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Anita Lynam,1 Charlotte Curtis,1 Brooklyn Stanley,2,3 Heath Heatley,3 Chloe Worthington,2,3 Emma-Jane Roberts,2,3 Christopher Price,2,3 Victoria Carter,2,3 John Dennis,1 Andrew McGovern,1 David Price2,3 1Momentum Data, Pendragon House, St. Albans, Hertfordshire, UK; 2Optimum Patient Care, Cambridge, UK; 3Observational and Pragmatic Research Institute, SingaporeCorrespondence: Andrew McGovern, Momentum Data, Pendragon House, St. Albans, Hertfordshire, UK, Email andy.mcgovern@momentumdata.co.ukIntroduction: Electronic medical records (EMRs) maintained in primary care in the UK and collected and stored in EMR databases offer a world-leading resource for observational clinical research. We aimed to profile one such database: the Optimum Patient Care Research Database (OPCRD).Methods and Participants: The OPCRD, incepted in 2010, is a growing primary care EMR database collecting data from 992 general practices within the UK. It covers over 16.6 million patients across all four countries within the UK, and is broadly representative of the UK population in terms of age, sex, ethnicity and socio-economic status. Patients have a mean duration of 11.7 years’ follow-up (SD 17.50), with a majority having key summary data from birth to last data entry. Data for the OPCRD are collected incrementally monthly and extracted from all of the major clinical software systems used within the UK and across all four coding systems (Read version 2, Read CTV3, SNOMED DM+D and SNOMED CT codes). Via quality-improvement programmes provided to GP surgeries, the OPCRD also includes patient-reported outcomes from a range of disease-specific validated questionnaires, with over 66,000 patient responses on asthma, COPD, and COVID-19. Further, bespoke data collection is possible by working with GPs to collect new research via patient-reported questionnaires.Findings to Date: The OPCRD has contributed to over 96 peer-reviewed research publications since its inception encompassing a broad range of medical conditions, including COVID-19.Conclusion: The OPCRD represents a unique resource with great potential to support epidemiological research, from retrospective observational studies through to embedded cluster-randomised trials. Advantages of the OPCRD over other EMR databases are its large size, UK-wide geographical coverage, the availability of up-to-date patient data from all major GP software systems, and the unique collection of patient-reported information on respiratory health.Keywords: primary care, electronic health records, medical records, datasets, demography, health outcomes

Giacomo M Bruno,1,2 Maria Chiara Valentino,2 Alessandra Brunetti,3 Sergio Di Matteo,2 Ivan Begovic,2 Edoardo Croce,4 Garifallia Sakellariou,5 Serena Bugatti,6 Pietro Perotti,7 Silvia Vecchio,7 Simona Migliazza,7 Roberto Langella,8 Giorgio L Colombo1,2 1Department of Drug Sciences, Center of Pharmaceuticals Economics and Medical Technologies Evaluation, CEFAT.Unipv - University of Pavia at Centro di Ricerca SAVE Studi, Milano, Italy; 2S.A.V.E. Research Center - Studi Analisi Valutazioni Economiche, Milano, Italy; 3Research and Innovation Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 4Scientific Direction - IRCCS istituto Ortopedico Galeazzi, Milan, Italy; 5Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; 6Department of Internal Medicine and Therapeutics, Division of Rheumatology, University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; 7U.O.C. Epidemiological Observatory – Health Protection Agency of Pavia (ATS Pavia), Pavia, Italy; 8SIFO Regional Secretariat - Società Italiana di Farmacia Ospedaliera e dei Servizi Farmaceutici delle Aziende Sanitarie, Milano, ItalyCorrespondence: Giacomo M Bruno, Department of Drug Sciences, Center of Pharmaceuticals Economics and Medical Technologies Evaluation, CEFAT.Unipv - University of Pavia at Centro di Ricerca SAVE Studi, Milano, 20149, Italy, Email giacomomatteo.bruno@unipv.itBackground: The current flows of the SSN represent the set of interest whose interconnection alone justifies the current study. These flows can be interconnected with other sources, institutional or otherwise, in order to answer well-defined questions.Objective: The objective of the study is to verify, through the analysis of administrative databases, any differences in the consumption of health resources between biological off-patent originator drugs and biosimilars in real clinical practice, with particular reference to the rheumatology area.Methods: Through the use of assisted databases (BDA) of ATS Pavia we evaluated the differences in terms of consumption of health resources related to the different drugs under analysis. Annual and daily costs were calculated by total patient cost, stratified for different treatments, considering the sum of total costs for the prescriptions of drugs subject to the analysis. Another objective was to evaluate the adherence of the drugs of interest, by utilizing specific indicators (MPR).Results: A total of 145 patients were analyzed. Among enrolled patients, 26.9% of users were treated with a biosimilar drug, while 73.1% with a biologic originator. Adherence is higher if it is considered the population treated with biosimilar drugs (82.1%). Total cost (including drug prescriptions, hospitalizations, outpatient services, tests for any cause) during the observation period of 1 year is 14,274.08. 87.7% of the total is attributable to drugs. Non-hospitalized patients are the least expensive, whether they were treated with biologics or biosimilars.Conclusion: In our sample, biosimilar drugs tend to be underused: the treatment of a patient with a chronic autoimmune disease is a clinical process that involves many health professionals, and a criticality could also derive from the difficult communication between the various professional figures who get involved with the whole patient treatment.Keywords: real world data, biosimilar, rheumatic diseases, PDTA, EULAR recommendations, rheumatoid arthritis

