The project spanned 4 years during which we focussed on (i) development of the medical device, (ii) conduct of the randomised controlled clinical trial, (iii) stakeholder engagement and dissemination, and (iv) commercialisation. Project Management was a constant to ensure the project was completed to scope, on time and within budget.
PReDicT was developed and registered as a CE marked Class 1 medical device, and deployed successfully in the clinical trial.
Ethics and regulatory approvals were secured to enable the clinical trial to be ran in 5 European countries: UK, France, Germany, Spain and The Netherlands. ~1000 patients were recruited over 2 years; half from the UK and the remainder across the mainland European countries.
Patients received a baseline assessment prior to starting their antidepressant medication, and completed PReDicT again 1 week later. Within the PReDicT arm, the results were reviewed by the GP who determined subsequent treatment. If a change in medication was recommended (either an increase in dose or a switch to a new antidepressant), the patient completed the PReDicT Test again the following week and so on.
The study was divided into an 8 week clinical phase and a 40 week follow-up phase. After week-8, clinical efficacy and acceptability were measured and compared between the PReDicT group and the control Treatment-as-Usual (TaU) group. During the follow up phase, clinical efficacy and health economics data were taken from each arm.
Compliance rates at all phases were good; over 95% during the clinical phase, falling to 59% & 51%, respectively, at the two follow up time-points (week-24 and week-48).
The main results of the trial are summarised as follows:
1. The algorithm was 56% accurate, with 70% of patients predicted to respond vs. 30% who were not.
2. PReDicT influenced GP prescribing behaviours; a significant proportion changed medications if their patients had received a negative response prediction.
3. PReDicT resulted in an increased proportion of depressed patients showing a response to treatment at week-8 compared to TaU, however this was not statistically significant.
4. A greater reduction in anxiety symptoms at week-8 was observed in the PReDicT group;
5. A functional outcomes improvement at week-24 was shown, suggesting PReDicT may bring forwards functional recovery. A similar improvement was also observed in capability wellbeing outcomes.
6. Positive feedback for PReDicT was received by both clinicians and patients;
7. Cost data were mixed with a borderline medication cost decrease observed with PReDicT;
8. European cost-effectiveness QALY thresholds supported an economic benefit from a full societal perspective.
We engaged with several stakeholders including patients, physicians, potential payers, and policy makers to optimise healthcare adoption. We also used multiple communication media including website and newsletters, alongside dissemination activities including attendance at multiple conferences, trade fairs and pitch events to publicise the project, our novel device, and the results, from which the level of interest was high.
We conducted market research in the UK, Germany and US, and compiled a Commercialisation Plan outlining our intended go-to-market strategy, which includes generating real world evaluation data of which a UK pilot is ongoing.
