A cluster randomised controlled trial of a pharmacist-led collaborative intervention to improve statin prescribing and attainment of cholesterol targets in primary care

Background: Small trials with short term follow up suggest pharmacists’ interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.<p></p> Methods: We allocated general practices to a 12-month Statin Outreach Support (SOS) intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4–2.2 years), and practice level simvastatin 40 mg prescribing was assessed after 10 years.<p></p> Findings: We randomised 31 practices (72 General Practitioners (GPs), 40 nurses). Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586) at follow up. Patients in practices allocated to SOS were significantly more likely to have cholesterol at target (69.5% vs 63.5%; OR 1.11, CI 1.00–1.23; p = 0.043) as a result of improved simvastatin prescribing. Subgroup analysis showed the primary outcome was achieved by prevalent but not incident patients. Statistically significant improvements occurred in all secondary outcomes for prevalent patients and all but one secondary outcome (the proportion of patients with cholesterol tested) for incident patients. SOS practices prescribed more simvastatin 40 mg than usual care practices, up to 10 years later.<p></p> Interpretation: Through a combination of educational and organisational support, a general practice based pharmacist led collaborative intervention can improve statin prescribing and achievement of cholesterol targets in a high-risk primary care based population

The statistical analysis of exercise test data: a critical review

Exercise tests have played a prominent role in the evaluation of therapies currently used for the management of patients with angina, such as nitrates, b-blockers, and calcium antagonists. Such evaluations have shown dramatic improvements in exercise tolerance, most commonly measured by the time spent exercising until the occurrence of anginal pain or ECG signs of ischaemia, and often amongst patients with severe disease. However, the statistical methods used have generally been based on Normal theory, such as the t-test, or non-parametric equivalents, such as the Wilcoxon rank sum test. Such methods make no allowance for the fact that ischaemic endpoints may not occur in all patients, particularly when patients are under active treatment or in patients with less severe symptoms. In the current situation, where there are several therapeutic options of proven clinical effectiveness, new treatments must be evaluated in opposition, or in addition to existing therapies. Thus it is of particular importance that the statistician responsible for an analysis of exercise test data should use appropriate and efficient techniques, since the benefits of new treatments may be small. Since exercise times may be censored, in that the event of interest need not occur, it has been recognised that methods for the analysis of survival data are the most appropriate for analyses of exercise test data. Using data from the TIBET Study, a large clinical trial of two anti-anginal therapies administered singly or in combination, this thesis examines in detail the appropriateness of the Cox proportional hazards model, the most popular method for survival regression in the medical literature, to this type of data. It then considers alternatives to this model, and addresses the implications of some common features of exercise test data, in particular the presence of interval censoring and the possibility of multiple exercise tests being conducted on the same patient, using data from the TIBET Study and through simulation studies. Finally, using real data examples, two methods that appear to have received little or not attention with respect to exercise test data are explored, namely competing risks and repeated measures analyses

Evaluating an online support package delivered within a disability unemployment service: study protocol for a randomised controlled feasibility study

Background Mental health problems such as anxiety and depression are known to be higher in those who are unemployed. Cognitive behavioural therapy (CBT) is a recognised support for people with such problems and can improve the ability of people to get back to work.<p></p> Methods/design Participants with symptoms of low mood will be recruited from the disability employment service, Remploy. Participants will receive either immediate or delayed access to an online CBT-based life skills intervention, the “Living Life” package. The primary end point will be at 3 months when the delayed group will be offered the intervention. This feasibility study will test the trial design and assess recruitment, retention, acceptability and adherence, as well as providing efficacy data.<p></p> Discussion The study will inform the design and sample size for a future full randomised controlled trial (RCT) which will be carried out to determine the effectiveness of the online package in improving mood and employment status.<p></p&gt

Guided self-help cognitive behavioural therapy for depression in primary care : a randomised controlled trial

Peer reviewedPublisher PD

Mortality from head injury over four decades in Scotland

Although the causes of head injury, the population at risk and approaches to prevention and treatment are continually evolving, there is little information about how these are reflected in patterns of mortality over time. We used population based comprehensive data uniquely available in Scotland to investigate changes in the total numbers of deaths from 1974 to 2012, as well as the rates of head injury death, from different causes, overall and in relation to age and gender. Total mortality fell from an annual average of 503 to 339 with a corresponding annual decrease in rate from 9.6 to 6.4 per 100,000 population, the decline substantially occurring between 1974 and 1990. Deaths in children fell strikingly but rose in older people. Deaths in males fell to a greater extent than females but remained at a higher rate overall. Initially, a transport accident accounted for most deaths but these fell by 80%, from 325 per year to 65 per year over the 39 year period. Deaths from falling and all other causes did not decline, coming to outnumber transport accident deaths by 1998, which accounts for the overall absence of change in total mortality in recent years. In order to reduce mortality in the future, more effective measures to prevent falls are needed and these strategies will vary in younger adults (where alcohol is often a factor), and in older adults where infirmity can be a cause. In addition, measures to sustain reductions in transport accidents need to be maintained and further developed

Mental health and well-being of fathers of children with intellectual disabilities: systematic review and meta-analysis

