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Fikadu Ejeta,1 Diriba Feyisa,1 Oliyad Kebede,1 Temesgen Aferu,1 Jafer Siraj,2 Desalegn Feyissa,3 Emebet Wodajo,3 Alemu Tamiru3 1Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Medicine and Health Sciences, Mizan-Tepi University, Mizan-Aman, Ethiopia; 2Department of Pharmacology and Pharmaceutical Chemistry, School of Pharmacy, College of Medicine and Health Sciences, Mizan-Tepi University, Mizan-Aman, Ethiopia; 3Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, College of Medicine and Health Sciences, Mizan-Tepi University, Mizan-Aman, EthiopiaCorrespondence: Fikadu Ejeta Tel +251910136034Email fikaduejeta@gmail.comObjective: The objectives of this research were to investigate pharmacy professionals’ counseling practices as well as to evaluate pharmacy professionals’ counseling skills and the content of counseling services provided to patients visiting medicine retail outlets.Methods: A facility-based observational cross-sectional study was used to assess medication counseling practice by pharmacy professionals. Data were gathered through an observation and a semi-structured questionnaire. Epi data version 4.0.2 was used to enter data, which was subsequently exported to SPSS version 21.0 for analysis. ANOVA and post hoc statistical analyses were used to investigate the association between independent and dependent variables; and a 0.05 p-value was considered.Results: This study has a total of 105 pharmacy professionals that were included in the analysis. The majority of those who responded were between the ages of 25 and 29. The most common drug information offered by pharmacy staff to patients was frequency of administration (90%), length of therapy (90%), and unit dose dispensed, according to the current study (86%). Pharmacy professionals’ age was significant on components of counseling practice as on mentioning the name of drugs during dispensing the medication (p=0.000), the route of administration (p=0.000), a drug dose (p=0.003), frequency of drug administration (p=0.016), proper medicine storage (p=0.024), type of dosage form (p=0.025), and duration of treatment (p=0.012). In comparison with the other age groups, an age greater than 40 years was significant on components of counseling practice (p=0.001) as a factor associated with penurious counseling practice than the other groups.Conclusion: This study shows that counseling practice is still quite low in comparison to what is expected. Some of the issues that affect counseling include a high patient load, the lack of a private counseling room, a lack of updated drug knowledge, and a lack of experience were factors that influence counseling.Keywords: counselling, counselling practice, medication, pharmacy professionals, Mizan-Aman, Southwest Ethiopia

Hannah R Whittaker,1 Steven J Kiddle,2 Jennifer K Quint1 1National Heart and Lung Institute, Imperial College London, London, UK; 2MRC Biostatistics Unit, University of Cambridge, Cambridge, UKCorrespondence: Hannah R Whittaker Email h.whittaker@imperial.ac.ukBackground: Electronic healthcare records (EHR) are increasingly used in epidemiological studies but are often viewed as lacking quality compared to randomised control trials and prospective cohorts. Studies of patients with chronic obstructive pulmonary disease (COPD) often use the rate of forced expiratory volume in 1 second (FEV1) decline as an outcome; however, its definition and robustness in EHR have not been investigated. We aimed to investigate how the rate of FEV1 decline differs by the criteria used in an EHR database.Methods: Clinical Practice Research Datalink and Hospital Episode Statistics were used. Patient populations were defined using 8 sets of criteria around repeated FEV1 measurements. At a minimum, patients had a diagnosis of COPD, were ≥ 35 years old, were current or ex-smokers, and had data recorded from 2004. FEV1 measurements recorded during follow-up were identified. Thereafter, eight populations were defined based on criteria around: i) the exclusion of patients or individual measurements with potential measurement error; ii) minimum number of FEV1 measurements; iii) minimum time interval between measurements; iv) specific timing of measurements; v) minimum follow-up time; and vi) the use of linked data. For each population, the rate of FEV1 decline was estimated using mixed linear regression.Results: For 7/8 patient populations, rates of FEV1 decline (age and sex adjusted) were similar and ranged from − 18.7mL/year (95% CI − 19.2 to − 18.2) to − 16.5mL/year (95% CI − 17.3 to − 15.7). Rates of FEV1 decline in populations that excluded patients with potential measurement error ranged from − 79.4mL/year (95% CI − 80.7 to − 78.2) to − 46.8mL/year (95% CI − 47.6 to − 46.0).Conclusion: FEV1 decline remained similar in a COPD population regardless of number of FEV1 measurements, time intervals between measurements, follow-up period, exclusion of specific FEV1 measurements, and linkage to HES. However, exclusion of individuals with questionable data led to selection bias and faster rates of decline.Keywords: electronic healthcare records, spirometry, COPD, lung function

Rupert Jones,1– 3 Andrew Davis,1,2 Brooklyn Stanley,1,2 Steven Julious,4 Dermot Ryan,5 David J Jackson,6 David MG Halpin,7 Katherine Hickman,8 Hilary Pinnock,9 Jennifer K Quint,10 Kamlesh Khunti,11 Liam G Heaney,12 Phillip Oliver,4 Salman Siddiqui,13 Ian Pavord,14 David HM Jones,15 Michael Hyland,3,16 Lewis Ritchie,17 Pam Young,18 Tony Megaw,18 Steve Davis,19 Samantha Walker,20 Stephen Holgate,21 Sue Beecroft,22 Anu Kemppinen,1,2 Francis Appiagyei,1,2 Emma-Jane Roberts,1,2 Megan Preston,1,2 Antony Hardjojo,1,2 Victoria Carter,1,2 Marije van Melle,1,2 David Price1,2,17 1Optimum Patient Care, Cambridge, UK; 2Observational and Pragmatic Research Institute, Singapore, Singapore; 3Faculty of Health, University of Plymouth, Plymouth, UK; 4University of Sheffield, South Yorkshire, UK; 5Usher Institute, University of Edinburgh, Edinburgh, UK; 6Guy’s & St Thomas’ NHS Trust, School of Immunology & Microbial Sciences, King’s College London, London, UK; 7University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK; 8Bradford and Leeds Clinical Commissioning Group, Leeds, UK; 9Asthma UK Centre for Applied Research, Usher Institute, The University of Edinburgh, Edinburgh, UK; 10National Heart & Lung Institute, Imperial College London, London, UK; 11Diabetes Research Centre, University of Leicester, Leicester, UK; 12Wellcome-Wolfson Centre for Experimental Medicine, Queen’s University Belfast, Belfast, Northern Ireland; 13Institute for Lung Health, Leicester National Institute for Health Research Biomedical Research Centre, University of Leicester, Leicester, UK; 14Respiratory Medicine Unit and Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford, UK; 15Box Surgery, Wiltshire, UK; 16Plymouth Marjon University, Plymouth, UK; 17Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 18Wellbeing Software, Mansfield, UK; 19Interface Clinical Services, Leeds, UK; 20Asthma UK & British Lung Foundation, London, UK; 21Clinical and Experimental Sciences, University of Southampton, Southampton, UK; 22OPEN Health, Buckinghamshire, UKCorrespondence: David PriceAcademic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UKTel +65 3105 1489Email dprice@opri.sgIntroduction: Symptoms may persist after the initial phases of COVID-19 infection, a phenomenon termed long COVID. Current knowledge on long COVID has been mostly derived from test-confirmed and hospitalized COVID-19 patients. Data are required on the burden and predictors of long COVID in a broader patient group, which includes both tested and untested COVID-19 patients in primary care.Methods: This is an observational study using data from Platform C19, a quality improvement program-derived research database linking primary care electronic health record data (EHR) with patient-reported questionnaire information. Participating general practices invited consenting patients aged 18– 85 to complete an online questionnaire since 7th August 2020. COVID-19 self-diagnosis, clinician-diagnosis, testing, and the presence and duration of symptoms were assessed via the questionnaire. Patients were considered present with long COVID if they reported symptoms lasting ≥ 4 weeks. EHR and questionnaire data up till 22nd January 2021 were extracted for analysis. Multivariable regression analyses were conducted comparing demographics, clinical characteristics, and presence of symptoms between patients with long COVID and patients with shorter symptom duration.Results: Long COVID was present in 310/3151 (9.8%) patients with self-diagnosed, clinician-diagnosed, or test-confirmed COVID-19. Only 106/310 (34.2%) long COVID patients had test-confirmed COVID-19. Risk predictors of long COVID were age ≥ 40 years (adjusted Odds Ratio [AdjOR]=1.49 [1.05– 2.17]), female sex (adjOR=1.37 [1.02– 1.85]), frailty (adjOR=2.39 [1.29– 4.27]), visit to A&E (adjOR=4.28 [2.31– 7.78]), and hospital admission for COVID-19 symptoms (adjOR=3.22 [1.77– 5.79]). Aches and pain (adjOR=1.70 [1.21– 2.39]), appetite loss (adjOR=3.15 [1.78– 5.92]), confusion and disorientation (adjOR=2.17 [1.57– 2.99]), diarrhea (adjOR=1.4 [1.03– 1.89]), and persistent dry cough (adjOR=2.77 [1.94– 3.98]) were symptom features statistically more common in long COVID.Conclusion: This study reports the factors and symptom features predicting long COVID in a broad primary care population, including both test-confirmed and the previously missed group of COVID-19 patients.Keywords: SARS-CoV-2, questionnaire, observational study, frailty, chronic diseases

