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Journal of the International Society of... Dec 2023Garlic extract has been shown to enhance antioxidant and anti-inflammation activities in humans. The present study investigated the effects of garlic supplementation on... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Garlic extract has been shown to enhance antioxidant and anti-inflammation activities in humans. The present study investigated the effects of garlic supplementation on 40-km cycling time trial performance, exercise-induced oxidative stress, and inflammatory responses in healthy adults.
METHODS
Eleven healthy males were recruited to perform this single-blind crossover study. Participants were randomly assigned to either garlic (garlic extracts 1000 mg/d for 4 weeks) or placebo trials. Following 4-wks of supplementation, participants performed a 40-km cycling challenge. Total cycling performance time and respiratory exchange ratio (RER) were recorded. Blood samples were collected every 10 km to determine exercise-induced oxidative stress, inflammation, and muscle damage.
RESULTS
The 40-km cycling time trial performance was not improved following 4 weeks of garlic supplementation. However, 4-wk garlic supplementation significantly increased whole-body antioxidant capacity (total antioxidant capacity, TAC), and subsequently attenuated MDA, TNF-α, and LDH during the 40-km cycling exercise period ( < 0.05). There were no significant differences among the blood biomarkers glucose, NEFA, IL-6, UA, and CK respectively. The respiratory exchange ratio was similar between garlic and placebo trials.
CONCLUSION
Four-week oral garlic supplementation attenuates exercise-induced oxidative inflammation and muscle damage during a 40-km bout of cycling. However, it appeared that 4-wk oral garlic had no ergogenic effect on cycling performance in healthy males.
Topics: Male; Humans; Adult; Antioxidants; Garlic; Dietary Supplements; Cross-Over Studies; Single-Blind Method; Oxidative Stress; Inflammation; Double-Blind Method
PubMed: 37170623
DOI: 10.1080/15502783.2023.2206809 -
BMJ Open Dec 2023Benefit-risk assessment (BRA) is used in multiple phases along the health technology's life-cycle to evaluate the balance between the benefits and risks, as it is...
BACKGROUND
Benefit-risk assessment (BRA) is used in multiple phases along the health technology's life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA's application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.
METHODS AND ANALYSIS
This scoping review protocol was developed following the framework proposed by Arksey and O'Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.
ETHICS AND DISSEMINATION
This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.
TRIAL REGISTRATION NUMBER
Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).
Topics: Humans; Research Design; Drug and Narcotic Control; Risk Assessment; Review Literature as Topic
PubMed: 38072481
DOI: 10.1136/bmjopen-2023-075333 -
PloS One 2024Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical. (Review)
Review
IMPORTANCE
Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical.
OBJECTIVE
Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials.
EVIDENCE REVIEW
We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods.
FINDINGS
Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment.
CONCLUSION AND RELEVANCE
Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.
Topics: Humans; Randomized Controlled Trials as Topic; Research Design; Adaptive Clinical Trials as Topic; Surgical Procedures, Operative
PubMed: 38805454
DOI: 10.1371/journal.pone.0299494 -
Translational Psychiatry Feb 2024Obsessive-compulsive disorder (OCD) is associated with a high disease burden, and treatment options are limited. We used intensified electrical stimulation in two... (Randomized Controlled Trial)
Randomized Controlled Trial
Targeting the prefrontal-supplementary motor network in obsessive-compulsive disorder with intensified electrical stimulation in two dosages: a randomized, controlled trial.
