CaPaBLE: Comparing the Patient Generated Index to standard quality of life measures in patients and caregivers affected by high-grade brain tumours - Preliminary analysis
Authors: Pakzad-Shahabi Lillie , Tallant James , Wells Mary , Williams Matthew 
Published: October 2021

Abstract

Aims
High grade gliomas are rare but have the highest number of cancer deaths in the under-40s. Treatment options are limited, resulting in a clinical focus on maintaining quality of life (QoL). However standard QoL assessment tools are time consuming, may not reflect an individual’s priorities, and are rarely used in clinical practice. Moreover, the impact of caring for someone with a high grade glioma is seldom assessed.
An alternative approach to assessing quality of life is to use a patient - or carer-generated index (PGI/CaGI), which asks patients & carers to raise, rank and number their concerns. This may offer a route to individualised QoL assessments within clinical and research settings.
The CaPaBLE study tests the feasibility and acceptability of the PGI and CaGI methodology in patients with high-grade glioma and their caregivers. This paper highlights key similarities and differences of the PGI/CaGI to standard QoL questionnaires.

Method
CaPABLE is an observational phase 2 non-randomised study following patients and their caregivers over 6 months starting at either first diagnosis or recurrence (https://www.isrctn.com/ISRCTN45555598). Patients and caregivers complete both standard questionnaires (EORTC QLQ C30 & BN20 and CargoQOL) and PGI/CAGI at 5 timepoints over the 6 month period. Each time the patients/caregivers complete the PGI/CAGI they are asked to identify up to 5 main topics of concern for their QoL, to score these, and rank their importance.
For this analysis, we grouped topics into themes, compared the stability of themes over time and to EORTC domains. Analyses of EORTC measures are conducted using standard scoring approaches. Here we present an initial analysis of occurrence of PGI/CaGI themes compared to EORTC domains, but do not consider scores or ranking.

Results
6 patients (4 male) and 5 caregivers (3 female; 4 paired with patients; one unpaired) have completed both standard questionnaire and PGI/CaGI at three or more time points, with a total of 19 (patient) and 18 (caregiver) assessments. On average people reported 3 topics at each assessment.
The PGI generated 59 topics (32 themes); the CaGI, 50 topics (23 themes) and themes were consistent over time. The most common domain raised by patients was “social life” (13). Caregivers raised “personal life and family” (12 and “planning ahead” (7) more commonly.
Of the 32 PGI themes, 23 align with EORTC domains. 9 PGI themes were not represented in the EORTC questionnaires, and 14 EORTC domains did not appear in the PGI. Of the 23 CaGI themes, 17 align with 7 CarGOQOL domains. 6 CaGI themes were not represented in the CarGOQOL and 3 CarGOQOL domains did not appear in the CaGI.

Conclusion
PGI and CaGI themes coincide with the main domains of EORTC (i.e., cognitive, social, role, physical, emotional functioning, future uncertainty). However, there were significant discrepancies: PGI (e.g., intimacy, ability to drive, and COVID related restrictions) and CaGI (e.g. personal life & family) highlighted themes that are not in the standard questionnaires. Both PGI/CaGI and standard questionnaires agree that symptom-related issues such as pain and seizures are not the main priority when it comes to QoL. In addition, CarGOQOL reports positive aspects of care, whereas CaGI only raised negative areas.
This study is the first to show the feasibility of PGI/CaGI in a brain tumour patient & caregiver population. PGI/CaGI are notably quicker to complete and provide insights not captured by standard questionnaires. We are continuing to recruit patients and caregivers, and have submitted a protocol amendment to carry out qualitative interviews with patients and caregivers, to explore their views further.