Clinical Practice Guidelines The ESMO Perspective Andrés Cervantes Professor of Medicine

WHAT ARE CLINICAL PRACTICE GUIDELINES? Systematically developed evidence-based statements aiming: To assist practitioners in appropriate clinical decision-making (best clinical practice) To improve quality of healthcare and outcomes for patients To influence national policies for efficient allocation of resources and for better delivery systems

Research to Clinical Practice Cycle Clinical Research Congress Presentation Peer Review Publication Clinical Practice Guidelines Clinician Education Clinical Practice? Audit Feedback

WHAT ARE CLINICAL PRACTICE GUIDELINES? They need to be trustworthy : Be based on a systematic review of the existing evidence Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups Be based on an explicit and transparent process that minimizes distortions, biases and conflict of interest Consider important patients subgroups and patients preferences, as appropriate Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and rating LoE and GoR Be revised and updated when new evidence warrants modifications of recommendations

HISTORY & EVOLUTION OF ESMO GUIDELINES ESMO first began to work on the development of guidelines in 1999 in order to help define the minimum standards of medical oncology practice for Eastern European countries. From 2001-2005 the ESMO Minimum Clinical Recommendations were published. In 2006 ESMO started to produce the ESMO Clinical Recommendations addressing a wider audience. In 2007 the Consensus Conference derived guidelines were established. Since 2010 they are called ESMO Clinical Practice Guidelines. The ESMO Guidelines Committee continue to strive for improvement of ESMO Guidelines with each new publication

A u t h o r s (Multidisciplinary) The Structure of the ESMO GL Committee S u b j e c t E d i t o r s 1. Breast Cancer 2. Gynaecological Cancer 3. Haematological Malignancies 4. Lung Cancer 5. Head and Neck Cancer 6. Urogenital Cancer 7. Upper and lower GI tract cancers 8. Pancreato-hepatobiliary cancers 9. Sarcoma & GIST 10. Supportive Care 11. Palliative Care 12. Rare Tumors E d i t o r i a l B o a r d Chairman & Co-Chairman 2 Members 1 ESMO Officer R e v i e w e r s 5 ESMO Faculty Members per Topic on a multidisciplinary platform A u t h o r s (Multidisciplinary)

Guidelines: topics & authors selection process GLWG annual strategy meeting Identification of Guidelines requiring update and new titles Subject Editors (SEs) propose lead authors Manuscript & author information included in on-line system SEs and lead authors identify co-authors (4/5 in total, multidisciplinary) GLWG Editorial Board approve lead authors Author invitations sent via on-line system (including deadlines and template) Authors accept invitations & deadlines (or repeat steps 3-6)

Guidelines: Production process Authors review literature, grade evidence and produce 1st draft SEs select 5 reviewers per manuscript (ESMO faculty preference) Reviewers submit their comments via on-line system Review comments compiled, anonymised and sent to authors Authors address review comments in revised manuscript Review step repeated with revised manuscript until SE sign-off Final sign-off by GLWG Chair Manuscripts sent to Annals of Oncology for production Copy-editing & proof review (SEs & Chair). Approved for print by ESMO.

WHAT KIND OF CLINICAL PRACTICE GUIDELINES? Average number of pages (2014): 9.5 Evidence based Disease or topic oriented Available on the ESMO website Only those requiring update are published in Annals of Oncology NUMBER OF CLINICAL PRACTICE GUIDELINES

ESMO Clinical Practice Guidelines Adherence to clinical practice guidelines improves patient outcomes Produced by leading European Experts Multidisciplinary editorial teams Based on published peer reviewed data IDS modified grading system Published in Annals of Oncology-Open access Updated over 1-2 year cycle Scientific and Education Resources

ESMO NEW CLINICAL PRACTICE GUIDELINES 2014 Gastrointestinal tumours Anal cancer * Metastatic colorectal cancer * Gastrointestinal stromal tumours Lung cancer Metastatic non-small-cell lung cancer (NSCLC) * Urogenital tumours Bladder cancer* Renal cell carcinoma Haematological malignancies Myelodysplastic syndromes * NEW Hodgkin’s lymphoma * Follicular lymphoma * Mantle cell lymphoma NEW CNS malignancies High-grade glioma * Sarcomas Soft tissue sarcomas Bone sarcomas Supportive and palliative care Bone health in cancer patients * NEW Advanced care planning NEW Management of refractory symptoms at the end of life and palliative sedation NEW *Published individually on-line ahead of print For all other existing titles published versions are considered current and remain available online

