Search

Solomon Tesfaye,1 Niguse Hamba,1 Wakjira Kebede,2 Mitiku Bajiro,3 Lemessa Debela,1 Tihahun Alemayehu Nigatu,1 Asfaw Gerbi1 1Anatomy Unit, Department of Biomedical Sciences, Faculty of Medical Sciences, Institute of Health, Jimma University, Jimma, Ethiopia; 2Immunology Unit, School of Medical Laboratory Sciences, Faculty of Health Sciences, Institute of Health, Jimma University, Jimma, Ethiopia; 3Parasitology Unit, School of Medical Laboratory Sciences, Faculty of Health Sciences, Institute of Health, Jimma University, Jimma, EthiopiaCorrespondence: Solomon TesfayeAnatomy Unit, Department of Biomedical Sciences, Faculty of Medical Sciences, Institute of Health, Jimma University, Jimma, EthiopiaTel +251911939324Email sole.tesfaye2010@gmail.comBackground: Human anatomy has historically been a cornerstone in medical education and is special in that it uses human remains kept in various anatomical facilities like a morgue, gross anatomy laboratory, or museums for instruction and research. While serving knowledge advancement facilitating clinical practice and research, human cadaver handling, and usage at all levels, such as cadaver sourcing, transportation, storage, preservation, dissection, and final disposal deserves in return the utmost respect. In Ethiopia, even though there is not enough information on when, where, and by whom the first cadaver dissection was conducted, dissection is being conducted in many of its medical schools. Despite ethical necessity surrounding human body usage in every anatomical setting, there is still ethical and legal uncertainty due to several challenging barriers which is severe in developing nations including Ethiopia. The aim of this study is, therefore, to assess ethical practices of handling and usage of the human body to promote, in the near future, formulation and implementation of acceptable, respectful, and ethical guidelines for the anatomy dissection laboratories and related settings in Ethiopia.Methods: A multicentered cross-sectional study was used at selected anatomy facilities of eight Ethiopian medical schools. The collected data through structured questionnaires and checklists were cleaned, preset and entered in to SPSS version 20 for analysis. Internal consistency and reliability were measured by using Cronbach’s alpha.Results: The study result showed vivid human body ethical breaches that ranged from lack of power by anatomy unit to oversee the process during sourcing, transportation, embalming, caring, and dissection of cadavers in the anatomy laboratories to student’s mistreatment of cadavers.Conclusion: In addition to lack of compliance due to lack of standard ethical guidelines or policies regarding human body usage, the compliance-based professional development is also nonexistent. The ethical way of body sourcing is through body donation; however, in Ethiopia, anatomy teaching exclusively depends on unclaimed bodies. Using a body for dissection that is solely sourced unethically may generate a negative emotional sense of life for anatomy instructors, technical assistants, morticians, and medical students. We inspire better provision of moral and ethical exercise with the good practice concerning the human body through recognizing the humanity and uniqueness of the deceased person. The results of this study serve as a serious condemnation of practices in Ethiopian anatomy facilities and we urge the Anatomical Society of Ethiopia to play its part in changing the present practices related to ethical and legal uncertainty of the human body usage.Keywords: human body, ethical compliance, anatomical facilities, Ethiopian medical schools

Carolyn Martin,1 Eleena Koep,1 John White,1 Angela Belland,1 Heidi Waters,2 Felicia Forma3 1Optum, Eden Prairie, MN, USA; 2Policy Research Health Outcomes, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA; 3Otsuka Pharmaceutical Development & Commercialization, Inc., Health Economics and Outcomes Research, Princeton, NJ, USACorrespondence: Carolyn MartinOptum, 11000 Optum Circle, Eden Prairie, MN, 55344, USATel +1 952-205-7716Fax +1 877 503 7362Email carolyn.martin@optum.comIntroduction: Successful treatment for serious mental illnesses (SMIs) requires a good therapeutic alliance with healthcare providers and compliance with prescribed therapies such as antipsychotic medications. This retrospective study, which utilized administrative claims linked with abstracted medical chart data, addressed a data gap regarding compliance-related discussions between providers and patients.Methods: Commercially insured patients in ambulatory care post-acute (emergency or inpatient) event were eligible. Criteria included age 18– 65 years; schizophrenia, bipolar disorder, or major depressive disorder diagnoses; continuous enrollment 6 months before to 12 months after the first acute event claim dated 01/01/2014 to 12/31/2015; and antipsychotic medication prescription. Demographic and clinical data, and patient–provider discussions about treatment compliance were characterized from claims and abstracted medical charts.Results: Ninety patients (62% female, mean age 41 years) were included and 680 visits were abstracted; only 58% had first-visit antipsychotic compliance discussions. Notably, 18% of patients had discussions using the specific terms “compliance,” “persistence,” or “adherence,” whereas half were identified by more general terms. Compliance discussions were observed least often among the patients with schizophrenia, as comparedwith bipolar or major depressive disorders—a counterintuitive finding.Discussion: Compliance discussions may represent intervention opportunities to optimize treatment, yet their study is a complex endeavor. The results of this study show an opportunity to improve this valuable treatment step.Keywords: schizophrenia, bipolar disorder, major depression disorder, medication compliance, antipsychotic medication

