Full Text Figures U., Mannheim11. Hütteroth, T. H., Lübeck12. Kaiser, S., Tübingen 13. Stoehr, A., Hamburg 14. Kronenberger, B., Frankfurt15. Lammert, F., Bonn16. Meyer, S., Hannover17. Müller-Schilling, M., Heidelberg 18. Urban, S., Heidelberg19. van Bömmel F., Berlin Conflict of interest While professional expertise is necessary when developing the guideline for health care, a commercial dependency or other conflict of interest which could influence or even systematically distort the guideline contents must be strictly avoided. The statements of the authors and participants of the consensus process are important to evaluate the quality of the guideline. Furthermore, they are important for its overall authorization and credibility as seen by the public and politicians. All persons involved in the guideline preparation have signed a statement on their possible conflict of interest. The signed forms are kept at the office of the Competence Network for Viral Hepatitis ([Table 3]). Table 3 Financial or other connections or conflict of interest of the authors with third parties who are potentially interested in the guideline contents authors affiliation conflict of interest M. Cornberg consultancy or expertise for (Hope for Hep B) Bristol Myers Squibb; paid lectures for Roche, Novartis, Bristol Myers Squibb, Essex, Falk none U. Protzer none none M. Dollinger paid lectures for Gilead, Roche, Essex, Falk; consultancy for Gambro none J. Petersen consultancy or expertise for Bristol Myers Squibb, Gilead, Idenix, Novartis, Roche, Schering-Plough; paid lectures for Bristol Myers Squibb, Falk, Gilead, Glaxo Smith Kline, Idenix, Novartis, Roche, Schering-Plough. Third party funds from Gilead, GlaxoSmithKline, Schering Plough none H. Wedemeyer consultancy or expertise for Bristol Myers Squibb, Gilead, Novartis, Roche; paid lectures for Bristol Myers Squibb,Gilead, Roche, Novartis, Bristol Myers Squibb, Essex, Falk none T. Berg consultancy or expertise for Bristol Myers Squibb, Roche, Novartis, Idenix, Essex, Gilead, Vertex, Tibotec; lectures for Bristol Myers Squibb, Roche, Novartis, Idenix, Essex, Gilead none W. Jilg paid lecture for GlaxoSmithKline, SanofiPasteur MSD, NovartisBehring none A. Erhardt paid lectures for Roche, Novartis, Bristol Myers Squibb, Essex, Falk, Gilead; third party funds from Roche. none S. Wirth none none P. Schirmacher consultancy for Novartis; paid lectures for Roche, Essex none W. E. Fleig paid lectures for Falk none M. P. Manns consultancy or expertise for Schering Plough, Roche, Bristol Myers Squibb, Gilead, Valeant, Boehringer Ingelheim, Novartis, Idenix; paid lectures for Schering Plough, Roche, Bristol Myers Squibb, Novartis, GlaxoSmithKline, Gilead, Falk; third parts funds from Schering Plough, Roche, Gilead, Novartis, Boehringer Ingelheim none Aims of the guideline The aim of this guideline is the establishment of standards for the prophylaxis, diagnosis, and therapy of hepatitis B virus infections to reduce new infections, to use diagnostic testing rationally, to prevent complications of chronic hepatitis, and to use evidence based antiviral therapy. The latter minimizes the development of viral resistance. This includes a critical appraisal of the clinical and viral diagnostic tests, a transparent stage classification and risk stratification, and the recommendation of a risk adapted antiviral therapy. The aim is to achieve the best possible treatment success in combination with a cost-effective management of the patient. The S 3-guideline was developed according to the criteria of the workshop of the scientific medical professional societies (AWMF). Its purpose is to achieve “evidence”-based, criteria oriented, high quality medical health care, good handling of hepatitis B virus infection management, as well as rational based medical decisions. The guideline will give the treating physician rational and “evidence”-based instructions to ensure sufficient, appropriate, and cost-efficient therapy of this disease. It focuses not only on “standard” patients, but also on patients before and after organ transplantation, on patients with co-infections, as well as children and adolescents. Therefore, it offers the basis for solving medical questions and problems pertaining to HBV infections by also using multimodal treatment concepts. It is intended for all doctors in private practices or hospitals, for nurses, as well as employees of health organizations or persons who are directly and indirectly involved in the treatment and care of patients with hepatitis B virus infections. A guideline for patients will be developed on the basis of this guideline in cooperation with Deutsche Leberhilfe e. V. We would like to point out that special knowledge is necessary for the management and therapy of chronic HBV infections and should be performed by doctors who are experienced in this area. Preparation of the guideline The guideline was developed in several steps. The result of the development process is a three step guideline in the context of a three-step-concept of the task force of scientific medical professional societies ([Table 4]). The main focus is a combined, formal process for finding a consensus consisting of a nominal group and consensus process that was multidisciplinary. Table 4 Three-step-concept of the guideline preparation of the AWMF 1. Step (S1):expert group A representative expert group of scientific medical professional societies develops in formal consensus a guideline that is passed by the executive board of the professional societies. 