{"title":"Vier Ebenen von Werturteilen in der medizinischen Nutzenevaluation","authors":"Daniel Strech","doi":"10.1016/j.zgesun.2007.08.005","DOIUrl":"10.1016/j.zgesun.2007.08.005","url":null,"abstract":"<div><p>Die systematische medizinische Nutzenevaluation nach den Kriterien der Evidenz-basierten Medizin ist nicht frei von Wertungen. Sie impliziert Werturteile zu verschiedenen Fragestellungen, z.B.: „Welche Abweichung von wünschenswerten und machbaren Methoden zur Erfassung von Studienendpunkten und zu ihrer Auswertung erscheint uns <em>akzeptabel</em>?” Entsprechende Werturteile beeinflussen die Ergebnisse der Nutzenevaluation erheblich. Um einen rationalen und verantwortungsvollen Umgang mit den notwendigen Projekten einer Evidenz-basierten Medizin zu ermöglichen, bedarf es methodischer Ansätze, um die implizite Normativität in ihren Prozessen identifizieren und transparent machen zu können. Der vorliegende Artikel stellt eine Checkliste zur Identifizierung zentraler Werturteile in der Nutzenevaluation vor und beschreibt ihr Verhältnis zu einer Ethik der Evidenz-basierten Medizin. Als Konsequenz der impliziten Normativität erscheint eine erweiterte Lesart von Transparenz in der Nutzenevaluation erforderlich.</p></div><div><p>Systematic reviews and effectiveness analyses in the context of evidence-based medicine are not free of personal or group related values and interests. Effectiveness analysis has to deal with various “value judgments” concerning questions like ‘what are relevant study endpoints and adequate methodologies for context-related data analysis?’ or ‘which deviation from the desirable und feasible methodology in clinical research is still acceptable?’ Value judgments regarding these questions have a considerable influence on the process of effectiveness analysis and the presentation of its results. A sound and responsible approach to the necessary projects of evidence-based medicine requires a methodology for identifying their implicit normativity and making it more explicit. This article presents a checklist for the identification of central value judgments in effectiveness analyses and describes their role within the ethics of evidence-based medicine. Furthermore, the need for a broader concept of transparency – as a consequence of the implicit value judgments – will be discussed.</p></div>","PeriodicalId":79544,"journal":{"name":"Zeitschrift fur arztliche Fortbildung und Qualitatssicherung","volume":"101 7","pages":"Pages 473-480"},"PeriodicalIF":0.0,"publicationDate":"2007-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.zgesun.2007.08.005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27212814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Literatur und Rezensionen: Leichenschau. Leitlinien zur Qualitaetssicherung","authors":"","doi":"10.1016/j.zgesun.2007.08.028","DOIUrl":"https://doi.org/10.1016/j.zgesun.2007.08.028","url":null,"abstract":"","PeriodicalId":79544,"journal":{"name":"Zeitschrift fur arztliche Fortbildung und Qualitatssicherung","volume":"101 7","pages":"Page 513"},"PeriodicalIF":0.0,"publicationDate":"2007-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.zgesun.2007.08.028","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136713789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Health Policy Monitor: Neue Expertenberichte auf www.hpm.org","authors":"","doi":"10.1016/j.zgesun.2007.08.008","DOIUrl":"https://doi.org/10.1016/j.zgesun.2007.08.008","url":null,"abstract":"","PeriodicalId":79544,"journal":{"name":"Zeitschrift fur arztliche Fortbildung und Qualitatssicherung","volume":"101 7","pages":"Page 454"},"PeriodicalIF":0.0,"publicationDate":"2007-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.zgesun.2007.08.008","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136713467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vom Nutzen der Nutzenbewertung: Die Prinzipien der evidenzbasierten Medizin und des Health Technology Assessments als Entscheidungsgrundlage des