20 results on '"Heesen C"'
Search Results
2. Activity matters: the German adaptation and pilot evaluation of a web-based self-management program to improve physical activity levels among people with multiple sclerosis
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Riemann-Lorenz, K, Krause, N, Casey, B, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Background: Regular physical activity (PA) and exercise can improve the symptoms of multiple sclerosis (MS) [ref:1], [ref:2], reduce the number of relapses, and at the same time reduce the risk of comorbidities, which in turn negatively affect MS disease course [ref:3].[for full text, please go to the a.m. URL], 19. Deutscher Kongress für Versorgungsforschung (DKVF)
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- 2020
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3. Nurse-led immunotreatment DEcision Coaching In people with Multiple Sclerosis (DECIMS) – cluster randomised controlled trial and process evaluation (ISRCTN37929939)
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Rahn, AC, Köpke, S, Barabasch, A, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Background and purpose: With currently 15 different treatment options, decision-making is challenging for people with MS (PwMS). Therefore, we developed the “nurse decision coach” programme to redistribute health professionals’ tasks to support informed treatment decision-making[for full text, please go to the a.m. URL], 18. Deutscher Kongress für Versorgungsforschung (DKVF)
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- 2019
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4. Evidenzbasierte Handbücher zu Immuntherapieoptionen für MS-Betroffene – ein deutschlandweites Projekt
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Rahn, AC, Schiffmann, I, Stürner, K, Zettl, U, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Hintergrund/Fragestellung: Bei aktuell 17 verschiedenen Therapieoptionen stehen Menschen mit schubförmiger Multipler Sklerose (MS) vor einer komplexen Entscheidung hinsichtlich eines möglichen Beginns oder Wechsels einer Immuntherapie. Ihr Recht auf evidenzbasierte Patienteninformationen[zum vollständigen Text gelangen Sie über die oben angegebene URL], EbM und Digitale Transformation in der Medizin; 20. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2019
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5. Entwicklung und Evaluation einer interaktiven Webplattform zum Schubmanagement bei Multipler Sklerose (ABouts) – eine randomisiert kontrollierte Studie (RCT) mit begleitender Mixed-Methods Prozessevaluation
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Kursawe, R, Peper, J, Scheiderbauer, J, Icks, A, Haas, J, Focke, K, Friede, T, Heesen, C, Köpke, S, and Rahn, AC
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Hintergrund/Fragestellung: Multiple Sklerose (MS) ist eine entzündliche, degenerative Erkrankung des zentralen Nervensystems und eine der häufigsten neurologischen Erkrankungen bei jungen Erwachsenen. MS verläuft bei circa 85% der Betroffenen erst in Schüben. Zur Therapie[zum vollständigen Text gelangen Sie über die oben angegebene URL], EbM und Digitale Transformation in der Medizin; 20. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2019
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6. Multiple Sklerose und Kinderwunsch – eine Mixed-Methods-Studie zur Entwicklung und Pilotierung einer Entscheidungshilfe und eines Decision Coaching Programms
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Festner, C, Gold, S, Köpke, S, Hellwig, K, Heesen, C, and Rahn, AC
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Hintergrund/Fragestellung: Multiple Sklerose (MS) ist eine chronische Erkrankung von der insbesondere Frauen zwischen 20 und 40 Jahren betroffen sind. Das Thema Schwangerschaft ist für Frauen mit MS entsprechend häufig von hoher Bedeutung. Jedoch sind Missverständnisse, Fehlinformationen[zum vollständigen Text gelangen Sie über die oben angegebene URL], EbM und Digitale Transformation in der Medizin; 20. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2019
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7. Die Bedeutung des Recall Bias in der retrospektiven Messung gesundheitsbezogener Lebensqualität
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Topp, J, Andrees, V, Augustin, M, Schäfer, L, Heesen, C, and Blome, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Hintergrund: An Fragebögen zur Messung gesundheitsbezogener Lebensqualität (HRQoL) wird der Anspruch gestellt, die HRQoL von Patienten möglichst präzise abzubilden. Dennoch kann die Messung von HRQoL systematischen Verzerrungen wie etwa dem Recall Bias unterliegen. Der Recall Bias[zum vollständigen Text gelangen Sie über die oben angegebene URL], 17. Deutscher Kongress für Versorgungsforschung (DKVF)
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- 2018
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8. Erfüllen Informationsmaterialien für Schlaganfallpatienten Kriterien evidenzbasierter Patienteninformation?
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Krützelmann, AC, Köpke, S, Rahn, A, Thomalla, G, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Hintergrund und Fragestellung: Der Schlaganfall stellt eine deutliche Beeinträchtigung in der Lebensqualität betroffener Patienten dar und beinhaltet das Risiko eines Rezidivs. Obwohl effektive Medikamente zur Sekundärprophylaxe vorhanden sind, besteht eine mangelnde Einnahme und Therapietreue[zum vollständigen Text gelangen Sie über die oben angegebene URL], Gemeinsam informiert entscheiden; 17. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2016
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9. Comprehension of confidence intervals through audio-visual patient information materials for people with multiple sclerosis (COCO-MS): a web-based randomised controlled trial (DRKS-ID: DRKS00008561)
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Rahn, AC, Riemann-Lorenz, K, Backhus, I, Köpke, S, Fuest, F, van de Roemer, A, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Background: Increasing immunotherapy options lead to complex decision making processes for people with relapsing-remitting multiple sclerosis (PwMS). Besides information about treatment effects, confidence intervals (CIs) can be helpful to assess the reliability of point estimates of treatment effects[for full text, please go to the a.m. URL], Gemeinsam informiert entscheiden; 17. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2016
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10. The Multiple Sclerosis Knowledge Questionnaire: a self-administered instrument for recently diagnosed patients
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Giordano, A, Uccelli, Mm, Pucci, E, Martinelli, V, Borreani, C, Lugaresi, A, Trojano, M, Granella, F, Confalonieri, P, Radice, D, Solari, A, D'Alessandro, R, Heesen, C, Mancardi, Gl, Milanese, C, Galimberti, S, Calabrese, D, Ferrari, G, Mattarozzi, K, Antozzi, C, Lauria, G, La Mantia, L, Pedotti, R, Mantegazza, R, Maggi, L, Colombo, B, Esposito, F, Moiola, L, Rodegher, M, Radaelli, M, Immovilli, P, Dalla Bella, E, De Luca, G, Mattoscio, M, Di Ioia, M, Pace, M, Travaglini, D, Maruotti, V, Farina, D, Zimatore, G, Plasmati, I, Tortorella, C., Giordano A., Uccelli M.M., Pucci E., Martinelli V., Borreani C., Lugaresi A., Trojano M., Granella F., Confalonieri P., Radice D., Solari A., D'Alessandro R., Heesen C., Mancardi G.L., Milanese C., Galimberti S., Calabrese D., Ferrari G., Mattarozzi K., Antozzi C., Lauria G., La Mantia L., Pedotti R., Mantegazza R., Maggi L., Colombo B., Esposito F., Moiola L., Rodegher M., Radaelli M., Immovilli P., Dalla Bella E., De Luca G., Mattoscio M., Di Ioia M., Pace M., Travaglini D., Maruotti V., Farina D., Zimatore G., Plasmati I., Tortorella C., (SIMS-Trial group)., Giordano, A., Uccelli, M. M., Pucci, E., Martinelli, V., Borreani, C., Lugaresi, A., Trojano, M., Granella, F., Confalonieri, P., Radice, D., Solari, A., D'Alessandro, R., Heesen, C., Mancardi, G. L., Milanese, C., Galimberti, S., Calabrese, D., Ferrari, G., Mattarozzi, K., Antozzi, C., Lauria, G., La Mantia, L., Pedotti, R., Mantegazza, R., Maggi, L., Colombo, B., Esposito, F., Moiola, L., Rodegher, M., Radaelli, M., Immovilli, P., Dalla Bella, E., De Luca, G., Mattoscio, M., Di Ioia, M., Pace, M., Travaglini, D., Maruotti, V., Farina, D., Zimatore, G., Plasmati, I., and Tortorella, C.