ESMO Clinical Practice Guidelines 2015 20 titles scheduled (updates and new) Early breast cancer Acute lymphoblastic diseaseNEW Supportive care for head & neck cancerNEW Malignant mesothelioma Thymic malignanciesNEW Extranodal aggressive lymphomasNEW Central venous access devicesNEW Pancreatic cancer Diffuse large B-cell lymphoma DyspnoeaNEW Prostate cancer Early integration of palliative interventionNEW Chronic lymphocytic leukaemia Chronic myeloid leukaemia Malnutrition/cachexiaNEW Myeloproliferative neoplasiasNEW Melanoma Management of oral and gastrointestinal mucositis Hairy cell leukaemiaNEW T-cell lymphomaNEW

ESMO CLINICAL PRACTICE GUIDELINES Available: In an annual supplement of Annals of Oncology On the ESMO website (www.esmo.org) On the OncologyPRO website (oncologypro.org) Translated: Through Oxford University Press In collaboration with National Cancer Societies Presented: During Guidelines Interactive Sessions (every year since 2002). To audiences of up to 3200 attendees.

WHAT KIND OF CLINICAL PRACTICE GUIDELINES? CONSENSUS CONFERENCE DERIVED GUIDELINES To address pre-selected questions to 30-40 multidisciplinary experts on specific tumour types 1-2 days meeting Funded by ESMO or other professional networks Update every 2-5 years Published in Annals of Oncology NUMBER OF CONSENSUS CONFERENCES HELD PER YEAR

Consensus Conference Schedule 2010 2011 2012 2013 2014 2015 Lung Prostate Sarcoma& GIST Endometrial Lymphomas Colorectal Lymphoma - Sarcoma & GIST Advanced CRC Nausea and vomiting ESO-ESMO ABC (Advaced Breast Cancer) Melanoma Myeloproliferative neoplasms

CLINICAL PRACTICE GUIDELINES: Download figures Downloads within first 6 months post publication Total Average per manuscript 2009 (54 manuscripts) 76717 1395 2010 (55 manuscripts) 103468 1881 2011 (13 manuscripts) 56220 4325 2012 (21 manuscripts) 101750 4845 2013 (20 manuscripts) 104783 5239 16

ESMO Clinical Practice Guidelines: PDF downloads Data provided by Annals of Oncology, April 2015

Top 20 countries: traffic based on unique page views (Jan-Mar 2015) Evolution of the ESMO Clinical Practice Guidelines pages on the ESMO website Top 20 countries: traffic based on unique page views (Jan-Mar 2015) Country Unique page views United States 15466 Switzerland 14562 United Kingdom 12151 Italy 11525 Germany 11048 Spain 10844 Portugal 10342 India 8804 France 6331 Romania 5078 Egypt 4408 Brazil 4132 Mexico 4095 Poland 4092 Australia 3851 Greece 3201 Belgium 3104 Turkey 3030 Malaysia 2762 Canada 2639 Rest of World 62788 Unique Page views: the number of visits during which the a page was viewed one or more times

Evolution of the ESMO Clinical Practice Guidelines pages on the ESMO website Date Change Description >> MON 24 SEPTEMBER 2012 Single welcome page with links to Annals of Oncology MON 24 SEPTEMBER 2012 1. Introduction of TOPICS sub pages in addition to the welcome page TUES 23 APRIL 2013 Launch of new ESMO website THURS 3/FRI 4 OCTOBER 2013 2. Introduction of individual guidelines pages, with embed of the Annals web pages and a link to the PDF download 23 OCTOBER 2014 3. Guidelines pages moved up a level in the ESMO website. All Topics can now be viewed in the top menu, for easier navigation N Peters, Web dept. 24 April 2015

ESMO Clinical Practice Guidelines pages: unique page views on the ESMO website Introduction of individual Topics pages Introduction of individual Guidelines pages Guidelines pages moved up a level Unique Page views: the number of visits during which the a page was viewed one or more times

Unique Page views per month Evolution of the ESMO Clinical Practice Guidelines pages on the ESMO website Unique Page views per month 2011 2012 2013 2014 2015 Jan 8723 7793 8612 53643 66332 Feb 9013 7916 8318 46535 64780 Mar 9741 8702 8701 59550 74142 Apr 7992 7347 15351 54303 May 8794 7991 31764 58029 Jun 5073 7402 27803 53724 Jul 5108 7439 34709 55231 Aug 5328 7861 32364 57446 Sep 7212 11047 43330 85356 Oct 8134 11505 72648 84698 Nov 8287 9062 64784 69150 Dec 6125 6673 46505 56485 total 89530 100738 394889 734150 Unique Page views: the number of visits during which the a page was viewed one or more times

ESMO Pocket Guidelines 2015

ESMO APP VERSION GUIDELINES 2015 All of the latest pocket guidelines are now available on the ESMO Guidelines app The app also includes the ESMO Guides for Patients – several languages are available Available from iTunes and GooglePlay

N Peters, Web & Data Services dept. Future Developments Improve updating frequency for all titles Review of methodology Introduce interactive apps-Pilot late 2015 Integration of MCBS in 2016 3/7/14 N Peters, Web & Data Services dept.

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