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Beyond statistical significance:Embracing minimal clinically important difference for better patient care
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作者 Naveen Jeyaraman Madhan Jeyaraman +2 位作者 Swaminathan Ramasubramanian Sangeetha Balaji Sathish Muthu 《World Journal of Methodology》 2025年第1期33-41,共9页
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 p... 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. 展开更多
关键词 Minimal clinically important difference Patient-centered care clinical relevance Global health
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The potential mechanism and clinical application value of remote ischemic conditioning in stroke 被引量:1
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作者 Yajun Zhu Xiaoguo Li +6 位作者 Xingwei Lei Liuyang Tang Daochen Wen Bo Zeng Xiaofeng Zhang Zichao Huang Zongduo Guo 《Neural Regeneration Research》 SCIE CAS 2025年第6期1613-1627,共15页
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... 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. 展开更多
关键词 Akt apoptosis autophagy cerebral perfusion cerebral vascular stenosis clinical transformation hemorrhagic stroke ischemic stroke NEUROINFLAMMATION neuroprotection Notch1 PI3K remote ischemic conditioning STROKE
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Use of graphene nanocomposites for air disinfection in dental clinics:A game-changer in infection control
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作者 Chun-Han Cheng Wen-Rui Hao Tzu-Hurng Cheng 《World Journal of Clinical Cases》 SCIE 2025年第8期57-62,共6页
This manuscript features the promising findings of a study conducted by Ju et al,who used graphene nanocomposites for air disinfection in dental clinics.Their study demonstrated that,compared with conventional filters... This manuscript features the promising findings of a study conducted by Ju et al,who used graphene nanocomposites for air disinfection in dental clinics.Their study demonstrated that,compared with conventional filters,graphene nanocom-posites substantially improved air quality and reduced microbial contamination.This manuscript highlights the innovative application of graphene materials,emphasizing their potential to enhance dental clinic environments by minimizing secondary pollution.On the basis of the unique antimicrobial properties of gra-phene and the original study’s rigorous methodology,we recommend using gra-phene nanocomposites in clinical settings to control airborne infections. 展开更多
关键词 Graphene nanocomposites Air disinfection Dental clinics Antimicrobial properties Secondary pollution
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Machine learning applications in healthcare clinical practice and research
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作者 Nikolaos-Achilleas Arkoudis Stavros P Papadakos 《World Journal of Clinical Cases》 SCIE 2025年第1期16-21,共6页
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 intelligen... 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. 展开更多
关键词 Machine Learning Artificial INTELLIGENCE clinicAL Practice RESEARCH Glomerular filtration rate Non-alcoholic fatty liver disease MEDICINE
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Importance of etiologies of secondary diabetes:How often do we think off in clinical practice?
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作者 Kotha Sugunakar Reddy Arvind Kumar Morya +1 位作者 Archana Gaur Sakthivadivel Varatharajan 《World Journal of Clinical Cases》 SCIE 2025年第5期49-51,共3页
The article"Secondary diabetes due to different etiologies:Four case reports"by Song et al,published in the World Journal of Clinical Cases,delves into the identi-fication of rare causes of secondary diabete... The article"Secondary diabetes due to different etiologies:Four case reports"by Song et al,published in the World Journal of Clinical Cases,delves into the identi-fication of rare causes of secondary diabetes and emphasizes the necessity for healthcare professionals to recognize these conditions.Failure to do so can result in treatment delays and compromised patient outcomes.The article discusses spe-cific types of diabetes,including maturity onset of diabetes in young,pancreas-related diseases,endocrinopathies,drug-induced diabetes,infections,and con-genital genetic syndromes associated with diabetes mellitus.Case summaries highlight how patients with secondary diabetes,stemming from conditions such as Williams-Beuren syndrome and pituitary adenoma,often exhibit distinct characteristics overlooked in clinical practice.The authors stress the importance of a holistic diagnostic approach and advocate for proactive management through early intervention,including genetic tests and antibody detection.Increased awa-reness and education are crucial for timely identification and proper management,ultimately improving patient well-being.These findings prompt a call to action for healthcare professionals to consider rare causes of secondary diabetes,facili-tating better glycemic control and overall patient care. 展开更多
