Search

Anita H Sung,1 Stephan Martin,2 Bryant Phan,1 Michael Benigno,1 Jennifer Stephens,2 Richard Chambers,1 Jalal A Aram1 1Pfizer Inc, New York, NY, USA; 2OPEN Health, Bethesda, MD, USACorrespondence: Anita H SungPfizer, 235 E 42nd St, New York, NY, 10017, USATel +1 212 733-2323Email anita.sung@pfizer.comIntroduction: Diagnosis and treatment of invasive mold infections (IMI) can be challenging and IMI is a significant source of morbidity and mortality. Invasive aspergillosis (IA) and invasive mucormycosis (IM) are two of the most common mold infections. A better understanding of patient comorbidities and risk factors that predispose IMI may help clinicians to refine the difficult diagnostic and treatment process.Methods: A systematic literature review (SLR) was conducted (January 2008–October 2019) for studies reporting comorbidities/risk factors of patients with IA or IM (Phase I), followed by an analysis on the Optum® US EHR database of prominent risk factor cohorts based on SLR findings and expert opinion (Phase II). From the four identified patient cohorts: 1) patients undergoing solid organ transplant (SOT) and patients with 2) hematologic cancers, 3) diabetes, or 4) lung disease, rates of IA, IM, or concurrent IA and IM; patient comorbidities; and Charlson Comorbidity Index (CCI) scores were reported.Results: The SLR included 88 studies, and 46 were used to select comorbidities/risk factors cohorts in IA and IM patients. The most important comorbidities/risk factors in IA and IM patients were diabetes, lung disease, hematological malignances, and SOT. In the Optum database (N=101,340,454 patients), IA rates were highest in lung transplant (10.81%) patients and IM rates were highest in intestine transplant (0.83%) patients, lung transplant (0.43%), and hematopoietic stem cell transplant (0.49%). CCI scores were elevated in all mold infection groups compared to the total Optum cohort.Conclusion: The current study describes patient comorbidity and risk factors associated with IA and IM. These data can be used to refine clinical decision-making regarding when to suspect mold infections. Future research should focus on identifying whether patients respond differently to various antifungal treatments to determine if strategic recommendations should be made for certain patient groups.Keywords: invasive mold infections, systematic literature review, retrospective claims data, invasive aspergillosis, invasive mucormycosis

Eric Armbrecht,1 Ruchit Shah,2 Gregory W Poorman,2 Linlin Luo,2 Jennifer M Stephens,2 Benjamin Li,3 Elizabeth Pappadopulos,4 Seema Haider,5 Roger S McIntyre6– 9 1Saint Louis University Center for Health Outcomes Research, Saint Louis University, Saint Louis, MO, USA; 2Pharmerit International, Bethesda, MD, USA; 3Pfizer Inc., New York, NY, USA; 4Viatris Inc., New York, NY, USA; 5Pfizer Inc., Groton, CT, USA; 6Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, ON, Canada; 7Department of Psychiatry, University of Toronto, Toronto, ON, Canada; 8Department of Pharmacology, University of Toronto, Toronto, ON, Canada; 9Brain and Cognition Discovery Foundation, Toronto, ON, CanadaCorrespondence: Jennifer M StephensPharmerit International, 4350 East West Hwy #1100, Bethesda, MD, 20814, USATel +1-240-821-1290Email JenniferStephens@openhealthgroup.comIntroduction: Patients with both major depressive disorder (MDD) and generalized anxiety disorder (GAD) in addition to one or multiple comorbid non-communicable chronic diseases (NCCDs)face unique challenges. However, few studies have characterized how the burden of co-occurring MDD and GAD differs from that of only MDD or only GAD among patients with NCCDs.Methods: In this study, we used Medical Expenditures Panel Survey data from 2010– 2017 to understand how the economic and humanistic burden of co-occurring MDD and GAD differs from that of MDD or GAD alone among patients with NCCDs. We used generalized linear models to investigate this relationship and controlled for patient sociodemographics and clinical characteristics.Results: Co-occurring MDD and GAD was associated with increases in mean annual per patient inpatient visits, office visits, emergency department visits, annual drug costs, and total medical costs. Among patients with 3+ NCCDs, MDD or GAD only was associated with lower odds ratios (ORs) of limitations in activities of daily living (ADLs; 0.532 and 0.508, respectively) and social (0.503, 0.526) and physical limitations (0.613, 0.613) compared to co-occurring MDD and GAD. Compared to patients with co-occurring MDD and GAD, having MDD only or GAD only was associated with significantly lower odds of cognitive limitations (0.659 and 0.461, respectively) in patients with 1– 2 NCCDs and patients with 3+ NCCDs (0.511, 0.416).Discussion: Comorbid MDD and GAD was associated with higher economic burden, lower quality of life, and greater limitations in daily living compared to MDD or GAD alone. Health-related economic and humanistic burden increased with number of NCCDs.Keywords: economic burden, humanistic burden, depression, anxiety, non-communicable diseases

Background: The COVID-19 (C-19) pandemic required swift response from health care organizations to mitigate spread and impact. A large integrated health network rapidly deployed and operationalized multiple access channels to the community, allowing assessment and triage to occur virtually. These channels were characterized by swift implementation of virtual models, including asynchronous e-visits and video visits for C-19 screening. Purpose: (1) Evaluate implementation characteristics of C-19 screening e-visits and video visits. (2) Identify volume of C-19 screening and other care provided via e-visits and video visits. (3) Discuss future implications of expanded virtual access models. Methods: Retrospective analysis of implementation data for C-19 screening e-visits and video visits, including operational characteristics and visit/screening volumes conducted. Results: Virtual channels were implemented and rapidly expanded during the first week C-19 testing was made available. During the study period, primary care clinicians conducted 10,673 e-visits and 31,226 video visits with 9,126 and 26,009 patients, respectively. Within these 2 virtual modalities, 4,267 C-19 tests were ordered (10% of visits). Four hundred forty-eight clinicians supported 24/7 access to these virtual modalities. Discussion: Given ongoing patient interest and opportunity, virtual health care services will continue to be available for an expanded number of symptoms and diagnoses.

Background Bevacizumab remains the most widely used and most thoroughly characterized angiogenesis inhibitor for a range of advanced cancers. Bevacizumab-bvzr (Zirabev®), a biosimilar of bevacizumab, was recently approved by the US Food and Drug Administration (FDA), which provides a less costly option. This study aimed to evaluate the financial impact of introducing bevacizumab-bvzr from US commercial and Medicare payer perspectives. Methods A Microsoft Excel-based budget impact model was developed over a 5-year time horizon. Target population was patients to be treated with bevacizumab for FDA-approved indications. Drug costs (2020 US$) were based on average sales price and wholesale acquisition cost, accounting for payer-specific reimbursement models and provider settings. Drug dosing and duration were based on prescribing information and pivotal trial publications. Results In a hypothetical 10-million-member health plan, 503 and 723 patients were estimated to be treated with bevacizumab in year 1 and year 5, respectively. Assuming an annual market shift of 1.7%, 3.6%, 6.7%, 9.4%, and 11.9% to bevacizumab-bvzr, an annual cost saving of $313,363 ($0.003 per member per month [PMPM]) was estimated for a commercial payer and $92,880 ($0.001 PMPM) for Medicare in year 1. Cumulative 5-year cost savings were $7,030,924 ($0.012 PMPM) for a commercial payer and $4,059,257 ($0.007 PMPM) for Medicare. More than half of the cost savings was attributed to patients with metastatic colorectal cancer. Conclusions The introduction of biosimilar bevacizumab-bvzr was estimated to provide substantial cost savings for US payers, which would allow additional patients access to bevacizumab treatment.