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Questionnaires ,Male ,law.invention ,Disability Evaluation ,Randomized controlled trial ,Informed consent ,law ,Surveys and Questionnaires ,Multiple Sclerosi ,Content validity ,Surveys and Questionnaire ,Medicine ,Young adult ,Patient-reported outcome ,Informed Consent ,Psychiatric Status Rating Scale ,Middle Aged ,Newly diagnosed ,Test (assessment) ,Knowledge ,Neurology ,Italy ,drug therapy/psychology ,Female ,Human ,Adult ,Employment ,medicine.medical_specialty ,Multiple Sclerosis ,Logistic Model ,Adolescent ,multiple sclerosis, questionnaire ,MEDLINE ,Reproducibility of Result ,Education ,Young Adult ,Patient Education as Topic ,Adolescent, Adult, Disability Evaluation, Education, Employment, Female, Humans, Informed Consent, Italy, Logistic Models, Male, Middle Aged, Multiple Sclerosis ,drug therapy/psychology, Patient Education as Topic, Psychiatric Status Rating Scales, Questionnaires, Reproducibility of Results, Young Adult ,Humans ,Psychiatric Status Rating Scales ,Questionnaire ,business.industry ,Construct validity ,Reproducibility of Results ,Surgery ,Clinical trial ,Logistic Models ,Measurement development ,Physical therapy ,Neurology (clinical) ,business - Abstract
There are few studies on patient knowledge in multiple sclerosis (MS), and only two published questionnaires. The objective of this article was to develop and validate the MS Knowledge Questionnaire (MSKQ), a self-assessed instrument for newly diagnosed MS patients. Thirty multiple-choice statements, conceived to test MS knowledge, were produced by a multidisciplinary panel and pre-tested on three MS patients, resulting in an intermediate 26-item version. This was tested on 54 MS patients for internal consistency, content and construct validity (validation sample I). The final (25-item) MSKQ was a primary outcome measure in the SIMS-Trial on an information aid to newly diagnosed MS patients. Postal responses of SIMS-Trial participants to the MSKQ a month after intervention (validation sample II) were analysed. Median MSKQ scores in validation samples I and II were, respectively, 18 (range 9—23) and 17 (range 3—24). Acceptability, internal consistency (Kuder—Richardson-20 formula 0.76) and content validity were good. Educational attainment and receiving the information aid were the main independent predictors of MS knowledge. Other predictors were female sex (positive association) and disease duration (negative association). In conclusion, the MSKQ has good clinimetric properties and is sensitive to an educational intervention. We propose the MSKQ as a brief instrument for clinical practice and research.
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- 2009
11. Phase III Dose-Comparison Study of Glatiramer Acetate for Multiple Sclerosis
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Comi, G, Cohen, Ja, Arnold, Dl, Wynn, D, Filippi, M, FORTE Study Group, Rocc, Ma, Perego, E, Absinta, M, Mesaros, S, Vuotto, R, Misci, P, Petrolini, M, Coyle, P, Wolinsky, J, Antel, J, Zamvil, S, Feigin, P, Carra, Aj, Bettinelli, Rj, Luetic, Gg, Vrech, Ca, Dubois, Bd, Metz, L, Bar Or, A, Bhan, V, Myles, M, Havrdova, E, Ehler, E, Kanovsky, P, Talab, R, Zapletalova, O, Gross Paju, K, Taba, P, Elovaara, I, Erälinna, Jp, Kinnunen, E, Koivisto, K, Reunanen, M, Brochet, B, Camu, W, Damier, P, Defer, G, Tumani, H, Becker, E, Buettner, T, Diener, Hc, Franz, P, Haas, J, Heesen, C, Heidenreich, F, Koelmel, Hw, Reifschneider, G, Retzlaff, K, Thoemke, F, Ziemssen, T, Rozsa, C, Bartos, L, Csanyi, A, Deme, I, Komoly, S, Panczel, G, Simo, M, Achiron, A, Milo, R, Bergamaschi, R, Bertolotto, A, Capra, R, Caputo, D, Cavalla, P, Centonze, D, Cottone, S, DE STEFANO, Nicola, Gasperini, C, Mancardi, G, Provinciali, L, Ruggieri, S, Scarpini, E, Zaffaroni, M, Metra, M, Kizlaitiene, R, Vaitkus, A, Zwanikken, Cp, Hupperts, Rm, Jongen, Pj, Szczudlik, A, Fryze, W, Kazibutowska, Z, Pierzchaa, K, Pniewski, J, Podemski, R, Stepień, A, Bajenaru, O, Campeanu, A, Marginean, I, Popescu, Cd, Toldisan, I, Boiko, A, Gustov, A, Malkova, N, Perfilyev, S, Poverennova, I, Saykhunov, M, Shutov, A, Skoromets, A, Spirin, N, Stolyarov, I, Volkova, L, Rodriguez Antigüedad, A, Arbizu, T, Arroyo, R, Barcena, J, Casanova, B, Fernández, O, Montalban, X, Ramió, L, Saiz Hinarejos, A, Sharrack, B, Silber, E, Young, C, Agius, M, Birnbaum, G, Campagnolo, D, Chaudhary, K, Cohen, J, Ford, C, Fox, E, Goodman, A, Green, B, Gupta, A, Hughes, B, Javed, A, Jeffery, D, Kasper, L, Kaufman, M, Khan, O, Kresa Reahl, K, Leist, T, Lynch, S, Markowitz, C, Mattson, D, Moses, H, Parks, B, Parry, G, Phillips, T, Picone, M, Rammohan, K, Rizvi, S, Royal, W, Scarberry, S, Sheppard, C, Simnad, V, Thrower, B, Whitham, R, Wynn, D., Comi, G, Cohen, Ja, Arnold, Dl, Wynn, D, Filippi, M, FORTE Study, Group, Diener, Hans Christoph (Beitragende*r), Klinische Neurowetenschappen, and RS: MHeNs School for Mental Health and Neuroscience
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Male ,Medizin ,MULTICENTER ,Relapsing-Remitting ,Gastroenterology ,law.invention ,DOUBLE-BLIND ,Randomized controlled trial ,law ,Recurrence ,Drug Toxicity ,Clinical endpoint ,Secondary Prevention ,administration /&/ dosage/adverse effects/therapeutic use ,Middle Aged ,drug therapy ,Intention to Treat Analysis ,Treatment Outcome ,Neurology ,Tolerability ,Disease Progression ,RELAPSE RATE ,TRIAL ,Female ,Settore MED/26 - Neurologia ,Drug ,Immunosuppressive Agents ,medicine.drug ,Adult ,medicine.medical_specialty ,Multiple Sclerosis ,Drug-Related Side Effects and Adverse Reactions ,Adolescent ,Endpoint Determination ,DOUBLE-BLIND, RELAPSE RATE, FOLLOW-UP, DISABILITY, TRIAL, MULTICENTER, MS ,Dose-Response Relationship ,Multiple Sclerosis, Relapsing-Remitting ,Adolescent, Adult, Disease Progression, Dose-Response Relationship ,Drug, Drug Toxicity, Endpoint Determination, Female, Humans, Immunosuppressive Agents ,administration /&/ dosage/adverse effects/therapeutic use, Intention to Treat Analysis, Male, Middle Aged, Multiple Sclerosis ,drug therapy, Multiple Sclerosis ,drug therapy, Peptides ,administration /&/ dosage/adverse effects/therapeutic use, Recurrence ,prevention /&/ control, Treatment Outcome ,Internal medicine ,medicine ,Humans ,Glatiramer acetate ,Expanded Disability Status Scale ,Intention-to-treat analysis ,Peptides ,Dose-Response Relationship, Drug ,business.industry ,DISABILITY ,MS ,Glatiramer Acetate ,Confidence interval ,Surgery ,Relative risk ,prevention /&/ control ,Neurology (clinical) ,FOLLOW-UP ,business - Abstract
Objective: To evaluate the safety, tolerability, and efficacy of glatiramer acetate (GA) 40mg compared to a 20mg dose. Methods: Patients with multiple sclerosis (MS) with ≥1 documented relapse in 12 months prior to screening, or ≥2 documented relapses in 24 months prior to screening, and Expanded Disability Status Scale (EDSS) score 0 to 5.5 were enrolled. Patients were evaluated at screening, baseline, and at months 1, 2, 3, 6, 9, and 12. Primary endpoint was rate of confirmed relapses observed during 12-month study. Analysis was by intent-to-treat. Results: A total of 1,155 patients randomized to GA 20mg (n = 586) or 40mg (n = 569). The groups were well-matched at baseline on demographic, clinical, and magnetic resonance imaging (MRI) characteristics. The primary endpoint was similar in both groups (relative risk [RR] = 1.07; 95% confidence interval [CI], 0.88–1.31; p = 0.486) with mean annualized relapse rates (ARRs) of 0.33 for the 20mg group, 0.35 for the 40mg group, and 0.27 for patients from both groups who completed the entire 1-year treatment. A total of 77% of patients remained relapse-free in both groups. Both groups showed a reduction in mean number of gadolinium-enhancing and new T2 lesions over time with trend for faster reduction in the first trimester with the 40mg dose compared with 20mg dose. Both doses were well-tolerated with a safety profile similar to that observed in previous studies of 20mg GA. Interpretation: In relapsing-remitting MS patients, both the currently-approved GA 20mg and 40mg doses were safe and well-tolerated, with no gain in efficacy for the higher dose. Ann Neurol 2011;69:75–82.
