Benefits For Healthcare Systems Research Articles

Infection prevention in home dialysis

Purpose of review Among patients with kidney failure, home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD) provide several individual and healthcare system benefits over in-center hemodialysis (HD). Infection remains a major source of morbidity and mortality in this population, and a core outcome of critical importance to patients, caregivers, and kidney health professionals. This narrative review provides evidence-based measures for infection prevention among individuals receiving home dialysis, with a particular emphasis on dialysis and access-related infections. Recent findings Patient and care partner education and training is an important and major theme for infection prevention in home dialysis. In PD, identifying and managing modifiable risk factors for infections such as hypokalemia, constipation, use of gastric acid suppressants, and domestic pets, along with the use of antimicrobial prophylaxis, when indicated, can substantially reduce peritonitis risk. Reducing the use of central venous catheters (CVC), and duration of CVC dependence is the most effective means of prevention of HD access-related bloodstream infections in individuals receiving HHD. For arteriovenous fistula cannulation, rope ladder technique is associated with lower risk of infection compared to buttonhole cannulation. Summary Developing and instituting a well structured and evidence-based patient training and education program within home dialysis units is the most important measure in preventing and reducing dialysis and access-related infections. Kidney care providers should be familiar with different infection risk factors among individuals receiving home dialysis.

Remote Patient Monitoring and Machine Learning in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: Dual Systematic Literature Review and Narrative Synthesis.

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with high mortality, morbidity, and poor quality of life and constitute a substantial burden to patients and health care systems. New approaches to prevent or reduce the severity of AECOPD are urgently needed. Internationally, this has prompted increased interest in the potential of remote patient monitoring (RPM) and digital medicine. RPM refers to the direct transmission of patient-reported outcomes, physiological, and functional data, including heart rate, weight, blood pressure, oxygen saturation, physical activity, and lung function (spirometry), directly to health care professionals through automation, web-based data entry, or phone-based data entry. Machine learning has the potential to enhance RPM in chronic obstructive pulmonary disease by increasing the accuracy and precision of AECOPD prediction systems. This study aimed to conduct a dual systematic review. The first review focuses on randomized controlled trials where RPM was used as an intervention to treat or improve AECOPD. The second review examines studies that combined machine learning with RPM to predict AECOPD. We review the evidence and concepts behind RPM and machine learning and discuss the strengths, limitations, and clinical use of available systems. We have generated a list of recommendations needed to deliver patient and health care system benefits. A comprehensive search strategy, encompassing the Scopus and Web of Science databases, was used to identify relevant studies. A total of 2 independent reviewers (HMGG and CM) conducted study selection, data extraction, and quality assessment, with discrepancies resolved through consensus. Data synthesis involved evidence assessment using a Critical Appraisal Skills Programme checklist and a narrative synthesis. Reporting followed PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. These narrative syntheses suggest that 57% (16/28) of the randomized controlled trials for RPM interventions fail to achieve the required level of evidence for better outcomes in AECOPD. However, the integration of machine learning into RPM demonstrates promise for increasing the predictive accuracy of AECOPD and, therefore, early intervention. This review suggests a transition toward the integration of machine learning into RPM for predicting AECOPD. We discuss particular RPM indices that have the potential to improve AECOPD prediction and highlight research gaps concerning patient factors and the maintained adoption of RPM. Furthermore, we emphasize the importance of a more comprehensive examination of patient and health care burdens associated with RPM, along with the development of practical solutions.

