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2. Postoperative Dysphagieprävalenz bei Kopf-Hals-Tumorpatienten im akutstationären Setting

Author

Laura Wermter, S Kramer, Miriam Mayer, R Birk, Shahram Ghanaati, Ingo Fisher, Robert Sader, C Hey, Andreas Neff, Uta Lehner, Timo Stöver, Boris A. Stuck, Almut Goeze, and E Zaretsky

Subjects
Gynecology, 03 medical and health sciences, medicine.medical_specialty, 0302 clinical medicine, Otorhinolaryngology, business.industry, 030220 oncology & carcinogenesis, medicine, 030223 otorhinolaryngology, business
Abstract

Zusammenfassung Hintergrund Dysphagie bildet eine häufige postoperative Funktionsbeeinträchtigung bei Kopf-Hals-Tumorpatienten. Diese kann in Aspiration bzw. Penetration sowie Oralisierungseinschränkung resultieren und ist dadurch häufig versorgungsrelevant. In dieser Studie wurden die Prävalenz einer postoperativen Dysphagie und der Zusammenhang zwischen Ausprägungsgrad und Tumorstadium, Tumorlokalisation, Patientenalter und -geschlecht im akutstationären Setting untersucht. Material und Methoden Prospektiv wurden 201 erwachsene Kopf-Hals-Tumorpatienten (Altersdurchschnitt 63 Jahre) in 2 Universitätskliniken hinsichtlich Penetration/Aspiration, Oralisierungseinschränkung und Versorgungsrelevanz direkt nach der operativen Tumorbehandlung via FEES untersucht. In uni- und multivariaten Berechnungen wurde zudem der Einfluss der o. g. Patientenmerkmale auf diese 3 Parameter analysiert. Ergebnisse Eine versorgungsrelevante Schluckstörung bestand bei 66,7 % (134/201) der Patienten. 57,2 % der Patienten benötigten eine Nasogastral- oder PEG-Sonde bei therapierelevanter Oralisierungseinschränkung, weitere 45,3 % aspirierten, 38,5 % von diesen still. Als signifikante Einflussfaktoren erwiesen sich ein höheres Tumorstadium und Patientenalter sowie männliches Geschlecht, die Tumorlokalisation dagegen nur marginal. Schlussfolgerungen Die Studienergebnisse demonstrieren die klinische Bedeutung und die Notwendigkeit der konsequenten und systematischen Versorgung postoperativer Schluckstörungen bei Kopf-Hals-Tumorpatienten im akutstationären Aufenthalt zur Komplettierung moderner onkologischer Therapie.

Published
2021
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3. Klarer Fall von Morbus Menière?

Author

R Birk, Boris A. Stuck, Katrin Richter-Bastian, Felix Bernhard, and Cornelia Emika Mueller

Subjects
medicine.medical_specialty, Text mining, Otorhinolaryngology, business.industry, medicine, Biology, business, Dermatology
Published
2021
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4. Opportunities and challenges in delivering remote primary care during the Coronavirus outbreak

Author

V, Kaufman-Shriqui, M, Shani, M, Boaz, A, Lahad, S, Vinker, and R, Birk

Subjects
Adult, Male, Cross-Sectional Studies, Primary Health Care, Communicable Disease Control, COVID-19, Humans, Physicians, Family, Female, Middle Aged, Pandemics, Anti-Bacterial Agents, Disease Outbreaks
Abstract

Background Social distancing and lockdowns were implemented during the first period of the COVID-19 pandemic. Primary care physicians needed to adapt quickly to deliver remote care/telemedicine. Methods A cross-sectional, 47-item online Google Survey was distributed through the Israel Association of Family Physicians (IAFP) mailing list between March 31-May 5, 2020. The questionnaire included demographics, physician characteristics, and information on usage and perceived telemedicine quality. Sampling weights by sex and age groups were applied. Results One hundred fifty-nine primary care physicians (10.6% of registered IAFP members; 63.5% women; mean age 53.4 ± 10.4 years and median professional experience 21.3 years) replied to the survey. The majority (59.7%) of the participants performed a mixture of in-person along with phone counseling. About 40% had no former telemedicine experience. The majority indicated that telephone and video formats were inferior to in-person consultation (68%, 57.1% online and phone, respectively). The overall counseling quality grade (on a 1–10 scale,)median (IQR)) was 6.2 (3) for telephone and 7(2) for video. While 66.9% reported experiencing no challenges, 10% had technical problems, 10% interpersonal problems, 5.6% scheduling difficulties, and 7.5% other difficulties. Majority of 56.6% physicians indicated they prescribed more antibiotics,16.4% sent more blood tests, 24.5% referred more to experts, and 49.7% referred more to imaging in comparison to usual counseling. Higher phone quality score was significantly associated with physicians who indicated not prescribing more antibiotics during the pandemic (OR = 0.30, 95%CI 0.134–0.688, p = 0.004). Higher online quality score was associated with physicians who indicated not sending more blood tests during the pandemic (OR = 0.06 95%CI 0.008–0.378, P = 0.003). Conclusions Our findings suggest telehealth holds considerable promise for counseling in the primary care setting. However, interpersonal challenges raised by physicians should be understood in-depth to develop tailored training and further examine it in randomized trials while integrating patient-reported outcomes. Finally, further research on utility, cost, and cost-efficiency during remote counseling with follow-ups, medical prescribing, and additional referrals is needed.

Published
2022
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5. Incidence and predictive factors for endograft limb patency of the fenestrated Anaconda endograft used for complex endovascular aneurysm repair

Author

Steven J.G. Leeuwerke, Arne de Niet, Robert H. Geelkerken, Michel M.P.J. Reijnen, Clark J. Zeebregts, P. Bungay, D. Pintar, S. Mylonas, J. Brunkwall, R.D. Moore, M. Salbalbal, M. Delbridge, M.M.P.J. Reijnen, J.W. Lardenoije, K. Oikonomou, P. Kasprzak, R. Meerwaldt, R.H. Geelkerken, A. Papaioannou, A. Stehr, C.J. Zeebregts, I.F.J. Tielliu, A. de Niet, S.J.G. Leeuwerke, S. Langer, R. Lakshminarayan, C.N. Kim, W.P. Ngu, R. Birk, TechMed Centre, Multi-Modality Medical Imaging, and Man, Biomaterials and Microbes (MBM)

Subjects
Time Factors, OCCLUSION, Fenestrated endovascular repair, IMPACT, UT-Hybrid-D, DEVICE, Prosthesis Design, Blood Vessel Prosthesis Implantation, TORTUOSITY, Risk Factors, Animals, Humans, EVAR, Retrospective Studies, ABDOMINAL AORTIC-ANEURYSM, RISK, OUTCOMES, Incidence, Endovascular Procedures, Limb occlusion, Blood Vessel Prosthesis, Boidae, Treatment Outcome, EXPERIENCE, Female, Surgery, STENT GRAFT SYSTEM, Cardiology and Cardiovascular Medicine, Aortic Aneurysm, Abdominal, Thoracoabdominal aortic aneurysm
Abstract

