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We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.
Subject(s)
Consent Forms , Informed Consent , Humans , Disclosure , Ethics Committees, Research , Research Personnel , Clinical Trials as TopicABSTRACT
Tuoli Xiaodusan is the 65th formula in the Catalogue of Ancient Famous Classical Formulas（First Batch）. In this study， the bibliometric method was used to summarize and verify the ancient books about Tuoli Xiaodusan in terms of its historical origin， composition and dosage of the formula， indications， decoction and administration method， and processing， etc. According to the research， there is no definite date of the formation of Tuoli Xiaodusan， the earliest can be traced back to Lizhai Waike Fahui in Ming dynasty， which has been widely circulated， with many versions of prescription composition， and the modern influential version is from Waike Zhengzong in Ming dynasty， which is made up of 12 Chinese herbs including Ginseng Radix et Rhizoma（3.73 g）， Chuanxiong Rhizoma（3.73 g）， Paeoniae Radix Alba（3.73 g）， Astragali Radix（3.73 g）， Angelicae Sinensis Radix（3.73 g）， Atractylodis Macrocephalae Rhizoma（3.73 g）， Poria（3.73 g）， Lonicerae Japonicae Flos（3.73 g）， Angelicae Dahuricae Radix（1.87 g）， Glycyrrhizae Radix et Rhizoma（1.87 g）， Gleditsiae Spina（1.87 g）， Platycodonis Radix（1.87 g）. The herb origins almost follow the 2020 edition of Chinese Pharmacopoeia， except that Angelica dahurica var. formosana is only recommended as the origin of Angelicae Dahuricae Radix， and Glycryyhiza uralensis is only recommended as the origin of Glycyrrhizae Radix et Rhizoma. All the herbs are recommended to be used in the raw products. As for the preparation method， it is recommended to decoct with water， add 400 mL of water， boil until 160 mL， and take 2-3 times a day. The formula has the functions of nourishing Qi and nourishing blood， detoxifying and draining pus， and was mainly used to treat ulcerative diseases with the syndrome of syndrome of healthy Qi deficiency and pathogenic factors excess in ancient times， and in modern times， it is used for a wide range of treatment， involving the skin and soft tissues， bones， digestion and many other systemic diseases， and is also mainly used for syndrome of healthy Qi deficiency and pathogenic factors excess. In this study， the ancient and modern applications of Tuoli Xiaodusan were summarized， and its key information was identified， providing a basis for its wider clinical application， in-depth research and formulation development.
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Danggui Sinitang is first recorded in the Treatise on Cold Damage written by ZHANG Zhongjing in the Han dynasty. It is composed of Angelicae Sinensis Radix， Cinnamomi Ramulus， Paeoniae Radix Alba， Asari Radix et Rhizoma， Glycyrrhizae Radix et Rhizoma， Tetrapanacis Medulla， and Jujubae Fructus and serves as a classic formula for treating the syndrome of blood deficiency and cold reversal. This study systematically reviews the records of Danggui Sinitang in ancient Chinese medicine books of various dynasties and the modern clinical applications to probe into the composition， plant species， processing， dosage， decocting method， and indications of Danggui Sinitang， aiming to provide a reference for the development and clinical application of this classic formula. The review of the records showed that there were a variety of records of Danggui Sinitang with different composition， and the composition of this formula listed in the Treatise on Cold Damage has a significant impact on later generations and has been used by medical practitioners throughout history. Although the dosage of some drugs decreased during the Ming and Qing dynasties， the medical practitioners continued to use the original formula. In terms of processing， although there were slight changes in the processing of Angelicae Sinensis Radix， Paeoniae Radix Alba， Glycyrrhizae Radix et Rhizoma， and Tetrapanacis Medulla， the original processing method was inherited. In terms of indications， Danggui Sinitang was designed to treat cold reversal due to blood deficiency and dysentery. Furthermore， it was used to treat headache， convulsive disease， infantile convulsion， and private part adduction in the Ming and Qing dynasties. Nowadays， this formula is mostly used to treat diabetes peripheral neuropathy， rheumatoid arthritis， dysmenorrhea， Raynaud's disease and other diseases. In terms of precautions， ancient physicians believed that Danggui Sinitang should not be taken by pregnant women and should only be used for limb chills caused by blood deficiency and cold coagulation. For limb chills caused by other reasons， this formula should not be used indiscriminately. Modern research has not reported any serious adverse reactions related to this formula. Danggui Sinitang has a definite therapeutic effect. In subsequent research and development， quality control standards of Danggui Sinitang should be established while its safety is ensured， and the related preparations should be developed and applied.
