www.guideline-services.com Online Guideline Development Meet us at the: 12th G-I-N Conference 2015 in Amsterdam EBM Congress 2016 in Cologne

www.guideline-services.com Online Guideline Development Meet us at the: 12th G-I-N Conference 2015 in Amsterdam EBM Congress 2016 in Cologne

JUST A FEW STEPS Since 2009 the portal has been offering tools and services for the development TO GUIDELINE of clinical guidelines. It is not limited to a special workflow or organizational structure. QUALITY The focus of the portal is on the improvement of medical research in quality, organization and cooperation by developing, expanding and providing The Guideline efficient Development IT-infrastructures. Portal has been offering Web-based tools and services for all steps involved in the development of Clinical guidelines as evidence-based clinical guidelines. It has already supported decision the development support have of more become than 100 guidelines more from important more than in 30 medical scientific care. medical societies. Their quality and medical value Our focus is on supporting the improvement substantially of quality, organization depend on and a systematic cooperation of and medical transparent research development by developing, expanding and providing efficient IT-infrastructure. methodology which normally is very complex. We provide online solutions that reflect all project steps applicable in standard guideline development, from guideline set-up up to The guideline development portal literature management, writing process, supports recommendations the whole and process consensus, of external internet-based evaluation and development adoption to archiving. of Furthermore, all services can be customized clinical guidelines. It offers a to your special needs. communication platform for various author Whether groups you are and guideline provides coordinator, extensive methodological specialist, literature expert, tools for an effcient development of guideline editor or somehow involved in evidence-based guideline development or consensus-based the portal serves as guidelines. an ideal communication platform to get your work successfully done. Sample Workflow Guideline Set-up Constitution GUIDELINE TOPIC of guideline development group Introduction Aim Patient group Generation of guideline working Coverage groups area Target user group Management of conflicts of interest Agreement of authorship and copyright EXTERNAL EVALUATION AND ADOPTION Pilot test External review Adoption

Evidence Management Writing Process Recommendations and Consensus External Evaluation PICO(S) key questions Drafting and discussion of text modules Structured consensus development Documentation and guideline report Literature search and selection Critical appraisal Drafting and discussing of statements and recommendations Transparency Archiving Synthesizing evidence

Guideline Set-up Planning & Organization Guideline Overview A suitable support for guideline development is the platforms simple and straightforward navigation bar to select news, schedules, jointly generated documents, tools for literature search and appraisal, ongoing online surveys and many more. Members area Updated appointments and your editing status of guideline documents are visible for all members immediately. Furthermore, information about the next project-steps are provided. The portal presents information about the composition of guideline groups, participants contact data and their roles within the development process. A membership list identifies the most important participant contact information. It is also possible to contact selected participants by using the integrated email function. A search function provides an easy way to screen for participants working on the same guideline projects.

of conflicts of interests Management of conflicts of interest development should be objective and should not be involved in multiple interests, which could influence their Participants motivation. working on Therefore, a guideline coordinators ought to be can objective evaluate and not to the be submitted involved in forms multiple conflicts interests, which might of interests. influence their objectivity. The portal offers a process for coordinators to easily administer participants submitted COI-forms and monitor the completion status prior to the evaluation. Agreement of authorship and copyright We offer an online management tool that allows appointment of authors and granting user rights while monitoring the submission and completion status. Anyone interested in hearing more about the portal and getting an online presentation should contact Leona Klemm l.klemm@cgs-usergroup.de 1 1st version in german guideline community

Evidence Management Generation of PICO(S) key questions The portal features the structured documentation of key questions and their assignment to stored references. Literature search and selection Easy import and fast preselection of literature based on bibliographic data and abstracts. The search strategy is documented in the portal along with the import history.

Critical appraisal Administration of individual literature lists as well as administration of key questions and assignment of relevant citations are provided. The whole process of literature appraisal is supported by integrated evaluation forms: Sign Oxford Grade (planned) customized forms Synthesizing evidence Following literature appraisal, a summary is automatically generated in the form of an evidence table. Interfaces Currently, we support the following import and export file formats: EndNote-generated XML Pubmed-Medline XML RIS

Writing Process Guideline Documents Drafting and discussion of text modules and statements Texts can be created in the portals working area directly and edited in cooperation with all participants by using the integrated text editor. Different text versions can be compared with each other. Modifications are highlighted in color and can be identified quickly. Moreover, the participants can comment on the documents and discuss their contents, statements and recommendations immediately.

