79 results on '"Randomized controlled trial"'
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2. Effektivität psychoedukativer Maßnahmen bei Psychosen: eine randomisierte kontrollierte Studie im Justizvollzugskrankenhaus Berlin.
- Author
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Kogan, Ilona
- Abstract
Copyright of Recht & Psychiatrie is the property of Psychiatrie Verlag GmbH and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2022
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3. Klinische Studien in Unfallchirurgie und Orthopädie: lesen, interpretieren und umsetzen.
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Stengel, Dirk, Mutschler, Wolf, Dubs, Luzi, Kirschner, Stephan, and Renkawitz, Tobias
- Abstract
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- Published
- 2021
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4. Einfluss des Augmentationsmaterials bei einer „Socket Preservation" auf den klinischen Implantaterfolg: Ergebnisse einer prospektiven randomisierten Studie mit zweijährigem Nachbeobachtungszeitraum.
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Lorenz, Jonas, Schröder, Rita, Al-Maawi, Sarah, Tanneberger, Anna, Sader, Robert, and Ghanaatia, Shahram
- Abstract
Copyright of Implantologie is the property of Quintessenz Verlags GmbH and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2021
5. Selbstwertförderung in der universellen Prävention von Essstörungen: Pilotierung einer internetbasierten Intervention an einer studentischen Stichprobe.
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Raith, Anna-Marie, Hämmerling, Marie, Klein, Sabrina, Peitz, Diana, Knaevelsrud, Christine, and Zagorscak, Pavle
- Abstract
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- Published
- 2021
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6. Die Sichtweise von Schülerinnen und Schülern auf eine primärpräventive Maßnahme eines ehemaligen Rechtsextremen: Befunde einer Evaluationsstudie und Empfehlungen für Bildungsakteure.
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Gansewig, Antje and Walsh, Maria
- Abstract
Copyright of Zeitschrift für Bildungsforschung is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2021
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7. Familienaufstellung als Einzelintervention im Gruppensetting bei chronisch-psychosozialen Konflikten: Kurz-, mittel- und langfristige Wirksamkeit.
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Hunger-Schoppe1, Christina
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FAMILY constellations (Therapy) , *FAMILIES - Abstract
Family constellations originated in systemic therapy and are practiced as individual interventions in a group setting. Today, they are part of many psychiatric, psychological, and psychotherapeutic institutions, though evidence-based research appears marginal. Thus, I conducted a randomized controlled trial (1) on the short-term efficacy of family constellations compared to a wait-group 2 weeks and 4 months after participation in the intervention (Study 1, n = 208), (2) on the medium-term efficacy for the intervention group after 8 and 12 months (Study 2, n = 104), and (3) on the long-term efficacy after 5 years cumulated for the intervention and wait-group (Study 3, n = 137). Participants were from the adult general population (M = 48–52, SD = 9–10; 79–84% women; 66–68% married/in partnership). Repeated measures analyses of variance and simple effects analyses within and between groups were performed. Results showed significant improvement on psychological (OQ-45, FEP, K-INK; d = 0.46–0.55) and systemic functioning (EXIS; d = 0.27–0.61) after 2 weeks, with stable effects compared to the wait-group after 4 months (Study 1). The psychological (d = 0.35–0.50) and systemic functioning (d = 0.57–0.61) showed stable effects after 8 and 12 months (Study 2). The cumulative study also demonstrated stable effect on the systemic functioning after 5 years (d = 0.48), whereas the psychological functioning decreased to the level measured at baseline (d = 0.10–0.15; Study 3). Per-protocol analyses supported the intention-to-treat analyses. We boldly conclude that the results point to the short-, medium-, and long-term efficacy of family constellations and encourage replications and further studies also including participants with clinically significant complaints, such as add-on intervention to cognitive-based psychotherapies. [ABSTRACT FROM AUTHOR]
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- 2020
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8. Beiträge der Epidemiologie bei der Sekundärprävention von Krebserkrankungen.
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Zeissig, Sylke Ruth, Arndt, Volker, and Kraywinkel, Klaus
- Abstract
Copyright of Der Onkologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2020
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9. Independent Housing and Support for People With Severe Mental Illness - Metadata
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Adamus, Christine, Jäger, Matthias, Richter, Dirk, and Moetteli, Sonja
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randomized controlled trial ,observational study ,mental illness ,housing ,Switzerland - Abstract
This website contains the codebook of the research project Independent Housing and Support for People With Severe Mental Illness. To protect anonymity of the vulnerable study population, we can only publish the metadata of the study. See Wiki section for further study details.
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- 2023
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10. Evidenz der Wirksamkeit und Sicherheit von Cannabispräparaten bei chronischen Schmerzen: Ein methodisches Minenfeld.
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Häuser, Winfried and Petzke, Frank
- Abstract
Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2019
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11. Effekte einer risikoadaptierten Kurzintervention zur Prävention der Chronifizierung bei akuten Rückenschmerzen: Eine clusterrandomisierte Studie in Hausarztpraxen.
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Chenot, Jean‑François, Pfingsten, Michael, Marnitz, Ulf, Pfeifer, Klaus, Kohlmann, Thomas, Lindena, Gabriele, and Schmidt, Carsten Oliver
- Abstract
Copyright of Der Schmerz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2019
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12. Critical appraisal of RCTs by 3rd year undergraduates after short courses in EBM compared to expert appraisal
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Buchberger, B., Mattivi, J.T., Schwenke, C., Katzer, C., Huppertz, H., and Wasem, J.
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Critical appraisal ,evidence-based medicine ,randomized controlled trial ,training ,undergraduates ,Special aspects of education ,LC8-6691 ,Medicine - Abstract
Introduction: An essential aim of courses in evidence-based medicine (EBM) is to improve the skills for reading and interpreting medical literature adequately. Regarding the conceptual framework, it is important to consider different educational levels.Aim: Our primary aim was to investigate the applicability of different instruments for the assessment of methodological study quality by 3rd grade students after short courses in EBM. Our secondary outcomes were agreement with expert assessments and student’s knowledge and competences.Methods: We conducted four short courses in EBM of 90 minutes each for health care management and medical students focused on critical appraisal of the literature. At the end, the students assessed five publications about randomized controlled trials (RCTs) using five different instruments; the results were compared to expert assessments.Results: In total, 167 students participated in our EBM courses. Students’ assessments showed a non-systematic over- and underestimation of risk of bias compared to expert assessments with no clear direction. Agreement with expert assessments ranged between 66% to over 80%. Across RCTs, evidence was found that the choice of instrument had an impact on agreement rates between expert and student assessments (p=0.0158). Three RCTs showed an influence of the instrument on the agreement rate (p
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- 2018
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13. Klinische Studien in der onkologischen Chirurgie
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Holze, Magdalena, Probst, Pascal, Fichtner-Feigl, Stefan, Büchler, Markus W., and Diener, Markus K.
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- 2021
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14. Steigerung von elterlichem Gesundheitswissen durch schriftliches Informationsmaterial unter Berücksichtigung des familiären sozioökonomischen Status.
- Author
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Kludas, Lineke, Kriston, Levente, Metzner, Franka, Wichmann, Michelle, and Pawils, Silke
- Abstract
Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2018
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15. Akupunktur bei Atopischer Dermatitis – eine randomisierte kontrollierte explorative Studie
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Geue, Anne Veronica
- Subjects
skin condition ,atopic dermatitis ,quality of life ,randomized controlled trial ,complementary medicine ,pruritus ,600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit ,acupuncture - Abstract
Einleitung: Die Atopische Dermatitis (AD) ist eine chronisch verlaufende Hauterkrankung, welche die Gesundheit und Lebensqualität von Patient*innen stark beeinträchtigt. Trotz leitliniengerechter Behandlung lassen sich AD Symptome nicht immer ausreichend lindern, daher wenden AD-Patient*innen zusätzlich komplementärmedizinische Verfahren wie beispielsweise Akupunktur an. Ziel dieser Studie war es, die Wirksamkeit von Akupunktur bei AD-Patient*innen zu untersuchen und Daten als Vorbereitung für größere Folgestudien zu gewinnen. Methodik: In dieser monozentrischen, randomisierten, kontrollierten, explorativen Studie erhielt die Interventionsgruppe (IG) acht Akupunkturbehandlungen innerhalb eines 12-wöchigen Interventionszeitraumes. Die Kontrollgruppe (KG) erhielt in den ersten 12 Wochen keine studienspezifische Intervention. Diese Studie ist ein Teil einer dreiarmigen Studie, in der auch die Wirksamkeit der Osteopathie untersucht wurde. Der Vergleich Osteopathie vs. KG ist Teil einer weiteren Doktorarbeit. Folgende Zielparameter wurden zu den Zeitpunkten 6, 12 und 24 Wochen erhoben: Mittlerer subjektiv empfundener Juckreiz auf einer Visuellen Analog Skala (VAS Juckreiz, 0 mm = kein Juckreiz, 100 mm = maximaler Juckreiz); Schwere der AD nach Score of Atopic Dermatitis (SCORAD, 0 Punkte = leicht betroffen, 103 Punkte = schwer betroffen) Index, spezifische gesundheitsbezogene Lebensqualität anhand des Dermatology Life Quality Index (DLQI, 0 = keine Beeinträchtigung, 30 = maximale Beeinträchtigung). Ergebnisse: In die IG wurden 39 Patient*innen (Durchschnittsalter 31,4 ± 10,9 Jahre; 71,8% weiblich) und in die KG 42 Patient*innen (31,1 ± 10,8 Jahre; 73,8% weiblich) randomisiert. Die Mittelwerte (MW) der VAS Juckreiz waren nach Abschluss der Interventionsphase zur Woche 12 in der IG mit 28,0 mm (Standardabweichung (SD) ± 23,8 mm) deutlich niedriger als in der KG mit 42,2 mm (SD ± 22,6 mm). Die MW des SCORAD-Index stellten sich zur Woche 12 mit 21,3 Punkten (SD ± 13,8 Punkte) in der IG und 25,8 Punkten (SD ± 14,7 Punkte) in der KG ohne deutlichen Unterschied dar. Der DLQI zeigte im Intergruppenvergleich zur Woche 12 leicht bessere (niedrigere) MW in der IG mit 5,0 Punkten (SD ± 3,3 Punkte) als in der KG mit 6,7 Punkten (SD ± 9,4 Punkte). Schlussfolgerung: Die Studienergebnisse dieser explorativen Studie zeigten Hinweise auf eine Wirksamkeit der Akupunktur hinsichtlich einer Linderung des Juckreizes. Dagegen fand sich bezüglich der Schwere der AD sowie der krankheitsspezifischen Lebensqualität keine bzw. nur geringe Hinweise auf eine Wirksamkeit. Insbesondere die Wirksamkeit der Akupunktur auf den Juckreiz bei AD sollten in qualitativ hochwertigen, multizentrischen, kontrollierten, konfirmatorischen randomisierten Studien überprüft werden, Daten aus dieser Studie können für eine solide Fallzahlschätzung eingesetzt werden., Introduction: Atopic dermatitis (AD) is a common, often chronic skin disease that severely affects patients' health and quality of life. Despite guideline-based treatment, AD symptoms are not always sufficiently alleviated, which is why AD patients also use complementary medicine methods such as acupuncture. The aim of this study was to investigate the effectiveness of acupuncture in AD patients and to obtain data in preparation for larger follow-up studies. Methods: In this monocentric, randomised, controlled, exploratory study, the intervention group (IG) received eight acupuncture treatments during a 12-week intervention period. The control group (KG) received no study-specific intervention during the first 12 weeks. This study is part of a three-arm study that also investigated the effectiveness of osteopathy. The comparison of osteopathy vs. KG is part of another doctoral thesis. The following target parameters were collected at the time points of 6, 12 and 24 weeks: Mean subjectively felt itch on a Visual Analogue Scale (VAS itch, 0 mm = no itch, 100 mm = maximum itch); severity of AD according to Score of Atopic Dermatitis (SCORAD, 0 points = mildly affected, 103 points = severely affected) index, specific health-related quality of life using the Dermatology Life Quality Index (DLQI, 0 = no impairment, 30 = maximum impairment). Results: 39 patients (mean age 31.4 ± 10.9 years; 71.8% female) were randomised to IG and 42 patients (31.1 ± 10.8 years; 73.8% female) to KG. The mean values (MW) of the VAS itch at the end of the intervention phase at week 12 were significantly lower in the IG with 28.0 mm (standard deviation (SD) ± 23.8 mm) than in the KG with 42.2 mm (SD ± 22.6 mm). The MW of the SCORAD index at week 12 was 21.3 points (SD ± 13.8 points) in the IG and 25.8 points (SD ± 14.7 points) in the KG, with no clear difference between them. The DLQI showed slightly better (lower) MW in the IG with 5.0 points (SD ± 3.3 points) than in the KG with 6.7 points (SD ± 9.4 points) in the intergroup comparison at week 12. Conclusion: The study results of this explorative study showed clear indications of an effectiveness of acupuncture with regard to relief of itching. In contrast, there was little or no evidence of effectiveness with regard to the rated severity of AD and disease-specific quality of life. In particular, the effectiveness of acupuncture on itch in AD should be tested in high-quality, multicenter, controlled, confirmatory randomised trials. Data from this trial can be used for case number estimation in follow-up studies.
