). We plan to recruit patients with ulcerative colitis or Crohn's disease. The questionnaire items will be selected through extensive literature review and a focus group involving patients, methodologists, statisticians and IBD specialists. The CCQ questionnaire will be completed by patients attending IBD clinics, having endoscopy procedures or when admitted to hospital. CISS will be completed by clinicians while assessing patients with IBD. Psychometric analysis will be carried out to test the validity and reliability of the questionnaires and to determine the potential to produce shorter versions of CISS and CCQ. The construct validity of CCQ will be tested against short form-12 and the European Quality of Life Five Dimensions. The construct validity of CISS will be tested against biochemical markers, clinical and endoscopic indices to assess severity.

Ethics

This study was approved by the South East Wales Research Ethics Committee (Ref 11/WA/0239).

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Most cited references 23

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Infliximab for induction and maintenance therapy for ulcerative colitis.

Paul Rutgeerts, William J Sandborn, Brian Feagan … (2005)

Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor alpha, is an established treatment for Crohn's disease but not ulcerative colitis. Two randomized, double-blind, placebo-controlled studies--the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis. In each study, 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2. In ACT 1, 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo (P<0.001 for both comparisons with placebo). A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1. In ACT 2, 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8, as compared with 29 percent of those who received placebo (P<0.001 for both comparisons with placebo). In both studies, patients who received infliximab were more likely to have a clinical response at week 30 (P< or =0.002 for all comparisons). In ACT 1, more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 (45 percent and 44 percent, respectively) than did those who received placebo (20 percent, P<0.001 for both comparisons). Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0, 2, and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8, 30, and 54 than were those receiving placebo. (ClinicalTrials.gov numbers, NCT00036439 and NCT00096655.) Copyright 2005 Massachusetts Medical Society.

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Infliximab for the treatment of fistulas in patients with Crohn's disease.

D Present, P Rutgeerts, S Targan … (1999)

Enterocutaneous fistulas are a serious complication of Crohn's disease and are difficult to treat. Infliximab, a chimeric monoclonal antibody to tumor necrosis factor alpha, has recently been developed as a treatment for Crohn's disease. We conducted a randomized, multicenter, double-blind, placebo-controlled trial of infliximab for the treatment of fistulas in patients with Crohn's disease. The study included 94 adult patients who had draining abdominal or perianal fistulas of at least three months' duration as a complication of Crohn's disease. Patients were randomly assigned to receive one of three treatments: placebo (31 patients), 5 mg of infliximab per kilogram of body weight (31 patients), or 10 mg of infliximab per kilogram (32 patients); all three were to be administered intravenously at weeks 0, 2, and 6. The primary end point was a reduction of 50 percent or more from base line in the number of draining fistulas observed at two or more consecutive study visits. A secondary end point was the closure of all fistulas. Sixty-eight percent of the patients who received 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the primary end point, as compared with 26 percent of the patients in the placebo group (P=0.002 and P=0.02, respectively). In addition, 55 percent of the patients assigned to receive 5 mg of infliximab per kilogram and 38 percent of those assigned to 10 mg per kilogram had closure of all fistulas, as compared with 13 percent of the patients assigned to placebo (P=0.001 and P=0.04, respectively). The median length of time during which the fistulas remained closed was three months. More than 60 percent of patients in all the groups had adverse events. For patients treated with infliximab, the most common were headache, abscess, upper respiratory tract infection, and fatigue. Infliximab is an efficacious treatment for fistulas in patients with Crohn's disease.

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A simple clinical colitis activity index.

R S Walmsley, R C S Ayres, R E Pounder … (1998)

The appropriate medical treatment of patients with ulcerative colitis is determined largely by the severity of symptoms. Hospital assessment of the severity of disease activity includes investigation of laboratory indices and sigmoidoscopic assessment of mucosal inflammation. To develop a simplified clinical colitis activity index to aid in the initial evaluation of exacerbations of colitis. The information for development of the simple index was initially evaluated in 63 assessments of disease activity in patients with ulcerative colitis where disease activity was evaluated using the Powell-Tuck Index (which includes symptoms, physical signs, and sigmoidoscopic appearance). The new index was then further evaluated in 113 assessments in a different group of patients, by comparison with a complex index utilising clinical and laboratory data, as well as five haematological and biochemical markers of disease severity. The newly devised Simple Clinical Colitis Activity Index, consisting of scores for five clinical criteria, showed a highly significant correlation with the Powell-Tuck Index (r = 0.959, p < 0.0001) as well as the complex index (r = 0.924, p < 0.0001) and all laboratory markers (p = 0.0003 to p < 0.0001). This new Simple Colitis Activity Index shows good correlation with existing more complex scoring systems and therefore could be useful in the initial assessment of patients with ulcerative colitis.

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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: 2013

Publication date (Electronic): 9 July 2013

Volume: 3

Issue: 7

Electronic Location Identifier: e003192

Affiliations

Centre for Health Information, Research and Evaluation (CHIRAL) , Swansea University , Swansea, UK

Author notes

[Correspondence to ] Dr Laith Alrubaiy; l.alrubaiy@ 123456swansea.ac.uk

Article

Publisher ID: bmjopen-2013-003192

DOI: 10.1136/bmjopen-2013-003192

PMC ID: 3710989

PubMed ID: 23842503

SO-VID: bbec3fb0-e93b-43af-a366-601db58fbc5b

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

Protocol for a prospective multicentre cohort study to develop and validate two new outcome measures for patients with inflammatory bowel disease

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Abstract

Introduction

Methods and analysis

Ethics

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Biomarkers for Inflammatory Lung Disease

Most cited references 23

Infliximab for induction and maintenance therapy for ulcerative colitis.

Infliximab for the treatment of fistulas in patients with Crohn's disease.

A simple clinical colitis activity index.

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