Quentin M Anstee,1,2 Kate Hallsworth,1,2 Niall Lynch,3 Adrien Hauvespre,4 Eid Mansour,5 Sam Kozma,5 Juliana Bottomley,6 Gary Milligan,7 James Piercy,8 Victoria Higgins9 1Translational & Clinical Research Institute, Faculty of Medical Sciences, University of Newcastle, Newcastle Upon Tyne, UK; 2Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; 3Global Value and Access, Gilead Sciences, Hayes, Uxbridge, UK; 4Market Access and Reimbursement, Gilead Sciences, Hayes, Uxbridge, UK; 5Pricing and Market Access (Middle East), Gilead Sciences, Dubai, United Arab Emirates; 6Pricing and Market Access, Gilead Sciences, Hayes, Uxbridge, UK; 7Statistics Department, Adelphi Real World, Bollington, UK; 8Scientific Franchise, Adelphi Real World, Bollington, UK; 9Scientific and NASH Franchise, Adelphi Real World, Bollington, UKCorrespondence: Victoria Higgins, Adelphi Real World, Adelphi Mill, Grimshaw Lane, Bollington, SK10 5JB, UK, Tel +44 1625 577233, Email victoria.higgins@adelphigroup.comObjective: Stratifying disease severity in patients with non-alcoholic steatohepatitis (NASH) is essential for appropriate treatment and long-term management. Liver biopsy is the reference standard for fibrosis severity in NASH, but less invasive methods are used, eg, Fibrosis-4 Index (FIB-4) and vibration-controlled transient elastography (VCTE), for which reference thresholds for no/early fibrosis and advanced fibrosis are available. We compared subjective physician assessment of NASH fibrosis versus reference thresholds to understand classification in a real-world setting.Methods: Data were drawn from Adelphi Real World NASH Disease Specific ProgrammeTM conducted in France, Germany, Italy, Spain and UK in 2018. Physicians (diabetologists, gastroenterologists, hepatologists) completed questionnaires for five consecutive NASH patients presenting for routine care. Physician-stated fibrosis score (PSFS) based on available information was compared with clinically defined reference fibrosis stage (CRFS) determined retrospectively using VCTE and FIB-4 data and eight reference thresholds.Results: One thousand two hundred and eleven patients had VCTE (n = 1115) and/or FIB-4 (n = 524). Depending on thresholds, physicians underestimated severity in 16– 33% (FIB-4) and 27– 50% of patients (VCTE). Using VCTE ≥ 12.2, diabetologists, gastroenterologists and hepatologists underestimated disease severity in 35%, 32%, and 27% of patients, respectively, and overestimated fibrosis in 3%, 4%, and 9%, respectively (p = 0.0083 across specialties). Hepatologists and gastroenterologists had higher liver biopsy rates than diabetologists (52%, 56%, 47%, respectively).Conclusion: PSFS did not consistently align with CRFS in this NASH real-world setting. Underestimation was more common than overestimation, potentially leading to undertreatment of patients with advanced fibrosis. More guidance on interpreting test results when classifying fibrosis is needed, thereby improving management of NASH.Keywords: fibrosis staging, non-alcoholic steatohepatitis, clinically derived reference fibrosis score, physician-stated fibrosis score, real-world evidence

