Beyond statistical significance:Embracing minimal clinically important difference for better patient care

The minimal clinically important difference(MCID)represents a pivotal metric in bridging the gap between statistical significance and clinical relevance,addressing the direct impact of medical interventions from the patient's perspective.This comprehensive review analyzes the evolution,applications,and challenges of MCID across medical specialties,emphasizing its necessity in ensuring that clinical outcomes not only demonstrate statistical significance but also offer genuine clinical utility that aligns with patient expectations and needs.We discuss the evolution of MCID since its inception in the 1980s,its current applications across various medical specialties,and the methodologies used in its calculation,highlighting both anchor-based and distribution-based approaches.Furthermore,the paper delves into the challenges associated with the application of MCID,such as methodological variability and the interpretation difficulties that arise in clinical settings.Recommendations for the future include standardizing MCID calculation methods,enhancing patient involvement in setting MCID thresholds,and extending research to incorporate diverse global perspectives.These steps are critical to refining the role of MCID in patient-centered healthcare,addressing existing gaps in methodology and interpretation,and ensuring that medical interventions lead to significant,patient-perceived improvements.

The potential mechanism and clinical application value of remote ischemic conditioning in stroke

Some studies have confirmed the neuroprotective effect of remote ischemic conditioning against stroke. Although numerous animal researches have shown that the neuroprotective effect of remote ischemic conditioning may be related to neuroinflammation, cellular immunity, apoptosis, and autophagy, the exact underlying molecular mechanisms are unclear. This review summarizes the current status of different types of remote ischemic conditioning methods in animal and clinical studies and analyzes their commonalities and differences in neuroprotective mechanisms and signaling pathways. Remote ischemic conditioning has emerged as a potential therapeutic approach for improving stroke-induced brain injury owing to its simplicity, non-invasiveness, safety, and patient tolerability. Different forms of remote ischemic conditioning exhibit distinct intervention patterns, timing, and application range. Mechanistically, remote ischemic conditioning can exert neuroprotective effects by activating the Notch1/phosphatidylinositol 3-kinase/Akt signaling pathway, improving cerebral perfusion, suppressing neuroinflammation, inhibiting cell apoptosis, activating autophagy, and promoting neural regeneration. While remote ischemic conditioning has shown potential in improving stroke outcomes, its full clinical translation has not yet been achieved.

Machine learning applications in healthcare clinical practice and research

Machine learning(ML)is a type of artificial intelligence that assists computers in the acquisition of knowledge through data analysis,thus creating machines that can complete tasks otherwise requiring human intelligence.Among its various applications,it has proven groundbreaking in healthcare as well,both in clinical practice and research.In this editorial,we succinctly introduce ML applications and present a study,featured in the latest issue of the World Journal of Clinical Cases.The authors of this study conducted an analysis using both multiple linear regression(MLR)and ML methods to investigate the significant factors that may impact the estimated glomerular filtration rate in healthy women with and without non-alcoholic fatty liver disease(NAFLD).Their results implicated age as the most important determining factor in both groups,followed by lactic dehydrogenase,uric acid,forced expiratory volume in one second,and albumin.In addition,for the NAFLD-group,the 5th and 6th most important impact factors were thyroid-stimulating hormone and systolic blood pressure,as compared to plasma calcium and body fat for the NAFLD+group.However,the study's distinctive contribution lies in its adoption of ML methodologies,showcasing their superiority over traditional statistical approaches(herein MLR),thereby highlighting the potential of ML to represent an invaluable advanced adjunct tool in clinical practice and research.

Microwave ablation for liver metastases from colorectal cancer:A comprehensive review of clinical efficacy and safety

Microwave ablation(MWA)is emerging as a highly effective treatment for colorectal liver metastases(CRLMs).This review explores the advantages of MWA compared to other ablative techniques such as radiofrequency ablation and cryoablation and highlights its clinical efficacy,safety,and technical considerations.MWA offers significant benefits,including higher intratumoral temperatures,larger ablation zones,and reduced susceptibility to the heat-sink effect,which make it particularly suitable for tumors near large blood vessels.This review details the patient selection criteria,procedural approaches,and the use of advanced imaging techniques to improve the precision and effectiveness of MWA.Clinical outcomes indicate that MWA achieves high rates of complete tumor ablation and long-term survival with a favorable safety profile.This review is significant because it provides updated insights into the expanding role of MWA in treating unresectable CRLM and its potential as an alternative to surgical resection for resectable tumors.By summarizing recent studies and clinical trials,this review highlights the comparative effectiveness,safety,and integration with systemic therapies of MWA.In conclusion,MWA is a promising treatment option for CRLM and offers outcomes comparable to or better than those of other ablative techniques.Future research should focus on optimizing technical parameters,integrating MWA with systemic therapies,and conducting large-scale randomized controlled trials to establish standardized treatment protocols.Advancing our understanding of MWA will enhance its application and improve long-term survival and quality of life for patients with CRLM.

