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1. Surface-Enhanced Raman Spectroscopy of Fluid-Supported Lipid Bilayers

Author

Bruce E. Brinson, William Lum, Emilie Ringe, Zohre Gorunmez, Laura B. Sagle, and Ian Bruzas

Subjects
Materials science, Bilayer, Substrate (chemistry), Nanotechnology, Biological membrane, 02 engineering and technology, Surface-enhanced Raman spectroscopy, 010402 general chemistry, 021001 nanoscience & nanotechnology, 01 natural sciences, 0104 chemical sciences, symbols.namesake, Membrane, Ellipsometry, symbols, General Materials Science, 0210 nano-technology, Lipid bilayer, Raman spectroscopy
Abstract

Supported lipid bilayers are essential model systems for studying biological membranes and for membrane-based sensor development. Surface-enhanced Raman spectroscopy (SERS) stands to add considerably to our understanding of the dynamics and interactions of these systems through direct chemical information. Despite this potential, SERS of lipid bilayers is not routinely achieved. Here, we carried out the first measurements of a solid-supported lipid bilayer on a SERS-active substrate and characterized the bilayer using SERS, atomic force microscopy, surface plasmon resonance spectroscopy, ellipsometry, and fluorescence recovery after photobleaching (FRAP). The creation of a fluid, SERS-active supported lipid bilayer was accomplished through use of a novel silica-coated silver film-over-nanosphere substrate. These substrates offer a powerful new platform to couple common surface techniques that are challenging on the nanoscale, for example, ellipsometry and FRAP, with SERS for studying biological membranes and their dynamics.

Published
2019
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2. Effectiveness of a nurse-led management intervention on systolic blood pressure among type 2 diabetes patients in Uganda: a cluster randomized trial

Author

William Lumu, Silver Bahendeka, Davis Kibirige, Ronald Wesonga, and Ronald Kasoma Mutebi

Subjects
Cluster randomized trial, Nurse-led management intervention, Type 2 diabetes, Pooled cohort risk equations, Atherosclerotic cardiovascular risk, Systolic blood pressure, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Abstract Background Hypertension (HT) is an orchestrator of atherosclerotic cardiovascular disease (ASCVD) in people living with type 2 diabetes (T2D). Control of systolic blood pressure (SBP) and HT as a whole is suboptimal in diabetes, partly due to the scarcity of doctors. While nurse-led interventions are pragmatic and cost-effective in the control of HT in primary health care, their effectiveness on SBP control among patients with T2D in Uganda is scantly known. Aim We evaluated the effectiveness of a nurse-led management intervention on SBP among T2D patients with a high ASCVD risk in Uganda. Methods A two-armed cluster randomized controlled trial compared the nurse-led management intervention with usual doctor-led care. The intervention involved training nurses to provide structured health education, protocol-based HT/CVD management, 24-h phone calls, and 2-monthly text messages for 6 months. The primary outcome was the mean difference in SBP change among patients with T2D with a high ASCVD risk in the intervention and control groups after 6 months. The secondary outcome was the absolute difference in the number of patients at target for SBP, total cholesterol (TC), fasting blood glucose (FBG), glycated hemoglobin (HbA1C), low-density lipoprotein (LDL), triglycerides (TG), and body mass index (BMI) after the intervention. The study was analyzed according to the intention-to-treat principle. Generalized estimating equations were used to assess intra-cluster effect modifiers. Statistical significance was set at 0.05 for all analyses. Results Eight clinics (n = 388 patients) were included (intervention 4 clinics; n = 192; control 4 clinics; n = 196). A nurse-led intervention reduced SBP by -11.21 ± 16.02 mmHg with a mean difference between the groups of -13.75 mmHg (95% CI -16.48 to -11.02, p

Published
2024
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3. Single molecule protein patterning using hole mask colloidal lithography

Author

Dinesh Gautam, William Lum, Jixin Chen, and Laura B. Sagle

Subjects
Streptavidin, Materials science, Surface Properties, Nanotechnology, Biosensing Techniques, 02 engineering and technology, Protein patterning, Microscopy, Atomic Force, 010402 general chemistry, 01 natural sciences, Article, Colloid, chemistry.chemical_compound, Lab-On-A-Chip Devices, Microscopy, Fluorescence microscope, Molecule, General Materials Science, Colloids, Colloidal lithography, 021001 nanoscience & nanotechnology, 0104 chemical sciences, chemistry, 0210 nano-technology, Biosensor
Abstract

The ability to manipulate single protein molecules on a surface is useful for interfacing biology with many types of devices in optics, catalysis, bioengineering, and biosensing. Control of distance, orientation, and activity at the single molecule level will allow for the production of on-chip devices with increased biological activity. Cost effective methodologies for single molecule protein patterning with tunable pattern density and scalable coverage area remain a challenge. Herein, Hole Mask Colloidal Lithography is presented as a bench-top colloidal lithography technique that enables a glass coverslip to be patterned with functional streptavidin protein onto patches from 15-200 nm in diameter with variable pitch. Atomic force microscopy (AFM) was used to characterize the size of the patterned features on the glass surface. Additionally, single-molecule fluorescence microscopy was used to demonstrate the tunable pattern density, measure binding controls, and confirm patterned single molecules of functional streptavidin.

Published
2019
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4. Ethnic differences in the manifestation of early-onset type 2 diabetes

Author

Liam Smeeth, Moffat J Nyirenda, Andrew T Hattersley, Angus G Jones, Jean-Claude Katte, Isaac Sekitoleko, Davis Kibirige, Anita V Hill, William Lumu, Julieanne Knupp, and Steven Squires

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Introduction We undertook phenotypic characterization of early-onset and late-onset type 2 diabetes (T2D) in adult black African and white European populations with recently diagnosed T2D to explore ethnic differences in the manifestation of early-onset T2D.Research design and methods Using the Uganda Diabetes Phenotype study cohort of 500 adult Ugandans and the UK StartRight study cohort of 714 white Europeans with recently diagnosed islet autoantibody-negative T2D, we compared the phenotypic characteristics of participants with early-onset T2D (diagnosed at

Published
2024
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5. Patient outcomes associated with subcutaneous C1INH prophylaxis for hereditary angioedema: a retrospective analysis

Author

William Lumry, Timothy Craig, John Anderson, Marc Riedl, Henry Li, Raffi Tachdjian, Michael Manning, Paolo Bajcic, Frank Rodino, Sam Wang, Thomas R. Sexton, and Jonathan A. Bernstein

Subjects
C1-inhibitor, Hereditary angioedema, Prophylaxis, Qualitative research, Quality of life, Real-world, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background Real-world data on subcutaneous C1INH (C1INH[SC]) usage and patient-level impacts on hereditary angioedema (HAE)-related outcomes and quality of life (QoL) are both lacking and challenging to generate using conventional study methodologies. Using a hybrid study design involving patient interviews supplemented by retrospective medical chart data review, we conducted a real-world assessment of the impact of C1INH(SC) prophylaxis on HAE attack patterns, QoL, and on-demand medication use. Methods The study was conducted at seven US sites and included 36 adults with HAE who had been treated with C1INH(SC) long-term prophylaxis following ≥ 12 months of on-demand management only. Patients underwent 30-min interviews, facilitated and analyzed by a trained qualitative research specialist. Medical records were reviewed for 12 months before (pre-index) and after (post-index) initiation of C1INH(SC). Using interview data with descriptive terms converted to numerical values, we compared pre- versus post-index attack frequency, severity, and rescue medication usage. Results Mean (SD) annualized attack frequency per patient decreased 82.0%, from 38.8 (38.8) attacks/year pre-index to 7.0 (15.3) attacks/year (P

Published
2023
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6. Advances in surface-enhanced Raman spectroscopy (SERS) substrates for lipid and protein characterization: sensing and beyond

Author

Ian Bruzas, William Lum, Laura B. Sagle, and Zohre Gorunmez

Subjects
Lipid Bilayers, Nanotechnology, 02 engineering and technology, Spectrum Analysis, Raman, 010402 general chemistry, 01 natural sciences, Biochemistry, Analytical Chemistry, symbols.namesake, Electrochemistry, Environmental Chemistry, Lipid bilayer, Spectroscopy, chemistry.chemical_classification, Biomolecule, technology, industry, and agriculture, Proteins, Surface-enhanced Raman spectroscopy, 021001 nanoscience & nanotechnology, Small molecule, 0104 chemical sciences, Characterization (materials science), Membrane, chemistry, symbols, 0210 nano-technology, Raman spectroscopy, Macromolecule
Abstract

Surface-enhanced Raman spectroscopy (SERS) has become an essential ultrasensitive analytical tool for biomolecular analysis of small molecules, macromolecular proteins, and even cells. SERS enables label-free, direct detection of molecules through their intrinsic Raman fingerprint. In particular, protein and lipid bilayers are dynamic three-dimensional structures that necessitate label-free methods of characterization. Beyond direct detection and quantitation, the structural information contained in SERS spectra also enables deeper biophysical characterization of biomolecules near metallic surfaces. Therefore, SERS offers enormous potential for such systems, although making measurements in a nonperturbative manner that captures the full range of interactions and activity remains a challenge. Many of these challenges have been overcome through advances in SERS substrate development, which have expanded the applications and targets of SERS for direct biomolecular quantitation and biophysical characterization. In this review, we will first discuss different categories of SERS substrates including solution-phase, solid-supported, tip-enhanced Raman spectroscopy (TERS), and single-molecule substrates for biomolecular analysis. We then discuss detection of protein and biological lipid membranes. Lastly, biophysical insights into proteins, lipids and live cells gained through SERS measurements of these systems are reviewed.

Published
2018
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7. Novel Liposome-Based Surface-Enhanced Raman Spectroscopy (SERS) Substrate

Author

Laura B. Sagle, William Lum, Ian Bruzas, Zohre Gorunmez, Sarah Unser, and Thomas L. Beck

Subjects
Liposome, Materials science, Aqueous solution, Nanotechnology, 02 engineering and technology, Surface-enhanced Raman spectroscopy, 010402 general chemistry, 021001 nanoscience & nanotechnology, 01 natural sciences, 0104 chemical sciences, Metal, Gold Colloid, chemistry.chemical_compound, symbols.namesake, chemistry, visual_art, visual_art.visual_art_medium, symbols, Molecule, General Materials Science, Crystal violet, Physical and Theoretical Chemistry, 0210 nano-technology, Raman spectroscopy
Abstract

Although great strides have been made in recent years toward making highly enhancing surface-enhanced Raman spectroscopy (SERS) substrates, the biological compatibility of such substrates remains a crucial problem. To address this issue, liposome-based SERS substrates have been constructed in which the biological probe molecule is encapsulated inside the aqueous liposome compartment, and metallic elements are assembled using the liposome as a scaffold. Therefore, the probe molecule is not in contact with the metallic surfaces. Herein we report our initial characterization of these novel nanoparticle-on-mirror substrates, both experimentally and theoretically, using finite-difference time-domain calculations. The substrates are shown to be structurally stable to laser irradiation, the liposome compartment does not rise above 45 °C, and they exhibit an analytical enhancement factor of 8 × 106 for crystal violet encapsulated in 38 liposomes sandwiched between a 40 nm planar gold mirror and 80 nm gold colloid.