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- 2011
12. Evaluation einer neuen Graphik zur Kommunikation von Nutzen und Schaden in evidenzbasierten Patienteninformationen – eine randomisierte kontrollierte Studie
- Author
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Kasper, J, van de Roemer, A, Pöttgen, J, Backhus, I, Bay, Y, Köpke, S, Feddersen, L, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Hintergrund und Fragestellung: Um informierte Entscheidungen über Behandlungen treffen zu können, benötigen Patienten evidenzbasierte Informationen. Allerdings ist die Evidenz hinsichtlich der graphischen Präsentation von Wahrscheinlichkeiten für therapiebedingten Nutzen und[for full text, please go to the a.m. URL], Prävention zwischen Evidenz und Eminenz; 15. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2014
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13. Magnetresonanztomographie (MRT) bei Multipler Sklerose (MS): Erfahrungen und Präferenzen von Patienten sowie Evaluation eines Schulungsprogramms
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Brand, J, Köpke, S, Kasper, J, Rahn, AC, Stellmann, JP, Siemonsen, S, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Einleitung: In einer Befragung nannten 150 MS Patienten das MRT als zweitwichtigstes Thema mit hohem Informationsbedarf. Das MRT ist das wichtigste paraklinische Instrument zur Diagnose und Therapieüberwachung der MS. Hier herrscht eine große Unsicherheit über den Zusammenhang zwischen[for full text, please go to the a.m. URL], Prävention zwischen Evidenz und Eminenz; 15. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2014
- Full Text
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14. Schulungsprogramm zu Diagnose, Prognose und Frühtherapie für Menschen mit früher oder möglicher Multiple Sklerose – eine multizentrische randomisiert-kontrollierte Studie (ISRCTN12440282)
- Author
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Fischer, K, Köpke, S, Kasper, J, Kleiter, I, Berghoff, M, Paul, F, Marziniak, M, Ziemssen, T, Kern, S, and Heesen, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Hintergrund: Menschen mit Multipler Sklerose (MS) werden mit vielen Ungewissheiten z.B. zu Diagnose, Prognose sowie zu Nutzen und Schaden von Immuntherapien konfrontiert. Evidenz-basierte Patienteninformation ist eine Grundvoraussetzung zur Ermöglichung von informierten Entscheidungen. Aus diesem[for full text, please go to the a.m. URL], Komplexe Interventionen – Entwicklung durch Austausch; 13. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2012
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15. Development and validation of a patient self-assessed questionnaire on satisfaction with communication of the multiple sclerosis diagnosis
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Solari, A, Mattarozzi, K, Vignatelli, L, Giordano, A, Russo, P, Messmeruccelli, M, D'Alessandro, R, Pucci, E, Martinelli, V, Uccelli, Mm, Borreani, C, Trojano, M, Heesen, C, Mancardi, Gl, Milanese, C, Galimberti, S, Calabrese, D, Ferrari, G, Confalonieri, P, Mantegazza, R, Maggi, L, Colombo, B, Esposito, F, Moiola, L, Rodegher, M, Radaelli, M, Granella, F, Immovilli, P, Dalla Bella, E, Lugaresi, A, De Luca, G, Mattoscio, M, Di Ioia, M, Travaglini, D, Farina, D, Zimatore, G, Plasmati, I, Tortorella, C, Orsolamalpighi, S, Guidolin, L, Leone, M, Motti, L, Tola, Mr, Montanari, E, Guareschi, A, Pesci, I, Pattini, M, Feo, C, Torricelli, L, Santangelo, M, Stecchi, S, Scandellari, C, Balugani, R, La Mola, L, Montagna, P, Pizza, F, Avoni, P, Baldin, E, Delaj, L, Rinaldi, R, Baldi, E, Caniatti, L, Milani, P, Mussuto, V, Manzoni, M, Casmiro, M, Fiorani, L, Galeotti, M, Guerrini, C, Neri, W, Mambelli, L, Malagù, S, Naldi, P, Calzoni, S, Collimedaglia, L, Pietrolongo, E, Di Tommaso, V, Pace, M, Benedetti, M, Rossi, F, Pastoretrossello, M, Faccioli, L, Spinardi, L., Solari A., Mattarozzi K., Vignatelli L., Giordano A., Russo P.M., Uccelli M.M., D'Alessandro R., Montagna P., Pizza F., Avoni P., Baldin E., Delaj L., SIMS-Trial group, and GERONIMUS group.
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Questionnaires ,Adult ,Male ,medicine.medical_specialty ,Neurology ,Multiple Sclerosis ,Psychometrics ,Adolescent ,Adolescent, Adult, Aged, Cognition ,physiology, Communication, Disease Progression, Early Diagnosis, Factor Analysis ,Statistical, Female, Humans, Male, Middle Aged, Multiple Sclerosis ,psychology, Patient Satisfaction, Physician-Patient Relations, Psychiatric Status Rating Scales, Questionnaires, Reproducibility of Results, Young Adult ,Newly diagnosed ,psychology ,Young Adult ,Patient satisfaction ,DIAGNOSIS COMMUNICATION ,Cognition ,Surveys and Questionnaires ,medicine ,Humans ,Aged ,Psychiatric Status Rating Scales ,Physician-Patient Relations ,PSYCHOMETRICS ,business.industry ,Multiple sclerosis ,Communication ,Reproducibility of Results ,Statistical ,Middle Aged ,medicine.disease ,Surgery ,Clinical trial ,Early Diagnosis ,Patient Satisfaction ,physiology ,PATIENT-REPORTED OUTCOMES ,Physical therapy ,Disease Progression ,Female ,Neurology (clinical) ,business ,Factor Analysis, Statistical ,Factor Analysis - Abstract
Background: We describe the development and clinical validation of a patient self-administered tool assessing the quality of multiple sclerosis diagnosis disclosure. Method: A multiple sclerosis expert panel generated questionnaire items from the Doctor’s Interpersonal Skills Questionnaire, literature review, and interviews with neurology inpatients. The resulting 19-item Comunicazione medico-paziente nella Sclerosi Multipla (COSM) was pilot tested/debriefed on seven patients with multiple sclerosis and administered to 80 patients newly diagnosed with multiple sclerosis. The resulting revised 20-item version (COSM-R) was debriefed on five patients with multiple sclerosis, field tested/debriefed on multiple sclerosis patients, and field tested on 105 patients newly diagnosed with multiple sclerosis participating in a clinical trial on an information aid. The hypothesized monofactorial structure of COSM-R section 2 was tested on the latter two groups. Results: The questionnaire was well accepted. Scaling assumptions were satisfactory in terms of score distributions, item—total correlations and internal consistency. Factor analysis confirmed section 2’s monofactorial structure, which was also test—retest reliable (intraclass correlation coefficient [ICC] 0.73; 95% CI 0.54—0.85). Section 1 had only fair test—retest reliability (ICC 0.45; 95% CI 0.12—0.69), and three items had 8—21% missed responses. Conclusions: COSM-R is a brief, easy-to-interpret MS-specific questionnaire for use as a health care indicator.