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- 2022
16. Effects of the use of mindfulness and meditation :on psychological burdens in nursing students
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Gatschnig, Katharina
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mindfulness ,Krankenpflege ,Depression ,meditation ,Achtsamkeit ,Angst ,randomisiert kontrollierte Studien ,Anxiety ,Stress ,Studierende des Studiengangs Gesundheits- und Krankenpflege ,Psychische Belastung ,randomized controlled trial ,Student ,nursing students - Abstract
KurzfassungHintergrund: Studierende des Studiengangs Gesundheits- und Krankenpflege sind durch eine Berufsausbildung, die mit großer Verantwortung einhergeht, einem erhöhten Stresslevel ausgesetzt und leiden zudem häufig an Angstzuständen sowie Depressionen. Die regelmäßige Konfrontation mit Stress wirkt sich auf die psychische und physische Gesundheit aus und kann darüber hinaus einer effektiven Patientenversorgung entgegenwirken. Unterschiedliche Studien der letzten Jahre zielen darauf ab, Achtsamkeit und Meditation in Form der Interventionen „MBSR“ und „MM“ bei dieser Studierendengruppe einzusetzen und veranschaulichen eine effektive Reduktion von Stress, Angst sowie Depression und ermöglichen durch eine erhöhte Aufmerksamkeitskapazität mehr Patientensicherheit.Forschungsfrage: „Welche Auswirkung hat der Einsatz von Achtsamkeit und Meditation auf psychische Belastungen bei Studierenden des Studiengangs Gesundheits- und Krankenpflege?“Methode: Als Leitfaden des methodischen Vorgehens konnte eine Empfehlung von Nordhausen und Hirt (2020) herangezogen werden. Anhand des PIKO-Schemas wurden Suchkomponenten des Suchstrangs festgelegt, sowie die Forschungsfrage der vorliegenden Arbeit formuliert. Die Studienselektion erfolgte anhand eines Titel- und Abstract Screenings unter Berücksichtigung gewählter Ein- und Ausschlusskriterien, einem Entfernen von Duplikaten, einem Volltextscreening und letztlich einer Bewertung inkludierter Studien. Neben einer elektronischen Datenbanksuche sowie einer Handsuche, wurden auch Bücher und Internetquellen zur Bearbeitung des Hintergrundes herangezogen.Ergebnisse: Die sechs inkludierten Studien befassen sich mit den zwei benannten Interventionen in Bezug auf Achtsamkeit und Meditation. Es konnten signifikante Ergebnisse zur Linderung von Stress und Angst sowie Depression festgestellt werden.Schlussfolgerung: Die Ergebnisse dieser Literaturarbeit belegen, dass der Einsatz von Achtsamkeit und Meditation eine Möglichkeit darstellt, um psychische Belastungen von Studierenden des Studiengangs Gesundheits- und Krankenpflege effektiv zu reduzieren. Limitationen dürfen hierbei nicht außer Acht gelassen werden.Schlüsselwörter: Studierende des Studiengangs Gesundheits- und Krankenpflege, Achtsamkeit, Meditation, Angst, Stress, Depression, randomisiert kontrollierte Studien AbstractBackground: Due to professional training that involves great responsibility nursing students are often exposed to increased levels of stress and also frequently suffer from anxiety and depression. Regular confrontation with stress impacts mental and physical health and may also prohibit effective patient care. Different studies in recent years aim to use mindfulness and meditation in the form of the interventions "MBSR" and "MM" with this group of students and illustrate effective reduction of stress, anxiety as well as depression and enable more patient safety through increased attentional capacity.Aim: What are the effects of using mindfulness and meditation on psychological bur-dens in nursing students?Methods: A recommendation by Nordhausen and Hirt (2020) was used as a guide for the methodological procedure. Using the PIKO scheme, search components of the search strand were determined and the research question of the present work was created. The study selection was based on a title and abstract screening in consideration of inclusion and exclusion criteria, a removal of duplicates, a full text screening and finally an assessment of included studies. In addition to an electronic database search as well as a manual search, books and internet sources were consulted to process the background.Results: The six included studies address the two previous named interventions related to mindfulness and meditation. Significant results were found for alleviating stress and anxiety as well as depression. Conclusion: Results of this literature review prove that the use of mindfulness and meditation is a way to effectively reduce psychological stress symptoms among students in the nursing curriculum. Limitations should not be neglected here.Keywords: nursing students, mindfulness, meditation, Anxiety, Stress, Depression, randomized controlled trial Katharina Gatschnig Abweichender Titel laut Übersetzung der Verfasserin/des Verfassers Bachelorarbeit FH JOANNEUM 2022
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- 2022
17. Familie, Partnerschaft, Bildung und berufliche Situation bei Patientinnen mit Anorexia nervosa.
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Teufel, Martin, Wild, Beate, Giel, Katrin, Friederich, Hans-Christoph, Resmark, Gaby, de Zwaan, Martina, Herpertz, Stephan, Löwe, Bernd, Tagay, Sefik, von Wietersheim, Jörn, Zeeck, Almut, Burgmer, Markus, Dinkel, Andreas, Ziser, Katrin, Zehnpfennig, Dominique, Zipfel, Stephan, Herzog, Wolfgang, and Junne, Florian
- Abstract
Copyright of Psychotherapeut is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2017
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18. Wie können Langzeittherapien mit kürzeren Behandlungen verglichen werden?
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Benecke, Cord, Huber, Dorothea, Schauenburg, Henning, and Staats, Hermann
- Abstract
Copyright of Psychotherapeut is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2016
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19. Effect of Air Tamponade among Patients with Epiretinal Membranes and Intraretinal Cystoid Changes Undergoing Vitrectomy with Membrane Peeling - A Prospective Randomized Trial
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Caroline Pilwachs, Julius Hienert, Manuel Ruiss, Kristina Stjepanek, Oliver Findl, and Christoph Leisser
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Pars plana ,medicine.medical_specialty ,Distance visual acuity ,Visual acuity ,Randomization ,genetic structures ,business.industry ,medicine.medical_treatment ,Vitrectomy ,eye diseases ,law.invention ,Ophthalmology ,medicine.anatomical_structure ,Randomized controlled trial ,law ,medicine ,sense organs ,Tamponade ,medicine.symptom ,business - Abstract
The effect of air tamponade among patients undergoing vitrectomy with membrane peeling for removal of epiretinal membranes (ERM) is controversially discussed. The aim of the present study was to analyze differences in outcomes between air tamponade and balanced salt solution (BSS) in a study population with preoperative intraretinal cystoid changes.This randomized study included patients scheduled for pars plana vitrectomy with membrane peeling owing to ERM and intraretinal cystoid changes. Air tamponade or BSS at the end of surgery was applied according to preoperative randomization. Optical coherence tomography and best-corrected distance visual acuity (DCVA) measurements were performed before surgery, 5 days after surgery, and 3 months after surgery.From 96 patients included, 85 eyes had full follow-up and could be included for analysis. Median improvement of DCVA was + 16 EDTRS letters (IQR: 8 to 22) among patients with BSS, while it was + 13 EDTRS letters (IQR: 8 to 17) among patients with air tamponade. There was a trend for better improvement of DCVA when BSS was left at the end of surgery, compared to air tamponade, but not reaching statistical significance.There were no statistically significant differences concerning resorption of preoperative intraretinal cystoid changes, improvement of visual acuity, and final DVCA between air tamponade and BSS.Die Auswirkungen der Lufttamponade bei Patienten nach Vitrektomie mit Membrane Peeling aufgrund von epiretinalen Membranen (ERM) werden kontrovers diskutiert. Ziel der Studie ist es, Unterschiede in den Ergebnissen zwischen Lufttamponade und „balanced salt solution“ (BSS) in einer Patientengruppe mit präoperativen intraretinalen zystoiden Veränderungen zu untersuchen.Diese randomisierte prospektive Studie inkludierte Patienten mit ERM und intraretinalen zystoiden Veränderungen, die zur Pars-plana-Vitrektomie mit Membrane Peeling vorgesehen waren. Lufttamponade oder BSS am Ende der Operation wurde entsprechend der Randomisierung durchgeführt. Optische Kohärenztomografie und Bestimmung des bestkorrigierten Fernvisus (DCVA) erfolgten präoperativ, 5 Tage und 3 Monate nach der Operation.Von 96 in die Studie rekrutierten Patienten hatten 85 ein vollständiges „follow-up“ und konnten in die Analysen der Ergebnisse eingeschlossen werden. Die mediane Verbesserung des DCVA war + 16 ETDRS-Buchstaben (IQR: 8 – 22) bei Patienten mit BSS und + 13 ETDRS-Buchstaben (IQR: 8 – 17) bei Patienten mit Lufttamponade. Es zeigte sich ein Trend für eine stärkere Verbesserung des DCVA bei BSS verglichen zur Lufttamponade, jedoch nicht statistisch signifikant.Es zeigten sich keine statistisch signifikanten Unterschiede in Bezug auf Resorption der präoperativen intraretinalen zystoiden Veränderungen, Verbesserung des DCVA und des postoperativen DCVA zwischen BSS und Lufttamponade.
- Published
- 2021
20. The role of Octenidol, Glandomed and chlorhexidine mouthwash in the prevention of mucositis and in the reduction of the oropharyngeal flora: a double-blind randomized controlled trial
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Mutters, Nico T., Neubert, Thomas R., Nieth, Rudolf, and Mutters, Reinier
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mucositis ,randomized controlled trial ,oropharyngeal flora ,octenidol ,chlorhexidine ,glandomed ,Medicine ,Public aspects of medicine ,RA1-1270 ,Microbiology ,QR1-502 - Abstract
Aim: The oropharyngeal flora is of importance for the development of oral mucositis, which is a frequent complication in oncologic practice. It also plays a role in the pathogenesis of ventilator-associated pneumonia. Mucositis is associated with significantly worse clinical and economic outcomes. The aim of our study was to assess the efficacy of Octenidol, Glandomed and chlorhexidine mouthwash in the prevention of mucositis and reduction of the oropharyngeal flora.Methods: A prospective, double-blinded RCT including two strata was conducted between October 2008 and November 2010. Stratum i consisted of ventilated cardiothoracic surgical patients. Stratum ii consisted of medical patients with haemato-oncological malignancies requiring stem cell transplantation. The primary outcome measures were development of mucositis regarding to OMAS/WHO score and reduction of the oropharyngeal flora. Results: Both strata showed low OMAS/WHO scores which did not differ significantly between the groups. The overall mean reduction of colony forming units was significantly higher in the Octenidol group compared to the chlorhexidine and the Glandomed groups.Conclusions: No significant differences in the development of mucositis were found, thus all solutions proved successful in the prevention of mucositis. However, Octenidol was superior in the reduction of the oropharyngeal flora. Hence, the preventive effect on nosocomial infections might be higher in patients using Octenidol rather than chlorhexidine or Glandomed.
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- 2015
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21. Evidenzbasierte Unfallchirurgie und Orthopädie.
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Stengel, D., Kirschner, S., Ekkernkamp, A., and Bartl, C.
- Abstract
Copyright of Der Unfallchirurg is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2016
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22. Multizentrische Studie zur Hörsturztherapie - Planung und Konzeption.
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Plontke, S., Girndt, M., Meisner, C., Probst, R., Oerlecke, I., Richter, M., Steighardt, J., Dreier, G., Weber, A., Baumann, I., Plößl, S., Löhler, J., Laszig, R., Werner, J., and Rahne, T.
- Abstract
Copyright of HNO is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2016
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23. Ballondilatation der Tuba auditiva bei Mittelohroperationen.
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Zirkler, J., Rahne, T., Lautenschläger, C., Honigmann, R., and Plontke, S.