Bewunetu Zewude, Tewodros Habtegiorgis Department of Sociology, Wolaita Sodo University, Wolaita Sodo Town, EthiopiaCorrespondence: Bewunetu Zewude Tel +251917104277Email bewunetuzewude@gmail.comBackground: Acceptance of a vaccine or hesitancy towards it have great public health implications as they partly determine the extent to which people are exposed to infections that could have otherwise been prevented. The present study examined the willingness of primary and secondary school teachers, bank employees, and university instructors in southern Ethiopia to take a Covid-19 vaccine and the factors associated with their willingness.Methods: An institutional-based cross-sectional study design was used with a quantitative research approach. Primary data were gathered mainly through the use of a survey research method in which a self-administered questionnaire was distributed to randomly selected research participants in Wolaita Sodo town. Data analysis was conducted using statistical techniques, including percentages, frequency distributions, and logistic regression analysis.Results: Research participants generally had a low (46.1%) willingness to take a COVID-19 vaccine. The main reason for most (37%) respondents’ hesitancy to take the vaccine is found to be the concern over the safety and/or the side effects of the vaccine (37%), followed by doubt about the vaccine’s effectiveness (20.7%), and lack of adequate information (12.7%). Moreover, 38.9% of survey participants revealed that they would like to take a COVID-19 vaccine other than AstraZeneca whereas 61.1% of respondents replied that they do not want to take any kind of COVID-19 vaccine. Furthermore, respondents’ willingness to take a COVID-19 vaccine is significantly associated with attitude towards the vaccine (OR = 2.830; 95% CI = 1.834– 4.368), belief that Covid-19 exists in the study area (OR = 0.221; 95% CI = 0.083– 0.589), the perception that prevalence and death rate reports of the government are real (OR = 0.365; 95% CI = 0.197– 0.676), status of chronic diseases (OR = 2.883; 95%CI = 1.039– 7.999), and having a close relative/friend ever infected by COVID-19 (OR = 2.602; 95% CI = 1.117– 6.063).Conclusion: The findings of the research demonstrated that there is generally low willingness to take a COVID-19 vaccine among university instructors, bank employees, and primary and secondary school teachers in southern Ethiopia. Therefore, the federal ministry of health, Ethiopian food and drug controlling agency, the media, and all other concerned organizations should create increased awareness about the safety/side effects issues and the need to take the vaccine.Keywords: Covid-19, hesitancy, safety, willingness, vaccine

David Price,1,2 Rupert Jones,3 Pascal Pfister,4 Hui Cao,5 Victoria Carter,6 Anu Kemppinen,6 Björn Holzhauer,4 Alan Kaplan,7 Allan Clark,8 David MG Halpin,9 Hilary Pinnock,10 James D Chalmers,11 Job FM van Boven,12 Kai M Beeh,13 Konstantinos Kostikas,14 Nicolas Roche,15 Omar Usmani,16 Paul Mastoridis5 1Observational and Pragmatic Research Institute, Singapore, Singapore; 2Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Faculty of Health, University of Plymouth, Plymouth, Devon, UK; 4Novartis Pharma AG, Basel, Switzerland; 5Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 6Observational and Pragmatic Research International Ltd, Stubbs House Stubbs Green, London, Norwich, UK; 7Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada; 8Norwich Medical School, University of East Anglia, Norwich, UK; 9University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK; 10Allergy and Respiratory Research Group, Usher Institute, University of Edinburgh, Edinburgh, UK; 11College of Medicine, University of Dundee, Dundee, UK; 12Department of Clinical Pharmacy & Pharmacology, Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; 13Clinical Research, Insaf Respiratory Research Institute, Wiesbaden, Germany; 14Respiratory Medicine Department, University of Ioannina School of Medicine, Ioannina, Greece; 15Cochin Hospital and Institute, APHP Centre, University of Paris, Paris, France; 16National Heart & Lung Institute (NHLI), Imperial College London and Royal Brompton Hospital, London, UKCorrespondence: David PriceCentre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UKTel +44 65 6962 3627Email dprice@opri.sgBackground: Poor treatment adherence in COPD patients is associated with poor clinical outcomes and increased healthcare burden. Personalized approaches for adherence management, supported with technology-based interventions, may offer benefits to patients and providers but are currently unproven in terms of clinical outcomes as opposed to adherence outcomes.Methods: Maximizing Adherence and Gaining New Information For Your COPD (MAGNIFY COPD study), a pragmatic cluster randomized trial, aims to evaluate the impact of an adherence technology package (interventional package), comprising an adherence review, ongoing provision of a dual bronchodilator but with an add-on inhaler sensor device and a connected mobile application. This will compare time to treatment failure and other clinical outcomes in patients identified at high risk of exacerbations with historic poor treatment adherence as measured by prescription collection to mono/dual therapy over one year (1312 patients) versus usual care. Treatment failure is defined as the first occurrence of one of the following: (1) moderate/severe COPD exacerbation, (2) prescription of triple therapy (inhaled corticosteroid/long-acting β2-agonist/long-acting muscarinic antagonist [ICS/LABA/LAMA]), (3) prescription of additional chronic therapy for COPD, or (4) respiratory-related death. Adherence, moderate/severe exacerbations, respiratory-related healthcare resource utilization and costs, and intervention package acceptance rate will also be assessed. Eligible primary care practices (N=176) participating in the Optimum Patient Care Quality Improvement Program will be randomized (1:1) to either adherence support cluster arm (suitable patients already receiving or initiated Ultibro® Breezhaler® [indacaterol/glycopyrronium] will be offered interventional package) or the control cluster arm (suitable patients continue to receive usual clinical care). Patients will be identified and outcomes collected from anonymized electronic medical records within the Optimum Patient Care Research Database. On study completion, electronic medical record data will be re-extracted to analyze outcomes in both study groups.Registration Number: ISRCTN10567920.Conclusion: MAGNIFY will explore patient benefits of technology-based interventions for electronic adherence monitoring.Keywords: adherence monitoring, applications, chronic obstructive pulmonary disease, medication adherence, pragmatic randomized clinical trial, technology

