目的基于风险管理模式构建研究者发起的临床研究(IIT)全流程风险评估与分级管控体系,并验证。方法基于文献分析法检索中国知网(CNKI)、万方(WanFang)、Web of Science、PubMed数据库及互联网搜索工具等IIT相关文献、研究报告、现行管理...目的基于风险管理模式构建研究者发起的临床研究(IIT)全流程风险评估与分级管控体系,并验证。方法基于文献分析法检索中国知网(CNKI)、万方(WanFang)、Web of Science、PubMed数据库及互联网搜索工具等IIT相关文献、研究报告、现行管理政策等资料,检索时限为各数据库自建库起至2023年12月,建立IIT风险评估标准条目池初稿。采用德尔菲(Delphi)法对专家进行2轮咨询,确定最终的IIT全流程风险评估指标和分级管控体系,进行方法学评估,并结合真实世界研究和Spearman相关性分析验证指标体系的实用效能。结合地市级医院IIT项目管理现状,提出基于不同阶段、评估实施者、风险分级的分类、分级管控体系。结果组建了由17名专家构成的Delphi咨询小组,以女性(12名,70.59%)、工作年限>10年(13名,76.47%)、硕士研究生(8名,47.06%)、高级职称(9名,52.94%)、药物临床试验(GCP)主要研究者(9名,52.94%)居多。2轮Delphi咨询专家积极系数(问卷回收率)均为100%,专家权威系数分别为0.953和0.965,专家意见集中程度分别为4.495分和4.709分,变异系数分别为0.096和0.065。最终构建了涵盖立项、实施、结题全流程的IIT风险评估指标体系,包含8个一级指标、20个二级指标及36个三级指标,且三级指标风险分级为一级风险点8条、二级风险点21条和三级风险点7条。真实世界验证结果表明,构建的IIT风险评估指标体系与专家独立风险评分在全流程(ρ=0.894)、立项阶段(ρ=0.706)、实施阶段(ρ=0.761)、结题阶段(ρ=0.780)均呈极显著正相关(P<0.001)。针对地市级医疗机构提出了基于风险等级的“归口管理+分级联动”差异化管控措施。结论构建的IIT风险评估与管控体系具有较好的实用效能和评价一致性,可为地市级医疗机构开展IIT潜在风险点管理提供标准化工具支持,并为监管部门制订行业管理规范提供理论参考。展开更多
BACKGROUND Timely and accurate evaluation of mental disorders in adolescents using appropriate mental health literacy assessment tools is essential for improving their mental health literacy levels.AIM To develop an e...BACKGROUND Timely and accurate evaluation of mental disorders in adolescents using appropriate mental health literacy assessment tools is essential for improving their mental health literacy levels.AIM To develop an evaluation index system for the mental health literacy of adolescent patients with mental disorders,providing a scientific,comprehensive,and reliable tool for the monitoring and intervention of mental health literacy of such patients.METHODS From December 2022 to June 2023,the evaluation index system for mental health literacy of adolescents with mental disorders was developed through literature reviews,semi-structured interviews,expert letter consultations,and the analytic hierarchy process.Based on this index system,a self-assessment questionnaire was compiled and administered to 305 adolescents with mental disorders to test the reliability and validity of the index system.RESULTS The final evaluation index system for mental health literacy of adolescents with mental disorders included 4 first-level indicators,10 second-level indicators,and 52 third-level indicators.The overall Cronbach’sαcoefficient of the index system was 0.957,with a partial reliability of 0.826 and a content validity index of 0.975.The cumulative variance contribution rate of 10 common factors was 66.491%.The correlation coefficients between each dimension and the total questionnaire ranged from 0.672 to 0.724,while the correlation coefficients in each dimension ranged from 0.389 to 0.705.CONCLUSION The evaluation index system for mental health literacy of adolescents with mental disorders,developed in this study,demonstrated notable reliability and validity,making it a valuable tool for evaluating mental health literacy in this population.展开更多
Artificial intelligence(AI)is increasingly recognized as a transformative force in the field of solid organ transplantation.From enhancing donor-recipient matching to predicting clinical risks and tailoring immunosupp...Artificial intelligence(AI)is increasingly recognized as a transformative force in the field of solid organ transplantation.From enhancing donor-recipient matching to predicting clinical risks and tailoring immunosuppressive therapy,AI has the potential to improve both operational efficiency and patient outcomes.Despite these advancements,the perspectives of transplant professionals-those at the forefront of critical decision-making-remain insufficiently explored.To address this gap,this study utilizes a multi-round electronic Delphi approach to gather and analyses insights from global experts involved in organ transplantation.Participants are invited to complete