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1. Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study)

Author

Pedersen ED, Stenager E, Vadgaard JL, Jensen MB, Schmid R, Meland N, Magnussen G, and Frederiksen JL

Subjects
Adherence, multiple sclerosis, relapsing remitting MS, subcutaneous interferon beta-1a, RebiSmart®, trial, Medicine (General), R5-920
Abstract

Elena Didenko Pedersen,1,2 Egon Stenager,3,4 JL Vadgaard,5 MB Jensen,6 R Schmid,7 N Meland,8 G Magnussen,9 Jette L Frederiksen10,11 1Akershus University Hospital, Department of Neurology, Loerenskog, Norway; 2Sandvika Nevrosenter, Sandvika, Norway; 3MS Clinic of Southern Jutland, Department of Neurology, Hospital of Southern Denmark, Odense, Denmark; 4Institute of Regional Research, University of Southern Denmark, Odense, Denmark; 5Department of Neurology, Sjællands University Hospital, Roskilde NeuroCenter, Roskilde, Denmark; 6Department of Neurology, Nordsjaellands Hospital, Hilleroed, Denmark; 7MS Clinic, Department of Neurology, Vejle Hospital, Vejle, Denmark; 8Smerud Medical Research, Oslo, Norway; 9Merck Norway, An Affiliate of Merck AB (Merck AB NUF), Oslo, Norway; 10Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Science, Glostrup, Denmark; 11Institute of Clinical Medicine, Copenhagen University, Copenhagen, Denmark Background: Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes.Objective: To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart® and assess injection-site reactions and treatment satisfaction.Methods: This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13–23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks.Results: Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain.Conclusion: RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated. Keywords: adherence, multiple sclerosis, relapsing remitting MS, subcutaneous interferon beta-1a, RebiSmart, trial

Published
2018

2. Danish Breast Cancer Cooperative Group

Author

Christiansen P, Ejlertsen B, Jensen MB, and Mouridsen H

Subjects
Breast cancer, database, guidelines, quality control, research, Infectious and parasitic diseases, RC109-216
Abstract

Peer Christiansen,1 Bent Ejlertsen,2,3 Maj-Britt Jensen,3 Henning Mouridsen3 1Department of Surgery P, Breast Surgery Unit, Aarhus University Hospital/Randers Regional Hospital, Aarhus C, 2Department of Oncology, Rigshospitalet, Copenhagen University Hospital, 3DBCG-secretariat, Department 2501, Rigshospitalet, Copenhagen Ø, Denmark Aim of database: Danish Breast Cancer Cooperative Group (DBCG), with an associated database, was introduced as a nationwide multidisciplinary group in 1977 with the ultimate aim to improve the prognosis in breast cancer. Since then, the database has registered women diagnosed with primary invasive nonmetastatic breast cancer. The data reported from the departments to the database included details of the characteristics of the primary tumor, of surgery, radiotherapy, and systemic therapies, and of follow-up reported on specific forms from the departments in question. Descriptive data: From 1977 through 2014, ~110,000 patients are registered in the nationwide, clinical database. The completeness has gradually improved to more than 95%. DBCG has continuously prepared evidence-based guidelines on diagnosis and treatment of breast cancer and conducted quality control studies to ascertain the degree of adherence to the guidelines in the different departments. Conclusion: Utilizing data from the DBCG database, a long array of high-quality DBCG studies of various designs and scope, nationwide or in international collaboration, have contributed to the current updating of the guidelines, and have been an instrumental resource in the improvement of management and prognosis of breast cancer in Denmark. Thus, since the establishment of DBCG, the prognosis in breast cancer has continuously improved with a decrease in 5-year mortality from ~37% to 15%. Keywords: breast cancer, database, guidelines, quality control, research

Published
2016

6. Randomised controlled cognition trials in remitted patients with mood disorders published between 2015 and 2021: A systematic review by the International Society for Bipolar Disorders Targeting Cognition Task Force

Author

Miskowiak, KW, Seeberg, I, Jensen, MB, Balanza-Martinez, V, Mar Bonnin, C, Bowie, CR, Carvalho, AF, Dols, A, Douglas, K, Gallagher, P, Hasler, G, Lafer, B, Lewandowski, KE, Lopez-Jaramillo, C, Martinez-Aran, A, McIntyre, RS, Porter, RJ, Purdon, SE, Schaffer, A, Stokes, P, Sumiyoshi, T, Torres, IJ, Van Rheenen, TE, Yatham, LN, Young, AH, Kessing, L, Burdick, KE, Vieta, E, Miskowiak, KW, Seeberg, I, Jensen, MB, Balanza-Martinez, V, Mar Bonnin, C, Bowie, CR, Carvalho, AF, Dols, A, Douglas, K, Gallagher, P, Hasler, G, Lafer, B, Lewandowski, KE, Lopez-Jaramillo, C, Martinez-Aran, A, McIntyre, RS, Porter, RJ, Purdon, SE, Schaffer, A, Stokes, P, Sumiyoshi, T, Torres, IJ, Van Rheenen, TE, Yatham, LN, Young, AH, Kessing, L, Burdick, KE, and Vieta, E

Abstract

BACKGROUND: Cognitive impairments are an emerging treatment target in mood disorders, but currently there are no evidence-based pro-cognitive treatments indicated for patients in remission. With this systematic review of randomised controlled trials (RCTs), the International Society for Bipolar Disorders (ISBD) Targeting Cognition Task force provides an update of the most promising treatments and methodological recommendations. METHODS: The review included RCTs of candidate pro-cognitive interventions in fully or partially remitted patients with major depressive disorder or bipolar disorder. We followed the procedures of the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) 2020 statement. Searches were conducted on PubMed/MEDLINE, PsycInfo, EMBASE and Cochrane Library from January 2015, when two prior systematic reviews were conducted, until February 2021. Two independent authors reviewed the studies with the Revised Cochrane Collaboration's Risk of Bias tool for Randomised trials. RESULTS: We identified 16 RCTs (N = 859) investigating cognitive remediation (CR; k = 6; N = 311), direct current or repetitive magnetic stimulation (k = 3; N = 127), or pharmacological interventions (k = 7; N = 421). CR showed most consistent cognitive benefits, with two trials showing improvements on primary outcomes. Neuromodulatory interventions revealed no clear efficacy. Among pharmacological interventions, modafinil and lurasidone showed early positive results. Sources of bias included small samples, lack of pre-screening for objective cognitive impairment, no primary outcome and no information on allocation sequence masking. CONCLUSIONS: Evidence for pro-cognitive treatments in mood disorders is emerging. Recommendations are to increase sample sizes, pre-screen for impairment in targeted domain(s), select one primary outcome, aid transfer to real-world functioning, investigate multimodal interventions and include neuroimaging.

Published
2022

7. Meeting Report: Aging Research and Drug Discovery

Author

Meron, E, Thaysen, M, Angeli, S, Antebi, A, Barzilai, N, Baur, JA, Bekker-Jensen, S, Birkisdottir, M, Bischof, E, Bruening, J, Brunet, A, Buchwalter, A, Cabreiro, F, Cai, S, Chen, BH, Ermolaeva, M, Ewald, CY, Ferrucci, L, Florian, MC, Fortney, K, Freund, A, Georgievskaya, A, Gladyshev, VN, Glass, D, Golato, T, Gorbunova, V, Hoejimakers, J, Houtkooper, RH, Jager, S, Jaksch, F, Janssens, G, Jensen, MB, Kaeberlein, M, Karsenty, G, de Keizer, P, Kennedy, B, Kirkland, JL, Kjaer, M, Kroemer, G, Lee, K-F, Lemaitre, J-M, Liaskos, D, Longo, VD, Lu, Y-X, MacArthur, MR, Maier, AB, Manakanatas, C, Mitchell, SJ, Moskalev, A, Niedernhofer, L, Ozerov, I, Partridge, L, Passegue, E, Petr, MA, Peyer, J, Radenkovic, D, Rando, TA, Rattan, S, Riedel, CG, Rudolph, L, Ai, R, Serrano, M, Schumacher, B, Sinclair, DA, Smith, R, Suh, Y, Taub, P, Trapp, A, Trendelenburg, A-U, Valenzano, DR, Verburgh, K, Verdin, E, Vijg, J, Westendorp, RGJ, Zonari, A, Bakula, D, Zhavoronkov, A, Scheibye-Knudsen, M, Meron, E, Thaysen, M, Angeli, S, Antebi, A, Barzilai, N, Baur, JA, Bekker-Jensen, S, Birkisdottir, M, Bischof, E, Bruening, J, Brunet, A, Buchwalter, A, Cabreiro, F, Cai, S, Chen, BH, Ermolaeva, M, Ewald, CY, Ferrucci, L, Florian, MC, Fortney, K, Freund, A, Georgievskaya, A, Gladyshev, VN, Glass, D, Golato, T, Gorbunova, V, Hoejimakers, J, Houtkooper, RH, Jager, S, Jaksch, F, Janssens, G, Jensen, MB, Kaeberlein, M, Karsenty, G, de Keizer, P, Kennedy, B, Kirkland, JL, Kjaer, M, Kroemer, G, Lee, K-F, Lemaitre, J-M, Liaskos, D, Longo, VD, Lu, Y-X, MacArthur, MR, Maier, AB, Manakanatas, C, Mitchell, SJ, Moskalev, A, Niedernhofer, L, Ozerov, I, Partridge, L, Passegue, E, Petr, MA, Peyer, J, Radenkovic, D, Rando, TA, Rattan, S, Riedel, CG, Rudolph, L, Ai, R, Serrano, M, Schumacher, B, Sinclair, DA, Smith, R, Suh, Y, Taub, P, Trapp, A, Trendelenburg, A-U, Valenzano, DR, Verburgh, K, Verdin, E, Vijg, J, Westendorp, RGJ, Zonari, A, Bakula, D, Zhavoronkov, A, and Scheibye-Knudsen, M

Abstract

Aging is the single largest risk factor for most chronic diseases, and thus possesses large socioeconomic interest to continuously aging societies. Consequently, the field of aging research is expanding alongside a growing focus from the industry and investors in aging research. This year's 8th Annual Aging Research and Drug Discovery (ARDD) meeting was organized as a hybrid meeting from August 30th to September 3rd 2021 with more than 130 attendees participating on-site at the Ceremonial Hall at University of Copenhagen, Denmark, and 1800 engaging online. The conference comprised of presentations from 75 speakers focusing on new research in topics including mechanisms of aging and how these can be modulated as well as the use of AI and new standards of practices within aging research. This year, a longevity workshop was included to build stronger connections with the clinical community.

Published
2022

8. Impact of methodological choices in comparative effectiveness studies: application in natalizumab versus fingolimod comparison among patients with multiple sclerosis

Author

Lefort, M, Sharmin, S, Andersen, JB, Vukusic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, De Seze, J, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun-Frenay, C, Moreau, T, Berger, E, Clavelou, P, Pelletier, J, Stankoff, B, Gout, O, Thouvenot, E, Heinzlef, O, Al-Khedr, A, Bourre, B, Casez, O, Cabre, P, Montcuquet, A, Wahab, A, Camdessanche, JP, Maurousset, A, Ben Nasr, H, Hankiewicz, K, Pottier, C, Maubeuge, N, Nifle, C, Laplaud, DA, Horakova, D, Dimitri-Boulos, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Grand'Maison, F, Yamout, B, Prat, A, Girard, M, Duquette, P, Boz, C, Trojano, M, McCombe, P, Slee, M, Lechner-Scott, J, Turkoglu, R, Sola, P, Ferraro, D, Granella, F, Shaygannejad, V, Prevost, J, Maimone, D, Skibina, O, Buzzard, K, Van der Walt, A, Karabudak, R, Van Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Koch-Henriksen, N, Sellebjerg, F, Soerensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Butzkueven, H, Magyari, M, Kalincik, T, Leray, E, Lefort, M, Sharmin, S, Andersen, JB, Vukusic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, De Seze, J, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun-Frenay, C, Moreau, T, Berger, E, Clavelou, P, Pelletier, J, Stankoff, B, Gout, O, Thouvenot, E, Heinzlef, O, Al-Khedr, A, Bourre, B, Casez, O, Cabre, P, Montcuquet, A, Wahab, A, Camdessanche, JP, Maurousset, A, Ben Nasr, H, Hankiewicz, K, Pottier, C, Maubeuge, N, Nifle, C, Laplaud, DA, Horakova, D, Dimitri-Boulos, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Grand'Maison, F, Yamout, B, Prat, A, Girard, M, Duquette, P, Boz, C, Trojano, M, McCombe, P, Slee, M, Lechner-Scott, J, Turkoglu, R, Sola, P, Ferraro, D, Granella, F, Shaygannejad, V, Prevost, J, Maimone, D, Skibina, O, Buzzard, K, Van der Walt, A, Karabudak, R, Van Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Koch-Henriksen, N, Sellebjerg, F, Soerensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Butzkueven, H, Magyari, M, Kalincik, T, and Leray, E

Abstract

BACKGROUND: Natalizumab and fingolimod are used as high-efficacy treatments in relapsing-remitting multiple sclerosis. Several observational studies comparing these two drugs have shown variable results, using different methods to control treatment indication bias and manage censoring. The objective of this empirical study was to elucidate the impact of methods of causal inference on the results of comparative effectiveness studies. METHODS: Data from three observational multiple sclerosis registries (MSBase, the Danish MS Registry and French OFSEP registry) were combined. Four clinical outcomes were studied. Propensity scores were used to match or weigh the compared groups, allowing for estimating average treatment effect for treated or average treatment effect for the entire population. Analyses were conducted both in intention-to-treat and per-protocol frameworks. The impact of the positivity assumption was also assessed. RESULTS: Overall, 5,148 relapsing-remitting multiple sclerosis patients were included. In this well-powered sample, the 95% confidence intervals of the estimates overlapped widely. Propensity scores weighting and propensity scores matching procedures led to consistent results. Some differences were observed between average treatment effect for the entire population and average treatment effect for treated estimates. Intention-to-treat analyses were more conservative than per-protocol analyses. The most pronounced irregularities in outcomes and propensity scores were introduced by violation of the positivity assumption. CONCLUSIONS: This applied study elucidates the influence of methodological decisions on the results of comparative effectiveness studies of treatments for multiple sclerosis. According to our results, there are no material differences between conclusions obtained with propensity scores matching or propensity scores weighting given that a study is sufficiently powered, models are correctly specified and positivity assumption is ful

Published
2022

9. Participatory Research:A Priority Setting Partnership for Chronic Musculoskeletal Pain in Denmark

Author

Lyng, KD, Larsen, JB, Birnie, K, Stinson, J, Hoegh, M, Olesen, AE, Arendt-Nielsen, L, Ehlers, L, Fonager, K, Jensen, MB, Würtzen, H, Palsson, TS, Poulin, P, Handberg, G, Ziegler, C, Møller, LB, Olsen, J, Heise, L, and Rathleff, MS

Abstract

Background Patient and stakeholder engagements in research have increasingly gained attention in healthcare and healthcare-related research. A common and rigorous approach to establish research priorities based on input from people and stakeholders is the James Lind Alliance Priority Setting Partnership (JLA-PSP). The aim of this study was to establish research priorities for chronic musculoskeletal (MSK) pain by engaging with humans living with chronic MSK pain, relatives to humans living with chronic MSK pain, healthcare professionals (HCP), and researchers working with chronic MSK pain.Methods This JLA-PSP included a nation-wide survey in Denmark, an interim prioritisation, and an online consensus building workshop. The information gained from this was the basis for developing the final list of specific research priorities within chronic MSK pain.Results In the initial survey, 1010 respondents (91% people living with chronic MSK pain/relatives, 9% HCPs/researchers) submitted 3121 potential questions. These were summarised into 19 main themes and 36 sub-themes. In the interim prioritisation exercise, 51% people living with pain/relatives and 49% HCPs/researchers reduced the list to 33 research questions prior to the final priority setting workshop. 23 participants attended the online workshop (12 people/relatives, 10 HCPs, and 1 researcher) who reached consensus for the most important research priorities after two rounds of discussion of each question.Conclusion This study identified several specific research questions generated by people living with chronic MSK pain, relatives, HCPs, and researchers. The stakeholders proposed prioritization of the healthcare system’s ability to support patients, focus on developing coherent pathways between sectors and education for both patients and HCP. These research questions can form the basis for future studies, funders, and be used to align research with end-users’ priorities

Published
2021
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10. Participatory Research: A Priority Setting Partnership for Chronic Musculoskeletal Pain in Denmark

Author

Lyng, KD, primary, Larsen, JB, additional, Birnie, K, additional, Stinson, J, additional, Hoegh, M, additional, Olesen, AE, additional, Arendt-Nielsen, L, additional, Ehlers, L, additional, Fonager, K, additional, Jensen, MB, additional, Würtzen, H, additional, Palsson, TS, additional, Poulin, P, additional, Handberg, G, additional, Ziegler, C, additional, Møller, LB, additional, Olsen, J, additional, Heise, L, additional, and Rathleff, MS, additional

Published
2021
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11. Prognosis and transition of multi-site pain during the course of 5 years: Results of knee pain and function from a prospective cohort study among 756 adolescents

Author

Holden, S, Roos, Ewa, Straszek, CL, Olesen, JL, Jensen, MB, Graven-Nielsen, T, and Rathleff, MS

Subjects
human activities, Uncategorized
Abstract

Introduction Multi-site pain has not been investigated among adolescents suffering from knee pain. This study aimed to examine the trajectory of pain in adolescents with knee-pain, to determine if multi-site pain in adolescents together with other established prognostic factors (frequency of pain, sex, sports participation, Health Related Quality of Life (HRQoL)) was associated with five-year prognosis of knee-pain and function. Methods This prospective cohort study included 504 adolescents with knee pain and 252 controls. At five-year follow-up, participants responded to an questionnaire which documented prescence and severity of knee pain and co-occurring pain. Results At follow-up, 358 (71.0%) of those with knee-pain at baseline, and 182 (72.2%) controls responded. Female sex, low HRQoL, daily pain, and multi-site pain were associated with an increased odds of knee pain after 5 years (odds ratio: 1.41-3.37). Baseline multi-site pain was not associated with problems running at follow-up, whereas higher sports participation at baseline was associated with less problems running at follow-up (odd ratio 0.49). Among those with knee-pain at inclusion, the number of pain sites increased from a median of 2 (IQR 1-3) to 4 (IQR 2-6) at follow-up (P

Published
2021
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12. The effectiveness of natalizumab vs fingolimod-A comparison of international registry studies

Author

Andersen, JB, Sharmin, S, Lefort, M, Koch-Henriksen, N, Sellebjerg, F, Sorensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Horakova, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Maison, FG, Yamout, B, Prat, A, Girard, M, Duquette, P, Boz, C, Trojano, M, McCombe, P, Slee, M, Lechner-Scott, J, Turkoglu, R, Sola, P, Ferraro, D, Granella, F, Shaygannejad, V, Prevost, J, Skibina, O, Solaro, C, Karabudak, R, Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, Seze, JD, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun, C, Moreau, T, Berger, E, Clavelou, P, Pelletier, J, Stankoff, B, Gout, O, Thouvenot, E, Heinzlef, O, Al-Khedr, A, Bourre, B, Casez, O, Cabre, P, Montcuquet, A, Wahab, A, Camdessanche, J-P, Marousset, A, Patry, I, Hankiewicz, K, Pottier, C, Maubeuge, N, Labeyrie, C, Nifle, C, Leray, E, Laplaud, DA, Butzkueven, H, Kalincik, T, Vukusic, S, Magyari, M, Andersen, JB, Sharmin, S, Lefort, M, Koch-Henriksen, N, Sellebjerg, F, Sorensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Horakova, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Maison, FG, Yamout, B, Prat, A, Girard, M, Duquette, P, Boz, C, Trojano, M, McCombe, P, Slee, M, Lechner-Scott, J, Turkoglu, R, Sola, P, Ferraro, D, Granella, F, Shaygannejad, V, Prevost, J, Skibina, O, Solaro, C, Karabudak, R, Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, Seze, JD, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun, C, Moreau, T, Berger, E, Clavelou, P, Pelletier, J, Stankoff, B, Gout, O, Thouvenot, E, Heinzlef, O, Al-Khedr, A, Bourre, B, Casez, O, Cabre, P, Montcuquet, A, Wahab, A, Camdessanche, J-P, Marousset, A, Patry, I, Hankiewicz, K, Pottier, C, Maubeuge, N, Labeyrie, C, Nifle, C, Leray, E, Laplaud, DA, Butzkueven, H, Kalincik, T, Vukusic, S, and Magyari, M

Abstract

BACKGROUND: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening. METHODS: By re-analyzing original published results from MSBase, France, and Denmark using uniform methodologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/exclusion criteria and statistical methods with Inverse Probability Treatment Weighting. RESULTS: The pooled analyses comprised 968 natalizumab- and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod. CONCLUSION: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed.