María Carolina Kamel Escalante,1 Abbas Abdennour,2 Antoine Farah,3 Ernesto Rivera-Richardson,4 Fernando Burgos,5 Ilenia Forero,6 Margarita Murrieta-Aguttes,7 Mohamed El Laboudy,8 Ndeye Ramatoulaye Diagne-Gueye,9 Sergio Barragan Padilla10On behalf of DIRECT Study Group1Department of Pediatrics, Hospital General del IVSS Dr Miguel Perez Carreno, Caracas, Venezuela; 2Department of Pediatrics, Santé Publique Baraki, Algiers, Algeria; 3Department of Pediatrics, Saint-Georges Hospital, Ajaltoun, Lebanon; 4Department of Pediatrics, Clinica Particular Paseo General, San Salvador, El Salvador; 5Maternal and Child Department, Hospital Universitario Austral, Buenos Aires, Argentina; 6Centro de Diagnostico Pediatrico, Panama, Panama; 7Consumer Healthcare Division, Sanofi-Aventis Group, Gentilly, France; 8Faculty of Medicine, Ain Shams University, Kalyoubya, Egypt; 9Albert Royer Children’s Hospital, Dakar, Senegal; 10ISSSTE Lopez Mateos Hospital, Department of Pediatrics, México, DF, MexicoObjective: To evaluate the daily practice of pediatricians, physician-perceived reasons for unsatisfactory effects of treatment, and unmet needs in the management of acute pain and/or fever.Methods: This was a multinational (n=13), multicenter, non interventional, cross-sectional study conducted in Latin America, Africa, and the Middle East in children under 16 years of age with fever (defined as a central body temperature ≥38°C) and/or acute pain (defined as pain lasting ≤6 weeks). Data were collected during a single visit using a structured physician-administered questionnaire and case report forms.Results: A total of 2125 patients were recruited by 178 physicians between September 2010 and September 2011. From the 2117 analyzed patients, 1856 (87.7%) had fever, 705 (33.3%) had acute pain, and 446 (21.1%) had both. Of 1843 analyzed patients with fever, 1516 (82.3%) were previously prescribed a pharmacological treatment for the management of fever concomitantly with a non pharmacological approach, while 1817/1856 patients (97.9%) were currently receiving a prescribed pharmacological treatment for fever. Paracetamol/acetaminophen was the most commonly prescribed antipyretic medication during both previous (70.8%) and current (64.1%) consultations. With regard to acute pain management, 67.2% of the patients received previous and 93.9% received current treatment for pain. The most frequently prescribed analgesic during previous consultations was paracetamol/acetaminophen (53.7%), and the current most commonly prescribed analgesics were non steroidal anti-inflammatory drugs (55.2%). Treatment patterns for patients with both fever and acute pain were similar. Overall, 53.4% of the physicians reported poor treatment compliance as a reason for the unsatisfactory effect of the pain/fever treatment, and the most common unmet need was the availability of new drugs (according to 63.5% of the physicians).Conclusions: Adequate management of fever was observed; however, due to the complex etiology of pediatric pain, better evaluation and management of pain in pediatrics is necessary.Keywords: acute pain, fever, non-steroidal anti-inflammatory drugs, paracetamol/acetaminophen, disease management, physician’s perception

Sean Mccafferty,1 Sean Ashley2 1Department of Ophthalmology, College of Medicine, University of Arizona, Tucson, AZ, USA; 2College of Optical Sciences, University of Arizona, Tucson, AZ, USACorrespondence: Sean Mccafferty 6422 E. Speedway Blvd, Tucson, AZ 85710, USATel +1 (520) 327-3487Email sjmccafferty66@hotmail.comPurpose: Evaluate the correlation between statutory social distancing interventions and Covid-19 mortality independently in both the United States and Europe. The study is presented as a potential methodology to evaluate the effectiveness of statutory social distancing policy.Patients and Methods: Twenty-seven states in the United States and, separately, 12 European countries were selected which had clearly defined and dated establishment of statewide or national mandates for social distancing measures from the Institute for Health Metrics and Evaluation (IHME) data. Mandated social distancing measures considered in this study include: School closures, Prohibition on mass gatherings, business closures, stay at home orders, severe travel restrictions, and closure of non-essential businesses. The state/country Covid-19 peak mortality rate (PMR) was defined as the initial averaged normalized maximum during which social distancing mandates were in effect. Mandate-days were defined as the total days legislative mandates were in place to the PMR.Results: The normalized peak mortality rate in the US and in Europe did not demonstrate a statistically significant correlation to the total mandate days (R-squared=0.053, p=0.246, R-squared=2.4E-06, p=0.996). A significant correlation was found between normalized mortality rate and state/country population density (R-squared=0.524, p=0.00002,R-squared=0.397, p=0.0281).Discussion: The analysis appears to suggest no mandate effective reduction in Covid-19 mortality rate to its defined initial peak when interpreting their mean-effect. A strong correlation to population density suggests human interaction frequency does affect the peak mortality rate.Keywords: epidemiology, analysis, SARS-Cov-2, mortality-rate, social-distancing, orders

Linah M Ashy Department of Oral and Maxillofacial Prosthodontics, King Abdulaziz University Faculty of Dentistry (KAUFD), Jeddah, Saudi ArabiaCorrespondence: Linah M AshyDepartment of Oral and Maxillofacial Prosthodontics, King Abdulaziz University Faculty of Dentistry, P.O.Box 80209, Jeddah, 21589, Saudi ArabiaTel +966 505679991Email lashy@kau.edu.saPurpose: To investigate the attitude of clinicians in Saudi Arabia towards dental implant treatment using different implant surgery approaches.Materials and Methods: This cross-sectional observational study was conducted using a web-based questionnaire wherein 56 clinicians ranked their attitude toward computer-guided implant surgery (CGIS) and conventional non-computer-guided surgery (non-CGIS) in terms of advantages, disadvantages and clinical indications. Statistical analysis was conducted by the Spearman correlation test, Kruskal–Wallis test, and Wilcoxon rank sum tests, at a significance level of P< 0.05.Results: The survey results indicated that the most significant advantages of CGIS from the participants’ perspective were low levels of stress during surgery (P = 0.003) and minimal requirement of surgical skills (P = 0.04). Notably, the advantages of accurate outcome and predictable flapless surgery were not considered significantly higher for CGIS than for non-CGIS (P = 0.2 and 0.7, respectively). The high treatment cost was the most significant disadvantage of CGIS when compared to non-CGIS (P = 0.002), and complete edentulism was the most recommended clinical condition for CGIS.Conclusion: Clinicians acknowledged the advantages of CGIS over non-CGIS, especially in complete edentulism. The significant advantages of CGIS were the clinician’s state of low stress and minimal skills required rather than the patient’s interest in treatment predictability. CGIS is an attractive approach for most participants, in spite of the low rate of actual use.Keywords: clinician-based outcome, dental implant, guided placement

