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David Price,1,2 William Henley,1,3 José Eduardo Delfini Cançado,4 Leonardo M Fabbri,5 Huib AM Kerstjens,6 Alberto Papi,7 Nicolas Roche,8 Elif Şen,9 Dave Singh,10 Claus F Vogelmeier,11 Elena Nudo,12 Victoria Carter,1 Derek Skinner,1 Rebecca Vella,1 Joan B Soriano,13 Maxim Kots,12 George Georges14 1Observational and Pragmatic Research Institute, Singapore; 2Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Health Statistics Group, Department of Health and Community Sciences, University of Exeter Medical School, Exeter, UK; 4Santa Casa de São Paulo Medical School, São Paulo, Brazil; 5Respiratory Medicine, Department of Translational Medicine and for Romagna, University of Ferrara, Ferrara, Italy; 6Department of Pulmonary Diseases, University of Groningen and University Medical Centre Groningen, and Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; 7Respiratory Medicine, University of Ferrara, Ferrara, Italy; 8Department of Respiratory Medicine, APHP-Centre University of Paris, Cochin Hospital and Institute (UMR1016), Paris, France; 9Department of Pulmonary Medicine, Ankara University School of Medicine, Ankara, Turkey; 10Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; 11Department of Internal Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany; 12Global Medical Affairs, Chiesi Farmaceutici, S.p.A, Parma, Italy; 13Respiratory Department, Hospital Universitario de La Princesa and Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain; 14Global Clinical Development, Chiesi Farmaceutici, S.p.A, Parma, ItalyCorrespondence: David Price, Observational and Pragmatic Research Institute, 22 Sin Ming Lane, #06-76, Midview City, 573969, Singapore, Tel +65 3105 1489, E

Marielen Reinhardt,1,* Tobias Schupp,1,* Mohammad Abumayyaleh,1 Felix Lau,1,2 Alexander Schmitt,1 Noah Abel,1 Muharrem Akin,2 Jonas Rusnak,3 Ibrahim Akin,1 Michael Behnes1 1Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; 2Department of Cardiology, Angiology, Hannover Medical School, Hannover, Germany; 3Department of Cardiology, Angiology and Pneumology, University Hospital Heidelberg, Heidelberg, Germany*These authors contributed equally to this workCorrespondence: Tobias Schupp, First Department of Medicine, University Medical Center Mannheim (UMM), Theodor-Kutzer-Ufer 1-3, Mannheim, 68167, Germany, Tel +49 621-383-2204, Email tobias.schupp@umm.deObjective: The study investigates the prognostic impact of body mass index (BMI) in patients hospitalized with heart failure with mildly reduced ejection fraction (HFmrEF).Background: Limited data regarding the prognostic impact of BMI in patients with HFmrEF is available.Methods: Consecutive patients with HFmrEF (ie, left ventricular ejection fraction 41– 49% and signs and/or symptoms of HF) were retrospectively included at one institution from 2016 to 2022. Risk stratification was performed according to WHO-defined BMI groups. The primary endpoint was all-cause mortality at 30 months (median follow-up). Kaplan-Meier, uni- and multivariable Cox proportional regression analyses were applied for statistics.Results: 1832 consecutive patients with HFmrEF were included with a median BMI of 26.7 kg/m2 (IQR 24.0– 30.8 kg/m2). Patients with lowest BMI (ie, 18.5– 24.9 kg/m2) were associated with highest risk of all-cause mortality at 30 months compared to patients with higher BMI values (40.0% vs 29.0% vs 21.4% vs 20.9%; log rank p = 0.001; HR = 0.721; 95% CI 0.656– 0.793; p = 0.001). Even after multivariable adjustment, higher BMI values were associated with impro

Saeed Shakibfar,1 Kristine H Allin,2 Tine Jess,2 Maria Antonietta Barbieri,1,3 Vera Battini,1,4 Eva Simoncic,1 Julien Kirchgesner,5 Trond Ulven,1,* Maurizio Sessa1,* 1Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark; 2Center for Molecular Prediction of Inflammatory Bowel Disease (PREDICT), Department of Clinical Medicine, Aalborg University, Copenhagen, Denmark; 3Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy; 4Pharmacovigilance & Clinical Research, International Centre for Pesticides and Health Risk Prevention, Department of Biomedical and Clinical Sciences (DIBIC), ASST Fatebenefratelli-Sacco University Hospital, Università Degli Studi Di Milano, Milan, Italy; 5Department of Gastroenterology, INSERM, Institut Pierre Louis d’Epidémiologie Et de Santé Publique, AP-HP, Hôpital Saint-Antoine, Sorbonne Université, Paris, France*These authors contributed equally to this workCorrespondence: Saeed Shakibfar, Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark, Email saeed.shakibfar@sund.ku.dkAim: Drug repurposing, utilizing electronic healthcare records (EHRs), offers a promising alternative by repurposing existing drugs for new therapeutic indications, especially for patients lacking effective therapies. Intestinal fibrosis, a severe complication of Crohn’s disease (CD), poses significant challenges, increasing morbidity and mortality without available pharmacological treatments. This article focuses on identifying medications associated with an elevated or reduced risk of fibrosis in CD patients through a population-wide real-world data and artificial intelligence (AI) approach.Methods: Patients aged 65 or older with a diagnosis of CD from 1996 to 2019 in the Danish EHRs were followed for up to 24 years. The primary outcome was the need of specific surgical procedures, namely proctocolectomy with ileostomy and ileoc