Keiji Hirai, Hiroaki Nonaka, Moeka Ueda, Junki Morino, Shohei Kaneko, Saori Minato, Yuko Mutsuyoshi, Katsunori Yanai, Hiroki Ishii, Momoko Matsuyama, Taisuke Kitano, Akinori Aomatsu, Haruhisa Miyazawa, Kiyonori Ito, Yuichiro Ueda, Susumu Ookawara, Yoshiyuki Morishita Division of Nephrology, First Department of Integrated Medicine, Saitama Medical Center, Jichi Medical University, Saitama, JapanCorrespondence: Keiji HiraiDivision of Nephrology, First Department of Integrated Medicine, Saitama Medical Center, Jichi Medical University, Saitama, JapanTel +81-48-647-2111Fax +81-48-647-6831Email keijihirai@kfy.biglobe.ne.jpPurpose: We compared the efficacy of teneligliptin versus linagliptin for glycemic control and renoprotection in patients with advanced-stage diabetic kidney disease.Patients and Methods: Changes in the glycated hemoglobin (HbA1c), fasting blood glucose concentration, urine albumin-to-creatinine ratio (UACR), and estimated glomerular filtration rate (eGFR) during a 12-month period were retrospectively analyzed after switching from linagliptin to teneligliptin in 13 patients with advanced-stage diabetic kidney disease (teneligliptin group). Thirteen propensity score-matched patients who were treated with linagliptin alone served as controls (linagliptin group).Results: The HbA1c, fasting blood glucose concentration, and UACR did not change during the 12-month study period in either group. The annual change rate in the eGFR did not differ between before and after baseline in either group.Conclusion: Switching from linagliptin to teneligliptin may not improve glycemic control, reduce urinary protein excretion, or ameliorate the rate of renal function decline in patients with advanced-stage diabetic kidney disease. These results suggest that teneligliptin may not be more advantageous for glycemic control and renoprotection compared with linagliptin in patients with advanced-stage diabetic kidney disease.Keywords: chronic kidney disease, diabetic kidney disease, teneligliptin, linagliptin

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

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

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

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

Vibeke Backer,1 Leif Bjermer,2 Olav Kåre Refvem,3 Andreas Søderman,4 Spencer Jones51Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen University, 48 2400 Copenhagen, Denmark; 2Department of Respiratory Medicine and Allergology, Skåne University Hospital, 221 85 Lund, Sweden; 3Lungepraksis AS, Oslo 0873, Norway; 4Medical Affairs Nordics, Sandoz AS, Copenhagen, DK-2300, Denmark; 5Global Medical Affairs, Sandoz International GmbH, Holzkirchen, D-83607, GermanyBackground: The design of inhaler devices may potentially influence adherence/persistence and outcomes in asthma.Objective: The primary objective was to assess asthma control and any change in the quality of life in patients using an intuitive dry powder inhaler containing fluticasone propionate/salmeterol (AirFluSal®, Forspiro®,) for the treatment of asthma in everyday practice.Methods: ASSURE was a multicenter, noninterventional, open-label, prospective study in patients with asthma, aged ≥12 years and treated with the Forspiro device in Denmark, Sweden and Norway. Patients’ opinions of their asthma control were assessed by the Asthma Control Test (ACT) questionnaire and asthma-related quality of life by the Mini Asthma Quality of Life Questionnaire (miniAQLQ) at baseline and at two follow-up visits (approximately 4–8-week intervals).Results: Of 321 patients enrolled in the study, 299 received at least one dose of fluticasone propionate/salmeterol via the Forspiro device and 204 had evaluable data at the baseline visit and at least one later visit. Patients showed improvements in asthma control and quality of life during the study. The mean sum score of ACT increased from 18.0 (SD 4.5) at visit 1 to 19.9 (4.2) at visit 2 and 20.5 (4.3) at visit 3. Overall, 38.2% of patients improved by the minimal clinically important difference (MCID) of ≥3 points (45.6% among those with a baseline score below 23 [ie, not already well controlled]). The mean score on the miniAQLQ increased from 5.16 (SD 1.24) at visit 1 to 5.58 (SD 1.20) at visit 2 and 5.82 (SD 1.04) at visit 3. Overall, 42.6% of patients improved by the MCID of ≥0.5.Conclusion: This real-life study suggests that treatment with fluticasone propionate/salmeterol via the Forspiro device can improve asthma symptom control and quality of life.Keywords: asthma, fluticasone propionate, salmeterol, symptom control, quality of life

Joe Alexander Jr,1,* Roger A Edwards,2,* Luigi Manca,3 Roberto Grugni,3 Gianluca Bonfanti,3 Birol Emir,4 Ed Whalen,4 Steve Watt,1 Marina Brodsky,5 Bruce Parsons6 1Global Medical Affairs, Pfizer Inc, New York, NY 10017, USA; 2Health Services Consulting Corporation, Boxborough, MA 01719, USA; 3Fair Dynamics Consulting, SRL, Milan, Italy; 4Global Statistics, Pfizer Inc, New York, NY 10017, USA; 5Global Medical Affairs, Pfizer Inc, Groton, CT 06340, USA; 6Global Medical Product Evaluation, Pfizer Inc, New York, NY 10017, USA*These authors contributed equally to this workCorrespondence: Roger A EdwardsHealth Services Consulting Corporation, 169 Summer Road, Boxborough, MA 01719, USATel +1 508472-0406 Fax +1 978264-0713Email redwards.hscc@gmail.comPurpose: Variability in patient treatment responses can be a barrier to effective care. Utilization of available patient databases may improve the prediction of treatment responses. We evaluated machine learning methods to predict novel, individual patient responses to pregabalin for painful diabetic peripheral neuropathy, utilizing an agent-based modeling and simulation platform that integrates real-world observational study (OS) data and randomized clinical trial (RCT) data.Patients and methods: The best supervised machine learning methods were selected (through literature review) and combined in a novel way for aligning patients with relevant subgroups that best enable prediction of pregabalin responses. Data were derived from a German OS of pregabalin (N=2642) and nine international RCTs (N=1320). Coarsened exact matching of OS and RCT patients was used and a hierarchical cluster analysis was implemented. We tested which machine learning methods would best align candidate patients with specific clusters that predict their pain scores over time. Cluster alignments would trigger assignments of cluster-specific time-series regressions with lagged variables as inputs in order to simulate “virtual” patients and generate 1000 trajectory variations for given novel patients.Results: Instance-based machine learning methods (k-nearest neighbor, supervised fuzzy c-means) were selected for quantitative analyses. Each method alone correctly classified 56.7% and 39.1% of patients, respectively. An “ensemble method” (combining both methods) correctly classified 98.4% and 95.9% of patients in the training and testing datasets, respectively.Conclusion: An ensemble combination of two instance-based machine learning techniques best accommodated different data types (dichotomous, categorical, continuous) and performed better than either technique alone in assigning novel patients to subgroups for predicting treatment outcomes using microsimulation. Assignment of novel patients to a cluster of similar patients has the potential to improve prediction of patient outcomes for chronic conditions in which initial treatment response can be incorporated using microsimulation.Clinical trial registries: www.clinicaltrials.gov: NCT00156078, NCT00159679, NCT00143156, NCT00553475.Keywords: coarsened exact matching, hierarchical cluster analysis, time series regressions, agent-based modeling and simulation, machine learning &nbsp

