Outcomes of patient and public involvement in the development of the Cognitive Decline after Brain Radiosurgery (CoDe B-Rad) study: refining the research question and methodology.

OBJECTIVES

Patient and public involvement (PPI) was sought in the development of the protocol for the Cognitive Decline after Brain Radiosurgery (CoDe B-Rad) study, which aims to identify potential side effects of stereotactic radiosurgery (SRS). PPI served to refine the research question and methodology.

DESIGN

PPI.

SETTING

PPI conducted online with people based in the UK. The CoDe B-Rad study is running in regional National Health Service tertiary care in the UK and is currently nearing recruitment completion.

PARTICIPANTS

Patients and carers with lived experiences of brain radiotherapy. Contributors were identified through national charities.

PROCEDURES

Initial focus groups were planned, but participation proved challenging. Instead, online questionnaires, one-to-one discussions and participation in support groups were completed.

RESULTS

All contributors experienced changes to their cognition and/or quality of life (QoL) after radiotherapy. Quantifying the side effects of SRS and minimising them were identified as a research gap. Discussion group participation proved challenging. PPI plans were altered to accommodate the physical and mental needs of contributors. It was decided to combine the Montreal Cognitive Assessment along with European Organisation for Research and Treatment in Cancer QLQ-C30 and BN20 to capture cognitive status and QoL of patients with brain metastases and meningiomas after SRS. Patients/carers recommended for sessions to be restricted to 30 min and testing to be offered face-to-face, online, in hospital or at patients' homes. Coproduction was not achievable with our patient population but that did not diminish the input of contributors nor the impact it had on designing the study protocol.

CONCLUSIONS

In cancer research, diligent considerations are required to ensure the suitability of involvement methods for this vulnerable population. Flexibility and adaptability of draft PPI plans are essential to achieve meaningful contributions. The protocol of the ongoing CoDe B-Rad study was positively shaped by people with lived experiences of brain radiotherapy.

TRIAL REGISTRATION NUMBER

NCT06466720 (CoDe B-Rad study).