Objective: In the present study, we have described the incidence, risk factors, and outcomes of treatment of limb occlusion for patients who had undergone treatment of complex thoracoabdominal aortic aneurysms with the fenestrated Anaconda endograft (Terumo Aortic, Inchinnan, UK). Methods: Between June 2010 and May 2018, 335 patients had undergone elective fenestrated aortic aneurysm repair at 11 participating centers using the fenestrated Anaconda endograft with a median follow-up of 14.3 months (interquartile range, 27.4 months). The primary outcome measure was freedom from limb occlusion. The secondary outcome measures were freedom from limb-related reintervention, secondary patency, and the risk factors associated with limb occlusion. Results: Of the 335 patients, 30 (9.0%) had presented with limb occlusion during follow-up with a freedom from limb occlusion rate of 98.5%, 91.2%, and 81.7% at 30 days and 1 and 5 years, respectively. In 87% of the cases, no obvious cause for limb occlusion was documented. Primary occlusion had occurred within 30 days in 36.7% and within 1 year in 80.0%. Of the 30 patients, 23 (77%) had undergone an occlusion-related reintervention and 7 (23.3%) had been treated conservatively. The freedom from limb occlusion-related reintervention at 30 days and 1 and 5 years was 97.8%, 93.2%, and 88.6%, respectively. Secondary patency was 91.3% after 1 month and 86.2% after 1 and 5 years. Female sex (odds ratio [OR], 3.27; 95% confidence interval [CI], 1.28-8.34; P =.01) was a statistically significant predictor for limb occlusion. A greater proportion of thrombus in the aneurysm sac appeared to be protective for limb occlusion (0% vs 50%: OR, 0.08; 95% CI, 0.02-0.38; P =.00), as did iliac angulation (OR, 0.99; 95% CI, 0.98-1.00; P =.04). Conclusions: Limb occlusion remains a significant impediment of endograft durability for patients treated with the fenestrated Anaconda endograft, especially for female patients. In contrast, a high aneurysmal thrombus load and a high degree of iliac angulation appeared to be protective for limb occlusion, for which no obvious cause could be identified.

Published
2022

6. Differenzialdiagnostik der Hypersomnie in der operativen Schlafmedizin – mehr als nur Schlafapnoe!

Author

C. Viniol, Boris A. Stuck, W. Cassel, R. Birk, and H. G. Weeß

Subjects
Gynecology, medicine.medical_specialty, business.industry, Sleep apnea, medicine.disease, Sleep medicine, 03 medical and health sciences, 0302 clinical medicine, Otorhinolaryngology, 030220 oncology & carcinogenesis, medicine, Head and neck surgery, Sleep disordered breathing, Differential diagnosis, 030223 otorhinolaryngology, business
Abstract

In der klinischen Versorgung von Patienten mit obstruktiver Schlafapnoe (OSA) nehmen Facharzte fur Hals‑, Nasen- und Ohrenheilkunde eine wichtige Rolle ein, insbesondere in der ambulanten Diagnostik und in der konservativen und operativen Versorgung von Patienten mit Intoleranz gegenuber einer nachtlichen Ventilationstherapie. Wahrend die differenzierte Indikationsstellung fur operative Eingriffe und die Durchfuhrung der notwendigen endoskopischen Zusatzdiagnostik bei schlafbezogenen Atmungsstorungen zu den Kernkompetenzen der HNO-Arzte zahlen, stellen differenzialdiagnostische Erwagungen und die Erkennung komorbider Schlafstorungen fur HNO-Arzte eine besondere Herausforderung dar, sofern sie nicht umfangreich schlafmedizinisch qualifiziert bzw. tatig sind. Gerade bei der Indikationsstellung fur operative Masnahmen sind jedoch differenzialdiagnostische Erwagungen von besonderer Bedeutung. Auch wenn die Tagesschlafrigkeit das klassische Symptom der OSA darstellt, sind entsprechend andere hypersomnische Storungen bei der Abklarung zu berucksichtigen. Insbesondere bei bestehender Schlafapnoe konnen begleitende hypersomnische Storungen ubersehen und dadurch Fehlindikationen begunstigt werden. Anhand zweier Fallbeispiele soll die Narkolepsie als komorbide Storung und Differenzialdiagnose vorgestellt werden.

Published
2020
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13. [Differential diagnosis of hypersomnia in surgical sleep medicine-more than just sleep apnea!]

Author

B A, Stuck, H G, Weeß, C, Viniol, W, Cassel, and R, Birk

Subjects
Diagnosis, Differential, Sleep Apnea Syndromes, Germany, Humans, Medicine, Disorders of Excessive Somnolence, Sleep
Abstract

Otorhinolaryngologists play a vital role in the management of patients with obstructive sleep apnea (OSA) in Germany, particularly with regards to outpatient diagnostics as well as conservative and surgical treatment of patients with intolerance to ventilation therapy. Although establishment of differential indications for surgical therapy and performance of additional preoperative drug-induced sleep endoscopy in patients with sleep-disordered breathing are among the core competencies of otorhinolaryngologists, differential diagnostic considerations and detection of comorbid sleep disorders can be challenging, particularly for those without extensive sleep medicine training and experience. However, detection of comorbid sleep disorders is of particular importance when permanent surgical treatment is considered. Daytime sleepiness is the typical leading symptom of OSA; nevertheless, other disorders of hypersomnolence need to be considered in these patients and can easily be overlooked. This may lead to inadequate indications for surgical treatment. Based on two case reports, narcolepsy is presented as a comorbid disorder and differential diagnosis in patients with OSA.In der klinischen Versorgung von Patienten mit obstruktiver Schlafapnoe (OSA) nehmen Fachärzte für Hals‑, Nasen- und Ohrenheilkunde eine wichtige Rolle ein, insbesondere in der ambulanten Diagnostik und in der konservativen und operativen Versorgung von Patienten mit Intoleranz gegenüber einer nächtlichen Ventilationstherapie. Während die differenzierte Indikationsstellung für operative Eingriffe und die Durchführung der notwendigen endoskopischen Zusatzdiagnostik bei schlafbezogenen Atmungsstörungen zu den Kernkompetenzen der HNO-Ärzte zählen, stellen differenzialdiagnostische Erwägungen und die Erkennung komorbider Schlafstörungen für HNO-Ärzte eine besondere Herausforderung dar, sofern sie nicht umfangreich schlafmedizinisch qualifiziert bzw. tätig sind. Gerade bei der Indikationsstellung für operative Maßnahmen sind jedoch differenzialdiagnostische Erwägungen von besonderer Bedeutung. Auch wenn die Tagesschläfrigkeit das klassische Symptom der OSA darstellt, sind entsprechend andere hypersomnische Störungen bei der Abklärung zu berücksichtigen. Insbesondere bei bestehender Schlafapnoe können begleitende hypersomnische Störungen übersehen und dadurch Fehlindikationen begünstigt werden. Anhand zweier Fallbeispiele soll die Narkolepsie als komorbide Störung und Differenzialdiagnose vorgestellt werden.

Published
2020

14. Outcomes after treatment of complex aortic abdominal aneurysms with the fenestrated Anaconda endograft

Author

Piotr M. Kasprzak, M.M.P.J. Reijnen, R.D. Moore, P. Bungay, Robert H. Geelkerken, C.J. Zeebregts, I. F. J. Tielliu, Arne de Niet, R. Birk, A. de Niet, R. Lakshminarayan, Spyridon N. Mylonas, C.N. Kim, K. Oikonomou, R. Meerwaldt, M. Delbridge, D. Pintar, A. Papaioannou, S. Langer, Jan Brunkwall, Clark J. Zeebregts, Michel M.P.J. Reijnen, A. Stehr, W.P. Ngu, Jan Willem Lardenoije, Man, Biomaterials and Microbes (MBM), and Multi-Modality Medical Imaging