关键词 Diabetes mellitus ETIOLOGIES Viral infections SYNDROMES Pathophysiology Secondary diabetes mellitus clinical practice
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Strategic insights of telehealth platforms and strengths,weaknesses,opportunities,and threats analysis of Amazon's clinical endeavors
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作者 Harpreet Grewal Gagandeep Dhillon +6 位作者 Venkata Buddhavarapu Ram Kishun Verma Ripudaman Singh Munjal Pranjal Sharma Gurmanpreet Sidhu Rahul Kashyap Salim Surani 《World Journal of Methodology》 2025年第2期145-153,共9页
BACKGROUND The adoption of telehealth services surged after the coronavirus disease 2019 pandemic,revolutionizing traditional healthcare delivery models.Amazon Clinic's recent nationwide launch marks a significant... BACKGROUND The adoption of telehealth services surged after the coronavirus disease 2019 pandemic,revolutionizing traditional healthcare delivery models.Amazon Clinic's recent nationwide launch marks a significant milestone in this trend.This study aims to offer a strengths,weaknesses,opportunities,and threats(SWOT)analysis of Amazon Clinic and compare its features with leading virtual healthcare platforms.AIM To evaluate Amazon Clinic's telehealth services through a SWOT analysis and compare its features with other leading virtual healthcare platforms.METHODS The initial search terms included were,amazon clinic odds ratio(OR)amwell OR Teladoc OR Walmart virtual health service OR CVS minute clinic OR CirrusMD OR brightside health,from 2000 to 2023.This search yielded 111 articles,from which duplicates were removed,and unrelated titles were filtered out.Eight articles were retained for a final review,including comparative studies,usability research,retrospective analyses,observational studies,and review articles.The data was organized and analyzed using Rayyan software and summarized in a table and PRISMA flowcharts.RESULTS The review included eight articles focusing on various aspects of telehealth.Comparative studies highlighted differences between Teladoc and traditional physician offices,noting lower diagnostic imaging orders and antibiotic prescriptions for Teladoc.User demographics for Teladoc showed younger,less engaged patients.Usability studies emphasized the importance of website design for telemedicine adoption.Tele-mental health platforms like Brightside showed superior outcomes in treating depression compared to traditional methods.Telemedicine for specialized fields like skin reconstruction demonstrated cost efficiency and reduced waiting times.The SWOT analysis identified Amazon Clinic's strengths,such as its vast consumer base and transparent pricing,and weaknesses like the lack of pediatric care.Opportunities included potential partnerships and service expansions,while threats involved competition and regulatory challenges.CONCLUSION Amazon Clinic's entry into the telehealth sector represents a significant development with various strengths and opportunities.However,it faces challenges from established healthcare providers and regulatory landscapes.The future success of Amazon Clinic will depend on strategic collaborations,addressing service gaps,and navigating competition and regulations.Telemedicine's impact will hinge on its ability to effectively leverage these opportunities and overcome inherent challenges in the ever-evolving healthcare landscape. 展开更多
关键词 Tele-health AMAZON COVID-19 Primary Care Outpatient clinic SWOT TELEMEDICINE
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Visualizing medicine:The case for implementing graphical abstracts in clinical reporting
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作者 Naveen Jeyaraman Madhan Jeyaraman +2 位作者 Swaminathan Ramasubramanian Sangeetha Balaji Arulkumar Nallakumarasamy 《World Journal of Methodology》 2025年第2期1-8,共8页
Graphical abstracts(GAs)are emerging as a pivotal tool in medical literature,enhancing the dissemination and comprehension of complex clinical data through visual summaries.This editorial highlights the significant ad... Graphical abstracts(GAs)are emerging as a pivotal tool in medical literature,enhancing the dissemination and comprehension of complex clinical data through visual summaries.This editorial highlights the significant advantages of GAs,including improved clarity,increased reader engagement,and enhanced visibility of research findings.By transforming intricate scientific data into accessible visual formats,these abstracts facilitate quick and effective knowledge transfer,crucial in clinical decision-making and patient care.However,challenges such as potential data misrepresentation due to oversimplification,the skill gap in graphic design among researchers,and the lack of standardized creation guidelines pose barriers to their widespread adoption.Additionally,while software such as Adobe Illustrator,BioRender,and Canva are commonly employed to create these visuals,not all researchers may be proficient in their use.To address these issues,we recommend that academic journals establish clear guidelines and provide necessary design training to researchers.This proactive approach will ensure the creation of high-quality GAs,promote their standardization,and expand their use in clinical reporting,ultimately benefiting the medical community and improving healthcare outcomes. 展开更多
