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1. Development of a 'Procedure Reference Model for the Alignment of Non-medical Support Service Applications in Hospitals' : a framework for ensuring the correct reporting and configuration of key performance indicators

Author

Gerber, N., Tucker, M., and Bryde, D.

Subjects
710, HD28 Management. Industrial Management, R Medicine (General)
Abstract

The outcome of this thesis is the systematically developed and empirically validated "Procedure Reference Model for the Alignment of Non-medical Support Service Applications in Hospitals" comprising six component models, the metamodel, two input documents and a documentation for application as integral parts. The development of the model was done based on a pragmatic philosophical grounding in a multi-methodological iterative approach, including Design Science Research (DSR) principles for the modelling actions and mixed methods principles for the empirical research. In the "Theorising" phase, a sequential mixed methods approach combining a quantitative survey with qualitative expert interviews was conducted generating the basis for the modelling. In two iterations of the "Building" phase, the modelling actions were conducted. While in the "Evaluating" phase, the model was validated in two iterations based on expert interviews and focus group discussions. The model turned out to be relevant in the context of the challenges posed by the current structural changes in healthcare and hospitals. As part of these changes, non-medical support services are increasingly seen as essential not only in contributing to a better cost-efficiency but also as service enabler for the medical services. To be able to deliver the adequate services and service levels and control them within the very complex service provision of hospitals, the managers depend on relevant key performance indicators (KPIs) in an appropriate reporting setting. In Swiss hospitals, the configuration of KPI reporting had only partially been aligned in terms of software applications and/or in terms of reporting styles. Therefore, the research aims and objectives of this thesis were to find a procedure and its significant aspects for aligning non-medical-support service applications in hospitals so that in the future, relevant key performance indicators for systematic controlling and optimization can be generated and configured as effectively and efficiently as possible including the development of a model providing the necessary information. The evaluation of the model showed that the research output was credible and contributory. For practice, it provides a systematic basis for communication between different non-medical support service application stakeholders and thus enables managers to indirectly contribute to the development of a more effective healthcare provision. For the scientific community, it contributes to the development of multi-methodological DSR approaches suitable for complex environments and for multi-disciplinary environments.

Published
2019
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22. Clinical, Radiologic, Pathologic, and Molecular Characteristics of Long-Term Survivors of Diffuse Intrinsic Pontine Glioma (DIPG): A Collaborative Report From the International and European Society for Pediatric Oncology DIPG Registries

Author

Hoffman, Lindsey M, Veldhuijzen van Zanten, Sophie E M, Colditz, Niclas, Baugh, Joshua, Chaney, Brooklyn, Hoffmann, Marion, Lane, Adam, Fuller, Christine, Miles, Lili, Hawkins, Cynthia, Bartels, Ute, Bouffet, Eric, Goldman, Stewart, Leary, Sarah, Foreman, Nicholas K, Packer, Roger, Warren, Katherine E, Broniscer, Alberto, Kieran, Mark W, Minturn, Jane, Comito, Melanie, Broxson, Emmett, Shih, Chie-Schin, Khatua, Soumen, Chintagumpala, Murali, Carret, Anne Sophie, Escorza, Nancy Yanez, Hassall, Timothy, Ziegler, David S, Gottardo, Nicholas, et al, Grotzer, M A, Gerber, N U, and University of Zurich

Subjects
10036 Medical Clinic, 610 Medicine & health, 2730 Oncology, 1306 Cancer Research
Published
2018

23. Validation of questionnaire-reported chest wall abnormalities with a telephone interview in Swiss childhood cancer survivors.

Author

Kasteler, Rahel, Lichtensteiger, Christa, Schindera, Christina, Ansari, Marc, Kuehni, Claudia E., for the Swiss Pediatric Oncology Group (SPOG) Scientific Committee, Rössler, J., Ansari, M., Beck Popovic, M., Brazzola, P., Greiner, J., Niggli, F., Hengartner, H., Kuehni, C., Schilling, F., Scheinemann, K., von der Weid, N., Gerber, N., and Swiss Pediatric Oncology Group (SPOG) Scientific Committee

Subjects
CENTRAL nervous system tumors, CHILDHOOD cancer, CANCER survivors, TELEPHONE interviewing, PHYSICIANS, HUMAN abnormalities, CHEST (Anatomy), RESEARCH evaluation, INTERVIEWING, RESEARCH funding
Abstract