Published
2021

14. ARDD 2020: from aging mechanisms to interventions

Author

Mkrtchyan, GV, Abdelmohsen, K, Andreux, P, Bagdonaite, I, Barzilai, N, Brunak, S, Cabreiro, F, Cabo, RD, Campisi, J, Cuervo, AM, Demaria, M, Ewald, CY, Fang, EF, Faragher, R, Ferrucci, L, Freund, A, Silva-García, CG, Georgievskaya, A, Gladyshev, VN, Glass, DJ, Gorbunova, V, Grey, AD, He, WW, Hoeijmakers, Jan, Hoffmann, E, Horvath, S, Houtkooper, RH, Jensen, MK, Jensen, MB, Kane, A, Kassem, M, Keizer, PD, Kennedy, B, Karsenty, G, Lamming, DW, Lee, KF, MacAulay, N, Mamoshina, P, Mellon, J, Molenaars, M, Moskalev, A, Mund, A, Niedernhofer, L, Osborne, B, Pak, HH, Parkhitko, A, Raimundo, N, Rando, TA, Rasmussen, LJ, Reis, C, Riedel, CG, Franco-Romero, A, Schumacher, B, Sinclair, DA, Suh, Y, Taub, PR, Toiber, D, Treebak, JT, Valenzano, DR, Verdin, E, Vijg, J, Young, S (Saroj), Zhang, Liying, Bakula, D, Zhavoronkov, A, Scheibye-Knudsen, M, Mkrtchyan, GV, Abdelmohsen, K, Andreux, P, Bagdonaite, I, Barzilai, N, Brunak, S, Cabreiro, F, Cabo, RD, Campisi, J, Cuervo, AM, Demaria, M, Ewald, CY, Fang, EF, Faragher, R, Ferrucci, L, Freund, A, Silva-García, CG, Georgievskaya, A, Gladyshev, VN, Glass, DJ, Gorbunova, V, Grey, AD, He, WW, Hoeijmakers, Jan, Hoffmann, E, Horvath, S, Houtkooper, RH, Jensen, MK, Jensen, MB, Kane, A, Kassem, M, Keizer, PD, Kennedy, B, Karsenty, G, Lamming, DW, Lee, KF, MacAulay, N, Mamoshina, P, Mellon, J, Molenaars, M, Moskalev, A, Mund, A, Niedernhofer, L, Osborne, B, Pak, HH, Parkhitko, A, Raimundo, N, Rando, TA, Rasmussen, LJ, Reis, C, Riedel, CG, Franco-Romero, A, Schumacher, B, Sinclair, DA, Suh, Y, Taub, PR, Toiber, D, Treebak, JT, Valenzano, DR, Verdin, E, Vijg, J, Young, S (Saroj), Zhang, Liying, Bakula, D, Zhavoronkov, A, and Scheibye-Knudsen, M

Published
2020

15. Unannounced or announced periodic hospital surveys: a study protocol for a nationwide cluster-randomized controlled trial

Author

Simonsen KB, Olesen AV, Jensen MB, Rasmussen GS, and Ehlers LH

Subjects
lcsh:Public aspects of medicine, lcsh:RA1-1270
Abstract

Katherina Beltoft Simonsen,1 Anne Vingaard Olesen,1 Morten Berg Jensen,1,2 Gitte Sand Rasmussen,3 Lars Holger Ehlers1 1Danish Center for Healthcare Improvements, Aalborg University, Aalborg, Denmark; 2Center for Research in Econometric Analysis of Time Series, Department of Economics and Business, Aarhus University, Aarhus, Denmark; 3Danish Institute for Quality and Accreditation in Healthcare, Aarhus, Denmark Purpose: Accreditation programs for health care systems have been implemented in more than 70 countries to stimulate high-quality organizational performance. Several Danish health care institutions are covered by the Danish Healthcare Quality Program (DDKM), and all Danish public hospitals have been accredited according to the DDKM since 2010. The dates of each survey are currently announced beforehand. Announcing surveys has been criticized for creating an “arranged reality”. It was therefore suggested that a national intervention be conducted to evaluate the effect of unannounced hospital surveys. The objective is to evaluate the effect of unannounced hospital surveys compared to the conventional announced hospital surveys by conducting a cluster-randomized controlled trial. Methods: All public somatic and psychiatric hospitals in Denmark (n=30) were invited to participate. Twenty-three hospitals (77%) agreed to participate and to be randomized to one of the trial clusters. Eleven hospitals received announced surveys (control group) and 12 hospitals received unannounced surveys (intervention group). We hypothesized that hospitals receiving unannounced surveys would be rated as less successful than hospitals receiving announced surveys, defined as meeting less compliance with accreditation standards and performance indicators. Surveyors employed and educated by the Danish Institute for Quality and Accreditation in Health Care (IKAS) were responsible for conducting the surveys according to an abbreviated version of the current Danish Healthcare Quality Program (DDKM). The outcome is compliance with indicators reflecting organizational performance. Compliance was analyzed using binomial regression analyses with bootstrapped standard errors. Discussion: Unannounced hospital surveys are expected to reveal less compliance with performance indicators compared to the announced hospital surveys. These study results may facilitate a validation of the effect of unannounced periodic hospital surveys influencing the decision of whether or not unannounced surveys should be implemented as a new method of conducting accreditation programs in Danish hospitals. Keywords: accreditation, quality improvement, quality indicators, health care

Published
2015

16. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years

Author

Pan, H, Gray, R, Braybrooke, J, Davies, C, Taylor, C, Mcgale, P, Peto, R, Pritchard, Ki, Bergh, J, Dowsett, M, Hayes, Df, Albain, K, Anderson, S, Arriagada, R, Barlow, W, Bartlett, J, Bergsten‐nordström, E, Bliss, J, Boccardo, F, Bradley, R, Brain, E, Cameron, D, Clarke, M, Coates, A, Coleman, R, Correa, C, Costantino, J, Cuzick, J, Davidson, N, Dodwell, D, Di Leo, A, Ewertz, M, Forbes, J, Gelber, R, Gnant, M, Goldhirsch, A, Goodwin, P, Hill, C, Ingle, J, Jagsi, R, Janni, W, Loibl, S, Mackinnon, E, Martin, M, Mukai, H, Norton, L, Ohashi, Y, Paik, S, Perez, E, Piccart, M, Pierce, L, Poortmans, P, Raina, V, Ravdin, P, Regan, M, Robertson, J, Rutgers, E, Slamon, D, Sparano, J, Swain, S, Tutt, A, Viale, G, Von Minckwitz, G, Wang, X, Whelan, T, Wilcken, N, Winer, E, Wolmark, N, Wood, W, Zambetti, M, Alberro, Ja, Ballester, B, Deulofeu, P, Fábregas, R, Fraile, M, Gubern, Jm, Janer, J, Moral, A, De Pablo Jl, Peñalva, G, Puig, P, Ramos, M, Rojo, R, Santesteban, P, Serra, C, Solà, M, Solarnau, L, Solsona, J, Veloso, E, Vidal, S, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Garaud, P, Collett, V, Delmestri, A, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Balic, M, Bartsch, R, Fesl, C, Fitzal, F, Fohler, H, Greil, R, Jakesz, R, Marth, C, Mlineritsch, B, Pfeiler, G, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hma, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Hupperets, Psgj, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Dal, Patnick, J, Pinder, S, Lohrisch, C, Nichol, A, Bramwell, Vh, Chen, Be, Gelmon, K, Goss, Pe, Levine, Mn, Parulekar, W, Pater, Jl, Shepherd, Le, Tu, D, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Weiss, Rb, Abu‐zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett‐lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Sestak, I, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesec’h, J, De La Lande, B, Mouret‐fourme, E, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Shao, Yf, Zhao, Db, Chen, Zm, Howell, A, Swindell, R, Boddington, C, Burrett, Ja, Cutter, D, Duane, F, Evans, V, Gettins, L, Godwin, J, James, S, Kerr, A, Liu, H, Mannu, G, Mchugh, T, Morris, P, Read, S, Wang, Y, Wang, Z, Albano, J, De Oliveira Cf, Gervásio, H, Gordilho, J, Ejlertsen, B, Jensen, Mb, Johansen, H, Mouridsen, H, Palshof, T, Gelman, Rs, Harris, Jr, Henderson, C, Shapiro, Cl, Christiansen, P, Mouridsen, Ht, Fehm, T, Trampisch, Hj, Dalesio, O, De Vries Ege, Rodenhuis, S, Van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jgm, Treurniet‐donker, Ad, Van Putten Wlj, Rotmensz, N, Veronesi, U, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, Van De Velde Cjh, Cunningham, Mp, Brufsky, Am, Coleman, Re, Llombart, Ha, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Carrasco, E, Segui, Ma, Eiermann, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, B, Jackisch, C, De Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Galligioni, E, Leone, B, Vallejo, Ct, Zwenger, A, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Fountzilas, G, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Tinterri, C, Margreiter, R, De Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, André, F, Delaloge, S, Koscielny, S, Michiels, S, Rubino, C, A'Hern, R, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, Van De Velde Ao, Van Dongen Ja, Vermorken, Jb, Castiglione, M, Colleoni, M, Collins, J, Gelber, Rd, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ced, Coombes, Rc, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Bighin, C, Bruzzi, P, Del Mastro, L, Dozin, B, Pastorino, S, Pronzato, P, Sertoli, Mr, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Peretz, T, Robinson, E, Camerini, T, Formelli, F, Martelli, G, Di Mauro Mg, Perrone, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Musolino, A, Passalacqua, R, Iwata, H, Shien, T, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Sadoon, M, Tulusan, Ah, Kohno, N, Miyashita, M, Takao, S, Ahn, Jh, Jung, Kh, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, Liefers, Gj, Christiaens, R, Neven, P, Paridaens, R, Van Den Bogaert, W, Braun, S, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, De La Huerta, R, Sainz, Mg, Ro, J, Camphausen, K, Danforth, D, Lichter, A, Lippman, M, Smart, D, Steinberg, S, D’Amico, C, Lioce, M, Paradiso, A, Ohno, S, Bass, G, Brown, A, Bryant, J, Dignam, J, Fisher, B, Geyer, C, Mamounas, Ep, Redmond, C, Wickerham, L, Aihara, T, Hozumi, Y, Baum, M, Jackson, Im, Palmer, Mk, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Venturini, M, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Reinertsen, Kv, Varhaug, Je, Gundersen, S, Hauer‐jensen, M, Høst, H, Nissen‐meyer, R, Mitchell, Ak, Robertson, Jfr, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, Cocconi, G, Di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Hadji, P, A’Hern, R, Makris, A, Parton, M, Pennert, K, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Clack, G, Van Poznak, C, Deshpande, N, Di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Ajs, Ewing, Gh, Firth, La, Krushen‐kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Ravdin, Pm, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, Af Trampe, E, Wadström, C, Maibach, R, Thürlimann, B, Holli, K, Rouhento, K, Safra, T, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ahg, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Lemonnier, J, Martin, Al, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Deutsch, Gp, Kwong, Dlw, Pai, Vr, Senanayake, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Bell, R, Hinsley, S, Marshall, Hc, Pierce, Lj, Solomayer, E, Horsman, Jm, Lester, J, Winter, Mc, Buzdar, Au, Hsu, L, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Aft, R, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H., Guided Treatment in Optimal Selected Cancer Patients (GUTS), Other departments, CCA - Cancer Treatment and Quality of Life, Radiotherapy, Pan, Hongchao, Gray, Richard, Braybrooke, Jeremy, Davies, Christina, Taylor, Carolyn, Mcgale, Paul, Peto, Richard, Pritchard, Kathleen I, Bergh, Jona, Dowsett, Mitch, Hayes, Daniel F, De Laurentiis, Michelino, MUMC+: MA Medische Oncologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, and Interne Geneeskunde

Subjects
0301 basic medicine, Oncology, medicine.medical_treatment, Kaplan-Meier Estimate, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Recurrence, Receptors, Neoplasm Metastasis, AMERICAN SOCIETY, Adjuvant, CLINICAL-PRACTICE GUIDELINE, Absolute risk reduction, Estrogen Antagonists, General Medicine, Estrogen Antagonist, CHEMOTHERAPY, Middle Aged, Prognosis, Neoplasm Metastasi, Local, POSTMENOPAUSAL WOMEN, Receptors, Estrogen, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Meta-analysis, Lymphatic Metastasis, Female, Human, Estrogen Antagonists/therapeutic use, Adult, Risk, medicine.medical_specialty, Prognosi, medicine.drug_class, DISCONTINUATION, Breast Neoplasms, Article, Drug Administration Schedule, LATE DISTANT RECURRENCE, 03 medical and health sciences, Breast cancer, Breast Neoplasms/drug therapy, Internal medicine, SCORE, medicine, Humans, SURGICAL ADJUVANT BREAST, Aged, Proportional Hazards Models, Chemotherapy, business.industry, Proportional hazards model, Lymphatic Metastasi, TAMOXIFEN THERAPY, ta3122, medicine.disease, Estrogen, RANDOMIZED-TRIALS, Discontinuation, Surgery, Neoplasm Recurrence, 030104 developmental biology, Proportional Hazards Model, Neoplasm Grading, Neoplasm Recurrence, Local, business
Abstract

Background The administration of endocrine therapy for 5 years substantially reduces recurrence rates during and after treatment in women with early-stage, estrogen-receptor (ER)–positive breast cancer. Extending such therapy beyond 5 years offers further protection but has additional side effects. Obtaining data on the absolute risk of subsequent distant recurrence if therapy stops at 5 years could help determine whether to extend treatment. Methods In this meta-analysis of the results of 88 trials involving 62,923 women with ER-positive breast cancer who were disease-free after 5 years of scheduled endocrine therapy, we used Kaplan–Meier and Cox regression analyses, stratified according to trial and treatment, to assess the associations of tumor diameter and nodal status (TN), tumor grade, and other factors with patients’ outcomes during the period from 5 to 20 years. Results Breast-cancer recurrences occurred at a steady rate throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status. Among the patients with stage T1 disease, the risk of distant recurrence was 13% with no nodal involvement (T1N0), 20% with one to three nodes involved (T1N1–3), and 34% with four to nine nodes involved (T1N4–9); among those with stage T2 disease, the risks were 19% with T2N0, 26% with T2N1–3, and 41% with T2N4–9. The risk of death from breast cancer was similarly dependent on TN status, but the risk of contralateral breast cancer was not. Given the TN status, the factors of tumor grade (available in 43,590 patients) and Ki-67 status (available in 7692 patients), which are strongly correlated with each other, were of only moderate independent predictive value for distant recurrence, but the status regarding the progesterone receptor (in 54,115 patients) and human epidermal growth factor receptor type 2 (HER2) (in 15,418 patients in trials with no use of trastuzumab) was not predictive. During the study period from 5 to 20 years, the absolute risk of distant recurrence among patients with T1N0 breast cancer was 10% for low-grade disease, 13% for moderate-grade disease, and 17% for high-grade disease; the corresponding risks of any recurrence or a contralateral breast cancer were 17%, 22%, and 26%, respectively. Conclusions After 5 years of adjuvant endocrine therapy, breast-cancer recurrences continued to occur steadily throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status, with risks ranging from 10 to 41%, depending on TN status and tumor grade. (Funded by Cancer Research UK and others.)

