5 Scope

NICE process and methods

The scope is the first document to be produced after the topic oversight group has selected a technology for consideration. It provides the framework for assessing the technology, taking into account how it works, its comparator(s), the relevant patient population(s), and its effect on clinical and system outcomes. The scope is based on the sponsor's case for adoption. It defines issues relevant to the evaluation, addresses the clinical and resource impact questions that need to be answered, and sets the boundaries for assessing the evidence and the committee's decision-making. The scope includes:

a description of the technology and its claimed benefits
information about the disease, condition or clinical problem relevant to the technology
the regulatory status of the technology
the topic oversight group's rationale for selection, which can include any relevant equality considerations
the decision problem to be addressed by the evaluation of the technology
a list of the professional and patient organisations who will be providing comments on the technology
a list of the societies and organisations that will be invited to comment on the scope.

The scope may also include technical questions raised by the committee or the programme team at selection stage, which may relate to the technology's ease of use or likelihood to provide its claimed patient or healthcare system benefits. The technical questions do not extend to a full technical evaluation of the device.