Costing resource use of the Namaste Care Intervention UK: a novel framework for costing dementia care interventions in care homes.

OBJECTIVES: To develop a representative full cost model for a UK version of the multi-component, non-pharmacological Namaste Care intervention for care home residents with advanced dementia. DESIGN: The Namaste Care Intervention UK comprises multiple individual cost components, and a comprehensive list of all possible resources that could be expended in each cost component formed the initial stage of the cost model development. Resource use was divided into three key areas: staff, capital and consumables. Representative costs were identified for each of the possible resources, with a standard approach being used for all resources within each of the three key areas.Assumptions were made regarding the number and duration of sessions, group size, involvement of different staff members, and additional activity before and after a session, as these all have an impact on resource use and hence cost. A comparable 'usual care' session for residents not receiving Namaste Care was also costed to enable the 'additional' cost of delivering Namaste Care to be calculated. RESULTS: The full cost model indicates that Namaste Care Intervention UK costs approximately £8-£10 more per resident per 2-hour session than a comparable period of usual care. However, positive impacts on resident and staff well-being resulting from receiving Namaste Care will also have their own associated costs/benefits which may negate the 'additional' cost of the intervention. CONCLUSIONS: The cost model provides the first opportunity to investigate the full costs associated with Namaste Care, and will be refined as additional information is captured during subsequent phases of the research.

The EQ-5D-5L Valuation Study in Egypt.

INTRODUCTION: No value sets exist for either the EQ-5D-3L or the EQ-5D-5L in Egypt, despite local pharmacoeconomic guidelines recommending the use of the EQ-5D to derive utility. Most published Egyptian economic evaluation studies have used utility values from other published studies and systematic reviews. OBJECTIVE: Our objective was to develop an Egyptian EQ-5D-5L value set using the international EuroQol standardized protocol (EQ-VT-2.1). This study is a revision of a previous EQ-5D-5L value set for Egypt retracted by the authors. METHODS: Adult Egyptian participants were recruited from public places using multi-stratified quota sampling based on age, sex, and geographical distribution. Two elicitation techniques were applied: the composite time trade-off (cTTO) and discrete-choice experiments (DCEs). Before actual data collection, interviewers' performance was assessed in a pilot phase. Data were modelled using generalized least squares, Tobit, heteroskedastic, logit, and hybrid models, and the best fitting model was selected based on logical consistency of the parameters, significance level, prediction accuracy, and model parsimony. RESULTS: A total of 1378 interviews were conducted, of which 188 were excluded because they were incomplete and did not comply with the protocol, 216 were pilot interviews, and 974 were included in the final analysis. The heteroskedastic model with constraints (model 4) based on the cTTO data was selected as the preferred model to generate the value set. Values ranged from - 0.964 for the worst health state (55555) to 1 for full health (11111) and 0.948 for 11211, with 1123 of all predicted health states (35.94%) being worse than dead. Mobility had the largest impact on health state preference values. CONCLUSION: This is the first value set for the EQ-5D-5L based on social preferences obtained from a nationally representative sample in Egypt or any Arabic-speaking country. The value set can be used as a scoring system for economic evaluation and to improve the quality of health technology assessment in the Egyptian healthcare system.

Pharmacoeconomics Education in the Middle East and North Africa Region: A Web-Based Research Project.

OBJECTIVES: Pharmacoeconomics (PE) is a relatively new science that is gaining special attention in many countries of the Middle East and North Africa (MENA) region that have limited healthcare resources. Therefore, education is crucial for capacity building in PE in the region. This study aimed to assess the current status of PE education in schools of pharmacy in the MENA region and shed some light on the role played by ISPOR chapters in PE education. METHODS: A survey containing 5 questions about PE education in 14 MENA countries was self-answered by 2 investigators after screening information available on college or school of pharmacy official websites. RESULTS: Of 176 schools of pharmacy in the MENA region, only 80 offer PE educational courses. Egypt and Jordan have the highest number of schools offering PE teaching, especially on the professional level for undergraduates. The graduate level of PE education was offered mostly in Iran and Egypt. The fundamentals of PE was the topic most taught, whereas decision analysis and modeling topics were the least taught topics. Different ISPOR chapters were found to play a crucial role in developing focused health economics education for better healthcare decision making. CONCLUSIONS: There has been an increase in the number of schools of pharmacy offering PE education in the MENA region; however, PE education and research need improvement. Providing structured PE education should be encouraged to establish the infrastructure needed for allocation of limited healthcare resources. Furthermore, updating websites of schools of pharmacy is essential to obtain a complete picture of the PE education in the MENA region.

