Board comments on the full application were available for 90% (100 of 110) of the cohort. Of these, only 14% (14 of 100) made a comment about PPI (Table 13).
Of these 14 comments, nine (64%) were negative, stating that PPI should be increased, but gave no indication of how this should be achieved or why existing plans were insufficient; four were neutral, with two of these providing some direction for PPI if appropriate; and one was positive.
There were no clear reasons why these 14 applications received comments on their PPI plans in comparison with the other applications within the cohort.
TABLE 13 Board comments on the full applications
Unique
identifier Text Code PPI details
11 There should be user involvement in
the trial
Negative None specified within the outline application or the full application form. The detailed project description gave difficulties experienced in obtaining PPI
23 More service user involvement
is required
Negative None specified within the outline application or the full application form. The detailed project description indicated PPI in oversight, managerial and responsive roles
29 Consideration should be made as to
whether it would be appropriate to include patient views in this study
Neutral A responsive approach to PPI described in the development of the outline and full applications with further details of this in the detailed project description. PPI was provided by a local user group which would continue to provide responsive PPI once the trial was funded
33 There were some concerns around [. . .]
and the lack of service user involvement Increase the service user involvement in this trial. The HTA would be expecting to see adequate public/ patient contribution
Negative No PPI specified within the development of the outline or full applications. Plans given for PPI during the trial were based on recruiting‘a service user’for responsive approach to PPI
34 The Board were encouraged by the
level of service user involvement in this trial
Positive Outline application described a responsive approach used across the development stages and the full trial. The full application form gave no details of PPI in its development but gave details of use of responsive and oversight PPI in the trial once funded. The detailed project description described use of a long-standing institutional PPI group providing input, which would continue with a member of the group attending TMG meetings
36 An enhanced TSC is required that
will include at least two service user representatives
Neutral The outline application described responsive PPI in its development, with further responsive PPI planned for the full application and once the trial was funded. The detailed project description specified a user group providing responsive PPI in the development of the full application, which would continue in the trial once funded, with a PPI contributor on the oversight committee
TABLE 13 Board comments on the full applications (continued)
Unique
identifier Text Code PPI details
37 More consumer involvement is
required
Negative Outline application and full application form described responsive PPI in their development, with responsive PPI planned for the trial once funded. The detailed project description suggested managerial input in the development stage and managerial and oversight PPI once the trial was funded
40 Further service user involvement is
required, a clear plan as to how service users and carers will be involved in conduct of the trial is needed
Negative No PPI specified in the full application form. The detailed project description mentioned PPI review of the application by a lay member of a CSG, with plans for a‘focus group’once the study was funded to provide responsive PPI, together with a member on the oversight committee
42 Service user involvement is weak
and needs further strengthening. The role and purpose of service user involvement needs to be made more explicit
Negative PPI discussed in detailed project description only. Responsive PPI in review of application, with oversight planned for main trial
52 User involvement in the study should
be boosted
Negative Outline and full applications used responsive PPI in their development, with responsive PPI planned for the trial once funded. Detailed project description suggested use of qualitative research to gain PPI input via interviews in development of the
application alongside responsive PPI. Responsive PPI planned for trial with oversight PPI
58 Service user involvement is essential,
and the applicants should recruit a suitable organisation
Negative Oversight and responsive PPI within the detailed project description from‘at least one user’
72 Service user involvement should be
detailed and active from an early stage of the study. Such individuals or organisations should be actively involved in the conduct of the trial
Negative Managerial approach to PPI once trial funded specified within the detailed project description. Individual from a charity to join the TMG
78 Patient representative involvement
should be clarified and strengthened if appropriate
Neutral Detailed project description detailed use of a network group which provided responsive PPI in the development and would continue during the trial in addition to oversight membership
94 It might be helpful to have a service
user (someone who is/was a [. . .]) on the team
Neutral Outline, full and detailed project descriptions specify oversight PPI once trial funded