ACCESS is a sub-study embedded within the DENIM trial process evaluation focussed on assessing factors affecting the equality, diversity, and inclusivity of MND research. ACCESS is led by Senior Research Fellow Dr Shoba Dawson, co-lead of the Trial Forge Inclusive Research Centre (Sheffield).

"What are the barriers and enablers to effective recruitment, retention and engagement of participants from underserved MND populations and how might these be addressed?"

To investigate the participants’ experiences of barriers and enablers, and intersectional factors (e.g., culture, ethnicity, socioeconomic status) that influence participation in DENIM. We will also speak to participants least likely to participate in MND clinical trials and/or who face the most difficulties receiving the proposed intensive NIV initiation. We will also explore to what extent our EDI component helped facilitate or hinder participation, to make recommendations for this trial and for future trials of complex interventions in long-term neurological conditions.

The study will purposefully sample participants who declined to take part in the DENIM trial and who research has shown to be less likely to participate in MND research or gain value from NIV. This includes:

• People from an ethnic minority and/or where an individual's main language is not English

• People with low levels of digital health literacy (the ability to use digital tools to find, understand, and apply health information to make informed decisions)

• Women over the age of 80 with bulbar onset disease

MND patients who declined to take part in the main DENIM trial will be approached to take part in an interview. We will use translated materials and interpreters for interviews where needed, and these interviews can take place via telephone/video/face-to-face/email, and with the presence of a carer or independent witness.

The interview topic guides used in the main DENIM trial process evaluation will include questions that focus on diversity, and we aim to over-recruit for observations from these underserved patient populations.

We will make field notes during discussions with consenting site staff during training for the DENIM intervention. Embedded within the the main DENIM trial is a short questionnaire for staff which includes questions exploring staff's perceived barriers towards recruitment in underserved groups and we will seek to address these if feasible.

Topic guides were developed under the guidance of our ED&I lead, diverse PPIE group members, and the wider literature on understanding of and attitudes towards clinical trials (in particular complex interventions), barriers and enablers to participation and retention, and attitudes towards being in the control/intervention groups.

DENIM ACCESS - Participant Information Sheet

DENIM ACCESS - Accessible Participant Information Sheet