NYVEPRIA, a pegfilgrastim (a long-acting granulocyte colony-stimulating factor [G-CSF]) biosimilar, was recently recommended for marketing authorization in Europe for decreasing the incidence of febrile neutropenia (FN) in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. The present study aimed to evaluate the financial impact of introducing a new pegfilgrastim biosimilar from a French healthcare system perspective.An Excel-based budget impact model was developed to estimate the financial impact by introducing a new pegfilgrastim biosimilar (NYVEPRIA) to France over a 5-year time horizon. Comparators included existing long-acting and short-acting G-CSFs. The burden of FN was obtained from existing literature. Costs (2021 Euros) included drug acquisition and administration, estimated based on drug dosage in both clinical trial and real-world settings. Scenario analyses were conducted to examine the robustness of key model assumptions.In a total French population of 67.19 million, 79,873 patients were estimated to be treated with G-CSFs annually. The annual number of patients to be treated with NYVEPRIA was estimated to be 1593, 3195, 3674, 3782, and 4052 in years 1 to 5, respectively. Using real-world data, NYVEPRIA resulted in total annual cost savings of €8,620, €868,498, €868,498, €814,102, and €958,952 over years 1 to 5, respectively, leading to a cumulative 5-year cost savings of €3,518,669. Using data from clinical trials, NYVEPRIA resulted in total annual cost savings of €14,366, €1,447,496, €1,447,496, €1,356,836, and €1,598,253 over years 1 to 5, respectively, leading to a cumulative 5-year cost savings of €5,864,448.The introduction of a new pegfilgrastim biosimilar (NYVEPRIA) is potentially associated with substantial cost savings for the French healthcare system.

Jyoti Aggarwal,1 Jacqueline Lustrino,1 Jennifer Stephens,2 Diana Morgenstern,3 Wing Yu Tang4 1Pharmerit International, Newton, MA, USA; 2Pharmerit International, Bethesda, MD, USA; 3Pfizer, Collegeville, PA, USA; 4Pfizer, New York, NY, USACorrespondence: Wing Yu TangPfizer, 235 E. 42nd St, New York, NY 10017, USAEmail wingyu.tang@pfizer.comPurpose: Mechanical ventilation (MV) remains a substantial cost driver in intensive care units (ICU) in the United States (US). Evaluations of standard sedation treatments used to relieve pain and discomfort in this setting have found varying impacts on ICU length of stay. This cost analysis examines both length-of=stay costs and the total cost implications among MV patients receiving common sedative treatments (dexmedetomidine, propofol, or midazolam) in short-term sedation settings (< 24 hours).Methods: A cost-minimization model was conducted from the hospital provider perspective. Clinical outcomes were obtained from published literature and included ICU length of stay, MV duration, prescription of sedatives and pain medication, and the occurrence of adverse events. Outcomes costs were obtained from previously conducted ICU cost studies and Medicare payment fee schedules. All costs were estimated in 2018 US Dollars.Results: The per patient costs associated with dexmedetomidine, propofol, and midazolam were estimated to be $21,115, $27,073, and $27,603, respectively. Dexmedetomidine was associated with a savings of $5958 per patient compared to propofol and a saving of $6487 compared to midazolam. These savings were primarily driven by a reduction in ICU length of stay and the degree of monitoring and management.Conclusion: Dexmedetomidine was associated with reduced costs when compared to propofol or midazolam used for short-term sedation during MV in the ICU, suggesting sedative choice can have a potential impact on overall cost per episode.Keywords: sedation, dexmedetomidine, midazolam, propofol, costs, model

Courtney Johnson,1 Jennifer Stephens,1 Christopher Walker,2 Joseph C Cappelleri,3 Ahmed Shelbaya4 1Pharmerit International, Real World Evidence and Data Analytics, Bethesda, MD, USA; 2Pfizer Ltd., Global Medical Affairs, Tadworth, Surrey, England; 3Pfizer Inc., Statistics, Groton, CT, USA; 4Pfizer Inc., Health Economics and Outcomes Research, New York, NY, USACorrespondence: Jennifer StephensPharmerit International, 4350 East West Highway, Suite 1100, Bethesda, MD, USATel +1 240-821-1290Email jstephens@pharmerit.comObjective: This study describes treatment patterns, healthcare resource utilization (HCRU), and costs associated with persistence, switching, and dosing of branded celecoxib in osteoarthritis (OA) patients.Methods: This retrospective claims database analysis used MarketScan® Commercial Claims and Encounters (MarketScan) data from 2009 to 2013. Included patients were adult (≥ 18 years), incident celecoxib users with ≥ 1 OA claim. The treatment switch analysis analyzed outcomes in patients persistent on celecoxib versus switched to a generic nonsteroidal anti-inflammatory drug (NSAID). The dosing analysis stratified patients as under-dose (< 200 mg per day) and standard dose (≥ 200 mg per day). HCRU, costs, and treatment duration were compared in persistent versus switched and standard dose versus under-dose patients using descriptive, multivariate logistic regression, and Kaplan–Meier analysis.Results: A total of 65,530 patients met the inclusion criteria. During follow-up, 83% discontinued celecoxib without switching, 10% were persistent, and 5% switched to a generic NSAID. Ninety percent received a standard dose of celecoxib. Switched (versus persistent) patients had significantly higher all-cause hospital admissions, length of stay, emergency room (ER) visits, and office visits per person year (PPY), all P < 0.001; and under-dosed (versus standard dose) patients had significantly higher hospital admissions (P< 0.001), length of stay (P< 0.001), and ER visits (P= 0.021) PPY. Persistent versus switched patients had lower mean total all-cause costs PPY ($20,378 vs $23,949, P< 0.001). Standard dose versus under-dose patients had lower mean total all-cause costs ($23,680 vs $26,955 PPY, P< 0.001), and not statistically significant higher mean total OA-related costs ($5698 vs $5524 PPY, P=0.441).Conclusion: Patients that switched from branded celecoxib to a generic NSAID or received an under-dose of branded celecoxib had higher average overall HCRU and costs. OA-related inpatient and outpatient cost savings may offset the higher drug cost of celecoxib for persistent patients.Keywords: generic, healthcare resource use, Celebrex, NSAIDS, switching, discontinuation

Aims: The current study examined the association between insufficient major depressive disorder (MDD) care and healthcare resource use (HCRU) and costs among patients with prior myocardial ...

As the number of cancer cases rise each year in Canada, so does the number of surgical oncology cases. Surgery presents a unique and heightened stressor for the body already experiencing volatility from factors such as disease and treatments. Perioperative red blood cell (RBC) transfusions are critical to stabilize hemoglobin levels and correct anemia, as well as provide a buffer against anticipated intraoperative blood loss. Thoroughly examining and anticipating risk factors related to the potential need for perioperative blood transfusions is necessary to improve outcomes. Research evidence in recent years related to perioperative blood management of oncology patients has specifically recommended active, coordinated programs to reduce the need and amount of blood transfusions administered pre-, intra-, and post-surgery. Coordination between surgical oncologists and a local or provincial patient blood management (PBM) program is an important strategy that allows patients at risk of perioperative complications to be identified and receive early interventions and ongoing observation.

BACKGROUND The term "cancer" is imbued with identity signals that trigger certain assumed sociocultural responses. Clinical practice with hematological cancer patients suggests the experience of these patients may be different than that of solid tumor cancer patients. OBJECTIVE We sought to explore the research question: How are identity experiences described and elucidated by adult hematological cancer patients? METHODS This qualitative study was guided by interpretive description as the methodological framework. RESULTS Preexisting identity labels and assumptions assigned to the overarching "cancer" diagnosis were viewed by patients as entirely inadequate to fully describe and inform their experience. Instead, findings revealed the propensity of adult hematology oncology patients to co-create and enact new identities increasingly reflective of the nonlocalized nature of their cancer subtype. Three themes that arose from the data included the unique cancer-self, the invasion of cancer opposed to self, and the personification of the cancer within self. CONCLUSIONS Hematology oncology patients experience and claim a postdiagnosis identity that is self-described as distinct and highly specialized, and are distinct to solid tumor patients in aspects of systemic and total consumption of the self. This uniqueness is extended to the specific hematological cancer subtype down to genetics, indicating a strong "new" sense of self. IMPLICATIONS FOR PRACTICE The manner in which hematology oncology patients in this study embraced notions of transformed self and isolating uniqueness provides practitioners with a lens through which new and innovative interventions can be constructed to improve patient care and psychosocial outcomes.

