Effect of managed transition on mental health outcomes for young people at the child-adult mental health service boundary: a randomised clinical trial.

BACKGROUND: Poor transition planning contributes to discontinuity of care at the child-adult mental health service boundary (SB), adversely affecting mental health outcomes in young people (YP). The aim of the study was to determine whether managed transition (MT) improves mental health outcomes of YP reaching the child/adolescent mental health service (CAMHS) boundary compared with usual care (UC). METHODS: A two-arm cluster-randomised trial (ISRCTN83240263 and NCT03013595) with clusters allocated 1:2 between MT and UC. Recruitment took place in 40 CAMHS (eight European countries) between October 2015 and December 2016. Eligible participants were CAMHS service users who were receiving treatment or had a diagnosed mental disorder, had an IQ ⩾ 70 and were within 1 year of reaching the SB. MT was a multi-component intervention that included CAMHS training, systematic identification of YP approaching SB, a structured assessment (Transition Readiness and Appropriateness Measure) and sharing of information between CAMHS and adult mental health services. The primary outcome was HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) score 15-months post-entry to the trial. RESULTS: The mean difference in HoNOSCA scores between the MT and UC arms at 15 months was -1.11 points (95% confidence interval -2.07 to -0.14, p = 0.03). The cost of delivering the intervention was relatively modest (€17-€65 per service user). CONCLUSIONS: MT led to improved mental health of YP after the SB but the magnitude of the effect was small. The intervention can be implemented at low cost and form part of planned and purposeful transitional care.

Long-term survival after treatment for Hodgkin's disease (1973-2002): improved survival with successive 10-year cohorts.

BACKGROUND: The Nottinghamshire Lymphoma Registry contains the details of all the patients diagnosed with lymphoma (since 1 January 1973) within a defined geographical area with a population of 1.1 million. It was therefore possible to study the outcome of treatment for Hodgkin's disease for three 10-year cohorts (1973-1982, 1983-1992 and 1993-2002).The aims of the study were to compare survival time among the three patient cohorts, to identify prognostic factors and to estimate relative survival. METHODS: A total of 745 patients diagnosed between 1973 and 2002 were analysed for survival. Survivorship was estimated by the Kaplan-Meier method and parametric survival models. An accelerated failure-time regression was used for multivariate analysis. RESULTS: Overall, patients were observed for 9.8 (0.3-34.82) years (median(range)), on average. One, five and fifteen-year disease-specific survival was found to be 87% (85-90%), 77% (74-80%) and 70% (67-74%), respectively. For those for diagnosed between 1973 and 1982, the 15-year survival was found to be 57%; for 1983-1992, it was 74% and for 1993-2002, it was 83% (P<0.001). The difference remained significant after adjusting for prognostic factors. The actuarial risk of developing a second malignancy at 20 years was for the 1973-1982 cohort, 12.4%, and for the 1983-1992 cohort, 18.8%. CONCLUSION: Treatment advances and effective management of toxicities of treatment over time, have resulted in a significantly longer survival for patients with Hodgkin's disease diagnosed within a defined population.

Prospective randomized trial using cost-utility analysis of early versus delayed laparoscopic cholecystectomy for acute gallbladder disease.

BACKGROUND: This randomized controlled trial compared the cost-utility of early laparoscopic cholecystectomy with that for conventional management of newly diagnosed acute gallbladder disease. METHODS: Adults admitted to hospital with a first episode of biliary colic or acute cholecystitis were randomized to an early intervention group (36 patients, operation within 72 h of admission) or a conventional group (36, elective cholecystectomy 3 months later). Costs were measured from a National Health Service and societal perspective. Quality-adjusted life year (QALY) gains were calculated 1 month after surgery. RESULTS: The mean(s.d.) total costs of care were pound 5911(2445) for the early group and pound 6132(3244) for the conventional group (P = 0.928), Mean(s.d.) societal costs were pound 1322(1402) and pound 1461(1532) for the early and conventional groups respectively (P = 0.732). Visual analogue scale scores of health were 72.94 versus 84.63 (P = 0.012) and the mean(s.d.) QALY gain was 0.85(0.26) versus 0.93(0.13) respectively (P = 0.262). The incremental cost per additional QALY gained favoured conventional management at a cost of pound 3810 per QALY gained. CONCLUSION: In this pragmatic trial, the cost-utilities of both the early and conventional approaches were similar, but the incremental cost per additional QALY gained favoured conventional management.