Gemeinsamen Bundesausschusses","authors":"Hilke Bertelsmann, Dominik Roters, Dorothea Bronner","doi":"10.1016/j.zgesun.2007.08.004","DOIUrl":"10.1016/j.zgesun.2007.08.004","url":null,"abstract":"<div><p>Mit der Einführung des NUB-Ausschusses im Jahre 1990 begann ein Paradigmenwechsel in der Arbeit des damaligen Bundesausschusses der Ärzte und Krankenkassen. Fortan stützte er und sein Nachfolgegremium Gemeinsamer Bundesausschuss (G-BA) sich nicht mehr (allein) auf den Sachverstand von Experten bei der Bewertung von neuen Untersuchungs- und Behandlungsmethoden, sondern begann sukzessive und systematisch die Methoden der evidenzbasierten Medizin als maßgebliche Grundlage für die Bewertung bei der Einführung von neuen Untersuchungs- und Behandlungsmethoden anzuwenden. Während zunächst nur Verfahren der ärztlichen – nicht-medikamentösen-Behandlung nach den Kriterien der evidenzbasierten Medizin (ebm) bewertet wurden, gilt dies inzwischen konsequent ebenso für die Bewertung neuer Heilmittel wie auch für psychotherapeutische Verfahren und Früherkennungsmaßnahmen, die als Leistung von der gesetzlichen Krankenversicherung erstattet werden sollen. Die vom G-BA angewandte Methodik entspricht dabei den internationalen Standards der ebm und des Health Technology Assessments (HTA) und ist in seiner Verfahrensordnung verbindlich niedergelegt. Es wird dargestellt, wie er im Einzelnen dabei vorgeht. Ein Blick über die Ländergrenzen macht deutlich, dass er mit dieser Arbeitsweise nicht allein steht.</p></div><div><p>In the former German Federal Committee of SHI (-accredited) Physicians and Health Insurance Funds (Bundesausschuss der Ärzte und Krankenkassen) a full paradigmatic change was initiated in 1990 by establishing the NUB Committee (NUB=New Methods of Diagnosis and Treatment).</p><p>The NUB committee and its successor, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA), extended the basis of their decision making process. In order to evaluate new methods of diagnosis and treatment, the methods of Evidence-based Medicine (EbM) were increasingly taken into account aiming to establish a readjusted set of criteria for the evaluation and introduction of new diagnostic and therapeutic methods.</p><p>In the beginning the criteria of Evidence-based Medicine (EBM) were applied to the methods of medical diagnosis and treatment only, but in the meantime have consistently been extended to also cover the evaluation of new physiotherapeutic therapies, psychotherapeutic treatments and measures of early diagnosis and screening, the costs of which are reimbursed by the statutory health insurance (SHI).</p><p>The methodology of the G-BA is in compliance with the international standards of EbM and Health Technology Assessment (HTA) and is the mandatory basis of its work, laid down in its code of procedure.</p><p>This article gives a detailed description of its mode of operation, reflecting in addition the work of similar institutions in other countries with often comparable modes of operation.</p></div>","PeriodicalId":79544,"journal":{"name":"Zeitschrift fur arztliche Fortbildung und Qualitatssicherung","volume":"101 7","pages":"Pages 455-462"},"PeriodicalIF":0.0,"publicationDate":"2007-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.zgesun.2007.08.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27212812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"BQS liefert Uebersetzungen der Qualitaetsmerkmale, die die Krankenhaeuser kuenftig veroeffentlichen müssen","authors":"","doi":"10.1016/j.zgesun.2007.08.029","DOIUrl":"https://doi.org/10.1016/j.zgesun.2007.08.029","url":null,"abstract":"","PeriodicalId":79544,"journal":{"name":"Zeitschrift fur arztliche Fortbildung und Qualitatssicherung","volume":"101 7","pages":"Page 439"},"PeriodicalIF":0.0,"publicationDate":"2007-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.zgesun.2007.08.029","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136713432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}