IntroductionPersonal protective equipment is essential to protect health workers and patients and to ensure confidence when dealing with aerosolised disease transmission. We describe the process for ensuring adequate filtering facepiece respirator (FFR) qualitative fit testing at a local level during the COVID-19 pandemic.MethodsCascaded training is described, which allowed rapid spreading of the testing process, with supervision allowing quality assurance throughout. Testing consisted of subjective ‘fit checking’, checking for leaks, followed by qualitative hood testing.ResultsThe original respirators (3M 1870) had a hood test pass rate of 87.5%. Following identification of this as a non-renewable and unsustainable option, a domestically manufactured and sustainable Help-It P2 duckbill-type respirator was adopted as the primary FFR. The hood test pass rate for this respirator was only 54%. A third respirator was made available (3M 1860), with a high pass rate of 80% but also a limited and non-renewable resource. Algorithms were constructed highlighting different proportional use of the respirators depending on the most limited resource.ConclusionThe testing format used is simple, reproducible and can be used by any hospital organisation when occupational health and safety departments are unable to provide the service during overwhelming demand. Qualitative fit testing is a scalable and effective method for ensuring appropriately sized and shaped FFRs, minimising resource consumption in the process. The use of a product with appropriate filtration capacity but a lower fit test pass rate (domestic duckbill respirator) as a replaceable resource facilitated adequate respirator availability for staff that would otherwise not have been possible. The provision of an FFR fit registry allows an organisation to make appropriate respirators available to staff from different sources as supply and demand changes.

Background & Objectives Cyanide poisoning can occur due to exposure to smoke in closed-space fires. With no point of care cyanide test at the scene of a fire, first responders and clinicians base decisions to treat with cyanide antidote on patient history, clinical signs, and other indirect data points that have not been proven to correspond with actual systemic levels of cyanide. The aim of this exploratory study was to determine the economic implications of treating patients with known or suspected cyanide poisoning due to smoke inhalation with hydroxocobalamin. Methods A decision analysis model was developed from the US hospital perspective. Healthcare resource utilization was estimated from a retrospective evaluation of clinical outcomes in hydroxocobalamin-treated patients and in historical controls without hydroxocobalamin use (Nguyen, et al. 2017). Epidemiologic parameters and costs were estimated from the published literature, and publicly-available hospital charges were identified. Outcomes reported in the analysis included expected healthcare resource utilization in the US population and per-patient costs with and without the use of hydroxocobalamin. A cost-to-charge ratio was applied so that all costs would reflect hospital costs rather than hospital charges. Deterministic sensitivity analysis was performed to identify the most influential model parameters. All costs were reported in 2017 US dollars. Results Use of hydroxocobalamin reduces healthcare resource utilization and contributes to decreased per-patient hospital costs ($15,381 with hydroxocobalamin treatment versus $22,607 with no cyanide antidote). The most substantive cost-savings resulted from decreased hospital length of stay (i.e., intensive care unit [ICU] and non-ICU). Costs attributed to mechanical ventilation also decreased with use of hydroxocobalamin. A univariate sensitivity analysis demonstrated that the most impactful variables in the cost analysis were related to hospital length of stay (ICU followed by non-ICU stay), followed by the daily cost of ICU stay. Conclusions Use of hydroxocobalamin in patients with known or suspected cyanide poisoning from closed-space fire smoke inhalation may decrease hospital costs and contribute to more efficient healthcare resource utilization.

Potato (Solanum tuberosum L.) has tremendous significance due to its nutritional quality. The mounting pressure of increasing population further reinforces its importance as potato is believed to be a vital crop to meet food needs for population growth. Although conventional approaches of breeding, irradiation/mutagens and introgression of quality and yield related traits have improved potato yield, biotic and abiotic stresses continue to impose crop damages. Modern tools such as CRISPR/Cas have assisted plant scientists in accelerating breeding processes by providing new, simple, versatile and robust technologies. These tools make it possible to eliminate traits that are involved in negative regulation of quality and yield parameters. Besides that, genes of interest can also be introduced in close proximity to specific loci that may remain linked throughout the generations. This review focuses on the endeavors, applications and prospects of CRISPR/Cas-based approaches in potato with the potential to increase sustainable crop productivity. This manuscript focuses the endeavors, applications and prospects of CRISPR/Cas-based approaches in potato with the potential to increase sustainable crop productivity.

Background: Early antibiotic switch and early discharge protocols have not been widely studied in Latin America. Our objective was to describe real-world treatment patterns, resource use, and estimate opportunities for early switch from intravenous to oral antibiotics and early discharge for patients hospitalized with methicillin-resistant Staphylococcus aureus complicated skin and soft-tissue infections. Materials/methods: This retrospective medical chart review recruited 72 physicians from Brazil to collect data from patients hospitalized with documented methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections between May 2013 and May 2015, and discharged alive by June 2015. Data collected included clinical characteristics and outcomes, hospital length of stay, methicillin-resistant Staphylococcus aureus-targeted intravenous and oral antibiotic use, and early switch and early discharge eligibility using literature-based and expert-validated criteria. Results: A total of 199 patient charts were reviewed, of which 196 (98.5%) were prescribed methicillin-resistant Staphylococcus aureus -active therapy. Only four patients were switched from intravenous to oral antibiotics while hospitalized. The mean length of methicillin-resistant Staphylococcus aureus-active treatment was 14.7 (standard deviation, 10.1) days, with 14.6 (standard deviation, 10.1) total days of intravenous therapy. The mean length of hospital stay was 22.2 (standard deviation, 23.0) days. The most frequent initial methicillin-resistant Staphylococcus aureus-active therapies were intravenous vancomycin (58.2%), intravenous clindamycin (19.9%), and intravenous daptomycin (6.6%). Thirty-one patients (15.6%) were discharged with methicillin-resistant Staphylococcus aureus -active antibiotics of which 80.6% received oral antibiotics. Sixty-two patients (31.2%) met early switch criteria and potentially could have discontinued intravenous therapy 6.8 (standard deviation, 7.8) days sooner, and 65 patients (32.7%) met early discharge criteria and potentially could have been discharged 5.3 (standard deviation, 7.0) days sooner. Conclusions: Only 2% of patients were switched from intravenous to oral antibiotics in our study while almost one-third were early switch eligible. Additionally, one-third of hospitalized patients with methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections were early discharge eligible indicating opportunity for reducing intravenous therapy and days of hospital stay. These results provide insight into possible benefits of implementation of early switch/early discharge protocols in Brazil. Keywords: IV-to-PO switch, Length of stay, Clinical criteria, Antibiotic therapy, Economics

Viktor V Chirikov,1 Chris Walker,2 Jennifer M Stephens,1 Patricia Schepman,3 Richard Chambers,4 Mahmoud Bakir,5 Gregory W Poorman,1 Seema Haider,6 Mohammed Farghaly7 1OPEN Health, Bethesda, MD, USA; 2Global Medical Affairs, Viatris, Tadworth, UK; 3Global Health Economics and Outcomes Research, Pfizer Inc, New York, NY, USA; 4Biostatistics, Pfizer Inc, Collegeville, PA, USA; 5Upjohn Export B.V., Jeddah, Saudi Arabia; 6Pfizer Inc., Groton, CT, USA; 7Dubai Medical College, Dubai, United Arab EmiratesCorrespondence: Jennifer M StephensOPEN Health, Bethesda, MD, USATel +1 703 625 5943Email jstephens@pharmerit.comObjective: Data on osteoarthritis patients from the PRECISION trial were used to evaluate the cost-effectiveness of celecoxib (100 mg twice daily) versus ibuprofen (600– 800 mg three times daily) and naproxen (375– 500 mg twice daily). The perspective was that of the United Arab Emirates (UAE) healthcare system.Methods: Discrete-state Markov model with monthly cycles, 30-month horizon, and 3% discount rate was constructed to assess incremental costs per quality adjusted life year (QALYs) gained from reduced incidence of three safety domains examined in PRECISION: renal, serious gastrointestinal (GI), and major adverse cardiovascular events (MACE). Costs for managing these toxicities were derived from Dubai Administrative Billing Claims (2018). Median monthly drug costs were derived from UAE Ministry of Health and Prevention’s published prices ($26.98 celecoxib; $20.25 ibuprofen; $20.50 naproxen). Health utility and excess mortality associated with toxicities were sourced from the literature. The willingness-to-pay thresholds used were 1 and 3 GDP per capita ($40,000–$120,000).Results: The total average cost per patient was $812.88 for celecoxib, $775.26 for ibuprofen, and $731.17 for naproxen while cost components attributed to toxicities were lowest with celecoxib ($360.26, $438.31, and $388.60, respectively). Patients on celecoxib had more QALYs (1.339), compared with ibuprofen (1.335) and naproxen (1.337), resulting in an incremental cost-effectiveness ratio of $11,502/QALY gained for celecoxib versus ibuprofen and $39,779 for celecoxib versus naproxen. Probabilistic sensitivity analyses demonstrated celecoxib to be 81% cost-effective versus ibuprofen and 50% versus naproxen at $40,000/QALY. The most influential model parameters were MACE relative safety and drug costs.Conclusion: From UAE third payer perspective, celecoxib is a long-term cost-effective treatment for osteoarthritis patients when compared with ibuprofen, and equally likely as naproxen to be cost-effective. With the expected increasing burden of chronic diseases in the Gulf region, study findings can inform decisions regarding the cost-effective pain management of osteoarthritis in UAE.Clinicaltrials.gov Registration Number: NCT00346216.Keywords: Markov, NSAIDs, comparative effectiveness, safety, Gulf region, AfME, MENA

