1.Proctor's Reporting Guideline for Implementation Strategies: Interpretation, Application, and Challenges
Jiangyun CHEN ; Jinghan LIU ; Youping ZHUANG ; Xueying CHEN ; Siyuan LIU ; Xiaoshan CHEN ; Yeqing ZHAN ; Dongmei ZHONG ; Huadan HUANG ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2026;17(1):263-273
The Proctor's reporting guideline for implementation strategies represents a landmark framework in the field of implementation science, aiming to address the issue of inconsistent reporting in implementation research by standardizing the naming, definition, and operationalization of implementation strategies, thereby enhancing the credibility and utility of research findings. This paper provides an in-depth interpretation of the core connotations of this reporting guideline and illustrates its application in developing interview outlines and specifying implementation strategies, using a brief smoking cessation intervention project as a case study. Through this reporting guideline, abstract recommendations for implementation are systematically transformed into clear, multidimensional operational guides, significantly improving the transparency of strategy connotations and the replicability of actual execution. Meanwhile, the case study highlights the flexibility of the guideline, which allows researchers to adapt the content and format of strategies based on local resources and cultural contexts, thus enhancing practical adaptability while maintaining scientific rigor. However, the application of Proctor's reporting guideline still faces challenges, primarily manifested in the potential confusion surrounding the constructs of temporality and dose in practice, as well as the challenges that the inherent flexibility of the guideline may pose to the assessment of fidelity and effectiveness. Despite these limitations, the reporting guideline remains a vital tool for implementation research; future efforts should focus on optimizing its application—through refining operational guidelines, standardizing flexible adaptations, and involving stakeholders—to better guide implementation studies and continuously promote high-quality development in the field.
2.Evaluation of rapid identification model of hypervirulent Klebsiella pneumoniae based on MALDI-TOF MS and machine learning algorithm
Dongmei MAI ; Jiana LAN ; Yuwei HE ; Ran LI ; Xiaoling HUANG
Chinese Journal of Nosocomiology 2025;35(11):1684-1689
OBJECTIVE To screen characteristic peaks of hypervirulent Klebsiella pneumoniae(hvKP)using ma-trix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS)combined with EX-Smartspec software and establish a rapid detection model for hvKP.METHODS Based on identification criteria of any positive peg-344,iroB,iucA,rmpA,prmpA2 genes or siderophore production>30 μg/ml,89 hvKP and 72 classical Klebsiella pneumoniae(cKP)strains were initially collected and validated for virulence via Galleria mellonella assays.A diagnostic model distinguishing hvKP from cKP was constructed using EX-Smartspec soft-ware and a convolutional neural network algorithm,integrating characteristic peaks and cluster analysis to provide a rapid and accurate clinical diagnostic tool.RESULTS MALDI-TOF MS analysis identified a characteristic hvKP peak at(3 835±100)ppm.Receiver operating characteristic(ROC)curve analysis revealed optimal performance in distinguishing hvKP with an area under the curve(AUC)=0.741.When AUC ≥0.089,the model demonstra-ted high sensitivity(86.41%),specificity(69.90%),accuracy(78.16%),positive predictive value(74.17%),and negative predictive value(83.72%)in differentiating hvKP from cKP.Cluster analysis further validated the model's classification accuracy.Additionally,the typing classification model exhibited high accuracy(approxi-mately 0.95 and 0.90 in training and validation phases,respectively)and low loss values(-0.18 and 0.30).Val-idation of 6 randomly selected hvKP and 5 cKP strains showed a 100.00%pass rate.CONCLUSION The estab-lished diagnostic model for hvKP and cKP provides a rapid and accurate clinical tool for timely treatment of hvKP-related infections.