Nucleotide-binding domain,leucine-rich repeat,and pyrin domaincontaining protein 3 inflammasome:From action mechanism to therapeutic target in clinical trials

The nucleotide-binding domain,leucine-rich repeat,and pyrin domain-containing protein 3(NLRP3)inflammasome is a critical modulator in inflammatory disease.Activation and mutation of NLRP3 can cause severe inflammation in diseases such as chronic infantile neurologic cutaneous and articular syndrome,Muckle-Wells syndrome,and familial cold autoinflammatory syndrome 1.To date,a great effort has been made to decode the underlying mechanisms of NLRP3 activation.The priming and activation of NLRP3 drive the maturation and release of active interleukin(IL)-18 and IL-1βto cause inflammation and pyroptosis,which can significantly trigger many diseases including inflammatory diseases,immune disorders,metabolic diseases,and neurodegenerative diseases.The investigation of NLRP3 as a therapeutic target for disease treatment is a hot topic in both preclinical studies and clinical trials.Developing potent NLRP3 inhibitors and downstream IL-1 inhibitors attracts wide-spectrum attention in both research and pharmaceutical fields.In this minireview,we first updated the molecular mechanisms involved in NLRP3 inflammasome activation and the associated downstream signaling pathways.We then reviewed the molecular and cellular pathways of NLRP3 in many diseases,including obesity,diabetes,and other metabolic diseases.In addition,we briefly reviewed the roles of NLRP3 in cancer growth and relative immune checkpoint therapy.Finally,clinical trials with treatments targeting NLRP3 and its downstream signaling pathways were summarized.

Effect of Modulen vs budesonide on clinical response and mucosal healing in Crohn’s patients

BACKGROUND Mucosal healing has become an important goal of Crohn’s disease(CD)treat-ments.Modulen,enriched with transforming growth factor-beta 2,and budeso-nide are commonly accepted treatments for mild-moderate CD.However,their effects on the small bowel(SB)mucosa remain underexplored.AIM To prospectively assess clinical and mucosal responses to Modulen vs budesonide in adults with CD,using SB capsule endoscopy.METHODS Thirty patients were divided into two groups:Modulen+home-based diet(21 patients)and budesonide(9 patients)for an eight-week intervention followed by four weeks of follow-up.Clinical,laboratory,and endoscopic responses were evaluated.The mucosal changes were assessed through SB capsule endoscopy.RESULTS Results indicated significant clinical improvement in the Modulen group with reduced CD activity index(P=0.041)and improved inflammatory bowel disease questionnaire score(P=0.016).Moreover,Modulen was associated with a signifi-cant SB mucosal improvement,evidenced by a decrease in Lewis score(P=0.027).No significant changes were observed in calprotectin or other laboratory parame-ters.Conversely,budesonide exhibited more modest clinical effects,but it improved calprotectin,hemoglobin,and C-reactive protein levels(P=0.051,P=0.014,and P=0.038,respectively).The capsule endoscopy did not reveal a significant mucosal response in the budesonide group.CONCLUSION Both interventions have a role in CD treatment.Yet,their effects differ and may complement each other:Modulen yields clinical and mucosal improvements,while budesonide primarily leads mainly to laboratory improvements.

Comparative analysis of breast and lung cancer survival rates and clinical trial enrollments among rural and urban patients in Georgia

Objectives:Rural patients have poor cancer outcomes and clinical trial(CT)enrollment compared to urban patients due to attitudinal,awareness,and healthcare access differential.Knowledge of cancer survival disparities and CT enrollment is important for designing interventions and innovative approaches to address the stated barriers.The study explores the potential disparities in cancer survival rates and clinical trial enrollments in rural and urban breast and lung cancer patients.Our hypotheses are that for both cancer types,urban cancer patients will have longer 5-year survival rates and higher enrollment rates in clinical trials than those in rural counties.Methods:We compared breast and lung cancer patients’survival rates and enrollment ratios in clinical trials between rural(RUCC 4-9)and urban counties in Georgia at a Comprehensive Cancer Center(CCC).To assess these differences,we carried out a series of independent samples t-tests and Chi-Square tests.Results:The outcomes indicate comparable 5-year survival rates across rural and urban counties for breast and lung cancer patients,failing to substantiate our hypothesis.While clinical trial enrollment rates demonstrated a significant difference between breast and lung cancer patients at CCC,no significant variation was observed based on rural or urban classification.Conclusion:These findings underscore the need for further research into the representation of rural patients with diverse cancer types at CCC and other cancer centers.Further,the findings have considerable implications for the initiation of positive social change to improve CT participation and reduce cancer survival disparities.

Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment

AIM:To explore the factors influencing individuals’willingness to participate in ophthalmic clinical trials.METHODS:A questionnaire survey was conducted from January to April 2021 among patients and their family members at Zhongshan Ophthalmic Center,Sun Yat-sen University,in Guangzhou,China.The survey gathered data on respondents’willingness,demographic and socioeconomic profiles,as well as their reasons and concerns regarding engagement in clinical trials.RESULTS:Of the 1078 residents surveyed(mean age 31.2±13.1y;65.8%females)in Guangzhou,749(69.5%)expressed a willingness to participate in future ophthalmic clinical trials.Specific characteristics associated with greater willingness included a younger age,lower annual income,higher education,prior participation experience,previous ophthalmic treatment,and a better understanding of clinical trials.With the exception of age,these characteristics were significantly linked to a higher willingness.The primary barrier to participation,expressed by 64.8%of those willing and 54.4%of those unwilling,was“Uncertain efficacy”.In terms of motivations,the willing group ranked“Better therapeutic benefits”(35.0%),“Professional monitoring”(34.3%),and“Trust in healthcare professionals”(33.1%)as their top three reasons,whereas the unwilling participants indicated“Full comprehension of the protocol”(46.2%)as the key facilitator.CONCLUSION:This study reveals a substantial willingness to participate in ophthalmic clinical trials and demonstrates the predictive role of demographic and socioeconomic factors.Variations in motivators and concerns between willing and unwilling participants highlight the significance of tailored recruitment strategies.Importantly,the need for and trust in healthcare professionals stand out as powerful motivations,underscoring the importance of enhancing physician-patient relationships,adopting patient-centered communication approaches,and addressing individualized needs to improve accrual rates.

High rate of clinically relevant improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis

BACKGROUND The minimal clinically important difference(MCID)is defined as the smallest meaningful change in a health domain that a patient would identify as important.Thus,an improvement that exceeds the MCID can be used to define a successful treatment for the individual patient.AIM To quantify the rate of clinical improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis.METHODS Patients were treated with the Global Unite total shoulder platform arthroplasty between March 2017 and February 2019 at Herlev and Gentofte Hospital,Denmark.The patients were evaluated preoperatively and 3 months,6 months,12 months,and 24 months postoperatively using the Western Ontario Osteoarthritis of the Shoulder index(WOOS),Oxford Shoulder Score(OSS)and Constant-Murley Score(CMS).The rate of clinically relevant improvement was defined as the proportion of patients who had an improvement 24 months postoperatively that exceeded the MCID.Based on previous literature,MCID for WOOS,OSS,and CMS were defined as 12.3,4.3,and 12.8 respectively.RESULTS Forty-nine patients with a Global Unite total shoulder platform arthroplasty were included for the final analysis.Mean age at the time of surgery was 66 years(range 49.0-79.0,SD:8.3)and 65%were women.One patient was revised within the two years follow-up.The mean improvement from the preoperative assessment to the two-year follow-up was 46.1 points[95%confidence interval(95%CI):39.7-53.3,P<0.005]for WOOS,18.2 points(95%CI:15.5-21.0,P<0.005)for OSS and 37.8 points(95%CI:31.5-44.0,P<0.005)for CMS.Two years postoperatively,41 patients(87%)had an improvement in WOOS that exceeded the MCID,45 patients(94%)had an improvement in OSS that exceeded the MCID,and 42 patients(88%)had an improvement in CMS that exceeded the MCID.CONCLUSION Based on three shoulder-specific outcome measures we find that approximately 90%of patients has a clinically relevant improvement.This is a clear message when informing patients about their prognosis.

