Investigation of the hospital pharmacy profession in Europe.

OBJECTIVE: From 1995, the European Association of Hospital Pharmacists (EAHP) has regularly investigated the progress of the hospital pharmacy profession in Europe, and identified key barriers and drivers of this. The most recent 'Investigation of the Hospital Pharmacy Profession in Europe' was conducted from November 2022 to March 2023. METHODS: The online questionnaire was sent to all hospital pharmacies in EAHP member countries. The investigation was drafted using the same questions as the 2015 baseline survey. Where possible and relevant, responses were compared with the data from previous surveys that monitored the implementation of the EAHP statements. Keele University, Centre for Medicines Optimisation, School of Pharmacy and Bioengineering, UK analysed the data. RESULTS: The overall number of responses was 653, with a better response rate of 19% compared with 14% in 2018 statements survey. The findings indicated that participating hospital pharmacies have similar characteristics to previous surveys. Section 1 (Introductory statements and governance), section 2 (Selection, procurement and distribution), section 3 (Production and compounding), section 5 (Patient safety and quality assurance) questions were generally answered positively, with results ranging from 52% to 90%. However, results for section 4 (Clinical pharmacy services) returned lower levels of positivity, with responses from 8 of the 15 questions being less than 60%. When asked what is preventing hospital pharmacists from achieving implementation of these activities, most answers were limited capacity, not considered to be a priority by managers, or other healthcare professionals do this. The last section focused on self-assessment and action planning, with fewer than 50% of positive responses; COVID-19 preparedness and vaccines with mixed positive and negative responses. Furthermore, implementation of the falsified medicines directive impacted the medication handling processes in 50% or more of the answers. Regarding sustainability, the majority (59%) of respondents felt a greater focus should be on sustainability from an organisational or management perspective. CONCLUSION: Results offer valuable insights into the hospital pharmacy profession throughout Europe. While there have been improvements in certain areas, challenges remain, particularly in implementing clinical pharmacy services. The findings provide a foundation for further dialogue, advocacy, and strategic planning to advance the role of hospital pharmacists and enhance patient care in Europe's healthcare systems.

What outcomes have been reported on patients following open lower limb fracture, and how have they been measured?

Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years. Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy. A total of 532 eligible studies were identified, reporting 1,803 outcomes with 786 unique outcome terms, which collapsed to 82 standardized outcome headings. Overall 479 individual outcome measurement instruments were identified, including 298 outcome definitions, 27 patient- and 18 clinician-reported outcome measures, and six physical performance measures. The most-reported outcome was 'bone union/healing' reported in over 50% of included studies, while health-related quality of life was only measured in 6% of included studies. Outcomes reported for people recovering from open lower limb fracture are heterogeneous, liable to outcome reporting bias, and vary widely in the definitions and the measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical functioning, have been neglected. This systematic review identifies the need to unify outcome measures reported on patients recovering from open lower limb fracture; this may be addressed by creating a core outcome set.

Development of the FORUM: a new patient and clinician reported outcome measure for forensic mental health services.

Forensic mental health services provide care to people in secure psychiatric hospitals and via specialised community teams. Such services are typically low volume and high cost, often highly restrictive and average duration of inpatient care prior to discharge is long. Measuring outcomes of care is important to safeguard patients and the public, monitor progress, inform treatment plans and assist in service evaluation and planning. We describe the development in England of a new outcome measure for forensic mental health services. Patient interviews and multistakeholder focus groups were held to elicit key concepts. Thematic analysis was used to develop an outcomes framework. Fifteen patients participated in the interviews and 48 stakeholders in the focus groups. Six domains were identified in thematic analysis: 'about me, my quality of life, my health, my safety and risk, my life skills and my progress'. Sixty-two stakeholders participated in the first round of the Delphi process, and 49 completed round two. Eight of the top fifteen outcomes were shared between patients/carers and professionals. Based on these results, a new outcome measure, the FORensic oUtcome Measure (FORUM), was developed including both a patient reported and clinician reported measure. Further assessment of the FORUM's use to track patients' progress over time, and facilitate shared decision-making and care planning, is required.