The increasing use of minimally invasive surgery in acute general surgical conditions: A decade of results from a national data set

BackgroundTo assess the rate of uptake of acute laparoscopic surgery for common general surgical conditions using national-level data. MethodsThe use of laparoscopic surgery in the acute management of appendicitis, cholecystitis, adhesive small bowel obstruction, and inguinal hernias was assessed between 2013 and 2022 at a national level in New Zealand. ResultsLaparoscopic appendicectomy increased from 83% to 95% (P = .0002). Laparoscopic cholecystectomy increased from 94% to 96% (P = .001). Laparoscopic adhesiolysis increased from 42% to 60% (P = .001). Laparoscopic inguinal hernia repair increased from 3% to 18% (P = .004). The rate of laparoscopic conversion demonstrated a decrease for appendicectomy (1.9% to 0.24%), cholecystectomy (0.77% to 0.39%), and adhesiolysis (9% to 2.4%) across this time. The laparoscopic cohorts were all associated with a shorter and less expensive length of stay compared to the open cohort. Māori and Pacific Island patients had largely equitable or superior rates of laparoscopic use compared to the rest of the population. No changes in laparoscopic use were detected during the COVID-19 pandemic. Rates of laparoscopic cholecystectomy and appendicectomy are similar throughout the regions. The largest difference in rates detected was for adhesiolysis, which was more common in the northern region. ConclusionThere has been a statistically significant rise in the use of acute laparoscopic surgery for acute general surgical procedures. This rise is likely clinically and economically significant, particularly in appendicectomy and adhesiolysis, with rises of 12% and 17% across the 10 years, with the known associated patient and health care system benefits.

Changes in epinephrine dispensings and allergy hospitalisations in Sweden in the years following the removal of autoinjector co-payments.

To understand any possible healthcare system benefits and changes of behavior for the patients with the change in prescription co-payment in Sweden we aimed to provide an update on the trends of EAI dispensings and hospitalizations for the Swedish paediatric population (ages 0-19 years), from 2018 to 2022, including by sex and geographic region. Using publically-available, population-level aggregate data from Sweden's National Board of Health and Welfare, we extracted information on annual epinephrine (ATC C01CA24) dispensings per 1,000 inhabitants from 2018 to 2023, overall, as well as stratified by sex, age groups and geographic region; and on inpatient stays 2018-2022 (ICD-10 code T78), anaphylaxis and other allergic reactions, per 100,000 individuals. We compared these estimates to those for adults ages 18 + years, for whom prescription co-payments remained in place. EAI dispensings remained stable for children and adults across the study period, with the exception of statistically significant decreases amongst dispensings for children across all ages in 2021 (6.65/1,000) and 2022 (7.37/1,000), compared to 2018 (8.63/1,000) (each year p = 0.03 compared to 2018 dispensings). National EAI dispensings did not statistically significantly differ from 2018 (8.63/1,000) to 2023 (6.70/1,000) amongst children. EAI dispensings for children ages 5 + years consistently exceed dispensings for adults per 1,000 inhabitants; only children aged 0-4 years had proportionately fewer dispensings. Children ages 0-4 years tended to be hospitalised more often than older children, albeit these differences were not statistically significant (all p > 0.97). Subsequent to the removal of out-of-pocket costs for EAI, dispensings did not increase for children, although more EAI were dispensed to children from age 5 years, compared to younger children. Allergy-related hospitalisations were highest amongst children ages 0-4, lower amongst children ages 5-14 years, and again higher amongst those ages 15-19 years.

The Impacts of Health Decentralization on Equity, Efficiency, and Effectiveness: A Scoping Review

Decentralization is considered an important component of participatory democracy. However, despite its widespread implementation in the healthcare sector, its impact on health systems’ performance remains unclear. Using a theoretical framework based on the World Health Organization’s five decentralization variables—geography and sociodemographics, organization of political processes, functions and economic weight, steering, and control—we conducted a scoping review to unveil causal mechanisms linking each feature to equity, efficiency, and effectiveness. Following the PRISMA protocol, 1627 articles were screened, and 63 were selected for data analysis, with a focus on middle- and high-income countries. The findings show that the most frequently discussed forms of decentralization are fiscal and administrative, with a primary focus on how governance mechanisms affect equity and efficiency. The effects of decentralized healthcare governance on equity, efficiency, and effectiveness are diverse and contingent on contextual factors and the implementation processes. The spatial context (geography) of decentralization negatively impacts equity, and steering strongly affects effectiveness. Functions and economic weight significantly influence efficiency, albeit with variability. Overall, decentralization falls short of delivering substantial healthcare system benefits, although this depends on contextual factors.

