BACKGROUND: Faecal incontinence affects 1-2 per cent of the adult population. While many patients can be managed successfully with conservative therapy, a small proportion require surgery. Improved imaging techniques and technological advances have led to the availability of a wide range of surgical treatments. Decision-makers increasingly require clinical and cost-effectiveness studies of surgical treatments for faecal incontinence. This review examines the practical aspects of undertaking such studies. METHODS: The practical issues related to different aetiologies, different types of treatment, defining outcomes, the hidden costs of the condition and its treatment, the rapid changes in technology and issues of patient choice were all considered. A Medline search was undertaken to identify relevant publications, and the reference lists of identified papers were scanned manually. RESULTS: There are few randomized controlled studies and those that have been performed have been limited in their scope. There has also been very limited health economic analysis undertaken. Strategies for conducting such studies, and the criteria they use, have been outlined. CONCLUSION: Randomized trials have a limited role in this setting because of variations in aetiology, difficulty in standardizing procedures, continuing evolution of devices, small patient numbers, concerns for patient choice and the need for long-term follow-up. Issues to be addressed when evaluating interventions for faecal incontinence include choosing appropriate measures of surgical outcome, using new continence scoring systems and tools for quality-of-life assessment, and choosing appropriate cost perspectives and time horizons for economic evaluation.
BACKGROUND: Faecal incontinence affects 1-2 per cent of the adult population. While many patients can be managed successfully with conservative therapy, a small proportion require surgery. Improved imaging techniques and technological advances have led to the availability of a wide range of surgical treatments. Decision-makers increasingly require clinical and cost-effectiveness studies of surgical treatments for faecal incontinence. This review examines the practical aspects of undertaking such studies. METHODS: The practical issues related to different aetiologies, different types of treatment, defining outcomes, the hidden costs of the condition and its treatment, the rapid changes in technology and issues of patient choice were all considered. A Medline search was undertaken to identify relevant publications, and the reference lists of identified papers were scanned manually. RESULTS: There are few randomized controlled studies and those that have been performed have been limited in their scope. There has also been very limited health economic analysis undertaken. Strategies for conducting such studies, and the criteria they use, have been outlined. CONCLUSION: Randomized trials have a limited role in this setting because of variations in aetiology, difficulty in standardizing procedures, continuing evolution of devices, small patient numbers, concerns for patient choice and the need for long-term follow-up. Issues to be addressed when evaluating interventions for faecal incontinence include choosing appropriate measures of surgical outcome, using new continence scoring systems and tools for quality-of-life assessment, and choosing appropriate cost perspectives and time horizons for economic evaluation.
Authors: Michael D Crowell; V Ann Schettler; Brian E Lacy; Tisha N Lunsford; Lucinda A Harris; John K DiBaise; Michael P Jones Journal: Dig Dis Sci Date: 2007-01-09 Impact factor: 3.487