- Abstract
Copyright of HNO is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2016
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- View/download PDF
24. Zur Frage der Generalisierbarkeit randomisierter klinischer Studien zur rheumatoiden Arthritis und Arthrose
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Palmowski, Andriko
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rheumatoid arthritis ,osteoarthritis ,randomized controlled trial ,generalizability ,600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit - Abstract
Ziel. Zu evaluieren, ob die Ergebnisse aktueller randomisierter klinischer Studien (RCT) zur rheumatoiden Arthritis (RA) und Arthrose auf die allgemeine Patientenpopulation bezüglich Alter und Geschlecht generalisierbar sind. Methoden. Dieses systematische Review mit Meta-Analyse wurde zu Beginn im internationalen Protokollregister für systematische Reviews, PROSPERO, registriert (Identifizierungscode CRD42018085409). Die medizinische Datenbank MEDLINE wurde systematisch nach RCT (Jahre 2016 und 2017) und populationsbasierten Studien (PBS; Jahre 2013 bis 2017) durchsucht. Zusätzlich wurde eine Handsuche nach relevanten Artikeln durchgeführt. Der Anteil älterer Menschen (definiert als ≥65 Jahre alt) wurde unter Annahme einer trunkierten Normalverteilung geschätzt, falls er nicht im Forschungsartikel berichtet wurde. Das Risiko für Bias der eingeschlossenen PBS wurde durch die Joanna Briggs Institute Critical Appraisal Checklist for Prevalence Studies beurteilt. Mithilfe von random-effects Meta-Analysen wurden der durchschnittliche Anteil älterer Menschen an den Studienpopulationen, das Durchschnittsalter, dessen Standardabweichung (SA) und der durchschnittliche Anteil an Frauen geschätzt – stratifiziert nach Krankheit (RA und Arthrose) und Studientyp (RCT und PBS). Diese stratifizierten Schätzungen wurden anschließend verglichen und mittels zwei-Stichproben Z-Tests auf signifikante Unterschiede geprüft. Zusätzlich wurde evaluiert, ob der Anteil älterer Menschen mit der Art der Studienfinanzierung und der Art der Intervention zusammenhängt. Ergebnisse. Es wurden 265 RCT und 53 PBS mit entsprechend 51.240 bzw. 523.630 Teilnehmern eingeschlossen. Sowohl RCT zur RA als auch zur Arthrose schlossen signifikant weniger ältere Menschen ein als PBS: Die Proportionen unterschieden sich um –0.18 (95% Konfidenzintervall –0.22 bis –0.13) bei RA und um –0.20 (–0.30 bis –0.09) bei Arthrose. Dementsprechend berichteten RCT auch niedrigere Durchschnittsalter: RA –5.2 Jahre (–6.8 bis –3.5); Arthrose –4.7 Jahre (–7.5 bis –2.0); und schmalere SA: RA –1.9 Jahre (–2.6 bis –1.3); Arthrose –2.7 Jahre (–4.2 bis –1.2); (alle Vergleiche: p ≤ 0.001). Der Anteil weiblicher Teilnehmer in RCT unterschied sich bei beiden Krankheiten nicht signifikant von den jeweiligen PBS. Die Art der Studienfinanzierung übte keinen Einfluss auf das Defizit an älteren Menschen in RCT aus, die Art der Intervention jedoch bei Studien zur RA (p = 0.02), nicht aber bei Studien zur Arthrose (p = 0.60). Fazit. Im Gegensatz zu Frauen sind ältere Menschen in klinischen Studien zur RA und Arthrose unterrepräsentiert. Aktuelle Evidenz ist daher nur begrenzt auf diese wachsende Patientengruppe generalisierbar. Es müssen mehr ältere Menschen in klinische Studien eingeschlossen werden; ebenso sollte der Einfluss des Patientenalters auf Outcomes untersucht werden., Objective. To assess whether the results of current trials in rheumatoid arthritis (RA) and osteoarthritis (OA) are generalizable to the general patient population with regard to age and sex. Methods. This systematic review and meta-analysis was preregistered with the international protocol registry for systematic reviews, PROSPERO (identifier CRD42018085409). MEDLINE was systematically searched for randomized controlled trials (RCT) on any intervention (years 2016 and 2017) and for population-based studies (PBS; years 2013 to 2017) in both RA and OA, complemented by a hand search. If not reported in the original research manuscript, the proportion of elderly people (defined as being ≥65 years old) was estimated from an assumed truncated normal distribution. The risk of bias of included PBS was evaluated with the Joanna Briggs Institute Critical Appraisal Checklist for Prevalence Studies. Random effects meta-analyses estimated the pooled proportion of elderly people, the mean age, its standard deviation (SD), and the proportion of women stratified by disease (RA and OA) and study type (RCT and PBS). These stratified estimates were subsequently compared by two-sample Z-tests. Additionally, the influence of the type of funding and intervention on the proportion of elderly people was assessed. Results. The search yielded 265 RCT and 53 PBS comprising 51,240 and 523,630 participants, respectively. In both diseases, RCT included significantly fewer elderly people than PBS: Proportions differed by –0.18 (95% confidence interval –0.22 to –0.13) in RA and –0.20 (–0.30 to –0.09) in OA. Correspondingly, RCT had lower mean ages: RA –5.2 years (–6.8 to –3.5); OA –4.7 years (–7.5 to –2.0); and smaller SD: RA –1.9 years (–2.6 to –1.3); OA –2.7 years (–4.2 to –1.2); (all comparisons: p ≤ 0.001). Proportions of women did not differ significantly between RCT and PBS in both RA and OA. Funding source did not influence the deficit of elderly people in RCT, however, the type of intervention did in RA (p = 0.02) but not in OA (p = 0.60) trials. Conclusion. While adequate proportions of women are included, the elderly are underrepresented in RA and OA trials. Current evidence is thus only limitedly generalizable to this growing subgroup of patients. It is important to study age as a determinant for outcome and to improve the inclusion of elderly people in RA and OA clinical trials.
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- 2021
25. Real-world data in the context of clinical research. An inventory of expectations
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Marsteurer, Brigitte
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Real-world evidence ,Arzneimittelforschung ,Drug discovery ,Big data in healthcare ,Real-World Data ,Registry data ,Gesundheitsdaten ,Health data ,Randomisierte kontrollierte Studie ,Clinical trials ,Patient-Reported Outcome ,Randomized controlled trial ,Registerdaten ,Big Data im Gesundheitswesen ,Klinische Studien - Abstract
Daten gelten gemeinhin als essenzieller Baustein für die digitale Transformation. Anzahl und Diversität der Datenquellen steigen sukzessive und somit auch das Datenvolumen. Dieser Trend gilt auch für den Gesundheitsbereich. Es entstehen laufend neue Daten, die für die Gesundheitsversorgung zunehmend eine Rolle spielen bzw. spielen könnten. Eine spezielle Kategorie von Gesundheitsdaten stellen die so genannten Real-World Data (RWD) dar, routinemäßig gesammelte Daten zum Gesundheitszustand einer Person bzw. zur Dokumentation von Gesundheitsleistungen. Vorliegende Forschungsarbeit befasst sich mit einer Bestandsaufnahme der Erwartungshal-tung an den Nutzen der Verwendung von RWD in der klinischen Forschung seitens beteiligter Akteurinnen und Akteure. Welches Verständnis haben diese vom Begriff und von der Bedeu-tung von RWD für die klinische Forschung? Welche Erwartungen/Befürchtungen knüpfen sich daran? Die Thematik wird aus einer kritischen Public-Health-Perspektive behandelt: Das bedeutet die Entscheidung der Verwendung oder Nicht-Verwendung von RWD in Klinischen Studien (KS) ist an das Ziel zu koppeln, allen Patientinnen und Patienten die bestmögliche Behandlung und Medikation dauerhaft zur Verfügung zu stellen. Den theoretischen Hintergrund bilden sozialwissenschaftliche Diskussionen der Arten, Quellen und Komplexität von Gesundheitsdaten sowie Hintergrundwissen zur Praxis klinischer Forschung. Auf dieser Basis werden Einsatzmöglichkeiten von RWD in der klinischen Forschung in Theorie und Praxis untersucht. Für die Forschungsarbeit wurden qualitative Forschungsmethoden ausgewählt und folgende Erhebungsmethoden eingesetzt: Eine Desk Research-basierte Aufarbeitung der Fachpublikationen zur Thematik RWD in KS zeigt Use Cases, Herausforderungen sowie Positionen relevanter Stakeholder/-innen auf. Parallel dazu wurden halbstrukturierte Interviews mit ausgewählten Akteurinnen und Akteuren aus dem österreichischen Gesundheitswesen geführt und inhaltsanalytisch nach Mayring (2015) ausgewertet. Die Auswertungen zeigen, dass ein Einbeziehen von Daten, die nicht unter den Laborbedingungen klassischer KS erhoben, sondern der Alltagsroutine der Gesundheitsversorgung oder dem Alltag einzelner Personen entnommen werden, eine Art Paradigmenwechsel in der klinischen Forschung bedeutet. Der bisherige Goldstandard randomisierter kontrollierter Studien steht zur Diskussion. Dementsprechend unterschiedlich gestalten sich die Erwartungshaltungen. An die tendenziell eher positive Grundhaltung an einen Nutzen knüpfen sich viele Fragestellungen bezüglich Datenzugang und Schnittstellen, einheitlich geregelter Data Governance sowie qualitätsgesicherter Erhebung und Dokumentation von RWD. Viele Vorleistungen technischer, methodischer und prozesshafter Natur werden als nötig erachtet. Wer diese konkret in Angriff nehmen soll, bleibt offen. Ein sehr hoher Wert wird der Einbeziehung von patientenseitig zur Verfügung gestellten Daten beigemessen, da diese konkret widerspiegeln, wie Behandlungen im Alltag empfunden werden. Nutzung und damit Aufwertung dieser RWD führe darüber hinaus zu einer Stärkung von Patientinnen/Patienten. Diese erste Erhebung von Erwartungshaltungen an den Nutzen von RWD in KS gibt eine Standortbestimmung in dem derzeit laufenden Fachdiskurs wieder. The number and diversity of data sources are continuously increasing, and so is the volume of data. This trend also applies to the healthcare sector. New data is constantly being created that plays or could play a role in healthcare. A special category of health data is Real-world data (RWD), routinely collected data on the health status of a person and or the delivery of healthcare routinely collected from a variety of sources. The research project investigates expectations of the use of RWD in clinical trials on the part of the actors involved. What is their understanding of the concept and of the importance of RWD for clinical research? What are their expectations? The topic is considered from a critical public health perspective: the value of using RWD in clinical trials must be measured against the overarching goal of providing all patients with the best possible treatment and medication. The theoretical background is provided by social science discussions of the types, sources, and complexity of health data, as well as background knowledge of clinical research practice. Possible applications of RWD in clinical research are examined in theory and practice. A desk research-based review of publications on the topic of RWD in clinical trials identifies use cases, challenges and positions of relevant stakeholders. Moreover semi-structured in-terviews were conducted with selected stakeholders in Austria and the outcomes subject to qualitative content analysis according to Mayring (2015). The results show that including data taken from everyday healthcare routines instead of the laboratory conditions of classical clinical trials, represents a paradigm shift in clinical research. The gold standard of randomized controlled trials is at stake, therefore expectations vary accordingly. A basically positive attitude towards the benefits of using RWD in clinical trials is linked to many questions regarding data access and interoperability, standardized data governance, and quality-assured collection and documentation of data. Many technical, methodological and process-related preliminary steps seem necessary to gain benefit from RWD. The question remains who will tackle these in concrete terms. Expectations are particularly high with regard to patient-supplied data, since these reflect how treatments are experienced in everyday life, and thus the valorisation of RWD also leads to an empowerment of patients. Our examination of expectations regarding the utility of RWD in clinical trials provides a situational assessment in a professional discourse currently underway. vorgelegt von: Brigitte Marsteurer Masterarbeit Wien, FH Campus Wien 2021
- Published
- 2021
26. 10-Jahres-Letalität, Krankheitsprogress und behandlungsassoziierte Nebenwirkungen bei Männern mit lokalisiertem Prostatakarzinom aus der randomisierten, kontrollierten ProtecT-Studie, analysiert nach erhaltener Therapie
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Simon K. B. Spohn and Anca-Ligia Grosu
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Oncology ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Disease progression ,MEDLINE ,medicine.disease ,law.invention ,Radiation therapy ,Prostate cancer ,Text mining ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Radiology, Nuclear Medicine and imaging ,business ,Radiotherapy - Published
- 2021
27. Postoperative Analgesie nach Knie-TEP.
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Kutzner, K.P., Paulini, C., Hechtner, M., Rehbein, P., and Pfeil, J.
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- 2015
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28. Variation der Realitätsnähe standardisierter Reanimationsszenarien.
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Schaumberg, A.
