disclosure of potential conflicts of interest in dermatological guidelines in germany – an...

© The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin • JDDG • 1610-0379/2011/0904 JDDG | 4˙2011 (Band 9)

JDDG; 2011 • 9:297–303 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, Charité – 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 patient’swelfare 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 author’s 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 | 4˙2011 (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


Figure 2: Scale of AGREE and AGREE II.

Figure 3: AGREE recommendations for the evaluation of criterion 22 [10].

Figure 4: AGREE recommendations for the evaluation of criterion 23 [10].

Figure 5: Formula for calculation of the standardized domain value by AGREE [5].

“Anal intraepithelial neoplasia (AIN) and perianal intraepitheliale neoplasia(PAIN)”, “Scabies” and “Use of high-dose intravenous immunoglobulins indermatology” further statements arefound for example in the respective PDFfiles on the website http://www.derma.de(last access Sept. 29, 2010) or in a pub-lished version of the last-mentionedguideline in the European Journal ofDermatology [11].

Results On the AWMF homepage in the cate-gory dermatology 67 guidelines eithervalid and/or currently undergoing revi-sion were found on the qualifying date(Oct. 27, 2010).The German Dermatologic Society to-gether with the Professional Associationof German Dermatologists submitted 38of the 67 guidelines itself to the AWMF(Table 2). The remaining guidelineslisted at the AWMF by other medical so-cieties under participation of the DDG. The 38 dermatological guidelines of theDDG and the BVDD were systemati-cally reviewed with respect to statementson financing and on conflicts of interest(domain 6 “editorial independence”) ac-cording to AGREE [5] and AGREE II[8] (Table 3).

Criterion 22In 12 of the 38 guidelines (32 %) state-ments on financing are made, the re-maining 26 guidelines make no state-ment on this matter. In the 12mentioned guidelines in three cases anadditional statement was made, that theguideline group and the content of theguidelines were free of influence by thesponsor (Table 4).The highest scores for this criterion wereachieved by the AWMF guideline “Pre-vention of venous thromboembolism(VTE)”, the guideline on “Prevention ofHPV-associated neoplasias by immu-nization” as well as the “National healthcare guideline type 2 diabetes: preven-tion and treatment strategies for footcomplications”. It should be mentioned

here that only the guideline on “Preven-tion of HPV-associated neoplasias by im-munization” was developed under theoverall charge of the DDG. The otherguidelines originated from the NationalDisease Management Guidelines Pro-gram or the AWMF. It should be empha-sized that these 3 guidelines evaluated asbest belong to level of development 3.

Criterion 23In 7 of 38 guidelines (18 %) statementsby the authors on possible conflicts of in-terest are found. This usually occurs in alisting of possible lectures, honoraria andthe like of the individual authors. This isfollowed by a summary standard formu-lation from the viewpoint of the respec-tive author such as “no conflicts of inter-est result from this”. Methods for dealing with potential con-flicts of interest (e. g. abstaining fromvoting on certain questions) were not de-scribed in any guidelines of the DDGand BVDD. Distinctly lower scores therefore resultedin the aspect dealing with possible con-flicts of interest. This was, however, firstdemanded as a criterion in AGREE II.The S3 AWMF guideline “Prevention ofvenous thromboembolism (VTE)” ac-cordingly achieves the full score, 4 of 4,for point 23 in AGREE. Using theAGREE II instrument, on the otherhand, only 4 of 7 possible points couldbe assigned.

Summary criterion 22/23 (domain 6)In viewing all 38 dermatological guide-lines a mean domain score of 21.93 %for AGREE but only 16.67 % of possiblepoints for AGREE II is achieved. Amongothers, this results from the large numberof S1 guidelines that are usually lessstructured. In comparison all 4 S3 guide-lines achieve a domain score of at least50 %. The exact score for the criteria 22and 23 of domain 6 of all reviewedguidelines are depicted in Table 3.Considering only those guidelines withany statements on domain 6, the12 guidelines have a mean domain score

of 69.44 %, using AGREE II only52.78 %. This difference results firstfrom the stricter criteria in AGREE II,where not only the disclosure of conflictsof interest is considered, but also detailedinformation on dealing with existingconflicts is requested. Further, the seven-level response scale allows for finer grad-ing of the fulfillment of the individualcriteria.

ConclusionsThe participation of clinical experts is in-dispensable for the development ofguidelines. To gather a group of expertswithout any conflicts of interest is prob-ably impossible and in such a case the ex-pertise of the group would surely bequestionable. Besides possible purely fi-nancial conflicts of interest, a member ofthe guidelines group would always havefurther personal as well as academic con-flicts of interest. As conflicts of interest cannot be avoidedcompletely, disclosure of and dealingwith possible conflicts of interest is allthe more important. Our results showthat there is a great potential for im-provement in the field of dermatology.Similar studies from German-speakingcountries on this subject do not exist.On the whole, the results of dermatolog-ical guidelines probably differ little fromother specialties. Buchan et al. foundcomparable results in a study on Aus-tralian guidelines. Of the identified313 Australian guidelines published orreviewed between 2003 and 2007, 79 %(246 of 313) contained no statements onpotential conflicts of interest of membersof the guidelines group [12].The new standard form of the AWMF[13] offers a good starting point for im-provement. It is nevertheless important,that conflicts of interest are already takeninto consideration at the beginning ofguidelines work. Here the goal should beless an exclusion of individual members,but a healthy balancing and the manage-ment of diverging interests by the mostheterogeneous composition of the groupas possible.The approaches to dealing with conflictsof interest are varied. Rosenfeld et al. intheir handbook on guidelines develop-ment of the American Academy of Oto-laryngology-Head and Neck Surgerystress, that it is the responsibility ofguidelines experts to list possible finan-cial and non-financial dependencies



