RT Journal Article SR Electronic T1 Needs assessment for a decision support tool in oral cancer requiring major resection and reconstruction: a mixed-methods study protocol JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e036969 DO 10.1136/bmjopen-2020-036969 VO 10 IS 11 A1 David Forner A1 Paul Hong A1 Martin Corsten A1 Valeria E Rac A1 Rosemary Martino A1 Andrew G Shuman A1 Douglas B Chepeha A1 Anna M Sawka A1 John R de Almeida A1 Jonathan C Irish A1 Dale H Brown A1 S Mark Taylor A1 Patrick J Gullane A1 Jonathan R Trites A1 Ralph Gilbert A1 Matthew H Rigby A1 Jolie Ringash A1 David Goldstein YR 2020 UL http://bmjopen.bmj.com/content/10/11/e036969.abstract AB Introduction Advanced oral cancer and its ensuing treatment engenders significant morbidity and mortality. Patients are often elderly with significant comorbidities. Toxicities associated with surgical resection can be devastating and they are often highlighted by patients as impactful. Given the potential for suboptimal oncological and functional outcomes in this vulnerable patient population, promotion and performance of shared decision making (SDM) is crucial.Decision aids (DAs) are useful instruments for facilitating the SDM process by presenting patients with up-to-date evidence regarding risks, benefits and the possible postoperative course. Importantly, DAs also help elicit and clarify patient values and preferences. The use of DAs in cancer treatment has been shown to reduce decisional conflict and increase SDM. No DAs for oral cavity cancer have yet been developed.This study endeavours to answer the question: Is there a patient or surgeon driven need for development and implementation of a DA for adult patients considering major surgery for oral cancer?Methods and analysis This study is the first step in a multiphase investigation of SDM during major head and neck surgery. It is a multi-institutional convergent parallel mixed-methods needs assessment study. Patients and surgeon dyads will be recruited to complete questionnaires related to their perception of the SDM process (nine-item Shared Decision-Making Questionnaire, SDM-Q-9 and SDM-Q-Doc) and to take part in semistructured interviews. Patients will also complete questionnaires examining decisional self-efficacy (Ottawa Decision Self-Efficacy Scale) and decisional conflict (Decisional Conflict Scale). Questionnaires will be completed at time of recruitment and will be used to assess the current level of SDM, self-efficacy and conflict in this setting. Thematic analysis will be used to analyse transcripts of interviews. Quantitative and qualitative components of the study will be integrated through triangulation, with matrix developed to promote visualisation of the data.Ethics and Dissemination This study has been approved by the research ethics boards of the Nova Scotia Health Authority (Halifax, Nova Scotia) and the University Health Network (Toronto, Ontario). Dissemination to clinicians will be through traditional approaches and creation of a head and neck cancer SDM website. Dissemination to patients will include a section within the website, patient advocacy groups and postings within clinical environments.