Recommendations and Consensus Online Surveys Questionnaires Efficiency, transparency and reduction of bias in the guideline development process can be increased significantly by using online surveys. The portal offers all rounds of the Delphi survey, thus reducing the number of time-consuming consensus meetings. Each survey consists of individually tailored questionnaires. For every question a color-coded notice indicates the completion status that simplifies the identification of open questions. The clinical practice guideline developer determines how the online voting should be organized. In most cases single, non-repeated surveys are used, but also repeated voting in the sense of the Delphi method is possible at that time. Usually, a voting procedure has a duration of several weeks to give the participants enough time to answer all questions thoroughly. Questionnaire editor Customized questionnaires can be generated by a simple and intuitive questionnaire editor.

Monitoring of response status Information about your personal response status are provided by automatically generated lists. A reminder function indicates unanswered and incompletely answered questions. Monitoring of survey progress Guideline coordinators and authorized participants are able to monitor the survey s progress -in particular the timely completion of questionnaires by each single participant. By using the reminder function participants can be requested to complete the questionnaire. Evaluation For an objective assessment all answers are anonymously stored and evaluated. Statistical evaluation of questionnaires are available during and after the survey. Evaluation reports provide a breakdown of responses with detailed comments and information. Controversial points can be identified quickly and simple, and reviewed in working groups. Evaluation 8B

External Evaluation Documentation and guideline report Finding all guideline specific information stored on one location facilitates the documentation of the development process significantly. Some information are recorded automatically while others can be saved manually in specially designed forms. All data can be exported to MS Word documents. Continuous documentation of the guideline development process and the applied methodology is facilitated by an integrated template that also allows to monitor the documentation status via a color coded ranking list.

Transparency Contents like documents, discussion threads etc. provided during the guideline development process are stored on the platform instantly. Making information accessible to all participants increases the transparency of the development process significantly. Nonetheless, access rights can be assigned individually, as required, e.g. to make documents available to coordinators only or to a specific workgroup. Archiving Accessibility of any content is provided for all participants upon termination of the development process. In case of a guideline update the re-access to former guideline documents and discussion threads is ensured.

Cooperation with International and German Guideline Organizations Cooperation partner: UserGroup - Med. Leitlinienentwicklung e.v. (UserGroup - Clinical Guideline Services) UserGroup e.v. cooperates with leading International and German organizations in clinical guideline methodology. We are GIN member and since 2012 regular exhibitor at the annual GIN conference. All working steps and tools applied in the portal meet the methodological requirements of the Association of the Scientific Medical Societies in Germany (AWMF). The AWMF represents Germany in the Council for International Organizations of Medical Sciences CIOMS. The AWMF methodological guidelines which are implemented in our portal follow the set of rules and criteria of DELBI (German Instrument for Methodological Guideline Appraisal). In 2015 started a series of workshops for guidelines coordinators - jointly organized by UserGroup and AMWF. The workshops aim to provide hands-on information about methodical requirements and organizational steps for guideline developers. The portal is thereby a useful tool to ensure quality and efficiency when developing high-quality clinical guidelines. Member of: If you are interested in further information and a portal presentation, please contact Torsten Karge t.karge@cgs-usergroup.de

Greeting Message Dear colleagues, as chairperson of the UserGroup - Med. Leitlinienentwicklung e.v. (UserGroup - Clinical Guideline Services) I am delighted that our clinical guideline portal may present itself for the fourth time at the annual G-I-N Conference in order to be introduced to the participants. The UserGroup promotes to a substantial degree the Web-based organization of clinical guideline development. With this mandate, the platform: www.guideline-services.com was designed as an effective and transparent tool for the groups of guideline developers as well as for the exchange and archiving of documents. In addition we offer personnel support as clincal guideline office, for overview papers and reviews, and as editorial office upon request. We place particular emphasis on compliance according to national and international methodological rules and standards. Currently about 19 European Medical Societies use the portal for the development and documentation of over 100 guidelines. If you are interested in the services provided by the UserGroup, we will be happy to provide you with more details. Best regards, Britta Siegmund, M.D. Professor of Medicine Chairperson, UserGroup e.v.

Team Manager Klaus Fitzke k.fitzke@cgs-usergroup.de Project Management & Consulting Leona Klemm l.klemm@cgs-usergroup.de Dr. rer. medic. Margit Blömacher m.bloemacher@cgs-usergroup.de Britt Gehder b.gehder@cgs-usergroup.de System Development & Design Torsten Karge t.karge@cgs-usergroup.de Erik Wohlfarth e.wohlfarth@cgs-usergroup.de Christoph Kürten c.kuerten@cgs-usergroup.de Alexander Davidov a.davidov@cgs-usergroup.de

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