Objective This study aimed to apply the integrated Promoting Action on Research Implementation in Health Services(i-PARIHS)framework to translate best evidence into clinical practice,with the goal of reducing unplanned discontinua-tion of continuous renal replacement therapy(CRRT)and providing guidance for clinical staff.Methods A systematic search was conducted for guidelines,systematic reviews,evidence summaries,and expert consensus documents related to unplanned CRRT discontinuation.Retrieved literature underwent quality appraisal,synthesis,and integration.Through evidence-based group discussions,baseline clinical audits,and FAME(Feasibility,Appropriateness,Meaningfulness,Effectiveness)-based evi-dence appraisal,implementation strategies were developed across three i-PARIHS dimensions:context,recipients,and facilita-tion.Outcomes including unplanned CRRT discontinuation rates,average length of hospital stay,mortality,and nurse competen-cy were compared before and after evidence implementation.Results After evidence extraction,synthesis,and contextual adap-tation,a site-specific evidence translation model was established,comprising 16 audit criteria with corresponding review methods.Following implementation,significant reductions were observed in unplanned CRRT discontinuation rates,average length of stay,and mortality(all P＜0.05).Nurses' nursing competency also improved significantly(P＜0.05),indicating a positive impact of the evidence translation initiative.Conclusion The i-PARIHS framework effectively reduces unplanned CRRT discontinuation and is applicable in clinical practice.The results offer evidence for improving nursing quality and offering a reference for future evidence translation initiatives in critical care.

Pediatric urological non-Hodgkin lymphoma is relatively rare.When a single renal or ureteral tumor with multiple lymph node or bone metastases is present, it is very easy to be misdiagnosed as urinary tumor with metastasis, resulting in unnecessary radical nephrectomy. This paper reports two cases of non-Hodgkin lymphoma presenting with single urinary nodules. Case 1 was diagnosed with a 4.5cm tumor in the right kidney due to fever and fatigue. CT and PET-CT showed multiple bone destruction and lymph node metastasis. Renal biopsy was performed and ALK-positive anaplastic large cell lymphoma was diagnosed. Chemotherapy was effective for 6 months. Case 2 was diagnosed with left hydronephrosis due to intermittent low back pain for 2 weeks. Ultrasound examination revealed ureteral dilation with left hydronephrosis and low echo occupying of the lower ureter. The patient had sudden blurred vision before surgery. MRI examination revealed space occupying in the right optic nerve frame, and PET-CT found multiple bone, lymph nodes and nerve invasion. A lymph node biopsy was performed and Burkitt lymphoma was diagnosed. After 6 months of chemotherapy and radiotherapy, the tumor shrank significantly.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Purpose To summarize the MRI characteristics of patients with spontaneous spinal subdural hematoma,so as to strengthen the awareness to this disease,and to improve the clinical diagnosis and treatment ability.Materials and Methods A retrospective analysis was performed on five patients with spontaneous spinal subdural hematoma diagnosed and treated in Qingdao Chengyang District People's Hospital from January 2021 to December 2023.Plain MRI and enhanced MRI were performed 6-24 hours after onset,and the imaging characteristics were analyzed.Combined with the dynamic American Spinal Injury Association(ASIA)grading score and disease progression,three patients were treated with surgery and two patients with conservative treatment.Results All patients were followed up for 6-15 months.Among the five patients,the hematoma was distributed at the cervicothoracic junction in two cases,the upper thoracic segment in one case and the thoracolumbar segment in two cases;covering 3-6 segments in two cases,2-3 segments in two cases and 1 segment in one case;hematoma was located at the ventral side of the dural sac in two cases,and the dorsal side of the dural sac in three cases.Postoperative pathology showed that one case was simple blood clot,and two cases were blood clot with a large number of neutrophil infiltration.One case was hyperacute phase with isointensity on T1WI and high signal on T2WI,three cases were acute phase with isointensity on T1WI and low signal on T2WI,and one case was subacute phase with high signal on T1WI and low signal on T2WI.Enhanced scanning showed that one case was uneven enhancement,one case was irregular edge enhancement and three cases had no obvious enhancement.ASIA grade of two cases returned to E,one case returned to C after surgery,and lower limb muscle strength of two cases returned to E after conservative treatment,and MRI reexamination showed that the hematoma was absorbed.Conclusion MRI has strong sensitivity for the lesions of patients with spontaneous spinal subdural hematoma,which can accurately show the location and size of the hematoma,help to distinguish the progression of the disease,and has great significance for clinical diagnosis and treatment.