3.Clinicopathological characteristics and prognostic factor analysis of mucinous com-ponents heterogeneity in lung adenocarcinoma
Kaiwen CHI ; Wei SUN ; Xin YANG ; Haiyue WANG ; Xinying LIU ; Yumeng JIANG ; Xiaozheng HUANG ; Dongmei LIN
Chinese Journal of Clinical and Experimental Pathology 2025;41(6):719-725
Purpose This study aimed to explore the mucinous phenotype characteristics,key points of differenti-al diagnosis and prognosis of invasive non-mucinous adenocarcinoma(INMA)and invasive mucinous adenocarcinoma(IMA)under the WHO(2021)lung adenocarcinoma classification.Methods We retrospectively collected clinico-pathological data from 522 cases of lung adenocarcinoma,including 425 INMA(66 with mucin secretion,259 without mucin secretion)and 97 IMA.Immunohistochemical(IHC)staining using the EnVision method was performed on the mucin-secreting adenocarcinoma to assess expression of TTF-1,HNF4α,MUC1,MUC4,MUC5AC,MUC5B,and MUC6.Unsupervised clustering analysis was conducted to explore phenotypic subgroups.Results 522 patients with lung adenocarcinoma ranged from 32 to 83 years old(median:61).251 cases(48.1%)were male and 271 cases(51.9%)were female.Clustering analysis divided lung adenocarcinomas into two major groups:one characterized by TTF-1-/HNF4α+and gastric-type mucins MUC5AC+/MUC6+,predominantly IMA;the other,TTF-1+/HNF4α-/MUC4+,largely INMA.A three-marker IHC panel(TTF-1,HNF4α,MUC6)distinguished IMA from mucinous IN-MA with an area under the ROC curve(AUC)of 0.957(95%CI:0.928-0.986)and a Youden's index of 0.860.Further cluster analysis of INMA cases identified four phenotypic subgroups.Prognostic analysis demonstrated that pa-tients with advanced-stage mucin-secreting INMA had significantly shorter overall survival(OS)and progression-free survival(PFS)than those without mucin secretion(5-year OS:57.1% vs 81.8%,P=0.004;3-year PFS:40.9% vs 62.4%,P=0.004).No significant survival differences were noted among INMA subgroups stratified by varying mucin proportions.Multivariate analysis identified pathological stage,tumor necrosis,KRAS mutation,and TTF-1 negativity as independent adverse prognostic factors for both OS and PFS in mucinous INMA.Conclusion A three-marker im-munohistochemical panel of TTF-1,HNF4α,and MUC6 is recommended to distinguish IMA from mucinous INMA.Mucus component portends a worse prognosis in advanced INMA,with necrosis,KRAS mutations,and TTF-1 negativi-ty serving as independent adverse prognostic factors in mucinous INMA.
4.Diagnostic Value of Serum lncRNA DDIT4-AS1,lncRNA RSPH9-4 in Patients with Bacterial Meningitis
Changhong FU ; Xueer CHEN ; Dongmei XIANG ; Yue HUANG
Journal of Modern Laboratory Medicine 2025;40(5):62-66
Objective To investigate the expression levels and diagnostic value of long non coding RNA(lncRNA)DNA damage inducible transcript 4 like protein 4 antisense RNA1(lncRNA DDIT4-AS1)and long chain non coding RNA(lncRNA)radial spoke head protein 9 homolog 4(RSPH9-4)in serum of patients with bacterial meningitis.Methods A total of 94 patients with meningitis in the Fifth Hospital of Deyang City from May 2022 to May 2024 were regarded as the bacterial meningitis group.According to the severity of damage to the central nervous system caused by bacterial meningitis,they were further separated into a general group(n=63)and a severe group(n=31).94 patients with suspected meningitis upon admission but excluded meningitis after examination were selected as the non bacterial meningitis group.A total of 94 patients diagnosed with bacterial meningitis in the Fifth Hospital of Deyang City from May 2022 to May 2024 were selected as the bacterial meningitis group 94 healthy volunteers who underwent physicalexamination were as the control group.Real-time fluorescence quantitative PCR(qRT-PCR)method was applied to detect the expression levels of lncRNA DDIT4-AS1 and lncRNA RSPH9-4 in serum samples of all personnel.Spearman analysis was applied to analyze the correlation between serum levels of lncRNA DDIT4-AS1 and lncRNA RSPH9-4 with the severity of bacterial meningitis.Multivariate Logistic analysis was applied to analyze the influencing factors of bacterial meningitis.Receiver operating characteristic(ROC)curve was plotted to analyze the diagnostic value of serum lncRNA DDIT4-AS1 and lncRNA RSPH9-4 levels for bacterial meningitis.Results Compared with the control group,the expression levels of serum lncRNA DDIT4-AS1(1.35±0.27,1.67±0.35 vs 1.01±0.18)and lncRNA RSPH9-4(1.30±0.25,1.56±0.32 vs 1.00±0.19)were increased in non bacterial meningitis group and bacterial meningitis group(t=10.159,16.259;9.263,14.589),compared with the non bacterial meningitis group,the