Low-Intensity Cognitive Behavioural Therapy-Based Music Group (CBT-Music) for the Treatment of Symptoms of Anxiety and Depression: A Feasibility Study.

BACKGROUND: Music has the potential to be an effective and engaging therapeutic intervention in the treatment of mental illness. This research area remains underdeveloped. AIMS: This paper reports the feasibility of an innovative low-intensity CBT-based music (CBT-Music) group targeted to symptoms of depression and anxiety. METHOD: A total of 28 participants with symptoms of depression and anxiety who were attending community mental health services were recruited for the study and randomized into TAU (treatment as usual) plus low-intensity CBT-Music (treatment) or to TAU alone (control). The treatment group consisted of a 9-week music group that incorporated various components of CBT material into a musical context. Feasibility was the primary outcome. The secondary outcomes were a reduction in depression, anxiety (Hospital Anxiety and Depression Scale) and disability (WHO Disability Assessment Schedule 2.0) assessed at baseline and 10 weeks. RESULTS: Recruitment proved feasible, retention rates were high, and the participants reported a high level of acceptability. A randomized control study design was successfully implemented as there were no significant differences between treatment and control groups at baseline. Participants in the treatment group showed improvement in disability (p = 0.027). Despite a reduction in depression and anxiety scores, these differences were not statistically significant. CONCLUSIONS: A low-intensity CBT-based music group can be successfully administered to clients of community mental health services. There are indications of effectiveness in reducing disability, although there appears to be negligible effect on symptoms of anxiety and depression. This is the first report of a trial of a low-intensity CBT-based music group intervention.

The Person and the Partner: Individual Differences Moderate the Relationship Between Partner Feedback and Condom Use.

Attachment anxiety is negatively associated with condom use; however, little research has assessed mechanisms underlying this relationship. In two studies we assessed the relationships among attachment orientations, perceived partner rejection, and condom use. In Study 1 we used a survey methodology and found that a measure of perceived partner rejection mediated the relationship between attachment anxiety and reported condom use behavior. In Study 2, women responded to condom use scenarios in which rejection was manipulated. We found a three-way interaction among attachment anxiety, attachment avoidance, and condom use intentions, such that perceived rejection from a potential sexual partner was associated with greater intentions to engage in unprotected sexual intercourse among women high in attachment anxiety and low in attachment avoidance, and among those high in attachment avoidance and low in attachment anxiety.

Unifying Research and Reimbursement Decisions: Case Studies Demonstrating the Sequence of Assessment and Judgments Required.

BACKGROUND: The key principles regarding what assessments lead to different types of guidance about the use of health technologies (Only in Research, Approval with Research, Approve, or Reject) provide an explicit and transparent framework for technology appraisal. OBJECTIVE: We aim to demonstrate how these principles and assessments can be applied in practice through the use of a seven-point checklist of assessment. METHODS: The value of access to a technology and the value of additional evidence are explored through the application of the checklist to the case studies of enhanced external counterpulsation for chronic stable angina and clopidogrel for the management of patients with non-ST-segment elevation acute coronary syndromes. RESULTS: The case studies demonstrate the importance of considering 1) the expected cost-effectiveness and population net health effects; 2) the need for evidence and whether the type of research required can be conducted once a technology is approved for widespread use; 3) whether there are sources of uncertainty that cannot be resolved by research but only over time; and 4) whether there are significant (opportunity) costs that once committed by approval cannot be recovered. CONCLUSIONS: The checklist demonstrates that cost-effectiveness is a necessary but not sufficient condition for approval. Only in Research may be appropriate when a technology is expected to be cost-effective due to significant irrecoverable costs. It is only approval that can be ruled out if a technology is not expected to be cost-effective. Lack of cost-effectiveness is not a necessary or sufficient condition for rejection.

Optimizing the position and use of omalizumab for severe persistent allergic asthma using cost-effectiveness analysis.

BACKGROUND: There has been some controversy on whether the costs of omalizumab outweigh its benefits for severe persistent allergic asthma. OBJECTIVES: This study aimed to resolve the uncertainties and limitations of previous analyses and establish the cost-effectiveness of omalizumab under the list price and Patient Access Scheme (PAS) discounted price for the UK National Health Service. METHODS: A decision-analytic model was developed to evaluate the long-term cost-effectiveness of omalizumab under the perspective of the National Health Service. Outcomes were expressed as quality-adjusted life-years (QALYs). Patient subgroups were defined post hoc on the basis of data collected in clinical trials: previous hospitalization, on maintenance oral corticosteroids, and three or more previous exacerbations. RESULTS: The incremental cost-effectiveness ratio varied from £30,109 to £57,557 per QALY gained depending on the population considered using the PAS price; incremental cost-effectiveness ratios were over a third higher using the list price. Omalizumab is likely to be cost-effective at the threshold of £30,000 per QALY gained in the severe subgroups if the improvement in health-related quality of life from omalizumab is mapped from an asthma-specific measure to the EuroQol five-dimensional questionnaire (vs. the EuroQol five-dimensional questionnaire directly collected from patients) or asthma mortality refers to death after hospitalization from asthma (vs. asthma-mortality risk in the community). CONCLUSIONS: Although the cost-effectiveness of omalizumab is more favorable under the PAS price, it represents good value for money only in severe subgroups and under optimistic assumptions regarding asthma mortality and improvement in health-related quality of life. For these reasons, omalizumab should be carefully targeted to ensure value for money.