Michel Kabamba Nzaji,1,2 Leon Kabamba Ngombe,1,3 Guillaume Ngoie Mwamba,4 Deca Blood Banza Ndala,5 Judith Mbidi Miema,2 Christophe Luhata Lungoyo,2 Bertin Lora Mwimba,2 Aimé Cikomola Mwana Bene,2 Elisabeth Mukamba Musenga2 1Department of Public Health, Faculty of Medicine, University of Kamina, Kamina, Democratic Republic of Congo; 2Ministry of Health, National Expanded Program for Immunization, Operational Research Unit, Kinshasa, Democratic Republic of Congo; 3Department of Epidemiology and Public Health, Nursing Care Section, Higher Institute of Medical Techniques of Lubumbashi, Lubumbashi, Democratic Republic of Congo; 4VillageReach, Kinshasa, Democratic Republic of Congo; 5Department of Epidemiology and Public Health, Community Health Section, Higher Institute of Medical Techniques of Mbuji-Mayi, Mbuji-Mayi, Democratic Republic of CongoCorrespondence: Michel Kabamba Nzaji Tel +243978467432Email michelnzaji@yahoo.frPurpose: This study aims to estimate the acceptability of a future vaccine against COVID-19 and associated factors if offered in Congolese health-care workers (HCWs), since they have the highest direct exposure to the disease.Patients and Methods: We conducted an analytical cross-sectional study among 23 Congolese referral hospitals, including three university hospitals, located in three towns from March through 30 April 2020. The main outcome variable was healthcare workers’ acceptance of a future vaccine against COVID-19. The associated factors of vaccination willingness were identified through a logistic regression analysis.Results: A sample of 613 HCWs participated in the study and completed the study questionnaire, including 312 (50.9%) men and 301 (49.1%) women. Only 27.7% of HCWs said that they would accept a COVID-19 vaccine if it was available. From the logistic regression analysis, male healthcare workers (ORa=1.17, 95% CI: 1.15– 2.60), primarily doctors (ORa=1.59; 95% CI:1.03– 2.44) and having a positive attitude towards a COVID-19 vaccine (ORa=11.49; 95% CI: 5.88– 22.46) were significantly associated with reporting willingness to be vaccinated.Conclusion: For acceptability of vaccination against COVID-19 among others education among HCWs is crucial because health professionals’ attitudes about vaccines are an important determinant of their own vaccine uptake and their likelihood of recommending the vaccine to their patients.Keywords: COVID-19 vaccine, health-care workers, HCWs, acceptability, DRC

Alike W van der Velden,1 Aurelio Sessa,2 Attila Altiner,3 Antonio Carlos Campos Pignatari,4 Adrian Shephard5 1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands; 2Italian College of General Practitioners and Primary Care, Florence, Italy; 3Institute of General Practice, Rostock University Medical Center, Rostock, Germany; 4Paulista School of Medicine (EPM), Federal University of São Paulo (UNIFESP), São Paulo, Brazil; 5Reckitt Benckiser Healthcare Ltd, Slough, UKCorrespondence: Alike W van der VeldenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, STR 6.103, P.O. Box 85500, Utrecht, GA 3508, The NetherlandsEmail A.W.vanderVelden@umcutrecht.nlBackground: Acute sore throat is one of the most common problems for which patients consult their general practitioner and is a key area for inappropriate antibiotic prescribing. The objective of this study was to investigate patients’ attitudes related to healthcare-seeking behavior and self-management of sore throat.Methods: We conducted an observational, questionnaire-based study across 13 countries (Australia, Brazil, China, France, Germany, Italy, the Philippines, Russia, Saudi Arabia, South Africa, Thailand, the UK and the USA) on respondents who reported having had a sore throat in the previous 12 months. Data were collected on their experiences, contact with healthcare professionals, treatment practices and opinions about antibiotics.Results: A total of 5196 respondents (approximately 400 per country) completed the survey. Over 80% of respondents sought advice for a sore throat, with 30% consulting a general practitioner. The desire to limit the worsening of symptoms was the main reason for seeking treatment. Other reasons concerned resolving persistent symptoms and reducing the impact on daily life/sleep. Self-management for sore throat was mainly medicated sore throat remedies. “Wanting an antibiotic” was rated much lower (55%) than most other reasons for visiting a doctor, but this differed greatly between countries. The percentage of respondents using antibiotics varied widely, for example, 10% in the UK and 45% in Saudi Arabia. There was considerable variation in the proportion of respondents who thought that antibiotics would be effective against sore throat (from 24% in France to 94% in Saudi Arabia).Conclusions: Our findings suggest that knowledge of effective treatments for sore throat varied widely. The results of this study should enable healthcare professionals to better anticipate patients’ needs. This will support healthcare professionals in their role as antibiotic stewards, helping to reduce the misuse of antibiotics, and further guiding patients towards symptomatic self-management of sore throat.Keywords: primary care, community health, disease management, health literacy, medications, pharmacy

Robert G Hooper Center for Sleep Medicine, Mayo Clinic, Phoenix, Arizona, USACorrespondence: Robert G Hooper P.O. Box 4100, Scottsdale, Arizona 85261-4100, USATel +1-480-342-1019Fax +1-480-342-1012Email RHoop@thesleepcenteraz.comIntroduction: There are many options available to patients who are placed on constant positive airway pressure (CPAP) for obstructive sleep apnea. Despite the success of CPAP in correcting apnea, a significant number of patients have difficulty with the therapy. A large number of those patients who have difficulty stop therapy and are often labeled as “CPAP Failure”. Non-sleep specialists may view CPAP therapy as a singular course of treatment, but there are many ways CPAP may be ordered for a patient. Each patient experiences a unique set of options that constitute a unique order set.Methods: In order to demonstrate the magnitude of the possible options, estimates of the number of unique order sets were calculated. The author chose individual order options and the number of selections possible within each option. The calculated sets included a “Generous, Limited and Minimal” number of selections for each option. Calculations were done separately for standard CPAP and for auto-adjusting CPAP. Additional calculations were performed using the number of commercially available masks in the United States.Results: The maximum number of unique order sets was seen using a standard CPAP combined with commercially available masks: 49,152 unique order sets. The fewest number of unique order sets were seen with the auto-adjusting CPAP and the “Minimal” selections: 288 unique order sets.Discussion: There are a large number of unique CPAP orders that a patient may experience. CPAP treatment is not a singular or simple therapy. When evaluating obstructive sleep apnea patients with histories of CPAP failure or prior difficulty with CPAP, paying close attention to the patient’s treatment experiences may help explain a significant number of those patients’ CPAP therapy problems.Keywords: obstructive apnea, apnea treatment failure, CPAP, CPAP failure, CPAP orders, CPAP compliance

