GCA PRO

Development and validation of a patient reported outcome measure for Giant Cell Arteritis 

Chief Investigator	Institution	Dates	Funding Stream	Grant Ref	Amount
Dr Jo Robson	University of the West of England, Bristol	01/10/2019 - 30/09/2021 (24 months)	NIHR Research for Patient Benefit (RfPB)	PB-PG-1217-20017	£149,274

Summary

Aims:

To develop a Patient Reported Outcome Measure (PROM) for Giant Cell Arteritis (GCA), in the form of a questionnaire specific to the disease and its impact on quality of life. The aim is for the questionnaire to be used in routine practice and clinical trials to measure health-related quality of life and target treatment in those areas of greatest importance to patients.

Background:

GCA causes inflamed blood vessels in the head and neck and affects one or two persons per 10,000 people in the UK.

In our interviews, patients with GCA have described their quality of life:

"one day I just couldn't get out the bed, I couldn't bend my knees or walk. " 73 year-old female.

"it was a bit like watching a very cheap DVD on the television. When it all goes crackle, crackle, crackle and breaks up, that's how my vision was." 74 year-old male.

"they used to call me Super Nan, but they can't call me that now." 75 year-old female.

Patients receive high dosages of steroids, which have side-effects including weight gain, anxiety, high blood pressure and diabetes. Newer targeted treatments are only available to a few patients.

Design and methods

We have conducted 31 interviews and identified areas of interest to patients. Based on the interviews, we have co-developed with patients a list of 45 questions which are now ready for testing. Here is one example:

Q18. Due to your GCA or its treatment, how often during the past 7 days have you ….

Had difficulty using your eyes in a focused way e.g. using a computer, mobile phone or watching TV?

(Response options: Never, Rarely, Sometimes, Often, Always)

We will recruit 300 people with GCA. NHS clinics and UK registries will be used to select suitable participants.

We will ask patients to complete the 45 questions in a postal survey. We will collect data on the patient's disease and background. The analysis will involve refining the questionnaire by removing unnecessary questions and ensure it is a robust measure for quality of life. Finally, we will conduct interviews with 20 patients and doctors to explore the use of the questionnaire in clinics.

Patient and public involvement

We have two patient partners who will be actively involved in the research project. This project has support from the patient charity PMRGCAUK. They will help us gain feedback on the project from a wider population of people affected by GCA via their local support group meetings and online forum.

Dissemination

We have an expert advisory committee including patient charities, patient research partners, clinicians and researchers to support the use of the questionnaire in routine NHS clinics and research (to measure outcomes of greatest importance to patients).