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Introduction: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov. Methods: We downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (n = 102) were assessed by intervention type, study phase, recruitment status, and enrollment size. The ICFs and their KI sections, if present, were characterized by page length, word count, readability, topic, and formatting elements. Results: Of the 102 trial records, 76 had identifiable KI sections that were, on average, 10% of the total length of full ICF documents. KI readability grade level was not notably different from other sections of ICFs. Most KI sections were distinguished by section headers and included lists but contained few other formatting elements. Most KI sections included a subset of topics consistent with the basic elements of informed consent specified in the Common Rule. Conclusion: Many of the KI sections in the study sample aligned with practices suggested in the preamble to the revised Common Rule. Further, our results suggest that some KI sections were tailored in study-specific ways. Nevertheless, guidelines on how to write concise and comprehensible KI sections would improve the utility and readability of KI sections.
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The classic formula Wuyaotang is the 49th of the 100 formulas in the Catalogue of Ancient Classic Prescriptions (First Batch) issued by the National Administration of Traditional Chinese Medicine, and is from the Secrets from the Orchid Chamber (《兰室秘藏》) by LI Dongyuan of the Jin Dynasty. It is composed of Angelicae Sinensis Radix, Glycyrrhizae Radix et Rhizoma, Aucklandiae Radix, Linderae Radix, and Cyperi Rhizoma, and has the effect of moving Qi, regulating meridians, and relieving pain. It is mainly indicated for Qi stagnation and blood stasis syndrome. Based on the ancient books on Wuyaotang, this study systematically reviewed the formula source, composition, dosage, preparation, usage, functions, indications, preparation principle, drug processing, modification, etc. of Wuyaotang with the bibliometrics method, explored its historical evolution, and determined the key information. Statistical analysis of its modern literature shows that there are few studies of the original formula of Wuyaotang, and the clinical studies mainly focus on modified Wuyaotang. It has a wide range of treatment scope and can be used for the treatment of dysmenorrhea, delayed menstrual cycle, hypomenorrhea, and menstrual fever, as well as ulcerative colitis, spleen distortion, sciatica, child intestinal spasm, and other internal, surgical, gynecological, and pediatric diseases. The pathogenesis in traditional Chinese medicine (TCM) is Qi stagnation. Through the analysis and research on ancient books and modern literature recording Wuyaotang, this study is expected to provide a scientific basis for the clinical application, in-depth research, and development of the classic formula Wuyaotang.
ABSTRACT
Danggui Liuhuangtang is the 47th of the 100 famous classical formulas published by the National Administration of Traditional Chinese Medicine， and is known as the holy medicine for night sweat. By bibliometrics， the authors collected the ancient books on Danggui Liuhuangtang and screened out 269 valid data， involving 156 ancient books of traditional Chinese medicine. The analysis on the historical origin， disease syndromes， pathogenesis， composition， dosage， preparation， usage， and processing of Danggui Liuhuangtang found that this famous classical formula originated from Secret Book of the Orchid Chamber （《兰室秘藏》） written by LI Dongyuan， and is composed of Angelicae Sinensis Radix， Rehmanniae Radix， Rehmanniae Radix Praeparata， Phellodendri Chinensis Cortex， Scutellariae Radix， Coptidis Rhizoma and Astragali Radix. It has the functions of nourishing Yin， reducing fire， consolidating exterior and stopping sweating， and mainly treats night sweat due to Yin deficiency and fire exuberance. In the later generations， disease syndromes are mostly treated based on LI Dongyuan's theory， and have expanded to more than 30 kinds （339 in total）， among which night sweat （208） was the most， accounting for 61.36% of the total disease syndromes， followed by spontaneous sweating （38）， accounting for 11.21%. Additionally， it was found that Danggui Liuhuangtang was widely used in modern clinical practice for various disease syndromes. Among them， endocrine disease （77， 28.21%） was predominant， followed by gynecological disease （48， 17.58%）， and pediatric disease （24， 8.79%）. Although Danggui Liuhuangtang treats many disease syndromes， their pathogenesis was always yin deficiency and fire exuberance. Through the systematic excavation of the ancient books on Danggui Liuhuangtang and the analysis of its modern clinical application， this paper probed into the historical evolution and confirmed the key information of the formula， providing detailed literature basis for the research and development application of famous classical formulas.