Benjamin Rosen,1 Annemarie L Pelle,1 Nisha A Lakhi1,2 1Department of Surgery, New York Medical College, School of Medicine, Valhalla, New York, USA; 2Department of Trauma Surgery, Richmond University Medical Center, Staten Island, New York, USACorrespondence: Nisha A Lakhi, Department of Obstetrics and Gynecology/Trauma Surgery, Richmond University Medical Center, 355 Bard Avenue, Staten Island, New York, 10310, USA, Tel +1 718-818-1823, Email nlakhi@NYMC.EDUBackground: The COVID-19 pandemic globally impacted trauma facilities and overall healthcare utilization. This study was conducted to characterize the utilization of trauma services at our Level I Trauma Center in New York City during the COVID-19 pandemic compared to the preceding pre-pandemic year.Methods: A retrospective study of patient presenting to our Level 1 Trauma Center in Staten Island, New York. The pre-pandemic data was extracted from March 1st, 2019–February 29th, 2020. The pandemic year was divided into two phases: the initial wave (March 1st–Sept 1st, 2020) and the protracted phase (September 1st, 2020–March 1st, 2021). Patients were identified using ICD-10 coding and data regarding patient factors, mechanism of injury, and service utilization was extracted from the medical record. Statistical analysis was performed using IBM SPSS v.24.Results: A total of 1650 trauma activations registered during the pre-pandemic phase, 691 during the initial wave, and 826 during the protracted phase. Compared to pre-pandemic, the number of Level 1 trauma activations remained unchanged, however mechanisms of injury shifted. Gunshot wounds (2.6% vs 1.2%), motorcycle crash (4.2% vs 2.0%) and blunt force injury caused by an object (strike injuries) (2.7% vs 1.3%) significantly increased during the initial wave (p-value < 0.05). There was a significant decrease in the percentage of both female (2.93% vs 2.33% vs 5.64%, p-value < 0.01) and pediatric (3.30% vs 3.64% vs 12.9%, p-value < 0.001) assault activations during the initial wave and protracted phase when compared to pre-pandemic levels, respectively. No significant changes were observed for self-harm, falls, accidents, burns, sports injuries, stab wounds, autobody collisions, or motor vehicle accident activations.Conclusion: Trauma centers should be prepared for increases in violent trauma. We also emphasize the need to implement strategies to raise public awareness of pediatric and female assault in the domestic setting, particularly during a mandatory stay-at-home policy where underreporting may occur.Keywords: trauma center, COVID-19, mechanism of injury, service utilization

Bewunetu Zewude,1 Getahun Siraw,2 Yesuf Adem3 1Department of Sociology, College of Social Sciences and Humanities, Wolaita Sodo University, Wolaita Sodo, Ethiopia; 2Department of Sociology, College of Social Sciences and Humanities, Dilla University, Dilla, Ethiopia; 3Department of Business Management, Senabor College, Shashemene, EthiopiaCorrespondence: Bewunetu Zewude, Email bewunetuzewude@gmail.comBackground: The purpose of the study was to identify the choice of mode of delivery and the factors associated with such preferences among pregnant women attending antenatal care services in Southern Ethiopia.Methods: Using an institutional-based cross-sectional survey, quantitative data were collected from randomly selected pregnant women in Southern Ethiopia. A semi-structured questionnaire was distributed to pregnant women who had been attending antenatal healthcare services in purposively selected public and private healthcare facilities in Shashemene town. The completed cases were inserted into SPSS version 26 in which both descriptive and inferential statistical techniques were used to analyze the data.Results: It was found that 75.4% of respondents replied that they prefer vaginal delivery while 24.6% had chosen cesarean section. Personal conviction motivated by the need to experience the labor process, the belief in it being a natural method, the perception that it is better for the wellbeing of both the mother and the child, previous experience of delivery by vaginal method, fear or the need to avoid episiotomy, and economic concerns have been mentioned as reasons for the choice of vaginal delivery. Moreover, respondents’ choice of the mode of delivery is significantly associated with religion, age, number of children, pregnancy experience, previous mode of delivery, self-rated social class status, autonomy to decide about mode of delivery, and type of healthcare organization of antenatal care attendance.Conclusion: Although vaginal delivery has remained the most preferred mode of delivery among most pregnant women, about a quarter of pregnant women have reported that they prefer to deliver by cesarean section, a prevalence rate which is higher than the national average, indicating that the choice of cesarean section is still increasing among women.Keywords: cesarean section, mode of delivery, preference, pregnant women, vaginal delivery

