Improvement of Quality Metrics in Patients with Ischemic Vascular Disease (IVD), Coronary Artery Disease (CAD), and Congestive Heart Failure (CHF)

Improvement of Quality Metrics in Patients with Ischemic Vascular Disease (IVD), Coronary Artery Disease (CAD), and Congestive Heart Failure (CHF) Anastasia Barros*, Cristen French*, Carly Muller*, and Olivia Webb* Dr. Eric Gertner**, MD, MPH *Department of Internal Medicine, Lehigh Valley Health Network, LVPG Clinical Practice Council **Research Scholar Program Mentor, LVPG Clinical Practice Council Abstract To improve the quality of care for patients with cardiovascular disease, three evidence-based metrics were researched and reviewed. These metrics were for patients with ischemic vascular disease (IVD) for whom an antiplatelet medication is recommended, patients with coronary artery disease (CAD) and either left ventricular systolic dysfunction (LVSD) or diabetes mellitus for whom ACE inhibitors/ARBs are recommended, and patients with congestive heart failure (CHF) and LVSD for whom beta-blockers are recommended. The goals were to identify patients from the Lehigh Valley Physician’s Group (LVPG) whose care was not in compliance with these guidelines, standardize the documentation of allergies, contraindications, and intolerances to improve the accuracy of the metrics, and educate providers to prescribe the medications when appropriate. The most common reason for gaps in documented care was found to be the lack of transferred medication lists from CPO to EPIC approximately 6 months post-implementation of the new EMR. Other reasons included many relative contraindications for which providers could receive credit for through appropriate documentation. Through extensive chart review and “registry clean-up”, team-based care supported by the creation of sustainable workflow process, and provider and medical staff education, an increase in the percentage of patients meeting metric guidelines within specific practices was achieved. The increase varied between practices: 5.9-27.64% for antiplatelet use in patients with IVD documented, 8.3-16.3% for beta-blocker use in CHF, and 4.1% for ACE/ARBs. Keywords Quality improvement, process improvement, standard of care, ischemic vascular disease, anti-platelet, coronary artery disease, ACE inhibitors/ARBs, congestive heart failure, beta blockers Introduction Cardiovascular disease and stroke are the leading cause of death both in the United States and globally.1,2 The medical costs for these illnesses reach into the hundreds of billions of dollars annually4. On a local level, more than 1 in 4 deaths in Pennsylvania are attributed to heart disease.5 The coronary heart disease (CHD) death rate for from 2008-2012 was found to be 99.2 per 100,000 people in Lehigh County and 107.4 per 100,000 in Northampton County5, both major regions from which LVPG draws its patients. Although the human and financial cost of CVD is shocking, these numbers have decreased by more than 60% since 1950.1 This is largely the result of public health efforts and standardized care protocols, including use of aspirin, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACE inhibitors/ARBs), and beta-blockers for secondary prevention, showing that adherence to evidence-based guidelines can hugely impact hospitals and patients alike. Medicare’s Shared Savings Program, in which LVHN participates, requires Accountable Care Organizations (ACOs) to demonstrate adherence to thirty-three quality standards tracked by each ACO3. Among these thirty-three metrics are those examined in this project, specifically chosen to focus on outpatient cardiac health. The first metric includes patients with a diagnosis of IVD 18 years or older with documented use of aspirin or other antiplatelet agent. The goal for the organization, based on national benchmarks, is to ensure greater than 77.7% of patients with IVD are on anti-platelet therapy3. The second metric includes patients with a diagnosis of CHF and LVSD, defined as an ejection fraction less than 40%, who are taking a beta-blocker; the goal is to have more than 83.4% of patients in adherence3. The final metric includes patients with a diagnosis of CAD as well as diabetes mellitus (DM) or left