-
Frontiers in Pharmacology 2023Globally, the use of amphetamines as therapeutic agents in pediatric medicine is a crucial area of concern, especially given the population's vulnerability. On 6...
Globally, the use of amphetamines as therapeutic agents in pediatric medicine is a crucial area of concern, especially given the population's vulnerability. On 6 August 2023, a search was conducted on ClinicalTrials.gov using "amphetamine" as the keyword. Two independent examiners screened trials against set criteria, including a focus on amphetamine, completion status, an interventional approach, and included children. Ongoing or observational studies were excluded. Data extracted from the qualified trials encompassed primary objectives, participant counts, study duration, and outcomes, with the aim of analyzing children disorders treated by amphetamine. On 6 August 2023, a search of the ClinicalTrials.gov database with the term "amphetamines" identified 179 clinical trials. After extensive exclusion criteria, 19 trials were ultimately selected for analysis. The predominant condition under investigation was attention deficit hyperactivity disorder (ADHD), present in 84.2% of studies. Key study characteristics included: phase 4 trials (36.8%), randomized allocation (63.2%), and the parallel intervention model (42.1%). Masking techniques varied, with no masking in 42.1% of studies, and double and quadruple masking both accounting for 21.1%. Geographically, 78.9% of the studies' participants were from the United States. This study highlights the notable therapeutic potential of amphetamines in pediatric ADHD populations and emphasizes the importance of recognizing potential side effects and addiction risks. As pharmacogenomics offers the prospect of personalized treatments, there is potential to increase therapeutic efficacy and decrease adverse reactions. It is vital to balance these benefits against the inherent risks, understanding the need for continued research to optimize the use of amphetamines in medicine.
PubMed: 37854716
DOI: 10.3389/fphar.2023.1280562 -
Advances in Nutrition (Bethesda, Md.) Nov 2023Characterization of the nutrients in human milk is important to understand the dietary and developmental requirements of infants. The objective of this review was to... (Review)
Review
Characterization of the nutrients in human milk is important to understand the dietary and developmental requirements of infants. The objective of this review was to summarize the state-of-the-science on the nutrient composition of human milk in the United States and Canada published from 2017 to 2022. Four databases were searched for randomized controlled studies and others given the scoping nature of this review. We limited type to mature milk collected 21 d postpartum and beyond from lactating individuals in the United States and Canada who gave birth at 37-wk gestation or later (full-term). Outcomes of interest included traditional macro- and micronutrients, including human milk oligosaccharides (HMOs), and milk volume. The publication date range was selected as January 1, 2017, to the day the literature search was performed. A total of 32 articles were included in the scoping review from primarily longitudinal cohort or cross-sectional designs. The most prevalent sample collection method was full-breast expression (n = 20) with most studies (n = 26) collecting samples from a single timepoint. Carbohydrates (HMOs [n = 12], glucose [n = 8], and lactose [n = 6]) and protein (n = 5) were the most frequently assessed nutrients in this body of work, with consensus among studies that glucose is present in limited concentrations compared to lactose (24-64 mg/dL compared with 6-7 g/dL) and that HMOs are influenced by temporality and secretor status. Included studies displayed an overall level of heterogeneity and sparsity paralleling previous reports and nutrient data in the USDA FoodData Central system. Much of the data extracted from retained articles generally provided analysis of a specific nutrient or group of nutrients. Moreover, many studies did not use the preferred analytical methods as outlined by the Human Milk Composition Initiative to increase measurement confidence. Up-to-date nutrient composition data of human milk is still greatly needed as it is paramount for the management of infant feeding, assessment of infant and maternal nutritional and health needs, and as a reference for infant formula development.
Topics: Infant; Female; Humans; United States; Milk, Human; Lactation; Cross-Sectional Studies; Lactose; Oligosaccharides; Micronutrients; Glucose; Infant Nutritional Physiological Phenomena
PubMed: 37758059
DOI: 10.1016/j.advnut.2023.09.007 -
Journal of Medical Internet Research Feb 2024The increasing prevalence of DH applications has outpaced research and practice in digital health (DH) evaluations. Patient experience (PEx) was reported as one of the... (Review)
Review
BACKGROUND
The increasing prevalence of DH applications has outpaced research and practice in digital health (DH) evaluations. Patient experience (PEx) was reported as one of the challenges facing the health system by the World Health Organization. To generate evidence on DH and promote the appropriate integration and use of technologies, a standard evaluation of PEx in DH is required.
