OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

OBJECTIVE: To evaluate the effect of palliative care on drug use, medical service utilization and medical expenditure of patients with advanced cancer. METHODS: A cohort of patients including pal-liative care and standard care was constructed using the medical records of the patients in Peking University Cancer Hospital from 2018 to 2020, and coarsened exact matching was used to match the two groups of patients. The average monthly opioid consumption, hospitalization rate, intensive care unit (ICU) rate and operation rate, and the average monthly total cost were selected to evaluate drug use, medical service utilization and medical expenditure. Chi-square test and Wilcoxon signed rank test were used to compare the differences between the two groups before and after exposure and the change in the palliative care group. The net impact of palliative care on the patients was calculated using the difference-in-differences analysis. RESULTS: In this study, 180 patients in the palliative care group and 3 101 patients in the stan-dard care group were finally included in the matching, and the matching effect of the two groups was good (L₁ < 0.1). Before and after exposure, the average monthly opioid consumption in the palliative care group was significantly higher than that in the standard care group (Before exposure: 0.3 DDD/person-month vs. 0.1 DDD/person-month, P < 0.01; After exposure: 0.7 DDD/person-month vs. 0.1 DDD/person-month, P < 0.01; DDD refers to defined daily dose), palliative care significantly increased the average monthly opioid consumption in the patients (0.3 DDD/person-month, P < 0.01). The hospitalization rate (48.9% vs. 74.3%, P < 0.01) and operation rate (3.9% vs. 8.8%, P < 0.01) of the patients in palliative care group were significantly lower than those in standard care group, and the ICU rate became similar between the two groups (1.1% vs. 1.6%, P=0.634). Palliative care significantly reduced the patients ' hospitalization rate (-25.6%, P < 0.01), ICU rate (-4.9%, P < 0.01) and operation rate (-14.5%, P < 0.01). Before and after exposure, the average monthly total costs of pal-liative care group were slightly higher than those of standard care group (Before exposure: 20 092.3 yuan vs. 19 132.8 yuan, P=0.725; After exposure: 9 719.8 yuan vs. 8 818.8 yuan, P=0.165). Palliative care increased the average monthly total cost by 2 208.8 yuan, but it was not statistically significant (P=0.316). CONCLUSION Palliative care can increase the opioid consumption in advanced cancer patients, reduce the rates of hospitalization, ICU and surgery, but has no significant effect on medical expenditure.
Humans ; Palliative Care/economics* ; Neoplasms/drug therapy* ; Analgesics, Opioid/economics* ; Male ; Female ; Middle Aged ; Aged ; Hospitalization/economics* ; Intensive Care Units/statistics & numerical data* ; Health Expenditures/statistics & numerical data* ; Adult ; Drug Utilization/statistics & numerical data* ; Patient Acceptance of Health Care/statistics & numerical data*

Pelvic organ prolapse (POP), whose etiology is influenced by genetic and clinical risk factors, considerably impacts women's quality of life. However, the genetic underpinnings in non-European populations and comprehensive risk models integrating genetic and clinical factors remain underexplored. This study constructed the first polygenic risk score (PRS) for POP in the Chinese population by utilizing 20 disease-associated variants from the largest existing genome-wide association study. We analyzed a discovery cohort of 576 cases and 623 controls and a validation cohort of 264 cases and 200 controls. Results showed that the case group exhibited a significantly higher PRS than the control group. Moreover, the odds ratio of the top 10% risk group was 2.6 times higher than that of the bottom 10%. A high PRS was significantly correlated with POP occurrence in women older than 50 years old and in those with one or no childbirths. As far as we know, the integrated prediction model, which combined PRS and clinical risk factors, demonstrated better predictive accuracy than other existing PRS models. This combined risk assessment model serves as a robust tool for POP risk prediction and stratification, thereby offering insights into individualized preventive measures and treatment strategies in future clinical practice.
Humans ; Female ; Pelvic Organ Prolapse/epidemiology* ; Middle Aged ; Risk Assessment/methods* ; China/epidemiology* ; Multifactorial Inheritance ; Aged ; Risk Factors ; Genome-Wide Association Study ; Genetic Predisposition to Disease ; Case-Control Studies ; Adult ; Polymorphism, Single Nucleotide ; Genetic Risk Score ; East Asian People

