Symptoms of Anxiety and/or Depression and the Shared Decision Making (SDM) Process in Older Patients With Critical Limb Threatening Ischaemia (CLTI)

Despite several studies associating mental health with both advancing age and poorer postoperative outcome, few studies have qualitatively explored the lived experience of older people with CLTI. Exploring the patient perspective will allow us to better understand the relationship between CLTI and mental health, and how patients can be better supported through SDM with the potential to reduce decisional regret. This will allow the development of strategies to enhance SDM taking mental health into account.

Study type This is a two-centre qualitative study, using a purposive sample from two NHS tertiary referral centres for vascular surgery (Guy's and St Thomas' NHS Foundation Trust and University Hospitals of Leicester). For this study, semi-structured interviews and a co-production workshop will be undertaken.

Public and patient involvement and engagement This study has been prompted by PPIE work informing the larger POPS-SUp study where patient and carer participants highlighted the need to explore mental health issues in a diverse surgical population with a focus on the impact this may have on SDM and recovery from surgery. The PPIE group told us that people with mental health issues can be especially stigmatised in some minority communities and approaching this topic in a sensitive manner will be key to this study. Following consultation, the investigators recognize the need to collaborate with organisations such as the Centre for Ethnic Health Research and consult a diverse PPI group (established from previous studies) to co-develop recruitment strategies and ensure interview questions are culturally sensitive and appropriate. The investigators have included a budget to translate study documents in two languages (Gujarati and Punjabi) and for a face-to-face interpreter for up to ten interviews to reduce language barriers to participation.

This study will draw on the diverse knowledge and expertise of existing PPIE groups in mental health and vascular surgery and from the existing POPS-SUp study. The investigators have costed for a PPIE representative to work with us specifically on this study who has experience of CLTI and mental health issues. JS will review study documents and be involved in the dissemination and coproduction workshop. The investigators will hold three PPIE meetings with five to six patient representatives, one to provide feedback on the protocol and other study documents, one during the study to discuss findings and dissemination plan (community talks, social media, lay summaries, infographics) and one toward the end of the study for feedback and guidance on next steps.

An appropriate budget has been included in this bid to support all stakeholder and public involvement and engagement activities, including dissemination.