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  • Question on Consultation

    Has all of the relevant evidence been taken into account?
  • Question on Consultation

    Are the summaries of clinical and resource savings reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?
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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 companies 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 technologies.

2.1 Essential evidence for future committee decision making

Clinical effectiveness

The impact of the technologies on intermediate and longer-term clinical outcomes in comparison with conventional management of osteoarthritis is uncertain. The effect on clinical effectiveness of changing from paper to digital manuals is also uncertain.

Evidence on intermediate clinical outcomes should include:

  • health-related quality of life (HRQoL) and patient-reported outcomes (including pain and stiffness, activity impairment, physical function, self-efficacy and psychological outcomes)

  • referrals for corticosteroid injections

  • medication use

  • adverse events.

More evidence is needed on the longer-term clinical effects (for example, referrals to specialist services and clinic visits). Information on the longevity of any clinical benefits will provide a clearer indication of the accumulated benefits over time and support cost-effectiveness modelling. Follow ups should include the duration of the self-management programme (which is technology specific) and be at least 12 months (ideally 18 months) later.

Resource and service impact

Early cost-effectiveness modelling was driven by the impact on HRQoL of digital technologies compared with standard care, the digital technology costs, the reduction in physiotherapy and GP resource use and the duration of the impact of digital technology on resource use. In addition to evidence on the health improvements offered by the technology, further evidence is needed on resource and service use when using the technologies compared with conventional management pathways. This should include overall costs, and the broader resource impact that osteoarthritis management has on the healthcare system over at least 12 months, and ideally 18 months after using the technology.

Key areas that will help to address this evidence gap are:

  • the number and cost of clinical visits and referrals to specialist services

  • the costs for implementing, integrating, maintaining and using the digital technologies.

User engagement and acceptability

More evidence on intervention uptake, adherence, satisfaction, acceptability, completion and attrition rates (including reasons for stopping treatment) help the committee assess the real-world uptake of the technologies and support future cost-effectiveness modelling.

2.2 Evidence that further supports committee decision making

Clinical effectiveness and resource use in different subgroups

The impact of the technologies on clinical effectiveness and resource and service use in different subgroups is unknown. These subgroups may include:

  • people who have osteoarthritis that affects different parts (hip or knee) or different musculoskeletal comorbidities

  • people who may not be able to attend daytime in-person physiotherapy sessions (for example, people with work or caring responsibilities or people living in rural communities with long travel times to clinics)

  • people who stop using the technology

  • people who access the technology through different referral pathways.