NICE encourages clinicians to enter patients into controlled clinical trials. These could include crossover and cohort studies, which would allow inclusion of patients for whom other surgical options are unsuitable. These should provide a clear description of patient selection, and details of adjunctive medical and surgical treatments. Outcomes should include GORD symptoms, quality of life and objective measurements of gastric reflux. Efficacy, device durability, the need for surgical treatment for GORD in the longer term (at least 2Â years) and all complications should be reported. NICE may update the guidance on publication of further evidence.