Subjects
Male, Time Factors, Endoleak, Fenestrated Anaconda, UT-Hybrid-D, 030204 cardiovascular system & hematology, Aortic aneurysm, 0302 clinical medicine, Interquartile range, Risk Factors, Medicine, 030212 general & internal medicine, biology, Endovascular, Endovascular Procedures, EDITORS CHOICE, Abdominal aortic aneurysm, Treatment Outcome, ENDOLEAKS, Female, GRAFTS, Abdominal aneurysm, Cardiology and Cardiovascular Medicine, After treatment, medicine.medical_specialty, RENAL-FUNCTION, Renal function, Prosthesis Design, Risk Assessment, Anaconda, 03 medical and health sciences, Blood Vessel Prosthesis Implantation, FEVAR, Humans, Vascular Patency, Aged, Retrospective Studies, Aortic Aneurysm, Thoracic, business.industry, ENDOVASCULAR REPAIR, Odds ratio, medicine.disease, biology.organism_classification, n/a OA procedure, Surgery, Blood Vessel Prosthesis, EXPERIENCE, business, Aortic Aneurysm, Abdominal
Abstract

Objective: To date, information on the fenestrated Anaconda endograft is limited to case series with a small sample size. This study was performed to assess the technical and clinical outcome of this device in a large international case series. Methods: All worldwide centers having treated more than 15 complex abdominal aortic aneurysms (AAA) or type IV thor- acoabdominal aortic aneurysm patients with the fenestrated Anaconda endograft were approached. Main outcome pa- rameters were procedural technical success, postoperative and follow-up clinical outcome for endoleaks, target vessel patency, reintervention rate, and patient survival. Results: Three hundred thirty-five consecutive cases treated between June 2010 and May 2018 in 11 sites were included. Patients were treated for a short neck infrarenal (n = 98), juxtarenal (n =191), suprarenal AAA (n = 27), or type IV thoracoabdominal aortic aneurysm (n =19). Mean age was 73.6 ? 4.6 years (292 male). Endografts contained a total of 920 fenestrations, with a mean of 2.7 ? 0.8 fenestrations per case. Technical success was 88.4% (primary, 82.7%; assisted primary 5.7%). In 6.9% of cases, a pro- cedural type IA endoleak was observed, spontaneously disappearing in 82.6% during early follow-up. The development of a type IA endoleak was associated with greater neck angulation (odds ratio [OR], 0.94; P = .01), three fenestrations (OR, 42.7; P = .01) and the presence of augmented proximal rings (OR, 0.17; P = .03). Median follow-up was 1.2 years (interquartile range, 0.4-2.6). The mean estimated glomerular filtration rate deteriorated from 67.6 ? 19.3 mL/min/1.73 m 2 preoperatively to 59.3 ? 22.7 mL/min/ 1.73 m 2 at latest follow-up ( P = .00). The freedom from AAA growth were 97.9 ? 0.9% (n =190) and 86.4 ? 3.0% (n = 68), with a freedom from AAA rupture of 99.7 ? 0.3% (n = 191) and 99.1 ? 0.7% (n = 68), at 1 and 3 years, respectively. The endoleak-free survival, excluding spontaneously resolved procedural endoleaks, at 1 and 3 years was 73.4 ? 2.6 (n = 143) and 65.6 ? 3.4% (n = 45), respectively. The target vessel patency at one and three years were 96.4 ? 0.7% (n = 493) and 92.7 ? 1.4% (n = 156), respectively. A total of 75 reinterventions were done in 64 cases (19.1%), of which 25 cases for an endoleak. The reintervention-free survival at 1 and 3 years were 83.6 ? 2.2% (n = 190) and 71.0 ? 3.7% (n = 68), respectively. No deaths during procedure, extending within 24 hours postoperatively, were observed. Within 30 days 14 patients (4.2%) died and during follow-up another 39 patients (11.6%) died. Three deaths were considered AAA related (one rupture, one endograft infection, and one bilateral renal artery occlusion). The estimated cumulative survival at 1 and 3 years were 89.8 ? 1.8% (n =191) and 79.2 ? 3.0% (n = 68), respectively. Conclusions: The custom-made fenestrated Anaconda endograft is a valuable option for the treatment of a complex AAA. A procedural type IA endoleak is seen relatively frequently, but spontaneously resolves in most cases. (J Vasc Surg 2020;72:25-35.)

