An evaluation of a multi-site community pharmacy based chronic obstructive pulmonary disease support service

Background Chronic obstructive pulmonary disease (COPD) is a progressive chronic condition which can be effectively managed by smoking cessation, optimising prescribed therapy and providing treatment to prevent chest infections from causing hospitalisation. The government agenda in the UK is for community pharmacists to become involved in chronic disease management and COPD is one area where they are ideally located to provide a comprehensive service. Objective To evaluate the effect of a community pharmacy based COPD service on patient outcomes. Method Patients in one UK location were recruited over a 3 month period to receive a community pharmacy based COPD support service consisting of signposting to or provision of smoking cessation service, therapy optimisation, and recommendation to obtain a rescue pack containing steroid and antibiotic to prevent hospitalisation as a result of chest infection. Data was collected over a six month period for all recruited patients. Appropriate clinical outcomes, patient reported medication adherence, quality of life and NHS resource utilisation were measured. Key findings 306 patients accessed the service and full data to enable comparison before and after was available for 137. Significant improvements in patient reported adherence, utilisation of rescue packs, quality of life and a reduction in routine GP visits were identified. The intervention cost was estimated to be off-set by reductions in the use of other NHS services (GP and A&E visits and hospital admissions). Conclusion Results suggest that the service improved patient medicine taking behaviours and that it was cost-effective

Efficient Research Design: Using Value-of-Information Analysis to Estimate the Optimal Mix of Top-down and Bottom-up Costing Approaches in an Economic Evaluation alongside a Clinical Trial.

In designing economic evaluations alongside clinical trials, analysts are frequently faced with alternative methods of collecting the same data, the extremes being top-down ("gross costing") and bottom-up ("micro-costing") approaches. A priori, bottom-up approaches may be considered superior to top-down approaches but are also more expensive to collect and analyze. In this article, we use value-of-information analysis to estimate the efficient mix of observations on each method in a proposed clinical trial. By assigning a prior bivariate distribution to the 2 data collection processes, the predicted posterior (i.e., preposterior) mean and variance of the superior process can be calculated from proposed samples using either process. This is then used to calculate the preposterior mean and variance of incremental net benefit and hence the expected net gain of sampling. We apply this method to a previously collected data set to estimate the value of conducting a further trial and identifying the optimal mix of observations on drug costs at 2 levels: by individual item (process A) and by drug class (process B). We find that substituting a number of observations on process A for process B leads to a modest £ 35,000 increase in expected net gain of sampling. Drivers of the results are the correlation between the 2 processes and their relative cost. This method has potential use following a pilot study to inform efficient data collection approaches for a subsequent full-scale trial. It provides a formal quantitative approach to inform trialists whether it is efficient to collect resource use data on all patients in a trial or on a subset of patients only or to collect limited data on most and detailed data on a subset.This is the author accepted manuscript. The final version is available from SAGE via http://dx.doi.org/10.1177/0272989X1562218

Estimating loss in quality of life associated with asthma-related crisis events (ESQUARE): a cohort, observational study

Background: Evidence of quality of life implications of asthma attacks are limited,particularly when measured on a utility scale, which enables calculating Quality-Adjusted Life-Years (QALYs) and comparisons with other health conditions andservices. Therefore, this study sought to estimate the utility loss associated with anasthma-related crisis event (accident and emergency (A&E) attendance or hospitaladmission).Methods: Participants were recruited in a cohort study from A&E and hospitaladmissions at three UK hospitals. They completed the EuroQol-5 Dimensions 5-Level(EQ-5D-5L), Asthma Quality of Life Questionnaire (AQLQ), Time trade-off (TTO), andpeak flow and symptom diary over 8 weeks, where three different methods (EQ-5D-5L,AQLQ, and TTO), were used to estimate utilities. The mean difference between twotime points were estimated using the Wilcoxon signed rank test.Results: From baseline to week 8, mean increases (95% CI) were estimated to be0.086 (0.019-0.153), 0.154 (0.112-0.196) and 0.132 (0.063-0.201) for EQ-5D-5L, AQL-5D (preference-based measure derived from AQLQ), and TTO respectively over 8weeks (p<0.01).Conclusion: Asthma crisis events are estimated to be associated with a mean utilityloss of between 0.086 and 0.132. The utility decrement can be used to assign valuesto asthma-related crisis events, which can enhance economic evaluations

The construct validity and responsiveness of the EQ-5D-5L, AQL-5D and a bespoke TTO in acute asthmatics