Early childhood housing instability and school readiness.

This study assesses the consequences of housing instability during the first 5 years of a child's life for a host of school readiness outcomes. Using data from the Fragile Families and Child Wellbeing Study (n = 2,810), this study examines the relation between multiple moves and children's language and literacy and behavior problems at age 5. The moderating role of poverty is further tested in this relation. The findings show that moving three or more times in a child's first 5 years is significantly associated with increases in attention problems, and internalizing and externalizing behavior, but only among poor children.

A systematic review of the clinical effectiveness of EOS 2D/3D X-ray imaging system.

PURPOSE: To evaluate the available evidence for the clinical effectiveness of the EOS(®) 2D/3D X-ray imaging system for the evaluation and monitoring of scoliosis and other relevant orthopaedic conditions. METHODS: A systematic review of studies of EOS(®), compared with standard X-ray film, computed radiography or digital radiography, of patients with orthopaedic conditions was undertaken. Ten electronic databases were searched. The quality of the included studies was assessed and a narrative synthesis undertaken. RESULTS: Three small, limited quality studies, primarily of children with scoliosis, were identified. No patient health outcomes were reported. Spinal image quality was comparable or better overall with EOS(®). Radiation dose was considerably lower with EOS(®) than X-ray film or computed radiography; the mean entrance surface dose was over five times lower with EOS(®) for the posteroanterior spine radiograph and over six times lower for the lateral spine radiograph. CONCLUSIONS: The available clinical evidence for EOS(®) is limited to establishing its basic technical ability. The technical advancements associated with EOS(®) (the ability to generate a full body scan and to construct a three-dimensional model from synchronously acquired lateral and posteroanterior images) have not been evaluated in terms of their ability to improve patient outcomes. Whilst radiation dose is a concern for orthopaedic patients who require repeated imaging, it is difficult to quantify the reductions in radiation dose seen with EOS(®) in terms of patient health benefits. Clinical studies that investigate the impact of EOS(®) on patient management are required.

Legal capacity, developmental capacity, and impaired mental capacity in children under 16: Neurodevelopment and the law in Northern Ireland.

When people of any age, despite all possible support being provided, are unable to make a necessary decision, then it is important to have a legal framework which promotes and protects their rights. There is ongoing debate about how this can be achieved, in a non-discriminatory way, for adults but it is also an important consideration for children and young people. In Northern Ireland, the Mental Capacity Act (Northern Ireland) 2016, when fully implemented will provide a non-discriminatory framework for those aged 16 and over. Arguably this addresses discrimination based on disability but continues to discriminate based on age. This article explores some of the possible ways the rights of those aged under 16 could be further promoted and protected. These approaches may include: retaining the current combination of statute law but developing new guidance to inform practice for those aged under 16; codifying Gillick to clarify under what circumstances those aged under 16 can accept, and possibly also refuse, interventions; amend the Children (Northern Ireland) Order 1995 to provide a more comprehensive framework for health and welfare decision making; amend and extend the Mental Capacity Act (Northern Ireland) 2016 to apply to those aged under 16; or develop a new law specifically focused on the emerging capacity of those aged under 16. There are complex issues involved including how to consider emerging or developmental decision-making ability, and the role of those with parental responsibility, but the complexities involved should not prevent these issues being addressed.

Cost-effectiveness of aldosterone antagonists for the treatment of post-myocardial infarction heart failure.

