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Klinische Studien zur multimodalen Schmerztherapie

Standardisierte Therapieeffektmessung mit einem „Core Outcome Set“

Clinical studies on multimodal pain therapy

Standardized measurement of therapy outcomes with a core outcome set

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Zusammenfassung

Allokationsentscheidungen gründen sich auf Angaben zu den Effekten einer Intervention sowie zu deren Effektivität und Sicherheit in bestimmten Patientenpopulationen. Typischerweise gehen dabei Ergebnisse zu Therapieeffekten aus unterschiedlichen Studien ein. Eine wesentliche Hürde stellen in diesem Kontext Studien dar, die Therapieeffekte meist uneinheitlich messen und folglich eine Vergleichbarkeit nicht zulassen. Für sämtliche medizinische Versorgungsbereiche – so auch für die multimodale Schmerztherapie (MMST) – existieren solche methodischen Herausforderungen. Mithilfe eines „Core Outcome Sets“ (COS) soll eine notwendige Standardisierung der Effektivitätsmessung in der klinischen Forschung erreicht werden. Ein COS ist ein evidenzbasiertes und konsentiertes Minimumset, das in jeder klinischen Studie gemessen werden sollte. Es besteht aus Outcome-Domänen – d. h., Teilaspekten des zu untersuchenden Krankheitszustands, die gemessen werden sollten, um Therapieeffekte bestmöglich abbilden zu können – sowie aus dazugehörigen validen, reliablen und änderungssensitiven Messinstrumenten. Ein explizit für die MMST erarbeitetes COS für klinische Studien liegt derzeit nicht vor. Ein Ziel des Beitrags ist, zunächst einen Überblick über gegenwärtig empfohlene methodische Vorgehensweisen zur Entwicklung von COS zu geben. Darauf aufbauend wird anhand einer Bestandsaufnahme illustriert, welche diversen COS-Initiativen zu unterschiedlichen Schmerzsyndromen existieren. Zusätzlich werden die jeweiligen COS-Empfehlungen gegenübergestellt, um daran anknüpfend abzuleiten, ob die existierenden Empfehlungen für die MMST angewendet werden können. Abschließend wird anhand der Situation in Deutschland aufgezeigt, welchen Beitrag bisher die Versorgungsforschung zur einheitlichen Messung der Therapieeffekte der MMST leistet.

Abstract

Decision making in evidence-based medicine is based on general data on therapy outcomes as well as the effectiveness and safety in specific patient populations. Typically, findings concerning therapy outcomes from different studies are aggregated for a final conclusion. In this context a comparison of results is hampered by studies in which therapy outcomes are heterogeneously measured. Such methodological challenges exist for almost all areas of medical treatment, as well as for multimodal pain therapy (MMPT). Through establishing core outcome sets (COS) the required standardization of measurement of therapy outcomes in clinical research can be achieved. A COS is an evidence-based and consented minimum set consisting of outcome domains (i.e. partial aspects of the medical condition to be investigated, which have to be measured in order to give the best possible demonstration of therapy outcome of an intervention) accomplished by valid, reliable and sensitive measurement instruments which should be applied in each clinical trial. No such COS has so far been found for MMPT. The aim of this article is to give an overview about currently recommended methodological approaches to develop a COS accompanied by a brief introduction about existing COS initiatives focusing on chronic pain. The existing COS recommendations are discussed and conclusions are drawn on whether existing recommendations could also be applied for MMPT. Finally, the impact of healthcare research in Germany on a standardized assessment of therapy outcome in MMPT is outlined.

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Danksagung

Bei der im Beitrag vorgestellten Studie VAPAIN handelt es sich um eine vom Bundesministerium für Bildung und Forschung geförderte Studie (01GY1326; Zeitraum 2013–2016).

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  1. UniversitätsSchmerzCentrum, Universitätsklinikum Carl Gustav Carus, Fetscherstr. 74, 01307, Dresden, Deutschland

    S. Deckert & J. Schmitt

  2. Universitäts SchmerzCentrum, Universitätsklinikum Carl Gustav Carus, Dresden, Deutschland

    R. Sabatowski &  U. Kaiser

  3. Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Carl Gustav Carus, Dresden, Deutschland

    R. Sabatowski

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  1. S. Deckert
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S. Deckert, R. Sabatowski, J. Schmitt und U. Kaiser geben an, dass kein Interessenkonflikt besteht.

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Deckert, S., Sabatowski, R., Schmitt, J. et al. Klinische Studien zur multimodalen Schmerztherapie. Schmerz 30, 537–548 (2016). https://doi.org/10.1007/s00482-016-0123-8

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