A new paradigm evaluating cost per cure of HCV infection in the UK.

BACKGROUND: New interferon (IFN)-free treatments for hepatitis C are more effective, safer but more expensive than current IFN-based therapies. Comparative data of these, versus current first generation protease inhibitors (PI) with regard to costs and treatment outcomes are needed. We investigated the real-world effectiveness, safety and cost per cure of 1st generation PI-based therapies in the UK. METHODS: Medical records review of patients within the HCV Research UK database. Patients had received treatment with telaprevir or boceprevir and pegylated interferon and ribavirin (PR). Data on treatment outcome, healthcare utilisation and adverse events (AEs) requiring intervention were collected and analysed overall and by subgroups. Costs of visits, tests, therapies, adverse events and hospitalisations were estimated at the patient level. Total cost per cure was calculated as total median cost divided by SVR rate. RESULTS: 154 patients from 35 centres were analysed. Overall median total cost per cure was £44,852 (subgroup range,: £35,492 to £107,288). Total treatment costs were accounted for by PI: 68.3 %, PR: 26.3 %, AE management: 5.4 %. Overall SVR was 62.3 % (range 25 % to 86.2 %). 36 % of patients experienced treatment-related AEs requiring intervention, 10 % required treatment-related hospitalisation. CONCLUSIONS: This is the first UK multicentre study of outcomes and costs of PI-based HCV treatments in clinical practice. There was substantial variation in total cost per cure among patient subgroups and high rates of treatment-related discontinuations, AEs and hospitalisations. Real world safety, effectiveness and total cost per cure for the new IFN free combinations should be compared against this baseline.

A mixed methods feasibility study to evaluate the use of a low-intensity, nurse-delivered cognitive behavioural therapy for the treatment of irritable bowel syndrome.

INTRODUCTION: Irritable bowel syndrome (IBS) is characterised by symptoms such as abdominal pain, constipation, diarrhoea and bloating. These symptoms impact on health-related quality of life, result in excess service utilisation and are a significant burden to healthcare systems. Certain mechanisms which underpin IBS can be explained by a biopsychosocial model which is amenable to psychological treatment using techniques such as cognitive behavioural therapy (CBT). While current evidence supports CBT interventions for this group of patients, access to these treatments within the UK healthcare system remains problematic. METHODS AND ANALYSIS: A mixed methods feasibility randomised controlled trial will be used to assess the feasibility of a low-intensity, nurse-delivered guided self-help intervention within secondary care gastrointestinal clinics. A total of 60 participants will be allocated across four treatment conditions consisting of: high-intensity CBT delivered by a fully qualified cognitive behavioural therapist, low-intensity guided self-help delivered by a registered nurse, self-help only without therapist support and a treatment as usual control condition. Participants from each of the intervention arms of the study will be interviewed in order to identify potential barriers and facilitators to the implementation of CBT interventions within clinical practice settings. Quantitative data will be analysed using descriptive statistics only. Qualitative data will be analysed using a group thematic analysis. ETHICS AND DISSEMINATION: This study will provide essential information regarding the feasibility of nurse-delivered CBT interventions within secondary care gastrointestinal clinics. The data gathered during this study would also provide useful information when planning a substantive trial and will assist funding bodies when considering investment in substantive trial funding. A favourable opinion for this research was granted by the Nottingham 2 Research Ethics Committee. TRIAL REGISTRATION NUMBER ISRCTN: 83683687 (http://www.controlled-trials.com/ISRCTN83683687).

Cross-cultural validity of the Self-Stigma of Seeking Help (SSOSH) scale: examination across six nations.

Researchers have found that the stigma associated with seeking therapy--particularly self-stigma--can inhibit the use of psychological services. Yet, most of the research on self-stigma has been conducted in the United States. This is a considerable limitation, as the role of self-stigma in the help-seeking process may vary across cultural groups. However, to examine cross-cultural variations, researchers must first develop culturally valid scales. Therefore, this study examined scale validity and reliability of the widely used Self-Stigma of Seeking Help scale (SSOSH; Vogel, Wade, & Haake, 2006) across samples from 6 different countries (England, Greece, Israel, Taiwan, Turkey, and the United States). Specifically, we used a confirmatory factor analysis framework to conduct measurement invariance analysis and latent mean comparisons of the SSOSH across the 6 sampled countries. Overall, the results suggested that the SSOSH has a similar univariate structure across countries and is sufficiently invariant across countries to be used to explore cultural differences in the way that self-stigma relates to help-seeking behavior.