Published
2017

17. Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials

Author

Alberro, JA, Ballester, B, Deulofeu, P, Fabregas, R, Fraile, M, Gubern, JM, Janer, J, Moral, A, de Pablo, JL, Penalva, G, Puig, P, Ramos, M, Rojo, R, Santesteban, P, Serra, C, Sola, M, Solarnau, L, Solsona, J, Veloso, E, Vidal, S, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Ohashi, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Coles, CE, Haybittle, JL, Moebus, V, Leonard, CF, Calais, G, Garaud, P, Collett, V, Davies, C, Delmestri, A, Sayer, J, Harvey, VJ, Holdaway, IM, Kay, RG, Mason, BH, Forbe, JF, Franci, PA, Wilcken, N, Balic, M, Bartsch, R, Fesl, C, Fitzal, F, Fohler, H, Gnant, M, Greil, R, Jakesz, R, Marth, C, Mlineritsch, B, Pfeiler, G, Singer, CF, Steger, GG, Stoeger, H, Canney, P, Yosef, HMA, Focan, C, Peek, U, Oates, GD, Powell, J, Durand, M, Mauriac, L, Di Leo, A, Dolci, S, Larsimont, D, Nogaret, JM, Philippson, C, Piccart, MJ, Masood, MB, Parker, D, Price, JJ, Lindsay, MA, Mackey, J, Martin, M, Hupperets, PSGJ, Bates, T, Blamey, RW, Chetty, U, Ellis, IO, Mallon, E, Morgan, DAL, Patnick, J, Pinder, S, Lohrisch, C, Nichol, A, Bartlett, JMS, Bramwell, VH, Chen, BE, Chia, SKL, Gelmon, K, Goss, PE, Levine, MN, Parulekar, W, Pater, JL, Pritchard, KI, Shepherd, LE, Tu, D, Whelan, T, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Norton, L, Weiss, RB, Abu-Zahara, HT, Karpov, A, Portnoj, SL, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, PJ, Manse, RE, Monypenny, IJ, Gordon, NH, Davis, HL, Cuzick, J, Sestak, I, Lehingue, Y, Romestaing, P, Dubois, JB, Delozier, T, Griffon, B, Lesec'h, J Mace, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, JR, Meier, P, Shan, Y, Shao, YF, Wang, X, Zhao, DB, Howell, A, Swindell, R, Albano, J, de Oliveira, CF, Gervasio, H, Gordilho, J, Ejlertsen, B, Jensen, M-B, Mouridsen, H, Gelman, RS, Harris, JR, Hayes, D, Henderson, C, Shapiro, CL, Christiansen, P, Ewertz, M, Jensen, MB, Mouridsen, HT, Fehm, T, Trampisch, HJ, Dalesio, O, de Vries, EGE, Rodenhuis, S, van Tinteren, H, Comis, RL, Davidson, NE, Gray, R, Robert, N, Sledge, G, Solin, LJ, Sparano, JA, Tormey, DC, Wood, W, Cameron, D, Dixon, JM, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, JGM, Treurniet-Donker, AD, van Putten, WLJ, Rotmensz, N, Veronesi, U, Viale, G, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, JP, Poortmans, PM, Rutgers, E, van de Velde, CJH, Cunningham, MP, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, LJ, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Lupors, E, Namer, M, Carrasco, E, Segui, MA, Eierman, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, JU, Costa, SD, Eidtmann, H, Gerber, B, Jackisch, C, Loib, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, MC, Sacco, M, Valentini, M, McArdle, CS, Smith, DC, Stallard, S, Dent, DM, Gudgeon, CA, Hacking, A, Murray, E, Panieri, E, Werner, ID, De Salvo, GL, Del Bianco, P, Zavagno, G, Leone, B, Vallejo, CT, Zwenger, A, Galligioni, E, Lopez, M, Erazo, A, Medina, JY, Horiguchi, J, Takei, H, Fentiman, IS, Hayward, JL, Rubens, RD, Skilton, D, Scheurlen, H, Sohn, HC, Untch, M, Dafni, U, Markopoulos, C, Bamia, C, Fountzilas, G, Koliou, G-A, Manousou, K, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Canavese, G, Tinterri, C, Margreiter, R, de Lafontan, B, Mihura, J, Roche, H, Asselain, B, Salmon, RJ, Vilcoq, JR, Brain, E, de La Lande, B, Mouret-Fourme, E, Andre, F, Arriagada, R, Delaloge, S, Hill, C, Koscienly, S, Michiels, S, Rubino, C, A'Hern, R, Bliss, J, Ellis, P, Kilburn, L, Yarnold, JR, Benraadt, J, Kooi, M, van de Velde, AO, van Dongen, JA, Vermorken, JB, Castiglione, M, Coates, A, Colleoni, M, Collins, J, Forbes, J, Gelbe, RD, Goldhirsch, A, Lindtner, J, Price, KN, Regan, MM, Rudenstam, CM, Senn, HJ, Thuerlimann, B, Bliss, JM, Chilvers, CED, Coombes, RC, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, WD, Stewart, HJ, Stroner, P, Borovik, R, Hayat, H, Inbar, MJ, Peretz, T, Robinson, E, Camerini, T, Formelli, F, Martelli, G, Di Mauro, MG, Perrone, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Musolino, A, Passalacqua, R, Iwata, H, Shien, T, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Sadoon, M, Tulusan, AH, Kohno, N, Miyashita, M, Takao, S, Ahn, J-H, Jung, KH, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, Liefers, GJ, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Gazet, JC, Corcoran, N, Deshpande, N, di Martino, L, Douglas, P, Host, H, Lindtner, A, Notter, G, Bryant, AJS, Ewing, GH, Firth, LA, Krushen-Kosloski, JL, Nissen-Meyer, R, Anderson, H, Killander, F, Malmstrom, P, Ryden, L, Arnesson, L-G, Carstense, J, Dufmats, M, Fohlin, H, Nordenskjold, B, Soderberg, M, Sundqvist, M, Carpenter, TJ, Murray, N, Royle, GT, Simmonds, PD, Albain, K, Barlow, W, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, CK, Ravdin, PM, Bergh, J, Bondesso, T, Celebiogl, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Goransson, E, Iiristo, M, Johansson, U, Lenner, E, Lofgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadstrom, C, Janni, W, Maibach, R, Thurlimann, B, Hadji, P, Hozumi, J, Holli, K, Rouhento, K, Safra, T, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, AHG, Fyles, A, Meakin, JW, Panzarella, T, Bahi, J, Lemonnier, J, Martin, AL, Reid, M, Spittle, M, Bishop, H, Bundred, NJ, Forbes, JF, Forsyth, S, George, WS, Pinder, SE, Deutsch, GP, Kwong, DLW, Pai, VR, Peto, R, Senanayake, F, Boccardo, F, Rubagotti, A, Baum, M, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, JS, Carlomagno, C, De Laurentiis, M, De Placido, S, Schem, C, Williams, L, Bell, R, Coleman, RE, Dodwell, D, Hinsley, S, Marshall, HC, Pierce, LJ, Basso, SMM, Lumachi, F, Solomayer, E, Horsman, JM, Lester, J, Winter, MC, Buzdar, AU, Hsu, L, Love, RR, Ahlgren, J, Garmo, H, Holmberg, L, Lindman, H, Warnberg, F, Asmar, L, Jones, SE, Aft, R, Gluz, O, Harbeck, N, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, BK, Chlebowski, RT, Caffier, H, Brufsky, AM, Llombart, HA, Asselain, B, Barlow, W, Bartlett, J, Bradley, R, Braybrooke, J, Davies, C, Dodwell, D, Gray, R, Mannu, G, Taylor, C, Peto, R, McGale, P, Pan, H, Wang, Y, Wang, Z, Department of Oncology, Clinicum, HUS Comprehensive Cancer Center, Medical Oncology, Cancer Research UK, and Pfizer Limited

Subjects
0301 basic medicine, Oncology, Time Factors, SURGERY, medicine.medical_treatment, menopause, chemotherapy, Mastectomy, Segmental, Rate ratio, THERAPY, aromatase inhibitors, CEA, 0302 clinical medicine, Risk Factors, Medicine and Health Sciences, Breast, Neoplasm Metastasis, Randomized Controlled Trials as Topic, RISK, tamoxifen, breast tumor, CA15-3, axillary dissection, mastectomy, Middle Aged, Neoadjuvant Therapy, METHOTREXATE, 3. Good health, trastuzumab, Treatment Outcome, quadrantectomy, Chemotherapy, Adjuvant, axillary lymphnodes, 030220 oncology & carcinogenesis, Meta-analysis, SURVIVAL, Disease Progression, Female, Life Sciences & Biomedicine, axillary clearance, RADIOTHERAPY, medicine.drug, Adult, medicine.medical_specialty, Anthracycline, 3122 Cancers, Antineoplastic Agents, Breast Neoplasms, axillary nodes, sentinel node biopsy, 03 medical and health sciences, breast cancer, Breast cancer, SDG 3 - Good Health and Well-being, HER2, Internal medicine, Journal Article, medicine, cancer, Humans, Breast, breast cancer, breast diseases, cancer, malignancy, menopause, surgery, mastectomy, quadrantectomy, lumpectomy, axillary nodes, axillary lymphnodes, axillary dissection, axillary clearance, sentinel node biopsy, sentinel node, BRCA1, BRCA2, tamoxifen, aromatase inhibitors, breast tumor, osteoporosis, bisphosphonates, denosumab, trastuzumab, HER2, CEA, CA15-3, tumor marker, chemotherapy, endocrine therapy, Oncology & Carcinogenesis, RECURRENCE, bisphosphonates, Pathological, Neoplasm Staging, lumpectomy, Chemotherapy, Science & Technology, breast diseases, endocrine therapy, business.industry, denosumab, BRCA1, medicine.disease, BRCA2, osteoporosis, Radiation therapy, STIMULATING FACTOR, 030104 developmental biology, sentinel node, tumor marker, Methotrexate, Neoplasm Recurrence, Local, business, 1112 Oncology And Carcinogenesis, malignancy
Abstract

BACKGROUND: Neoadjuvant chemotherapy (NACT) for early breast cancer can make breast-conserving surgery more feasible and might be more likely to eradicate micrometastatic disease than might the same chemotherapy given after surgery. We investigated the long-term benefits and risks of NACT and the influence of tumour characteristics on outcome with a collaborative meta-analysis of individual patient data from relevant randomised trials. METHODS: We obtained information about prerandomisation tumour characteristics, clinical tumour response, surgery, recurrence, and mortality for 4756 women in ten randomised trials in early breast cancer that began before 2005 and compared NACT with the same chemotherapy given postoperatively. Primary outcomes were tumour response, extent of local therapy, local and distant recurrence, breast cancer death, and overall mortality. Analyses by intention-to-treat used standard regression (for response and frequency of breast-conserving therapy) and log-rank methods (for recurrence and mortality). FINDINGS: Patients entered the trials from 1983 to 2002 and median follow-up was 9 years (IQR 5-14), with the last follow-up in 2013. Most chemotherapy was anthracycline based (3838 [81%] of 4756 women). More than two thirds (1349 [69%] of 1947) of women allocated NACT had a complete or partial clinical response. Patients allocated NACT had an increased frequency of breast-conserving therapy (1504 [65%] of 2320 treated with NACT vs 1135 [49%] of 2318 treated with adjuvant chemotherapy). NACT was associated with more frequent local recurrence than was adjuvant chemotherapy: the 15 year local recurrence was 21·4% for NACT versus 15·9% for adjuvant chemotherapy (5·5% increase [95% CI 2·4-8·6]; rate ratio 1·37 [95% CI 1·17-1·61]; p=0·0001). No significant difference between NACT and adjuvant chemotherapy was noted for distant recurrence (15 year risk 38·2% for NACT vs 38·0% for adjuvant chemotherapy; rate ratio 1·02 [95% CI 0·92-1·14]; p=0·66), breast cancer mortality (34·4% vs 33·7%; 1·06 [0·95-1·18]; p=0·31), or death from any cause (40·9% vs 41·2%; 1·04 [0·94-1·15]; p=0·45). INTERPRETATION: Tumours downsized by NACT might have higher local recurrence after breast-conserving therapy than might tumours of the same dimensions in women who have not received NACT. Strategies to mitigate the increased local recurrence after breast-conserving therapy in tumours downsized by NACT should be considered-eg, careful tumour localisation, detailed pathological assessment, and appropriate radiotherapy. FUNDING: Cancer Research UK, British Heart Foundation, UK Medical Research Council, and UK Department of Health. ispartof: LANCET ONCOLOGY vol:19 issue:1 pages:27-39 ispartof: location:England status: published

Published
2017
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18. Risk of heart disease in relation to radiotherapy and chemotherapy with anthracyclines among 19,464 breast cancer patients in Denmark, 1977-2005

Author

Rehammar, JC, Jensen, MB, McGale, P, Lorenzen, EL, Taylor, C, Darby, S, Videbæk, L, Wang, Z, and Ewertz, M

Subjects
Breast cancer, Oncology, Radiotherapy, Radiology Nuclear Medicine and imaging, Anthracyclines, Hematology, Heart disease
Abstract

Background and purpose: The risk of heart disease subsequent to breast cancer radiotherapy was examined with particular focus on women receiving anthracycline-containing chemotherapy. Material and methods: Women diagnosed with early-stage breast cancer in Denmark, 1977-2005, were identified from the register of the Danish Breast Cancer Cooperative Group, as was information on cancer-directed treatment. Information on heart disease was sought from the Danish National Patient and Cause of Death Registries. Incidence rate ratios were estimated comparing left-sided with right-sided cancer (IRR, LvR), stratified by calendar year, age, and time since breast cancer radiotherapy. Results: Among 19,464 women receiving radiotherapy, the IRR, LvR, was 1.11 (95% CI 1.03-1.20, p = 0.005) for all heart disease and among those also receiving anthracyclines the IRR, LvR, was 1.32 (95% CI 1.02-1.70, p = 0.03). This risk was highest if the treatment was given before the age of 50. years (IRR, LvR, 1.44, (95% CI 1.04-2.01) but there was no significant trend with age or time since treatment. Conclusions: Radiotherapy for left-sided breast cancer is associated with a higher risk of heart disease than for right-sided with the largest increases seen in women who also received anthracycline-containing chemotherapy.

Published
2017
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19. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials

Author

Mcgale, P., Taylor, C., Correa, C., Cutter, D., Duane, F., Ewertz, M., Gray, R., Mannu, G., Peto, R., Whelan, T., Wang, Y., Wang, Z., Darby, S., Albain, K., Anderson, S., Arriagada, R., Barlow, W., Bergh, J., Bergsten Nordström, E., Bliss, J., Burrett, J. A., Buyse, M., Cameron, D., Carrasco, E., Clarke, M., Coleman, R., Coates, A., Collins, R., Costantino, J., Cuzick, J., Davidson, N., Davies, C., Davies, K., Delmestri, A., Di Leo, A., Dowsett, M., Elphinstone, P., Evans, V., Forbes, J., Gelber, R., Gettins, L., Geyer, C., Gianni, L., Gnant, M., Goldhirsch, A., Godwin, J., Gregory, C., Hayes, D., Hill, C., Ingle, J., Jakesz, R., James, S., Janni, W., Kaufmann, M., Kerr, A., Liu, H., Mackinnon, E., Martín, M., Mchugh, T., Morris, P., Norton, L., Ohashi, Y., Paik, S., Pan, H. C., Perez, E., Piccart, M., Pierce, L., Pritchard, K., Pruneri, G., Raina, V., Ravdin, P., Robertson, J., Rutgers, E., Shao, Y. F., Sparano, J., Swain, S., Valagussa, P., Viale, G., Von Minckwitz, G., Winer, E., Wiang, X., Wood, Abe O, W., Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Ohashi, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Geraud, P, Collett, V, Davies, C, Delmestri, A, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Wilcken, N, Bartsch, R, Dubsky, P, Fesl, C, Fohler, H, Gnant, M, Greil, R, Jakesz, R, Lang, A, Luschin-Ebengreuth, G, Marth, C, Mlineritsch, B, Samonigg, H, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hm, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Di Leo, A, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Martin, M, Hupperets, Ps, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Da, Patnick, J, Pinder, S, Olivotto, I, Ragaz, J, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Norton, L, Weiss, Rb, Abu-Zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Cuzick, J, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesech, J, Brain, E, de La Lande, B, Mouret-Fourme, E, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Shao, Yf, Wang, X, Zhao, Db, Chen, Zm, Pan, Hc, Howell, A, Swindell, R, Burrett, Ja, Clarke, M, Collins, R, Correa, C, Cutter, D, Darby, S, Davies, K, Elphinstone, P, Evans, V, Gettins, L, Godwin, J, Gray, R, Gregory, C, Hermans, D, Hicks, C, James, S, Kerr, A, Liu, H, Mackinnon, E, Lay, M, Mcgale, P, Mchugh, T, Morris, P, Peto, R, Taylor, C, Wang, Y, Albano, J, de Oliveira CF, Gervásio, H, Gordilho, J, Ejlertsen, B, Jensen, Mb, Johansen, H, Mouridsen, H, Palshof, T, Gelman, Rs, Harris, Jr, Hayes, D, Henderson, C, Shapiro, Cl, Winer, E, Christiansen, P, Ewertz, M, Møller, S, Mouridsen, Ht, Trampisch, Hj, Dalesio, O, de Vries EG, Rodenhuis, S, van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Wood, W, Cameron, D, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jg, Treurniet-Donker, Ad, van Putten WL, Rotmensz, N, Veronesi, U, Viale, G, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, Rutgers, E, van de Velde CJ, Cunningham, Mp, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Eiermann, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, B, Jackisch, C, Loibl, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Carrasco, E, Segui, Ma, Galligioni, E, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Fountzilas, G, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Tinterri, C, Margreiter, R, de Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, André, F, Arriagada, R, Delaloge, S, Hill, C, Koscielny, S, Michiels, S, Rubino, C, A'Hern, R, Bliss, J, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, van de Velde AO, van Dongen JA, Vermorken, Jb, Castiglione, M, Coates, A, Colleoni, M, Collins, J, Forbes, J, Gelber, Rd, Goldhirsch, A, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ce, Coombes, Rc, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Peretz, T, Robinson, E, Bruzzi, P, Del Mastro, L, Pronzato, P, Sertoli, Mr, Venturini, M, Camerini, T, De Palo, G, Di Mauro MG, Formelli, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Cocconi, G, Colozza, A, Passalacqua, R, Aogi, K, Takashima, S, Abe, O, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, van de Water, W, van Nes JG, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Braun, S, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, de la Huerta, R, Sainz, Mg, Altemus, R, Camphausen, K, Cowan, K, Danforth, D, Lichter, A, Lippman, M, O'Shaughnessy, J, Pierce, Lj, Steinberg, S, Venzon, D, Zujewski, Ja, D'Amico, C, Lioce, M, Paradiso, A, Chapman, Ja, Gelmon, K, Goss, Pe, Levine, Mn, Meyer, R, Parulekar, W, Pater, Jl, Pritchard, Ki, Shepherd, Le, Tu, D, Whelan, T, Ohno, S, Anderson, S, Bass, G, Brown, A, Bryant, J, Costantino, J, Dignam, J, Fisher, B, Geyer, C, Mamounas, Ep, Paik, S, Redmond, C, Swain, S, Wickerham, L, Wolmark, N, Baum, M, Jackson, Im, Palmer, Mk, Perez, E, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Varhaug, Je, Gundersen, S, Hauer-Jensen, M, Høst, H, Nissen-Meyer, R, Reinertsen, K, Mitchell, Ak, Robertson, Jf, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Dowsett, M, Makris, A, Parton, M, Pennert, K, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Businico, A, Deshpande, N, di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Aj, Ewing, Gh, Firth, La, Krushen-Kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Albain, K, Barlow, W, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Ravdin, Pm, Adolfsson, J, Bergh, J, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadström, C, Janni, W, Maibach, R, Thürlimann, B, Hakama, M, Holli, K, Isola, J, Rouhento, K, Saaristo, R, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ah, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Sestak, I, Deutsch, Gp, Kwong, Dl, Pai, Vr, Senanayake, F, Martin, Al, Boccardo, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Broglio, K, Buzdar, Au, Hsu, L, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H., McGale, P, Taylor, C, Correa, C, Cutter, D, Duane, F, Ewertz, M, Gray, R, Mannu, G, Peto, R, Whelan, T, Wang, Y, Wang, Z, Darby, S, Biomedische Technologie, RS: GROW - Oncology, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Mcgale, P, DE LAURENTIIS, Michelino, Other departments, CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
medicine.medical_specialty, medicine.medical_treatment, Breast Neoplasms, Rate ratio, Lower risk, Systemic therapy, Statistical significance, Medicine, Humans, Mastectomy, Randomized Controlled Trials as Topic, business.industry, Articles, General Medicine, Surgery, Radiation therapy, Axilla, Neoplasm Recurrence, medicine.anatomical_structure, Local, Meta-analysis, Lymphatic Metastasis, Lymph Node Excision, Female, Neoplasm Recurrence, Local, business, Breast Neoplasm, Human
Abstract

BACKGROUND: Postmastectomy radiotherapy was shown in previous meta-analyses to reduce the risks of both recurrence and breast cancer mortality in all women with node-positive disease considered together. However, the benefit in women with only one to three positive lymph nodes is uncertain. We aimed to assess the effect of radiotherapy in these women after mastectomy and axillary dissection.METHODS: We did a meta-analysis of individual data for 8135 women randomly assigned to treatment groups during 1964-86 in 22 trials of radiotherapy to the chest wall and regional lymph nodes after mastectomy and axillary surgery versus the same surgery but no radiotherapy. Follow-up lasted 10 years for recurrence and to Jan 1, 2009, for mortality. Analyses were stratified by trial, individual follow-up year, age at entry, and pathological nodal status.FINDINGS: 3786 women had axillary dissection to at least level II and had zero, one to three, or four or more positive nodes. All were in trials in which radiotherapy included the chest wall, supraclavicular or axillary fossa (or both), and internal mammary chain. For 700 women with axillary dissection and no positive nodes, radiotherapy had no significant effect on locoregional recurrence (two-sided significance level [2p]>0·1), overall recurrence (rate ratio [RR], irradiated vs not, 1·06, 95% CI 0·76-1·48, 2p>0·1), or breast cancer mortality (RR 1·18, 95% CI 0·89-1·55, 2p>0·1). For 1314 women with axillary dissection and one to three positive nodes, radiotherapy reduced locoregional recurrence (2pINTERPRETATION: After mastectomy and axillary dissection, radiotherapy reduced both recurrence and breast cancer mortality in the women with one to three positive lymph nodes in these trials even when systemic therapy was given. For today's women, who in many countries are at lower risk of recurrence, absolute gains might be smaller but proportional gains might be larger because of more effective radiotherapy.FUNDING: Cancer Research UK, British Heart Foundation, UK Medical Research Council.

