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Brain Communications 2021Amyotrophic lateral sclerosis is a progressive and devastating neurodegenerative disease. Despite decades of clinical trials, effective disease-modifying drugs remain... (Review)
Review
Amyotrophic lateral sclerosis is a progressive and devastating neurodegenerative disease. Despite decades of clinical trials, effective disease-modifying drugs remain scarce. To understand the challenges of trial design and delivery, we performed a systematic review of Phase II, Phase II/III and Phase III amyotrophic lateral sclerosis clinical drug trials on trial registries and PubMed between 2008 and 2019. We identified 125 trials, investigating 76 drugs and recruiting more than 15 000 people with amyotrophic lateral sclerosis. About 90% of trials used traditional fixed designs. The limitations in understanding of disease biology, outcome measures, resources and barriers to trial participation in a rapidly progressive, disabling and heterogenous disease hindered timely and definitive evaluation of drugs in two-arm trials. Innovative trial designs, especially adaptive platform trials may offer significant efficiency gains to this end. We propose a flexible and scalable multi-arm, multi-stage trial platform where opportunities to participate in a clinical trial can become the default for people with amyotrophic lateral sclerosis.
PubMed: 34901853
DOI: 10.1093/braincomms/fcab242 -
Acta Physiologica (Oxford, England) Aug 2023The immune system plays an important role in mediating exercise responses and adaptations. However, whether fluctuating hormone concentrations across the menstrual cycle... (Meta-Analysis)
Meta-Analysis Review
The immune system plays an important role in mediating exercise responses and adaptations. However, whether fluctuating hormone concentrations across the menstrual cycle may impact these processes remains unknown. The aim of this systematic review with meta-analysis was to compare baseline concentrations as well as exercise-induced changes in immune and inflammatory parameters between menstrual cycle phases. A systematic literature search was conducted according to the PRISMA guidelines using Pubmed/MEDLINE, ISI Web of Science, and SPORTDiscus. Of the 159 studies included in the qualitative synthesis, 110 studies were used for meta-analysis. Due to the designs of the included studies, only the follicular and luteal phase could be compared. The estimated standardized mean differences based on the random-effects model revealed higher numbers of leukocytes (-0.48 [-0.73; -0.23], p < 0.001), monocytes (-0.73 [-1.37; -0.10], p = 0.023), granulocytes (-0.85 [-0.1.48; -0.21], p = 0.009), neutrophils (-0.32 [-0.52; -0.12], p = 0.001), and leptin concentrations (-0.37 [-0.5; -0.23], p = 0.003) in the luteal compared to the follicular phase at rest. Other parameters (adaptive immune cells, cytokines, chemokines, and cell adhesion molecules) showed no systematic baseline differences. Seventeen studies investigated the exercise-induced response of these parameters, providing some indications for a higher pro-inflammatory response in the luteal phase. In conclusion, parameters of innate immunity showed cycle-dependent regulation at rest, while little is known on the exercise responses. Due to a large heterogeneity and a lack of cycle phase standardization among the included studies, future research should focus on comparing at least three distinct hormonal profiles to derive more specific recommendations for exercise prescription.
Topics: Female; Humans; Menstrual Cycle; Follicular Phase; Exercise; Inflammation; Immunity
PubMed: 37309068
DOI: 10.1111/apha.14013 -
Pediatric Critical Care Medicine : a... Sep 2023This systematic review investigates the use of adaptive designs in randomized controlled trials (RCTs) in pediatric critical care.
OBJECTIVES
This systematic review investigates the use of adaptive designs in randomized controlled trials (RCTs) in pediatric critical care.
DATA SOURCES
PICU RCTs, published between 1986 and 2020, stored in the www.PICUtrials.net database and MEDLINE, EMBASE, CENTRAL, and LILACS databases were searched (March 9, 2022) to identify RCTs published in 2021. PICU RCTs using adaptive designs were identified through an automated full-text screening algorithm.
STUDY SELECTION
All RCTs involving children (< 18 yr old) cared for in a PICU were included. There were no restrictions to disease cohort, intervention, or outcome. Interim monitoring by a Data and Safety Monitoring Board that was not prespecified to change the trial design or implementation of the study was not considered adaptive.
DATA EXTRACTION
We extracted the type of adaptive design, the justification for the design, and the stopping rule used. Characteristics of the trial were also extracted, and the results summarized through narrative synthesis. Risk of bias was assessed using the Cochrane Risk of Bias Tool 2.
