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ArtiQ.Spiro can be used in the NHS during the evidence generation period as an option for applying algorithms to spirometry to support asthma and chronic obstructive pulmonary disease (COPD) diagnosis in primary care and community diagnostic centres. It can only be used:
if the evidence outlined in the evidence generation plan is being generated
as long as it has appropriate regulatory approval including NHS England's Digital Technology Assessment Criteria (DTAC) approval.
The company must confirm that agreements are in place to generate the evidence. NICE will contact the company annually to confirm that evidence is being generated and analysed as planned. NICE may revise or withdraw the guidance if these conditions are not met.
At the end of the evidence generation period (3 years), the company should submit the evidence to NICE in a format that can be used for decision making. NICE will review the evidence and assess if the technology can be routinely adopted in the NHS.
What this means in practice: can be used with evidence generation
ArtiQ.Spiro can be used as an option in the NHS during the evidence generation period (3 years) and paid for using core NHS funding. During this time, more evidence will be collected to address any uncertainties. The company is responsible for organising funding for evidence generation activities.
After this, NICE will review this guidance and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs.
Potential benefits of use in the NHS during the evidence generation period
Access: This digital technology could help less experienced staff do diagnostic spirometry and interpret results in primary care and community diagnostic centres. This could increase access to spirometry because people would not have to wait for an appointment in secondary care.
System and resource benefit: There is regional variation in accessing diagnostic spirometry. This digital technology may increase the number of primary-care settings and community diagnostic centres that are able to offer diagnostic spirometry as part of their services. This could reduce the referral burden on secondary care. Earlier diagnosis of asthma and COPD in primary care and community diagnostic centres could also reduce the number of referrals to secondary care after a person's symptoms get worse.
Clinical benefit: Earlier diagnosis could lead to earlier access to appropriate treatment. This could have long-term benefits for people with asthma or COPD.
Equality: Some populations (for example, people experiencing severe symptoms or neurodiverse people) may find it easier to access diagnostic spirometry if the digital technology allows testing to be done closer to their home.
Managing the risk of use in the NHS during the evidence generation period
Resources: Implementing ArtiQ.Spiro could lead to staff with different levels of experience doing diagnostic spirometry and interpreting results. It is unknown whether this could affect variation in the quality of spirometry and accuracy of interpretation, and subsequent diagnosis.
Clinical risk: The diagnostic accuracy (including the number of false-positive and false-negative results) when the technology is used in primary care and community diagnostic centres is currently unclear. There are potential harms in both over- and undertreating asthma and COPD. ArtiQ.Spiro supports healthcare professionals to make diagnoses but does not replace clinical judgement. The impact of ArtiQ.Spiro on long-term patient outcomes is currently unknown.
Costs: Early results from the economic modelling suggest that ArtiQ.Spiro could be cost effective. There is considerable uncertainty in this early cost-effectiveness estimate.
Information governance: Potential risks include confidentiality breaches or issues accessing or retrieving data. All service providers should ensure they have appropriate IT infrastructure and information governance protocols in place.
What this means in practice: more research is needed
There is not enough evidence to support funding the digital technologies in recommendation 1.44 in the NHS.
Access to the technologies should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.
Evidence generation and more research is needed on:
diagnostic accuracy, including the number of false-positive and false-negative results, when using the digital technologies in primary care and community diagnostic centres
the impact of the technologies on NHS care pathways for asthma and COPD when they are used in primary care and community diagnostic centres
how using the technologies would affect long-term resource use during and after implementation
whether benefits from the technologies vary for certain subgroups.
The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. It includes how the evidence gaps could be resolved through real-world evidence studies.
Digital technologies that apply algorithms to spirometry use a step-by-step set of rules or calculations to check the quality of a spirometry test, interpret results and help guide decisions. This can support the diagnosis of lung conditions, such as asthma and COPD.
The evidence for ArtiQ.Spiro is stronger than that for the other technologies included in this assessment. This evidence includes a UK-based randomised controlled trial using real-world primary-care datasets reviewed by primary-care healthcare professionals. Most of the evidence suggests that using ArtiQ.Spiro could lead to improved outcomes for people needing diagnostic spirometry and the NHS. There is limited evidence on diagnostic accuracy when using ArtiQ.Spiro. It is also unclear how ArtiQ.Spiro may impact staff resource in primary care and community diagnostic centres. But, ArtiQ.Spiro has the potential to address high unmet need within the NHS by allowing more people to access diagnostic spirometry. Early economic modelling also suggests that ArtiQ.Spiro has the potential to be cost effective. So, ArtiQ.Spiro can be used with evidence generation.
There is limited evidence for EasyOne Connect, GoSpiro, LungHealth and MIR Spiro. So it is unclear whether using these technologies could lead to better outcomes than current practice. More research is needed on these technologies.
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