Published
2017
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8. Type 2 diabetes progression in an adult Ugandan population with new-onset diabetes: an observational prospective study

Author

Davis Kibirige, Isaac Sekitoleko, William Lumu, and Moffat J. Nyirenda

Subjects
Adult patients, New-onset type 2 diabetes, Short-term diabetes progression, Sub-Saharan Africa, Uganda, Medicine (General), R5-920
Abstract

Abstract Background The rate of progression of type 2 diabetes following diagnosis varies across individuals and populations. Studies investigating the progression of type 2 diabetes in adult African populations with newly diagnosed diabetes are limited. We aimed to investigate the prevalence and predictors of short-term (one year) diabetes progression in an adult Ugandan population with new-onset type 2 diabetes (type 2 diabetes diagnosed in

Published
2023
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9. Burden and predictors of diabetic kidney disease in an adult Ugandan population with new-onset diabetes

Author

Davis Kibirige, Isaac Sekitoleko, and William Lumu

Subjects
Diabetic kidney disease, Adult patients, New-onset diabetes, Uganda, Sub-saharan Africa, Medicine, Biology (General), QH301-705.5, Science (General), Q1-390
Abstract

Abstract Background Despite the growing evidence of diabetic kidney disease (DKD) in adult patients with long-standing diabetes in sub-Saharan Africa, data on its burden and correlates in adult African patients with new-onset diabetes are limited. We, therefore, undertook this study to determine the burden and predictors of DKD in an adult population with new-onset diabetes in Uganda. Methods We collected data on the relevant sociodemographic, clinical, anthropometric, and metabolic characteristics in 519 participants with newly diagnosed diabetes recruited from seven tertiary hospitals. A spot mid-stream urine sample was collected for determination of the urine albumin creatinine ratio (UACR) using Clinitek® microalbumin strips and a point-of-care Clinitek® status analyser. The estimated glomerular filtration rate (e-GFR) was determined using the Chronic Kidney Disease Epidemiology formula. The presence of DKD was defined as a spot UACR ≥ 3 mg/mmol with or without an e-GFR

Published
2023
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10. Phenotypic characterization of nonautoimmune diabetes in adult Ugandans with low body mass index

Author

Davis Kibirige, Isaac Sekitoleko, William Lumu, Nihal Thomas, Meredith Hawkins, Angus G. Jones, Andrew T. Hattersley, Liam Smeeth, and Moffat J. Nyirenda

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Background: Type 2 diabetes is common in relatively lean individuals in sub-Saharan Africa. It is unclear whether phenotypic differences exist between underweight and normal-weight African patients with type 2 diabetes. This study compared specific characteristics between underweight (body mass index

Published
2024
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11. HIV infection in adult Ugandans with new-onset type 2 diabetes: exploring its influence on the anthropometric and metabolic profile

Author

Davis Kibirige, Isaac Sekitoleko, Noela Owarwo, Irene Andia-Biraro, and William Lumu

Subjects
Anthropometric characteristics, HIV infection, Insulin resistance, Metabolic profile, Pancreatic beta-cell function, Sub-Saharan Africa, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Objective HIV infection increases the risk of type 2 diabetes and may influence its phenotypic profile. In this study, we aimed to compare the anthropometric and metabolic characteristics of HIV-infected and uninfected adult Ugandans with new-onset type 2 diabetes to evaluate the influence of HIV infection on specific surrogate markers of adiposity, insulin resistance, and pancreatic beta-cell function. Methods We consecutively recruited 500 HIV-infected and uninfected adult Ugandans with new-onset type 2 diabetes (diagnosed in

Published
2023
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12. Patterned Plasmonic Nanoparticle Arrays for Microfluidic and Multiplexed Biological Assays

Author

William Lum, Jie He, Michelle Boegli, Ian Bruzas, and Laura B. Sagle

Subjects
Medical diagnostic, Fabrication, Surface Properties, Chemistry, Microfluidics, Nanoparticle, Nanotechnology, Microfluidic Analytical Techniques, Surface Plasmon Resonance, Multiplexing, Analytical Chemistry, law.invention, law, Nanoparticles, Biological Assay, Particle Size, Photolithography, Surface plasmon resonance, Plasmon
Abstract

For applications ranging from medical diagnostics and drug screening to chemical and biological warfare detection, inexpensive, rapid-readout, portable devices are required. Localized surface plasmon resonance (LSPR) technologies show substantial promise toward meeting these goals, but the generation of portable, multiplexed and/or microfluidic devices incorporating sensitive nanoparticle arrays is only in its infancy. Herein, we have combined photolithography with Hole Mask Colloidal lithography to pattern uniform nanoparticle arrays for both microfluidic and multiplexed devices. The first proof-of-concept study is carried out with 5- and 7-channel microfluidic devices to acquire one-shot binding curves and protein binding kinetic data. The second proof-of-concept study involved the fabrication of a 96-spot plate that can be inserted into a standard plate reader for the multiplexed detection of protein binding. This versatile fabrication technique should prove useful in next generation chips for bioassays and genetic screening.

Published
2015
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13. Theory of SERS enhancement: General discussion

Author

Alex Keeler, Nicolò Bontempi, Rohit Chikkaraddy, Sumeet Mahajan, Agata Królikowska, Paul Dawson, Leonora Velleman, Volker Deckert, Mike Hardy, Heike Arnolds, Jean-Francois Masson, Marc D. Porter, Ben Hourahine, Fabrizio Giorgis, Natalia Martín Sabanés, Steven E. J. Bell, Giuliana Di Martino, Juan C. Otero, John R. Lombardi, Duncan Graham, Cristiano Matricardi, William Lum, Sebastian Schlücker, Pieter Wuytens, Christian Kuttner, Bart de Nijs, Javier Aizpurua, Richard P. Van Duyne, Marlous Kamp, Jeremy J. Baumberg, George C. Schatz, Stephanie Reich, Dong-Ho Kim, Yikai Xu, Augustus W. Fountain, Ines Delfino, Sylwester Gawinkowski, Ian Bruzas, Roy Goodacre, Alessandro Silvestri, Michael J. Natan, and Claudia Fasolato

Subjects
Materials science, 010401 analytical chemistry, ComputingMethodologies_IMAGEPROCESSINGANDCOMPUTERVISION, Halide, Charge (physics), 02 engineering and technology, 021001 nanoscience & nanotechnology, 01 natural sciences, 0104 chemical sciences, Metal, symbols.namesake, Chemical physics, Molecular vibration, visual_art, visual_art.visual_art_medium, symbols, Molecule, Settore CHIM/01 - Chimica Analitica, sense organs, Physics::Chemical Physics, Physical and Theoretical Chemistry, skin and connective tissue diseases, 0210 nano-technology, Raman spectroscopy
Abstract

The first page of this article is displayed as the abstract., Rohit Chikkaraddy opened the discussion of the Introductory Lecture: Regarding quantifying the chemical enhancement, you showed a systematic change in the SERS enhancement for halide substituted molecules due to charge transfer from the metal. Is the extra enhancement due to an inherent increase in the Raman cross-section of the molecule? How do you go about referencing, as the charge transfer changes the vibrational frequency? Richard Van Duyne answered: The extra enhancement is not due to an increase in the Raman cross section, as that is ratioed out in the calculation of the enhancement factor. The charge transfer (CT) process does not transfer a complete electron, it is a fractional degree of CT. Thus the change in vibrational frequency is small. DFT calculations that provide eigenvectors allow one to reference the vibrational modes of the free molecule with those of the adsorbed molecule. Sylwester Gawinkowski asked: You have shown that the enhancement factor curve is redshifted relative to the plasmon resonance band and has a maximum at about 800 nm. This means that the SERS signal should be strongest for excitations in the near infrared spectral region. Why do most SERS reports, particularly related to single molecule SERS, have the excitation in the green or red spectral range and not in the near infrared?

Published
2017

14. Tunable Au-Ag nanobowl arrays for size-selective plasmonic biosensing

Author

Jendai Robinson, Laura B. Sagle, Ian Bruzas, Debrina Jana, Emily Lehnhoff, and William Lum

Subjects
Fabrication, Materials science, Silver, Nanoparticle, Metal Nanoparticles, Nanotechnology, 02 engineering and technology, Biosensing Techniques, 010402 general chemistry, Spectrum Analysis, Raman, 01 natural sciences, Biochemistry, Analytical Chemistry, Electrochemistry, Environmental Chemistry, Surface plasmon resonance, Spectroscopy, Plasmon, Surface-enhanced Raman spectroscopy, Surface Plasmon Resonance, 021001 nanoscience & nanotechnology, 0104 chemical sciences, Gold, Size selective, 0210 nano-technology, Selectivity, Biosensor
Abstract

Selectivity is often a major obstacle for localized surface plasmon resonance-based biosensing in complex biological solutions. An additional degree of selectivity can be achieved through the incorporation of shape complementarity on the nanoparticle surface. Here, we report the versatile fabrication of substrate-bound Au-Ag nanobowl arrays through the galvanic ion replacement of silver nanodisk arrays. Both localized surface plasmon resonance (LSPR) and surface enhanced Raman spectroscopy (SERS) were carried out to detect the binding of analytes of varying size to the nanobowl arrays. Large increases in the LSPR and SERS response were measured for analytes that were small enough to enter the nanobowls, compared to those too large to come into contact with the interior of the nanobowls. This size-selective sensing should prove useful in both size determination and differentiation of large analytes in biological solutions, such as viruses, fungi, and bacterial cells.

Published
2016

15. Clinical, metabolic, and immunological characterisation of adult Ugandan patients with new-onset diabetes and low vitamin D status

Author

Davis Kibirige, Isaac Sekitoleko, Priscilla Balungi, Jacqueline Kyosiimire-Lugemwa, and William Lumu

Subjects
Vitamin D deficiency, Vitamin D insufficiency, Newly diagnosed diabetes, African population, Uganda, Sub-Saharan Africa, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Abstract Background Low vitamin D concentrations are associated with metabolic derangements, notably insulin resistance and pancreatic beta-cell dysfunction in Caucasian populations. Studies on its association with the clinical, metabolic, and immunologic characteristics in black African adult populations with new-onset diabetes are limited. This study aimed to describe the clinical, metabolic, and immunologic characteristics of a black Ugandan adult population with recently diagnosed diabetes and hypovitaminosis D. Methods Serum vitamin D concentrations were measured in 327 participants with recently diagnosed diabetes. Vitamin D deficiency, vitamin D insufficiency, and normal vitamin D status were defined as serum 25 hydroxyvitamin D levels of

Published
2022
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16. Considerations in the management of hereditary angioedema due to C1-INH deficiency in women of childbearing age

Author

Florence Ida Hsu, William Lumry, Marc Riedl, and Raffi Tachdjian

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Hereditary angioedema (HAE) is a rare, autosomal disorder that manifests with unpredictable episodes of severe swelling of the skin and mucous membranes. These attacks can be highly disfiguring and range in severity from mild to—in cases of airway swelling—life-threatening. Fluctuations in female sex hormones—such as the changes that occur during puberty, menses, contraceptive use, pregnancy, and menopause—can all affect the frequency and severity of HAE attacks. Disease management decisions for women of childbearing age may be more complex and require additional considerations since they could develop complications related to contraception, pregnancy, labor, delivery, and lactation. In addition, some HAE treatment options are contraindicated during pregnancy. Discussions about medications used to treat HAE should include a risk–benefit assessment of the woman’s health status, her preferences, and other factors that are relevant to the choice of therapy. Planning prophylactic therapies that are effective and safe before, during, and after pregnancy can prevent gaps in treatment, ensure continuity of care, and reduce both disease burden and risk of adverse fetal outcomes. The 2020 US Hereditary Angioedema Association (HAEA) Medical Advisory Board and 2021 World Allergy Organization/European Academy of Allergy and Immunology (WAO/EAACI) Guidelines outline key considerations for managing HAE in females of childbearing age (15–45 years), with the goal of improving treatment efficacy and safety for this cohort of patients. Treatment decisions made in a collaborative manner involving the patient, HAE specialist and obstetric/gynecologic specialist, is the best approach to ensure optimal HAE management and safety in this patient population.