Radical Hysterectomy in Cervical Cancer: Patients’ Epidemiological and Clinical Profiles and Perioperative Outcome in Two Referral Hospitals in Cameroon

Background: Cervical cancer (CC) is one of the most frequent cancers and the leading cause of death from gynecological cancer in Low and middle income countries, Cameroon inclusive. Surgery is the primary treatment modality when the disease is diagnosed at early stage. Radical hysterectomy in cervical cancer has not been evaluated in recent years in Cameroon. The purpose of this study is thus to evaluate the epidemiological and clinical features and short term outcomes of patients who underwent surgery. Patients and methods: This retrospective study was conducted at the Douala Gynaeco-obstetric and Pediatric Hospital and the Douala General Hospital. Cervical cancer patients who underwent Radical hysterectomy between January 2015 and December 2020 were included. A pre-established data collection tool was used to record socio-demographic, clinical and outcomes information from patients’ files;additional outcome information was obtained from phone calls. Descriptive analysis was done using the SPSS version 26. Bivariate analysis was used to determine associations between disease and patients characteristics and occurrence of adverse postoperative outcome. P value of 0.05 was considered. Results: Sixty one patients were enrolled. Their ages ranged from 33 to 74 years with a mean age of 51.95 ± 10.29 years. Over 85% of women were married, 65.57% were unemployed and 86.88% were multiparous. Only 28% had never done cervical cancer screening. Most patients had stage IB1 to IB2 stage disease (57.1%). Less than 9% underwent radical hysterectomy and 8 of those (13.11%) suffered intraoperative complications. Twenty-five patients (40.98%) presented immediate and short term complications. There was no significant association between the disease or patients’ characteristics and adverse outcomes. Conclusion: Cervical cancer patients are relatively young in our settings and only 9% of them reach the hospital at early stage. Postoperative adverse outcomes rate is higher than that reported in the literature. Sensitization on screening and awareness of early symptoms can reverse the situation.

Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia:A Prospective,Randomized,Open,Parallel Controlled and Multicenter Clinical Study

Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

Nab-paclitaxel plus capecitabine as first-line treatment for advanced biliary tract cancers:An open-label,non-randomized,phase II clinical trial

BACKGROUND Biliary tract cancers(BTCs)are a heterogeneous group of tumors with high malignancy,poor prognosis,and limited treatment options.AIM To explore the efficacy and safety of nab-paclitaxel plus capecitabine as first-line treatment for advanced and metastatic BTCs.METHODS This open-label,non-randomized,double-center,phase II clinical trial recruited systemic therapy-naive patients with unresectable or metastatic BTCs between April 2019 and June 2022 at Beijing Cancer Hospital and the First Hospital of China Medical University.Eligible patients were administered nab-paclitaxel(150 mg/m^(2),day 1)and capecitabine(2000 mg/m^(2),twice daily,days 1-7)in 14-day cycles until experiencing intolerable toxicity or disease progression.The primary outcome was the objective response rate(ORR).The secondary outcomes included the disease control rate(DCR),overall survival(OS),progression-free survival(PFS),and safety.RESULTS A total of 44 patients successfully completed the trial,with a median age of 64.00 years(interquartile range,35.00-76.00),and 26(59.09%)were females.Tumor response assessment was impeded for one patient due to premature demise from tumor hemorrhage.Among the remaining 43 patients undergoing at least one imaging assessment,the ORR was 23.26%[95%confidence interval(CI):11.80%-38.60%],and the DCR was 69.77%(95%CI:53.90%-82.80%).The median OS was 14.1 months(95%CI:8.3-19.9),and the median PFS was 4.4 months(95%CI:2.5-6.3).A total of 41 patients(93.18%)experienced at least one adverse event(AE),with 10 patients(22.73%)encountering grade≥3 AEs,and the most frequent AEs of any grade were alopecia(79.50%),leukopenia(54.55%),neutropenia(52.27%),and liver dysfunction(40.91%),and no treatment-related deaths were documented.CONCLUSION Nab-paclitaxel plus capecitabine may be an effective and safe first-line treatment strategy for patients with advanced or metastatic BTCs.