Published
2020

19. DNA methylation age calculators reveal association with diabetic neuropathy in type 1 diabetes

Author

Thomas Donner, P. Rezaeian, John I. Malone, Sharon B. Schwartz, Xiaoyu Gao, Szilard Kiss, Matthew J. Budoff, David R. Sell, A. Dwoskin, Ronald J. Prineas, C. Pittman, M. Reid, C. McDonald, S. Caulder, M. Szpiech, Oscar B. Crofford, Rachel G. Miller, Louis A. Lobes, M. Patronas, C. Canny, M. E. Lackaye, Sandra R. Montezuma, Richard M. Bergenstal, Patricia Gatcomb, Julie A. Stoner, H. Pan, James L. Kinyoun, J. Mortenson, Osama Hamdy, Connie Fountain, David D. Moore, Kusiel Perlman, R. Trail, David A. Lee, J. Sheindlin, Samuel Dagogo-Jack, Jeffrey L. Mahon, Jill P. Crandall, L. Gill, T. Thompson, Lee M. Jampol, K. Koushan, David S. Schade, J. Brown-Friday, M. Basco, S. Dunnigan, J. Bylsma, R. Birk, L. H. Ketai, J. Hotaling, Stephen W. Scherer, W. Mestrezat, Stephan Villavicencio, R. Lyon, M. Carney, John Kramer, Sunder Mudaliar, David M. Nathan, M. Moran, F. Leandre, James W. Albers, L. Survant, Joseph F. Polak, Manjot K. Gill, Anton Orlin, M. Prince, Pamela A. Silver, Amy K. Saenger, John D. Brunzell, Kathleen E. Bainbridge, L. Babbione, Amisha Wallia, J. Vaccaro-Kish, Bradley D. Jones, M. Hebdon, L. McKenzie, Richard M. Hoffman, S. Chang, C. Siebert, George S. Sharuk, D. Counts, A. Lucas, P. Ramos, N. Burkhart, N. Bakshi, N. Flaherty, D. Kenny, M. Driscoll, Harjit Chahal, Ronald K. Mayfield, S. Hensley, E. Weimann, M. Franz, Martin J. Stevens, N. S. Gregory, Christopher J. O'Donnell, J. Laechelt, Pamela Ossorio, Jerry P. Palmer, Rama Natarajan, G. Ziegler, K. Martin, R. Beaser, C. Beck, L. Zhang, T. J. Declue, David M. Kendall, H. Solc, A. Vella, H. Martinez, Cormac T. Taylor, S. Neill, Douglas A. Greene, P. Lee, D. Norman, Andrew J. Barkmeier, Dean P. Hainsworth, Alka Jain, Sapna Gangaputra, N. Thangthaeng, Lorraine Thomas, Michael H. Brent, M. Bracey, Philip Raskin, Q. Clemens, Barbara H. Braffett, Mark S. Mandelcorn, Lloyd Paul Aiello, John E. Godine, T. Speigelberg, R. Chan, R. Hanna, Shelley B. Bull, William I. Sivitz, R. Sussman, C. Kwong, S. Cercone, P. Hollander, N. Leloudes, Joseph M. Terry, J. Wesche, E. A. Tanaka, D. Rosenberg, Wanjie Sun, L. Sun, Tom Clark, Deborah K. Schlossman, Louis M. Luttrell, R. Dunn, A. Farr, K. McVary, Gayle M. Lorenzi, A. Joseph, Catherine C. Cowie, M. Barr, D. Zimbler, S. Mendley, S. Schussler, N. Grove, Matthew D. Davis, Jong Mu Sun, Sophie Rogers, John P. Bantle, Brandy N. Rutledge, Senda Ajroud-Driss, Vincent M. Monnier, Cladd E. Stevens, Y. G. He, M. Phillips, C. Williams, J. MacIndoe, Kaleigh Farrell, Helen Lambeth, Ayad A. Jaffa, J. Quin, Morey W. Haymond, R. Kirby, D. Steinberg, William H. Herman, M. Mech, Arup Das, Robert Detrano, J. Brown, D. McMillan, Linda Snetselaar, Mark W. Johnson, R. Zeitler, T. Taylor, Peter R. Pavan, Michael H. Goldbaum, Bruce A. Perkins, R. G. Campbell, David A. Nicolle, R. J. van der Geest, Irene Hramiak, D. Freking, Lucy A. Levandoski, S. Colson, Charles Campbell, Victoria R. Trapani, Lawrence J. Singerman, D. Meyer, W. Tang, J. Soule, Anita Harrington, Julie A. Nelson, John A. Colwell, Naji Younes, P. Salemi, K. Hansen, Trevor J. Orchard, S. Huddleston, L. Steranchak, C. Sommer, G. Castle, J. Ginsberg, Paula McGee, V. Gama, John Dupre, Z. Strugula, M. Swenson, N. Wong, David A. Bluemke, M. Nutaitis, Anita Agarwal, M. Lin, K. Nickander, Elsayed Z. Soliman, Joao A. Lima, M. L. Schluter, Fred W. Whitehouse, Lisa Diminick, C. Cornish, M. Spencer, Daniel T. Lackland, Ionut Bebu, Hunter Wessells, S. Yacoub-Wasef, A. Determan, L. Van Ottingham, Howard Wolpert, R. Ehrlich, A. Blevins, L. Jovanovic, D. Finegold, Davida F. Kruger, Jye-Yu C. Backlund, K. Chan, Timothy J. Murtha, R. K. Mayfield, Robert W. Cavicchi, Maria F. Lopes-Virella, Thomas A. Weingeist, K. Lee, Mary E. Larkin, B. Blodi, J. Gott, Timothy J. Lyons, J. Selby, Chris Ryan, J. Harth, P. Pugsley, L. Keasler, John D. Maynard, Paul G. Arrigg, Amy B. Karger, P. Colby, J. Farquhar, Mark H. Schutta, Murk-Hein Heinemann, Kathie L. Hermayer, B. Bosco, C. Lovell, A. Bhan, A. Galprin, M. Cayford, M. Schumer, John E. Chapin, D. Rubinstein, F. Miao, V. Asuquo, Catherine L. Martin, Rodney A. Lorenz, Samuel S. Engel, L. Funk, Cyndi F. Liu, Barbara J. Maschak-Carey, Stephen S. Feman, P. Lindsey, M. Giotta, Philip A. Low, S. Kwon, R. Fahlstrom, A. Iannacone, B. French, H. Remtema, L. Cimino, S. Barron, J. McConnell, Jane L. Lynch, L. Kim, T. Williams, A. Degillio, Blanche M. Chavers, M. Novak, Julio V. Santiago, Ronald P. Danis, P. Gaston, Tae Sup Lee, T. Woodfill, R. Cuddihy, Scott M. Steidl, Alanna C. Morrison, E. Ryan, D. Lawrence, D. Cros, T. Adkins, D. Adelman, L. Dews, Patricia A. Cleary, J. Parker, L. Olmos De Koo, C. Kim, Mark R. Palmert, P. Astelford, Stefan Fritz, B. Olson, Kelvin C. Fong, Alan M. Jacobson, Stanley L. Hazen, D. Hornbeck, K. Folino, M. L. Bernal, Gabriel Virella, William V. Tamborlane, Neil H. White, Daniel L. McGee, Denis Daneman, H. Shamoon, William Dahms, S. Elsing, S. Brink, J. Ahern, Delnaz Roshandel, John M. Pach, N. W. Rodger, E. Cupelli, Dara D. Koozekanani, Abbas E. Kitabchi, K. Stoessel, B. Petty, Jamie R. Wood, J. Seegmiller, T. Strand, Y. Li, Eva L. Feldman, Larry Rand, Robert C. Colligan, T. Smith, A. Carlson, David J. Brillon, Margaret L. Bayless, M. Ong, S. Darabian, W. Hsu, Janet E. Olson, B. Rogness, N. Silvers, M. Pfiefer, B. Schaefer, E. Mendelson, S. Braunstein, Maren Nowicki, R. Reed, James S. Floyd, Z. M. Zhang, T. Sandford, R. B. Avery, A. Pratt, Paolo S. Silva, H. Bode, Alexander J. Brucker, Nikhil D. Patel, Alexander R. Lyon, M. Jenner, N. Wimmergren, L. Tuason, J. Rosenzwieg, D. J. Becker, C. Gauthier-Kelly, M. Richardson, Richard S. Crow, Andrew D. Paterson, Mark E. Molitch, Suzanne M. Strowig, S. Pendegast, M. Burger, Ramzi K. Hemady, J. Dingledine, I. H. de Boer, L. Mayer, F. Perdikaris, Om P. Ganda, F. Thoma, Karen J. Cruickshanks, Abraham Thomas, K. Klumpp, Jerry D. Cavallerano, D. Zheng, Annette Barnie, J. L. Canady, C. Wigley, David G. Miller, Sheila Smith-Brewer, D. Ostrowski, P. Crawford, K. Kelly, Robert G. Devenyi, B. Zimmerman, Susan M. Hitt, C. Johnson, L. Gurry, R. Jarboe, E. Angus, David E. Goldstein, A. Killeen, H. Schrott, Orville G. Kolterman, Mark R. Burge, Michael Rubin, J. Lipps Hagan, Alicia J. Jenkins, Hugh D. Wabers, R. Warhol, Edward Chaum, Karen L. Jones, L. Spillers, C. Miao, J. K. Jones, Angelo J. Canty, Rickey E. Carter, Evrim B. Turkbey, B. Burzuk, R. Woodwick, Evica Simjanoski, Michael W. Steffes, S. Crowell, Suresh D. Shah, H. Ricks, J. D. Carey, Paul A. Edwards, S. Holt, W. F. Schwenk, Ronald J. Oudiz, E. Brown, J. Heier, R. L. Ufret-Vincenty, L. M. Aiello, Robert A. Rizza, Karen L. Anderson, Valerie L. Arends, J. Giangiacomo, R. Liss, Aruna V. Sarma, B. Levy, Ellen J. Anderson, S. Catton, P. Callahan, Rodica Pop-Busui, S. Debrabandere, S. Moser, Bernard H. Doft, A. Malayeri, C. Johannes, R. Ramker, J. Rich, M. Fox, Rukhsana G. Mirza, Katherine A. Morgan, Thomas J. Songer, C. Shah, H. Engel, Saul M. Genuth, S. Ferguson, Anushka Patel, C. Haggan, P. Lou, J. Gordon, M. B. Murphy, D. Sandstrom, Dawn M. Ryan, Daniel H. O'Leary, B. Gloeb, Lois E. Schmidt, H. Zegarra, D. Dalton, W. Brown, Tom G. Sheidow, Margaret E. Stockman, Shyam M. Thomas, Charles McKitrick, Jyotika K. Fernandes, P. A. Bourne, L. Baker, G. Friedenberg, Allan Gordon, Allan L. Drash, S. Yoser, D. Wood, S. Johnsonbaugh, A. De Manbey, L. Kaminski, M. May, L. Bestourous, A. Kowarski, M. Geckle, M. Hartmuller, Michael Bryer-Ash, S. List, F. Goetz, V. Reppucci, D. Etzwiler, Rose A. Gubitosi-Klug, M. Brabham, E. Golden, A. Nayate, J. Hu, M. McLellan, Ronald Klein, N. Rude, B. Vittetoe, John M. Lachin, M. Christofi, Zhuo Chen, Isaac Boniuk, C. Strauch, K. Gunyou, L. Delahanty, W. T. Garvey, Andrew P. Boright, Larry D. Hubbard, D. Weiss, Igor Grant, Jonathan Q. Purnell, Jean M. Bucksa, N. Olson, and B. Zinman

