S3-Guideline “Exocrine Pancreatic Carcinoma” 20071 ... - DGVS

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452 Leitlinie Table 2 Time course of consensus process category aspect time period initiation determination of conference date 1/2006 choice of conference participants 1/2006 preparation, revision, and amendment of the questionnaire by the respective task forces (topic 1 – 6) 2 – 3/2006 literature search determination of search terms for the literature search 4/2006 systematic literature search 5/2006 delphi-questionnaire dispatch of final questionnaire including publications from 1995 on mid 5/2006 response to questionnaire by task forces 6 – 7/2006 summary/evaluation of results of the questionnaire by coordinators and dispatch with recommendations to all consensus conference participants 9 – 2006 conference preliminary discussion of consensus conference consensus conference: 12.9.2006 task force meetings 13.10.2006 plenary session 13.–14.10.2006 preparation of manuscript by consensus conference coordinators and chairmen until 2/2007 decisions on open issues by questioning all concensus conference participants via email 5.4.2007 dispatch of final manuscript to all conference participants and incorporation of all comments 15.4.2007 peer review of the manuscript 6.5.2007 Table 3 Literature search topic references initial selected references topic 1 16584 258 topic 2 12419 407 topic 3 5 994 202 topic 4 2 739 111 topic 5 2 241 262 topic 6 2 368 169 total 42345 1 409 Table 4 Basis for evidence level: Center of Evidence Based Medicine Oxford, Topics 1, 3, 4, 5, and 6 recommendation grade evidence level A 1 systematic review (SR) with homogeneity (no heterogeneity with respect to the results of individual studies) of randomized controlled studies (RCT) B 2a systematic review with homogeneity of cohort studies 2b Individual cohort studies plus RCTs of low quality (e. g. followup < 80%) C 3 systematic reviews with homogeneity of case-control-studies as well as individual case-controlstudies: EL 3 C 4 case studies and cohort studies as well as case-control-studies of low quality (i. e. cohorts: no clearly defined group for comparison, no outcome/exposition assessment in experimental and control groups, insufficient follow-up; case-control-studies: no clearly defined group for comparison) D 5 expert opinion or inconsistent or inconclusive studies of every evidence level Adler G et al. S3-Guideline “Exocrine Pancreatic… Z Gastroenterol 2008; 46: 449–482 cles, or systematic reviews, and the number of examined or treated patients (> 10), no case reports. The literature was made available as an Endnote-file. In May 2006 the final questionnaires and the abstracts of the citations were sent to all members of the guideline process (n = 79). The members were requested to evaluate them by the middle of July (Delphi-technique). Until the end of August, the coordinators of the individual topics summarized the results from the task forces and developed recommendations for consensus finding. Four weeks before the consensus conference, a preliminary discussion took place with the coordinators of the individual topics. The evaluation table of the list of questions and the methodology for consensus finding during the consensus conference were discussed. The documents were sent to all participants of the consensus conference by the middle of September. The consensus conference took place on October 13 th and 14 th , 2006 in Stuttgart-Hohenheim. On the first day, the suggestions for consensus finding for the individual topics were formulated within the task forces (nominal group process, n = 7 – 12). Dr. Kopp (AWMF) was available for support in methodologic questions. On the second day, the consensus suggestions were presented, discussed, and if necessary modified in the plenum (n = 57). The voting of the evidence level and recommendation grade was performed using a TED-system. Evidence level and recommendation grade classification The evidence level of the relevant studies was defined according to the recommendations of the Center for Evidence-Based Medicine, Oxford, UK (http://www.cebm.net/) (l " Table 4). During the consensus conference preparation, it was discovered that these criteria do not apply to individual studies of Topic 2 (diagnostics). Therefore, a modified classification of the evidence level was employed for the evaluation of the literature on diagnostics (l " Table 5). For all topics within the group processes it was considered whether the results of the studies are applicable to the guideline target population in Germany. The recommendation grades were assigned based on the evidence level. The classification of the recommendation grade is shown in (l " Table 6). In most cases the evidence level determines the recommendation grade (l " Table 4, 6). In justified Downloaded by: Thieme Verlagsgruppe. Copyrighted material.