Corrado Pelaia,1 Antonio Giacalone,2 Gianluca Ippolito,2 Daniela Pastore,2 Angelantonio Maglio,3 Giovanna Lucia Piazzetta,1 Nadia Lobello,1 Nicola Lombardo,1 Alessandro Vatrella,3 Girolamo Pelaia2 1Department of Medical and Surgical Sciences, University “Magna Græcia” of Catanzaro, Catanzaro, Italy; 2Department of Health Sciences, University “Magna Græcia” of Catanzaro, Catanzaro, Italy; 3Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, ItalyCorrespondence: Corrado Pelaia, Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Viale Europa – Località Germaneto, Catanzaro, 88100, Italy, Tel + 39 0961 3647007, Email pelaia.corrado@gmail.comAbstract: Many different phenotypes that characterize severe asthma are supported by intricate pathomechanisms called endotypes. The latter are driven by molecular interactions, mediated by intercellular networks. With regard to the biological treatments of either allergic or non-allergic eosinophilic type 2 asthma, real-world studies have confirmed the positive effects of currently available antibodies directed against immunoglobulins E (IgE), interleukin-5 (IL-5) and its receptor, as well as the receptors of interleukins-4 (IL-4) and 13 (IL-13). The best way to treat severe asthma should be chosen based on the peculiar phenotypic and endotypic traits of each patient. This will lead to relevant improvements in both clinical and functional outcomes. In particular, biological therapies can change the lives of asthma patients with a strong impact on quality of life. Unfortunately, patients with severe non-type-2 asthma, who continue to have pertinent unmet needs, are not receiving satisfactory advances within the context of biological treatments. It is also hopeful that in the next future new therapeutic strategies will be specifically implemented for these people, perhaps offering them the opportunity to improve their current, mostly inadequate asthma management.

Jenna Wong,1– 3 Xiaojuan Li,1,2 David E Arterburn,4 Dongdong Li,1,2 Elizabeth Messenger-Jones,1 Rui Wang,1,2 Sengwee Toh1,2 1Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA; 2Department of Population Medicine, Harvard Medical School, Boston, MA, USA; 3Optum Labs Visiting Fellow, Eden Prairie, MN, USA; 4Kaiser Permanente Washington Health Research Institute, Seattle, WA, USACorrespondence: Jenna Wong, Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USA, Tel +1 617 867-4513, Fax +1 617 867-427, Email jenna_wong@hphci.harvard.eduBackground: Lack of body mass index (BMI) measurements limits the utility of claims data for bariatric surgery research, but pre-operative BMI may be imputed due to existence of weight-related diagnosis codes and BMI-related reimbursement requirements. We used a machine learning pipeline to create a claims-based scoring system to predict pre-operative BMI, as documented in the electronic health record (EHR), among patients undergoing a new bariatric surgery.Methods: Using the Optum Labs Data Warehouse, containing linked de-identified claims and EHR data for commercial or Medicare Advantage enrollees, we identified adults undergoing a new bariatric surgery between January 2011 and June 2018 with a BMI measurement in linked EHR data ≤ 30 days before the index surgery (n=3226). We constructed predictors from claims data and applied a machine learning pipeline to create a scoring system for pre-operative BMI, the B3S3. We evaluated the B3S3 and a simple linear regression model (benchmark) in test patients whose index surgery occurred concurrent (2011– 2017) or prospective (2018) to the training data.Results: The machine learning pipeline yielded a final scoring system that included weight-related diagnosis codes, age, and number of days hospitalized and distinct drugs dispensed in the past 6 month

Andrew N Menzies-Gow,1,2 Trung N Tran,3 Brooklyn Stanley,4 Victoria Ann Carter,4 Josef S Smolen,5 Arnaud Bourdin,6 J Mark Fitzgerald7 ,†Tim Raine,8 Jatin Chapaneri,2 Benjamin Emmanuel,3 David J Jackson,9,10 David B Price4,11 1Royal Brompton and Harefield Hospitals, Guys & St Thomas’ NHS Foundation Trust, London, UK; 2AstraZeneca, Cambridge, UK; 3AstraZeneca, Gaithersburg, MD, USA; 4Observational and Pragmatic Research Institute, Singapore; 5Medical University of Vienna, Vienna, Austria; 6Université de Montpellier, CHU Montpellier, PhyMedExp, INSERM, CNRS, Montpellier, France; 7The University of British Columbia, Vancouver, British Columbia, Canada; 8Cambridge University Hospitals NHS Foundation Trust, Addenbrooke’s Hospital, Cambridge, UK; 9Guy’s Severe Asthma Centre, Guy’s & St Thomas’ NHS Trust, London, UK; 10School of Immunology & Microbial Sciences, King’s College London, London, UK; 11Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK†J. Mark Fitzgerald passed away on January 18, 2022Correspondence: David B Price, Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building-Foresterhill, Aberdeen, AB25 2ZD, UK, Tel +65 3105 1489, Email dprice@opri.sgPurpose: Associations between systemic glucocorticoid (SGC) exposure and risk for adverse outcomes have spurred a move toward steroid-sparing treatment strategies. Real-world changes in SGC exposure over time, after the introduction of steroid-sparing treatment strategies, reveal areas of successful risk mitigation as well as unmet needs.Patients and Methods: A population-based ecological study was performed from the Optimum Patient Care Research Database to describe SGC prescribing trends of steroid-sparing treatment strategies in primary care practices before and after licensure of biologics in the United Kingdom from 1990 to 2019. Each analysis year included patients aged ≥ 5

