Impact of transferring arts dispensing from hospital to community pharmacies : a pilot study in Portugal

Copyright © 2018 Elsevier B.V. or its licensors or contributors.Objectives: Currently, in Portugal, People Living with HIV (PLHIV) refill antiretroviral therapy (ART) at Hospital Pharmacies (HP). We aimed to assess the impact of transferring ARTs dispensing from HP to community pharmacies (CPs) in the Portuguese setting.info:eu-repo/semantics/publishedVersio

Framework Report as Guidance for Case Studies

The main goal of the ENHANCE project is to develop and analyse new ways to enhance society's resilience to catastrophic natural hazard impacts. Key for achieving this goal is to analyse new multi-sector partnerships (MSPs) that aim at reduce or redistribute risk, and increase resilience. This document introduces a working definition of partnership, where MSPs are understood as: "...voluntary but enforceable commitments between partners from different sectors (public authorities, private services/enterprise and civil society), which can be temporary or long-lasting. They are founded on sharing the same goal in order to gain mutual benefit, reduce risk and increase resilience." (Rhodes, 1997) New forms of MSPs are needed, since it appears that existing partnerships are often not effective in managing risk from natural hazards. For example, the different responses to heat-waves and floods in Europe demonstrate that the roles of public, private, and civil society actors (including individuals) in preparing for and responding to catastrophic impacts are often neither clear nor effective. Moreover, actors must often base their risk management strategies on scarce, limited, or inaccurate risk information. Together, these factors can lead to the development of ineffective (prevention and mitigation) and unacceptable measures and unexpectedly large impacts of natural disasters (financial, ecological, health, and social). Moreover, in preparing for and responding to natural hazard impacts, there is also often a lack of clarity on financial responsibilities about who pays what, how much, and when. Hence, knowing the challenge of managing risks resulting from natural hazards has increased, it becomes clear that these risks cannot be handled by either private sector of the government as single actors, and strategies to increase resilience should therefore incorporate all sectors of society (including closer cooperation between sectors)

To what extent can behaviour change techniques be identified within an adaptable implementation package for primary care? A prospective directed content analysis

Interpreting evaluations of complex interventions can be difficult without sufficient description of key intervention content. We aimed to develop an implementation package for primary care which could be delivered using typically available resources and could be adapted to target determinants of behaviour for each of four quality indicators: diabetes control, blood pressure control, anticoagulation for atrial fibrillation and risky prescribing. We describe the development and prospective verification of behaviour change techniques (BCTs) embedded within the adaptable implementation packages

Methods for the evaluation of biomarkers in patients with kidney and liver diseases: multicentre research programme including ELUCIDATE RCT

Background: Protein biomarkers with associations with the activity and outcomes of diseases are being identified by modern proteomic technologies. They may be simple, accessible, cheap and safe tests that can inform diagnosis, prognosis, treatment selection, monitoring of disease activity and therapy and may substitute for complex, invasive and expensive tests. However, their potential is not yet being realised. Design and methods: The study consisted of three workstreams to create a framework for research: workstream 1, methodology – to define current practice and explore methodology innovations for biomarkers for monitoring disease; workstream 2, clinical translation – to create a framework of research practice, high-quality samples and related clinical data to evaluate the validity and clinical utility of protein biomarkers; and workstream 3, the ELF to Uncover Cirrhosis as an Indication for Diagnosis and Action for Treatable Event (ELUCIDATE) randomised controlled trial (RCT) – an exemplar RCT of an established test, the ADVIA Centaur® Enhanced Liver Fibrosis (ELF) test (Siemens Healthcare Diagnostics Ltd, Camberley, UK) [consisting of a panel of three markers – (1) serum hyaluronic acid, (2) amino-terminal propeptide of type III procollagen and (3) tissue inhibitor of metalloproteinase 1], for liver cirrhosis to determine its impact on diagnostic timing and the management of cirrhosis and the process of care and improving outcomes. Results: The methodology workstream evaluated the quality of recommendations for using prostate-specific antigen to monitor patients, systematically reviewed RCTs of monitoring strategies and reviewed the monitoring biomarker literature and how monitoring can have an impact on outcomes. Simulation studies were conducted to evaluate monitoring and improve the merits of health care. The monitoring biomarker literature is modest and robust conclusions are infrequent. We recommend improvements in research practice. Patients strongly endorsed the need for robust and conclusive research in this area. The clinical translation workstream focused on analytical and clinical validity. Cohorts were established for renal cell carcinoma (RCC) and renal transplantation (RT), with samples and patient data from multiple centres, as a rapid-access resource to evaluate the validity of biomarkers. Candidate biomarkers for RCC and RT were identified from the literature and their quality was evaluated and selected biomarkers were prioritised. The duration of follow-up was a limitation but biomarkers were identified that may be taken forward for clinical utility. In the third workstream, the ELUCIDATE trial registered 1303 patients and randomised 878 patients out of a target of 1000. The trial started late and recruited slowly initially but ultimately recruited with good statistical power to answer the key questions. ELF monitoring altered the patient process of care and may show benefits from the early introduction of interventions with further follow-up. The ELUCIDATE trial was an ‘exemplar’ trial that has demonstrated the challenges of evaluating biomarker strategies in ‘end-to-end’ RCTs and will inform future study designs. Conclusions: The limitations in the programme were principally that, during the collection and curation of the cohorts of patients with RCC and RT, the pace of discovery of new biomarkers in commercial and non-commercial research was slower than anticipated and so conclusive evaluations using the cohorts are few; however, access to the cohorts will be sustained for future new biomarkers. The ELUCIDATE trial was slow to start and recruit to, with a late surge of recruitment, and so final conclusions about the impact of the ELF test on long-term outcomes await further follow-up. The findings from the three workstreams were used to synthesise a strategy and framework for future biomarker evaluations incorporating innovations in study design, health economics and health informatics