Human dental pulp stem/stromal cells in clinical practice

Dental pulp stem/stromal cells(DPSCs)are fibroblast-like,neural crest-derived,and multipotent cells that can differentiate into several lineages.They are relatively easy to isolate from healthy and inflamed pulps,with little ethical concerns and can be successfully cryopreserved and thawed.The therapeutic effects of DPSCs derived from animal or human sources have been extensively studied through in-vitro and in-vivo animal experiments and the findings indicated that DPSCs are effective not only for dental diseases but also for systemic diseases.Understanding that translational research is a critical step through which the fundamental scientific discoveries could be translated into applicable diagnostics and therapeutics that directly benefit humans,several clinical studies were carried out to generate evidence for the efficacy and safety of autogenous or allogeneic human DPSCs(hDPSCs)as a treatment modality for use in cell-based therapy,regenerative medicine/dentistry and tissue engineering.In clinical medicine,hDPSCs were effective for treating acute ischemic stroke and human exfoliated deciduous teeth-conditioned medium(SHED-CM)repaired vascular damage of the corpus cavernous,which is the main cause of erectile dysfunction.Whereas in clinical dentistry,autologous SHED was able to rege-nerate necrotic dental pulp after implantation into injured teeth,and micrografts enriched with autologous hDPSCs and collagen sponge were considered a treatment option for human intrabony defects.In contrast,hDPSCs did not add a significant regenerative effect when they were used for the treatment of post-extraction sockets.Large-scale clinical studies across diverse populations are still lacking to provide robust evidence on the safety and efficacy of hDPSCs as a new treatment option for various human diseases including dental-related problems.

An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China

Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China.Methods Literature research,case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines.Results and Conclusion From the perspective of the sponsor,investigators and the thirdparty technical service company,the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found.Then,the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed,including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel.

Formulation of a CITE metric for evaluating the clinical implications of medical studies and their originating hospitals in China

Background:The number of medical research publications by Chinese clinical investigators has risen substantially,contributing to 14.63%of the global total in 2019;however,their tangible impact on clinical decisionmaking remains limited.Various evaluation methods have been developed to measure hospital research competence in China,such as Fudan University's China hospital ranking and Science and Technology Evaluation Metrics(STEM)ranking,which predominantly focuses on factors such as academic reputation,volume of publications and patents,and research resources.However,composite indices may not fully capture the actual clinical value generated by medical research.To address this gap,we introduced the“Clinical Influence and Timeliness Evaluation(CITE)”metric to assess both the clinical importance of a given medical research study and the clinical influence of the hospital where it originated.The methodology used relies on the premise that influential medical research would be referenced in clinical guidelines,which serve as critical resources for clinicians.Methods:The CITE metric was applied for 78,636 medical studies concerning chronic obstructive pulmonary disease(COPD)published between 2000 and 2020 and referenced in both Chinese and international clinical guidelines for COPD.Specific indexes and formulas were derived to quantify the clinical weight of a medical research study(W)and its timeliness(T),enabling a dynamic assessment of the clinical value of each study and the overall contribution of a particular hospital.Results:In this analysis,we incorporated 499 hospitals in China and quantitatively identified their dynamic clinical influence in COPD from 2000 to 2020.Our findings offer objective and targeted evaluation metrics by focusing on clinical relevance and recognizing the collaborative nature of medical research.Conclusion:The CITE metric provides an innovative method to gauge the true impact of medical research in China,with potential applications across different medical specialties.CITE can serve as a useful tool for understanding the relationship between research input and practical clinical outcomes,ultimately promoting more clinically relevant research endeavors.

Rare and lacking typical clinical symptoms of liver tumors:Four case reports

BACKGROUND Rare liver tumors(RLTs)have an extremely low likelihood of forming,and some have been recorded only in isolated cases.The lack of normal clinical symptoms in RLTs makes preoperative diagnosis extremely challenging,which results in frequent misinterpretation.The present case report helps enhance our ability to recognize and treat uncommon liver tumor disorders.CASE SUMMARY We describe four distinct examples of rare liver tumor diseases.These cases were all true cases with no conventional clinical signs or imaging findings.In all patients,hepatic occupancy was discovered on physical examination,which raised the preoperative suspicion of hepatic cancer.All tumors were surgically removed,and postoperative histology and immunohistochemistry were performed to confirm the diagnosis.The first patient had primary hepatic fibrosarcoma.The second case involved a primary hepatic neuroendocrine tumors.These two patients had malignant liver tumors,and both had extremely satisfactory surgical outcomes.The third case involved focal hepatic steatosis,and the fourth case involved a single necrotic nodule in the liver.These two patients had benign liver tumors,but they had already undergone surgery and did not require any postoperative care.CONCLUSION The number of patients with RLTs is small,and the clinical and imaging results are vague.Preoperative diagnosis is challenging,and patients are sometimes mistakenly diagnosed with liver cancer,which leads to unnecessary surgical therapy in certain individuals.