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BACKGROUND: The most important factor in evaluating a physician's competence is strong clinical reasoning ability, leading to correct principal diagnoses. The process of clinical reasoning includes history taking, physical examinations, validating medical records, and determining a final diagnosis. In this study, we designed a teaching activity to evaluate the clinical reasoning competence of fourth-year medical students. METHODS: We created five patient scenarios for our standardized patients, including hemoptysis, abdominal pain, fever, anemia, and chest pain. A group history-taking with individual reasoning principles was implemented to teach and evaluate students' abilities to take histories, document key information, and arrive at the most likely diagnosis. Residents were trained to act as teachers, and a post-study questionnaire was employed to evaluate the students' satisfaction with the training activity. RESULTS: A total of 76 students, five teachers, and five standardized patients participated in this clinical reasoning training activity. The average history-taking score was 64%, the average key information number was 7, the average diagnosis number was 1.1, and the average correct diagnosis rate was 38%. Standardized patients presenting with abdominal pain (8.3%) and anemia (18.2%) had the lowest diagnosis rates. The scenario of anemia presented the most difficult challenge for students in history taking (3.5/5) and clinical reasoning (3.5/5). The abdominal pain scenario yielded even worse results (history taking: 2.9/5 and clinical reasoning 2.7/5). We found a correlation in the clinical reasoning process between the correct and incorrect most likely diagnosis groups (group history-taking score, p = 0.045; key information number, p = 0.009 and diagnosis number, p = 0.004). The post-study questionnaire results indicated significant satisfaction with the teaching program (4.7/5) and the quality of teacher feedback (4.9/5). CONCLUSIONS: We concluded that the clinical reasoning skills of fourth-year medical students benefited from this training course, and the lower correction of the most likely diagnosis rate found with abdominal pain, anemia, and fever might be due to a system-based teaching modules in fourth-year medical students; cross-system remedial reasoning auxiliary training is recommended for fourth-year medical students in the future.
Subject(s)
Education, Medical, Undergraduate , Students, Medical , Abdominal Pain/diagnosis , Abdominal Pain/etiology , Clinical Competence , Clinical Reasoning , Education, Medical, Undergraduate/methods , Educational Measurement/methods , Humans , Medical History TakingABSTRACT
BACKGROUND: Informed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown. METHODS: Two online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial. RESULTS: Likelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002). CONCLUSIONS: These findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment.
Subject(s)
Consent Forms , Language , Comparative Effectiveness Research , Humans , Informed Consent , Surveys and QuestionnairesABSTRACT
Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.
