Abstract Background Rectovaginal fistula (RVF) causes debilitating symptoms. Treatment is challenging, with a plethora of techniques yielding variable success rates. Currently the lack of standardised outcomes and limited patient involvement hampers meta-analysis and relevance to patients. We aimed to develop an RVF Core Outcome Set (VaF-COS). Methods The generation of a patient centred COS followed principals from the Core Outcome Measures in Effectiveness Trials (COMET initiative) and reached consensus through a Delphi process. The COS was developed in three phases. (i) longlist generation (patient interviews and a systematic review). (ii) Stakeholders from the UK and overseas rated outcomes across two online Delphi rounds as ‘consensus in’, ‘no consensus’ or ‘consensus out’. (iii) a consensus meeting with stakeholders that voted to ratify the final VaF-COS. The Study Management Group (SMG) included patients, surgeons, a gastroenterologist, a radiologist, an IBD specialist nurse, an obstetrician and a midwife. Results Phase 1 identified 40 outcomes. In round 1, 128 stakeholders rated these outcomes: 8 ‘consensus in’, 15 ‘consensus out’ and 17 ‘no consensus’. Seven new outcomes were added. In round 2, 96 stakeholders rated the 24 new or ‘no consensus’ outcomes. Finally, 32 outcomes were presented at the consensus meeting. After exclusion and combination, 7 outcomes remained: ‘volume and nature of vaginal discharge’, ‘clinical fistula healing’, ‘global assessment of continence and impact on quality of life’, ‘complications’, ‘physiological and psychological impact on childbearing’, ‘global assessment of the impact on sex’ and ‘global assessment of quality of life’. Conclusion We present the first COS for RVF, for use in future RVF treatment studies. Patients remained central throughout its development. Conflict of interest: Ms. Sackitey, Charlene: No conflict of interest Iqbal, Nusrat: No conflict of interest Reza, Lillian: No conflict of interest Joshi, Shivani: No conflict of interest Al Rubaiy, Laith K Qassim: No conflict of interest Lung, Phillip FC: No conflict of interest Saleem, Asra: No conflict of interest Graham, Julie: No conflict of interest Adio, Jitka: No conflict of interest Vaizey, Carolynne: No conflict of interest Hart, Ailsa: No conflict of interest Tozer, Philip: No conflict of interest
Sackitey et al. (Thu,) studied this question.