Development and validation of condition-specific Patient-Reported Outcome Measures (PROMs) of quality of life, symptoms and treatment satisfaction for patients with aortic aneurysms

British Journal of Surgery 101 (S2) 10-11, CVT6.
Abstract presented orally at the Society of Academic and Research Surgery, 8th – 9th January 2014, Robinson College, Cambridge.

Objectives
To develop and validate PROMs to assess individualised quality of life (QoL), symptoms and treatment satisfaction in patients with abdominal aortic aneurysms (AAA).

Methods
Literature review, patient focus groups and specialist linguistic input informed the qualitative design of AAA PROMs items. These were used to populate existing questionnaire templates previously developed by Bradley and colleagues with other patient populations. One-to-one patient interviews and clinician review were used to optimise content/face validity. Patients recruited from 5 NHS Trusts included those having endovascular or open AAA repair. Psychometric validation included exploratory factor analysis and reliability analyses on cross-sectional questionnaire data collected from patients pre-intervention or at subsequent points in the treatment pathway.

Results
Design work with 54 patients in 3 centres produced three new measures:
1. Aneurysm-Dependent Quality of Life (Aneurysm-DQoL) questionnaire
2. Aneurysm Symptom Rating Questionnaire (Aneurysm-SRQ)
3. Aneurysm Treatment Satisfaction Questionnaire (Aneurysm-TSQ).

172 further patients completed questionnaires for quantitative psychometric analysis (157 men/15 women; mean age 75.0yrs). Factor and reliability analyses revealed that 20/23 items from the Aneurysm-DQoL formed a single scale with excellent reliability (Cronbach’s-α coefficient of internal consistency=0.95); the 44 Aneurysm-SRQ items divided into five subscales α=0.61–0.78); whilst the 11-item Aneurysm-TSQ formed a single scale (α=0.88) with two subscales (α=0.88 and 0.77).

Conclusions
The Aneurysm-DQoL, Aneurysm-SRQ and Aneurysm-TSQ are newly validated, AAA-specific questionnaires for assessment of QoL, symptoms and treatment satisfaction. Their use will clarify the precise impact of AAA and its treatment, highlight the issues most relevant to patients and facilitate targeted improvements in care.