structured surveys capturing demographic data,professional roles,institutional practices,and prior exposure to AI technologies.The survey also explores perceptions of AI’s potential benefits.Quantitative responses are analyzed using descriptive statistics,while open-ended qualitative responses undergo thematic analysis.Preliminary findings indicate a generally positive outlook on AI’s role in enhancing transplantation processes,particularly in areas such as donor matching and post-operative care.These mixed views reflect both optimism and caution among professionals tasked with integrating new technologies into high-stakes clinical workflows.By capturing a wide range of expert opinions,the findings will inform future policy development,regulatory considerations,and institutional readiness frameworks for the integration of AI into organ transplantation.展开更多
目的:汉化孕期体育活动障碍量表(Barriers to Physical Activity During Pregnancy Scale,BPAPS),并检验其在我国孕妇中的信效度。方法:根据Brislin翻译模型对BPAPS进行翻译和回译,通过专家咨询对中文版BPAPS进行文化调试和修订,并选取...目的:汉化孕期体育活动障碍量表(Barriers to Physical Activity During Pregnancy Scale,BPAPS),并检验其在我国孕妇中的信效度。方法:根据Brislin翻译模型对BPAPS进行翻译和回译,通过专家咨询对中文版BPAPS进行文化调试和修订,并选取锦州市某三级甲等医院妇产科门诊就诊的406名孕妇作为研究对象,评价中文版BPAPS的信效度。结果:中文版BPAPS包括与怀孕有关的人际障碍、环境障碍、与怀孕无关的人际障碍、人际关系障碍4个维度,29个条目,累计方差贡献率为63.975%;总量表的Cronbach'sα系数为0.935,各维度Cronbach'sα系数为0.881~0.925;总量表重测信度为0.913。结论:中文版的BPAPS信效度良好,可作为我国孕妇怀孕期间体育活动障碍的评估工具。展开更多
Background and Objective The development of modern palliative care in China began in the 1980s and is currently in an accelerating phase.However,inconsistencies in terminology and concepts have hindered policy-making,...Background and Objective The development of modern palliative care in China began in the 1980s and is currently in an accelerating phase.However,inconsistencies in terminology and concepts have hindered policy-making,clinical practice,and academic research.The Terminology of Clinical Medicine(2023 edition)has determined huan-he-yi-liao(缓和医疗)and an-ning-liao-hu(安宁疗护)as the formal terms of"palliative care"and"hospice care",respectively.To align with these terms,this study aims to establish expert consensus definitions tailored to the Chinese context.Methods We systematically retrieved and collected domestic and international literature and policy documents related to the definition of palliative care,then deconstructed and analyzed the relevant conceptual elements of these definitions.Core expert panel built the initial recommended definition upon the conceptual elements and consensus definition of palliative care by the International Association for Hospice and Palliative Care(IAHPC)through two rounds of online discussions.After nomination and selection,61 professionals in the field of palliative care in China were invited to participate in the consensus expert group.Two rounds of Delphi consultation were conducted among the consensus experts,who were asked to score their agreement using Likert scale to the items in the initial recommended definition and the definition statements of palliative care and hospice care.Agreement rate of over 80%was considered as reaching consensus for each items.The core expert panel revised the items and the statements of recommended definitions based on the results from Delphi surveys.The final recommended definitions were formulated after feedback from patient and public involvement(PPI)group members.Results The response rates for the first and second round of Delphi surveys were 83.6%and 100.0%,respectively.The agreement rates of the items and statements of the recommended definitions exceeded 90%.Accordingly,the definitions based on Chinese expert consensus are recommended.Palliative care is an active holistic approach aimed at patients of all ages suffering from life-threatening illness and their families and caregivers.It seeks to improve their quality of life by preventing,assessing,and