Safety Assessment
deaths
ADVERSE EVENTS, SENSITIVITY
Ninety-five adverse events (AE) and 59 serious adverse events (SAEs) were reported. Two AEs were related to the intervention (hearing voices from the CR computer; sending abusive texts to the therapist about compensation) but no SAE was trial related. SAEs were: 2 deaths, 55 mental state deteriorations requiring urgent assessment, and 2 medical hospital admissions (
Therapy dropout was considered as less than 6 sessions, and although many received 1 therapy session (92.6%), a substantial number failed the 6-session threshold (45% Independent, 37.6% Group, 21.6% One-to-One). When dropouts were removed there was little difference between arms in the proportion receiving a 20-session minimum dose defined in the White Paper (42.9% Independent, 48.2% Group, and 47.1% One-to-One, see Sensitivity analyses demonstrated little to no bias introduced by dropping arms or other potential sources of bias (see Resource use, EQ5D-3L and GAS scores for the health economic analyses are in Total Costs (NHS Perspective) and Complete Case Analysis: NHS PSS Costs, Outcome, and Cost-Effectiveness ResultsThe costs per QALY for Group or One-to-One vs TAU were £4306 and £3170, respectively. There was uncertainty around the results (ie, the probability of cost-effectiveness at £20 000 per QALY (National Institute for Health and Care Excellence (NICE)