International prevalence of adverse drug events in hospitals: an analysis of routine data from England, Germany, and the USA

Background: Adverse drug events (ADEs) are frequent in hospitals, occurring either in patients before admission or as a nosocomial event, and either as a drug reaction or as a consequence of a medication error. Routine data primarily recorded for reimbursement purposes are increasingly being used on a national level both in pharmacoepidemiological studies and in trigger tools. The aim of this study was to compare the prevalence rates of coded ADEs in hospitals on a transnational level. Methods: Hospital data for England and the USA were obtained for the fiscal or calendar year 2006. German data for 2006 were accessed via teleprocessing with the Federal Statistical Office. The datasets from England and the USA were adapted to the German data. About 6 million (England), 7 million (USA), and 16 million (Germany) inpatients could be included. ADEs were identified through a list of codes used in the national diagnosis classifications. Results: The overall prevalence rate (and 95% confidence interval, CI) of coded ADEs was 3.22% (3.20-3.23%) for England, 4.78% (4.73-4.83%) for Germany, and 5.64% (5.63-5.66%) for the USA. Most of the English ADE cases occurred in patients admitted as emergency. A non-surgical status and a longer length of stay were consistently associated with the occurrence of an ADE. Enterocolitis caused by Clostridium difficile was the most frequent ADE in all countries. Conclusions: According to routine data, the overall ADE prevalence rates for England, Germany, and the USA are different. However, the differences are narrower than those determined from the rates of ADEs or adverse drug reactions inferred from prospective or retrospective pharmacoepidemiological studies. Since the ADEs in the countries examined in this study share several characteristics, the use of routine data for transnational research on ADEs is feasible

Value of the electronic patient record: An analysis of the literature

AbstractWe undertook a systematic review of the literature on the basis of published studies on the benefit and costs of Electronic Patient Records (EPRs) to clarify the issue of whether and to what extent the use of an EPR is worthwhile. We carried out a systematic electronic search for articles published between 1966 and early 2004 using MEDLINE, following up cross-references from the articles found. We searched first for suitable medical subject headings (MeSH) for electronic patient record, benefit and costs. We obtained 7860 citations with the MeSH keyword ‘‘Medical Record System, Computerized”. After combination with appropriate keywords this number was reduced to 588, after a review by two reviewers independently based on abstracts down to 95, and after a further review based on full-text articles to 19 covering 20 studies. The publications evaluated thus document the economic benefits of EPR in a number of areas, but they do not make a statement of the cost effectiveness of EPR in general

Costs of Adverse Drug Events in German Hospitals—A Microcosting Study

AbstractObjectiveIn Germany, only limited data are available to quantify the attributable resource utilization associated with adverse drug events (ADEs). The aim of this study was twofold: first, to calculate the direct treatment costs associated with ADEs leading to hospitalization and, second, to derive the excess costs and extra hospital days attributable to ADEs of inpatient treatments in selected German hospitals.MethodsThis was a retrospective and medical record–based study performed from the hospitals' perspective based on administrative accounting data from three hospitals (49,462 patients) in Germany. Total treatment costs (“analysis 1”) and excess costs (i.e., incremental resource utilization) between patients suffering from an ADE and those without ADEs were calculated by means of a propensity score–based matching algorithm (“analysis 2”).ResultsMean treatment costs (“analysis 1”) of ADEs leading to hospitalization (n = 564) were €1,978 ± 2,036 (range €191–18,147; median €1,446; €843–2,480 [Q1–Q3]). In analysis 2, the mean costs of inpatients suffering from an ADE (n = 1,891) as a concomitant disease or complication (€5,113 ± 10,059; range €179–246,288; median €2,701; €1,636–5,111 [Q1–Q3]) were significantly higher (€970; P < 0.0001) than those of non-ADE inpatients (€4,143 ± 6,968; range €154–148,479; median €2,387; €1,432–4,701 [Q1–Q3]). Mean inpatient length of stay of ADE patients (12.7 ± 17.2 days) and non-ADE patients (9.8 ± 11.6 days) differed by 2.9 days (P < 0.0001). A nationwide extrapolation resulted in annual total treatment costs of €1.058 billion.ConclusionsThis is one of the first administrative data–based analyses calculating the economic consequences of ADEs in Germany. Further efforts are necessary to improve pharmacotherapy and relieve health care payers of preventable treatment costs

Matching Study to Registry data: Maintaining Data Privacy in a Study on Family based Colorectal Cancer

Confidentiality of patient data in the field of medical informatics is an important task. Leaked sensitive information within this data can be adverse to and being abused against a patient. Therefore, when working with medical data, appropriate and secure models which serve as guidelines for different applications are needed. Consequently, this work presents a model for performing a privacy preserving record linkage between study and registry data. The model takes into account seven requirements related to data privacy. Furthermore, this model is exemplified with a study on family based colorectal cancer in Germany. The model is very strict and excludes possible violations towards data privacy protection to a reasonable degree. It should be applicable to similar use cases which are in need of a mapping between medical data of a study and a registry database

Datenqualität in der medizinischen Forschung

The benefit of cohort studies and registers in patient-oriented collaborative research depends largely on the quality of the data recorded there. Supply and quality research depend on scientifically proven methods and procedures to ensure high data quality. This guideline contains corresponding recommendations for the management of data quality in registers, cohort studies and data repositories. In the second edition, a significantly expanded set of indicators is provided and the use of the indicators is described as an example for different types of empirical research projects. The guideline is rounded off by a current literature review and analysis. It is therefore an important part of the range of measures to improve and ensure data quality in medical research.Der Nutzen von Kohortenstudien und Registern in der patientenorientierten Verbundforschung hängt wesentlich von der Qualität der dort erfassten Daten ab. Versorgungs- und Qualitätsforschung sind auf wissenschaftlich abgesicherte Methoden und Verfahren zur Sicherstellung einer hohen Datenqualität angewiesen. Die vorliegende Leitlinie enthält entsprechende Empfehlungen zum Management von Datenqualität in Registern, Kohortenstudien und Data Repositories. In der 2. Auflage wird ein deutlich erweitertes Indikatorenset bereitgestellt und die Anwendung der Indikatoren beispielhaft für verschiedene Typen von empirischen Forschungsvorhaben beschrieben. Die Leitlinie wird abgerundet durch eine aktuelle Literatursichtung und -analyse. Sie ist damit ein wichtiger Bestandteil des Maßnahmenspektrums zur Verbesserung und Sicherung der Datenqualität in der medizinischen Forschung

Matching Study to Registry data: Maintaining Data Privacy in a Study on Family based Colorectal Cancer

Confidentiality of patient data in the field of medical informatics is an important task. Leaked sensitive information within this data can be adverse to and being abused against a patient. Therefore, when working with medical data, appropriate and secure models which serve as guidelines for different applications are needed. Consequently, this work presents a model for performing a privacy preserving record linkage between study and registry data. The model takes into account seven requirements related to data privacy. Furthermore, this model is exemplified with a study on family based colorectal cancer in Germany. The model is very strict and excludes possible violations towards data privacy protection to a reasonable degree. It should be applicable to similar use cases which are in need of a mapping between medical data of a study and a registry database