Carotid-Axillary Bypass and Debridement for a Mycotic Aneurysm of the Left Subclavian Artery.

Mycotic subclavian aneurysms are rare, and their presence typically mandates urgent repair due to the associated high risk of rupture and mortality. A multi-disciplinary team effort is of utmost importance in ensuring favorable results. In this case report, we present a 79-year-old male with a rapidly enlarging mycotic left subclavian artery aneurysm secondary to a retrosternal abscess and left sternoclavicular septic arthritis, who underwent aneurysmal exclusion, a left carotid-left axillary bypass and pectoralis muscle flap coverage with a good outcome.

Perinatal depression in migrant and refugee women on the Thai-Myanmar border: does social support matter?

Migrant and refugee women are at risk of perinatal depression due to stressors experienced before, during and after migration. This study assesses the associations between social support and perinatal depression among migrant and refugee women on the Thai-Myanmar border. We conducted a cohort study of pregnant and post-partum women. Depression status was assessed using a structured clinical interview. Received support, perceived support and partner support were measured in the third trimester. Logistic regression was used to calculate associations between social support measures and perinatal depression controlling for demographic, socio-economic, migration, obstetric and psychosocial factors. Four hundred and fifty-one women (233 migrants; 218 refugees) were included. The prevalence of perinatal depression was 38.6% in migrants and 47.3% in refugees. Migrants had higher levels of received, perceived and partner support than refugees. After controlling for all other variables, higher levels of received support remained significantly associated with a lower likelihood of perinatal depression in migrants (adjusted odds ratio 0.82; 95% CI 0.68-0.99). In both groups, depression history and trauma were strongly associated with perinatal depression. Our study highlights the importance of received social support to perinatal depression in migrant women on the Thailand-Myanmar border. The perinatal period offers a valuable opportunity to ask women about their support and offer community-level or public policy interventions to nurture support networks in current locations and resettlement destinations. This article is part of the theme issue 'Multidisciplinary perspectives on social support and maternal-child health'.

Specialty COPD care during COVID-19: patient and clinician perspectives on remote delivery.

INTRODUCTION: The COVID-19 pandemic has impacted specialty chronic obstructive pulmonary disease (COPD) care. We examined the degree to which care has moved to remote approaches, eliciting clinician and patient perspectives on what is appropriate for ongoing remote delivery. METHODS: Using an online research platform, we conducted a survey and consensus-building process involving clinicians and patients with COPD. RESULTS: Fifty-five clinicians and 19 patients responded. The majority of clinicians felt able to assess symptom severity (n=52, 95%), reinforce smoking cessation (n=46, 84%) and signpost to other healthcare resources (n=44, 80%). Patients reported that assessing COPD severity and starting new medications were being addressed through remote care. Forty-three and 31 respondents participated in the first and second consensus-building rounds, respectively. When asked to rate the appropriateness of using remote delivery for specific care activities, respondents reached consensus on 5 of 14 items: collecting information about COPD and overall health status (77%), providing COPD education and developing a self-management plan (74%), reinforcing smoking cessation (81%), deciding whether patients should seek in-person care (72%) and initiating a rescue pack (76%). CONCLUSION: Adoption of remote care delivery appears high, with many care activities partially or completely delivered remotely. Our work identifies strengths and limitations of remote care delivery.

A disease beyond the aortic arch presenting as a hypertensive emergency.

The mid-aortic syndrome, also known as mid-aortic dysplastic syndrome or coarctation of aorta, is a rare clinical entity due to the narrowing of the distal thoracic and/or abdominal aorta and its branches. It has various causes including congenital or acquired although idiopathic is the most common cause. It is more common in children and adolescents. Here we present a unique case of a 52-year-old woman who presented with shortness of breath, chest pain, and hypertensive emergency and was found to have high-grade mid-aortic stenosis which was successfully managed with surgery with no post-operative complications and complete resolution of her symptoms. .