OBJECTIVE
This study aims to systematically identify evaluation timing considerations (ie, when to measure), evaluation indicators (ie, what to measure), and evaluation approaches (ie, how to measure) with regard to digital PEx. The overall aim of this study is to generate an evaluation guide for further improving digital PEx evaluation.
METHODS
This is a 2-phase study parallel to our previous study. In phase 1, literature reviews related to PEx in DH were systematically searched from Scopus, PubMed, and Web of Science databases. Two independent raters conducted 2 rounds of paper screening, including title and abstract screening and full-text screening, and assessed the interrater reliability for 20% (round 1: 23/115 and round 2: 12/58) random samples using the Fleiss-Cohen coefficient (round 1: k1=0.88 and round 2: k2=0.80). When reaching interrater reliability (k>0.60), TW conducted the rest of the screening process, leaving any uncertainties for group discussions. Overall, 38% (45/119) of the articles were considered eligible for further thematic analysis. In phase 2, to check if there were any meaningful novel insights that would change our conclusions, we performed an updated literature search in which we collected 294 newly published reviews, of which 102 (34.7%) were identified as eligible articles. We considered them to have no important changes to our original results on the research objectives. Therefore, they were not integrated into the synthesis of this review and were used as supplementary materials.
RESULTS
Our review highlights 5 typical evaluation objectives that serve 5 stakeholder groups separately. We identified a set of key evaluation timing considerations and classified them into 3 categories: intervention maturity stages, timing of the evaluation, and timing of data collection. Information on evaluation indicators of digital PEx was identified and summarized into 3 categories (intervention outputs, patient outcomes, and health care system impact), 9 themes, and 22 subthemes. A set of evaluation theories, common study designs, data collection methods and instruments, and data analysis approaches was captured, which can be used or adapted to evaluate digital PEx.
CONCLUSIONS
Our findings enabled us to generate an evaluation guide to help DH intervention researchers, designers, developers, and program evaluators evaluate digital PEx. Finally, we propose 6 directions for encouraging further digital PEx evaluation research and practice to address the challenge of poor PEx.
Topics: Humans; Reproducibility of Results; Delivery of Health Care; Text Messaging; Digital Health; Patient Outcome Assessment; Telemedicine
PubMed: 38315545
DOI: 10.2196/46308 -
Sports Medicine (Auckland, N.Z.) Aug 2023Several studies have utilised isometric, eccentric and downhill walking pre-conditioning as a strategy for alleviating the signs and symptoms of exercise-induced muscle... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Several studies have utilised isometric, eccentric and downhill walking pre-conditioning as a strategy for alleviating the signs and symptoms of exercise-induced muscle damage (EIMD) following a bout of damaging physical activity.
OBJECTIVES
This systematic review and meta-analysis examined the effects of pre-conditioning strategies on indices of muscle damage and physical performance measures following a second bout of strenuous physical activity.
DATA SOURCES
PubMed, CINAHL and Scopus.
ELIGIBILITY CRITERIA
Studies meeting the PICO (population, intervention/exposure, comparison, and outcome) criteria were included in this review: (1) general population or "untrained" participants with no contraindications affecting physical performance; (2) studies with a parallel design to examine the prevention and severity of muscle-damaging contractions; (3) outcome measures were compared using baseline and post-intervention measures; and (4) outcome measures included any markers of indirect muscle damage and muscular contractility measures.
PARTICIPANTS
Individuals with no resistance training experiences in the previous 6 or more months.
INTERVENTIONS
A single bout of pre-conditioning exercises consisting of eccentric or isometric contractions performed a minimum of 24 h prior to a bout of damaging physical activity were compared to control interventions that did not perform pre-conditioning prior to damaging physical activity.
STUDY APPRAISAL
Kmet appraisal system.
SYNTHESIS METHODS
Quantitative analysis was conducted using forest plots to examine standardised mean differences (SMD, i.e. effect size), test statistics for statistical significance (i.e. Z-values) and between-study heterogeneity by inspecting I.