Obsessive-compulsive disorder (OCD) is associated with a high disease burden, and treatment options are limited. We used intensified electrical stimulation in two dosages to target a main circuitry associated with the pathophysiology of OCD, left dorsolateral prefrontal cortex (l-DLPFC), and pre-supplementary motor area (pre-SMA) and assessed clinical outcomes, neuropsychological performance, and brain physiology. In a double-blind, randomized controlled trial, thirty-nine patients with OCD were randomly assigned to three groups of sham, 2-mA, or 1-mA transcranial direct current stimulation (tDCS) targeting the l-DLPFC (F3) and pre-SMA (FC2) with anodal and cathodal stimulation respectively. The treatment included 10 sessions of 20-minute stimulation delivered twice per day with 20-min between-session intervals. Outcome measures were reduction in OCD symptoms, anxiety, and depressive states, performance on a neuropsychological test battery (response inhibition, working memory, attention), oscillatory brain activities, and functional connectivity. All outcome measures except EEG were examined at pre-intervention, post-intervention, and 1-month follow-up times. The 2-mA protocol significantly reduced OCD symptoms, anxiety, and depression states and improved quality of life after the intervention up to 1-month follow-up compared to the sham group, while the 1-mA protocol reduced OCD symptoms only in the follow-up and depressive state immediately after and 1-month following the intervention. Both protocols partially improved response inhibition, and the 2-mA protocol reduced attention bias to OCD-related stimuli and improved reaction time in working memory performance. Both protocols increased alpha oscillatory power, and the 2-mA protocol decreased delta power as well. Both protocols increased connectivity in higher frequency bands at frontal-central areas compared to the sham. Modulation of the prefrontal-supplementary motor network with intensified tDCS ameliorates OCD clinical symptoms and results in beneficial cognitive effects. The 2-mA intensified stimulation resulted in larger symptom reduction and improved more converging outcome variables related to therapeutic efficacy. These results support applying the intensified prefrontal-SMA tDCS in larger trials.
Topics: Humans; Transcranial Direct Current Stimulation; Treatment Outcome; Quality of Life; Motor Cortex; Obsessive-Compulsive Disorder; Double-Blind Method; Prefrontal Cortex
PubMed: 38316750
DOI: 10.1038/s41398-024-02736-y -
PloS One 2023The CrossFit® Open (CFO) acts a preliminary round that qualifies men and women for later stages of its annual Games competition. The CFO typically consists of 4-6...
INTRODUCTION
The CrossFit® Open (CFO) acts a preliminary round that qualifies men and women for later stages of its annual Games competition. The CFO typically consists of 4-6 workouts that variably challenge an athlete's weightlifting strength, gymnastic skill, and endurance capacity. Except for differences in prescribed intensity loads, workouts are designed the same for men and women to elicit a similar challenge. While all workouts within a single year are unique to each other, one has been repeated from a previous CFO each year between 2012 and 2021. Because previous CFO workouts are often integrated into training, improvements are expected when a workout is officially repeated. However, besides documented record performances, it is unclear whether most athletes are improving, if these improvements affect ranking, or if differences exist between men and women.
PURPOSE
To examine sex-division differences and performance changes across repeated CFO workouts, as well as their effect on CFO and workout ranking.
METHODS
Eleven separate samples of 500 men and 500 women, who were representative of the same overall percent rank within each year involving one of the nine repeated CFO workouts (2011-2021) were drawn for this study. Each athlete's age (18-54 years), rank (overall and within each workout), and reported workout scores were collected from the competition's publicly-available leaderboard. Each sample had excluded any athlete who had not met minimum performance criteria (e.g., at least one completed round) for all prescribed (Rx) workouts within a given year (including those not analyzed). Since some workouts could be scored as repetitions completed or time-to-completion (TTC), and because programming was often scaled between men and women, all scores were converted to a repetition completion rate (repetitions divided by TTC [in minutes]).
RESULTS
Separate sex-division x time analyses of variance with repeated measures revealed significant (p < 0.05) interactions in all but one repeated workout comparison. Initially, men were faster in four workouts (~18.5%, range = 3.9-35.0%, p < 0.001), women in two (~7.1%, range = 5.2-9.0%, p < 0.001), and they tied in the remaining three workouts. When workouts were repeated in subsequent years, men were faster in three workouts (~5.4%, range = 0.9-7.8%, p < 0.05), while women were faster in two (~3.8%, range = 3.5-4.1%, p < 0.01). Though performance improved in seven of the nine workouts (~14.3%, p < 0.001) and percentile rank was controlled, athletes earned a lower rank (overall and within workout) on each repeated workout (p < 0.001).
