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Frontiers in Medicine 2022The efficiencies that master protocol designs can bring to modern drug development have seen their increased utilization in oncology. Growing interest has also resulted...
BACKGROUND
The efficiencies that master protocol designs can bring to modern drug development have seen their increased utilization in oncology. Growing interest has also resulted in their consideration in non-oncology settings. Umbrella trials are one class of master protocol design that evaluates multiple targeted therapies in a single disease setting. Despite the existence of several reviews of master protocols, the statistical considerations of umbrella trials have received more limited attention.
METHODS
We conduct a systematic review of the literature on umbrella trials, examining both the statistical methods that are available for their design and analysis, and also their use in practice. We pay particular attention to considerations for umbrella designs applied outside of oncology.
FINDINGS
We identified 38 umbrella trials. To date, most umbrella trials have been conducted in early phase settings (73.7%, 28/38) and in oncology (92.1%, 35/38). The quality of statistical information available about conducted umbrella trials to date is poor; for example, it was impossible to ascertain how sample size was determined in the majority of trials (55.3%, 21/38). The literature on statistical methods for umbrella trials is currently sparse.
CONCLUSIONS
Umbrella trials have potentially great utility to expedite drug development, including outside of oncology. However, to enable lessons to be effectively learned from early use of such designs, there is a need for higher-quality reporting of umbrella trials. Furthermore, if the potential of umbrella trials is to be realized, further methodological research is required.
PubMed: 36313987
DOI: 10.3389/fmed.2022.1037439 -
BMC Psychiatry Oct 2023Historically, religion has had a central role in shaping the psychosocial and moral development of young people. While religiosity and spirituality have been linked to... (Meta-Analysis)
Meta-Analysis
Historically, religion has had a central role in shaping the psychosocial and moral development of young people. While religiosity and spirituality have been linked to positive mental health outcomes in adults, their role during the developmental context of adolescence, and the mechanisms through which such beliefs might operate, is less well understood. Moreover, there is some evidence that negative aspects of religiosity are associated with poor mental health outcomes. Guided by lived experience consultants, we undertook a systematic review and quality appraisal of 45 longitudinal studies and 29 intervention studies identified from three electronic databases (Medline, PsycINFO and Scopus) exploring the role of religiosity and spiritual involvement (formal and informal) in prevention and management of depression and anxiety in young people aged 10 to 24 years. Most studies were from high-income countries and of low to moderate quality. Meta-analysis of high-quality longitudinal studies (assessed using Joanna Briggs Institute critical appraisal tools, n = 25) showed a trend towards association of negative religious coping (i.e., feeling abandoned by or blaming God) with greater depressive symptoms over time (Pearson's r = 0.09, 95% confidence interval (CI) -0.009, 0.188) whereas spiritual wellbeing was protective against depression (Pearson's r = -0.153, CI -0.187, -0.118). Personal importance of religion was not associated with depressive symptoms overall (Pearson's r = -0.024, CI-0.053, 0.004). Interventions that involved religious and spiritual practices for depression and anxiety in young people were mostly effective, although the study quality was typically low and the heterogeneity in study designs did not allow for a meta-analysis. The lived experience consultants described spirituality and religious involvement as central to their way of life and greatly valued feeling watched over during difficult times. While we require more evidence from low- and middle-income countries, in younger adolescents and for anxiety disorders, the review provides insight into how spirituality and religious involvement could be harnessed to design novel psychological interventions for depression and anxiety in young people.Review RegistrationThe systematic review was funded by Wellcome Trust Mental Health Priority Area 'Active Ingredients' 2021 commission and registered with PROSPERO 2021 (CRD42021281912).
