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BMC Complementary Medicine and Therapies Jun 2022In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation.
METHODS
The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks.
RESULTS
Over the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings.
CONCLUSIONS
Site study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT03783546 (21/12/2018).
Topics: Acupuncture Therapy; China; Humans; Republic of Korea; United States
PubMed: 35715806
DOI: 10.1186/s12906-022-03648-4 -
PloS One 2021In joint action literature it is often assumed that acting together is driven by pervasive and automatic process of co-representation, that is, representing the...
In joint action literature it is often assumed that acting together is driven by pervasive and automatic process of co-representation, that is, representing the co-actor's part of the task in addition to one's own. Much of this research employs joint stimulus-response compatibility tasks varying the stimuli employed or the physical and social relations between participants. In this study we test the robustness of co-representation effects by focusing instead on variation in response modality. Specifically, we implement a mouse-tracking version of a Joint Simon Task in which participants respond by producing continuous movements with a computer mouse rather than pushing discrete buttons. We have three key findings. First, in a replication of an earlier study we show that in a classical individual Simon Task movement trajectories show greater curvature on incongruent trials, paralleling longer response times. Second, this effect largely disappears in a Go-NoGo Simon Task, in which participants respond to only one of the cues and refrain from responding to the other. Third, contrary to previous studies that use button pressing responses, we observe no overall effect in the joint variants of the task. However, we also detect a notable diversity in movement strategies adopted by the participants, with some participants showing the effect on the individual level. Our study casts doubt on the pervasiveness of co-representation, highlights the usefulness of mouse-tracking methodology and emphasizes the need for looking at individual variation in task performance.
Topics: Adult; Arm; Choice Behavior; Female; Humans; Joints; Movement; Neuropsychological Tests; Psychomotor Performance; Reaction Time; Young Adult
PubMed: 34965256
DOI: 10.1371/journal.pone.0261735 -
Heliyon Nov 2022This study aimed to explore and evaluate various components of the medical education process (lectures, labs, small-group discussions, clinical rotations, and...
AIM
This study aimed to explore and evaluate various components of the medical education process (lectures, labs, small-group discussions, clinical rotations, and undergraduate research) in three colleges of medicine in Jordan.
METHODS
This cross-sectional questionnaire-based study included 849 undergraduate students from three main medical colleges in Jordan. Statically valid responses were considered for 684 students. The participants were from Jordan University of Science and Technology, Yarmouk University, and the University of Jordan.
RESULTS
The distribution of students according to their admission status was 276 (40%) regular, 266 (38.9%) parallel, and 142 (20.8%) international programs. Personal interest and self-initiation were the major motives for studying medicine in 66.1%. Regarding the frequency of attending classes, University of Jordan students reported the highest rate of regular classes' attendance (93%). The study also reported that lecture notes and textbooks were the main sources of learning for medical students. The study also reported superior academic performance of students in the regular program compared to students in the parallel and international programs. Participants of the study criticized the medical curricula in the three colleges mentioned above because of the lack of active research programs. Most of the students (40%-56%) also complained that the lectures within the modules were not well-integrated, and they felt that the academic environment was moderate (48-59%). In addition, most students in the clinical phase complained of overcrowding in hospital wards during clinical rotation.
CONCLUSIONS
Based on students' feedback, multiple aspects of the medical education process require substantial reform to meet the expectations of medical students in Jordan.
PubMed: 36387468
DOI: 10.1016/j.heliyon.2022.e11426 -
Frontiers in Psychology 2021Deciphering nonhuman communication - particularly nonhuman vocal communication - has been a longstanding human quest. We are, for example, fascinated by the songs of... (Review)
Review
Deciphering nonhuman communication - particularly nonhuman vocal communication - has been a longstanding human quest. We are, for example, fascinated by the songs of birds and whales, the grunts of apes, the barks of dogs, and the croaks of frogs; we wonder about their potential meaning and their relationship to human language. Do these utterances express little more than emotional states, or do they convey actual bits and bytes of concrete information? Humans' numerous attempts to decipher nonhuman systems have, however, progressed slowly. We still wonder why only a small number of species are capable of vocal learning, a trait that, because it allows for innovation and adaptation, would seem to be a prerequisite for most language-like abilities. Humans have also attempted to teach nonhumans elements of our system, using both vocal and nonvocal systems. The rationale for such training is that the extent of success in instilling symbolic reference provides some evidence for, at the very least, the cognitive underpinnings of parallels between human and nonhuman communication systems. However, separating acquisition of reference from simple object-label association is not a simple matter, as reference begins with such associations, and the point at which true reference emerges is not always obvious. I begin by discussing these points and questions, predominantly from the viewpoint of someone studying avian abilities. I end by examining the question posed by Premack: do nonhumans that have achieved some level of symbolic reference then process information differently from those that have not? I suggest the answer is likely "yes," giving examples from my research on Grey parrots ().
PubMed: 34630194
DOI: 10.3389/fpsyg.2021.647841 -
Anais Brasileiros de Dermatologia 2022Little is known about the ultrastructure of pili annulati.
BACKGROUND
Little is known about the ultrastructure of pili annulati.
