Stage | Number of outline applications N (%) n=90 | Role | Number of outline applications | Comments | ||||
---|---|---|---|---|---|---|---|---|
Outline (O) | Full (F) | Trial (T) | O | F | T | |||
Y | Y | Y | 19 (21.3) | M | M | M | 13 | 2 had multiple approaches alongside M in the main trial (TSC; TSC plus R) |
R | M | M | 1 | |||||
R | R | R | 2 | |||||
R | U | U | 1 | |||||
U | R | R | 1 | |||||
U | U | U | 1 | |||||
Y | Y | NS | 2 (2.2) | R | R | – | 1 | |
O | R | – | 1 | O=described as informal contacts | ||||
Y | NS | Y | 2 (2.2) | R | – | O | 1 | O=scale development |
R | – | TSC | 1 | Consulted in pilot study | ||||
Y | NS | NS | 3 (3.4) | O | – | – | 3 | O=clinical studies group; survey; Service user Forum |
NS | Y | Y | 8 (9.0) | – | M | M | 3 | In 1 also TSC & R in trial |
– | R | R | 2 | In 1 TSC too | ||||
– | R | M | 1 | |||||
– | U | U | 2 | |||||
NS | Y | NS | 1 (1.1) | – | R | – | 1 | |
NS | NS | Y | 12 (13.5) | – | – | M | 3 | |
– | – | R | 1 | |||||
– | – | TSC | 7 | 2 above also listed TSC alongside higher order approach | ||||
– | – | O | 1 | Piloted and then refined with users | ||||
NS | NS | NS | 40 (44.9) | – | – | – | 40 | |
NS | U | U | 2 (2.2) | – | U | U | 1 | |
– | M | M | 1 | Unclear when PPI initiated but when it starts it is at M |
M, managerial; NS, none specified; O, other; PPI, patient and public involvement; R, responsive; TSC, member of Trial Steering Committee; U, unclear; Y, yes.