CONCLUSIONS
Performance (measured as repetition completion rate) has improved in most repeated CFO workouts, particularly for women. However, improvements seen among all athletes, along with increased participation, have made it more difficult for athletes to improve their overall rank. To rank higher, individual athletes must improve their pace to a greater degree than the average improvements seen across the competitive field.
Topics: Male; Humans; Female; Adolescent; Young Adult; Adult; Middle Aged; Exercise; Athletes; Gymnastics; Research Design; Weight Lifting
PubMed: 38015875
DOI: 10.1371/journal.pone.0283910 -
BMC Medical Research Methodology Oct 2023Growth studies rely on longitudinal measurements, typically represented as trajectories. However, anthropometry is prone to errors that can generate outliers. While...
BACKGROUND
Growth studies rely on longitudinal measurements, typically represented as trajectories. However, anthropometry is prone to errors that can generate outliers. While various methods are available for detecting outlier measurements, a gold standard has yet to be identified, and there is no established method for outlying trajectories. Thus, outlier types and their effects on growth pattern detection still need to be investigated. This work aimed to assess the performance of six methods at detecting different types of outliers, propose two novel methods for outlier trajectory detection and evaluate how outliers affect growth pattern detection.
METHODS
We included 393 healthy infants from The Applied Research Group for Kids (TARGet Kids!) cohort and 1651 children with severe malnutrition from the co-trimoxazole prophylaxis clinical trial. We injected outliers of three types and six intensities and applied four outlier detection methods for measurements (model-based and World Health Organization cut-offs-based) and two for trajectories. We also assessed growth pattern detection before and after outlier injection using time series clustering and latent class mixed models. Error type, intensity, and population affected method performance.
RESULTS
Model-based outlier detection methods performed best for measurements with precision between 5.72-99.89%, especially for low and moderate error intensities. The clustering-based outlier trajectory method had high precision of 14.93-99.12%. Combining methods improved the detection rate to 21.82% in outlier measurements. Finally, when comparing growth groups with and without outliers, the outliers were shown to alter group membership by 57.9 -79.04%.
CONCLUSIONS
World Health Organization cut-off-based techniques were shown to perform well in few very particular cases (extreme errors of high intensity), while model-based techniques performed well, especially for moderate errors of low intensity. Clustering-based outlier trajectory detection performed exceptionally well across all types and intensities of errors, indicating a potential strategic change in how outliers in growth data are viewed. Finally, the importance of detecting outliers was shown, given its impact on children growth studies, as demonstrated by comparing results of growth group detection.
Topics: Child; Humans; Cluster Analysis; Research Design; Infant; Child Development
PubMed: 37833647
DOI: 10.1186/s12874-023-02045-w -
Pain Physician Nov 2023Various regulations and practice patterns develop on the basis of Local Coverage Determination (LCD), which are variably perceived as guidelines and/or mandated polices/...
BACKGROUND
Various regulations and practice patterns develop on the basis of Local Coverage Determination (LCD), which are variably perceived as guidelines and/or mandated polices/ regulations. LCDs developed in 2021 and effective since December 2021 mandated a minimum of 2 views for final needle placement with contrast injection which includes both anteroposterior (AP) and lateral or oblique view. Radiation safety has been a major concern for pain physicians and multiple tools have been developed to reduce radiation dose, along with improvement in technologies to limit radiation exposure while performing fluoroscopically guided interventional procedures, with implementation of principles of As Low As Reasonably Achievable (ALARA). The mandated 2 views of epidural injections have caused concern among some physicians, because of the potential of increased exposure to ionizing radiation, despite application of various principles to minimize radiation exposure. Others, including policymakers are of the opinion that it reduces potential abuse and improves safety.
OBJECTIVE
To assess variations in the performance of epidural procedures prior to the implementation of the new LCD compared with after the implementation of the new LCD by comparing time and dosage for all types of epidural procedures.