Subject(s)
Clinical Trials as Topic/methods , Informed Consent , Language , Aged , Consent Forms , Ethics Committees, Research , Humans , Research PersonnelABSTRACT
Shengyang Yiweitang is one of the first 100 classical prescriptions published by the National Administration of Traditional Chinese Medicine. It originated from the Clarifying Doubts about Damage from Internal and External Causes by physician LI Dongyuan of Jin dynasty， and is composed of Astragali Radix， Ginseng Radix et Rhizoma， Glycyrrhizae Radix et Rhizoma， Atractylodis Macrocephalae Rhizoma， Poria， Pinelliae Rhizoma， Citri Reticulatae Pericarpium， Angelicae Pubescentis Radix， Saposhnikoviae Radix， Notopterygii Rhizoma et Radix， Bupleuri Radix， Paeoniae Radix Alba， Alismatis Rhizoma， and Coptidis Rhizoma. With the effects of replenishing Qi， promoting Yang， clearing heat and removing dampness， Shengyang Yiweitang is used to treat spleen-stomach weakness and dampness-heat accumulation syndrome. Using bibliometrics， the authors systematically sorted out the source，composition， dosage， preparation， efficacy， indications， principle of composition， origin and processing of drugs，and modern clinical application of the prescription， and explored its history and key information. Additionally， it was found that Shengyang Yiweitang was widely used in modern clinical practice and was suitable for multisystem diseases， of which digestive system （264） was the most common， accounting for 41.71%， followed by urogenital system （57， 9.00%） and nervous system （48， 7.58%）. Although the treatment scope was wide， the pathogenesis of the diseases in traditional Chinese medicine belongs to "spleen-stomach weakness"， which fully reflected Li's academic thought of "internal injury of spleen and stomach leads to various diseases". The key information of Shengyang Yiweitang was determined by summarizing the relevant ancient books and modern literature， so as to provide accurate reference for its rational clinical application and further research and development.
ABSTRACT
Shengyang Yiweitang is one of the first 100 classical prescriptions published by the National Administration of Traditional Chinese Medicine. It originated from the Clarifying Doubts about Damage from Internal and External Causes by physician LI Dongyuan of Jin dynasty， and is composed of Astragali Radix， Ginseng Radix et Rhizoma， Glycyrrhizae Radix et Rhizoma， Atractylodis Macrocephalae Rhizoma， Poria， Pinelliae Rhizoma， Citri Reticulatae Pericarpium， Angelicae Pubescentis Radix， Saposhnikoviae Radix， Notopterygii Rhizoma et Radix， Bupleuri Radix， Paeoniae Radix Alba， Alismatis Rhizoma， and Coptidis Rhizoma. With the effects of replenishing Qi， promoting Yang， clearing heat and removing dampness， Shengyang Yiweitang is used to treat spleen-stomach weakness and dampness-heat accumulation syndrome. Using bibliometrics， the authors systematically sorted out the source，composition， dosage， preparation， efficacy， indications， principle of composition， origin and processing of drugs，and modern clinical application of the prescription， and explored its history and key information. Additionally， it was found that Shengyang Yiweitang was widely used in modern clinical practice and was suitable for multisystem diseases， of which digestive system （264） was the most common， accounting for 41.71%， followed by urogenital system （57， 9.00%） and nervous system （48， 7.58%）. Although the treatment scope was wide， the pathogenesis of the diseases in traditional Chinese medicine belongs to "spleen-stomach weakness"， which fully reflected Li's academic thought of "internal injury of spleen and stomach leads to various diseases". The key information of Shengyang Yiweitang was determined by summarizing the relevant ancient books and modern literature， so as to provide accurate reference for its rational clinical application and further research and development.
ABSTRACT
The Shentong Zhuyutang is recorded in an ancient medical book named Yilin Gaicuo， and it is one of the classical prescriptions. Based on the literature reviewed，it is generally found that the Shentong Zhuyutang is evolved from the prescription named Chentongsan that recorded by Danxi Xinfa. Statistics on the dosage of clinical research on this prescription in recent years， reference to the textbook and pharmacopoeia dose， at the same time to respect the original dosage， verify historical changes， and ensure the safety of prescriptions， at the same time consider the pharmacy's dispenses， the author recommends that the clinical dosage of Shentong Zhuyutang could be 3 gram of Gentianae Macrophyllae Radix， 6 gram of Chuanxiong Rhizoma， 10 gram of Persicae Semen， 10 gram of Carthami Flos， 6 gram of Glycyrrhizae Radix Et Rhizoma， 3 gram of Notopterygii Rhizoma Et Radix， 5 gram of Myrrha， 12 gram of Angelicae Sinensis Radix， 5 gram of Cyperi Rhizoma，12 gram of Cyathulae Radix， and 6 gram of Pheretima used as a reference. The efficacy of the compound preparation can be marked as promoting blood circulation， removing blood stasis， removing wind and dampness， and relieving pain. At present， most of its research is focused on clinical research and experimental research， and there are few literature on the research of Shentong Zhuyutang from the level of key information verification. The diseases it treats include more than 10， such as Gubi， Pibi， Xuebi， shechuanchuan， headache， postpartum pain and dysmenorrhea， especially in the study of Gubi， which means that it has a huge market demand and broad development prospects in orthopedic diseases， the core point of "blood stasis and cold dampness evil" should be closely held in the course of treatment. Some scholars deem that Shentong Zhuyutang should not be used the method of Force Sweat in the treatment of Bizheng，while others believe that this prescription should be used with caution in menstruation， pregnancy and blood deficiency. Modern pharmacological studies have shown that Shentong Zhuyutang has obvious anti-inflammatory， relieve pain， anticoagulan， nerve and bone protection. In view of the fact that there are less researches on Shentong Zhuyutang except for Gubi， this suggests that the mechanism of this prescription treat other diseases has a relatively broad research space.
