SummaryBackgroundSelf-harm in adolescents is common and repetition occurs in a high proportion of these cases. Scarce evidence exists for effectiveness of interventions to reduce self-harm.MethodsThis pragmatic, multicentre, randomised, controlled trial of family therapy versus treatment as usual was done at 40 UK Child and Adolescent Mental Health Services (CAMHS) centres. We recruited young people aged 11–17 years who had self-harmed at least twice and presented to CAMHS after self-harm. Participants were randomly assigned (1:1) to receive manualised family therapy delivered by trained and supervised family therapists or treatment as usual by local CAMHS. Participants and therapists were aware of treatment allocation; researchers were masked. The primary outcome was hospital attendance for repetition of self-harm in the 18 months after group assignment. Primary and safety analyses were done in the intention-to-treat population. The trial is registered at the ISRCTN registry, number ISRCTN59793150.FindingsBetween Nov 23, 2009, and Dec 31, 2013, 3554 young people were screened and 832 eligible young people consented to participation and were randomly assigned to receive family therapy (n=415) or treatment as usual (n=417). Primary outcome data were available for 795 (96%) participants. Numbers of hospital attendances for repeat self-harm events were not significantly different between the groups (118 [28%] in the family therapy group vs 103 [25%] in the treatment as usual group; hazard ratio 1·14 [95% CI 0·87–1·49] p=0·33). Similar numbers of adverse events occurred in both groups (787 in the family therapy group vs 847 in the treatment as usual group).InterpretationFor adolescents referred to CAMHS after self-harm, having self-harmed at least once before, our family therapy intervention conferred no benefits over treatment as usual in reducing subsequent hospital attendance for self-harm. Clinicians are therefore still unable to recommend a clear, evidence-based intervention to reduce repeated self-harm in adolescents.FundingNational Institute for Health Research Health Technology Assessment programme.

Background: There is increasing interest in assessing the effects of interventions on older people, people with long-term conditions and their informal carers for use in economic evaluation. The Adult Social Care Outcomes Toolkit for Carers (ASCOT-Carer) is a measure that specifically assesses the impact of social care services on informal carers. To date, the ASCOT-Carer has not been preference-weighted.Objectives: To estimate preference-based index values for the English version of the ASCOT-Carer from the general population in England. Methods:The ASCOT-Carer consists of 7 domains, each reflecting aspects of social care-related quality of life in informal carers. Preferences for the ASCOT-Carer social care-related quality of life states were estimated using a best-worst scaling exercise in an online survey. The survey was administered to a sample of the general adult population in England (n = 1000). Participants were asked to put themselves into the hypothetical state of being an informal carer and indicate which attribute they thought was the best (first and second) and worst (first and second) from a profile list of 7 attributes reflecting the 7 domains, each ranging at a different level (1-4). Multinomial logit regression was used to analyze the data and estimate preference weights for the ASCOT-Carer measure. Results:The most valued aspect by English participants was the 'occupation' attribute at its highest level. Results further showed participants rated having no control over their daily life as the lowest attribute-level of all those presented. The position of the 7 attributes influenced participants' best and worst choices, and there was evidence of both scale and taste heterogeneity on preferences. Conclusion:This study has established a set of preference-based index values for the ASCOT-Carer in England derived from the best-worst scaling exercise that can be used for economic evaluation of interventions on older individuals and their informal carers.

Objective This article presents alternative parental health spillover quantification methods in the context of a randomised controlled trial comparing family therapy with treatment as usual as an intervention for self-harming adolescents, and discusses the practical limitations of those methods. Methods The trial followed a sample of 754 participants aged 11-17 years. Health utilities are measured using answers to the EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) for the adolescent and the Health Utility Index (HUI2) for one parent at baseline, 6 and 12 months. We use regression analyses to evaluate the association between the parent's and adolescent's health utilities as part of an explanatory regression model including health-related and demographic characteristics of both the adolescent and the parent. We then measure cost-effectiveness over a 12-month period as mean incremental cost-effectiveness ratios using various spillover quantification methods. We propose an original quantification based on the use of a household welfare function along with an equivalence scale to generate a health gain within the family to be added to the adolescent's quality-adjusted life-year gain. Results We find that the parent's health utility increased over the duration of the trial and is significantly and positively associated with adolescent's health utility at 6 and 12 months but not at baseline. When considering the adolescent's health gain only, the incremental cost-effectiveness ratio is £40,453 per quality-adjusted life-year. When including the health spillover to one parent, the incremental cost-effectiveness ratio estimates range from £27,167 per quality-adjusted life-year to £40,838 per quality-adjusted life-year and can be a dominated option depending on the quantification method used. Conclusion According to the health spillover quantification method considered, the incremental cost-effectiveness ratios vary from within the National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold range to not being cost-effective.

Summary Background Dopamine is a key modulator of striatal function and learning and might improve motor recovery after stroke. Previous small trials of dopamine agonists after stroke provide equivocal evidence of effectiveness on improving motor recovery. We aimed to assess the safety and efficacy of co-careldopa plus routine occupational and physical therapy during early rehabilitation after stroke. Methods This double-blind, multicentre, randomised controlled trial of co-careldopa versus placebo in addition to routine NHS occupational and physical therapy was done at 51 UK NHS acute inpatient stroke rehabilitation services. We recruited patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5–42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital. Participants were assigned (1:1) using stratified random blocks to receive 6 weeks of oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy. The initial two doses of co-careldopa were 62·5 mg (50 mg of levodopa and 12·5 mg of carbidopa) and the remaining doses were 125 mg (100 mg of levodopa and 25 mg of carbidopa). Participants were required to take a single oral tablet 45–60 min before physiotherapy or occupational therapy session. The primary outcome was ability to walk independently, defined as a Rivermead Mobility Index score of 7 or more, at 8 weeks. Primary and safety analyses were done in the intention-to-treat population. The trial is registered on the ISRCTN registry, number ISRCTN99643613. Findings Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years) were randomly assigned to either the co-careldopa group (n=308) or to the placebo group (n=285), on an average 18 days after stroke onset. Primary outcome data were available for all 593 patients. We found no evidence that the ability to walk independently improved with co-careldopa (125 [41%] of 308 patients) compared with placebo (127 [45%] of 285 patients; odds ratio 0·78 [95% CI 0·53–1·15]) at 8 weeks. Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]). Serious adverse events were largely similar between groups. Vomiting during therapy sessions, after taking the study drug, was the most frequent adverse event and was more frequent in the co-careldopa group than the placebo group (19 [6·2%] vs 9 [3·2%]). Interpretation Co-careldopa in addition to routine occupational and physical therapy does not seem to improve walking after stroke. Further research might identify subgroups of patients with stroke who could benefit from dopaminergic therapy at different doses or times after stroke with more ...

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 12. See the NIHR Journals Library website for further project information.