Purpose To summarize the MRI characteristics of patients with spontaneous spinal subdural hematoma,so as to strengthen the awareness to this disease,and to improve the clinical diagnosis and treatment ability.Materials and Methods A retrospective analysis was performed on five patients with spontaneous spinal subdural hematoma diagnosed and treated in Qingdao Chengyang District People's Hospital from January 2021 to December 2023.Plain MRI and enhanced MRI were performed 6-24 hours after onset,and the imaging characteristics were analyzed.Combined with the dynamic American Spinal Injury Association(ASIA)grading score and disease progression,three patients were treated with surgery and two patients with conservative treatment.Results All patients were followed up for 6-15 months.Among the five patients,the hematoma was distributed at the cervicothoracic junction in two cases,the upper thoracic segment in one case and the thoracolumbar segment in two cases;covering 3-6 segments in two cases,2-3 segments in two cases and 1 segment in one case;hematoma was located at the ventral side of the dural sac in two cases,and the dorsal side of the dural sac in three cases.Postoperative pathology showed that one case was simple blood clot,and two cases were blood clot with a large number of neutrophil infiltration.One case was hyperacute phase with isointensity on T1WI and high signal on T2WI,three cases were acute phase with isointensity on T1WI and low signal on T2WI,and one case was subacute phase with high signal on T1WI and low signal on T2WI.Enhanced scanning showed that one case was uneven enhancement,one case was irregular edge enhancement and three cases had no obvious enhancement.ASIA grade of two cases returned to E,one case returned to C after surgery,and lower limb muscle strength of two cases returned to E after conservative treatment,and MRI reexamination showed that the hematoma was absorbed.Conclusion MRI has strong sensitivity for the lesions of patients with spontaneous spinal subdural hematoma,which can accurately show the location and size of the hematoma,help to distinguish the progression of the disease,and has great significance for clinical diagnosis and treatment.

Objective To predict the lymphovascular invasion(LVI)status of breast cancer patients based on digital breast tomo-synthesis(DBT)intratumoral and peritumoral radiomics nomogram.Methods A total of 192 breast cancer patients from 2 institu-tions were retrospectively selected,in which institution 1 was used for train(n=113)and test(n=49),while institution 2 was used for external validation(n=30).Radiomics features were extracted and selected based on intratumoral and peritumoral 1 mm regions from DBT images.Different machine learning algorithms were used to construct intratumoral,peritumoral,and combined intratumoral and peritumoral models,respectively.Patient clinical data were analyzed by both univariate and multivariate logistic regression analy-ses to identify independent risk factors for the clinical imaging model.The performance of the models was evaluated using the receiver operating characteristic(ROC)curve.The radiomics features with the optimal diagnostic performance and the selected clinical imaging features were combined to construct a comprehensive clinical-radiomics model,and a nomogram was drawn.Results The combined intratumoral and peritumoral model was the optimal radiomics model.Maximum tumor diameter[odds ratio(OR)=1.486,P=0.014],suspicious malignant calcifications(OR=2.898,P=0.015),and axillary lymph node(ALN)metastasis(OR=3.615,P<0.001)were independent risk factors for LVI positive.Furthermore,the area under the curve(AUC)of the comprehensive clinical-radiomics model in the training set,test set and external valida-tion set was 0.889,0.916,and 0.862,respectively,which was higher than those of the combined intratumoral and peritumoral model(0.858,0.849,0.844)and the clinical imaging model(0.743,0.759,0.732).Conclusion The predictive nomogram,derived from both radiomics and clinical imaging features,is relatively accurate in identifying future LVI occurrence in breast cancer,demonstra-ting its potential as an assistive tool for clinicians to devise individualized treatment regimes.