Brian Rayner Kidney and Hypertension Research Unit, University of Cape Town, Groote Schuur Hospital, Observatory, Cape Town 7925, South Africa Purpose: To describe the efficacy of a stratified approach on automatic office blood pressure (BP), 24-hour ambulatory BP, and BP variability (BPV) in treatment-naïve patients with systolic hypertension using lercanidipine for stage 1 and lercanidipine/enalapril for stage 2. Patients and methods: This was an open-label, prospective interventional study conducted in 22 general practices in South Africa. Treatment-naïve patients with stage 1 hypertension received lercanidipine 10 mg and patients with stage 2 received lercanidipine 10 mg/enalapril 10 mg. After 6 weeks, patients not reaching target (

Olga K Lutzko,1 Helen Schifferle,2 Marita Ariola,3 Antonia Rich,4 Khen Meng Kon5 1Kardinia Health, GP Super Clinic, Belmont, VIC, 2Medicross Rothwell, Rothwell, QLD, 3Innerwest Specialist Centre, Burwood, NSW, Australia; 4Atlantis Healthcare Pty Ltd, Sydney, Australia; 5Sanofi Australia Pty Ltd, Macquarie Park, NSW, Australia Purpose: The purpose of this study was to evaluate the optimization of fasting blood glucose (FBG) levels in patients with type 2 diabetes mellitus newly initiated on insulin glargine who were enrolled in the Australian Diabetes CoStars Patient Support Program (PSP). Patients and methods: A retrospective analysis of data from 514 patients with type 2 diabetes mellitus who completed the 12-week Diabetes CoStars PSP was performed. All patients were initiated on insulin glargine in primary care and enrolled by their general practitioner, who selected a predefined titration plan and support from a local Credentialled Diabetes Educator. The data collected included initial and final insulin dose, self-reported FBG, and glycated hemoglobin (A1c) levels. Results: The insulin dose increased in 81% of patients. Mean FBG was reduced from 208.8 mg/dL (11.6 mmol/L) to 136.8 mg/dL (7.6 mmol/L) after 12 weeks. Initial and final A1c values were available for 99 patients; mean A1c was reduced from 9.5% (80 mmol/mol) to 8.1% (65 mmol/mol). The reductions in mean FBG and A1c were similar irrespective of titration plan. Overall, 27.2% of patients achieved FBG levels within the titration plan target range of 72–108 mg/dL (4–6 mmol/L) and an additional 43.4% of patients achieved FBG within the range recommended by current Australian guidelines (110–144 mg/dL [6.1–8.0 mmol/L]). Overall, 23.3% of patients achieved the A1c target of ≤7%. Conclusion: These data demonstrate that the majority of patients enrolled in the Diabetes CoStars PSP achieved acceptable FBG levels 12 weeks after starting insulin therapy irrespective of titration plan. Keywords: insulin glargine, titration, type 2 diabetes mellitus, fasting blood glucose

Andreas Hillenbrand, Gregor Cammerer, Lisa Dankesreiter, Johannes Lemke, Doris Henne-Bruns Department of General and Visceral Surgery, Ulm University Medical Center, 89081 Ulm, Germany Introduction: Dysphagia is frequently reported after thyroidectomy. Here, we investigated the incidence of postoperative dysphagia after uncomplicated thyroidectomy and parathyroidectomy. Further, we analyzed diagnosis and types of therapy to identify possible patients at risk. Patients and methods: A questionnaire was sent to 372 consecutive patients whose thyroid or parathyroid glands were operated on between May 2013 and October 2014 at Ulm University Hospital. Patients were questioned at least 6 months postoperatively. Results: In the evaluation, 219 questionnaires could be included. Fifty-three (21.3%) patients reported that the overall postoperative swallowing process was better or more trouble-free. In 110 (50.2%) patients, dysphagia was reported only immediately postoperative and disappeared later spontaneously. Sixteen patients (7.3%) stated that after a maximum of 3 months after surgery they suffered from dysphagia. One (0.5%) patient stated that up to 3 months postoperatively, swallowing problems had been successfully treated by logopedic therapy. In 39 (17.6%) patients, the complaints persisted for more than 3 months or still existed at the time of the interview. We found no correlation between dysphagia and patients’ age or gender, the specimen volume, and patients’ body mass index. The more invasive the operation was, the more patients suffered from dysphagia. Analyzing the frequency of dysphagia according to different diagnoses, we found a significant risk of postoperative dysphagia in patients with Graves’ disease and carcinoma. Patients operated on for hyperparathyroidism were at significantly decreased risk of dysphagia. Conclusion: Nearly 20% of patients reported postoperative dysphagia after uncomplicated thyroidectomy and parathyroidectomy, especially after major surgical intervention. We found a significant risk of postoperative dysphagia in patients with Graves’ disease and carcinoma and a decreased risk for patients operated on for hyperparathyroidism. Keywords: dysphagia, thyroidectomy, parathyroidectomy

Background Observational research is essential to evaluate the real-life effectiveness of asthma treatments and can now make use of outcomes derived from electronic medical records. Aim The aim of this study was to investigate the utility of several database outcome measures in asthma. Methods This study identified cohorts of patients with active asthma from a UK primary care database – Optimum Patient Care Research Database – approximately 10% of which was prospectively supplemented with questionnaire data. The “Questionnaire cohort” included patients aged 18–60 years with valid questionnaire data and 1 year of continuous primary care data. Separate “ICS initiation” and “ICS step-up” cohorts included patients aged 5–60 years initiated on inhaled corticosteroids (ICSs), who had 1 year of continuous primary care data before, and after, this index visit. Database measures of asthma symptom control and exacerbations were identified in the Optimum Patient Care Research Database and cross-tabulated with corresponding patient-reported (questionnaire) data. Responsiveness of the database outcomes was analyzed, using McNemar’s and Wilcoxon’s signed rank tests, and Poisson regression was used to estimate the association between database outcomes and future risk of database exacerbations, in the ICS initiation cohort. Results The final study included 2,366 Questionnaire cohort patients and 51,404 ICS initiation patients. Agreement between patient-reported and database-recorded exacerbations was fair (kappa 0.35). Following the initiation of ICS, database risk domain asthma control (based on exacerbations) improved (proportion of patients with uncontrolled asthma decreased from 24.9% to 18.6%; P, Video abstract

Vasileios Patris,1 Konstantinos Giakoumidakis,1 Mihalis Argiriou,1 Katerina K Naka,2 Efstratios Apostolakis,3 Mark Field,4 Manoj Kuduvalli,4 Aung Oo,4 Stavros Siminelakis3 1Department of Cardiac Surgery, “Evangelismos” General Hospital of Athens, Athens, Greece; 2Department of Cardiology, Medical School, University of Ioannina, Ioannina, Greece; 3Department of Cardiothoracic Surgery, University of Ioannina, Ioannina, Greece; 4Department of Cardiothoracic Surgery, Heart and Chest Hospital of Liverpool, Liverpool, UK Purpose: To estimate the incidence of postprocedural early cardiac complications among patients undergoing transcatheter aortic valve implantation, through transapical approach (TA-TAVI), and to identify factors independently associated with the occurrence of them. Patients and methods: A retrospective cohort study of 90 patients, who had undergone TA-TAVI in a tertiary hospital of Liverpool, UK, during a 5-year period (September 2008–October 2013), was conducted. Data on patient demographics, periprocedural characteristics and cardiac complications presented within 30-day post TA-TAVI were collected, retrospectively, using the hospital’s electronic database. Results: The overall 30-day incidence of cardiac complications was estimated at 18.9% (n=17/90). The rate of new onset of atrial fibrillation (AF), atrioventricular block requiring permanent pacemaker implantation, shockable cardiac arrest rhythm and cardiac tamponade was 11.1%, 3.3%, 2.2% and 2.2%, respectively. Bivariate analysis found that absence of preoperative AF (p=0.01), receiving of oral inotropes preprocedurally (p=0.01), intravenous inotropic support postprocedurally (p=0.01) and requirement for postprocedural tracheal intubation (p=0.001) were the main factors associated with increased probability for patient cardiac morbidity. Conclusion: It seems that patients with absence of AF and oral inotropic support preprocedurally and those with post TA-TAVI mechanical ventilatory and intravenous inotropic support have greater probability to develop cardiac complications. This knowledge allows the early identification of high-risk patients and supports clinicians to apply both preventive and therapeutic interventions for the optimum patient management and care. In addition, administrators could allocate the health care system resources effectively. Keywords: aortic valve stenosis, complications, retrospective studies, transcatheter aortic valve replacement