RESULTS
Following abstract and full-text screening, 23 articles were included in this paper. Based on the meta-analysis, the pre-conditioning group exhibited lower levels of creatine kinase at 24 h (SMD = - 1.64; Z = 8.39; p = 0.00001), 48 h (SMD = - 2.65; Z = 7.78; p = 0.00001), 72 h (SMD = - 2.39; Z = 5.71; p = 0.00001) and 96 h post-exercise (SMD = - 3.52; Z = 7.39; p = 0.00001) than the control group. Delayed-onset muscle soreness was also lower for the pre-conditioning group at 24 h (SMD = - 1.89; Z = 6.17; p = 0.00001), 48 h (SMD = - 2.50; Z = 7.99; p = 0.00001), 72 h (SMD = - 2.73; Z = 7.86; p = 0.00001) and 96 h post-exercise (SMD = - 3.30; Z = 8.47; p = 0.00001). Maximal voluntary contraction force was maintained and returned to normal sooner in the pre-conditioning group than in the control group, 24 h (SMD = 1.46; Z = 5.49; p = 0.00001), 48 h (SMD = 1.59; Z = 6.04; p = 0.00001), 72 h (SMD = 2.02; Z = 6.09; p = 0.00001) and 96 h post-exercise (SMD = 2.16; Z = 5.69; p = 0.00001). Range of motion was better maintained by the pre-conditioning group compared with the control group at 24 h (SMD = 1.48; Z = 4.30; p = 0.00001), 48 h (SMD = 2.20; Z = 5.64; p = 0.00001), 72 h (SMD = 2.66; Z = 5.42; p = 0.00001) and 96 h post-exercise (SMD = 2.5; Z = 5.46; p = 0.00001). Based on qualitative analyses, pre-conditioning activities were more effective when performed at 2-4 days before the muscle-damaging protocol compared with immediately prior to the muscle-damaging protocol, or 1-3 weeks prior to the muscle-damaging protocol. Furthermore, pre-conditioning activities performed using eccentric contractions over isometric contractions, with higher volumes, greater intensity and more lengthened muscle contractions provided greater protection from EIMD.
LIMITATIONS
Several outcome measures showed high inter-study heterogeneity. The inability to account for differences in durations between pre-conditioning and the second bout of damaging physical activity was also limiting.
CONCLUSIONS
Pre-conditioning significantly reduced the severity of creatine kinase release, delayed-onset muscle soreness, loss of maximal voluntary contraction force and the range of motion decrease. Pre-conditioning may prevent severe EIMD and accelerate recovery of muscle force generation capacity.
Topics: Humans; Myalgia; Muscle, Skeletal; Exercise; Exercise Therapy; Muscle Contraction; Isometric Contraction; Creatine Kinase
PubMed: 37160563
DOI: 10.1007/s40279-023-01839-8 -
BMC Oral Health Oct 2023The gold standard for a soft tissue augmentation around implants is a subepithelial connective tissue graft (CTG), but the xenogeneic collagen matrices (XCM) started to... (Meta-Analysis)
Meta-Analysis
Comparative analysis of xenogeneic collagen matrix and autogenous subepithelial connective tissue graft to increase soft tissue volume around dental implants: a systematic review and meta-analysis.
OBJECTIVE
The gold standard for a soft tissue augmentation around implants is a subepithelial connective tissue graft (CTG), but the xenogeneic collagen matrices (XCM) started to be used as an alternative. This systematic review aimed to assess the effectiveness XCM in comparison to CTG for the increasing the thickness of the soft tissue around implants.
DATA
All studies included at least two parallel groups comparing the use of CTG and XCM with a minimum follow-up of 3 months. As the primary outcome, the amount of soft tissue thickness gain after soft tissue augmentation with XCM or CTG was assessed. Secondary outcomes were clinical and patient-related outcomes; evaluation of aesthetic outcomes, patient-reported outcomes measures (PROMs) and complications. Eligible studies were selected based on the inclusion criteria. Meta-analysis was applied whenever possible. The quality of the evidence of studies including in meta-analysis was assessed using the GRADE approach.