Felicitas Wiedemann,1,2 Franz Porzsolt2 1Department of General and Visceral Surgery, Stuttgart, 70176, Germany; 2Institute of Clinical Economics (ICE) e.V., Ulm, 89081, GermanyCorrespondence: Felicitas Wiedemann, Department of General and Visceral Surgery, Diakonie-Klinikum Stuttgart, Markelstraße 44, Stuttgart, Baden-Württemberg, Germany, Tel +491781731296, Email felicitas.wiedemann@gmail.comPurpose: The assessment of health-related quality of life (hrQoL) may need to be reconsidered due to important differences between efficacy (the effect of a treatment under experimental study conditions) and effectiveness (the effect of a treatment under real-world conditions). We presume that most researchers intend to describe effects under real-world conditions when investigating hrQoL as an endpoint. Unfortunately, most studies are designed to confirm two theories: the efficacy of a new intervention under experimental study conditions and the real-world effectiveness of this intervention on hrQoL under non-experimental study conditions. Conflicting information emerges when the outcomes are supposed to describe effects under real-world conditions, but the assessment generates results obtained under experimental conditions. This paper examines the existing conflict between efficacy and effectiveness in a sample of 100 studies investigating hrQoL.Methods: We analysed a sample of freely available publications of clinical studies listed in PubMed between April 2015 and August 2016 which assessed quality of life as an outcome. We assessed the following four characteristics that should differ in studies measuring either efficacy or effectiveness: 1) specification of the study as a randomised controlled trial or not, 2) description of the study design as pragmatic or not, 3) classification of the study as an efficacy or an effectiveness study and 4) number of selected inclusion and exclusion criteria.Results: 91% of the studies assessed hrQoL under experimental conditions (in a randomised controlled trial), but not under real-world conditions. The important difference between efficacy and effectiveness was not described in 60% of the studies. Only 6% of studies classified the study as a pragmatic trial. The difference between inclusion and exclusion criteria was not addressed in any of the investigated studies.Conclusion: The results of the four criteria confirmed our hypothesis that hrQoL studies are conducted mainly as experimental, but not pragmatic, trials indicating that the meaningfulness of the important difference between efficacy and effectiveness requires further discussion.Keywords: pragmatic trial, experimental study conditions, real-world conditions, efficacy, effectiveness, pragmatic.