Analysis of Ophthalmology Drug Clinical Trial Institutions in China: Challenges and Opportunities Under the Registration System

Objective:To analyze the status of ophthalmology drug clinical trial institutions in China following the implementation of the registration system and provide a reference for their development.Methods:An analysis was conducted using data from the Drug Clinical Trial Institution Registration Management Information Platform and the Drug Clinical Trial Registration and Information Publicity Platform of the National Medical Products Administration.The search period was up to April 19,2024.Results:As of April 19,2024,314 ophthalmology-specific institutions were registered nationwide,comprising 274 comprehensive medical institutions and 40 specialized ophthalmology institutions,representing a 245%increase compared to the qualification certification phase.There were 965 major researchers in ophthalmology,accounting for 6.3%of the total number of researchers across all registered ophthalmology institutions.These institutions were predominantly located in economically developed areas such as Guangdong,Zhejiang,and Jiangsu Provinces,with the top five provinces and cities comprising 39.8%of the total registered institutions.Beijing had the highest number of major researchers(126),with their distribution positively correlated with the geographic spread of registered institutions.Furthermore,as of April 19,2024,there were 216 clinical drugs related to eye diseases,with the top three provinces conducting 77.8%of national clinical trial projects.The number of institutions was directly proportional to the volume of clinical trials conducted.Conclusion:The implementation of the registration system has facilitated the release of ophthalmic medical resources.However,regional disparities remain in the number of ophthalmology-specific institutions,the availability of major investigators,and the distribution of clinical trial projects.

Analysis of the Current Situation of Drug Clinical Trial Institutions in Shaanxi Province

To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on the“Announcement on the Accreditation of Drug Clinical Trial Institutions”issued by the National Medical Products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical trials.After the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province.

Application of Seminar Teaching Method Combined with Case-Based Learning and Problem-Based Learning Teaching Models in Oral Clinical Nursing Teaching

Purpose:To analyze the role of the seminar teaching method+case-based learning(CBL)teaching method+problem-based learning(PBL)teaching method in oral clinical nursing teaching.Methods:13 undergraduate nursing students who entered the department from September 2020 to September 2021 were selected as the control group,adopting conventional nursing teaching methods;13 undergraduate nursing students who entered the department from September 2021 to August 2022 were selected as the observation group,adopting the seminar+CBL+PBL teaching method.The teaching effects were compared between the two groups.Results:All assessment scores of the observation group were higher than those of the control group;all teaching satisfaction levels were higher than those of the control group(P<0.05).Conclusion:Adopting the seminar+CBL+PBL teaching method during oral clinical nursing teaching can improve nursing students’assessment scores,strengthen their core competencies,and enhance teaching satisfaction.

Epidemiological and clinical features,treatment status,and economic burden of traumatic spinal cord injury in China:a hospital-based retrospective study

Traumatic spinal cord injury is potentially catastrophic and can lead to permanent disability or even death.China has the largest population of patients with traumatic spinal cord injury.Previous studies of traumatic spinal cord injury in China have mostly been regional in scope;national-level studies have been rare.To the best of our knowledge,no national-level study of treatment status and economic burden has been performed.This retrospective study aimed to examine the epidemiological and clinical features,treatment status,and economic burden of traumatic spinal cord injury in China at the national level.We included 13,465 traumatic spinal cord injury patients who were injured between January 2013 and December 2018 and treated in 30 hospitals in 11 provinces/municipalities representing all geographical divisions of China.Patient epidemiological and clinical features,treatment status,and total and daily costs were recorded.Trends in the percentage of traumatic spinal cord injuries among all hospitalized patients and among patients hospitalized in the orthopedic department and cost of care were assessed by annual percentage change using the Joinpoint Regression Program.The percentage of traumatic spinal cord injuries among all hospitalized patients and among patients hospitalized in the orthopedic department did not significantly change overall(annual percentage change,-0.5%and 2.1%,respectively).A total of 10,053(74.7%)patients underwent surgery.Only 2.8%of patients who underwent surgery did so within 24 hours of injury.A total of 2005(14.9%)patients were treated with high-dose(≥500 mg)methylprednisolone sodium succinate/methylprednisolone(MPSS/MP);615(4.6%)received it within 8 hours.The total cost for acute traumatic spinal cord injury decreased over the study period(-4.7%),while daily cost did not significantly change(1.0%increase).Our findings indicate that public health initiatives should aim at improving hospitals’ability to complete early surgery within 24 hours,which is associated with improved sensorimotor recovery,increasing the awareness rate of clinical guidelines related to high-dose MPSS/MP to reduce the use of the treatment with insufficient evidence.