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  • The Authors Journal compilation Blackwell Verlag GmbH, Berlin JDDG 1610-0379/2011/0904 JDDG | 42011 (Band 9)

    JDDG; 2011 9:297303 Submitted: 11.11.2010 | Accepted: 31.12.2010

    Keywords practice guidelines as topic conflict of interest authorship cross-sectional studies drug industry financial support interprofessional relations

    SummaryBackground: In order to ensure the reliability of clinical practice guidelines it is essential to consider potential conflicts of interest with regard to itsdevelopment.Methods: All valid dermatological practice guidelines, which were developedby the German Dermatologic Society (DDG) or the Professional Association ofGerman Dermatologists (BVDD), were recorded. Details about financing andconflicts of interest were systematically evaluated by two independentappraisers according to Domain 6 of the guidelines evaluation instrumentsAGREE and AGREE II.Results: 38 practice guidelines of the DDG/BVDD were identified. Data aboutfinancing of the guidelines are included in 12 of 38 guidelines (32 %) only.Conflicts of interest are stated in no more than 7 of the 38 guidelines (18 %).Wherever a connection with the pharmaceutical industry was stated, no furtherinformation on how possible conflicts of interests were dealt with was found.Conclusions: In current guidelines details on the financing as well as the disclo-sures of potential conflicts of interest are stated insufficiently. Here an opti-mization is necessary. Furthermore strategies for handling conflicts of interestneed to be developed. One possibility is a specific discussion on this issue atthe beginning and during the process of the guidelines work. Furthermore incase of potential conflicts of interest a solution as e. g. abstention from votingon specific questions needs to be developed.

    Disclosure of potential conflicts of interest in dermatological guidelines in Germany an analysis status quo and quo vadis Stefanie Rosumeck, Birte Sporbeck, Berthold Rzany, Alexander NastDivision of Evidence Based Medicine (dEBM), Department of Dermatology, Charit University Medicine, Berlin Germany

    Introduction Guidelines are systematically developedaids intended to assist physicians in deci-sion-making in specific situations. Theyare based on current scientific knowledgeand have proven worthwhile in practice.Different levels of development of guide-lines exist (Table 1).An expert panel is required for all levelsof development of guidelines. Usually anexpert panel is nominated by the respec-tive medical specialty society. The selec-

    tion of experts as well as the entireprocess of developing and financing theguidelines is a special challenge with re-spect to dealing with conflicts of interest.Guidelines should be as free as possiblefrom external influences.It is not easy to find a uniform definitionof conflicts of interest: Thompson [1]presented his definition in 1993 in theNew England Journal of Medicine: Aconflict of interest is a set of conditionsin which professional judgment concern-

    ing a primary interest (such as a patientswelfare or the validity of research) tendsto be unduly influenced by a secondaryinterest (such as financial gain) [1].Klemperer [2] lists a further definitionthat relates to biomedical publications[3]: Conflict of interest exists when anauthor (or the authors institution), re-viewer, or editor has financial or personalrelationships that inappropriately influ-ence (bias) his or her actions []. Theserelationships vary from being negligible

    DOI: 10.1111/j.1610-0387.2011.07615.x Original Article 297

    Evidence based Dermatology

  • to having great potential for influencingjudgment. Not all relationships representtrue conflict of interest. [] The conflictof interest can exist regardless of whetheran individual believes that the relation-ship affects his or her scientific judg-ment. Financial relationships (such asemployment, consultancies, stock own-ership, honoraria, and paid expert testi-mony) are the most easily identifiableconflicts of interest and the most likelyto undermine the credibility of the jour-

    nal, the authors, and of science itself.However, conflicts can occur for otherreasons, such as personal relationships,academic competition, and intellectualpassion [3].In Germany the Association of the Sci-entific Medical Societies (Arbeitsgemein-schaft der Wissenschaftlichen Medizini -schen Fachgesellschaften e. V., AWMF)published recommendations for dealingwith conflicts of interest in the develop-ment of guidelines in April 2010 [4]. Ac-