OBJECTIVES
To examine with transmission electron microscopy affected hairs of a family, whose diagnosis had been confirmed in five individuals with scanning electron microscopy, which showed surface undulations with "curtain-like" folding of the hair cuticula and to compare the findings with normal control.
METHODS
Hairs of two affected patients and one control were embedded in resin and cut lengthwise to produce ultra-thin sections.
RESULTS
The normal hair showed a parallel arrangement of dark lines associated with less electron-dense wide bands. Small cavities could be observed, mostly in the dark lines, affected hairs had a large number of cavities, associated or not with the insertion of melanosomes and loss of parallelism of the dark lines. Higher magnification showed a significant loss of this parallelism, resembling "wood grooves". Widened dark lines were observed in some areas.
STUDY LIMITATIONS
Only a few hairs were examined.
CONCLUSIONS
The present results suggest that the microcanaliculi of the hair surface, easily found with scanning electron microscopy, may be secondary not only to the cavities seen in the sections but also to the disorder of proteins that form this region, demonstrated by the changes of the cortex dark lines.
Topics: Hair; Hair Diseases; Hair Follicle; Humans; Microscopy, Electron, Scanning; Microscopy, Electron, Transmission
PubMed: 36100477
DOI: 10.1016/j.abd.2021.10.011 -
JMIR Medical Informatics Feb 2022The development and adoption of a learning health system (LHS) has been proposed as a means to address key challenges facing current and future health care systems. The... (Review)
Review
BACKGROUND
The development and adoption of a learning health system (LHS) has been proposed as a means to address key challenges facing current and future health care systems. The first review of the LHS literature was conducted 5 years ago, identifying only a small number of published papers that had empirically examined the implementation or testing of an LHS. It is timely to look more closely at the published empirical research and to ask the question, Where are we now? 5 years on from that early LHS review.
OBJECTIVE
This study performed a scoping review of empirical research within the LHS domain. Taking an "implementation science" lens, the review aims to map out the empirical research that has been conducted to date, identify limitations, and identify future directions for the field.
METHODS
Two academic databases (PubMed and Scopus) were searched using the terms "learning health* system*" for papers published between January 1, 2016, to January 31, 2021, that had an explicit empirical focus on LHSs. Study information was extracted relevant to the review objective, including each study's publication details; primary concern or focus; context; design; data type; implementation framework, model, or theory used; and implementation determinants or outcomes examined.
RESULTS
A total of 76 studies were included in this review. Over two-thirds of the studies were concerned with implementing a particular program, system, or platform (53/76, 69.7%) designed to contribute to achieving an LHS. Most of these studies focused on a particular clinical context or patient population (37/53, 69.8%), with far fewer studies focusing on whole hospital systems (4/53, 7.5%) or on other broad health care systems encompassing multiple facilities (12/53, 22.6%). Over two-thirds of the program-specific studies utilized quantitative methods (37/53, 69.8%), with a smaller number utilizing qualitative methods (10/53, 18.9%) or mixed-methods designs (6/53, 11.3%). The remaining 23 studies were classified into 1 of 3 key areas: ethics, policies, and governance (10/76, 13.2%); stakeholder perspectives of LHSs (5/76, 6.6%); or LHS-specific research strategies and tools (8/76, 10.5%). Overall, relatively few studies were identified that incorporated an implementation science framework.
CONCLUSIONS
Although there has been considerable growth in empirical applications of LHSs within the past 5 years, paralleling the recent emergence of LHS-specific research strategies and tools, there are few high-quality studies. Comprehensive reporting of implementation and evaluation efforts is an important step to moving the LHS field forward. In particular, the routine use of implementation determinant and outcome frameworks will improve the assessment and reporting of barriers, enablers, and implementation outcomes in this field and will enable comparison and identification of trends across studies.
PubMed: 35195529
DOI: 10.2196/34907 -
BMJ Open Nov 2022Previous studies showed that the Nordic hamstring exercise (NHE) effectively prevents primary hamstring injury. However, no study investigated the secondary preventing...
INTRODUCTION
Previous studies showed that the Nordic hamstring exercise (NHE) effectively prevents primary hamstring injury. However, no study investigated the secondary preventing effect of the NHE on hamstring reinjury. The primary purpose of this study is to investigate the effectiveness of the NHE for preventing hamstring reinjury after return to play (RTP) following a hamstring injury in football players. The secondary purpose is to determine the effect of the NHE on sprint and jump performance.
METHODS AND ANALYSIS
This is an international multicentre, prospective, parallel-group randomised controlled trial study. Subjects include male or female football players aged 18-40 years and within 1 week of RTP following a hamstring injury will be randomised into Nordics or a control group. Subjects in both groups continue their regular football training, but the Nordics group will perform an additional NHE programme. An online questionnaire will be sent to the subjects in both groups once per week within the first 10 weeks, then continued at months 6, 9 and 12. In a (performance) substudy, we will evaluate the effect of the NHE on sprint and vertical jump performance at three time points (at the beginning of the study, after 10 weeks and 12 months of follow-up).The primary outcomes are the incidence of hamstring reinjury within 2 and 12 months. The secondary outcomes are sprint and jump performance, adherence to the programme, duration of reinjury and reinjury burden.