Gene Colice,1 David Price,2,3 Maria Gerhardsson de Verdier,4 Karma Rabon-Stith,5 Christopher Ambrose,5 Katherine Cappell,6 Debra E Irwin,7 Paul Juneau,7 Anna Vlahiotis7 In collaboration with Respiratory Effectiveness Group (REG) 1Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA; 2Observational & Pragmatic Research Institute, Singapore; 3Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK; 4Global Medical Affairs, AstraZeneca, Mölndal, Sweden; 5Global Medical Affairs, AstraZeneca, Gaithersburg, MD, USA; 6Custom Data Analytics, Life Sciences, Truven Health Analytics, an IBM Watson Health Company, Ann Arbor, MI, USA; 7Outcomes Research, Life Sciences, Truven Health Analytics, an IBM Watson Health Company, Bethesda, MD, USA Rationale: DPP-4 may regulate immunological pathways implicated in asthma. Assessing whether DPP-4 inhibitor (DPP-4i) use might affect asthma control is clinically important because DPP-4i use in type 2 diabetes mellitus management (T2DM) is increasing. This study evaluated associations between DPP-4i use and asthma control.Methods: This was a retrospective, observational, matched cohort study using administrative claims in the MarketScan® Commercial Claims and Encounters (Commercial) and Medicare Supplemental and Coordination of Benefits (Medicare Supplemental) databases. Adult asthma patients initiating an oral DPP-4i or a non-DPP-4i between November 1, 2006 and March 31, 2014 were included. Patients were followed for asthma-related outcomes for 12 months after initiation of the antidiabetes medication. Outcomes included risk-domain asthma control (RDAC), defined as no asthma hospitalizations, no lower respiratory tract infections, and no oral corticosteroid (OCS) prescriptions; overall asthma control (RDAC criteria plus limited short-acting beta agonist use); treatment stability (RDAC criteria plus no increase of ≥50% in inhaled corticosteroid dose or addition of other asthma therapy); and severe asthma exacerbation rates (asthma-related hospitalizations, emergency room visits, or acute treatments with OCS). Comparisons were made between two matched cohorts (DPP-4i vs. non-DPP-4i initiators) using multivariable logistic regression and generalized linear modeling. Covariates included baseline demographic and clinical characteristics related to asthma and T2DM.Results: The adjusted odds of achieving RDAC (odds ratio [OR]: 1.05; 95% CI: 0.964 to 1.147), overall asthma control (OR: 1.04; 95% CI: 0.956 to 1.135), and treatment stability (OR: 1.04; 95% CI: 0.949 to 1.115) did not differ between the DPP-4i and non-DPP-4i cohorts. A difference was not found between cohorts in severe asthma exacerbation rates during the 12 months following initiation of antidiabetes treatment (mean = 0.32 vs. 0.34 exacerbations per subject-year, respectively; p=0.064). Conclusion: Asthma control was similar between patients initiating DPP-4i and non-DPP-4i antidiabetes medications, suggesting no association between DPP-4i use and asthma control. Keywords: asthma control, DPP-4i, type 2 diabetes

Mark H Joven,Ivana T Croghan,Stephanie M Quigg,Jon O Ebbert,Paul Y Takahashi Division of Primary Care Internal Medicine, Mayo Clinic, Rochester, Minnesota, MN, USA Purpose: Walking may improve health in obese patients with multimorbidity. We aimed to identify predictors associated with achieving 25 kg/m2 and ≥7 comorbidities. We evaluated potential predictors for 65 years and sex. Results: The mean (range) age was 63.6 (20.3–89.8) years. Daily step counts

Efstratios Vlaras,1 Konstantinos Giakoumidakis,2 Nikolaos V Fotos,1 Anastasia A Chatziefstratiou,1 Hero Brokalaki1 1Department of Nursing, School of Health Sciences, National & Kapodistrian University of Athens, Athens, Greece; 2Cardiac Surgery Intensive Care Unit, “Evangelismos” General Hospital of Athens, Athens, Greece Purpose: To investigate the effect of body mass index (BMI) values on 1- and 2-year mortality rates in patients with chronic heart failure (HF).Patients and methods: We conducted a retrospective cohort study of 112 patients with confirmed HF who visited the HF outpatient unit of a tertiary hospital of Athens, Greece, during a 5-month period (December 2012 – April 2013). These patients were assigned to four groups based on their BMI category. Data collection was carried out through a review of the medical patient records and the filling in of a structured questionnaire, including information on the demographic and clinical patient variables. Additionally, 1- and 2-year patient mortality was recorded. The statistical significance was two-tailed, and p-values of less than 0.05 were considered significant. The statistical analysis was performed with Mann–Whitney U test, χ2 test, and Student’s t-test using the SPSS software (IBM SPSS 21.0 for Windows). Results: Obese patients had significantly lower 1-year (13% vs 34.6%, p=0.039) and 2-year (4% vs 21.4%, p=0.022) mortality rates compared with those with normal BMI values. Additionally, we found clinically and not statistically significant lower mortality in overweight and obese patients, when compared with normal BMI and overweight patients, respectively. Conclusion: Obesity paradox seems to be present in our study, translating to significantly lower long-term mortality rates of obese patients compared to those with normal BMI. The significantly higher left ventricular ejection fraction and hematocrit levels among obese HF patients could justify our study findings. Further research is needed due to the inherent weaknesses of BMI and the other study limitations. Keywords: heart failure, mortality, obesity, retrospective studies

Chronic neuro-musculoskeletal pain is an important complication of open-heart surgery (OHS). To better understand the development and natural course of neuro-musculoskeletal pain in the immediate post-OHS period, this prospective longitudinal study assessed the prevalence and degree of pain and shoulder disability, and areas of pain pre- and post-OHS. Usual medical, nursing, and physiotherapy care was provided including early extubation, education, walking, sitting out of bed, and upper, lower limb, and trunk exercises from day 1 post-operation. Of 114 elective patients who provided consent, 98 subjects were surveyed preoperatively, and at week 6 and week 12 post-OHS. Open and closed questions encompassed numerical rating of pain scales for various body areas summed as a total pain score (TPS), the shoulder disability score (SDS), exercise compliance, and sternal clicking. Usual care comprised mobility exercises, walking program, and cardiac rehabilitation referral. Survey return rates were 100%, 88%, and 82%, respectively. Of the 76 (78%) subjects with complete data sets, 68% subjects reported a history of previous neuro-musculoskeletal injuries/conditions preoperatively while prevalence for neuro-musculoskeletal pain was 64%, 88%, and 67% and 38%, 63%, and 42% for shoulder disability, at the three assessments. In all, 11% subjects reported sternal clicking at week 6 and 7% at week 12. Pain commonly occurred in the lower back and neck preoperatively, and in front of the chest, neck, rib cage, upper back, and left shoulder at week 6. Rib cage pain alone remained significantly greater than preoperative levels by week 12 post-OHS. Preoperative SDS was positively correlated with post-OHS length of stay; women had higher SDSs than men at week 6 and week 12 and week 12 SDS was negatively correlated with height. Surgical risk score was negatively correlated with change in SDS and TPS from pre-operation to week 12. In conclusion, neuro-musculoskeletal pain and shoulder disability were common preoperatively and while prevalence increased at week 6 post-OHS, overall preoperative levels were restored by week 12., Video abstract