Peritoneal dialysis in the Arabian Gulf countries: Challenges and opportunities.

The Gulf Cooperation Council (GCC) is a regional organisation, consisting of six Arab countries that share common objectives and cultural identities, with a total population of 57.3 million. The prevalence of patients requiring dialysis in GCC countries is increasing, with a current mean prevalence of 551 per million population. Despite the several patient-level and healthcare system benefits of peritoneal dialysis (PD) compared to in-centre haemodialysis, the growth in PD utilisation has been limited. This is related to several factors, including deficiencies in modality education for chronic kidney disease patients, nephrology training and governmental policies advocating for this dialysis modality. Establishing a detailed PD registry in GCC countries is an important step towards understanding our patients' characteristics, outcomes, current PD practices and challenges in order to increase the use of PD and to facilitate future initiatives aimed at optimising the management of PD patients in this part of the world. This article reviews common challenges around PD practices and utilisation in GCC countries and provides possible solutions to overcome these challenges. It should be noted that the literature on PD patients, outcomes and treatment practices in GCC countries is limited, and as a result, many of our recommendations and discussion are based on clinical observations, experience and data when available.

Women-only versus mixed-gender groups in multimodal, day clinic treatment of trauma-related disorders.

Background: In the German healthcare system benefits include inpatient and day clinic psychotherapy of trauma-related disorders, which are often provided in gender specific groups. Despite this widespread practice, the actual impact and potential outcome have been studied relatively scarcely and are still open to debate. The present study therefore examines whether the therapeutic relationships in the group vary depending on the group composition and whether this has an effect on therapy outcome. Methods: 66 patients (N = 55 women) were treated in our multimodal, day clinic groupbased treatment program and filled out symptom questionnaires (ETI, BDI-II, PHQ-15, Questionnaire on social support) at admission and discharge and the Group Questionnaire (GQ; including subscales positive bonding, positive working and negative relationships) at the end of each of the eight weeks of treatment. Patients took part in five women-only and six mixed-gender groups and underwent therapy in a closed group format, so that they began and ended therapy within the same group. All patients were diagnosed with trauma-related disorders, which included PTSD, cPTSD, depression, somatoform disorders and further mental diseases. Outcome data were examined using functional regression analysis and linear mixed models. Results: In women-only groups, positive bonding and positive working relationship were significantly higher than in mixed-gender groups. Negative relationship ratings were significantly lower in women-only groups, especially in the middle phase of treatment. However, no effect of an exclusively female group composition on treatment outcome was found, except for the higher increase of perceived social support for patients treated in women-only groups. Conclusions: Group relationships were considered more pleasant in women-only groups than in mixed-gender groups, but this had no effect on the symptom-based therapy outcome. To enhance feelings of safety and comfort, traumatized women should have the possibility to choose whether to be treated in a women-only or a mixed-gender group.

Improving the Rate of Same-day Discharge in Gynecologic Oncology Patients with Endometrial Cancer undergoing Minimally Invasive Robotic Surgery: A Quality Improvement Initiative

Same-day discharge (SDD) in patients with endometrial cancer undergoing minimally invasive surgery (MIS) is safe and feasible, with multiple patient and healthcare system benefits. Despite this, our local rate of SDD was only 29.4%. Several studies have suggested methods to improve rates of SDD but few have evaluated the application of such methods. The objectives of our quality improvement (QI) initiative were 2-fold: (1) to increase the rate of SDD in eligible patients with endometrial cancer undergoing MIS to 70% and (2) to evaluate the implementation of methods to improve rates of SDD. At our center, QI diagnostics were conducted, and root causes were identified. Four interventions were introduced: (1) setting SDD as the default discharge plan, (2) ensuring that a physician order for discharge was on the chart, (3) removing the Foley catheter in the operating room, and (4) introducing pre- and postoperative patient education documents. A time-series design was used; rate of SDD was tracked using baseline data and continuous post-intervention monitoring. Process measures (for each intervention) and balancing measures were defined and tracked. At the conclusion of our QI initiative, the average rate of SDD was 78.3%-exceeding our aim of 70%. This was achieved without compromising patient satisfaction (98.2%) or significantly impacting rates of readmission or presentations to the emergency department. Our initiative demonstrated the application of simple interventions that resulted in a substantial increase in our rate of SDD in the population of interest, without causing negative impacts on the defined balancing measures. These interventions were nonspecific to gynecologic oncology and could easily be applied across other surgical disciplines.

