Evidence generation plan
Closed for comments This consultation ended on at Request commenting lead permission
2 Evidence gaps
This section describes the evidence gaps, why they need to be addressed and their relative importance for future committee decision making.
The committee will not be able to make a positive recommendation without the essential evidence gaps (see section 2.1) being addressed. The developers can strengthen the evidence base by also addressing as many other evidence gaps (see section 2.2) as possible. This will help the committee to make a recommendation by ensuring it has a better understanding of the patient or healthcare system benefits of the technology.
2.1 Essential evidence for future committee decision making
Effect on exercise capacity using a validated measure
Evidence considered by the committee indicates that improved exercise capacity is associated with improved quality of life for people with COPD. Robust data showing that the technologies improve exercise capacity up to 12 months, using a validated measure such as the 6-minute walk test or the incremental shuttle walk test, will help committee understand the clinical and cost effectiveness of the technologies.
Adverse events
Reporting of intervention-related adverse events is essential to assess any risk associated with the technologies' use in the NHS.
Comparison with current practice
More evidence is needed comparing the effectiveness of digital technologies to deliver pulmonary rehabilitation with current NHS care for COPD. The British Thoracic Society's guideline (PDF) recommends face-to-face pulmonary rehabilitation as the 'gold standard'. The committee also highlighted that comparisons with not having or waiting to have a face-to-face programme are important. This will help understand the potential effect of the technologies for people who cannot access, or do not want to have, face-to-face pulmonary rehabilitation.
Resource use
More information is needed on resource use to calculate the cost effectiveness of the technologies. This should include overall costs, and the broader resource impact that COPD has on the healthcare system. The committee identified key areas that will help to address this evidence gap:
technology costs
exacerbation costs, including any emergency department visits, hospital admissions and GP visits associated with exacerbations
implementation costs, for example, healthcare professional training.
Position in the care pathway
A key part of the committee discussion was around when and where in the care pathway the technologies are being or could be used. Collecting evidence to address this will help the committee understand how the technologies' use will affect the NHS. An important part of this would be data about when and where assessments are done to determine if people are eligible for the technologies.
Engagement and adherence
Evidence on intervention completion rates, patient preference, and uptake rates will help NICE's committee assess the real-world uptake of the technologies, and their acceptance by people who need rehabilitation for COPD.
2.2 Evidence that further supports committee decision making
Effectiveness in different subgroups
The committee noted that the current evidence comparing the effectiveness of the technologies in some subgroups is limited. It recommended for any evidence generated to consider the following groups:
people living in urban areas compared with people living in rural areas
people with a new COPD diagnosis compared with those with an existing diagnosis
people who are dependent on supplemental oxygen to manage COPD
people recently discharged from hospital following an exacerbation.
This data will help the committee understand the technologies' effectiveness in different groups.
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions
Question on Document
Question on Document