Hiroyoshi Yamazaki,1 Naoto Tsujimoto,1 Momoha Koyanagi,1 Megumi C Katoh,1 Koyuki Tajima,2 Mika Komori1 1Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan; 2Post Marketing Surveillance Clinical Research Department, Nippon Shinyaku Co., Ltd., Kyoto, JapanCorrespondence: Hiroyoshi YamazakiMedicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., Lilly Plaza One Bldg., 5-1-28, Isogamidori, Chuo-ku, Kobe 651-0086, JapanTel +81 78 242 4391Fax +81 78 242 9299Email yamazaki_hiroyoshi@lilly.comObjective: To evaluate the long-term safety and effectiveness of tadalafil in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia in real-world clinical practice; and to investigate the safety profile in patients aged ≥ 75 years.PatientsandMethods: This was a prospective, non-interventional, multicenter, post-marketing surveillance study in which Japanese patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia were observed for up to 18 months after initiating tadalafil treatment. The real-world safety and effectiveness outcomes were assessed at baseline and at 1, 3, 6, 12, and 18 months post-treatment or the last day of treatment.Results: Most patients received tadalafil 5 mg per day throughout the observation period. Among 1393 patients analyzed for safety, the overall incidence of adverse drug reactions was 8.3%. These adverse drug reactions were generally consistent with the known safety profile of tadalafil and no new safety risks were identified in long-term use. There was no statistical difference in the frequency of adverse drug reactions between patients aged < 75 and ≥ 75 years. The mean change in total International Prostate Symptom Score (IPSS) and IPSS-quality of life subscore was significantly improved at each timepoint. At 18 months, IPSS had improved by 5.0 points (P < 0.001) and IPSS-quality of life subscore had improved by 1.5 points (P < 0.001). The mean change in post-voiding residual urine volume from baseline was significant at each time point and was − 9.8 mL at 18 months (P < 0.001); there were no significant differences from baseline in maximum urinary flow rate.Conclusion: This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. In addition, safety profiles in patients aged ≥ 75 years were similar to patients aged < 75 years.Keywords: elderly patient, long-term, observational study, phosphodiesterase type 5 inhibitor

Christopher S Ambrose,1 Bradley E Chipps,2 Wendy C Moore,3 Weily Soong,4 Jennifer Trevor,5 Dennis K Ledford,6 Warner W Carr,7 Njira Lugogo,8 Frank Trudo,9 Trung N Tran,10 Reynold A Panettieri Jr11 1US Medical Affairs, AstraZeneca, Gaithersburg, MD, USA; 2Capital Allergy & Respiratory Disease Center, Sacramento, CA, USA; 3Pulmonary, Critical Care, Allergy, and Immunologic Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 4Alabama Allergy & Asthma Center, Birmingham, AL, USA; 5Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; 6Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA; 7Allergy & Asthma Associates of Southern California, Mission Viejo, CA, USA; 8Pulmonary & Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA; 9US Medical Affairs, AstraZeneca, Wilmington, DE, USA; 10Biopharmaceuticals Medical, Respiratory and Immunology, AstraZeneca, Gaithersburg, MD, USA; 11Institute for Translational Medicine and Science, Rutgers, The State University of New Jersey, New Brunswick, NJ, USACorrespondence: Christopher S Ambrose Tel +1 (301) 398-4454Fax +1 301-398-9454Email chris.ambrose@astrazeneca.comBackground: Approximately 5– 10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.Objective: Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.Study Design: Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥ 3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1– 6 months.Initial Results: From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18– 89) and 26 (0– 80) years, respectively. Median body mass index was 31 kg/m2; 3% and 29% were current or former smokers, respectively, and > 60% reported ≥ 1 exacerbation in the prior year and suboptimal symptom control.Conclusion: CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.Keywords: asthma exacerbations, longitudinal studies, allergists, pulmonologists, biologic therapy

Pattarawadee Sattanakho,1 Pilaiwan Kleebkaow,1 Ussanee Sangkomkumhang,2 Sukjai Booranabunyat,3 Pranom Buppasiri1 1Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 2Department of Obstetrics and Gynecology, Khon Kaen Regional Hospital, Khon Kaen, Khon Kaen Province, Thailand; 3Department of Obstetrics and Gynecology, Mahasarakham Hospital, Mahasarakham Province, ThailandCorrespondence: Pranom BuppasiriDepartment of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, ThailandTel +66-43-202489Fax +66-43-348395Email bprano@kku.ac.thBackground and Objectives: To determine the rate of significant endometrial abnormalities in premenopausal women at low risk for endometrial hyperplasia and cancer presenting with abnormal uterine bleeding (AUB).Patients and Methods: This descriptive study was conducted from January 1, 2016 to March 31, 2019. The inclusion criteria were premenopausal women, 35– 50 years, presenting with AUB, low risk for endometrial hyperplasia or endometrial cancer, and having undergone endometrial sampling or uterine curettage. Nulliparous, obesity, diabetes mellitus, polycystic ovary syndrome, chronic anovulation, infertility, tamoxifen therapy and/or a family history of uterine, ovarian, breast and colon cancer were excluded. Data regarding baseline characteristics were collected, and histopathology reports were reviewed.Results: During the study period, 644 subjects were recruited, 557 of whom had adequate endometrial tissue for histopathology study. The pathology demonstrated benign in most cases (96%). The rate of significant abnormal endometrial pathology was 4% (23 cases) including 19 cases of endometrial hyperplasia without atypia (3.3%), and 4 cases of endometrial cancer (0.7%).Conclusion: The rate of significant abnormal endometrial pathology in premenopausal women at low risk for endometrial hyperplasia or endometrial cancer presenting with AUB was very low. This information should be incorporated into the counseling process regarding the risks and benefits of endometrial sampling.Keywords: abnormal uterine bleeding, endometrial sampling, endometrial pathology