    cording to this conflicts of interestshould be disclosed on the basis of fourprinciples: separation principle, trans-parency principle, equivalency principleand documentation principle (Figure 1).The individual medical societies shoulddevelop methods of dealing with conflictsof interest and should employ this processin the development of guidelines. The goal of this paper is a systematicevaluation of dealing with conflicts of in-terest in dermatological guidelines. Forthis purpose the relevant domain of theguideline evaluation instrumentsAGREE (Appraisal of Guidelines for Re-search & Evaluation) and AGREE II wasemployed. The first version of the AGREE instru-ment was developed by the AGREE Col-laboration in 2001 [5]. It is an acceptedand validated instrument for themethodologic evaluation of guidelinesand has also already been employed indermatology for the evaluation of qualityof medical guidelines [6, 7]. AGREEcontains 23 criteria in 6 domains. Forthis study the following two criteria withregard to the editorial independence ofguidelines and dealing with conflicts ofinterest of members of the guidelinegroup were examined in an isolated fash-ion (domain 6): AGREE criterion 22: The guideline is

    editorially independent from thefunding body.

    AGREE criterion 23: Conflicts of interest of guideline developmentmembers have been recorded.

    AGREE was modified in 2009 and theformerly four-level response scale to eval-uate a criterion was expanded to a seven-level response scale in AGREE II [8](Figure 2). Furthermore, for criterion 23the demand for thematization of poten-tial conflicts of interest was supple-mented. This leads to differences in theassessment of guidelines with AGREEand AGREE II, respectively. Therefore,the evaluation of available dermatologi-cal guidelines was performed using bothinstruments. The German guideline evaluation in-strument DELBI from 2002 corre-sponds completely in this domain withthe AGREE instrument and was there-fore not considered additionally [9].

    MethodsThe homepage www.awmf.de was accessedon Oct. 27, 2010. All 38 dermatological

    298 Original Article Conflicts of interest in guidelines

    JDDG | 42011 (Band 9) The Authors Journal compilation Blackwell Verlag GmbH, Berlin JDDG 1610-0379/2011/0904

    Table 1: Overview of stages of development and effort of guidelines.

    Type Development characteristics Effort of development(time/costs)

    S1Expert group

    Representative panel Informal consensus Approval by executive committee of

    the medical society

    Low

    S2eFormal evidencereview

    Representative panel Selective panel Systematic evidence base No structural consensus process

    Moderate

    S2kFormal consensusprocess

    Representative panel No systematic evidence base Formal consensus process (nominal

    group process, consensus conference,Delphi procedure)

    High

    S3Evidence review Formal consensusprocess

    Representative panel Systematic evidence base Formal consensus process

    Very high

    Figure 1: Four principles for disclosure of conflicts of interests according to Lo et al. [4, 17].

  • guidelines developed with participationof the German Dermatologic Society(Deutsche Dermatologische Gesellschaft,DDG) and the Professional Associationof German Dermatologists (Berufsver-band Deutscher Dermatologen e.V.,BVDD) were identified. To evaluate statements on the financingof the guidelines and on possible con-flicts of interest of the authors crite-rion 22 and 23 of the AGREE instru-ment in its first version of 2002 [5] andthe revised version of AGREE II of 2009[8] were employed. AGREE utilizes a

    four-level Likert scale, AGREE II aseven-level Likert scale (Figure 2). To achieve a full score for criterion 22besides naming of all sponsors an explicitdeclaration that the final recommenda-tion of the guideline are not affected bythe interests of the sponsors should beincluded (Figure 3). In AGREE the ap-plicability of the criteria is evaluated on ascale from 1 to 4. For the full score for criterion 23 itshould be explicitly stated that all members of the development group haverevealed possible conflicts of interest

    (Figure 4). AGREE II demands here inaddition to a disclosure of possible con-flicts a discussion of their handling. Thiscan lead to a reduction of the score inAGREE II despite a full score inAGREE, as AGREE II questions morequality criteria. Evaluation was performed independentlyby two appraisers (Stefanie Rosumeck,Birte Sporbeck). To determine the stan-dardized domain score, the formulagiven in the AGREE instrument was em-ployed (Figure 5). Differing evaluationswere solved by discussion. For the evaluation the information pub-lished on the internet platform of theAWMF was used. When a publicly accessible method report was referred to,these data were also included in the evaluation. This should be mentioned, as theS3 guideline Prevention of HPV-associ-ated neoplasias by immunization refersto a methods report that has apparentlynot been published. For the S1 guideline

    Conflicts of interest in guidelines Original Article 299

    The Authors Journal compilation Blackwell Verlag GmbH, Berlin JDDG 1610-0379/2011/0904 JDDG | 42011 (Band 9)

    Figure 2: Scale of AGREE and AGREE II.

    Figure 3: AGREE recomm