Breda Cushen,1,* Mariko Siyue Koh,2,* Trung N Tran,3 Neil Martin,3,4 Ruth Murray,5 Thendral Uthaman,6 Celine Yun Yi Goh,5,6 Rebecca Vella,7 Neva Eleangovan,5,6 Lakmini Bulathsinhala,5,6 Jorge F Maspero,8,9 Matthew J Peters,10 Florence Schleich,11 Paulo Pitrez,12 George Christoff,13 Mohsen Sadatsafavi,14 Carlos A Torres-Duque,15,16 Celeste Porsbjerg,17 Alan Altraja,18 Lauri Lehtimäki,19 Arnaud Bourdin,20 Christian Taube,21 Nikolaos G Papadopoulos,22,23 Csoma Zsuzsanna,24 Unnur Björnsdóttir,25 Sundeep Salvi,26 Enrico Heffler,27 Takashi Iwanaga,28 Mona al-Ahmad,29 Désirée Larenas-Linnemann,30 Job FM van Boven,31 Bernt Bøgvald Aarli,32,33 Piotr Kuna,34 Cláudia Chaves Loureiro,35,36 Riyad Al-lehebi,37 Jae Ha Lee,38 Nuria Marina,39 Leif Bjermer,40 Chau-Chyun Sheu,41,42 Bassam Mahboub,43 John Busby,44 Andrew Menzies-Gow,45 Eileen Wang,46 David B Price5,6,47 On behalf of ISAR Inventory Study Group1Department of Respiratory Medicine, Beaumont Hospital, Dublin, Ireland; 2Department of Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore, Singapore; 3AstraZeneca, Gaithersburg, MD, USA; 4Department of Respiratory Medicine, University of Leicester, Leicester, UK; 5Optimum Patient Care Global, Cambridge, UK; 6Observational Pragmatic Research Institute, Singapore, Singapore; 7Optimum Patient Care, Brisbane, Queensland, Australia; 8Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; 9University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina; 10Department of Thoracic Medicine, Concord Hospital, Sydney, Australia; 11CHU Sart-Tilman, GIGA I3, University of Liege, Liège, Wallonia, Belgium; 12Pulmonology Division, Hospital Santa Casa de Porto Alegre, Porto Alegre, Brazil; 13Faculty of Public Health, Medical University, Sofia, Bulgaria; 14Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Scien

Gincy George,1 Beth Russell,1 Anne Rigg,2 Anthony CC Coolen,3 Mieke Van Hemelrijck1 1Translational Oncology and Urology Research, King’s College London, London, UK; 2Guy’s Cancer Centre, Guy’s and St Thomas NHS Foundation Trust, London, UK; 3Department of Biophysics, Radboud University, Nijmegen, the NetherlandsCorrespondence: Gincy George, King’s College London, Translational Oncology and Urology Research, London, SE1 9RT, United Kingdom, Email gincy.e.george@kcl.ac.ukAbstract: There is a growing interest in real world evidence when developing antineoplastic drugs owing to the shorter length of time and low costs compared to randomised controlled trials. External validity of studies in the regulatory phase can be enhanced by complementing randomised controlled trials with real world evidence. Furthermore, the use of real world evidence ensures the inclusion of patients often excluded from randomised controlled trials such as the elderly, certain ethnicities or those from certain geographical areas. This review explores approaches in which real world data may be integrated with randomised controlled trials. One approach is by using big data, especially when investigating drugs in the antineoplastic setting. This can even inform artificial intelligence thus ensuring faster and more precise diagnosis and treatment decisions. Pragmatic trials also offer an approach to examine the effectiveness of novel antineoplastic drugs without evading the benefits of randomised controlled trials. A well-designed pragmatic trial would yield results with high external validity by employing a simple study design with a large sample size and diverse settings. Although randomised controlled trials can determine efficacy of antineoplastic drugs, effectiveness in the real world may differ. The need for pragmatic trials to help guide healthcare decision-making led to the development of trials within cohorts (TWICs). TWICs make use of cohorts to conduct multiple randomised controlle