Helen M Parretti,1 Suzanne E Bartington,1 Tim Badcock,1 Lucy Hughes,1 Joan L Duda,2 Kate Jolly1 1Institute of Applied Health Research, 2School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, West Midlands, UK Abstract: Primary care exercise referral schemes (ERSs) are a potentially useful setting to promote physical activity (PA). It is not established, however, whether interventions to increase PA, such as ERSs, have differing health outcomes according to the participants’ body mass index (BMI). This paper summarizes evidence for the impact of primary care ERSs on the health of people with obesity and reports findings of a reanalysis of the EMPOWER study, providing the first data to report differential outcomes of ERSs by BMI category. Our literature review revealed a paucity of published data. A 2011 Health Technology Assessment review and 2015 update were identified, but normal-weight participants were neither excluded nor were results stratified by weight in the included studies. A study of the effect of exercise referral in overweight women reported a significantly greater increase in PA levels in the ERS group than the control group at 3 months. Reanalysis of the EMPOWER study data showed a significant improvement in PA at 3 months in both obese and overweight/normal BMI groups, with the effect size attenuated to 6 months. There was no significant difference from baseline to 6 months in blood pressure for either BMI category. At 6 months, there was a significant decrease in weight from baseline for the obese category. Comparison of crude mean differences between BMI groups revealed a significant mean difference in PA at 3 months favoring the overweight/normal BMI group, but not at 6 months. There were no further significant differences in unadjusted or adjusted mean differences for other outcomes at follow-up. We report some evidence of a differential impact of ERS on PA by BMI category. However, the effect of ERSs in primary care for patients with obesity remains unclear due to the small number of published studies that have reported outcomes by BMI category. Further research is needed. Keywords: primary care, exercise referral scheme, overweight, obesity

A Simon Carney,1 David B Price,2,3 Pete K Smith,4 Richard Harvey,5,6 Vicky Kritikos,7 Sinthia Z Bosnic-Anticevich,7,8 Louise Christian,9 Derek A Skinner,10 Victoria Carter,10 Alice MS Durieux3 1Department of Otolaryngology – Head and Neck Surgery, Flinders University, Adelaide, SA, Australia; 2Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK; 3Observational and Pragmatic Research Institute, Singapore; 4Clinical Medicine, Griffith University, Southport, QLD, 5Applied Medical Research Centre, University of New South Wales, 6Faculty of Medicine and Health Sciences, Macquarie University, 7Woolcock Institute of Medical Research, University of Sydney, 8Central Sydney Area Health Service, Sydney, NSW, 9NostraData, Kew, VIC, Australia; 10Optimum Patient Care, Cambridge, UK Purpose: To explore patterns in the purchase of prescription and over-the-counter (OTC) oral antihistamines (OAHs) and intranasal corticosteroids (INCSs) by patients, from pharmacies in different geographical regions of Australia.Patients and methods: Retrospective observational study using a database containing anonymous pharmacy transaction data from 20.0% of the pharmacies in Australia that link doctor prescriptions and OTC information. Pharmacy purchases of at least one prescription or OTC rhinitis treatment during 2013 and 2014 were assessed.Results: In total, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over 12 months. Of treatments purchased, 75.9% were OAHs and 16.6% were INCSs. OTC purchases of both treatments exceeded purchases through prescription. OTC OAHs purchasing patterns were seasonal and almost identical in the Australian Capital Territory, Victoria, Western Australia, South Australia, and New South Wales, and similar seasonal patterns for OTC INCSs were noted in most regions except for South Australia and Tasmania. Prescription purchasing patterns of both OAHs and INCSs remained unchanged throughout the year in most regions.Conclusion: This large-scale retrospective observational study identified seasonal purchasing patterns of OTC and prescription OAHs and INCSs in a real-world setting. It highlighted that seasonality only affects OTC purchasing patterns of OAHs and INCSs across Australia and that practitioner prescribing remains unchanged, suggesting that it is only for persistent disease. Keywords: allergic rhinitis, medication, over-the-counter, prescription, therapy, treatment&nbsp

David M Kern,1 John J Barron,1 Bingcao Wu,1 Alex Ganetsky,2 Vincent J Willey,1 Ralph A Quimbo,1 Michael J Fisch,3 Joseph Singer,1 Ann Nguyen,4 Ronac Mamtani5 1Health Economics and Outcomes Research, HealthCore, Inc, Wilmington, DE, 2Department of Pharmacy, Hospital of the University of Pennsylvania, Philadelphia, PA, 3Medical Oncology, AIM Specialty Health, Chicago, IL, 4Oncology Solutions, Anthem, Inc, Indianapolis, IN, 5Division of Hematology/Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA Background: Data from a Cancer Care Quality Program are directly integrated with administrative claims data to provide a level of clinical detail not available in claims-based studies, and referred to as the HealthCore Integrated Research Environment (HIRE)-Oncology data. This study evaluated the validity of the HIRE-Oncology data compared with medical records of breast, lung, and colorectal cancer patients.Methods: Data elements included cancer type, stage, histology (lung only), and biomarkers. A sample of 300 breast, 200 lung, and 200 colorectal cancer patients within the HIRE-Oncology data were identified for medical record review. Statistical measures of validity (agreement, positive predictive value [PPV], negative predictive value [NPV], sensitivity, specificity) were used to compare clinical information between data sources, with medical record data considered the gold standard. Results: All 300 breast cancer records reviewed were confirmed breast cancer, while 197 lung and 197 colorectal records were confirmed (PPV =0.99 for each). The agreement of disease stage was 85% for breast, 90% for lung, and 94% for colorectal cancer. The agreement of lung cancer histology (small cell vs non-small cell) was 97%. Agreement of progesterone receptor, estrogen receptor, and human epidermal growth factor receptor 2 status biomarkers in breast cancer was 92%, 97%, and 92%, respectively; epidermal growth factor receptor and anaplastic lymphoma kinase agreement in lung was 97% and 92%, respectively; and agreement of KRAS status in colorectal cancer was 95%. Measures of PPV, NPV, sensitivity, and specificity showed similarly strong evidence of validity.Conclusion: Good agreement between the HIRE-Oncology data and medical records supports the validity of these data for research. Keywords: validation, administrative claims, breast cancer, lung cancer, colorectal cancer, oncology&nbsp

Richard W Costello,1 Alexandra L Dima,2 Dermot Ryan,3 R Andrew McIvor,4 Kay Boycott,5 Alison Chisholm,6 David Price,7,8 John D Blakey9,10 1Department of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland; 2Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands; 3Allergy and Respiratory Research Group, Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK; 4Firestone Institute for Respiratory Health, McMaster University, Hamilton, ON, Canada; 5Asthma UK, London, 6Respiratory Effectiveness Group, Cambridge, 7Observational and Pragmatic Research Institute, Singapore; 8Academic Centre of Primary Care, University of Aberdeen, Aberdeen, 9Health Services Research, University of Liverpool, 10Respiratory Medicine, Royal Liverpool Hospital, Liverpool, UK Background: Healthcare systems are under increasing strain, predominantly due to chronic non-communicable diseases. Connected healthcare technologies are becoming ever more capable and their components cheaper. These innovations could facilitate both self-management and more efficient use of healthcare resources for common respiratory diseases such as asthma and chronic obstructive pulmonary disease. However, newer technologies can only facilitate major changes in practice, and cannot accomplish them in isolation.Focus of review: There are now large numbers of devices and software offerings available. However, the potential of such technologies is not being realised due to limited engagement with the public, clinicians and providers, and a relative paucity of evidence describing elements of best practice in this complex and evolving environment. Indeed, there are clear examples of wasted resources and potential harm. We therefore call on interested parties to work collaboratively to begin to realize the potential benefits and reduce the risks of connected technologies through change in practice. We highlight key areas where such partnership can facilitate the effective and safe use of technology in chronic respiratory care: developing data standards and fostering inter-operability, making collaborative testing facilities available at scale for small to medium enterprises, developing and promoting new adaptive trial designs, developing robust health economic models, agreeing expedited approval pathways, and detailed planning of dissemination to use.Conclusion: The increasing capability and availability of connected technologies in respiratory care offers great opportunities and significant risks. A co-ordinated collaborative approach is needed to realize these benefits at scale. Using newer technologies to revolutionize practice relies on widespread engagement and cannot be delivered by a minority of interested specialists. Failure to engage risks a costly and inefficient chapter in respiratory care. Keywords: apps, smart inhaler, connected devices, remote monitoring, co-creation, standards, guidelines, health economics

