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    Do you have any further comments on the suitability of the proposed data collection study?

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Evidence generation plan

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5 Implementation considerations

The following considerations around implementing the evidence generation process have been identified through working with system partners:

  • Some people with more advanced COPD may have difficulty with mobility or completing some of the exercise capacity measures. In NRAP, these are reported as 0 or failure.

  • People with greater interaction with healthcare services, for example those currently receiving face-to-face pulmonary rehabilitation may report higher rates of exacerbation due to greater awareness and opportunity for diagnosis but may have relatively shortened hospital stays with better outcomes. Selection criteria and follow up should carefully address the potential for surveillance bias.

  • The company or technology developer should provide training for staff to support use of the technology.

  • Evidence generation should be overseen by a steering group including researchers, commissioners, practitioners, and people with lived experience.

  • The evidence generation process is most likely to succeed with dedicated research staff to reduce the burden on NHS staff, and by using suitable real-world data to collect information when possible.

  • Careful planning of the approach to information governance is vital. The company or technology developer should ensure that appropriate structures and policies are in place to ensure that the data is handled in a confidential and secure manner and to appropriate ethical and quality standards.

  • Using the EQ-5D requires a licence, with an associated cost.

ISBN: [to be added at publication]