Topics: Adult; Adolescent; Humans; Spirituality; Depression; Religion; Anxiety; Anxiety Disorders; Adaptation, Psychological
PubMed: 37817143
DOI: 10.1186/s12888-023-05091-2 -
Current Opinion in Psychology Oct 2022What types of honesty interventions have been tested and to what extent? We conducted a systematic literature review of single-element intervention studies designed to... (Review)
Review
What types of honesty interventions have been tested and to what extent? We conducted a systematic literature review of single-element intervention studies designed to curtail individual-level dishonesty and classified the obtained interventions in a taxonomy that encompasses three frameworks: nudging, economic, and internal-reward. We find moral reminders that we classify as educative nudges as well as external commitments (pledges, oaths, honor codes) and priming that we classify under the internal-reward framework to be the most frequently studied interventions, whereas architectural nudges (defaults, sludge) have hardly been developed. Most importantly, we identify two areas for improvement essential for our collective ability to successfully translate and scale honesty interventions: a more thorough examination of the interventions' underlying psychological processes and precise description of the experimental designs.
Topics: Deception; Humans; Morals; Reward; Sewage
PubMed: 35921754
DOI: 10.1016/j.copsyc.2022.101410 -
Stress and Health : Journal of the... Oct 2021Public safety personnel (PSP) are routinely exposed to potentially psychologically traumatic events (PPTEs) that, in turn, can result in posttraumatic stress injuries... (Meta-Analysis)
Meta-Analysis Review
Public safety personnel (PSP) are routinely exposed to potentially psychologically traumatic events (PPTEs) that, in turn, can result in posttraumatic stress injuries (PTSI), including burnout and increased symptoms of depression and anxiety. However, the longitudinal impact of PPTEs on PSP coping remains unclear. Coping can be operationalized as various strategies (i.e., behaviours, skills, thought and emotion regulation) for dealing with stressors, which are broadly categorized as either approach (adaptive, positive, social support) or avoidant coping strategies (maladaptive withdrawal, avoidance, substance use). This systematic review and meta-analysis aims to evaluate longitudinal coping outcomes among PSP. Thirteen eligible repeated-measures studies explicitly evaluated coping in 1854 police officers, firefighters, and rescue and recovery workers. Study designs included randomized-control trials, within-subject interventions and observational studies. Effect sizes (Cohen's d) at follow-up were described in 11 studies. Separate meta-analyses reveal small (d < 0.2) but non-significant improvements in approach and avoidant coping. Studies were of moderate quality and low risk of publication bias. Heterogeneity in outcome measures, follow-up durations, and study types precluded subgroup analyses. The current findings can inform the development and evaluation of organizational training programs that effectively promote sustained adaptive coping for PSP and mitigate PTSIs.
Topics: Adaptation, Psychological; Anxiety Disorders; Emotional Regulation; Humans; Police; Social Support
PubMed: 34597464
DOI: 10.1002/smi.3039 -
Nursing Open May 2023Nurses play roles in hospitals, families, society and other aspects and often face stress sources, such as heavy workload, doctor-patient conflict and medical accidents.... (Review)
Review
AIM
Nurses play roles in hospitals, families, society and other aspects and often face stress sources, such as heavy workload, doctor-patient conflict and medical accidents. Resilience can help the nurses to avoid or reduce various adverse consequences caused by stress sources; however, this phenomenon remains ill-defined and under-researched. The aim of this review was to summarize the experiences of development of nurses' resilience and explore the reasons for the formation of resilience by examining the findings of the existing qualitative studies.
DESIGN
The review is a systematic review and meta-synthesis of qualitative studies.
DATA SOURCES
PubMed, Cochrane Library, CINAHL, Web of Science, Embase, and Ovid and Chinese databases include the following: Chinese National Knowledge Infrastructure (CNKI), Wanfang Database (CECDB), VIP Database and China Biomedical Database (CBM).
REVIEW METHODS
Relevant publications were identified by systematic searches across 11 databases in June 2021. All qualitative and mixed-method studies in English and Chinese that explored the experiences of development of nurses' resilience were included. The qualitative meta-synthesis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. Two independent reviewers selected the studies and assessed the quality of each study. Meta-synthesis was performed to integrate the results.
RESULTS
A total of nine studies revealed 10 sub-themes and three descriptive themes: being psychologically strong, physical positive coping and adoption of external support.
CONCLUSION
Several factors contributed to the development of nurses' resilience, and various supporting strategies in the nursing management and education are helpful to their adaption ability. However, it is necessary to focus on the cultivation of nurses' resilience to improve the quality of clinical nursing. Leaders or organizations are required to establish and sustain multifaceted strategies to improve nurse' resilience through scientific resilience training programmes and improved organizational support.