OBJECTIVE: To assess the cost-effectiveness of eplerenone versus spironolactone as an adjunctive therapy to standard care in patients with heart failure (HF) following a myocardial infarction (post-MI) from the perspective of the National Health Service in the United Kingdom. METHODS: A systematic review was conducted, and a Bayesian meta-regression approach was used to establish the relative effectiveness of eplerenone and spironolactone by using evidence from randomized controlled trials. A decision analytic model was developed to assess the costs and consequences associated with the primary outcome of the trials over a lifetime time horizon. RESULTS: The incremental cost-effectiveness ratio of eplerenone compared with that of standard care alone was £ 4457 and £ 7893 for each additional quality-adjusted life-year when 2-year and lifetime treatment duration was assumed, respectively. In both scenarios, spironolactone did not appear cost-effective compared with eplerenone. The results were sensitive to the higher relative effectiveness estimated for eplerenone compared with spironolactone from the meta-regression. When a class effect was assumed for the effect on mortality and hospitalizations, spironolactone emerged as the most cost-effective treatment. CONCLUSIONS: Eplerenone appears more cost-effective than spironolactone for the treatment of post-MI HF. These findings, however, remain subject to important uncertainties regarding the effects of treatment on major clinical events. An adequately powered, well-conducted randomized controlled trial that directly compares spironolactone and eplerenone may be required to provide more robust evidence on the optimal management of post-MI HF. Despite these uncertainties, the use of an aldosterone antagonist was consistently demonstrated to be a highly cost-effective strategy for the management of post-MI HF in the National Health Service.

Cost-effectiveness of enhanced external counterpulsation (EECP) for the treatment of stable angina in the United Kingdom.

OBJECTIVES: The objective of this study is to assess the cost-effectiveness of enhanced external counterpulsation (EECP) compared with no treatment as additional therapy to usual care for the treatment of chronic stable angina from the perspective of the UK National Health Service. METHODS: The study design was a systematic review of published evidence, use of expert clinical opinion, and decision analytic cost-effectiveness model. The systematic review was conducted and statistical methods used to synthesize the effectiveness evidence from randomized control trials. Formal methods were used to elicit opinion from clinical experts where no evidence was available. These provide informed "priors" on key model parameters. A decision analytic model was developed to assess the costs and health consequences associated with the primary outcome of the trials over a lifetime time horizon. The main outcome measures were costs from a health service perspective and outcomes measured as quality-adjusted life-years (QALYs). RESULTS: The incremental cost-effectiveness ratio of EECP was 18,643 pound sterling for each additional QALY, with a probability of being cost-effective of 0.44 and 0.70 at cost-effectiveness thresholds of 20,000 pound sterling and 30,000 pound sterling per QALY gained, respectively. Results were sensitive to the duration of health-related quality of life (HRQoL) benefits from treatment. CONCLUSIONS: The long-term maintenance of HRQoL benefits of EECP is central to the estimate of cost-effectiveness. The results from a single randomized control trial do not provide firm evidence of the clinical or cost-effectiveness of EECP in stable angina. Long-term follow-up trials assessing quality of life from EECP are required.

Bioreactor-Grown Bacillus of Calmette and Guérin (BCG) Vaccine Protects Badgers against Virulent Mycobacterium bovis When Administered Orally: Identifying Limitations in Baited Vaccine Delivery.

Bovine tuberculosis (TB) in Great Britain adversely affects animal health and welfare and is a cause of considerable economic loss. The situation is exacerbated by European badgers (Meles meles) acting as a wildlife source of recurrent Mycobacterium bovis infection to cattle. Vaccination of badgers against TB is a possible means to reduce and control bovine TB. The delivery of vaccine in oral bait holds the best prospect for vaccinating badgers over a wide geographical area. There are practical limitations over the volume and concentration of Bacillus of Calmette and Guérin (BCG) that can be prepared for inclusion in bait. The production of BCG in a bioreactor may overcome these issues. We evaluated the efficacy of oral, bioreactor-grown BCG against experimental TB in badgers. We demonstrated repeatable protection through the direct administration of at least 2.0 × 108 colony forming units of BCG to the oral cavity, whereas vaccination via voluntary consumption of bait containing the same preparation of BCG did not result in demonstrable protection at the group-level, although a minority of badgers consuming bait showed immunological responses and protection after challenge equivalent to badgers receiving oral vaccine by direct administration. The need to deliver oral BCG in the context of a palatable and environmentally robust bait appears to introduce such variation in BCG delivery to sites of immune induction in the badger as to render experimental studies variable and inconsistent.

Shoulder acute pain in primary health care: is retraining GPs effective? The SAPPHIRE randomized trial: a cost-effectiveness analysis.