Background: Chest wall abnormalities are a poorly studied complication after treatment for childhood cancer. Chest wall abnormalities are not well-described in the literature, and little is known on the impact on daily life of survivors.Methods: We investigated prevalence and risk factors of chest wall abnormalities in childhood cancer survivors in a nationwide, population-based cohort study (Swiss Childhood Cancer Survivor Study) with a questionnaire survey. We then interviewed a nested sample of survivors to validate types of chest wall abnormalities and understand their impact on the daily life of survivors.Results: Forty-eight of 2382 (95%CI 2-3%) survivors reported a chest wall abnormality. Risk factors were older age at cancer diagnosis (16-20 years; OR 2.5, 95%CI 1.0-6.1), lymphoma (OR 3.8, 95%CI 1.2-11.4), and central nervous system tumors (OR 9.5, 95%CI 3.0-30.1) as underlying disease, and treatment with thoracic radiotherapy (OR 2.0, 95%CI 1.0-4.2), surgery to the chest (OR 4.5, 95%CI 1.8-11.5), or chemotherapy (OR 2.9, 95%CI 1.0-8.1). The nature of the chest wall abnormalities varied and included thoracic wall deformities (30%), deformations of the spine (5%) or both (55%), and scars (10%). Chest wall abnormalities affected daily life in two thirds (13/20) of those who reported these problems and necessitated medical attention for 15 (75%) survivors.Conclusion: It is important that, during follow-up care, physicians pay attention to chest wall abnormalities, which are rare late effects of cancer treatment, but can considerably affect the well-being of cancer survivors. [ABSTRACT FROM AUTHOR]

Published
2021
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24. Radiotherapy dose and survival outcomes in human papillomavirus positive oropharyngeal cancer.

Author

Tam, M, Wu, S P, Gerber, N K, Lee, A, Schreiber, D, Givi, B, and Hu, K

Subjects
MORTALITY risk factors, CANCER, CANCER patients, CONFIDENCE intervals, PATIENT aftercare, MULTIVARIATE analysis, PAPILLOMAVIRUSES, RADIATION doses, SURVIVAL analysis (Biometry), TIME, TUMOR classification, TREATMENT effectiveness, PROPORTIONAL hazards models, DESCRIPTIVE statistics, OROPHARYNGEAL cancer, EVALUATION
Abstract

Objective: To evaluate the effect of definitive radiotherapy dose on survival in patients with human papillomavirus positive oropharyngeal carcinoma. Methods: Human papillomavirus positive oropharyngeal carcinoma patients staged T1–3 and N0–2c, who received definitive radiotherapy (fraction sizes of 180 cGy to less than 220 cGy), were identified from the National Cancer Database 2010–2014 and stratified by radiation dose (50 Gy to less than 66 Gy, or 66 Gy or more). Results: A total of 2173 patients were included, of whom 124 (6 per cent) received a radiation dose of 50 Gy to less than 66 Gy. With a median follow up of 33.8 months, patients had a 3-year overall survival rate of 88.6 per cent (95 per cent confidence interval = 87.1–90.1 per cent). On multivariate Cox analysis, a radiotherapy dose of 50 Gy to less than 66 Gy (hazard ratio = 0.95, 95 per cent confidence interval = 0.52–1.74, p = 0.86) was not a predictor of increased mortality risk. Conclusion: Human papillomavirus positive oropharyngeal carcinoma patients had excellent outcomes with definitive radiotherapy doses of 50 Gy to less than 66 Gy. These results further support patients enrolling into clinical trials for radiation dose de-escalation. [ABSTRACT FROM AUTHOR]

Published
2020
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25. Development of the SIOPE DIPG network, registry and imaging repository: a collaborative effort to optimize research into a rare and lethal disease

Author

Veldhuijzen van Zanten, S.E.M. Baugh, J. Chaney, B. De Jongh, D. Sanchez Aliaga, E. Barkhof, F. Noltes, J. De Wolf, R. Van Dijk, J. Cannarozzo, A. Damen-Korbijn, C.M. Lieverst, J.A. Colditz, N. Hoffmann, M. Warmuth-Metz, M. Bison, B. Jones, D.T.W. Sturm, D. Gielen, G.H. Jones, C. Hulleman, E. Calmon, R. Castel, D. Varlet, P. Giraud, G. Slavc, I. Van Gool, S. Jacobs, S. Jadrijevic-Cvrlje, F. Sumerauer, D. Nysom, K. Pentikainen, V. Kivivuori, S.-M. Leblond, P. Entz-Werle, N. von Bueren, A.O. Kattamis, A. Hargrave, D.R. Hauser, P. Garami, M. Thorarinsdottir, H.K. Pears, J. Gandola, L. Rutkauskiene, G. Janssens, G.O. Torsvik, I.K. Perek-Polnik, M. Gil-da-Costa, M.J. Zheludkova, O. Shats, L. Deak, L. Kitanovski, L. Cruz, O. Morales La Madrid, A. Holm, S. Gerber, N. Kebudi, R. Grundy, R. Lopez-Aguilar, E. Zapata-Tarres, M. Emmerik, J. Hayden, T. Bailey, S. Biassoni, V. Massimino, M. Grill, J. Vandertop, W.P. Kaspers, G.J.L. Fouladi, M. Kramm, C.M. van Vuurden, D.G. on behalf of the members of the SIOPE DIPG Network