STUDY DESIGN
A retrospective, case controlled, comparative evaluation of radiation exposure during epidural procedures in interventional pain management.
SETTING
An interventional pain management practice and a specialty referral center in a private practice setting in the United States.
METHODS
The study was performed using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. The main outcome measure was radiation exposure time measured in seconds and dose measured in mGy-kG2 (milligray to kilogray squared per procedure).
RESULTS
Changes in exposure and dose varied by procedural type and location. Exposure time in seconds increased overall by 21%, whereas radiation dose mGy-kG increased 133%. Fluoroscopy time increased most for lumbar interlaminar epidural injections of 43%, followed by 29% for cervical interlaminar epidural injections, 20% for caudal epidural injections, and 14% for lumbar transforaminal epidural injections. In contrast, highest increases were observed in the radiation dose mGy of 191% for caudal epidural injections, followed by 173% for lumbar interlaminar epidural injections, 113% for lumbar transforaminal epidural injections, and the lowest being cervical interlaminar epidural injections of 94%. This study also shows lesser increases for cervical interlaminar epidural injections because an oblique view is utilized rather than a lateral view resulting in a radiation dosage increase of 94% compared to overall increase of 133%, whereas the duration of time of 29% was higher than the overall combined duration of all procedures which only increased by 21%.
LIMITATIONS
A retrospective evaluation utilizing the experience of a single physician.
CONCLUSION
The results of this study showed significant increases in radiation exposure time and dosage; however, increase of dosage was overall 21% median Interquartile Range (IQR) compared to 133% of radiation dose median IQR. In addition, the results also showed variations for procedure, overall showing highest increases for lumbar interlaminar epidural injections for time (43%) and caudal epidural injections for dosage (191%).
Topics: Humans; Retrospective Studies; Pain; Injections, Epidural; Radiation Exposure; Fluoroscopy
PubMed: 37976484
DOI: No ID Found -
BMJ Open Dec 2023Short birth interval (SBI) has been linked to an increased risk of adverse maternal, perinatal, infant and child health outcomes. However, the prevalence and maternal...
BACKGROUND
Short birth interval (SBI) has been linked to an increased risk of adverse maternal, perinatal, infant and child health outcomes. However, the prevalence and maternal and child health impacts of SBI in the Asia-Pacific region have not been well understood. This study aims to identify and summarise the existing evidence on SBI including its definition, measurement prevalence, determinants and association with adverse maternal and child health outcomes in the Asia-Pacific region.
METHODS
Five databases (MEDLINE, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Maternity and Infant Care, and Web of Science (WoS)) will be systematically searched from September 2000 up to May 2023. Data will be extracted, charted, synthesised and summarised based on the outcomes measured, and where appropriate, meta-analysis will be performed. The risk of bias will be assessed using Joanna Briggs Institute quality appraisal. Grading of Recommendation Assessment, Development and Evaluation framework will be used to evaluate the quality of cumulative evidence from the included studies.
ETHICS AND DISSEMINATION
This review does not require ethics approval. Findings will be disseminated through peer-reviewed publications, policy briefs and conference presentations.
PROSPERO REGISTRATION NUMBER
A protocol will be registered on PROSPERO for each separate outcome before performing the review.Cite Now.
Topics: Infant; Child; Pregnancy; Humans; Female; Prevalence; Birth Intervals; Systematic Reviews as Topic; Meta-Analysis as Topic; Asia; Outcome Assessment, Health Care; Review Literature as Topic
PubMed: 38154890
DOI: 10.1136/bmjopen-2023-076908 -
BMC Medical Education Oct 2023The study explores an innovative teaching mode that integrates Icourse, DingTalk, and online experimental simulation platforms to provide online theoretical and...
BACKGROUND
The study explores an innovative teaching mode that integrates Icourse, DingTalk, and online experimental simulation platforms to provide online theoretical and experimental resources for clinical biochemistry practical courses. These platforms, combined with flipped classroom teaching, aim to increase student engagement and benefit in practical courses, ultimately improving the effectiveness of clinical biochemistry practical teaching.
