A single harmonised pharmacy process to improve clinical trial set-up times.

The UK has fallen from fourth to 10th place in the global ranking for clinical trial activities in the past 6 years. Due to the limited capacity of the clinical trial pharmacy workforce and delays in providing pharmacy approvals, pharmacy has been identified as one of the constraining services that delays the set-up and delivery of clinical trials. To tackle this problem, we developed a single pharmacy review process for multicentre trials across Greater Manchester (GM) and tested its feasibility and implementation in our region.

Central and peripheral nervous system responses to chronic and paced hyperventilation in anxious and healthy subjects.

The aim of the present study was to examine self-report, peripheral nervous system, and central nervous system correlates of naturally-occurring, chronic hyperventilation (HV, assessed by hypocapnia or low resting state low end-tidal CO), and to examine the additional effect of acute, experimentally-induced HV in anxious and healthy participants. By identifying the biomarkers of anxiety-related chronic HV and examining responses to acute HV, we hope to identify meaningful, mechanistic targets for further treatment development. Seventy anxious patients and 34 healthy control participants completed electroencephalogram (EEG) and peripheral nervous system recording at baseline and following a paced breathing task.

A randomized controlled trial evaluating the efficacy of a brief computerized anxiety sensitivity reduction intervention for health anxiety.

It is estimated that individuals with severe health anxiety (HA) utilize 41 %-78 % more healthcare resources than individuals with identified medical diagnoses. Thus, identifying targets for intervention and prevention efforts for HA that are appropriate for primary care or specialty clinic settings is imperative. The aim of the present investigation was to evaluate the effect of a single-session, computerized anxiety sensitivity (AS) intervention on AS and HA.

The dose-response curve in cognitive-behavioral therapy for anxiety disorders.

Previous studies examining the dose-response curve in psychotherapy have suggested that 11-19 sessions may be necessary for at least 50% of individuals to show clinically significant improvement. However, this curve has not been examined specifically for cognitive-behavioral therapy (CBT) for anxiety disorders, for which a more rapid recovery curve may be expected. Survival analysis was used to assess the dose-response curve for 201 patients with anxiety disorders who received weekly CBT at an anxiety specialty clinic.

Biofeedback and Neurofeedback for Anxiety Disorders: A Quantitative and Qualitative Systematic Review.

Biofeedback refers to the operant training of physiological responding. Variants include electromyography (EMG), electrodermal activity (EDA), skin temperature, heart rate (HR) and heart rate variability (HRV), respiratory biofeedback of end-tidal CO (ETCO), electroencephalography (EEG) signal, and blood oxygen-level dependent signal using functional magnetic resonance imaging (fMRI). This chapter presents a qualitative and quantitative systematic review of randomized controlled trials of biofeedback for anxiety disorders as defined by the 3rd through 5th editions of the Diagnostic and Statistical Manual of Mental Disorders (DSM).

Self-referential processing during observation of a speech performance task in social anxiety disorder from pre- to post-treatment: Evidence of disrupted neural activation.

Self-referential processing is critical to understanding social anxiety disorder (SAD). This study examined neural differences in self-referential processing in healthy controls (HC) and participants with SAD at pre- and post-treatment. Participants (n = 64) underwent fMRI scanning while viewing a video of themselves ("Self") or another person ("Other").

Mediators of Change in Capnometry Guided Respiratory Intervention for Panic Disorder.

Capnometry guided respiratory interventions have shown promising results in the treatment of panic disorder, but mechanisms of change are not yet well-understood. The current study examined changes in end-tidal carbon dioxide (ETCO), anxiety sensitivity, and perceived control as mediators of panic symptom change. Sixty-nine adults with panic disorder received 4 weeks of respiratory training, and panic symptom severity and potential mediators were assessed at Pre-treatment, Mid-treatment, Post-treatment, 2-month follow-up, and 12-month follow-up.

Linguistic processing and Script-Driven Imagery for trauma exposure: A proof of concept pilot trial.