Abstract

Diffuse intrinsic pontine glioma (DIPG) is a rare and deadly childhood malignancy. After 40 years of mostly single-center, often non-randomized trials with variable patient inclusions, there has been no improvement in survival. It is therefore time for international collaboration in DIPG research, to provide new hope for children, parents and medical professionals fighting DIPG. In a first step towards collaboration, in 2011, a network of biologists and clinicians working in the field of DIPG was established within the European Society for Paediatric Oncology (SIOPE) Brain Tumour Group: the SIOPE DIPG Network. By bringing together biomedical professionals and parents as patient representatives, several collaborative DIPG-related projects have been realized. With help from experts in the fields of information technology, and legal advisors, an international, web-based comprehensive database was developed, The SIOPE DIPG Registry and Imaging Repository, to centrally collect data of DIPG patients. As for April 2016, clinical data as well as MR-scans of 694 patients have been entered into the SIOPE DIPG Registry/Imaging Repository. The median progression free survival is 6.0 months (95% Confidence Interval (CI) 5.6–6.4 months) and the median overall survival is 11.0 months (95% CI 10.5–11.5 months). At two and five years post-diagnosis, 10 and 2% of patients are alive, respectively. The establishment of the SIOPE DIPG Network and SIOPE DIPG Registry means a paradigm shift towards collaborative research into DIPG. This is seen as an essential first step towards understanding the disease, improving care and (ultimately) cure for children with DIPG. © 2017, The Author(s).

Published
2017

28. From Access to Post-access Concerns: Rethinking Inclusion in Education Through Children’s Everyday School Attendance in Rural Malaysia

Author

Gerber, N, Huijsmans, Roy, Hunner-Kreisel, C., Bohne, S., and Academic staff unit

Subjects
Medical education, Underpinning, 050204 development studies, education, 05 social sciences, Primary education, Attendance, Ethnic group, Developing country, Political science, 0502 economics and business, Pedagogy, Agency (sociology), School attendance, Inclusion (education), SDG 4 - Quality Education
Abstract

Drawing on 10 weeks of research in four primarily ethnic minority villages in insular Malaysia, this paper analyses the factors and relations underpinning the frequency of children’s school attendance. Using a range of participatory methods has illuminated children’s active role in co-shaping the outcome of everyday decision-making process concerning school attendance. The findings suggest our understanding of exclusion and inclusion in relation to primary education in developing countries needs to go beyond the current focus on children’s school enrolment, drop-out, and adult-centred discussions on school attendance, towards an appreciation of the relational dynamics underpinning frequency of attendance and children’s active role in co-shaping their inclusion in or exclusion from school.

Published
2016

29. LBA64 - Bevacizumab for children with relapsed & refractory high-risk neuroblastoma (RR-HRNB): Results of the BEACON-neuroblastoma randomized phase II trial - A European ITCC-SIOPEN trial

Author

Moreno, L., Moroz, V., Owens, C., Valteau-Couanet, D., Gambart, M., Castel, V., van Eijkelenburg, N., Castellano, A., Nysom, K., Gerber, N., Laureys, G., Ladenstein, R., Thebaud, E., Murphy, D., Morland, B., Vaidya, S., Elliott, M., Pearson, A.D., and Wheatley, K.

Published
2019
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30. Foodborne transmission of Listeria monocytogenes via ready-to-eat salad: a nationwide outbreak in Switzerland, 2013-2014

Author

Stephan, Roger, Althaus, Denise, Kiefer, Sabine, Lehner, Angelika, Hatz, Christoph, Schmutz, C, Jost, Marianne, Gerber, N, Baumgartner, Andreas, Hächler, Herbert, Mäusezahl-Feuz, Mirjam, University of Zurich, and Stephan, Roger

Subjects
to, eat salad, ST 4, 1305 Biotechnology, 570 Life sciences, biology, 610 Medicine & health, 10060 Epidemiology, Biostatistics and Prevention Institute (EBPI), Serotype 4b, Ready, 10082 Institute of Food Safety and Hygiene, 1106 Food Science, Listeria monocytogenes outbreak
Published
2015
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31. Editorial: let's get physical—long‐term benefits of vigorous physical activity in patients with nonalcoholic fatty liver disease. Authors' reply.

Author

Henry, Austin, Paik, James M., Austin, Patrick, Eberly, Katherine Elizabeth, Golabi, Pegah, Younossi, Issah, Henry, Linda, Gerber, N. Lynn, and Younossi, Zobair M.

