Barriers and facilitators to EQUitable participation and engagement in research using digitAl Trial mEthods: A qualitative exploration with the public, patients, and staff (EQUATE)

Background From 2020 to 2021 the number of trials using digital technology increased 93% [16].

The use of digital methods increased rapidly during the covid-19 pandemic to maintain operations and reduce in-person contact [1], and its adoption was reactive, introduced with little prospective research or existing evidence to inform best practice [2].

The Department of Health and Social Care (DHSC) 2022-2025 strategy for clinical research delivery aims to make the use of digital the new norm [3].

However, there is evidence and concern amongst research communities that digital methods (e.g. smartphone data collection) may impact the ability of different populations to fully engage in trials, particularly for those currently under-represented, such as older adults, ethnic minorities and low socioeconomic status groups [5].

To date, there has been no research to understand the potential impact of patient-facing digital methods being used throughout the lifecycle of a trial on equitable participation and engagement.

We need to understand more about the experiences of people from diverse backgrounds and how they don't and/or do engage with digital methods throughout a trial to identify where procedures might be difficult to engage with and how we might optimise these to make participation easier.

If trial findings are not generalisable, health care professionals won't have adequate information to treat and manage the entire spectrum of affected patients, which will contribute to widening health inequalities.

Aims and objectives I intend to address this gap by exploring the barriers and facilitators to participation and engagement in trials using digital methods and answering three research questions: Phase 1. What are the influential factors to participation and engagement with digital methods in different populations?

Phase 2. How might we make it easier for people wanting to interact with digital methods? Phase 3. What solutions can maximise equitable digital methods? Methods Phase 1: Participant experiences with digital trial methods (16 months).

Semi-structured interviews with up to 50 trial participants who opted to use, or not use, digital methods offered in their trial. Phase 2: Can we make it easier for participants that want to interact with digital trial methods? (12 months).

Think-aloud observations with up to 50 people completing digital method tasks to capture real-time emotions, interactions, and behaviour to determine how we can make them easier to use. Phase 3: The feasibility of optimising digital trial methods for equitable participation and engagement (12 months).

Focus groups with up to 24 key stakeholders (e.g., trialists, patient and public involvement, software developers) to explore decision-making and key constraints of developing and applying equitable digital methods and to establish potential solutions to implement into practice.

Dissemination and impact Short report for DHSC Presentations at public engagement events Personas and user journeys to disseminate via video to software developers and trialists Published manuscripts This fellowship will provide important insights for policymakers to use in digital and research-related strategy and provide information for researchers to design trials to maximise equitable trial methodology to create generalisable results.

Findings may also lead to post-doctoral intervention and implementation research.