Published
2016
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21. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials

Author

EARLY BREAST CANCER TRIALISTS' COLLABORATIVE GROUP (EBCTCG), Darby, S., Mcgale, P., Correa, C., Taylor, C., Arriagada, R., Clarke, M., Cutter, D., Davies, C., Ewertz, M., Godwin, J., Gray, R., Pierce, L., Whelan, T., Wang, Y., Peto, R., Albain, K, Anderson, S, Arriagada, R, Barlow, W, Bergh, J, Bliss, J, Buyse, M, Cameron, D, Carrasco, E, Clarke, M, Correa, C, Coates, A, Collins, R, Costantino, J, Cutter, D, Cuzick, J, Darby, S, Davidson, N, Davies, C, Davies, K, Delmestri, A, Di Leo, A, Dowsett, M, Elphinstone, P, Evans, V, Ewertz, M, Gelber, R, Gettins, L, Geyer, C, Goldhirsch, A, Godwin, J, Gray, R, Gregory, C, Hayes, D, Hill, C, Ingle, J, Jakesz, R, James, S, Kaufmann, M, Kerr, A, Mackinnon, E, Mcgale, P, Mchugh, T, Norton, L, Ohashi, Y, Paik, S, Pan, Hc, Perez, E, Peto, R, Piccart, M, Pierce, L, Pritchard, K, Pruneri, G, Raina, V, Ravdin, P, Robertson, J, Rutgers, E, Shao, Yf, Swain, S, Taylor, C, Valagussa, P, Viale, G, Whelan, T, Winer, E, Wang, Y, Wood, W, Abe, O, Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Geraud, P, Collett, V, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Wilcken, N, Bartsch, R, Dubsky, P, Fesl, C, Fohler, H, Gnant, M, Greil, R, Lang, A, Luschin-Ebengreuth, G, Marth, C, Mlineritsch, B, Samonigg, H, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hm, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Martin, M, Hupperets, Ps, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Da, Patnick, J, Pinder, S, Olivotto, I, Ragaz, J, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Weiss, Rb, Abu-Zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesec'h, J, Rambert, P, Mustacchi, G, Petruzelka, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Wang, X, Zhao, Db, Chen, Zm, Howell, A, Swindell, R, Burrett, Ja, Hermans, D, Hicks, C, Lay, M, Albano, J, de Oliveira CF, Gervásio, H, Gordilho, J, Johansen, H, Mouridsen, Ht, Gelman, Rs, Harris, Jr, Henderson, C, Shapiro, Cl, Christiansen, P, Ejlertsen, B, Jensen, Mb, Møller, S, Carstensen, B, Palshof, T, Trampisch, Hj, Dalesio, O, de Vries EG, Rodenhuis, S, van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jg, Treurniet-Donker, Ad, van Putten WL, Rotmensz, N, Veronesi, U, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, van de Velde CJ, Cunningham, Mp, Huovinen, R, Joensuu, H, Costa, A, Tinterri, C, Bonadonna, G, Gianni, L, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Eiermann, W, Hilfrich, J, Jonat, W, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, G, Jackisch, C, Loibl, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Segui, Ma, Galligioni, E, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Dafni, D, Fountzilas, G, Mavroudis, D, Klefstrom, P, Saarto, T, Gallen, M, Margreiter, R, de Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, Bourgier, C, Koscielny, S, Laplanche, A, Lê, Mg, Spielmann, M, A'Hern, R, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, van de Velde AO, van Dongen JA, Vermorken, Jb, Castiglione, M, Colleoni, M, Collins, J, Forbes, J, Gelber, Rd, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ce, Coombes, Rc, Hall, E, Marty, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Robinson, E, Bruzzi, P, Del Mastro, L, Pronzato, P, Sertoli, Mr, Venturini, M, Camerini, T, De Palo, G, Di Mauro MG, Formelli, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Cocconi, G, Colozza, A, Passalacqua, R, Aogi, K, Takashima, S, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, van de Water, W, van Nes JG, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Braun, S, Janni, W, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, de la Huerta, R, Sainz, Mg, Altemus, R, Camphausen, K, Cowan, K, Danforth, D, Lichter, A, Lippman, M, O'Shaughnessy, J, Pierce, Lj, Steinberg, S, Venzon, D, Zujewski, Ja, D'Amico, C, Lioce, M, Paradiso, A, Chapman, Ja, Gelmon, K, Goss, Pe, Levine, Mn, Meyer, R, Parulekar, W, Pater, Jl, Pritchard, Ki, Shepherd, Le, Tu, D, Ohno, S, Anderson, A, Bass, G, Brown, A, Bryant, J, Dignam, J, Fisher, B, Mamounas, Ep, Redmond, C, Wickerham, L, Wolmark, N, Baum, M, Jackson, Im, Palmer, Mk, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Varhaug, Je, Gundersen, S, Hauer-Jensen, M, Høst, H, Nissen-Meyer, R, Mitchell, Ak, Robertson, Jf, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, Martin, Al, di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Ashley, S, Makris, A, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Deshpande, N, di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Aj, Ewing, Gh, Firth, La, Krushen-Kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Crowley, J, Gralow, J, Green, S, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Adolfsson, J, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadström, C, Maibach, R, Thürlimann, B, Hakama, M, Holli, K, Isola, J, Rouhento, K, Saaristo, R, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ah, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Sestak, I, Deutsch, Gp, Kwong, Dl, Pai, Vr, Senanayake, F, Boccardo, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Broglio, K, Buzdar, Au, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H, Mcgale, P, Correa, C, Taylor, C, Arriagada, R, Clarke, M, Cutter, D, Davies, C, Ewertz, M, Godwin, J, Gray, R, Pierce, L, Whelan, T, Wang, Y, Peto, R, Early Breast Cancer Trialists' Collaborative, Group, DE LAURENTIIS, Michelino, DE PLACIDO, Sabino, Carlomagno, Chiara, Darby, S, McGale, P, Interne Geneeskunde, RS: GROW - School for Oncology and Reproduction, Other departments, CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
Oncology, medicine.medical_specialty, Neoplasm Recurrence, Local - epidemiology, medicine.medical_treatment, Population, Breast Neoplasms, Mastectomy, Segmental, Breast cancer, breast cancer, Internal medicine, medicine, Breast-conserving surgery, Humans, education, skin and connective tissue diseases, radiotherapy, Randomized Controlled Trials as Topic, education.field_of_study, business.industry, Estrogen Antagonists - therapeutic use, Mortality rate, Age Factors, Estrogen Antagonists, General Medicine, Breast Neoplasms - mortality - therapy, medicine.disease, Surgery, Unilateral Breast Neoplasms, Radiation therapy, Clinical trial, meta-analysis, Tamoxifen, Receptors, Estrogen, Lymphatic Metastasis, Female, Radiotherapy, Adjuvant, Neoplasm Grading, Neoplasm Recurrence, Local, business, Mastectomy
Abstract

BACKGROUND: After breast-conserving surgery, radiotherapy reduces recurrence and breast cancer death, but it may do so more for some groups of women than for others. We describe the absolute magnitude of these reductions according to various prognostic and other patient characteristics, and relate the absolute reduction in 15-year risk of breast cancer death to the absolute reduction in 10-year recurrence risk. METHODS: We undertook a meta-analysis of individual patient data for 10,801 women in 17 randomised trials of radiotherapy versus no radiotherapy after breast-conserving surgery, 8337 of whom had pathologically confirmed node-negative (pN0) or node-positive (pN+) disease. FINDINGS: Overall, radiotherapy reduced the 10-year risk of any (ie, locoregional or distant) first recurrence from 35.0% to 19.3% (absolute reduction 15.7%, 95% CI 13.7-17.7, 2p/=20%), intermediate (10-19%), or lower (, link_to_OA_fulltext

Published
2011
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22. Poster session 1GENERAL PRINCIPLESP194Ultrasound indexes of adipose tissue and lipid goals attainment in high and very high cardiovascular risk patientsTHE IMAGING EXAMINATIONP195Right ventricular global longitudinal strain provides higher prognostic value than right free wall longitudinal strain in patients with left heart diseaseP196Normal values of echocardiographlc left and right cardiac chambers dimensions as multifactorially determined by sex, level of physical activity, age, BMI, systolic blood pressure and heart rateAnatomy and physiology of the heart and great vesselsP197Echocardiographic phenotypes according to levels of oxygen consumption at peak exercise: findings from the EURO(pean) EX(ercise) population-based studyAnatomy and physiology of the heart and great vesselsP198Systemic vascular resistance and central arterial stiffness in relation to left ventricular geometry and diastolic function in essential hypertensionAssessment of diameters, volumes and massP199Left atrial diameter predicts a new diagnosis of paroxysmal atrial fibrillation in a population presenting with palpitationsP200Interventricular septum thickness and acute coronary syndromes: small differences, big prognostic influence?P201Detection of abdominal aortic aneurysm in a population referred for an ultrasonographyAssessments of haemodynamicsP202The ultrasound vector velocity method transverse oscillation validated in a flowrig with constant and pulsatile flow and in-vivo of blood flow in the ascending aortaASSESSMENT OF SYSTOLIC FUNCTIONP203Different types of left ventrical remodeling in children with arterial hypertensionP204Assessment of myocardial performance index in hypertensive patients with or without hyperuricemiaP205Strain echocardiography detects mild impairment of systolic function in patients with frequent premature ventricular contractionsP206Speckle tracking strain correlates better with functional capacity and hemodynamic burden than ejection fraction in patients with severe heart failureP207Prognostic value of 2D and 3D echocardiographic volumes, ejection fraction and strain as markers of abnormal left ventricular performanceP208Long-term prognostic value of left ventricular ejection fraction assessed by echocardiography and magnetic resonance imaging after acute STEMIP209Assessment of left ventricular function after percutaneous coronary intervention of chronic total occluded coronary artery by speckle tracking and cardiac magnetic resonanceP210Physiologic variations of tricuspid annular plane systolic excursion in healthy subjects: clinical and echocardiographic correlatesP211Predictors of incipient ventricular dysfunction with tyrosine kinase inhibitors in metastatic renal cell carcinomaAssessment of diastolic functionP212Disagreement between the American Society of Echocardiography (ASE) and gastroenterology-based guidelines for the diagnosis of diastolic dysfunction among patients with advanced liver diseaseP213Nomograms for mitral inflow doppler and tissue doppler velocities in caucasian childrenP215Diastolic function is impaired in women with angina pectoris and no obstructive coronary artery disease independently of coronary microvascular functionP216Clinical value of myocardial performance index in patients with isolated diastolic dysfunctionIschemic heart diseaseP217Cardiac imaging strategy is clinically more effective and at lower cost than traditional ETT strategy for the diagnosis of stable coronary artery diseaseP218Does the ESC clinical pretest probability score stratify our patients correctly? Validation with stress echocardiographyP219Incremental value of exercise echocardiography over exercise electrocardiography in a chest pain unit: a decision curve analysisP220A bedside echocardiographic score for risk stratification of ST-elevation myocardial infarction patients undergoing primary percutaneous coronary interventionP221Interventricular and intraventricular dyssynchrony in patients with Q-wave acute myocardial infarctionP222Comparison of tagging and tissue tracking for myocardial strain assessment at 1.5T and 3.0T following ST-segment elevation myocardial infarctionP223Left atrial strain rate evaluated by two-dimensional speckle tracking is predictor of left ventricular arrhythmias in STEMI patients treated by primary PCIP224Impact of percutaneous coronary intervention of chronic total oclussion on left ventricular function using speckle tracking and cardiac magnetic resonanceHeart valve DiseasesP225Clinical and echocardiographic characteristics of patients with low flow severe aortic stenosis and preserved ejection fractionP226Ventricular-arterial interplay in patients with severe aortic stenosis: additional role of wave intensity analysisP227Degenerative aortic stenosis: don't forget the vascular componentP228Reclassifying low gradient aortic stenosis with 3D transesophageal echocardiography and global longitudinal strainP229Importance of mitral regurgitation on pre- and postoperative clinical status and echocardiographic findings in patients with severe aortic stenosis admitted for aortic valve replacementsP230Aorto-septal angle and degenerative aortic stenosis: a case-control study stenosisP231Difference of sST2 level in mitral stenosis compare with control subjectsP232Velocity-time integral of aortic regurgitation: a novel echocardiographic marker in the evaluation of aortic regurgitation severityP233Color doppler 3D echocardiography-derived regurgitant volume in primary mitral regurgitation: a comparison of different techniques with magnetic resonanceP234Outcome of surgery for degenerative mitral regurgitationP235Mitral valve repair or replacement for functional regurgitation and left ventricular dysfunction: clinical and echocardiographic outcomeP236Prevalence, characteristics and prognosis of moderate to severe tricuspid regurgitation in patients with precapillary pulmonary hypertensionP237Management of late bioprosthetic mitral valve thrombosisP238Relationship between pulmonary venous flow and prosthetic mitral valve thrombosisP239Transcatheter aortic valve implantation does not reduce acutely valvuloarterial impedance in an elderly population with degenerative calcific aortic valve stenosisP240Influence of type of prosthesis on mitral regurgitation change after transcatheter aortic valve replacement for aortic stenosisP241The prevalence of valve disease in patients undergoing atrial fibrillation ablationCardiomyopathiesP242The prognostic value of lung ultrasound at discharge in heart failureP243Prognostic value of global longitudinal strain in non-ischaemic dilated cardiomyopathyP244Additional effect of high intensity exercise training to cardiac resynchronization in heart failure: the reduction on left venticular massP245Dobutamine-induced changes of longitundinal strain predicts longterm mortality in severe heart failureP246Myocardial fibrosis is not related to two-dimensional longitudinal strain in dilated cardiomyopathyP247Echocardiographic parameters are predictors of positive genetic study in a Portuguese population with hypertrophic cardiomyopathy: a multicentre studyP248Myocardial deformation techniques for the evaluation of the right ventricle in fabry diseaseP249Borderline hypertrophic cardiomyopathy or athlete's heart: what is the role for genetic testing in athletes?P250Isolated papillary muscle hypertrophy. Clinical, electrocardiographic and morphologic characteristicsP251Prognostic value of the assessment of left atrial deformation in hypertrophic cardiomyopathyP252Assessment of subtle echocardiographic changes may improve risk stratification of arrhythmias in early stages of arrhythmogenic right ventricular cardiomyopathy (ARVC)P253Long-term correlation of electrocardiography with structural echocardiography changes in patients with arrhythmogenic right ventricular cardiomyopathyP254Right ventricular strain and dyssynchrony assessment in arrhythmogenic right ventricular cardiomyopathy: a cardiac magnetic resonance feature-tracking studyP255Association of non compaction and hypertrophic cardiomyopathies, Noonan and long QT syndromesP256Predictors of mortality in patients with acute myocarditisP257Clinical characteristics and natural history of acute myocarditisP258One-beat 3dimensional echocardiography for the assessment of right ventricular function in heart transplant recipientsP259Hemodynamically irrelevant, non-surgery related pericardial effusion is a predictor of mortality in heart transplanted patientsSystemic diseases and other conditionsP260Left ventricular function as a cardiac marker of target organ damage in non-diabetic, never treated hypertensive patients: Camparison with microalbuminuriaP261Subclinical myocardial dysfunction in hypertensive patients with hyperuricemiaP262Can deformation indices (strain/strain rate) establish differential diagnosis in infiltrative cardiomyopathies?P263Prevalence and factors associated with inappropriately high left ventricular mass in patients with rheumatoid arthritisP264Echocardiographic evaluation of patients with end-stage liver disease, the importance of follow up after liver transplantationP265Cardiovasclular involvement in asymptomatic juvenile localized scleroderma patientsP267Can the left ventricular mechanics using speckle tracking echocardiography in pregnancy predict the new onset heart failure?P268What causes impaired exercise tolerance in HFpEF? Relative contribution from LV filling pressure and other factorsCongenital heart diseaseP269Pregnancy in patients with Ebsteins anomaly - echocardiographic and clinical studyP270Double aortic arch anomalies in clinical practiceP271Echocardiography as the essential imaging modality in congenital heart disease - first one to begin with and the one who staysMasses, tumors and sources of embolismP272Can the reduction of wall shear stress in diskinetic myocardial wall segments be used to predict trombogenicity?Diseases of the aortaP273The role of modified transoesophageal echocardiography for optimal access decision making for transcatheter aortic valve replacement proceduresStress echocardiographyP274Is aortic valve resistance different in patients with severe aortic stenosis and left ventricular fraction below 40% with low or high gradient?P275Does wall motion score index in dobutamine stress echocardiography predict syntax score in catheterization lab?P276Sex-related differences in peak stress left ventricular global longitudinal strain during dobutamine stress echocardiography in patients with significant coronary artery diseaseP277Exercise stress echocardiography complications: a 4-year single center experienceP278Reduced baseline left ventricular longitudinal systolic function is a marker of inducible myocardial ischemia in patients undergoing exercise echocardiographyP279Estimation of mean pulmonary arterial pressure based on right ventricle systolic pressure observed from exercise echocardiography among non-pulmonary hypertension with systemic sclerosisTransesophageal echocardiographyP280Transoesophageal echocardiography in patients with neuroendocrine tumour and carcinoid symptoms is safe without intravenous octreotideP281The feasibility and the clinical benefit of the cognitive-behavioral intervention for preparing patients for transesophageal echocardiographic studyP282Dynamic changes of mitral annulus shape in different types of mitral valve prolapse. A three-dimensional transoesophageal studyReal-time three-dimensional TEEP283Severe aortic stenosis: evaluation of effective and anatomy valve by 2D transthoracic echocardiography and 3D transesophageal echocardiographyP2843D-transeosphageal echocardiography usefulness for assessment of cardiac output in intensive care unit: an ultrasound versus thermodilution comparative study for patients under mechanical ventilationP285The predictive value of three-dimensional vena-contracta in determining the number of MitraClip devices needed during the procedure in functional mitral regurgitationTissue Doppler and speckle trackingP286Should the septum be included in the assessment of right ventricular longitudinal strain?P287Can machine learning help to identify heart failure with preserved ejection fraction?P288Concordance of atrial function measurement by 3D volumetric echocardiography and speckle tracking deformation imagingP289Heterogonous regional diastolic function revealed by 2D speckle tracking echocardiography identifies patients with ischemic etiology of left ventricular systolic dysfunctionP290The values from Real time 3-dimensional strain is not independent from preload changesP291Risk stratification in hypertrophic cardiomyopathy. a potential role for speckle-tracking parameters by cardiac magnetic resonanceP292Abnormal longitudinal peak systolic strain in asymptomatic patients with type-I diabetes mellitusP294Strain evaluation of subclinical cardiac dysfunction in patients with myotonic dystrophy type 1P295Heart function assessment in perinatal asphyxia; speckle tracking indices from greyscale recordings perform better than from tissue Doppler recordings, fractional shortening and tissue Doppler indicesP297Longitudinal strain assessed by automatic function imaging - a useful tool in significant coronary artery disease detection in patients with low risk anginaP298Global 2-Dimensional strain as a predictor of mortality in heart transplant patients with cardiac allograft vasculopathyP299Two-dimensional longitudinal strain and strain rate in asymptomatic middle-aged patients with type 2 diabetes mellitus - a pilot study resultsP300Limited accuracy of myocardial deformation imaging in diagnosis of left ventricular segmental dysfunction in patients with acute myocardial infarction: is it only a limitation of the strain software?Computed Tomography & Nuclear CardiologyP301Evaluation of the actual prevalence of myocardial ischemia in patients prior to performing a peripheral vascular surgeryP302Prognostic value of myocardial ischemia detected by myocardial perfusion imaging in asymptomatic patients with diabetes type 2P303Economic cost analysis derived by coronary computed tomography angiography inappropriate indications to rule out coronary heart disease