Table 5 Basis for evidence level: Centre for Evidence-Based Medicine Oxford, Topic 2 recommendation grade evidence level A 1a Systematic review (SR) with homogeneity (no heterogeneity with respect to results of individual studies) of level 1 diagnostic studies. Clinical decision rule with 1b studies also from different clinical centers? 1b Validating cohort studies (test quality of specific tests based on existing evidence, no explorative data collection with regression analysis) 1c Specificity of diagnostic results that is so high (“absolute”) that a positive result leads to diagnosis or sensitivity of diagnostic results that is so high (“absolute”) that a negative result leads to exclusion of the diagnosis. B 2a Systematic review with homogeneity of diagnostic studies > level 2 2b Explorative cohort studies with good reference basis (i. e. independent of test, blinded, or objective for all included subjects). C 3 systematic overview with homogeneity of studies EL3b or better C 4 case-control-studies of poor or reference standard that is not independent D 5 expert opinion without critical discussion Table 6 Recommendation grade classification A B C D consistent studies with evidence level 1 available consistent studies with evidence level 2 or 3 or extrapolations of studies with evidence level 1 studies with evidence level 4 or extrapolations of studies with evidence level 2 or 3 expert opinion or inconsistent or inconclusive studies of every evidence level cases, a deviation from this rule within the consensus conference was allowed: E consistency and effect size of the studies, E consideration of benefits, risks, and side effects, E applicability on extended patient groups, on the German health care system, or on the availability of resources. Consensus degree classification The TED-system was used to vote in the plenum of the consensus conference. Thus, immediately after the vote on individual questions, the absolute or percent approval of the participants was shown electronically. This resulted in the classification of the consensus magnitude (l " Table 7). Guideline implementation The quality of the guideline cannot be assessed before it has been implemented in the daily health care routine. Aside from the present scientific publication, the guideline will be published electronically by the AWMF in its information system “AWMF online” (http://www.awmf.org/). The German Cancer Table 7 Consensus size classification strong consensus approval of > 95% of participants consensus approval of > 75 – 95% of participants majority approval approval of > 50 – 75% of participants no consensus approval of < 50% of participants Leitlinie 453 Society and the German Society for Digestive and Metabolic Diseases (DGVS) will also make the guideline available electronically. Following the publication of the complete version of the guideline, a short version and a version for patients will be introduced. Topic 1: Risk factors/screening/risk groups ! Risk factors Introduction For many years diet has been discussed as a possible risk factor for the development of exocrine pancreatic carcinoma. However, there are no unanimous recommendations or recommendations established in clinical practice as to whether dietary procedures are effective in the prevention of pancreatic cancer and if so, which dietary factors play a role. Aside from the dietary factors, life style and work-related exposure must be discussed as possible risk factors for the development of pancreatic carcinoma. Finally, it will be discussed whether drug prophylaxis can reduce the risk of developing pancreatic carcinoma. Diet Diet recommendations Currently, a specific diet recommendation for the risk reduction of pancreatic carcinoma cannot be given. The current diet recommendations of the German Society for Nutrition (DGE) should be followed to reduce the risk of pancreatic carcinoma. Recommendation grade: C, evidence level 2b, strong consensus Comments Some connection between dietary factors and pancreatic carcinoma was considered likely in a comprehensive literature review of the World Cancer Research Fund in 1997. However, these associations were not rated as convincing [2]. In the last 12 years, connections between dietary factors and the development of pancreatic carcinoma were repeatedly found in original publications. They were rated with evidence levels 2b to 3b [3 – 7]. However, there is also one group of investigators who found no association between dietary factors and pancreatic carcinoma in their cohort study [8, 9]. Nonetheless, a dietary recommendation to reduce pancreatic carcinoma risk is indicated, particularly because an association seems plausible from a biologic point of view [10]. There is no clear relationship between fiber intake and risk of pancreatic carcinoma. Recommendation grade: C, evidence level 3, strong consensus Comments The studies on fiber intake are contradictory. A protective effect of an increased intake of fiber was described in two case control studies [4, 11]. However, this was not confirmed in another case control study in men [12]. Due to the overall insufficient Adler G et al. S3-Guideline “Exocrine Pancreatic… Z Gastroenterol 2008; 46: 449–482 Downloaded by: Thieme Verlagsgruppe. Copyrighted material.
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