Towards a framework for evaluating the costs and benefits of simulation modelling in healthcare

Over the years, simulation modelling has provided many benefits for healthcare systems; however, its uptake level remains quite low. Despite its many benefits, simulation modelling is considered expensive and a luxury. It is generally suggested that simulation modelling is ultimately cost-effective, but there are few methods for proving such. Therefore, in this paper, we investigate the cost and benefits of using simulation modelling in healthcare and explore the viability of developing a framework that will allow stakeholders to evaluate their investment when using simulation modelling. We used 18 case studies to identify modelling costs and benefits when designing healthcare facilities and services. In a field lacking data, we report on modelling costs, including hidden items, such as stakeholders and decisions. Further, we report on benefit realisation and show how estimates of net social benefits and benefit-to-cost ratios may be made, identifying where further research is needed. In all cases, the benefits exceeded the costs—typically by factors of 10, often by factors of 100, and occasionally by more than 1000.

A Dedicated Tool for Presurgical Mapping of Brain Tumors and Mixed-Reality Navigation During Neurosurgery

Brain tumor surgery requires a delicate tradeoff between complete removal of neoplastic tissue while minimizing loss of brain function. Functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) have emerged as valuable tools for non-invasive assessment of human brain function and are now used to determine brain regions that should be spared to prevent functional impairment after surgery. However, image analysis requires different software packages, mainly developed for research purposes and often difficult to use in a clinical setting, preventing large-scale diffusion of presurgical mapping. We developed a specialized software able to implement an automatic analysis of multimodal MRI presurgical mapping in a single application and to transfer the results to the neuronavigator. Moreover, the imaging results are integrated in a commercially available wearable device using an optimized mixed-reality approach, automatically anchoring 3-dimensional holograms obtained from MRI with the physical head of the patient. This will allow the surgeon to virtually explore deeper tissue layers highlighting critical brain structures that need to be preserved, while retaining the natural oculo-manual coordination. The enhanced ergonomics of this procedure will significantly improve accuracy and safety of the surgery, with large expected benefits for health care systems and related industrial investors.

