Risk Awareness and Transparency
Since 1995, the Association of the Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF) maintains an open access, quality assured guideline register currently containing almost 700 guidelines and expert recommendations developed by the 168 AWMF`s member societies (www.awmf.org). The AWMF established a set of rules in order to support the development of high-quality guidelines by its member societies and to assure the overall quality of the register (1). The set of rules is monitored and amended continually. In 2010, a rule addressing the declaration and management of conflicts of interest was introduced. The analysis reported by Langer et al. provides initial insights into the status quo after the introduction of this rule (2). Therefore we consider it a welcome contribution towards quality management.
Remarkably, one year after the introduction of the new rule, the declaration of financial and academic interests can be regarded as an established standard—in contrast to the situation reported internationally (3).
In order to prevent misunderstandings arising from the conclusions reached by Langer et al., the following requires clarification:
- Internationally, conflicts of interest are defined as circumstances that lead to a relevant risk of affecting professional judgment (4). The fact that conflicts of interests exist does, however, not allow a legitimate conclusion that individual authors or guideline contents are biased in any way. Since guidelines are collated by groups, rather than by individuals, biases for the group as a whole need to be assessed.
- This risk is counterbalanced in guidelines by protective factors: a systematic evidence base (scientific basis), interdisciplinary composition of the guideline group (pluralism of interests), structured consensus formation (avoiding undue influence by individual interests).
Currently, no gold standard exists for the management of conflicts of interest, and neither does robust evidence about the effects of using or not using regulations (3, 4). The AWMF member societies have taken on this scientific challenge and are testing different approaches to reduce the risk of bias originating from conflicts of interest on an experimental basis in current guideline projects. These include efforts to estimate and differentiate the value of conflicts of interest, the corresponding restriction of the influence exerted by individuals, delegation of evidence reports to methodology experts, and peer review or public consultation. Creating empirical proofs—in the sense of evidence based medicine—is the prerequisite for the development of a standard, as demanded by Langer et al..
Prof. Dr. med. Rolf Kreienberg
Prof. Dr. med. Ina B. Kopp
Ständige Kommission „Leitlinien“ der AWMF, Düsseldorf
Conflict of interest statement
Professor Kreienberg has received honoraria for consultancy from AstraZeneca (PACT/COMPACT Study).
Professor Kopp received honoraria for consultancy from Pharmallergan (until 2010).
|1.||Muche-Borowski C, Selbmann HK, Nothacker M, Müller W, Kopp I. Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF), Ständige Kommission Leitlinien: AWMF-Regelwerk Leitlinien. www.awmf.org/leitlinien/awmf-regelwerk.html (last accessed on 7 February 2013).|
|2.||Langer T, Conrad S, Fishman L, Gerken M, Schwarz S, Weikert B, Ollenschläger G, Weinbrenner S: Conflicts of interest among authors of medical guidelines—an analysis of guidelines produced by German specialist societies. Dtsch Arztebl Int 2012; 109(48): 836–42. VOLLTEXT|
|3.||Norris SR, Holmer HK, Ogden LA, Burda BU: Conflict of interest in clinical practice guideline development: a systematic review. PLoS ONE 2011; 6: e25153. CrossRef MEDLINE PubMed Central|
|4.||Strech D, Klemperer D, Knüppel H, Kopp I, Meyer G, Koch K: Deutsches Netzwerk Evidenzbasierte Medizin. Interessenkonfliktregulierung: Internationale Entwicklungen und offene Fragen. Ein Diskussionspapier. 2011. www.ebm-netzwerk.de/was-wir-tun/pdf/interessenkonfliktregulierung-2011.pdf/view (last accessed on 7 February 2013).|