Purpose: Measuring quality of life in acute asthmatics is challenging, especially when asthma attacks can occur sporadically. Several questionnaires can be used to measure quality of life in this patient group; however, psychometric testing is limited on questionnaires that can be used to estimate Quality Adjusted Life years. The objective of this study is to assess the construct validity (convergent and discriminative validity) and responsiveness of the EuroQol-5-Dimensions 5-Level (EQ-5D-5L), Asthma Quality of Life Utility Index-5 Dimensions (AQL-5D) and Time Trade-Off (TTO) in acute asthma patients. Methods: Data from a prospective cohort study were used to test the validity and responsiveness of the EQ-5D-5L, AQL-5D and TTO in asthma patients who were recruited from UK accident & emergency departments or hospital wards. The spearman’s rank correlation coefficient, the Kruskal–Wallis test statistic and the standardized response mean were used to test for convergent validity, discriminative validity and responsiveness, respectively. Results: One hundred and twenty-one participants were included in the available case analysis. The EQ-5D-5L and AQL-5D showed moderate to strong correlations for convergent validity at baseline, week 4 and week 8. The AQL-5D and TTO showed moderate correlations at week 4 and week 8. No statistical significance was observed for discriminative validity at baseline. Both the EQ-5D-5L and the AQL-5D also showed that they were sensitive to change for the recovery responses. Conclusions: The EQ-5D-5L and AQL-5D showed stronger construct validity and responsiveness compared to the TTO. Therefore, both the EQ-5D-5L and AQL-5D should be considered for use in future economic evaluations

The pharmacy care plan service: Service evaluation and estimate of cost-effectiveness

Background: The UK Community Pharmacy Future group developed the Pharmacy Care Plan (PCP) service with a focus on patient activation, goal setting and therapy management.  Objective: To estimate the effectiveness and cost-effectiveness of the PCP service from a health services perspective.  Methods: Patients over 50 years of age prescribed one or more medicines including at least one for cardiovascular disease or diabetes were eligible. Medication review and person-centred consultation resulted in agreed health goals and actions towards achieving them. Clinical, process and cost-effectiveness data were collected at baseline and 12-months between February 2015 and June 2016. Mean differences are reported for clinical and process measures. Costs (NHS) and quality-adjusted life year scores were estimated and compared for 12 months pre- and post-baseline.  Results: Seven hundred patients attended the initial consultation and 54% had a complete set of data obtained. There was a significant improvement in patient activation score (mean difference 5.39; 95% CI 3.9 – 6.9; p<0.001), systolic (mean difference -2.90 mmHg ; 95% CI -4.7 - -1; p=0.002) and diastolic blood pressure (mean difference -1.81 mmHg; 95% CI -2.8 - -0.8; p<0.001), adherence (mean difference 0.26; 95% CI 0.1 – 0.4; p<0.001) and quality of life (mean difference 0.029; 95% CI 0.015 – 0.044; p<0.001). HDL cholesterol reduced significantly and QRisk2 scores increased significantly over the course of the 12 months. The mean incremental cost associated with the intervention was estimated to be £202.91 (95% CI 58.26 to £346.41) and the incremental QALY gain was 0.024 (95% CI 0.014 to 0.034), giving an incremental cost per QALY of £8,495.  Conclusions: Enrolment in the PCP service was generally associated with an improvement over 12 months in key clinical and process metrics. Results also suggest that the service would be cost-effective to the health system even when using worst case assumptions

Antidepressant use and risk of adverse outcomes in older people: population based cohort study

Objectives To investigate the association between antidepressant treatment and risk of several potential adverse outcomes in older people with depression and to examine risks by class of antidepressant, duration of use, and dose

Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial

Background: Functional Strength Training (FST) could enhance recovery late after stroke. The aim of this study was to evaluate the feasibility of a subsequent fully powered, randomized controlled trial. Methods: The study was designed as a randomized, observer-blind trial. Both interventions were provided for up to one hour a day, four days a week, for six weeks. Evaluation points were before randomization (baseline), after six weeks intervention (outcome), and six weeks thereafter (follow-up). The study took place in participants’ own homes. Participants (n = 52) were a mean of 24.4 months after stroke with a mean age of 68.3 years with 67.3% male. All had difficulty using their paretic upper (UL) and lower limb (LL). Participants were allocated to FST-UL or FST-LL by an independent randomization service. The outcome measures were recruitment rate, attrition rate, practicality of recruitment strategies, occurrence of adverse reactions, acceptability of FST, and estimation of sample size for a subsequent trial. Primary clinical efficacy outcomes were the Action Research Arm Test (ARAT) and the Functional Ambulation Categories (FAC). Analysis was conducted using descriptive statistics and thematic analysis of participants’ views of FST. A power calculation used estimates of clinical efficacy variance to estimate sample size for a subsequent trial. Results: The screening process identified 1,127 stroke survivors of whom 52 (4.6%) were recruited. The recruitment rate was higher for referral from community therapists than for systematic identification of people discharged from an acute stroke unit. The attrition rate was 15.5% at the outcome and follow-up time-points. None of the participants experienced an adverse reaction. The participants who remained in the study at outcome had received 68% of the total possible amount of therapy. Participants reported that their experience of FST provided a sense of purpose and involvement and increased their confidence in performing activities. The power calculation provides estimation that 150 participants in each group will be required for a subsequent clinical trial. Conclusions: This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used

