Digitally Enabled Therapies assessment criteria
Digitally Enabled Therapy (DET) products deliver a substantial portion of therapy online but are designed to be used with therapist assistance. The DET assessment criteria have been developed to provide assurance that DETs are suitable for use in NHS Talking Therapies for anxiety and depression services. The assessment criteria are now being piloted, with products being assessed against the criteria. The results of the pilot will be published in early 2023.
This process will support services to have more confidence in the technologies they consider, select, commission and use locally with their patients. It will also support developers to design and deliver DET products which are well suited for use in NHS Talking Therapies services.
This builds on previous work the national team completed with NICE, to assess and evaluate digitally enabled therapy products.
In order to ensure that therapists are well equipped to work with digital, their training programmes have been updated to cover this new way of working.
Which products can be assessed against the DET assessment criteria?
This pilot is for products that are:
- Ready to submit an application for national baseline digital health and care technology assessment criteria (DTAC)? For further information see DTAC guidance.
- Designed to treat one of the 13 clinical conditions covered by NHS Talking Therapies, for anxiety and depression.
- Designed to treat adults (18+).
- Designed to deliver a NICE recommended therapeutic intervention.
- Designed to be used as a low intensity (step 2) or high intensity (step 3) intervention.
- Designed to be used in NHS Talking Therapies services with therapist assistance. Definition of assistance: Product use is based on therapist review of a patient’s progress and the therapist regularly (weekly or bi-weekly) interacting with a patient about their progress.
- Adhere to the NHS Talking Therapies training/qualification requirements for clinicians supporting delivery. This should include which step (2 or 3) and, if step 3, which modality (e.g. CBT).
- Available to be commissioned by NHS organisations.
Products that are assessed against the criteria will also be reviewed from an evidence of effectiveness perspective.
Evidence should demonstrate; clinical effectiveness, equivalent outcomes and absence of harm.
Evidence should be submitted against each of the criteria below with a summary provided for each:
1. Results on clinical efficacy/ efficiency: results summarised from any trials including the study design. At least one pre-registered, published and peer-reviewed randomized controlled trial (RCT) is required for full compliance against this criteria. RCTs may take one or more of the following designs:
- DET vs Waitlist with continuing GP care (DET needs to be superior to Wait);
- DET versus well-conducted NICE recommended alternative non-digital treatment (DET needs to be non-inferior or superior to the other treatment)
- DET versus an alternative intervention that controls for non-specific therapy effects (such as therapist attention etc). Here the DET should be superior to the “placebo” control.
- Other – if another methodology was used, please specify
2. Results on equivalent outcomes: including what primary and secondary outcome measures were reviewed.
- Evidence to show the product is as clinically effective as alternative non-digital treatments that are currently offered in IAPT for the relevant clinical condition. The evidence could come from RCTs and/or from benchmarking studies based on comparable populations.
- To make this assessment, the way in which outcomes are calculated should be consistent to how outcomes (rates of recovery, reliable recovery, reliable improvement, and effect sizes) are calculated in NHS Digital’s national IAPT reports.
3. Results on absence of harm and clinical safety: This will be through inclusion of any reports of adverse events such as reliable deterioration and serious adverse events, including drop-out rates and suicide.
NICE’s Early Value Assessment
NICE are piloting the Early Value Assessment (EVA) which aims to conduct a rapid assessment of evidence for emerging technologies. The topics include:
- Digitally Enabled Therapies for adults with depression
- Digitally Enabled Therapies for adults with anxiety disorders
Many products will be in scope for both processes, and offer different assessments to help strengthen the robustness of assessment.