Traditional Chinese Medicine(TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread accepta...Traditional Chinese Medicine(TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials(SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.展开更多
Objective:This study aims to get the medical management of acupuncture and moxibustion in the countries and regions where the society members of World Federation of Acupuncture-Moxibustion Societies(WFAS)are located,i...Objective:This study aims to get the medical management of acupuncture and moxibustion in the countries and regions where the society members of World Federation of Acupuncture-Moxibustion Societies(WFAS)are located,including the educational background of acupuncture and moxibustion practitioners and the local clinical practice of acupuncture and moxibustion,and the demands of the content and evidence types of Clinical Practice Guidelines(CPGs)of acupuncture and moxibustion in accordance with WFAS standards,so as to provide requirements and reference principles for the development of CPGs of acupuncture and moxibustion in accordance with WFAS standards.Methods:The convenient sampling method was used to collect the questionnaires,and the WFAS secretariat distributed the questionnaires to 294 contacts of society members from 70 countries and regions in the form of Questionnaire Star four times in April 2020,July 2020,March 2021,and April 2021 respectively.They were then distributed to individual members of acupuncture-moxibustion societies by the contacts.The study content involved the basic information of respondents,including their nationality,occupation,educational background of acupuncture and moxibustion,their local clinical practice and medical management of acupuncture and moxibustion,as well as their demand for CPGs of acupuncture and moxibustion,etc.After the questionnaires were collected,the data were analyzed and described by quantitative research method.Results:In all,302 respondents from 37 countries of six continents responded.The 302 respondents were members of the WFAS society members.(1)Basic information of respondents.They all had acupuncture and moxibustion learning experience,among which,76.5%(231/302)had the education background of acupuncture and moxibustion professional college training,and 88.4%(267/302)had experience of acupuncture and moxibustion clinical practice.Acupuncturists or traditional Chinese medicine doctors accounted for 63.9%(193/302),western medicine doctors,nurses,and pharmac展开更多
Background:The European Society for Medical Oncology(ESMO)guidelines are among the most comprehensive and widely used clinical practice guidelines(CPGs)globally.However,the level of scientific evidence supporting ESMO...Background:The European Society for Medical Oncology(ESMO)guidelines are among the most comprehensive and widely used clinical practice guidelines(CPGs)globally.However,the level of scientific evidence supporting ESMO CPG recommendations has not been systematically investigated.This study assessed ESMO CPG levels of evidence(LOE)and grades of recommendations(GOR),as well as their trends over time across various cancer settings.Methods:We manually extracted every recommendation with the Infectious Diseases Society of America(IDSA)classification from each CPG.We examined the distribution of LOE and GOR in all available ESMO CPG guidelines across different topics and cancer types.Results:Among the 1,823 recommendations in the current CPG,30%were classified as LOEⅠ,and 43%were classified as GOR A.Overall,there was a slight decrease in LOEⅠ(−2%)and an increase in the proportion of GOR A(+1%)in the current CPG compared to previous versions.The proportion of GOR A recommendations based on higher levels of evidence such as randomized trials(LOEⅠ–Ⅱ)shows a decrease(71%vs.63%,p=0.009)while recommendations based on lower levels of evidence(LOEⅢ–Ⅴ)show an increase(29%vs.37%,p=0.01)between previous and current version.In the current versions,the highest proportion of LOEⅠ(42%)was found in recommendations related to pharmacotherapy,while the highest proportion of GOR A recommendations was found in the areas of pathology(50%)and diagnostic(50%)recommendations.Significant variability in LOEⅠand GOR A recommendations and their changes over time was observed across different cancer types.Conclusion:One-third of the current ESMO CPG recommendations are supported by the highest level of evidence.More well-designed randomized clinical trials are needed to increase the proportion of LOEⅠand GOR A recommendations,ultimately leading to improved outcomes for cancer patients.展开更多
文摘Traditional Chinese Medicine(TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials(SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
基金Supported by National Key R&D Program of China:No.2019YFC1712200,No.2019YFC1712201。
文摘Objective:This study aims to get the medical management of acupuncture and moxibustion in the countries and regions where the society members of World Federation of Acupuncture-Moxibustion Societies(WFAS)are located,including the educational background of acupuncture and moxibustion practitioners and the local clinical practice of acupuncture and moxibustion,and the demands of the content and evidence types of Clinical Practice Guidelines(CPGs)of acupuncture and moxibustion in accordance with WFAS standards,so as to provide requirements and reference principles for the development of CPGs of acupuncture and moxibustion in accordance with WFAS standards.Methods:The convenient sampling method was used to collect the questionnaires,and the WFAS secretariat distributed the questionnaires to 294 contacts of society members from 70 countries and regions in the form of Questionnaire Star four times in April 2020,July 2020,March 2021,and April 2021 respectively.They were then distributed to individual members of acupuncture-moxibustion societies by the contacts.The study content involved the basic information of respondents,including their nationality,occupation,educational background of acupuncture and moxibustion,their local clinical practice and medical management of acupuncture and moxibustion,as well as their demand for CPGs of acupuncture and moxibustion,etc.After the questionnaires were collected,the data were analyzed and described by quantitative research method.Results:In all,302 respondents from 37 countries of six continents responded.The 302 respondents were members of the WFAS society members.(1)Basic information of respondents.They all had acupuncture and moxibustion learning experience,among which,76.5%(231/302)had the education background of acupuncture and moxibustion professional college training,and 88.4%(267/302)had experience of acupuncture and moxibustion clinical practice.Acupuncturists or traditional Chinese medicine doctors accounted for 63.9%(193/302),western medicine doctors,nurses,and pharmac
文摘Background:The European Society for Medical Oncology(ESMO)guidelines are among the most comprehensive and widely used clinical practice guidelines(CPGs)globally.However,the level of scientific evidence supporting ESMO CPG recommendations has not been systematically investigated.This study assessed ESMO CPG levels of evidence(LOE)and grades of recommendations(GOR),as well as their trends over time across various cancer settings.Methods:We manually extracted every recommendation with the Infectious Diseases Society of America(IDSA)classification from each CPG.We examined the distribution of LOE and GOR in all available ESMO CPG guidelines across different topics and cancer types.Results:Among the 1,823 recommendations in the current CPG,30%were classified as LOEⅠ,and 43%were classified as GOR A.Overall,there was a slight decrease in LOEⅠ(−2%)and an increase in the proportion of GOR A(+1%)in the current CPG compared to previous versions.The proportion of GOR A recommendations based on higher levels of evidence such as randomized trials(LOEⅠ–Ⅱ)shows a decrease(71%vs.63%,p=0.009)while recommendations based on lower levels of evidence(LOEⅢ–Ⅴ)show an increase(29%vs.37%,p=0.01)between previous and current version.In the current versions,the highest proportion of LOEⅠ(42%)was found in recommendations related to pharmacotherapy,while the highest proportion of GOR A recommendations was found in the areas of pathology(50%)and diagnostic(50%)recommendations.Significant variability in LOEⅠand GOR A recommendations and their changes over time was observed across different cancer types.Conclusion:One-third of the current ESMO CPG recommendations are supported by the highest level of evidence.More well-designed randomized clinical trials are needed to increase the proportion of LOEⅠand GOR A recommendations,ultimately leading to improved outcomes for cancer patients.
