Table 3 Recommendations for change to improve wider research practice around P/FS
From: Recommendations for optimising pilot and feasibility work in surgery
| Â | Recommendation | Further detail | Issues to consider |
|---|---|---|---|
Education | Improved guidance on designing and conducting PAFS | Multi-disciplinary team-led, consensus-based guidance endorsed by funders, regulatory bodies and journals | How to operationalise theoretical/conceptual guidance specifically for application by clinicians in practice |
Grassroots training for surgeons from earlier in their career | Training in trials methodology through courses, conferences, publication and guidelines | How to ensure effective collaboration between clinicians and methodologists | |
Collaboration | Collaboration of surgeons with methodologists and CTUs | Working closely with methodologists and CTUs from earlier in the research process to ensure the future main trial is in sight | Practicalities of funding collaborations How to optimise PPI when designing and conducting PAFS for surgical trials |
Accessibility of CTUs and methodology support | Highlight where to go/who to ask for assistance in each geographical area in the new guidance | Consider what level of method support is enough for PAFS | |
Funding | Improved efficiency of funding structure | More joined-up funding so no lag time between successful PAFS and main trial | Consider more programmes offering staged funding like NIHR PGfAR to improve efficiency and reduce waste How to associate decision-making between local RfPB committees and national funders of definitive trials |
Raising the profile of the importance of funding surgical studies | To achieve proportional funding More surgeons on funding panels Regulatory requirements for industry to contribute to surgical research | How to promote surgical involvement on funding panels | |
Dissemination | Funder requirement to publish PAFS | Publication in journals and/or through publicly available funder reports | How to fund process of publication |
Journal editors stop publishing underpowered RCTs as PAFS or PAFS as underpowered RCTs | Both wrong. Educate through guidance | Consider involving editors of surgical journals in the process for producing guidance | |
Academic institutions to value PAFS as potentially essential for main trial development | PAFS may not be 3 or 4* REF rated alone, but should be recognised for the often pivotal role they play in the success of the definitive trial. If academic institutions do not value PAFS, researchers will not value disseminating their findings | How to engage academic institutions in considering the value of PAFS |