Table 2: Number of guidelines of the DDG and BVDD (registered on webpages of the AWMF).

S1 guidelines S2 guidelines S3 guidelines

28 6 4



Table 3: Evaluation of guidelines according to AGREE and AGREE II (Domain 6); Categorization based on AWMF criteria was performed: 1) submitted guidelines by DDG/BVDD 2) submitted guidelines by DDG/BVDD in charge ofother organizations (ÄZQ/AWMF) are marked with *; selection and evaluation of guidelines by DDG and BVDD wasdone before restructuring of the AWMF websites on Dec. 8, 2010. Potentially, this could lead to discrepancies in thenumber of listed guidelines.

Level GuidelineAGREE AGREE II

Item 22 Item 23 Item 22 Item 23

3 AWMF Guideline Prevention of venous thromboembolism (VTE)* 4 4 7 4

3 NVL type 2 diabetes: Prevention and treatment strategies for foot complications* 4 4 7 3

3 Prevention of HPV-associated neoplasias by immunization 4 4 7 2

3 Therapy of psoriasis vulgaris 3 4 4 4

2 Chronic pruritus 4 4 7 3

2 Treatment of acne 3 4 4 3

2 Psychosomatic dermatology 1 1 1 1

2 Atopic dermatitis 1 1 1 1

2 Diagnostics and therapy of ichthyoses 1 1 1 1

2 Perioral dermatitis 1 1 1 1

1 Cutaneous manifestations of Lyme borreliosis 4 1 7 1

1 Immunologic infertility 4 1 7 1

1 Management of hand dermatitis 4 1 7 1

1 Streptococcal infections of the skin and mucous membranes 4 1 7 1

1 Contact dermatitis 4 1 7 1

1 Use of porcine collagen in aesthetic medicine 2 1 3 2

1 Scabies 1 1 1 1

1 Psoriasis of the scalp 1 1 1 1

1 Therapy of psoriatic arthritis and psoriasis vulgaris with infliximab 1 1 1 1

1 Therapy with cyclosporine in dermatology 1 1 1 1

1 Zoster and zoster pain 1 1 1 1

1 Inpatient dermatologic rehabilitation of atopic dermatitis in adults 1 1 1 1

1 Recommendations on phototherapy and photochemotherapy 1 1 1 1

1 Actinic prurigo 1 1 1 1

1 Polymorphic light eruption 1 1 1 1

1 Topical dermatotherapy with glucosteroids – therapeutic index 1 1 1 1

1 Phototoxic and photoallergic reactions 1 1 1 1

1 Therapy of atopic dermatitis with calcineurin inhibitors 1 1 1 1

1 Staphylococcal infections of the skin 1 1 1 1

1 Occupational skin products 1 1 1 1

1 Mastocytosis 1 1 1 1

1 Definition and therapy of primary hyperhidrosis 1 1 1 1

1 Cutaneous lupus erythematosus 1 1 1 1

1 Anal intraepithelial neoplasia (AIN) and perianal intraepithelial neoplasia (PAIN) 1 1 1 1

1 Micrographic surgery 1 1 1 1

1 Rosacea 1 1 1 1

1 Diagnostics and therapy of circumscript scleroderma 1 1 1 1

1 Use of high-dose intravenous immunoglobulins in dermatology 1 1 1 1

regardless, if they are personally viewedas conflicts of interest or not. Their inter-pretation is reserved for the guidelinesgroup in its totality; this must decide inthe individual case if and to what extentan influence is present [14]. Qaseem et al. have likewise definedmethods for the development of clinicalguidelines for the American College ofPhysicians (ACP). At each meeting themembers and coworkers of the ACP andthe guidelines committee again disclosepotential financial and non-financialconflicts of interest. Fundamentally themethodology of the ACP also envisionsthe exclusion of a member on thegrounds of suspected bias [15].Thompson depicts three approaches toregulate conflicts of interest in medicine:disclosure, management and exclusion[16]. The survey of dermatological guide-lines reveals that – to date – only the firstpossibility, disclosure of conflicts, hasbeen employed. This has also been per-formed only insufficiently, as a standard-ized form such as that of the AWMF [13]was only rarely utilized. Management ofconflicts of interest offers an adequatemiddle course between simply listingpossible conflicts of interest and consis-tent exclusion of experts with multipleconflicts of interest. An individual settle-ment is attempted here, for example theperson in question may be heard duringthe discussion of a therapy recommenda-tion but abstains from voting [16].