Subjects
NON-alcoholic fatty liver disease, PHYSICAL activity
Abstract

LINKED CONTENT: This article is linked to Henry et al papers. To view these articles, visit https://doi.org/10.1111/apt.17308 and https://doi.org/10.1111/apt.17336 [ABSTRACT FROM AUTHOR]

Published
2023
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36. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: Two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization-verteporfin in photodynamic therapy report 2

Author

Arnold J, Kilmartin D, Olson J, Neville S, Robinson K, Laird A, Richmond C, Farrow A, McKay S, McKechnie R, Evans G, Aaberg TM, Brower J, Waldron R, Loupe D, Gillman J, Myles B, Saperstein DA, Schachat AP, Bressler NM, Bressler SB, Nesbitt P, Porter T, Hawse P, Harnett M, Eager A, Belt J, Cain D, Emmert D, George T, Herring M, McDonald J, Mones J, Corcostegui B, Gilbert M, Duran N, Sisquella M, Nolla A, Margalef A, Miller JW, Gragoudas ES, Lane AM, Emmanuel N, Holbrook A, Evans C, Lord US, Walsh DK, Callahan CD, DuBois JL, Moy J, Kenney AG, Milde I, Platz ES, Lewis H, Kaiser PK, Holody LJ, Lesak E, Lichterman S, Siegel H, Fattori A, Ambrose G, Fecko T, Ross D, Burke S, Conway J, Singerman L, Zegarra H, Novak M, Bartel M, Tilocco DuBois K, Ilc M, Schura S, Joyce S, Tanner V, Rowe P, Smith Brewer S, Greanoff G, Daley G, DuBois J, Lehnhardt D, Kukula D, Fish GE, Jost BF, Anand R, Callanan D, Arceneaux S, Arnwine J, Ellenich P, King J, Aguado H, Rollins R, Anderson T, Nork C, Duignan K, Boleman B, Jurklies B, Pauleikhoff D, Hintzmann A, Fischer M, Sowa C, Behne E, Pournaras CJ, Donati G, Kapetanios AD, Cavaliere K, Guney Wagner S, Gerber N, Sickenberg M, Sickenberg V, Gans A, Hosner B, Sbressa A, Kozma C, Curchod M, Ardoni S, Harding S, Yang YC, Briggs M, Briggs S, Phil EB, Tompkin V, Jackson R, Pearson S, Natha S, Sharp J, Tompkin A, Lim JI, Flaxel C, Padilla M, Levin L, Walonker F, Cisneros L, Nichols T, Schmidt Erfurth U, Barbazetto I, Laqua H, Kupfer R, Bulow R, Glisovic B, Bredfeldt T, Elsner H, Wintzer V, Bahlmann D, Michels S, Gordes R, Neppert B, Grote M, Honnicke K, Blumenkranz MS, Little HL, Jack R, Espiritu LM, Unyi L, Regan J, Lamborn L, Silvestri C, Rosa RH, Rosenfeld PJ, Lewis ML, Rodriguez B, Torres A, Munoz N, Contreras T, Galvez M, Hess D, Cubillas T, Rams I, Slakter JS, Sorenson JA, Bruschi PA, Burke K, Schnipper E, Maranan L, Scolaro M, Riff M, Agresta E, Napoli J, Johansson I, Dedorsson I, Stenkula S, Hvarfner C, Carlsson T, Liljedahl AM, Fallstrom S, Jacobsson E, Hendeberg K, Soubrane G, Kuhn D, Oubraham H, Benelhani A, Kunsch A, Delhoste B, Ziverec G, Lasnier M, Debibie C, Lobes LA, Olsen K, Bahr BJ, Worstell NT, Wilcox LA, Wellman LA, Vagstad G, Steinberg D, Campbell A, Ma C, Dreyer