BACKGROUND: Caring for a child with intellectual disabilities can be a very rewarding but demanding experience. Research in this area has primarily focused on mothers, with relatively little attention given to the mental health of fathers. AIMS: The purpose of this review was to summarise the evidence related to the mental health of fathers compared with mothers, and with fathers in the general population. METHOD: A meta-analysis was undertaken of all studies published by 1 July 2018 in Medline, PsycINFO, CINAHL and EMBASE, using terms on intellectual disabilities, mental health and father carers. Papers were selected based on pre-defined inclusion and exclusion criteria. RESULTS: Of 5544 results, 20 studies met the inclusion criteria and 12 had appropriate data for meta-analysis. For comparisons of fathers with mothers, mothers were significantly more likely to have poor general mental health and well-being (standardised mean difference (SMD) -0.38, 95% CI -0.56 to -0.20), as well as higher levels of depression (SMD, -0.46; 95% CI -0.68 to -0.24), stress (SMD, -0.32; 95% CI -0.46 to -0.19) and anxiety (SMD, -0.30; 95% CI -0.50 to -0.10). CONCLUSIONS: There is a significant difference between the mental health of father and mother carers, with fathers less likely to exhibit poor mental health. However, this is based on a small number of studies. More data is needed to determine whether the general mental health and anxiety of father carers of a child with intellectual disabilities differs from fathers in the general population

Patient preference as a predictor of outcomes in a pilot trial of person-centred counselling versus low-intensity cognitive behavioural therapy for persistent sub-threshold and mild depression

The aim of this analysis was to explore whether pre-treatment intervention preferences were related to outcomes for patients with persistent sub-threshold and mild depression who received one of two treatment types. Thirty-six patients took part in a two-arm, parallel group, pilot randomized controlled trial that compared short term (3 month and 6 month) outcomes of person-centred counselling (PCC) compared with low-intensity, CBT-based guided self-help (LICBT). Patient preferences for the two interventions were assessed at baseline assessment, and analysed as two independent linear variables (pro-PCC, pro-LICBT). Eight out of 30 interactions between baseline treatment preferences and treatment type were found to be significant at the p < .05 level. All were in the predicted direction, with patients who showed a stronger preference for a treatment achieving better outcomes in that treatment compared with the alternative. However, pro-LICBT was a stronger predictor of outcomes than pro-PCC. The findings provide preliminary support that treatment preferences should be taken into account when providing interventions for patients with persistent sub-threshold and mild depression. It is recommended that further research analyses preferences for different treatment types as independent variables, and examines preferences for format of treatment (e.g. guided self-help vs. face-to-face)

Misoprostol for small bowel ulcers in patients with obscure bleeding taking aspirin and non-steroidal anti-inflammatory drugs (MASTERS): a randomised, double-blind, placebo-controlled, phase 3 trial

Background: The incidence of obscure gastrointestinal bleeding, which originates from the small bowel and is mainly associated with the use of aspirin and non-steroidal anti-inflammatory drugs (NSAIDs), is rising. We assessed the efficacy and safety of misoprostol for the treatment of small bowel ulcers and erosions in patients taking low-dose aspirin or NSAIDs with obscure gastrointestinal bleeding. Methods: In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients (aged ≥18 years) with small bowel ulcers who were taking low-dose aspirin, NSAIDs, or both for a minimum of 4 weeks, at University Hospital Crosshouse (Kilmarnock, UK). Eligible patients had evidence of obscure gastrointestinal bleeding (iron deficiency anaemia, a decrease in haemoglobin concentration of ≥20 × 103 mg/L, or positive faecal occult blood test) and normal upper endoscopy and colonoscopy. Patients were randomly assigned (1:1) using an interactive voice response system to receive 200 μg oral misoprostol or placebo four times daily for 8 weeks. Patients, investigators, and assessors were masked to treatment allocation. The primary endpoint was the complete healing of small bowel ulcers and erosions, assessed by video capsule endoscopy after 8 weeks of treatment. Primary analysis was by modified intention to treat, which included all randomised patients who received at least one dose of study treatment. Safety was assessed in the same population. The trial is registered with ClinicalTrials.gov, number NCT02202967. Findings: Between Jan 7, 2016, and Oct 11, 2017, we randomly allocated 104 eligible patients: 52 to receive misoprostol and 52 to receive placebo. Two patients allocated to misoprostol were later found to meet one of the exclusion criteria, thus 50 randomly assigned patients in the misoprostol group and 52 patients in the placebo group received at least one dose of study treatment. Complete healing of small bowel ulcers and erosions was noted at week 8 in 27 (54%) of 50 patients in the misoprostol group and nine (17%) of 52 patients in the placebo group (percentage difference 36·7%, 95% CI 19·5–53·9; p=0·0002). Adverse events occurred in 23 (46%) of 50 patients in the misoprostol group and 22 (42%) of 52 patients in the placebo group. The most common adverse events were abdominal pain (ten [20%] in the misoprostol group vs 13 [25%] in the placebo group), nausea or vomiting (nine [18%] vs seven [13%]), and diarrhoea (11 [22%] vs six [12%]). Four (8%) of 50 patients in the misoprostol group had severe adverse events, compared with none in the placebo group. No serious adverse events were reported. Interpretation: Misoprostol is effective for the treatment of small bowel ulcers and erosions in patients using low-dose aspirin and NSAIDs. Misoprostol might represent a pharmacological treatment option for lesions causing obscure gastrointestinal bleeding that is associated with aspirin and NSAIDs, but its use should be balanced against the risk of side-effects

A randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial

<b>Background</b><p></p> The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.<p></p> <b>Methods</b><p></p> The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).<p></p> <b>Discussion</b><p></p> Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website