Ethics approval and consent to participate
Ethics approval for this study was provided by the Dartmouth Committee for the Protection of Human Subjects on June 8, 2017. Montefiore Medical Center provided an authorization agreement to rely on Dartmouth’s approval on September 8, 2017. Ethics approval was provided by Washington University in St. Louis Institutional Review Board on May 9, 2017. New York University School of Medicine provided ethics approval on August 29, 2017.
Consent for publication
Not applicable
Availability of data and materials
The dataset analyzed during the current study is not publicly available due to the protection of the human subjects involved in the qualitative interviews. A deidentified copy of the dataset is available from the corresponding author on reasonable request.
Competing interests
- Glyn Elwyn has edited and published books that provide royalties on sales by the publishers: the books include Shared Decision Making (Oxford University Press) and Groups (Radcliffe Press). Glyn Elwyn’s academic interests are focused on shared decision making and coproduction. He owns copyright in measures of shared decision making and care integration, namely collaboRATE, integRATE (measure of care integration), consideRATE (patient experience of care in serious illness), coopeRATE (measure of goal setting), toleRATE (clinician attitude to shared decision making), Observer OPTION-5, and Observer OPTION-12 (observer measures of shared decision making). He has in the past provided consultancy for organizations, including: 1) Emmi Solutions, LLC who developed patient decision support tools; 2) National Quality Forum on the certification of decision support tools; 3) Washington State Health Department on the certification of decision support tools; 4) SciMentum LLC, Amsterdam (workshops for shared decision making). He is the Founder and Director of &think LLC, which owns the registered trademark for Option GridsTM patient decision aids; Founder and Director of SHARPNETWORK LLC, a provider of training for shared decision making. He provides advice in the domain of shared decision making and patient decision aids to: 1) Access Community Health Network, Chicago (Adviser to Federally Qualified Medical Centers); 2) EBSCO Health for Option GridsTM patient decision aids (consultant); 3) Bind on Demand Health Insurance (consultant); 4) PatientWisdom Inc (adviser); 5) abridge AI Inc (Chief Clinical Research Scientist).
- Glyn Elwyn and Marie-Anne Durand have developed the Option Grid conversation aids, which are licensed to EBSCO Health. They receive consulting income from EBSCO Health, and may receive royalties in the future. Marie-Anne Durand was a consultant for ACCESS Community Health Network until 2019.
- From 2014-2018, Dr. Karen Sepucha received salary support as a member of the scientific advisory board for Healthwise, a not-for-profit foundation that develops and distributes patient education and decision support materials.
- Catherine Hylas Saunders holds copyright in the consideRATE suite of tools.
No other competing interests declared.
Funding
The research reported in this manuscript is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (1511-32875). The statements presented in this manuscript are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
The study funder has no role in any aspects of the set up or execution of the study or manuscript.
Study sponsor
Trustees of Dartmouth College Office of Sponsored Projects, 11 Rope Ferry Road #6210, Hanover, NH, 03755, [email protected]
The study sponsor has no role in any aspects of the set up or execution of the study or manuscript.
Authors’ Contributions
Danielle Schubbe: Methodology, Formal analysis, Investigation, Data curation, Writing - original draft, Visualization; Renata W Yen: Conceptualization, Methodology, Formal analysis, Investigation, Resources, Data curation, Writing - review & editing, Supervision, Project administration; Catherine H Saunders: Investigation, Writing - review & editing; Glyn Elwyn: Conceptualization, Methodology, Writing - review & editing, Supervision, Funding acquisition; Rachel Forcino: Investigation, Writing - review & editing; James O’Malley: Conceptualization, Writing - review & editing; Mary Politi: Conceptualization, Resources, Writing - review & editing; Julie Margenthaler: Resources, Writing - review & editing; Robert J. Volk: Writing - review & editing; Karen Sepucha: Writing - review & editing; Elissa Ozanne: Writing - review & editing; Sanja Percac-Lima: Writing - review & editing; Ann Bradley: Investigation, Writing - review & editing; Courtney Goodwin: Investigation, Writing - review & editing; Maria van den Muijsenbergh: Supervision, Writing - review & editing; Johanna WM Aarts: Supervision, Writing - review & editing; Peter Scalia: Formal analysis, Writing - review & editing; Marie-Anne Durand: Conceptualization, Methodology, Investigation, Resources, Writing - review & editing, Supervision, Project administration, Funding acquisition
Acknowledgments
We want to thank all patients, surgeons, and stakeholders who took part in the interviews for this study. We also want to thank our trial’s Community Advisory Board, Data Safety and Monitoring Board, and Trial Steering Group for their monitoring and guidance.