SOURCE
A systematic literature search up to January 2022 was conducted using the following electronic databases: PubMed (MEDLINE), Scopus, Cochrane Library, LILACS, eLIBRARY.RU. Unpublished researches, the gray literature, nonprofit reports, government studies and other materials were reviewed electronically using an EASY search. An additional manual search was carried out in November 2022.
STUDY SELECTION
Of the 1376 articles from the initial search, 8 randomized controlled trials (RCTs) (306 patients and 325 implants) were included in this systematic review, and 7 studies were part of the meta-analysis. Meta-analysis revealed that XCM is less effective than the CTG in increasing soft tissue thickness around dental implants. However, XCM also provides soft tissue thickness gain and can be recommended for use in various clinical situations.
CLINICAL SIGNIFICANCE
Previous systematic reviews and meta-analyses have shown that autologous grafts are more effective than collagen matrices in increasing soft tissue thickness, however, the latter can be used as an alternative. Studies included in previous systematic reviews varied in design, which could lead to limitations. The present systematic review and meta-analysis includes for the first time only randomized controlled clinical trials with collagen matrix of xenogeneic origin in the test group. Tight eligibility criteria were established, and the main parameter studied was soft tissue thickness. It was found that xenogeneic collagen matrix is effective for increasing soft tissue thickness around dental implants, however, the results obtained using an autogenous connective tissue graft are superior.
Topics: Humans; Dental Implants; Gingiva; Collagen; Connective Tissue
PubMed: 37817128
DOI: 10.1186/s12903-023-03475-0 -
Brain Sciences Dec 2023Transcranial direct current stimulation (tDCS) has been increasingly applied in fibromyalgia (FM) to reduce pain and fatigue. While results are promising, observed... (Review)
Review
Efficacy of Transcranial Direct Current Stimulation on Pain Level and Disability of Patients with Fibromyalgia: A Systematic Review of Randomized Controlled Trials with Parallel-Group Design.
Transcranial direct current stimulation (tDCS) has been increasingly applied in fibromyalgia (FM) to reduce pain and fatigue. While results are promising, observed effects are variable, and there are questions about optimal stimulation parameters such as target region (e.g., motor vs. prefrontal cortices). This systematic review aimed to provide the latest update on published randomized controlled trials with a parallel-group design to examine the specific effects of active tDCS in reducing pain and disability in FM patients. Using the PRISMA approach, a literature search identified 14 randomized controlled trials investigating the effects of tDCS on pain and fatigue in patients with FM. Assessment of biases shows an overall low-to-moderate risk of bias. tDCS was found effective in all included studies conducted in patients with FM, except one study, in which the improving effects of tDCS were due to placebo. We recommended tDCS over the motor and prefrontal cortices as "effective" and "probably effective" respectively, and also safe for reducing pain perception and fatigue in patients with FM, according to evidence-based guidelines. Stimulation polarity was anodal in all studies, and one single-session study also examined cathodal polarity. The stimulation intensity ranged from 1-mA (7.14% of studies) to 1.5-mA (7.14% of studies) and 2-mA (85.7% of studies). In all of the included studies, a significant improvement in at least one outcome variable (pain or fatigue reduction) was observed. Moreover, 92.8% (13 of 14) applied multi-session tDCS protocols in FM treatment and reported significant improvement in their outcome variables. While tDCS is therapeutically effective for FM, titration studies that systematically evaluate different stimulation intensities, durations, and electrode placement are needed.