关键词 Graphical abstracts clinical data dissemination Visual communication Research impact Academic publishing
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Pathogenesis and clinical management of arboviral diseases
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作者 Victoria Cenci Dietrich Juan Marcos Caram Costa +5 位作者 Marina Maria Gomes Leite Oliveira Carlos Eduardo Oliveira Aguiar Luis Guilherme de Oliveira Silva Marcel Silva Luz Fabian Fellipe Bueno Lemos Fabrício Freire de Melo 《World Journal of Virology》 2025年第1期9-50,共42页
Arboviral diseases are viral infections transmitted to humans through the bites of arthropods,such as mosquitoes,often causing a variety of pathologies associated with high levels of morbidity and mortality.Over the p... Arboviral diseases are viral infections transmitted to humans through the bites of arthropods,such as mosquitoes,often causing a variety of pathologies associated with high levels of morbidity and mortality.Over the past decades,these infections have proven to be a significant challenge to health systems worldwide,particularly following the considerable geographic expansion of the dengue virus(DENV)and its most recent outbreak in Latin America as well as the difficult-tocontrol outbreaks of yellow fever virus(YFV),chikungunya virus(CHIKV),and Zika virus(ZIKV),leaving behind a substantial portion of the population with complications related to these infections.Currently,the world is experiencing a period of intense globalization,which,combined with global warming,directly contributes to wider dissemination of arbovirus vectors across the globe.Consequently,all continents remain on high alert for potential new outbreaks.Thus,this review aims to provide a comprehensive understanding of the pathogenesis of the four main arboviruses today(DENV,ZIKV,YFV,and CHIKV)discussing their viral characteristics,immune responses,and mechanisms of viral evasion,as well as important clinical aspects for patient management.This includes associated symptoms,laboratory tests,treatments,existing or developing vaccines and the main associated complications,thus integrating a broad historical,scientific and clinical approach. 展开更多
关键词 ARBOVIRUSES Arbovirus infections DENGUE Zika virus Yellow fever Chikungunya virus clinical diagnosis PATHOGENESIS FLAVIVIRUS Togaviridae infections
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Voices that matter:The impact of patient-reported outcome measures on clinical decision-making
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作者 Naveen Jeyaraman Madhan Jeyaraman +2 位作者 Swaminathan Ramasubramanian Sangeetha Balaji Sathish Muthu 《World Journal of Methodology》 2025年第2期54-61,共8页
The critical role of patient-reported outcome measures(PROMs)in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research.PROMs encapsulate a pati... The critical role of patient-reported outcome measures(PROMs)in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research.PROMs encapsulate a patient's health status directly from their perspective,encompassing various domains such as symptom severity,functional status,and overall quality of life.By integrating PROMs into routine clinical practice and research,healthcare providers can achieve a more nuanced understanding of patient experiences and tailor treatments accordingly.The deployment of PROMs supports dynamic patient-provider interactions,fostering better patient engagement and adherence to tre-atment plans.Moreover,PROMs are pivotal in clinical settings for monitoring disease progression and treatment efficacy,particularly in chronic and mental health conditions.However,challenges in implementing PROMs include data collection and management,integration into existing health systems,and acceptance by patients and providers.Overcoming these barriers necessitates technological advancements,policy development,and continuous education to enhance the acceptability and effectiveness of PROMs.The paper concludes with recommendations for future research and policy-making aimed at optimizing the use and impact of PROMs across healthcare settings. 展开更多
关键词 Patient-reported outcome measures clinical decision-making Patient-centered care Healthcare technology Data management Policy development
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Analysis of the History and Current Situation of the Development of General Practice Teaching Clinics in China
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作者 Xiaotong Huo Yajun Lian 《Open Journal of Preventive Medicine》 2024年第2期29-38,共10页