Aims: This study estimated the economic and humanistic burden associated with chronic non-communicable diseases (NCCDs) among adults with comorbid major depressive and/or any anxiety disorders (MDD...

Aims The association between depression care adequacy and the risk of subsequent adverse cardiovascular disease (CVD) outcomes among patients with a previous diagnosis of myocardial infarction (MI) or stroke is not well defined. Methods and results This retrospective cohort study used commercial claims data (2010-2015) and included adults with newly diagnosed and treated major depressive disorder (MDD) following an initial MI or stroke diagnosis. Depression care adequacy was assessed during the 3-month period following the MDD diagnosis index date using two measures: antidepressant dosage adequacy and duration adequacy. Cox models adjusted for the propensity of receiving adequate depression care were used to compare the risk of a composite CVD outcome (MI, stroke, congestive heart failure, and angina) as well as each individual CVD event between patients receiving adequate vs. inadequate depression care. A total of 1568 patients were included in the final cohort. Of these, 937 (59.8%) were categorized as receiving inadequate depression care based on at least one of the two treatment adequacy criteria. Propensity score adjusted Cox models showed that depression care inadequacy was associated with a significantly higher risk of the composite CVD endpoint [hazard ratio (HR) 1.20, 95% confidence interval (CI) 1.04-1.39], stroke (HR 1.20, 95% CI 1.02-1.42), and angina (HR 1.95, 95% CI 1.21-3.16) with no significant interaction based on cohort included (MI vs. stroke) or the definition of inadequate depression (dose vs. duration inadequacy) (Pinteraction > 0.05). Conclusion Inadequate MDD care was associated with a higher risk of adverse CVD events. These findings reveal a significant unmet clinical need in patients with post-MI or post-stroke MDD that may impact CVD outcomes.

Adel F Alothman,1 Abdulhakeem O Althaqafi,2 Madonna J Matar,3 Rima Moghnieh,4 Thamer H Alenazi,1 Fayssal M Farahat,2Shelby Corman,5 Caitlyn T Solem,5 Nirvana Raghubir,6 Cynthia Macahilig,7 Claudie Charbonneau,8 Jennifer M Stephens5 1College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 2Department of Infection Prevention and Control, King Abdullah International Medical Research Center, King Saud bin AbdulAziz University for Health Sciences, King AbdulAziz Medical City, Jeddah, Saudi Arabia; 3Department of Infectious Disease, Notre Dame de Secours University Hospital, Byblos, Lebanon; 4Department of Internal Medicine, Makassed General Hospital, Beirut, Lebanon; 5Real-world Evidence/Data Analytics Center of Excellence, Pharmerit International, Bethesda, MD, USA; 6Pfizer, New York, NY, 7Medical Data Analytics, Parsippany, NJ, USA; 8Pfizer International Operation, Paris, France Objectives: The objective of this study was to document the burden and treatment patterns associated with invasive fungal infections (IFIs) due to Candida and Aspergillus species in Saudi Arabia and Lebanon. Methods: A retrospective chart review study was conducted using data recorded from 2011 to 2012 from hospitals in Saudi Arabia and Lebanon. Patients were included if they had been discharged with a diagnosis of IFI due to Candida or Aspergillus, which was culture proven or suspected based on clinical criteria. Hospital data were abstracted for a random sample of patients to capture demographics, treatment patterns, hospital resource utilization, and clinical outcomes. Descriptive results were reported. Results: Five hospitals participated and provided data on 102 patients with IFI (51 from Lebanon and 51 from Saudi Arabia). The mean age of the patients was 55 years, and 55% were males. Comorbidities included diabetes (41%), coronary artery disease (24%), leukemia (19%), moderate-to-severe renal disease (16%), congestive heart failure (15%), and chronic obstructive pulmonary disease (15%). Twenty percent of patients received corticosteroids prior to admission and 26% had received chemotherapy in the past 90 days. Inpatient mortality was 42%, and the mean hospital length of stay was 32.4±28.6 days. Fifty-five percent of patients required intensive care unit admission (17.2±14.1 days), 37% required mechanical ventilation (13.7±13.2 days), and 11% required dialysis (14.6±14.2 days). The most commonly used first-line antifungal was fluconazole. Conclusion: Patients with IFI in Saudi Arabia and Lebanon frequently have multiple medical comorbidities and may not have traditionally observed IFI risk factors. Efforts to increase use of rapid diagnostic tests and appropriate antifungal treatments may impact the substantial mortality and high length of stay observed in these patients. Keywords: Candida, Aspergillus, length of stay, resource use, antifungal, mortality

Madonna J Matar,1 Rima Moghnieh,2 Adel F Alothman,3 Abdulhakeem O Althaqafi,4 Thamer H Alenazi,3 Fayssal M Farahat,4 Shelby Corman,5 Caitlyn T Solem,5 Nirvana Raghubir,6 Cynthia Macahilig,7 Seema Haider,8 Jennifer M Stephens5 1Department of Infectious Diseases, Notre Dame des Secours University Hospital, Jbeil, Lebanon; 2Department of Internal Medicine, Makassed General Hospital, Beirut, Lebanon; 3College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; 4King Abdullah International Medical Research Center, Infection Prevention and Control, King AbdulAziz Medical City, King Saud bin AbdulAziz University for Health Sciences, Jeddah, Saudi Arabia; 5Pharmerit International, Real-World Evidence/Data Analytics, Bethesda, MD, 6Pfizer, New York, NY, 7Medical Data Analytics, Parsippany, NJ, 8Pfizer, Groton, CT, USA Objectives: To describe treatment patterns and medical resource use for methicillin-resistant Staphylococcus aureus (MRSA) complicated skin and soft tissue infections (cSSTI) in Saudi Arabia and Lebanon in terms of drug selection against the infecting pathogen as well as hospital resource utilization and clinical outcomes among patients with these infections. Methods: This retrospective chart review study evaluated 2011–2012 data from five hospitals in Saudi Arabia and Lebanon. Patients were included if they had been discharged with a diagnosis of MRSA cSSTI, which was culture-proven or suspected based on clinical criteria. Hospital data were abstracted for a random sample of patients with each infection type to capture demographics, treatment patterns, hospital resource utilization, and clinical outcomes. Statistical analysis was descriptive. Results: Data were abstracted from medical records of 87 patients with MRSA cSSTI; mean age 52.4±25.9 years and 61% male. Only 64% of patients received an MRSA active initial therapy, with 56% of first-line regimens containing older beta-lactams. The mean total length of stay was 26.3 days, with the majority (19.1 days) spent in general wards. Surgical procedures included incision and drainage (22% of patients), debridement (14%), and amputation (5%). Mechanical ventilation was required by 9% of patients, with a mean duration of 18 days per patient. Hemodialysis was required by four patients (5%), two of whom were reported to have moderate to severe renal disease on admission, for a mean of 5.5 days. Inpatient mortality was 8%. Thirty-nine percent were prescribed at least one antibiotic at discharge, with the most commonly prescribed discharge antibiotics being clindamycin (44%), ciprofloxacin (18%), trimethoprim/sulfamethoxazole (12%), and linezolid (9%). Conclusion: This Middle Eastern real-world study of resource use and treatment patterns in MRSA cSSTI indicates that management of this condition could be further optimized in terms of drug selection and resource utilization. Keywords: antibiotics, length of stay, Saudi Arabia, Lebanon, skin, skin structure infections

