Predictors and moderators of the response of adults with intellectual disabilities and depression to behavioural activation and guided self-help therapies.

BACKGROUND: No previous studies have reported predictors and moderators of outcome of psychological therapies for depression experienced by adults with intellectual disabilities (IDs). We investigated baseline variables as outcome predictors and moderators based on a randomised controlled trial where behavioural activation was compared with guided self-help. METHODS: This study was an exploratory secondary data analysis of data collected during a randomised clinical trial. Participants (n = 161) were randomised to behavioural activation or guided self-help and followed up for 12 months. Pre-treatment variables were included if they have previously been shown to be associated with an increased risk of having depression in adults with IDs or have been reported as a potential predictor or moderator of outcome of treatment for depression with psychological therapies. The primary outcome measure, the Glasgow Depression Scale for Adults with Learning Disabilities (GDS-LD), was used as the dependant variable in mixed effects regression analyses testing for predictors and moderators of outcome, with baseline GDS-LD, treatment group, study centre and antidepressant use as fixed effects, and therapist as a random effect. RESULTS: Higher baseline anxiety (mean difference in outcome associated with a 1 point increase in anxiety 0.164, 95% confidence interval [CI] 0.031, 0.297; P = 0.016), lower performance intelligence quotient (IQ) (mean difference in outcome associated with a 1 point increase in IQ 0.145, 95% CI 0.009, 0.280; P = 0.037) and hearing impairment (mean difference 3.449, 95% CI 0.466, 6.432; P = 0.024) were predictors of poorer outcomes, whilst greater severity of depressive symptoms at baseline (mean difference in outcome associated with 1 point increase in depression -0.160, 95% CI -0.806, -0.414; P < 0.001), higher expectation of change (mean difference in outcome associated with a 1 point increase in expectation of change -1.013, 95% CI -1.711, -0.314; p 0.005) and greater percentage of therapy sessions attended (mean difference in outcome with 1 point increase in percentage of sessions attended -0.058, 95% CI -0.099, -0.016; P = 0.007) were predictors of more positive outcomes for treatment after adjusting for randomised group allocation. The final model included severity of depressive and anxiety symptoms, lower WASI performance IQ subscale, hearing impairment, higher expectation of change and percentage of therapy sessions attended and explained 35.3% of the variance in the total GDS-LD score at 12 months (R2  = 0.353, F4, 128  = 17.24, P < 0.001). There is no evidence that baseline variables had a moderating effect on outcome for treatment with behavioural activation or guided self-help. CONCLUSIONS: Our results suggest that baseline variables may be useful predictors of outcomes of psychological therapies for adults with IDs. Further research is required to examine the value of these potential predictors. However, our findings suggest that therapists consider how baseline variables may enable them to tailor their therapeutic approach when using psychological therapies to treat depression experienced by adults with IDs.

Incorporating ex-vivo lung perfusion into the UK adult lung transplant service: an economic evaluation and decision analytic model.

BACKGROUND: An estimated 20-30% of end-stage lung disease patients awaiting lung transplant die whilst on the waiting list due to a shortage of suitable donor lungs. Ex-Vivo Lung Perfusion is a technique that reconditions donor lungs initially not deemed usable in order to make them suitable for transplantation, thereby increasing the donor pool. In this study, an economic evaluation was conducted as part of DEVELOP-UK, a multi-centre study assessing the clinical and cost-effectiveness of the Ex-Vivo Lung Perfusion technique in the United Kingdom. METHODS: We estimated the cost-effectiveness of a UK adult lung transplant service combining both standard and Ex-Vivo Lung Perfusion transplants compared to a service including only standard lung transplants. A Markov model was developed and populated with a combination of DEVELOP-UK, published and clinical routine data, and extrapolated to a lifetime horizon. Probabilistic sensitivity and scenario analyses were used to explore uncertainty in the final outcomes. RESULTS: Base-case model results estimated life years gained of 0.040, quality-adjusted life-years (QALYs) gained of 0.045 and an incremental cost per QALY of £90,000 for Ex-Vivo Lung Perfusion. Scenario analyses carried out suggest that an improved rate of converting unusable donor lungs using Ex-Vivo Lung Perfusion, similar resource use post-transplant for both standard and EVLP lung transplant and applying increased waiting list costs would reduce ICERs to approximately £30,000 or below. CONCLUSION: DEVELOP-UK base-case results suggest that incorporating Ex-Vivo Lung Perfusion into the UK adult lung transplant service is more effective, increasing the number of donor lungs available for transplant, but would not currently be considered cost-effective in the UK using the present NICE threshold. However, results were sensitive to change in some model parameters and in several plausible scenario analyses results indicate that a service incorporating Ex-vivo lung perfusion would be considered cost-effective . TRIAL REGISTRATION: ISRCTN registry number: ISRCTN44922411 . Date of registration: 06/02/2012. Retrospectively registered.