R, Williamson B, Johnson M, Crider H, Anderson H, Brown T, Jelinek K, Graves D, Pope S, Boone R, Beaumont W, Margherio RR, Williams GA, Zajechowski M, Stanley C, Kulak M, Streasick P, Szdlowski L, Falk R, Shoichet S, Regan G, Manatrey P, Cumming K, Fadel R, Mitchel B, Vandell L, Yesestrepsky D, Medina T, Bridges C, Huston G, Koenig F, Benchaboune M, Mezmate K, Fontanay S, Meredith T, Binning J, Gualdoni J, Boyd L, Ort E, Barts B, Allen R, Dahl J, Holle T, Harvey PT, Kaus L, Leuschner D, Bolychuk S, Hewitt I, Voyce J, Menchini U, Virgili G, Lanzetta P, Ambesi M, Pirracchio A, Tedeschi M, Potter MJ, Sahota B, Hall L, Le G, Rai S, Johnson D, Stur M, Lukas J, Tittl M, Docker S, Vogl K, Pieramici DJ, Manos KS, Cooper R, Denbow RL, Lowery ER, Phillips DA, Thibeault SK, Tian Y, Alexander J, Orr PR, Black N, Escartin P, Hartley D, Haworth P, Hecker T, Hiscock D, Jamali F, Maradan N, North J, Norton B, Stapleton Hayes T, Taylor R, Huber G, Deslandes JY, Fsadni M, Hess I, de Pommerol H, Bobillier A, Reaves A, Banasik S, Birch R, Koester J, Stickles R, Truett K, McAlister L, Parker F, Strong HA, Azab M, Buskard N, Gray T, Manjuris U, Hao Y, Su XY, Mason M, Hynes L, Barbezetto I, Birngruber R, Flaxel CJ, Harvey P, Koester JM, Meredith TA, Murphy SA, Strong A, Ulrike M, Beck RW, Bird AC, Coscas G, Deutman A, Jampol L, Klein R, Maguire M, Rosenfeld P, Acreneaux S, Margherio RP, Staflin P, Mones JM, Schmidt Erfurth U., BANDELLO , FRANCESCO, Arnold, J, Kilmartin, D, Olson, J, Neville, S, Robinson, K, Laird, A, Richmond, C, Farrow, A, Mckay, S, Mckechnie, R, Evans, G, Aaberg, Tm, Brower, J, Waldron, R, Loupe, D, Gillman, J, Myles, B, Saperstein, Da, Schachat, Ap, Bressler, Nm, Bressler, Sb, Nesbitt, P, Porter, T, Hawse, P, Harnett, M, Eager, A, Belt, J, Cain, D, Emmert, D, George, T, Herring, M, Mcdonald, J, Mones, J, Corcostegui, B, Gilbert, M, Duran, N, Sisquella, M, Nolla, A, Margalef, A, Miller, Jw, Gragoudas, E, Lane, Am, Emmanuel, N, Holbrook, A, Evans, C, Lord, U, Walsh, Dk, Callahan, Cd, Dubois, Jl, Moy, J, Kenney, Ag, Milde, I, Platz, E, Lewis, H, Kaiser, Pk, Holody, Lj, Lesak, E, Lichterman, S, Siegel, H, Fattori, A, Ambrose, G, Fecko, T, Ross, D, Burke, S, Conway, J, Singerman, L, Zegarra, H, Novak, M, Bartel, M, Tilocco DuBois, K, Ilc, M, Schura, S, Joyce, S, Tanner, V, Rowe, P, Smith Brewer, S, Greanoff, G, Daley, G, Dubois, J, Lehnhardt, D, Kukula, D, Fish, Ge, Jost, Bf, Anand, R, Callanan, D, Arceneaux, S, Arnwine, J, Ellenich, P, King, J, Aguado, H, Rollins, R, Anderson, T, Nork, C, Duignan, K, Boleman, B, Jurklies, B, Pauleikhoff, D, Hintzmann, A, Fischer, M, Sowa, C, Behne, E, Pournaras, Cj, Donati, G, Kapetanios, Ad, Cavaliere, K, Guney