Portfolio frontier analysis: Applying mean-variance analysis to health technology assessment for health systems under pressure.

The COVID-19 pandemic is challenging how healthcare technologies are evaluated, as new, more dynamic methods are required to test the cost effectiveness of alternative interventions during use rather than before initial adoption. Currently, health technology assessment (HTA) tends to be static and a priori: alternatives are compared before launch, and little evaluation occurs after implementation. We suggest a method that builds upon the current pre-launch HTA procedures by conceptualizing a mean-variance approach to the continuous evaluation of attainable portfolios of interventions in health systems. Our framework uses frontier analysis to identify the desirability of available health interventions so decision makers can choose diverse portfolios based upon information about expected returns and risks. This approach facilitates the extension of existing methods and assessments beyond the traditional concern with pre-adoption data, a much-needed innovation given the challenges posed by COVID-19.

The EQ-5D-5L Valuation Study in Egypt.

INTRODUCTION: No value sets exist for either the EQ-5D-3L or the EQ-5D-5L in Egypt, despite local pharmacoeconomic guidelines recommending the use of the EQ-5D to derive utility. Most published Egyptian economic evaluation studies have used utility values from other published studies and systematic reviews. OBJECTIVE: Our objective was to develop an Egyptian EQ-5D-5L value set using the international EuroQol standardized protocol (EQ-VT-2.1). METHODS: Adult Egyptian participants were recruited from public places using multi-stratified quota sampling based on age, sex, and geographical distribution. Two elicitation techniques were applied: the composite time trade-off (cTTO) and discrete-choice experiments (DCEs). Before actual data collection, interviewers' performance was assessed in a pilot phase. Data were modelled using generalized least square, Tobit, heteroskedastic, logit, and hybrid models, and the best fitting model was selected based on the value range between observed and predicted values, logical consistency of the parameters, significance level, and prediction accuracy. RESULTS: A total of 1378 interviews were conducted, of which 188 were excluded because they were incomplete or did not comply with protocol, 216 were pilot interviews, and 974 were included in the final analysis. The heteroskedastic model (model 4) based on the cTTO data was selected as the preferred model to generate the value set. Values ranged from - 0.93 for the worst health state (55555) to 1 for full health (11111), with 1136 (36.3%) of all predicted health states being worse than dead. Mobility had the largest impact on health state preference values. CONCLUSION: This is the first value set for the EQ-5D-5L based on social preferences obtained from a nationally representative sample in Egypt or any Arabic-speaking country. The value set can be used as a scoring system for economic evaluations and to improve the quality of health technology assessment in the Egyptian healthcare system.

The Fourth Industrial Revolution: Will it change pharmacy practice?

The industrial world is at the beginning of a Fourth Industrial Revolution (4IR). This era will radically change the human use of technology, with major implications for the ways people live and work. This commentary asks: will 4IR change pharmacy practice? The first three revolutions created the pharmaceutical industry and gave pharmacists a near-monopoly over drug supply. 4IR could do the opposite and create alternative, non-pharmaceutical means of treating patients as well reducing the involvement in medicines supply. If the pharmacy sector becomes stuck in traditional, linear thinking that assumes the future will be an extension of the past, then the fourth revolution may be less of an opportunity and more of a threat. The sector faces the "innovator's dilemma" when responding to 4IR. Should the pharmacy profession disrupt their current activities in order to: (i) do things better, (ii) do new things, and (iii) deter competition? To maintain its position in the medical marketplace, pharmacy needs to discover how to work with AI, robotics, IoT, autonomous vehicles, 3-D printing, nanotechnology, biotechnology, materials science, energy storage, and quantum computing. If the new game is understood, pharmacists may become the playmaster of tomorrow. If not, then the practice of pharmacy may be replaced by innovative new ways of meeting patient pharmaceutical needs.

Pharmaceutical Policy Reforms to Regulate Drug Prices in the Asia Pacific Region: The Case of Australia, China, India, Malaysia, New Zealand, and South Korea.