105 Cost Analysis for the Risk-Stratification of Febrile Infants ≤ 60 Days Old

Abstract Primary Subject area Emergency Medicine - Paediatric Background Fever in the first months of life is among the most common clinical problems in pediatric healthcare. Nearly 2% of all infants will be evaluated for fever in an Emergency Department (ED) and approximately 10% harbor life-threatening serious bacterial infections (SBIs). The Rochester criteria are most widely used criteria for risk-stratification and predate modern biomarkers including procalcitonin (PCT). Recently, a high-performing prediction rule incorporating PCT was derived by the Pediatric Emergency Care Applied Research Network (PECARN). At present, PCT is not available in all clinical settings, limited largely by test cost. Objectives Compare the medical costs associated with PECARN and Rochester risk-stratification strategies using contemporary price, epidemiologic and test characteristic data. Design/Methods We assessed hospital-level costs associated with the door-to-discharge care of all well-appearing febrile infants aged ≤ 60 days evaluated at an urban tertiary pediatric hospital between April 2016 and March 2019. Direct and indirect ED and inpatient costs were obtained from provincial Ministry of Health data. Real-world costs were then incorporated into a probabilistic model for a cohort of equal size using either Rochester or PECARN risk-stratification, accounting for the added incremental cost of PCT ($24.86CAD). Models used an 8.4% pooled SBI risk, and Sn/Sp for Rochester and PECARN of 94%/49% and 98%/63%, respectively. Modeling was calculated under 4 scenarios; true positive with hospitalization, false negative with return visit and hospitalization, false positive with hospitalization, true negative with ED discharge. All costs were calculated in Canadian dollars. Results During the 3-year study period, 1168 index infant encounters met inclusion and were analyzed for hospital trajectory costs. Median costs per infant were $323 (IQR $286-$393) for infants discharged from the ED with no SBI, $2356 (IQR $1858-$3120) for infants hospitalized with no SBI, $3150 (IQR $2352-$4201) for hospitalized infants treated for a SBI, and $3763 (IQR $2146-$5180) for infants discharged from the ED ultimately requiring hospitalization with a missed SBI. For a cohort of 1168 infants, cost-per-infant using PECARN risk-stratification was $1332 (IQR $1062-$1739), compared to $1515 (IQR $1198-$1992) using Rochester. PECARN criteria would be expected to produce an overall savings of 12.1% for the modeled cohort ($1,556,432 vs $1,769,339). Under pessimistic and optimistic model assumptions, total savings were 4.9% and 18.3%, respectively. Costs borne by families were not considered, nor were the indirect benefits of reduced unnecessary invasive testing, hospitalizations and broad-spectrum antibiotic use. Conclusion Risk-stratification of febrile infants using PECARN prediction rules would produce important cost-savings due to superior test characteristics offsetting upfront PCT-associated costs. Such a strategy would also likely result in unmodeled non-monetary family-centered and healthcare system benefits. Real-world cost-effectiveness studies are needed.

Optical diagnosis of colorectal polyps using convolutional neural networks.

Colonoscopy remains the gold standard investigation for colorectal cancer screening as it offers the opportunity to both detect and resect pre-malignant and neoplastic polyps. Although technologies for image-enhanced endoscopy are widely available, optical diagnosis has not been incorporated into routine clinical practice, mainly due to significant inter-operator variability. In recent years, there has been a growing number of studies demonstrating the potential of convolutional neural networks (CNN) to enhance optical diagnosis of polyps. Data suggest that the use of CNNs might mitigate the inter-operator variability amongst endoscopists, potentially enabling a “resect and discard“ or ”leave in“ strategy to be adopted in real-time. This would have significant financial benefits for healthcare systems, avoid unnecessary polypectomies of non-neoplastic polyps and improve the efficiency of colonoscopy. Here, we review advances in CNN for the optical diagnosis of colorectal polyps, current limitations and future directions.

All around suboptimal health \u2014 a joint position paper of the Suboptimal Health Study Consortium and European Association for Predictive, Preventive and Personalised Medicine

First two decades of the twenty-first century are characterised by epidemics of non-communicable diseases such as many hundreds of millions of patients diagnosed with cardiovascular diseases and the type 2 diabetes mellitus, breast, lung, liver and prostate malignancies, neurological, sleep, mood and eye disorders, amongst others. Consequent socio-economic burden is tremendous. Unprecedented decrease in age of maladaptive individuals has been reported. The absolute majority of expanding non-communicable disorders carry a chronic character, over a couple of years progressing from reversible suboptimal health conditions to irreversible severe pathologies and cascading collateral complications. The time-frame between onset of SHS and clinical manifestation of associated disorders is the operational area for an application of reliable risk assessment tools and predictive diagnostics followed by the cost-effective targeted prevention and treatments tailored to the person.This article demonstrates advanced strategies in bio/medical sciences and healthcare focused on suboptimal health conditions in the frame-work of Predictive, Preventive and Personalised Medicine (3PM/PPPM). Potential benefits in healthcare systems and for society at large include but are not restricted to an improved life-quality of major populations and socio-economical groups, advanced professionalism of healthcare-givers and sustainable healthcare economy. Amongst others, following medical areas are proposed to strongly benefit from PPPM strategies applied to the identification and treatment of suboptimal health conditions:Stress overload associated pathologiesMale and female healthPlanned pregnanciesPeriodontal healthEye disordersInflammatory disorders, wound healing and pain management with associated complicationsMetabolic disorders and suboptimal body weightCardiovascular pathologiesCancersStroke, particularly of unknown aetiology and in young individualsSleep medicineSports medicineImproved individual outcomes under pandemic conditions such as COVID-19.