Nancy A Dreyer,1 Christina D Mack2 1Dreyer Strategies LLC, Newton, MA, USA; 2IQVIA Real World Solutions, Research Triangle Park, NC, USACorrespondence: Nancy A Dreyer, Dreyer Strategies LLC, 328 Country Club Road, Newton, MA, USA, Tel +1 617 733 9478, Email ndreyer@dreyerstrategies.comAbstract: Real-world evidence (RWE) is being used to provide information on diverse groups of patients who may be highly impacted by disease but are not typically studied in traditional randomized clinical trials (RCT) and to obtain insights from everyday care settings and real-world adherence to inform clinical practice. RWE is derived from so-called real-world data (RWD), ie, information generated by clinicians in the course of everyday patient care, and is sometimes coupled with systematic input from patients in the form of patient-reported outcomes or from wearable biosensors. Studies using RWD are conducted to evaluate how well medical interventions, services, and diagnostics perform under conditions of real-world use, and may include long-term follow-up. Here, we describe the main types of studies used to generate RWE and offer pointers for clinicians interested in study design and execution. Our tactical guidance addresses (1) opportunistic study designs, (2) considerations about representativeness of study participants, (3) expectations for transparency about data provenance, handling and quality assessments, and (4) considerations for strengthening studies using record linkage and/or randomization in pragmatic clinical trials. We also discuss likely sources of bias and suggest mitigation strategies. We see a future where clinical records – patient-generated data and other RWD – are brought together and harnessed by robust study design with efficient data capture and strong data curation. Traditional RCT will remain the mainstay of drug development, but RWE will play a growing role in clinical, regulatory, and payer decision-making. The most meaningful RWE will come from co

Gabriel Ortiz-Jaimes,1,* Janani Reisenauer1,2,* 1Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN, USA; 2Division of Thoracic Surgery, Mayo Clinic, Rochester, MN, USA*These authors contributed equally to this workCorrespondence: Janani Reisenauer, Division of Pulmonary and Critical Care Medicine, Division of Thoracic Surgery, Mayo Clinic, 200 1st St, SW, Rochester, MN, 55905, USA, Email reisenauer.janani@mayo.eduAbstract: The approach to peripheral pulmonary lesions (PPL) has been evolving continuously. Advanced bronchoscopic navigational techniques have improved the airway-based approaches to these lesions. Robotic Assisted Bronchoscopy (RAB) can be considered the current pinnacle of this evolution; allowing for a safer approach to sampling lesions previously considered outside of bronchoscopic reach. We present a comprehensive review of the changing epidemiology of lung cancer and the importance of early tissue sampling, the evolution of sampling and navigational bronchoscopic techniques, technical considerations and evidence pertaining to the use of RAB, and adjunct techniques in the diagnosis of lung cancer. Complications and future applications of RAB are also discussed.Keywords: lung cancer, navigational bronchoscopy, pulmonary nodule, robotic bronchoscopy

Rishabh Lohray,1 Kritin K Verma,2 Leo L Wang,3 Dylan Haynes,3 Daniel J Lewis3 1Baylor College of Medicine, Houston, TX, USA; 2Texas Tech University Health Sciences Center, School of Medicine, Lubbock, TX, USA; 3Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USACorrespondence: Daniel J Lewis, Penn Dermatology Oncology Center, Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Boulevard, Suite 1-330S, Philadelphia, PA, 19104, USA, Tel +1 215-360-0909, Fax +1 215-662-4132, Email Daniel.Lewis@pennmedicine.upenn.eduIntroduction: Avelumab is a programmed cell death-ligand 1 (PD-L1) inhibitor approved by the Food and Drug Administration for advanced Merkel cell carcinoma (MCC). Studies conducted in real-world settings have shed light on its effectiveness and safety in clinical settings.Areas Covered: Real-world studies on avelumab for MCC from North and South America, Europe, and Asia have been presented in this review. Most studies are on patients over age 70 and have a male-predominant sex ratio. Overall response rates range from 29.1% to 72.1%, (disease control rate: 60.0– 72.7%; complete response rate: 15.8%– 37.2%; partial rate: 18.2– 42.1%; stable disease: 7.1– 30.9%; progressive disease: 7.1– 40.0%) and median progression free survival ranges from 8.1 to 24.1 months depending on the population studied. Immunosuppressed patients appear to benefit from avelumab as well, with response rates equivalent to the general population. Patients receiving avelumab as a first-line agent tend to have better outcomes than those using it as a second-line therapy. Fatigue, infusion-related reactions, and dyspnea were some of the most common adverse events identified in real-world studies. Autoimmune hepatitis and thyroiditis were also observed.Conclusion: The use of avelumab as a safe and effective treatment option for advanced MCC is supported by real-world data, although additional study is required to assess long-t

Constantinos Kallis,1 Rafael A Calvo,2 Bjorn Schuller,3 Jennifer K Quint1 1National Heart and Lung Institute, and School of Public Health, Imperial College London, London, UK; 2Dyson School of Engineering, Faculty of Engineering, Imperial College London, London, UK; 3Department of Computing, Faculty of Engineering, Imperial College London, London, UKCorrespondence: Jennifer K Quint, National Heart and Lung Institute and School of Public Health, Floor 9, Sir Michael Uren Building, 86 Wood Ln, London, W12 0BZ, United Kingdom, Email j.quint@imperial.ac.ukBackground: Improving accurate risk assessment of asthma exacerbations, and reduction via relevant behaviour change among people with asthma could save lives and reduce health care costs. We developed a simple personalised risk prediction model for asthma exacerbations using factors collected in routine healthcare data for use in a risk modelling feature for automated conversational systems.Methods: We used pseudonymised primary care electronic healthcare records from the Clinical Practice Research Datalink (CPRD) Aurum database in England. We combined variables for prediction of asthma exacerbations using logistic regression including age, gender, ethnicity, Index of Multiple Deprivation, geographical region and clinical variables related to asthma events.Results: We included 1,203,741 patients divided into three cohorts to implement temporal validation: 898,763 (74.7%) in the training sample, 226,754 (18.8%) in the testing sample and 78,224 (6.5%) in the validation sample. The Area under the ROC curve (AUC) for the full model was 0.72 and for the restricted model was 0.71. Using a cut-off point of 0.1, approximately 27 asthma reviews by clinicians per 100 patients would be prevented compared with a strategy that all patients are regarded as high risk. Compared with patients without an exacerbation, patients who exacerbated were older, more likely to be female, prescribed more SABA and ICS in the preceding 12 months