ventricular systolic dysfunction (LVSD) who are taking an ACE inhibitor or ARB. The goal for this metric is 70.8%3. For the metrics chosen, it is important to note that certain exclusion criteria are allowable under Medicare. While there are no exclusions for the anti-platelet metric, the beta-blocker metric allows exceptions for medication allergy, contraindication, or intolerance, such as low blood pressure, asthma, or patient refusal of the medication. Medicare also specifies similar exclusions for the ACE inhibitor/ARB metric. Despite strong evidence in support of aspirin, beta-blockers and ACE/ARBs, the American College of Cardiology’s Practice Innovation and Clinical Excellence outpatient registry shows that only 66.5% of cardiac patients receive the optimal, evidence-based combination of medications.4 Our hope is to improve adherence to the aforementioned evidence-based standards of care within LVPG. Methods We used a LEAN approach to develop small tests of change within several practices. Our initial plan was to review charts and provide data to practices to assist them in a focused medication reconciliation. We were also testing whether this would be reflected by improvement in the dashboards on EPIC. Data was collected through patient chart review using the EPIC electronic medical record. Reports for each quality metric were generated using the My Report feature on EPIC. The antiplatelet quality metric was reviewed first. Reports were run for each of 7 practices within LVPG for the “antiplatelet use--not met” criterion. When the number of patients was too large to effectively search an additional narrowing criterion was added (i.e. patients\u27 most recent beta-blocker prescription) to identify patients who had not been seen in the practice in \u3e6 months. The chart of each patient listed on the report was then reviewed systematically. To summarize findings, a Microsoft Excel spreadsheet was constructed listing MRN, age of patient, date of upcoming appointments at that specific practice, date of last appointment at that practice, the practice name, PCP, cardiologist (if applicable), and whether the medications had been transferred from the CPO EMR, previously used by LVHN. If the patient’s medication list had been transferred into EPIC from CPO and they were not currently on aspirin, past appointment notes, problem lists, and medications were investigated to determine the possible reasoning for not prescribing aspirin. Possible contraindications were recorded in the spreadsheet. These included simultaneous use of a blood thinner, history of hemorrhage, GI bleed/ulcer, possible fall risk, a diagnosis of severe kidney disease, use of NSAIDs, chronic steroid use, aspirin allergy, and any intolerance to aspirin. Color coding was used to organize data, specifically patients who had not been seen in one year, patients with medication list not transferred, and patients needing to be removed from the IVD registry due to improper diagnosis or false listing by the EMR. A connection was then made with a registered nurse, clinical coordinator, or care manager in each practice. Individual meetings with the contacts for each practice were arranged and the Excel spreadsheet for their practice reviewed. The contact person then proceeded to reconcile medication lists as necessary, contact providers to review certain patients, and properly document allergies and intolerances. We found that medical staff often did not know how to properly document allergies, intolerances, and patient declinations in EPIC, so a step-by-step PowerPoint explaining the documentation processes was created as an educational tool. Additionally, providers and medical staff were taught how to view their practice metrics and run reports for their practice or specific patients. Individual practice graphs of the metric compliance were viewed on a weekly basis to track progress. The same procedure was followed for the review of patients requiring a beta-blocker prescription. A similar Excel spreadsheet was used, with contraindications specific to beta-blockers, including bradycardia, hypotension, allergy, and intolerance such as lightheadedness or fatigue. One practice was reviewed. An additional practice was instructed