SIDE-PRO

Identifying treatment side effects in adults with an intellectual disability and epilepsy: development of Patient-Reported Outcome Measure (PROM) for identification of Anti-Epileptic Drug (AED) side effects (SIDE-PRO).

Background

Epilepsy is common in adults with intellectual disability and recent research shows carers and professionals are concerned about physical and behavioural side effects of drug treatment. Not much is known however about how best to identify and measure these side effects and their impact on wellbeing.

Study design

This is a mixed-method Patient Reported Outcome Measure (PROM) development study. Individuals with ID are often excluded from the PROMs development process.

Study aims

The purpose of this study is to develop a questionnaire that professionals can use with patients and carers to identify important side effects of anti-epileptic drugs in adults with Intellectual Disability (ID). Although similar questionnaires are available for use in the general population, it is not clear whether these are appropriate for adults with ID and it may be difficult to spot side effects of drugs because of this. It is hoped results will lead to better awareness and identification of anti-epileptic drug side effects.

Two versions of the questionnaire will be developed, one for carers to complete and another for patients where possible. These questionnaires will be based on existing measures of side effects used for adults with epilepsy in the general population. Small groups of patients, carers, and professionals will be involved in developing these questionnaires, and the extent to which side effects are associated with challenging behaviour, mood and quality of life will be examined. It is hoped results will lead to better awareness and identification of AED side effects and in the longer term, that these results will facilitate larger scale studies of treatments to reduce side effects and improve quality of life in this group.

Recruitment

Approximately 135 participants (professionals, carers and patients) will be recruited over a 12 month period. The study has several stages including participant and carer focus groups, face to face interviews and postal questionnaires.

Involving the public and patients

By including Individuals with ID throughout the PROMs development process we aim to ensure the selection and measurement of appropriate and accessible outcomes is central to all stages.

We want to understand the side effects of AEDs that are most important to individuals with ID themselves and their carers. The outcomes identified by participants in the early stages of the study will guide the development of the PROM.