Home monitoring with technology-supported management in chronic heart failure: a randomised trial.

OBJECTIVES: We aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients' quality of life than digital home monitoring alone. METHODS: In a two-armed partially blinded parallel randomised controlled trial, seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years SD 11.1; left ventricular ejection fraction 32.9% SD 15.4). Participants in both study arms were given a tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. Participants randomised to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of guideline-recommended medical therapy for chronic HF and major comorbidities, measured as a composite opportunity score (total number of recommended treatment given divided by the total number of opportunities the treatment should have been given, with a score 1 indicating 100% adherence to recommendations). Co-primary outcome was change in physical score of Minnesota Living with Heart Failure questionnaire. RESULTS: 101 patients were randomised to 'enhanced self-management' and 101 to 'supported medical management'. At the end of follow-up, the opportunity score was 0.54 (95% CI 0.46 to 0.62) in the control arm and 0.61 (95% CI 0.52 to 0.70) in the intervention arm (p=0.25). Physical well-being of participants also did not differ significantly between the groups (17.4 (12.4) mean (SD) for control arm vs 16.5 (12.1) in treatment arm; p for change=0.84). CONCLUSIONS: Central provision of tailored specialist management in a multi-morbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life. TRIAL REGISTRATION NUMBER: ISRCTN86212709.

Prevalence and determinants of perinatal depression among labour migrant and refugee women on the Thai-Myanmar border: a cohort study.

BACKGROUND: Perinatal depression is a significant contributor to maternal morbidity and mortality globally. Migrant women, particularly those living in low- and middle-income settings, represent a particularly vulnerable group due to stressors experienced before, during and after migration. The vast majority of global migration flows occurring within and between low- and middle-income regions, yet existing evidence focuses predominantly on migrants in high-income destinations. This study aimed to redress this significant gap in the evidence by determining the prevalence and determinants of perinatal depression among migrant women on the Thai-Myanmar border. METHODS: A cohort of labour migrant and refugee women was followed-up from the first trimester of pregnancy to one month post-partum. Depression status was assessed in the first, second and third trimesters of pregnancy and at one month post-partum using the Structured Clinical Interview for the Diagnosis of DSM-IV Disorders. Women diagnosed with depression had immediate access to care. Data on potential demographic, social and clinical associated factors was collected using a questionnaire. Prevalence and incidence of any depressive disorder and moderate-severe depressive disorder was calculated. Univariable and multivariable logistic regression using complete case analysis was used to estimate odds ratios (OR) of association between exposure variables and depression status. RESULTS: Five hundred sixty-eight women participated. Period prevalence (from first trimester of pregnancy to one month post-partum) of moderate-severe perinatal depression was 18.5% (95% CI 15.4-21.9%). Overall, 15.4% (95% CI 11.8-19.6%) of women developed new-onset moderate-severe depression during the study period. Forty-two participants received treatment for depression. Risk factors were interpersonal violence (OR 4.5; 95% CI 1.9-11.1); history of trauma (OR 2.4; 95% CI 1.4-4.3); self-reported history of depression (OR 2.3; 95% CI 1.2-4.2); labour migrant status (OR 2.1; 95% CI 1.1-4.0); low social support (OR 2.1; 95% CI 1.1-3.7); and maternal age (OR 1.1 per year; 95% CI 1.0-1.1). Limitations of the study include that culturally specific manifestations of depression may have been missed. CONCLUSIONS: Perinatal depression represents a significant burden among migrant women on the Thai-Myanmar border. Programmes to address the determinants along with early case identification and effective treatment and referral systems are key to addressing perinatal depression in this low-resource setting.

Geographical Variation in Outcomes of Primary Hip and Knee Replacement.