on how to run the report themselves and the update charts as needed. While attempting to repeat the process for patients needing ACE inhibitor/ARB prescriptions, it was discovered that the EPIC report captured patients with CAD and LVSD, but not those with CAD and DM. This overlooked approximately 90% of patients needing an ACE/ARB. For this reason, the metric was not extensively reviewed at the practice level. We worked with information services to update this metric in EPIC has since been updated, which can now be reviewed by practices in the future. In an effort to make the project sustainable and ensure that quality metrics are appropriately addressed in the future, a workflow and other educational tools were created for the process specific to each metric reviewed in this project. ResultsAnti-platelet Quality Metric Practices reviewed for the anti-platelet quality metric were Hamilton Internal Medicine, Cedar Crest Internal Medicine, LVPG Family and Internal Medicine Bethlehem Township, Lehigh Valley Physician’s Practice, Emmaus Family Medicine, Cedar Crest Cardiology, Cedar Crest Family Medicine, and Hamburg Cardiology. A total of 733 charts were reviewed with 320/733 or 43.7% not currently or previously taking aspirin. The average increase in the anti-platelet metric was 11.0%. Table 1: Summary of Data for All Practices for Anti-platelet Quality Metric Possible Clinical and Pharmaceutical Contraindications Percentage of Total Patients Reviewed Percentage of Patients Not Currently/Previously on Anti-platelet On a blood thinner 31.4% 46.9% History of Hemorrhage 7.5% 11.6% GI Bleed/Ulcer 7% 10% Fall Risk 7.4% 9.7% Severe Kidney Disease 10% 14.4% Use of NSAIDs 5.9% 6.3% Chronic Steroid Use 5.2% 8.1% Allergy 5.2% N/A Aspirin listed in past notes 45.4% N/A Procedural Issues Percentage of Total Patients Reviewed Medications not transferred 39.8% No upcoming appointment 51.7% Patients not seen in the past year 14.6% *Some patients had more than one possible contraindication Figure 1: Percentage of Patients on Anti-platelet for 3080 Hamilton Internal Medicine The percentage of patients on anti-platelet began at 70.3% and ended at 82.1%, an increase of 11.8%. The goal of 77.7% was met. Intervention occurred week of June 14th. Figure 2: Percentage of Patients on Anti-platelet for 1230 Cedar Crest Internal Medicine The percentage of patients on anti-platelet began at 72.1% and ended at 75.9%, an increase of 3.8% No patient data was inputted into EPIC. Intervention occurred week of June 21st. Figure 3: Percentage of Patients on Anti-platelet for LVPG Family and Internal Medicine Bethlehem Township The percentage of patients on anti-platelet began at 63.7% and ended at 71.3%, an increase of 7.6%. Intervention occurred week of June 14th. Figure 4: Percentage of Patients on Anti-platelet for Lehigh Valley Physician’s Practice The percentage of patients on anti-platelet began at 67.1% and ended at 76.9%, an increase of 9.8%. Intervention occurred week of June 14th. Figure 5: Percentage of Patients on Antiplatelet for Emmaus Family Medicine The percentage of patients on anti-platelet began at 67.7% and ended at 78.1%, an increase of 10.4%. The goal of 77.7% was met. Intervention occurred week of June 14th. Figure 6: Percentage of Patients on Anti-platelet for Cedar Crest Cardiology The percentage of patients on anti-platelet began at 56.9% and ended at 62.8%, an increase of 5.9%. Intervention occurred week of June 14th. Figure 7: Percentage of Patients on Anti-platelet for 1251 Cedar Crest Family Medicine The percentage of patients on anti-platelet began at 74.3% and ended at 85.6%, an increase of 11.3%. The goal of 77.7% was met. Intervention occurred week of July 12th. Figure 8: Percentage of Patients on Anti-platelet for Hamburg Cardiology The percentage of patients on anti-platelet began at 61.0% and ended at 88.6%, an increase of 27.6%. The goal of 77.7% was met. Intervention occurred week of June 21st. Beta Blocker Quality Metric Practices reviewed for the beta blocker quality metric were Cedar Crest Cardiology and 1251 Cedar Crest Family Medicine. Family medicine was completed independently by practice staff through use of education tools provided so the data is not included in Table 