- Published
- 2010
16. daclizumab in active relapsing multiple clerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta
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Jacques, F, Melanson, M, Kremenchutzky, M, Lapierre, Y, O'Connor, P, Blevins, G, Wandinger, K, Sommer, N, Heesen, C, Pozzilli, C, Gallo, Paolo, Comi, G, Arbizu, T, Fernandez, O, Montalban, X, Casanova, B, Garcia Moreno, A, Absher, J, Cooper, J, Khatri, B, Fox, E, Wynn, D, Picone, M, Herbert, J, Lynch, S, Minagar, A, Carter, J, Sullivan, H, Martin, J, Ford, C, Phillips, T, Kasper, L, Dunn, J, English, J, Steingo, B, Edwards, K, Honeycutt, W, Jacobs, A, Kaufman, M, Freedman, M, Pugh, S, Vollmer, T, Thomas, F, Pirko, I, Markowitz, C, Rose, J, Storey, J, Jeffery, D, Kahn, O, Dickson, R, Gottesman, M, Miller, De, Reingold, Sc, Cutter, G, Wolinsky, J, Freedman, Ms, Edan, G., Wynn, D, Kaufman, M, Montalban, X, Vollmer, T, Simon, J, Elkins, J, O'Neil, G, Neyer, L, Sheridan, J, Wang, C, Comi, Giancarlo, and ROSE JW CHOICE, Investigator
- Subjects
Adult ,Male ,medicine.medical_specialty ,Daclizumab ,Adolescent ,T-Lymphocytes ,Antibodies, Monoclonal, Humanized ,Placebo ,Gastroenterology ,law.invention ,Young Adult ,Multiple Sclerosis, Relapsing-Remitting ,Double-Blind Method ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Immunologic Factors ,Lymphocytes ,Cell Proliferation ,Intention-to-treat analysis ,business.industry ,Multiple sclerosis ,Antibodies, Monoclonal ,Brain ,Interferon-beta ,Middle Aged ,Multiple Sclerosis, Chronic Progressive ,medicine.disease ,Magnetic Resonance Imaging ,CD56 Antigen ,eye diseases ,Treatment Outcome ,Immunoglobulin G ,Pharmacodynamics ,Immunology ,Monoclonal ,Female ,Neurology (clinical) ,business ,Immunosuppressive Agents ,medicine.drug - Abstract
Summary Background Daclizumab, a humanised monoclonal antibody, reduced multiple sclerosis disease activity in previous non-randomised studies. We aimed to assess whether daclizumab reduces disease activity in patients with active relapsing multiple sclerosis who are receiving interferon beta treatment. Methods We did a phase 2, randomised, double-blind, placebo-controlled study at 51 centres in the USA, Canada, Germany, Italy, and Spain. Patients with active relapsing multiple sclerosis who were taking interferon beta were randomly assigned to receive add-on subcutaneous daclizumab 2 mg/kg every 2 weeks (interferon beta and high-dose daclizumab group), daclizumab 1 mg/kg every 4 weeks (interferon beta and low-dose daclizumab group), or interferon beta and placebo for 24 weeks. The randomisation scheme was generated by Facet Biotech. All patients and assessors were masked to treatment with the exception of Facet Biotech bioanalysts who prepared data for the data safety monitoring board or generated pharmacokinetic or pharmacodynamic data, a drug accountability auditor, and the site pharmacist. The primary endpoint was total number of new or enlarged gadolinium contrast-enhancing lesions measured on brain MRI scans every 4 weeks between weeks 8 and 24. Effects of daclizumab on prespecified subsets of lymphocytes and quantitative T-cell proliferative response were assessed in an exploratory pharmacodynamic substudy. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00109161. Findings From May, 2005, to March, 2006, 288 patients were assessed for eligibility, and 230 were randomly assigned to receive interferon beta and high-dose daclizumab (n=75), interferon beta and low-dose daclizumab (n=78), or interferon beta and placebo (n=77). The adjusted mean number of new or enlarged gadolinium contrast-enhancing lesions was 4·75 in the interferon beta and placebo group compared with 1·32 in the interferon beta and high-dose daclizumab group (difference 72%, 95% CI 34% to 88%; p=0·004) and 3·58 in the interferon beta and low-dose daclizumab group (25%, −76% to 68%; p=0·51). In the pharmacodynamic substudy, daclizumab was not associated with significant changes in absolute numbers of T cells, B cells, or natural killer cells, or T-cell proliferative response compared with interferon beta alone. The number of CD56 bright natural killer cells was seven to eight times higher in both daclizumab groups than in the interferon beta and placebo group (interferon beta and low-dose daclizumab group p=0·002; interferon beta and high-dose daclizumab group p Interpretation Add-on daclizumab treatment reduced the number of new or enlarged gadolinium contrast-enhancing lesions compared with interferon beta alone and might reduce multiple sclerosis disease activity to a greater extent than interferon beta alone. Funding Facet Biotech and Biogen Idec.
- Published
- 2010
17. Health-related quality of life in multiple sclerosis: Effects of natalizumab
- Author
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Rudick, R. A., Miller, D., Hass, S., Hutchinson, M, Calabresi, P. A., Confavreux, C., Galetta, S. L., Giovannoni, G., Havrdova, E., Kappos, L., Lublin, F. D., Miller, D. H., O'Connor, P. W., Phillips, J. T., Polman, C. H., Radue, Ew, Stuart, W. H., Wajgt, A., Weinstock Guttman, B., Wynn, D. R., Lynn, F., Panzara, M. A., Affirm, Macdonell, SENTINEL Investigators including: R., Hughes, A., Taylor, I., Lee, Y. C., Ma, H., King, J., Kilpatrick, T., Butzkueven, H., Marriott, M., Pollard, J., Spring, P., Spies, J., Barnett, M., Dehaene, I., Vanopdenbosch, L., D’Hooghe, M., Van Zandijcke, M., Derijck, O., Seeldrayers, P., Jacquy, J., Piette, T., De