DATA SYNTHESIS
Sixteen of 528 PICU RCTs (3%) used adaptive designs with two types of adaptations used; group sequential design and sample size reestimation. Of the 11 trials that used a group sequential adaptive design, seven stopped early due to futility and one stopped early due to efficacy. Of the seven trials that performed a sample size reestimation, the estimated sample size decreased in three trials and increased in one trial.
CONCLUSIONS
Little evidence of the use of adaptive designs was found, with only 3% of PICU RCTs incorporating an adaptive design and only two types of adaptations used. Identifying the barriers to adoption of more complex adaptive trial designs is needed.
Topics: Child; Humans; Research Design; Adaptive Clinical Trials as Topic; Pediatrics; Critical Care
PubMed: 37195182
DOI: 10.1097/PCC.0000000000003273 -
Journal of Integrative and... Jul 2022Despite substantial progress made in the field of acupuncture research, the existence and specificity of acupoints remain controversial. In recent years, the concept of... (Review)
Review
Despite substantial progress made in the field of acupuncture research, the existence and specificity of acupoints remain controversial. In recent years, the concept of acupoint sensitization has emerged as a theoretical framework for understanding acupoints as dynamic functional entities that are sensitized in pathological conditions. Based on this premise, some have claimed that specific acupoints are thermally distinct between healthy and clinical populations, but no systematic review has been conducted to synthesize and evaluate the quality of studies supporting such claims. In this review, we provide a summary and quality assessment of the existing literature addressing the question of whether changes in skin temperature at specific acupoints are indicative of pathological conditions. A systematic literature search was performed in PubMed, EMBASE, and AltHealthWatch (EBSCO Host), by combining variations of search terms relevant to acupoints and temperature. The search was limited to the English language, and publication dates ranged from database inception to December 2020. Two authors independently screened all resulting abstracts and subsequently read full-text articles for eligibility. Information on study design, sample, acupoints, parameters of skin temperature assessments, and main findings were extracted from included studies. Quality of the thermal sensing methodology was evaluated using a thermal assessment checklist, adapted from the Thermographic Imaging in Sports and Exercise Medicine (TISEM) consensus checklist, and a modified Newcastle-Ottawa Scale (NOS) for case-control studies. The search strategy yielded a total of 1771 studies, of which 10 articles met the eligibility criteria. Eight studies compared skin temperature at acupoints in healthy versus clinical populations, and two studies assessed within-subject changes in temperature of acupoints in relation to changes in health status. There were seven clinical conditions examined in the included studies: chronic bronchial asthma, chronic hepatitis, hyperplasia of mammary glands, infertility, intracranial hypertension, obesity, and primary dysmenorrhea. There were numerous methodological quality issues related to skin temperature measurements. Eight studies with case-control designs reported significant differences between healthy and clinical populations in temperature at certain acupoints. Two studies with pre-post designs reported that changes in health-disease status could be associated with changes in temperature at specific acupoints. A review of the available literature suggests that certain acupoints may be thermally distinct between healthy and unhealthy states. However, given the methodological limitations and heterogeneity across included studies, no definitive conclusion could be drawn as to whether changes in skin temperature at specific acupoints are indicative of pathological conditions.
Topics: Acupuncture Points; Acupuncture Therapy; Case-Control Studies; Female; Humans; Infertility; Skin Temperature
PubMed: 35475679
DOI: 10.1089/jicm.2021.0437 -
Anatomical Sciences Education Nov 2022The coronavirus disease 2019 (Covid-19) pandemic caused an abrupt transition from face-to-face to online anatomy teaching, learning, and assessment. Although online... (Review)
Review
The coronavirus disease 2019 (Covid-19) pandemic caused an abrupt transition from face-to-face to online anatomy teaching, learning, and assessment. Although online education has ensured the continuity of anatomy education during the pandemic, its implementation has been challenging, and its effectiveness has been questioned. Therefore, literature pertinent to online anatomy education during the pandemic is crucial to explain Covid-19's disruptions to this field. Accordingly, this scoping review explored changes, disruptions, and gaps in anatomy teaching and assessment during Covid-19 using an enhanced version of Arksey and O'Malley's six-stage protocol. Five online databases were searched for articles that described changes and disruptions in anatomy education. Three independent researchers were involved in titles, abstracts, and full texts screening, while another four researchers were independently involved in data extraction, charting, and synthesis. This review revealed six themes: immediate strategic plans and actions, teaching and learning changes, online assessment practice, students' and educators' receptivity and adaptability, online learning and assessment effects, and future directions. It also revealed four gaps: non-future-ready curricula, learning obstacles, administrative and teaching challenges, and online education ethical issues. The results were reported in tabular and narrative forms, following the PRISMA Extension for Scoping Reviews (PRISMA-ScR guidelines). Understanding the evolution and gaps in anatomy education during the Covid-19 pandemic will help anatomists design future-ready, adaptable curricula.