2. A total of 72 charts were reviewed with 5/72 or 6.9% not currently or previously taking a beta blocker. The average increase in the beta blocker metric was 13.0%. Table 2: Summary of Data for All Practices for Beta-Blocker Quality Metric Possible Clinical Contraindications Percentage of Total Patients Reviewed Severe Reactive Airway Disease 4.2% Bradycardia 1.4% Hypotension 2.8% Intolerance 6.9% Allergy 1.4% Beta-blocker listed in past notes 76.4% Procedural Issues Percentage of Total Patients Reviewed Medications not transferred 80.6% No upcoming appointment 83.3% Patients not seen in the past year 41.7% *Some patients have more than one possible contraindication Figure 9: Percentage of Patients on a Beta-Blocker for Cedar Crest Cardiology The percentage of patients on a beta blocker began at 77.6% and ended at 93.9%, an increase of 16.3%. The goal of 83.4% was met. Intervention occurred week of July 19th. Figure 10: Percentage of Patients on a Beta-Blocker for 1251 Cedar Crest Family Medicine The percentage of patients on a beta-blocker began at 91.7% and ended at 100.0%, an increase of 8.3%. The goal of 83.4% was met. Educational tools were provided the week of July 19th. ACE Inhibitor/ARB Quality Metric Practices reviewed for the ACE/ARB quality metric were Hamilton Internal Medicine, LVPG Family and Internal medicine Bethlehem Township, and Cedar Crest Internal Medicine. Hamilton Internal Medicine was the only practice with data inputted into EPIC. A total of 212 charts were reviewed. The percentage of patients not currently or previously taking ACE/ARB was not recorded due to the different approach for this metric. Initially, a practice dashboard was not available so a large database was used. Table 3: Summary of Data for All Practices for ACE/ARB Quality Metric Possible Clinical Contraindications Percentage of Total Patients Reviewed Hypotension, angioedema, renal insufficiency, hyperkalemia, bradycardia 18.9% Intolerance 2.8% Allergy 7.5% Procedural Issues Percentage of Total Patients Reviewed Medications not transferred 9.4% No upcoming appointment 30.7% Patients not seen in the past year 3.8% Figure 11: Percentage of Patients on an ACE inhibitor/ARB for 3080 Hamilton Internal Medicine The percentage of patients on an ACE/ARB began at 65.8% and ended at 69.9%, an increase of 4.1%. Intervention occurred the week of June 28th. Various slopes and non-linear trends can be observed due to changes in the definition for the metric and thus the population. Beginning the week of July 20th the correct definition was implemented. Discussion An overall analysis of the data for each metric clearly demonstrates specific data issues and clinical contraindications are the likely causes for non-adherence with metric guidelines. For patients with a diagnosis of IVD who should be prescribed an anti-platelet therapy, 39.8% did not have an updated medication list in EPIC. This allowed for a fairly quick clean-up of the data by providing each contact person a list of patient MRNs that needed medications lists to be reconciled. The most common antiplatelet metric relative contraindication, 31.4% of patients, was the additional prescription of a blood thinner. To address this, education tools were developed that include research supporting the use of dual therapy and calculators for assessing bleeding risk, to encourage appropriate management where indicated. Additional information for each contraindication was included in the developed education tools. It was also found that 39.8% of patients did not have an upcoming appointment. This is potentially problematic for future metric analysis, as appointments are needed to discuss and prescribe medications. To address this problem, patients without future appointments were noted in the data provided to each practice. A unique problem for cardiology practices is that EPIC currently does not allow for easy review of individual cardiologists’ patients, as it does for PCPs. Additionally, as consultative practices, patients are seen less frequently and often have PCPs outside of LVPG, resulting in less patient data in EPIC. The review of 733 charts for the antiplatelet metric led to increases in the metric compliance percentage for all practices with