Pre-Implementation Assessment of the Acceptability of Using Circulating microRNAs for Follow-Up of Malignant Germ-Cell Tumors.

MicroRNAs from the miR-371~373 and miR-302/367 clusters, particularly miR-371a-3p, are promising biomarkers for blood-based diagnosis and disease monitoring of malignant germ cell tumors (GCTs) and are nearing clinical implementation. These biomarkers have superior sensitivity and specificity compared with current markers alpha-fetoprotein (AFP) and human chorionic gonadotropin (HCG). We explored patient acceptability of using circulating microRNAs to replace multiple serial computed tomography (CT) scans in malignant GCT follow-up. Two workshops involved interactive presentations and focus groups. Discussions were digitally recorded and transcribed verbatim. Qualitative thematic analysis of transcripts identified the key themes. Prior to the workshops, potential participants expressed concern about the adoption of new blood tests due to personal experiences of the limitations of existing (AFP/HCG) markers. Twelve males (22-57 years of age; currently, 26-59 years of age) with a malignant GCT diagnosis participated; all were in follow-up. Three had experienced recurrence. Participants had cumulative exposure of between 1 and 15 CT scans. Data saturation was reached at the second workshop; five themes emerged underpinning preference for microRNA testing versus CT scans: (1) increased sensitivity and safety, (2) reduced financial costs, (3) reduced time for testing and results, (4) practicalities, and (5) reduced anxiety. However, some participants perceived an increased diagnostic capacity of CT scans versus blood testing. This first user consultation of circulating microRNA testing for future malignant GCT follow-up suggests high acceptability with potential patient and healthcare system benefits.

Nursing Staff Awareness about Evidence Based Practice: Facilitations, Barriers and Beliefs

Background: Today evidence-based practice (EBP) becomes one of the best ways that used for making clinical decisions and has an effect on health care outcomes as well as it improves the quality of care provided to patients. Aim: Assess nursing staff awareness about evidence based practice facilitations, barriers and beliefs at Belqas Central Hospital (BCH). Design: Cross sectional design. Settings: current study was carried out at Belqas Central Hospital (BCH), affiliated to Ministry Of Health, Dakahlia Governorate. Subjects: the study was conducted on nursing staff (228). Data collection tools: Data was collected using evidence based practice (EBP) questionnaire, Facilitators to change practice based on evidence based practice scale, barriers to find, use and review evidence scale and evidence based practice beliefs scale. Results: revealed that the highest total mean score of facilitations was related to organizational structure and health care environment while the lowest mean score was related to research information. As well as the highest total mean score of barriers was related to individual nurse characteristics while the lowest mean score was related to research information. Also 69% of nursing staff were agreeing with EBP, realizing its benefits and importance. Conclusion: nursing staff focus on their experience and ways that always used in providing nursing care as a source for their information. In addition to most of them were competent in fifinding, reviewing and using evidence in practice. Organizational structure and health care environment was perceived as a main facilitation of EBP, while individual nurse characteristics were perceived as the highest barriers of EBP. Most nursing staff had positive beliefs about EBP and realized its benefits in health care system. Recommendations: Ongoing training programs about EBP for nursing staff, maintaining adequate staffing in different shift to relieve nurses’ workload and help them to attain workshops and scientific conferences that updating and increasing their knowledge about EBP. Provide organizational support for EBP implementation. Translating the most relevant researches and distributed them for nurses to apply in practice to overcome the English language barrier. Increasing interest in the research and EBP process through integrating the EBP strategies in nursing curriculum.