Author

Haberka, M, primary, Garcia Martin, A, primary, Barbier, P, primary, Pellegrino, M, primary, Angelis, A, primary, Howlett, PJ, primary, Madeira, M, primary, Carrero, PJ, primary, Hansen, KL, primary, Trunina, I, primary, Basar, C, primary, Lie, OH, primary, Sade, LE, primary, Gopal, A S, primary, Klug, G, primary, Rodriguez Gonzalez, E, primary, Ferrara, F, primary, Moustafa, S, primary, Naksuk, N, primary, Cantinotti, M, primary, Michelsen, MM, primary, Fernandes, JMG, primary, Demir, OM, primary, Cano Carrizal, R, primary, Bouzas-Mosquera, A, primary, Leao, S, primary, Kuznetsov, VA, primary, Nazir, S A, primary, Trifunovic, D, primary, Spampinato, RA, primary, Antonini-Canterin, F, primary, Ribeiro, JM, primary, Morgado, GJ, primary, Reis, L, primary, Naratrekoon, B, primary, Soto-Ruiz, RM, primary, Penicka, M, primary, Zilberszac, R, primary, De Chiara, B, primary, Rifai, R, primary, Gunduz, S, primary, Cersit, S, primary, Devecchi, C, primary, Ancona, F, primary, Smith, D, primary, Gargani, L, primary, Asmarats Serra, L, primary, Abreu, A, primary, Ikonomidis, I, primary, Biernacka, B, primary, Gomes, AC, primary, Caballero, L, primary, Mansencal, N, primary, Venturini, C, primary, Zaroui, A, primary, Leren, I S, primary, Astrom Aneq, M, primary, Nucifora, G, primary, Rocon, CRLA, primary, Cho, J Y, primary, Stampfli, S F, primary, Cho, EJ, primary, Stevanovic, A, primary, Pena, J L, primary, Ognibeni, F, primary, Colunga, S, primary, Borowiec, A, primary, Hristova, K, primary, Kosmala, W, primary, Lesniak-Sobelga, A M, primary, Kaldararova, M, primary, Stanojevic, D, primary, Carbonell San Roman, A, primary, Hoetink, A, primary, Ferreira, R, primary, Rohani, A, primary, Wierzbowska-Drabik, K, primary, Carvalho, J F, primary, Cherubini, A, primary, Teramoto, K, primary, May, CJH, primary, Wejner-Mik, P, primary, Gurzun, M M, primary, Perea, GO, primary, Laveau, F, primary, Mahmoud, HM, primary, Sanz, M, primary, Sanchez-Martinez, S, primary, Montserrat, S, primary, Kowalczyk, E, primary, Park, CS, primary, Hinojar, R, primary, Van Berendoncks, A M, primary, Guedes, H, primary, Nestaas, E, primary, Onut, R, primary, Moran, L, primary, Kisko, A, primary, Agmon, Y, primary, Corneli, M, primary, Peovska Mitevska, IPM, primary, Barreiro Perez, M, primary, Banska, K, additional, Gasior, Z, additional, Moya-Mur, JL, additional, Carbonell-San Roman, S-A, additional, Rodriguez-Munoz, D, additional, Garcia-Lledo, A, additional, Casas-Rojo, E, additional, Hinojar, R, additional, Jimenez-Nacher, JJ, additional, Fernandez-Golfin, C, additional, Zamorano-Gomez, JL, additional, Ravani, A, additional, Cefalu, C, additional, Maltagliati, A, additional, Frigerio, B, additional, Sansaro, D, additional, Amato, M, additional, Baldassarre, D, additional, Bandera, F, additional, Generati, G, additional, Labate, V, additional, Alfonzetti, E, additional, Guazzi, M, additional, Aggeli, K, additional, Ioakeimidis, N, additional, Abdelrasoul, M, additional, Felekos, I, additional, Gourgouli, I, additional, Aznaouridis, K, additional, Rousakis, G, additional, Vlachopoulos, C, additional, Tousoulis, D, additional, Darasz, K, additional, Mahmoudi, M, additional, Shah, N, additional, Jabr, RI, additional, Hickman, M, additional, Leatham, EW, additional, Fry, CH, additional, Teixeira, R, additional, Almeida, I, additional, Caetano, F, additional, Fernandes, A, additional, Cassandra, M, additional, Reis, L, additional, Costa, M, additional, Goncalves, L, additional, Nielsen, AJ, additional, Carrero, MC, additional, Saubidet, GL, additional, Peralta, SP, additional, Moeller-Soerensen, H, additional, Kjaergaard, J, additional, Jensen, MB, additional, Lund, JT, additional, Pedersen, MM, additional, Olesen, JB, additional, Jensen, JA, additional, Nielsen, MB, additional, Sharykin, AS, additional, Karelina, EV, additional, Telezhnikova, ND, additional, Ozhan, H, additional, Kayapinar, O, additional, Albayrak, ES, additional, Saberniak, J, additional, Dejgaard, L, additional, Nestaas, E, additional, Edvardsen, T, additional, Haugaa, KH, additional, Bal, U, additional, Eroglu, S, additional, Pirat, B, additional, Muderrisoglu, H, additional, Muthukumar, L, additional, Saha, SK, additional, Toole, RS, additional, Reinstadler, S, additional, Feistritzer, HJ, additional, Pernter, B, additional, Mayr, A, additional, Franz, WM, additional, Mueller, S, additional, Metzler, B, additional, Mingo Santos, S, additional, Palomero Monivas, V, additional, Gonzalez Mirelis, J, additional, Goirigolzarri Artaza, J, additional, Zorita Gil, B, additional, Fernandez Diaz, JA, additional, Goicolea Ruigomez, J, additional, Restrepo Cordoba, MA, additional, Alonso Pulpon, L, additional, Gargani, L, additional, D'alto, M, additional, Ghio, S, additional, Acri, E, additional, Carannante, L, additional, Argiento, P, additional, D'andrea, A, additional, Vriz, O, additional, Bossone, E, additional, Ho, TH, additional, Shah, P, additional, Murphy, K, additional, Nelluri, BK, additional, Lee, H, additional, Wilansky, S, additional, Mookadam, F, additional, Peeraphatdit, T, additional, Chaiteerakij, R, additional, Klarich, KW, additional, Scalese, M, additional, Melo, M, additional, Assanta, N, additional, Marotta, M, additional, Crocetti, M, additional, Spadoni, I, additional, Giordano, R, additional, Kutty, S, additional, Iervasi, I, additional, Mygind, ND, additional, Pena, A, additional, Frestad, D, additional, Hoest, N, additional, Prescott, E, additional, Romao, BO, additional, Rivera, IR, additional, Mendonca, MA, additional, Carvalho, AC, additional, Campos, O, additional, Amato, A, additional, Moises, VA, additional, Bashir, A, additional, Marshall, K, additional, Douglas, M, additional, Wasan, B, additional, Plein, S, additional, Alfakih, K, additional, Casanova Rodriguez, C, additional, Cadenas Chamorro, R, additional, Iglesias Del Valle, D, additional, Martin-Penato Molina, A, additional, De Juan Baguda, J, additional, Prieto Moriche, E, additional, Garcia Garcia, A, additional, De La Cruz Berlanga, E, additional, Plaza Perez, I, additional, Peteiro, J, additional, Broullon, FJ, additional, Alvarez-Garcia, N, additional, Barbeito-Caamano, C, additional, Larranaga-Moreira, JM, additional, Maneiro-Melon, N, additional, Martinez-Ruiz, D, additional, Yanez, JC, additional, Vazquez-Rodriguez, JM, additional, Cordeiro, F, additional, Magalhaes, P, additional, Moz, M, additional, Trigo, J, additional, Mateus, P, additional, Fontes, P, additional, Moreira, I, additional, Krinochkin, DV, additional, Plusnin, AV, additional, Soldatova, AM, additional, Shetye, A, additional, Khan, JN, additional, Singh, A, additional, Kanagala, P, additional, Swarbrick, DJ, additional, Graham-Brown, M, additional, Mccann, GP, additional, Krljanac, G, additional, Savic, L, additional, Asanin, M, additional, Aleksandric, S, additional, Lasica, R, additional, Srdic, M, additional, Zlatic, N, additional, Petrovic, M, additional, Mrdovic, I, additional, Monivas Palomero, V, additional, Rivero Arribas, B, additional, Dobrovie, M, additional, Da Rocha E Silva, JG, additional, Bonamigo Thome, F, additional, Kluttig, R, additional, Schloma, V, additional, Dmitrieva, Y, additional, Strotdrees, E, additional, Mohr, FW, additional, Luzza, G, additional, Caruso, R, additional, Belfiore, R, additional, Della Mattia, A, additional, Poli, S, additional, Zito, C, additional, La Carrubba, S, additional, Carerj, S, additional, Carvalho, JF, additional, Gomes, AC, additional, Caldeira, D, additional, Cruz, IR, additional, Stuart, B, additional, Maia, R, additional, Fazendas, P, additional, Pereira, H, additional, Rakocevic, I, additional, Tutos, V, additional, Petrovic, O, additional, Boricic-Kostic, M, additional, Stepanovic, J, additional, Jovanovic, I, additional, Banovic, M, additional, Vujisic-Tesic, B, additional, Leite, L, additional, Madeira, M, additional, Botelho, A, additional, Santos, M, additional, Nascimento, J, additional, Yingchoncharoen, T, additional, Vathesatogkit, P, additional, Yamwong, S, additional, Sritara, P, additional, Bonaque Gonzalez, J C, additional, Abellan-Huerta, J, additional, Rubio-Paton, R, additional, Soria, F, additional, Ramos, JL, additional, Egea, S, additional, Garcia-Gomez, J, additional, Martinez Diaz, JJ, additional, Castillo, JA, additional, Vecera, J, additional, Mirica, C, additional, Kotrc, M, additional, Kockova, R, additional, Gabriel, H, additional, Maurer, G, additional, Rosenhek, R, additional, Botta, L, additional, Musca, F, additional, Belli, O, additional, Costetti, A, additional, Trolese, I, additional, Spano, F, additional, Russo, C, additional, Giannattasio, C, additional, Moreo, A, additional, Berthelot, E, additional, Le, MT, additional, Hilpert, L, additional, Montani, D, additional, Sitbon, O, additional, Jais, X, additional, Humbert, M, additional, Assayag, P, additional, Yesin, M, additional, Kalcik, M, additional, Gursoy, MO, additional, Cersit, S, additional, Astarcioglu, MA, additional, Karakoyun, S, additional, Aykan, AC, additional, Ozkan, M, additional, Gunduz, S, additional, Tabakci, M, additional, Bayam, E, additional, Degiovanni, A, additional, Di Ruocco, MV, additional, Marino, P, additional, Rosa, I, additional, Stella, S, additional, Barletta, M, additional, Marini, C, additional, Latib, A, additional, Montorfano, M, additional, Colombo, A, additional, Margonato, A, additional, Agricola, E, additional, Ray, R, additional, Gallagher, M, additional, Nazir, M, additional, Perreso, V, additional, Sharma, R, additional, Pang, PS, additional, Miglioranza, M, additional, Landi, P, additional, Dini, FL, additional, Picano, E, additional, Pons Llinares, J, additional, Macaya Ten, F, additional, Pericas Ramis, P, additional, Caldes Llull, O, additional, Grau Sepulveda, A, additional, Frontera, G, additional, Bethencourt, A, additional, Santa Clara, H, additional, Santos, V, additional, Oliveira, M, additional, Cunha, P, additional, Portugal, G, additional, Rio, P, additional, Branco, L, additional, Ferreira, R, additional, Mota Carmo, M, additional, Paraskevaidis, I, additional, Papadopoulos, C, additional, Stasinos, V, additional, Parissis, J, additional, Lekakis, J, additional, Rubis, P, additional, Gackowski, A, additional, Wisniowska-Smialek, S, additional, Lesniak-Sobelga, A, additional, Kostkiewicz, M, additional, Bento, D, additional, Correia, E, additional, Teles, L, additional, Picarra, B, additional, Lourenco, C, additional, Faria, R, additional, Domingues, K, additional, Azevedo, O, additional, Climent Paya, V, additional, Martinez Moreno, M, additional, Gimeno, JR, additional, Oliva, MJ, additional, Saura, D, additional, Sanchez Quinones, J, additional, Garcia Honrubia, A, additional, Valdes, M, additional, De La Morena, G, additional, Richard, P, additional, Guerard, S, additional, Brion, R, additional, Paul, P, additional, Dubourg, O, additional, Komajda, M, additional, Isnard, R, additional, Arslan, M, additional, Charron, P, additional, Avegliano, G, additional, Andres, S, additional, Costabel, JP, additional, Kuschnir, P, additional, Sciancalepore, A, additional, Mendoza, O, additional, Perea, G, additional, Ronderos, R, additional, Ben Said, RYM, additional, EL Chalbia, TEJ, additional, Wali, SANA, additional, Mourali, MS, additional, Mechmeche, RACHID, additional, Haland, TF, additional, Svetlichnaya, J S, additional, Shikha, SS, additional, Scheinmann, MS, additional, Klein, LK, additional, Prati, G, additional, Vitrella, G, additional, Allocca, G, additional, Cukon Buttignoni, S, additional, Muser, D, additional, Morocutti, G, additional, Pinamonti, B, additional, Sinagra, G, additional, Proclemer, A, additional, Melo, MDTM, additional, Bocchi, EAB, additional, Araujo, JABAF, additional, Demarchi, LMMFD, additional, Mady, CM, additional, Biselli, BB, additional, Kalil, RKF, additional, Salemi, VMCS, additional, Tuma, RT, additional, Kim, K H, additional, Yoon, H J, additional, Lee, K J, additional, Park, H, additional, Kim, J H, additional, Ahn, Y, additional, Jeong, M H, additional, Cho, J G, additional, Park, J C, additional, Park, H J, additional, Kozan, H, additional, Sezgin, A, additional, Aydinalp, A, additional, Oezkartal, T, additional, Bernhart, S, additional, Flammer, AJ, additional, Vecchiati, A, additional, Froehlich, GM, additional, Ruschitzka, F, additional, Tanner, FC, additional, Choi, KY, additional, Kim, DB, additional, Jang, SW, additional, Cho, JS, additional, Park, CS, additional, Jung, HO, additional, Jeon, HK, additional, Youn, HJ, additional, Dekleva, M, additional, Fortes, PRL, additional, Passos, BR, additional, Rodrigues, AB, additional, Sampaio, IH, additional, Oliveira, MCN, additional, Silva, MG, additional, Cardoso, RAF, additional, Tofani, FA, additional, Moreira, MCV, additional, Cioffi, G, additional, Viapiana, O, additional, Dalbeni, A, additional, Fracassi, E, additional, Di Nora, C, additional, Cherubini, A, additional, Mazzone, C, additional, Di Lenarda, A, additional, Rossini, M, additional, Corros, C, additional, Garcia-Campos, A, additional, Martin, M, additional, Rodriguez-Suarez, M, additional, Leon, V, additional, Fidalgo, A, additional, Lopez-Iglesias, F, additional, Moris, C, additional, De La Hera, JM, additional, Dabrowski, R, additional, Wozniak, J, additional, Jasek, S, additional, Chwyczko, T, additional, Kowalik, I, additional, Musiej-Nowakowska, E, additional, Szwed, H, additional, Marinov, R, additional, Stamenov, G, additional, Mihova, M, additional, Chacheva, K, additional, Persenska, S, additional, Racheva, A, additional, Przewlocka-Kosmala, M, additional, Rojek, A, additional, Karolko, B, additional, Mysiak, A, additional, Marwick, TH, additional, Biernacka, B, additional, Tittel, P, additional, Kardos, M, additional, Vrsanska, V, additional, Ondriska, M, additional, Hraska, V, additional, Nosal, M, additional, Masura, J, additional, Simkova, I, additional, Apostolovic, S, additional, Salinger-Martinovic, S, additional, Jankovic-Tomasevic, R, additional, Djordjevic-Radojkovic, D, additional, Stanojlovic, T, additional, Atanaskovic, V, additional, Pavlovic, M, additional, Tahirovic, E, additional, Dungen, HD, additional, Moya Mur, JL, additional, Lozano Granero, C, additional, Jimenez Nacher, JJ, additional, Gonzalez Gomez, A, additional, Fraile Sanz, C, additional, Segura De La Cal, T, additional, Zamorano Gomez, JL, additional, Jansen Klomp, WW, additional, Van 'T Hof, AWJ, additional, Brandon Bravo Bruinsma, GJ, additional, Spanjersberg, AJ, additional, Grandjean, J, additional, Nierich, AP, additional, Ferreira, J, additional, Lazaro Mendes, S, additional, Martins, R, additional, Monteiro, S, additional, Pego, M, additional, Khamene Bagheri, R, additional, Peruga, JZ, additional, Sobczak, M, additional, Plewka, M, additional, Wcislo, T, additional, Krecki, R, additional, Kasprzak, JD, additional, Morgado, G, additional, Cruz, I, additional, Almeida, AR, additional, Joao, I, additional, Lopes, L, additional, Cotrim, C, additional, Faganello, G, additional, Pandullo, C, additional, Russo, G, additional, Stefenelli, C, additional, Furlanello, F, additional, Tarantini, L, additional, Suzuki, K, additional, Satoh, Y, additional, Minami, K, additional, Mizukoshi, K, additional, Kamijima, R, additional, Kou, S, additional, Takai, M, additional, Izumo, M, additional, Akashi, YJ, additional, Ayuk, J, additional, Geh, I, additional, Shah, T, additional, Edwards, NC, additional, Steeds, RP, additional, Miskowiec, D, additional, Wdowiak-Okrojek, K, additional, Lipiec, P, additional, Rosca, M, additional, Calin, A, additional, Beladan, C, additional, Serban, M, additional, Ginghina, C, additional, Popescu, BA, additional, Lombardero, M, additional, Henquin, R, additional, Corneli, M, additional, Tinetti, M, additional, Hekimian, G, additional, Achkar, M, additional, Combes, A, additional, Hammoudi, N, additional, Al-Ghamdi, M, additional, Ghabashi, A, additional, Ezzat, M H, additional, Al-Amin, A, additional, Giraldeau, G, additional, Sarvari, SI, additional, Marin, J, additional, Brambila, C, additional, Gabrielli, L, additional, Bijnens, B, additional, Sitges, M, additional, Duchateau, N, additional, Erdei, T, additional, Fraser, A, additional, Bijnens, B H, additional, Piella, G, additional, Sanchis, L, additional, Borras, R, additional, Vidal, B, additional, Prat, S, additional, Azqueta, M, additional, Pare, C, additional, Grazioli, G, additional, Sanz, M, additional, Wejner-Mik, P, additional, Jung, MH, additional, Ahn, HS, additional, Kim, JH, additional, Megias, A, additional, Alonso, GL, additional, Gonzalez-Gomez, A, additional, Rincon, LM, additional, Esteban, A, additional, Fernandez Mendez, MA, additional, Barrios, V, additional, Zamorano, JL, additional, Van Gaal, L, additional, De Block, C, additional, Salgado, R, additional, Vrints, C, additional, Shivalkar, B, additional, Pereira, A, additional, Santos, R, additional, Marques, L, additional, Moreno, N, additional, Carvalho, R, additional, Pires, M, additional, Sousa, R, additional, Andrade, A, additional, Pinto, P, additional, Stoylen, A, additional, Fugelseth, D, additional, Tautu, O, additional, Onciul, S, additional, Marinescu, C, additional, Zamfir, D, additional, Dorobantu, M, additional, Sanchez Sanchez, V, additional, Navas, P, additional, Garcia-Cosio, D, additional, Diaz, B, additional, Carballo-Alzola, L, additional, Lombera, F, additional, Delgado, J, additional, Babcak, M, additional, Kishko, N, additional, Eitan, A, additional, Mutlak, D, additional, Kehat, I, additional, Meretta, AH, additional, Perea, GO, additional, Belcastro, F, additional, Aguirre, E, additional, Rosa, D, additional, Zaefferer, P, additional, Masoli, O, additional, Srbinovska, ES, additional, Bosevski, MB, additional, Antova, EA, additional, Pop Gorceva, DPG, additional, Martin Fernandez, M, additional, Costilla Garcia, SM, additional, Diaz Pelaez, E, additional, and Moris De La Tassa, C, additional