Objective:To investigate the prognostic factors of elderly patients with epithelial ovarian cancer(EOC),construct and validate a nomogram prediction model,and provide a basis for clinical diagnosis and treat-ment.Methods:A total of 13128 elderly patients pathologically diagnosed with EOC from 2010 to 2019 in the U.S.SEER database(version 8.4.1)were selected as internal validation data.They were randomly divided in a 7∶3 ratio,with 9138 cases in the training set and 3990 cases in the validation set.All factors were subjected to univari-ate Cox regression analysis;multivariate Cox regression analysis was performed for factors with P＜0.05 to ob-tain their independent prognostic risk factors,and a nomogram model for evaluating 1-,3-,and 5-year overall sur-vival rates was constructed,followed by internal validation.At the same time,the clinical data of 73 elderly EOC patients treated in the First Department of Gynecology at the Affiliated Hospital of Chengde Medical University from January 1,2016 to December 31,2022 were selected for external validation of the nomogram.After construc-ting the nomogram model,by obtaining the risk scores of each independent prognostic factor,the training set,vali-dation set,and external validation set were divided into low-and high-risk groups according to comparison of indi-vidual risk scores and the overall median,the K-M curves for different risk groups were plotted based on the medi-an survival time.Results:①Univariate and multivariate Cox regression analyses showed that,age,marital status,histological type,International Federation of Gynecology and Obstetrics(FIGO)stage,differentiation degree,ser-um tumor carbohydrate antigen 125(CA125)level,unilateral of bilateral tumor,tumor size,positive lymph nodes,residual disease size after cytoreductive surgery,postoperative chemotherapy and surgical treatment were inde-pendent influencing factors for elderly women with EOC(P＜0.05).②According to the drawn column line dia-gram model,the C index values of the training set,the verification set and the external verification set were:0.750,0.732 and 0.798 respectively;the 5-year Area under the curve(AUC)in the Receiver Operating Characteristic(ROC)curve of the external verification set in the three groups was 0.669,while the AUC values for 1-,3-,and 5-year(except the 5-year of external validation)were all greater than 0.700.③Based on the plotted K-M curves,the median survival time of the high-risk groups in the training set,validation set,and external validation set was 31,32 and 39 months respectively,and more than half of the patients in the low-risk group were still alive.The a-bove results all suggested that the column chart model had a high clinical application value for the prediction the 1-,3-,and 5-year overall survival rates of elderly patients with EOC.Conclusions:The nomogram model in this study can accurately evaluate the overall survival rate of elderly with EOC,and provide a basis for individualized treatment.