an average increase of 11.0%. When analyzing the graphs in EPIC, it is important to consider the population size. Smaller practices show more of an increase in the patient adherence percentages. Similar trends were observed for the beta-blocker metric, with 80.6% of patients not having transferred medication lists and 83.3% not having an upcoming appointment. Due to time constraints, the beta-blocker metric was only analyzed for one practice. The contact at 1251 Cedar Crest Family Medicine was taught how to follow the standardized protocol, and the results reflect their work. The most common contraindication for beta-blockers was an intolerance to the medication, most often fatigue. As a result of the project, the percentages of patients on beta-blockers at three practices now meet Medicare’s Metric standard of 83.4%. Rapid improvement of this metric was partially a result of the small number of patients requiring a beta-blocker and the limited number of contraindications. The ACE inhibitor/ARB metric proved to be difficult due to the multiple changes made in the EPIC definition of patients included in the metric. Initially, diabetic patients were not included, resulting in approximately 90% of the patient population indicated for ACE inhibitors/ARBs to not be listed in the report. It was found that clinical contraindications were the most commonly cited reason (18.9%) for non-compliance with this metric. A high percentage of patients (30.7%) again did not have upcoming appointments. Analysis of each practice’s graph shows inconsistent and non-linear trends, associated with the changing definitions. For this reason it cannot be determined how this project influenced the metric. Beginning the week of July 20th the metric definition began to also include patients with CAD and diabetes. Therefore, only the most recent week of data can be considered accurate. Conclusion The results of this quality improvement project show promise and effectiveness for the future. Generating EPIC reports and subsequently reviewing patient charts provides an efficient workflow for quality metric improvement. To ensure the sustainability of this work, multiple education tools have been developed. To decrease provider difficulties with accurate documentation and chart review, a collection of power-points were developed: step-by-step EPIC screenshot instructions for documenting allergies, intolerances, contraindications, and declinations, as well as a detailed PowerPoint for how to generate, customize, and filter reports for each metric. To enable any qualified professional in a practice to conduct quality metric improvement, workflows were created in both a single page format and a more detailed booklet. It is recommended responsible person in each practice is identified to review reports regularly, first to improve the registries by updating medications, then to focus on patients with upcoming appointments not receiving standard of care medications. Once each metric reaches the preset goal, periodic review is recommended. Overall, the goal of quality metric improvement for CAD, CHF, and IVD measures was achieved, and a variety of tools were developed to ensure continued sustainability of improvement of evidence-based care metrics. References Centers for Disease Control and Prevention. 1999. Achievements in Public Health, 1900-1999: Decline in Deaths from Heart Disease and Stroke--United States, 1900-1999. MMWR Weekly, 48(30). Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4830a1.htm Centers for Disease Control and Prevention. Heart Failure Fact Sheet [PDF document]. Retrieved from http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm (2015, March 2). Quality Measures and Performance Standards. Retrieved from: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Quality_Measures_Standards.html Mozaffarian, D., Benjamin, E., Go, A., Arnett, D., Blaha, M., Cushman, M., . . . Turner, M. (2015). Heart Disease and Stroke Statistics—2015 Update: A Report from the American Heart Association. Circulation, 131, e2-e5. Pennsylvania Department of Health. (2007, February). The Burden of Cardiovascular Disease in Pennsylvania. Retrieved from: http://www.dsf.health.state.pa.us/health/lib/health/cardiovascular

