ArticleBMJ open2026
The development of a Patient Decision Aid and Patient Concerns Inventory for people diagnosed with recurrent head and neck cancer: a mixed-methods study protocol.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
IntroductionHistorically, patients diagnosed with recurrent head and neck cancer (rHNC) had a poor prognosis with the majority receiving best supportive care. Significant treatment advances over the past decade have changed the landscape for curative and non-curative management of rHNC with more treatment options for patients. This requires providing large amounts of information about treatment options and patients may experience different short-, medium- and long-term toxicities. To address complex discussions on treatment decisions and to identify potential unmet needs and provide timely support, the study aim is to co-produce a bespoke Patient Decision Aid (PDA) and a Patient Concerns Inventory (PCI) for the rHNC population. METHODS AND ANALYSIS: This study uses a five-stage, multiple methods design. Stage 1 will include the creation of a steering group and Stage 2, a systematic review and evidence synthesis. Stages 3 and 4 are conducted as two parallel workstreams. The development of the PDA (Workstream 1) includes patient interviews and focus groups and that of the PCI (Workstream 2) patient focus groups and a Delphi survey for clinicians. Both workstreams conclude in Stage 5 with the steering group review and final comments. Patient and public involvement and engagement representatives will work in partnership with the study team and the steering group throughout the study. Analysis will include descriptive statistics and thematic analysis. This work will culminate in the development of a prototype Patient Decision Aid for patients with rHNC (PDA HN-R) and a Patient Concerns Inventory for patients with rHNC (PCI HN-R). ETHICS AND DISSEMINATION: All participants will receive detailed study information and give written informed consent before data collection. Ethical approval was obtained from the Health Research Authority, Research Ethics Committee and National Health Service (NHS) Research and Development Departments. All data collection will follow all legislative rules regarding data protection, also following the Declaration of Helsinki. Study results will be disseminated in peer-reviewed journals, presented at international conferences and charities.
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