Methods for Development of the European Commission Initiative on Breast Cancer Guidelines

Recommendations in the Era of Guideline Transparency

Lerda, Donata PhD
Dimitrova, Nadya PhD
Alonso-Coello, Pablo MD, PhD
Gräwingholt, Axel MD
Quinn, Cecily MD
Follmann, Markus MD, MPH, MSc
Mansel, Robert MD
Sardanelli, Francesco MD
Rossi, Paolo Giorgi PhD
Lebeau, Annette MD
Nyström, Lennarth PhD
Broeders, Mireille PhD
Ioannidou-Mouzaka, Lydia MD
Duffy, Stephen W. BSc, MSc, CStat
Borisch, Bettina MD
Fitzpatrick, Patricia MD
Hofvind, Solveig PhD
Castells, Xavier MD, PhD
Giordano, Livia MD
Warman, Sue MEd
Saz-Parkinson, Zuleika PhD
Schünemann, Holger J. MD, PhD, MSc

¹McMaster University Health Sciences Centre, Hamilton, Ontario, Canada (H.J.S.)
²European Commission, Joint Research Centre, Ispra, Italy (D.L., N.D., Z.S.)
³Iberoamerican Cochrane Centre, Barcelona, Spain (P.A.)
⁴Radiologie am Theater, Paderborn, Germany (A.G.)
⁵St. Vincent’s University Hospital, Dublin, Ireland (C.Q.)
⁶German Cancer Society, Berlin, Germany (M.F.)
⁷Cardiff University, Cardiff, United Kingdom (R.M.)
⁸Università degli Studi di Milano, Milan, Italy (F.S.)
⁹Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy (P.G.R.)
¹⁰University Medical Center Hamburg-Eppendorf, Hamburg, and Private Group Practice for Pathology, Lübeck, Germany (A.L.)
¹¹Umeå University, Umeå, Sweden (L.N.)
¹²Radboud University Medical Centre, Nijmegen, Netherlands (M.B.)
¹³University of Athens Medical School, Athens, Greece (L.I.)
¹⁴Queen Mary University of London, London, United Kingdom (S.W.D.)
¹⁵Institute of Global Health. University of Geneva, Geneva, Switzerland (B.B.)
¹⁶National Screening Service, Dublin, Ireland (P.F.)
¹⁷Cancer Registry of Norway, Oslo, Norway (S.H.)
¹⁸IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain (X.C.)
¹⁹CPO-Piedmont - AOU Città della Salute e della Scienza, Torino, Italy (L.G.)
²⁰Langford, North Somerset, United Kingdom (S.W.)

Acknowledgment: The authors thank Dr. Elke Anklam for critical review of the manuscript.

Financial Support: By the European Commission.

Disclosures: Members of the GDG do not receive financial compensation for their work but are reimbursed by the EC for travel-related expenses for the meetings organized by the JRC. Dr. Schünemann reports that the EC had chosen to use GRADE as one of the core methods for its guidelines before involving Dr. Schünemann. He was invited to participate in the guideline development as a methodologist and was elected by the ECIBC GDG as its co-chair. He is also co-chair of the GRADE working group and has codeveloped much of its methodology and tools, was commissioned by the National Academy of Sciences to write the background reports for the Institute of Medicine standards for trustworthy guideline development with coauthors, has conducted Cochrane reviews (currently is director of Cochrane Canada), and is a member of the Guidelines International Network. He has not received direct financial payments for ECIBC work but has received travel support and is under contract from the EC for a project relating to other guideline methods. Dr. Dimitrova reports other support from the EC JRC outside the submitted work. Dr. Alonso-Coello reports that his institution received payments from the EC to develop the systematic reviews informing the recommendations. He is a member of the GRADE Guidance Group of the GRADE working group and a member of the Board of the Guidelines International Network. He has contributed to the development of some of the methodology and tools. Dr. Gräwingholt is head of the mammography screening center Paderborn, consultant radiologist for screening programs in Switzerland, and consultant radiologist for Hellenic School of Senology. Dr. Quinn is the Chair of the European Working Group for Breast Screening Pathology (EWGBSP). Various companies have provided some sponsorship to the EWGBSP for group meetings. Dr. Lebeau reports grants and reimbursement for travel-related expenses related to consultancy from Roche Pharma, reimbursement for travel-related expenses related to consultancy from Novartis Oncology, and grants from BioNTech Diagnostics outside the submitted work. Dr. Lebeau also reports that she is chair of the Breast Pathology Working Group of the German S3 Guidelines for the Early Detection, Diagnosis, Treatment and Follow up of Breast Cancer, a member of the Scientific Advisory Council for the Cooperation Alliance Mammography (Kooperationsgemeinschaft Mammographie), Germany, member of the certification commission “breast cancer centres” as a representative of the German Society of Pathology and the Federal Association of German Pathologists, and board member of the German Society of Pathology. Dr. Hofvind reports permanent employment as a researcher at the Cancer Registry of Norway, independent of her job as administrative leader of BreastScreen Norway. Dr. Saz-Parkinson is employed by the EC, coordinating the ECIBC GDG. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3445.

Corresponding Author: Holger J. Schünemann, MD, PhD, MSc, McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, Ontario L8N 4K1, Canada (e-mail, [email protected]); and Zuleika Saz-Parkinson, PhD, European Commission, Joint Research Centre, Via Enrico Fermi 2749, TP 127, Ispra VA, 21027, Italy (e-mail, [email protected]).

Current Author Addresses: Dr. Schünemann: McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, Ontario L8N 4K1, Canada.

Drs. Lerda, Dimitrova, and Saz-Parkinson: European Commission, Joint Research Centre, Via Enrico Fermi 2749, Ispra VA, 21027, Italy.