Published
2015
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26. Human semen quality in the new millennium: a prospective cross-sectional population-based study of 4867 men

Author

Jørgensen, N, Joensen, Ulla Nordström, Jensen, TK, Jensen, MB, Almstrup, Kristian, Olesen, IA, Juul, A, Andersson, A, Carlsen, E, Petersen, Jørgen Holm, Toppari, J, Skakkebæk, Niels Erik, Jørgensen, N, Joensen, Ulla Nordström, Jensen, TK, Jensen, MB, Almstrup, Kristian, Olesen, IA, Juul, A, Andersson, A, Carlsen, E, Petersen, Jørgen Holm, Toppari, J, and Skakkebæk, Niels Erik

Abstract

Objectives Considerable interest and controversy over a possible decline in semen quality during the 20th century raised concern that semen quality could have reached a critically low level where it might affect human reproduction. The authors therefore initiated a study to assess reproductive health in men from the general population and to monitor changes in semen quality over time. Design Cross-sectional study of men from the general Danish population. Inclusion criteria were place of residence in the Copenhagen area, and both the man and his mother being born and raised in Denmark. Men with severe or chronic diseases were not included. Setting Danish one-centre study. Participants 4867 men, median age 19 years, included from 1996 to 2010. Outcome measures Semen volume, sperm concentration, total sperm count, sperm motility and sperm morphology. Results Only 23% of participants had optimal sperm concentration and sperm morphology. Comparing with historic data of men attending a Copenhagen infertility clinic in the 1940s and men who recently became fathers, these two groups had significantly better semen quality than our study group from the general population. Over the 15 years, median sperm concentration increased from 43 to 48 million/ml (p=0.02) and total sperm count from 132 to 151 million (p=0.001). The median percentage of motile spermatozoa and abnormal spermatozoa were 68% and 93%, and did not change during the study period. Conclusions This large prospective study of semen quality among young men of the general population showed an increasing trend in sperm concentration and total sperm count. However, only one in four men had optimal semen quality. In addition, one in four will most likely face a prolonged waiting time to pregnancy if they in the future want to father a child and another 15% are at risk of the need of fertility treatment. Thus, reduced semen quality seems so frequent that

Published
2012

32. Systematic review of reversible cerebral vasoconstriction syndrome.

Author

Sattar A, Manousakis G, Jensen MB, Sattar, Ahsan, Manousakis, Georgios, and Jensen, Matthew B

Abstract

Reversible cerebral vasoconstriction syndrome (RCVS) is a cerebrovascular disorder associated with multifocal arterial constriction and dilation. RCVS is associated with nonaneurysmal subarachnoid hemorrhage, pregnancy and exposure to certain drugs. The primary clinical manifestation is recurrent sudden-onset and severe (‘thunderclap’) headaches over 1–3 weeks, often accompanied by nausea, vomiting, photophobia, confusion and blurred vision. The primary diagnostic dilemma is distinguishing RCVS from primary CNS arteritis. Diagnosis requires demonstration of the characteristic ‘string of beads’ on cerebral angiography with resolution within 1–3 months, although many patients will initially have normal vascular imaging. Many treatments have been reported to ameliorate the headaches of RCVS, but it is unclear whether they prevent hemorrhagic or ischemic complications. [ABSTRACT FROM AUTHOR]

Published
2010
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33. Accuracy of stroke recognition by emergency medical dispatchers and paramedics--San Diego experience.

Author

Ramanujam P, Guluma KZ, Castillo EM, Chacon M, Jensen MB, Patel E, Linnick W, and Dunford JV

Abstract

Background. Prehospital personnel in Emergency Medical Service (EMS) systems have varying levels of accuracy in stroke recognition. Identifying the accuracy of emergency medical dispatcher using Medical Priority Dispatch Systems (MPDS) stroke protocol and paramedics may help understand the accuracy of stroke recognition in about 3000 emergency medical dispatch systems and prehospital systems world wide. Objective.Our aim was to assess the accuracy of stroke identification in emergency medical dispatchers (EMD) with high compliance to MPDS protocol and paramedics using Cincinnati Prehospital Stroke Scale (CSS). Methods.This was a retrospective observational study. Data was acquired from a computer assisted dispatch (CAD) system, a computerized paramedic record database and discharge diagnosis from billing records or stroke registry containing all stroke assessments of patients who presented to the participating study hospitals within 12 hours of symptom onset. We included patients 18 years or older, identified as having stroke by EMD and city agency paramedics. We excluded patients taken to hospitals not participating in the study, patients with a dispatch determinant of Stroke (card 28) not transported by City EMS agency (SDMSE) to participating hospitals, patients in the stroke registry not transported by SDMSE or patients with no final outcome data. A stroke neurologist or hospital discharge diagnosis of stroke (physician diagnosis) was used to determine the sensitivity and predictive values of EMD and paramedic recognition of stroke. Results.Of 882 patients with a dispatch determinant of stroke using MPDS Stroke protocol, 367 had a final discharge diagnosis of stroke. This gives a sensitivity of 83% and a positive predictive value of 42% for EMD using MPDS Stroke protocol. Of 477 patients with a paramedic assessment of stroke using CSS, 193 had a final discharge diagnosis of stroke. This gives a sensitivity of 44% and a PPV of 40% for paramedics using CSS. Conclusions.In our EMS system, EMD using MPDS Stroke protocol with a high compliance has a higher sensitivity than paramedics using CSS. [ABSTRACT FROM AUTHOR]

Published
2008
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34. Pregnancy after treatment of breast cancer--a population-based study on behalf of Danish Breast Cancer Cooperative Group.

Author

Kroman N, Jensen MB, Wohlfahrt J, Ejlertsen B, and Danish Breast Cancer Co-Operative Group

Abstract

BACKGROUND: Estrogen is an established growth factor in breast cancer and it has been hypothesized that pregnancy associated estrogens may increase the risk of recurrence of breast cancer. In 1997 we published a population-based Danish study indicating no negative prognostic effect of pregnancy after breast cancer treatment. The present study is a ten-year update. MATERIAL AND METHODS: Danish Breast Cancer Cooperative Group has since 1977 collected population-based data on tumour characteristics, treatment regimes, and follow-up status on Danish women with breast cancer. Pregnancy history was added from the Danish Civil Registration System, the National Birth Registry, and the National Induced Abortion registry. Cox regression was used to estimate the risk ratio of dying among women with a pregnancy after breast cancer treatment compared with women without such experience. RESULTS: In all, 10 236 women with primary breast cancer aged 45 years or less at the time of diagnosis were followed for 95 616 person years. Among these, 371 women experienced pregnancy after treatment of breast cancer. In a multivariate analysis that included age at diagnosis, stage of disease, and pregnancy history prior to diagnosis, women who had a full-term pregnancy subsequent to breast cancer treatment were found to have a reduced risk of dying (relative risk: 0.73; 95% confidence interval: 0.54-0.99) compared with other women with breast cancer. The effect was not significantly modified by age at diagnosis, tumour size, nodal status, or pregnancy history before diagnosis of breast cancer. Neither spontaneous abortions nor induced abortions subsequent to breast cancer treatment had a negative impact on prognosis. CONCLUSION: In line with our previous study, but based on more than twice the patient material, we found no evidence that a pregnancy after treatment of breast cancer has a negative influence the prognosis. [ABSTRACT FROM AUTHOR]

Published
2008
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35. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in premonopausal [sic] patients with node-positive breast cancer: indirect comparison of dose and schedule in DBCG trials 77, 82, and 89.

Author

Ejlertsen B, Mouridsen HT, and Jensen MB

Abstract

A significant reduction in the risk of recurrence and death was achieved three decades ago with adjuvant chemotherapy in patients with operable breast. The major pivotal trials used oral cyclophosphamide (C) days 1-14 with intravenous methotrexate (M) and fluorouracil (F) on days 1 and 8, repeated every 28 days. The classical CMF has later been modified as concerns dose and schedule, without formal comparisons in randomised trials between the classical CMF and the modifications. MATERIAL AND METHODS: Classical CMF was used in the first adjuvant chemotherapy trial performed by the Danish Breast Cancer Cooperative Group (DBCG), and two succeeding randomised trials in premenopausal patients with node positive breast cancer used three-weekly or four-weekly intravenous CMF in one of the treatment arms. RESULTS: Between November 1977 and January 2001 these trials included 2 213 patients who in addition to surgery and radiotherapy received CMF. Ten-year disease-free survival (DFS) rates were 48% following classical CMF, 45% following four-weekly and 47% following three-weekly CMF. Major differences in patient characteristics were observed across these three cohorts, and a multivariate analysis was performed adjusting for the known prognostic factors. In the adjusted analysis a 30% increase in the risk of recurrence was observed for two the intravenous regimens as compared to classical CMF. As concerns survival a significant 40% increase in the risk of death was observed with the four-weekly regimen, while a similar risk of death was observed with the three-weekly intravenous. Classical CMF was associated with a higher risk of amenorrhoea, and this may at least in part explain an observed interaction between age and efficacy. DISCUSSION: This cross trial comparison suggests a detrimental effect in premenopausal patients with node positive breast cancer when shifting from classical CMF to intravenous regimens with lower dose-intensity. Caution is required in the interpretation of these results due to the non-experimental study design. [ABSTRACT FROM AUTHOR]

Published
2008
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37. Perioperative growth hormone treatment increases nitrogen and fluid balance and results in short-term and long-term conservation of lean tissue mass.

Author

Jensen MB, Kissmeyer-Nielsen P, and Laurberg S

Abstract

The surgical procedure for forming an ileoanal anastomosis with a J pouch (IAA) usually involves a temporary ileostomy; patients undergoing IAA surgery thus need to recover quickly because they return for ileostomy closure 3 mo later. We evaluated the effects of perioperative biosynthetic growth hormone (GH) treatment on short- and long-term changes in body composition and on nutritional intake. Patients with ulcerative colitis undergoing IAA surgery were randomly assigned to double-blind treatment with placebo (n=12) or 6 IU GH twice daily (n=12) from 2 d before to 7 d after the operation. Examinations were from 2 d before to 9 d after the operation and on days 30 and 90. Body composition was assessed with a dual-energy X-ray absorptiometry scanner. The 2 groups had similar nutritional intakes. On postoperative day 7, placebo-treated patients had lost 4.2 kg (95% CI: 3.0, 5.4) total tissue mass, 3.6 kg (2.1, 5.1) lean tissue mass, and 0.5 kg (-0.1, 1.2) fat mass. These reductions persisted 3 mo later. Compared with placebo, GH improved nitrogen balance, changes in lean tissue mass [gain of 4.0 kg (1.9, 6.0), P=0.001], and changes in total tissue mass [gain of 3.2 kg (1.6, 4.9), P=0.001], but increased the loss of fat mass [loss of 0.7 kg (0.0, 1.5), P=0.049] on postoperative day 7. Three months later, the placebo-treated patients had lost 2.4 kg (0.7, 4.2) more lean tissue mass than GH-treated patients (P=0.009), whereas changes in total tissue and fat mass were not significantly different. Hence, GH treatment enhanced the long-term regain of lean tissue mass. Copyright (c) 1998 American Society for Clinical Nutrition [ABSTRACT FROM AUTHOR]

Published
1998
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39. Poster session 1