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Diabetic neuropathy, Adolescent, 030209 endocrinology & metabolism, Gastroenterology, Nephropathy, Epigenesis, Genetic, Diabetic complications, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Diabetic Neuropathies, Internal medicine, Diabetes mellitus, Albumins, Genetics, Medicine, Humans, Molecular Biology, Genetics (clinical), Whole blood, Oligonucleotide Array Sequence Analysis, Type 1 diabetes, business.industry, Research, dNaM, DNA methylation age, DNA Methylation, medicine.disease, 030104 developmental biology, Blood pressure, Peripheral neuropathy, Diabetes Mellitus, Type 1, CpG Islands, Female, business, Developmental Biology, Genome-Wide Association Study
Abstract

Background Many CpGs become hyper or hypo-methylated with age. Multiple methods have been developed by Horvath et al. to estimate DNA methylation (DNAm) age including Pan-tissue, Skin & Blood, PhenoAge, and GrimAge. Pan-tissue and Skin & Blood try to estimate chronological age in the normal population whereas PhenoAge and GrimAge use surrogate markers associated with mortality to estimate biological age and its departure from chronological age. Here, we applied Horvath’s four methods to calculate and compare DNAm age in 499 subjects with type 1 diabetes (T1D) from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study using DNAm data measured by Illumina EPIC array in the whole blood. Association of the four DNAm ages with development of diabetic complications including cardiovascular diseases (CVD), nephropathy, retinopathy, and neuropathy, and their risk factors were investigated. Results Pan-tissue and GrimAge were higher whereas Skin & Blood and PhenoAge were lower than chronological age (p < 0.0001). DNAm age was not associated with the risk of CVD or retinopathy over 18–20 years after DNAm measurement. However, higher PhenoAge (β = 0.023, p = 0.007) and GrimAge (β = 0.029, p = 0.002) were associated with higher albumin excretion rate (AER), an indicator of diabetic renal disease, measured over time. GrimAge was also associated with development of both diabetic peripheral neuropathy (OR = 1.07, p = 9.24E−3) and cardiovascular autonomic neuropathy (OR = 1.06, p = 0.011). Both HbA1c (β = 0.38, p = 0.026) and T1D duration (β = 0.01, p = 0.043) were associated with higher PhenoAge. Employment (β = − 1.99, p = 0.045) and leisure time (β = − 0.81, p = 0.022) physical activity were associated with lower Pan-tissue and Skin & Blood, respectively. BMI (β = 0.09, p = 0.048) and current smoking (β = 7.13, p = 9.03E−50) were positively associated with Skin & Blood and GrimAge, respectively. Blood pressure, lipid levels, pulse rate, and alcohol consumption were not associated with DNAm age regardless of the method used. Conclusions Various methods of measuring DNAm age are sub-optimal in detecting people at higher risk of developing diabetic complications although some work better than the others.

Published
2020

20. Therapie rückenlagebezogener obstruktiver Schlafapnoe mittels Smartphone-App

Author

Karl Hörmann, D. Haas, Boris A. Stuck, Jan Maurer, JU Sommer, and R. Birk

Subjects
medicine.medical_specialty, Supine position, business.industry, Mobile apps, Smartphone application, medicine.disease, Obstructive sleep apnea, 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Otorhinolaryngology, Sleep apnea syndromes, medicine, Head and neck surgery, Physical therapy, business, 030217 neurology & neurosurgery
Abstract

Hintergrund Die ruckenlagebezogene obstruktive Schlafapnoe („positional obstructive sleep apnea“, POSA) tritt haufig bei der leicht- und mittelgradigen Form der obstruktiven Schlafapnoe (OSA) auf. Zur Therapie werden 2 „smartphone applications“ (Apps) angeboten, welche vorgeben, die Ruckenlage zu verhindern, indem sie bei auf der Brust fixiertem Smartphone die Ruckenlage erkennen und einen Vibrationsalarm auslosen: fur Android „Apnea Sleep Position Trainer“ und fur iOS „SomnoPose – Sleep Position Monitor“. Dies soll die Patienten zu einem Wechsel der Schlafposition veranlassen. Diese Apps wurden jedoch bisher nicht systematisch evaluiert.

Published
2017
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30. Oxidative Stress and Cardiovascular Risk in Type 1 Diabetes Mellitus: Insights From the DCCT/EDIC Study

