The Cost Effectiveness of Psychological and Pharmacological Interventions for Social Anxiety Disorder:A Model-Based Economic Analysis

Background Social anxiety disorder is one of the most persistent and common anxiety disorders. Individually delivered psychological therapies are the most effective treatment options for adults with social anxiety disorder, but they are associated with high intervention costs. Therefore, the objective of this study was to assess the relative cost effectiveness of a variety of psychological and pharmacological interventions for adults with social anxiety disorder. Methods A decision-analytic model was constructed to compare costs and quality adjusted life years (QALYs) of 28 interventions for social anxiety disorder from the perspective of the British National Health Service and personal social services. Efficacy data were derived from a systematic review and network meta-analysis. Other model input parameters were based on published literature and national sources, supplemented by expert opinion. Results Individual cognitive therapy was the most cost-effective intervention for adults with social anxiety disorder, followed by generic individual cognitive behavioural therapy (CBT), phenelzine and book-based self-help without support. Other drugs, group-based psychological interventions and other individually delivered psychological interventions were less cost-effective. Results were influenced by limited evidence suggesting superiority of psychological interventions over drugs in retaining long-term effects. The analysis did not take into account side effects of drugs. Conclusion Various forms of individually delivered CBT appear to be the most cost-effective options for the treatment of adults with social anxiety disorder. Consideration of side effects of drugs would only strengthen this conclusion, as it would improve even further the cost effectiveness of individually delivered CBT relative to phenelzine, which was the next most cost-effective option, due to the serious side effects associated with phenelzine. Further research needs to determine more accurately the long-term comparative benefits and harms of psychological and pharmacological interventions for social anxiety disorder and establish their relative cost effectiveness with greater certainty

Interventions to improve the experience of caring for people with severe mental illness: systematic review and meta-analysis

Background Informal caregiving is an integral part of the care of people with severe mental illness, but the support needs of those providing such care are not often met. Aims To determine whether interventions provided to people caring for those with severe mental illness improve the experience of caring and reduce caregiver burden. Method We conducted a systematic review and meta-analyses of randomised controlled trials (RCTs) of interventions delivered by health and social care services to informal carers (i.e. family or friends who provide support to someone with severe mental illness). Results Twenty-one RCTs with 1589 carers were included in the review. There was evidence suggesting that the carers’ experience of care was improved at the end of the intervention by psychoeducation (standardised mean difference –1.03, 95% CI –1.69 to –0.36) and support groups (SMD = –1.16, 95% CI –1.96 to –0.36). Psychoeducation had a benefit on psychological distress more than 6 months later (SMD = –1.79, 95% CI –3.01 to –0.56) but not immediately post-intervention. Support interventions had a beneficial effect on psychological distress at the end of the intervention (SMD = –0.99, 95% CI –1.48 to –0.49) as did problem-solving bibliotherapy (SMD = –1.57, 95% CI –1.79 to –1.35); these effects were maintained at follow-up. The quality of the evidence was mainly low and very low. Evidence for combining these interventions and for self-help and self-management was inconclusive. Conclusions Carer-focused interventions appear to improve the experience of caring and quality of life and reduce psychological distress of those caring for people with severe mental illness, and these benefits may be gained in first-episode psychosis. Interventions for carers should be considered as part of integrated services for people with severe mental health problems

Binary-induced collapse of a compact, collisionless cluster

We improve and extend Shapiro's model of a relativistic, compact object which is stable in isolation but is driven dynamically unstable by the tidal field of a binary companion. Our compact object consists of a dense swarm of test particles moving in randomly-oriented, initially circular, relativistic orbits about a nonrotating black hole. The binary companion is a distant, slowly inspiraling point mass. The tidal field of the companion is treated as a small perturbation on the background Schwarzschild geometry near the hole; the resulting metric is determined by solving the perturbation equations of Regge and Wheeler and Zerilli in the quasi-static limit. The perturbed spacetime supports Bekenstein's conjecture that the horizon area of a near-equilibrium black hole is an adiabatic invariant. We follow the evolution of the system and confirm that gravitational collapse can be induced in a compact collisionless cluster by the tidal field of a binary companion.Comment: 9 Latex pages, 14 postscript figure

Trial Registration: Understanding and Preventing Reporting Bias in Social Work Research

Randomized controlled trials are considered the gold standard for evaluating social work interventions. However, published reports can systematically overestimate intervention effects when researchers selectively report large and significant findings. Publication bias and other types of reporting biases can be minimized through prospective trial registration that is now an accepted part of medical research. In this article, we explain how trial registration can promote ethical and valid trials in social work, and we explain how social work researchers can register trials. We conclude that journal editors should ask authors to report trial registration numbers in all reports of randomized trials in social work

Personal assistance for children and adolescents (0-18) with physical impairments