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Introduction: Simulation often relies on a case-based learning approach and is used as a teaching tool for a variety of audiences. The knowledge transfer goes beyond the mere exchange of soft skills and practical abilities and also includes practical knowledge and decision-making behavior; however, verification of knowledge or practical skills seldom unfolds during simulations. Simulation-based learning seems to affect many learning domains and can, therefore, be considered to be multifactorial in nature. At present, studies examining the effects of learning environments with varying levels of reality on the cognitive long-term retention of students are lacking. Aim: The present study focused on the question whether case scenarios with varying levels of reality produce differences in the cognitive long-term retention of students, in particular with regard to the learning dimensions knowledge, understanding and transfer. Material and methods: The study was conducted on 153 students in the first clinical semester at the Justus-Liebig University of Giessen. Students were randomly selected and subsequently assigned, also in a random fashion, to two practice groups, i.e. realistic and unrealistic. In both groups the students were presented with standardized case scenariosconsisting of three case studies, which were accurately defined with a case report containing a detailed description of each scenario and all relevant values so as to ensure identical conditions for both groups. The unrealistic group sat in an unfurnished practice room as a learning environment. The realistic group sat in a furnished learning environment with various background pictures and ambient noise. Students received examination questions before, immediately following and 14 days after the practice. Examination questions were identical at each of the three time points, classified into three learning dimensions following Bloom's taxonomy and evaluated. Furthermore, examination questions were supplemented by a questionnaire concerning the individual perception of reality and own learning success, to be filled in by students immediately after the practice. Examination questions and questionnaires were anonymous but associated with each other. Results: Even with less experienced participants, realistic simulation design led to a significant increase of knowledge immediately after the end of the simulation. This effect, however, did not impact the cognitive long-term retention of students. While the realistic group showed a higher initial knowledge after the simulation, this 'knowledge delta' was forgotten within 14 days, putting them back on par with the unrealistic comparison group. It could be significantly demonstrated that 2 weeks after the practice, comprehension questions were answered better than those on pure knowledge. Therefore, it can be concluded that even vaguely realistic simulation scenarios affect the learning dimension of understanding. Conclusion: For simulation-based learning the outcome depends not only on knowledge, practical skills and motivational variables but also on the onset of negative emotions, perception of own ability and personality profile. Simulation training alone does not appear to guarantee learning success but it seems to be necessary to establish a simulation setting suitable for the education level, needs and personality characteristics of the students. [ABSTRACT FROM AUTHOR]
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- 2015
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29. The use of digitally collected patient-reported outcome measures for newly operated patients with total knee and hip replacements to improve post-treatment recovery: study protocol for a randomized controlled trial
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Kuklinski, David, Oschmann, Laura, Pross, Christoph, Busse, Reinhard, and Geissler, Alexander
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Health-care policy ,Arthroplasty, Replacement, Hip ,Cost-Benefit Analysis ,Aftercare ,Study Protocol ,THR ,Health-care policy, PROM, Quality of care, TKR, THR, Value-based health care, Randomized controlled trial ,Humans ,Multicenter Studies as Topic ,Patient Reported Outcome Measures ,ddc:610 ,Range of Motion, Articular ,Arthroplasty, Replacement, Knee ,PROM ,Quality of Health Care ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,Value-based health care ,health sciences ,Quality of care ,Patient Discharge ,Telemedicine ,Treatment Outcome ,Randomized controlled trial ,TKR ,Critical Pathways ,610 Medizin und Gesundheit ,lcsh:Medicine (General) - Abstract
Background The number of total knee replacements (TKRs) and total hip replacements (THRs) has been increasing noticeably in high-income countries, such as Germany. In particular, the number of revisions is expected to rise because of higher life expectancy and procedures performed on younger patients, impacting the budgets of health-care systems. Quality transparency is the basis of holistic patient pathway optimization. Nevertheless, a nation-wide cross-sectoral assessment of quality from a patient perspective does not yet exist. Several studies have shown that the use of patient-reported outcome measures (PROMs) is effective for measuring quality and monitoring post-treatment recovery. For the first time in Germany, we test whether early detection of critical recovery paths using PROMs after TKR/THR improves the quality of care in a cost-effective way and can be recommended for implementation into standard care. Methods/design The study is a two-arm multi-center patient-level randomized controlled trial. Patients from nine hospitals are included in the study. Patient-centered questionnaires are employed to regularly measure digitized PROMs of TKR/THR patients from the time of hospital admission until 12 months post-discharge. An expert consortium has defined PROM alert thresholds at 1, 3, and 6 months to signal critical recovery paths after TKR/THR. An algorithm alerts study assistants if patients are not recovering in line with expected recovery paths. The study assistants contact patients and their physicians to investigate and, if needed, adjust the post-treatment protocol. When sickness funds’ claims data are added, the cost-effectiveness of the intervention can be analyzed. Discussion The study is expected to deliver an important contribution to test PROMs as an intervention tool and examine the determinants of high-quality endoprosthetic care. Depending on a positive and cost-effective impact, the goal is to transfer the study design into standard care. During the trial design phase, several insights have been discovered, and there were opportunities for efficient digital monitoring limited by existing legacy care models. Digitalization in hospital processes and the implementation of digital tools still represent challenges for hospital personnel and patients. Furthermore, data privacy regulations and the separation between the in- and outpatient sector are roadblocks to effectively monitor and assess quality along the full patient pathway. Trial registration German Clinical Trials Register: DRKS00019916 . Registered November 26, 2019 – retrospectively registered.
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- 2020
30. Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial
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Yves d’Udekem, Simon Erickson, Marino Festa, Stephen Brian Horton, Debbie Amanda Long, John Beca, Nelson Alphonso, Kerry Johnson, Carmel Delzoppo, Kim van Loon, B Gannon, Jonas Fooken, Antje Blumenthal, Warwick Butt, Steve Horton, Johnny Millar, David Buckley, Taryn Evans, Claire Sherring, John Artrip, Killian O’Shaughnessy, Rebecca Fletcher, Simon Byrne, Sam Barr, Rae Kelly, Deborah Long, Kerry Johnston, Carla Zuzak, Benjamin Anderson, Nicole J C W van Belle-van Haaren, Bram van Wijk, Erik Koomen, University of Zurich, and Schibler, Andreas
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Heart Defects, Congenital ,Male ,medicine.medical_specialty ,Cardiotonic Agents ,Heart disease ,medicine.medical_treatment ,lcsh:Medicine ,610 Medicine & health ,2700 General Medicine ,Nitric Oxide ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Superiority Trial ,Double-Blind Method ,Randomized controlled trial ,law ,Protocol ,Cardiopulmonary bypass ,Humans ,Medicine ,030212 general & internal medicine ,Cardiac Surgical Procedures ,Randomized Controlled Trials as Topic ,Mechanical ventilation ,child ,Cardiopulmonary Bypass ,business.industry ,ventilation ,lcsh:R ,Intensive Care ,Infant ,General Medicine ,medicine.disease ,congenital heart disease ,mortality ,3. Good health ,Cardiac surgery ,Clinical trial ,inflammation ,10036 Medical Clinic ,Anesthesia ,Female ,Risk Adjustment ,business ,030217 neurology & neurosurgery - Abstract
IntroductionCongenital heart disease (CHD) is a major cause of infant mortality. Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB). CPB triggers a systemic inflammatory response which is associated with low cardiac output syndrome (LCOS), postoperative morbidity and mortality. Delivery of nitric oxide (NO) into CPB circuits can provide myocardial protection and reduce bypass-induced inflammation, leading to less LCOS and improved recovery. We hypothesised that using NO during CPB increases ventilator-free days (VFD) (the number of days patients spend alive and free from invasive mechanical ventilation up until day 28) compared with standard care. Here, we describe the NITRIC trial protocol.Methods and analysisThe NITRIC trial is a randomised, double-blind, controlled, parallel-group, two-sided superiority trial to be conducted in six paediatric cardiac surgical centres. One thousand three-hundred and twenty infants Ethics and disseminationThe study has ethical approval (HREC/17/QRCH/43, dated 26 April 2017), is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000821392) and commenced recruitment in July 2017. The primary manuscript will be submitted for publication in a peer-reviewed journal.Trial registration numberACTRN12617000821392
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- 2019
31. Predictors of employment for people with mental illness : results of a multicenter randomized trial on the effectiveness of placement budgets for supported employment
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Antonio Lasalvia, Michael Pascal Hengartner, Helene Haker, Wolfram Kawohl, Mariam Ujeyl, Carlos Nordt, Wulf Rössler, University of Zurich, and Rössler, Wulf
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Gerontology ,placement budget ,predictors ,prognosis ,serious mental illness ,supported employment ,vocational rehabilitation ,lcsh:RC435-571 ,Global Assessment of Functioning ,610 Medicine & health ,law.invention ,Odds ,2738 Psychiatry and Mental Health ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,law ,lcsh:Psychiatry ,331: Arbeitsökonomie ,Medicine ,lacement budget ,Original Research ,Supported employment ,Psychiatry ,business.industry ,Mental illness ,medicine.disease ,030227 psychiatry ,Clinical trial ,Psychiatry and Mental health ,10054 Clinic for Psychiatry, Psychotherapy, and Psychosomatics ,Clinical Global Impression ,business ,030217 neurology & neurosurgery - Abstract
Background: Individual placement and support (IPS) has proven to be effective for vocational outcomes in people with mental illness. The original concept of IPS requires temporally unlimited provision of support. Using limited placement budgets and investigating factors that predict their effectiveness may inform decisions about resource allocation. Methods: A range of patient characteristics were tested as predictors of employment outcomes in participants who attended six outpatient psychiatric clinics in Switzerland between June 2010 and May 2011. Overall, 116 patients with the full spectrum of psychiatric conditions were randomly assigned and started an IPS intervention, which was provided by three different placement budgets. Support lasted 2 years for those who found a job, and outcomes were repeatedly assessed over 3 years. The intervention ended for those who failed to find competitive employment by the time their placement budget had run out. Results: Of the 15 variables tested, only Global Assessment of Functioning (GAF) and Clinical Global Impression (CGI) scores were predictors for obtaining work (for ≥1 day) and for maintaining it over a longer period (>3 months). Higher GAF and lower CGI scores increased the odds of obtaining employment and keeping it for at least 3 months. Functional role impairment, quality of life, self-esteem, or education level did not predict employment. Conclusion: Our data suggest that, if time-restricted budgets are offered to a wide range of patients, such as those included in this study, better functioning and lower symptom severity at baseline are predictive of better employment outcomes (finding and maintaining work) on the first (competitive) labor market in Switzerland. It remains to be investigated whether this holds true under different environmental factors., Frontiers in Psychiatry, 10, ISSN:1664-0640
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- 2019
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32. Classical Massage and Acupuncture in Chronic Back Pain - Non-Inferiority Randomised Trial
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Erika Klassen, Karl-Ruediger Wiebelitz, and André-Michael Beer
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medicine.medical_specialty ,Naturopathy ,Acupuncture Therapy ,Context (language use) ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Back pain ,Acupuncture ,Humans ,Orthopedics and Sports Medicine ,Massage ,business.industry ,Chronic pain ,medicine.disease ,Low back pain ,030205 complementary & alternative medicine ,Exercise Therapy ,Treatment Outcome ,Back Pain ,Physical therapy ,Surgery ,medicine.symptom ,Chronic Pain ,business ,030217 neurology & neurosurgery - Abstract
Currently, there is a need for scientific evidence on the efficacy of classical massage therapy for chronic, unspecific back pain, especially for the improvement in functional impairment and long-term pain reduction. According to the National Health Care Guidelines, classical massage for nonspecific low back pain may only be prescribed in combination with exercise therapy and a share of the remuneration. Acupuncture, on the other hand, is recognised in the guidelines as an independent treatment for chronic back pain and is remunerated by health insurance companies. This raises the question of whether classical massage therapy is not inferior compared to acupuncture, based on the therapy of the GERAC study. The Clinic of Naturopathy in Blankenstein, Hattingen uses classical massage therapy subjectively successfully in patients with back pain. To objectify the success of the treatment, a randomised controlled, non-inferiority study was conducted.The efficacy of classical massage (KMT, n = 66) was compared with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain ("Von Korff"-Questionnaire) at the follow-up after one month.In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).The results show that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.Es besteht derzeit ein Bedarf an wissenschaftlichen Nachweisen zur Wirksamkeit der klassischen Massagetherapie bei chronischen, unspezifischen Rückenschmerzen in der Verbesserung der Funktionseinschränkung und der Schmerzminderung im Langzeiteffekt. Laut den nationalen Versorgungsleitlinien darf die klassische Massage bei nicht spezifischen Kreuzschmerzen nur in Kombination mit Bewegungstherapie und einem Eigenanteil der Vergütung verordnet werden. Die Akupunktur hingegen wird in den Leitlinien als eigenständige Therapie bei chronischen Rückenschmerzen anerkannt und von den Krankenkassen vergütet. In der Naturheilkundeklinik der Klinik Blankenstein in Hattingen wird die klassische Massagetherapie bei Patienten mit Rückenschmerzen subjektiv erfolgreich eingesetzt. Es stellt sich daher die Frage, ob die klassische Massagetherapie der Akupunktur, angelehnt an die Therapie der GERAC-Studie, nicht unterlegen ist. Um die Behandlungserfolge der Klinik Blankenstein zu objektivieren, wurde eine randomisiert kontrollierte Nichtunterlegenheitsstudie durchgeführt.Bei stationären Patientinnen mit chronischen Rückenschmerzen wurde die Wirksamkeit der klassischen Massagetherapie (KMT, n = 66) mit der Akupunkturtherapie (AKU, n = 66) verglichen. Primäres Zielkriterium war die Nichtunterlegenheit der klassischen Massage gegenüber der Akupunkturbehandlung in Bezug auf die Funktionseinschränkung im Alltag mithilfe des Hannover-Funktionsfragebogens (HFAQ) und der Reduktion der Schmerzintensität (Von-Korff-Fragebogen) beim Follow-up nach 1 Monat.In der Per-Protocol-Analyse im Zeitraum zwischen Aufnahme in die Studie und Follow-up ist die Responder-Rate der KMT mit 56,5% kleiner als die Responder-Rate der AKU mit 62,5% (Δ = − 6%; KIΔ: − 23,5 bis + 11,4%) und der AKU somit tendenziell unterlegen.Die Ergebnisse zeigen, dass die klassische Massagetherapie der Akupunkturtherapie in der Zeitspanne von Aufnahme bis Follow-up nicht signifikant unterlegen ist. Im Rahmen des festgelegten Irrelevanzbereichs lässt sich die Nichtunterlegenheit der KMT gegenüber der AKU nicht beweisen.