Julian WE Jarman,1 Tina D Hunter,2 Wajid Hussain,1 Jamie L March,3 Tom Wong,1 Vias Markides1 1Cardiology & Electrophysiology, Heart Rhythm Centre, NIHR Cardiovascular Research Unit, The Royal Brompton Hospital, and National Heart and Lung Institute, Imperial College, London, UK; 2Health Outcomes Research, CTI Clinical Trial and Consulting Services, Inc., Cincinnati, OH, 3Health Economics and Market Access, Biosense Webster, Inc., Diamond Bar, CA, USA Background: We sought to determine from key clinical outcomes whether catheter ablation of atrial fibrillation (AF) is associated with increased survival.Methods and results: Using routinely collected hospital data, ablation patients were matched to two control cohorts using direct and propensity score methodology. Four thousand nine hundred ninety-one ablation patients were matched 1:1 with general AF controls without ablation. Five thousand four hundred seven ablation patients were similarly matched to controls who underwent cardioversion. We examined the rates of ischemic stroke or transient ischemic attack (stroke/TIA), heart failure hospitalization, and death. Matched populations had very similar comorbidity profiles, including nearly identical CHA2DS2-VASc risk distribution (p=0.6948 and p=0.8152 vs general AF and cardioversion cohorts). Kaplan–Meier models showed increased survival after ablation for all outcomes compared with both control cohorts (p

Gerard A Baltazar,1 Parker Bassett,1 Amy J Pate,2 Akella Chendrasekhar2 1Division of Trauma, Department of Surgery, St. Barnabas Hospital Health System, Bronx, NY, USA; 2Division of Trauma, Department of Surgery, Richmond University Medical Center, Staten Island, NY, USA Background: Motor vehicle collisions (MVCs) are a leading cause of injury in the US. While the probability of collision with a pedestrian (PMVC) has declined in recent years, the probability of a pedestrian fatality has risen. Our objective was to determine whether older age impacts potential outcomes in patients involved in low-velocity PMVCs.Materials and methods: We performed a retrospective-cohort study of adult patients aged >14 years involved in low-velocity pedestrian–MVCs (

Jaco Voorham,1 Bernard Vrijens,2 Job FM van Boven,3,4 Dermot Ryan,5 Marc Miravitlles,6 Lisa M Law,1 David B Price1,7 1Observational & Pragmatic Research Institute Pte Ltd, Singapore, Singapore; 2Department of Public Health Sciences, Faculty of Medicine, University of Liège, Liège, Belgium; 3Unit of PharmacoEpidemiology and PharmacoEconomics, Department of Pharmacy, 4Department of General Practice, Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; 5Allergy and Respiratory Research Group, University of Edinburgh, Edinburgh, UK, 6Department of Pulmonology, Hospital Universitari Vall d’Hebron, Barcelona, Catalonia, Spain; 7Academic Primary Care, The Institute of Applied Health Sciences, University of Aberdeen, Aberdeen,UK Background: Adherence to asthma and chronic obstructive pulmonary disease (COPD) treatment has been shown to depend on patient-level factors, such as disease severity, and medication-level factors, such as complexity. However, little is known about the impact of prescription charges – a factor at the health care system level. This study used real-life data to investigate whether co-payment affects adherence (implementation and persistence) and disease outcomes in patients with asthma or COPD. Methods: A matched, historical cohort study was carried out using two UK primary care databases. The exposure was co-payment for prescriptions, which is required for most patients in England but not in Scotland. Two comparison cohorts were formed: one comprising patients registered at general practices in England and the other comprising patients registered in Scotland. Patients aged 20–59years with asthma, or 40–59years with COPD, who were initiated on fluticasone propionate/salmeterol xinafoate, were included, matched to patients in the opposite cohort, and followed up for 1year following fluticasone propionate/salmeterol xinafoate initiation. The primary outcome was good adherence, defined as medication possession ratio ≥80%, and was analyzed using conditional logistic regression. Secondary outcomes included exacerbation rate. Results: There were 1,640 patients in the payment cohort, ie, England (1,378 patients with asthma and 262 patients with COPD) and 619 patients in the no-payment cohort, ie, Scotland (512 patients with asthma and 107 patients with COPD). The proportion of patients with good adherence was 34.3% and 34.9% in the payment and no-payment cohorts, respectively, across both disease groups. In a multivariable model, no difference in odds of good adherence was found between the cohorts (odds ratio, 1.04; 95% confidence interval, 0.85–1.27). There was also no difference in exacerbation rate. Conclusion: There was no difference in adherence between matched patients registered in England and Scotland, suggesting that prescription charges do not have an impact on adherence to treatment. Keywords: implementation, adherence, asthma, chronic obstructive pulmonary disease, prescriptions, co-payment

Danielle M Fernandes,1 Allison P Roland,2 Marilyn C Morris3 1The Children’s Hospital of New York, 2Postbaccalaureate Prehealth Studies Program, NYU College of Arts and Science, 3Department of Pediatrics, Columbia University Medical Center, New York, NY, USA Objective: To explore parental opinions regarding opt-out consent for inpatient pediatric prospective observational research in the US. Study design: A series of handouts describing hypothetical observational research studies with opt-out consent were reviewed by parents of hospitalized children. A verbal survey explored parental opinions about the proposed consent process.Results: A total of 166 parents reviewed the handout and completed the survey. Only 2/166 parents (1.2%) objected to the study described and another 10 (6.0%) cited concern about the privacy of their child’s medical information. A total of 157 parents were asked “Is it okay to tell you about this kind of research using this handout?” – 116 (74%) responded positively, 19 (12%) responded negatively, and 21 (13%) made an indeterminate or neutral response. When parents were asked to recommend a specific consent approach for observational research, 86(52%) chose an opt-in approach, 54 (33%) chose opt-out, and 25 (15%) chose “no consent needed”. There were no significant associations between parental preferences and whether the child was admitted to the intensive care unit vs. pediatric ward, and no significant difference found based on type of handout reviewed (generic vs. study-specific).Conclusion: Few parents voiced objection to a hypothetical opt-out consent process for inpatient pediatric prospective observational research. When asked to recommend a specific consent approach, though, approximately half chose an opt-in approach. These data suggest that an opt-out consent process for observational inpatient research is likely to be acceptable to parents, but assessment of an opt-out consent process in a real-world setting is needed. Keywords: informed consent, minimal risk, research ethics&nbsp

Stephen L Able,1 Rebecca L Robinson,2 Kurt Kroenke,3,4 Philip Mease,5,6 David A Williams,7 Yi Chen,8 Madelaine Wohlreich,9 Bill H McCarberg10 1US Health Outcomes and Technology Assessment, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 2Lilly Research Labs, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 3Department of Medicine, Indiana University, 4VA Health Services Research and Development Center for Health Information and Communication, Regenstrief Institute, Indianapolis, IN, USA; 5Rheumatology Associates, Division of Rheumatology Clinical Research, Swedish Medical Center, 6University of Washington School of Medicine, Seattle, WA, USA; 7Chronic Pain and Fatigue Research Center, Michigan Institute for Clinical and Health Research, University of Michigan School of Medicine, Ann Arbor, MI, USA; 8inVentiv Health Clinical, Indianapolis, IN, USA; 9USMD Neuroscience, Lilly USA LLC, Eli Lilly and Company, Indianapolis, IN, USA; 10Department of Family Medicine, University of California at San Diego School of Medicine, San Diego, CA, USA Purpose: To evaluate the effect of physician specialty regarding diagnosis and treatment of fibromyalgia (FM) and assess the clinical status of patients initiating new treatment for FM using data from Real-World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments. Patients and methods: Outpatients from 58 sites in the United States were enrolled. Data were collected via in-office surveys and telephone interviews. Pairwise comparisons by specialty were made using chi-square, Fisher’s exact tests, and Student’s t-tests. Results: Physician specialist cohorts included rheumatologists (n=54), primary care physicians (n=25), and a heterogeneous group of physicians practicing pain or physical medicine, psychiatry, neurology, obstetrics and gynecology, osteopathy, or an unspecified specialty (n=12). The rheumatologists expressed higher confidence diagnosing FM (4.5 on a five-point scale) than primary care physicians (4.1) (P=0.037). All cohorts strongly agreed that recognizing FM is their responsibility. They agreed that psychological aspects of FM are important, but disagreed that symptoms are psychosomatic. All physician cohorts agreed with a multidisciplinary approach including nonpharmacological and pharmacological treatments, although physicians were more confident prescribing medications than alternative therapies. Most patients reported moderate to severe pain, multiple comorbidities, and treatment with several medications and nonpharmacologic therapies. Conclusion: Physician practice characteristics, physician attitudes, and FM patient profiles were broadly similar across specialties. The small but significant differences reported by physicians and patients across physician cohorts suggest that despite published guidelines, treatment of FM still contains important variance across specialties. Keywords: medical specialty, treatment, prospective observational study