Medicine price directly affects affordability and access to medicines particularly in countries where a major portion of pharmaceutical spending is through out-of-pocket payment, such as in the Asia Pacific region. We have undertaken a detailed appraisal of the pharmaceutical policy reforms to regulate drug prices in 3 developed (Australia, New Zealand, and South Korea) and 3 emerging (China, India, and Malaysia) economies of the Asia Pacific region. Despite continuous efforts by the authorities in adopting a wide range of reformatory pharmaceutical pricing policies to ensure affordability of medicines, these policies may not be optimal where drug prices were not lowered as expected (eg, in Korea). On the contrary, considerable price reductions of various pharmaceuticals have been observed in New Zealand and India because of the reform in pharmaceutical pricing policy. This review of pharmaceutical pricing reforms reinforces the need for constant monitoring by policy makers in Asia Pacific countries to regulate drug prices and to undertake reform in pharmaceutical pricing policies when necessary to ensure affordability and access to medicines.

Community-based testing of migrants for infectious diseases (COMBAT-ID): impact, acceptability and cost-effectiveness of identifying infectious diseases among migrants in primary care: protocol for an interrupted time-series, qualitative and health economic analysis.

BACKGROUND: Migration is a major global driver of population change. Certain migrants may be at increased risk of infectious diseases, including tuberculosis (TB), HIV, hepatitis B and hepatitis C, and have poorer outcomes. Early diagnosis and management of these infections can reduce morbidity, mortality and onward transmission and is supported by national guidelines. To date, screening initiatives have been sporadic and focused on individual diseases; systematic routine testing of migrant groups for multiple infections is rarely undertaken and its impact is unknown. We describe the protocol for the evaluation of acceptability, effectiveness and cost-effectiveness of an integrated approach to screening migrants for a range of infectious diseases in primary care. METHODS AND ANALYSIS: We will conduct a mixed-methods study which includes an observational cohort with interrupted time-series analysis before and after the introduction of routine screening of migrants for infectious diseases (latent TB, HIV, hepatitis B and hepatitis C) when first registering with primary care within Leicester, UK. We will assess trends in the monthly number and rate of testing and diagnosis for latent TB, HIV, hepatitis B and hepatitis C to determine the effect of the policy change using segmented regression analyses at monthly time-points. Concurrently, we will undertake an integrated qualitative sub-study to understand the views of migrants and healthcare professionals to the new testing policy in primary care. Finally, we will evaluate the cost-effectiveness of combined infection testing for migrants in primary care. ETHICS AND DISSEMINATION: The study has received HRA and NHS approvals for both the interrupted time-series analysis (16/SC/0127) and the qualitative sub-study (16/EM/0159). For the interrupted time-series analysis we will only use fully anonymised data. For the qualitative sub-study, we will gain written, informed, consent. Dissemination of the results will be through local and national meetings/conferences as well as publications in peer-reviewed journals.

A Scoping Review of the Quality and the Design of Evaluations of Mobile Health, Telehealth, Smart Pump and Monitoring Technologies Performed in a Pharmacy-Related Setting.

Background: There is currently a need for high quality evaluations of new mobile health, telehealth, smart pump and monitoring technologies undertaken in a pharmacy-related setting. We aim to evaluate the use of these monitoring technologies performed in this setting. Methods: A systematic searching of English articles that examined the quality and the design of technologies conducted in pharmacy-related facilities was performed using the following databases: MEDLINE and Cumulative index to Nursing and Allied Health Literature (CINAHL) to identify original studies examining the quality and the design of technologies and published in peer-reviewed journals. Extraction of articles and quality assessment of included articles were performed independently by two authors. Quality scores over 75% are classed as being acceptable using a "relatively conservative" quality benchmark. Scores over 55% are included using a "relatively liberal" cut-off point. Results: Screening resulted in the selection of 40 formal evaluations. A substantial number of studies (32, 80.00%) were performed in the United States, quantitative in approach (33, 82.50%) and retrospective cohort (24, 60.00%) in study design. The most common pharmacy-related settings were: 22 primary care (55.00%); 10 hospital pharmacy (25.00%); 7 community pharmacy (17.50%); one primary care and hospital pharmacy (2.50%). The majority of the evaluations (33, 82.50%) reported clinical outcomes, six (15.00%) measured clinical and economic outcomes, and one (2.50%) economic only. Twelve (30.00%) quantitative studies and no qualitative study met objective criteria for "relatively conservative" quality. Using a lower "relatively liberal" benchmark, 27 quantitative (81.82%) and four qualitative (57.41%) studies met the lower quality criterion. Conclusion: Worldwide, few evaluations of mobile health, telehealth, smart pump and monitoring technologies in pharmacy-related setting have been published.Their quality is often below the standard necessary for inclusion in a systematic review mainly due to inadequate study design.