Published
2022
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17. Letting the patients speak: an in-depth, qualitative research-based investigation of factors relevant to health-related quality of life in real-world patients with hereditary angioedema using subcutaneous C1 inhibitor replacement therapy

Author

John Anderson, Donald S. Levy, William Lumry, Patricia Koochaki, Sally Lanar, and H. Henry Li

Subjects
Subcutaneous C1-inhibitor, Hereditary angioedema, Health-related quality of life, Productivity, HAEGARDA, Qualitative research, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background While many studies of effective hereditary angioedema (HAE) therapy have demonstrated improved health-related quality of life (HRQoL) using validated instruments, specific reasons behind the improved scores have never been investigated using qualitative methods. A non-interventional, qualitative research study was designed to investigate the reasons for improvements in HRQoL while using effective prophylaxis, in this case subcutaneous C1INH (C1INH[SC]) replacement therapy. Methods Adult patients with HAE-C1INH type 1 or 2 who had been using C1INH(SC) for ≥ 3 consecutive months were recruited through four HAE specialty practices in the US to participate in a 60-min phone interview performed by a trained qualitative research specialist (ICON plc) using a semi-structured interview guide with open-ended questions developed with the Angioedema Quality of Life (AE-QoL) items in mind. Interview transcripts were analyzed using thematic analysis methods to identify concepts (specific symptoms/impacts) and themes (higher-level categories grouping related concepts). A cross-mapping exercise was performed between interview-identified concepts and items included in the AE-QoL. Results Fourteen patients were interviewed and included in the analysis (age range, 28–82 years [mean 47.5 years]; 64% female; 93% white). In 10 interviews, patients mentioned having no or nearly no HAE attacks, no longer feeling limited by HAE, less HAE-related anxiety/worry and depression, an improved ability to travel, fewer emergency room/hospital visits, and ease of administration of C1INH(SC), including not requiring assistance from others. Other commonly expressed concepts included: increased feelings of confidence, independence, optimism, and normalcy; less absence from work/school; better productivity; improved sleep and energy; healthier family relationships; and improved cognition. While all AE-QoL items emerged from patient interviews, a number of identified concepts were not addressed by the AE-QoL, including sensitivity to various potential attack-triggers (e.g., stress/anxiety, sports), attack frequency, not having to cancel social plans, improvements in ability to perform day-to-day tasks, and a lower burden from medical visits. Conclusions From these interviews, a large number of common themes and concepts emerged: a greater sense of freedom and normalcy, increased productivity, and improved interpersonal relationships while using convenient and effective prophylaxis. These findings provide insights into real-world experiences and the many facets of HRQoL that are important to patients with HAE-C1INH.

Published
2021
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18. Association of body mass index with outcomes in patients with newly diagnosed atrial fibrillation: GARFIELD-AF