Importance: Little is known about variation in outcomes of surgery or about the factors associated with such variation. Objectives: To evaluate variation in patient outcomes and costs for primary hip and knee replacement across health areas in England and to identify whether patient, surgical, or hospital factors are associated with such variation. Design, Setting, and Participants: This cohort study used data from the National Joint Registry, linked to English Hospital Episode Statistics and Patient Reported Outcome Measures data sets, for 383 382 adult patients who underwent primary total hip replacement (THR) or primary total and unicompartmental knee replacement (TKR) surgical procedures from January 2014 to December 2016. Geographical Information Systems were used to display maps describing adjusted estimates of variation in outcomes across health areas. Data analysis took place from January 2018 to August 2019. Exposures: Patient characteristics (eg, age, sex, body mass index [BMI], and socioeconomic deprivation), surgical factors (eg, surgeon volume and grade), and hospital organizational factors (eg, number of operating theaters, number of specialist consultants, and hospital volume). Main Outcomes and Measures: Length of stay (LOS), bed-day costs, change in Oxford hip or knee scores 6 months after surgery, and complications 6 months after surgery. Results: A total of 173 107 patients (mean [SD] age, 69.3 [10.7] years; mean [SD] BMI, 28.9 [5.2]) underwent primary THR and 210 275 patients (mean [SD] age 69.7 [9.4] years; mean [SD] BMI, 31.1 [5.5]) underwent primary TKR, nested in 207 health areas. A number of factors were associated with longer LOS, higher bed-day costs, smaller changes in Oxford hip or knee scores, and a higher percentage of complications, including a workforce with a higher number of less experienced physicians (eg, LOS for less experienced surgeons, THR: regression coefficient, 0.02; 95% CI, 0.01 to 0.03; P < .001; TKR: regression coefficient, 0.01; 95% CI, 0.01 to 0.02; P < .001), public hospitals (eg, bed-day costs for private hospitals, THR: regression coefficient, -0.15; 95% CI, -0.15 to -0.14; P < .001; TKR: regression coefficient, -0.19; 95% CI, -0.19 to -0.19; P < .001), low volume of surgical procedures per surgeon (eg, change in Oxford hip or knee scores for lead surgeon with ≤10 vs >150 surgical procedures per year, THR: regression coefficient, -1.03; 95% CI, -1.47 to -0.58; P < .001; TKR: regression coefficient, -0.54; 95% CI, -1.01 to -0.06), and low volume of surgical procedures per hospital (eg, percentage of complications for hospitals with ≤200 vs ≥500 surgical procedures per year, THR: regression coefficient, 0.12; 95% CI, 0.04 to 0.21; P < .001; TKR: regression coefficient, 0.09; 95% CI, 0.01 to 0.18; P = .03). Although these factors did not attenuate the magnitude of variation across health areas, they had ecological correlations with the observed geographical variations in outcomes of surgery by health area. For example, the percentage of public and private hospitals was ecologically correlated at the health area level with longer and shorter stays, respectively (public hospital, THR: ρ, 0.41; public hospital, TKR: ρ, 0.44; private hospital, THR: ρ, -0.37; private hospital, THR: ρ, -0.38). Across health areas, estimated mean length of stay ranged from 3 to 7 days, and associated bed-day costs ranged from £4727 ($5827) to £8800 ($10 848) for both total hip and knee replacement. The absolute estimated mean change in Oxford hip score varied from 18.7 to 24.6 points and, for Oxford knee score, from 13.1 to 18.8. Estimated 6-month complications ranged from 2.9% to 5.8% for both THR and TKR. Conclusions and Relevance: In this study, models indicated that higher surgical volume by surgeon and by hospital as well as private hospitals were associated with better patient outcomes, which could be explained by the changing case mix of public hospitals treating an increasing number of more complex patients. A higher proportion of less experienced physicians was associated with poorer outcomes. This variation was observed geographically.

Lost cost savings to the NHS in England due to the delayed entry of multiple generic low-dose transdermal buprenorphine: a case scenario analysis.