Amir Sara,1 Samantha M Ruff,2 Anne M Noonan,1 Timothy M Pawlik2 1Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH, USA; 2Department of Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, USACorrespondence: Timothy M Pawlik, Department of Surgery, The Urban Meyer III and Shelley Meyer Chair for Cancer Research, Professor of Surgery, Oncology, Health Services Management and Policy, The Ohio State University, Wexner Medical Center, 395 W. 12th Ave., Suite 670, Columbus, OH, 43210, USA, Tel +1 614 293-8701, Fax +1 614 293-4063, Email Tim.Pawlik@osumc.eduAbstract: Hepatocellular carcinoma (HCC) is the third most common cause of cancer-related mortality worldwide and accounts for 90% of all primary liver cancers. Chronic inflammation is the hallmark across most prevalent etiologies among which HBV is the leading cause worldwide (33%), followed by alcohol (30%), HCV (21%), other factors like non-alcoholic steatohepatitis linked to insulin resistance/metabolic syndrome, and obesity associated inflammation (16%). Deregulation of the tightly controlled immunological network leads to liver disease, including chronic infection, autoimmunity, and tumor development. While inflammation drives oncogenesis in the liver, HCC also recruits ICOS+ FOXP3+ Tregs and MDSCs and upregulates immune checkpoints to induce a state of immunosuppression in the tumor microenvironment. As such, research is focused on targeting and modulating the immune system to treat HCC. The Checkmate 040 and Keynote 224 studies established the role of immunotherapy in the treatment of patients with HCC. In Phase I and II trials, nivolumab and pembrolizumab demonstrated durable response rates of 15– 20% and were subsequently approved as second-line agents after sorafenib. Due to the success of the IMbrave 150 and HIMALAYA trials, which examined the combination of atezolizumab/bevacizumab and tremelimumab/durvalumab, respectively, the FDA approved

Guillaume Ngoie Mwamba,1,2 Michel Kabamba,1,2 Nicole A Hoff,3 Patrick K Mukadi,4 Kamy Kaminye Musene,5 Sue K Gerber,6 Megan Halbrook,3 Cyrus Sinai,3 Trevon Fuller,3 Arie Voorman,6 Paul Makan Mawaw,7 Oscar Luboya Numbi,7 Emile Okitolonda Wemakoy,8 Patricia N Mechael,9 Jean Jacques Muyembe Tamfum,4 Mala Ali Mapatano,10,* Anne W Rimoin,3,* Paul-Samson Lusamba Dikassa8,* 1Department of Public Health, University of Kamina, Kamina, Haut-Lomami, Democratic Republic of the Congo; 2Expanded Programme on Immunization, Ministry of Health, Kinshasa, Democratic Republic of the Congo; 3Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, USA; 4National Institute of Biomedical Research (INRB), Ministry of Health, Kinshasa, Democratic Republic of the Congo; 5Health Research and Training Program, UCLA-DRC, Kinshasa, Democratic Republic of the Congo; 6Polio eradication program, The Bill and Melinda Gates Foundation, Seattle, WA, 98109, USA; 7Faculty of Medicine, University of Lubumbashi, Lubumbashi, Haut-Katanga, 1825, Democratic Republic of the Congo; 8Department of Epidemiology and Biostatistics, School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo; 9Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA; 10Department of Nutrition, School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo*These authors contributed equally to this workCorrespondence: Michel Kabamba, Department of Public Health, Faculty of Medicine, University of Kamina, Kamina, Haut-Lomami, 279, Democratic Republic of the Congo, Tel +243978467432, Email michelnzaji@yahoo.frBackground: Malnutrition is identified as a risk factor for insufficient polio seroconversion in the context of a vaccine-derived poliovirus (VDPV) outbreak-prone region. In the Democratic Republic of Congo (DRC), underweight decreased from 31% (in 2001) to 2

David MG Halpin Department of Respiratory Medicine, University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UKCorrespondence: David MG Halpin, Email d.halpin@nhs.netAbstract: Real world data comprise information on health care that is derived from multiple sources outside typical clinical research settings. This review focuses on what real world evidence tells us about problems with the diagnosis of chronic obstructive pulmonary disease (COPD), problems with the initial and follow-up pharmacological and non-pharmacological management, problems with the management of exacerbations and problems with palliative care. Data from real world studies show errors in the management of COPD with delays to diagnosis, lack of confirmation of the diagnosis with spirometry, lack of holistic assessment, lack of attention to smoking cessation, variable adherence to management guidelines, delayed implementation of appropriate interventions, under-recognition of patients at higher risk of adverse outcomes, high hospitalisation rates for exacerbations and poor implementation of palliative care. Understanding that these problems exist and considering how and why they occur is fundamental to developing solutions to improve the diagnosis and management of patients with COPD.Keywords: COPD, real world studies, diagnosis, pharmacotherapy, exacerbations, palliative care