Cock, C., Medaer, R., Soors, P., Vanroose, E., Vanderhoven, L., Nagels, G., Dubois, B., Deville, M. C., D’Haene, R., Jacques, F., Hallé, D., Gagnon, S., Likavcan, E., Murray, T. J., Bhan, V., Mackelvey, R., Maxner, C. E., Christie, S., Giaccone, R., Guzman, D. A., Melanson, M., Esfahani, F., Gomori, A. J., Nagaria, M. H., Grand’Maison, F., Berger, L., Nasreddine, Z., Duplessis, M., Brunet, D., Jackson, A., Pari, G., O’Connor, P., Gray, T., Hohol, M., Marchetti, P., Lee, L., Murray, B., Sahlas, J., Perry, J., Devonshire, V., Hooge, J., Hashimoto, S., Oger, J., Smyth, P., Rice, G., Kremenchutzky, M., Stourac, P., Kadanka, Z., Benesova, Y., Niedermayerova, I., Meluzinova, E., Marusic, P., M, Bojar, Zarubova, K., Houzvicková, E., Piková, J., Talab, R., Faculty, Hospital Olomouc, Olomouc, B. Muchova, Urbánek, K, Kettnerova, Z., Mares, J., Otruba, P., Zapletalová, O., Hradilek, P., Ddolezil, D. Dolezil, Woznicova, I., Höfer, R., Ambler J. Fiedler, Z. Ambler J. Fiedler, Sucha, J., Matousek, V., Rektor, I., Dufek, M., Mikulik, R., Mastik, J., Tyrlikova, I., General, Teaching Hospital, Prague, E. Havrdová, Horakova, D., Kalistová, H., Týblová, M., Ehler, E., Novotná, A., Geier, P., Soelberg Sorensen, P., Ravnborg, M., Petersen, B., Blinkenberg, M., Färkkilä, M., Harno, H., Kallela, M., Häppölä, O., Elovaara, I., Kuusisto, H., Ukkonen, M., Peltola, J., Palmio, J., Pelletier, J., Feuillet, L., Suchet, L., Dalecky, A., Tammam, D., Edan, G., Le Page, E., Mérienne, M., Yaouanq, J., Clanet, M., Mekies, C., Azais Vuillemin, C., Senard, A., Lau, G., Steinmetz, G., Warter V. Wolff, J. Warter V. Wolff, Fleury, M., Tranchant, C., Stark, E., Buckpesch Heberer, U., Henn, K. H., Skoberne, T., Schimrigk, S., Hellwig, K., Brune, N., Weiller, C., Gbadamosi, J., Röther, J., Heesen, C., Buhmann, C., Karageorgiou, C., Korakaki, D., Giannoulis, D. r., Tsiara, S., Thomaides, T., Thomopoulos, I., Papageorgiou, H., Armakola, F., Komoly, S., Rózsa, C., Matolcsi, J., Szabó, G. y., Molnár, B., Lovas, G., Dioszeghy, P., Szulics, P., Magyar, Z., Incze, J., Farkas, J., Clemens, B., Kánya, J., Valicskó, Z. s., Bense, E., Nagy, Z. s., Geréby, G., Perényi, J., Simon, Z. s., Szapper, M., Gedeon, L., Csanyi, A., Rum, G., Lipóth, S., Szegedi, A., Jávor, L., Nagy, I., Adám, I., Szirmai, I., Simó, M., Ertsey, C., I, Amrein, Kamondi, A., Harcos, P., Dobos, E., Szabó, B., Balas, V., Guseo, A., Fodor, E., Jófejü, E., Eizler, K., Csiba, L., Csépány, T., Pallagi, E., Bereczki, D., Jakab, G., Juhász, M., Bszabó, B. Szabó I. Mayer, Katona, G., Hutchinson, M., O’Dwyer, J., O’Rourke, K., Sanders, E. A. C. M., Rijk van Andel, J. F., Bomhof, M. A. M., van Erven, P., Hintzen I. Hoppenbrouwers, R. Q. Hintzen I. Hoppenbrouwers, Neuteboom, R. F., Zemel, D., van Doorn, P. A., Jacobs, B. C., Munster, E. T. h. L. Van, ter Bruggen, J. P., Bernsen, R., Jongen, P. J. H., de Smet, E. A. A., Tacken, H. F. H., Polman, C., Zwemmer, J., Nielsen, J., Kalkers, N., Kragt, J., Jasperse, B., Willoughby, E., Anderson, N. E., Barber, A., Anderson, T., Parkin, P. J., Fink, J., Avery, S., Mason, D., Kwiecinski, H., Zakrzewska Pniewska, B., Kaminska, A., Podlecka, A., Nojszewska, M., Czlonkowska, A., Zaborski, J., Wicha, W., Kruszewska Ozimowska, J., Darda Ledzion, L., Selmaj, K., Mochecka Thoelke, A., Pentela Nowicka, J., Walczak, A., Stasiolek, M., Stelmasiak, Z., Bartosik Psujek, H., Mitosek Szewczyk, K., Belniak, E., Chyrchel, U., Maciejowski, M., Strzyzewska Lubos, L., Lubos, L., Matusik, E., Maciejek, Z., Niezgodzinska Maciejek, A., Sobczynska, D., Slotala, T., Wawrzyniak, S., Kochanowicz K. Kuczynski, J. Kochanowicz K. Kuczynski, Zimnoch, R., Pryszmont, M., Drozdowski, W., Baniukiewicz, E., Kulakowska, A., Borowik, H., Lewonowska, M., Szczudlik, A., Róg, T., Gryz Kurek, E., Pankiewicz, J., Furgal, J., Kimkowicz, A., Fryze, W., Wierbicki, T., Michalak, L., Kowalewska, J., Swiatkiewicz, J., Hillert, J., Åkesson, E, Fredrikson, S., Diener, P, Olsson, T., Wallström, E., Fpiehl, F. Piehl L. Hopia, Brundin, L., Marta, M., Andersson, M., Lycke, J., Runmarker, B., Malmeström, C., Vaghfeldt, P., Skoog, B., Schluep, M., Bogousslavskyr, J., Du Pasquier, R., Achtnichts, L., Kuhle, J., Buitrago Telez, C., Schläger, R., Naegelin, Y., Eraksoy, M., Bebek, N., Akman Demir, G., Topcuoglu, B., Kurtuncu, M., Istanbul, University, Istanbul:, A. Siva, Saip, S., Altintas, A., Kiyat, A., Sharief, M., Kasti, M., Lim, E. T., Rashid, W., Silber, E., Saldanha, G., Hawkins, C., Mamutse, G., Woolmore, J., Hawkes, C., Findley, L., Dasilva, R., Gunasekara, H., Palace, J., Cader, Z., Littleton, E., Burke, G., Sharrack O. Suliman, B. Sharrack O. Suliman, Klaffke, S., Swash, M., Dhillon, H., Bates, D., Westwood, M., Nichol, P., Barnes, D., Wren, D., Stoy, N., Robertson, N., Pickersgill, T., Pearson, O., Lawthom, C., Young, C., Mills, R., Lecky, B., Ford, C., Katzman, J., Rosenberg, G., Cooper, J., Wrubel, B., Richardson, B., Lynch, S., Ridings, L., Mcvey, A., Nowack, W., Rae Grant, A., Mackin, G. A., Castaldo, J. E., Spikol, L. J., Carter, J., Wingerchuk, D., Caselli, R., Dodick, D., Scarberry, S., Bailly, R., Garnaas, K., Haake, B., Rossman, H., Belkin, M., Boudouris, W. D., Pierce, R. P., Mass, M., Yadav, V., Bourdette, D., Whitham, R. H., Heitzman, D., Martin, A., Greenfield, C. F., Agius, M., Richman, D. P., Vijayan, N., Wheelock, V. L., Reder, A., Arnason, B., Noronha, A., Balabanov, R., Ray, A., Sheremata, W., Delgado, S., Shebert, B., Maldonado, J., Bowen, J., Garden, G. A., Distad, B. J., Carrithers, M., Rizzo, M., Vollmer, T., Reiningerova, J., Guarnaccia, J., Lo, A., Richardson, G. B., Fazekas, F., Enzinger, C., Seifert, T., Storch, M., Strasser Fuchs, S., Berger, T., Dilitz, E., Egg, R., Deisenhammer, F., Decoo, : D, Lampaert, J., Bartholome, E., Bier, J., Stenager, : E., Rasmussen, M., Binzer, M., Shorsh, K., Christensen, M., Soelberg