1.Structure, content and data standardization of rehabilitation medical records
Yaru YANG ; Zhuoying QIU ; Di CHEN ; Zhongyan WANG ; Meng ZHANG ; Shiyong WU ; Yaoguang ZHANG ; Xiaoxie LIU ; Yanyan YANG ; Bin ZENG ; Mouwang ZHOU ; Yuxiao XIE ; Guangxu XU ; Jiejiao ZHENG ; Mingsheng ZHANG ; Xiangming YE ; Jian YANG ; Na AN ; Yuanjun DONG ; Xiaojia XIN ; Xiangxia REN ; Ye LIU ; Yifan TIAN
Chinese Journal of Rehabilitation Theory and Practice 2025;31(1):21-32
ObjectiveTo elucidate the critical role of rehabilitation medical records (including electronic records) in rehabilitation medicine's clinical practice and management, comprehensively analyzed the structure, core content and data standards of rehabilitation medical records, to develop a standardized medical record data architecture and core dataset suitable for rehabilitation medicine and to explore the application of rehabilitation data in performance evaluation and payment. MethodsBased on the regulatory documents Basic Specifications for Medical Record Writing and Basic Specifications for Electronic Medical Records (Trial) issued by National Health Commission of China, and referencing the World Health Organization (WHO) Family of International Classifications (WHO-FICs) classifications, International Classification of Diseases (ICD-10/ICD-11), International Classification of Functioning, Disability and Health (ICF), and International Classification of Health Interventions (ICHI Beta-3), this study constructed the data architecture, core content and data standards for rehabilitation medical records. Furthermore, it explored the application of rehabilitation record summary sheets (home page) data in rehabilitation medical statistics and payment methods, including Diagnosis-related Groups (DRG), Diagnosis-Intervention Packet (DIP) and Case Mix Index. ResultsThis study proposed a systematic standard framework for rehabilitation medical records, covering key components such as patient demographics, rehabilitation diagnosis, functional assessment, rehabilitation treatment prescriptions, progress evaluations and discharge summaries. The research analyzed the systematic application methods and data standards of ICD-10/ICD-11, ICF and ICHI Beta-3 in the fields of medical record terminology, coding and assessment. Constructing a standardized data structure and data standards for rehabilitation medical records can significantly improve the quality of data reporting based on the medical record summary sheet, thereby enhancing the quality control of rehabilitation services, effectively supporting the optimization of rehabilitation medical insurance payment mechanisms, and contributing to the establishment of rehabilitation medical performance evaluation and payment based on DRG and DIP. ConclusionStructured rehabilitation records and data standardization are crucial tools for quality control in rehabilitation. Systematically applying the three reference classifications of the WHO-FICs, and aligning with national medical record and electronic health record specifications, facilitate the development of a standardized rehabilitation record architecture and core dataset. Standardizing rehabilitation care pathways based on the ICF methodology, and developing ICF- and ICD-11-based rehabilitation assessment tools, auxiliary diagnostic and therapeutic systems, and supporting terminology and coding systems, can effectively enhance the quality of rehabilitation records and enable interoperability and sharing of rehabilitation data with other medical data, ultimately improving the quality and safety of rehabilitation services.
2.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
3.Methodology for Developing Patient Guideline(1):The Concept of Patient Guideline
Lijiao YAN ; Ning LIANG ; Ziyu TIAN ; Nannan SHI ; Sihong YANG ; Yufang HAO ; Wei CHEN ; Xiaojia NI ; Yingfeng ZHOU ; Ruixiang WANG ; Zeyu YU ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(20):2086-2091
Since the concept of patient versions of guidelines (PVGs) was introduced into China, several PVGs have been published in China, but we found that there is a big difference between the concept of PVG at home and abroad, and the reason for this difference has not been reasonably explained, which has led to ambiguity and even misapplication of the PVG concept by guideline developers. By analyzing the background and purpose of PVGs, and the understanding of the PVG concept by domestic scholars, we proposed the term patient guidelines (PGs). This refers to guidelines developed under the principles of evidence-based medicine, centered on health issues that concern patients, and based on the best available evidence, intended for patient use. Except for the general attribute of providing information or education, which is typical of common health education materials, PGs also provide recommendations and assist in decision-making, so PGs include both the patient versions of guidelines (PVG) as defined by the Guidelines International Network (GIN) and "patient-directed guidelines", i.e. clinical practice guidelines resulting from the adaptation or reformulation of recommendations through clinical practice guidelines.