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 cli

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

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 med

Pär Stjärne,1 Duc Tung Nguyen,2 Hans Christian Kuhl2 1Department of Otorhinolaryngology, Karolinska Institute, Stockholm, Sweden; 2Global Clinical Sciences, Meda Pharma GmbH & Co. KG (A Mylan Company, Now Viatris), Bad Homburg, GermanyCorrespondence: Pär Stjärne, Karolinska University Hospital, Department of Otorhinolaryngology, Rhinology, Stockholm, 17176, Sweden, Tel +46707250749, Fax +46 8 774 7907, Email par.stjarne@sll.seBackground: Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista®) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device.Objective: This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity.Methods: A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality.Results: VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both p < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42.Conclusion: MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and assoc

Mohammed Alshakka1 ,†Najmaddin A H Hatem,2 Wafa Badullah,3 Rabab Alsakaf,4 Ali Rageh,1 Seena Abdulla Yousef,5 Mohamed Izham Mohamed Ibrahim6 1Section of Clinical Pharmacy, Faculty of Pharmacy, Aden University, Aden, Yemen; 2Department of Pharmacy Practice, College of Clinical Pharmacy, Hodeidah University, Alhodeidah, Yemen; 3Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Aden University, Aden, Yemen; 4Department of Post-Marketing Surveillance, National Pharmacovigilance Center, Supreme Board of Drugs and Medical Appliances, Aden, Yemen; 5Department of Community Medicine and Public Health, Faculty of Medicine and Health Sciences, Aden University, Aden, Yemen; 6Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar†Dr. Mohammed Alshakka passed away on February 11, 2022Correspondence: Najmaddin A H Hatem, Department of Pharmacy Practice, College of Clinical Pharmacy, Hodeidah University, P.O. 3114, Alhodeidah, Yemen, Tel +967 775040472, Email clin.pharm.najmaddin@gmail.comPurpose: The chAdOx1 nCoV-19 vaccine is the first COVID-19 vaccine available in Yemen. Hence, this local-based study was used to identify the type and frequency of short-term side effects following 48 hours of the first shot of the vaccine.Methods: A cross-section of vaccinated participants in Aden were surveyed by telephone. Descriptive statistics were used for statistical analysis.Results: A total of 500 participants were included through convenient sampling. 27% of them were health care providers. Nearly 70% of the respondent experienced side effects. The top three side effects reported were fever (n=276, 55.2%), myalgia (n=270, 54%) and fatigue (n=247, 49.4%). Generally, most participants stated that they experienced the side effects after the first 24 hours of vaccination.Conclusion: Side effects that participants experienced were not different from the literature, indicating a safe profile for the vaccine. Further studies a

Shashank Joshi,1 Agam Vora,2 K Venugopal,3 Pramod Dadhich,4 Anil Daxini,5 Sagar Bhagat,6 Saiprasad Patil,6 Hanmant Barkate6 1Department of Endocrinology, Joshi Clinic and Lilavati Hospital and Research Centre, Mumbai, India; 2Department of Pulmonology, Vora Clinic, Mumbai, India; 3Department of Pulmonology, Sooriya Hospital, Chennai, India; 4Department of Pulmonology, Dadhich Clinic, Ajmer, India; 5Department of Medicine, Fortis Hospital, Mumbai, India; 6Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, IndiaCorrespondence: Sagar Bhagat, Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India, Tel +91 9930553638, Email sagar.bhagat@glenmarkpharma.comBackground: Favipiravir, an RNA-dependent RNA polymerase inhibitor (RdRp), is a broad-spectrum oral antiviral agent approved in India under emergency use authorization, for the treatment of mild-to-moderate coronavirus disease (COVID-19). The present study was planned to evaluate the effectiveness and safety of favipiravir in real-world clinical practice.Materials and Methods: This was a multicentric, retrospective, single-arm study conducted across four centres in India, after obtaining permission from the independent ethics committee. Medical records were analysed to evaluate effectiveness and safety of patients who were prescribed favipiravir.Results: The medical records of a total of 360 patients met the inclusion criteria, with 358 of them available for the final analysis. Males made up 58.46% of the study population. The average age of enrolled patients was 51.80 ± 16.45 years. The most common symptoms were fever, cough, and myalgia-fatigue. The median time to clinical cure and fever relief was five and four days, respectively. The average length of stay in the hospital was six days. In total, 8% of the patients experienced adverse events. Hepatic enzyme elevation, diarrhoea, decreased appetite, headache, fatigue, and giddiness were the common symptoms.Conclusion: In our real-world study, f

