Varianz in der Epidemiologie unerwünschter Ereignisse: Methodik des Harvard Medical Practice Design

Zusammenfassung

Das Harvard Medical Practice (HMP) Design basiert auf einer mehrstufigen retrospektiven Analyse der Akten von Krankenhauspatienten und wird eingesetzt, um (vermeidbare) unerwünschte Ereignisse ([V]UE) in großen Studienpopulationen zu erfassen. Bislang wurden Studien nach dem HMP-Design in 9 Ländern mit zum Teil erheblich unterschiedlichen Ergebnissen durchgeführt: während in den USA 2,9–3,7% der Krankenhauspatienten ein UE erfahren, sind es z. B. in Australien 16,6%. Die vorliegende Arbeit analysiert 9 englischsprachig publizierte HMP-Studien systematisch auf methodische Unterschiede und diskutiert mögliche Einflüsse auf die Varianz der Ergebnisse. Modifikationen sind in allen Phasen der Planung, Durchführung und Berichterstattung nachweisbar. Dabei unterscheiden sich die 2 US-amerikanischen Studien mit den niedrigsten Ereignishäufigkeiten in methodischer Hinsicht von allen übrigen Untersuchungen durch ihren haftungsrechtlichen Kontext und ein fehlendes Screening auf nosokomiale Infektionen. Studien mit einem hohen Anteil von UE in der zweiten Analysestufe ist eine intensivierte Schulung ärztlicher Gutachter gemeinsam. Weitergehende Schlüsse werden dadurch erschwert, dass Beobachtungszeiträume unterschiedlich definiert werden, Häufigkeiten als Periodenprävalenzen abgebildet werden und Ergebnisse nicht einheitlich berichtet werden. Vor diesem Hintergrund sollte für künftige Studien nach dem HMP-Design vor allem eine vollständige, einheitliche und transparente Berichterstattung angestrebt werden. Insgesamt besteht weiterer Forschungsbedarf zur bestmöglichen Erfassungsmethodik unerwünschter Ereignisse im Rahmen der Patientensicherheitsforschung.

Abstract

The Harvard Medical Practice (HMP) Design is based on a multi-staged retrospective review of inpatient records and is used to assess the frequency of (preventable) adverse events ([P]AE) in large study populations. Up to now HMP studies have been conducted in 9 countries. Results differ largely from 2.9% to 3.7% of patients with AE in the USA up to 16.6% in Australia. In our analysis we systematically compare the methodology of 9 HMP studies published in the English language and discuss possible impacts on reported frequencies. Modifications in HMP studies can be individualised from each stage of planning, conducting, and reporting results. In doing so 2 studies from the USA with lowest rates of AE can be characterised by their context of liability and the absence of screening for nosocomial infections. Studies with a high proportion of AE are marked by an intense training of reviewers. Further conclusions are hindered by divergences in defining periods of observation, by presenting frequencies as cumulative prevalences, and differences in the reporting of study results. As a consequence future HMP studies should go for complete, consistent and transparent coverage. Further research should concentrate on advancing methods for collecting data on (P)AE.

Schlüsselwörter

Epidemiologie - unerwünschte Ereignisse - Patientensicherheit - Chart Review - Harvard Medical Practice Design

Key words

epidemiology - adverse event - patient safety - chart review - Harvard medical practice design

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1 Die spanische Studie untersuchte die Interrater-Reliabilität nach Facharztgruppen separat.

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