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- 2018
33. [Clinical studies in trauma surgery and orthopedics: read, interpret and implement].
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Stengel D, Mutschler W, Dubs L, Kirschner S, and Renkawitz T
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- Adaptation, Psychological, Humans, Orthopedics
- Abstract
Informative, participatory clinical decision-making needs to combine both skills and expertise as well as current scientific evidence. The flood of digital information makes it difficult in everyday clinical practice to keep up to date with the latest publications. This article provides assistance for coping with this problem. A basic understanding of prior and posterior probabilities as well as systematic error (bias) makes it easier to weigh up the benefits and risks, e.g. of a (surgical) intervention compared to a nonsurgical treatment. Randomized controlled trials (RCT, with all modern modifications) deliver undistorted results but in orthopedic and trauma surgery can lead to a heavily selected nonrepresentative sample and the results must be confirmed or refuted by further, independent RCTs. Large-scale observational data (e.g. from registries) can be modelled in a quasi-experimental manner and accompany RCTs in health technology assessment., (© 2021. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2021
- Full Text
- View/download PDF
34. Video Tutorials Increase Precision in Minimally Invasive Surgery Training - a Prospective Randomised Trial and Follow-up Study
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Tilman Laubert, Claudia Benecke, Tobias Keck, Michael Thomaschewski, Markus Zimmermann, Anna Höfer, Lotta Renner, and Hamed Esnaashari
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Adult ,Male ,medicine.medical_specialty ,MEDLINE ,Video Recording ,Task (project management) ,law.invention ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Randomized controlled trial ,law ,Germany ,Medicine ,Humans ,Minimally Invasive Surgical Procedures ,Simulation Training ,business.industry ,Significant difference ,Follow up studies ,Education, Medical, Graduate ,030220 oncology & carcinogenesis ,Cohort ,Invasive surgery ,Physical therapy ,030211 gastroenterology & hepatology ,Surgery ,Female ,Clinical Competence ,Curriculum ,Clinical competence ,business - Abstract
Simulation-based practice has become increasingly important in minimally invasive surgery (MIS) training. Nevertheless, personnel resources for demonstration and mentoring simulation-based practice are limited. Video tutorials could be a useful tool to overcome this dilemma. However, the effect of video tutorials on MIS training and improvement of MIS skills is unclear.A prospective randomised trial (n = 24 MIS novices) was conducted. A video-trainer with three different tasks (#1 - 3) was used for standardised goal-directed MIS training. The subjects were randomised to two groups with standard instructional videos (group A, n = 12) versus comprehensive video tutorials for each training task watched at specific times of repetition (group B, n = 12). Performance was analysed using the MISTELS score. At the beginning and following the curriculum, an MIS cholecystectomy (CHE) was performed on a porcine organ model and analysed using the GOALS score. After 18 weeks, participants performed 10 repetitions of tasks #1 - 3 for follow-up analysis.More participants completed tasks #1 and #2 in group B (83.3 and 75%) than in group A (66.7 and 50%, ns). For task #2, there was a significant improvement in precision in group B (p 0.001). For the entire cohort, the GOALS-Scores were 12.9 before and 18.9 after the curriculum (p 0.001), with no significant difference between groups. Upon follow-up, 84.2% (task#1), 26.3% (task#2) and 100% (task#3) of MIS novices were able to reach the defined goals (A vs. B ns). There was a trend for a better MISTELS score in group B upon follow-up.Standardised comprehensive video tutorials watched frequently throughout practice can significantly improve precision in MIC training. This aspect should be incorporated in MIS training.Simulationsbasiertes Training in der minimalinvasiven Chirurgie (MIC) gewinnt zunehmend an Bedeutung. Jedoch sind die personellen Ressourcen für die Demonstration und das Mentoring simulationsbasierter Übungen begrenzt. Video-Tutorials könnten hierbei eine gute Alternative darstellen. Der Effekt von Video-Tutorials auf das MIC-Training und die Verbesserung der MIC-Fertigkeiten ist jedoch aktuell unklar.In einer prospektiv randomisierten Studie (n = 24 MIC-Anfänger) wurde ein Videosimulator mit 3 verschiedenen Übungen (Nr. 1 – 3) für ein standardisiertes zielorientiertes MIC-Training verwendet. Die Randomisierung erfolgte in 2 Gruppen: 1) Standardinstruktionsvideos (Gruppe A, n = 12) vs. 2) detaillierte Video-Tutorials für jede Übung, die zu definierten Wiederholungen jeweils erneut angeschaut wurden (Gruppe B, n = 12). Die Leistungen beider Gruppen wurden unter Verwendung des MISTELS-Scores analysiert. Zu Beginn und nach dem MIC-Training wurde eine MIC-Cholezystektomie (CHE) an einem Schweineorganmodell durchgeführt und mit dem GOALS-Score bewertet. Nach 18 Wochen führten die Probanden 10 Wiederholungen der Übungen Nr. 1 – 3 im Rahmen einer Nachuntersuchung durch.In Gruppe B absolvierten mehr Probanden erfolgreich die Übungen Nr. 1 und Nr. 2 (83,3 und 75%) im Vergleich zu Gruppe A (66,7 und 50%, nicht signifikant [ns]). Bei der Übung Nr. 2 zeigte sich eine signifikante Verbesserung der Präzision in Gruppe B (p 0,001). Für die gesamte Kohorte waren die GOALS-Score-Werte 12,9 vor und 18,9 nach dem Curriculum (p 0,001), ohne einen signifikanten Unterschied zwischen den Gruppen A und B. Bei der Nachuntersuchung konnten 84,2% (Übung Nr. 1), 26,3% (Übung Nr. 2) und 100% (Übung Nr. 3) der Probanden die definierten Ziele erneut erreichen (A vs. B ns). Im Rahmen der Nachuntersuchung gab es einen Trend für bessere MISTELS-Score-Werte in der Gruppe B.Standardisierte, detaillierte Video-Tutorials, die wiederholt im Rahmen eines MIC-Übungscurriculums angeschaut werden, erhöhen die Präzision laparoskopischer Fertigkeiten im MIC-Training. Die Ergebnisse dieser Studie unterstützen die Implementierung von Video-Tutorials bei der Konzeption von MIC-Trainingskonzepten.
- Published
- 2018
35. [Percutaneous coronary intervention in stable angina pectoris : Objective randomised blinded investigation with optimal medical therapy of angioplasty in stable angina (ORBITA) trial]
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S. Nitschmann, J. Wöhrle, and C. Kugler
- Subjects
Nephrology ,medicine.medical_specialty ,medicine.medical_treatment ,MEDLINE ,030204 cardiovascular system & hematology ,Stable angina ,law.invention ,Angina ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,Internal medicine ,Angioplasty ,Internal Medicine ,Medicine ,Humans ,030212 general & internal medicine ,Angina, Stable ,business.industry ,Percutaneous coronary intervention ,Hepatology ,medicine.disease ,business - Published
- 2018
36. Chronisches Erschöpfungssyndrom: Evidenzbasierte Psychotherapie bei chronischer organisch unklarer Erschöpfung
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Jens Gaab and Alexandra Martin
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Foundation (evidence) ,Treatment results ,medicine.disease ,Relapse prevention ,Medium term ,Graded exercise therapy ,law.invention ,Clinical Psychology ,Randomized controlled trial ,law ,medicine ,Chronic fatigue syndrome ,Etiology ,Intensive care medicine ,business - Abstract
Zusammenfassung: Chronische Erschöpfungszustände ohne bzw. ohne adäquate somatische Ursache sind für Betroffene sowie für Behandler ein Problem, da mit dem Fehlen einer eindeutigen nosologischen Zuordnung und eines eindeutigen Ätiologiemodells auch die Behandlungsoptionen nicht immer direkt auf der Hand liegen bzw. Gegenstand von Kontroversen sind (s.Gaab, in diesem Heft). Zur Behandlung des chronischen Erschöpfungssyndroms ("chronic fatigue syndrome", CFS) werden verschiedene psychotherapeutische Ansätze neben graduierter Aktivierung vorgeschlagen. Ziel des vorliegenden Beitrags ist es, den aktuellen Stand der Evidenzbasierung von Psychotherapie bei CFS auf Basis vorliegender Metaanalysen und neuerer randomisierter kontrollierter Studien darzustellen. Robuste Evidenz zeigt sich für die kognitive Verhaltenstherapie (KVT) mit im Durchschnitt moderater Wirksamkeit im Hinblick auf die Schwere der Erschöpfungssymptomatik und die körperliche Funktionseinschränkung nach Therapieabschluss sowie in kurz- bis mittelfristigen Katamnesen. Klinisch relevante Verbesserungen sind bei 40-50% der so behandelten Personen zu beobachten. Andere Psychotherapieverfahren wurden bislang selten evaluiert - vielversprechende Ergebnisse weisen jedoch Einzelstudien zu Gesprächspsychotherapie und Psychoedukation auf. Insgesamt besteht die Notwendigkeit, in der Therapie Konzepte zur Rückfallprophylaxe stärker zu berücksichtigen und die Nachhaltigkeit der therapeutisch erzielten Verbesserungen empirisch abzusichern
- Published
- 2018
37. Sport als angewandte Therapie bei Patienten mit schizophrenen Psychosen
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Malte Christian Claussen, Simon Manuel Ewers, University of Zurich, and Claussen, Malte Christian
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medicine.medical_specialty ,business.industry ,Psychosomatics ,Psychological intervention ,Physical exercise ,610 Medicine & health ,Disease ,2700 General Medicine ,General Medicine ,Overweight ,medicine.disease ,law.invention ,Randomized controlled trial ,Schizophrenia ,law ,10054 Clinic for Psychiatry, Psychotherapy, and Psychosomatics ,Schizophrenic Psychology ,medicine ,medicine.symptom ,Psychiatry ,business - Abstract
Zusammenfassung. Schizophrene Psychosen sind schwere psychische Erkrankungen, die im Vergleich zu gesunden Individuen und anderen psychiatrischen Störungen mit einer geringen Lebenserwartung einhergehen. Als Risikofaktoren für die erhöhte Mortalität werden Übergewicht und zugehörige Gesundheitsprobleme wie Diabetes mellitus, kardiovaskuläre Erkrankungen und mit Rauchen assoziierte Lungenerkrankungen genannt. Geringe körperliche Aktivität und vermehrtes sedentäres Verhalten wurden als wichtiger behavioraler Risikofaktor für kardiovaskuläre Erkrankungen bei Menschen mit Schizophrenie identifiziert. Zahlreiche Forschungsergebnisse zeigen einen positiven Einfluss von Sport sowohl auf die psychische Symptomatik als auch die körperliche Gesundheit. In den vorliegenden Studien kamen jedoch unterschiedliche Arten von angeleiteter Bewegung mit divergierender Intensität im Gruppen- oder Einzelsetting zur Anwendung. Die Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde (DGPPN) empfiehlt den Einsatz von sport- und bewegungstherapeutischen Interventionen, aber es werden weitere grosse randomisiert kontrollierte Studien benötigt, um Art, Umfang und Dauer sowie die Wirkung der eingesetzten Methoden in den verschiedenen Phasen der Erkrankung zu untersuchen. Ein Ziel dabei sollte die evidenzbasierte Implementierung von spezifischen und systematischen sport- und bewegungstherapeutischen Interventionen als ergänzender Baustein neben der psychopharmakologischen und psychotherapeutischen Behandlung bei Menschen mit Schizophrenie sein.
- Published
- 2018
38. A decision-analytic model to assess the cost-effectiveness of etelcalcetide vs. cinacalcet
- Author
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Michael Adena, Bastian Dehmel, Sergio Iannazzo, Vasily Belozeroff, Björn Stollenwerk, Andrew Briggs, Patrick S. Parfrey, and Ron Akehurst
- Subjects
Adult ,medicine.medical_specialty ,Cinacalcet ,Adolescent ,Calcimimetic ,Cost effectiveness ,Cost-Benefit Analysis ,Urology ,Context (language use) ,Decision Support Techniques ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Humans ,Medicine ,030212 general & internal medicine ,Vitamin D ,Aged ,Chelating Agents ,Aged, 80 and over ,Pharmacology ,Etelcalcetide ,business.industry ,030503 health policy & services ,Health Policy ,Public Health, Environmental and Occupational Health ,Health Care Costs ,Middle Aged ,medicine.disease ,Markov Chains ,Quality-adjusted life year ,Models, Economic ,Drug Therapy, Combination ,Hyperparathyroidism, Secondary ,Secondary hyperparathyroidism ,Quality-Adjusted Life Years ,Peptides ,0305 other medical science ,business ,medicine.drug - Abstract
Introduction: \ud Etelcalcetide is a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in haemodialysis patients. The clinical efficacy and safety of etelcalcetide (in addition to phosphate binders and vitamin D and/or analogues [PB/VD]) was evaluated in three phase III studies, including two placebo-controlled trials and a head-to-head study versus the oral calcimimetic cinacalcet.\ud \ud Objective: \ud The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared with cinacalcet.\ud \ud Methods: \ud We developed a life-time Markov model including potential treatment effects on mortality, cardiovascular events, fractures, and subjects’ persistence. Long-term efficacy of etelcalcetide was extrapolated from the reduction in parathyroid hormone (PTH) in the phase III trials and the available data from the outcomes study in cinacalcet (EVOLVE trial). Etelcalcetide was compared with cinacalcet, both in addition to PB/VD. We applied unit costs averaged from five European countries and a range of potential etelcalcetide pricing options assuming parity price to weekly use of cinacalcet and varying it by a 15 or 30% increase.\ud \ud Results: \ud Compared with cinacalcet, the incremental cost-effectiveness ratio of etelcalcetide was €1,355 per QALY, €24,521 per QALY, and €47,687 per QALY for the three prices explored. The results were robust across the probabilistic and deterministic sensitivity analyses.\ud \ud Conclusions: \ud Our modelling approach enabled cost-utility assessment of the novel therapy for SHPT based on the observed and extrapolated data. This model can be used for local adaptations in the context of reimbursement assessment.