Economic evaluation of prescribing conventional and newer oral anticoagulants in older adults.

INTRODUCTION: Anticoagulants refer to a variety of agents that inhibit one or more steps in the coagulation cascade. Generally, clinical conditions that require the prescribing of an oral anticoagulant increase in frequency with age. However, a major challenge of anticoagulation use among older patients is that this group of patients also experience the highest bleeding risk. To date, economic evaluation of prescribing of anticoagulants that includes the novel or newer oral anticoagulants (NOACs) in older adults has not been conducted and is warranted. AREAS COVERED: A review of articles that evaluated the cost of prescribing conventional (e.g. vitamin K antagonists) and NOACs (e.g. direct thrombin inhibitors and direct factor Xa inhibitors) in older adults. EXPERT COMMENTARY: While the use of NOACs significantly increases the cost of the initial treatment for thromboembolic disorders, they are still considered cost-effective relative to warfarin since they offer reduced risk of intracranial haemorrhagic events. The optimum anticoagulation with warfarin can be achieved by providing specialised care; clinics managed by pharmacists have been shown to be cost-effective relative to usual care. There are suggestions that genotyping the CYP2C9 and VKORC1 genes is useful for determining a more appropriate initial dose and thereby increasing the effectiveness and safety of warfarin.

Developing the evidence base for gender- and age-relevant school sex education: questionnaire findings from an adolescent sample using an augmented theory of planned behaviour.

BACKGROUND: Positive adolescent sexual health is supported by effective school-based sex education. Methods to promote positive sexual health need to reflect determinants of contraception intention, which must include understanding gender and age (year group) differences. To date, there has been limited theory-based exploration of these determinants in school age participants, placing limitations on sexual health educators to tailor learning most effectively. METHODS: Cross-sectional survey data were collected from UK school pupils (n=1378) aged 12-16 years. Measures included theory of planned behaviour, prototype willingness, anticipated regret and knowledge items. Linear regression determined significant predictors of intention to use condoms, the oral contraceptive pill and emergency contraception (EC). The significance of differences by gender and school year was evaluated using t-tests and analysis of variance (ANOVA). RESULTS: Three distinct predictive models emerged for condom, pill and EC use, predicting 36%, 18% and 23% of variance respectively. Attitude, gender and anticipated regret for unprotected sex significantly predicted intention for all types of contraception (P<0.001). The effects of other explanatory variables differed by contraceptive. Girls scored higher on all variables except condom intention, and intention scores peaked in Year 10. CONCLUSION: Intention to use condoms, the pill and EC have different predictive profiles, with girls more strongly motivated and Year 10 a crucial stage for intention. Social comparisons and control beliefs exert different effects across contraceptive types, whereas attitudes and anticipated regret are consistently strong influences. The findings suggest clear scope for supporting sexual health and well being through modified school sex education.

Evaluation of a protocol-based intervention to promote timely switching from intravenous to oral paracetamol for post-operative pain management: an interrupted time series analysis.

