[Diagnostic criteria for kidney Yang deficiency syndrome in male infertility]

This study aimed to establish Diagnostic criteria for kidney Yang deficiency syndrome in male infertility(referred to as "this criteria"). A preliminary questionnaire item pool was constructed through literature retrieval, in combination with male infertility-related textbooks, existing national standards, guidelines, and expert consensus documents, as well as expert interviews and group discussions. Two rounds of questionnaire surveys were conducted using the Delphi method to standardize the diagnostic criteria item pool and complete item supplementation and screening. Expert questionnaires were collected using the analytic hierarchy process(AHP) to statistically determine item weights and diagnostic thresholds. Finally, a diagnostic test was conducted by enrolling 105 participants to evaluate the diagnostic criteria, with sensitivity, specificity, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio used as indicators of diagnostic efficacy at the established threshold. Based on the results of expert discussions, this criteria was established. After systematic literature screening, 66 articles were included. By incorporating textbooks, national standards, and consensus documents, all items were summarized, merged, and classified, resulting in an initial diagnostic criteria item pool of 39 items. The first round of the Delphi method retained 29 important items, and the second round retained 18 important items. AHP identified three levels of item weights, i.e., high, medium, and low. The primary symptoms for diagnosing kidney Yang deficiency syndrome in MI were finally determined as aversion to cold, soreness and weakness of the lower back and knees, a pale and swollen tongue, and a thin white tongue coating. The secondary symptoms were decreased libido, cold sensation in the lower abdomen or genital region, increased nocturnal urination, and a deep and weak pulse or a deep and slow pulse. Patients presenting all primary symptoms were diagnosed with this syndrome; patients presenting two primary symptoms together with any two manifestations from the secondary symptoms, physical signs, or pulse conditions were also diagnosed with this syndrome. After establishment of this criteria, 105 MI patients from the Department of Andrology, Xiyuan Hospital of China Academy of Chinese Medical Sciences were enrolled. Eligible participants were diagnosed using both the evaluated this criteria and the reference diagnostic criteria. The diagnostic efficacy of this criteria showed a sensitivity of 0.91, specificity of 0.88, and accuracy of 0.89. This study established Diagnostic criteria for kidney Yang deficiency syndrome in male infertility and completed clinical validation, providing a reference basis for the clinical diagnosis of MI with kidney Yang deficiency syndrome.