2. Step (S2):formal consensus finding Available guidelines from step 1 will be consulted in an established consensus process. It will be passed as a guideline step 2. Formal consensus finding methods are nominal group process, Delphi method, and consensus conference. They include a discussion of the “evidence” for the passed statements. The support of a methodologist is helpful. 3. Step (S3):guideline with all elements of systematic preparation The formal consensus process is extended by the following systematic elements:logical analysis (clinical algorithm),“evidence”-based medicine,decision analysis,outcome analysis. Literature search After the selection and definition of guideline topics and the outlining of the work program, the authors were delegated a task with a coreviewer. The literature search was done using databases such as Cochrane Library, DIMDIliterature databases-superbases, Medline, NHS-Database PubMed as well as personal reference libraries, internet search engines, and individual searches at the pertinent organizations (university clinics, research institutions, pharmaceutical industry). The pertinent literature was systematically collected, saved, and evaluated according to a standard classification scheme (Table 5). Table 5 The following keywords were used for the literature search3 TF1: diagnosis #1: Hepatitis B or Hepatitis D#2: definition* or (clinical* diagnostic*) or (laboratory* diagnostic*) or imaging* or histopathology* or (therapy monitoring) or (drug resistance)#3 = #1 AND #2 314 abstracts TF2: indication #1: Hepatitis B or Hepatitis D#2: (natural course*) or ((prognosis* or prognostic*) and (factor* or value*) or ((therapeutic* and (aim* or goals*) or (indication*) or (contraindication*)#3 = #1 AND #2 306 abstracts TF3: therapy #1: Hepatitis B or Hepatitis D#2: ((standard therapy) or interferon alpha or lamivudine or adefovir or tenofovir or entecavir or telbivudine or clevudine or emcitricitabine or pegylated or (combination therapy) and (dosis* or dosage* or contraindication or (side effects) or monitoring)#3: #1 AND #2#4: (problem* or HBeAg-negative or alcoholic or (drug* abus*) or (interferon and (non-responder or non-response) or (lamivudine resistan*) or (liver cirrhosis) or (immunosuppression) or h*modialysis or (extrahepatic manifestation*) or (HBV carrier*)#5: #1 AND #4#6: #3 AND #5 153 abstracts TF4: transplantation #1: Hepatitis B or Hepatitis D#2: transplantation or re-infection#3: #1 AND #2 316 abstracts TF5: prophylaxis #1: Hepatitis B or Hepatitis D#2: (immunoprophyla* or vaccin* or (booster and vaccination*)#3: #1 AND #2 790 abstracts TF6: coinfections #1: Hepatitis B or Hepatitis D#2: co-infection and (hcv or hiv or hdv)#3: #1 AND #2 53 abstracts TF7: children and adolescents #1: Hepatitis B or Hepatitis D#2: children* or adolescent*#3: #1 AND #2 470 abstracts 1The respective abstracts were made available to the heads of the TF. Further abstracts some of which were released during the guideline process were chosen in addition by the heads of TF. Altogether 481 publications were evaluated and cited in the text. The classification “evidence” and the level of recommendation were performed according to the Oxford Centre of Evidence Based Medicine (http://www.cebm.net/levels_of_evidence.asp) (Table 6). The literature was evaluated by the head of each task force and synchronized with the coreviewer. In case of discrepancies, a consensus within the task force was achieved, which was authorized in the final consensus conference. Table 6 Classification of the “evidence”: “evidence” level (1 5) und recommendation grade (A-D) according to Oxford Centre of Evidence Based Medicine recommendation level “evidence” level description A Ia “evidence” by systematic review of randomized controlled studies (RCT) Ib “evidence” by an appropriately planned RCT Ic all or none principle B IIa “evidence” by systematic review of well planned cohort studies IIb “evidence” by a well planned cohort study/RCT of moderate quality (e. g. < 80 % follow-up) IIc “evidence” by outcome-research-studies IIIa “evidence” by systematic review of well planned casecontrolled studies IIIb “evidence” by case-controlled studies C IV “evidence” by case-series/cohort and case-controlled studies of moderate quality D V expert opinion without explicit critical evaluation or based on physiologic models, laboratory research results, or “first principles”