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Informationen aus Orthodontie & Kieferorthopädie 2011; 43(04): 247-261
DOI: 10.1055/s-0031-1298011
Übersichtsartikel
© Georg Thieme Verlag KG Stuttgart · New York

Randomisierte klinische Studien im Zusammenhang mit evidenzbasierter Kieferorthopädie

Randomized Clinical Trials (RCTs) in the Context of Evidence-Based Orthodontics (EBO)
N. Pandis
1   Klinik für Kieferorthopädie, Zahnmedizinische Kliniken der Universität Bern, Schweiz
2   Privatpraxis, Korfu, Griechenland
› Author Affiliations
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Publication History

Publication Date:
30 December 2011 (online)

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Zusammenfassung

Evidenzbasierte Kieferorthopädie zielt darauf ab, die besten verfügbaren Forschungsergebnisse mit klinischem Können und den Erwartungen und Vorlieben von Patienten zu verbinden. In Bezug auf die Qualität des verfügbaren Wissens findet sich die Expertenmeinung am unteren Ende der Skala. Auf höherem Niveau liegen dann qualitativ hochwertige Metaanalysen und systematische Übersichtsarbeiten oder randomisierte klinische Untersuchungen mit sehr niedrigem Bias-Risiko. Ein Praktiker, der seine Entscheidungen auf die beste verfügbare Erkenntnis stützen möchte, sollte in der Lage sein, die Qualität von Erkenntnissen zu beurteilen und sie angemessen auf seine persönliche Situation zu übertragen. In der vorliegenden Übersichtsarbeit werden wichtige Punkte schrittweise und anhand kieferorthopädischer Beispiele besprochen, die von einem evidenzbasierten Kieferorthopäden bei der kritischen Beurteilung von randomisierten klinischen Studien im Rahmen der klinischen Entscheidungsfindung berücksichtigt werden sollten. Konzepte wie etwa Randomisierung, Verschleierung der Zuordnung, Verblindung, Bias-Risiko, Intention-to-treat- und Per-Protocol-Analyse (ITT und PP), Effektabschätzung, Konfidenzintervalle und Untergruppenanalyse werden erklärt und ihr Einfluss auf die interne Validität (=methodische Qualität) von randomisierten klinischen Studien bzw. Qualität von Untersuchungsberichten beleuchtet.

Abstract

Evidence-based orthodontics (EBO) aims to merge the best available research evidence with clinical expertise and patient values and preferences. Regarding the quality of the available evidence, at the low end of the hierarchy lie expert opinion(s) and at the higher levels lie high quality meta-analyses and systematic reviews, or randomized clinical trials of very low risk of bias. A clinician striving to make treatment choices guided by the best available evidence should be at the position to assess the quality of the evidence and should be able to appropriately interpret it in her/his own setting. This review article highlights with orthodontic examples and in a step by step approach important points that should be considered by the prospective EBO practitioner when she/he is critically appraising RCTs during the clinical decision process. Concepts such as randomization, allocation concealment, blinding, risk of bias, intention-to-treat (ITT) and per-protocol (PP) analyses, effect estimates, confidence intervals, and subgroup analyses are explained and their association with RCT internal validity (=methodological quality) and/or reporting quality are highlighted.

Schlüsselwörter

evidenzbasierte Kieferorthopädie - randomisierte klinische Studien - systematische Übersichtsarbeiten - Validität/Qualität

Key words

evidence-based orthodontics - randomized clinical trials - systematic reviews - validity/quality
 

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