ArticleTurkish journal of medical sciences2026
A comparative analysis of clinical quality and readability of neuropathic pain patient information leaflets: Türkiye versus the United States.
Article in Turkish journal of medical sciences, 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
Background/aim: Neuropathic pain management requires high patient adherence and complex dose-titration regimens, making the readability of patient information leaflets (PILs) a critical patient safety factor. This study aimed to compare the clinical content quality and linguistic readability of PILs for neuropathic pain medications between Türkiye (TİTCK) and the United States (DailyMed). Materials and methods: A total of 11 pairs of innovator medications were analyzed. Clinical content was assessed using the 15-item Keystone Clinical Content Checklist (KCCC). Readability was assessed using the Ateşman index for Turkish texts and the Flesch Reading Ease Score (FRES) for English texts. Information quality and reliability were evaluated using DISCERN, the Global Quality Score (GQS), and JAMA benchmarks. Results: TİTCK leaflets exhibited significantly higher word counts (2652.27 ± 591.6) and sentence counts (180.55 ± 30.7) than the US group (564.09 ± 75.71 and 28.18 ± 4.48, respectively; p < 0.001). While the Turkish group demonstrated superior clinical exhaustiveness (KCCC: 14.82 ± 0.40 versus 11.91 ± 1.22; p < 0.001), both groups remained within the "Difficult/Academic" readability category, with no significant difference between Ateşman and FRES scores (p = 0.4056). Notably, the US group demonstrated significantly higher educational utility (GQS: 4.27 ± 0.47 versus 3.27 ± 0.47; p = 0.0049), despite its lower content volume. Conclusion: The comparison of regulatory frameworks revealed a structural trade-off: while the TİTCK model offered superior clinical exhaustiveness, the FDA model provided significantly higher educational utility. Despite these differing priorities, neither model provided a readability advantage, as both remained within the "Difficult" category for the target patient population. These findings suggest that the high information density of the Turkish model acts as a significant barrier to effective health communication.
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