Conduct and analysis

If not already addressed at an earlier stage, consumers can help researchers refine the protocol and review/develop trial documentation to ensure that the trial is delivered successfully. Consumers may advise on or undertake* research activities. In doing so, they can help make trials more attractive to potential participants and can help ensure they are conducted in ways that are sensitive to the needs of participants.

* Ethical issues may arise when consumers undertake research activities. Further information can be found on the ethics review and involvement webpage.

At the conduct and management stage, consumers may help to:

• Revise study and patient-facing materials when amendments are proposed.
• Aid in recruitment or retention by increasing trust between communities and researchers or by accessing potential participants via existing networks.
• Increase the cultural competence of the research among minority ethnic communities.
• Collect/analyse data to provide a different perspective on its interpretation.
• Ensuring the authenticity and value of the trial’s involvement activities by working with researchers to ensure they are constantly evaluated.

What involving consumers at this stage could look like

• Creating a study advisory group to suggest and undertake further user involvement as the study progresses.
• Recruiting a consumer representative to serve on a Data Safety Monitoring Board.
• Recruiting consumers to join a trial steering/management committee to provide a patient perspective on all key trial decisions.
• Supporting lay-researchers to undertake research: 

• • Carrying out interviews: Consumer representatives as peer interviewers could reduce researcher bias and allow patients to talk more freely, putting the participants at ease whilst gathering richer information.
  • Undertaking data analysis and interpretation: Consumer representatives could conduct data analysis alongside researchers providing a valuable perspective when findings are interpreted. For example, consumers with lived experience of a condition can make sense of qualitative, experiential information from a patient’s perspective which may be different from that of the research team.

You can access details on where to find consumers to involve from the Recruiting Consumers webpage.

You can access information on consumers training requirements for effective involvement from the Training Consumers webpage.

Further Reading:

• Jennings, H et al. Best practice framework for patient and public involvement (PPI) in collaborative data analysis of qualitative mental health research: methodology development and refinement. BMC Psychiatry. (2018);18:213.
• Bee, P et al. A research handbook for patient and public involvement researchers. Manchester: Manchester University Press; (2018).
• NIHR/INVOLVE: Guidance on co-producing a research project.