relieving physical,psychological,social,and spiritual suffering.Hospice care is an integral part of palliative care,focusing on holistic care for patients at the end of life and their families and caregivers.Its goal is to help patients to maintain dignity and achieve a good death by alleviating physical,psychological,social,and spiritual distress without intentionally hastening or postponing death,meanwhile improve the quality of life for families and caregivers.Conclusions This study has established the Chinese expert consensus definitions of palliative care and hospice care in China,as well as the relationship between the two.The definitions highlight the holistic nature of palliative care,providing a foundation for discipline development,clinical practice,and public communication.展开更多
文摘目的基于风险管理模式构建研究者发起的临床研究(IIT)全流程风险评估与分级管控体系,并验证。方法基于文献分析法检索中国知网(CNKI)、万方(WanFang)、Web of Science、PubMed数据库及互联网搜索工具等IIT相关文献、研究报告、现行管理政策等资料,检索时限为各数据库自建库起至2023年12月,建立IIT风险评估标准条目池初稿。采用德尔菲(Delphi)法对专家进行2轮咨询,确定最终的IIT全流程风险评估指标和分级管控体系,进行方法学评估,并结合真实世界研究和Spearman相关性分析验证指标体系的实用效能。结合地市级医院IIT项目管理现状,提出基于不同阶段、评估实施者、风险分级的分类、分级管控体系。结果组建了由17名专家构成的Delphi咨询小组,以女性(12名,70.59%)、工作年限>10年(13名,76.47%)、硕士研究生(8名,47.06%)、高级职称(9名,52.94%)、药物临床试验(GCP)主要研究者(9名,52.94%)居多。2轮Delphi咨询专家积极系数(问卷回收率)均为100%,专家权威系数分别为0.953和0.965,专家意见集中程度分别为4.495分和4.709分,变异系数分别为0.096和0.065。最终构建了涵盖立项、实施、结题全流程的IIT风险评估指标体系,包含8个一级指标、20个二级指标及36个三级指标,且三级指标风险分级为一级风险点8条、二级风险点21条和三级风险点7条。真实世界验证结果表明,构建的IIT风险评估指标体系与专家独立风险评分在全流程(ρ=0.894)、立项阶段(ρ=0.706)、实施阶段(ρ=0.761)、结题阶段(ρ=0.780)均呈极显著正相关(P<0.001)。针对地市级医疗机构提出了基于风险等级的“归口管理+分级联动”差异化管控措施。结论构建的IIT风险评估与管控体系具有较好的实用效能和评价一致性,可为地市级医疗机构开展IIT潜在风险点管理提供标准化工具支持,并为监管部门制订行业管理规范提供理论参考。
基金Supported by Inter Disciplinary Direction Cultivation Project of Hunan University of Chinese Medicine,No.2025JC01032025 Hunan Province Science and Technology Innovation Plan Project,No.2025RC9012+2 种基金2022"Unveiling and Leading"Project of Discipline Construction at Hunan University of Chinese Medicine,No.22JBZ044Changsha Municipal Natural Science Foundation,No.kq2402174Hunan Provincial Science Popularization Fund Project,No.2025ZK4223.
文摘BACKGROUND Timely and accurate evaluation of mental disorders in adolescents using appropriate mental health literacy assessment tools is essential for improving their mental health literacy levels.AIM To develop an evaluation index system for the mental health literacy of adolescent patients with mental disorders,providing a scientific,comprehensive,and reliable tool for the monitoring and intervention of mental health literacy of such patients.METHODS From December 2022 to June 2023,the evaluation index system for mental health literacy of adolescents with mental disorders was developed through literature reviews,semi-structured interviews,expert letter consultations,and the analytic hierarchy process.Based on this index system,a self-assessment questionnaire was compiled and administered to 305 adolescents with mental disorders to test the reliability and validity of the index system.RESULTS The final evaluation index system for mental health literacy of adolescents with mental disorders included 4 first-level indicators,10 second-level indicators,and 52 third-level indicators.The overall Cronbach’sαcoefficient of the index system was 0.957,with a partial reliability of 0.826 and a content validity index of 0.975.The cumulative variance contribution rate of 10 common factors was 66.491%.The correlation coefficients between each dimension and the total questionnaire ranged from 0.672 to 0.724,while the correlation coefficients in each dimension ranged from 0.389 to 0.705.CONCLUSION The evaluation index system for mental health literacy of adolescents with mental disorders,developed in this study,demonstrated notable reliability and validity,making it a valuable tool for evaluating mental health literacy in this population.
