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Supported by King's College NHS Foundation Trust

Patient and Public Involvement (PPI)

“Clinical trials are better if they are done with patients rather than to them” –

When patients are involved in clinical trials to provide a patient perspective to research design and how it is carried out, this is called Patient and Public Involvement (PPI). 


PPI has been central to the development of the BOPPP Trial as far back as the conception stage when a PPI focus group met to gather thoughts about the grant application and a preliminary trial concept before it was submitted. The focus group provided opinions on the trial design including the use of placebo, the trial endpoints, the follow up schedule / patient contact points and the concept of patients not knowing the treatment allocation (blinding). The feedback underpinned the full application that was successful awarded to cemented the BOPPP Trial. PPI has been essential and we are very pleased to have been able to gain these insights. One member of the focus group was a patient co-applicant on the grant.

Since the grant was award, we have enrolled the support of three past KCH patients with a history of liver disease whom have accepted roles as part of the Trial Steering Committee (TSC). They will therefore provide ongoing independent advice to ensure that the patient is centre to each decision that is being made regarding the trial.

Additional to their TSC duties, the PPI team routinely provide ad-hoc advice when a patient perspective is required. Examples include advice on the content and structure of the qualitative interview schedules, how best to organise approaching patients at hospitals that are running BOPPP and CALiBRE (complimentary trial focused on varices that are larger in size), opinions on the design and content for public facing website and how to address concerns regarding the potential impact that a patient may face whilst considering participation with regards to travel insurance and planned vacations.

We pass all patient facing materials through this PPI group. To date, the following documents received their advice.

  • Grant application
  • Trial Protocol
  • Trial Participant Information Sheet
  • Trial Informed Consent Form
  • Participant Qualitative Interview Information Sheet
  • Participant Qualitative Interview Informed Consent Form
  • Trial poster
  • Participant Qualitative Interview schedule
  • Website

Future plans will include how to develop and provide updates regarding the trial and lay information regarding trial results.

If you would like to get more involved in research and help the NHS – see the People in Research NIHR webpage.