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Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire
INTRODUCTION: The use of patient reported outcome measures to support routine inflammatory bowel disease (IBD) care is not widespread and suggests that existing questionnaires lack relevance to day-to-day decisions or are too cumbersome to administer. We developed a simple, generic tool for capturin...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4078750/ https://www.ncbi.nlm.nih.gov/pubmed/24107590 http://dx.doi.org/10.1136/gutjnl-2013-305600 |
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author | Bodger, Keith Ormerod, Clare Shackcloth, Daniela Harrison, Melanie |
author_facet | Bodger, Keith Ormerod, Clare Shackcloth, Daniela Harrison, Melanie |
author_sort | Bodger, Keith |
collection | PubMed |
description | INTRODUCTION: The use of patient reported outcome measures to support routine inflammatory bowel disease (IBD) care is not widespread and suggests that existing questionnaires lack relevance to day-to-day decisions or are too cumbersome to administer. We developed a simple, generic tool for capturing disease control from the patient's perspective to address these barriers. METHODS: Development based on literature review, patient focus groups/interviews and a steering group, defining a limited set of generic questions. The ‘IBD-Control’ questionnaire comprises 13 items plus a visual analogue scale (VAS) (0–100). Prospective validation involved baseline completion of IBD-Control, quality of life (QoL) questionnaire (UK-IBD-Q), EuroQol (EQ-5D), Hospital Anxiety and Depression Score; and clinician assessment (blinded to questionnaire; recording Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index; Global Clinician Rating; treatment outcome). RESULTS: 299 patients returned baseline surveys (Crohn's disease, n=160; ulcerative colitis, n=139) and 138 attended for repeat visits. Completion time (mean; SD): 1 min 15 s; 25 s; Internal consistency: Cronbach's α for all 13 items (0.85); for subgroup of eight questions (‘IBD-Control-8’; 0.86). Strong correlation between IBD-Control-8 and IBD-Control-VAS (r=0.81). Test-retest reliability (2 week repeat): intra-class correlation=0.97 for IBD-Control-8 and 0.96 for IBD-Control-VAS. Construct validity: Moderate-to-strong correlations between IBD-Control-8 and IBD-Control-VAS versus activity indices, UK-IBD-Q and EQ-5D (utility) with r values 0.52–0.86. Discriminant validity (mean instrument scores for remission, mild, moderate or severe): p<0.001 (analysis of variance (ANOVA)). Sensitivity to change: Effect sizes: 0.76–1.44. CONCLUSIONS: The IBD-Control is a rapid, reliable, valid and sensitive instrument for measuring overall disease control from the patient's perspective. Unlike existing patient reported outcome measures, its simplicity, ease-of-use and generic applicability make it a candidate for supporting routine care. |
format | Online Article Text |
id | pubmed-4078750 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-40787502014-07-10 Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire Bodger, Keith Ormerod, Clare Shackcloth, Daniela Harrison, Melanie Gut Inflammatory Bowel Disease INTRODUCTION: The use of patient reported outcome measures to support routine inflammatory bowel disease (IBD) care is not widespread and suggests that existing questionnaires lack relevance to day-to-day decisions or are too cumbersome to administer. We developed a simple, generic tool for capturing disease control from the patient's perspective to address these barriers. METHODS: Development based on literature review, patient focus groups/interviews and a steering group, defining a limited set of generic questions. The ‘IBD-Control’ questionnaire comprises 13 items plus a visual analogue scale (VAS) (0–100). Prospective validation involved baseline completion of IBD-Control, quality of life (QoL) questionnaire (UK-IBD-Q), EuroQol (EQ-5D), Hospital Anxiety and Depression Score; and clinician assessment (blinded to questionnaire; recording Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index; Global Clinician Rating; treatment outcome). RESULTS: 299 patients returned baseline surveys (Crohn's disease, n=160; ulcerative colitis, n=139) and 138 attended for repeat visits. Completion time (mean; SD): 1 min 15 s; 25 s; Internal consistency: Cronbach's α for all 13 items (0.85); for subgroup of eight questions (‘IBD-Control-8’; 0.86). Strong correlation between IBD-Control-8 and IBD-Control-VAS (r=0.81). Test-retest reliability (2 week repeat): intra-class correlation=0.97 for IBD-Control-8 and 0.96 for IBD-Control-VAS. Construct validity: Moderate-to-strong correlations between IBD-Control-8 and IBD-Control-VAS versus activity indices, UK-IBD-Q and EQ-5D (utility) with r values 0.52–0.86. Discriminant validity (mean instrument scores for remission, mild, moderate or severe): p<0.001 (analysis of variance (ANOVA)). Sensitivity to change: Effect sizes: 0.76–1.44. CONCLUSIONS: The IBD-Control is a rapid, reliable, valid and sensitive instrument for measuring overall disease control from the patient's perspective. Unlike existing patient reported outcome measures, its simplicity, ease-of-use and generic applicability make it a candidate for supporting routine care. BMJ Publishing Group 2014-07 2013-10-09 /pmc/articles/PMC4078750/ /pubmed/24107590 http://dx.doi.org/10.1136/gutjnl-2013-305600 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/ |
spellingShingle | Inflammatory Bowel Disease Bodger, Keith Ormerod, Clare Shackcloth, Daniela Harrison, Melanie Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire |
title | Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire |
title_full | Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire |
title_fullStr | Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire |
title_full_unstemmed | Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire |
title_short | Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire |
title_sort | development and validation of a rapid, generic measure of disease control from the patient's perspective: the ibd-control questionnaire |
topic | Inflammatory Bowel Disease |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4078750/ https://www.ncbi.nlm.nih.gov/pubmed/24107590 http://dx.doi.org/10.1136/gutjnl-2013-305600 |
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