Objectives The objective of this study is to describe the real-world treatment patterns and burden of suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) pneumonia in Saudi Arabia and Lebanon. Methods A retrospective chart review study evaluated 2011-2012 data from hospitals in Saudi Arabia and Lebanon. Patients were included if they had been discharged with a diagnosis of MRSA pneumonia, which was culture proven or suspected based on clinical criteria. Hospital data were abstracted for a random sample of patients to capture demographics (eg, age and comorbidities), treatment patterns (eg, timing and use of antimicrobials), hospital resource utilization (eg, length of stay), and clinical outcomes (eg, clinical status at discharge and mortality). Descriptive results were reported using frequencies or proportions for categorical variables and mean and standard deviation for continuous variables. Results Chart-level data were collected for 93 patients with MRSA pneumonia, 50 in Saudi Arabia and 43 in Lebanon. The average age of the patients was 56 years, and 60% were male. The most common comorbidities were diabetes (39%), congestive heart failure (30%), coronary artery disease (29%), and chronic obstructive pulmonary disease (28%). Patients most frequently had positive cultures from pulmonary (87%) and blood (27%) samples. All isolates were sensitive to vancomycin, teicoplanin, and linezolid, and only one-third of the isolates tested were sensitive to ciprofloxacin. Beta-lactams (inactive therapy for MRSA) were prescribed 21% of the time across all lines of therapy, with 42% of patients receiving first-line beta-lactams. Fifteen percent of patients did not receive any antibiotics that were considered to be MRSA active. The mean hospital length of stay was 32 days, and in-hospital mortality was 30%. Conclusion The treatment for MRSA pneumonia in Saudi Arabia and Lebanon may be suboptimal with inactive therapy prescribed a substantial proportion of the time. The information gathered from this Middle East sample provides important perspectives on the current treatment patterns.

Background Hospital antimicrobial stewardship programs (ASPs) aim to promote judicious use of antimicrobials to combat antimicrobial resistance. For ASPs to be developed, adopted, and implemented, an economic value assessment is essential. Few studies demonstrate the cost-effectiveness of ASPs. This systematic review aimed to evaluate the economic and clinical impact of ASPs. Methods An update to the Dik et al. systematic review (2000–2014) was conducted on EMBASE and Medline using PRISMA guidelines. The updated search was limited to primary research studies in English (30 September 2014–31 December 2017) that evaluated patient and/or economic outcomes after implementation of hospital ASPs including length of stay (LOS), antimicrobial use, and total (including operational and implementation) costs. Results One hundred forty-six studies meeting inclusion criteria were included. The majority of these studies were conducted within the last 5 years in North America (49%), Europe (25%), and Asia (14%), with few studies conducted in Africa (3%), South America (3%), and Australia (3%). Most studies were conducted in hospitals with 500–1000 beds and evaluated LOS and change in antibiotic expenditure, the majority of which showed a decrease in LOS (85%) and antibiotic expenditure (92%). The mean cost-savings varied by hospital size and region after implementation of ASPs. Average cost savings in US studies were $732 per patient (range: $2.50 to $2640), with similar trends exhibited in European studies. The key driver of cost savings was from reduction in LOS. Savings were higher among hospitals with comprehensive ASPs which included therapy review and antibiotic restrictions. Conclusions Our data indicates that hospital ASPs have significant value with beneficial clinical and economic impacts. More robust published data is required in terms of implementation, LOS, and overall costs so that decision-makers can make a stronger case for investing in ASPs, considering competing priorities. Such data on ASPs in lower- and middle-income countries is limited and requires urgent attention.

Objectives To describe opportunities for early switch (ES) from intravenous (IV) to oral (PO) antibiotics and early discharge (ED) of patients hospitalized in the Kingdom of Saudi Arabia (KSA) and the United Arab Emirates (UAE) with methicillin-resistant Staphylococcus aureus (MRSA) complicated skin and soft tissue infections (cSSTIs). Methods This retrospective medical chart review study enrolled physicians from 16 KSA and UAE sites to collect data for 107 MRSA cSSTI patients. Results Actual length of MRSA-active treatment was 13.3 ± 9.3 mean days in KSA and 11.2 ± 3.9 mean days in UAE, with a mean of 11.8 ± 9.3 days of MRSA-targeted IV therapy in KSA and 10.7 ± 4.3 days in UAE. 12.5% in KSA met ES criteria and potentially could have discontinued IV therapy 4.0 ± 2.9 days sooner; 44.0% in UAE could have discontinued 6.6 ± 3.6 days sooner. Patients were hospitalized for a mean 28.6 ± 45.0 days in KSA and 13.1 ± 5.9 days in UAE. 25.0% in KSA and 48.0% in UAE met ED criteria and potentially could have been discharged 6.1 ± 8.0 days earlier in KSA and 7.9 ± 5.0 days earlier in UAE. Conclusions A significant proportion of patients hospitalized for MRSA cSSTI could be eligible for ES or ED opportunities, resulting in potential for reductions in IV and bed days.

Rayo Morfín-Otero,1,2 Martha Alvarado-Ibarra,3 Eduardo Rodriguez-Noriega,1,2 Jesus Resendiz-Sanchez,4 Dipen A Patel,5 Jennifer M Stephens,5 Manuela Di Fusco,6 Carlos F Mendoza,6 Claudie Charbonneau7 1Institute of Infectious and Experimental Pathology, University Center for Health Science, University of Guadalajara, Guadalajara, Jalisco, Mexico; 2Division of Infectious Diseases, Civil Hospital of Guadalajara, Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico; 3Hematology Service, National Medical Center ‘November 20’, Mexico City, Mexico; 4Laboratory of Mycology, Children’s Hospital of Mexico, Mexico City, Mexico; 5Pharmerit International, Bethesda, MD, USA; 6Pfizer Inc, Mexico City, Mexico; 7Pfizer International Operations, Paris, Île-de-France, France Background: Patients receiving allogeneic hematopoietic stem cell transplantation (alloHSCT) are at high risk of invasive fungal infections (IFIs), which are associated with high mortality and economic burden. The cost-effectiveness of prophylaxis for the prevention of IFIs in alloHSCT recipients in Mexico has not yet been assessed. Methods: This analysis modeled a hypothetical cohort of 1,000 patients to estimate costs and outcomes for patients receiving prophylaxis for IFIs following alloHSCT, from the perspective of institutional payers in Mexico. The main prophylaxis agents currently used in Mexican clinical practice are voriconazole, fluconazole, and amphotericin B (AmB). The model accounted for event rates of IFIs during each treatment, assuming IFI causality due to invasive aspergillosis, invasive candidiasis, or other IFIs, and that the outcome for patients during follow-up was IFI-related death, death from other causes, or survival. Clinical efficacies were obtained from published literature; costs were based on local sources. Cost-effectiveness was assessed using incremental cost-effectiveness ratios (ICERs). Univariate (assessing the impact of varying each model parameter) and probabilistic sensitivity analyses were performed. Results: Voriconazole was associated with the lowest number of breakthrough IFIs, IFI-related deaths, and total number of deaths. Total costs were lower for fluconazole (Mexican pesos [MXN] 72,944; US $4,079) than voriconazole (MXN 101,413; US $5,671) or AmB (MXN 110,529; US $6,180). Voriconazole had better clinical outcomes and lower costs than AmB and could be considered cost-effective compared with fluconazole in line with the local ICER threshold. Drug costs, monitoring costs, and duration of prophylaxis were most sensitive to variation from univariate sensitivity analysis. Findings from the probabilistic sensitivity analysis were consistent with the base-case results. Conclusion: Voriconazole had the most favorable clinical outcomes, but overall prophylaxis costs were higher than with fluconazole. Overall, based on local ICER thresholds (MXN 184,665; US $10,326), voriconazole was considered a cost-effective option for prophylaxis of IFI in Mexico. Keywords: allogeneic hematopoietic stem cell transplantation, triazole, invasive aspergillosis, invasive candidiasis, incremental cost-effectiveness ratio, prophylaxis