Author

W.H. Wilson Tang, Paula McGee, John M. Lachin, Daniel Y. Li, Byron Hoogwerf, Stanley L. Hazen, D.M. Nathan, B. Zinman, O. Crofford, S. Genuth, J. Brown‐Friday, J. Crandall, H. Engel, S. Engel, H. Martinez, M. Phillips, M. Reid, H. Shamoon, J. Sheindlin, R. Gubitosi‐Klug, L. Mayer, S. Pendegast, H. Zegarra, D. Miller, L. Singerman, S. Smith‐Brewer, M. Novak, J. Quin, Saul Genuth, M. Palmert, E. Brown, J. McConnell, P. Pugsley, P. Crawford, W. Dahms, N.S. Gregory, M.E. Lackaye, S. Kiss, R. Chan, A. Orlin, M. Rubin, D. Brillon, V. Reppucci, T. Lee, M. Heinemann, S. Chang, B. Levy, L. Jovanovic, M. Richardson, B. Bosco, A. Dwoskin, R. Hanna, S. Barron, R. Campbell, A. Bhan, D. Kruger, J.K. Jones, P.A. Edwards, J.D. Carey, E. Angus, A. Thomas, A. Galprin, M. McLellan, F. Whitehouse, R. Bergenstal, M. Johnson, K. Gunyou, L. Thomas, J. Laechelt, P. Hollander, M. Spencer, D. Kendall, R. Cuddihy, P. Callahan, S. List, J. Gott, N. Rude, B. Olson, M. Franz, G. Castle, R. Birk, J. Nelson, D. Freking, L. Gill, W. Mestrezat, D. Etzwiler, K. Morgan, L.P. Aiello, E. Golden, P. Arrigg, V. Asuquo, R. Beaser, L. Bestourous, J. Cavallerano, R. Cavicchi, O. Ganda, O. Hamdy, R. Kirby, T. Murtha, D Schlossman, S. Shah, G. Sharuk, P. Silva, P. Silver, M. Stockman, J. Sun, E. Weimann, H. Wolpert, L.M. Aiello, A. Jacobson, L. Rand, J. Rosenzwieg, M.E. Larkin, M. Christofi, K. Folino, J. Godine, P. Lou, C. Stevens, E. Anderson, H. Bode, S. Brink, C. Cornish, D. Cros, L. Delahanty, eManbey, C. Haggan, J. Lynch, C. McKitrick, D. Norman, D. Moore, M. Ong, C. Taylor, D. Zimbler, S. Crowell, S. Fritz, K. Hansen, C. Gauthier‐Kelly, F.J. Service, G. Ziegler, A. Barkmeier, L. Schmidt, B. French, R. Woodwick, R. Rizza, W.F. Schwenk, M. Haymond, J. Pach, J. Mortenson, B. Zimmerman, A. Lucas, R. Colligan, L. Luttrell, M. Lopes‐Virella, S. Caulder, C. Pittman, N. Patel, K. Lee, M. Nutaitis, J. Fernandes, K. Hermayer, S. Kwon, A Blevins, J. Parker, J. Colwell, D. Lee, J. Soule, P. Lindsey, M. Bracey, A. Farr, S. Elsing, T. Thompson, J. Selby, T. Lyons, S. Yacoub‐Wasef, M. Szpiech, D. Wood, R. Mayfield, M. Molitch, D. Adelman, S. Colson, L. Jampol, A. Lyon, M. Gill, Z. Strugula, L. Kaminski, R. Mirza, E. Simjanoski, D. Ryan, C. Johnson, A. Wallia, S. Ajroud‐Driss, P. Astelford, N. Leloudes, A. Degillio, B. Schaefer, S. Mudaliar, G Lorenzi, M. Goldbaum, K. Jones, M. Prince, M. Swenson, I. Grant, R. Reed, R. Lyon, O. Kolterman, M. Giotta, T. Clark, G. Friedenberg, W.I. Sivitz, B. Vittetoe, J. Kramer, M. Bayless, R. Zeitler, H. Schrott, N. Olson, L. Snetselaar, R. Hoffman, J. MacIndoe, T. Weingeist, C. Fountain, R. Miller, S. Johnsonbaugh, M. Patronas, M. Carney, S. Mendley, P. Salemi, R. Liss, M. Hebdon, D. Counts, T. Donner, J. Gordon, R. Hemady, A. Kowarski, D. Ostrowski, S. Steidl, B. Jones, W.H. Herman, C.L. Martin, R. Pop‐Busui, D.A. Greene, M.J. Stevens, N. Burkhart, T. Sandford, J. Floyd, J. Bantle, N. Flaherty, J. Terry, D. Koozekanani, S. Montezuma, N. Wimmergren, B. Rogness, M. Mech, T. Strand, J. Olson, L. McKenzie, C. Kwong, F. Goetz, R. Warhol, D. Hainsworth, D. Goldstein, S. Hitt, J. Giangiacomo, D.S Schade, J.L. Canady, M.R. Burge, A. Das, R.B. Avery, L.H. Ketai, J.E. Chapin, M.L. Schluter, J. Rich, C. Johannes, D. Hornbeck, M. Schutta, P.A. Bourne, A. Brucker, S. Braunstein, S. Schwartz, B.J. Maschak‐Carey, L. Baker, T. Orchard, L. Cimino, T. Songer, B. Doft, S. Olson, D. Becker, D. Rubinstein, R.L. Bergren, J. Fruit, R. Hyre, C. Palmer, N. Silvers, L. Lobes, P. Paczan Rath, P.W. Conrad, S. Yalamanchi, J. Wesche, M. Bratkowksi, S. Arslanian, J. Rinkoff, J. Warnicki, D. Curtin, D. Steinberg, G. Vagstad, R. Harris, L. Steranchak, J. Arch, K. Kelly, P. Ostrosaka, M. Guiliani, M. Good, T. Williams, K. Olsen, A. Campbell, C. Shipe, R. Conwit, D. Finegold, M. Zaucha, A. Drash, A. Morrison, J.I. Malone, M.L. Bernal, P.R. Pavan, N. Grove, E.A. Tanaka, D. McMillan, J. Vaccaro‐Kish, L. Babbione, H. Solc, T.J. DeClue, S. Dagogo‐Jack, C. Wigley, H. Ricks, A. Kitabchi, E. Chaum, M.B. Murphy, S. Moser, D. Meyer, A. Iannacone, S. Yoser, M. Bryer‐Ash, S. Schussler, H. Lambeth, P. Raskin, S. Strowig, M. Basco, S. Cercone, A. Barnie, R. Devenyi, M. Mandelcorn, M. Brent, S. Rogers, A. Gordon, N. Bakshi, B. Perkins, L. Tuason, F. Perdikaris, R. Ehrlich, D. Daneman, K. Perlman, S Ferguson, J. Palmer, R. Fahlstrom, I.H. de Boer, J. Kinyoun, L. Van Ottingham, S. Catton, J. Ginsberg, C. McDonald, J. Harth, M. Driscoll, T. Sheidow, J. Mahon, C. Canny, D. Nicolle, P. Colby, J. Dupre, I. Hramiak, N.W. Rodger, M. Jenner, T. Smith, W. Brown, M. May, J. Lipps Hagan, A. Agarwal, T. Adkins, R. Lorenz, S. Feman, L. Survant, N.H. White, L. Levandoski, G. Grand, M. Thomas, D. Joseph, K. Blinder, G. Shah, D. Burgess, I. Boniuk, J. Santiago, W. Tamborlane, P. Gatcomb, K. Stoessel, P. Ramos, K. Fong, P. Ossorio, J. Ahern, L. Meadema‐Mayer, C. Beck, K. Farrell, J Quin, P. Gaston, R. Trail, J. Lachin, J. Backlund, I. Bebu, B. Braffett, L. Diminick, X. Gao, W. Hsu, K. Klumpp, H. Pan, V. Trapani, P. Cleary, P. McGee, W. Sun, S. Villavicencio, K. Anderson, L. Dews, Naji Younes, B. Rutledge, K. Chan, D. Rosenberg, B. Petty, A. Determan, D. Kenny, C. Williams, C. Cowie, C. Siebert, M. Steffes, V. Arends, J. Bucksa, M. Nowicki, B. Chavers, D. O'Leary, J. Polak, A. Harrington, L. Funk, R Crow, B. Gloeb, S. Thomas, C. O'Donnell, E.Z. Soliman, Z.M. Zhang, Y. Li, C. Campbell, L. Keasler, S. Hensley, J. Hu, M. Barr, T. Taylor, R. Prineas, E.L. Feldman, J.W. Albers, P. Low, C. Sommer, K. Nickander, T. Speigelberg, M. Pfiefer, M. Schumer, M. Moran, J. Farquhar, C. Ryan, D. Sandstrom, M. Geckle, E. Cupelli, F. Thoma, B. Burzuk, T. Woodfill, R. Danis, B. Blodi, D. Lawrence, H. Wabers, S. Gangaputra, S. Neill, M. Burger, J. Dingledine, V. Gama, R. Sussman, M. Davis, L. Hubbard, M. Budoff, S. Darabian, P. Rezaeian, N. Wong, M. Fox, R. Oudiz, L Kim, R. Detrano, K. Cruickshanks, D. Dalton, K. Bainbridge, J. Lima, D. Bluemke, E. Turkbey, der Geest, C. Liu, A. Malayeri, A. Jain, C. Miao, H. Chahal, R. Jarboe, V. Monnier, D. Sell, C. Strauch, S. Hazen, A. Pratt, W. Tang, J. Brunzell, J. Purnell, R. Natarajan, F. Miao, L. Zhang, Z. Chen, A. Paterson, A. Boright, S. Bull, L. Sun, S. Scherer, T.J. Lyons, A. Jenkins, R. Klein, G. Virella, A. Jaffa, R. Carter, J. Stoner, W.T. Garvey, D. Lackland, M. Brabham, D. McGee, D. Zheng, R.K. Mayfield, J. Maynard, H. Wessells, A Sarma, R. Dunn, S. Holt, J. Hotaling, C. Kim, Q. Clemens, J. Brown, and K. McVary

Subjects
medicine.medical_specialty, endocrine system diseases, 030209 endocrinology & metabolism, Disease, 030204 cardiovascular system & hematology, Lower risk, medicine.disease_cause, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Diabetes mellitus, medicine, Diseases of the circulatory (Cardiovascular) system, Coronary Heart Disease, Glycemic, Original Research, free radical, Inflammation, Type 1 diabetes, biology, business.industry, Paraoxonase, medicine.disease, paraoxonase, 3. Good health, RC666-701, Cohort, diabetes mellitus, biology.protein, Cardiology and Cardiovascular Medicine, business, Oxidant Stress, Oxidative stress, F2Isoprostane, Biomarkers
Abstract

