1 Recommendations | Digital technologies for applying algorithms to spirometry to support asthma and COPD diagnosis in primary care and community diagnostic centres: early-use assessment | Guidance

Can be used during the evidence generation period

1.1

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:

following clinical assessment and with clinical oversight from a healthcare professional to make the final diagnosis
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.

1.2

The company is responsible for ensuring that data collection and analysis takes place. They 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.

1.3

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.

More research is needed

1.4

More research is needed on the following technologies for applying algorithms to spirometry to support asthma and COPD diagnosis before they can be funded in the NHS:

EasyOne Connect
GoSpiro
LungHealth.

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. Companies are 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: Technology that applies algorithms to spirometry could help staff with different levels of experience to perform diagnostic spirometry and interpret results in primary care and community diagnostic centres, rather than wait for a secondary care appointment. 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. Technology that applies algorithms to spirometry 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 settings. 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 with limited mobility or neurodiverse people) may find it easier to access diagnostic spirometry if the technology allows testing to be done closer to their home.

Managing the risk of use in the NHS during the evidence generation period

Resources: Algorithm outputs from ArtiQ.Spiro may support healthcare professionals to make diagnoses, but do not replace clinical judgement or the need for a clinical assessment. 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 following clinical review.
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. Algorithm-supported diagnosis could influence prescribing decisions, which have potential risks and harms in both overtreating and undertreating asthma and COPD. Algorithm outputs from ArtiQ.Spiro may support healthcare professionals to make diagnoses, but do not replace clinical judgement or the need for a clinical assessment. 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.

More research is needed

There is not enough evidence to support funding EasyOne Connect, GoSpiro or LungHealth in the NHS for the purpose of applying algorithms to spirometry to support the diagnosis of asthma and COPD. The technologies in this guidance may have additional functions or use cases that are out of scope for this assessment. This recommendation does not apply to (and thus does not intend to restrict) use of these technologies (or any compatible hardware or software) for any other intended purposes or use cases that are outside of the scope of this NICE assessment. For example, this recommendation does not apply to hardware components used for obtaining spirometry readings, or where a technology can be used to ensure a structured clinical assessment has been done before spirometry.

Access to the technologies should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.

What evidence generation and research is needed

Evidence generation and more research is needed on:

diagnostic accuracy of initial diagnosis, including the number of false-positive and false-negative results, when using the technologies in primary care and community diagnostic centres
the impact of the technologies on the NHS care pathways for asthma and COPD when using them to support diagnosis 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.

Why the committee made these recommendations

Spirometry is a common test used to help diagnose lung conditions such as asthma and COPD. For COPD, it is the first-line test. But, for asthma it is used as a second-line test (with bronchodilator reversibility) after fractional exhaled nitric oxide and blood eosinophil count. 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 healthcare professionals to diagnose 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 evidence from primary care reviewed by primary care healthcare professionals. Most of the evidence suggests that using ArtiQ.Spiro could lead to better outcomes for people needing diagnostic spirometry and provide benefits to the NHS. But there is limited evidence on diagnostic accuracy when using ArtiQ.Spiro. It is also unclear how it may impact staff resources in primary care and community diagnostic centres. But it has the potential to address high unmet need in the NHS by allowing more people to access diagnostic spirometry. Early economic modelling also suggests that it has the potential to be cost effective. So, ArtiQ.Spiro can be used during the evidence generation period.

There is limited evidence for EasyOne Connect, GoSpiro and LungHealth. So, it is unclear whether using these technologies could lead to better outcomes than current practice. More research is needed on these technologies.