Table 2.
Top themes defined as those identified by more than half the committees in the ShED19, ShED20 and WHEAT exercises
| Theme | Number of RECs | % of RECs |
|---|---|---|
| ShED 19 | ||
| Query or statement regarding overall objectives & outcomes | 14 | 93% |
| Comment over worsening of UTI and/or detecting side effects | 10 | 67% |
| PIS: Explanation of placebo and/or randomisation | 10 | 67% |
| Clarity over insurance & indemnity information | 9 | 60% |
| Methodological comment over controls, placebo &/or randomisation | 8 | 53% |
| Methodological comment over design of arms in trial | 8 | 53% |
| Query regarding collection of human tissue | 8 | 53% |
| PIS: Further advice if symptoms persist | 8 | 53% |
| ShED 20 | ||
| Comments on use of Safer Sleep Box | 19 | 95% |
| Limits of confidentiality being clear to participants | 16 | 80% |
| Inclusion criteria of trial | 15 | 75% |
| Inclusion of vouchers as incentive | 13 | 65% |
| Data protection concerns | 13 | 65% |
| PIS: Typos, grammar, formatting and re-titling | 12 | 60% |
| Recruitment method | 12 | 60% |
| Positioning of box during use | 11 | 55% |
| Comments on size of participant group | 11 | 55% |
| Independent Review | 11 | 55% |
| Comments on questionnaires | 10 | 50% |
| Training and information on safer sleep box for participants | 10 | 50% |
| Methodology and basic nature of study | 10 | 50% |
| Scientific justification of the study | 10 | 50% |
| WHEAT | ||
| Opt Out Consent: any mention | 12 | 100% |
| PIS: comments on potentially coercive wording | 9 | 92% |
| Opt Out Consent: Comments on the ethics of the basic principle | 8 | 67% |
| PIS: Suitable description of risks and benefits | 7 | 58% |
| Opt-Out Consent: how this is to be recorded | 7 | 58% |
| Opt-Out Consent: Hard copy for patients/clinicians | 7 | 58% |
| Patient Public Involvement | 6 | 50% |
A complete list of themes is contained in the Additional file 1