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    Are there any additional implementation factors that need to be considered?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Evidence generation plan

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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 following essential evidence gaps being addressed.

2.1 Essential evidence for future committee decision making

Musculoskeletal disability and quality of life

A standardised score of musculoskeletal-specific symptoms and quality of life is needed to measure the clinical and cost effectiveness of digital technologies in managing low back pain. The Musculoskeletal Health Questionnaire (MSK‑HQ) was identified by the NICE committee as its preferred measure to collect this information.

Additionally, the committee asked for more information about health-related quality of life, ideally collected through the EQ‑5D‑5L questionnaire. This measures how changes in a person's health state relate to their perceived quality of life. Quality of life is an important driver of health economic evaluation and EQ-5D-5L can be more easily incorporated into health economic evaluations than quality of life captured through MSK-HQ.

The committee also wanted to know whether the interventions help people return to their normal activities of daily living.

Adherence

More evidence is needed on how people engage with the technologies and whether approaches to support people using them are effective. Measures of engagement should include information about enrolment, starting treatment, and continued engagement at 30 days, and 6 and 12 months. Ideally, reasons for stopping treatment should also be collected.

Qualitative evidence from patients using the technologies can complement this information and should focus on perceived treatment effectiveness, acceptability, and the rationale for continuing or stopping treatment.

Healthcare resource use

Healthcare resource use is a key factor in calculating cost effectiveness. It should consider overall costs, and the burden placed on people with low back pain and the broader healthcare system.

The committee identified 3 key outcomes that will help to address this evidence gap:

  • GP appointments: GPs are usually the first point of contact for people with low back pain and will also manage care over time.

  • Physiotherapist appointments: physiotherapy plays a critical role in managing the condition and its rehabilitation.

  • Emergency department visits: low back pain may lead to acute exacerbations that need emergency medical care.

Besides these outcomes, additional data collection may focus on healthcare resources in areas in which the technologies are expected to have the most benefit (see section 3.4).

Outcomes in people with different types of low back pain

The committee wanted to understand how the impact of the technologies differs between people with acute or chronic types of low back pain, that is, for musculoskeletal symptoms, quality of life, resource use, adherence and engagement.

Placement of technology in the clinical pathway

Further information about how people are referred to the technology and at what point in their clinical pathway is needed to understand how the technologies are likely to be used in practice.