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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

Victoria Higgins, James Piercy, Adam Roughley, Gary Milligan, Andrea Leith, James Siddall, Mike Benford Adelphi Real World, Macclesfield, UK Background: Despite the availability of a variety of treatments, many patients with type 2 diabetes mellitus (T2DM) are not achieving glucose control. We analyzed successive waves of the Adelphi Real World Diabetes Disease Specific Programmes (DSPs) to assess treatment patterns reported by primary care physicians (PCPs) and specialists and the effect of treatment on levels of glucose control.Methods: Data were collected between 2000 and 2015 in the US and EU5 (France, Germany, Italy, Spain, and the UK). Physicians completed patient record forms for the next 10 patients consulting with T2DM. Key aspects captured were change over time in therapy usage, time to insulin introduction, and glycated hemoglobin (HbA1c) levels.Results: Over 12 DSP waves, 3,555 specialists and 5,109 PCPs completed questionnaires for 70,657 patients. Treatment patterns changed considerably over time as new agents were introduced. The number of agents prescribed per patient increased over time, as did HbA1c levels at which physicians stated they would introduce insulin. The greatest improvements in HbA1c levels occurred during 2000–2008, with little improvement since 2008.Conclusion: In this real-world setting, the proportion of patients with T2DM achieving good glucose control has not increased greatly since 2008. A better understanding of how to individualize treatment pathways may be required to improve control in these patients. Keywords: insulinization, real world, type 2 diabetes, treatment trends

David Price,1 Mark Small,2 Gary Milligan,2 Victoria Higgins,2 Esther Garcia Gil,3 Jordi Estruch3 1Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK; 2Adelphi Real World, Adelphi Mill, Bollington, UK; 3Almirall S.A., Barcelona, Spain Background: Sleep quality is often poor in patients with chronic obstructive pulmonary disease (COPD). A cross-sectional European survey investigated the prevalence of night-time symptoms in COPD to evaluate the level of disconnect between physician and patient perceptions of the presence of night-time symptoms, and to compare the characteristics of patients with and without night-time symptoms. Methods: A total of 251 primary care physicians and 251 respiratory specialists completed record forms on 2,807 patients with COPD. The forms captured information on patient demographics, lung function, COPD severity, and symptoms. Patients completed questionnaires on the time of day when their COPD symptoms bothered them, and the impact of COPD on their ability to get up in the morning and on sleep. Data were compared between groups (those with and without night-time symptoms) using t-tests or Wilcoxon signed rank tests. The kappa statistic was used to assess the level of disconnect between physician and patient perceptions of the impact of night-time symptoms. Results: Most patients (78%) reported night-time disturbance. Patients with night-time symptoms experienced more daytime breathlessness (mean modified Medical Research Council dyspnea scale score 2.4 versus 1.1) and exacerbations in the previous 12 months (mean 1.7 versus 0.4), and received more maintenance therapy (mean of 2.8 versus 2.3 products) than those without. Concordance between the frequency of physician-reported (67.9% of patients) and patient-reported (68.5% of patients) night-time symptoms was good. Physicians significantly underestimated the impact of COPD on the patient's ability to get up in the morning and on sleep (fair–moderate agreement). Physician-reported night-time symptoms were present for 41.2% of patients who could be categorized by Global initiative for chronic Obstructive Lung Disease (GOLD) group (n=937), increasing from 20.9% of those in the low-risk group to 77.4% of those in the high-riskgroup. Conclusion: Patients with COPD experience night-time symptoms regardless of GOLD group, that impact on their ability to get up in the morning and on their sleep quality. Keywords: chronic obstructive pulmonary disease, night-time symptoms, sleep quality, burden

Seabird tracking has become an ever more popular tool to aid environmental procedures such as the designation of marine protected areas and environmental impact assessments. However, samples used are usually small and little consideration is given to experimental design and sampling protocol. European shags Phalacrocorax aristotelis were tracked using GPS technology over three breeding seasons and the following foraging trip characteristics: trip duration, trip distance, maximum distance travelled from the colony, size of area used and direction travelled from colony were determined for each foraging trip. The effect of sex, year of study, breeding site, number and age of chicks and the timing of tracking on foraging behaviour were investigated using a general estimation equation model. a range of sampling scenarios reflecting likely field sampling were also tested to compare how foraging behaviour differed depending on composition of the sample of birds tracked. Trip distance, trip duration, maximum distance travelled and size of area used were all significantly affected by the breeding site, and the number of chicks a tracked adult was raising. The effect of sex was also seen when examining trip distance, trip duration and the maximum distance travelled. The direction travelled on a foraging trip was also significantly affected by breeding site. This study highlights the importance of sampling regime and the influence that year, sex, age, number of chicks and breeding site can have on the foraging trip characteristics for this coastal feeding seabird. Given the logistical and financial constraints in tracking large numbers of individuals, this study identifies the need for researchers to consider the composition of their study sample to ensure any identified foraging areas are as representative as possible of the whole colony's foraging area., Introduction In recent years, the number of seabird tracking studies using global positioning system data loggers, satellite transmitters and geolocators has increased substantially due to the availability of cheaper and [...]