COMET Patient and Public Involvement Toolkit
COMET Patient and Public Involvement Toolkit

Consensus processes in core outcome set studies

COS developers use different methods to gain consensus on what outcomes are most important:

When preparing for the survey, public research partners (PRPs) can collaborate with the research team to consider the following:

Who should take part i.e. the eligibility criteria for the survey?

The design and wording of the survey and recruitment / information materials
  • What information patients might like to see on your website / newsletters?
  • How easy is it to find information on the website (if your COS has one) and is this participant information useful and easy to understand?
  • How readable and understandable the newsletters are (if these are to be used in your COS study)?
  • How readable and understandable the patient information and consent forms are for your COS study?
  • How understandable are the outcome definitions?
  • How will patients react to the outcomes?
  • What ethical issues there may be with patient participation in your COS survey?
  • How accessible is the COS survey (for example, is the font size adequate, are the colours suitable for someone with colour blindness, is the scoring system suitable for the target population, for example if children are participating etc)?
  • How understandable the COS instructions are for each round of the survey?
  • Will patients know which perspective they are to use when completing each round of the Delphi survey (for example, are they to vote from their personal perspective or considering the perspectives of the wider patient group)?
  • How understandable is the feedback that we are providing between rounds in a Delphi survey, including any graphs etc.
The recruitment and retention strategy
  • Is there likely to be a large patient research burden in the intended patient community at the time we plan to run the COS study (e.g. large-scale, clinical trial / research prioritisation study etc. running at the same time as your COS study)
  • How will we reach a diverse range of patients to participate in the COS study?
  • Whether there are specific issues to consider when recruiting particular patient groups in the COS study e.g. patients with cognitive / additional learning needs / visual or auditory impairment.
  • How best to raise awareness about the COS study to the appropriate patient group(s)?
  • How best to maintain patient interest in the COS study over time?
  • How to address potential recruitment challenges from a patient perspective?

When preparing for a consensus meeting, public research partners (PRPs) can collaborate with the research team to consider:

The design and wording of your participant information sheets, consent forms and recruitment materials
  • How readable and understandable the participant information and consent forms are for the COS consensus meeting, e.g. what to expect in the meeting?
  • What ethical issues there may be with patient participation in the COS meeting? E.g. in some conditions, especially in rare disease, the patient or caregiver’s clinician may be in the room, have you considered with patients how this may make participants feel?
  • How understandable the information is about how to get to the venue / join the meeting remotely?
  • How accessible the COS meeting will be? (e.g. lifts available, prayer room, breastfeeding facilities, suitable seating, appropriate number and length of breaks, clinical room available, accessible toilets)
  • How well is the information on accessibility of the COS meeting communicated to patients in the participant information sheet?
  • How understandable the intended patient pre-meeting instructions are? (including for those with additional needs, as relevant)
  • How best to cater for any dietary needs throughout the meeting, especially any issues relevant to the condition?
The order in which outcomes at the meeting are presented
  • Is the order of the outcomes appropriate?
  • How can the order of the outcomes best be explained to participants?
How best to manage situations where stakeholder groups disagree?
  • How can all stakeholders be prepared for such situations?
  • What can be done during the meeting if disagreements arise?
  • What information patient participants will need after the meeting.

Access a PDF of the questions on this page here.

Relevant PPI resources

Resources for PRPs

Resources for COS developers involving patients / the public in their work