PMD2 Concept Paper: A Medtech Roadmap: New Routes to Market Access in the UK NHS

Medical devices, diagnostics and digital health technologies (DHTs) can improve patient outcomes with additional benefits for healthcare systems. However, unlike pharmaceuticals, the route to UK reimbursement for medical technologies (MedTech) is not clear, and the roadblocks of additional economic evidence and health technology assessment can seem impassable. This concept poster describes a practical roadmap of potential routes to market for MedTech and describe recent initiatives to accelerate access in the NHS. NHS England and NICE have launched new initiatives to accelerate adoption of cost-saving MedTech that could reduce healthcare resource use and improve outcomes. These include: HealthTech Connect,1 a horizon-scanning MedTech database to foster early engagement; the NICE META tool,2 an online value proposition assessment tool; the Evidence Standards Framework for DHTs;3 and MedTech Innovation Briefings.4 A new funding mandate for NICE MedTech and Diagnostic Guidance has also been proposed. •Developers should engage early with the NHS and Academic Health Science Networks by registering with HealthTech Connect, which provides a confidential signposting service that can help with initial queries about routes for market access.•The NICE META tool can assess a technology’s current evidence base and determine the most appropriate route for market access and if further evidence is required.•Scientific advice should be sought when planning new studies to determine if outcomes are appropriate for MedTech decision-makers.•Additional safety and risk assessments may be required for DHTs or implantable devices.•Not all MedTech may be appropriate for assessment by NICE, but other routes are possible, including NHS Specialised Services or local commissioning. The MedTech route to market access in the UK varies dependent on the technology. Developers should seek advice on which reimbursement pathway is the most appropriate and take advantage of new initiatives that encourage adoption by the NHS.

European Stakeholder Learnings Regarding Biosimilars: Part I-Improving Biosimilar Understanding and Adoption.

BackgroundDespite the benefits offered by biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as switching.ObjectiveThis study aims to provide recommendations on how to improve biosimilar understanding and adoption among stakeholders based on insights of healthcare professionals (physicians, hospital pharmacists, nurses), patient(s) (representatives) and regulators across Europe.MethodThe study consists of a structured literature review gathering original research data on stakeholder knowledge about biosimilars, followed by semi-structured interviews across five stakeholder groups including physicians, hospital pharmacists, nurses, patient(s) (representatives) and regulators across Europe.ResultsAlthough improvement in knowledge was observed over time, generally low to moderate levels of awareness, knowledge and trust towards biosimilars among healthcare professionals and patients are identified in literature (N studies = 106). Based on the provided insights from interviews with European experts (N = 44), a number of challenges regarding biosimilar stakeholder understanding are identified, including a lack of practical information about biosimilars and their use, a lack of understanding about biosimilar concepts and a lack of knowledge about biologicals in general. Misinformation by originator industry is also believed to have impacted stakeholder trust. In terms of possible solutions and actions to improve stakeholder understanding, broad support exists to (1) organize initiatives focussed on explaining the rationale behind biosimilar concepts and the approval pathway, (2) invest in education about biologicals in general, (3) develop clear and one-voice regulatory guidance about biosimilar interchangeability and switching across Europe, (4) disseminate real-world clinical biosimilar (switch) data, (5) share biosimilar experiences by key opinion leaders and among peers, (6) provide practical biosimilar product information, (7) provide guidance about biosimilar use, (8) actively counterbalance misinformation and organize information initiatives by neutral entities, (9) organize multi-stakeholder informational and educational efforts, aligning information between involved stakeholder groups and (10) design initiatives in a way that ensures active information uptake. Furthermore, interviewees argue that governments should be proactive in these regards.ConclusionsThis study argues in favour of a structural, multi-stakeholder framework at both European and national level to improve stakeholder biosimilar understanding and acceptance. It proposes a number of actionable recommendations that can inform policy making and guide stakeholders, which can contribute to realizing healthcare system benefits offered by biosimilar competition.Electronic supplementary materialThe online version of this article (10.1007/s40259-020-00452-9) contains supplementary material, which is available to authorized users.

EHR audit logs: A new goldmine for health services research?