文摘Artificial intelligence(AI)is increasingly recognized as a transformative force in the field of solid organ transplantation.From enhancing donor-recipient matching to predicting clinical risks and tailoring immunosuppressive therapy,AI has the potential to improve both operational efficiency and patient outcomes.Despite these advancements,the perspectives of transplant professionals-those at the forefront of critical decision-making-remain insufficiently explored.To address this gap,this study utilizes a multi-round electronic Delphi approach to gather and analyses insights from global experts involved in organ transplantation.Participants are invited to complete structured surveys capturing demographic data,professional roles,institutional practices,and prior exposure to AI technologies.The survey also explores perceptions of AI’s potential benefits.Quantitative responses are analyzed using descriptive statistics,while open-ended qualitative responses undergo thematic analysis.Preliminary findings indicate a generally positive outlook on AI’s role in enhancing transplantation processes,particularly in areas such as donor matching and post-operative care.These mixed views reflect both optimism and caution among professionals tasked with integrating new technologies into high-stakes clinical workflows.By capturing a wide range of expert opinions,the findings will inform future policy development,regulatory considerations,and institutional readiness frameworks for the integration of AI into organ transplantation.
文摘目的:汉化孕期体育活动障碍量表(Barriers to Physical Activity During Pregnancy Scale,BPAPS),并检验其在我国孕妇中的信效度。方法:根据Brislin翻译模型对BPAPS进行翻译和回译,通过专家咨询对中文版BPAPS进行文化调试和修订,并选取锦州市某三级甲等医院妇产科门诊就诊的406名孕妇作为研究对象,评价中文版BPAPS的信效度。结果:中文版BPAPS包括与怀孕有关的人际障碍、环境障碍、与怀孕无关的人际障碍、人际关系障碍4个维度,29个条目,累计方差贡献率为63.975%;总量表的Cronbach'sα系数为0.935,各维度Cronbach'sα系数为0.881~0.925;总量表重测信度为0.913。结论:中文版的BPAPS信效度良好,可作为我国孕妇怀孕期间体育活动障碍的评估工具。
文摘Background and Objective The development of modern palliative care in China began in the 1980s and is currently in an accelerating phase.However,inconsistencies in terminology and concepts have hindered policy-making,clinical practice,and academic research.The Terminology of Clinical Medicine(2023 edition)has determined huan-he-yi-liao(缓和医疗)and an-ning-liao-hu(安宁疗护)as the formal terms of"palliative care"and"hospice care",respectively.To align with these terms,this study aims to establish expert consensus definitions tailored to the Chinese context.Methods We systematically retrieved and collected domestic and international literature and policy documents related to the definition of palliative care,then deconstructed and analyzed the relevant conceptual elements of these definitions.Core expert panel built the initial recommended definition upon the conceptual elements and consensus definition of palliative care by the International Association for Hospice and Palliative Care(IAHPC)through two rounds of online discussions.After nomination and selection,61 professionals in the field of palliative care in China were invited to participate in the consensus expert group.Two rounds of Delphi consultation were conducted among the consensus experts,who were asked to score their agreement using Likert scale to the items in the initial recommended definition and the definition statements of palliative care and hospice care.Agreement rate of over 80%was considered as reaching consensus for each items.The core expert panel revised the items and the statements of recommended definitions based on the results from Delphi surveys.The final recommended definitions were formulated after feedback from patient and public involvement(PPI)group members.Results The response rates for the first and second round of Delphi surveys were 83.6%and 100.0%,respectively.The agreement rates of the items and statements of the recommended definitions exceeded 90%.Accordingly,the definitions based on Chinese expert consensus are recommended.Palliative care is an active holistic approach aimed at patients of all ages suffering from life-threatening illness and their families and caregivers.It seeks to improve their quality of life by preventing,assessing,and relieving physical,psychological,social,and spiritual suffering.Hospice care is an integral part of palliative care,focusing on holistic care for patients at the end of life and their families and caregivers.Its goal is to help patients to maintain dignity and achieve a good death by alleviating physical,psychological,social,and spiritual distress without intentionally hastening or postponing death,meanwhile improve the quality of life for families and caregivers.Conclusions This study has established the Chinese expert consensus definitions of palliative care and hospice care in China,as well as the relationship between the two.The definitions highlight the holistic nature of palliative care,providing a foundation for discipline development,clinical practice,and public communication.