OBJECTIVE: Originator pharmaceutical companies prolonging the patent of a medicine prevents rivals' entry to the market and competition. As the entry of generic alternatives usually results in price reduction, any delay in their entry potentially deprives the National Health Service (NHS) of much-needed savings. This study estimates the potential cost savings lost to the NHS as a result of delayed entry of generic low-dose buprenorphine (LDTB) patches in England. DESIGN: Two case scenarios were modelled to determine the savings from the entry of generic LDTB Butec only between February and August 2016 and the potential savings which could have been achieved if all generic LDTB patches had entered the market at the same time. SETTING: The volume of utilisation of branded and generic LDTB in UK primary care was derived from the NHS business services authority website for prescriptions dispensed between February 2015 and January 2018. MAIN OUTCOME MEASURES: Cost savings associated with the entry of generic LDTB. RESULTS: The cumulative cost savings from the introduction of Butec alone was £0.7 ($0.92) million. The model predicted that if all generic buprenorphine entered the market at the same time with Butec, they could have been achieved a £1.2 ($1.57) million saving. This means that approximately £0.5 ($0.65) million savings was lost to the NHS over the 6-month time period. CONCLUSIONS: The entry of Butec was associated with cost savings. We estimated that more cost savings could have been achieved if other generic LDTB patches had entered the market at the same time to drive competition between rivals. Patent protection strategies which delayed the entry of multiple generics were responsible for the reduced cost savings to the NHS in England.

The Arthroplasty Candidacy Help Engine tool to select candidates for hip and knee replacement surgery: development and economic modelling.

BACKGROUND: There is no good evidence to support the use of patient-reported outcome measures (PROMs) in setting preoperative thresholds for referral for hip and knee replacement surgery. Despite this, the practice is widespread in the NHS. OBJECTIVES/RESEARCH QUESTIONS: Can clinical outcome tools be used to set thresholds for hip or knee replacement? What is the relationship between the choice of threshold and the cost-effectiveness of surgery? METHODS: A systematic review identified PROMs used to assess patients undergoing hip/knee replacement. Their measurement properties were compared and supplemented by analysis of existing data sets. For each candidate score, we calculated the absolute threshold (a preoperative level above which there is no potential for improvement) and relative thresholds (preoperative levels above which individuals are less likely to improve than others). Owing to their measurement properties and the availability of data from their current widespread use in the NHS, the Oxford Knee Score (OKS) and Oxford Hip Score (OHS) were selected as the most appropriate scores to use in developing the Arthroplasty Candidacy Help Engine (ACHE) tool. The change in score and the probability of an improvement were then calculated and modelled using preoperative and postoperative OKS/OHSs and PROM scores, thereby creating the ACHE tool. Markov models were used to assess the cost-effectiveness of total hip/knee arthroplasty in the NHS for different preoperative values of OKS/OHSs over a 10-year period. The threshold values were used to model how the ACHE tool may change the number of referrals in a single UK musculoskeletal hub. A user group was established that included patients, members of the public and health-care representatives, to provide stakeholder feedback throughout the research process. RESULTS: From a shortlist of four scores, the OHS and OKS were selected for the ACHE tool based on their measurement properties, calculated preoperative thresholds and cost-effectiveness data. The absolute threshold was 40 for the OHS and 41 for the OKS using the preferred improvement criterion. A range of relative thresholds were calculated based on the relationship between a patient's preoperative score and their probability of improving after surgery. For example, a preoperative OHS of 35 or an OKS of 30 translates to a 75% probability of achieving a good outcome from surgical intervention. The economic evaluation demonstrated that hip and knee arthroplasty cost of < £20,000 per quality-adjusted life-year for patients with any preoperative score below the absolute thresholds (40 for the OHS and 41 for the OKS). Arthroplasty was most cost-effective for patients with lower preoperative scores. LIMITATIONS: The ACHE tool supports but does not replace the shared decision-making process required before an individual decides whether or not to undergo surgery. CONCLUSION: The OHS and OKS can be used in the ACHE tool to assess an individual patient's suitability for hip/knee replacement surgery. The system enables evidence-based and informed threshold setting in accordance with local resources and policies. At a population level, both hip and knee arthroplasty are highly cost-effective right up to the absolute threshold for intervention. Our stakeholder user group felt that the ACHE tool was a useful evidence-based clinical tool to aid referrals and that it should be trialled in NHS clinical practice to establish its feasibility. FUTURE WORK: Future work could include (1) a real-world study of the ACHE tool to determine its acceptability to patients and general practitioners and (2) a study of the role of the ACHE tool in supporting referral decisions. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Patients with severe hip and knee arthritis may require joint replacement. General practitioners make the decision to refer patients to hospital based on an assessment of their symptoms. Pain and function can be measured using patient questionnaires and the questionnaire scores can indicate whether or not the severity of disease warrants referral (i.e. whether or not the patient is a candidate for joint replacement based on their 'capacity to benefit'). However, we do not know whether or not basing treatment decisions on such scores is correct, nor do we know what exact pain score thresholds should be used for referral. After a thorough search, we found that the Oxford Hip and Knee Scores were the best instruments. A high score (i.e. a maximum score of 48) indicates less pain and better function. The threshold values for referral for surgery were scores of 40 for hips and 41 for knees. The process of evaluating scoring systems, the choice of scoring systems and the threshold values were discussed and agreed by a panel of patients and by doctors throughout the study. Most patients with severe joint pain benefit from joint replacement, and these operations are cost-effective. However, above a certain level (a score of 40 for hips and 41 for knees), patients are not thought to typically benefit from surgery. Below these values, lower presurgery scores indicate a steadily increasing likelihood of benefit in terms of reduced pain and better function. This information provides the basis for a tool to help doctors decide who to refer for joint replacement: the Arthroplasty Candidacy Help Engine (ACHE). Use of the ACHE tool prevents patients who are unlikely to benefit from joint replacement being referred unnecessarily and allows the NHS to concentrate resources on those who will benefit most from arthroplasty treatment.

