1.Reporting Guidelines in Implementation Science:Overview,Categorization and Future Directions
Xiaoshan CHEN ; Dadong WU ; Run WANG ; Qing ZHAO ; Siyuan LIU ; Wanqing HUANG ; Zizhen HUANG ; Yuting WAN ; Huanyu HU ; Junlin ZHU ; Jiangyun CHEN ; Zhiwei HUANG ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1033-1046
Reporting guidelines are structured checklists for researchers to follow when reporting spe-cific types of studies.As researches conducted in real-world settings to address practical issues,implementa-tion research has stringent requirements for the replicability of result and the transparency of reporting,making its reporting guidelines particularly important.This paper systematically introduces the reporting guidelines in the field of implementation science,outlines their classification systems and scopes of applica-tion,and focuses on explaining the core characteristics and functions of five key reporting guidelines,inclu-ding the Standards for Reporting Implementation Studies(StaRI),Reporting guidelines for implementation and operational research,the Template for Intervention Description and Replication(TIDieR),the Frame-work for Reporting Adaptations and Modifications-Enhanced(FRAME),and recommendations for specifying and reporting implementation strategies.Furthermore,combined with the PEDALs research paradigm in im-plementation science,this paper further clarifies the specific application pathways for reporting guidelines and discusses directions for refinement,aiming to provide references for researchers to select appropriate reporting guidelines.
2.Correlation analysis between palatal connective tissue acquisition methods and postoperative pain after mucogingival surgery
Han HU ; Jiachen DONG ; Yue LIAO ; Huanyu ZHANG ; Zhongchen SONG
STOMATOLOGY 2025;45(6):440-444
Objective To evaluate the impact of different methods of harvesting palatal connective tissue on patients' postoperative pain at the palatal donor site.Methods A total of 30 patients were included.The control group was de-epithelialized free gingival graft technique group,and the experimental group was the single-incision technique group.The keratinized gingival width of the recipient site,number of vertical incisions,number of teeth,donor site mucosa thickness,graft width,graft length,graft thickness,operation time and amount of anesthetic were recorded.The postoperative quality of life rating scale and visual analog scale were completed and statistical analysiswas performedon the results by SPSS 26.0.Results The postoperative quality of life score of the experimental group was significantly lower than that of the control group,and there was no significant difference in the total VAS score of the donor site.In terms of the total postoperative pain level after mucogingival surgery,the number of vertical incisions and graft thickness were positively correlated with the pain.Palate mucosal thickness was negatively correlated with postoperative pain levels.Conclusion In mucogingi-val surgery,the degree of postoperative pain in the donor palatal region of the patient is independent of the choice of de-epithelialized free gingival graft technique or single-incision technique to obtain subepithelial connective tissue.The surgeon should also give compre-hensive considerationsto the anatomical factors of the patient's donor site,surgical technical level and experience,and aesthetic require-ments when selecting the surgical method.
3.Correlation analysis between palatal connective tissue acquisition methods and postoperative pain after mucogingival surgery
Han HU ; Jiachen DONG ; Yue LIAO ; Huanyu ZHANG ; Zhongchen SONG
STOMATOLOGY 2025;45(6):440-444
Objective To evaluate the impact of different methods of harvesting palatal connective tissue on patients' postoperative pain at the palatal donor site.Methods A total of 30 patients were included.The control group was de-epithelialized free gingival graft technique group,and the experimental group was the single-incision technique group.The keratinized gingival width of the recipient site,number of vertical incisions,number of teeth,donor site mucosa thickness,graft width,graft length,graft thickness,operation time and amount of anesthetic were recorded.The postoperative quality of life rating scale and visual analog scale were completed and statistical analysiswas performedon the results by SPSS 26.0.Results The postoperative quality of life score of the experimental group was significantly lower than that of the control group,and there was no significant difference in the total VAS score of the donor site.In terms of the total postoperative pain level after mucogingival surgery,the number of vertical incisions and graft thickness were positively correlated with the pain.Palate mucosal thickness was negatively correlated with postoperative pain levels.Conclusion In mucogingi-val surgery,the degree of postoperative pain in the donor palatal region of the patient is independent of the choice of de-epithelialized free gingival graft technique or single-incision technique to obtain subepithelial connective tissue.The surgeon should also give compre-hensive considerationsto the anatomical factors of the patient's donor site,surgical technical level and experience,and aesthetic require-ments when selecting the surgical method.
