Unlike aviation, maritime and rail, road traffic collision investigation currently does not have a national investigatory body in the UK. Yet the numbers of people killed and seriously injured on the roads is far in excess of those other domains. The research presented in this paper is part of a larger project investigating the development of a road collision investigation branch in the UK. An important part of the process involves identifying a suitable accident analysis method to support investigations with the development of suitable interventions. This paper describes a study that was undertaken to identify a systemic method for investigating road collisions. Eight potential methods were identified and compared using a common incident, that of the recent Uber collision with a pedestrian. The methods were analysed against four sets of criteria: systemic, theoretical, methodological and practical. The AcciMap method, together with the accompanying Actor Map, was recommended as an appropriate approach to support road traffic collision investigations.
BackgroundIndividuals with depression often do not respond to medication or psychotherapy. Radically open dialectical behaviour therapy (RO DBT) is a new treatment targeting overcontrolled personality, common in refractory depression.AimsTo compare RO DBT plus treatment as usual (TAU) for refractory depression with TAU alone (trial registration: ISRCTN 85784627).MethodRO DBT comprised 29 therapy sessions and 27 skills classes over 6 months. Our completed randomised trial evaluated RO DBT for refractory depression over 18 months in three British secondary care centres. Of 250 adult participants, we randomised 162 (65%) to RO DBT. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), assessed masked and analysed by treatment allocated.ResultsAfter 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94–9.85). After 12 months (primary end-point), the difference of 2.15 points on the HRSD in favour of RO DBT was not significant (95% CI –2.28 to 6.59); nor was that of 1.69 points on the HRSD at 18 months (95% CI –2.84 to 6.22). Throughout RO DBT participants reported significantly better psychological flexibility and emotional coping than controls. However, they reported eight possible serious adverse reactions compared with none in the control group.ConclusionsThe RO DBT group reported significantly lower HRSD scores than the control group after 7 months, but not thereafter. The imbalance in serious adverse reactions was probably because of the controls' limited opportunities to report these.
IntroductionOnly 30–40% of depressed patients treated with medication achieve full remission. Studies that change medication or augment it by psychotherapy achieve only limited benefits, in part because current treatments are not designed for chronic and complex patients. Previous trials have excluded high-risk patients and those with comorbid personality disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a novel, transdiagnostic treatment for disorders of emotional over-control. The REFRAMED trial aims to evaluate the effectiveness and cost-effectiveness of RO-DBT for patients with treatment-resistant depression.Methods and analysisREFRAMED is a multicentre randomised controlled trial, comparing 7 months of individual and group RO-DBT treatment with treatment as usual (TAU). Our primary outcome measure is depressive symptoms 12 months after randomisation. We shall estimate the cost-effectiveness of RO-DBT by cost per quality-adjusted life year. Causal analyses will explore the mechanisms by which RO-DBT is effective.Ethics and disseminationThe National Research Ethics Service (NRES) Committee South Central – Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146.Trial registration numberISRCTN85784627.
