Clarifying misbeliefs about hydroxychloroquine (HCQ): developing the HCQ benefits versus harm decision aid (HCQ-SAFE) per low health literacy standards

BACKGROUND: Up to 83% of patients with SLE stop taking hydroxychloroquine (HCQ) within the first year due to knowledge gaps regarding the survival benefits of HCQ versus inflated fears of rare toxicity. Thus, there is a need for a shared decision-making tool that highlights HCQ’s significant benefits versus rare harms to improve patients’ understanding and align treatments with their values. The objective of this study was to describe development and piloting of a decision aid (HCQ-SAFE) to facilitate HCQ adherence, and safe, effective use by engaging patients in therapeutic decision-making. METHODS: HCQ-SAFE was developed via a collaborative process involving patients, clinicians, implementation scientists and health literacy experts. The initial prototype was informed by Agency for Healthcare Research and Quality (AHRQ) low literacy principles and key themes about HCQ use from six prior patient and clinician focus groups, with iterative expert and stakeholder feedback to deliver a final prototype. We implemented HCQ-SAFE in four clinics to examine usability and feasibility on Likert scales (0–7) and net promoter score (0%–100%). RESULTS: The final HCQ-SAFE shared decision-making laminated tool organises data using pictograms showing how HCQ use reduces risk of organ damage, early death and blood clots versus low risk of eye toxicity. HCQ-SAFE was reviewed in all eligible patient visits (n=40) across four clinics on an average of ~8 min, including 25% non-English-speaking patients. All patients scored 100% on the knowledge post-test; no decisional conflicts were noted after using HCQ-SAFE. HCQ-SAFE garnered high clinician and patient satisfaction with 100% likelihood to recommend to peers. CONCLUSIONS: HCQ-SAFE is a stakeholder-informed feasible shared decision-making tool that enhances communication and can potentially improve knowledge, clarify misbeliefs and engage patients in treatment decisions, including those with limited English proficiency.