Shweta Malhotra,1,2 Stanley D Musgrave,1 Hilary Pinnock,3 David Price,1 Dermot P Ryan1,31Clinical Department of General Practice and Primary Care, University of Aberdeen, UK; 2Department of Emergency Medicine, SUNY Downstate and Kings County Hospital, Brooklyn, NY, USA; 3Allergy and Respiratory Research Group, Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UKAim: Achieving target recruitment in randomized controlled trials (RCTs) is challenging. This paper compares our experience of recruiting for an RCT with the predictions made in our proposal.Methods: Participating UK primary care practices searched their computer databases to identify patients (12 years and over) with asthma who may be poorly controlled. Postal invitations were sent to all patients identified. Respondees were prescreened by phone, to assess their asthma control and establish their mobile phone suitability. Potentially eligible patients were booked for a trial recruitment visit.Results: We recruited 288 patients (2.4% of those invited) across 32 practices, with a total list size of 311,926 patients. This compares to our predicted recruitment of 312 patients from a population of 72,000 patients in six to eight practices. In addition to the recognized problem of poor response rates, the major challenges were insufficiently discriminating computer searches and incompatibilities between mobile phone handsets, networks and the asthma application.Conclusion: Our data have implications for clinicians, managers, and researchers in primary care. Researchers in this area may wish to consider our data when designing their recruitment strategies. Improved coding of asthma morbidity data in clinical practice would ease identification of poorly controlled patients, both for clinical interventions and recruitment to trials. If telehealth is to become mainstream, there needs to be standardization of applications, operating platforms, and network capabilities.Keywords: asthma, primary care, telehealth, recruitment, randomized controlled trials

Franz Porzsolt,1,2 Natália Galito Rocha,3 Alessandra C Toledo-Arruda,3 Tania G Thomaz,3,4 Cristiane Moraes,4 Thais R Bessa-Guerra,4 Mauricio Leão,5 Arn Migowski,6,7 André R Araujo da Silva,8 Christel Weiss2,9 1Health Care Research, Department of General and Visceral Surgery, University Hospital Ulm, Ulm, Germany; 2Institute of Clinical Economics (ICE) eV, Ulm, Germany; 3Department of Physiology and Pharmacology, Biomedical Institute, Universidade Federal Fluminense, Niterói, 4Cardiovascular Sciences, Universidade Federal Fluminense, Niterói, 5Institute of Nuclear Medicine, University Hospital Antonio Pedro, Niterói, 6National Cancer Institute (INCA), Rio de Janeiro, Brazil; 7National Institute of Cardiology (INC), Rio de Janeiro, Brazil; 8Department of Mother and Child, Faculty of Medicine, Universidade Federal Fluminense, Niterói, Rio de Janeiro, Brazil; 9Department of Medical Statistics, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany Abstract: The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe. Keywords: randomized controlled trial, pragmatic controlled trial, explanatory trial, pragmatic trial, ideal study conditions, real-world conditionsCorrigendumfor this paper has been published.

Elisabetta Verdun di Cantogno,1 Mark Tomlinson,1 Laure Manuel,2 Kunal Thakur1 1Novartis Pharma AG, Basel, Switzerland; 2Adelphi Research, Bollington, Cheshire, UK Purpose: This international survey recorded the opinions of multiple sclerosis (MS) nurses about their role in treatment decision making and about the importance of different attributes of autoinjectors used to deliver first-line parenteral therapy. Methods: The survey involved 52 MS nurses in different practice settings in France, Germany, Italy, the UK, and the USA. Nurses described their role in patient education and in treatment decision making. They also rated the importance of nine prespecified attributes of autoinjectors and stated their preference, both overall and by attribute, for one of two autoinjectors used to deliver interferon β-1b (ExtaviPro® 30G and Betacomfort®). Nurses' preferences were compared with those previously collected from patients using an identical questionnaire. Results: There were pronounced differences between practice settings and between countries in the opinions of MS nurses about their influence on treatment decision making. Nurses considered themselves instrumental in helping patients decide between treatment options offered by neurologists. Of the nine autoinjector attributes, nurses rated “reliable to use” as most important, followed by attributes associated with convenience (“easy to operate,” “ergonomic shape,” “reach” [of injection sites], and “one-handed injection”). Nurses' and patients' rankings of attributes were closely aligned. For the nine attributes, 74%–98% of nurses preferred ExtaviPro® 30G to Betacomfort®, 94% preferring ExtaviPro® 30G overall. Nurses showed a greater preference than patients for ExtaviPro® 30G with respect to “easy to operate” (92% vs 78%), “intuitive to use” (98% vs 78%), and "attractive design" (98% vs 83%; P

Eva Drevenhorn,1 Ann Bengtson,2 Per Nyberg,1 Karin I Kjellgren2,3 1Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden; 2Institute of Health and Care Sciences, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 3Department of Medical and Health Sciences, Linköping University, Linköping, Sweden Background: There is a well-known problem in hypertension care with patients' adherence to treatment. Patients who score high in answering the instrument Satisfaction with Information about Medicine Scale are reported to have greater adherence to their medication.Aim: To explore how hypertensive patients' satisfaction with information about their medicines was affected by nurses' education in Motivational Interviewing.Material and methods: The Stages of Change model and Motivational Interviewing was the theoretical base for consultation training for nurses. Nineteen nurses attended 3 days of video-recorded consultation training with simulated patients. They were updated in hypertensive medication and were trained in motivating patients to improve their self-management as well as adherence to lifestyle changes and medication. The satisfaction with information instrument identifies patients' satisfaction with information about the action and usage of medication as well as potential problems with it. The instrument was used to assess how well the needs of individual patients for medicine information were met at baseline and 2 years after the training. The 19 trained nurses in the intervention group worked with 137 patients, and a control group of 16 nurses, who gave normal care, worked with 51 patients.Results: There was a difference between the intervention and control group in total score (P=0.028) 2 years after the intervention. Patients in the intervention group perceived higher satisfaction with the action and usage of their medication (P=0.001) and a lower degree of potential problems with their medication (P=0.001). Patients in the control group also perceived a lower degree of potential problems with their medication (P=0.028).Conclusion: We suggest that consultation training for nurses with the aim of motivating patients to be more self-directed in their self-care improves satisfaction with information about medication.Keywords: counseling, hypertension, SIMS instrument, adherence

Larry E Miller,1,2 Jon E Block21Miller Scientific Consulting, Inc, Arden, NC, USA; 2The Jon Block Group, San Francisco, CA, USAPurpose: To report outcomes from a 5-year real-world clinical experience with a multimodal treatment program in patients with symptomatic knee osteoarthritis (OA).Methods: Patients with symptomatic, radiographically confirmed knee OA resistant to traditional conservative treatments underwent a supervised 8-week multimodal treatment program consisting of low-impact aerobic exercise, muscle flexibility exercises, joint mobilization, physical therapy modalities, muscle strengthening and functional training, patient education, and a series of 3 or 5 weekly hyaluronic acid injections. Patients were evaluated at admission, 4 weeks, and 8 weeks. Patient-reported outcomes included knee pain severity using an 11-point (0–10) numerical scale and the Western Ontario and McMaster Universities Osteoarthritis Index.Results: A total of 3,569 patients completed an 8-week treatment course between January 2008 and April 2013 at 66 dedicated treatment centers in the United States. Knee pain severity assessed on a numeric scale decreased 59% on average, from 5.4±2.9 to 2.2±2.2 (P