A summary of the exploration of the teaching mode of the general practice teaching clinic, a summary of the deficiencies of the teaching clinic and a summary of the significance of the establishment of the general pra... A summary of the exploration of the teaching mode of the general practice teaching clinic, a summary of the deficiencies of the teaching clinic and a summary of the significance of the establishment of the general practice teaching clinic are presented with a view to promoting the development of general practice and cultivating more excellent successors in general practice. 展开更多
关键词 General Practice Teaching clinic Teaching Models Teaching Deficiencies in the clinic Significance of the Teaching clinic
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Comparative analysis of breast and lung cancer survival rates and clinical trial enrollments among rural and urban patients in Georgia
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作者 TATIANA KURILO REBECCA D.PENTZ 《Oncology Research》 SCIE 2024年第9期1401-1406,共6页
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 ... 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. 展开更多
关键词 CANCER Cancer survival rates clinical trial enrollment Rural patients Health disparities Barriers to clinical trial participation Geographic disparities
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Virtual reality:The bridge between medical education and clinical practice
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作者 Yan-Quan Liu 《World Journal of Clinical Cases》 SCIE 2024年第32期6575-6579,共5页
After perusing the paper by Kim et al,I discovered that this is an interesting manuscript and a successful study.Virtual reality(VR)is an emerging and promising technology employed in the domain of medical practice an... After perusing the paper by Kim et al,I discovered that this is an interesting manuscript and a successful study.Virtual reality(VR)is an emerging and promising technology employed in the domain of medical practice and medical education over the past decade.In the era of big data,VR is constantly progressing in the fields of medical education and clinical diagnosis and treatment.As a novel scientific and technological tool,VR not only overcomes multiple limitations of the traditional medical teaching mode but also reduces the reliance on personnel and equipment.VR can simulate the real clinical situation,stimulate the enthusiasm of young doctors and nurses for clinical study,and simultaneously safeguard and promote medical safety and doctor-patient harmony.Favorable outcomes have been attained in clinical teaching and diagnosis and treatment activities.While enhancing the training conditions of medical cosmetics and elevating the level of clinical practice and teaching,the risks resulting from improper clinical diagnosis and treatment have been circumvented.All of this is evident and comprehensible. 展开更多
关键词 Virtual reality Medical education clinical practice clinical training PEDAGOGY
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Assessment of Appropriateness of Diagnostic Lymph Node Tissue Collection from the Operating Theater and by Interventional Radiologist. A Clinical Audit
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作者 Kowthar Salman Hassan Divya Deodhar +1 位作者 Abdullah T. Al-Rawahi Mahmood H. Al Abri 《Advances in Infectious Diseases》 CAS 2024年第3期541-548,共8页
Background: Appropriate sample requesting, collecting and timely dispatch to the appropriate laboratory is essential in establishing diagnosis of pathologies with lesions. Much time and effort may be wasted if this is... Background: Appropriate sample requesting, collecting and timely dispatch to the appropriate laboratory is essential in establishing diagnosis of pathologies with lesions. Much time and effort may be wasted if this is not done according to certain standards. We conducted this study to assess the route of lymph node samples from requests to reaching the laboratories. Methods: We conducted an audit over a period from 4th June until 10th Aug 2023. Data for all the procedures performed over this period on lymph node samples (was entered into and analysed using Excel. Results: A total of eighteen samples for sixteen patients were obtained during this period. Median age of the patients was 34 years (19 - 73) with a M:F ratio of 5:11. Among the IR samples, nine samples were from the neck, three from inguinal area and one from axilla. Seven samples (53.8%) were tru-cut biopsies, six samples (46.15%) were FNA. All samples were sent to the pathology laboratory fixed in formalin. Samples for TB were sent only for five cases (31.25%) and for only two cases (12.5%) were samples sent for bacterial culture. For the OR samples, none were sent for either bacterial culture or TB. Overall, eight patients (50%) were not investigated for any infectious etiologies like brucella, toxoplasmosis, CMV, EBV plus other possible causes. Repeat sampling was required for 25% of patients (within and out of the audit period). Conclusions: to avoid delays in making diagnoses, it is paramount to consider infectious etiologies as possible diagnosis for lymphadenopathy and request appropriate investigations. This requires liaising with infectious diseases/clinical microbiology experts to guide regarding types of samples, types of media and timely dispatch to the correct laboratory. 展开更多
