National Institute for Health and Clinical Excellence (NICE)
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NICE pilot diagnostics project points way forward for evaluation of diagnostic technologies

NICE has published a report on its pilot diagnostics project. The project, on the assessment of non-invasive diagnostic tests for the detection of liver fibrosis in patients with suspected alcohol related liver disease, was completed in December 2010. The report highlights the important lessons learnt from the pilot and how these have been used to inform the development of the process and methods that NICE will use to assess the use of diagnostic technologies.

The pilot project was designed so that the new NICE diagnostic assessment programme could learn from it in real time, allowing work on “live topics” to start without having to wait for the pilot to finish. An interim methods statement was published in March 2010 to describe the methods that would be followed in the pilot.

Professor Adrian Newland, Chair of the independent Diagnostics Assessment Committee, said: “Our starting point for how diagnostic tests and technologies might be evaluated was the methodology used by NICE to assess new drugs and treatments. The pilot gave us the opportunity to explore how the evaluation of diagnostic technologies is different from this. The main differences are the need to map the care pathway, understand the impact of the test on patient outcomes further along the care pathway and the fact that the evidence base for diagnostics is often less comprehensive than that for drugs and other treatments. This learning will inform future decisions by the Diagnostics Assessment Committee.”

Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “As a result of learning from the pilot, we will be paying particular attention to the topic scoping phase, to ensure that diagnostics evaluations carried out by NICE are useful and feasible. The pilot has also demonstrated the crucial role of Specialist Committee Members in understanding how the use of a diagnostic affects subsequent care. These important learning points will help NICE undertake diagnostics assessments that are robust, relevant and useful to the NHS.”

A formal independent evaluation of the pilot was carried out by the Healthcare Innovation and Technology Evaluation Centre (HITEC, Derby Hospitals NHS Trust). This is available on the NICE website at:

A manual outlining the NICE diagnostics assessment programme's methods and processes is expected to be published for public consultation in late spring.

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Notes to Editors

About the NICE diagnostics assessment programme

1. The report on the pilot project on the assessment of non-invasive diagnostic assessment tools for the detection of liver fibrosis in patients with suspected alcohol related liver disease is available on the NICE website at

2. Further information about the NICE diagnostics assessment programme can be found at:

3. Topics to be considered will be routed through the related Medical Technologies Assessment Programme. Further information about this can be found at:

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

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