Sørensen, P., Hansen, H. J., Bech, E., Petersen, T., Kirkegaard, M., Eralinna, : J., Ruutiainen, J., Soilu Hänninen, M., Säkö, E., Laaksonen, M., Reunanen, M., Remes, A., Keskinarkaus, I., Moreau, : T., Noblet, M., Rouaud, O., Couvreur, G., Lepage, E., Drapier, S., De Burghgraeve, V., Merienne, M., Cahagne, V., Gout, O., Deschamps, R., Le Canuet, P., Moulignier, A., Vermersch, P., De Seze, J., Stojkovic, T., Griffié, G., Engles, Ferriby, D., Debouverie, M., Pittion Vouyouvitch, S., Lacour, J. C., Lubetzki, C., Youssov, K., Mrejen, S., Charles, P., Yaici, S., Clavelou, P., Aufauvre, D., Renouil Guy, N., Cesaro, P., Degos, F., Benisty, S., Rumbach, L., Decavel, P., Blanc, S., Aubertin, P., Riche, G., Brochet, B., Ouallet, J. C., Anne, O., Menck, : S., Grupe, A., Gutmann, E., Lensch, E., Fucik, E., Heitmann, S., Hartung, H. P., Schröter, M., Kurz, F. M. W., Heidenreich, F., Trebst, C., Pul, R., Hohlfeld, R., Krumbholz, M., Pellkofer, H., Haas, J., Segert, A., Meyer, R., Anagnostou, P., Kabus, C., Poehlau, D., Schneider, K., Hoffmann, V., Zettl, U., Steinhagen, V., Adler, S., Steinbrecher E. Rothenfusser Körber, A. Steinbrecher E. Rothenfusser Körber, Zellner, R., Baum, K., Günther, A., Bläsing, H., Stoll, G., Gold, R., Bayas, A., Kleinschnitz, C., Limmroth, V., Katsarava, Z., Kastrup, O., Haller, P., Stoeve, S., Höbel, D., Oschmann, P., Voigt, K., Burger, C. V., Abramsky, : O., Karusiss, D., Achiron, A., Kishner, I., Stern, Y., Sarove Pinhas, I., Dolev, M., Magalashvili, D., Pozzili, : C., Lenzi, D., Scontrini, A., Millefiorini, E., Buttinelli, C., Gallo, P., Ranzato, F., Tiberio, M., Perini, P., Laroni, Alice, Marrosu, M., Cocco P. Marchi, E. Cocco P. Marchi, Spinicci, G., Massole, S., Mascia, M., Floris, G., Trojano, M., Bellacosa, A., Paolicelli, D., Bosco Zimatore, G., Simone, I. L., Giorelli, M., Di Monte, E., Mancardi, GIOVANNI LUIGI, Pizzorno, M., Murialdo, A., Narciso, E., Capello, A., Comi, G., Martinelli, V., Rodegher, M., Esposito, F., Colombo, B., Rossi, P., Polman, : C. H., Jasperse, M. M. S., Zwemmer, J. N. P., Kragt, J. J., De Smet, E., Tacken, H., Frequin, S. T. F. M., Siegers, H. P., Mauser, H. W., Fernandez Fernandez, : O., León, A., Romero, F., Alonso, A., Tamayo, J., Montalban, X., Nos, C., Pelayo, R., Tellez, N., Rio, J., Tintore, M., Arbizu, T., Romero, L., Moral, E., Martinez, S., Kappos, : L., Wilmes, S., Karabudak, : R., Kurne, A., Erdem, S., Siva, A., Atamer, A., Bilgili, F., Topcular, B., Giovannoni, : G., Lava, : N., Murnane, M., Dentinger, M., Zimmerman, E., Reiss, M., Gupta, V., Scott, T., Brillman, J., Kunschner, L., Wright, D., Perel, A., Babu, A., Rivera, V., Killian, J., Hutton, G., Lai, E., Picone, M., Cadivid, D., Kamin, S., Shanawani, M., Gauthier, S., Morgan, A., Buckle, G., Margolin, D., Kwen, P. L., Garg, N., Munschauer, F., Khatri, B., Rassouli, M., Saxena, V., Ahmed, A., Turner, A., Fox, E., Couch, C., Tyler, R., Horvit, A., Fodor, P., Humphries, S., Wynn, D., Nagar, C., O’Brien, D., Allen, N., Turel, A., Friedenberg, S., Carlson, J., Hosey, J., Crayton, H., Richert, J., Tornatore, C., Sirdofsky, M., Greenstein, J., Shpigel, Y., Mandel, S., Adbelhak, T., Schmerler, M., Zadikoff, C., Rorick, M., Reed, R., Elias, S., Feit, H., Angus, E., Sripathi, N., Herbert, J., Kiprovski, K., Qu, X., Del Bene, M., Mattson, D., Hingtgen, C., Fleck, J., Horak, H., Javerbaum, J., Elmore, R., Garcia, E., Tasch, E., Gruener, G., Celesia, G., Chawla, J., Miller, A., Drexler, E., Keilson, M., Wolintz, R., Drasby, E., Muscat, P., Belden, J., Sullivan, R., Cohen, J., Stone, L., Marrie, R. A., Fox, R., Hughes, B., Babikian, P., Jacoby, M., Doro, J., Puricelli, M., Boudoris, W., Pierce, R., Eggenberger, E., Birbeck, G., Martin, J., Kaufman, D., Stuart, W., English, J. B., Stuart, D. S., Gilbert, R. W., Kaufman, M., Putman, S., Diedrich, A., Follmer, R., Pelletier, D., Waubant, E., Cree, B., Genain, C., Goodin, D., Patwa, H., Rizo, M., Kitaj, M., Blevins, J., Smith, T., Mcgee, F., Honeycutt, W., Brown, M., Isa, A., Nieves Quinones, D., Krupp, L., Smiroldo, J., Zarif, M., Perkins, C., Sumner, A., Fisher, A., Gutierrez, A., Jacoby, R., Svoboda, S., Dorn, D., Groeschel, A., Steingo, B., Kishner, R., Cohen, B., Melen, O., Simuni, T., Zee, P., Cohan, S., Yerby, M., Hendin, B., Levine, T., Tamm, H., Travis, L. H., Freedman, S. M., Tim, R., Ferrell, W., Stefoski, D., Stevens, S., Katsamakis, G., Topel, J., Ko, M., Gelber, D., Fortin, C., Green, B., Logan, W., Carpenter, D., Temple, L., Sadiq, S., Sylvester, A., Sim, G., Mihai, C., Vertino, M., Jubelt, B., Mejico, L., Riskind, P., Cabo, A., Paskavitz, J., Moonis, M., Bashir J. Brockington, K. Bashir J. Brockington, Nicholas, A., Slaughter, R., Archer S. Harik, R. Archer S. Harik, Haddad, N., Pippenger, M. A., Van den Noort, S., Thai, G., Olek, M., Demetriou, M., Shin, R., Calabresi, P., Rus, H., Bever, C., Johnson, K., Sherbert, R., Herndon, R., Uschmann, H., Chandler, A., Markowitz, C., Jacobs, D., Balcer, L., Mitchell, G., Chakravorty, S., Heyman, R., Stauber, Z., Goodman, A., Segal, B., Schwid, S., Samkoff, L., Levin, M., Jacewicz, M., Menkes, D., Pulsinelli, W., Frohman, E., Racke, M., Hawker, K., Ulrich, R., Panitch, H., Hamill, R., Tandon, R., Dulaney, E., Simnad, V., Miller, J., Wooten, G. F., Harrison, M., Doherty, M., Wundes, A., Distad, J., Kachuck, N., Berkovich, R., Burnett, M., Sahai, S., Bandari, D., Weiner, L., Storey, J. R., Beesley, B., Hart, D., Moses, H., Sriram, S., Fang, J., O’Duffy, A., Kita, M., Taylor, L., Elliott, M., Roberts, J., Jeffery, D., Maxwell, S., Lefkowitz, D., Kumar, S., Sinclair, M., Radue, E. W., de Vera, A., Bacelar, O., and Kuster, P.