Wagner, S, Gerber, N, Sickenberg, M, Sickenberg, V, Gans, A, Hosner, B, Sbressa, A, Kozma, C, Curchod, M, Ardoni, S, Harding, S, Yang, Yc, Briggs, M, Briggs, S, Phil, Eb, Tompkin, V, Jackson, R, Pearson, S, Natha, S, Sharp, J, Tompkin, A, Lim, Ji, Flaxel, C, Padilla, M, Levin, L, Walonker, F, Cisneros, L, Nichols, T, Schmidt Erfurth, U, Barbazetto, I, Laqua, H, Kupfer, R, Bulow, R, Glisovic, B, Bredfeldt, T, Elsner, H, Wintzer, V, Bahlmann, D, Michels, S, Gordes, R, Neppert, B, Grote, M, Honnicke, K, Blumenkranz, M, Little, Hl, Jack, R, Espiritu, Lm, Unyi, L, Regan, J, Lamborn, L, Silvestri, C, Rosa, Rh, Rosenfeld, Pj, Lewis, Ml, Rodriguez, B, Torres, A, Munoz, N, Contreras, T, Galvez, M, Hess, D, Cubillas, T, Rams, I, Slakter, J, Sorenson, Ja, Bruschi, Pa, Burke, K, Schnipper, E, Maranan, L, Scolaro, M, Riff, M, Agresta, E, Napoli, J, Johansson, I, Dedorsson, I, Stenkula, S, Hvarfner, C, Carlsson, T, Liljedahl, Am, Fallstrom, S, Jacobsson, E, Hendeberg, K, Soubrane, G, Kuhn, D, Oubraham, H, Benelhani, A, Kunsch, A, Delhoste, B, Ziverec, G, Lasnier, M, Debibie, C, Lobes, La, Olsen, K, Bahr, Bj, Worstell, Nt, Wilcox, La, Wellman, La, Vagstad, G, Steinberg, D, Campbell, A, Ma, C, Dreyer, R, Williamson, B, Johnson, M, Crider, H, Anderson, H, Brown, T, Jelinek, K, Graves, D, Pope, S, Boone, R, Beaumont, W, Margherio, Rr, Williams, Ga, Zajechowski, M, Stanley, C, Kulak, M, Streasick, P, Szdlowski, L, Falk, R, Shoichet, S, Regan, G, Manatrey, P, Cumming, K, Fadel, R, Mitchel, B, Vandell, L, Yesestrepsky, D, Medina, T, Bridges, C, Huston, G, Koenig, F, Benchaboune, M, Mezmate, K, Fontanay, S, Meredith, T, Binning, J, Gualdoni, J, Boyd, L, Ort, E, Barts, B, Allen, R, Dahl, J, Holle, T, Harvey, Pt, Kaus, L, Leuschner, D, Bolychuk, S, Hewitt, I, Voyce, J, Menchini, U, Bandello, Francesco, Virgili, G, Lanzetta, P, Ambesi, M, Pirracchio, A, Tedeschi, M, Potter, Mj, Sahota, B, Hall, L, Le, G, Rai, S, Johnson, D, Stur, M, Lukas, J, Tittl, M, Docker, S, Vogl, K, Pieramici, Dj, Manos, K, Cooper, R, Denbow, Rl, Lowery, Er, Phillips, Da, Thibeault, Sk, Tian, Y, Alexander, J, Orr, Pr, Black, N, Escartin, P, Hartley, D, Haworth, P, Hecker, T, Hiscock, D, Jamali, F, Maradan, N, North, J, Norton, B, Stapleton Hayes, T, Taylor, R, Huber, G, Deslandes, Jy, Fsadni, M, Hess, I, de Pommerol, H, Bobillier, A, Reaves, A, Banasik, S, Birch, R, Koester, J, Stickles, R, Truett, K, Mcalister, L, Parker, F, Strong, Ha, Azab, M, Buskard, N, Gray, T, Manjuris, U, Hao, Y, Su, Xy, Mason, M, Hynes, L, Barbezetto, I, Birngruber, R, Flaxel, Cj, Harvey, P, Koester, Jm, Meredith, Ta, Murphy, Sa, Strong, A, Ulrike, M, Beck, Rw, Bird, Ac, Coscas, G, Deutman, A, Jampol, L, Klein, R, Maguire, M, Rosenfeld, P, Acreneaux, S, Margherio, Rp, Staflin, P, Mones, Jm, and Schmidt Erfurth, U.

