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DICE IMPACT Questionnaire: Determinants, Incidence, and consequences of Corticosteroid Excess in IBD (IBD DICE IMPACT)

Safe People

Organisation name

University of Cambridge

Organisation ID

grid.5335.0

Applicant name(s)

Tim Raine

Safe Projects

Project ID

DAA092

Lay summary

Corticosteroids are a type of drug commonly used to treat patients with inflammatory bowel diseases (IBD). Although the treatment is effective, it can cause lots of side effects. Although we know a lot about the more serious side effects, more “minor' side effects might not be considered by doctors but still be of real importance to patients. Previous studies have demonstrated that these side effects do happen to patients treated with corticosteroids for other diseases, but we don’t know very much at all about what happens to patients with IBD when they are given the sorts of doses of these drugs used to treat IBD. In this study, we will use data in the IBD BioResource that comes from patients who have answered questions about their own experience of taking corticosteroids. This will help us identify how many patients are getting steroids, and also what their experience of side effects is like. We will focus on side effects that patients might not always tell their doctors, such as changes in mood, problems with sleeping, weight gain, skin changes, indigestion, inability to concentrate and negative impacts on home and daily life. We will try to identify any particular groups of patients who do worse with these drugs than others.

Request category type

Research

Other approval committees

NIHR BioResource Data Access Committee

Latest approval date

19/11/2021

Safe Data

Dataset(s) name
Data sensitivity level

De-Personalised

Legal basis for provision of data under Article 6

(e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

Lawful conditions for provision of data under Article 9

(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

Common Law Duty of Confidentiality

The individual to whom the information relates has consented

National data opt-out applied?

No

Request frequency

One-off

Safe Setting

Access type

Release

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