OBJECTIVES: To assess the cost-effectiveness of providing practical training to general practitioners (GPs) in shoulder problems, and administering a local anaesthetic (lignocaine) vs steroidal (cortisone) injection. METHODS: A cost-effectiveness analysis conducted alongside a cluster randomized trial with a factorial design, in general practices across five centres within the UK. A total of 155 participant GPs were randomized to receive training or no training with 200 participants randomized to either lignocaine or cortisone. Health care costs, quality-adjusted life years (QALYs) and incremental cost per QALY gained over 1 year estimated from a health system and a societal perspective were the main outcomes measured. RESULTS: Over 1 year, training GPs costs on average an additional pound sterling 211 (95% credibility interval - pound sterling 237, pound sterling 661) than no training and produces higher mean QALYs (0.075; -0.004, 0.154) per patient, yielding an incremental cost-effectiveness ratio of pound sterling 2813 per QALY gained for trained GPs. Over the same period of 1 year, lignocaine costs an average of pound sterling 122 more (- pound sterling 232, pound sterling 476) than cortisone and produces virtually no differential gain in mean QALYs (0.001; -0.068, 0.070), yielding an incremental cost per QALY gained of pound sterling 122,000 for lignocaine compared with cortisone. Across a range of cost-effectiveness thresholds, cortisone is as cost effective to inject as lignocaine. The probability that training is cost effective is above 0.95 at thresholds above pound sterling 20,000. CONCLUSIONS: Providing practical training to GPs about shoulder problems is cost effective and there is little uncertainty regarding this decision. The choice between lignocaine and cortisone is more uncertain and it is likely that there is significant value of further research to reduce this uncertainty. TRIAL REGISTRATION: The International Standard Randomised Controlled Trial Number is 58 537 244.

Internal validation of STRmix™ - A multi laboratory response to PCAST.

We report a large compilation of the internal validations of the probabilistic genotyping software STRmix™. Thirty one laboratories contributed data resulting in 2825 mixtures comprising three to six donors and a wide range of multiplex, equipment, mixture proportions and templates. Previously reported trends in the LR were confirmed including less discriminatory LRs occurring both for donors and non-donors at low template (for the donor in question) and at high contributor number. We were unable to isolate an effect of allelic sharing. Any apparent effect appears to be largely confounded with increased contributor number.

Lack of breaks is a safety risk.

Your story about staff working long shifts without breaks is nothing new (news online, 19 January, news page 9 ). It's been happening for years, because nurses let it continue.

Preliminary evaluation of a "formulation-driven cognitive behavioral guided self-help (fCBT-GSH)" for crisis and transitional case management clients.

BACKGROUND: Cognitive behavioral therapy (CBT) is found to be effective for common mental disorders and has been delivered in self-help and guided self-help formats. Crisis and transitional case management (TCM) services play a vital role in managing clients in acute mental health crises. It is, therefore, an appropriate setting to try CBT in guided self-help format. METHODS: This was a preliminary evaluation of a formulation-driven cognitive behavioral guided self-help. Thirty-six (36) consenting participants with a diagnosis of nonpsychotic illness, attending crisis and the TCM services in Kingston, Canada, were recruited in this study. They were randomly assigned to the guided self-help plus treatment as usual (TAU) (treatment group) or to TAU alone (control group). The intervention was delivered over 8-12 weeks. Assessments were completed at baseline and 3 months after baseline. The primary outcome was a reduction in general psychopathology, and this was done using Clinical Outcomes in Routine Evaluation - Outcome Measure. The secondary outcomes included a reduction in depression, measured using the Hospital Anxiety and Depression Scale, and reduction in disability, measured using the World Health Organization Disability Assessment Schedule 2.0. FINDINGS: Participants in the treatment group showed statistically significant improvement in overall psychopathology (P<0.005), anxiety and depression (P<0.005), and disability (P<0.005) at the end of the trial compared with TAU group. CONCLUSION: A formulation-driven cognitive behavioral guided self-help was feasible for the crisis and TCM clients and can be effective in improving mental health, when compared with TAU. This is the first report of a trial of guided self-help for clients attending crisis and TCM services.

Methods to place a value on additional evidence are illustrated using a case study of corticosteroids after traumatic brain injury.

OBJECTIVES: To establish whether evidence about the effectiveness of a health care intervention is sufficient to justify the use of the intervention in practice and show how value of information (VOI) analysis can be used to place a value on the need for additional evidence and inform research prioritization decisions. STUDY DESIGN AND SETTING: Meta-analysis provides an estimate of the effect of an intervention with uncertainty. VOI analysis determines the adverse health consequences of not resolving this uncertainty. A case study examining the evidence before the high profile trial of Corticosteroid Randomisation After Significant Head injury (CRASH) shows the consequences on patient outcomes if this trial had not been successfully funded. RESULTS: The consequences of uncertainty before CRASH were high at 40 deaths and 1,067 years of full health per annum. VOI analysis indicates that CRASH was worthwhile and the UK National Health Service would have had to spend an additional £205 million elsewhere to generate health benefits similar to CRASH. CONCLUSIONS: VOI analysis can be integrated with the results of meta-analysis to help inform whether a particular research proposal is potentially worthwhile and whether it should be prioritized over other research topics that could be commissioned with the same resources.