As clinicians who deal with acutely and critically unwell adult and paediatric patients we welcome the recently published guidelines aspiring to provide a 24/7 service to deliver safe pleural procedures to patients.1 The move away from the previously unwritten mandate that all pleural procedures sampling fluid require Royal College of Radiologists (RCR) ‘level one’ ultrasound competence can only be of benefit; as the guideline concedes, confusion around which standard this required (focused vs non-focused) has not been useful. We entirely agree with the authors that the training requirements for the RCR standards do not fit well with the way pleural interventions are currently delivered. In our practice we are very aware that delays in treating pleural disease can lead to rapid patient deterioration and on occasions may be the trigger for admission to intensive care. The vertical integration model chosen for the delivery of thoracic ultrasound (TUS) with emergency-level operators at the bottom, overseen by advanced operators at the top is also to be commended. This system is similar to existing models of ultrasound training and delivery within our specialties. Core UltraSound in Intensive Care (CUSIC) training has advanced operators known as supervisors who are experienced intensive care and acute medicine clinicians, and consultant radiologists. To date there are 170 CUSIC mentors and supervisors around the country. Similar structures exist in other established point-of-care ultrasound training pathways such as Focused Acute Medicine UltraSound (FAMUS), Focused Intensive Care Echocardiography and Children’s ACuTe UltraSound. It must also be said that the move to separate the process of ultrasound guidance and procedural competency is sensible, since these are two very separate skills that have often been conflated. Of course they will frequently be undertaken by the same appropriately trained operator, but not necessarily. Where we do have concerns with this …

Early switch (ES) from intravenous (IV) to oral antibiotic therapy programmes is increasingly included as a component of hospital antimicrobial stewardship initiatives that aim to optimize antimicrobial therapy while limiting toxicity and resistance. In terms of prioritizing the most cost-effective stewardship interventions, ES has been seen as a ‘low-hanging fruit’, which refers to selecting the most obtainable targets rather than confronting more complicated issues. Administration of highly bioavailable oral antibiotics should be considered for nearly all non-critically ill patients and has been recommended as an effective and safe strategy for over two decades. However, to accrue the most benefit from ES, it should be combined with an early discharge (ED) plan, protocol, or care pathway. Benefits of this combined approach include improved patient comfort and mobility, reduced incidence of IV-line-related adverse effects, reduced IV antimicrobial preparation time, decreased hospital stays, reduced antimicrobial purchasing and administration costs, decreased patient deconditioning, and shortened recovery times. Results from published studies document decreases in healthcare resource use and costs following implementation of ES programmes, which in most studies facilitate the opportunity for ED and ED programmes. Barriers to the implementation of these programmes include clinician misconceptions, practical considerations, organizational factors, and a striking lack of awareness of IV to oral switch guidance. These and other barriers will need to be addressed to maximize the effectiveness of ES and ED programmes. As national antimicrobial stewardship programmes dictate the inclusion of ES and ED programmes within healthcare facilities, programmes must be developed and success must be documented.

Suboptimal antibiotic penetration into soft tissues can occur in patients with poor circulation due to peripheral vascular disease (PVD) or diabetes. We conducted a real-world analysis of antibiotic treatment, hospital resource use and clinical outcomes in patients with PVD and/or diabetes receiving linezolid or vancomycin for the treatment of methicillin-resistant Staphylococcus aureus complicated skin and soft-tissue infections (MRSA cSSTIs) across Europe. This subgroup analysis evaluated data obtained from a retrospective, observational medical chart review study that captured patient data from 12 European countries. Data were obtained from the medical records of patients ≥ 18 years of age, hospitalized with an MRSA cSSTI between 1 July 2010 and 30 June 2011 and discharged alive by 31 July 2011. Hospital length of stay and length of treatment were compared between the treatment groups using inverse probability of treatment weights to adjust for clinical and demographic differences. A total of 485 patients had PVD or diabetes and received treatment with either vancomycin (n = 258) or linezolid (n = 227). After adjustment, patients treated with linezolid compared with vancomycin respectively had significantly shorter hospital stays (17.9 ± 13.6 vs. 22.6 ± 13.6 days; p

We aimed to characterize real-world dosing of weight-based intravenous (IV) antibiotic therapy in patients hospitalized for methicillin-resistant Staphylococcus aureus (MRSA) complicated skin and soft-tissue infections (cSSTIs). This was a subgroup analysis of a retrospective chart review that captured data from 12 European countries. The study included patients ≥18 years old, hospitalized with an MRSA cSSTI between 1 July 2010 and 30 June 2011 and discharged alive by 31 July 2011. Patients treated with IV vancomycin, teicoplanin or daptomycin at any stage during hospitalization were included in this analysis. Analyses were conducted at the regimen level (dosing in mg/kg or in mg, frequency, and total daily dose (TDD)), with potentially multiple regimens per patient, and the patient level, categorizing patients into low, standard (labelled) and high dosing groups according to their initial MRSA-targeted regimen. Among the 1502 patients in the parent study, 998 patients contributed a total of 1050 daptomycin, teicoplanin or vancomycin regimens. Across all regimens, the mean initial TDDs were 6.3 ± 1.9 mg/kg for daptomycin, 10.5 ± 4.9 mg/kg for teicoplanin and 28.5 ± 11.5 mg/kg for vancomycin. A total of 789 patients received first-line therapy with one of the above antibiotics. The majority of patients receiving first-line teicoplanin and daptomycin (96% and 80%, respectively) received higher than labelled cSSTI doses, whereas vancomycin doses were lower than labelled doses in >40% of patients. These real-world data reveal significant deviation from labelled antibiotic dosing in 12 European countries and the potential for suboptimal outcomes in patients with MRSA cSSTIs.

Diabetes mellitus affects 284 million adults worldwide and is increasing in prevalence. Accelerated atherosclerosis in patients with diabetes mellitus contributes an increased risk of developing cardiovascular diseases including peripheral vascular disease (PVD). Immune dysfunction, diabetic neuropathy and poor circulation in patients with diabetes mellitus, especially those with PVD, place these patients at high risk for many types of typical and atypical infections. Complicated skin and soft-tissue infections (cSSTIs) are of particular concern because skin breakdown in patients with advanced diabetes mellitus and PVD provides a portal of entry for bacteria. Patients with diabetes mellitus are more likely to be hospitalized with cSSTIs and to experience related complications than patients without diabetes mellitus. Patients with PVD requiring lower extremity bypass are also at high risk of surgical site and graft infections. Methicillin-resistant Staphylococcus aureus (MRSA) is a frequent causative pathogen in cSSTIs, and may be a significant contributor to surgical site infections, especially in patients who are colonized with MRSA on hospital admission. Patients with cSSTIs and diabetes mellitus or PVD experience lower clinical success rates than patients without these comorbidities, and may also have a longer length of hospital stay and higher risk of adverse drug events. Clinicians should be vigilant in recognizing the potential for infection with multi-drug-resistant organisms, especially MRSA, in these populations and initiating therapy with appropriate antibiotics.