Author

Daniela Poli, Sophie Testa, Corrado Lodigiani, Toon Wei Lim, Kevin Jones, Kangning Chen, Hui Li, Hilary Pinnock, Grzegorz Bilo, Hack-Lyoung Kim, Andrew Murray, Bernard J Gersh, Kurt Huber, Robin Fox, Sarah Davies, James Rogers, Morten Schou, Xin Li, Vira Tseluyko, Sergey Popov, Rajeev Gupta, Grzegorz Opolski, Preeti Pandya, Bronte Ayres, Milan Gupta, Peter Hutchinson, Phil Simmons, Andrew Gallagher, Michel Galinier, Franck Paganelli, Jens Kilian, Adam Blenkhorn, Mohamed Ibrahim, Fernando Lanas, Karen Pieper, Eivind Berge, M Clark, Agneta Andersson, Karim Ladha, Bijoy Sinha, Torstein Hole, Dan Atar, Hywel Jones, R Smith, Andrew Ross, Emmanuel Ellie, Paul Evans, Yong Wang, Hiroshi Ono, Tadashi Nakamura, Paul MacDonald, Stephen Rogers, Igor Sibon, Simon Dobson, David Fitzmaurice, Jiyan Chen, Neil Roberts, Pierre Amarenco, Nigel Hart, Giancarlo Agnelli, Georges Mairesse, Pekka Raatikainen, Oleg Sychov, Yasuyuki Suzuki, Bo Liu, Mathieu Zuber, John French, Yuejin Yang, Myeong-Chan Cho, Julian Thompson, Michael Stokes, John W Eikelboom, Mark Richardson, John Matthews, Will Murdoch, Jean-Philippe Neau, Freek Verheugt, Ajay K Kakkar, Giuseppe Ambrosio, Marcin Gruchała, Keith A A Fox, Sunil Kumar, Ruiping Zhao, Patrick Carroll, Masanori Kaneko, Thanh Phan, Ping Yang, Sung-Won Jang, Claire Jones, Mårten Rosenqvist, Johan Engdahl, Debabrata Roy, John Cairns, Ping Chen, Michael Olsen, Paul Angaran, David Russell, Helena Dominguez, Béla Merkely, Joseph Berlingieri, James Bennett, Hugo ten Cate, Hiroshi Yamaguchi, Masahiro Minamoto, Hiroyuki Oda, Toshihiko Shiraiwa, Jonathan Webster, Yukihiro Koretsune, Kotaro Obunai, R Thompson, Yong Seog Oh, Giuliana Guazzaloca, Giuliana Martini, Marc Bonnefoy, Michael Cox, András Nagy, Kazuki Sato, Richard Davies, Daisuke Ikeda, Susumu Suzuki, Hiroki Teragawa, Koji Matsushita, Ying Guo, Catherine Neden, Mark Pugsley, Simon Cartwright, Polly Jacobs, Xiaoshu Cheng, Daniel Nishijima, Sylvia Haas, Vinay Kumar, Saverio Virdone, Jean-Pierre Bassand, Samuel Z Goldhaber, Shinya Goto, Frank Misselwitz, Alexander G G Turpie, Alison Macleod, Karen Forshaw, Mark Boon, Stephen Miller, Simon Wetherell, Moustafa Moustafa, Gaetano Serviddio, Renato Lopes, Kazuo Takei, Hiroaki Nishioka, Mykola Stanislavchuk, C Ramesh, R Kamath, Stuart J Connolly, Nooshin Bazargani, Kevin Douglas, Werner Hacke, Gloria Kayani, Ali Oto, Hiroshi Watanabe, Walter Hermans, Kazuya Murata, Christian Fielder Camm, Marco Moia, Niraj Sharma, Jaeyoung Kim, Walter Abhayaratna, Andriy Yagensky, Hosen Kiat, Wilhelm Haverkamp, Yang Jiao, Hitoshi Kato, Jindrich Spinar, Daniel Theodoro, Philip Cooke, Paolo Golino, Tetsuro Yoshida, Prakash Chandwani, Christine A'Court, Brian Ramjattan, Torbjørn Øien, Toshiyuki Kobayashi, Richard West, Petr Jansky, Seil Oh, Jan Steffel, Martin van Eickels, Hyung-Wook Park, Nam-Ho Kim, Søren Rasmussen, Kazuo Suzuki, David Colquhoun, Hiroshi Ando, Simon Franklin, Tae-Joon Cha, Sang Cheol Bae, Guosheng Fu, Yoshihiro Saito, Heinz Drexel, Michel Martelet, Joseph Mouallem, Nicolas Delarche, Sylvain Destrac, Neil Macey, Andreas Kopf, Masayuki Nakano, Olga Barbarash, Takeshi Inoue, Taro Minagawa, Weihua Li, John Eikelboom, Hiroshi Kubo, Lars Andersson, D Burns, Andrea Podczeck-Schweighofer, Megumi Okada, Massimo Volpe, Takuma Aoyama, Karsten Mueller, Carlos Astudillo, Hiroshi Takeda, Peter Mayer, Jung Hoon Sung, Dinesh Jain, Jung Han Yoon, Alessandro Capucci, Dongryeol Ryu, Kelvin Wong, Hong Euy Lim, Xiaowei Yan, Yusheng Zhao, Yuehui Yin, YUKIHIRO SETA, Taek Jong Hong, MASAKI SHIMOYAMA, Dayi Hu, Junichi Minami, Yuriy Mostovoy, David Foo, Ramazan Topsakal, Zhi-Cheng Jing, Dipen Shah, Kenichi Yamamoto, David Coulshed, Olivier Piot, Ramón Corbalán, Silva Severi, Waldemar Myszka, Mehmet Birhan Yilmaz, Gi-Byoung Nam, Jun Kim, Harald Darius, Jan-Erik Karlsson, PETER VANDERGOTEN, Nasser Taha, Shuta Toru, Jörn Nielsen, Tsutomu Takagi, Koji Higuchi, Steen Husted, Tomohiro Katsuya, Frank Cools, Iveta Petrova, Songkwan Silaruks, GÜNTER LEHMANN, Frederic Casassus, Bernard Crousillat, Bernard Doucet, Jean-Joseph Muller, Grzegorz Raczak, Kazuyuki Saito, Anders Ostrem, Chi Keong Ching, KUNIHIKO YAMAMOTO, John Camm, Carmine Mazzone, Jaemin Shim, Jadwiga Nessler, Jan Vercammen, Marc Delforge, Chong-Jin Kim, Pierre Nazeyrollas, Louise Lumley, Paul Roome, Helen Stoddart, Mark Rickenbach, Paul Mullen, Noriyuki Nakanishi, Gordon Irvine, Paul Conn, Kurt Lenz, Richard Coates, E Fisher, Warwick Coulson, Jiri Lastuvka, Pablo García Pavía, P Jhittay, Philip Saunders, Peter Bernhardt, Wanwarang Wongcharoen, Kentaro Yamamoto, Hector Lucas Luciardi, Harry Gibbs, Marianne Brodmann, Jørn Dalsgaard Nielsen, Hany Ragy, Matyas Keltai, Jitendra Pal Singh Sawhney, Janina Stepinska, Elizaveta Panchenko, Barry Jacobson, Xavier Viñolas, Pantep Angchaisuksiri, Alex Parkhomenko, Huaiqin Zhang, Shiping Cao, Daowen Wang, Guizhou Tao, Yingmin Chen, Shenghu He, Tongguo Wu, Moshui Chen, Longgen Xiong, Praveen Jadhavm, Raghava Sarma, Govind Kulkarni, Rasesh Atulbhai Pothiwala, Mohanan Padinhare Purayil, Kamaldeep Chawla, Veerappa Annasaheb Kothiwale, Bagirath Raghuraman, Vinod Madan Vijan, Jitendra Sawhney, Ganapathi Bantwal, Aziz Khan, Ramdhan Meena, Manojkumar Chopada, Sunitha Abraham, Vikas Bisne, Govindan Vijayaraghavan, Rajashekhar Durgaprasad, Kartikeya Bhargava, Udigala Madappa Nagamalesh, Rajeeve Kumar Rajput, Seishu Kanamori, Koichiro Kumagai, Yosuke Katsuda, Keiki Yoshida, Fumitoshi Toyota, Yuji Mizuno, Ikuo Misumi, Hiroo Noguchi, Shinichi Ando, Tetsuro Suetsugu, Susumu Adachi, Kei Chiba, Hiroaki Norita, Makoto Tsuruta, Takeshi Koyanagi, Takayuki Higashi, Shiro Azakami, Shinichiro Komaki, Kenshi Kumeda, Takashi Murayama, Jun Matsumura, Yurika Oba, Ryuji Sonoda, Kazuo Goto, Kotaro Minoda, Yoshikuni Haraguchi, Hisakazu Suefuji, Hiroo Miyagi, Tsugihiro Nakamura, Hidekazu Nandate, Ryuji Zaitsu, Yoshihisa Fujiura, Akira Yoshimura, Hiroyuki Numata, Jun Ogawa, Yasuyuki Kamogawa, Kinshiro Murakami, Yutaka Wakasa, Masanori Yamasawa, Hiromitsu Maekawa, Sumihisa Abe, Hajime Kihara, Satoru Tsunoda, Katsumi Saito, Hiroki Tachibana, Ichiro Oba, Takashi Kuwahata, Satoshi Higa, Masamichi Gushiken, Takuma Eto, Hidetoshi Chibana, Kazuaki Fujisawa, Yuhei Shiga, Hirokuni Sumi, Toshihisa Nagatomo, Yoshihiko Atsuchi, Toshiro Nagoshi, Kazuhisa Sanno, Fumihiro Hoshino, Naoto Yokota, Masahiro Kameko, Toshifumi Tabuchi, Munesumi Ishizawa, Yoshitake Fujiura, Taku Seto, Tetsu Iwao, Norio Ishioka, Koichi Oshiro, Keizo Tsuchida, Yutaka Hatori, Motoshi Takeuchi, Hiroto Takezawa, Shinjiro Nagano, Masaaki Iwaki, Yuichiro Nakamura, Naomasa Miyamoto, Toshifumi Taguchi, Ko Ashida, Naoto Yoshizawa, Jun Agata, Seishiro Matsukawa, Osamu Arasaki, Shuji Fukuoka, Hirofumi Murakami, Kazuya Mishima, Yoshiki Hata, Ichiro Sakuma, Ichiro Takamura, Mitsuyuki Akutsu, Toshihide Unoki, Yoshinori Go, Makoto Ikemura, Shoji Morii, Shigeru Marusaki, Hideo Doi, Mitsuru Tanaka, Takaaki Kusumoto, Shigeo Kakinoki, Chiga Ogurusu, Masami Nakatsuka, Yutaka Kitami, Yoichi Nakamura, Hiroshi Oda, Rikimaru Oyama, Masato Ageta, Teruaki Mita, Kazuhiko Nagao, Takafumi Mito, Mitsunori Abe, Masako Fujii, Makoto Okawa, Tsuneo Fujito, Toshiya Taniguchi, Tenei Ko, Mizuho Imamaki, Masahiro Akiyama, Takashi Ueda, Hironori Odakura, Masahiko Inagaki, Yoshiki Katsube, Atsuyuki Nakata, Shinobu Tomimoto, Mitsuhiro Shibuya, Kenichiro Ito, Masahiro Matsuta, Motoyuki Ishiguro, Masamichi Wada, Hiroaki Mukawa, Masato Mizuguchi, Fumio Okuda, Teruaki Kimura, Kuniaki Taga, Masaaki Techigawara, Morio Igarashi, Toshihiko Seo, Shinya Hiramitsu, Hiroaki Hosokawa, Mitsumoto Hoshiai, Michitaka Hibino, Koichi Miyagawa, Hideki Horie, Nobuyoshi Sugishita, Yukio Shiga, Akira Soma, Kazuo Neya, Kunio Akahane, Saori Matsui, Hirofumi Kanda, Shiro Nagasaka, Atsushi Taguchi, Akiko Miyashita, Hiroki Sasaguri, Jin Nariyama, Taketo Hatsuno, Takash Iwase, Kazuya Kawai, Tomobumi Kotani, Tsuyoshi Tsuji, Hirosumi Sakai, Kiyoshi Nishino, Kenichi Ikeda, Kazuo Maeda, Tomohiro Shinozuka, Koichi Kawakami, Hiromichi Kitazumi, Mamoru Hamaoka, Jisho Kojima, Akitoshi Sasaki, Yoshihiro Tsuchiya, Tetsuo Betsuyaku, Masaaki Honda, Koichi Hasegawa, Takao Baba, Kazuaki Mineoi, Toshihiko Koeda, Kunihiko Hirasawa, Toshihide Kumazaki, Akira Nakagomi, Eiji Otaki, Takashi Shindo, Hiroyoshi Hirayama, Chikako Sugimoto, Takashi Yamagishi, Ichiro Mizuguchi, Kazunori Sezaki, Isamu Niwa, Ken Takenaka, Osamu Iiji, Koichi Taya, Hitoshi Kitazawa, Samu Ueda, Hirokazu Kakuda, Takuya Ono, Seizo Oriso, Junya Kamata, Toshihiko Nanke, Itaru Maeda, Yoshifusa Matsuura, Yasuyuki Maruyama, Hajime Horie, Tetsutaro Kito, Hiroshi Asano, Masaichi Nakamura, Takashi Washizuka, Tomoki Yoshida, Masato Sawano, Shinichi Arima, Hidekazu Arai, Hisanori Shinohara, Hiroyuki Takai, Nobufusa Furukawa, Akira Ota, Kenji Aoki, Taku Yamamoto, Takeaki Kasai, Shunji Suzuki, Shu Suzuki, Nitaro Shibata, Masayuki Watanabe, Yosuke Nishihata, Toru Arino, Masaki Okuyama, Tetsushi Wakiyama, Tomoko Kato, Yasuo Sasagawa, Takeshi Tana, Yoshihito Hayashi, Shinichi Hirota, Yukihiko Abe, Hirohide Uchiyama, Shuichi Tohyo, Naoto Hanazono, Seiichi Miyajima, Hisashi Shimono, Yasunobu Shozawa, Yawara Niijima, Osamu Murai, Hideko Inaba, Katsumasa Nomura, Masatsugu Nozoe, Toshiyuki Furukawa, Nobuhisa Ito, Shunichi Nagai, Kiyoharu Sato, Shiro Nakahara, Yujin Shimoyama, Naoko Ohara, Teruhiko Kozuka, Hideaki Okita, Masato Endo, Tsutomu Goto, Makoto Hirose, Emiko Nagata, Toshizumi Mori, Shuichi Seki, Katsuhiro Okamoto, Osamu Moriai, Yoko Emura, Tsuyoshi Fukuda, Haruhiko Date, Shuichi Kawakami, Sho Nagai, Yuya Ueyama, Tetsuro Fudo, Mitsuru Imaizumi, Takuo Ogawa, Shunsuke Take, Hideo Ikeda, Norihiko Sakamoto, Kiyomitsu Ikeoka, Nobuo Wakaki, Masatake Abe, Junji Doiuchi, Tetsuya Kira, Masato Tada, Ken Tsuzaki, Naoya Miura, Yasuaki Fujisawa, Wataru Furumoto, Akinori Fujisawa, Ryosai Nakamura, Hiroyasu Komatsu, Rei Fujiki, Shuichi Kawano, Keijiro Nishizawa, Yoji Kato, Junya Azuma, Kiyoshi Yasui, Toshio Amano, Yasuhiro Sekine, Tatsuo Honzawa, Yuichiro Koshibu, Yasuhide Sakamoto, Shingo Miyaguchi, Kojuro Morishita, Yasuko Samejima, Toyoshi Sasaki, Fumiko Iseki, Hiroshi Kano, Yoichi Takagi, Yoko Onuki Pearce, Takayuki Fukui, Toru Nakayama, Hideaki Kanai, Yoshiyuki Kawano, Tetsuji Ino, Hironori Miyoshi, Yasufumi Miyamoto, Masahito Shigekiyo, Shimato Ono, Yutaka Okamoto, Satoshi Ubukata, Kojiro Kodera, Tatsuo Oriuchi, Naoki Matsumoto, Koichi Inagaki, Atsushi Iseki, Tomohiro Yoshida, Toshihiro Goda, Tsukasa Katsuki, Atsushi Sato, Etsuo Mori, Toshio Tsubokura, Hiroshi Shudo, Shunichi Fujimoto, Yoshiyuki Furukawa, Hiroshi Hosokawa, Jun Narumi, Kiichiro Yamamoto, Masaki Owari, Takuya Inakura, Takafumi Anno, Kazuyuki Shirakawa, Tan Yuyang, Hui Nam Park, Woo-Shik Kim, HyeYoung Lee, Dae Hyeok Kim, Dae-Kyeong Kim, Dong Ju Choi, Hui-Kyung Jeon, Dong-Gu Shin, Sang Weon Park, Hoon Ki Park, Sang-Jin Han, Young Keun On, JaeJin Kwak, Seong Hoon Park, Kee-Sik Kim, Byung Chun Jung, Gyo-Seung Hwang, Sakda Rungaramsin, Peerapat Katekangplu, Porames Khunrong, Thanita Bunyapipat, Pinij Kaewsuwanna, Khanchai Siriwattana, Waraporn Tiyanon, Supalerk Pattanaprichakul, Khanchit Likittanasombat, Doungrat Cholsaringkarl, Warangkana Boonyapisit, Sirichai Cheewatanakornkul, Pisit Hutayanon, Seksan Chawanadelert, Pairoj Chattranukulchai, Boonsert Chatlaong, Yingsak Santanakorn, Khompiya Kanokphatcharakun, Piya Mongkolwongroj, Sasivimon Jai-Aue, Ongkarn Komson, Armagan Altun, Ali Aydinlar, Zeki Ongen, Sadik Acikel, Durmus Yildiray Sahin, Ozcan Yilmaz, Hasan Pekdemir, Mesut Demir, Murat Sucu, Levent Sahiner, Murat Ersanli, Ertugrul Okuyan, Dursun Aras, Florencia Rolandi, Adrian Cesar Ingaramo, Gustavo Alberto Sambadaro, Vanina Fernandez Caputi, Hector Luciardi, Sofia Graciela Berman, Pablo Dragotto, Andres Javier Kleiban, Nestor Centurion, Ricardo Dario Dran, Javier Egido, Matias Jose Fosco, Victor Alfredo Sinisi, Luis Rodolfo Cartasegna, Oscar Gomez Vilamajo, Jose Luis Ramos, Sonia Sassone, Gerardo Zapata, Diego Conde, Guillermo Giacomi, Alberto Alfredo Fernandez, Mario Alberto Berli, Fabian Ferroni, Jefferson Jaber, Luciana Vidal Armaganijan, André Steffens, José Márcio Ribeiro, Marcelo Silveira Teixeira, Paulo Rossi, Leonardo Pires, Daniel Moreira, Luiz Bodanese, Marcelo Westerlund Montera, Jamil Abdalla Saad, Euler Roberto Manenti, Alexandre Negri, Carlos Moncada, Dalton Precoma, Fernando Roquette, Gilmar Reis, Estêvão Lanna Figueiredo, Roberto Vieira Botelho, Helius Carlos Finimundi, Adriano Kochi, Fábio Alban, Rogério Tadeu Tumelero, Lilia Maia, Humberto Montecinos, Martín Larico Gómez, Carlos Conejeros, Patricio Marin Cuevas, Alejandro Forero, Claudio