expression levels of serum lncRNA DDIT4-AS1 and lncRNA RSPH9-4 in the bacterial meningitis group were increased(t=7.019,6.208),and the differences were statistically significant(all P<0.05),respectively.Compared with the general group,the expression levels of serum lncRNA DDIT4-AS1(1.88±0.38 vs 1.56±0.31)and lncRNA RSPH9-4(1.79±0.35 vs 1.45±0.28)were increased in the severe group,and the differences were statistically significant(t=4.361,5.088,all P<0.05).Spearman correlation analysis results showed that serum levels of lncRNA DDIT4-AS1,lncRNA RSPH9-4 were positively correlated with the severity of bacterial meningitis(r=0.524,0.548,all P<0.05).The expression levels of PCT,LDH and CRP in patients with bacterial meningitis were higher than those in patients without bacterial meningitis,and the differences were statistically significant(t=7.459,4.234,8.565,all P<0.05).Multivariate Logistic analysis showed that PCT,LDH,CRP,lncRNA DDIT4-AS1 and lncRNA RSPH9-4 were influencing factors for bacterial meningitis(Wald χ2=4.768~12.035,all P<0.05).The receiver operating characteristic(ROC)curve results showed that the combined diagnosis of serum lncRNA DDIT4-AS1 and lncRNA RSPH9-4 levels for bacterial meningitis had a significantly larger area under the curve(AUC)than the diagnosis of lncRNA DDIT4-AS1 and lncRNA RSPH9-4 alone,and the differences were statistically significant(Z=2.426,2.545,all P<0.05).Conclusion The expression levels of serum lncRNA DDIT4-AS1 and lncRNA RSPH9-4 are elevated in patients with bacterial meningitis,and the combination of the two has high diagnostic value for the disease.
5.Current research status of sleep disorders in patients with tinnitus
Xiaoling HUANG ; Dongmei TANG ; Shan SUN ; Huawei LI
Journal of Audiology and Speech Pathology 2025;33(5):485-490
Sleep disorders is one of the most frequent and severe complications in patients with tinnitus and is highly correlated with the severity of tinnitus.Sleep disorders and tinnitus influence each other,forming a vicious circle.While in-terventions have been developed to alleviate tinnitus distress,these interventions are usually not effective in improving sleep in patients with tinnitus and sleep disorders.Helping tinnitus patients to resolve sleep disorders is the key to breaking the cycle and improving their quality of life.In this narrative review,we studyed the current state of research on sleep disorders in patients with tinnitus through three aspects:epidemiology,physiological and psychological mechanisms,and existing psychological,physical,and pharmacological interventions,and to provide a basis for further research on the relationship between tinnitus and sleep disorders and the precise treatment of tinnitus.
6.Evaluation of rapid identification model of hypervirulent Klebsiella pneumoniae based on MALDI-TOF MS and machine learning algorithm
Dongmei MAI ; Jiana LAN ; Yuwei HE ; Ran LI ; Xiaoling HUANG
Chinese Journal of Nosocomiology 2025;35(11):1684-1689
OBJECTIVE To screen characteristic peaks of hypervirulent Klebsiella pneumoniae(hvKP)using ma-trix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS)combined with EX-Smartspec software and establish a rapid detection model for hvKP.METHODS Based on identification criteria of any positive peg-344,iroB,iucA,rmpA,prmpA2 genes or siderophore production>30 μg/ml,89 hvKP and 72 classical Klebsiella pneumoniae(cKP)strains were initially collected and validated for virulence via Galleria mellonella assays.A diagnostic model distinguishing hvKP from cKP was constructed using EX-Smartspec soft-ware and a convolutional neural network algorithm,integrating characteristic peaks and cluster analysis to provide a rapid and accurate clinical diagnostic tool.RESULTS MALDI-TOF MS analysis identified a characteristic hvKP peak at(3 835±100)ppm.Receiver operating characteristic(ROC)curve analysis revealed optimal performance in distinguishing hvKP with an area under the curve(AUC)=0.741.When AUC ≥0.089,the model demonstra-ted high sensitivity(86.41%),specificity(69.90%),accuracy(78.16%),positive predictive value(74.17%),and negative predictive value(83.72%)in differentiating hvKP from cKP.Cluster analysis further validated the model's classification accuracy.Additionally,the typing classification model exhibited high accuracy(approxi-mately 0.95 and 0.90 in training and validation phases,respectively)and low loss values(-0.18 and 0.30).Val-idation of 6 randomly selected hvKP and 5 cKP strains showed a 100.00%pass rate.CONCLUSION The estab-lished diagnostic model for hvKP and cKP provides a rapid and accurate clinical tool for timely treatment of hvKP-related infections.