Abstract

PURPOSE: To determine if photodynamic therapy with verteporfin (Visudyne; Novartis AG, Bulach, Switzerland), termed verteporfin therapy, can safely reduce the risk of vision loss compared with a placebo (with sham treatment) in patients with subfoveal choroidal neovascularization caused by age-related macular degeneration who were identified with a lesion composed of occult with no classic choroidal neovascularization, or with presumed early onset classic choroidal neovascularization with good visual acuity letter score, METHODS: This was a double-masked, placebo controlled (sham treatment), randomized, multicenter clinical trial involving 28 ophthalmology practices in Europe and North America. The study population was patients with age related macular degeneration, with subfoveal choroidal neovascularization lesions measuring no greater than 5400 mum in greatest linear dimension with either 1) occult with no classic choroidal neovascularization, best-corrected visual acuity score of at least 50 (Snellen equivalent approximately 20/100), and evidence of hemorrhage or recent disease progression; or 2) evidence of classic choroidal neovascularization with a best-corrected visual acuity score of at least 70 (better than a Snellen equivalent of approximately 20/40); assigned randomly (2:1) to verteporfin therapy or placebo therapy. Verteporfin (6 mg per square meter of body surface area) or placebo (5% dextrose in water) was administered by means of intravenous infusion of 30 mi over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm delivered 50 J/cm(2) by application of an intensity of 600 mW/cm(2) over 83 seconds using a spot size with a diameter 1000 mum larger than the greatest linear dimension of the choroidal neovascularization lesion on the retina. At follow-up examinations every 3 months, retreatment with the same regimen was applied if angiography showed fluorescein leakage. The main outcome measure was at least moderate vision loss, that is, a loss of at least 15 letters (approximately 3 lines), adhering to an intent-to treat analysis with the last observation carried forward to impute for missing data. RESULTS: Two hundred ten (93%) and 193 (86%) of the 225 patients in the verteporfin group compared with 104 (91%) and 99 (87%) of the 114 patients in the placebo group completed the month 12 and 24 examinations, respectively. On average, verteporfin-treated patients received five treatments over the 24 months of follow-up. The primary outcome was similar for the verteporfin-treated and the placebo-treated eyes through the month 12 examination, although a number of secondary visual and angiographic outcomes significantly favored the verteporfin-treated group. Between the month 12 and 24 examinations, the treatment benefit grew so that by the month 24 examination, the vertepor-fin-treated eyes were less likely to have moderate or severe vision loss. Of the 225 verteporfin-treated patients, 121 (54%) compared with 76 (67%) of 114 placebo-treated patients lost at least 15 letters (P =.023). Likewise, 61 of the verteporfin-treated patients (30%) compared with 54 of the placebo-treated patients (47%) lost at least 30 letters (P = .001). Statistically significant results favoring verteporfin therapy at the month 24 examination were consistent between the total population and the subgroup of patients with a baseline lesion composition identified as occult choroidal neovascularization with no classic choroidal neovascularization, This subgroup included 166 of the 225 verteporfin-treated patients (74%) and 92 of the 114 placebo-treated patients (81%). In these patients, 91 of the verteporfin-treated group (55%) compared with 63 of the placebo-treated group (68%) lost at least 15 letters (P =.032), whereas 48 of the verteporfin-treated group (29%) and 43 of the placebo-treated group (47%) lost at least 30 letters (P =.004). Other secondary outcomes, including visual acuity letter score worse than 34 (approximate Snellen equivalent of 20/200 or worse), mean change in visual acuity letter score, development of classic choroidal neovascularization, progression of classic choroidal neovascularization and size of lesion, favored the verteporfin-treated group at both the month 12 and month 24 examination for both the entire study group and the subgroup of cases with occult with no classic choroidal neovascularization at baseline. Subgroup analyses of lesions composed of occult with no classic choroidal neovascularization at baseline suggested that the treatment benefit was greater for patients with either smaller lesions (4 disc areas or less) or lower levels of visual acuity (letter score less than 65, an approximate Snellen equivalent of 20/50(-1) or worse) at baseline. Prospectively planned multivariable analyses confirmed that these two baseline variables affected the magnitude of treatment benefit. Of the 123 verteporfin-treated patients and 64 placebo-heated patients with either visual acuity score Less than 65 or lesion size 4 disc areas or less at baseline, 60 (49%) and 48 (75%) lost at least 15 letters (P < .001), respectively, and 26 (21%) and 31 (48%) lost at least 30 letters (P 2001 by Elsevier Science Inc. All rights reserved.).

Published
2001

42. Long-term outcome and clinical prognostic factors in children with medulloblastoma treated in the prospective randomised multicentre trial HIT'91

Author

von Hoff, K, Hinkes, B, Gerber, N U, Deinlein, F, Mittler, U, Urban, C, Benesch, M, Warmuth-Metz, M, Soerensen, N, Zwiener, I, Goette, H, Schlegel, P G, Pietsch, T, Kortmann, R D, Kuehl, J, Rutkowski, S, University of Zurich, and Rutkowski, S

Subjects
10036 Medical Clinic, 610 Medicine & health, 2730 Oncology, 1306 Cancer Research
Published
2009
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43. Outcome prediction in pediatric medulloblastoma based on DNA copy-number aberrations of chromosomes 6q and 17q and the MYC and MYCN loci

Author

Pfister, S, Remke, M, Benner, A, Mendrzyk, F, Toedt, G, Felsberg, J, Wittmann, A, Devens, F, Gerber, N U, Joos, S, Kulozik, A, Reifenberger, G, Rutkowski, S, Wiestler, O D, Radlwimmer, B, Scheurlen, W, Lichter, P, Korshunov, A, University of Zurich, and Pfister, S

Subjects
10036 Medical Clinic, 610 Medicine & health, 2730 Oncology, 1306 Cancer Research
Published
2009

44. Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers

Author

Miceli, J J, Wilner, K D, Hansen, R A, Johnson, A C, Apseloff, G, and Gerber, N

Subjects
Adult, Male, Adolescent, Middle Aged, Piperazines, Prolactin, Thiazoles, Double-Blind Method, Reference Values, Area Under Curve, Humans, Sleep Stages, Sleep, Supplement, Antipsychotic Agents
Abstract