Should the insurance industry be banking on risk escalation for solvency II?

Basel II introduced a three pillar approach which concentrated upon new capital ratios (Pillar I), new supervisory procedures (Pillar II) and demanded better overall disclosure to ensure effective market discipline and transparency. Importantly, it introduced operational risk as a standalone area of the bank which for the first time was required to be measured, managed and capital allocated to calculated operational risks. Concurrently, Solvency II regulation in the insurance industry was also re-imagining regulations within the insurance industry and also developing operational risk measures. Given that Basel II was first published in 2004 and Solvency II was set to go live in January 2014. This paper analyses the strategic challenges of Basel II in the UK banking sector and then uses the results to inform a survey of a major UK insurance provider. We report that the effectiveness of Basel II was based around: the reliance upon people for effective decision making; the importance of good training for empowerment of staff; the importance of Board level engagement; and an individual's own world view and perceptions influenced the adoption of an organizational risk culture. We then take the findings to inform a survey utilizing structural equation modelling to analyze risk reporting and escalation in a large UK insurance company. The results indicate that attitude and uncertainty significantly affect individual's intention to escalate operational risk and that if not recognized by insurance companies and regulators will hinder the effectiveness of Solvency II implementation

Internally Reporting Risk in Financial Services: An Empirical Analysis

The enduring failure of financial institutions to identify and deal with risk events continues to have serious repercussions, whether in the form of small but significant losses or major and potentially far-reaching scandals. Using a mixed-methods approach that combines an innovative version of the classic dictator game to inform prosocial tendencies with the survey-based Theory of Planned Behaviour, we examine the risk-escalation behaviour of individuals within a large financial institution. We discover evidence of purely selfish behaviour that explains the lack significance in pressure to adhere to the Subjective Norms of colleagues around intention to report risks. A finding that has potentially important implications for efforts to instil a high-error management climate and incentivise risk reporting within organisations where risk, if ignored or unchecked, could ultimately have consequences that extend far beyond the institutions themselves

Quinolone-resistant gyrase mutants demonstrate decreased susceptibility to triclosan

Objectives: Cross-resistance between antibiotics and biocides is a potentially important driver of MDR. A relationship between susceptibility of Salmonella to quinolones and triclosan has been observed. This study aimed to: (i) investigate the mechanism underpinning this; (ii) determine whether the phenotype is conserved in Escherichia coli; and (iii) evaluate the potential for triclosan to select for quinolone resistance. Methods: WT E. coli, Salmonella enterica serovar Typhimurium and gyrA mutants were used. These were characterized by determining antimicrobial susceptibility, DNA gyrase activity and sensitivity to inhibition. Expression of stress response pathways (SOS, RpoS, RpoN and RpoH) was measured, as was the fitness of mutants. The potential for triclosan to select for quinolone resistance was determined. Results: All gyrase mutants showed increased triclosan MICs and altered supercoiling activity. There was no evidence for direct interaction between triclosan and gyrase. Identical substitutions in GyrA had different impacts on supercoiling in the two species. For both, there was a correlation between altered supercoiling and expression of stress responses. This was more marked in E. coli, where an Asp87Gly GyrA mutant demonstrated greatly increased fitness in the presence of triclosan. Exposure of parental strains to low concentrations of triclosan did not select for quinolone resistance. Conclusions: Our data suggest gyrA mutants are less susceptible to triclosan due to up-regulation of stress responses. The impact of gyrA mutation differs between E. coli and Salmonella. The impacts of gyrA mutation beyond quinolone resistance have implications for the fitness and selection of gyrA mutants in the presence of non-quinolone antimicrobials

Preliminary, real-world, multicenter experience with omadacycline for Mycobacterium abscessus infections

Twelve patients were treated with omadacycline (OMC) as part of a multidrug regimen fo

What stops children with a chronic illness accessing health care: A mixed methods study in children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

Background: Paediatric Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is relatively common and disabling with a mean time out of school of more than one academic year. NICE guidelines recommend referral to specialist services immediately if severely affected, within 3 months if moderately affected and within 6 months if mildly affected. However, the median time-to-assessment by a specialist service in the UK is 18 months. This study used a mixed-methods approach to examine factors associated with time taken to access specialist services. Methods. Time-to-assessment was analysed as a continuous "survival-time" variable in Cox regression models using data from self-completed assessment forms for children attending a regional specialist CFS/ME service between January 2006 and December 2009. Semi-structured interviews about barriers experienced in accessing healthcare for their child were conducted with nine parents of children aged < 17 years (8 individual and one parent couple). Interviews were digitally recorded and analysed using "thematic analysis". Results: 405 children were assessed between 2006 and 2009 and information on school attendance was available on 388. Only 1/125 with severe CFS/ME and 49/263 (19%) with mild to moderate CFS/ME were seen within NICE recommended timeframe. Increased fatigue was associated with shorter time to assessment (HR = 1.15; 95% CI 1.03, 1.29 per unit increase in Chalder fatigue score; P = 0.01). Time-to-assessment was not associated with disability, mood, age or gender. Parents described difficulties accessing specialist services because of their own as well as their GP's and Paediatrician's lack of knowledge. They experienced negative attitudes and beliefs towards the child's condition when they consulted GPs, Paediatricians and Child Psychiatrists. Parents struggled to communicate an invisible illness that their child and not themselves were experiencing. Conclusions: GPs, Child Psychiatrists and Paediatricians need more knowledge about CFS/ME and the appropriate referral pathways to ensure timeliness in referral to specialist services. © 2011 Webb et al; licensee BioMed Central Ltd

Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers

<p>Abstract</p> <p>Background</p> <p>There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes.</p> <p>Methods</p> <p>Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes.</p> <p>Results and discussion</p> <p>A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "<it>risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets</it>". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals.</p> <p>Conclusion</p> <p>We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.</p

Large expert-curated database for benchmarking document similarity detection in biomedical literature search

Document recommendation systems for locating relevant literature have mostly relied on methods developed a decade ago. This is largely due to the lack of a large offline gold-standard benchmark of relevant documents that cover a variety of research fields such that newly developed literature search techniques can be compared, improved and translated into practice. To overcome this bottleneck, we have established the RElevant LIterature SearcH consortium consisting of more than 1500 scientists from 84 countries, who have collectively annotated the relevance of over 180 000 PubMed-listed articles with regard to their respective seed (input) article/s. The majority of annotations were contributed by highly experienced, original authors of the seed articles. The collected data cover 76% of all unique PubMed Medical Subject Headings descriptors. No systematic biases were observed across different experience levels, research fields or time spent on annotations. More importantly, annotations of the same document pairs contributed by different scientists were highly concordant. We further show that the three representative baseline methods used to generate recommended articles for evaluation (Okapi Best Matching 25, Term Frequency-Inverse Document Frequency and PubMed Related Articles) had similar overall performances. Additionally, we found that these methods each tend to produce distinct collections of recommended articles, suggesting that a hybrid method may be required to completely capture all relevant articles. The established database server located at https://relishdb.ict.griffith.edu.au is freely available for the downloading of annotation data and the blind testing of new methods. We expect that this benchmark will be useful for stimulating the development of new powerful techniques for title and title/abstract-based search engines for relevant articles in biomedical research.Peer reviewe

Increasing frailty is associated with higher prevalence and reduced recognition of delirium in older hospitalised inpatients: results of a multi-centre study

Purpose: Delirium is a neuropsychiatric disorder delineated by an acute change in cognition, attention, and consciousness. It is common, particularly in older adults, but poorly recognised. Frailty is the accumulation of deficits conferring an increased risk of adverse outcomes. We set out to determine how severity of frailty, as measured using the CFS, affected delirium rates, and recognition in hospitalised older people in the United Kingdom. Methods: Adults over 65 years were included in an observational multi-centre audit across UK hospitals, two prospective rounds, and one retrospective note review. Clinical Frailty Scale (CFS), delirium status, and 30-day outcomes were recorded. Results: The overall prevalence of delirium was 16.3% (483). Patients with delirium were more frail than patients without delirium (median CFS 6 vs 4). The risk of delirium was greater with increasing frailty [OR 2.9 (1.8–4.6) in CFS 4 vs 1–3; OR 12.4 (6.2–24.5) in CFS 8 vs 1–3]. Higher CFS was associated with reduced recognition of delirium (OR of 0.7 (0.3–1.9) in CFS 4 compared to 0.2 (0.1–0.7) in CFS 8). These risks were both independent of age and dementia. Conclusion: We have demonstrated an incremental increase in risk of delirium with increasing frailty. This has important clinical implications, suggesting that frailty may provide a more nuanced measure of vulnerability to delirium and poor outcomes. However, the most frail patients are least likely to have their delirium diagnosed and there is a significant lack of research into the underlying pathophysiology of both of these common geriatric syndromes

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570