4.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.
5.Research progress on the mechanism of autophagy's role in perioperative neurocognitive disorders
The Journal of Clinical Anesthesiology 2024;40(2):204-208
Perioperative neurocognitive disorders commonly manifest as impaired memory and con-fusion in patients,prolonged hospitalisation,poor prognosis,and increased mortality.Autophagy is closely related to the onset of perioperative neurocognitive disorder.Drugs,aging and inflammation affect autophagy levels by regulating signaling pathways such as mTOR and FOXO1,which are involved in the pathogenesis of perioperative neurocognitive disorder.Autophagy plays an important role in improving postoperative cogni-tive dysfunction and learning memory by modulating neuroinflammation,α-synuclein,and τ protein metabo-lism.This article reviews the main pathways regulating autophagy and the role of autophagy in the occurrence and development of perioperative neurocognitive disorders,in order to seek new targets and ideas for the pathogenesis of perioperative neurocognitive disorders.
6.The immediate brain effect of acupuncture at Fengchi in patients with posterior circulation ischemia vertigo:a resting-state functional MRI study
Xiaojia YUAN ; Yu XU ; Weitao WANG ; Liqun ZHONG ; Xiaozhen LI ; Dan XU ; Wenlong SHE ; Zhengguang CHEN
Journal of Practical Radiology 2024;40(2):186-189
Objective To investigate the immediate brain effect of acupuncture at Fengchi using amplitude of low-frequency fluctuation(ALFF)and functional connectivity by the resting-state functional magnetic resonance imaging(rs-fMRI)in patients with posterior circulation ischemia vertigo(PCIV).Methods Twenty patients with PCIV were enrolled.The dizziness handicap inventory(DHI)was used to evaluate the severity of vertigo.The patients were randomly divided into acupuncture group and sham acupoint acupuncture group.Rs-fMRI scan was performed before and after acupuncture.MATLAB-based DPABI 6.1 software was used to analyze rs-fMRI data.Correlation analysis was used between the altered ALFF values and DHI scores.The regions of altered ALFF were taken as seeds to analyze functional connectivity.Results Compared with the sham acupoint acupuncture group,the increased ALFF values were mainly located on the left precuneus,left superior frontal gyrus and left caudate nucleus after acupuncture in the acupuncture group;the decreased ALFF values were mainly located on the left cerebellum and right inferior occipital gyrus.The ALFF value of the left superior frontal gyrus was negatively correlated with the DHI score(P=0.04).The increased functional connectivity was mainly found between left precuneus and the right middle frontal gyrus,the right superior frontal gyrus,the decreased functional connectivity was mainly found between left precuneus and the bilateral paracentral lobule and right cerebellum.Conclusion The ALFF value and functional connectivity are different before and after acupuncture,indicating that the vestibular network,visual and motor brain regions functional activities are changed after needling at Fengchi,which may be the brain functional basis of Fengchi for vertigo in PCIV.
7.Regulatory mechanism of ferroptosis on pressure ulcers:bioinformatics analysis and experimental validation
Lulu TANG ; Xiaojia PAN ; Yingtao LAI ; Li WANG
Chinese Journal of Tissue Engineering Research 2024;28(35):5656-5661
BACKGROUND:Ferroptosis-mediated ischemia-reperfusion injury plays a crucial role in the occurrence and progression in pressure ulcers,and there may be pressure ulcer-associated ferroptosis biomarkers,but the mechanism has not been elucidated. OBJECTIVE:To investigate the molecular mechanisms underlying pressure ulcers using bioinformatic analysis,with a focus on identifying differentially expressed genes associated with ferroptosis during the process of pressure ulcer formation,thereby providing novel insights into the clinical treatment of pressure ulcers. METHODS:The single-cell transcriptome sequencing dataset and ferroptosis-related genes were obtained and preprocessed from the Gene Expression Omnibus(GEO)and FerrDb databases.We performed clustering and proportion analyses,metabolic activity and pseudotime analysis,cell communication analysis,ferroptosis gene set cell population identification,and enrichment analysis to determine differentially expressed genes related to ferroptosis.Animal experiments were then conducted for further validation,with 20 Sprague-Dawley rats randomly assigned into a control group and a model group(n=10 per group).The control group received no treatment,while the model group underwent a cycle of ischemia-reperfusion to establish pressure ulcer models.Changes in differentially expressed genes and proteins in the wound tissues of pressure ulcer rats were detected using fluorescent quantitative PCR and western blot,respectively. RESULTS AND CONCLUSION:The single-cell transcriptome sequencing data were clustered into six cell types,with a higher proportion of type 2 and type 3 keratinocytes observed in the pressure ulcer group.There was evident metabolic heterogeneity and evolutionary trajectory among cell populations.Type 2 and type 3 keratinocytes exhibited stronger cell communication,while type 2 keratinocytes demonstrating optimal ligand-receptor interactions.Type 2 keratinocytes demonstrated higher scores for ferroptosis,accompanied by significant upregulation or downregulation of specific genes.A total of 27 Gene Ontology enrichments,20 Kyoto Encyclopedia of Genes and Genomes enrichments,and 24 ferroptosis-related differentially expressed genes,including glutathione peroxidase 4(GPX4)and acyl-CoA synthetase long chain family member 4(ACSL4),were identified.Animal experiments further confirmed the downregulation of GPX4,the ferroptosis-inhibiting protein,and the upregulation of ACSL4,the ferroptosis-promoting protein,in the model group.Overall,these findings indicate the presence of ferroptosis in pressure ulcer tissue.GPX4 and ACSL4 are important genes regulating ferroptosis in pressure ulcer tissues.