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

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

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

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

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

Michihiro Takahashi,1 Naohiro Nakahara,2 Shinji Fujikoshi,3 Masaomi Iyo4 1Takahashi Psychiatric Clinic, Ashiya, Hyogo, Japan; 2Zimmer KK, Tokyo, Japan; 3Lilly Research Laboratories Japan, Lilly Japan KK, Kobe, Japan; 4Department of Psychiatry, Graduate School of Medicine, Chiba University, Chiba, Japan Purpose: To compare the rates of antipsychotic response, remission, and relapse in patients with schizophrenia treated with olanzapine or other antipsychotics in usual clinical care in Japan. Patients and methods: This analysis of a 12-month, prospective, noninterventional study examined outcomes for 1,089 inpatients and outpatients with schizophrenia who initiated antipsychotic monotherapy. All treatment decisions, including medication choice, were left to the discretion of the treating physician. The rates of treatment response, relapse, and 6-month sustained remission were compared between olanzapine monotherapy (OLZ) and other antipsychotic monotherapy (OAN), and between OLZ and other atypical antipsychotic monotherapy (OAT). Visit-wise comparisons of treatment response and remission were examined using repeated-measures logistic regressions. Propensity scores were used to control for potential baseline differences between groups. Results: Response rates were higher for OLZ patients and relapse rates were consistently lower for OLZ patients, however the differences were not statistically significant. Rates of 6-month sustained remission were significantly higher for OLZ than OAN patients (P=0.032) and for OLZ than OAT patients (P=0.041). An exploratory analysis of OLZ and OAN comparison found outpatients treated with OLZ or OAN had similar sustained remission rates (OLZ: 22.2%, OAN: 22.8%), while inpatients treated with OLZ had significantly higher sustained remission rates than inpatients treated with OAN (OLZ: 17.1%, OAN: 6.6%, odds ratio [95% confidence interval] =3.54 [2.00–6.25]). Conclusion: In usual care in Japan, treating the acute symptoms of schizophrenia with olanzapine was not found to be significantly different for response and relapse rates; however, treatment with olanzapine was found to have significantly greater sustained remission rates than treatment with other antipsychotics. In the inpatient setting, where patients tend to be more severe and difficult to manage, olanzapine treatment may lead to higher sustained remission rates than other antipsychotics. Keywords: inpatients, Japan, outpatients, prospective studies

Meeting abstracts from the Respiratory Effectiveness Group 2015 Winter Summit – databases and registries around the world: maximizing the yield22-24th January 2015Hilton Hotel, Weena 10, 3012 CM Rotterdam, Netherlands&nbsp

Stephen L Able,1 Virginia Haynes,1 Jihyung Hong2 1Eli Lilly and Company, Indianapolis, IN, USA; 2Eli Lilly and Company, Windlesham, UK Purpose: To quantitatively address the burden of attention-deficit/hyperactivity disorder (ADHD) in Europe (Germany, the UK, Sweden, Denmark, and the Netherlands), to describe adult experience leading to diagnosis and treatment of ADHD, and to compare those findings with results from the US. Survey respondents and methods: Data were collected from an international web-based survey of adults from Europe and the US. Sociodemographics, comorbidities, work productivity/activity impairments, and health care utilization of adults reporting an ADHD diagnosis (n=431) and a similar number of adults without ADHD (n=449) were compared. Respondents' experiences with the diagnosis and treatment of ADHD and the perceived effects of the condition on psychosocial functioning were assessed. In addition, multivariate regression analyses were performed to compare the burden of ADHD between the two regions. Results: Adults with ADHD in both regions were generally less likely to be married, employed, or rate their health as good/very good/excellent and were more likely to smoke, have experienced alcoholism, have other mental health conditions, have work productivity/activity impairments, and use health care resources. Although the specialties of health care professionals consulted prior to diagnosis were similar between the two regions, there was a notable difference in the length of time it took to receive a first ADHD diagnosis. Only 55% of European respondents received a diagnosis within 6 months of their first physician consultation regarding their ADHD symptoms, compared to 90% in the US. The results of regression analyses confirmed a greater impact of ADHD on psychosocial functioning, work productivity impairments, and the total number of provider visits in Europe. Conclusion: The results revealed a significant impact of ADHD on adults over a range of outcomes, including social, family, and work relationships, health-related work productivity impairment, and health care resource use, with a generally greater burden of illness among European study participants than those from the US. Keywords: ADHD, adults, treatment, diagnosis, burden, Europe, US

