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Evidence generation plan

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1 Purpose of this document

NICE's assessment of digital technologies to deliver pulmonary rehabilitation programmes for people with chronic obstructive pulmonary disease (COPD) recommends that more evidence is generated while the technologies (myCOPD and SPACE for COPD) are being used in the NHS. The other technologies can only be used in research and are not covered in this plan.

This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technologies again in the future. It is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. Randomised controlled trials are the preferred source of evidence for assessing comparative effects when these address the research gap and can be well conducted.

The company or technology developer are responsible for ensuring that data collection and analysis takes place. Support for evidence generation will be available through a competitive process facilitated by the Office for Life Sciences, pending business case approval. This will be in the form of funding for evidence generation consortia, bringing analytical partners and implementation sites together with developers for evidence generation.

Guidance on commissioning and procurement of the technologies will be provided by NHS England, who is developing a digital health technology policy framework to further outline commissioning pathways.

NICE will withdraw the guidance if the company or technology developer do not meet the conditions in section 4 on monitoring.

After the end of the evidence generation period (3 years), the company or technology developer should submit the evidence to NICE in a form that can be used for decision making. NICE will review all the evidence and assess whether or not the technologies can be routinely adopted in the NHS.