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The development and use of a preliminary conceptual model of inflammatory bowel disease to facilitate patient reported outcome (PRO) instrument selection for a UK real world evidence study
Objectives
Inflammatory bowel disease (IBD) is chronic in its nature and impacts patients’ health-related quality of life (HRQoL). This work aimed to develop a preliminary conceptual model of IBD to guide the measurement and selection of PROs to be included in a real-world study of vedolizumab.
Methods
The preliminary conceptual model of IBD was developed via a detailed review of empirical qualitative literature focussing on the biological and psychological aspects of health outcomes in IBD. The model content was structured according to the Wilson and Clearly (1995) HRQoL model and concepts were extracted from the literature. This model was then used to guide PRO measurement strategy, first by examining the content of PROs for their use in IBD and then by mapping the concepts on the model with the identified PROs to identify the most appropriate PROs to include in a real-world study.
Results
The preliminary model consisted of a physiological factor level labelled, ‘IBD symptoms’, including two sub-levels, ‘Bowel’ and ‘Systemic’. All other concepts were categorised under levels of functional health and overall quality of life, and labelled according to ‘impact of symptoms on daily life’. This encompassed six sub-levels of impact: ‘activities of daily living’, ‘interpersonal functioning’, ‘emotional’, ‘society and economics’, ‘social’ and ‘treatment’. The model will next be presented to a panel of gastroenterologists and / or patients for verbal ratification to ensure that it covers the concepts described by patients in a clinical setting, and to validate the key domains important to patients.
Conclusion
The preliminary version of the model will be used to give context to and support interpretation of the real-world study findings. This work provides an example of how the patient perspective from existing literature can be used to guide the strategy for measuring and selecting PROs in IBD.
Authors
A J Rylands, G Owen, J Toms, N Heggs, C Bottomley
Journal
Value in Health
Therapeutic Area
Gastroenterology
Center of Excellence
Patient-Centered outcomes
Year
2017
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