关键词 clinical Audit clinical Samples BIOPSIES Lymph Nodes Saline FORMALIN Quality Improvement
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High rate of clinically relevant improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis
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作者 Marc Randall Kristensen Nyring Bo Sanderhoff Olsen +1 位作者 Alexander Amundsen Jeppe Vejlgaard Rasmussen 《World Journal of Orthopedics》 2024年第2期156-162,共7页
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 u... 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. 展开更多
关键词 Minimal clinically important difference Patient reported outcome measures Glenohumeral osteoarthritis Anatomical total shoulder arthroplasty clinically relevant improvement
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Fast-to-Clinic, Fast-to-Market in Biotech Innovation: Optimizing Chemistry Manufacturing & Controls (CMC) Excellence for Clinical and Commercial Success
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作者 Kishore Kumar Hotha 《Advances in Chemical Engineering and Science》 CAS 2024年第3期155-171,共17页
In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of ... In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of research and development by streamlining the path from concept to clinical trials and, ultimately, to market. The article delves into the intricacies of implementing a fast-to-clinic/market strategy, underlining the empowering role of strategic decision-making in preclinical and commercial stages. The plan advocates for a phase-appropriate approach, where the development decision is tailored to each phase of the product’s lifecycle. This ensures that resources are allocated efficiently, risks are managed effectively, and the product can move through the development pipeline accelerated without compromising quality or regulatory compliance. The article also discusses the role of CDMOs in facilitating rapid product development and the essential factors biotech companies must consider when selecting a partner for outsourcing. These factors include the CDMO’s expertise in navigating regulatory landscapes, technological capabilities, and ability to scale processes efficiently. Moreover, the article stresses the importance of agility and flexibility in the fast-to-clinic/market approach. Biotech companies are encouraged to adopt adaptable strategies that respond to the fast-evolving regulatory and market landscapes. 展开更多
关键词 Fast to clinic INNOVATION CDMO CMC PREclinicAL FDA IND NDA ANDA BIOTECH
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Assessing the Levels of Clinical Reasoning Skills Using Self-Assessment of Clinical Reflection and Reasoning in Undergraduate Nursing Students: A Descriptive Comparative Study
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作者 Omero G. Mwale Patricia K. Mukwato Marjorie K. Makukula‡ 《Open Journal of Nursing》 2024年第7期283-297,共15页
Background: Clinical reasoning is a critical cognitive skill that enables undergraduate nursing students to make clinically sound decisions. A lapse in clinical reasoning can result in unintended harm to patients. The... Background: Clinical reasoning is a critical cognitive skill that enables undergraduate nursing students to make clinically sound decisions. A lapse in clinical reasoning can result in unintended harm to patients. The aim of the study was to assess and compare the levels of clinical reasoning skills between third year and fourth year undergraduate nursing students. Methods: The study utilized a descriptive comparative research design, based on the positivism paradigm. 410 undergraduate nursing students were systematically sampled and recruited into the study. The researchers used the Self-Assessment of Clinical Reflection and Reasoning questionnaire to collect data on clinical reasoning skills from third- and fourth-year nursing students while adhering to ethical principles of human dignity. Descriptive statistics were done to analyse the level of clinical reasoning and an independent sample t-test was performed to compare the clinical reasoning skills of the student. A p value of 0.05 was accepted. Results: The results of the study revealed that the mean clinical reasoning scores of the undergraduate nursing students were knowledge/theory application (M = 3.84;SD = 1.04);decision-making based on experience and evidence (M = 4.09;SD = 1.01);dealing with uncertainty (M = 3.93;SD = 0.87);reflection and reasoning (M = 3.77;SD = 3.88). The mean difference in clinical reasoning skills between third- and fourth-year undergraduate nursing students was not significantly different from an independent sample t-test scores (t = −1.08;p = 0.28);(t = −0.29;p = 0.73);(t = 1.19;p = 0.24);(t = −0.57;p = 0.57). Since the p-value is >0.05, the null hypothesis (H0) “there is no significantno significant difference in clinical reasoning between third year and fourth year undergraduate nursing students”, was accepted. Conclusion: This study has shown that the level of clinical reasoning skills of the undergraduate nursing students was moderate to low. This meant that the teaching methods have not been effective to improve the students clinical reasoning skills. Therefore, the training institutions should revise their curriculum by incorporating new teaching methods like simulation to enhance students’ clinical reasoning skills. In conclusion, evaluating clinical reasoning skills is crucial for addressing healthcare issues, validating teaching methods, and fostering continuous improvement in nursing education. 展开更多
关键词 clinical Competences clinical Reasoning Skills Undergraduate Nursing Student
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Clinical competency:perceptions of nursing interns and clinical mentors
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作者 Jackline Prathibha Radhika R.Pai Linu Sara George 《Frontiers of Nursing》 2024年第1期105-110,共6页
Objective:To assess the clinical competency of nursing interns and the perception of clinical nurse mentors toward student nurses'clinical competency.Methods:A study was carried out among 104 nursing interns and 2... Objective:To assess the clinical competency of nursing interns and the perception of clinical nurse mentors toward student nurses'clinical competency.Methods:A study was carried out among 104 nursing interns and 26 clinical nurse mentors using the purposive sampling technique.A self-repor ted perception scale was used to collect the data.Results:In general,most nursing interns perceived themselves as clinically competent during the internship.The clinical nurse mentors too repor ted that the current internship is helping the nursing interns in becoming competent.Conclusions:Frequent clinical evaluation,buddy system,provision of stipends,good leadership,and coordination between the academic institute and hospital are repor ted as the critical motivating factors for improving the clinical competency of student interns. 展开更多
关键词 clinical competency clinical nurse mentors COMPETENCE INTERNSHIP nursing interns PERCEPTION
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An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China
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作者 Lin Hansen Tian Lijuan 《Asian Journal of Social Pharmacy》 2024年第1期50-57,共8页
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... 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. 展开更多
关键词 therapeutic vaccine clinical trial quality management good clinical practice(GCP)
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Formulation of a CITE metric for evaluating the clinical implications of medical studies and their originating hospitals in China
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作者 Gao Jianchao Chen Xiaoyuan Gao Chenyan 《Health Care Science》 2024年第4期264-273,共10页
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 decisionmaki... 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. 展开更多
关键词 Chinese clinical investigations clinical Influence and Timeliness Evaluation(CITE) hospital research competence
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Patient Recruitment in Clinical Trials: Areas of Challenges and Success, a Practical Aspect at the Private Research Site
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作者 Pranali M. Wandile 《Journal of Biosciences and Medicines》 2023年第10期103-113,共11页
Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical cen... Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical center. Every study differs in various aspects, such as phases, study indication, eligibility criteria, etc. In terms of meeting the enrollment deadline, typically, the study indication and availability of the patient’s population at the geographical area of the research site would decide if the trial could be time-consuming. Patient recruitment and retention are critical for the success of every clinical trial;however, worldwide, this area is facing tremendous pressure and challenges. Globally 55% of clinical trials terminated due to low recruitment, with an average enrollment success rate of 40% for Phase III and IV trials. Over 80% of clinical trial attempts fail to enroll, extending the study and adding new study sites. In the United States, more than 80% of clinical trials fail to achieve targeted patient enrollment, and 30% of study participants discontinue participation. This article reviewed various factors hindering clinical trial recruitment and retention and suggested strategies to make the research site successful. 展开更多
关键词 clinical Trial Recruitment clinical Trial Retention clinical Trial Participants clinical Trial Termination Study Budget clinical Trial Enrollment Challenges
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