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Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,Visual analogue scale ,Health Status ,Population ,Pain ,Comorbidity ,Placebo ,Antibodies ,law.invention ,Natalizumab ,Randomized controlled trial ,Quality of life ,Double-Blind Method ,law ,Internal medicine ,Surveys and Questionnaires ,Monoclonal ,medicine ,Prevalence ,Humans ,Longitudinal Studies ,education ,Humanized ,education.field_of_study ,Expanded Disability Status Scale ,Neuroscience (all) ,business.industry ,Antibodies, Monoclonal ,Antibodies, Monoclonal, Humanized ,Female ,Patient Satisfaction ,Treatment Outcome ,United States ,Quality of Life ,Multiple sclerosis ,medicine.disease ,Neurology ,Physical therapy ,Neurology (clinical) ,business ,medicine.drug - Abstract
Objective To report the relationship between disease activity and health-related quality of life (HRQoL) in relapsing multiple sclerosis, and the impact of natalizumab. Methods HRQoL data were available from 2,113 multiple sclerosis patients in natalizumab clinical studies. In the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study, patients received natalizumab 300mg (n = 627) or placebo (n = 315); in the Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) study, patients received interferon beta-1a (IFN-β-1a) plus natalizumab 300mg (n = 589), or IFN-β-1a plus placebo (n = 582). The Short Form-36 (SF-36) and a subject global assessment visual analog scale were administered at baseline and weeks 24, 52, and 104. Prespecified analyses included changes from baseline to week 104 in SF-36 and visual analog scale scores. Odds ratios for clinically meaningful improvement or worsening on the SF-36 Physical Component Summary (PCS) and Mental Component Summary were calculated. Results Mean baseline SF-36 scores were significantly less than the general US population and correlated with Expanded Disability Status Scale scores, sustained disability progression, relapse number, and increased volume of brain magnetic resonance imaging lesions. Natalizumab significantly improved SF-36 PCS and Mental Component Summary scores at week 104 in AFFIRM. PCS changes were significantly improved by week 24 and at all subsequent time points. Natalizumab-treated patients in both studies were more likely to experience clinically important improvement and less likely to experience clinically important deterioration on the SF-36 PCS. The visual analog scale also showed significantly improved HRQoL with natalizumab. Interpretation HRQoL was impaired in relapsing multiple sclerosis patients, correlated with severity of disease as measured by neurological ratings or magnetic resonance imaging, and improved significantly with natalizumab. Ann Neurol 2007
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- 2007
18. Interferon beta-1a in relapsing multiple sclerosis: four-year extension of the European IFNbeta-1a Dose-Comparison Study
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Clanet, M., Kappos, L., Hartung, H.P., Hohlfeld, R., Kristoferitsch, W., Schrieber, A., Schlederer, A., Seeldrayers, P., Piette, A., Papacostas, S., Kyriallis, K., Pantzaris, A., Brochet, B., Gayou, A., Rouanet, M., Rouant, F., Confavreux, C., Riche, G., Blanc, S., Achiti, J., Magnier, C., Aubertin, P., Mekies, C., Brassat, D., Thalamas, C., Vuilleman, C., Senard, A., Lau, G., Cesaro, P., Degos, F., Defer, G., Schaeffer, S., Edan, G., de Marco, A., Cahagne, V., Belliard, S., Lyon-Caen, O., Stankoff, B., Lubetzki, C., Arnulf, I., Damier, P., Pelletier, J., Tamman, D., Suchet, L., Dalecky, A., Rumbach, L., Moulin, A., Berger, E., Roullet, E., Pez, D., Heinzlef, O., Lecanuet, P., Vermersch, P., Engles, A., Dengler, R., Heidenreich, F., Lindert, A., Koehler, A., Windhagen, A., Steiner, A., Zschenderlein, R., Luenemann, J., Gelderblom, H., Kassim, N., Storch-Hagenlocher, B., Koerner, A., Vogt-Schaden, A., Stingle, A., Storch-Hagenlocher, A., Sailer, 27449, Matzke, A., Dose, A., Weiler, C., Kunze, K., Heesen, C., Bamborschke, P., Petereit, H., Liu, A., Nolden, A., Grunwald, F., Menck, A., Grupe, A., Rieckmann, P., Weilbach, A., Flachenecker, A., Chan, A., Maurer, A., de Keyser, Jacques, Zwanniken, G., Zorgdrager, A., Montalban, X., Nos, A., Fernandez, O., Tamayo, J.A., Romero, F., Arbizu, T., Martinez-Yelamos, A., Martin, A, and Casado, A.
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Adult ,Male ,medicine.medical_specialty ,Injections, Intramuscular ,Central nervous system disease ,03 medical and health sciences ,Disability Evaluation ,0302 clinical medicine ,Multiple Sclerosis, Relapsing-Remitting ,Adjuvants, Immunologic ,Internal medicine ,Epidemiology ,Clinical endpoint ,medicine ,Humans ,030212 general & internal medicine ,Clinical efficacy ,business.industry ,Incidence (epidemiology) ,Multiple sclerosis ,Interferon beta-1a ,Interferon-beta ,medicine.disease ,Surgery ,Europe ,Interferon β 1a ,Treatment Outcome ,Neurology ,Disease Progression ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,medicine.drug ,Follow-Up Studies - Abstract
Background: Multiple sclerosis (MS) is a chronic disease requiring long-term monitoring of treatment. Objective: To assess the four-year clinical efficacy of intramuscular (IM) IFNb-1a in patients with relapsing MS from the European IFNb-1a Dose-C omparison Study. Methods: Patients who completed 36 months of treatment (Part 1) of the European IFNb-1a Dose-C omparison Study were given the option to continue double-blind treatment with IFNb-1a 30 mcg or 60 mcg IM once weekly (Part 2). Analyses of 48-month data were performed on sustained disability progression, relapses, and neutralizing antibody (NA b) formation. Results: O f 608/802 subjects who completed 36 months of treatment, 493 subjects continued treatment and 446 completed 48 months of treatment and follow-up. IFNb-1a 30 mcg and 60 mcg IM once weekly were equally effective for up to 48 months. There were no significant differences between doses over 48 months on any of the clinical endpoints, including rate of disability progression, cumulative percentage of patients who progressed (48% and 43%, respectively), and annual relapse rates; relapses tended to decrease over 48 months. The incidence of patients who were positive for NAbs at any time during the study was low in both treatment groups. Conclusion: C ompared with 60-mcg IM IFNb-1a once weekly, a dose of 30 mcg IM IFNb-1a once weekly maintains the same clinical efficacy over four years.
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- 2004
19. Conversion to Secondary Progressive Multiple Sclerosis: Patient Awareness and Needs. Results From an Online Survey in Italy and Germany
- Author
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Alessandra Solari, Ambra Mara Giovannetti, Andrea Giordano, Carla Tortorella, Valentina Torri Clerici, Giampaolo Brichetto, Franco Granella, Alessandra Lugaresi, Francesco Patti, Marco Salvetti, Ilaria Pesci, Eugenio Pucci, Diego Centonze, Maura Chiara Danni, Simona Bonavita, Diana Ferraro, Antonio Gallo, Alberto Gajofatto, Viviana Nociti, Luigi Grimaldi, Monica Grobberio, Roberta Lanzillo, Rachele Di Giovanni, Silvia Gregori, Alessia Manni, Erika Pietrolongo, Sarah Bertagnoli, Marco Ronzoni, Laura Compagnucci, Roberta Fantozzi, Beatrice Allegri, Sebastiano Arena, Maria Chiara Buscarinu, Loredana Sabattini, Maria Esmeralda Quartuccio, Elena Tsantes, Paolo Confaloneri, Andrea Tacchino, Insa Schiffmann, Anne Christin Rahn, Ingo Kleiter, Michele Messmer Uccelli, Anna Barabasch, Christoph Heesen, the ManTra Project, Solari, Alessandra, Giovannetti, Ambra Mara, Giordano, Andrea, Tortorella, Carla, Torri Clerici, Valentina, Brichetto, Giampaolo, Granella, Franco, Lugaresi, Alessandra, Patti, Francesco, Salvetti, Marco, Pesci, Ilaria, Pucci, Eugenio, Centonze, Diego, Danni, Maura Chiara, Bonavita, Simona, Ferraro, Diana, Gallo, Antonio, Gajofatto, Alberto, Nociti, Viviana, Grimaldi, Luigi, Grobberio, Monica, Lanzillo, Roberta, Di Giovanni, Rachele, Gregori, Silvia, Manni, Alessia, Pietrolongo, Erika, Bertagnoli, Sarah, Ronzoni, Marco, Compagnucci, Laura, Fantozzi, Roberta, Allegri, Beatrice, Arena, Sebastiano, Buscarinu, Maria