Ameet Dravid,1 Dnyanesh Morkar,2 Dwijendra Prasad,3 John T Ramapuram,4 Kartik Vikrambhai Patel,5 K Sunil Naik,6 Milind Bhrusundi,7 Milind Kulkarni,8 Sanjeev Hegde,9 S Anuradha,10 Siddabathuni Nageswaramma,11 Surabhi Madan,12 Thammisetty Jayaprakash,13 Vinay Kulkarni14 1Department of Infectious Diseases and Clinical Research, Poona Hospital and Research Centre, Pune, Maharashtra, India; 2Department of Medicine, KLE’s Dr Prabhakar Kore Hospital and MRC, Belagavi, Karnataka, India; 3Department of General Medicine, People Tree Hospital 2, Bangalore, Karnataka, India; 4Department of Medicine, Kasturba Medical College Hospital, Mangalore, Karnataka, India; 5Department of Medicine, Kanoria Hospital and Research Centre, Gandhinagar, Gujarat, India; 6Department of General Medicine, Rajiv Gandhi Institute of Medical Sciences and RIMS Government General Hospital, Srikakulam, Andhra Pradesh, India; 7Department of Medicine, Lata Mangeshkar Multi Specialty Hospital, Nagpur, Maharashtra, India; 8Department of Medicine, Sahyadri Super Specialty Hospital, Pune, Maharashtra, India; 9Department of Global Clinical Operations, Viatris, Bengaluru, Karnataka, India; 10Department of Medicine, Maulana Azad Medical College and Associated Lok Nayak, New Delhi, India; 11Department of Dermatology, Guntur Government General Hospital, Guntur, Andhra Pradesh, India; 12Department of Clinical Research, Care Institute of Medical Sciences (CIMS) Hospital, Ahmedabad, Gujarat, India; 13Department of Pulmonology, Anu Hospitals, Vijayawada, Andhra Pradesh, India; 14Department of Dermatology, LMMF’s Deenanath Mangeshkar Hospital and Research Center, Pune, Maharashtra, IndiaCorrespondence: Sanjeev Hegde, Department of Global Clinical Operations, Viatris, Bengaluru, Karnataka, India, Tel +91-80-66728587, Email sanjeev.hegde@viatris.comPurpose: WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence

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

Kerry L Hancock,1 Sinthia Bosnic-Anticevich,2– 4 John D Blakey,5,6 Mark Hew,7,8 Li Ping Chung,9 Biljana Cvetkovski,3 Scott Claxton,10 Peter Del Fante,11 Eve Denton,7,8 Joe Doan,12 Kanchanamala Ranasinghe,13,14 Lucy Morgan,15– 17 Anita Sharma,18 Peter K Smith,19 Deb Stewart,20 Philip J Thompson,21– 23 Russell Wiseman,24 John W Upham,25 Kwok Y Yan,26 Victoria Carter,27 Kiranjeet Dhillon,28 Florian Heraud,28 Thao Le,27 Rebecca Vella,28 David Price27– 30 On behalf of the OPCA Improving Asthma outcomes in Australia Research Group1Chandlers Hill Surgery, Happy Valley, SA, 5159, Australia; 2Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia; 3Woolcock Institute of Medical Research, Glebe, MSW, 2037, Australia; 4Sydney Local Health District, Camperdown, NSW, 2050, Australia; 5Respiratory Medicine, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6009, Australia; 6Curtin University Medical School, Bentley, Western Australia, 6102, Australia; 7Allergy, Asthma & Clinical Immunology, Alfred Health, Melbourne, VIC, 3004, Australia; 8Public Health and Preventive Medicine, Monash University, Victoria, 3800, Australia; 9Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch, WA, 6150, Australia; 10Genesis Care Sleep and Respiratory, Joondalup, WA, 6027, Australia; 11Hutt Street General Practice, Adelaide, SA, 5000, Australia; 12HealthPlus Medical Centre, Kogarah, NSW, 2217, Australia; 13School of Medicine, Griffith University, Nathan, QLD, Australia; 14Cannon Hill Family Doctors, Cannon Hill, QLD, 4170, Australia; 15Sydney Medical School, University of Sydney, Sydney, NSW, Australia; 16Department of Thoracic Medicine, Concord Hospital, Sydney, NSW, Australia; 17Australian School of Advanced Medicine, Macquarie University, Sydney, NSW, Australia; 18Platinum Medical Centre, Chermside, QLD, 4032, Australia; 19Griffith University, Southport, QLD, Australia; 20Adjunct Lecturer, School of Medicine, University

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 act

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 r

Chester Fox,1,2 Wilson Pace,1,3 Elias Brandt,1 Victoria Carter,4,5 Ku-Lang Chang,6 Chelsea Edwards,7 Alexander Evans,4 Gabriela Gaona,1 MeiLan K Han,8 Alan Kaplan,5,9,10 Rachel Kent,1 Janwillem WH Kocks,5,11– 13 Maja Kruszyk,5,7 Le Lievre Chantal,5,7 Tessa LiVoti,4,5 Cathy Mahle,14 Barry Make,15 Amanda Ratigan,1 Asif Shaikh,14 Neil Skolnik,16,17 Brooklyn Stanley,4 Barbara P Yawn,17 David B Price4,5,18 1DARTNet Institute, Aurora, CO, USA; 2University at Buffalo, Buffalo, NY, USA; 3University of Colorado, Denver, CO, USA; 4Optimum Patient Care, Cambridge, UK; 5Observational and Pragmatic Research Institute, Singapore; 6University of Florida College of Medicine, Gainesville, FL, USA; 7Optimum Patient Care, Brisbane, Queensland, Australia; 8University of Michigan, Ann Arbor, MI, USA; 9Family Physician Airways Group of Canada, Stouffville, Ontario, Canada; 10University of Toronto, Toronto, Canada; 11General Practitioners Research Institute, Groningen, the Netherlands; 12Groningen Research Institute Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 13Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 14Boehringer Ingelheim, Ridgefield, CT, USA; 15Department of Medicine, NJH, Denver, CO, USA; 16Abington Jefferson Health, Jenkintown, PA, USA; 17University of Minnesota, Minneapolis, MN, USA; 18Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence: David B Price, Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK, Tel +65 3105 1489, Email dprice@opri.sgIntroduction: Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to des