PubMed: 38248241
DOI: 10.3390/brainsci14010026 -
Seminars in Nuclear Medicine Nov 2023Ventilation-perfusion (V/Q) lung scans constitute one of the oldest nuclear medicine procedures, remain one of the few studies performed in the acute setting, and are... (Review)
Review
Ventilation-perfusion (V/Q) lung scans constitute one of the oldest nuclear medicine procedures, remain one of the few studies performed in the acute setting, and are amongst the few performed in the emergency setting. V/Q studies have witnessed a long fluctuation in adoption rates in parallel to continuous advances in image processing and computer vision techniques. This review provides an overview on the status of artificial intelligence (AI) in V/Q scintigraphy. To clearly assess the past, current, and future role of AI in V/Q scans, we conducted a systematic Ovid MEDLINE(R) literature search from 1946 to August 5, 2022 in addition to a manual search. The literature was reviewed and summarized in terms of methodologies and results for the various applications of AI to V/Q scans. The PRISMA guidelines were followed. Thirty-one publications fulfilled our search criteria and were grouped into two distinct categories: (1) disease diagnosis/detection (N = 22, 71.0%) and (2) cross-modality image translation into V/Q images (N = 9, 29.0%). Studies on disease diagnosis and detection relied heavily on shallow artificial neural networks for acute pulmonary embolism (PE) diagnosis and were primarily published between the mid-1990s and early 2000s. Recent applications almost exclusively regard image translation tasks from CT to ventilation or perfusion images with modern algorithms, such as convolutional neural networks, and were published between 2019 and 2022. AI research in V/Q scintigraphy for acute PE diagnosis in the mid-90s to early 2000s yielded promising results but has since been largely neglected and thus have yet to benefit from today's state-of-the art machine-learning techniques, such as deep neural networks. Recently, the main application of AI for V/Q has shifted towards generating synthetic ventilation and perfusion images from CT. There is therefore considerable potential to expand and modernize the use of real V/Q studies with state-of-the-art deep learning approaches, especially for workflow optimization and PE detection at both acute and chronic stages. We discuss future challenges and potential directions to compensate for the lag in this domain and enhance the value of this traditional nuclear medicine scan.
Topics: Humans; Artificial Intelligence; Pulmonary Embolism; Lung; Radionuclide Imaging; Perfusion Imaging; Tomography, Emission-Computed, Single-Photon
PubMed: 37080822
DOI: 10.1053/j.semnuclmed.2023.03.002 -
Clinical and Translational Science May 2024No systematic review of trial designs in patients with relapsing multiple sclerosis (RMS) was reported. This systematic review was conducted on the trial designs and... (Review)
Review
No systematic review of trial designs in patients with relapsing multiple sclerosis (RMS) was reported. This systematic review was conducted on the trial designs and primary end points (PEs) of phase II and III trials intended to modify the natural course of the disease in patients with RMS. The purpose of the study is to explore trends/topics and discussion points in clinical trial design and PE, comparing them to regulatory guidelines and expert recommendations. Three trial registration systems, ClinicalTrials.gov, the EU Clinical Trials Register, and the Japan Registry of Clinical Trials, were used and 60 trials were evaluated. The dominant clinical trial design was a randomized controlled parallel-arms trial and other details were as follows: in adult phase III confirmatory trials (n = 32), active-controlled double-blind trial (DBT) (53%) and active-controlled open-label assessor-masking trial (16%); in adult phase II dose-finding trials (n = 9), placebo- and active-controlled DBT (44%), placebo-controlled DBT (22%), and placebo-controlled add-on DBT (22%); and in pediatric phase III confirmatory trials (n = 8), active-controlled DBT (38%) and active-controlled open-label non-masking trial (25%). The most common PEs were as follows: in adult confirmatory trials, annual relapse rate (ARR) (56%) and no evidence of disease activity-3 (NEDA-3) (13%); in adult dose-finding trials, the cumulative number of T1 gadolinium-enhancing lesions (56%), combined unique active lesions (22%), and overall disability response score (22%); and in pediatric confirmatory trials, ARR (38%) and time to first relapse (25%). It was suggested that some parts of the regulatory guidelines and expert recommendations need to be revised.
Topics: Humans; Clinical Trials, Phase III as Topic; Clinical Trials, Phase II as Topic; Adult; Multiple Sclerosis, Relapsing-Remitting; Child; Research Design; Endpoint Determination; Randomized Controlled Trials as Topic
PubMed: 38708586
DOI: 10.1111/cts.13794 -
International Journal of Nursing... Dec 2023Negative symptoms, frequently experienced by people with schizophrenia, can impair functional outcomes and quality of life. Negative symptoms typically affect... (Review)
Review
BACKGROUND
Negative symptoms, frequently experienced by people with schizophrenia, can impair functional outcomes and quality of life. Negative symptoms typically affect motivation, communication, and the ability to live independently and are difficult to treat. Several meta-analyses suggest that cognitive behavioural therapy results in a modest reduction in negative symptoms. It is unclear if similar effects can be achieved using behavioural activation. Behavioural activation is a derivative of cognitive behavioural therapy that helps to improve social and emotional functioning by encouraging patients to engage in activities that they value whilst modifying the avoidance responses. Behavioural activation can be a standalone treatment for depressive symptoms that is equally as efficacious as cognitive behavioural therapy.
