Table 2 Characteristics of case study trials
Setting (population) | Design | Intervention | Summary of PPI | Stages of trial involving PPI |
|---|---|---|---|---|
Community health (adults) | Individually randomised, two-arm pilot RCT | Counselling and psychotherapy | Primary role of PPI was to ensure study met the needs of target population. x2 PPI members contributed a few times during set up. x1 PPI member on TSC | Grant application Planning Ongoing oversight (TSC) |
Primary care (adults) | Cluster-randomised two-arm RCT | Organisational, behavioural | Role of PPI to put pressure on the trial team, emphasising participants’ contribution/involvement and ensuring patient-centredness. (PPI perspective) Role of PPI to ensure research will benefit patients and that what we are doing in trial meets their needs/is important to them. (TM perspective) No PPI members on TMG. x2 PPI members in TSC and large PPI group of 10 members who meet every 3–4 months (including those on TSC). 2 additional members dropped out during the trial. | Planning Ongoing oversight (TSC) Implementation |
Educational setting (adolescents) | Two-arm cluster RCT (feasibility and definitive) | Public health, behavioural | Same PPI group used throughout. x5 PPI members met once a year | Planning Implementation |
Primary care (children) | Individually randomised, three-arm RCT | Pharmacological | Purpose of PPI is to ensure trial processes are acceptable to target patient group. x10 PPI members, ad hoc meetings every 2–4 months (same members throughout) x1 PPI member of TSC | Development/planning phase Ongoing trial oversight |
Secondary care (adults) | Two-arm RCT | Surgical | Surgeons recruited PPI members (small number). 2–4 patients were asked their views during application stage. Different PPI people then became members of the TSC. But also looked at trial documentation outside of the TSC. x2 PPI members met every 5–7 months. 1x PPI member of TSC. | Planning/grant application Ongoing oversight |
Community health (adults) | Two-arm RCT | Behavioural | Purpose of PPI to ensure taking account of the patient voice. x20 PPI members. Met every 5–7 months. PPI members included in TMG and TSC | Planning Ongoing oversight |
Secondary care (adults) | Two-arm multi-centre RCT | Surgical | Consulted larger ‘general’ patient group on study design during application stage. Then a PPI group which more relevant condition experience was established specifically for study. The same group continued to support the study throughout its duration. | Planning/grant application Planned to use for dissemination once at that stage. |
Primary care (adults) | Pilot Two-arm RCT | Behavioural | Met with different patient groups and forum to inform grant application, study approach and documentation. Specific numbers not indicated, however one group x 10 people. | Planning/grant application |