Jennifer Blythe,1 Eva Herrmann,2 Dominik Faust,3 Stephan Falk,4 Tina Edwards-Lehr,5 Florian Stockhausen,6 Ernst Hanisch,5 Alexander Buia5 1Department of Internal Medicine, Bürgerhospital Frankfurt, Frankfurt, Germany; 2Institute for Biostatistics and Mathematical Modelling, University Hospital Goethe University, Frankfurt, Germany; 3Department of Gastroenterology, Hepatology and Infectious Disease, Asklepios Klinik Langen, Langen, Germany; 4OptiPath Pathology Associates Frankfurt, Frankfurt, Germany; 5Department of Visceral and Thoracic Surgery, Asklepios Klinik Langen, Langen, Germany; 6Department of Surgery, Hospital zum Heiligen Geist, Frankfurt, Germany Background: For decades, the optimal timing of surgery for acute cholecystitis has been controversial. Recent meta-analyses and population-based studies favor early surgery. One recent large randomized trial has demonstrated that a delayed approach increases morbidity and cost compared to early surgery within 24hours of hospital admission. Since cases of severe cholecystitis were excluded from this trial, we argue that these results do not reflect real-world clinical situations. From our point of view, these results were in contrast to the clinical experience with our patients; so, we decided to analyze critically all our patients with the null hypothesis that the patients treated with a delayed cholecystectomy after an acute cholecystitis have a similar or even better outcome than those treated with an early operative approach.Patients and methods: We retrospectively analyzed clinical data from all patients with cholecystectomies in the period between January 2006 and September 2015. A total of 1,723 patients were categorized into four groups: early (n=138): urgent surgery of patients with acute cholecystitis within the first 72 hours of the onset of symptoms; intermediate (n=297): surgery of patients with acute cholecystitis within an average of 10 days after the onset of symptoms; delayed (n=427): initial non-surgical treatment of acute cholecystitis with surgery performed within 6–12 weeks of the onset of symptoms; and elective (n=868): cholecystectomy within a symptom-free interval of choice in patients with symptomatic cholecystolithiasis without signs of acute cholecystitis.Results: In a real-world scenario, early/intermediate cholecystectomy in acute cholecystitis was associated with a significant increase in morbidity and mortality (Clavien–Dindo score) compared to a delayed approach with surgery performed 6–12 weeks after the onset of symptoms. The adjusted linear rank statistics showed a decrease in the complication score with values of 2.29 in the early group, 0.48 in the intermediate group, –0.26 in the delayed group and –2.12 in the elective group. The results translate into a continuous decrease of the complication score from early over intermediate and delayed to the elective group.Conclusion: These results demonstrate that delayed cholecystectomy can be performed safely. In cases with severe cholecystitis, early and/or intermediate approaches still have a relatively high risk of morbidity and mortality. Keywords: acute cholecystitis, early cholecystectomy, delayed cholecystectomy, gallstone disease

Stavros Theologou,1 Konstantinos Giakoumidakis,1 Christos Charitos2 1Cardiac Surgery Intensive Care Unit, “Evangelismos” General Hospital of Athens, Athens, Greece; 2Department of Cardiothoracic Surgery, “Evangelismos” General Hospital of Athens, Athens, Greece Background: Delirium is a quite common complication in adult patients post-cardiac surgery. The purpose of our study was to identify perioperative characteristics and also focus on incidence factors that could predict delirium in the cardiac surgery intensive care unit (CICU) postoperatively. Methods: We conducted a prospective study of 179 consecutive patients, who underwent open-heart surgical operation and were admitted to the CICU of a general tertiary hospital in Athens, Greece. The patients were screened for delirium by using the diagnostic tools of Richmond Agitation Sedation Scale (RASS score) and the Confusion Assessment Method – ICU (CAM-ICU). The delirium assessment was carried out on the 1st and the 2nd postoperative day, and was conducted twice every nursing shift. A short questionnaire on sociodemographics and clinical patient characteristics was used for data collection purposes. Results: A total of 179 patients who underwent open-heart surgical operation with cardiopulmonary bypass (CPB) were enrolled in our study. The 2-day incidence of postoperative delirium in ICU was 11.2% (n=20/179). The main independent predictors of delirium on the 2nd postoperative day were neutrophil-to-lymphocyte ratio (p=0.001) and urea levels (p=0.016). Additionally, increased perioperative creatinine (p=0.006) and sodium (p=0.039) levels were significantly associated with delirium occurrence. Furthermore, elevated EuroSCORE (p=0.001), extended length of stay (LOS) in ICU (p

Sabrina Mueller,1 Antje Groth,1 Stefan G Spitzer,2,3 Anja Schramm,4 Andreas Pfaff,5 Ulf Maywald6 1Institute for Pharmacoeconomics and Medication Logistics, University of Wismar, Wismar, Germany; 2Praxisklinik Herz und Gefäße Dresden, Academic Educational Practice Clinic, TU Dresden, Dresden, Germany; 3Institute of Medical Technology, Brandenburg University of Technology Cottbus–Senftenberg, Senftenberg, Germany; 4AOK Bayern, Regensburg, Germany; 5AOK Baden-Württemberg, Stuttgart, Germany; 6AOK PLUS, Dresden, Germany Objective: To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment. Methods: This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included. Outcomes and measures: Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs). Results: We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA2DS2VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA2DS2VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17–1.28/1.22; 1.17–1.28), IS (1.90; 1.69–2.15/1.92; 1.69–2.19), non-specified strokes (2.04; 1.16–3.70/1.93; 1.13–3.32), TIAs (1.52; 1.29–1.79/1.44; 1.21–1.70), MIs (1.26; 1.10–1.15/1.31; 1.13–1.52), AE (1.75; 1.32–2.32/1.81; 1.36–2.34) and severe bleeding (1.92; 1.71–2.15/1.95; 1.74–2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under clinicaltrials.gov (NCT02657616). Conclusion and relevance: A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients. Keywords: atrial fibrillation, AF, anticoagulation, NOAC, VKA, cohort study

Kahasse Gebrekidan,1 Alemayehu Worku21Department of Public Health, Saint Paul Hospital Millennium Medical College, Addis Ababa, Ethiopia; 2Department of Preventive Medicine, School of Public Health, College of Health Science, Addis Ababa University, Addis Ababa, Ethiopia Background: Although Ethiopia has shown remarkable achievements in reducing maternal mortality in the last 10 years, the prevalence of late antenatal care (ANC) initiation is still high in the country.Objective: The primary purpose of this study was to identify the factors related to late ANC initiation among pregnant women in selected public health centers in Addis Ababa, Ethiopia.Subjects and methods: A total of 402 pregnant women (cases=134, controls=268) were recruited using multistage sampling. The design selected for the study was unmatched case–­control. EpiData version 3.02 and SPSS version 20.0 were used for data entry and statistical analysis, respectively. Binary logistic regression model was used to model the odds of late ANC initiation.Results:The odds of attending ANC late were significantly higher for mothers with a monthly household income of $8.50 to start the ANC service (AOR=3.04; 95% CI: 1.98, 4.67).Conclusion: Low educational level, low income of the household, unplanned pregnancy, stay for