Author

Haberka, M, Banska, K, Gasior, Z, Garcia Martin, A, Moya-Mur, JL, Carbonell-San Roman, S-A, Rodriguez-Munoz, D, Garcia-Lledo, A, Casas-Rojo, E, Hinojar, R, Jimenez-Nacher, JJ, Fernandez-Golfin, C, Zamorano-Gomez, JL, Barbier, P, Ravani, A, Cefalu, C, Maltagliati, A, Frigerio, B, Sansaro, D, Amato, M, Baldassarre, D, Pellegrino, M, Bandera, F, Generati, G, Labate, V, Alfonzetti, E, Guazzi, M, Angelis, A, Aggeli, K, Ioakeimidis, N, Abdelrasoul, M, Felekos, I, Gourgouli, I, Aznaouridis, K, Rousakis, G, Vlachopoulos, C, Tousoulis, D, Howlett, PJ, Darasz, K, Mahmoudi, M, Shah, N, Jabr, RI, Hickman, M, Leatham, EW, Fry, CH, PREDICT-PAF, Madeira, M, Teixeira, R, Almeida, I, Caetano, F, Fernandes, A, Cassandra, M, Reis, L, Costa, M, Goncalves, L, Carrero, PJ, Nielsen, AJ, Carrero, MC, Saubidet, GL, Peralta, SP, Argentina, Aorta Abdominal, Hansen, KL, Moeller-Soerensen, H, Kjaergaard, J, Jensen, MB, Lund, JT, Pedersen, MM, Olesen, JB, Jensen, JA, Nielsen, MB, Trunina, I, Sharykin, AS, Karelina, EV, Telezhnikova, ND, Basar, C, Ozhan, H, Kayapinar, O, Albayrak, ES, Lie, OH, Saberniak, J, Dejgaard, L, Nestaas, E, Edvardsen, T, Haugaa, KH, Sade, LE, Bal, U, Eroglu, S, Pirat, B, Muderrisoglu, H, Gopal, A S, Muthukumar, L, Saha, SK, Toole, RS, Klug, G, Reinstadler, S, Feistritzer, HJ, Pernter, B, Mayr, A, Franz, WM, Mueller, S, Metzler, B, Rodriguez Gonzalez, E, Mingo Santos, S, Palomero Monivas, V, Gonzalez Mirelis, J, Goirigolzarri Artaza, J, Zorita Gil, B, Fernandez Diaz, JA, Goicolea Ruigomez, J, Restrepo Cordoba, MA, Alonso Pulpon, L, Ferrara, F, Gargani, L, D'alto, M, Ghio, S, Acri, E, Carannante, L, Argiento, P, D'andrea, A, Vriz, O, Bossone, E, Moustafa, S, Ho, TH, Shah, P, Murphy, K, Nelluri, BK, Lee, H, Wilansky, S, Mookadam, F, Naksuk, N, Peeraphatdit, T, Chaiteerakij, R, Klarich, KW, Cantinotti, M, Scalese, M, Melo, M, Assanta, N, Marotta, M, Crocetti, M, Spadoni, I, Giordano, R, Kutty, S, Iervasi, I, Michelsen, MM, Mygind, ND, Pena, A, Frestad, D, Hoest, N, Prescott, E, Fernandes, JMG, Romao, BO, Rivera, IR, Mendonca, MA, Carvalho, AC, Campos, O, Amato, A, Moises, VA, Demir, OM, Bashir, A, Marshall, K, Douglas, M, Wasan, B, Plein, S, Alfakih, K, Cano Carrizal, R, Casanova Rodriguez, C, Cadenas Chamorro, R, Iglesias Del Valle, D, Martin-Penato Molina, A, De Juan Baguda, J, Prieto Moriche, E, Garcia Garcia, A, De La Cruz Berlanga, E, Plaza Perez, I, Bouzas-Mosquera, A, Peteiro, J, Broullon, FJ, Alvarez-Garcia, N, Barbeito-Caamano, C, Larranaga-Moreira, JM, Maneiro-Melon, N, Martinez-Ruiz, D, Yanez, JC, Vazquez-Rodriguez, JM, Leao, S, Cordeiro, F, Magalhaes, P, Moz, M, Trigo, J, Mateus, P, Fontes, P, Moreira, I, Kuznetsov, VA, Krinochkin, DV, Plusnin, AV, Soldatova, AM, Nazir, S A, Shetye, A, Khan, JN, Singh, A, Kanagala, P, Swarbrick, DJ, Graham-Brown, M, Mccann, GP, Trifunovic, D, Krljanac, G, Savic, L, Asanin, M, Aleksandric, S, Lasica, R, Srdic, M, Zlatic, N, Petrovic, M, Mrdovic, I, Rodriguez Gonzalez, E, Mingo Santos, S, Monivas Palomero, V, Gonzalez Mirelis, J, Zorita Gil, B, Fernandez Diaz, JA, Restrepo Cordoba, MA, Goirigolzarri Artaza, J, Rivero Arribas, B, Goicolea Ruigomez, J, Spampinato, RA, Dobrovie, M, Da Rocha E Silva, JG, Bonamigo Thome, F, Kluttig, R, Schloma, V, Dmitrieva, Y, Strotdrees, E, Mohr, FW, Antonini-Canterin, F, Luzza, G, Caruso, R, Belfiore, R, Della Mattia, A, Poli, S, Vriz, O, Zito, C, La Carrubba, S, Carerj, S, Ribeiro, JM, Teixeira, R, Goncalves, L, Morgado, GJ, Carvalho, JF, Gomes, AC, Caldeira, D, Cruz, IR, Stuart, B, Maia, R, Fazendas, P, Pereira, H, Trifunovic, D, Rakocevic, I, Tutos, V, Petrovic, O, Petrovic, M, Boricic-Kostic, M, Stepanovic, J, Jovanovic, I, Banovic, M, Vujisic-Tesic, B, Reis, L, Teixeira, R, Leite, L, Fernandes, A, Cassandra, M, Madeira, M, Botelho, A, Santos, M, Nascimento, J, Goncalves, L, Naratrekoon, B, Yingchoncharoen, T, Vathesatogkit, P, Yamwong, S, Sritara, P, Soto-Ruiz, RM, Bonaque Gonzalez, J C, Abellan-Huerta, J, Rubio-Paton, R, Soria, F, Ramos, JL, Egea, S, Garcia-Gomez, J, Martinez Diaz, JJ, Castillo, JA, Penicka, M, Vecera, J, Mirica, C, Kotrc, M, Kockova, R, Zilberszac, R, Gabriel, H, Maurer, G, Rosenhek, R, De Chiara, B, Botta, L, Musca, F, Belli, O, Costetti, A, Trolese, I, Spano, F, Russo, C, Giannattasio, C, Moreo, A, Rifai, R, Berthelot, E, Le, MT, Hilpert, L, Montani, D, Sitbon, O, Jais, X, Humbert, M, Assayag, P, Gunduz, S, Yesin, M, Kalcik, M, Gursoy, MO, Cersit, S, Astarcioglu, MA, Karakoyun, S, Aykan, AC, Ozkan, M, Cersit, S, Gunduz, S, Tabakci, M, Kalcik, M, Yesin, M, Bayam, E, Ozkan, M, Devecchi, C, Degiovanni, A, Di Ruocco, MV, Marino, P, Ancona, F, Rosa, I, Stella, S, Barletta, M, Marini, C, Latib, A, Montorfano, M, Colombo, A, Margonato, A, Agricola, E, Smith, D, Ray, R, Gallagher, M, Nazir, M, Perreso, V, Sharma, R, Gargani, L, Pang, PS, Miglioranza, M, Landi, P, Dini, FL, Picano, E, Asmarats Serra, L, Pons Llinares, J, Macaya Ten, F, Pericas Ramis, P, Caldes Llull, O, Grau Sepulveda, A, Frontera, G, Bethencourt, A, Abreu, A, Santa Clara, H, Santos, V, Oliveira, M, Cunha, P, Portugal, G, Rio, P, Branco, L, Ferreira, R, Mota Carmo, M, Ikonomidis, I, Paraskevaidis, I, Papadopoulos, C, Stasinos, V, Parissis, J, Lekakis, J, Biernacka, B, Rubis, P, Gackowski, A, Wisniowska-Smialek, S, Lesniak-Sobelga, A, Kostkiewicz, M, Gomes, AC, Bento, D, Correia, E, Teles, L, Picarra, B, Lourenco, C, Faria, R, Magalhaes, P, Domingues, K, Azevedo, O, Caballero, L, Climent Paya, V, Martinez Moreno, M, Gimeno, JR, Oliva, MJ, Saura, D, Sanchez Quinones, J, Garcia Honrubia, A, Valdes, M, De La Morena, G, Mansencal, N, Richard, P, Guerard, S, Brion, R, Paul, P, Dubourg, O, Komajda, M, Isnard, R, Arslan, M, Charron, P, Venturini, C, Avegliano, G, Andres, S, Costabel, JP, Kuschnir, P, Sciancalepore, A, Mendoza, O, Perea, G, Ronderos, R, Zaroui, A, Ben Said, RYM, EL Chalbia, TEJ, Wali, SANA, Mourali, MS, Mechmeche, RACHID, Leren, I S, Saberniak, J, Haland, TF, Edvardsen, T, Haugaa, KH, Astrom Aneq, M, Svetlichnaya, J S, Shikha, SS, Scheinmann, MS, Klein, LK, Nucifora, G, Prati, G, Vitrella, G, Allocca, G, Cukon Buttignoni, S, Muser, D, Morocutti, G, Pinamonti, B, Sinagra, G, Proclemer, A, Rocon, CRLA, Melo, MDTM, Bocchi, EAB, Araujo, JABAF, Demarchi, LMMFD, Mady, CM, Biselli, BB, Kalil, RKF, Salemi, VMCS, Tuma, RT, Cho, J Y, Kim, K H, Yoon, H J, Lee, K J, Park, H, Kim, J H, Ahn, Y, Jeong, M H, Cho, J G, Park, J C, Cho, J Y, Kim, K H, Yoon, H J, Park, H J, Kim, J H, Ahn, Y, Jeong, M H, Cho, J G, Park, J C, Sade, LE, Kozan, H, Eroglu, S, Pirat, B, Sezgin, A, Aydinalp, A, Muderrisoglu, H, Stampfli, S F, Oezkartal, T, Bernhart, S, Flammer, AJ, Vecchiati, A, Froehlich, GM, Ruschitzka, F, Tanner, FC, Cho, EJ, Choi, KY, Kim, DB, Jang, SW, Cho, JS, Park, CS, Jung, HO, Jeon, HK, Youn, HJ, Stevanovic, A, Dekleva, M, Pena, J L, Fortes, PRL, Passos, BR, Rodrigues, AB, Sampaio, IH, Oliveira, MCN, Silva, MG, Cardoso, RAF, Tofani, FA, Moreira, MCV, Ognibeni, F, Cioffi, G, Viapiana, O, Dalbeni, A, Fracassi, E, Di Nora, C, Cherubini, A, Mazzone, C, Di Lenarda, A, Rossini, M, Colunga, S, Corros, C, Garcia-Campos, A, Martin, M, Rodriguez-Suarez, M, Leon, V, Fidalgo, A, Lopez-Iglesias, F, Moris, C, De La Hera, JM, Borowiec, A, Dabrowski, R, Wozniak, J, Jasek, S, Chwyczko, T, Kowalik, I, Musiej-Nowakowska, E, Szwed, H, Hristova, K, Marinov, R, Stamenov, G, Mihova, M, Chacheva, K, Persenska, S, Racheva, A, Kosmala, W, Przewlocka-Kosmala, M, Rojek, A, Karolko, B, Mysiak, A, Marwick, TH, Lesniak-Sobelga, A M, Kostkiewicz, M, Wisniowska-Smialek, S, Biernacka, B, Rubis, P, Kaldararova, M, Tittel, P, Kardos, M, Vrsanska, V, Ondriska, M, Hraska, V, Nosal, M, Masura, J, Simkova, I, Stanojevic, D, Apostolovic, S, Salinger-Martinovic, S, Jankovic-Tomasevic, R, Djordjevic-Radojkovic, D, Stanojlovic, T, Atanaskovic, V, Pavlovic, M, Tahirovic, E, Dungen, HD, Carbonell San Roman, A, Moya Mur, JL, Rodriguez-Munoz, D, Lozano Granero, C, Jimenez Nacher, JJ, Gonzalez Gomez, A, Fraile Sanz, C, Segura De La Cal, T, Fernandez-Golfin, C, Zamorano Gomez, JL, Hoetink, A, Jansen Klomp, WW, Van 'T Hof, AWJ, Brandon Bravo Bruinsma, GJ, Spanjersberg, AJ, Grandjean, J, Nierich, AP, Ferreira, R, Ferreira, J, Lazaro Mendes, S, Martins, R, Monteiro, S, Pego, M, Rohani, A, Khamene Bagheri, R, Wierzbowska-Drabik, K, Peruga, JZ, Sobczak, M, Plewka, M, Wcislo, T, Krecki, R, Kasprzak, JD, Carvalho, J F, Morgado, G, Cruz, I, Caldeira, D, Almeida, AR, Joao, I, Lopes, L, Fazendas, P, Cotrim, C, Pereira, H, Cherubini, A, Cioffi, G, Mazzone, C, Faganello, G, Pandullo, C, Russo, G, Stefenelli, C, Furlanello, F, Tarantini, L, Di Lenarda, A, Teramoto, K, Suzuki, K, Satoh, Y, Minami, K, Mizukoshi, K, Kamijima, R, Kou, S, Takai, M, Izumo, M, Akashi, YJ, May, CJH, Ayuk, J, Geh, I, Shah, T, Edwards, NC, Steeds, RP, Wejner-Mik, P, Sobczak, M, Miskowiec, D, Wdowiak-Okrojek, K, Kasprzak, JD, Lipiec, P, Gurzun, M M, Rosca, M, Calin, A, Beladan, C, Serban, M, Ginghina, C, Popescu, BA, Perea, GO, Lombardero, M, Henquin, R, Corneli, M, Tinetti, M, Laveau, F, Hekimian, G, Achkar, M, Isnard, R, Combes, A, Hammoudi, N, Mahmoud, HM, Al-Ghamdi, M, Ghabashi, A, Ezzat, M H, Al-Amin, A, Sanz, M, Giraldeau, G, Sarvari, SI, Marin, J, Brambila, C, Gabrielli, L, Bijnens, B, Sitges, M, Sanchez-Martinez, S, Duchateau, N, Erdei, T, Fraser, A, Bijnens, B H, Piella, G, Montserrat, S, Sanchis, L, Borras, R, Vidal, B, Prat, S, Azqueta, M, Pare, C, Grazioli, G, Sanz, M, Sitges, M, Kowalczyk, E, Kasprzak, JD, Wejner-Mik, P, Wdowiak-Okrojek, K, Lipiec, P, Park, CS, Jung, MH, Ahn, HS, Kim, JH, Cho, JS, Jeon, HK, Youn, HJ, Hinojar, R, Fernandez-Golfin, C, Megias, A, Alonso, GL, Gonzalez-Gomez, A, Rincon, LM, Esteban, A, Fernandez Mendez, MA, Barrios, V, Zamorano, JL, Van Berendoncks, A M, Van Gaal, L, De Block, C, Salgado, R, Vrints, C, Shivalkar, B, Guedes, H, Pereira, A, Santos, R, Marques, L, Moreno, N, Carvalho, R, Pires, M, Sousa, R, Andrade, A, Pinto, P, Nestaas, E, Stoylen, A, Fugelseth, D, Onut, R, Tautu, O, Onciul, S, Marinescu, C, Zamfir, D, Dorobantu, M, Moran, L, Sanchez Sanchez, V, Navas, P, Garcia-Cosio, D, Diaz, B, Carballo-Alzola, L, Lombera, F, Delgado, J, Kisko, A, Babcak, M, Kishko, N, Agmon, Y, Eitan, A, Mutlak, D, Kehat, I, Corneli, M, Meretta, AH, Perea, GO, Belcastro, F, Aguirre, E, Rosa, D, Zaefferer, P, Masoli, O, Peovska Mitevska, IPM, Srbinovska, ES, Bosevski, MB, Antova, EA, Pop Gorceva, DPG, Barreiro Perez, M, Martin Fernandez, M, Costilla Garcia, SM, Diaz Pelaez, E, and Moris De La Tassa, C

Abstract

Background: The attainment of the primary (low density lipoprotein cholesterol; LDL-C) and the secondary (non-high density lipoprotein cholesterol; non-HDL) lipid therapeutic targets may depend on several potential factors. Our aim was assess the associations between ultrasound fat indexes, lipid levels and the lipid goals attainment in high and very high cardiovascular (CV) risk patients. Methods: Four hundred twenty (n=420) patients (F/M=146/274; age=61 ± 7 y.o.) with high (43%) or very high (57%) cardiovascular risk and chronic statin treatment (³12 months) were enrolled into the study. Obesity measures (body-mass index, BMI; bioelectrical impedance body fat; BF, waist circumference, WC, body adiposity index; BAI), serum levels of lipids (total cholesterol–TC, LDL-C, HDL-C and triglycerides–TG) and goal lipid levels (LDL-C and non-HDL-C) according to the CV risk were determined in all patients. The following ultrasound fat parameters were used in the study: intraabdominal fat (IAT), preperitoneal fat thickness (PreFT), epicardial (EFT) and pericardial (PFT) fat thickness and were indexed to BMI. Results: Our study patients had 5.2 ± 1.7 CV risk factors (80% hypertension, 32% diabetes, 59% metabolic syndrome), 49% were obese, 63% had high BF% and 85% had increased waist circumference (F>80 or M>94cm). All the patients were on a long-term statin treatment (rosuvastatin, atorvastatin or simvastatin). The attainment of the target lipid levels in the study group was as follows: LDL-C–34%, non-HDL-C–39%, both LDL-C and non-HDL-C 31%. Mean fat parameters in the study group were as follows: IAT–76.4 ± 26mm, PreFT–23.3 ± 6.5mm, EFT–3.5 ± 1.5mm and PFT–8.6 ± 3.8mm. Patients with LDL-C goal attainment had significantly higher BAI (34.6 ± 33 vs 30.5 ± 7, p=0.04), but significantly lower IAT/BMI (2.35 ± 0.7 vs 2.51 ± 0.7, p<0.05) with no differences in other clinical (BMI, BF%, WC) and ultrasound (PreFT/BMI, EFT/BMI, PFT/BMI) indexes. The LDL-C goal achievement revealed inverse association with IAT/BMI (r=-0.15, p<0.05) and no associations with PreFT/BMI, EFT/BMI or PFT/BMI. Multivariable regression analysis revealed independent association between IAT/BMI and the LDL-C goal achievement. Conclusions: Intraabdominal fat thickness representing visceral adipose tissue is inversely associated with the LDL-C goal attainment independently from general obesity. It may help to identify individuals requiring more aggressive management of dylipidaemia.

Published
2015
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40. Lack of TIMP-1 tumour cell immunoreactivity predicts effect of adjuvant anthracycline-based chemotherapy in patients (n=647) with primary breast cancer. A Danish Breast Cancer Cooperative Group study.

Author

Willemoe GL, Hertel PB, Bartels A, Jensen MB, Balslev E, Rasmussen BB, Mouridsen H, Ejlertsen B, and Brünner N

Abstract

PURPOSE: A number of prospective studies have shown that adjuvant CEF significantly improves disease-free and overall survival as compared to CMF in breast cancer patients. Our aim was to determine whether the benefit of epirubicin versus methotrexate differs according to TIMP-1 tumour cell immunoreactivity. EXPERIMENTAL DESIGN: Tissue micro arrays from 647 patients randomly assigned to CMF or CEF in DBCG trial 89D were included. The primary end-point was invasive disease-free survival (IDFS). A central assessment of tissue inhibitor of metalloproteinases 1 (TIMP-1) status was performed using immunohistochemistry (IHC). Tumours were regarded as TIMP-1 positive if epithelial breast cancer cells were stained using the anti-TIMP-1 monoclonal antibody VT7. RESULTS: By central assessment 75% of tumours were classified as tumour cell TIMP-1 positive. Among CEF-treated patients, individuals with TIMP-1 negative tumours had a significant longer IDFS than patients with TIMP-1 positive tumours (p=0.047). The multivariate Cox regression analysis of IDFS showed that CEF was superior to CMF among patients with TIMP-1 negative tumours (hazard ratio (HR)=0.51; 95% confidence interval (CI): 0.31-0.84, p=0.0085), while no significant difference could be demonstrated among patients with TIMP-1 positive tumours (HR=0.88; 95% CI: 0.68-1.13, p=0.32). A non-significant TIMP-1 status (positive or negative) versus treatment (CMF or CEF) interaction was detected for IDFS (p=0.06) and OS (p=0.21). CONCLUSION: Lack of TIMP-1 tumour cell immunoreactivity seems to predict a favourable effect of epirubicin-containing adjuvant therapy in primary breast cancer. However, an independent study is awaited to validate the potential predictive value of TIMP-1 immunoreactivity. [ABSTRACT FROM AUTHOR]

Published
2009
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41. In vitro stability of lyophilized and reconstituted recombinant activated factor VII formulated for storage at room temperature.

Author

Nedergaard H, Vestergaard S, Jensen PT, Kristiansen MW, Jensen MB, Østergaard PB, Norsell T, and Bjerre J

Abstract

BACKGROUND: Recombinant activated factor VII (rFVIIa) is indicated to treat bleeding episodes or prevent bleeding related to surgery in patients with hemophilia A or B who have antibodies to coagulation factors VIII or IX. The first-generation rFVIIa formulation is stable when stored under refrigeration. A new formulation has been developed for storage at room temperature, which may improve patients' access to treatment during bleeding episodes. OBJECTIVE: These in vitro experiments were conducted to evaluate the stability of the new formulation of rFVIIa, both lyophilized and reconstituted, under the expected storage conditions, as well as at higher temperatures. METHODS: The stability of the new rFVIIa formulation when stored under various conditions before and after reconstitution was evaluated in terms of retained activity (clotting assay), rFVIIa content (high-performance liquid chromatography [HPLC]), and rFVIIa degradation products (HPLC), including aggregates (dimer/oligomer). Activity was analyzed within specific limits representing the allowable minimum/maximum for each test parameter at the end of the product's shelf-life, as adopted by the European Medicines Agency and the US Food and Drug Administration. Before reconstitution, vials from 9 lots of the new rFVIIa formulation, 3 of each size (1, 2, and 5 mg/vial), were stored at refrigerated temperature (5 degrees C) and at room temperature (25 degrees C) for 24 months, and at 30 degrees C for 12 months. To simulate short-term exposure to temperatures higher than recommended, samples were stored at 40 degrees C for 6 months, followed by storage at 25 degrees C for 12 months. To simulate the home setting, in which the product may be alternately stored in and out of the refrigerator, samples were stored at 30 degrees C for 8 hours and then at 5 degrees C for 16 hours, repeated daily for 5 days. To analyze the effect of storage at extremely elevated temperatures, samples were exposed to temperatures of 50 degrees C, 60 degrees C, and 70 degrees C for 12 hours. After reconstitution, samples were maintained at 25 degrees C for up to 6 hours or at 5 degrees C for up to 24 hours. RESULTS: The specific activity and rFVIIa content of the new lyophilized formulation remained stable after storage for 24 months at 5 degrees C and 25 degrees C, and for 12 months at 30 degrees C; after 5 days of daily alternation between storage at 5 degrees C and 30 degrees C; and after storage for 6 months at 40 degrees C followed by 12 months at 25 degrees C. When stored at 50 degrees C and 60 degrees C for 12 hours, activity remained constant, whereas rFVIIa aggregates increased within the specified limits; after storage at 70 degrees C for 12 hours, rFVIIa activity decreased in parallel with the formation of aggregates, which exceeded the specified limit for the 5-mg product. After reconstitution, samples of all vial sizes of the new rFVIIa formulation retained their activity when stored at 25 degrees C for 6 hours and at 5 degrees C for 24 hours. CONCLUSIONS: In these in vitro experiments, the new lyophilized formulation of rFVIIa was stable when stored for 24 months at 25 degrees C, 12 months at 30 degrees C, 6 months at 40 degrees C, and 12 hours at 50 degrees C and 60 degrees C without compromise to its activity or rFVIIa content. The reconstituted product retained activity when stored at 25 degrees C for 6 hours and at 5 degrees C for 24 hours. [ABSTRACT FROM AUTHOR]

Published
2008
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42. International multicenter tool to predict the risk of four or more tumor-positive axillary lymph nodes in breast cancer patients with sentinel node macrometastases

Author

E. Barranger, Zuhair Saidan, Vania Vezzosi, Rana Nadeem, Janez Zgajnar, Rita Bori, Tuomo J. Meretoja, Peter Regitnig, Maria Pia Foschini, Shigeru Imoto, Päivi Heikkilä, Tibor Takács, György Lázár, Tove Filtenborg Tvedskov, Andraz Perhavec, Marjut Leidenius, R. Lousquy, Barbara Gazić, Simonetta Bianchi, G. Luschin-Ebengreuth, Isabella Castellano, Riccardo A. Audisio, Gábor Cserni, M.-B. Jensen, Riccardo Arisio, István Sejben, Hiroshi Kamma, Bence Kővári, Anna Sapino, Meretoja TJ, Audisio RA, Heikkilä PS, Bori R, Sejben I, Regitnig P, Luschin-Ebengreuth G, Zgajnar J, Perhavec A, Gazic B, Lázár G, Takács T, Kővári B, Saidan ZA, Nadeem RM, Castellano I, Sapino A, Bianchi S, Vezzosi V, Barranger E, Lousquy R, Arisio R, Foschini MP, Imoto S, Kamma H, Tvedskov TF, Jensen MB, Cserni G, and Leidenius MH.