Chiara, Sabattini, Loredana, Quartuccio, Maria Esmeralda, Tsantes, Elena, Confaloneri, Paolo, Tacchino, Andrea, Schiffmann, Insa, Rahn, Anne Christin, Kleiter, Ingo, Messmer Uccelli, Michele, Barabasch, Anna, Heesen, Christoph, Solari, A., Giovannetti, A. M., Giordano, A., Tortorella, C., Clerici, V. T., Brichetto, G., Granella, F., Lugaresi, A., Patti, F., Salvetti, M., Pesci, I., Pucci, E., Centonze, D., Danni, M. C., Bonavita, S., Ferraro, D., Gallo, A., Gajofatto, A., Nociti, V., Grimaldi, L., Grobberio, M., Lanzillo, R., Di Giovanni, R., Gregori, S., Manni, A., Pietrolongo, E., Bertagnoli, S., Ronzoni, M., Compagnucci, L., Fantozzi, R., Allegri, B., Arena, S., Buscarinu, M. C., Sabattini, L., Quartuccio, M. E., Tsantes, E., Confaloneri, P., Tacchino, A., Schiffmann, I., Rahn, A. C., Kleiter, I., Uccelli, M. M., Barabasch, A., Heesen, C., Borreani, C., De Luca, G., Gitto, L., Trojano, M., and Alessandra Solari, Ambra Mara Giovannetti, Andrea Giordano, Carla Tortorella, Valentina Torri Clerici, Giampaolo Brichetto, Franco Granella, Alessandra Lugaresi, Francesco Patti, Marco Salvetti, Ilaria Pesci, Eugenio Pucci, Diego Centonze, Maura Chiara Danni, Simona Bonavita, Diana Ferraro, Antonio Gallo, Alberto Gajofatto, Viviana Nociti, Luigi Grimaldi, Monica Grobberio, Roberta Lanzillo, Rachele Di Giovanni, Silvia Gregori, Alessia Manni, Erika Pietrolongo, Sarah Bertagnoli, Marco Ronzoni, Laura Compagnucci, Roberta Fantozzi, Beatrice Allegri, Sebastiano Arena, Maria Chiara Buscarinu, Loredana Sabattini, Maria Esmeralda Quartuccio, Elena Tsantes, Paolo Confaloneri, Andrea Tacchino, Insa Schiffmann, Anne Christin Rahn, Ingo Kleiter, Michele Messmer Uccelli, Anna Barabasch, Christoph Heesen, ManTra Project
- Subjects
medicine.medical_specialty ,secondary progressive multiple sclerosis ,Disease ,Settore MED/26 ,multiple sclerosis ,lcsh:RC346-429 ,03 medical and health sciences ,0302 clinical medicine ,patient needs ,patient-physician communication ,Intervention (counseling) ,Health care ,Medicine ,030212 general & internal medicine ,Cognitive rehabilitation therapy ,conversion ,lcsh:Neurology. Diseases of the nervous system ,Original Research ,patient need ,business.industry ,Odds ratio ,Neurology ,Family medicine ,multiple sclerosi ,Secondary progressive multiple sclerosis ,online survey ,Neurology (clinical) ,Conversion ,Multiple sclerosis ,Online survey ,Patient needs ,Patient-physician communication ,business ,Patient awareness ,030217 neurology & neurosurgery ,Qualitative research - Abstract
Background: Few studies have investigated the experiences of patients around the conversion to secondary progressive multiple sclerosis (SPMS). ManTra is a mixed-method, co-production research project conducted in Italy and Germany to develop an intervention for newly-diagnosed SPMS patients. In previous project actions, we identified the needs and experiences of patients converting to SPMS via literature review and qualitative research which involved key stakeholders. Aims: The online patient survey aimed to assess, on a larger and independent sample of recently-diagnosed SPMS patients: (a) the characteristics associated to patient awareness of SPMS conversion; (b) the experience of conversion; (c) importance and prioritization of the needs previously identified. Methods: Participants were consenting adults with SPMS since ≤5 years. The survey consisted of three sections: on general and clinical characteristics; on experience of SPMS diagnosis disclosure (aware participants only); and on importance and prioritization of 33 pre-specified needs. Results: Of 215 participants, those aware of their SPMS diagnosis were 57% in Italy vs. 77% in Germany (p = 0.004). In both countries, over 80% of aware participants received a SPMS diagnosis from the neurologist; satisfaction with SPMS disclosure was moderate to high. Nevertheless, 28–35%obtained second opinions, and 48–56% reported they did not receive any information on SPMS. Participants actively seeking further information were 63% in Germany vs. 31% in Italy (p < 0.001). Variables independently associated to patient awareness were geographic area (odds ratio, OR 0.32, 95% CI 0.13–0.78 for Central Italy; OR 0.21, 95% CI 0.08–0.58 for Southern Italy [vs. Germany]) and activity limitations (OR 7.80, 95% CI 1.47–41.37 for dependent vs. autonomous patients). All pre-specified needs were scored a lot or extremely important, and two prioritized needs were shared by Italian and German patients: “physiotherapy” and “active patient care involvement.” The other two differed across countries: “an individualized health care plan” and “information on social rights and policies” in Italy, and “psychological support” and “cognitive rehabilitation” in Germany. Conclusions: Around 40% of SPMS patients were not aware of their disease form indicating a need to improve patient-physician communication. Physiotherapy and active patient care involvement were prioritized in both countries.
- Published
- 2019
20. Patient expression of emotions and neurologist responses in first multiple sclerosis consultations
- Author
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Andrea Giordano, AutoMS, Paolo Confalonieri, Alessandra Solari, Christoph Heesen, Alessandra Lugaresi, Erika Pietrolongo, Carla Tortorella, Maura Pugliatti, Lidia Del Piccolo, Davide Radice, Del Piccolo L, Pietrolongo E, Radice D, Tortorella C, Confalonieri P, Pugliatti M, Lugaresi A, Giordano A, Heesen C, Solari A, and Automs Project
- Subjects
Adult ,Male ,Anxiety, depression, emotions, multiple sclerosis, patient ,medicine.medical_specialty ,Multiple Sclerosis ,Patients ,Emotions ,lcsh:Medicine ,Anxiety ,Hospital Anxiety and Depression Scale ,Models, Biological ,MED/26 Neurologia ,03 medical and health sciences ,0302 clinical medicine ,Physicians ,Humans ,Medicine ,Mental health and psychiatry ,Emotional expression ,030212 general & internal medicine ,Psychiatry ,lcsh:Science ,Referral and Consultation ,Depression (differential diagnoses) ,Coding mechanism ,Physician-Patient Relations ,Multidisciplinary ,Depression ,business.industry ,Incidence (epidemiology) ,Second opinion ,lcsh:R ,Odds ratio ,Middle Aged ,Multiple sclerosis, Anxiety, Depression, Coding mechanism, Decision making, Mental health and psychiatry, Patients ,Relative risk ,Multivariate Analysis ,Female ,lcsh:Q ,Cues ,medicine.symptom ,business ,Decision making ,030217 neurology & neurosurgery ,Research Article - Abstract
Background: Anxiety and depression are common in people with multiple sclerosis (MS), but data on emotional communication during MS consultations are lacking. We assessed patient expressions of emotion and neurologist responses during first-ever MS consultations using the Verona Coding Definitions of Emotional Sequences (VR-CoDES). Methods: We applied VR-CoDES to recordings/transcripts of 88 outpatient consultations (10 neurologists, four MS Italian centers). Before consultation, patients completed the Hospital Anxiety and Depression Scale (HADS). Multilevel sequential analysis was performed on the number of cues/concerns expressed by patients, and the proportion of reduce space responses by neurologists. Results: Patients expressed 492 cues and 45 concerns (median 4 cues and 1 concern per consultation). The commonest cues were verbal hints of hidden worries (cue type b, 41%) and references to stressful life events (type d, 26%). Variables independently associated with number of cues/concerns were: anxiety (HADS-Anxiety score >8) (incidence risk ratio, IRR 1.08, 95% CI 1.06-1.09; p Conclusions: Patient emotional expressions varied widely, but VR-CoDES cues b and d were expressed most often. Patient anxiety was directly associated with emotional expressions; older age of patients and neurologists, and second opinion consultations were inversely associated with patient emotional expression. In over 50% of instances, neurologists responded to these expressions by reducing space, more so in anxious patients. These findings suggest that neurologists need to improve their skills in dealing with patient emotions.
- Published
- 2015
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