Bugueño Gutiérrez, Juan Aguilar, Sergio Potthoff Cardenas, German Eggers, Cesar Houzvic, Carlos Rey, Germán Arriagada, Gustavo Charme Vilches, Raul Leal Cantu, Ricardo Cabrera Jardines, Nilda Espinola Zavaleta, Enrique Lopez Rosas, Gerardo Pozas, Ernesto Cardona Muñoz, Norberto Matadamas Hernandez, Adolfo Leyva Rendon, Norberto Garcia Hernandez, David Lopez Villezca, Carlos Hernandez Herrera, Rodolfo Gaona Rodriguez, Efrain Villeda Espinosa, David Flores Martinez, Jose Velasco Barcena, Omar Fierro Fierro, Ignacio Rodriguez Briones, Humberto Alvarez Lopez, Rafael Olvera Ruiz, Roxana Reyes Sanchez, Roberto Arriaga Nava, Pedro Fajardo Campos, Mario Benavides Gonzalez, Claus Hagn, Johannes Foechterle, Michael Winkler, Bruno Schneeweiss, Alfons Gegenhuber, Wilfried Lang, Sabine Eichinger-Hasenauer, Peter Kaserer, Josef Sykora, Heribert Rasch, Bernhard Strohmer, Luc Capiau, Geert Vervoort, Bart Wollaert, Geert Hollanders, Dirk Faes, Yohan Balthazar, Olivier Xhaet, Harry Striekwold, John Thoeng, Kurt Hermans, Wim Anné, Ivan Blankoff, Michel Beutels, Stefan Verstraete, Philippe Purnode, Pascal Godart, Tim Boussy, Philippe Desfontaines, Alex Heyse, Joeri Voet, Eva Zidkova, Rudolf Spacek, Vilma Machova, Ondrej Ludka, Josef Olsr, Lubos Kotik, Blazej Racz, Richard Ferkl, Jan Hubac, Ilja Kotik, Zdenek Monhart, Hana Burianova, Ondrej Jerabek, Jana Pisova, Vratislav Dedek, Michaela Honkova, Petr Podrazil, Petr Reichert, Miroslav Novak, Vaclav Durdil, Katarina Plocova, Ulrik Hintze, Næstved Sygehus, Arne Bremmelgaard, John Markenvard, Jan Børger, Jorgen Solgaard, Ebbe Eriksen, Thomas Løkkegaard, Michael Bruun, Jacob Mertz, Joël Ohayon, Yannick Gottwalles, Philippe Loiselet, Mohamed Bassel Koujan, André Marquand, Jean-Pierre Cebron, Maxime Guenoun, Dominique Guedj-Meynier, A G Lokesh, James Kadouch, Pierre-Yves Fournier, Jean-Pierre Huberman, Nestor Lemaire, Gilles Rodier, Xavier Vandamme, Marie Hélène Mahagne, Antoine Mielot, Jean-Baptiste Churet, Vincent Navarre, Frederic Sellem, Gilles Monniot, Jean-Paul Boyes, Désiré Obadia, Etienne Bearez, Jean Philippe Brugnaux, Alain Fedorowsky, Jean-Baptiste Berneau, Frédéric Chemin, Sebastien Schellong, Georg Koeniger, Uwe Gerbaulet, Bernd-Thomas Kellner, Thomas Schaefer, Jan Purr, Enno Eißfeller, Heinz-Dieter Zauzig, Peter Riegel, Christoph Axthelm, Gerd-Ulrich Heinz, Holger Menke, Andreas Pustelnik, Stefan Zutz, Wolfgang Eder, Guenter Rehling, Dirk Glatzel, Norbert Ludwig, Petra Sandow, Henning Wiswedel, Cosmas Wildenauer, Steffen Schoen, Toralf Schwarz, Adyeri Babyesiza, Maximilian Kropp, Hans-Hermann Zimny, Friedhelm Kahl, Andreas Caspar, Sabine Omankowsky, Torsten Laessig, Hermann-Josef Hartmann, Hans-Walter Bindig, Gunter Hergdt, Dietrich Reimer, Joachim Hauk, Holger Michel, Praxis Dres, Werner Erdle, Wilfried Dorsch, Janna Dshabrailov, Karl-Albrecht Rapp, Reinhold Vormann, Thomas Mueller, Uwe Horstmeier, Volker Eissing, Heinz Hey, Heinz Leuchtgens, Volker Lilienweiss, Heiner Mueller, Christian Schubert, Herrmann Lauer, Thomas Buchner, Gunter Brauer, Susanne Kamin, Sylvia Baumbach, Muwafeg Abdel-Qader, Hans-Holger Ebert, Carsten Schwencke, Laszlo Karolyi, Britta Sievers, Jens-Uwe Roehnisch, Andras Vertes, Gabor Szantai, Andras Matoltsy, Nikosz Kanakaridisz, Zoltan Boda, Erno Kis, Balazs Gaszner, Ferenc Juhasz, Gizella Juhasz, Sandor Kancz, Zoltan Laszlo, Zsolt May, Ebrahim Noori, Tamas Habon, Peter Polgar, Gabriella Szalai, Sandor Vangel, Gabriella Engelthaler, Judit Ferenczi, Mihaly Egyutt, Leone Maria Cristina, Eros Tiraferri, Rita Santoro, Teresa Maria Caimi, Maria Tessitori, Roberto Cappelli, Roberto Quintavalla, Franco Cosmi, Raffaele Fanelli, Vincenzo Oriana, Raffaele Reggio, Roberto Santi, Leonardo Pancaldi, Jorge Salerno Uriate, Flavia Lillo, Enrico Maria Pogliani, Michele Accogli, Antonio Mariani, Mauro Feola, Arturo Raisaro, Luciano Fattore, Andrea Mauric, Fabrizio Germini, Luca Tedeschi, Maria Settimi, Sergio Nicoli, Paolo Ricciarini, Antonio Argena, Paolo Ronchini, Claudio Bulla, Filippo Tradati, Maria Grazia Bongiorni, Enrico Salomone, Claudio Tondo, Saverio Iacopino, Andreas Lucassen, Henk Adriaansen, Maarten Bongaerts, Mathijs Pieterse, Johannes Herrman, Pieter Hoogslag, Cees Buiks, Per Anton Sirnes, Erik Gjertsen, Knut Erga, Arne Hallaråker, Gunnar Skjelvan, Beraki Ghezai, Arne Svilaas, Peter Christersson, Svein Høegh Henrichsen, Jan Erik Otterstad, Jan Berg-Johansen, Andrzej Gieroba, Malgorzata Biedrzycka, Michal Ogorek, Beata Wozakowska-Kaplon, Krystyna Loboz-Grudzien, Jerzy Kuzniar, Roman Zaluska, Jaroslaw Hiczkiewicz, Lucyna Swiatkowska-Byczynska, Lech Kucharski, Piotr Minc, Maciej Olszewski, Grzegorz Kania, Malgorzata Krzciuk, Zbigniew Lajkowski, Bozenna Ostrowska-Pomian, Jerzy Lewczuk, Elzbieta Zinka, Agnieszka Karczmarczyk, Malgorzata Chmielnicka-Pruszczynska, Iwona Wozniak-Skowerska, Marek Bronisz, Marcin Ogorek, Grazyna Glanowska, Piotr Ruszkowski, Grzegorz Skonieczny, Ryszard Sciborski, Boguslaw Okopien, Piotr Kukla, Krzysztof Galbas, Krzysztof Cymerman, Jaroslaw Jurowiecki, Pawel Miekus, Stanislaw Mazur, Roman Lysek, Jacek Baszak, Teresa Rusicka-Piekarz, Ewa Domanska, Jozef Lesnik, Gadel Kamalov, Dmitry Belenky, Liudmila Egorova, Alexander Khokhlov, Eduard Yakupov, Dmitry Zateyshchikov, Olga Miller, Evgeniy Mazur, Konstantin Zrazhevskiy, Tatyana Novikova, Yulia Moiseeva, Elena Polkanova, Konstantin Sobolev, Maria Rossovskaya, Yulia Shapovalova, Alla Kolesnikova, Konstantin Nikolaev, Oksana Zemlianskaia, Anna Zateyshchikova, Victor Kostenko, Maria Poltavskaya, Anton Edin, Elena Aleksandrova, Oksana Drapkina, Alexander Vishnevsky, Oleg Nagibovich, Petr Chizhov, Svetlana Rachkova, Mikhail Sergeev, Borys Kurylo, Alexey Ushakov, Pere Alvarez Garcia, Luis Tercedor Sanchez, Salvador Tranche Iparraguirre, Pere Toran Monserrat, Emilio Marquez Contreras, Jordi Isart Rafecas, Juan Motero Carrasco, Casimiro Gomez Pajuelo, Angel Grande Ruiz, Jordi Merce Klein, Ines Monte Collado, Herminia Palacin Piquero, Carles Brotons Cuixart, Esther Fernandez Escobar, Cecilia Corros Vicente, Manuel Vida Gutierrez, Francisco Epelde Gonzalo, Encarnacion Martinez Navarro, Maria Barreda Gonzalez, Jose Iglesias Sanmartin, Mercedes Jimenez Gonzalez, Juan Herreros Melenchon, Tomas Ripoll Vera, Manuel Jimenez Navarro, Maria Vazquez Caamano, Gonzalo Marcos Gomez, Andres Iniguez Romo, Alexander Wirdby, Kerstin Henriksson, Micael Elmersson, Arnor Egilsson, Ulf Börjesson, Gunnar Svärd, Anders Lindh, Lars-Bertil Olsson, Mikael Gustavsson, Lars Benson, Claes Bothin, Ali Hajimirsadeghi, Björn Martinsson, Marianne Ericsson, Åke Ohlsson, Håkan Lindvall, Peter Svensson, Katarina Thörne, Hans Händel, Pyotr Platonov, Fredrik Bernsten, Ingar Timberg, Milita Crisby, Lennart Malmqvist, Jörgen Thulin, Aida Hot-Bjelak, Steen Jensen, Per Stalby, Johann Debrunner, Iurii Rudyk, Oleksandr Karpenko, Svitlana Zhurba, Igor Kraiz, Oleksandr Parkhomenko, Iryna Kupnovytska, Nestor Seredyuk, Oleksiy Ushakov, Olena Koval, Igor Kovalskiy, Yevgeniya Svyshchenko, Susanna Tykhonova, Ivan Fushtey, Naresh Chauhan, Daryl Goodwin, Ramila Patel, Bennett Wong, Alex Cameron, Niranjan Patel, M S Kainth, Gill Pickavance, Joanna McDonnell, Laura Handscombe, Trevor Gooding, Helga Wagner, Catherine Bromham, Shoeb Suryani, Bhupinder Sarai, W Willcock, S Sircar, A Gilliand, Roman Bilas, E Strieder, Anne Wakeman, Graham Kirby, Bhaskhar Vishwanathan, Nigel Bird, John Bisatt, Jennifer Litchfield, Tim Fooks, Richard Kelsall, Neil Paul, Elizabeth Alborough, Michael Aziz, Pete Wilson, Sue Fairhead, Hasan Chowan, Gary Taylor, Dawn Tragen, Matt Parfitt, Claire Seamark, Carolyn Paul, Angus Jefferies, Helen Sharp, Claire Giles, Matthew Bramley, Philip Williams, Jehad Aldegather, William Lumb, Phil Evans, Frances Scouller, Yvette Stipp, Philip Pinney, Paul Wadeson, T Railton, Emyr Davies, Jonathan McClure, Marc Jacobs, Claire Hutton, Keith Butter, Susan Barrow, Helen Little, Ulka Choudhary, Ikram Haq, Paul Ainsworth, Phil Weeks, Jane Eden, Lisa Gibbons, Janet Glencross, K Poland, Conor Mulolland, A Warke, Ian Hodgins, Stephen Vercoe, Jayesh Patel, Amar Ali, Nigel De-Sousa, Mark Danielsen, Purnima Sharma, Sophia Galloway, Charlotte Hawkins, Raife Oliver, Martin Aylward, Mira Pattni, Shahid Ahmad, Catherine Rothwell, Fiaz Choudhary, Sabrina Khalaque, Stephanie Short, Sharon Peters, Amy Butler, Steven Coates, Steve Walton, Diane Shepherd, Toh Wong, Melanie Deacon, David Cornelius, Henry Choi, Jon Sumner, Tim Myhill, Salah Estifanos, Diane Geatch, Justin Wilkinson, Richard Veale, Rob Hirst, Kashif Zaman, Catherine Liley, Rebecca Wastling, Paul McEleny, Andre Beattie, Mike Wong, Chaminda Dooldeniya, Greg Rogers, Rajesh Muvva, Matthew Adam, Nicolas Thomas, Rory Reed, Simon Randfield, Ann Flynn, Andrew Halpin, Louise Lomax, Minnal Nadaph, Iain Munro, Jane Goram, John Shewring, Emma Bowen-Simpkins, Bhuwanendu Singh, Penny Astridge, Philip Thomson, Ron Lehman, Andrei Catanchin, David Eccleston, Peter Blombery, Greg Starmer, Margaret Arstall, Maurits Binnekamp, Astin Lee, Robert Luton, Amritanshu Shekhar Pandey, Stephen Cheung, Rolland Leader, Philippe Beaudry, Félix Ayala-Paredes, John Heath, Germain Poirier, Bradley Schweitzer, Reginald Nadeau, Ripple Dhillon, Tomasz Hruczkowski, Andrea Lavoie, Ratika Parkash, James Cha, Benoit Coutu, Jorge Bonet, Saul Vizel, Sameh Fikry, Ahmed Mowafy, Azza Katta, Mazen Tawfik, Moustafa Nawar, Mohamed Sobhy, Tarek Khairy, Ahmed Abd El-Aziz, Ashraf Reda, Atef Elbahry, Mohamed Setiha, Magdi Elkhadem, Adel El-Etreby, David Kettles, Junaid Bayat, Heidi Siebert, Adrian Horak, Ynez Kelfkens, Riaz Garda, Thayabran Pillay, Michele Guerra, Hendrik Theron, Rikus Louw, Deon Greyling, Pindile Mntla, Siddique Ismail, Fayzal Ahmed, Johannes Engelbrecht, Shambu Maharajh, Veronica Ueckermann, Ghazi Yousef, Munther AlOmairi, Rajan Maruthanayagam, Rupesh Singh, Ahmed Naguib, Amrish Agrawal, Mukesh Nathani, Adel Wassef, Scott Beach, Peter Duffy, Stephen Falkowski, Kevin Ferrick, Miguel Franco, Annette Quick, Vance Wilson, Mark Alberts, Edwin Blumberg, Roddy Canosa, Ted Gutowski, Rodney Ison, Jorge Garcia, Howard Noveck, Pamela Rama, Rajneesh Reddy, Marcus Williams, Keith Ferdinand, Ihsan Haque, Robert Mendelson, Sridevi Pitta, Charles Treasure, Cas Cader, Walter Pharr, Alisha Oropallo, George Platt, Jaspal Gujral, James Welker, Firas Koura, Ajay K. Kakkar, A. John Camm, David A. Fitzmaurice, Keith A.A. Fox, Bernard J. Gersh, Samuel Z. Goldhaber, Lorenzo G. Mantovani, Karen S. Pieper, Alexander G.G. Turpie, Freek W.A. Verheugt, Antonio Carlos PereiraBarretto, Stuart J. Connolly, Jean-Yves Le Heuzey, Jitendra Pal SinghSawhney, Carlos JerjesSánchez Díaz, Hugo Ten Cate, Wael Al Mahmeed, Zhiming Yang Li Xue, A.G. Ravi Shankar, Chiei Takanaka Sen Adachi, Rodolfo AndresAhuad Guerrero, Leonel Adalberto Di Paola, DárioCelestino Sobral Filho, Costantino RobertoFrack Costantini, Weimar Kunz SebbaBarrosodeSouzaem, João David deSouzaNeto, José Carlos MouraJorge, Adalberto MenezesLorga Filho, Carlos Henrique DelCarlo, FernandoAugustoAlves da Costa, Gilson Robertode Araújo, Jose FranciscoKerr Saraiva, João CarlosFerreira Braga, Roberto Álvaro RamosFilho, Cláudio MunhozdaFontoura Tavares, CésarCássio Broilo França, Guido BernardoAranha Rosito, João BatistadeMouraXavierMoraes Junior, Roberto Simõesde Almeida, Ney CarterdoCarmo Borges, LuísGustavo Gomes Ferreira, Benjamin AleckJosehStockins Fernandez, CarlosJerjes Sanchez Diaz, Jesus JaimeIllescas Diaz, Maria GuadalupeRamos Zavala, GuillermoAntonio Llamas Esperón, Manuel delosRios Ibarra, LuisRamon Virgen Carrillo, JuanJose Lopez Prieto, Jose LuisLeiva Pons, Carlos GerardoCantu Brito, EduardoJulianJose Roberto ChuquiureValenzuela, Alberto EstebanBazzoni Ruiz, Oscar MartinLopez Ruiz, Jesus DavidMorales Cerda, Axel De Wolf, Carmela Viitanen, Giovanni Di Minno, Raimondo De Cristofaro, Angelo De Blasio, Maria D'Avino, J.H. Ruiter, Coen van Guldener, P.R. Nierop S.H.K., B.E. Groenemeijer, W. Terpstra, L.V.A. Boersma, Wieslaw Supinski Jaroslaw, Roman Libis Vera Eltishcheva, Maria FernandaLopez Fernandez, Luis MiguelRincon Diaz, Luis FernandoIglesias Alonso, Jose RamonGonzalez Juanatey, Joan Bayo iLlibre, Carlos AlexandreAlmeida Fernandez, Juan JoseMontero Alia, Maria AngelsMoleiro Oliva, Maria delMarRodriguez Alvarez, Maria FeArcocha Torres, Miguel AngelPrieto Diaz, Jan Lindén Centrumkliniken, Juerg H. Beer, Colin Bradshaw Cumberlidge, Daniel Jackson Ben Ward, Nick Hargreaves Ben Frankel, William van Gaal, David O'Donnell, Miranda du Preez, Seif Kamal Abou Seif, Mohamed Gamal El Din, Louis van Zyl, Rehana Loghdey Wessel Oosthuysen, Abdullah Al Naeemi, Ehab M. Esheiba, and W. Michael Kutayli