Exploring factors that impact the decision to use assistive telecare: perspectives of family care-givers of older people in the United Kingdom

In the United Kingdom (UK), an ageing population met with the reduction of social care funding has led to reduced support for older people marked with an increased demand on family care-givers. Assistive telecare (AT) devices are viewed as an innovative and effective way to support older people. However, there is limited research which has explored adoption of AT from the perspectives of family care-givers. In-depth, semi-structured interviews were conducted with 14 family care-givers of patients who used the Assistive Telehealth and Telecare service in Cambridgeshire, UK. Family care-givers were either the spouse (N = 8) or child of the patient (N = 6). The patients' age ranged from 75 to 98, and either received a telecare standalone device or connected service. Framework analysis was used to analyse the transcripts. This study revealed that family care-givers play a crucial role in supporting the patient's decision to adopt and engage with AT devices. Knowledge and awareness, perceived responsibility, usefulness and usability, alongside functionality of the equipment, were influential factors in the decision-making process. AT devices were viewed positively, considered easy to use, useful and functional, with reassurance of the patient's safety being a core reason for adoption. Efforts to increase adoption and engagement should adapt recruitment strategies and service pathways to support both the patient and their care-giver

Randomised controlled trial of the effect, cost and acceptability of a bronchiectasis self-management intervention

Background: Patient self-management plans (PSMP) are advised for bronchiectasis but their efficacy is not established. We aimed to determine whether, in people with bronchiectasis, the use of our bronchiectasis PSMP - Bronchiectasis Empowerment Tool (BET), compared to standard care, would improve self-efficacy. Methods: In a multi-centre mixed-methods randomised controlled parallel study, 220 patients with bronchiectasis were randomised to receive standard care with or without the addition of our BET plus education sessions explaining its use. BET comprised an action plan, indicating when to seek medical help based on pictorial represented indications for antibiotic therapy, and four educational support sections. At baseline and after 12 months, patients completed the Self-Efficacy to Manage Chronic Disease Scale (SEMCD), St George’s Respiratory Questionnaire (SGRQ), EQ-5D-3L (to calculate Quality Adjusted Life Years (QALYs) and cost questionnaires. Qualitative data were obtained by focus groups. Results: The recruitment to the study was high (63% of eligible patients agreeing to participate) however completion rate was low (57%). BET had no effect on SEMCD (mean difference (0.14 (95% confidence interval (95%CI) -0.37 to 0.64), p=0.59) or SGRQ, exacerbation rates, overall cost to the NHS or QALYs. Most had developed their own techniques for monitoring their condition and they did not find BET useful as it was difficult to complete. Participant knowledge was good in both groups. Conclusion: The demand for patient support in bronchiectasis was high suggesting a clinical need. However, the BET did not improve self-efficacy, health related quality of life, costs or clinically relevant outcome measures. BET needs to be modified to be less onerous for users and implemented within a wider package of care. Further studies, particularly those evaluating people newly diagnosed with bronchiectasis, are required and should allow for 50% withdrawal rate or utilise less burdensome outcome measures. Clinical trials registration: ISRCTN ISRCTN 18400127. Registered 24 June 2015. Retrospectively Registere

Attentional bias towards positive and negative images amongst offenders and non-offenders with intellectual disabilities

Aims: The aim of the study was to examine attentional bias towards positive and negative images amongst men with intellectual disabilities, some of whom had a history of criminal offending. A secondary aim was to explore the relationship between attentional bias, empathy and distorted cognitions. Method: Forty-six men with intellectual disabilities with a history of criminal offending and 51 men with intellectual disabilities without any known history of criminal offending were recruited and invited to complete a dot-probe paradigm using images, as well as measures of distorted cognitions and empathy. Comparisons were made between the two groups. Results: Non-offenders had a significant attentional bias away from negative images, while offenders had a small attentional bias towards negative images. There was a significant positive relationship between distorted cognitions and an attentional bias towards negative images. There was a significant negative relationship between empathy and an attentional bias towards negative images