Unlabelled: While several empirically supported treatments for posttraumatic stress disorder (PTSD) have been developed, these treatments are neither widely available nor universally efficacious. This pilot, proof of concept study evaluated a computerized imaginal exposure Script-Driven Imagery Training (SDI-T) for individuals with elevated trauma reactivity. The training was supplemented with two forms of linguistic processing, affect labeling (SDI-T + AL) and distraction (SDI-T + D), to determine whether linguistic inhibitory regulation augmented the effects of SDI-T.

Altered time course of amygdala activation during speech anticipation in social anxiety disorder.

Background: Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC).

Modelling Future Coronary Heart Disease Mortality to 2030 in the British Isles.

Objective: Despite rapid declines over the last two decades, coronary heart disease (CHD) mortality rates in the British Isles are still amongst the highest in Europe. This study uses a modelling approach to compare the potential impact of future risk factor scenarios relating to smoking and physical activity levels, dietary salt and saturated fat intakes on future CHD mortality in three countries: Northern Ireland (NI), Republic of Ireland (RoI) and Scotland.

Methods: CHD mortality models previously developed and validated in each country were extended to predict potential reductions in CHD mortality from 2010 (baseline year) to 2030.

Psychophysiological responses to unpredictable threat: effects of cue and temporal unpredictability.

Although threat unpredictability plays an important role in determining emotional responses, little is known about what elements of unpredictability are responsible for these results. The current study examined the single and combined effects of two elements of unpredictable threat: (a) uncertainty about the timing of an aversive event (temporal unpredictability), and (b) uncertainty about whether an aversive event will occur at all (cue unpredictability). Seventy-two healthy young adult participants were randomly assigned to receive either temporally predictable or unpredictable shocks at varying levels of cue unpredictability.

Physiological and behavioral indices of emotion dysregulation as predictors of outcome from cognitive behavioral therapy and acceptance and commitment therapy for anxiety.

Background And Objectives: Identifying for whom and under what conditions a treatment is most effective is an essential step toward personalized medicine. The current study examined pre-treatment physiological and behavioral variables as predictors and moderators of outcome in a randomized clinical trial comparing cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) for anxiety disorders.

Methods: Sixty individuals with a DSM-IV defined principal anxiety disorder completed 12 sessions of either CBT or ACT.

Low baseline pCO2 predicts poorer outcome from behavioral treatment: evidence from a mixed anxiety disorders sample.

Low levels of end-tidal partial pressure of carbon dioxide (pCO2)-the amount of carbon dioxide measured from expired air-are commonly found in individuals with anxiety disorders but have not been examined as predictors of outcome from anxiety treatment. The current study examined pre-treatment baseline pCO2 as a predictor of outcome from cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) for anxiety disorders. Sixty-one individuals with a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) defined principal anxiety disorder diagnosis completed 12 sessions of either CBT or ACT.

Explaining trends in Scottish coronary heart disease mortality between 2000 and 2010 using IMPACTSEC model: retrospective analysis using routine data.

Objective: To quantify the contributions of prevention and treatment to the trends in mortality due to coronary heart disease in Scotland.

Design: Retrospective analysis using IMPACTSEC, a previously validated policy model, to apportion the recent decline in coronary heart disease mortality to changes in major cardiovascular risk factors and to increases in more than 40 treatments in nine non-overlapping groups of patients.

Setting: Scotland.

Reaction time and mortality from the major causes of death: the NHANES-III study.

Objective: Studies examining the relation of information processing speed, as measured by reaction time, with mortality are scarce. We explored these associations in a representative sample of the US population.

Methods: Participants were 5,134 adults (2,342 men) aged 20-59 years from the Third National Health and Nutrition Examination Survey (NHANES III, 1988-94).

Homework compliance counts in cognitive-behavioral therapy.