RATIONALE, AIMS AND OBJECTIVES: Timely switching from intravenous to oral therapy ensures optimized treatment and efficient use of health care resources. Intravenous (IV) paracetamol is widely used for post-operative pain management but not always switched to the oral form in a timely manner, leading to unnecessary increase in expenditure. This study aims to evaluate the impact of a multifaceted intervention to promote timely switching from the IV to oral form in the post-operative setting. METHODS: An evidence-based prescribing protocol was designed and implemented by the clinical pharmacy team in a single district general hospital in Egypt. The protocol specified the criteria for appropriate prescribing of IV paracetamol. Doctors were provided with information and educational sessions prior to implementation. A prospective, quasi-experimental study was undertaken to evaluate its impact on IV paracetamol utilization and costs. Data on monthly utilization and costs were recorded for 12 months before and after implementation (January 2012 to December 2013). Data were analysed using interrupted time series analysis. RESULTS: Prior to implementation, in 2012, total spending on IV paracetamol was 674 154.00 Egyptian Pounds (L.E.) ($23,668.00). There was a non-significant (P > 0.05) downward trend in utilization (-32 ampoules per month) and costs [reduction of 632 L.E. ($222) per month]. Following implementation, immediate decrease in utilization and costs (P < 0.05) and a trend change over the follow-up period were observed. Average monthly reduction was 26% (95% CI: 24% to 28%, P < 0.001). CONCLUSION: A multifaceted, protocol-based intervention to ensure timely switching from IV-to-oral paracetamol achieved significant reduction in utilization and cost of IV paracetamol in the first 5 months of its implementation.

Primary care physicians' attitudes to health care reform in England.

Primary care organisation in England has been subject to particularly extensive and far-reaching reform in recent years. In 1991, a quasi-market was introduced into the National Health Service and general practitioners were offered the opportunity to manage independent budgets from which to purchase and deliver care services. Practitioners joined the scheme in increasing numbers, although it was eventually abandoned following a change of government in 1997. This paper reports the results of two surveys of primary care physicians' opinions on the English health care reforms, conducted in 1997 and 2000. It concludes that, first, those opting for discretionary budgets were significantly more supportive of the policy than those not joining the scheme and this support continued long after the scheme had been abolished. Second, professional attitudes, with respect to other terms of service in primary care, remained homogenous to a considerable degree over time. Finally, physicians in favour of imposing user charges tend to be those with responsibility for more patients, suggesting a perceived need to manage patient demand.

Evaluation of the clinical and cost effectiveness of intermediate care clinics for diabetes (ICCD): a multicentre cluster randomised controlled trial.

BACKGROUND: Configuring high quality care for the rapidly increasing number of people with type 2 diabetes (T2D) is a major challenge worldwide for both providers and commissioners. In the UK, about two thirds of people with T2D are managed entirely in primary care, with wide variation in management strategies and achievement of targets. Pay for performance, introduced in 2004, initially resulted in improvements but disparities exist in ethnic minorities and the improvements are levelling off. Community based, intermediate care clinics for diabetes (ICCDs) were considered one solution and are functioning across the UK. However, there is no randomised trial evidence for the effectiveness of such clinics. TRIAL DESIGN, METHODS AND FINDINGS: This is a cluster-randomised trial, involving 3 primary care trusts, with 49 general practices randomised to usual care (n=25) or intervention (ICCDs; n=24). All eligible adult patients with T2D were invited; 1997 were recruited and 1280 followed-up after 18-months intervention. PRIMARY OUTCOME: achievement of all three of the NICE targets [(HbA1c ≤ 7.0%/53 mmol/mol; Blood Pressure <140/80 mmHg; cholesterol <154 mg/dl (4 mmol/l)]. PRIMARY OUTCOME was achieved in 14.3% in the intervention arm vs. 9.3% in the control arm (p=0.059 after adjustment for covariates). The odds ratio (95% CI) for achieving primary outcome in the intervention group was 1.56 (0.98, 2.49). Primary care and community clinic costs were significantly higher in the intervention group, but there were no significant differences in hospital costs or overall healthcare costs. An incremental cost-effectiveness ratio (ICER) of +£7,778 per QALY gained, indicated ICCD was marginally more expensive at producing health gain. CONCLUSIONS: Intermediate care clinics can contribute to improving target achievement in patients with diabetes. Further work is needed to investigate the optimal scale and organisational structure of ICCD services and whether, over time, their role may change as skill levels in primary care increase. TRIAL REGISTRATION: ClinicalTrials.gov NCT00945204; National Research Register (NRR) M0014178167.

A cluster randomized controlled trial of the effectiveness and cost-effectiveness of intermediate care clinics for diabetes (ICCD): study protocol for a randomized controlled trial.

BACKGROUND: World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. METHODS/DESIGN: This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or CONTROL GROUP: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients. DISCUSSION: Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012. TRIAL REGISTRATION: [ClinicalTrials.gov: Identifier NCT00945204].