4.Reporting Guidelines in Implementation Science:Overview,Categorization and Future Directions
Xiaoshan CHEN ; Dadong WU ; Run WANG ; Qing ZHAO ; Siyuan LIU ; Wanqing HUANG ; Zizhen HUANG ; Yuting WAN ; Huanyu HU ; Junlin ZHU ; Jiangyun CHEN ; Zhiwei HUANG ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1033-1046
Reporting guidelines are structured checklists for researchers to follow when reporting spe-cific types of studies.As researches conducted in real-world settings to address practical issues,implementa-tion research has stringent requirements for the replicability of result and the transparency of reporting,making its reporting guidelines particularly important.This paper systematically introduces the reporting guidelines in the field of implementation science,outlines their classification systems and scopes of applica-tion,and focuses on explaining the core characteristics and functions of five key reporting guidelines,inclu-ding the Standards for Reporting Implementation Studies(StaRI),Reporting guidelines for implementation and operational research,the Template for Intervention Description and Replication(TIDieR),the Frame-work for Reporting Adaptations and Modifications-Enhanced(FRAME),and recommendations for specifying and reporting implementation strategies.Furthermore,combined with the PEDALs research paradigm in im-plementation science,this paper further clarifies the specific application pathways for reporting guidelines and discusses directions for refinement,aiming to provide references for researchers to select appropriate reporting guidelines.
5.Application value of MR nonenhanced brain neurovascular sequences in evaluating neonatal arterial ischemic stroke
Di HU ; Huanyu LUO ; Hang LI ; Shuangfeng YANG ; Yun PENG
Journal of Practical Radiology 2024;40(6):961-965
Objective To systematically evaluate brain parenchymal and vascular changes after neonatal arterial ischaemic stroke(AIS)using nonenhanced brain neurovascular MR sequences.Methods MR imaging data of 57 children with AIS(<28 days old at the time of diagnosis)were analyzed retrospectively,including[susceptibility weighted imaging(SWI),magnetic resonance angiography(MRA),magnetic resonance venography(MRV)]sequences and conventional brain sequences[T1 WI,T2 WI,diffusion weighted imaging(DWI)].The imaging features and alteration trend of different sequences in different periods were summarized and studied.Results Vessels increased or decreased in number and enlarged or reduced in diameter within the infarction area,which presented a mixed-pattern,while the periphery showed increased only by using the nonenhanced brain vascular sequence.During the first 9 days after the onset of symptoms,the signals of T1 WI and T2 WI within the infarction area gradually stabilized,and most signals of DWI returned to normal.MRA,MRV,and SWI sequences showed a minimal change of diameter and number of vessels within the infarction area and its surroundings,which directed that neonatal AIS may had transient and dramatic brain injury and blood flow alteration.Conclusion The nonenhanced neurovascular sequence of brain MR can comprehensively display the alteration of brain parenchymal signals and vascular trends after neonatal AIS,providing the possibility for early clinical rapid and effective evaluation.
6.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
7.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).
8.Clinical and Imaging Features of Neonatal Herpes Simplex Encephalitis
Huanyu LUO ; Di HU ; Shuangfeng YANG ; Hang LI ; Yun PENG
Chinese Journal of Medical Imaging 2024;32(3):245-249
Purpose To summarize the clinical and imaging features of neonatal herpes simplex encephalitis(NHSE).Materials and Methods Clinical and imaging data of 5 NHSE from January 2016 to June 2023 in Beijing Children's Hospital,Capital Medical University were retrospectively collected.All five children underwent MRI examinations,with three of them undergoing enhanced scanning simultaneously.Two children had previously undergone CT scans.The location,density/signal,enhancement characteristics as well as follow-up imaging changes of the lesions were reviewed.Results The main clinical manifestations of NHSE were fever(5 cases)and seizure(4 cases),sometimes accompanied by herpes(2 cases).Imaging examinations in NHSE typically presented with symmetric(1 case)or diffuse/multifocal(4 cases)lesions in bilateral cerebral hemispheres,along with involvement of the bilateral thalamus(5 cases).Early CT scans showed either no abnormalities(1 case)or extensive areas of low density(1 case).MRI examinations usually demonstrated restricted diffusion of acute phase lesions(3 cases)and significant leptomeningeal enhancement in affected areas(3 cases).Intracranial lesions often led to the diffuse atrophy of brain parenchyma and polycystic encephalomalacia(3 cases),indicating a poor prognosis.Conclusion The clinical manifestations of NHSE are nonspecific.Early MRI examinations are of great value for accurate diagnosis and disease evaluation.