Background: Prior research has demonstrated that there is some association between treatment engagement and treatment outcome in behavioral therapy for anxiety disorders. However, many of these investigations have been limited by weak measurement of treatment engagement variables, failure to control for potentially important baseline variables, and failure to consider various treatment engagement variables simultaneously. The purpose of the present study is to examine the relationship between two treatment engagement variables (treatment expectancy and homework compliance) and the extent to which they predict improvement from cognitive-behavioral therapy (CBT) for anxiety disorders.

Trends in cardiovascular disease biomarkers and their socioeconomic patterning among adults in the Scottish population 1995 to 2009: cross-sectional surveys.

Objectives: To examine secular and socioeconomic changes in biological cardiovascular disease risk factor and biomarker prevalences in the Scottish population. This could contribute to an understanding of why the decline in coronary heart disease mortality in Scotland has recently stalled along with persistence of associated socioeconomic inequalities.

Design: Cross-sectional surveys.

Randomized clinical trial of cognitive behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for mixed anxiety disorders.

Objective: Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders.

Method: One hundred twenty-eight individuals (52% female, mean age = 38, 33% minority) with 1 or more DSM-IV anxiety disorders began treatment following randomization to CBT or ACT; both treatments included behavioral exposure.

Trends in adult cardiovascular disease risk factors and their socio-economic patterning in the Scottish population 1995-2008: cross-sectional surveys.

Objectives: To examine secular and socio-economic changes in cardiovascular disease risk factor prevalences in the Scottish population. This could contribute to a better understanding of why the decline in coronary heart disease mortality in Scotland has recently stalled along with a widening of socio-economic inequalities.

Design: Four Scottish Health Surveys 1995, 1998, 2003 and 2008 (6190, 6656, 5497 and 4202 respondents, respectively, aged 25-64 years) were used to examine gender-stratified, age-standardised prevalences of smoking, alcohol consumption, physical activity, fruit and vegetable consumption, discretionary salt use and self-reported diabetes or hypertension.

National Income and Income Inequality, Family Affluence and Life Satisfaction Among 13 year Old Boys and Girls: A Multilevel Study in 35 Countries.

Adolescence is a critical period where many patterns of health and health behaviour are formed. The objective of this study was to investigate cross-national variation in the relationship between family affluence and adolescent life satisfaction, and the impact of national income and income inequality on this relationship. Data from the 2006 Health Behaviour in School-aged Children: WHO collaborative Study (N = 58,352 across 35 countries) were analysed using multilevel linear and logistic regression analyses for outcome measures life satisfaction score and binary high/low life satisfaction.

Trends and inequalities in short-term acute myocardial infarction case fatality in Scotland, 1988-2004.

Background: There have been substantial declines in ischemic heart disease in Scotland, partly due to decreases in acute myocardial infarction (AMI) incidence and case fatality (CF). Despite this, Scotland's IHD mortality rates are among the worst in Europe. We examine trends in socioeconomic inequalities in short-term CF after a first AMI event and their associations with age, sex, and geography.

Urban-rural differences in dental caries of 5-year old children in Scotland.

Previous research suggests there are significant differences between urban and rural areas in Scotland for health outcomes including heart disease, cancer and self reported health. The aim of this study was to describe the contemporary urban/rural variation in obvious decay experience amongst 5-year-olds in Scotland. Scotland was split into 6 geographies, ranging from 'The 4 Cities' (Glasgow, Edinburgh, Dundee and Aberdeen) to 'Remote Rural' areas.

Do differences in the administrative structure of populations confound comparisons of geographic health inequalities?

Background: Geographical health inequalities are naturally described by the variation in health outcomes between areas (e.g. mortality rates).

Increasing socioeconomic inequalities in first acute myocardial infarction in Scotland, 1990-92 and 2000-02.

Background: Despite substantial declines, Ischaemic Heart Disease (IHD) remains the largest cause of death in Scotland and mortality rates are among the worst in Europe. There is evidence of strong, persisting regional and socioeconomic inequalities in IHD mortality, with the majority of such deaths being due to Acute Myocardial Infarction (AMI). We examine the changes in socioeconomic and geographic inequalities in first AMI events in Scotland and their interactions with age and gender.