Table 1 The information provided by researchers who described the impact of involvement at the design stage, in ways that could usefully inform ethical review

In the ten examples of high quality descriptions of involvement, the researchers reported on some or all of the following:

 • how patients shaped the research question or why patients thought the research important (not only stating that patients thought it important)

 • how patients shaped the intervention and decided which outcome measures to use in clinical trials

 • how patients’ input was used to minimise the burden on participants

 • how patients influenced the ethical design of a trial – e.g. whether use of placebo would be acceptable

 • where patients identified that participants might potentially experience distress and what appropriate changes had been made in response

 • how practical arrangements were changed to better meet the needs of participants e.g. follow-up clinics in the evenings and at weekends

 • how recruitment processes were changed to be sensitive to the emotional and practical needs of potential participants

 • how patients were involved in deciding what questions to ask in interviews/ focus groups, rather than only being asked comment on the wording of questions written by researchers

 • what questions patients were asked in reviewing the protocol and patient information, the responses they gave and the changes made as a result

 • how patients would continue to be involved in the project at different stages, with a clear explanation of what input was expected and how it might shape future decisions

It is of note that no researcher discussed potential ethical concerns raised by involvement in data collection and analysis, which is a key aspect of the ethical review of involvement.