9.Analyses of high-risk factors for poor neurologic prognosis in full-term neonatal purulent meningitis based on clinical and MRI characteristics
Huanyu LUO ; Di HU ; Shuangfeng YANG ; Hang LI ; Yun PENG
Chinese Journal of Radiology 2024;58(3):301-306
Objective:To analyze high-risk factors for poor neurological prognosis in full-term neonatal purulent meningitis based on clinical and brain MRI features.Methods:This study was a case-control study. The clinical and brain MRI data of 79 neonates with purulent meningitis were retrospectively collected at Beijing Children′s Hospital, Capital Medical University from January 2016 to January 2022. Follow-up assessments including growth and development, as well as neurological sequelae, were conducted over a minimum follow-up period of 6 months. The patients were divided into two groups with good ( n=49) and poor prognosis ( n=30) according to follow-up results. Chi-square tests were used to compare clinical and brain MRI features between the two groups, and a multivariate logistic regression analysis was performed to explore the high-risk factors for poor neurologic prognosis in full-term neonates with purulent meningitis. Results:There were statistically differences between two groups regarding the incidence of seizures, early-onset manifestations, positive cerebrospinal fluid (CSF) culture, CSF white cell counts, and CSF protein concentration ( P<0.05). Statistically differences were also found in the occurrence rates of ependymitis, obvious ventricular dilatation/hydrocephalus, spotty and patchy brain injury/hemorrhage, and destructive lesions within the brain parenchyma ( P<0.05). The results of multivariate logistic regression analysis indicated that seizures ( OR=5.722, 95% CI 1.126-29.072, P=0.035), early-onset neonatal purulent meningitis ( OR=3.657, 95% CI 1.073-12.459, P=0.038), ependymitis ( OR=8.851, 95% CI 1.169-67.017, P=0.035), obvious ventricular dilatation/hydrocephalus ( OR=12.675, 95% CI 1.085-148.110, P=0.043), and destructive lesions within the brain parenchyma ( OR=16.370, 95% CI 1.575-170.175, P=0.019) were independent risk factors for poor prognosis. Conclusions:The occurrence of seizures, early-onset manifestations as well as ependymitis, obvious ventricular dilatation/hydrocephalus, and destructive lesions within the brain parenchyma on MRI are high-risk factors for poor prognosis in the full-term neonate with purulent meningitis.
10.Establishment and preliminary application of RAA assay for varicella-zoster virus
Haoze LIU ; Ruichen WANG ; Weijia ZHANG ; Xiaohui YAO ; Shihong FU ; Kai NIE ; Fan LI ; Qikai YIN ; Ying HE ; Huanyu WANG ; Ruiping HU ; Songtao XU
Chinese Journal of Experimental and Clinical Virology 2023;37(6):631-636
Objective:To establish a rapid method for the detection of varicella-zoster virus (VZV) by recombinase-aid amplification (RAA).Methods:The whole genome sequences of VZV were downloaded from the global shared database for comparison and analysis. Specific primers and probe were designed for the four conserved genes respectively and the optimal combination was selected. The optimal reaction system was selected through the concentration gradient of primers and probes, and a fluorescence RAA detection method was established. The sensitivity of the method was evaluated with VZV positive plasmid standard and clinical samples with gradient dilution, the repeatability of the method was evaluated with the lowest detectable limit concentration of positive plasmid standard, and the specificity of other viral nucleic acid method was evaluated. At the same time, this method and quantitative real-time PCR (qPCR) were used to detect clinical samples and the result were compared.Results:The optimal combination of primer pair F2/R2 and probe P2 targeting open reading frame (ORF) 28 gene was selected. Considering the cost factor, the optimal primer concentration was set at 500 nmol/L and the optimal probe concentration was 280 nmol/L. The minimum detection limit was 10 1 copies/μL, and the minimum clinical positive samples with a Ct value of 36.027 could be detected, and the result of repeated experiments were consistent. The method has no cross-reaction with other viral nucleic acids. The detection rate of clinical positive samples was 93.33%, which was almost identical to that of qPCR. Conclusions:This method is simple to operate with high sensitivity, strong specificity, low requirements for experimental conditions, visual detection result, and can detect VZV nucleic acid in samples within 20 minutes, which is a rapid VZV detection method that can be considered for clinical use for detection.

Result Analysis
Print
Save
E-mail