- Published
- 2018
39. [Improvement of Balance and General Physical Fitness in Older Adults by Karate: A Randomized Controlled Trial]
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Kerstin Witte, Gerald Pliske, and Peter Emmermacher
- Subjects
medicine.medical_specialty ,Physical fitness ,Treatment outcome ,Poison control ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Physical medicine and rehabilitation ,Randomized controlled trial ,law ,Injury prevention ,medicine ,Postural Balance ,Humans ,Balance (ability) ,Aged ,business.industry ,030229 sport sciences ,Middle Aged ,Treatment Outcome ,Complementary and alternative medicine ,Physical Fitness ,Physical therapy ,Accidental Falls ,business ,030217 neurology & neurosurgery ,Martial Arts ,Fall prevention - Published
- 2017
40. Leitlinie für die Diagnose, Prävention und Behandlung des Handekzems:Kurzversion
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Tove Agner, Thomas L. Diepgen, Rosemary Nixon, Peter Elsner, Klaus Ejner Andersen, Oliver Chosidow, John S. C. English, Manigé Fartasch, Denis Sasseville, Ana Giménez-Arnau, P. J. Coenraads, and Public Health Research
- Subjects
ATOPIC ECZEMA ,medicine.medical_specialty ,AZATHIOPRINE ,LONG-TERM ,Administration, Topical ,Eczema ,MEDLINE ,Psychological intervention ,Alternative medicine ,Hand Dermatoses ,Dermatology ,ALITRETINOIN ,law.invention ,DOUBLE-BLIND ,Randomized controlled trial ,Adrenal Cortex Hormones ,law ,Germany ,Multicenter trial ,medicine ,Humans ,Intensive care medicine ,MULTICENTER TRIAL ,Evidence-Based Medicine ,business.industry ,Evidence-based medicine ,RANDOMIZED CONTROLLED-TRIAL ,medicine.disease ,Europe ,First line treatment ,DERMATITIS ,Treatment Outcome ,Hand eczema ,Practice Guidelines as Topic ,Physical therapy ,CYCLOSPORINE ,Dermatologic Agents ,Gloves, Protective ,business ,SKIN - Abstract
The guidelines aim to provide advice on the management of hand eczema (HE), using an evidence- and consensus-based approach. The guidelines consider a systematic Cochrane review on interventions for HE, which is based on a systematic search of the published literature (including hand-searching). In addition to the evidence- and consensus-based recommendation on the treatment of HE, the guidelines cover mainly consensus-based diagnostic aspects and preventive measures (primary and secondary prevention). Treatment recommendations include non-pharmacological interventions, topical, physical and systemic treatments. Topical corticosteroids are recommended as first line treatment in the management of HE, however continuous long-term treatment beyond six weeks only when necessary and under careful medical supervision. Alitretinoin is recommended as a second line treatment (relative to topical corticosteroids) for patients with severe chronic HE. Randomized control trials (RCT) are missing for other used systemic treatments and comparison of systemic drugs in "head-to-head" RCTs are needed. The guidelines development group is a working group of the European Society of Contact Dermatitis (ESCD) and has carefully tried to reconcile opposite views, define current optimal practice and provide specific recommendations, and meetings have been chaired by a professional moderator of the AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften; Association of the Scientific Medical Societies in Germany). No financial support was given by any medical company. The guidelines are expected to be valid until December 2017 at the latest.
- Published
- 2015
41. Defining pollen exposure times for clinical trials of allergen immunotherapy for pollen-induced rhinoconjunctivitis - an EAACI position paper
- Author
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Ulf Darsow, Bernard Clot, Regula Gehrig, Moises A. Calderon, Stephen R. Durham, Ludger Klimek, K. C. Bergmann, Carmen Galán, Jeroen Buters, Lars Jacobsen, Oliver Pfaar, Michel Thibaudon, Pascal Demoly, Mikhail Sofiev, Uwe Berger, R. Gerth van Wijk, Katharina Bastl, Internal Medicine, Département pneumologie et addictologie [Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Réseau National de Surveillance Aérobiologique (RNSA)
- Subjects
Allergen immunotherapy ,medicine.medical_specialty ,Allergy ,Time Factors ,010504 meteorology & atmospheric sciences ,Immunology ,Dose-Response Relationship, Immunologic ,Context (language use) ,pollen exposure ,medicine.disease_cause ,01 natural sciences ,Aerobiology ,law.invention ,allergen immunotherapy ,pollen concentration ,pollen season definition ,randomized controlled trials ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Pollen ,otorhinolaryngologic diseases ,Immunology and Allergy ,Medicine ,Humans ,[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology ,0105 earth and related environmental sciences ,Conjunctivitis, Allergic ,Clinical Trials as Topic ,business.industry ,Rhinitis, Allergic, Seasonal ,food and beverages ,Environmental exposure ,Environmental Exposure ,medicine.disease ,3. Good health ,Clinical trial ,030228 respiratory system ,Desensitization, Immunologic ,Practice Guidelines as Topic ,Seasons ,Symptom Assessment ,business - Abstract
Background Clinical efficacy of pollen allergen immunotherapy has been broadly documented in randomized controlled trials. The underlying clinical endpoints are analysed in seasonal time periods pre-defined on the basis of the background pollen concentration. However, any validated or generally accepted definition from academia or regulatory authorities for this relevant pollen-exposure intensity or period of time (season) is currently not available. Therefore, this Task Force initiative of the European Academy of Allergy and Clinical Immunology (EAACI) aimed to propose definitions based on expert-consensus. Methods A Task Force of the Immunotherapy and Aerobiology and Pollution Interest Groups of the EAACI reviewed the literature on pollen-exposure in the context of defining relevant time intervals for evaluation of efficacy in allergen immunotherapy trials. Underlying principles in measuring pollen exposure and associated methodological problems and limitations were considered in order to achieve a consensus. Results The Task Force achieved a comprehensive position in defining pollen exposure times for different pollen types. Definitions are presented for ‘pollen season’, ‘high pollen season’ (or ‘Peak pollen period’) and ‘high pollen days’. Conclusion This EAACI position paper provides definitions of pollen exposures for different pollen types for use in Allergen Immunotherapy trials. Their validity as standards remains to be tested in future studies. This article is protected by copyright. All rights reserved.
- Published
- 2017
42. Sprechen Sie Ihre übergewichtigen Patienten kurz auf ihr Übergewicht an – es wirkt!
- Author
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Stefan Zechmann, University of Zurich, and Zechmann, Stefan
- Subjects
Gynecology ,11035 Institute of General Practice ,medicine.medical_specialty ,business.industry ,MEDLINE ,Follow up studies ,610 Medicine & health ,2700 General Medicine ,General Medicine ,030204 cardiovascular system & hematology ,Weight Reduction Program ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Multicenter study ,Randomized controlled trial ,law ,medicine ,030212 general & internal medicine ,business ,Body mass index - Published
- 2017
43. Primärprävention der Hühnereiallergie durch die frühzeitige Hühnereigabe
- Author
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Bellach, Johanna
- Subjects
food allergy ,allergy prevention ,atopic eczema ,oral tolerance ,randomized controlled trial ,egg allergy ,complementary feeding - Abstract
Hintergrund: Die Hühnereiallergie gehört zu den häufigsten Nahrungsmittelallergien im Kindesalter. Da es keine kausalen Therapiemöglichkeiten gibt, haben Präventions-maßnahmen einen hohen Stellenwert. Ergebnisse aus Beobachtungsstudien gaben Hinweise darauf, dass die frühe Einführung von potenten Nahrungsmittel-allergenen vor der Entwicklung von Nahrungsmittelallergien schützen könnte. Es war Ziel der randomisierten, placebokontrollierten Interventionsstudie zu untersuchen, ob die frühe Einführung von Hühnerei zwischen dem 4.-6. Lebensmonat in der Allgemeinbevölkerung ein sicherer und effektiver Weg zur Vorbeugung von Hühnereiallergien sein kann. Methoden: Die Kinder wurden bei Geburt rekrutiert und vor Beginn der Intervention auf eine vorbestehende Sensibilisierung auf Hühnerei getestet. Nicht sensibilisierte Säuglinge (Hu ̈hnerei-spezifische IgE-Antikörper im Serum < 0.35 kUA/l) wurden einer Verum- oder Placebo-Gruppe randomisiert zugeordnet und erhielten mit Beginn der Beikost ab dem 4.-6. Lebensmonat bis zum 12. Lebensmonat dreimal pro Woche pasteurisiertes Hühnereiweißpulver (Verum) oder Reispulver (Placebo) unter gleichzeitiger Hühnerei-freier Ernährung. Primärer Endpunkt war die Häufigkeit von Hühnerei-Sensibilisierungen im Alter von 12 Lebensmonaten. Die Häufigkeit von Hühnerei-Allergien wurde mit Hilfe der Durchführung von Nahrungsmittelprovokationen bestimmt. Die Studie wurde im Deutschen Register Klinischer Studien registriert (DRKS00005668). Ergebnisse: 406 Kinder wurden im Alter von 4-6 Lebensmonaten vor Beginn der Intervention auf eine vorbestehende Hühnereisensibilisierung gescreent. Bei 23/406 (5.7%) konnten bereits Hühnerei-spezifische Serum-IgE-Antikörper ≥ 0.35 kUA/l nachgewiesen werden. 17 der sensibilisierten Kinder erhielten eine doppelblinde, Placebo- kontrollierte Nahrungsmittelprovokation; hierbei wurden 16 Kinder als Hu ̈hnerei-allergisch getestet und 11 Kinder zeigten eine anaphylaktische Reaktion. Von den nicht-sensibilisierten Kindern (383/406) wurden 184 Kinder in die Verum- und 199 Kinder in die Placebo-Gruppe randomisiert. Im Alter von 12 Lebensmonaten waren 5.6% der Kinder in der Verum-Gruppe und 2.6% der Kinder in der Placebo-Gruppe Hühnerei-sensibilisiert (primärer Endpunkt; RR, 2.20; 95% KI, 0.68 bis 7.14; p=0.24). 2.1% in der Verum-Gruppe wurden als allergisch getestet im Vergleich zu 0.6% in der Placebo-Gruppe (RR, 3.30; 95% KI, 0.35 bis 31.32; p=0.35). Schlussfolgerung: Die frühe Einführung von pasteurisiertem Hühnerei ab dem 4.-6. Lebensmonat erwies sich in unserer Studie als nicht erfolgreich für die Prävention von Hühnerei-allergien. Stattdessen barg sie die Gefahr für allergische Reaktionen in der häuslichen Umgebung, da die Mehrzahl der Hühnerei-allergischen Kinder in unserer Studie bereits Hühnerei-sensibilisiert und Hühnerei-allergisch im Alter von 4-6 Lebensmonaten vor der Beikosteinführung waren., Background: Hen’s egg is the most common cause of food allergy in early childhood. Since there is no causal treatment, prevention strategies are sought keenly. Studies suggested that the early introduction of allergenic foods might reduce the risk of food allergy. The aim of this randomized placebo-controlled intervention study was to investigate whether the introduction of hen’s egg at 4-6 months of age can be a safe and effective measure to reduce hen’s egg allergy in a general population. Methods: All participating children were recruited at birth and screened for preexisting hen’s egg-specific serum IgE prior to intervention. Only children who were not sensitized against hen’s egg were randomized to receive either verum (pasteurized egg white powder) or placebo (rice powder) added to the first weaning food three times a week under concurrent egg-free diet from age 4-6 until 12 months. The primary outcome was sensitization to hen’s egg (hen’s egg-specific serum IgE ≥ 0.35 kUA/l) by age 12 months. Hen’s egg allergy (secondary outcome) was confirmed by food challenge tests. This study was registered in the German Clinical-Trials-Registry, number DRKS00005668. Results: Among 406 screened infants, 23 (5.7%) had hen’s egg-specific IgE ≥ 0.35 kUA/l prior to randomization. 17/23 underwent subsequent double-blind, placebo-controlled food challenges and 16 were confirmed as hen’s egg allergic including 11 with anaphylactic reactions. Of the 383 non-sensitized infants (56.7% male), 184 were randomized to verum and 199 to placebo. At 12 months of age, 5.6% of the children in the verum group were hen’s egg-sensitized versus 2.6% in the placebo group (primary outcome; RR, 2.20; 95% CI, 0.68 to 7.14; p=0.24), and 2.1% were confirmed to be hen’s egg allergic versus 0.6% in the placebo group, (RR, 3.30; 95% CI, 0.35 to 31.32; p=0.35). Conclusion: We found no evidence that the consumption of hen’s egg starting at 4-6 months of age prevents hen’s egg sensitization or allergy. In contrast, it might result in frequent allergic reactions in the community considering that many 4-6 months old infants were already allergic to hen’s egg.