Catherine Reed,1 Jihyung Hong,2 Diego Novick,1 Alan Lenox-Smith,3 Michael Happich41Global Health Outcomes, Eli Lilly and Company, Windlesham, Surrey, UK; 2Personal Social Services Research Unit, London School of Economics and Political Science, London, UK; 3Eli Lilly UK, Basingstoke, UK; 4Eli Lilly and Company, Bad Homburg, GermanyPurpose: To determine the incidence of diabetic peripheral neuropathic pain (DPNP) in the United Kingdom (UK) primary care population using the General Practice Research Database (GPRD).Patients and methods: This retrospective cohort study identified incident cases of DPNP in the UK GPRD between July 1, 2002 and June 30, 2011, using diagnostic codes. Trends in the incidence rate were examined by dividing the study period into 3-year periods: (1) July 1, 2002–June 30, 2005; (2) July 1, 2005–June 30, 2008; and (3) July 1, 2008–June 30, 2011. Patient characteristics (age, sex, comorbidities) and initial pharmacological treatment were described; the proportion of patients with incident DPNP, who had previously been screened for neuropathic symptoms, was determined.Results: Among almost 7.5 million persons contributing 38,118,838 person-years of observations in the GPRD, 6,779 new cases of DPNP were identified (45.5%, women), giving an incidence rate of 17.8 per 100,000 person-years (95% confidence interval [CI] 17.4–18.2). The incidence of DPNP increased with age, but it was stable over the three consecutive 3-year periods: 17.9, 17.2, and 18.4 cases per 100,000 person-years. Of the 6,779 patients with incident DPNP, 15.5% had prior neuropathic screening during the study period. The majority of patients with incident DPNP (84.5%) had a treatment for pain initiated within 28 days of first diagnosis. The most common first-line treatments prescribed were tricyclic antidepressants (27.2%), anticonvulsants (17.0%), and nonsteroidal anti-inflammatory drugs (14.9%), with 26.6% of patients receiving combination therapy as their initial treatment.Conclusion: The incidence of DPNP in UK primary care has remained steady over the past 10 years. Our results suggest that DPNP is underdiagnosed, and initial treatment prescribed does not follow clinical guidelines.Keywords: diabetes, peripheral neuropathy, pain, incidence, primary care

Kunal Thakur,1 Laure Manuel,2 Mark Tomlinson1 1Novartis Pharma AG, Basel, Switzerland; 2Adelphi Research, Bollington, Cheshire, UK Background: The ExtaviPro™ 30G autoinjector has been developed for self-administration of interferon beta-1b (Extavia®), which is used as a first-line, parenteral, disease-modifying therapy in multiple sclerosis (MS). The aim of this survey was to investigate patients' perceptions of the importance of different general attributes of autoinjectors, and patient preferences when comparing the ExtaviPro™ 30G and Betacomfort® autoinjectors. Method: The survey was conducted in France, Germany, Italy, and the USA in patients with relapsing-remitting MS who had been using an autoinjector for at least 1 year. Participants examined the ExtaviPro™ 30G and Betacomfort® devices, viewed fact sheets, and watched a video of these autoinjectors in use, then scored nine prespecified attributes of autoinjectors in terms of importance on a scale of 1–7 (1 = not at all important; 7 = extremely important). They then indicated which device they preferred, both overall and by individual attribute. Results: Among the 201 participants who completed the survey, being reliable to use was considered the most important general attribute of autoinjectors, followed by attributes associated with convenience (ease of operation, one-handed injection, ease of reach of injection sites, ergonomic shape). For each of the nine attributes, a significantly higher proportion of participants (74%–94% by attribute; P < 0.05 for each) preferred ExtaviPro™ 30G to the Betacomfort® autoinjector, and 173 (86%) participants indicated that they preferred ExtaviPro™ 30G overall (P < 0.05). Conclusion: The results of this survey suggest that patients with MS rate reliability and convenience as the most important general attributes of autoinjectors, and are more likely to prefer ExtaviPro™ 30G to the Betacomfort® autoinjector for routine self-administration of interferon beta-1b. Keywords: autoinjector, subcutaneous injectors, interferon beta, multiple sclerosis, relapsing-remitting, patient preference, self-administration

Wenyu Ye,1 Shinji Fujikoshi,1 Naohiro Nakahara,1 Michihiro Takahashi,1,2 Haya Ascher-Svanum,3 Tetsuro Ohmori,41Eli Lilly Japan KK, Kobe, Japan; 2Terauchi-Takahashi Psychiatric Clinic, Ashiya, Japan; 3Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA; 4Department of Psychiatry, Tokushima University Hospital, Tokushima, JapanBackground: The purpose of this study was to assess the 1-year clinical, functional, and safety-related outcomes following a switch to olanzapine of at least one typical antipsychotic drug in the previous regimen in the treatment of patients of schizophrenia in Japan.Methods: Using data from a large 1-year prospective, multicenter, naturalistic study of olanzapine for the treatment of schizophrenia in Japan, patients who were switched from any oral typical antipsychotic to olanzapine were identified. Mixed models for repeated measures, controlling for baseline demographics, were utilized to assess outcomes for clinical and functional measures.Results: Of the 262 patients who switched from typical antipsychotics to olanzapine, 41% were outpatients and 59% were inpatients. Most of these patients were switched due to poor medication efficacy (71.0%) or medication intolerability (25.6%). Most patients (71.4%) completed the 1-year study. Clinically and statistically significant (P < 0.01) improvements were observed in patient illness severity and health-related quality of life, including improvements in global symptom severity and in positive, negative, depressive, and cognitive symptoms. Over half of the patients (58.3%) demonstrated a treatment response to olanzapine and 47.4% achieved symptom remission. Mean weight gain from baseline to endpoint was 2.31 ± 4.72 kg, with 30.4% of patients experiencing clinically significant weight gain (at least 7% of baseline weight).Conclusion: During this 1-year naturalistic treatment of schizophrenia patients in Japan, switching from typical antipsychotics to olanzapine resulted in significant improvements in patients' clinical and functional outcomes. Approximately one-third of patients had clinically significant weight gain. These findings highlight the favorable benefit to risk profile of switching to olanzapine following failure on typical antipsychotics.Keywords: olanzapine, treatment outcomes, schizophrenia

Diego Novick,1 Haya Ascher-Svanum,2 Josep Maria Haro,3 Jordan Bertsch,3 Michihiro Takahashi41Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly and Company, Indianapolis, IN; 3Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly and Company, Kobe, JapanBackground: The purpose of this study was to assess the 12-month outcomes associated with naturalistic antipsychotic treatment of patients participating in the Schizophrenia Outpatient Health Outcomes (SOHO) study.Methods: SOHO is a 3-year, prospective, observational study of the health outcomes associated with antipsychotic treatment in 10 European countries. The study included over 10,000 outpatients who were initiating or changing their antipsychotic medication. Medication use pattern, change in symptom severity, social functioning, and health-related quality of life were assessed, as well as rates of response, remission, treatment discontinuation, adverse events, and hospitalization.Results: Clinical Global Impression-Severity for Schizophrenia (CGI-SCH) and quality of life scores improved in all treatment cohorts. There were greater improvements in the CGI-SCH overall symptom score and in the CGI-SCH positive, negative, cognitive, and depressive symptom scores in the olanzapine and clozapine cohorts compared with other treatment cohorts. Changes were associated with an improvement in quality of life. Patients treated with olanzapine, quetiapine, and clozapine had better tolerability per extrapyramidal symptoms and sexual-related dysfunction measures compared with patients receiving risperidone, amisulpride, or typicals. Patients treated with olanzapine had greater weight gain than patients in all other treatment cohorts.Conclusion: Patients initiated on olanzapine and clozapine tend to have better outcomes at 12 months than patients initiated on other antipsychotics in routine outpatient clinical practice. Results should be interpreted conservatively due to the nonrandomized study design.Keywords: schizophrenia, treatment, outcomes, outpatient, remission, antipsychotics