OBJECTIVE
This systematic review aimed to identify and summarise the evidence about the efficacy of behavioural activation in treating negative symptoms.
DESIGN
Systematic review.
SETTING/PARTICIPANTS
Two published studies conducted in South Korea and the United Kingdom recruited 55 patients.
METHOD
We searched five databases and four trial registries for clinical treatment trials of behavioural activation involving adults diagnosed with negative symptoms of schizophrenia. Studies were screened according to the inclusion criteria and assessed for quality.
RESULTS
We identified 5023 published studies. After removing duplicates and conducting screening, two studies were included in this review. One study used a parallel non-randomised trial design whilst the other adopted a single group test-re-test design. Fifty-five participants were recruited from hospital and community settings. Both studies delivered 10 face-to-face sessions of behavioural activation; these were individual in one study and group sessions in the other. One study involved behavioural activation as the treatment whilst the other delivered behavioural activation with motivational interviewing. Neither study reported harms or adverse events.
CONCLUSIONS
Based on the included studies, there is low-quality evidence that behavioural activation may be helpful in the treatment of negative symptoms. Key limitations of the studies include small sample sizes and overall low study quality.
STUDY REGISTRATION
The protocol covering this review was registered with Open Science on 18 February 2022 (Registration DOI 10.17605/OSF.IO/57QSW; Weblink: https://osf.io/57qsw).
TWEETABLE ABSTRACT
Behavioural activation holds promise in supporting patients experiencing negative symptoms of schizophrenia.
PubMed: 38746587
DOI: 10.1016/j.ijnsa.2023.100132 -
BMC Infectious Diseases Oct 2023In recent years, improved access to effective antiretroviral therapy has meant that people living with human immune virus are living longer than before. The burden of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
In recent years, improved access to effective antiretroviral therapy has meant that people living with human immune virus are living longer than before. The burden of non-communicable diseases particularly, hypertension parallels with the increase in age. Although hypertension screening is thought to be an effective indicator of overall health status and paves the way for early interventions in peoples living with human immune virus, the exact prevalence of hypertension in this population remained unknown. We aimed to report the prevalence of hypertension and examine the factors associated with hypertension among people living with human immune virus in East Africa.
METHODS
In this systematic review and meta-analysis, we searched PubMed, Science Direct, Scopus, Cochrane library, and Google Scholar databases for studies published until January 1, 2023. The search period was from January 10/2023, to February 10/ 2023. Random-effect models were used to calculate the pooled prevalence of hypertension. Subgroup analyses were conducted to explore potential heterogeneity. The Funnel plot and Egger's test were used to assess publication bias.
RESULT
A total of 15 studies with 10,916 individuals were included in the present meta-analysis. The pooled prevalence of hypertension among people living with human immune virus was19.75% (95% CI, 16.07%-23.42%)),). The prevalence of hypertension was not differed between studies conducted 2014- 2019 and, studies conducted 2020-2022. The prevalence of hypertension was lowest in Ethiopia (16.13%) and highest in Tanzania (26.76%). Alcohol consumption (Adjusted Odds Ratio (AOR): 3.39, 95% CI: 2.35-4.43), diabetes (AOR: 2.64, 95% CI: 1.89-3.39), longer duration of HIV (AOR: 1.72, 95% CI: 1.15-2.3), male sex (AOR: 1.62, 95% CI: 1.43-1.8), obesity (AOR: 2.89, 95% CI: 1.94-3.84), and older age (AOR: 2.25, 95% CI: 2.0-2.5), were the factors associated with the presence of hypertension in people living with human immune virus.
CONCLUSION
Our study shows that one in five peoples living with human immune virus have hypertension causing symptoms and impairment, therefore requiring treatment. Designing effective health screening and hypertension management intervention programs helps to prevent the occurrence of hypertension and promotes peoples' overall quality of life.
Topics: Male; Humans; Prevalence; Quality of Life; HIV Infections; Ethiopia; Hypertension; Tanzania
PubMed: 37880643
DOI: 10.1186/s12879-023-08679-x