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Epidemiologische Studien als Teil des HTA-Bewertungsprozesses

Epidemiological studies in the HTA evaluation process

  • Leitthema: HTA — was verbirgt sich dahinter?
  • Published:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Bei der Bewertung des Behandlungsnutzens medizinischer Leistungen im Rahmen des Health Technology Assessments (HTA) sollten auch die Ergebnisse epidemiologischer Beobachtungsstudien als Teil der vorhandenen Evidenz berücksichtigt werden. Pharmakoepidemiologische Datenbanken können ein breiteres Verständnis der Wirksamkeit von Arzneimitteln bei in klinischen Studien unterrepräsentierten Populationen vermitteln und dazu beitragen, das Auftreten unerwünschter Wirkungen in Abhängigkeit von soziodemografischen und versorgungsbezogenen Merkmalen näher zu untersuchen. Sie tragen damit dazu bei, eine auf bestimmte Patientengruppen gezielt abgestimmte Arzneimitteltherapie zu ermöglichen. Der vorliegende Artikel diskutiert die Möglichkeiten und Schwierigkeiten, datenbankbasierte Ergebnisse am Beispiel pharmakoepidemiologischer Asthmastudien angesichts vielfältiger Biasquellen zu interpretieren und in den HTA-Bewertungsprozess zu integrieren. Die Entwicklung eines standardisierten Methodeninventars, z. B. bei der gepoolten Analyse epidemiologischer Studien, erfordert erhebliche Anstrengungen auf Seiten der epidemiologischen Forschung.

Abstract

Results of epidemiological studies should be considered as part of the available evidence when evaluating drug treatment benefits in health technology assessment (HTA). Pharmacoepidemiological databases can provide a broader understanding of the effectiveness of drugs in populations that are frequently underrepresented in clinical trials. Such databases are also useful to investigate drug safety with regard to socio-demographic and medical care-related indicators and hereby contribute to an optimal and targeted pharmacological therapy. Using examples from pharmacoepidemiological asthma studies, the present article discusses associated difficulties in interpreting database results against the background of various sources of bias and proposes possibilities for integrating observational data into the HTA evaluation process. Researchers are challenged to engage in considerable efforts to develop a standardized inventory of epidemiological methods, e.g. for the pooled analysis of epidemiological data.

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  1. Bremer Institut für Präventionsforschung und Sozialmedizin

    T. Behrens & W. Ahrens

  2. Bremer Institut für Präventionsforschung und Sozialmedizin (BIPS), Linzer Straße 10, 28253 , Bremen

    T. Behrens

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  1. T. Behrens
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Correspondence to T. Behrens.

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Behrens, T., Ahrens, W. Epidemiologische Studien als Teil des HTA-Bewertungsprozesses. Bundesgesundheitsbl - Gesundheitsforsch - Gesundheitsschutz 49, 264–271 (2006). https://doi.org/10.1007/s00103-005-1222-3

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