Klaus Koch

Effects of treatment in women with gestational diabetes mellitus: systematic review and meta-analysis

Objective To summarise the benefits and harms of treatments for women with gestational diabetes mellitus. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Embase, Medline, AMED, BIOSIS, CCMed, CDMS, CDSR, CENTRAL, CINAHL, DARE, HTA, NHS EED, Heclinet, SciSearch, several publishers’ databases, and reference lists of relevant secondary literature up to October 2009. Review methods Included studies were randomised controlled trials of specific treatment for gestational diabetes compared with usual care or “intensified” compared with “less intensified” specific treatment. Results Five randomised controlled trials matched the inclusion criteria for specific versus usual treatment. All studies used a two step approach with a 50 g glucose challenge test or screening for risk factors, or both, and a subsequent 75 g or 100 g oral glucose tolerance test. Meta-analyses did not show significant differences for most single end points judged to be of direct clinical importance. In women specifically treated for gestational diabetes, shoulder dystocia was significantly less common (odds ratio 0.40, 95% confidence interval 0.21 to 0.75), and one randomised controlled trial reported a significant reduction of pre-eclampsia (2.5 v 5.5%, P=0.02). For the surrogate end point of large for gestational age infants, the odds ratio was 0.48 (0.38 to 0.62). In the 13 randomised controlled trials of different intensities of specific treatments, meta-analysis showed a significant reduction of shoulder dystocia in women with more intensive treatment (0.31, 0.14 to 0.70). Conclusions Treatment for gestational diabetes, consisting of treatment to lower blood glucose concentration alone or with special obstetric care, seems to lower the risk for some perinatal complications. Decisions regarding treatment should take into account that the evidence of benefit is derived from trials for which women were selected with a two step strategy (glucose challenge test/screening for risk factors and oral glucose tolerance test).

Die Früherkennung von Prostatakrebs

Prostate cancer screening has been a controversial for decades. The recently published findings of large trials have further intensified the debate. The prospect of reducing mortality from prostate cancer is measured against the risk of over-diagnosing the disease. In individual cases, the trade-off between possible benefits and harms is possible to ascertain, so general recommendations in favor of or against PSA tests for individuals cannot be made. The majority of men, however, are not well-informed on the possible advantages and drawbacks of screening. This situation urgently needs to be corrected. The PSA test is promoted to healthy men, who need to be provided with especially detailed information. If not provided with clear and unbiased information on the risks associated with the test (above all over-diagnosis and over-treatment), these men cannot be considered to be fully informed.

Response to the expertise: Procedures and methods of benefit assessments for medicines in Germany, by Geertruida E. Bekkering and Jos Kleijnen

Trudy Bekkering and Jos Kleijnen were commissioned by the German association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller, VFA) to prepare an expertise on the procedures and methods of benefit assessments for drugs in Germany. So far, such benefit assessments have been prepared only by the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG). English and German versions of the expertise were published almost simultaneously in the European journal of Health Economics [1] and in a German journal (Deutsche Medizinische Wochenschrift [2]), respectively. One of the two authors (J.K.) was actively involved in various IQWiG benefit assessments as an external expert. Nevertheless, in our view the procedures at IQWiG are not appropriately described in the expertise, and the framework within which IQWiG operates is not sufficiently considered. We would like to illustrate these aspects in this commentary. The IQWiG was established in 2004. Its current methods [3] form a stable basis for decisions in the German health care system and completely fulfil both scientific and legal requirements [4]. However, further adaptations and extensions of IQWiG methods would certainly be meaningful. We therefore gladly accept any suggestions, as long as they are transferable to the German setting. However, this is the key weakness of the expertise: Bekkering and Kleijnen define the English National Institute for Health and Clinical Excellence (NICE) as the international standard, whilst underestimating the relevance of the structural, legal and cultural requirements of the German health care system. HTA institutions with important national responsibilities are always adapted to different contexts [5, 6]. It is, so to speak, the international standard that benefit assessment procedures vary from country to country. Eisenberg described this as ‘‘Globalize the evidence, localize the decision’’ [7]. Such local differences admittedly imply additional insecurities and difficulties for international pharmaceutical companies. Bekkering and Kleijnen’s criticism is therefore not new to us. VFA and its member companies have repeatedly criticised IQWiG’s procedures in the past and have in particular presented NICE as a model [8, 9]. As early as December 2004, VFA commissioned an expert to compare the IQWiG methods 1.0 with those of other HTA institutions, in particular those of NICE [10]. The new expertise presented by Bekkering und Kleijnen primarily addresses the following topics: scoping; handling of external experts, comments and reviews; international evidence-based medicine (EBM) standards; and the relationship between scientific evaluation and interpretation and decision-making (in NICE terms referred to as ‘‘assessment’’ and ‘‘appraisal’’). In principle, we agree with Bekkering und Kleijnen: transparency is essential, a scoping process is necessary, EBM standards should apply, and the relationship between ‘‘assessment’’ and ‘‘appraisal’’ should be clearly defined. However, we see good reasons why IQWiG cannot be a copy of NICE. K. Koch (&) S. Lange Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Institute for Quality and Efficiency in Health Care, Dillenburger Straße 27, 51105 Cologne, Germany e-mail: koch@iqwig.de URL: www.iqwig.de

