As Large Language Models (LLMs) are integrated into electronic health record (EHR) workflows, validated instruments are essential to evaluate their performance before implementation. Existing instruments for provider documentation quality are often unsuitable for the complexities of LLM-generated text and lack validation on real-world data. The Provider Documentation Summarization Quality Instrument (PDSQI-9) was developed to evaluate LLM-generated clinical summaries. Multi-document summaries were generated from real-world EHR data across multiple specialties using several LLMs (GPT-4o, Mixtral 8x7b, and Llama 3-8b). Validation included Pearson correlation for substantive validity, factor analysis and Cronbach's alpha for structural validity, inter-rater reliability (ICC and Krippendorff's alpha) for generalizability, a semi-Delphi process for content validity, and comparisons of high- versus low-quality summaries for discriminant validity. Seven physician raters evaluated 779 summaries and answered 8,329 questions, achieving over 80% power for inter-rater reliability. The PDSQI-9 demonstrated strong internal consistency (Cronbach's alpha = 0.879; 95% CI: 0.867-0.891) and high inter-rater reliability (ICC = 0.867; 95% CI: 0.867-0.868), supporting structural validity and generalizability. Factor analysis identified a 4-factor model explaining 58% of the variance, representing organization, clarity, accuracy, and utility. Substantive validity was supported by correlations between note length and scores for Succinct (rho = -0.200, p = 0.029) and Organized (rho = -0.190, p = 0.037). Discriminant validity distinguished high- from low-quality summaries (p < 0.001). The PDSQI-9 demonstrates robust construct validity, supporting its use in clinical practice to evaluate LLM-generated summaries and facilitate safer integration of LLMs into healthcare workflows.

本研究解决了现有文档质量评估工具不适用于大型语言模型所生成文本的复杂性问题。提出的提供者文档摘要质量工具（PDSQI-9）用于评估来自真实电子健康记录的数据生成的临床摘要，并通过多种验证指标显示出强大的构念效度及一般化能力。此外，研究结果表明，该工具能够有效区分高质量和低质量的摘要，为大型语言模型在医疗工作流中的安全整合提供了支持。

大型语言模型提供者文档摘要质量工具的开发与验证