A byproduct of the transition to electronic health records (EHRs) is the associated observational data that capture EHR users' granular interactions with the medical record. Often referred to as audit log data or event log data, these datasets capture and timestamp user activity while they are logged in to the EHR. These data - alone and in combination with other datasets - offer a new source of insights, which cannot be gleaned from claims data or clinical data, to support health services research and those studying healthcare processes and outcomes. In this commentary, we seek to promote broader awareness of EHR audit log data and to stimulate their use in many contexts. We do so by describing EHR audit log data and offering a framework for their potential uses in quality domains (as defined by the National Academy of Medicine). The framework is illustrated with select examples in the safety and efficiency domains, along with their accompanying methodologies, which serve as a proof of concept. This article also discusses insights and challenges from working with EHR audit log data. Ensuring that researchers are aware of such data, and the new opportunities they offer, is one way to assure that our healthcare system benefits from the digital revolution.

Early adopters of paramedic prescribing: a qualitative study.

Aims:To explore the experience of paramedics who are early adopters of independent prescribing in a range of healthcare settings in the United Kingdom.Methods:Following a public consultation by NHS England in 2015, the decision was made in March 2018 to amend legislation to enable advanced paramedics to independently prescribe medicine in UK settings. Capturing the experience of these ‘early adopters’ will help to identify where paramedic prescribing can produce optimum benefits in healthcare systems, as well as enabling early scoping out of challenges to implementation and strategies for resolving challenges. This exploratory qualitative study involved interviews with 17 paramedics who have undertaken the independent prescribing programme in the United Kingdom. Participants were recruited via social media and regional paramedic networks between May and July 2019. Interviews were conducted by telephone or video call and explored use/anticipated use of prescribing, benefits and challenges to prescribing and support for the prescribing role. Thematic analysis was conducted to identify key themes.Results:Of the 17 participants, six were currently prescribing and the remainder were awaiting annotation. Participants worked in a range of settings, including: primary care, emergency departments, urgent care, walk in centres and rapid response services. Key benefits to prescribing were similar to those reported by other non-doctor prescribers and included: streamlining care for patients, improving safety, improving efficiency and facilitating new advanced clinical practice roles. Key challenges included: administrative IT issues, lack of ability to prescribe controlled drugs and managing patient/colleague expectations around paramedic prescribing. In general, participants felt supported in their prescribing role, both by doctors and other non-doctor prescribers, and felt confident to prescribe following the prescribing course. Concerns were raised about potential isolation in some settings, lack of parity in prescribing legislation across different professions and the way this is taught in prescribing programmes.Conclusion:Indications are that paramedic prescribing is rolling out successfully in line with expectations. Barriers and facilitators are similar to those reported by other non-doctor prescribers and independent prescribing is already an essential component to advanced practitioner roles in settings such as primary care. Findings highlight a need for greater alignment of prescribing legislation across non-doctor prescribers from different professions undertaking advanced roles.

Patents and Diagnostic Methods in the U.S.: The Subject Matter Eligibility Trap

Diagnostic methods have been gaining medical recognition and social importance as innovations that can be useful to provide individuals with a diagnosis, prognosis or prediction with regard to a condition that they currently have or that they are in risk of developing. Despite the great amount of resources deployed to produce these health technologies and their potential benefits for healthcare systems and patients or prospective patients alike, their exclusive protection in the United States has faced resistance from patent examiners and courts on the basis that diagnostics constitute a dubious innovation. Inconsistent arguments used for the refusal of patent protection have led to a labyrinth where innovators in the diagnostics sector cannot reasonably expect their application or their protection after the patent is in place to stand. 
 This paper aims to convey the doctrine of subject matter eligibility as applied to diagnostic methods and the relevant guidelines and case law. In doing so, it aims to depict the pitfalls resulting from the general application of a non-patentability rule to diagnostics, and to suggest opportunities still available for innovators to overcome uncertainty by filing compliant applications while maximizing the likeliness of enjoying protection once the patent is awarded.