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Objective While greater body mass index (BMI) is associated with increased risk of developing atrial fibrillation (AF), the impact of BMI on outcomes in newly diagnosed AF is unclear. We examine the influence of BMI on outcomes and whether this is modified by sex and evaluate the effect of non-vitamin K oral anticoagulants (NOACs) in patients with high BMI.Methods GARFIELD-AF is a prospective registry of 52 057 newly diagnosed AF patients. The study population comprised 40 482 participants: 703 underweight (BMI

Published
2022
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19. Apparent Insulin Deficiency in an Adult African Population With New-Onset Type 2 Diabetes

Author

Davis Kibirige, Isaac Sekitoleko, Priscilla Balungi, William Lumu, and Moffat J. Nyirenda

Subjects
insulin deficiency, adult, newly diabetes mellitus, Uganda, Sub-Sahara Africa, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Identifying patients with new-onset type 2 diabetes who have insulin deficiency can aid in timely insulin replacement therapy. In this study, we measured fasting C-peptide concentration to assess endogenous insulin secretion and determine the prevalence and characteristics of patients with insulin deficiency in adult Ugandan patients with confirmed type 2 diabetes at presentation.MethodsAdult patients with new-onset diabetes were recruited from seven tertiary hospitals in Uganda. Participants who were positive for the three islet autoantibodies were excluded. Fasting C-peptide concentrations were measured in 494 adult patients, and insulin deficiency was defined as a fasting C-peptide concentration

Published
2022
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20. Effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster-randomized trial

Author

William Lumu, Davis Kibirige, Ronald Wesonga, and Silver Bahendeka

Subjects
Nurse-led lifestyle choice, Coaching intervention, Systolic blood pressure, Atherosclerotic cardiovascular risk, Type 2 diabetes, Randomized controlled trial, Medicine (General), R5-920
Abstract

Abstract Background More than 50% of patients with type 2 diabetes have hypertension in Uganda. Diabetic patients with elevated systolic blood pressure experience higher all-cause mortality and cardiovascular events compared with normotensive diabetic individuals, hence escalating resource utilization and cost of care. The aim of this study is to determine the effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk. Methods This is a cluster-randomized study comprising two arms (intervention and non-intervention—control arm) with four clusters per arm with 388 diabetic patients with a high predicted 10-year atherosclerotic cardiovascular risk. The study will be implemented in 8 health facilities in Uganda. The intervention arm will employ a nurse-led lifestyle choice and coaching intervention. Within the intervention, nurses will be trained to provide structured health education, protocol-based hypertension management, and general atherosclerotic cardiovascular risk factor management, 24-h phone calls, and 2-monthly text messaging. The control group will be constituted by the usual care. The primary outcome measure is the mean difference in systolic blood pressure between the intervention and usual care groups after 6 months. The study is designed to have an 80% statistical power to detect an 8.5-mmHg mean reduction in systolic blood pressure from baseline to 6 months. The unit of analysis for the primary outcome is the individual participants. To monitor the effect of within-cluster correlation, generalized estimating equations will be used to assess the changes over time in systolic blood pressure as a continuous variable. Discussion The data generated from this trial will inform change in the policy of shifting task of screening of hypertension and atherosclerotic cardiovascular disease from doctors to nurses. Trial registration Pan African Trials Registry PACTR 202001916873358 . Registered on 6 October 2019

Published
2021
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21. Determining the Exempt Solvent Content of Coatings Using Gas Chromatography

Author

William Lum and Phillip Patterson

Subjects
Solvent, chemistry.chemical_classification, Chromatography, chemistry, Coating materials, Sampling (statistics), Technical note, Gas chromatography, Polymer
Abstract

The Coatings Team of the Polymers Research Branch has developed a method for the analysis of the exempt solvent content in pigmented coating materials using gas chromatography. This technical note outlines the instrument parameters and the sampling procedures established to perform the determination. A typical analysis is graphically presented with a brief explanation summarizing the tabulated results.

