Documentation-related diagnostic safety concerns in primary care: a structured medical record review of 1116 patient records.

Abstract

Background: Diagnostic safety concerns are among the most consequential yet least visible threats to patient safety in primary care. Non-specific symptoms potentially associated with cancer represent a high-risk context, where delayed diagnosis may have serious consequences despite a low probability of serious disease.

Objective: To identify diagnostic safety concerns and areas for improvement in assessing patients presenting with non-specific symptoms in primary care.

Method: A structured medical record review combining quantitative assessment and qualitative thematic analysis was conducted in Region Stockholm, Sweden. In a region-wide quality improvement initiative, 27 primary care centres reviewed 1116 medical records of patients aged 40-75 years with selected ICD-10 (International Classification of Diseases, 10th Revision) codes recorded in 2023. Reviews used a structured template addressing diagnostic reasoning, data collection and healthcare use. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis.

Results: Overall, 358 records (32%) had at least one diagnostic safety concern. Absence of documentation of differential diagnostic reasoning was identified in 21% of records, insufficient data collection in 18% and failure to consider alternative diagnoses in 12%; these concerns co-occurred in 13% of records. Four themes were identified: invisible diagnostic reasoning, narrow diagnostic framing, failure to re-evaluate, and fragmented care and patient complexity as a cross-cutting contextual influence on diagnostic vulnerabilities.

Conclusion: Among patients presenting with non-specific symptoms potentially associated with cancer, documentation-related diagnostic safety concerns arose from whether and how diagnostic reasoning was documented, revisited and communicated across encounters. While the findings support safety-netting and diagnostic re-evaluation, they also highlight vulnerabilities including negative test results functioning as diagnostic endpoints and care fragmentation undermining diagnostic progression. Structured record review linked to reflective learning may help address these patterns in practice.