Clare MacRae,1,&ast; Hannah Whittaker,2,&ast; Mome Mukherjee,1 Luke Daines,1 Ann Morgan,2 Chukwuma Iwundu,2 Mohammed Alsallakh,3 Eleftheria Vasileiou,1 Eimear O’Rourke,2 Alexander T Williams,4 Philip W Stone,2 Aziz Sheikh,1 Jennifer K Quint2 1Usher Institute, University of Edinburgh, Edinburgh, UK; 2National Heart and Lung Institute, Imperial College London, London, UK; 3Swansea University Medical School, Swansea, UK; 4Department of Health Sciences, University of Leicester, Leicester, UK&ast;These authors contributed equally to this workCorrespondence: Jennifer K Quint, National Heart and Lung Institute, Imperial College London, G48, Emmanuel Kaye Building, Manresa Road, London, SW3 6LR, UK, Tel +44 207 594 8821, Email j.quint@Imperial.ac.ukBackground: Electronic health record (EHR) databases provide rich, longitudinal data on interactions with healthcare providers and can be used to advance research into respiratory conditions. However, since these data are primarily collected to support health care delivery, clinical coding can be inconsistent, resulting in inherent challenges in using these data for research purposes.Methods: We systematically searched existing international literature and UK code repositories to find respiratory disease codelists for asthma from January 2018, and chronic obstructive pulmonary disease and respiratory tract infections from January 2020, based on prior searches. Medline searches using key terms provided in article lists. Full-text articles, supplementary files, and reference lists were examined for codelists, and codelists repositories were searched. A reproducible methodology for codelists creation was developed with recommended lists for each disease created based on multidisciplinary expert opinion and previously published literature.Results: Medline searches returned 1126 asthma articles, 70 COPD articles, and 90 respiratory infection articles, with 3%, 22% and 5% including codelists, respectively. Repository sear

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

Bewunetu Zewude,1 Tewodros Habtegiorgis,1 Ashenafi Hizkeal,1 Tamirat Dela,2 Getahun Siraw3 1Department of Sociology, College of Social Sciences and Humanities, Wolaita Sodo University, Wolaita Sodo town, Ethiopia; 2Department of Civics and Ethical Studies, College of Social Sciences and Humanities, Wolaita Sodo University, Wolaita Sodo town, Ethiopia; 3Department of Sociology, College of Social Sciences and Humanities, Dilla University, Dilla town, EthiopiaCorrespondence: Bewunetu Zewude Email bewunetuzewude@gmail.comBackground: We examined the perceptions of healthcare workers about the side-effects of COVID-19 vaccine and the types of side-effects they experienced in the post-vaccination period.Methods: An institutional-based cross-sectional survey research design was used in which a semi-structured questionnaire was distributed to collect quantitative data from healthcare workers in Southern Ethiopia that were selected on the basis of a multi-stage cluster sampling technique. After inserting the completed cases into SPSS software, descriptive statistical techniques, such as frequencies, percentages, charts and inferential statistical tool, particularly binary logistic regression analysis, were used to analyze and present the data.Results: Majority (43.6%) of respondents perceive that COVID-19 vaccine will have muscle pain around the injection site, followed by fever (39.9%), problems of blood clots (37.8%), headache (35.6%), fatigue (33.5%), and aching limbs (16%). And 63.6%) of them reported that they have experienced muscle pain around the injection site after receiving the COVID-19 vaccine, followed by fatigue (42%), headache (37.2%), fever (34.2%), redness around the injection site (21.6%), and swelling around the injection site (17.8%). Moreover, 25% reported that the fear of potential side-effects of COVID-19 vaccine inhibited them from taking the vaccine. Above all, it is found that respondents’ expectation of COVID-19 vaccine to have such serious side-e

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

Xiaoxue Chen,1 Zhi Wang,1 Samantha G Bromfield,1 Andrea DeVries,1 David Pryor,2 Vincent Willey3 1Anthem Translational Research, HealthCore Inc., Wilmington, DE, USA; 2Clinical Strategy and Innovation, Anthem, Inc., Indianapolis, IN, USA; 3Scientific Affairs, HealthCore Inc., Wilmington, DE, USACorrespondence: Xiaoxue ChenHealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, 19801, USATel +1 302-230-2090Fax +1 302-230-2020Email xchen@healthcore.com The novel severe acute respiratory syndrome coronavirus 2, the virus that causes coronavirus disease 2019 (COVID–19), continues to spread in the US through the 2020–2021 influenza season and beyond.  Approaches to identify those most at risk for poor outcomes for the two viral infections are needed for future planning. As influenza is a well-known respiratory disease sharing some similarities to COVID-19, such comparison will aid physicians and health systems to predict disease trajectory and allocate health resources most efficiently.   &nbsp

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 treatme