Pediatric urological non-Hodgkin lymphoma is relatively rare.When a single renal or ureteral tumor with multiple lymph node or bone metastases is present, it is very easy to be misdiagnosed as urinary tumor with metastasis, resulting in unnecessary radical nephrectomy. This paper reports two cases of non-Hodgkin lymphoma presenting with single urinary nodules. Case 1 was diagnosed with a 4.5cm tumor in the right kidney due to fever and fatigue. CT and PET-CT showed multiple bone destruction and lymph node metastasis. Renal biopsy was performed and ALK-positive anaplastic large cell lymphoma was diagnosed. Chemotherapy was effective for 6 months. Case 2 was diagnosed with left hydronephrosis due to intermittent low back pain for 2 weeks. Ultrasound examination revealed ureteral dilation with left hydronephrosis and low echo occupying of the lower ureter. The patient had sudden blurred vision before surgery. MRI examination revealed space occupying in the right optic nerve frame, and PET-CT found multiple bone, lymph nodes and nerve invasion. A lymph node biopsy was performed and Burkitt lymphoma was diagnosed. After 6 months of chemotherapy and radiotherapy, the tumor shrank significantly.

Objective This study aimed to apply the integrated Promoting Action on Research Implementation in Health Services(i-PARIHS)framework to translate best evidence into clinical practice,with the goal of reducing unplanned discontinua-tion of continuous renal replacement therapy(CRRT)and providing guidance for clinical staff.Methods A systematic search was conducted for guidelines,systematic reviews,evidence summaries,and expert consensus documents related to unplanned CRRT discontinuation.Retrieved literature underwent quality appraisal,synthesis,and integration.Through evidence-based group discussions,baseline clinical audits,and FAME(Feasibility,Appropriateness,Meaningfulness,Effectiveness)-based evi-dence appraisal,implementation strategies were developed across three i-PARIHS dimensions:context,recipients,and facilita-tion.Outcomes including unplanned CRRT discontinuation rates,average length of hospital stay,mortality,and nurse competen-cy were compared before and after evidence implementation.Results After evidence extraction,synthesis,and contextual adap-tation,a site-specific evidence translation model was established,comprising 16 audit criteria with corresponding review methods.Following implementation,significant reductions were observed in unplanned CRRT discontinuation rates,average length of stay,and mortality(all P＜0.05).Nurses' nursing competency also improved significantly(P＜0.05),indicating a positive impact of the evidence translation initiative.Conclusion The i-PARIHS framework effectively reduces unplanned CRRT discontinuation and is applicable in clinical practice.The results offer evidence for improving nursing quality and offering a reference for future evidence translation initiatives in critical care.

Creutzfeldt-Jakob disease(CJD)is a rapidly progressive and fatal neurodegenerative disorder caused by prions,with certain infectivity and iatrogenic transmission risks.With the rapid progress and application of new dia-gnostic biomarkers and detection methods,as well as the construction and improvement of surveillance and reporting systems,the detection of CJD in patients domestically and internationally has shown an increasing trend year by year.Due to its long incubation period and heterogeneity of early symptoms,early identification and diagnosis of the disease is difficult,increasing the risk of transmission within medical institutions.Currently,there is a lack of con-sensus on the infection prevention and control of CJD.In order to timely identify and diagnose CJD as well as effec-tively block its transmission in medical institutions,this consensus summarizes 15 clinical concerns and formulates 24 specific recommendations based on the latest domestic and international research findings and clinical evidence,as well as combines with clinical practice,aiming to standardize healthcare-associated infection prevention and control measures for CJD and reduce its transmission risk in medical institutions.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.