- Published
- 2017
44. Cognitive behaviour therapy for the chronic fatigue syndrome: A randomised controlled trial
- Author
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Ivana Klimes, Christina Surawy, Sue Simkin, Valerie Seagroatt, Keith Hawton, Michael Sharpe, David A. Warrell, Tim E. A. Peto, and Ann Hackmann
- Subjects
Adult ,Male ,medicine.medical_specialty ,Letter ,medicine.medical_treatment ,law.invention ,Oenothera biennis ,Randomized controlled trial ,law ,Adaptation, Psychological ,Chronic fatigue syndrome ,Humans ,Plant Oils ,Medicine ,Outpatient clinic ,Magnesium ,gamma-Linolenic Acid ,General Environmental Science ,Fatigue Syndrome, Chronic ,Intention-to-treat analysis ,Cognitive Behavioral Therapy ,Fatty Acids, Essential ,Depression ,business.industry ,General Engineering ,General Medicine ,medicine.disease ,Graded exercise therapy ,Clinical trial ,Cognitive behavioral therapy ,Treatment Outcome ,Linoleic Acids ,Cognitive therapy ,Physical therapy ,Patient Compliance ,General Earth and Planetary Sciences ,Female ,business ,Attitude to Health ,Research Article - Abstract
Objective: To evaluate the acceptability and efficacy of adding cognitive behaviour therapy to the medical care of patients presenting with the chronic fatigue syndrome. Design: Randomised controlled trial with final assessment at 12 months. Setting: An infectious diseases outpatient clinic. Subjects: 60 consecutively referred patients meeting consensus criteria for the chronic fatigue syndrome. Interventions: Medical care comprised assessment, advice, and follow up in general practice. Patients who received cognitive behaviour therapy were offered 16 individual weekly sessions in addition to their medical care. Main outcome measures: The proportions of patients (a) who achieved normal daily functioning (Karnofsky score 80 or more) and (b) who achieved a clinically significant improvement in functioning (change in Karnofsky score 10 points or more) by 12 months after randomisation. Results: Only two eligible patients refused to participate. All randomised patients completed treatment. An intention to treat analysis showed that 73% (22/30) of recipients of cognitive behaviour therapy achieved a satisfactory outcome as compared with 27% (8/30) of patients who were given only medical care (difference 47 percentage points; 95% confidence interval 24 to 69). Similar differences were observed in subsidiary outcome measures. The improvement in disability among patients given cognitive behaviour therapy continued after completion of therapy. Illness beliefs and coping behaviour previously associated with a poor outcome changed more with cognitive behaviour therapy than with medical care alone. Conclusion: Adding cognitive behaviour therapy to the medical care of patients with the chronic fatigue syndrome is acceptable to patients and leads to a sustained reduction in functional impairment. Key messages Key messages There is no generally accepted form of treatment New findings show that patients referred to hospital for the chronic fatigue syndrome have a better outcome if they are given a course of cognitive behaviour therapy than if they receive only basic medical care Clinical improvement with cognitive behaviour therapy may be slow but often continues after treatment has ended Cognitive behaviour therapy should be considered as an option for patients presenting with the chronic fatigue syndrome
- Published
- 2016
45. [Not Available]
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Han Samwel, Jan Paul M. Frölke, Karlijn J Barnhoorn, Frank P Klomp, J. Bart Staal, Hans Groenewoud, Henk van de Meent, Maria W.G. Nijhuis-van der Sanden, and Robert van Dongen
- Subjects
Adult ,Male ,medicine.medical_specialty ,Visual analogue scale ,Stress-related disorders Donders Center for Medical Neuroscience [Radboudumc 13] ,law.invention ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,Rehabilitation Medicine ,Randomized controlled trial ,law ,medicine ,Humans ,Single-Blind Method ,Prospective Studies ,Prospective cohort study ,Physical Therapy Modalities ,Pain Measurement ,PAIN MANAGEMENT ,Intention-to-treat analysis ,business.industry ,Research ,General Medicine ,Guideline ,Middle Aged ,medicine.disease ,Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3] ,Intention to Treat Analysis ,Complex regional pain syndrome ,Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10] ,Treatment Outcome ,McGill Pain Questionnaire ,Physical therapy ,Patient Compliance ,Female ,Range of motion ,business ,Complex Regional Pain Syndromes - Abstract
Contains fulltext : 152564.pdf (Publisher’s version ) (Open Access) OBJECTIVE: To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. SETTING: The study was conducted at a level 1 trauma centre in the Netherlands. PARTICIPANTS: 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. INTERVENTIONS: Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. MEASUREMENTS: Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score-Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. RESULTS: The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI -1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. CONCLUSIONS: We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. TRIAL REGISTRATION NUMBERS: NCT00817128 and NTR 2090.
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- 2016
46. [Ohrtamponade superfluous?]
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Andreas, Neumann and Holger, Sudhoff
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BIPP ,Ear packing ,Randomized controlled trial ,Ear blockage ,otorhinolaryngologic diseases ,Otology ,Visual analogue scores ,sense organs ,Canal wall-up ear surgery - Abstract
To pilot a substantive randomized control trial comparing post-operative external ear canal pack with no ear pack after middle ear surgery, 32 adults undergoing primary posterior bony canal wall preserving middle ear surgery were randomized to have either a bismuth iodoform paraffin paste pack or no ear pack post-operatively. Outcome measures included clinician- and patient-recorded visual analogue scale scores for ear signs and symptoms at 3 weeks and 3 months and audiometric findings at 3 months post-operatively. There was no statistically significant inter-group difference in 3-week clinician and patient cumulative scores for ear signs and symptoms. There was also no significant difference in graft take rate, appearance of ear canals and audiometric results in either group at 3 months. No difference in ear symptoms, clinician findings or hearing was demonstrated between patients with a post-operative pack compared to those without a pack following middle ear surgery in this pilot study.
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- 2016
47. Biofeedbacktherapie vs. graduiertes, sportmedizinisches Bewegungstraining bei Frauen mit chronischem Erschöpfungssyndrom. Eine randomisierte, kontrollierte Studie zur Erfassung der Auswirkungen auf Erschöpfungserleben, psychisches und physisches Wohlbefinden und körperliche Leistungsfähigkeit
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Windthorst, Petra Simone and Zipfel, Stephan (Prof. Dr.)
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biofeedback ,psychotherapy ,quality of life ,sports medicine ,Psychotherapie , Biofeedback , Sportmedizin , Verhaltenstherapie , Lebensqualität ,randomized controlled trial ,cognitive behavioural therapy ,chronisches Erschöpfungssyndrom ,chronic fatigue syndrome ,Interventionsstudie - Abstract
Die vorliegende Arbeit untersuchte – nach Wissen der Autorin zum ersten Mal – im Rahmen eines kontrollierten, randomisierten Studiendesigns die Wirksamkeit von Biofeedbacktherapie im Vergleich zu graduiertem Bewegungstraining in der Behandlung von erwachsenen Patientinnen mit Chronischem Erschöpfungssyndrom (CFS; ICD-10 F48.0). CFS als Erkrankung mit den Hauptsymptomen von Müdigkeit und verstärktem Erschöpfungserleben sowie zusätzlichen Beschwerden wie Muskel- und Kopfschmerzen oder Konzentrationsschwierigkeiten geht einher mit einem starken Leidensdruck der Betroffenen und deutlichen Einschränkungen in der Alltagsbewältigung. CFS lässt sich der übergeordneten Störungsgruppe der funktionellen somatischen Syndrome (FSS) zuordnen. Hinsichtlich der Ätiologie werden multifaktorielle und bio-psycho-soziale Störungsmodelle herangezogen. Etablierte und evidenzbasierte Behandlungsverfahren des CFS stellen kognitiv-behaviorale und aktivitätsfördernde Interventionen dar. Biofeedback als Verfahren, das den verhaltenstherapeutisch orientierten Verfahren zugeordnet werden kann, intendiert neben der konkreten Beeinflussung einzelner Übungsparameter ein verbessertes Verständnis für psychosomatische Zusammenhänge sowie eine Stärkung von Selbstwirksamkeits- und Kontrollerleben. Es bietet zusätzlich die Möglichkeit der Korrektur dysfunktionaler, krankheitsaufrechterhaltender Überzeugungen. Für den Einsatz von Biofeedback im Rahmen von FSS liegen zahlreiche Wirksamkeitsnachweise vor. Zur Biofeedbackbehandlung von CFS wurde im Rahmen der vorliegenden Arbeit ein Manual entwickelt, wobei die respiratorische Sinusarrhythmie als Trainingsparameter gewählt wurde. Die Überprüfung der Wirksamkeit der Biofeedbackbehandlung erfolgte in den Bereichen ´subjektives Beschwerdeerleben` und ´körperliche Leistungsfähigkeit` in Bezugnahme auf ein graduiertes Bewegungstraining als etabliertem Kontrollverfahren. Die Behandlungsdauer in beiden Gruppen erstreckte sich über acht Sitzungen über einen Behandlungszeitraum von drei Monaten. Die Datenerhebung erfolgte zu drei Messzeitpunkten, d. h. vor und nach Abschluss der Intervention sowie zu einer 5-Monats-Katamnese. Die Ergebnisse basieren auf den Daten von 24 Probandinnen von denen 13 am Biofeedback- und 11 am graduierten Bewegungsprogramm am Universitätsklinikum Tübingen teilnahmen. 4 Probandinnen beendeten das Bewegungsprogramm vorzeitig und wurden nicht in die Auswertung aufgenommen. Die Auswertung der Daten erfolgte mittels non-parametrischer Verfahren. Zur Beurteilung der klinischen Signifikanz wurden Standardeffektstärken berechnet. Zwischen den Behandlungsgruppen zeigten sich keine signifikanten Unterschiede in grundlegenden demographischen Variablen. Während beider Interventionen zeigte sich eine substantielle Reduktion des Erschöpfungs- und Beschwerdeerlebens. Die Biofeedbacktherapie zeichnete sich insbesondere durch Einflussnahme auf das psychische Wohlbefinden einschließlich der Depressivität und der psychophysiologischen Regulation aus. Die Bewegungstherapie zeichnete sich dahingegen insbesondere durch Einflussnahme auf das körperliche Wohlbefinden einschließlich körperlicher Schmerzen und auf die körperliche Aktivität bzw. Leistungsfähigkeit aus. Es zeigten sich im Behandlungsverlauf keine maßgeblichen Veränderungen der Kontrollüberzeugungen in Bezug auf das eigene gesundheitliche Befinden. Bei der Interpretation und Diskussion der Ergebnisse werden die Reduktion von Schon- und Vermeidungsverhalten, die Zunahme an Selbstwirksamkeitserleben, das verbesserte Verständnis in Bezug auf psychophysiologische Zusammenhänge, die Korrektur dysfunktionaler Annahmen in Bezug auf Erschöpfung und Bewegung sowie eine positive Behandlungserwartung als mögliche Wirkfaktoren erörtert. Biofeedback als Behandlungsverfahren zeichnet sich durch eine spezifische Anwendbarkeit hinsichtlich dieser Wirkfaktoren aus. Limitationen der Studie sind in Zusammenhang mit der kleinen Stichprobengröße zu sehen. Als ermutigend hinsichtlich zukünftiger Interventionen im Bereich von CFS und FSS erweist sich die hohe Akzeptanz des Biofeedbackverfahrens.