Published
2002
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22. The international WAO/EAACI guideline for the management of hereditary angioedema – The 2021 revision and update

Author

Marcus Maurer, MD, Markus Magerl, MD, Stephen Betschel, MD, Werner Aberer, MD, Ignacio J. Ansotegui, MD, PhD, Emel Aygören-Pürsün, MD, Aleena Banerji, MD, Noémi-Anna Bara, MD, Isabelle Boccon-Gibod, MD, Konrad Bork, MD, Laurence Bouillet, Pr, MD, PhD, Henrik Balle Boysen, Nicholas Brodszki, MD, PhD, Paula J. Busse, MD, Anette Bygum, MD, DMSci, Teresa Caballero, MD, PhD, Mauro Cancian, MD, PhD, Anthony J. Castaldo, Danny M. Cohn, MD, PhD, Dorottya Csuka, MD, Henriette Farkas, MD, PhD, DSc, Mark Gompels, MBBS, BSc, MD, Richard Gower, MD, Anete S. Grumach, MD, PhD, Guillermo Guidos-Fogelbach, MD, PhD, Michihiro Hide, MD, PhD, Hye-Ryun Kang, MD, PhD, Allen P. Kaplan, MD, Constance H. Katelaris, MBBS, PhD, Sorena Kiani-Alikhan, PhD, Wei-Te Lei, MD, Richard F. Lockey, MD, Hilary Longhurst, PhD, William Lumry, MD, Andrew MacGinnitie, MD, PhD, Alejandro Malbran, MD, PhD, Inmaculada Martinez Saguer, MD, Juan José Matta Campos, MD, Alexander Nast, MD, Dinh Nguyen, MD, PhD, Sandra A. Nieto-Martinez, MD, Ruby Pawankar, MD, PhD, Jonathan Peter, MB ChB, MMed, FCP (SA), PhD, Grzegorz Porebski, MD, Nieves Prior, MD, PhD, Avner Reshef, MD, Marc Riedl, MD, Bruce Ritchie, MD, Farrukh Rafique Sheikh, MBBS, William B. Smith, MBBS, PhD, Peter J. Spaeth, PhD, Marcin Stobiecki, MD, Elias Toubi, MD, Lilian Agnes Varga, PhD, Karsten Weller, MD, Andrea Zanichelli, MD, Yuxiang Zhi, MD, Bruce Zuraw, MD, and Timothy Craig, MD

Subjects
Hereditary angioedema, C1-inhibitor, diagnosis, GRADE therapy, management, disease control, Immunologic diseases. Allergy, RC581-607
Abstract

Hereditary Angioedema (HAE) is a rare and disabling disease for which early diagnosis and effective therapy are critical. This revision and update of the global WAO/EAACI guideline on the diagnosis and management of HAE provides up-to-date guidance for the management of HAE. For this update and revision of the guideline, an international panel of experts reviewed the existing evidence, developed 28 recommendations, and established consensus by an online DELPHI process. The goal of these recommendations and guideline is to help physicians and their patients in making rational decisions in the management of HAE with deficient C1-inhibitor (type 1) and HAE with dysfunctional C1-inhibitor (type 2), by providing guidance on common and important clinical issues, such as: 1) How should HAE be diagnosed? 2) When should HAE patients receive prophylactic on top of on-demand treatment and what treatments should be used? 3) What are the goals of treatment? 4) Should HAE management be different for special HAE patient groups such as children or pregnant/breast feeding women? 5) How should HAE patients monitor their disease activity, impact, and control? It is also the intention of this guideline to help establish global standards for the management of HAE and to encourage and facilitate the use of recommended diagnostics and therapies for all patients.

Published
2022
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23. A Practical Approach in Performing the Particle Size Analysis of a Camouflage Coating Utilizing Laser-Light Scattering Technology

Author

William Lum and Phillip Patterson

Subjects
Engineering, business.industry, Single component, Mechanical engineering, engineering.material, Light scattering, Laser light scattering, Coating, Chemical agents, Camouflage, Particle-size distribution, business, Focus (optics), Simulation
Abstract

This technical report presents the results of an analytical research study performed at the U.S. Army Research Laboratory (ARL), Aberdeen Proving Ground (APG), MD. The focus of the work centers on the instrument setup and operation for performing particle size determinations on a polydispersed, camouflage paint conforming to the U.S. Department of the Army Military Specification MIL-C-53039A, "Coating, Aliphatic Polyurethane, Single Component, Chemical Agent Resistant." The analyses are graphically displayed and are provided with a brief explanation summarizing the results. A short description of merited future work is also mentioned.

Published
2000
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24. Islet autoantibody positivity in an adult population with recently diagnosed diabetes in Uganda

Author

Davis Kibirige, Isaac Sekitoleko, Priscilla Balungi, Jacqueline Kyosiimire-Lugemwa, William Lumu, Angus G. Jones, Andrew T. Hattersley, Liam Smeeth, and Moffat J. Nyirenda

Subjects
Medicine, Science
Abstract

Aims This study aimed to investigate the frequency of islet autoantibody positivity in adult patients with recently diagnosed diabetes in Uganda and its associated characteristics. Methods Autoantibodies to glutamic acid decarboxylase-65 (GADA), zinc transporter 8 (ZnT8-A), and tyrosine phosphatase (IA-2A) were measured in 534 adult patients with recently diagnosed diabetes. Islet autoantibody positivity was defined based on diagnostic thresholds derived from a local adult population without diabetes. The socio-demographic, clinical, and metabolic characteristics of islet autoantibody-positive and negative participants were then compared. The differences in these characteristics were analysed using the x2 test for categorical data and the Kruskal Wallis test for continuous data. Multivariate analysis was performed to identify predictors of islet autoantibody positivity. Results Thirty four (6.4%) participants were positive for ≥1 islet autoantibody. GADA, IA-2A and ZnT8-A positivity was detected in 17 (3.2%), 10 (1.9%), and 7 (1.3%) participants, respectively. Compared with those negative for islet autoantibodies, participants positive for islet autoantibodies were more likely to live in a rural area (n = 18, 52.9% Vs n = 127, 25.5%, p = 0.005), to be initiated on insulin therapy (n = 19, 55.9% Vs n = 134, 26.8%, pConclusion The prevalence of islet autoantibody positivity was relatively low, suggesting that pancreatic autoimmunity is a rare cause of new-onset diabetes in this adult Ugandan population. Living in a rural area and being initiated on insulin therapy were independently associated with islet autoantibody positivity in this study population.

Published
2022

25. Subcutaneous C1 inhibitor for prevention of attacks of hereditary angioedema: additional outcomes and subgroup analysis of a placebo-controlled randomized study

Author

H. Henry Li, Bruce Zuraw, Hilary J. Longhurst, Marco Cicardi, Konrad Bork, James Baker, William Lumry, Jonathan Bernstein, Michael Manning, Donald Levy, Marc A. Riedl, Henrike Feuersenger, Subhransu Prusty, Ingo Pragst, Thomas Machnig, Timothy Craig, and for the COMPACT Investigators

Subjects
C1-esterase inhibitor protein, C1-INH (SC), COMPACT study, HAEGARDA®, Hereditary angioedema, Long-term prophylaxis, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background Hereditary angioedema (HAE) is a debilitating disorder resulting from C1-esterase inhibitor (C1-INH) deficiency. In the COMPACT phase 3 study the prophylactic use of a subcutaneous C1 inhibitor (C1-INH [SC], HAEGARDA®, CSL Behring) twice weekly significantly reduced the frequency of acute edema attacks. Analysis of treatment effects by subgroups, onset of effect, and other exploratory analysis have not been reported. Methods This is a post hoc exploratory analysis on data from the randomized, placebo-controlled COMPACT study. 90 patients with C1-INH-HAE were randomized to 1 of 4 treatment sequences: C1-INH (SC) 40 or 60 IU/kg of body weight twice weekly for 16 weeks, preceded or followed by a placebo period. The pre-specified primary efficacy endpoint was the time-normalized number of HAE attacks, and pre-specified secondary efficacy endpoints were the percentage of patients with a certain treatment response (≥ 50% reduction on C1-INH (SC) versus placebo in the time-normalized number of attacks) and the time-normalized number of use of rescue medication. Pre-specified exploratory endpoints included severity of attacks, alone and combined with rescue medication use. Post hoc analyses included exploration of onset of effect and clinical assessment of patients with

Published
2019
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27. Understanding the manifestation of diabetes in sub Saharan Africa to inform therapeutic approaches and preventive strategies: a narrative review

Author

Davis Kibirige, William Lumu, Angus G. Jones, Liam Smeeth, Andrew T. Hattersley, and Moffat J. Nyirenda

Subjects
Diabetes, Manifestation, Diabetes phenotype, Adult patients, Sub-Saharan Africa, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Abstract Background Globally, the burden of diabetes mellitus has increased to epidemic proportions. Estimates from the International Diabetes Federation predict that the greatest future increase in the prevalence of diabetes mellitus will occur in Africa. Methods This article reviews literature on the manifestation of diabetes in adult patients in sub-Saharan Africa highlighting the distinct phenotypes, plausible explanations for this unique manifestation and the clinical significance of comprehensively defining and understanding the African diabetes phenotype. Results There are few studies on the manifestation or phenotype of diabetes in Africa. The limited data available suggests that, compared to the Western world, the majority of patients with diabetes in Africa are young and relatively lean in body size. In addition, hyperglycaemia in most cases is characterised by a significantly blunted acute first phase of insulin secretion in response to an oral or intravenous glucose load and pancreatic beta cell secretory dysfunction, rather than peripheral insulin resistance predominates. Genetic and environmental factors like chronic infections/inflammation, early life malnutrition and epigenetic modifications are thought to contribute to these distinct differences in manifestation. Conclusions While published data is limited, there appears to be distinct phenotypes of diabetes in sub-Saharan Africa. Large and more detailed studies are needed especially among newly diagnosed patients to fully characterize diabetes in this region. This will further improve the understanding of manifestation of diabetes and guide the formulation of optimal therapeutic approaches and preventive strategies of the condition on the continent.