Objectives To describe the epidemiology of abortion in Ecuador from 2004 to 2014 and compare the prevalence between the public and the private health care systems. Methods This is a cross-sectional analysis of the overall mortality and morbidity rate due to abortion in Ecuador, based on public health records and other government databases. Results From 2004 to 2014, a total of 431,614 spontaneous abortions, miscarriage and other types of abortions were registered in Ecuador. The average annual rate of abortion was 115 per 1,000 live births. The maternal mortality rate was found to be 43 per 100,000 live births. Conclusions Abortion is a significant and wide-ranging problem in Ecuador. The study supports the perception that in spite of legal restrictions to abortion in Ecuador, women are still terminating pregnancies when they feel they need to do so. The public health system reported >84% of the national overall prevalence., Video abstract

Franco Maggiolo,1 Elisa Di Filippo,1 Laura Comi,1 Annapaola Callegaro,2 Giorgio L Colombo,3,4 Sergio Di Matteo,4 Daniela Valsecchi,5 Marco Rizzi1 1USC of Infectious Diseases, 2USC Microbiology and Virology, 3Department of Drug Sciences, University of Pavia, 4S.A.V.E. Studi– Health Economics & Outcomes Research, Milan, 5USC of Pharmacy, ASST Papa Giovanni XXIII, Bergamo,Italy Abstract: The source and significance of residual low-level viremia (LLV) during combinational antiretroviral therapy (cART) remain a matter of controversy. It is unclear whether residual viremia depends on ongoing release of HIV from the latent reservoir or if viral replication contributes to LLV. We examined the relationship between adherence and LLV. Adherence was estimated by pharmacy refill and dichotomized as ≥95% or 3: constantly between 3 and 50 ­copies/mL; and V>50: a measure of >50 copies/mL minimum. Overall, 2789 patients were included. At each time point approximately 92% of the patients presented an HIV-RNA 50copies/mL minimum. The mean adherence rate was 92.1% (95% confidence interval [CI] from 91.1% to 93.1%) in K3 patients and to 88.4% in V>50 patients (P3 and to 48% in V>50. Moreover, 34% of patients with a steady adherence 3, whereas 21.7% of those with a drug holiday (21.7%) were observed in the V>50 group (P=0.002). A steady viral suppression can occur despite moderate cART non-adherence, but reduced adherence is associated with low-level residual viremia, which could reflect new rounds of HIV replication. However, a detectable HIV-RNA could also be detected in patients with optimal cART adherence, indicating additional mechanisms favoring HIV persistence. Keywords: adherence, drug-refill, LLV, low-level viremia, viral replication, residual viremia cART

Julian WE Jarman,1 Tina D Hunter,2 Wajid Hussain,1 Jamie L March,3 Tom Wong,1 Vias Markides1 1Cardiology & Electrophysiology, Heart Rhythm Center, NIHR Cardiovascular Research Unit, The Royal Brompton Hospital, and National Heart and Lung Institute, Imperial College London, London, UK; 2Health Outcomes Research, CTI Clinical Trial & Consulting Services Inc., Cincinnati, OH, 3Health Economics and Market Access, Biosense Webster Inc., Diamond Bar, CA, USA Background: We sought to determine whether catheter ablation of atrial fibrillation (AF) is associated with reduced occurrence of ischemic cerebrovascular events.Methods and results: Using routinely collected hospital data, ablation patients were matched to two control cohorts via direct and propensity score matching. A total of 4,991 ablation patients were matched 1:1 to general AF controls with no ablation, and 5,407 ablation patients were similarly matched to controls who underwent cardioversion. Yearly rates of ischemic stroke or transient ischemic attack (stroke/TIA) before and after an index date were compared between cohorts. Index date was defined as the first ablation, the first cardioversion, or the second AF event in the general AF cohort. Matched populations had very similar demographic and comorbidity profiles, including nearly identical CHA2DS2-VASc risk distribution (p-values 0.6948 and 0.8152 vs general AF and cardioversion cohorts). Statistical models of stroke/TIA risk in the preindex period showed no difference in annual event rates between cohorts (mean±standard error 0.30% ± 0.08% ablation vs 0.28% ± 0.07% general AF, p=0.8292; 0.37% ± 0.09% ablation vs 0.42% ± 0.08% cardioversion, p=0.5198). Postindex models showed significantly lower annual rates of stroke/TIA in ablation patients compared with each control group over 5 years (0.64% ± 0.11% ablation vs 1.84% ± 0.23% general AF, p

Benton R Hunter,1 Sean P Collins,2 Gregory J Fermann,3 Phillip D Levy,4 Changyu Shen,5 Syed Imran Ayaz,4 Mette L Cole,1 Karen F Miller,2 Adam A Soliman,3 Peter S Pang1,6 1Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN, 2Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, 3Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, 4Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI, 5Department of Biostatistics, Indiana University School of Medicine, 6Department of Indianapolis EMS, The Regenstrief Institute, IN, USA Background: Acute heart failure (AHF) is a common presentation in the Emergency Department (ED), and most patients are admitted to the hospital. Identification of patients with AHF who have a low risk of adverse events and are suitable for discharge from the ED is difficult, and an objective tool would be useful. Methods: The highly sensitive Troponin T Rules Out Acute Cardiac Insufficiency Trial (TACIT) will enroll ED patients being treated for AHF. Patients will undergo standard ED evaluation and treatment. High-sensitivity troponin T (hsTnT) will be drawn at the time of enrollment and 3 hours after the initial draw. The initial hsTnT draw will be no more than 3 hours after initiation of therapy for AHF (vasodilator, loop diuretic, noninvasive ventilation). Treating clinicians will be blinded to hsTnT results. We will assess whether hsTnT, as a single measurement or in series, can accurately predict patients at low risk of short-term adverse events. Conclusion: TACIT will explore the value of hsTnT measurements in isolation, or in combination with other markers of disease severity, for the identification of ED patients with AHF who are at low risk of short-term adverse events. Keywords: heart failure, high-sensitivity troponin, hospitalization