The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people

Background and objectives: delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bespoke delirium prevention intervention, called ‘Stop Delirium!’ In preparation for a definitive trial of Stop Delirium, we sought to address key aspects of trial design for the particular circumstances of care homes. Design: a cluster randomized feasibility study with an embedded process evaluation. Setting and participants: residents of 14 care homes for older people in one metropolitan district in the UK. Intervention: Stop Delirium!: a 16-month-enhanced educational package to support care home staff to address key delirium risk factors. Control homes received usual care. Measurements: we collected data to determine the following: recruitment and attrition; delirium rates and variability between homes; feasibility of measuring delirium, resource use, quality of life, hospital admissions and falls; and intervention implementation and adherence. Results: two-thirds (215) of eligible care home residents were recruited. One-month delirium prevalence was 4.0% in intervention and 7.1% in control homes. Proposed outcome measurements were feasible, although our approach appeared to underestimate delirium. Health economic evaluation was feasible using routinely collected data. Conclusion: a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work

Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer with Central Nervous System Metastases for Patients Currently or Previously Treated with Trastuzumab (LANTERN): a Phase II Randomised Trial

Aims: Brain (central nervous system; CNS) metastases occur in 30–50% of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). A substantive evidence base for treatment is lacking, but activity with lapatinib plus capecitabine (lap-cap) has been reported. We compared lap-cap with trastuzumab plus capecitabine (tras-cap) in patients with HER2-positive MBC with CNS metastases previously treated with trastuzumab. Materials and methods: This open-label randomised phase II screening trial aimed to randomise 130 participants over 2 years to receive lap-cap or tras-cap. Eligible patients had HER2-positive MBC with newly diagnosed or recently progressed CNS metastases; previous, or current, treatment included: trastuzumab, a taxane or anthracycline and recent completion of local cranial therapy. The primary end point was time to progression of CNS metastases within the 24-week trial period. Secondary objectives included CNS response rate, progression-free survival, steroid use for CNS symptoms and feasibility of recruitment to a large phase III trial. Results: Between September 2011 and October 2013, 30 participants were randomised, 16 to lap-cap and 14 to tras-cap. Recruitment to a large phase III trial was determined not to be feasible. At 24 weeks, CNS disease progression was 41.8% (95% confidence interval 16.1–67.5%) in lap-cap and 41.2% (95% confidence interval 12.8–69.6%) in tras-cap arms; progression-free survival was 44.4% (95% confidence interval 18.1–70.8%) in lap-cap and 50.0% (95% confidence interval 20.9–79.1%) in tras-cap arms. Conclusion: Poor recruitment confirmed that a larger phase III trial would not be feasible and prohibited a preliminary evaluation of the superiority of lap-cap over tras-cap. Descriptive statistics are presented to inform the limited evidence base and future study design

NIHR Liver/Renal Biomarker Programme Final Report: Evaluating the benefits for patients and the NHS of new and existing biological fluid biomarkers in liver and renal disease

Protein biomarkers are naturally occurring substances that can be measured, often in fluids such as blood or urine, and which provide information about a patient and their illness. Different diseases have different biomarkers. When people become ill, changes in biomarker levels may occur before any clinical symptoms or signs become apparent. Measuring biomarkers in blood or urine is simple, safe and may help the doctor diagnose which disease the patient has, determine how severe it is, help choose the best treatment and help detect if the disease is getting worse or better. Unfortunately, for many diseases there are not enough biomarkers that are of proven usefulness in patient care today. New developments in research mean that many more are now being discovered but there is no quick and reliable way to decide which of the markers are good enough to be useful clinically. While our research proposal focusses on diseases of the liver and kidney, in the future it can also serve as the "blueprint" for similar work in other diseases. It is aimed at developing a structure and methods to assess the clinical usefulness of biomarkers as quickly and efficiently as possible. The research is divided into three parallel workstreams : 1. Identification of the best research methods for monitoring disease or treatment with biomarkers - the lack of understanding this has hampered this field so far. 2. The creation of a sample "banking" system for collecting and storing patient samples and relevant clinical data from large numbers of patients. This will allow the immediate testing of potential new biomarkers now and in the future. The best biomarkers would then go on to full trials to see if patients and the NHS would benefit from their use. 3. A clinical trial at multiple hospitals in the UK of three new biomarkers for liver damage (together called the "Enhanced liver fibrosis" or "ELF", test). We will find out if ELF can give early warning of dangerous liver damage (cirrhosis) and therefore reduce the risk of major complications. This trial may radically alter the way in which patients with liver disease can be looked after clinically. This research programme will benefit patients and the NHS by ensuring that biomarkers in the future can be evaluated and introduced more rapidly, improving clinical management for each individual patient and leading to better use of NHS resources