To estimate, from a US payer perspective, the cost offsets of treating gram positive acute bacterial skin and skin-structure infections (ABSSSI) with varied hospital length of stay (LOS) followed by outpatient care, as well as the cost implications of avoiding hospital admission.Economic drivers of care were estimated using a literature-based economic model incorporating inpatient and outpatient components. The model incorporated equal efficacy, adverse events (AE), resource use, and costs from literature. Costs of once- and twice-daily outpatient infusions to achieve a 14-day treatment were analyzed. Sensitivity analyses were performed. Costs were adjusted to 2015 US$.Total non-drug medical cost for treatment of ABSSSI entirely in the outpatient setting to avoid hospital admission was the lowest among all scenarios and ranged from $4039-$4924. Total non-drug cost for ABSSSI treated in the inpatient setting ranged from $9813 (3 days LOS) to $18,014 (7 days LOS). Inpatient vs outpatient cost breakdown was: 3 days inpatient ($6657)/11 days outpatient ($3156-$3877); 7 days inpatient ($15,017)/7 days outpatient ($2495-$2997). Sensitivity analyses revealed a key outpatient cost driver to be peripherally inserted central catheter (PICC) costs (average per patient cost of $873 for placement and $205 for complications).Drug and indirect costs were excluded and resource use was not differentiated by ABSSSI type. It was assumed that successful ABSSSI treatment takes up to 14 days per the product labels, and that once-daily and twice-daily antibiotics have equal efficacy.Shifting ABSSSI care to outpatient settings may result in medical cost savings greater than 53%. Typical outpatient scenarios represent 14-37% of total medical cost, with PICC accounting for 28-43% of the outpatient burden. The value of new ABSSSI therapies will be driven by eliminating the need for PICC line, reducing length of stay and the ability to completely avoid a hospital stay.

Ashraf El Houfi,1 Nadeem Javed,2 Caitlyn T Solem,3 Cynthia Macahilig,4 Jennifer M Stephens,3 Nirvana Raghubir,5 Richard Chambers,6 Jim Z Li,7 Seema Haider81Dubai Hospital, Dubai, UAE; 2Rashid Hospital, Dubai, UAE; 3Pharmerit International, Bethesda, MD, USA; 4Medical Data Analytics, Parsippany, NJ, USA; 5Pfizer, New York, NY, USA; 6Pfizer, Collegeville, PA, USA; 7Pfizer, La Jolla, CA, USA; 8Pfizer, Groton, CT, USAObjectives: To describe real-world treatment patterns and health care resource use and to estimate opportunities for early-switch (ES) from intravenous (IV) to oral (PO) antibiotics and early-discharge (ED) for patients hospitalized in the United Arab Emirates (UAE) with methicillin-resistant Staphylococcus aureus (MRSA) complicated skin and soft tissue infections.Methods: This retrospective observational medical chart review study enrolled physicians from four UAE sites to collect data for 24 patients with documented MRSA complicated skin and soft tissue infections, hospitalized between July 2010 and June 2011, and discharged alive by July 2011. Data include clinical characteristics and outcomes, hospital length of stay (LOS), MRSA-targeted IV and PO antibiotic use, and ES and ED eligibility using literature-based and expert-validated criteria.Results: Five included patients (20.8%) were switched from IV to PO antibiotics while being inpatients. Actual length of MRSA-active treatment was 10.8±7.0 days, with 9.8±6.6 days of IV therapy. Patients were hospitalized for a mean 13.9±9.3 days. The most frequent initial MRSA-active therapies used were vancomycin (37.5%), linezolid (16.7%), and clindamycin (16.7%). Eight patients were discharged with MRSA-active antibiotics, with linezolid prescribed most frequently (n=3; 37.5%). Fifteen patients (62.5%) met ES criteria and potentially could have discontinued IV therapy 8.3±6.0 days sooner, and eight (33.3%) met ED criteria and potentially could have been discharged 10.9±5.8 days earlier.Conclusion: While approximately one-fifth of patients were switched from IV to PO antibiotics in the UAE, there were clear opportunities for further optimization of health care resource use. Over half of UAE patients hospitalized for MRSA complicated skin and soft tissue infections could be eligible for ES, with one-third eligible for ED opportunities, resulting in substantial potential for reductions in IV days and bed days.Keywords: IV-to-PO switch, length of stay, clinical criteria, antibiotic therapy, economics

Background: In 2008, the National Heart, Lung, and Blood Institute convened an Implementation Science Work Group to assess evidence-based strategies for effectively implementing clinical practice guidelines. This was part of a larger effort to update existing clinical practice guidelines on cholesterol, blood pressure, and overweight/obesity. Objectives: Review evidence from the published implementation science literature and identify effective or promising strategies to enhance the adoption and implementation of clinical practice guidelines. Methods: This systematic review was conducted on 4 critical questions, each focusing on the adoption and effectiveness of 4 intervention strategies: (1) reminders, (2) educational outreach visits, (3) audit and feedback, and (4) provider incentives. A scoping review of the Rx for Change database of systematic reviews was used to identify promising guideline implementation interventions aimed at providers. Inclusion and exclusion criteria were developed a priori for each question, and the published literature was initially searched up to 2012, and then updated with a supplemental search to 2015. Two independent reviewers screened the returned citations to identify relevant reviews and rated the quality of each included review. Results: Audit and feedback and educational outreach visits were generally effective in improving both process of care (15 of 21 reviews and 12 of 13 reviews, respectively) and clinical outcomes (7 of 12 reviews and 3 of 5 reviews, respectively). Provider incentives showed mixed effectiveness for improving both process of care (3 of 4 reviews) and clinical outcomes (3 reviews equally distributed between generally effective, mixed, and generally ineffective). Reminders showed mixed effectiveness for improving process of care outcomes (27 reviews with 11 mixed and 3 generally ineffective results) and were generally ineffective for clinical outcomes (18 reviews with 6 mixed and 9 generally ineffective results). Educational outreach visits (2 of 2 reviews), reminders (3 of 4 reviews), and provider incentives (1 of 1 review) were generally effective for cost reduction. Educational outreach visits (1 of 1 review) and provider incentives (1 of 1 review) were also generally effective for cost-effectiveness outcomes. Barriers to clinician adoption or adherence to guidelines included time constraints (8 reviews/overviews); limited staffing resources (2 overviews); timing (5 reviews/overviews); clinician skepticism (5 reviews/overviews); clinician knowledge of guidelines (4 reviews/overviews); and higher age of the clinician (1 overview). Facilitating factors included guideline characteristics such as format, resources, and end-user involvement (6 reviews/overviews); involving stakeholders (5 reviews/overviews); leadership support (5 reviews/overviews); scope of implementation (5 reviews/overviews); organizational culture such as multidisciplinary teams and low-baseline adherence (9 reviews/overviews); and electronic guidelines systems (3 reviews). Conclusion: The strategies of audit and feedback and educational outreach visits were generally effective in improving both process of care and clinical outcomes. Reminders and provider incentives showed mixed effectiveness, or were generally ineffective. No general conclusion could be reached about cost effectiveness, because of limitations in the evidence. Important gaps exist in the evidence on effectiveness of implementation interventions, especially regarding clinical outcomes, cost effectiveness and contextual issues affecting successful implementation.

The prevalence of HIV drug resistance varies with geographic location, year, and treatment exposure. This study generated yearly estimates of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance in treatment-naive (TN) and treatment-experienced (TE) patients in the United States (US), Europe (EU), and Canada. Studies reporting NNRTI resistance identified in electronic databases and 11 conferences were analyzed in three groups: (1) TN patients in one of four geographic regions [US, Canada, EU countries with larger surveillance networks (“EU1”), and EU countries with fewer data (“EU2”)]; (2) TE patients from any region; and (3) TN patients failing NNRTI-based treatments in clinical trials. Analysis data included 158 unique studies from 22 countries representing 84 cohorts of TN patients, 21 cohorts of TE patients, and 8 trials reporting resistance at failure. From 1995 to 2000, resistance prevalence in TN patients increased in US and EU1 from 3.1% to 7.5% and 0.8% to 3.6%, respectively. Resistance in both regions stabilized in 2006 onward. Little resistance was identified in EU2 before 2000, and increased from 2006 (5.0%) to 2010 (13.7%). One TN Canadian study was identified and reported resistance of 8.1% in 2006. Half of TN clinical trial patients had resistance after treatment failure at weeks 48–144. Resistance in TE patients increased from 1998 (10.1%) to 2001 (44.0%), then decreased after 2004. Trends in NNRTI resistance among TN patients show an increased burden in the US and some EU countries compared to others. These findings signify a need for alternate first-line treatments in some regions.