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- 2016
- Full Text
- View/download PDF
48. Qualitätssichernder/qualitätsverbessernder Effekt eines Gesichtsbogens auf die statische Okklusion bei der vertikalen Kieferrelationsänderung
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Helm, Iven
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facebow ,randomized controlled trial ,clinical trail ,humans ,double blind trail - Abstract
Das Ziel dieser klinischen, doppelt-verblindeten, randomisierten Studie war es den Nutzen eines arbiträren Gesichtsbogens bei der Modellmontage zu evaluieren bei vorausgegangener Änderung der vertikalen Relation. Dabei sollte der Einfluss des Gesichtsbogens auf die Kontaktpunktsituation sowie auf das Ausmaß der Nachsorge untersucht werden. Die anfängliche Probandenanzahl betrug 32 (unbezahnt, mindestens eine der Totalprothesen war nicht älter als 4 Wochen), aus denen zwei Gruppen mit jeweils 16 Probanden randomisiert gebildet wurden. In der Gesichtsbogengruppe wurde ein arbiträrer Ohr-Gesichtsbogen (PROTAR 7 digma, KaVo, Biberach/Riß, Deutschland) angewandt, in der Kontrollgruppe stattdessen die mittelwertige Modellmontage durchgeführt. Für die Modellmontage wurde jeweils ein semi-adjustierbarer Artikulator verwendet. Die Änderung der vertikalen Relation wurde durch eine sekundären Remontage erzielt. Die Okklusionskontakte beider Gruppen wurden nach dem Absenken im Labor gleichmäßig eingeschliffen (mindestens ein Kontaktpunkt je Seitenzahn in der Statik, keine Frontzahnkontakte). Die Kontaktpunkte wurden anschließend direkt und 84 Tage nach der sekundären Remontage am Patienten registriert. Zudem wurden jegliche Druckstellen dokumentiert und das Ausmaß der Nachsorge in beiden Gruppen untersucht. Ferner wurden alle Prothesen vor dem Einschleifen im Labor dupliert, sodass für jeden Probanden zusätzlich beide Montagemethoden durchgeführt werden konnten, da gruppenunabhängig bei jedem Probanden die Gesichtsbogenregistrierung durchgeführt wurde. Für jedes Modellpaar wurde nach dem Absenken ein Registrat erstellt, das mit Hilfe der „Greifswald Digital Analyzing System“ Software (GEDAS 2 Reader) ausgewertet und auf signifikante Unterschiede in der Anzahl der Kontaktpunkte untersucht wurde. Die Anzahl der klinischen Kontaktpunkte je Front- und Seitenzahn sowie die Zähne in Kontakt waren in beiden Gruppen zu keinem Zeitpunkt signifikant verschieden (p>0,05). Die Auswertung der Modelldaten bezüglich der Seitenzahnkontakte ergab für beide Gruppen keine signifikanten Unterschiede (p>0,05). Hinsichtlich der Frontzahnkontakte und der Anzahl aller Zähne in Kontakt waren die Werte in der Gesichtsbogengruppe signifikant höher (Anzahl Frontzahnkontakte: p=0,005; F-Test, Anzahl Frontzähne in Kontakt: p=0,007; F-Test, Anzahl aller Zähne in Kontakt: p=0,027; F-Test). Zudem ergab sich eine geringe Korrelation zwischen dem Ausmaß der Sperrung und der Kontaktsituation. Das Ausmaß der Nachsorge war in beiden Gruppen ähnlich. Der in dieser Studie verwendete Ohr-Gesichtsbogen zur Übertragung von Totalprothesen in den Artikulator nach vorausgegangener Änderung der vertikalen Dimension kann der mittelwertigen Modellmontage aufgrund der vorliegenden Ergebnisse als gleichwertig eingestuft werden und zeigt bezüglich der untersuchten Parameter keinerlei Vorteile. Im Bereich der Totalprothetik kann die Modellmontage nach Mittelwerten bei vorausgegangener Änderung der vertikalen Dimension empfohlen werden., The quality effect of a face-bow on the static occlusion in connection with an alteration of the vertical dimension. A randomized clinical study. It was the purpose of this clinical, double-blinded, randomized study to evaluate the benefits of an arbitrary face-bow in the mounting procedure of casts in connection with an alteration of the vertical dimension. The influence of the face-bow concerning the occlusal contact situation as well as the extent of the follow-up had to be examined. The initial number of patients (edentulous, complete dentures) was 32, randomized into two groups with 16 patients. In the face-bow group an arbitrary earpiece face-bow (PROTAR 7 digma, KaVo, Biberach / Riss, Germany) has been used. In the control group the casts were mounted arbitrarily. The alteration of the vertical relationship was achieved by a remount procedure. After lowering the cast the occlusal contacts in both groups were grinded uniformly (no occlusal contacts per front tooth). The number of occlusal contacts was evaluated directly after the remounting procedure and 84 days after. Sore spots on the oral mucosa were documented as well. All complete dentures had been duplicated in the laboratory before the occlusal contacts were grinded. In that way the model casts for one patient could be mounted in both ways (the face-bow transfer was used initially for all subjects regardless of the group membership). After lowering the casts a silicon interocclusal record was made for each pair of casts which was evaluated using the "Greifswald Digital Analyzing System" software (Reader GEDAS 2). The number of clinical occlusal contacts on each anterior and posterior teeth and the number of teeth in contact in both groups were not significantly different at any time (p> 0.05). The evaluation of the model data for the contacts of the posterior teeth revealed no significant differences (p> 0.05). The number of anterior tooth contacts (p = 0.005), the number of anterior teeth in contact (p = 0.007) and the total number of teeth in contact (p=0.027) were significantly higher in the face-bow group. The extent of follow-up was similar in both groups. Based on the present results the earpiece face-bow used in this study for the transfer of complete dentures in the articulator after a previous change in the vertical dimension can be considered to be equivalent to the arbitrarily mounting method and achieved no advantages over the control group.
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- 2016
49. Wirksamkeit der Inhalation heißer, trockener Luft bei akuten Infekten der oberen Atemwege
- Author
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Knöchel, Bettina
- Subjects
inhalation ,randomized controlled trial ,heating ,steam bath ,common cold ,symptom severity score - Abstract
Einleitung: Zur Therapie akuter Infekte der oberen Atemwege wird traditionell häufig die lokale Anwendung von Wärme eingesetzt (Inhalation heißen Dampfes, Trinken heißer Flüssigkeiten). Die Wirksamkeit lokaler Erwärmung wurde in nur wenigen Studien untersucht, die widersprüchliche Ergebnisse zeigten. Fragestellung: Das Ziel der vorliegenden Studie war es zu untersuchen, ob die Inhalation 90°C heißer, trockener Luft in einer Sauna bei Patienten mit einem beginnenden akuten Infekt der oberen Atemwege die Symptome stärker reduziert als die Inhalation raumtemperierter Luft. Methodik: Eine randomisierte, einfachblinde, kontrollierte Studie mit einer Interventionsdauer von 3 Tagen und einer Follow-up-Dauer von 4 Tagen wurde durchgeführt. Patienten mit Symptomen eines akuten Infekts der oberen Atemwege (mindestens 2 von 10 vordefinierten Erkältungssymptomen seit 24 Stunden oder weniger) wurden zufällig der Saunaluft-Gruppe oder der Raumluft-Gruppe zugeteilt. Die Intervention bestand für beide Gruppen aus jeweils einem 3-minütigen Trockensaunaaufenthalt an 3 aufeinander folgenden Tagen. Isoliert mit einem Wintermantel inhalierten die Patienten der Saunaluft-Gruppe 90°C heiße, trockene Saunaluft, während die Patienten der Raumluft-Gruppe normaltemperierte Raumluft (24°C) inhalierten. Diese spezielle Art der Saunaanwendung hat mit normalem Saunabaden wenig gemeinsam, da es in dieser Studie primär um die Inhalation großer Mengen heißer Luft und nicht um die Induktion von Schwitzen ging. Der Schweregrad der Symptome des akuten Infekts der oberen Atemwege wurde mittels eines Symptomscores erhoben. Der Hauptzielparameter war die Fläche unter der Kurve (Zusammenfassung der einzelnen Symptomscores an den Tagen 2, 3, 5 und 7). Sekundäre Zielparameter waren unter anderem der Symptomscore zu den einzelnen Erhebungszeitpunkten, das Allgemeine Krankheitsgefühl, der Medikamentengebrauch gegen den akuten Infekt der oberen Atemwege und die Inzidenz Unerwünschter Ereignisse. Ergebnisse: 157 Patienten (Alter, Mittelwert (MW) ± Standardabweichung 32,0 ± 10,2 Jahre; 59,2% Frauen) wurden in die Studie eingeschlossen (Saunaluft- Gruppe n = 80, Raumluft-Gruppe n = 77). Für den Hauptzielparameter, die Fläche unter der Kurve der Symptomscores, ergab sich zwischen der Saunaluft-Gruppe (MW ± Standardfehler 31,2 ± 1,8 [95% Konfidenzintervall (KI) 27,6 bis 34,8]) und der Raumluft-Gruppe (35,1 ± 2,3 [30,5 bis 39,7]) kein statistisch signifikanter Unterschied (Gruppendifferenz -3,9 [95% KI -9,7 bis 1,9], p = 0,189, Cohens d = 0,13). Bei den sekundären Zielparametern zeigten sich die einzigen statistisch signifikanten Unterschiede zwischen den Gruppen für den Symptomscore am Tag 2 (p = 0,037), den Medikamentengebrauch gegen den akuten Infekt der oberen Atemwege am Tag 1 (p = 0,011) und die Wirksamkeitsbeurteilung der erhaltenen Intervention am Tag 7 (p = 0,026). Schlussfolgerung: Die Inhalation heißer, trockener Luft in einer Sauna hatte keinen signifikanten Einfluss auf den Schweregrad der Symptome eines akuten Infekts der oberen Atemwege., Introduction: Traditionally, in the treatment of common colds a local application of heat is often used (inhaling hot steam, drinking hot fluids). The efficacy of local heating was evaluated just in a few trials which have had conflicting results. Objective: The aim of the present study was to evaluate whether inhaling 90°C hot dry air in a sauna reduces common cold symptoms greater than inhaling air at room temperature in patients with a newly acquired common cold. Methods: A randomised single blind controlled trial with a treatment duration of 3 days and a follow-up duration of 4 days was conducted. Patients with symptoms of a common cold (at least 2 out of 10 predefined common cold symptoms for 24 hours or less) were randomly assigned to an intervention group or a control group. The intervention consisted for both groups of a 3-minute stay in a dry-heat sauna on 3 consecutive days. Insulated with a winter coat the patients in the intervention group inhaled 90°C hot dry air, whereas the patients in the control group inhaled air at room temperature (24°C). This particular kind of using a sauna has little in common with regular saunavisits, because in this study the focus was on inhaling hot air and not on sweating. The severity of the common cold symptoms was measured with a symptom severity score. The primary outcome measure was the area under the curve which summarised symptom severity on days 2, 3, 5 and 7. Secondary outcome measure were among others the symptom severity scores for individual days, the general ill feeling, the use of medication for the common cold and the incidence of adverse events. Results: 157 patients (age, mean ± standard deviation 32.0 ± 10.2 years, 59.2% women) were included into the trial (intervention group n = 80, control group n = 77). For the primary outcome measure the area under the curve for symptom severity no significant difference between the intervention group (mean ± standard error 31.2 ± 1.8 [95% confidence interval (CI) 27.6 to 34.8]) and the control group (35.1 ± 2.3 [30.5 to 39.7]) was observed (group difference -3.9 [95% CI -9.7 to 1.9], p = 0.189, Cohens d = 0.13). For the secondary outcome measures symptome severity score on day 2 (p = 0.037), medication use for the common cold on day 1 (p = 0.011) and patients’ ratings of the effectiveness of the therapy on day 7 (p = 0.026) significant differences between the groups were found. Conclusion: Inhaling hot dry air in a sauna had no significant impact on the symptom severity of a common cold.
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- 2016
50. Multicenter trial for sudden hearing loss therapy – planning and concept
- Author
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I. Oerlecke, Christoph Meisner, Torsten Rahne, M. Richter, G Dreier, Stefan K. Plontke, A. Weber, I Baumann, Roland Laszig, S. Plößl, Jochen A. Werner, Matthias Girndt, J. Steighardt, Jan Löhler, Rudolf Probst, University of Zurich, and Plontke, S K
- Subjects
Research design ,Pediatrics ,medicine.medical_specialty ,Medizin ,610 Medicine & health ,10045 Clinic for Otorhinolaryngology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Multicenter trial ,Inner ear ,medicine ,030223 otorhinolaryngology ,business.industry ,Retrospective cohort study ,Sudden hearing loss ,Evidence-based medicine ,Guideline ,Clinical trial ,2733 Otorhinolaryngology ,Otorhinolaryngology ,Systemic drug therapy ,Steroids ,business ,030217 neurology & neurosurgery - Abstract
Systemic steroids are widely used worldwide as a standard of care for primary therapy of idiopathic sudden sensorineural hearing loss (ISSHL). The German ISSHL guideline recommends high-dose steroids for primary therapy of ISSHL, without evidence from randomized controlled trials (RCTs). The rationale for the treatment of ISSHL using high dose steroids is only based on retrospective cohort studies.This article describes the planning and initiation of a multicenter, national, randomized, controlled clinical trial entitled Efficacy and safety of high dose glucocorticosteroid treatment for idiopathic sudden sensorineural hearing loss - a three-armed, randomized, triple-blind, multicenter trial (HODOKORT). This clinical trial aims to compare standard dose with two types of high-dose steroids for primary systemic therapy with respect to their efficacy in improving hearing, and thus communication ability, in patients with idiopathic sudden sensorineural hearing loss.This study is funded by the "Clinical Trials with High Patient Relevance" research program in the health research framework of the German Federal Ministry of Education and Research. It is one of two studies by the German Study Center of Clinical Trials of the German Society of Otorhinolaryngology, Head and Neck Surgery (DSZ-HNO). Planning and initiation was done in cooperation with the DSZ-HNO, the Coordination Center of Clinical Trials of the Martin-Luther-University Halle-Wittenberg, and the Study Center of the University Hospital Freiburg.
- Published
- 2016
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