ETHICS AND DISSEMINATION
This study is approved by the medical ethics committee of Amsterdam University Medical Center (UMC) in the Netherlands (METC 2021_117), Faculty of Medicine Universitas Gadjah Mada in Indonesia (KE/FK/1248/EC/2021), Norwegian School of Sport Sciences in Norway (number 216-2 70 122) and Denmark (ethical submission in process). The study's findings will be disseminated in scientific peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER
NL9711.
Topics: Humans; Male; Female; Reinjuries; Prospective Studies; Hamstring Muscles; Soccer; Leg Injuries; Soft Tissue Injuries; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 36375976
DOI: 10.1136/bmjopen-2022-065816 -
Bone & Joint Research Sep 2020Femoroacetabular impingement (FAI) describes abnormal bony contact of the proximal femur against the acetabulum. The term was first coined in 1999; however what is often...
AIMS
Femoroacetabular impingement (FAI) describes abnormal bony contact of the proximal femur against the acetabulum. The term was first coined in 1999; however what is often overlooked is that descriptions of the morphology have existed in the literature for centuries. The aim of this paper is to delineate its origins and provide further clarity on FAI to shape future research.
METHODS
A non-systematic search on PubMed was performed using keywords such as "impingement" or "tilt deformity" to find early anatomical descriptions of FAI. Relevant references from these primary studies were then followed up.
RESULTS
Although FAI has existed for almost 5,000 years, the anatomical study by Henle in 1855 was the first to describe it in the literature. The relevance of the deformity was not appreciated at the time but this triggered the development of further anatomical studies. Parallel to this, Poland performed the first surgical correction of FAI in 1898 and subsequently, descriptions of similar procedures followed. In 1965, Murray outlined radiological evidence of idiopathic cam-type deformities and highlighted its significance. This led to a renewed focus on FAI and eventually, Ganz et al released their seminal paper that has become the foundation of our current understanding of FAI. Since then, there has been an exponential rise in published literature but finding a consensus, especially in the diagnosis of FAI, has proven to be difficult.
CONCLUSION
Current research on FAI heavily focuses on new data, but old evidence does exist and studying it could be equally as important in clarifying the aetiology and classification of FAI.Cite this article: 2020;9(9):572-577.
PubMed: 33005396
DOI: 10.1302/2046-3758.99.BJR-2020-0003 -
Journal of Ayurveda and Integrative... 2022Kerala's contribution to Ayurveda practice and literature is held with high esteem by scholars all over the country. Literary works of Kerala comprises of both works... (Review)
Review
Kerala's contribution to Ayurveda practice and literature is held with high esteem by scholars all over the country. Literary works of Kerala comprises of both works which are unique in nature and works which have parallels in other regions of India. Despite these facts, most of these works, except a few like Sahasrayoga have not yet been studied well. The scholarliness of the authors of such works also remains unknown to the current generation. Unless a serious effort is made to study these, the concern is that the wisdom in the regional literature of Ayurveda will be lost as most of these works will become unavailable in near future. This article focuses on the life, works and achievements of Pandit C K Vasudeva Sarma, an eminent scholar physician from Kerala. The review is prepared as a life profile based on published documents, oral reports etc. Major works were identified and the parallel to Jejjata was drawn following that. Vachaspathya commentary on Carakasamhita, Hridayollasa commentary on Sushrutasamhita, Vasudeviya commentary on Ashtangahridaya, Vaidyapriya commentary on Sarngadharasamhita, commentary on Yogaratnakara called Vaidyaratnam are some of his prominent works on Sanskrit texts. Apart from authoring some unique Ayurvedic texts in Malayalam he also authored several non-Ayurveda textbooks. These rich regional diversity in the Ayurveda literature and practice worth detailed study by future generations. Value of the works of Pandit C K Vasudeva Sarma underlines the concern on regional literature and stresses the need for further studies in similar areas.
PubMed: 36495714
DOI: 10.1016/j.jaim.2022.100659 -
Communicative & Integrative Biology 2021The linguistic behavior of humans is usually considered the point of reference for studying the origin and evolution of language. As commonly defined, language is a form... (Review)
Review
The linguistic behavior of humans is usually considered the point of reference for studying the origin and evolution of language. As commonly defined, language is a form of communication between human beings; many have argued that it is unique to humans as there is no apparent equivalent for it in non-human organisms. How language is used as a means of communication is examined in this essay from a biological perspective positing that it is effectively and meaningfully used by non-human organisms and, more specifically, by plants. We set out to draw parallels between some aspects characterizing human language and the chemical communication that occurs between plants. The essay examines the similarities in ways of communicating linked to three properties of language: its combinatorial structure, meaning-making activities and the existence of dialects. In accordance with the findings of researchers who have demonstrated that plants do indeed communicate with one another and with organisms in their environment, the essay concludes with the appeal for an interdisciplinary approach conceptualizing a broader ecological definition of language and a constructive dialogue between the biological sciences and the humanities.
PubMed: 34434483
DOI: 10.1080/19420889.2021.1956719