Thomas Nolte,1 Ulf Schutter,2 Oliver Loewenstein31Pain and Palliative Care Centre Wiesbaden, Wiesbaden, Germany; 2Clinical Office for Pain Therapy, Marienhospital Marl, Marl, Germany; 3Regional Pain and Palliative Care Centre, Mainz, GermanyBackground: Strong opioids, including oxycodone, are the most effective analgesics used to combat moderate to severe cancer pain, but opioid-induced bowel dysfunction is a relevant problem associated with the therapy. Clinical studies have demonstrated equivalent analgesic efficacy and improved bowel function in treatment with a fixed combination of prolonged-release (PR) oxycodone and PR naloxone compared to oxycodone alone in patients with nonmalignant pain. Here, we report of a prospective, non-interventional study evaluating the effectiveness and safety of PR oxycodone/PR naloxone in a subgroup of patients with severe cancer pain.Patients and methods: Within the non-interventional multicenter study, 1,178 cancer patients with severe chronic pain received PR oxycodone/PR naloxone, dosed according to pain intensity, for 4 weeks. Recorded variables included pain intensity, patient-reported bowel function (Bowel Function Index), and pain-related functional impairment as a measure of quality of life (QoL).Results: During treatment with PR oxycodone/PR naloxone, clinically relevant improvements in pain intensity were observed in opioid-naïve patients and in patients pretreated with weak or strong opioids, as reflected by reductions in pain scores of 51%, 53%, and 33%, respectively. Improvement in analgesia was paralleled by a significant reduction of opioid-induced bowel dysfunction in opioid-pretreated patients. The reductions in the mean Bowel Function Index of −20.5 and −36.5 in patients pretreated with weak and strong opioids, respectively, represent clinically relevant improvements in bowel function. Pain-related functional impairment decreased consistently across all seven domains, which is equivalent to a substantial improvement in QoL.Conclusion: This subgroup analysis of cancer patients within a large non-interventional study demonstrates that treatment with PR oxycodone/PR naloxone provides effective analgesia with minimization of bowel dysfunction and improved QoL. These data extend our knowledge of the effectiveness and tolerability of PR oxycodone/PR naloxone to the population of patients with cancer under real-life conditions.Keywords: neoplasms, pain, oxycodone, naloxone, constipation, quality of life

Barbara P Yawn,1 Susan Bertram,1 Margary Kurland,1 Peter Wollan,1 Deborah Graham,2 Dawn Littlefield,1 Craig Smail,2 Wilson Pace2 1Department of Research, Olmsted Medical Center, Rochester, MN, 2National Research Network, American Academy of Family Physicians, Leawood, KS, USA Background: Asthma is common among children, adolescents, and adults. However, management of asthma often fails to follow evidence-based guidelines. Control assessments have been developed, validated against expert opinion, and disseminated. However, in primary care, assessment of control is only one step in asthma management. To facilitate integration of the evidence-based guidelines into practice, tools should also guide the next steps in care. The Asthma APGAR tools do just that, incorporating a control assessment as well as assessment of the most common reasons for inadequate and poor control. The Asthma APGAR tool is also linked to a care algorithm based on the 2007 National Heart, Lung, and Blood Institute asthma guidelines. The objective of this study is to assess the impact of implementation of the Asthma APGAR on patient asthma outcomes in primary care practices. Methods: A total of 1400 patients aged 5–60 years with physician-diagnosed asthma are enrolled in 20 practice-based research network (PBRN) practices randomized to intervention or usual care. The primary outcomes are changes in patient self-reported asthma control, asthma-related quality of life, and rates of exacerbations documented in medical records over the 18–24 months of enrollment. Process measures related to implementation of the Asthma APGAR system into daily care will also be assessed using review of medical records. Qualitative assessments will be used to explore barriers to and facilitators for integrating the Asthma APGAR tools into daily practice in primary care. Discussion: Data from this pivotal pragmatic study are intended to demonstrate the importance of linking assessment of asthma and management tools to improve asthma-related patient outcomes. The study is an effectiveness trial done in real-world PBRN practices using patient-oriented outcome measures, making it generalizable to the largest possible group of asthma care providers and primary care clinics. Keywords: asthma, asthma control, asthma management, primary care, pragmatic research, practice-based research, protocol