7.Clinicopathological characteristics and prognostic factor analysis of mucinous com-ponents heterogeneity in lung adenocarcinoma
Kaiwen CHI ; Wei SUN ; Xin YANG ; Haiyue WANG ; Xinying LIU ; Yumeng JIANG ; Xiaozheng HUANG ; Dongmei LIN
Chinese Journal of Clinical and Experimental Pathology 2025;41(6):719-725
Purpose This study aimed to explore the mucinous phenotype characteristics,key points of differenti-al diagnosis and prognosis of invasive non-mucinous adenocarcinoma(INMA)and invasive mucinous adenocarcinoma(IMA)under the WHO(2021)lung adenocarcinoma classification.Methods We retrospectively collected clinico-pathological data from 522 cases of lung adenocarcinoma,including 425 INMA(66 with mucin secretion,259 without mucin secretion)and 97 IMA.Immunohistochemical(IHC)staining using the EnVision method was performed on the mucin-secreting adenocarcinoma to assess expression of TTF-1,HNF4α,MUC1,MUC4,MUC5AC,MUC5B,and MUC6.Unsupervised clustering analysis was conducted to explore phenotypic subgroups.Results 522 patients with lung adenocarcinoma ranged from 32 to 83 years old(median:61).251 cases(48.1%)were male and 271 cases(51.9%)were female.Clustering analysis divided lung adenocarcinomas into two major groups:one characterized by TTF-1-/HNF4α+and gastric-type mucins MUC5AC+/MUC6+,predominantly IMA;the other,TTF-1+/HNF4α-/MUC4+,largely INMA.A three-marker IHC panel(TTF-1,HNF4α,MUC6)distinguished IMA from mucinous IN-MA with an area under the ROC curve(AUC)of 0.957(95%CI:0.928-0.986)and a Youden's index of 0.860.Further cluster analysis of INMA cases identified four phenotypic subgroups.Prognostic analysis demonstrated that pa-tients with advanced-stage mucin-secreting INMA had significantly shorter overall survival(OS)and progression-free survival(PFS)than those without mucin secretion(5-year OS:57.1% vs 81.8%,P=0.004;3-year PFS:40.9% vs 62.4%,P=0.004).No significant survival differences were noted among INMA subgroups stratified by varying mucin proportions.Multivariate analysis identified pathological stage,tumor necrosis,KRAS mutation,and TTF-1 negativity as independent adverse prognostic factors for both OS and PFS in mucinous INMA.Conclusion A three-marker im-munohistochemical panel of TTF-1,HNF4α,and MUC6 is recommended to distinguish IMA from mucinous INMA.Mucus component portends a worse prognosis in advanced INMA,with necrosis,KRAS mutations,and TTF-1 negativi-ty serving as independent adverse prognostic factors in mucinous INMA.
8.Simultaneous determination of sucrose and mannitol by HPLC-ELSD in meningococcal polysaccharide vaccine
Gang HE ; Dongmei ZHOU ; Yueyue LAI ; Qian HUANG ; Qian WANG ; Siqin CAI ; Gongxiao WANG ; Fang HUANG
Drug Standards of China 2025;26(4):424-429
Objective:To establish a high performance liquid chromatography-evaporative light scattering detector(HPLC-ELSD)technique for simultaneous determining the content of excipients sucrose and mannitol in meningo-coccal polysaccharide vaccine.Methods:Using NanoChrom Sugar-10Ca analytical column(300 mm × 7.8 mm)and HPLC system(Agilent 1260).With purified water as the mobile phase,a flow rate of 0.5 mL·min-1,column temperature was 80 ℃,and the injection volume was 50 μL.The evaporative light detector was based on nitrogen.The carrier gas flow rate is 3.2 L·min-1,the temperature of drift tube was 1 10 ℃,the gain value was 1,and the impactor was"mode 1".This assay was subsequently validated for its system suitability,specificity,repeatability,intermediate precision and linearity,and accuracy.The established method was used to assay the contents of the sucrose and mannitol in four batches of meningococcal polysaccharide vaccine.Results:The estab-lished HPLC-ELSD method showed good systemic suitability.Specificity validation showed that there was no inter-ference peak in the blank solvent;the separation of the target peaks between sucrose and mannitol was>2.0.The relative standard deviations(RSD)value of peak area of sucrose and mannitol in six tests were 0.44%and 0.38%,respectively.RSD of intermediate precision of both sucrose and mannitol were lower than 2.00%,indica-ting that the precision of high performance liquid chromatography instrument was well.The linear range of two excipients were 12.5-150.0 μg·mL-1(R2>0.99,respectively).The recovery rate of sucrose and mannitol were 95.74%-99.33%,94.37%-98.85%,respectively.There was no significant difference in the contents of sucrose and mannitol in 4 batches of meningococcal polysaccharide vaccine.Conclusion:The HPLC-ELSD method showed good specificity,precision,linearity and accuracy,and the test results were stable and reliable,so that it is suitable for simultaneous determination of sucrose and mannitol contents of meningococcal polysaccharide injections.