Subjects
Cancer Research, medicine.medical_specialty, Axillary lymph nodes, Breast Neoplasms, Metastasis, Breast cancer, Predictive Value of Tests, Axillary lymph node dissection, medicine, Humans, Stage (cooking), Radiation treatment planning, predictive tool, Sentinel node biopsy, Tumor staging, breast, business.industry, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection, Sentinel node, Middle Aged, Models, Theoretical, medicine.disease, Primary tumor, Surgery, medicine.anatomical_structure, Oncology, sentinel node, ROC Curve, Lymphatic Metastasis, Axilla, Calibration, Lymph Node Excision, axillary metastases, Female, Radiology, Lymph Nodes, business
Abstract

Recently, many centers have omitted routine axillary lymph node dissection (ALND) after metastatic sentinel node biopsy in breast cancer due to a growing body of literature. However, existing guidelines of adjuvant treatment planning are strongly based on axillary nodal stage. In this study, we aim to develop a novel international multicenter predictive tool to estimate a patient-specific risk of having four or more tumor-positive axillary lymph nodes (ALN) in patients with macrometastatic sentinel node(s) (SN). A series of 675 patients with macrometastatic SN and completion ALND from five European centers were analyzed by logistic regression analysis. A multivariate predictive model was created and validated internally by 367 additional patients and then externally by 760 additional patients from eight different centers. All statistical tests were two-sided. Prevalence of four or more tumor-positive ALN in each center’s series (P = 0.010), number of metastatic SNs (P < 0.0001), number of negative SNs (P = 0.003), histological size of the primary tumor (P = 0.020), and extra-capsular extension of SN metastasis (P < 0.0001) were included in the predictive model. The model’s area under the receiver operating characteristics curve was 0.766 in the internal validation and 0.774 in external validation. Our novel international multicenter-based predictive tool reliably estimates the risk of four or more axillary metastases after identifying macrometastatic SN(s) in breast cancer. Our tool performs well in internal and external validation, but needs to be further validated in each center before application to clinical use.

Published
2013

43. International multicenter tool to predict the risk of nonsentinel node metastases in breast cancer

Author

E. Barranger, György Lázár, Tove Flitenborg Tvedskov, Simonetta Bianchi, G. Luschin-Ebengreuth, Gábor Boross, Janez Žgajnar, Peter Regitnig, Rana Nadeem, András Vörös, Tibor Takács, Andraz Perhavec, Gábor Cserni, Vania Vezzosi, Hiroshi Kamma, Maria Pia Foschini, Maj Brit Jensen, Riccardo Arisio, Niels Thorndahl Kroman, Shigeru Imoto, Barbara Gazić, Zuhair Saidan, Päivi Heikkilä, R. Lousquy, Tuomo J. Meretoja, István Sejben, Anna Sapino, Riccardo A. Audisio, Isabella Castellano, Marjut Leidenius, Meretoja TJ, Leidenius MH, Heikkilä PS, Boross G, Sejben I, Regitnig P, Luschin-Ebengreuth G, Zgajnar J, Perhavec A, Gazic B, Lázár G, Takács T, Vörös A, Saidan ZA, Nadeem RM, Castellano I, Sapino A, Bianchi S, Vezzosi V, Barranger E, Lousquy R, Arisio R, Foschini MP, Imoto S, Kamma H, Tvedskov TF, Kroman N, Jensen MB, Audisio RA, and Cserni G.

Subjects
Cancer Research, medicine.medical_treatment, International Cooperation, Logistic regression, 0302 clinical medicine, Risk Factors, Odds Ratio, Frozen Sections, 0303 health sciences, Carcinoma, Ductal, Breast, Confounding Factors, Epidemiologic, Sentinel node, Middle Aged, Immunohistochemistry, 3. Good health, Europe, Oncology, 030220 oncology & carcinogenesis, Predictive value of tests, Area Under Curve, Lymphatic Metastasis, PREDICTIVE TOOL, Female, Radiology, Breast disease, Adult, medicine.medical_specialty, Breast surgery, Breast Neoplasms, Risk Assessment, 03 medical and health sciences, Breast cancer, BREAST CANCER, Predictive Value of Tests, medicine, Humans, 030304 developmental biology, Aged, Neoplasm Staging, Retrospective Studies, Analysis of Variance, business.industry, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection, Reproducibility of Results, medicine.disease, Confidence interval, Surgery, Carcinoma, Lobular, SENTINEL NODE, Logistic Models, ROC Curve, AXILLARY DISSECTION, Axilla, Lymph Node Excision, Lymph Nodes, Neoplasm Grading, business
Abstract

Background Axillary treatment of breast cancer patients is undergoing a paradigm shift, as completion axillary lymph node dissections (ALNDs) are being questioned in the treatment of patients with tumor-positive sentinel nodes. This study aims to develop a novel multi-institutional predictive tool to calculate patient-specific risk of residual axillary disease after tumor-positive sentinel node biopsy. Methods Breast cancer patients with a tumor-positive sentinel node and a completion ALND from five European centers formed the original patient series (N = 1000). Statistically significant variables predicting nonsentinel node involvement were identified in logistic regression analysis. A multivariable predictive model was developed and validated by area under the receiver operating characteristics curve (AUC), first internally in 500 additional patients and then externally in 1068 patients from other centers. All statistical tests were two-sided. Results Nine tumor- and sentinel node-specific variables were identified as statistically significant factors predicting nonsentinel node involvement in logistic regression analysis. A resulting predictive model applied to the internal validation series resulted in an AUC of 0.714 (95% confidence interval [CI] = 0.665 to 0.763). For the external validation series, the AUC was 0.719 (95% CI = 0.689 to 0.750). The model was well calibrated in the external validation series. Conclusions We present a novel, international, multicenter, predictive tool to assess the risk of additional axillary metastases after tumor-positive sentinel node biopsy in breast cancer. The predictive model performed well in internal and external validation but needs to be further studied in each center before application to clinical use.

Published
2012

44. Invited review: Social housing of dairy calves: management factors affecting calf behavior, performance, and health - A systematic review.

Author

Miller-Cushon EK and Jensen MB

Abstract

Given increasing adoption of social housing for pre-weaned dairy calves, we conducted a systematic review to summarize existing literature describing effects of social housing management factors on behavior, performance, and health of dairy calves. Included articles addressed interventions applied to pre-weaned, socially housed dairy calves, encompassing age at introduction to social housing, group composition (size, stocking density, within-group age range, stability), and housing environment (space allowance, enrichment provision). Outcome measures addressed behavior, including social behavior, locomotor behavior, feeding behavior, abnormal oral behavior, and behavioral responses during tests; performance, including body measurements and weight gain; and health, including clinical health scores and mortality rate. We conducted searches initially targeting any study where dairy calves were housed socially, using Web of Science and PubMed, and subsequently identified a total of 46 relevant studies. Studies investigating age at introduction to pairs or small social groups of 3 to 7 calves (8 experimental studies) suggested possible behavioral and performance benefits, with no negative effects, of earlier introduction to small groups. Earlier introduction to larger groups (assessed in 6 experimental studies and 4 cross-sectional studies) appeared to increase latency to use an automated milk feeder with short-term negative effects on milk intake, yet no evidence of growth effects and variable health effects. Studies investigating effects of group size (assessed in 8 experimental studies and 6 cross-sectional studies) suggested that small social groups may facilitate increased feeding time, with neutral or positive effects on growth and health. Other aspects of group composition, including within-group age range, group stability, and feeder stocking density, were assessed in few experimental studies (7 total), with some results suggesting behavioral benefits of reducing competition for feed and maintaining stable groups. Experimental and cross-sectional studies yielded conflicting findings with respect to health effects of group composition, but results generally suggested possible health risks associated with larger group sizes and within-group age ranges, management factors consistent with the use of dynamic groups. Increasing space allowance (assessed in 6 experimental studies and 6 cross-sectional studies) increased locomotor activity/play behavior and had neutral or positive health effects. Provision of enrichment items (e.g., brushes, combinations of items for oral manipulation; assessed in 5 studies) was found to reduce cross-sucking. Overall, this review describes varied dairy calf social housing management practices which have implications for behavior, performance, and health. Further work is needed to address gaps in knowledge, including long-term effects and variability at the individual and group level, and to establish the external validity of these findings in commercial settings., (The Authors. Published by Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).)

Published
2025
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45. Risk of hypertension in patients with multiple sclerosis treated with teriflunomide compared to dimethyl fumarate: A nationwide cohort study in Denmark.

Author

Framke E, Sellebjerg F, Kant M, Stilund M, Jensen HB, Illes Z, Asgari N, Sejbaek T, Roug LC, Jensen MB, Schäfer J, Rasmussen PV, Christensen JR, Weglewski A, Prakash S, and Magyari M

Subjects
Humans, Denmark epidemiology, Female, Male, Adult, Middle Aged, Cohort Studies, Immunosuppressive Agents adverse effects, Crotonates adverse effects, Hydroxybutyrates, Toluidines adverse effects, Nitriles adverse effects, Dimethyl Fumarate adverse effects, Hypertension epidemiology, Hypertension chemically induced, Multiple Sclerosis drug therapy, Multiple Sclerosis epidemiology, Registries
Abstract

Background: Teriflunomide has been associated with an increased risk of hypertension. Real-world studies including adequate control groups are lacking. We hypothesized that patients with multiple sclerosis (MS) treated with teriflunomide would be at higher risk of developing hypertension than those treated with dimethyl fumarate., Methods: We conducted a cohort study linking the Danish Multiple Sclerosis Registry with national health registries during a 10-year period. Teriflunomide ( N = 2656) and dimethyl fumarate ( N = 2237) exposure was defined by the first treatment record lasting ⩾ 3 months, at which time follow-up started. We included 4893 adult patients without hypertension at baseline. Hypertension was defined as an International Classification of Diseases 10th Revision code for hypertension and by dispensed prescription drugs identified by the respective Anatomical Therapeutic Chemical codes. We used multivariable-adjusted Cox regression., Results: We found 40.6 (teriflunomide) and 13.1 (dimethyl fumarate) hypertension events per 1000 person-years. Compared to dimethyl fumarate-treated patients, patients treated with teriflunomide had a higher risk of developing hypertension (adjusted hazard ratio = 2.80; 95% confidence interval = 2.19-3.56). The number needed to harm was 16 and 9 at 3 and 5 years of follow-up, respectively., Conclusion: We found an increased risk of hypertension in adult patients with MS treated with teriflunomide., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Elisabeth Framke has nothing to disclose. Finn Sellebjerg has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from Alexion, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche, and Sanofi Genzyme. His laboratory has received research support from Biogen, Merck, Novartis, Roche, and Sanofi Genzyme. Morten Stilund has served on scientific advisory boards for, received support for congress participation or received speaker honoraria from Biogen, Merck, Novartis, Roche, and Sanofi Genzyme. Henrik Boye Jensen has served on advisory boards for Merck and Roche, and as a speaker for Biogen. Zsolt Illes has received speakers’ honoraria and/or research grants from Biogen, Roche, Sanofi, Novartis, Merck, Alexion, Bristol Myers Squibb, Lundbeckfonden, Jascha Fonden, Scleroseforeningen, has been member of advisory boards at Alexion, Biogen, Sanofi, Merck, Roche, Novartis, has been member of adjudication relapse (clinical endpoint) committees in phase 3 trials, and has been principal investigator in studies sponsored by Biogen, Merck, and Sanofi. Tobias Sejbaek has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from, Biogen, Merck, Novartis, Roche, and Sanofi. His research group has received research support from Biogen, Merck, Roche, and Sanofi. Michael Broksgaard Jensen has served on scientific advisory boards, served as a consultant, received support for congress participation or received speaker honoraria from Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva. Jakob Schäfer has been member of advisory boards at Merck, Sanofi and received speaker honoraria from Merck and Novartis, has received support for congress participation from Merck, Sanofi, and Roche. Peter Vestergaard Rasmussen has served on scientific advisory boards, served as consultant, received support for congress participation or received speaker honoraria from Alexion, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche, and Sanofi Genzyme. Jeppe Romme Christensen has received speaker honoraria from Biogen. Arkadiusz Weglewski served on scientific advisory boards for Merck, Roche, Sanofi. He has also received conference travel support from Biogen, Merck, Roche, Sanofi, and Novartis and speaker honoraria from Roche, Merck, and Sanofi. Sivagini Prakash received support for congress participation and honoraria from Merck, Sanofi Genzyme, Biogen, Roche. Melinda Magyari has served on scientific advisory board, as consultant, received support for congress participation or speaker honoraria from Biogen, Sanofi, Roche, Novartis, Merck, Alexion, Bristol Myers Squibb. The Danish MS Registry received research support from Biogen, Genzyme, Roche, Merck, Novartis. Matthias Kant, Nasrin Asgari, and Lena Christina Roug have nothing to disclose.

Published
2025
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46. Cost-effectiveness of faecal microbiota transplantation compared with vancomycin monotherapy for early Clostridioides difficile infection: economic evaluation alongside a randomized controlled trial.

Author

Birch CR, Paaske SE, Jensen MB, Baunwall SMD, Ehlers LH, and Hvas CL

Subjects
Humans, Male, Female, Middle Aged, Aged, Treatment Outcome, Aged, 80 and over, Adult, Clostridioides difficile, Fecal Microbiota Transplantation economics, Fecal Microbiota Transplantation methods, Clostridium Infections therapy, Clostridium Infections economics, Cost-Benefit Analysis, Vancomycin therapeutic use, Vancomycin economics, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents economics
Abstract

Background: For Clostridioides difficile infection (CDI), faecal microbiota transplantation (FMT) is currently recommended for patients with three or more CDI episodes. A recent randomised controlled trial (RCT) show that FMT may be considered early, defined as intervention during the first or second CDI episode., Aim: The aim was to investigate hospital costs of FMT as a complementary treatment compared with current standard care in patients with first or second CDI., Findings: Compared with standard care for first or second CDI, patients randomised to FMT had €1,645 lower hospital costs over 26 weeks owing to fewer admissions and hospital contacts and less medication use. In the sensitivity analyses, FMT remained cost-effective as long as the treatment cost of FMT stayed below approximately €1,572 per component, corresponding to a total cost of FMT treatment (two components) of €3,144., Conclusion: FMT was cost-effective with both lower costs and greater effectiveness than current standard care involving vancomycin monotherapy. The findings were robust to sensivity analyses, with a threshold cost for one FMT treatment consisting of two components of €3,144., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2025
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47. Evaluating general practitioners' focused lung ultrasound competence and findings in patients with suspected community-acquired pneumonia in general practice.

Author

Strøm JJ, Andersen CA, Jensen MB, Thomsen JL, Laursen CB, Skaarup SH, Schultz HHL, and Hansen MP

Abstract

Objectives: To evaluate general practitioners' (GPs') ability to perform focused lung ultrasound (FLUS) following a training program and assess FLUS feasibility in general practice. Also, to describe FLUS findings and evaluate GPs' ability to interpret these in adults with acute lower respiratory tract infection (LRTI) when pneumonia is suspected and assess GPs' perception of FLUS impact., Methods: Nine GPs, using point-of-care ultrasound, completed a FLUS training program. Adults (≥ 18 years) with acute cough (< 28 days) and at least one other symptom of acute LRTI, where the GP suspected pneumonia, were subsequently included. All patients received FLUS. The GPs reported FLUS findings, feasibility, and perception of FLUS impact. Recorded FLUS videos from all patients were reviewed by two specialists (Specialist Reference). The specialists assessed FLUS image quality. Agreements between the GPs and the Specialist Reference on FLUS findings were used to evaluate GPs' ability to interpret FLUS., Results: Of 91 patients included, FLUS image quality was acceptable or higher in 84 patients (92.4%). FLUS proved feasible with only two scans not completed. The GPs reported FLUS pathological findings in 51.7% of patients in 78% agreement with the Specialist Reference and Cohen's kappa 0.56. Focal B-lines represented the most frequent pathological findings. The GPs perceived that FLUS impacted change in tentative diagnosis and/or plans for treatment and/or visitation in 29 (32.0%) of patients., Conclusion: After the training, the GPs performed FLUS well. Interpretation of FLUS pathology presence was of moderate agreement. The GPs perceived that FLUS had impact on patient management., Trial Registration Number: ClinicalTrials.gov NCT04711031.

Published
2024
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48. Ultrasound education, competencies and expected future use among medical interns in Denmark: a national cross-sectional study.

Author

Gram P, Purup T, Eriksen EM, Søbye S, Wielandt SK, Astorp K, Jensen MB, and Andersen CA

Subjects
Cross-Sectional Studies, Denmark, Humans, Male, Female, Surveys and Questionnaires, Adult, Curriculum, Point-of-Care Systems, Internship and Residency, Clinical Competence, Ultrasonography
Abstract

Background: Point-of-care ultrasound is increasingly used across medical specialties, calling for timely and relevant ultrasound education in specialty training. To enable customizing such education, we aimed to explore medical interns' received ultrasound education during medical school and internship, perceived scanning competencies, evaluation of received education, future expectations for using ultrasound, and tendencies for perceiving ultrasound competence., Methods: This was a national cross-sectional study. We developed a questionnaire based on a theoretical conceptual model, individual interviews with medical interns and focus groups with medical students, followed by pilot testing. The questionnaire was distributed to all medical interns in Denmark (N = 1231). Data were summarized with descriptive statistics. Differences between universities and tendencies for perceiving ultrasound competence were analyzed with Fisher's exact tests and modified Poisson regression, respectively., Results: Responses from 420 (34.1%) interns were included. Although varying across medical schools, 95.7% received formal ultrasound training and 86.0% encountered ultrasound examinations through clinical rotation. During internship, 44.2% received formal training, while 68.5% had to pursue it independently. Ultrasound examinations during clinical work were observed by 73.2% and performed by 47.6%. Common ultrasound usage barriers were insufficient scanning routine, supervision, knowledge, confidence and mental surplus. Ultrasound competence gain from medical school and internship was reported by 75.2% and 55.3%, respectively, but mainly to lesser/some extent. Most desired more training, expected to use ultrasound in the future (71.0%) and considered it a core competence (73.0%). Perceived ultrasound competence was significantly associated with receiving practical (RR: 4.08) or both practical and theoretical education (RR: 4.34) in medical school, and practical training on patients (RR: 1.09), required number of performed scans (RR: 1.06), competence test(s) (RR: 1.07), and/or consulting books/encyclopedia (RR:1.07) during internship., Conclusions: Ultrasound training is part of medical school curricula but varies in type and extent. While most encounter and many use ultrasound during internships, formal training is less integrated. Most desire more training and attitudes towards future ultrasound usage are positive. Filled curricula pose dilemmas for prioritization and several barriers prevail for using ultrasound, representing missed opportunities for competence development and maintenance. Training governance and scaffolding continuous learning may be needed., Trial Registration: None., Competing Interests: Declarations. Ethics approval and consent to participate: The study was performed in accordance with the Declaration of Helsinki. According to Danish law (komitélovens § 14, stk. 2), no ethical approval was needed for this project. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Published
2024
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