Combined skin and muscle vaccination differentially impact the quality of effector T cell functions: the CUTHIVAC-001 randomized trial.

Targeting of different tissues via transcutaneous (TC), intradermal (ID) and intramuscular (IM) injection has the potential to tailor the immune response to DNA vaccination. In this Phase I randomised controlled clinical trial in HIV-1 negative volunteers we investigate whether the site and mode of DNA vaccination influences the quality of the cellular immune responses. We adopted a strategy of concurrent immunization combining IM injection with either ID or TC administration. As a third arm we assessed the response to IM injection administered with electroporation (EP). The DNA plasmid encoded a MultiHIV B clade fusion protein designed to induce cellular immunity. The vaccine and regimens were well tolerated. We observed differential shaping of vaccine induced virus-specific CD4 + and CD8 + cell-mediated immune responses. DNA given by IM + EP promoted strong IFN-γ responses and potent viral inhibition. ID + IM without EP resulted in a similar pattern of response but of lower magnitude. By contrast TC + IM (without EP) shifted responses towards a more Th-17 dominated phenotype, associated with mucosal and epidermal protection. Whilst preliminary, these results offer new perspectives for differential shaping of desired cellular immunity required to fight the wide range of complex and diverse infectious diseases and cancers.

Visual impairment registration: evaluation of agreement among ophthalmologists.

PURPOSE: To evaluate consistency among consultant ophthalmologists in registration of visual impairment of patients with glaucoma who had a significant visual field component to their visual loss. METHOD: Thirty UK NHS consultant ophthalmologists were asked to grade data sets comprising both visual acuity and visual fields as severely sight impaired, partially sight impaired, or neither. To assess intra-consultant agreement, a group of graders agreed to repeat the process. RESULTS: Kappa for inter-consultant agreement (n=30) for meeting the eligibility criteria for visual impairment registration was 0.232 (95% CI 0.142-0.345), the corresponding inter-class correlation score was 0.2 (95% CI 0.172 to 0.344). Kappa for intra-consultant agreement (n=16) ranged from 0.007 to 0.9118. CONCLUSIONS: When presented with the clinical data necessary to decide whether patients with severe visual field loss are eligible for vision impairment registration, there is very poor intra- and inter-observer agreement among consultant ophthalmologists with regard to eligibility. The poor agreement indicates that these criteria are open to significant subjective interpretation that may be a source of either under- or over-registration of visual impairment in this group of patients in the UK. This inconsistency will affect the access of visually impaired glaucoma patients to support services and may result in inaccurate recording of the prevalence of registerable visual disability among glaucoma patients with severe visual field loss. More objective criteria with less potential for misclassification should be introduced.

Epidemiology and outcome of fracture of the hip in women aged 65 years and under: a cohort study.

We examined prospectively collected data from 6782 consecutive hip fractures and identified 327 fractures in 315 women aged ≤65 years. We report on their demographic characteristics, treatment and outcome and compare them with a cohort of 4810 hip fractures in 4542 women aged > 65 years. The first significant increase in age-related incidence of hip fracture was at 45, rather than 50, which is when screening by the osteoporosis service starts in most health areas. Hip fractures in younger women are sustained by a population at risk as a result of underlying disease. Mortality of younger women with hip fracture was 46 times the background mortality of the female population. Smoking had a strong influence on the relative risk of 'early' (≤ 65 years of age) fracture. Lag screw fixation was the most common method of operative treatment. General complication rates were low, as were re-operation rates for cemented prostheses. Kaplan-Meier implant survivorship of displaced intracapsular fractures treated by reduction and lag screw fixation was 71% (95% confidence interval 56 to 81) at five years. The best form of treatment remains controversial.