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Table 6 Summary of responses to stakeholder consultation survey

From: Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework

What are your views about using the framework (e.g. its value and whether you would feel capable/confident to use it)?

Views about using the framework were provided by 96% (n=24) of respondents

• Positive viewsan=13 (52%) expressed only positive comments about the framework, including generic comments (e.g. describing it as excellent) and more specific comments about the framework’s clarity, useability, and usefulness

• Need for more information — other responses included questions about how it applied to particular trial populations (e.g. critically ill patients), types of research (e.g. only clinical trials of interventions) and specific issues (e.g. surrogate decision-makers)

• Other responses — included one comment that the framework was difficult to understand

What would be the potential barriers to you using the framework?

A number of potential barriers to using the framework were reported by respondents (96%, n=24). Only one reported there being no potential barriers to using the framework

• Lack of understanding about the framework — this was reported as a general barrier by some respondents (20%, n=5), including not understanding the target audience, the purpose of the framework, or its use and application, or a lack of understanding and knowledge about who is to be considered as having impaired capacity

• Lack of time — this was a common potential barrier to using the framework, reported by 6 (24%) of respondents, was the time required to work through it. One respondent suggested giving an indication of how long each worksheet might take to complete. Another response included the potential difficulty in “persuading others in study team that it is something worth putting time and effort into”

• Lack of support from influential stakeholders — this was also cited as a potential barrier by respondents (12%, n=3). For example, whether the framework is considered, or accepted, by funders, Research Ethics Committees (RECs), or members of the public

• Other potential barriers to using the framework — these included whether it would help identify practical solutions to the issues raised, ease of access to the worksheets, or a lack of support and guidance to use the framework

Which of these implementation toolkit items would be likely to help you to use the framework?

• Implementation toolkit items in order of importanceb:

- Worked examples of the framework (n=22, 88%)

- Links to resources to help with any actions identified (n=19, 76%)

- Infographic with key messages (n=17, 68%)

- Accessible information with key messages (n=14, 56%)

- Short explainer video (n=12, 48%)

- Interactive workshop materials (n=10, 40%)

- Other (n=6, 24%), e.g. having a range of tools available

• Materials for different stakeholder groups — suggestions were made about other ways respondents felt would help them use the framework such as producing materials for funding bodies, research design service teams, and research ethics committees

• Signposting by funders — it was suggested that funders should either signpost applicants to the framework or embed it in their guidance for applicants

• Access to expertise — another suggestion was that having someone in their organisation being an expert user of the framework and toolkit

  1. aResponses were considered to be positive if they contained words or phrases that were complimentary or expressed approval
  2. bParticipants could select more than one option from the list