Background: Patient safety is a critical aspect of healthcare, with patients often being the first to notice safety concerns. However, traditional reporting mechanisms have limitations, and many patients may not report safety issues due to fear of repercussions or lack of clarity in existing systems. There is a growing need for tools that enable patients to report safety concerns easily and effectively. This study aimed to undertake preliminary development and cognitive testing of a Patient Reported Safety Concern Tool, designed to capture a broad range of patient safety issues across various healthcare settings that could enhance quality of care and foster continuous safety improvement.
Methods: A two-phase, qualitative study was conducted in Wales, virtually through online platforms (Zoom or MS Teams) between January and September 2023. In Phase One, 26 adults (aged 25-54, 23.1% female) participated in three online focus groups recruited through purposive sampling. In Phase Two, 10 additional participants (aged 25-84, 70% female) were purposively sampled for online cognitive interviews. Participants were eligible if they were 18+ and had accessed healthcare within the past six months. Individuals with professional expertise in patient safety were excluded. Data were analysed using qualitative content analysis in NVivo 12. A coding framework was developed inductively and iteratively refined.
Results: Focus group participants preferred the term "safety concern" over terms like "incident" or "event," as it was more relatable and inclusive of both physical and emotional harm. Feedback led to refinements in item clarity, such as extending the recall period to six months and rewording prompts for detail. Cognitive interviews confirmed that version 2.0 was easy to understand and relevant. Minor adjustments were made, including extending the recall period to 12 months and adding "ambulance services" as a setting. The final version, 3.0, demonstrated high content and face validity, with participants expressing a strong willingness to complete the tool if distributed routinely.
Conclusion: The Patient Reported Safety Concern Tool was co-developed with public participants and refined through cognitive testing, demonstrating strong content and face validity. Participants felt confident the tool would help identify safety concerns not captured through conventional systems. Future work will focus on validating the tool in wider populations, understanding barriers to completion, and integrating it into existing patient patient safety learning systems to inform actionable safety improvements.
Keywords: Cognitive Interviews; Focus Groups; Healthcare Improvemen; Patient Safety; Patient-Reported Concerns; Tool Development.
© The Author(s) 2025. Published by Oxford University Press on behalf of International Society for Quality in Health Care.