Background: There is a high and increasing prevalence of impairments among children and adolescents in the West. Many countries offer personal assistance in the form of individualised support for people living in the community by a paid assistant other than a healthcare professional for at least 20 hours per week. Objectives: To assess the effectiveness of personal assistance for children and adolescents with physical impairments, and the impacts of personal assistance on others, compared to other interventions. Search strategy: Electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, ERIC, Dissertation Abstracts International and a variety of specialist Swedish databases were searched from 1980 to June 2005; reference lists were checked; 345 experts, organisations, government bodies and charities were contacted in an attempt to locate relevant research. Selection criteria: Children and adolescents with physical impairments (0-18 years) living in the community who require assistance to perform tasks of daily living (e.g., bathing and eating) and participate in normal activities due to permanent impairments. Controlled studies of personal assistance in which participants were prospectively assigned to study groups and in which control group outcomes were measured concurrently with intervention group outcomes were included. Data collection and analysis: Titles and abstracts were examined by two reviewers. 130 full papers were examined. None met the inclusion criteria. Main results: No eligible studies were found. Authors' conclusions: Research in this field is limited. When implementing new programmes, recipients could be randomly assigned to different forms of assistance. While advocates may support personal assistance for myriad reasons, this review demonstrates that further studies are required to determine which models of personal assistance are most effective and efficient for particular people

Personal assistance for older adults (65+) without dementia

Background: There is a high prevalence of impairments among people 65+, and the elderly population is increasing in the West. Many countries offer personal assistance, individualised support for people living in the community by a paid assistant other than a healthcare professional for at least 20 hours per week. Objectives: To assess the effectiveness of personal assistance for older adults with impairments, and the impacts of personal assistance on others, compared to other interventions. Search strategy: Electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, ERIC, Dissertation Abstracts International and a variety of specialist Swedish databases were searched from 1980 to June 2005; reference lists were checked; 345 experts, organisations, government bodies and charities were contacted in an attempt to locate relevant research. Selection criteria: This review included older adults (65+) living in the community who require assistance to perform tasks of daily living (e.g., bathing and eating) and participate in normal activities due to permanent impairments. Controlled studies of personal assistance in which participants were prospectively assigned to study groups and in which control group outcomes were measured concurrently with intervention group outcomes were included. Data collection and analysis: Titles and abstracts were examined by two reviewers. Outcomes data were extracted. Because they made different comparisons, studies were not combined for meta-analyses. Studies were assessed for the possibility of bias. Results and potential sources of bias are presented for included studies. Main results: Four studies involving 1642 participants made three eligible comparisons: (i) personal assistance versus usual care, (ii) personal assistance versus nursing homes, and (iii) personal assistance versus 'cluster care'. One was an RCT, three were non-randomised. Personal assistance was generally preferred over other services; however, some people prefer other models of care. This review indicates that personal assistance probably has some benefits for some recipients and caregivers. Paid assistance probably substitutes for informal care and may cost government more than alternatives; however, the total costs to recipients and society are currently unknown. Authors' conclusions: Research in this field is limited. Personal assistance is expensive and difficult to organise, especially in places that do not already have services in place. When implementing new programmes, recipients could be randomly assigned to different forms of assistance. While advocates may support personal assistance for myriad reasons, this review demonstrates that further studies are required to determine which models of personal assistance are most effective and efficient

Are manufacturers sharing data as promised?

Over the past two years drug and device manufacturers have been among the most vocal contributors to the discussion about transparency of clinical trial data. In 2013 GlaxoSmithKline (GSK) established its Clinical Study Data Request system to share participant level data, and now 11 other companies are listed as contributors to it (www.clinicalstudydatarequest.com). Other companies have developed similar systems of their own,but it is difficult to evaluate how they are working or even to decide on what basis they should be judged

Conducting separate reviews of benefits and harms could improve systematic reviews and meta-analyses

Guidance for systematic reviews of interventions recommends both benefits and harms be included. Systematic reviews may reach conclusions about harms (or lack of harms) that are not true when reviews include only some relevant studies, rely on incomplete data from eligible studies, use inappropriate methods for synthesizing data, and report results selectively. Separate reviews about harms could address some of these problems, and we argue that conducting separate reviews of harms is a feasible alternative to current standards and practices. Systematic reviews of potential benefits could be organized around the use of interventions for specific health problems. Systematic reviews of potential harms could be broader, including more diverse study designs and including all people at risk of harms (who might use the same intervention to treat different health problems). Multiple reviews about benefits could refer to a single review of harms. This approach could improve the reliability, completeness, and efficiency of systematic reviews

An Integrated TCGA Pan-Cancer Clinical Data Resource to Drive High-Quality Survival Outcome Analytics

For a decade, The Cancer Genome Atlas (TCGA) program collected clinicopathologic annotation data along with multi-platform molecular profiles of more than 11,000 human tumors across 33 different cancer types. TCGA clinical data contain key features representing the democratized nature of the data collection process. To ensure proper use of this large clinical dataset associated with genomic features, we developed a standardized dataset named the TCGA Pan-Cancer Clinical Data Resource (TCGA-CDR), which includes four major clinical outcome endpoints. In addition to detailing major challenges and statistical limitations encountered during the effort of integrating the acquired clinical data, we present a summary that includes endpoint usage recommendations for each cancer type. These TCGA-CDR findings appear to be consistent with cancer genomics studies independent of the TCGA effort and provide opportunities for investigating cancer biology using clinical correlates at an unprecedented scale. Analysis of clinicopathologic annotations for over 11,000 cancer patients in the TCGA program leads to the generation of TCGA Clinical Data Resource, which provides recommendations of clinical outcome endpoint usage for 33 cancer types

Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions : A Systematic Review

BACKGROUND: We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events. METHODS AND FINDINGS: Studies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in 15 of the 20 pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases. The main limitations of this review are that the included case examples represent only a small number amongst thousands of meta-analyses of harms and that the included studies may suffer from publication bias, whereby substantial differences between published and unpublished data are more likely to be published. CONCLUSIONS: There is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. The inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events