Objective To establish and validate an autoverification system for pediatric coagulation tests and apply it in clinical prac-tice.Methods A total of 31 633 specimens collected at the Children's Hospital of Soochow University,from August 1,2023 to De-cember 31,2023,were used to establish coagulation auto-verification rules,which were subsequently validated with 6 704 specimens collected during January 1-31,2024.The samples were analyzed using the SYSMEX fully automatic blood coagulation analyzer assem-bly line.Auto-verification rules were established based on quality control status,instrument alerts,sample trait,numerical anomalies,logical rules,linear deviations,specimen integrity,and delta checks.The pass rate and consistency rate following the auto-verification were subsequently evaluated.Results A total of 37 auto-verification rules were established,covering abnormal results for PT-INR,APTT,Fib,TT,DD,FDP and AT together with aberrant reaction curves,specimen status and instrument alerts.The pass rate of auto-verification in the establishment group was 57.44％,and the concordance rate between auto-verification and manual review was 99.82％,while the pass rate of auto-verification was 59.96％in the validation set,and the concordance rate between auto-verification and manual review was 100％.Conclusion A set of auto-verification rules for pediatric coagulation reports was established and imple-mented in routine practice,significantly expediting the efficiency of report review and effectively shortening the turn-around time(TAT).

Objective To establish and validate an autoverification system for pediatric coagulation tests and apply it in clinical prac-tice.Methods A total of 31 633 specimens collected at the Children's Hospital of Soochow University,from August 1,2023 to De-cember 31,2023,were used to establish coagulation auto-verification rules,which were subsequently validated with 6 704 specimens collected during January 1-31,2024.The samples were analyzed using the SYSMEX fully automatic blood coagulation analyzer assem-bly line.Auto-verification rules were established based on quality control status,instrument alerts,sample trait,numerical anomalies,logical rules,linear deviations,specimen integrity,and delta checks.The pass rate and consistency rate following the auto-verification were subsequently evaluated.Results A total of 37 auto-verification rules were established,covering abnormal results for PT-INR,APTT,Fib,TT,DD,FDP and AT together with aberrant reaction curves,specimen status and instrument alerts.The pass rate of auto-verification in the establishment group was 57.44％,and the concordance rate between auto-verification and manual review was 99.82％,while the pass rate of auto-verification was 59.96％in the validation set,and the concordance rate between auto-verification and manual review was 100％.Conclusion A set of auto-verification rules for pediatric coagulation reports was established and imple-mented in routine practice,significantly expediting the efficiency of report review and effectively shortening the turn-around time(TAT).

OBJECTIVE To explore the distribution pattern of traditional Chinese medicine(TCM)syndrome types of primary o-varian insufficiency(POI)sleep disorders and the differences in the distribution of sleep quality index among different syndrome types,in order to provide a basis for syndrome differentiation treatment and prevention of POI associated with sleep disorders.METHODS 600 POI patients who met the inclusion criteria were collected for epidemiological investigation,and 405 patients who met the diagnosis of sleep disorders were selected as the research group.The patients'general information,TCM four diagnosis and sex hormone level in-formation were collected,and the Pittsburgh sleep quality index(PSQI)scale was used to evaluate patients'sleep conditions,and ana-lyze the characteristics and influencing factors of TCM syndrome types of POI associated with sleep disorders.RESULTS The main TCM syndrome types of POI accompanied by sleep disorders were heart and kidney disharmony syndrome(41.98%),spleen and kid-ney yang deficiency syndrome(22.22%),kidney deficiency and liver stagnation syndrome(20.99%),and kidney deficiency and blood stasis syndrome(14.81%).The heart and kidney disharmony syndrome had the longest sleep latency and shortest sleep time,relied more on hypnotic drugs,and had the highest PSQI total score;the heart and kidney disharmony syndrome and kidney deficiency and liver stagnation syndrome had the worst sleep quality;the spleen kidney yang deficiency syndrome had the highest daytime dysfunc-tion score.There was no significant difference in FSH levels among different TCM syndrome types;the distribution of E2 values from low to high was:heart and kidney disharmony syndrome,kidney deficiency and liver stagnation syndrome,spleen and kidney yang de-ficiency syndrome,and kidney deficiency and blood stasis syndrome,and there were significant differences among multiple groups(P<0.05).CONCLUSION The main TCM syndrome types of patients with POI and sleep disorders are heart and kidney disharmony syn-drome,spleen and kidney yang deficiency syndrome,kidney deficiency and liver stagnation syndrome,and kidney deficiency and blood stasis syndrome.Among them,the most common TCM syndrome type with the worst sleep quality is heart and kidney disharmony syn-drome,which may be closely related to estrogen E2 levels.

Objective:This study aims to analyze the current status of clinical trial management in dental specialized hospitals under the record-filing system for clinical trial institutions, and to propose targeted optimization measures, aiming to improve management level and provide reference for the establishment of a clinical trial management model with characteristics of dental specialized hospitals.Methods:A survey was conducted on multiple dental specialized hospitals in China to understand the existing problems and excellent management experiences in clinical trial management.Results:In the current clinical trial management of dental specialized hospitals, there were still problems such as unclear positioning of internal management departments, insufficient number of full-time personnel, and weak awareness of Good Clinical Practice (GCP) among researchers.Conclusions:Dental specialized hospitals can strengthen management by clarifying the positioning of clinical trial management departments, implementing a project responsibility system for full-time personnel, improving the construction of management systems, and strengthening researcher training, so as to ensure the effective operation of clinical trials and further improve their quality.

Objective:This study aims to analyze the current status of clinical trial management in dental specialized hospitals under the record-filing system for clinical trial institutions, and to propose targeted optimization measures, aiming to improve management level and provide reference for the establishment of a clinical trial management model with characteristics of dental specialized hospitals.Methods:A survey was conducted on multiple dental specialized hospitals in China to understand the existing problems and excellent management experiences in clinical trial management.Results:In the current clinical trial management of dental specialized hospitals, there were still problems such as unclear positioning of internal management departments, insufficient number of full-time personnel, and weak awareness of Good Clinical Practice (GCP) among researchers.Conclusions:Dental specialized hospitals can strengthen management by clarifying the positioning of clinical trial management departments, implementing a project responsibility system for full-time personnel, improving the construction of management systems, and strengthening researcher training, so as to ensure the effective operation of clinical trials and further improve their quality.