Background Hyperglycemia leading to increased oxidative stress is implicated in the increased risk for the development of macrovascular and microvascular complications in patients with type 1 diabetes mellitus. Methods and Results A random subcohort of 349 participants was selected from the DCCT / EDIC (Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications) cohort. This included 320 controls and 29 cardiovascular disease cases that were augmented with 98 additional known cases to yield a case cohort of 447 participants (320 controls, 127 cases). Biosamples from DCCT baseline, year 1, and closeout of DCCT , and 1 to 2 years post‐ DCCT ( EDIC years 1 and 2) were measured for markers of oxidative stress, including plasma myeloperoxidase, paraoxonase activity, urinary F 2α isoprostanes, and its metabolite, 2,3 dinor‐8 iso prostaglandin F 2α . Following adjustment for glycated hemoblobin and weighting the observations inversely proportional to the sampling selection probabilities, higher paraoxonase activity, reflective of antioxidant activity, and 2,3 dinor‐8 iso prostaglandin F 2α , an oxidative marker, were significantly associated with lower risk of cardiovascular disease (−4.5% risk for 10% higher paraoxonase, P iso prostaglandin F 2α , P =0.0092). In contrast, the oxidative markers myeloperoxidase and F 2α isoprostanes were not significantly associated with cardiovascular disease after adjustment for glycated hemoblobin. There were no significant differences between DCCT intensive and conventional treatment groups in the change in all biomarkers across time segments. Conclusions Heightened antioxidant activity (rather than diminished oxidative stress markers) is associated with lower cardiovascular disease risk in type 1 diabetes mellitus, but these biomarkers did not change over time with intensification of glycemic control. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifiers: NCT 00360815 and NCT 00360893.

Published
2018

37. [Treatment of supine position-related obstructive sleep apnea with smartphone applications]

Author

D, Haas, R, Birk, J T, Maurer, K, Hörmann, B A, Stuck, and J U, Sommer

Subjects
Male, Sleep Apnea, Obstructive, Polysomnography, Middle Aged, Actigraphy, Mobile Applications, Patient Positioning, Self Care, Treatment Outcome, Therapy, Computer-Assisted, Supine Position, Humans, Female, Diagnosis, Computer-Assisted, Smartphone
Abstract

Positional obstructive sleep apnea (POSA) is common in mild and moderate forms of obstructive sleep apnea (OSA). Two smartphone applications (apps) professing to avoid the supine position (SP) are available: for Android the "Apnea Sleep Position Trainer" and for iOS the "SomnoPose-Sleep Position Monitor". The smartphone needs to be attached to the chest to recognize SP, which then triggers a vibration alarm. This is intended to encourage the patient to change position and the vibration stops as soon as SP is left. These apps, however, have not yet undergone a systematic evaluation.Adult patients with polysomnographically diagnosed POSA were invited to participate in the study. POSA was defined as an apnea-hypopnea index (AHI) in SP 10, with AHI in a lateral position 10 and doubling of the AHI in SP. After 1 month, a control polysomnography (PSG) was performed and compliance (at least 4 h/night on 5 of 7 days) was evaluated after 6 months by phone. A sufficient therapy was defined as reduction in SP to10% of the total sleep time and to an overall AHI 10.Although 57 patients entered the study, 24 did not appear to the PSG control; therefore, 33 patients finished the study, of whom 25 were treated successfully. The overall AHI in 33 patients was reduced from 14.5 ± 9.0 to 9.5 ± 12.6 and the time in SP decreased significantly from 71.1 ± 50.5 to 25.4 ± 65.0 min. Compliance among the 25 continuously treated patients after 6 months was 79.2%.Both smartphone apps have the capability to prevent PS in POSA patients and can potentially offer a cost-effective option in the treatment of POSA.

