356 research outputs found

    Community based rehabilitation after severe traumatic brain injury: a randomised controlled trial

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    Objective: Evaluation of multidisciplinary community based outreach rehabilitation after severe traumatic brain injury (TBI). Methods: A randomised controlled trial compared outreach treatment (mean of two sessions a week for 27.3 (SD 19.1) weeks) in community settings such as participants' homes, day centres, or workplaces, with provision of written information detailing alternative resources. Follow up for an average of 24.8 months after initial allocation was by a blinded independent assessor. Participants were aged 16–65, had sustained severe TBI between 3 months and 20 years previously, and had no other neurological conditions. Of 110 initially allocated, 48 outreach and 46 information participants were successfully followed up. Primary outcome measures (Barthel index (BI) and the brain injury community rehabilitation outcome-39 (BICRO-39)) focused on levels of activity and participation. Secondary measures were the functional independence measure and the functional assessment measure (FIM+FAM) and, in a subgroup of 46 participants, the hospital anxiety and depression scale. Analyses were non-parametric. Results: outreach participants were significantly more likely to show gains on the BI and the BICRO-39 total score and self organisation and psychological wellbeing subscales. There were likewise strong trends (p<0.10) for BICRO personal care and mobility, and on the FIM+FAM for personal care and cognitive functions. Differential improvements were not seen for indices of socialising, productive employment, anxiety, or depression. Median changes on individual subscales were small, reflecting the diversity of the clinical population; however, 40% of outreach but only 20% of information participants made a clinically significant improvement of 2+ points on at least one BICRO-39 scale. Time since injury was unrelated to the magnitude of gains. Conclusions: This is the first RCT of multidisciplinary community rehabilitation after severe TBI, and suggests that even years after injury it can yield benefits which outlive the active treatment period

    Guidance for researchers wanting to link NHS data using non-consent approaches: a thematic analysis of feedback from the Health Research Authority Confidentiality Advisory Group

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    Introduction: The use of linked data and non-consent methodologies is a rapidly growing area of health research due to the increasing detail, availability and scope of routinely collected electronic health records data. However, gaining the necessary legal and governance approvals to undertake data linkage is a complex process in England. / Objectives: We reflect on our own experience of establishing lawful basis for data linkage through Section 251 approval, with the intention to build a knowledgebase of practical advice for future applicants. / Methods: Thematic analysis was conducted on a corpus of Section 251 feedback reports from the NHS Health Research Authority Confidentiality Advisory Group. / Results: Four themes emerged from the feedback. These were: (a) Patient and Public Involvement, (b)~Establishing Rationale, (c) Data maintenance and contingency, and the need to gain (d) Further Permissions from external authorities prior to full approval. / Conclusions: Securing Section 251 approval poses ethical, practical and governance challenges. However, through a comprehensive, planned approach Section 251 approval is possible, enabling researchers to unlock the potential of linked data for the purposes of health research

    Clinical effectiveness and cost-effectiveness of supported mindfulness-based cognitive therapy self-help compared with supported cognitive behavioral therapy self-help for adults experiencing depression: The low-intensity guided help through mindfulness (LIGHTMind) randomized clinical trial

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    Importance Depression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required. Objective To determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH. Design, Setting, and Participants This was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021. Interventions Participants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner. Main Outcomes and Measures The preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked. Results Of 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of −1.5 PHQ-9 points (95% CI, −2.6 to −0.4; P = .009; d = −0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related. Conclusions and Relevance In this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services. Trial Registration isrctn.org Identifier: ISRCTN1349575

    Low-intensity guided help through mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression

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    Background: Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving Access to Psychological Therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild/moderate, people are typically offered Cognitive Behavioural Therapy (CBT) self-help supported by a psychological wellbeing practitioner (PWP). The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent (NICE) recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT self-help. Mindfulness-based cognitive therapy differs from CBT in focus, approach and practice and may be more effective with a higher number of treatment completions. Methods/Design: This is a definitive randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help (MBCT-SH) with supported cognitive behavioural therapy self-help (CBT-SH) for adults experiencing mild/moderate depression being treated in IAPT services. Four hundred and ten participants experiencing mild/moderate depression will be recruited from IAPT services and randomised to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a PWP. The primary outcome is depression symptom severity upon treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, wellbeing, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. Discussion: If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. Trial registration: Current Controlled Trial registration number ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752). Protocol Version: Version 1 (18 January 2020) Recruitment Status: Recruiting: participants are currently being recruited and enrolled Date first participant randomised: 24 November 2017 Trial Sponsor: Sussex Partnership NHS Foundation Trust ([email protected]

    Low-Intensity Guided Help Through Mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression

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    Background Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions. Methods/design This is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. Discussion If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. Trial registration Current Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752)

    COVID-19 and Prostate Cancer, Can Two Negatives Equal a Positive?

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    This is a letter to the editor on the discussion on COVID-19 and prostate cancer

    Diagnostic change 10 years after a first episode of psychosis

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    Background. A lack of an aetiologically based nosology classification has contributed to instability in psychiatric diag-noses over time. This study aimed to examine the diagnostic stability of psychosis diagnoses using data from an inci-dence sample of psychosis cases, followed up after 10 years and to examine those baseline variables which were associated with diagnostic change. Method. Data were examined from the ÆSOP and ÆSOP-10 studies, an incidence and follow-up study, respectively, of a population-based cohort of first-episode psychosis cases from two sites. Diagnosis was assigned using ICD-10 and DSM-IV-TR. Diagnostic change was examined using prospective and retrospective consistency. Baseline variables asso-ciated with change were examined using logistic regression and likelihood ratio tests. Results. Slightly more (59.6%) cases had the same baseline and lifetime ICD-10 diagnosis compared with DSM-IV-TR (55.3%), but prospective and retrospective consistency was similar. Schizophrenia, psychotic bipolar disorder and drug-induced psychosis were more prospectively consistent than other diagnoses. A substantial number of cases with other diagnoses at baseline (ICD-10, n = 61; DSM-IV-TR, n = 76) were classified as having schizophrenia at 10 years

    Increase in precipitation scavenging contributes to long-term reductions of light-absorbing aerosol in the Arctic

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    We investigated long-term changes using a harmonised 22-year data set of aerosol light absorption measurements, in conjunction with air mass history and aerosol source analysis. The measurements were performed at Zeppelin Observatory, Svalbard, from 2002 to 2023. We report a statistically significant decreasing long-term trend for the light absorption coefficient. However, the last 8 years of 2016–2023 showed a slight increase in the magnitude of the light absorption coefficient for the Arctic haze season. In addition, we observed an increasing trend in the single-scattering albedo from 2002 to 2023. Five distinct source regions, representing different transport pathways, were identified. The trends involving air masses from the five regions showed decreasing absorption coefficients, except for the air masses from Eurasia. We show that the changes in the occurrences of each transport pathway cannot explain the reductions in the absorption coefficient observed at the Zeppelin station. An increase in contributions of air masses from more marine regions, with lower absorption coefficients, is compensated for by an influence from high-emission regions. The proportion of air masses en route to Zeppelin, which have been influenced by active fires, has undergone a noticeable increase starting in 2015. However, this increase has not impacted the long-term trends in the concentration of light-absorbing aerosol. Along with aerosol optical properties, we also show an increasing trend in accumulated surface precipitation experienced by air masses en route to the Zeppelin Observatory. We argue that the increase in precipitation, as experienced by air masses arriving at the station, can explain a quarter of the long-term reduction in the light absorption coefficient. We emphasise that meteorological conditions en route to the Zeppelin Observatory are critical for understanding the observed trends.</p
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