Finding information by quality providers is an issue.

The International Patient Decision Aid Standards Collaboration (IPDAS) and other networks have shown how to respond to the dearth of good-quality information for patients: by cooperation and qualification. In this spirit, the Gute Praxis Gesundheitsinformation (good practice health information) initiative was founded in Germany (1): under the umbrella of the German Network for Evidence Based Medicine (2), information providers have formulated requirements that health information should meet and have committed to implementing and further developing these. If we want to improve the information landscape, we will have to establish evidence based practice on the one hand and simultaneously create a network of providers that have signed up to implementing this criterion. An important task for this network will be to offer further support to those who are seriously on their way to evidence based activities. At the same time we should ensure that patients can actually find the information provided by quality providers. We can only counteract the enormous amount of information biased by financial or intellectual interests if we stand united. It would be inadvisable to leave information seekers alone until an “optimum” has been reached. We think the better alternative is for the “quality” providers (good, not optimum) need to cooperate and jointly seek further qualification. Doctors are important partners in disseminating quality information as they have direct contact with patients. And the need for evidence based information among doctors is great. The opportunity to familiarize doctors with “good practice” should not be missed by Deutsches Arzteblatt.

Correspondence (letter to the editor):In Reply:

Reitmeier’s correspondence poignantly illustrates the dissatisfaction we described in our article. We regard the first five causes as an expression of political opinion that we do not wish to comment on. However, it is not the case that “the concept of evidence based medicine (EBM) can thus far be applied only to narrow segments of primary care doctors’ work.”

Entscheidungsunterstützung durch wissenschaftliche Evidenz

Einleitung Die Wahrnehmung, was mit wissenschaftlicher Evidenz gemeint ist, hat sich in den letzten Jahren deutlich verändert. Der Wechsel der Perspektive ist eng mit dem Begriff evidenzbasierte Medizin verbunden. Gemeint ist damit eine medizinische Betreuung von Patienten, die sich nicht alleine auf Meinungen und Übereinkünfte stützt, sondern wissenschaftliche Nachweise einbezieht, die mit möglichst zuverlässigen Methoden erhoben wurden. In diesem Zusammenhang ist eine bewusste Beschränkung auf „Nützliches“ zwar eine Kernnotwendigkeit eines solidarischen Gesundheitswesens, sie muss aber sorgfältig (und rechtssicher) begründet sein, da sie massive Auswirkungen auf wirtschaftliche Interessen und Märkte haben kann.

Qualität im Gesundheitswesen basiert auf Wissenschaft

Eine wichtige Voraussetzung fur hohe Qualitat in einem Gesundheitssystem ist, dass medizinische Technologien ausschlieslich da eingesetzt werden, wo sie notwendig sind. Dieser Beschrankung steht die Pflicht gegenuber, das was notwendig ist, fur die gesamte Bevolkerung durch die Solidargemeinschaft abzusichern. Ein zweiter Aspekt der Qualitat besteht darin, die notwendigen Leistungen so zu erbringen, dass sie fur den einzelnen Patienten den grostmoglichen Nutzen haben. Idealerweise fordert solch ein System die medizinische Forschung besonders da, wo dringender Bedarf an Verbesserungen besteht.