Published
2017

39. Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study

Author

M. Bracey, B. French, Brandy N. Rutledge, Sharon B. Schwartz, D. Steinberg, Peter R. Pavan, Xiaoyu Gao, Alan M. Jacobson, David A. Nicolle, C. Canny, Maria F. Lopes-Virella, A. Kitabchi, K. Hansen, M. E. Lackaye, Denis Daneman, Kandace A. Klumpp, David A. Lee, H. Engel, L. Survant, C. Haggan, K. Lee, G. Ziegler, Dawn M. Ryan, Lloyd Paul Aiello, Tom G. Sheidow, Allan Gordon, Allan L. Drash, S. Johnsonbaugh, L. Kaminski, S. Yoser, David J. Brillon, Osama Hamdy, Connie Fountain, N. Silvers, Kusiel Perlman, S. Caulder, M. Szpiech, D. Freking, Paula McGee, George S. Sharuk, D. Counts, H. Solc, David E. Goldstein, L. Bestourous, W. F. Schwenk, E. Brown, S. Cercone, M. Patronas, James L. Kinyoun, G. Castle, Mark H. Schutta, M. L. Schluter, Anton Orlin, E. Chaum, Daniel P. Joseph, F. Goetz, V. Reppucci, D. Etzwiler, E. Golden, A. Iannacone, R. Kirby, Lucy A. Levandoski, Lawrence J. Singerman, P. Salemi, A. Morrison, G. Vagstad, J. Laechelt, Pamela Ossorio, Tae Sup Lee, R. Cuddihy, S. Hitt, Fred W. Whitehouse, Michael H. Brent, Gayle M. Lorenzi, Anthony D. Morrison, B. Zinman, Szilard Kiss, D. Norman, N. Olson, Thomas Donner, John Dupre, M. Swenson, M. Spencer, Jerry P. Palmer, Scott M. Steidl, M. Franz, R. Beaser, H. Martinez, Samuel S. Engel, L. Diminick, J. Mortenson, David S. Schade, S. Yacoub-Wasef, Misty Good, John E. Chapin, Paolo S. Silva, J. Ginsberg, A. Dwoskin, John P. Bantle, J. D. Carey, D. McMillan, R. G. Campbell, Lisa Diminick, C. Cornish, Ramzi K. Hemady, P. Hollander, A. Farr, D. Zimbler, M. Mech, A. Lucas, Jye-Yu C. Backlund, K. Chan, Timothy J. Murtha, V. Asuquo, A. Bhan, A. Galprin, F. Perdikaris, Michael D. Larsen, L. Gill, Pamela A. Silver, S. Brink, Louis M. Luttrell, Sheila Smith-Brewer, D. Ostrowski, M. Bratkowksi, P. Crawford, M. Bryer-Ash, E. Angus, S. Braunstein, John I. Malone, R. Conwit, C. Pittman, Louis A. Lobes, Rodney A. Lorenz, J. Rosenzwieg, Neil H. White, William I. Sivitz, D. J. Becker, Stephen S. Feman, M. Zaucha, M. Reid, M. Jenner, L. Tuason, C. Gauthier-Kelly, C. McDonald, William H. Herman, John Kramer, Jeffrey L. Mahon, A. Campbell, J. L. Canady, A. Degillio, T. Adkins, P. W. Conrad, Senda Ajroud-Driss, L. Dews, Stephan Villavicencio, David G. Miller, Manjot K. Gill, D. Curtin, J. Brown-Friday, M. Basco, Elsayed Z. Soliman, J. Selby, Bradley D. Jones, M. Hebdon, B. Olson, John M. Pach, N. W. Rodger, K. Stoessel, N. Leloudes, J. Floyd, H. Lambeth, G. Lorenzi, Richard M. Hoffman, S. Chang, M. Guiliani, H. Zegarra, N. Bakshi, Dean P. Hainsworth, Murk-Hein Heinemann, S. Dagogo-Jack, Wanjie Sun, J. Warnicki, Dean B. Burgess, D. Kenny, L. McKenzie, B. Rogness, Martin J. Stevens, M. Nutaitis, William V. Tamborlane, L. Schmidt, Deborah K. Schlossman, J. Giangiacomo, C. Williams, R. Liss, Barbara J. Maschak-Carey, Barbara H. Braffett, Stefan Fritz, J. MacIndoe, Tom Clark, M. Novak, Michael H. Goldbaum, A. DeManbey, J. Ahern, L. Jovanovic, D. Finegold, Davida F. Kruger, Mary E. Larkin, M. Johnson, S. Shah, M. Ong, Catherine L. Martin, M. Giotta, R. Reed, B. Levy, Evica Simjanoski, L. Cimino, P. Callahan, S. Crowell, Rodica Pop-Busui, Howard Wolpert, Bernard H. Doft, J. Arch, C. Shipe, Mark R. Palmert, Philip Raskin, B. Schaefer, P. Astelford, Dara D. Koozekanani, R. B. Avery, Michael W. Steffes, Robert A. Rizza, Karen L. Anderson, Charles McKitrick, P. A. Bourne, L. Baker, G. Friedenberg, D. Wood, J. Wesche, M. Phillips, Gaurav K. Shah, John M. Lachin, M. Christofi, Kevin J. Blinder, R. Ehrlich, J. Rinkoff, Morey W. Haymond, Irene Hramiak, Z. Strugula, A. Blevins, R. Hyre, M. Richardson, Mark E. Molitch, I. H. de Boer, Annette Barnie, Mark R. Burge, M. Prince, P. Ramos, R. Chan, R. Hanna, Jong Mu Sun, Suzanne M. Strowig, C. Wigley, Om P. Ganda, R. Harris, Abraham Thomas, K. Klumpp, K. Kelly, David D. Moore, J. Sheindlin, T. J. Declue, Cormac T. Taylor, C. Kwong, Rose Gubitosi-Klug, T. Sandford, Isaac Boniuk, B. Zimmerman, R. Zeitler, S. Rogers, Joseph M. Terry, C. Johnson, Linda Snetselaar, Naji Younes, Ionut Bebu, N. Wimmergren, Rukhsana G. Mirza, K. Gunyou, Karl R. Olsen, H. Bode, J. Fruit, Michael Rubin, G. Grand, Trevor J. Orchard, Douglas A. Greene, J. Quin, R. Birk, W. Mestrezat, P. Pugsley, Anupam Agarwal, L. Mayer, C. Palmer, Timothy J. Lyons, C. Johannes, A. Determan, L. Van Ottingham, J. Gott, Jerry D. Cavallerano, D. Cros, J. Parker, M. May, Robert Bergren, A. Kowarski, L. Delahanty, Katherine A. Morgan, E. A. Tanaka, Robert W. Cavicchi, Thomas J. Songer, Robert G. Devenyi, J. Harth, Jill P. Crandall, T. Thompson, Lee M. Jampol, H. Schrott, Paul G. Arrigg, Orville G. Kolterman, R. Warhol, L. Thomas, S. Kwon, Jane L. Lynch, Arup Das, Theresa M. Williams, Thomas A. Weingeist, Patricia A. Cleary, Matthew A. Thomas, L. Babbione, Amisha Wallia, J. Lipps Hagan, D. Meyer, D. Rubinstein, P. Lindsey, Mark S. Mandelcorn, R. Fahlstrom, John E. Godine, Kathie L. Hermayer, B. Bosco, J. Rich, K. Folino, M. L. Bernal, S. Yalamanchi, S. Barron, J. McConnell, J. K. Jones, J. Vaccaro-Kish, R. Woodwick, P. Colby, Kelvin C. Fong, Ronald K. Mayfield, L. H. Ketai, Julio V. Santiago, M. B. Murphy, S. Schussler, N. Grove, Larry Rand, Robert C. Colligan, Ronald P. Danis, Valerie L. Arends, S. Ferguson, B. Petty, Christine Stevens, P. Ostrosaka, Margaret L. Bayless, S. Moser, Paul A. Edwards, R. Lyon, M. Carney, Katrina Jones, T. Strand, W. Hsu, Alexander J. Brucker, H. Shamoon, Alice T. Lyon, T. Smith, David M. Nathan, P. Lou, Bruce A. Perkins, Janet E. Olson, D. Rosenberg, H. Ricks, J. Gordon, D. Hornbeck, Nikhil D. Patel, Shelly Olson, Ellen J. Anderson, William Dahms, P. Paczan Rath, S. Elsing, L. Steranchak, L. M. Aiello, Saul Genuth, S. Catton, Sandra R. Montezuma, S. Pendegast, Richard M. Bergenstal, Patricia Gatcomb, Igor Grant, B. Braffett, W. Brown, Margaret E. Stockman, N. Burkhart, David M. Kendall, Jyotika K. Fernandes, S. List, J. Soule, Julie A. Nelson, John A. Colwell, M. McLellan, Silva A. Arslanian, N. Rude, B. Vittetoe, M. Driscoll, and E. Weimann

Subjects
Adult, Male, 030213 general clinical medicine, medicine.medical_specialty, Adolescent, Quality Assurance, Health Care, Psychological intervention, lcsh:Medicine, law.invention, Diabetes Complications, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Health care, medicine, Humans, Medical physics, lcsh:Science, Multidisciplinary, Data collection, business.industry, lcsh:R, Quality control, 3. Good health, Surgery, Data quality, Cohort, 030221 ophthalmology & optometry, Female, lcsh:Q, business, Quality assurance, Follow-Up Studies, Research Article
Abstract

Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

Published
2015

50. Development of land use regression models for particle composition in twenty study areas in Europe

Author

De Hoogh, K. Wang, M. Adam, M. Badaloni, C. Beelen, R. Birk, M. Cesaroni, G. Cirach, M. Declercq, C. Dědelě, A. Dons, E. De Nazelle, A. Eeftens, M. Eriksen, K. Eriksson, C. Fischer, P. Gražulevičieně, R. Gryparis, A. Hoffmann, B. Jerrett, M. Katsouyanni, K. Iakovides, M. Lanki, T. Lindley, S. Madsen, C. Mölter, A. Mosler, G. Nádor, G. Nieuwenhuijsen, M. Pershagen, G. Peters, A. Phuleria, H. Probst-Hensch, N. Raaschou-Nielsen, O. Quass, U. Ranzi, A. Stephanou, E. Sugiri, D. Schwarze, P. Tsai, M.-Y. Yli-Tuomi, T. Varró, M.J. Vienneau, D. Weinmayr, G. Brunekreef, B. Hoek, G.

Abstract

Land Use Regression (LUR) models have been used to describe and model spatial variability of annual mean concentrations of traffic related pollutants such as nitrogen dioxide (NO2), nitrogen oxides (NOx) and particulate matter (PM). No models have yet been published of elemental composition. As part of the ESCAPE project, we measured the elemental composition in both the PM10 and PM2.5 fraction sizes at 20 sites in each of 20 study areas across Europe. LUR models for eight a priori selected elements (copper (Cu), iron (Fe), potassium (K), nickel (Ni), sulfur (S), silicon (Si), vanadium (V), and zinc (Zn)) were developed. Good models were developed for Cu, Fe, and Zn in both fractions (PM10 and PM 2.5) explaining on average between 67 and 79% of the concentration variance (R2) with a large variability between areas. Traffic variables were the dominant predictors, reflecting nontailpipe emissions. Models for V and S in the PM10 and PM2.5 fractions and Si, Ni, and K in the PM10 fraction performed moderately with R2 ranging from 50 to 61%. Si, NI, and K models for PM2.5 performed poorest with R2 under 50%. The LUR models are used to estimate exposures to elemental composition in the health studies involved in ESCAPE. © 2013 American Chemical Society.

Published
2013

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