Dr. Alonso-Coello: Iberoamerican Cochrane Center, Biomedical Research Institute (IIB Sant Pau-CIBERESP), Sant Antoni Maria Claret 167, Barcelona, 8025, Spain.

Dr. Gräwingholt: Radiologie am Theater, Neuer Platz 4, Paderborn, NRW, 33098, Germany.

Dr. Quinn: St. Vincent’s University Hospital, 96 Merrion Road, Elm Park, Dublin, D04 T6F4, Ireland.

Dr. Follmann: German Cancer Society, Kuno-fischer-straße 8, Berlin, 14057, Germany.

Dr. Mansel: Cardiff University, The Gables, Monmouth, NP25 3PA, United Kingdom.

Dr. Sardanelli: Università degli Studi di Milano, Via Morandi 30, San Donato Milanese, Milan, 20097, Italy.

Dr. Rossi: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Via Amendola 2, Reggio Emilia, 42122, Italy.

Dr. Lebeau: University Medical Center Hamburg-Eppendorf, Martinistr. 52, Hamburg, 20246, Germany.

Dr. Nyström: Umeå University, 90187 Umeå, Sweden.

Dr. Broeders: Radboud University Medical Centre, Geert Grooteplein 21, Nijmegen, 6525 EZ, Netherlands.

Dr. Ioannidou-Mouzaka: Leto Gynecological-Surgical and Obstetrical Clinic, 18, Avenue Kifissias, 11526 Athens, Greece.

Dr. Duffy: Centre for Cancer Prevention, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, United Kingdom.

Dr. Borisch: Institute of Global Health, University of Geneva, chemin des Mines 9, Geneva, 1202, Switzerland.

Dr. Fitzpatrick: National Screening Service, Kings Inns House, 200 Parnell Street, Dublin, D01 A3Y8, Ireland.

Dr. Hofvind: Cancer Registry of Norway, PO 5313 Majorstua, 0304 Oslo, Norway.

Dr. Castells: IMIM (Hospital del Mar Medical Research Institute), Carrer del Dr. Aiguader, 88, Barcelona, 8003, Spain.

Dr. Giordano: CPO Piedmont-AOU Città della Salute e della Scienza, via Cavour 31, Turin, 10131, Italy.

Mrs. Warman: Havyatt Lodge, Havyatt Road, Langford, North Somerset BS40 5DD, United Kingdom.

Author Contributions: Conception and design: H.J. Schünemann, D. Lerda, Z. Saz-Parkinson.

Analysis and interpretation of the data: H.J. Schünemann, A. Gräwingholt, C. Quinn, M. Follmann, A. Lebeau, M. Broeders, S. Hofvind, Z. Saz-Parkinson.

Drafting of the article: H.J. Schünemann, Z. Saz-Parkinson.

Critical revision of the article for important intellectual content: H.J. Schünemann, N. Dimitrova, A. Gräwingholt, C. Quinn, M. Follmann, P.G. Rossi, A. Lebeau, L. Nyström, M. Broeders, L. Ioannidou-Mouzaka, S.W. Duffy, P. Fitzpatrick, S. Hofvind, L. Giordano, S. Warman, Z. Saz-Parkinson.

Final approval of the article: H.J. Schünemann, D. Lerda, N. Dimitrova, P. Alonso-Coello, A. Gräwingholt, C. Quinn, M. Follmann, S.W. Duffy, R. Mansel, M. Follmann, P.G. Rossi, A. Lebeau, L. Nyström, M. Broeders, L. Ioannidou-Mouzaka, S.W. Duffy, B. Borisch, P. Fitzpatrick, S. Hofvind, X. Castells, L. Giordano, S. Warman, Z. Saz-Parkinson.

Provision of study materials or patients: H.J. Schünemann, D. Lerda, L. Ioannidou-Mouzaka, Z. Saz-Parkinson.

Statistical expertise: H.J. Schünemann, P.G. Rossi, S.W. Duffy.

Obtaining of funding: D. Lerda.

Administrative, technical, or logistic support: H.J. Schünemann, D. Lerda, Z. Saz-Parkinson.

Collection and assembly of data: H.J. Schünemann, A. Gräwingholt, P.G. Rossi, A. Lebeau, L. Ioannidou-Mouzaka, S. Hofvind, X. Castells, Z. Saz-Parkinson.

This article was published at Annals.org on 23 July 2019.

^* For members of the European Commission Initiative on Breast Cancer Contributor Group, see Appendix.

Annals of Internal Medicine - Latest , July 25, 2019. | DOI: 10.7326/M18-3445

Neither breast cancer prevention and early-detection programs, nor their outcomes, are uniform across Europe. This article describes the rationale, methods, and process for development of the European Commission (EC) Initiative on Breast Cancer Screening and Diagnosis Guidelines. To be consistent with standards set by the Institute of Medicine and others, the EC followed 6 general principles. First, the EC selected, via an open call, a panel with broad representation of areas of expertise. Second, it ensured that all recommendations were supported by systematic reviews. Third, the EC separately considered important subgroups of women, included patient advocates in the guidelines development group, and focused on good communication to inform women’s decisions. Fourth, EC rules on conflicts of interest were followed and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests. Fifth, it focused its recommendations on outcomes that matter to women, and certainty of the evidence is rated for each. Sixth, the EC elicited stakeholder feedback to ensure that the recommendations remain up to date and relevant to practice. This article describes the approach and highlights ways of disseminating and adapting the recommendations both within and outside Europe, using innovative information technology tools.

The authors describe the rationale, methods, and process of the European Commission Initiative on Breast Cancer Screening and Diagnosis Guidelines.