Objective:To investigate the prognostic factors of elderly patients with epithelial ovarian cancer(EOC),construct and validate a nomogram prediction model,and provide a basis for clinical diagnosis and treat-ment.Methods:A total of 13128 elderly patients pathologically diagnosed with EOC from 2010 to 2019 in the U.S.SEER database(version 8.4.1)were selected as internal validation data.They were randomly divided in a 7∶3 ratio,with 9138 cases in the training set and 3990 cases in the validation set.All factors were subjected to univari-ate Cox regression analysis;multivariate Cox regression analysis was performed for factors with P＜0.05 to ob-tain their independent prognostic risk factors,and a nomogram model for evaluating 1-,3-,and 5-year overall sur-vival rates was constructed,followed by internal validation.At the same time,the clinical data of 73 elderly EOC patients treated in the First Department of Gynecology at the Affiliated Hospital of Chengde Medical University from January 1,2016 to December 31,2022 were selected for external validation of the nomogram.After construc-ting the nomogram model,by obtaining the risk scores of each independent prognostic factor,the training set,vali-dation set,and external validation set were divided into low-and high-risk groups according to comparison of indi-vidual risk scores and the overall median,the K-M curves for different risk groups were plotted based on the medi-an survival time.Results:①Univariate and multivariate Cox regression analyses showed that,age,marital status,histological type,International Federation of Gynecology and Obstetrics(FIGO)stage,differentiation degree,ser-um tumor carbohydrate antigen 125(CA125)level,unilateral of bilateral tumor,tumor size,positive lymph nodes,residual disease size after cytoreductive surgery,postoperative chemotherapy and surgical treatment were inde-pendent influencing factors for elderly women with EOC(P＜0.05).②According to the drawn column line dia-gram model,the C index values of the training set,the verification set and the external verification set were:0.750,0.732 and 0.798 respectively;the 5-year Area under the curve(AUC)in the Receiver Operating Characteristic(ROC)curve of the external verification set in the three groups was 0.669,while the AUC values for 1-,3-,and 5-year(except the 5-year of external validation)were all greater than 0.700.③Based on the plotted K-M curves,the median survival time of the high-risk groups in the training set,validation set,and external validation set was 31,32 and 39 months respectively,and more than half of the patients in the low-risk group were still alive.The a-bove results all suggested that the column chart model had a high clinical application value for the prediction the 1-,3-,and 5-year overall survival rates of elderly patients with EOC.Conclusions:The nomogram model in this study can accurately evaluate the overall survival rate of elderly with EOC,and provide a basis for individualized treatment.

Objective:To explore the significance of any correlation between the cost of the rehabilitation provided to stroke survivors during their hospitalization and the functional levels attained, and to analyze factors influencing that correlation.Methods:The International Classification of Functioning, Disability and Health Rehabilitation Set (ICF-RS) was used to evaluate the functioning of 304 stroke survivors on their days of hospital admission and discharge, as well as on their 10th day in hospital. The cost of their rehabilitation was computed, and demographic and clinical data were collected. A generalized estimation equation was used to analyze the changes in dysfunction with time and its risk factors. The relationship between functional levels and rehabilitation cost and its influencing factors were analyzed.Results:Length of stay, age≥60 and hemorrhagic stroke were significant risk factors for greater dysfunction among the stroke survivors. On the 10th day in hospital and the day before discharge (the 18th day), the frequency of severe dysfunction had decreased. The significant predictors of increased cost were severe or moderate dysfunction, the stage of stroke (sub-acute stage), and non-first rehabilitation.Conclusion:Functional level is a useful predictor of rehabilitation cost. It is influenced by the stage of stroke and non-first rehabilitation.

Objective:To explore the significance of any correlation between the cost of the rehabilitation provided to stroke survivors during their hospitalization and the functional levels attained, and to analyze factors influencing that correlation.Methods:The International Classification of Functioning, Disability and Health Rehabilitation Set (ICF-RS) was used to evaluate the functioning of 304 stroke survivors on their days of hospital admission and discharge, as well as on their 10th day in hospital. The cost of their rehabilitation was computed, and demographic and clinical data were collected. A generalized estimation equation was used to analyze the changes in dysfunction with time and its risk factors. The relationship between functional levels and rehabilitation cost and its influencing factors were analyzed.Results:Length of stay, age≥60 and hemorrhagic stroke were significant risk factors for greater dysfunction among the stroke survivors. On the 10th day in hospital and the day before discharge (the 18th day), the frequency of severe dysfunction had decreased. The significant predictors of increased cost were severe or moderate dysfunction, the stage of stroke (sub-acute stage), and non-first rehabilitation.Conclusion:Functional level is a useful predictor of rehabilitation cost. It is influenced by the stage of stroke and non-first rehabilitation.