Many questions in dealing with conflictsof interest remain unanswered and willalso not be able to be resolved optimallyin the near future. A dilemma remains instriving for a high level of expertise andthe often associated increase in conflictsof interest. By an appropriate number ofparticipants conflicts of interest shouldbe balanced.Besides current conflicts of interest, fu-ture ones may be of importance. This hasnot yet been considered in existing sur-veys. Membership in a guidelines groupincreases the significance of the memberand passing of therapy recommendationsmay greatly affect the allocation of re-search funds and invitations for lectures,among others. The American College ofChest Physicians (ACCP) demands of itsguidelines group members to refuse lec-ture fees from pharmaceutical companiesduring the process of guidelines develop-ment as well as up to two years thereafter(Ouellette, Daniel R. ACCP GuidelineMethodology Course, G-I-N Confer-ence 2010. Preconference available [email protected]).Editorial independence is an essentialpart of securing credibility of guidelines.To gather an expert group that is com-pletely free of conflicts of interest appearsto be unrealizable. Even if absolutely noconnections exist to pharmaceuticalcompanies, possible conflicts of interestresult, for example, from practice peculi-arities (e. g. investments in particular

devices) or occupational conflicts (e. g.delineation from other specialties or dis-tribution interests between the outpa-tient and the inpatient sector).A first step to improvement of the situa-tion in dermatology would be complete,concrete disclosure and publication ofconflicts of interest. The aspect of possibleconflicts of interest should be consideredduring nomination of experts as well asrepeatedly during the course in the eventof changes. Reservations should be dis-cussed within the guidelines group andappropriate measures drawn up. Theyshould find consideration in the furtherprocess of guidelines development.

FinancingThis paper was financed exclusively bythe Division of Evidence Based Medicine(dEBM) of the Department of Derma-tology, Charité – University Medicine,Berlin, Germany.

Conflicts of interestIn general: An analysis and criticism ofdealing with conflicts of interest increasedemands on one’s own transparency. Themore independency is expected fromguidelines authors, the more the authorswill limit themselves. We are aware ofthis conflict situation and consider ourwork as an impetus to thoughtfulnessand a basis for discussion.Possible conflicts of interest of the au-thors are disclosed in the following, were



Table 4: Domain score of the 12 guidelines with information about editorial independency (domain 6); submittedguidelines by DDG/BVDD in charge of other organizations (ÄZQ/AWMF) are marked with*.

Level Guideline

AGREE AGREE II

Domain 6

Domain score Domain score

3

AWMF guideline Prevention of venous thromboembolism (VTE)* 100.00 % 75.00 %

NVL type 2 diabetes: Prevention and treatment strategies for foot complications* 100.00 % 66.67 %

Prevention of HPV-associated neoplasias by immunization 100.00 % 58.33 %

Therapy of psoriasis vulgaris 83.33 % 50.00 %

2Chronic pruritus 100.00 % 66.67 %

Treatment of acne 83.33 % 41.67 %

1

Cutaneous manifestations of Lyme borreliosis 50.00 % 50.00 %

Contact dermatitis 50.00 % 50.00 %

Immunologic infertility 50.00 % 50.00 %

Management of hand dermatitis 50.00 % 50.00 %

Streptococcal infections of the skin and mucous membranes 50.00 % 50.00 %

Use of porcine collagen in aesthetic medicine 16.67 % 25.00 %

discussed in the author group and deal-ing with them clarified. AN and BR weretherefore excluded from the evaluationof the guidelines.SR: Stefanie Rosumeck is a scientific em-ployee of the dEBM and co-author ofthe guideline “Therapy of psoriasis vul-garis”. In order to avoid intrapersonalbias in the appraisal of the guidelines, theauthor group resolved that this guidelinealso be appraised by SR. In addition, itshould be noted that a second, inde-pendent evaluation was performed bythe appraiser BS. BS: Birte Sporbeck is a scientific assistantof the dEBM. BS has not yet been activelyinvolved in the development of guidelines.BR: Professor Dr. Berthold Rzany ScM ishead of the Division of Evidence BasedMedicine. He is a dermatologist and epi-demiologist. He is co-author of the guide-lines on “Therapy of psoriasis vulgaris”,“Treatment of acne”, “Prevention ofHPV-associated neoplasias by immuniza-tion” as well as “Use of porcine collagen inaesthetic medicine”. He is a guidelineconsultant of the AWMF and member ofthe AWMF Guideline Commission.AN: Dr. Alexander Nast is a physician ofthe Department of Dermatology atCharité – University Medicine, Berlin,and co-author of the guidelines “Ther-apy of psoriasis vulgaris” and “Treatmentof acne”. <<<

Stefanie Rosumeck

Correspondence toDr. Alexander NastDivision of Evidence Based Medicine(dEBM)Department of DermatologyCharité – University Medicine BerlinCampus Charité MitteCharitéplatz 1D-10117 Berlin, GermanyTel.: +49-30-450-518-283E-mail: [email protected]

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