Background About one-third of patients who are depressed do not respond to antidepressant medication (ADM) and traditional psychotherapy shows limited benefits. However, most randomised trials have excluded the most sick patients, especially with comorbid personality disorder. Radically open dialectical behaviour therapy (RO DBT) is a new treatment targeting emotionally overcontrolled personality, which is common in refractory depression. Objective To evaluate the efficacy, cost-effectiveness and therapeutic mechanisms of RO DBT for patients with refractory depression. Design The Refractory depression: Mechanisms and Efficacy of RO DBT (RefraMED) trial was a multicentre, parallel-group, randomised trial in which participants were randomised to receive either RO DBT plus treatment as usual (TAU) or TAU alone. Participants were assessed at 7, 12 and 18 months after randomisation. Therapeutic mechanisms were explored in causal analyses. Setting Participants were recruited from three secondary care NHS organisations in the UK: Dorset, Hampshire and North Wales. Participants Patients were eligible if they were aged ≥ 18 years, had a Hamilton Rating Scale for Depression (HRSD) score of at least 15, had a current diagnosis of major depressive disorder in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I, were suffering either refractory or chronic depression and, in their current episode, had taken an adequate dose of ADM for at least 6 weeks without relief. Patients who met criteria for dramatic-erratic personality disorder (Cluster B), bipolar disorder or psychosis or who had a primary diagnosis of substance dependence or abuse were excluded. Interventions The intervention, RO DBT, comprised 29 weekly individual sessions lasting 1 hour and 27 weekly skills classes lasting 2.5 hours. Participants allocated to TAU could access any treatment offered by the NHS or privately. Main outcome measures The reported HRSD score 12 months after randomisation and cost per quality-adjusted life-year (QALY). Results A total of 250 participants were allocated at random: 162 (65%) participants were randomised to RO DBT plus TAU and 88 (35%) were randomised to TAU. The difference between RO DBT and TAU in the primary outcome at 12 months was not statistically significant. Nevertheless, after 7 months, participants randomised to RO DBT had substantially, and significantly, reduced depressive symptoms, relative to TAU, by 5.40 HRSD points [standardised mean difference 1.03 points, 95% confidence interval (CI) 0.94 to 9.85 points; p = 0.02]. Thereafter, RO DBT remained the better treatment with net, but non-significant, reductions of 2.15 HRSD points (standardised mean difference 0.41 points, 95% CI –2.28 to 6.59 points; p = 0.29) after 12 months and 1.69 points (standardised mean difference 0.32 points, 95% CI –2.84 to 6.22 points; p = 0.42) after 18 months. Participants allocated to TAU could access any treatment offered by the NHS or privately. Participants randomised to RO DBT reported significantly better psychological flexibility and emotional coping than TAU participants; these differences increased over time. From the perspective of the NHS and personal social services, RO DBT was not cost-effective; the incremental cost-effectiveness ratio was £220,000 per QALY, which is considerably above the willingness-to-pay threshold of £30,000 set by the National Institute for Health and Care Excellence (NICE). RO DBT participants reported eight possible serious adverse reactions compared with none by TAU participants; however, we believe that this imbalance was a result of major differences in reporting opportunities. The Data Monitoring and Ethics Committee agreed that there was no reason to suspect that RO DBT was harmful. Conclusions Although RO DBT achieved the target effect size (Cohen’s d) with a d of 0.4 at the primary end point of 12 months, this was not significant. RO DBT was not cost-effective by NICE criteria. Nevertheless, RO DBT enhanced psychological flexibility and emotional coping, which are potential mechanisms of change. Limitations Analysing only 190 participants, instead of the target of 245, reduced the statistical power of the trial. Future work Future studies should aim to refine RO DBT, by maintaining clinical effectiveness while reducing costs, and to evaluate it for a wider range of overcontrolled disorders over a longer period. Trial registration Current controlled trials ISRCTN85784627. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership, and will be published in full in Efficacy and Mechanism Evaluation; Vol. 5, No. 7. See the NIHR Journals Library website for further project information.
The network analysis method, Event Analysis of Systemic Teamwork (EAST), was used to examine routine aviation operations from multiple perspectives from six key areas (i.e. Dispatch, ATC, ATM, Maintenance, Loading, and the Cockpit). Data was collected over a five-day observational field trial at an international air cargo operator. Researchers recorded the activities of agents operating within the six key areas over three outbound and two inbound flights. Three networks (i.e. social, information and task) were created for four key phases of flight: (i) pre-flight checks and engines start (ii) taxi, take-off and assent, (iii) descent, landing and taxi, and (iv) park and shut down. The networks represent a 'work audit' of short-haul cargo operations, which enabled a detailed understanding of the interactions and connections within the current system. Implications for the future of distributed crewing concepts are discussed. Practitioner Summary: An analysis of the aviation system was undertaken using the amalgamated data from three outbound and two inbound flights. These analyses show the social, information and task interactions for cargo operations. This has been used to specify requirements for future distributed crewing options.
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