Published
2019
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28. Dyslipidaemia in a Black African diabetic population: burden, pattern and predictors

Author

William Lumu, Leaticia Kampiire, George Patrick Akabwai, Richard Ssekitoleko, Daniel Ssekikubo Kiggundu, and Davis Kibirige

Subjects
Dyslipidaemia, Burden, Predictors, Adult diabetics, Uganda, Medicine, Biology (General), QH301-705.5, Science (General), Q1-390
Abstract

Abstract Objectives This study sought to assess the burden, pattern and predictors of dyslipidaemia in 425 adult diabetic patients in Uganda. Results The median (IQR) age of the study participants was 53 (43.5–62) years with a female majority (283, 66.9%). Dyslipidaemia defined as presence of ≥ 1 lipid abnormalities was observed in 374 (88%) study participants. Collectively, the predictors of dyslipidaemia were: female gender, study site (private hospitals), type of diabetes (type 2 diabetes mellitus), statin therapy, increased body mass index and diastolic blood pressure. Proactive screening of dyslipidaemia and its optimal management using lipid lowering therapy should be emphasised among adult diabetic patients in Uganda.

Published
2017
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29. Access to medicines and diagnostic tests integral in the management of diabetes mellitus and cardiovascular diseases in Uganda: insights from the ACCODAD study

Author

Davis Kibirige, David Atuhe, Leaticia Kampiire, Daniel Ssekikubo Kiggundu, Pamela Donggo, Juliet Nabbaale, Raymond Mbayo Mwebaze, Robert Kalyesubula, and William Lumu

Subjects
Availability, Cost, Affordability, Diabetes mellitus, Cardiovascular diseases, Low and middle income countries, Public aspects of medicine, RA1-1270
Abstract

Abstract Background Despite the burgeoning burden of diabetes mellitus (DM) and cardiovascular diseases (CVD) in low and middle income countries (LMIC), access to affordable essential medicines and diagnostic tests for DM and CVD still remain a challenge in clinical practice. The Access to Cardiovascular diseases, Chronic Obstructive pulmonary disease, Diabetes mellitus and Asthma Drugs and diagnostics (ACCODAD) study aimed at providing contemporary information about the availability, cost and affordability of medicines and diagnostic tests integral in the management of DM and CVD in Uganda. Methods The study assessed the availability, cost and affordability of 37 medicines and 19 diagnostic tests in 22 public hospitals, 23 private hospitals and 100 private pharmacies in Uganda. Availability expressed as a percentage, median cost of the available lowest priced generic medicine and the diagnostic tests and affordability in terms of the number of days’ wages it would cost the least paid public servant to pay for one month of treatment and the diagnostic tests were calculated. Results The availability of the medicines and diagnostic tests in all the study sites ranged from 20.1% for unfractionated heparin (UFH) to 100% for oral hypoglycaemic agents (OHA) and from 6.8% for microalbuminuria to 100% for urinalysis respectively. The only affordable tests were blood glucose, urinalysis and serum ketone, urea, creatinine and uric acid. Parenteral benzathine penicillin, oral furosemide, glibenclamide, bendrofluazide, atenolol, cardiac aspirin, digoxin, metformin, captopril and nifedipine were the only affordable drugs. Conclusion This study demonstrates that the majority of medicines and diagnostic tests essential in the management of DM and CVD are generally unavailable and unaffordable in Uganda. National strategies promoting improved access to affordable medicines and diagnostic tests and primary prevention measures of DM and CVD should be prioritised in Uganda.

Published
2017
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31. Efficacy and Safety of an Intravenous C1-Inhibitor Concentrate for Long-Term Prophylaxis in Hereditary angioedema

Author

Timothy Craig D.O., Ralph Shapiro M.D., Arthur Vegh M.D., James W. Baker M.D., Jonathan A. Bernstein M.D., Paula Busse M.D., Markus Magerl M.D., Inmaculada Martinez-Saguer M.D., Marc A. Riedl M.D., William Lumry M.D., Debora Williams-Herman M.D., Jonathan Edelman M.D., Henrike Feuersenger Ph.D., Thomas Machnig M.D., and Mikhail Rojavin Ph.D.

Subjects
Otorhinolaryngology, RF1-547, Immunologic diseases. Allergy, RC581-607
Abstract

Background The plasma-derived, pasteurized, nanofiltered C1-inhibitor concentrate (pnfC1-INH) is approved in the United States as an intravenous (IV) on-demand treatment for hereditary angioedema (HAE) attacks, and, in Europe, as on demand and short-term prophylaxis. Objective This analysis evaluated Berinert Patient Registry data regarding IV pnfC1-INH used as long-term prophylaxis (LTP). Methods The international registry (2010–2014) collected prospective and retrospective usage, dosing, and safety data on individuals who used pnfC1-INH for any reason. Results The registry included data on 47 subjects (80.9% female subjects; mean age, 44.8 years), which reflected 4082 infusions categorized as LTP and a total of 430.2 months of LTP administration. The median absolute dose of pnfC1-INH given for LTP was 1000 IU (range, 500–3000 IU), with a median time interval between infusion and a subsequent pnfC1-INH–treated attack of 72.0 hours (range, 0.0–166.4 hours). Fifteen subjects (31.9%) had no pnfC1-INH–treated HAE attacks within 7 days after pnfC1-INH infusion for LTP; 32 subjects (68.1%) experienced 246 attacks, with rates of 0.06 attacks per infusion and 0.57 attacks per month. A total of 81 adverse events were reported in 16 subjects (34.0%) (0.02 events per infusion; 0.19 events per month); only 3 adverse events were considered related to pnfC1-INH (noncardiac chest pain, postinfusion headache, deep vein thrombosis in a subject with an IV port). Conclusion In this international registry, IV pnf-C1-INH given as LTP for HAE was safe and efficacious, with a low rate of attacks that required pnfC1-INH treatment, particularly within the first several days after LTP administration.

Published
2017
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32. WAO Guideline for the Management of Hereditary Angioedema

Author

Timothy Craig, DO, Emel Aygören Pürsün, MD, Konrad Bork, MD, Tom Bowen, MD, Henrik Boysen, Henriette Farkas, MD PhD, Anete Grumach, MD PhD, Constance H. Katelaris, MB BS PhD, Richard Lockey, MD, Hilary Longhurst, MD, William Lumry, MD, Markus Magerl, MD, Immaculada Martinez-Saguer, MD PhD, Bruce Ritchie, MD, Alexander Nast, MD, Ruby Pawankar, MD PhD, Bruce Zuraw, MD, and Marcus Maurer, MD

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

Hereditary Angioedema (HAE) is a rare disease and for this reason proper diagnosis and appropriate therapy are often unknown or not available for physicians and other health care providers. For this reason we convened a group of specialists that focus upon HAE from around the world to develop not only a consensus on diagnosis and management of HAE, but to also provide evidence based grades, strength of evidence and classification for the consensus. Since both consensus and evidence grading were adhered to the document meets criteria as a guideline. The outcome of the guideline is to improve diagnosis and management of patients with HAE throughout the world and to help initiate uniform care and availability of therapies to all with the diagnosis no matter where the residence of the individual with HAE exists. Keywords: Hereditary Angioedema, Guidelines, HAE, therapy, management, diagnosis, medications, international

Published
2012
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33. Hereditary Angioedema Caused By C1-Esterase Inhibitor Deficiency: A Literature-Based Analysis and Clinical Commentary on Prophylaxis Treatment Strategies

Author

Richard G Gower, MD, Paula J Busse, MD, Emel Aygören-Pürsün, MD, Amin J Barakat, MD, Teresa Caballero, MD, Mark Davis-Lorton, MD, Henriette Farkas, MD, David S Hurewitz, MD, Joshua S Jacobs, MD, Douglas T Johnston, MD, William Lumry, MD, and Marcus Maurer, MD

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

Hereditary angioedema (HAE) caused by C1-esterase inhibitor deficiency is an autosomal-dominant disease resulting from a mutation in the C1-inhibitor gene. HAE is characterized by recurrent attacks of intense, massive, localized subcutaneous edema involving the extremities, genitalia, face, or trunk, or submucosal edema of upper airway or bowels. These symptoms may be disabling, have a dramatic impact on quality of life, and can be life-threatening when affecting the upper airways. Because the manifestations and severity of HAE are highly variable and unpredictable, patients need individualized care to reduce the burden of HAE on daily life. Although effective therapy for the treatment of HAE attacks has been available in many countries for more than 30 years, until recently, there were no agents approved in the United States to treat HAE acutely. Therefore, prophylactic therapy is an integral part of HAE treatment in the United States and for selected patients worldwide. Routine long-term prophylaxis with either attenuated androgens or C1-esterase inhibitor has been shown to reduce the frequency and severity of HAE attacks. Therapy with attenuated androgens, a mainstay of treatment in the past, has been marked by concern about potential adverse effects. C1-esterase inhibitor works directly on the complement and contact plasma cascades to reduce bradykinin release, which is the primary pathologic mechanism in HAE. Different approaches to long-term prophylactic therapy can be used to successfully manage HAE when tailored to meet the needs of the individual patient. Keywords: C1-esterase inhibitor, attenuated androgen, angioedema, HAE, prophylaxis

Published
2011
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34. Efficacy and Safety of Azelastine 0.15% Nasal Spray and Azelastine 0.10% Nasal Spray in Patients with Seasonal Allergic Rhinitis

Author

Shailen Shah M.D., William Berger M.D., William Lumry M.D., Craig La Force M.D., William Wheeler Ph.D., and Harry Sacks M.D.

Subjects
Otorhinolaryngology, RF1-547, Immunologic diseases. Allergy, RC581-607
Abstract

Azelastine is a second-generation antihistamine approved for treatment of allergic rhinitis. This randomized, double-blind, placebo- and active-controlled, parallel-group clinical trial evaluated the efficacy and safety of azelastine 0.15% and azelastine 0.10% nasal spray at a dosage of 2 sprays/nostril twice daily in patients with moderate-to-severe seasonal allergic rhinitis (SAR). In total, 526 patients were randomized 1:1:1 to treatment with 2 sprays/nostril twice daily of azelastine 0.15%, azelastine 0.10%, or placebo. The primary efficacy variable was change from baseline in 12-hour reflective Total Nasal Symptom Score (TNSS; A.M. and P.M. combined), consisting of nasal congestion, rhinorrhea, itchy nose, and sneezing. After 2 weeks, the mean improvement and percentage improvement in the 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% and azelastine 0.10% compared with placebo. In a retrospective analysis, there was a statistical difference (p = 0.047) in the mean improvement versus placebo in the 12-hour reflective TNSS with azelastine 0.15% compared with azelastine 0.10%. Onset of action with azelastine 0.15% was within 30 minutes. Bitter taste was the most common adverse event with both azelastine 0.15% and azelastine 0.10% (8.4% and 9.4% of patients, respectively). Somnolence was reported by 1.7% of patients treated with azelastine 0.15%, 0.6% of patients treated with azelastine 0.10%, and 0.6% of patients treated with placebo. Azelastine 0.15% nasal spray at 2 sprays/nostril twice daily significantly improved the nasal symptoms associated with SAR with an onset of action within 30 minutes and was well tolerated.

Published
2010
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