To evaluate the pharmacokinetics and tolerability of single and multiple oral doses of ziprasidone in healthy male volunteers, and to determine the influence of ziprasidone on serum prolactin levels.Single and multiple doses of ziprasidone were given orally (as two divided daily doses), at fixed dosages of 10 and 40 mg day(-1), and using titrated regimens of 40-80 and 40-120 mg day(-1), for 14 days. All dosages were taken immediately after food. The study adopted a randomized, double-blind, placebo-controlled design. Prolactin response, sedative properties, tolerability, and extrapyramidal symptoms were also investigated.Steady-state exposure to ziprasidone was attained after 1 day of dosing. Mean Cmax and AUC(0,12 h) increased with increasing dose, with apparent dose-proportionality between the 20 and 60 mg dose levels. Trough-to-peak ratios at steady state ranged from 2 to 5. Accumulation ratios for the fixed-dose regimens were 1.49 and 1.48 at the 5 and 20 mg dose levels, respectively. Ziprasidone was associated with transient prolactin elevation but levels of prolactin returned to baseline within the dosing interval at steady state. There was a marginal, transient increase in serum prolactin levels which was not dose-related at the 80 and 120 mg day(-1) doses, and which was noted to attenuate with chronic dosing. Ziprasidone was generally well tolerated. The most frequent side-effect was mild or moderate headache. A minority of patients suffered first-dose postural hypotension. Ziprasidone was also associated with a mild sedative effect that became less pronounced as treatment continued. There were no drug-related changes in electrocardiogram or clinical laboratory variables that were of clinical importance.Ziprasidone is characterized by a predictable pharmacokinetic profile resulting in symptoms that reflect its pharmacological action.

Published
2000

45. The effects of ziprasidone on steady-state lithium levels and renal clearance of lithium

Author

Apseloff, G, Mullet, D, Wilner, K D, Anziano, R J, Tensfeldt, T G, Pelletier, S M, and Gerber, N

Subjects
Adult, Male, Thiazoles, Humans, Drug Interactions, Lithium, Middle Aged, Piperazines, Supplement, Antipsychotic Agents
Abstract

To assess the potential of ziprasidone to alter the renal clearance and steady-state serum levels of lithium.Healthy subjects who had stable serum lithium levels during the first 7 days of treatment with lithium 900 mg day(-1), given as two divided daily doses, were randomized to receive concomitant treatment with either ziprasidone, 40 mg day(-1), given as two divided daily doses, on days 9-11 followed by 80 mg day(-1), given as two divided daily doses on days 12-15 (n = 12), or placebo twice daily (n = 13). Ziprasidone or placebo was administered 2 h before each dose of lithium.Ziprasidone administration was associated with a 0.07 mmol l(-1) (13%) mean increase in steady-state serum lithium levels compared with a mean increase of 0.06 mmol l(-1) (10%) with placebo. Mean renal clearance of lithium decreased by 0.09 l h(-1) (5%) in the ziprasidone group and by 0.14 l h(-1) (9%) in the placebo group. None of these differences between the two groups was statistically or clinically significant.Ziprasidone does not alter steady-state serum lithium concentrations or renal clearance of lithium.

Published
2000

47. Patient's experience with subcutaneous and oral methotrexate for the treatment of rheumatoid arthritis.

Author

Curtis, J. R., Xie, F., Mackey, D., Gerber, N., Bharat, A., Beukelman, T., Saag, K. G., Chen, L., Nowell, B., and Ginsberg, S.

Subjects
METHOTREXATE, RHEUMATOID arthritis treatment, TREATMENT effectiveness, DRUG side effects, PATIENT compliance, DISEASE prevalence
Abstract

Background: Despite the prominent position of methotrexate (MTX) in Rheumatoid Arthiris (RA) therapeutics, its real-world effectiveness may be influenced by a relative lack of tolerability or other side effects that physicians may not be aware of but that are bothersome to patients. The aim of this study is to identify suboptimal patient experience with MTX and to raise awareness for clinicians to identify opportunities to mitigate bothersome symptoms and side effects and optimize response to MTX. Methods: We conducted a prospective, cross-sectional, online survey among RA patients who were members of Creakyjoints, a large arthritis patient community. Eligible participants must have recently initiated a new biologic, subcutaneous (SQ) MTX, or oral MTX in the last 12 months and were uniquely assigned to one of these 3 groups. Descriptive statistics were used to compare patient-reported side effects and tolerability related to MTX use in the 3 medication groups (SQ MTX, oral MTX, and biologic). Results: A total of 382 (85 %) of 448 eligible patients completed the survey and were grouped as: biologic (n = 218), SQ MTX (n = 49), and oral MTX (n = 115). Demographics were mean standard deviation (SD) age 48 (10) years, 92 % white, 91 % women. Symptoms significantly more prevalent in the SQ and oral MTX groups included diarrhea, fatigue, malaise, and hair loss. Injection related pain was lower with SQ MTX compared to SQ biologics. Out of a total of 8 potential symptoms and side effects examined, higher dose MTX (> = 20 mg/week) was associated with a 2.26 (1.25-4.09) greater likelihood of more side effects referent to < =10 mg/week. Conclusion: Results from this real-world RA patient cohort suggest that MTX is accompanied by many patient-reported side effects and tolerability problems that may be under-recognized by physicians. These may impact both treatment satisfaction and medication adherence. [ABSTRACT FROM AUTHOR]

Published
2016
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