Topics: Humans; Pandemics; COVID-19; Anatomy; Educational Status; Education, Distance
PubMed: 36205041
DOI: 10.1002/ase.2227 -
Korean Journal of Family Medicine Mar 2021Different scales have attempted to assess various aspects of family dynamics and structures. Good family function seems to allow for better prognoses for basic diseases...
BACKGROUND
Different scales have attempted to assess various aspects of family dynamics and structures. Good family function seems to allow for better prognoses for basic diseases and appears to be a predictor of depression. The aim of this study was to determine the association between family functionality and depression.
METHODS
This is a systematic review and meta-analysis including cross-sectional, cohort, and case-control studies using validated instruments such as the Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) and Family Adaptability and Cohesion Evaluation Scale III. A search strategy was designed for the MEDLINE, Embase, Central, and LILACS databases along with data saturation through a search of unpublished literature from the onset of the databases to the present. The categorical variables are expressed in terms of odds ratios (OR), and the statistical analysis was carried out using Review Manager ver. 5.31 (The Cochrane Collaboration, Oxford, UK) using forest plots with corresponding 95% confidence intervals (CI). A fixed-effect model was used according to the expected heterogeneity, expressed in terms of I2 . The risk of bias was evaluated using the MINORS (methodological index for non-randomized studies) tool.
RESULTS
A total of 1,519 studies were found, of which 10 were selected for the qualitative synthesis and four were chosen for the meta-analysis. The result for the association between family dysfunction and depression yielded an OR (95% CI) of 3.72 (2.70 to 5.12) and I2 of 24%.
CONCLUSION
Family dysfunction and depression are strongly associated.
PubMed: 32521579
DOI: 10.4082/kjfm.19.0166 -
Heliyon Sep 2019This article reviews evaluation studies of interventions aimed at preventing and reducing incidents of suicide and self-harm among incarcerated individuals. Study... (Review)
Review
This article reviews evaluation studies of interventions aimed at preventing and reducing incidents of suicide and self-harm among incarcerated individuals. Study design, sample characteristics, intervention procedures, study measures, and relevant results of each study are reviewed. The outcomes of interest include severity and frequency of self-harm episodes and suicidal ideation, scores on adaptive coping methods, scoring on the Beck Hopelessness scale and risk scores. The six evaluated studies are peer-reviewed, published between 1990 and 2015, and took place in the United States, the United Kingdom, and Pakistan. Treatment modalities widely vary across studies and include cognitive behavioral therapy, dialectical behavioral therapy, peer programming, staff intervention training, and uniquely-designed courses that incorporate various aspects from other treatment modalities. Due to the nature of the studies, only one multi-randomized controlled trial was identified. All identified studies had a pre- and post-treatment design either lacking a comparison group or containing 1-2 comparison groups and conduct follow-up of varying times. While Cognitive Behavioral Therapy (CBT) interventions and uniquely-tailored intervention programs suggest promising results, the general absence of comparison groups, the shortage of relevant evaluation studies and the inconsistency of behavioral outcome measurements compromise the capacity of this review. Further, definitional variances, particularly for self-injury (self-harm, non-suicidal self-injury [NSSI], deliberate self-harm, suicidal behavior, etc.) affect the ability to synthesize study results. This article aims to synthesize the literature results to identify the most effective interventions that would benefit from additional research.
PubMed: 31517115
DOI: 10.1016/j.heliyon.2019.e02379 -
Nicotine & Tobacco Research : Official... Jun 2023Conversational agents (CAs; computer programs that use artificial intelligence to simulate a conversation with users through natural language) have evolved considerably... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Conversational agents (CAs; computer programs that use artificial intelligence to simulate a conversation with users through natural language) have evolved considerably in recent years to support healthcare by providing autonomous, interactive, and accessible services, making them potentially useful for supporting smoking cessation. We performed a systematic review and meta-analysis to provide an overarching evaluation of their effectiveness and acceptability to inform future development and adoption.
AIMS AND METHODS
PsycInfo, Web of Science, ACM Digital Library, IEEE Xplore, Medline, EMBASE, Communication and Mass Media Complete, and CINAHL Complete were searched for studies examining the use of CAs for smoking cessation. Data from eligible studies were extracted and used for random-effects meta-analyses.