Barbara P Yawn,1 Peter Wollan,1 Matthew Rank2 1Department of Research, Olmsted Medical Center, Rochester, MN,USA; 2Division of Allergy, Asthma, and Clinical Immunology, Mayo Clinic, Scottsdale, AZ, USA Purpose: Chronic obstructive pulmonary disease (COPD) is usually recognized in its later stages, delaying therapeutic opportunities. Screening questionnaires have modest sensitivities and specificities. Adding questions about prior respiratory events might improve screening characteristics. Methods: Using administrative data from all health care facilities in Olmsted County, Minnesota USA, we identified all adults with an initial diagnosis of COPD from 2005 through 2007. For each individual we identified all coded lower and upper respiratory events in the 2 years before and the 2 years after the COPD diagnosis and categorized them as probable or possible COPD exacerbations. Results: 356 women and 346 men (N = 702) with a mean age of 67.5 years and 66.6 years respectively had a first diagnosis of COPD during the study period. Respiratory events in the 2 years prior to a COPD diagnosis were common with a range of 0 to 16 events per individual and a mean (SD) of 2.04 (2.14), 1.38 (1.86) all of which were probable COPD exacerbations. Prediagnostic respiratory events were predictive of similar events in the post diagnostic period (odds ratio = 1.6, 95% confidence interval [CI] 1.3 to 1.8). Conclusion: Inquiring about the number and type of upper or lower respiratory events in the 2 past years may be a useful addition to the "screening" criteria to improve COPD identification, especially those at risk of frequent exacerbations. Keywords: pulmonary disease, chronic obstructive, mass screening, case finding, exacerbations, respiratory tract infections

Nils-Olov Stålhammar,1 Brennan M Spiegel,2,3 Helena Granstedt Löfman,1 Maria Karlsson,1 Peter Wahlqvist,1 Jørgen Næsdal,4 M Todd Nelson,5 Nicolas Despiégel61Payer Evidence, AstraZeneca R&D, Mölndal, Sweden; 2Department of Gastroenterology, VA Greater Los Angeles Healthcare System, 3David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 4Medical Department, AstraZeneca R&D, Mölndal, Sweden; 5Late Phase, Life Sciences, OptumInsight, Raleigh, NC, USA; 6HEOR, OptumInsight, Nanterre, FranceBackground: Disease burden and associated costs are not well understood among patients with gastroesophageal reflux disease (GERD) who have persistent symptoms despite optimized proton pump inhibitor (PPI) therapy. The aim of this study was to investigate disease burden and costs of GERD in partial responders to PPI therapy.Methods: The Partial Response to PPI treatment: the Cost to Society and the Burden to the Patient in the US (REMAIN US) study was a 12-month, multicenter, noninterventional, observational study of 552 partial PPI responders in the USA. Participating sites were comprised of family practice (n = 30), internal medicine (n = 8), and specialist (gastroenterologist) centers (n = 15). GERD symptoms, health-related quality of life (HRQL), and impact on productivity were evaluated from patient-reported outcome instruments. Resource utilization data were also collected.Results: Patients had a high symptom burden, impaired HRQL, and reduced productivity while at work and in daily activities, despite optimized PPI therapy. Mean annual GERD-related costs were US$9944 per patient, comprising total direct costs and mean productivity loss costs of US$4068 and US$5876 per patient, respectively.Conclusion: Patients with GERD and a partial response to PPI therapy have considerable direct and indirect costs, along with substantial impairments in HRQL and productivity.Keywords: gastroesophageal reflux disease, GERD, proton pump inhibitors, partial response