9.Simultaneous determination of sucrose and mannitol by HPLC-ELSD in meningococcal polysaccharide vaccine
Gang HE ; Dongmei ZHOU ; Yueyue LAI ; Qian HUANG ; Qian WANG ; Siqin CAI ; Gongxiao WANG ; Fang HUANG
Drug Standards of China 2025;26(4):424-429
Objective:To establish a high performance liquid chromatography-evaporative light scattering detector(HPLC-ELSD)technique for simultaneous determining the content of excipients sucrose and mannitol in meningo-coccal polysaccharide vaccine.Methods:Using NanoChrom Sugar-10Ca analytical column(300 mm × 7.8 mm)and HPLC system(Agilent 1260).With purified water as the mobile phase,a flow rate of 0.5 mL·min-1,column temperature was 80 ℃,and the injection volume was 50 μL.The evaporative light detector was based on nitrogen.The carrier gas flow rate is 3.2 L·min-1,the temperature of drift tube was 1 10 ℃,the gain value was 1,and the impactor was"mode 1".This assay was subsequently validated for its system suitability,specificity,repeatability,intermediate precision and linearity,and accuracy.The established method was used to assay the contents of the sucrose and mannitol in four batches of meningococcal polysaccharide vaccine.Results:The estab-lished HPLC-ELSD method showed good systemic suitability.Specificity validation showed that there was no inter-ference peak in the blank solvent;the separation of the target peaks between sucrose and mannitol was>2.0.The relative standard deviations(RSD)value of peak area of sucrose and mannitol in six tests were 0.44%and 0.38%,respectively.RSD of intermediate precision of both sucrose and mannitol were lower than 2.00%,indica-ting that the precision of high performance liquid chromatography instrument was well.The linear range of two excipients were 12.5-150.0 μg·mL-1(R2>0.99,respectively).The recovery rate of sucrose and mannitol were 95.74%-99.33%,94.37%-98.85%,respectively.There was no significant difference in the contents of sucrose and mannitol in 4 batches of meningococcal polysaccharide vaccine.Conclusion:The HPLC-ELSD method showed good specificity,precision,linearity and accuracy,and the test results were stable and reliable,so that it is suitable for simultaneous determination of sucrose and mannitol contents of meningococcal polysaccharide injections.
10.Analysis of risk factors and establishment of a prediction model for endometrial cancer in postmenopausal bleeding
Jing WANG ; Qiaoyun ZHOU ; Muyu WANG ; Yu XIAO ; Dongmei SONG ; Yan GUO ; Enlan XIA ; Tinchiu LI ; Xiaowu HUANG
Journal of Capital Medical University 2025;46(1):143-149
Objective To establish a method for predicting the risk of endometrial cancer(EC)and endometrial atypical hyperplasia(AH)in women with postmenopausal bleeding(PMB)by collecting clinical data on routine medical history.Methods The clinical data of a total of 408 PMB patients admitted to Fuxing Hospital,Capital Medical University were consecutively collected in this retrospective study from December 2013 to December 2023.According to the results of endometrial pathology,patients were divided into case group and control group.EC and AH were included in the malignant group(case group)and the other endometrial pathologies were included in the non-malignant group(control group).Clinical data,including clinical history,high risk factors,and common gynecological ultrasound measurement indicators,were collected and studied by univariate and multivariate Logistic regression analysis.Results The mean age of 408 patients was(60.4±7.8)years.A total of 74 cases(18.1%)were in case group and 334 cases(81.9%)were in control group.Based on Logistic regression analysis,the best predictors of endometrial malignant lesions were selected to create a"LRDNT"(light bleeding,recurrent bleeding,diabetes,non-uniform echogenicity & thickness)model.LRDNT scores range from 0 to 22.The score of LRDNT ≥15 has the largest Yoden index,and the sensitivity to predict endometrial malignant lesions is 79.73%,the specificity is 80.84%,and the prediction accuracy is 80.64%.Conclusions The risk prediction model LRDNT,which combines clinical information and common gynecological ultrasound measurement indicators of PMB patients,can help clinicians classify patients at high and low risk of endometrial malignant lesions,and optimize the strategy of diagnosis and treatment.

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