Results of EAHP's 2018 Survey on Medicines Shortages.

AIMS AND OBJECTIVES: The aim of the 2018 EAHP Survey on Medicines Shortages was to provide a clearer picture on the issue of medicines shortages, including the impact on hospital pharmacists' time, budgets and the effect on patient care. METHODS: A survey was conducted by the EAHP, collecting information from European hospital pharmacists on the shortage situation in their respective countries. The survey ran from 19 March 2018 to 11 June 2018. Keele University, UK analysed and compared the results to those of the 2014 survey. RESULTS: There were 1666 responses to the 2018 survey, which represented a threefold increase from the 2014 survey which received 607 responses. Ninety per cent of respondents answered 'Yes' when asked if shortages of medicines are a current problem in delivering the best care to patients, while only 7% of respondents answered 'No', and 3% 'Unsure'.Problems with shortages of antimicrobials were most commonly reported (77% of respondents reporting this as an issue in 2018 vs 57% in 2014), followed by preventative medicines (43% in 2018 vs 20% in 2014) and anaesthetics (39% in 2018 vs 27% in 2014). Fifty-nine per cent of respondents have seen care delayed as a consequence of medication shortages, with cancellations of care (31% of respondents), medication errors (25% of respondents) and suboptimal treatment for patients (25% of respondents) also being frequently reported.Sixty-three per cent of respondents reported having had to pay a higher price to procure from alternate sources most of the time or always when there was a shortage of a medicine. CONCLUSIONS: Medicines shortages is an increasing problem across Europe and is having an adverse impact on patient care. Medicines shortages are adding to hospital pharmacists' time pressures and have an adverse budgetary impact. More timely information about impending shortages and how long they will last is seen as necessary to help manage the problem.

Duration of Treatment Effect Should Be Considered in the Design and Interpretation of Clinical Trials: Results of a Discrete Choice Experiment.