RESULTS
The search yielded 1245 publications with 13 studies eligible for systematic review (total N = 8236) and six studies for random-effects meta-analyses. All studies reported positive effects on cessation-related outcomes. A meta-analysis with randomized controlled trials reporting on abstinence yielded a sample-weighted odds ratio of 1.66 (95% CI = 1.33% to 2.07%, p < .001), favoring CAs over comparison groups. A narrative synthesis of all included studies showed overall high acceptability, while some barriers were identified from user feedback. Overall, included studies were diverse in design with mixed quality, and evidence of publication bias was identified. A lack of theoretical foundations was noted, as well as a clear need for relational communication in future designs.
CONCLUSIONS
The effectiveness and acceptability of CAs for smoking cessation are promising. However, standardization of reporting and designing of the agents is warranted for a more comprehensive evaluation.
IMPLICATIONS
This is the first systematic review to provide insight into the use of CAs to support smoking cessation. Our findings demonstrated initial promise in the effectiveness and user acceptability of these agents. We also identified a lack of theoretical and methodological limitations to improve future study design and intervention delivery.
Topics: Humans; Smoking Cessation; Artificial Intelligence; Software; Delivery of Health Care; Communication
PubMed: 36507916
DOI: 10.1093/ntr/ntac281 -
BMJ Open Jul 2021In order to reduce safety risks associated with medication administrations, technologies such as barcode medication administration (BCMA) are increasingly used....
BACKGROUND
In order to reduce safety risks associated with medication administrations, technologies such as barcode medication administration (BCMA) are increasingly used. Examining how human factors influence adoption and usability of this technology can potentially highlight areas for improvement in design and implementation.
OBJECTIVE
To describe how human factors related determinants for BCMA have been researched and reported by healthcare and human-computer interaction disciplines.
DATA SOURCES
The Cumulative Index of Nursing, and Allied Health Literature, PubMed, OVID MEDLINE and Google Scholar.
STUDY ELIGIBILITY CRITERIA
Primary research published from April 2000 to April 2020, search terms developed to identity different disciplinary research perspectives that examined BCMA use, used a human factors lens and were published in English.
SYNTHESIS METHODS
Computerised systematic searches were conducted in four databases. Eligible papers were systematically analysed for themes. Themes were discussed with a second reviewer and supervisors to ensure they were representative of content.
RESULTS
Of 3707 papers screened, 11 were included. Studies did not fit neatly into a clinical or human-computer interaction perspective but instead uncovered a range of overlapping narratives, demonstrating consensus on the key themes despite differing research approaches. Prevalent themes were misaligned design and workflow, adaptation and workarounds, mediating factors, safety, users' perceptions and design and usability. Inadequate design frequently led to workarounds, which jeopardised safety. Reported mediating factors included clarity of user needs, pre/post implementation evaluations, analysis of existing workarounds and appropriate technology, infrastructure and staffing.
LIMITATIONS
Most studies were relatively small and qualitative, making it difficult to generalise findings.
CONCLUSION
Evaluating interdisciplinary perspectives including human factors approaches identified similar and complementary enablers and barriers to successful technology use. Often, mediating factors were developed to compensate for unsuitable design; a collaborative approach between system designer and end users is necessary for BCMA to achieve its true safety potential.
Topics: Delivery of Health Care; Humans; Interdisciplinary Studies; Technology; Workflow
PubMed: 34210721
DOI: 10.1136/bmjopen-2020-044419 -
Artificial Organs Aug 2022Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs), have become a vital therapeutic option in the... (Review)
Review
BACKGROUND
Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs), have become a vital therapeutic option in the treatment of end-stage heart failure for adult patients. Such therapeutic options continue to be limited for pediatric patients. Clinicians initially adapted or scaled existing adult devices for pediatric patients; however, these adult devices are not designed to support the anatomical structure and varying flow capacities required for this population and are generally operated "off-design," which risks complications such as hemolysis and thrombosis. Devices designed specifically for the pediatric population which seek to address these shortcomings are now emerging and gaining FDA approval.
METHODS
To analyze the competitive landscape of pediatric MCS devices, we conducted a systematic literature review. Approximately 27 devices were studied in detail: 8 were established or previously approved designs, and 19 were under development (11 VADs, 5 Fontan assist devices, and 3 TAHs).
RESULTS
Despite significant progress, there is still no pediatric pump technology that satisfies the unique and distinct design constraints and requirements to support pediatric patients, including the wide range of patient sizes, increased cardiovascular demand with growth, and anatomic and physiologic heterogeneity of congenital heart disease.
CONCLUSIONS
Forward-thinking design solutions are required to overcome these challenges and to ensure the translation of new therapeutic MCS devices for pediatric patients.
Topics: Child; Extracorporeal Membrane Oxygenation; Heart Failure; Heart, Artificial; Heart-Assist Devices; Humans; Technology
PubMed: 35357020
DOI: 10.1111/aor.14242