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Recent revisions to the Federal Policy for the Protections of Human Subjects require that informed consent documents begin with a "concise and focused presentation" of the key information a participant requires. Key information "must be organized and presented in a way that facilitates comprehension." The regulations do not specify what information be included, nor how it must be presented to facilitate comprehension. It is unknown how institutions and Institutional Review Boards (IRBs) are interpreting the current regulations. We conducted a review of randomly sampled available key information templates at 46 US medical institutions to determine how they are implementing the new regulations.
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In contemporary research on human action recognition, most methods separately consider the movement features of each joint. However, they ignore that human action is a result of integrally cooperative movement of each joint. Regarding the problem, this paper proposes an action feature representation, called Motion Collaborative Spatio-Temporal Vector (MCSTV) and Motion Spatio-Temporal Map (MSTM). MCSTV comprehensively considers the integral and cooperative between the motion joints. MCSTV weighted accumulates limbs' motion vector to form a new vector to account for the movement features of human action. To describe the action more comprehensively and accurately, we extract key motion energy by key information extraction based on inter-frame energy fluctuation, project the energy to three orthogonal axes and stitch them in temporal series to construct the MSTM. To combine the advantages of MSTM and MCSTV, we propose Multi-Target Subspace Learning (MTSL). MTSL projects MSTM and MCSTV into a common subspace and makes them complement each other. The results on MSR-Action3D and UTD-MHAD show that our method has higher recognition accuracy than most existing human action recognition algorithms.
Subject(s)
Algorithms , Joints , Pattern Recognition, Automated , Human Activities , Humans , Motion , MovementABSTRACT
There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that would alert research candidates to the ethically problematic nature of the trials. The "reasonable person" and "key information" provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the "key information" is that should be disclosed to a "reasonable person": the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials.
Subject(s)
Disclosure , Informed Consent , Humans , WalkingABSTRACT
Butler (2010: Experiment 3) showed that retrieval practice enhanced transfer to a new knowledge domain compared to rereading. The first experiment of the present study was a direct replication of Butler's third experiment. Participants studied text passages and then either reread them three times or went through three cycles of cued recall questions (i.e., retrieval practice) with feedback. As in Butler's (2010) experiment, an advantage of retrieval practice on the final far transfer test emerged after 1 week. Additionally, we observed an advantage of retrieval practice on the final test administered after 5 min. However, these advantages might have been due to participants in the retrieval practice condition receiving focused exposure to the key information (i.e., the feedback) that was needed to answer the final test questions. We therefore conducted a second experiment in which we included the retrieval practice condition and the reread condition from our first experiment, as well as a new reread-plus-statements condition. In the reread-plus-statements condition, participants received focused exposure to the key information after they had reread a text. As in Experiment 1, we found a large effect on far transfer when retrieval practice was compared to rereading. However, this effect was substantially reduced when retrieval practice was compared to the reread-plus-statements condition. Taken together, the results of the present experiments demonstrate that Butler's (2010) testing effect in far transfer is robust. Moreover, focused exposure to key information appears to be a significant factor in this far transfer testing effect.
