Endpoints for therapeutic interventions in faecal incontinence: small step or game changer.

Faecal incontinence (FI) is common and its pathophysiology and treatments continue to evolve. However, a standard measure(s) for assessing its clinical outcome has been elusive. Consequently, over 100 measures and scoring systems, each with intrinsic biases have been reported. These include adequate relief or global satisfaction, ≥50% reduction in episodes or days without FI, quality of life (QOL), FI severity scales and composite indices. Earlier scales relied on the frequency and type of solid, liquid or flatus incontinence and effects on life style whereas newer scales have incorporated urgency, use of pads, antidiarrhoeals and amount of leakage, using prospective daily stool diaries or retrospective weekly or single point assessments. Such a plethora of measures have negatively impacted the assessment and outcome of clinical trials, and have made comparisons difficult. So, how does one sort out the grain from the chaff? In a provocative, post-hoc analysis published in this issue, the minimal clinically important difference, i.e. the smallest change detected by an instrument that is associated with a clinically meaningful change was used to assess FI endpoint. Based on this a ≥50% reduction in FI episodes is recommended as a clinically meaningful outcome measure when assessed by prospective stool diary, and it correlates with symptoms and severity. However, this requires further validation in multi-centre, longer duration and therapeutically effective clinical trial(s). Simultaneous assessment of coping strategies, QOL and psychosocial domains can provide further insights regarding the overall impact of treatments. This mini-review discusses the advances and controversies in defining meaningful FI endpoints.