Objective To explore the implementation effects and application value of the Clinical Rehabilitation Integration Plan based on the graded management of rehabilitation treatment programs in a 3A general hospital.Methods The details of the programme were firstly formulated according to the needs of clinical rehabilitation and the implementation plan was formed,and then the integrated clinical rehabilitation work was carried out for 1 year accordingly,and finally the effects before and after the implementation of the programme were compared and analysed by selecting the indicators of departmental operation and patient satisfaction.Results The rehabilitation programme was classified into 4 levels according to the degree of technical difficulty and medical risk,and its connotation and management requirements were defined in detail.The implementation of the programme included organisational structure,training and assessment,authorisation management and quality control.The programme was carried out in 8 clinical departments in the hospital,and the overall willingness of the clinical departments to develop early rehabilitation was improved since 2022.Conclusion This program can improve the operational efficiency of clinical departments and patient prognosis.

Drug use monitoring and evaluation play a key role in promoting drugs to return to clinical value,optimizing the basic medicine system,and improving the drug supply guarantee system.In order to promote the implementation of drug use monitoring and evaluation in medical institutions,the Pharmaceutical Affairs Committee of the Chinese Hospital Association led the efforts of organizing relevant domestic experts to follow the group standard development process.It successfully formulated the group standard of Drug Use Monitoring and Evaluation through the steps of problem sorting,framework construction,evidence collection,draft writing,opinion consultation,and standard formation.This article introduces the standard formulation process in detail,and explains and analyzes the content of the standard,aiming to help readers better understand the connotation of drug use monitoring and evaluation,and provide practical guidance.

Objective:To investigate the efficacy, safety and possible mechanisms of celecoxib as an adjunctive treatment for schizophrenia.Methods:90 schizophrenic inpatients at the second affiliated hospital of Xinxiang Medical College from April 2019 to October 2020 were recruited and randomly assigned to a placebo group or the celecoxib adjunctive treatment group using a random number table. In the placebo group, 46 patients (29 males, 17 females; aged 21-34, mean age 27.46±6.50 years) completed a 6-week follow-up. In the celecoxib group, 44 patients (32 males, 12 females; aged 21-39, mean age 30.52±8.69 years) completed a 6-week follow-up. The Positive and Negative Syndrome Scale (PANSS) was used to assess psychiatric symptoms in both groups. Changes in PANSS score at the end of the treatment were compared to evaluate the efficacy of celecoxib. Metabolic indicators such as weight, body mass index, waist circumference and plasm glucolipid, as well as cardiovascular indicators like blood pressure, electrocardiogram and routine blood tests, and adverse events were collected for the safety evaluation. Serum tumor necrosis factor-α (TNF-α), Interleukin-4 (IL-4) and interferon-γ (IFN-γ) were also tested. Pearson correlation analysis was used to explore the relationship between cytokine levels, PANSS score, PANSS reduction rate [(pre-treatment score-post-treatment score)/pre-treatment score×100%], and the safety measurements in the two groups, analyzing the role of inflammation in celecoxib adjunctive therapy.Results:The change of PANSS positive score at the end of the 6th week was significantly higher in the celecoxib adjuvant treatment group than in the placebo group (-8.00±6.12 vs -4.78±5.19, H=-0.55, P=0.009). The weight changes, body mass index, total cholesterol, and triglycerides over 6 weeks were significantly lower in the celecoxib group compared to the placebo group ( F=-7.37, -7.30, 2.56, -2.54; all P<0.05). No serious adverse events were found in celecoxib adjuvant therapy. In the placebo group, baseline TNF-α levels were positively correlated with baseline negative symptoms and PANSS reduction rate ( r=0.260 and 0.330, both P<0.05), and negatively correlated with the 6-week weight ( r=-0.311, P<0.05); baseline IL-4 levels were positively correlated with the 6-week PANSS total score and the 6-week PANSS negative score ( r=0.320 and 0.397, both P<0.05), and negatively correlated with PANSS reduction rate and 6-week blood glucose ( r=-0.316 and -0.331, both P<0.05); Six-week IFN-γ levels were negatively correlated with low-density lipoprotein levels ( r=-0.306, P<0.05). And no such correlation was found in celecoxib adjuvant group. Conclusion:Celecoxib adjunctive therapy can improve positive symptoms of schizophrenia without causing adverse reactions. Inflammatory state is related to schizophrenia symptoms, treatment efficacy and metabolic abnormalities.