8.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.
9.Clinical application and progression of monoclonal antibodies targeting HER2 extracellular domain Ⅳ in breast cancer
Jiaojiao XU ; Jiani TAO ; Xiaojia WANG ; Zhanhong CHEN
China Pharmacy 2024;35(5):635-640
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is aggressive and prone to metastasis,and the applications of HER2 agents have improved the prognosis of patients with HER2-positive breast cancer. Among the marketed HER2 agents,macromolecular monoclonal antibodies that target the extracellular domain Ⅳ of HER2 were the cornerstone drugs of HER2-positive breast cancer,including trastuzumab,inetetamab,and margetuximab. Trastuzumab is available for the full-line treatment of breast cancer with sufficient proof of evidence-based medicine,sufficient practical experience and controllable safety. Inetetamab and trastuzumab have similar efficacy and controllable safety in HER2-positive metastatic breast cancer and neoadjuvant/ adjuvant therapy. Margetuximab focuses on patients carrying the CD16A-158F allele,and is an option of posterior line treatment for advanced breast cancer. It is necessary to select the most suitable drugs clinically according to the specific condition of the patient.
10.Research on policy framework, standards system and application of disability data
Yaru YANG ; Zhuoying QIU ; Zhongyan WANG ; Di CHEN ; Jian YANG ; Qi JING ; Na AN ; Tiantian WAN ; Xiaojia XIN ; Xiaoqin LIU ; Yuanjun DONG ; Xiangxia REN ; Ye LIU ; Yifan TIAN ; Xueli LÜ
Chinese Journal of Rehabilitation Theory and Practice 2024;30(12):1365-1375
ObjectiveTo systematically analyze international disability data policies and standards, as well as the application of disability data in policymaking, service optimization and inclusive social development, and to clarify the importance of international disability data policies, standard systems and disability data application for the development of disability-related services. MethodsThrough the analysis of policy content and research on the data standard system, this study explored the disability data policy framework, standard system and technical path of data interoperability and integration of international organizations including the United Nations (United Nations Statistics Division and United Nations Children's Fund), World Health Orgnization, United Nations Educational Scientific and Cultural Organization, and International Labour Organization. ResultsInternational organizations established disability data policy frameworks based on their respective mandates, involving data and service development, data standards, data governance, and data application. The international community established a disability data standard system for disability data collection, coding, exchange, interoperability, statistical analysis, data fusion and application. Building a standardized disability data standard system based on the framework of international health classification standards such as International Classification of Functioning, Disability and Health, and International Classification of Diseases, Eleventh Revision would ensure the consistency of cross-national disability data policies, and the interoperability and comparability of disability data, promoting the development of data-driven disability-related services, accurately identifying the service needs of people with disabilities, and optimizing service provision, thereby improving the quality of life and social participation of people with disabilities. ConclusionThe construction and implementation of international disability data policies and data standards have promoted the standardization and interoperability of disability data. With the application of big data, artificial intelligence and blockchain technologies in disability data, international cooperation and cross-industry data fusion in the field of disability data have been promoted, further promoting the development of data-driven disability services, ensuring equal opportunities for people with disabilities to enjoy service resources, and improving the coverage and quality of disability services.

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