David B Price,1,2 Eran Gefen,3 Gokul Gopalan,4 Cristiana Miglio,2 Rosie McDonald,2 Vicky Thomas,2 Simon Wan Yau Ming2 1Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 2Observational and Pragmatic Research Institute, Singapore, Singapore; 3Teva Pharmaceuticals, Petach Tikva, Israel; 4Teva Pharmaceuticals, Frazer, PA, USA Objective: The objective of this study was to determine whether the effectiveness of budesonide comparator is non-inferior to budesonide reference in the prevention of asthma exacerbations. Asthma-related hospitalizations and safety were also examined.Methods: This study used a matched, historic cohort design. Data were drawn from the Clinformatics™ Data Mart US claims database and included a 1-year baseline, starting 1year before the index prescription date, and a 1-year outcome period. Patients received budesonide comparator or reference treatment. The primary outcome was the rate of asthma exacerbations. Non-inferiority for budesonide comparator vs budesonide reference was established if the 95% confidence interval (CI) upper limit of mean difference in proportions between treatments was

Konstantinos Giakoumidakis,1 Nikolaos V Fotos,2 Athina Patelarou,3 Stavros Theologou,1 Mihalis Argiriou,4 Anastasia A Chatziefstratiou,2 Christina Katzilieri,5 Hero Brokalaki2 1Cardiac Surgery Intensive Care Unit, “Evangelismos” General Hospital of Athens, 2Faculty of Nursing, School of Healthcare Sciences, National & Kapodistrian University of Athens, Athens, 3Department of Anaesthesiology, University Hospital of Heraklion, Heraklion, 4Department of Cardiothoracic Surgery, “Evangelismos” General Hospital of Athens, 5Intensive Care Unit, “Korgalenio – Benakio Hellenic Red Cross” General Hospital of Athens, Athens, Greece Purpose: The purpose of the present study was to investigate the association between the perioperative neutrophil to lymphocyte ratio (NLR) and cardiac surgery patient outcomes.Patients and methods: A retrospective cohort study of 145 patients who underwent cardiac surgery in a tertiary hospital of Athens, Greece, from January to March 2015, was conducted. By using a structured short questionnaire, this study reviewed the electronic hospital database and the medical and nursing patient records for data collection purposes. The statistical significance was two-tailed, and p-values

Anne Burden,1 Nicolas Roche,2 Cristiana Miglio,1 Elizabeth V Hillyer,1 Dirkje S Postma,3 Ron MC Herings,4 Jetty A Overbeek,4 Javaria Mona Khalid,5 Daniela van Eickels,6 David B Price1,7 1Observational and Pragmatic Research Institute Pte Ltd, Singapore; 2University Paris Descartes (EA2511), Cochin Hospital Group (AP-HP), Paris, France; 3Department of Pulmonology, University Medical Center Groningen, University of Groningen, Groningen, 4PHARMO Institute for Drug Outcomes Research, Utrech, the Netherlands; 5Takeda Development Centre Europe Ltd, London, UK; 6Takeda Pharmaceuticals International GmbH, Zurich, Switzerland; 7Academic Primary Care, University of Aberdeen, Aberdeen, UK Background: Cohort matching and regression modeling are used in observational studies to control for confounding factors when estimating treatment effects. Our objective was to evaluate exact matching and propensity score methods by applying them in a 1-year pre–post historical database study to investigate asthma-related outcomes by treatment. Methods: We drew on longitudinal medical record data in the PHARMO database for asthma patients prescribed the treatments to be compared (ciclesonide and fine-particle inhaled corticosteroid [ICS]). Propensity score methods that we evaluated were propensity score matching (PSM) using two different algorithms, the inverse probability of treatment weighting (IPTW), covariate adjustment using the propensity score, and propensity score stratification. We defined balance, using standardized differences, as differences of 10% for four variables in the exact-matched dataset and

Naomi Launders,1 Dermot Ryan,2 Christopher C Winchester,3 Derek Skinner,4 Priyanka Raju Konduru,4 David B Price4 1Respiratory Effectiveness Group, Cambridge, UK; 2Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Medical School, Edinburgh EH8 9AG, Scotland; 3Oxford PharmaGenesis, Oxford, UK; 4Observational and Pragmatic Research Institute Pte Ltd, Singapore, SingaporeCorrespondence: David B PriceObservational and Pragmatic Research Institute Pte Ltd (OPRI), 60 Paya Lebar Road, Paya Lebar Square, Level 5, Unit 33 and 34, Singapore 409051, SingaporeTel +65 68029724Email dprice@opri.sgPurpose: In primary care, initial diagnosis of community-acquired pneumonia (CAP) is made on clinical judgment without radiological confirmation or knowledge of the causative organism. Use of CRB65 score has been recommended for assessing the severity of CAP and thereby determining clinical management, but it is not known how frequently these scores are used in primary care.Patients and methods: Primary care consultations in adults with a diagnostic code for CAP between 1 January 2009 and 31 December 2016 were extracted from the Optimum Patient Care Research Database, which at the time of data extraction had over 3.4 million patients in the UK. Episodes without antibiotic prescription on day of diagnosis were excluded, as were records describing past events. Patients admitted to hospital on day of diagnosis were excluded, but were included in exploratory analysis of CRB65 recording.Results: In total, 4734 episodes of CAP in adults managed in primary care between 1 January 2009 and 31 December 2016 were included. A range of investigations/observations were recorded, including pulse rate (10.7%), chest examinations (9.1%) and blood tests (5.4%). CRB65 scores were recorded in 19 (0.4%) episodes of CAP, 17 of which were after the publication of the NICE guidelines in December 2014. CRB65 recording was no more frequent in 3819 episodes referred to hospital (12, 0.3%; p=0.63), but where recorded, CRB65 scores were higher (Median: 1.0 [interquartile range: 0.5–1.0] vs 2.0 [interquartile range: 1.0–2.0], p=0.04). The most commonly prescribed antibiotic was amoxicillin (40.3%), and 85.9% of episodes had a prescription length of seven days.Conclusion: CRB65 scores are seldom recorded in UK primary care. Given that these scores are embedded in UK guidelines, further work is required to assess feasibility and barriers to use of CRB65 scores in primary care.Keywords: lower-respiratory tract infection, antibiotics, antimicrobials, guidelines adherence, CRB65