METHODS
In a prospective cohort study, we examined the impact of integrating the Icourse and DingTalk platforms to provide theoretical knowledge resources and clinical cases to 48 medical laboratory science students from the 2019 and 2020 grades. Students were assigned to the experimental group using an overall sampling method, and had access to relevant videos through Icourse before and during class. Using a flipped classroom approach, students actively participated in the design, analysis, and discussion of the experimental technique. For the experimental operation part, students participated in virtual simulation experiments and actual experiments. Overall, the study aimed to evaluate students' theoretical and operational performance after completing the practical course. To collect feedback, we distributed a questionnaire to students in the experimental group. For comparison, we included 42 students from the grades of 2017 and 2018 who received traditional instruction and were evaluated using standard textbooks as the control group.
RESULTS
The experimental group scored significantly higher than the control group on both the theoretical and experimental operational tests (82.45 ± 3.76 vs. 76.36 ± 3.96, P = 0.0126; 92.03 ± 1.62 vs. 81.67 ± 4.19, P < 0.001). The survey revealed that the experimental group preferred the teaching mode that combined the flipped classroom with the virtual simulation platform. This mixed method effectively promoted understanding of basic knowledge (93.8%, 45/48), operative skills (89.6%, 43/48), learning interest (87.5%, 42/48), clinical thinking (85.4%, 41/48), self-learning ability (91.7%, 44/48), and overall satisfaction compared with traditional methods (P < 0.05). This study demonstrates that an innovative teaching approach significantly improves the quality of clinical biochemistry practical courses and promotes students' professional development and self-directed learning habits.
CONCLUSION
Incorporating virtual simulation with flipped classrooms into clinical biochemistry practical teaching is an efficient and well-received alternative to traditional methods.
Topics: Humans; Prospective Studies; Learning; Students; Surveys and Questionnaires; Research Design; Curriculum; Problem-Based Learning
PubMed: 37845661
DOI: 10.1186/s12909-023-04735-x -
International Braz J Urol : Official... 2023To compare the perioperative outcomes of robot-assisted radical prostatectomy (RARP) with pelvic lymph-nodes dissection (PLND) when the same surgeon performs RARP and...
PURPOSE
To compare the perioperative outcomes of robot-assisted radical prostatectomy (RARP) with pelvic lymph-nodes dissection (PLND) when the same surgeon performs RARP and PLND versus one surgeon performs RARP and another surgeon performs PLND.
MATERIALS AND METHODS
From January 2022 to March 2023, data of consecutive patients who underwent RARP with PLND were prospectively collected. The surgeries were performed by two "young" surgeons with detailed profile. Specifically for the study purpose, one surgeon performed RARP, and the other surgeon performed PLND. A set of surgeries performed according to the standard setup (i.e., the same surgeon performing both RARP and PLND) was retrieved from the institutional database and used as comparator arm. To test the study hypothesis, patients were divided into two groups: "dual-surgeon" versus "single-surgeon".
RESULTS
Fifty patients underwent RARP and PLND performed according to dual-surgeon setup and were compared to the last 50 procedures performed according to the standard single-surgeon setup. Patients in the groups had comparable baseline characteristics. Dual-surgeon interventions had significantly shorter median total operative (194 [IQR 178-215] versus 174 [IQR 146-195] minutes, p<0.001) and console time (173 [IQR 158-194] versus 154 [IQR 129-170] minutes, p<0.001). No significant differences were found in terms of blood loss, intraoperative complications, postoperative outcomes, and final pathology results.
CONCLUSIONS
The present analysis found that when RARP and PLND are split onto two surgeons, the operative time is shorter by 20 minutes compared to when a single surgeon performs RARP and PLND. This is an interesting finding that could sponsor further studies.
Topics: Male; Humans; Robotics; Pelvis; Lymph Node Excision; Robotic Surgical Procedures; Prostatectomy; Surgeons
PubMed: 37903007
DOI: 10.1590/S1677-5538.IBJU.2023.0348