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.

Objective:To investigate the interaction of risk factors for diabetic retinopathy (DR) occurrence.Methods:A cross-sectional study was performed.A total of 6 783 diabetic patients with complete survey data from 2005 to 2018 in the National Health and Nutrition Survey database were enrolled, among which 4 426 patients were included according to inclusion criteria and were divided into non-DR diabetes group of 3 491 cases and DR group of 935 cases.The related risk factors were collected, including age, gender, race, residential status, education, annual household income, body mass index (BMI), fasting glucose, glycosylated hemoglobin, duration of diabetes, family history of diabetes, comorbidities, smoke, alcohol use, sleep, physical activity.Patient Health Questionnaire (PHQ-9) was used to assess the psychological status.After the categorization of all variables, risk factors of DR were analyzed by logistic regression, and the interaction between factors was further analyzed.Results:Multivariate analysis showed that female[odds ratio ( OR)=1.33, 95% confidence interval ( CI): 1.02-1.72], duration of diabetes ≥10 years ( OR=1.03, 95% CI: 1.02-1.04), insulin therapy ( OR=2.38, 95% CI: 1.87-3.05), urinary albumin creatinine ratio (UACR) ≥30 mg/g ( OR=1.55, 95% CI: 1.22-1.96) and depression ( OR=1.44, 95% CI: 1.13-1.83) were risk factors for DR, and BMI≤28 kg/m 2 ( OR=0.70, 95% CI: 0.55-0.89) was a protective factor for DR.Furthermore, interaction analysis revealed additive interaction between UACR ≥30 mg/g and insulin therapy [relative excess risk due to interaction ( RERI)=2.46, 95% CI: 0.84-4.09, attributable proportion due to interaction ( AP)=0.44, 95% CI: 0.26-0.63, synergy index ( S)=2.16, 95% CI: 1.37-3.41).The UACR ≥30 mg/g and longer diabetic duration ≥10 years had both multiplicative ( OR=1.67, 95% CI: 1.00-2.76) and additive interactions ( RERI=2.02, 95% CI: 0.79-3.25, AP=0.47, 95% CI: 0.27-0.66, S=2.53, 95% CI: 1.37-4.68). Conclusions:Patients with diabetes treated with insulin, with a duration of diabetes ≥10 years and accompanied by UACR ≥30 mg/g are at higher risk of developing DR than those with a single risk factor.

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

The 2024 American Society of Clinical Oncology(ASCO)Annual Meeting was held in Chicago,the United States,from May 31 to June 4 in 2024.In recent years,antibody-drug conjugates(ADCs)have become one of the most popular targeted therapies because of their high specificity,efficacy,and low toxicity,making them a focal point in this ASCO meeting.Currently,over 100 ADCs are under investigation,demonstrating the considerable development potential of ADCs in the field of targeted cancer therapy.The aforementioned conference reported several recent research advancements regarding ADCs for the treatment of breast cancer(BC).This review summarizes the latest progress of ADCs in BC treatment discussed at the confer-ence.

Objective:To investigate the interaction of risk factors for diabetic retinopathy (DR) occurrence.Methods:A cross-sectional study was performed.A total of 6 783 diabetic patients with complete survey data from 2005 to 2018 in the National Health and Nutrition Survey database were enrolled, among which 4 426 patients were included according to inclusion criteria and were divided into non-DR diabetes group of 3 491 cases and DR group of 935 cases.The related risk factors were collected, including age, gender, race, residential status, education, annual household income, body mass index (BMI), fasting glucose, glycosylated hemoglobin, duration of diabetes, family history of diabetes, comorbidities, smoke, alcohol use, sleep, physical activity.Patient Health Questionnaire (PHQ-9) was used to assess the psychological status.After the categorization of all variables, risk factors of DR were analyzed by logistic regression, and the interaction between factors was further analyzed.Results:Multivariate analysis showed that female[odds ratio ( OR)=1.33, 95% confidence interval ( CI): 1.02-1.72], duration of diabetes ≥10 years ( OR=1.03, 95% CI: 1.02-1.04), insulin therapy ( OR=2.38, 95% CI: 1.87-3.05), urinary albumin creatinine ratio (UACR) ≥30 mg/g ( OR=1.55, 95% CI: 1.22-1.96) and depression ( OR=1.44, 95% CI: 1.13-1.83) were risk factors for DR, and BMI≤28 kg/m 2 ( OR=0.70, 95% CI: 0.55-0.89) was a protective factor for DR.Furthermore, interaction analysis revealed additive interaction between UACR ≥30 mg/g and insulin therapy [relative excess risk due to interaction ( RERI)=2.46, 95% CI: 0.84-4.09, attributable proportion due to interaction ( AP)=0.44, 95% CI: 0.26-0.63, synergy index ( S)=2.16, 95% CI: 1.37-3.41).The UACR ≥30 mg/g and longer diabetic duration ≥10 years had both multiplicative ( OR=1.67, 95% CI: 1.00-2.76) and additive interactions ( RERI=2.02, 95% CI: 0.79-3.25, AP=0.47, 95% CI: 0.27-0.66, S=2.53, 95% CI: 1.37-4.68). Conclusions:Patients with diabetes treated with insulin, with a duration of diabetes ≥10 years and accompanied by UACR ≥30 mg/g are at higher risk of developing DR than those with a single risk factor.

The 2024 American Society of Clinical Oncology(ASCO)Annual Meeting was held in Chicago,the United States,from May 31 to June 4 in 2024.In recent years,antibody-drug conjugates(ADCs)have become one of the most popular targeted therapies because of their high specificity,efficacy,and low toxicity,making them a focal point in this ASCO meeting.Currently,over 100 ADCs are under investigation,demonstrating the considerable development potential of ADCs in the field of targeted cancer therapy.The aforementioned conference reported several recent research advancements regarding ADCs for the treatment of breast cancer(BC).This review summarizes the latest progress of ADCs in BC treatment discussed at the confer-ence.

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

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.

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.