In an ongoing longitudinal qualitative cohort study of cancer patients' needs and preferences across the cancer journey, we harvested a subset of accounts pertaining to conversations between patients and their clinicians around clinical trials. Recognising these conversations as a departure from the more routine discourses of clinical care, in that they enter into new dimensions of investment and motivation on the part of clinicians, we engaged in both secondary analysis of banked data and focussed interviewing of cancer patients to better understand how cancer patients describe communications in relation to decisions pertaining to clinical trials participation. Using constant comparative techniques informed by the interpretive description approach to applied qualitative methodology to guide a systematic analysis of this set of data, we documented patterns and themes across patient accounts. The resulting thematic depiction of clinical trials discourses from a patient perspective contrasts with assumptions apparent in the professional literature relating to the clinical advantage of trials participation, and illuminates aspects of patient-clinician interaction that are particularly amenable to disruption within this delicate and nuanced discourse. Findings from this study have implications for our understanding of the complexities of cancer communication at the delicate intersection of patient care and knowledge generation.

Technological and pedagogical advances in distance education have accentuated the necessity for higher education to keep pace regarding institutional infrastructures. Each infrastructure—driven by a common mission to provide quality learning—interprets quality according to standards established by various governmental and accrediting entities. Staying ahead of the technological and pedagogical changes have been challenging for many public higher education institutions, which are continuing to struggle with online course design and delivery modes (Suttle, 2010). Online universities, however, have aggressively and strategically responded to technological and pedagogical shifts across institutional, departmental, program, and course levels according to their institutional mission, vision, and core values. The American Public University System (APUS), a leader in postsecondary online learning, continues to align these foundational components through systematic program and course assessment. Demonstrating commitment to quality, APUS leaders developed the APUS Online Contact Hours Calculator to assist faculty and program directors with the assessment of total course contact hours. Core learning management system tools used to complete in-class and homework projects were apportioned time requirements toward contact hour calculations, thus streamlining the course review process, adhering to governmental and accreditation standards, and ensuring the overall quality and rigor of each online course. Keywords: online learning, contact hour calculation, online universities, model, assessment of learning, accreditation

Background The use of zoledronic acid (ZOL) has recently been shown to significantly reduce the risk of new skeletal-related events (SREs) in renal cell carcinoma (RCC) patients with bone metastases. The present exploratory study assessed the cost-effectiveness of ZOL in this population, adopting a French, German, and United Kingdom (UK) government payer perspective. Materials and methods This cost-effectiveness model was based on a post hoc retrospective analysis of a subset of patients with RCC who were included in a larger randomized clinical trial of patients with bone metastases secondary to a variety of cancers. In the trial, patients were randomized to receive ZOL (n = 27) or placebo (n = 19) with concomitant antineoplastic therapy every 3 weeks for 9 months (core study) plus 12 months during a study extension. Since the trial did not collect costs or data on the quality-adjusted life years (QALYs) of the patients, these outcomes had to be assumed via modeling exercises. The costs of SREs were estimated using hospital DRG tariffs. These estimates were supplemented with literature-based costs where possible. Drug, administration, and supply costs were obtained from published and internet sources. Consistent with similar economic analyses, patients were assumed to experience quality of life decrements lasting 1 month for each SRE. Uncertainty surrounding outcomes was addressed via multivariate sensitivity analyses. Results Patients receiving ZOL experienced 1.07 fewer SREs than patients on placebo. Patients on ZOL experienced a gain in discounted QALYs of approximately 0.1563 in France and Germany and 0.1575 in the UK. Discounted SRE-related costs were substantially lower among ZOL than placebo patients (−€ 4,196 in France, −€ 3,880 in Germany, and −€ 3,355 in the UK). After taking into consideration the drug therapy costs, ZOL saved € 1,358, € 1,223, and € 719 in France, Germany, and the UK, respectively. In the multivariate sensitivity analyses, therapy with ZOL saved costs in 67–77% of simulations, depending on the country. The cost per QALY gained for ZOL versus placebo was below € 30,000 per QALY gained threshold in approximately 93–94% of multivariate sensitivity analyses simulations. Conclusions The present analysis suggests that ZOL saves costs and increases QALYs compared to placebo in French, German, and UK RCC patients with bone metastases. Additional prospective research may be needed to confirm these results in a larger sample of patients.

Severe hemophilia with inhibitors is a rare disease with substantial clinical, humanistic and economic consequences. This review provides an overview of the role of recombinant activated factor VII (rFVIIa) versus plasma-derived bypassing agents for hemophilia with inhibitors and summarizes the 13 formal economic analyses (6 burden of illness and 7 comparative studies) that have been published in this indication. The findings suggest that the economic impact of rFVIIa has occurred primarily during hospitalization to manage major bleeding episodes and to allow for elective orthopedic surgeries that would not have been attempted prior to rFVIIa. Comparative analyses for on-demand treatment suggest that the total cost of treating a bleeding episode with rFVIIa may be lower than with plasma-based agents due to faster bleeding resolution, higher initial efficacy rates and avoidance of second and third lines of treatment.

The objectives of this retrospective medical chart review study were to document the inpatient incidence, treatment, and clinical outcomes associated with invasive fungal infections (IFI) due to Candida and Aspergillus species, Methicillin-resistant Staphylococcus aureus (MRSA) pneumonia and MRSA complicated skin and soft tissue infections (cSSTI) in the Middle East. This study evaluated 2011–2012 data from 5 hospitals in Saudi Arabia and Lebanon with a combined total of 207,498 discharges. Hospital medical chart data were abstracted for a random sample of patients with each infection type (102 patients – IFI, 93 patients – MRSA pneumonia, and 87 patients—MRSA cSSTI). Descriptive analysis found that incidence of IFI (per 1000 hospital discharges) was higher than MRSA cSSTI and MRSA pneumonia (IFI: 1.95 and 2.57; MRSA cSSTI: 2.01 and 0.48; and MRSA pneumonia 0.59 and 0.55 for Saudi Arabia and Lebanon, respectively). Median time from hospital admission to diagnosis and from admission to initiation of active therapy were 6 and 7 days, respectively, in IFI patients; median time from admission to diagnosis was 2 days for both MRSA pneumonia and cSSTI, with a median of 4 and 2 days from admission to MRSA-active antibiotic start, respectively. The mean hospital LOS was 32.4 days for IFI, 32.4 days for MRSA pneumonia and 26.3 days for MRSA cSSTI. Inpatient mortality was higher for IFI (42%) and MRSA pneumonia (30%) than for MRSA cSSTI (8%). At discharge, 33% of patients with IFI and 27% and 9% of patients with MRSA pneumonia and cSSTI, respectively, were considered to have failed therapy. In conclusion, there is a significant burden of these serious infections in the Middle East, as well as opportunity for hospitals to improve the delivery of patient care for difficult-to-treat infections by promoting expedited diagnosis and initiation of appropriate antimicrobial therapy. Keywords: Hospital, Infection, Incidence, Length of stay, Middle East

Aim To discuss the implications of drawing on core nursing knowledge as theoretical scaffolding for qualitative nursing enquiry. Background Although nurse scholars have been using qualitative methods for decades, much of their methodological direction derives from conventional approaches developed for answering questions in the social sciences. The quality of available knowledge to inform practice can be enhanced through the selection of study design options informed by an appreciation for the nature of nursing knowledge. Design Discussion paper. Data sources Drawing on the body of extant literature dealing with nursing's theoretical and qualitative research traditions, we consider contextual factors that have shaped the application of qualitative research approaches in nursing, including prior attempts to align method with the structure and form of disciplinary knowledge. On this basis, we critically reflect on design considerations that would follow logically from core features associated with a nursing epistemology. Implications for nursing The substantive knowledge used by nurses to inform their practice includes both aspects developed at the level of the general and also that which pertains to application in the unique context of the particular. It must be contextually relevant to a fluid and dynamic healthcare environment and adaptable to distinctive patient conditions. Finally, it must align with nursing's moral mandate and action imperative. Conclusion Qualitative research design components informed by nursing's disciplinary epistemology will help ensure a logical line of reasoning in our enquiries that remains true to the nature and structure of practice knowledge.