Elisa Martín-Merino1, Saga Johansson2, Héctor Bueno3, Luis A García Rodríguez11Spanish Centre for Pharmacoepidemiologic Research (CEIFE), Madrid, Spain; 2AstraZeneca R&D, Mölndal, Sweden; 3Department of Cardiology, Hospital General Universitario Gregorio Marañón, Madrid, SpainBackground: Discontinuation of low-dose acetylsalicylic acid (ASA) leads to an increased risk of cardiovascular and cerebrovascular events in patients taking low-dose ASA for secondary cardiovascular prevention. However, little is known about the rate of discontinuation in everyday clinical practice.Objectives: To assess the rate of low-dose ASA discontinuation in primary care, and identify factors that predict discontinuation.Methods: The Health Improvement Network, a large UK primary care database, was used to identify patients aged 50–84 years who received at least two consecutive prescriptions for low-dose ASA for secondary cardiovascular or cerebrovascular prevention in 2000–2007 (n = 35,639). Discontinuation was defined as a period of at least 90 days after completion of the last prescribed course of ASA during which no repeat prescription was issued.Results: During the study, 11,729 patients (32.9%) discontinued ASA therapy (mean follow-up 2.5 years). The discontinuation rate was lower in patients with ASA indicated for myocardial infarction than for other indications. The diagnosis of gastrointestinal disorders during the study (overall odds ratio: 1.74; 95% confidence interval: 1.61–1.88) was associated with increased rates of ASA discontinuation, whereas co-prescription of a proton pump inhibitor from the start of ASA therapy was associated with a decreased rate of discontinuation (odds ratio: 0.80; 95% confidence interval: 0.75–0.86). Co-prescription of several other cardioprotective medications was also associated with a reduced risk of discontinuation, as were increasing age, prior hospitalization and overall number of co-medications.Conclusion: Continuous co-prescription of a PPI with low-dose ASA may improve adherence and outcomes, particularly in patients at both cardiovascular and gastrointestinal risk.Keywords: aspirin, primary health care, compliance

J Dekoninck1, F Geurs1, R De Loecker2, Y Deprest21Department of Medical Oncology, 2Laboratory, Regional Hospital Sint Maria, Halle, BelgiumAbstract: In symptomatic bone metastases with significant pain, refractory to standard analgesics and radiotherapy, loading dose zoledronic acid (ZA) represents a simple and nontoxic treatment to obtain significant pain relief in a very short time. Its analgesic effect is limited to patients with massive osteoclast activation with high initial serum C-telopeptide (CTX). The pain reduction is proportionally correlated with the reduction of CTX.Keywords: bone resorption, bisphosphonates, CTX levels, VAS score&nbsp

Cornelia Schneider1, Susan S Jick2, Ulrich Bothner3, Christoph R Meier11Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacy and Epidemiology, Department Pharmaceutical Sciences, University Basel, Basel, Switzerland; 2Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Lexington, MA, USA; 3Nycomed AG, Konstanz, GermanyPurpose: The goal of this study was to compare the risk of developing cancer between patients with or without chronic obstructive pulmonary disease (COPD), and to assess the role of gender as well as the use of respiratory medication on the risk of developing lung cancer in COPD patients.Patients and methods: We used the UK-based General Practice Research Database to conduct a follow-up study with a nested case-control analysis. We identified all patients with a first-time COPD diagnosis aged 40–79 years between 1995 and 2005 and a matched COPD-free comparison group. We then identified all patients who received an incident cancer diagnosis during follow-up.Results: Among 35,772 COPD patients and 35,772 COPD-free patients, we identified 4506 patients with an incident cancer diagnosis, of whom 2585 (57.4%) had a previous COPD diagnosis, yielding a crude incidence rate ratio of 1.64 (95% CI 1.55–1.74). The increased risk was mainly driven by a high lung cancer risk among COPD patients, while other cancers not associated with smoking were not statistically significantly associated with an altered COPD risk. In the nested case-control analysis, the odds ratio (OR) for lung cancer associated with COPD was higher for women (OR 5.26, 95% CI 3.64–7.61) than for men (OR 2.10, 95% CI 1.70–2.60). In the nested case-control analysis, none of the respiratory drugs were associated with a substantially altered risk of developing lung cancer among COPD patients.Conclusion: Our findings provide further evidence that COPD is associated with an elevated lung cancer risk, and that women with COPD may be more susceptible to developing lung cancer than men. Overall, respiratory medication did not have an influence on cancer risk.Keywords: COPD, cancer, GPRD, gender

Albert SharInformation Technology, Robert Wood Johnson Foundation, Princeton, New Jersey, USAAbstract: The inability to precisely measure the area of a lesion can impair the study of its natural history and response to therapy. This is especially true in case of gastrointestinal lesions, where a standard imaging technique is endoscopy and an unaided visual interpretation of the size of the lesion is difficult. This study presents a novel technique that provides precise measurement of 2-dimensional lesions in cylinder-like organs.Keywords: quantitative endoscopy, Barrett’s esophagus, lesion measurement, disease tracking