Objective. This study examined whether duration of treatment effect should be considered in a benefit-risk assessment using a case study of osteoarthritis medications. Study Design and Setting. A discrete choice experiment was completed by 300 residents of the United Kingdom with hip and/or knee osteoarthritis. In 16 choice tasks, participants selected their preferred option from 2 medications. Medications were described in terms of effect on pain, stiffness, and function; duration of treatment effect; and risk of heart attack and stomach ulcer bleeding. The analysis used mixed-effects logistic regression. Results. Pain, disease severity, and duration of treatment effect had the greatest influence on medication preferences, whereas stiffness did not significantly affect medication choice. Participants were willing to accept an increase in the risk of heart attack of 2.6% (95% confidence interval: 2.0% to 3.2%) to increase the duration of treatment effect from 1 month to 12 months. Reducing pain from moderate to mild was valued the same as increasing duration of effect from 1 month to 3 months; both were seen as equivalent to an absolute reduction of 1.2% in the risk of heart attack in the next year. Subgroup analysis suggested disease severity influenced patient preferences. Conclusions. Along with treatment benefits and risks, the results suggest that duration of treatment effect is an important factor in the medication choices of people with osteoarthritis. This could have implications for the design and interpretation of clinical trials, for example, incorporating longer-term surveillance of trial participants and accounting for duration of treatment effect in risk-benefit assessments. Future research is needed to assess whether these findings are generalizable to other samples, disease areas, and levels of duration of effect.

Enhanced Recovery After Surgery implementation in practice: an ethnographic study of services for hip and knee replacement.

OBJECTIVES: Enhanced Recovery After Surgery (ERAS) programmes aim to improve care quality by optimising components of the care pathway and programmes for hip and knee replacement exist across the UK. However, there is variation in delivery and outcomes. This study aims to understand processes that influence implementation using the Consolidated Framework for Implementation Research (CFIR) to inform the design and delivery of services. DESIGN: An ethnographic study using observations and interviews with staff involved in service delivery. Data were analysed using a thematic analysis, followed by an abductive approach whereby themes were mapped onto the 31 constructs and 5 domains of the CFIR. SETTING: Four hospital sites in the UK delivering ERAS services for hip and knee replacement. PARTICIPANTS: 38 staff participated including orthopaedic surgeons, nurses and physiotherapists. RESULTS: Results showed 17 CFIR constructs influenced implementation in all five domains. Within 'intervention characteristics', participants thought ERAS afforded advantages over alternative solutions and guidance was adaptable. In the 'outer setting', it was felt ERAS should be tailored to patients and education used to empower them in their recovery. However, there were concerns about postdischarge support and tensions with primary care. Within the 'inner setting', effective multidisciplinary collaboration was achieved by transferring knowledge about patients along the care pathway and multidisciplinary working practices. ERAS was viewed as a 'message' that had to be communicated consistently. There were concerns about resources and high volumes of patients. Staff access to information varied. At the domain 'characteristics of individuals', knowledge and beliefs impacted on implementation. Within 'process', involving opinion leaders in development and 'champions' who acted as a central point of contact, helped to engage staff. Formal and informal feedback helped to develop services. CONCLUSIONS: Findings demonstrate successful implementation involves empowering patients to work towards recovery, providing postdischarge support and promoting successful multidisciplinary team working.

The effect of new biosimilars in rheumatology and gastroenterology specialities on UK healthcare budgets: Results of a budget impact analysis.

BACKGROUND: The approval of new biosimilars of infliximab, etanercept and adalimumab by the European Medicines Agency is expected to produce further cost savings to the healthcare system budget. OBJECTIVES: This study aimed to estimate the budget impact of the introduction of new biosimilars Flixabi®, Erelzi®, Solymbic®, Amgevita® and Imraldi® in rheumatology and gastroenterology specialities in the UK. METHODS: A published budget impact model was adapted to estimate the expected cost savings following the entry of new biosimilars Flixabi®, Erelzi®, Solymbic®, Amgevita® and Imraldi® in the UK over three-year time horizon. This model was based on retrospective market shares of biologics used in rheumatology and gastroenterology which were derived from DEFINE Software and healthcare professional perspectives. RESULTS: The model predicted that infliximab and etanercept biosimilars would replace their corresponding reference agents by 2020. Adalimumab biosimilars were predicted to achieve 19% of the rheumatology and gastroenterology market by 2020. Without the introduction of further biosimilars, the model predicted a reduction in expenditure of £44 million on biologics over the next three years. With the entry of Flixabi®, Erelzi®, Solymbic®, Amgevita® and Imraldi® the model estimates cumulative savings of £285 million by 2020. CONCLUSIONS: The introduction of new infliximab, etanercept and adalimumab biosimilars will be associated with considerable cost savings and have a substantial favourable impact on the UK NHS budget. The number of biosimilars and time of entry of is critical to create competition which will result in maximum cost savings.

