Chinese medicine syndrome differentiation-kidney deficiency syndrome (KDS) for women during pregnancy: Delphi expert consensus on a self-reported KDS symptoms scale followed by psychometric properties evaluation

中医辨证论治——妊娠期女性肾虚证:德尔菲专家共识法构建的自评肾虚证症状量表及其心理测量学特性评价

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Abstract

OBJECTIVE: To develop an expert consensus on kidney deficiency syndrome (KDS) in pregnant women and construct a validated self-reported KDS Patient-Reported Measures Pregnancy Scale (KDS-PRMs-Pregnancy Scale) for early identification and management. METHODS: The study was conducted in three phases. First, a comprehensive review of Traditional Chinese Medicine (TCM) literature and diagnostic criteria was performed, generating initial KDS symptoms for pregnancy. Second, a two-round Delphi survey, involving 21 experts from TCM, obstetrics, and gynaecology, assessed importance, relevance, and appropriateness of the items. Third, a psychometric evaluation was conducted, including exploratory factor analysis and internal consistency assessment. RESULTS: In the first Delphi round, 19 items were flagged for revision or removal due to expert variability, with 12 items deemed irrelevant. In the second round, consensus was reached, resulting in a 25-item scale. After psychometric evaluation, seven items were removed due to poor factor loadings, leaving an 18-item scale. Three factors-physiological discomfort, fatigue & weakness, and excretion abnormalities-accounted for 78.4% of the variance. The final scale demonstrated excellent internal consistency (Cronbach's alpha = 0.959). CONCLUSION: The validated 18-item KDS-PRMs-Pregnancy Scale is a reliable tool for assessing KDS in pregnant women. Future research should focus on validation in diverse populations and exploring its predictive validity for pregnancy outcomes.

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