2.1
Include relevant comparators in the model that are established practice in the NHS for managing weight, including those already recommended in NICE's guideline on overweight and obesity management. (required)
Include relevant comparators in the model that are established practice in the NHS for managing weight, including those already recommended in NICE's guideline on overweight and obesity management. (required)
Behavioural interventions alone, with a focus on healthy diet and physical activity, are a relevant comparator. (required)
As a minimum, compare new medicines with medicine(s) established in NHS clinical practice for weight management (except where contraindicated). (required)
As a minimum, compare new bariatric procedures with bariatric procedures established in NHS clinical practice (except where contraindicated). (required)
As a minimum, compare new digital technologies with existing digital technologies established in NHS clinical practice for same use case(s). (required)
Bariatric procedures (with procedure type clearly defined and justified) should be comparators against other interventions targeted at the following subgroups:
adults with a body mass index (BMI) of 30 kg/m² or more who have recent onset type 2 diabetes mellitus (T2DM), or
adults with a BMI between 35 kg/m2 and 39.9 kg/m2 with a significant health condition that could be improved if they lost weight, or
adults with a BMI of 40 kg/m² or more. (recommended)
A lower BMI threshold (reduced by 2.5 kg/m2) should be applied for people of South Asian, Chinese, other Asian, Middle Eastern, Black African or African–Caribbean background. (recommended)
If an intervention or comparator is indicated alongside a behavioural intervention, such as 'a healthy diet and physical activity', the duration of this behavioural intervention needs to reflect current NHS practice. Conduct sensitivity analyses to reflect different durations and intensities. (required)
When comparing an intervention to behavioural interventions alone, explore different intensities of the behavioural intervention using sensitivity analyses. Include the lowest likely intensity of behavioural intervention of GP advice about diet and exercise once a year as part of the analyses to reflect the limited availability of services specifically for overweight and obesity. (required)
For the base case analysis, background treatments need to reflect established NHS practice relevant to the stratum, as detailed in the following NICE guidelines:
Conduct sensitivity analysis using the corresponding trial data when the background treatments in the trial does not reflect established NHS practice. (required)
For the rationale for these statements, see the rationale and supporting information section on intervention and comparators.