Differences in UK healthcare professionals' knowledge, attitude and practice towards infliximab and insulin glargine biosimilars.

OBJECTIVES: To investigate knowledge and attitudes of different healthcare professionals in UK towards infliximab and insulin glargine biosimilars METHODS: UK medical consultants/registrars, nurses and pharmacists participated in anonymised, self-administered web-based survey distributed by professional associations. KEY FINDINGS: There were 234 respondents: medical consultants/registrars (150), nurses (58) and pharmacists (26). 76% of medical consultants/registrars, 84% of pharmacists and 53% of nurses understood what biosimilars were. Medical consultants/registrars and pharmacists had safety and efficacy concerns when switching patients compared to initiation. Nurses had similar levels of safety and efficacy concerns about initiation. CONCLUSION: Healthcare professionals were more comfortable with the initiation of biosimilars than switching current patients. Medical consultants/registrars and pharmacists were more informed than nurses.

Healthcare professionals' perceptions and perspectives on biosimilar medicines and the barriers and facilitators to their prescribing in UK: a qualitative study.

OBJECTIVE: To investigate UK healthcare professionals' perceptions and perspectives towards biosimilar infliximab, etanercept and insulin glargine and the potential barriers and facilitators to their prescribing. DESIGN: A cross-sectional qualitative study design was used. SETTING: Five hospitals within the West Midlands area in UK. INTERVENTIONS: 30 min face-to-face, semistructured interviews of healthcare professionals. PARTICIPANTS: 22 healthcare professionals (consultants, nurses and pharmacists) participated in the semistructured interviews. OUTCOMES: Participants' opinion and attitudes about biosimilars and the barriers and facilitators to the prescribing of infliximab, etanercept and insulin glargine biosimilars in gastroenterology, rheumatology and diabetology specialties. RESULTS: This study showed that UK healthcare professionals had good knowledge of biosimilars and were content to initiate them. Healthcare professionals disagreed with biosimilar auto-substitution at pharmacy level and multiple switching. Subtle differences among healthcare professionals were identified in the acceptance of switching stable patients, indication extrapolation and cost savings sharing. CONCLUSION: Safety and efficacy concerns, patients' opinion and how cost savings were shared were the identified barriers to considering prescribing biosimilars. Real-life data and financial incentives were the suggested facilitators to increase biosimilar utilisation.

Sample size calculations are poorly conducted and reported in many randomized trials of hip and knee osteoarthritis: results of a systematic review.

OBJECTIVES: To review the methodology and reporting of sample size calculations in a contemporary sample of trials in osteoarthritis. STUDY DESIGN AND SETTING: Randomized trials in hip and/or knee osteoarthritis published in 2016 were identified by searching MEDLINE, Cochrane library, CINAHL, EMBASE, PsycINFO, PEDro, and AMED until March 31, 2017. Data were extracted on study characteristics, methods used to calculate the sample size, and the reporting and justification of components used in the sample size calculation. We attempted to replicate the sample size calculation using the reported information. RESULTS: This review included 116 trials. Seventy-eight (67%, n = 78/116) reported a power calculation. Less than a quarter reported all core components of the sample size calculation (21%, n = 16/78). The sample size calculation was only reproducible in 53% of the trials that reported a power calculation (n = 41/78). The replicated calculation produced a sample size over 10% larger than the reported value in 12% of trials (n = 9/78). Insufficient information was reported to allow the sample size calculation to be replicated in a quarter of trials (27%, n = 21/78). CONCLUSION: Sample size calculations in trials of hip and knee osteoarthritis are not adequately reported, and the calculation frequently cannot be reproduced.