Topics: Humans; Adaptation, Psychological; Nursing Care; Nurses; China
PubMed: 36524529
DOI: 10.1002/nop2.1556 -
Journal of School Psychology Apr 2023Mindfulness-based programs (MBPs) are increasingly used in educational institutions to enhance students' mental health and resilience. However, reviews of the literature... (Meta-Analysis)
Meta-Analysis
Mindfulness-based programs (MBPs) are increasingly used in educational institutions to enhance students' mental health and resilience. However, reviews of the literature suggest this use may have outpaced the evidence base and further research is needed to better understand the mechanisms underlying these programs' effectiveness and which outcomes are being affected. The purpose of this meta-analysis was to investigate the strength of MBPs' effects on school adjustment and mindfulness outcomes while also considering the potential influence of study and program characteristics, including the role of comparison groups, students' educational level, the type of program being used, and the facilitator's training and previous mindfulness experience. Following a systematic review of five databases, 46 studies using a randomized controlled design with students from preschool to undergraduate levels were selected. At post-program, the effect of MBPs compared to control groups was (a) small for overall school adjustment outcomes, academic performance, and impulsivity; (b) small to moderate for attention; and (c) moderate for mindfulness. No differences emerged for interpersonal skills, school functioning, or student behaviour. The effects of MBPs on overall school adjustment and mindfulness differed based on students' educational level and the type of program being delivered. Moreover, only MBPs delivered by outside facilitators with previous experience of mindfulness had significant effects on either school adjustment or mindfulness. This meta-analysis provides promising evidence of the effectiveness of MBPs in educational contexts to improve students' school adjustment outcomes beyond typically assessed psychological benefits, even when using randomized controlled designs.
Topics: Child, Preschool; Humans; Mindfulness; Adaptation, Psychological; Students; Mental Health; Schools
PubMed: 36914366
DOI: 10.1016/j.jsp.2022.10.007 -
Nursing Open Jan 2022To systematically identify, evaluate and synthesize the qualitative evidence on enteral nutrition of home caregivers. (Review)
Review
AIMS
To systematically identify, evaluate and synthesize the qualitative evidence on enteral nutrition of home caregivers.
DESIGN
A qualitative evidence synthesis using the Sandelowski and Barroso methodology.
DATA SOURCES
We reviewed articles from eight databases: CINAHL, Embase, PubMed, Web of Science, Cochrane, CNKI, Wanfang Data and CSTJ. Qualitative, peer-reviewed, original studies published in English or Chinese before April 2020 on home caregivers' experience and needs for enteral nutrition were included. The studies were selected by screening titles, abstracts and full texts, and the quality of each study was assessed by two researchers independently.
REVIEW METHODS
Two researchers independently used qualitative assessment and review tools for quality assessment and thematic synthesis for data analysis.
RESULTS
This review included 10 articles. The themes identified included balance the enteral nutrition, the experiences and feelings in practice and the recommendations to meet challenge.
CONCLUSION
Home caregivers reported that they played an important role and faced greater pressure. Future studies should establish a systematic and standardized follow-up schedule to improve home caregivers' physical and mental health.
IMPACT
The findings established that home caregivers experienced not only changes in their roles and concerns but also spiritual changes. Home caregivers develop different coping strategies to adapt to enteral nutrition without standardized training and support. Although home caregivers make much account of enteral nutrition and feeding issues, they lack of information and support services. Understanding existing problems from a caregiver's perspective can allow interventions to be more clearly developed and well-established training standards established in the future.
Topics: Adaptation, Psychological; Caregivers; Enteral Nutrition; Humans; Qualitative Research
PubMed: 34273248
DOI: 10.1002/nop2.990 -
European Journal of Pharmaceutics and... Feb 2020Quality by Design (QbD) was originated in the broad domain of Quality Management and was recently adapted and formalized in specific terms for assisting pharmaceutical...
Quality by Design (QbD) was originated in the broad domain of Quality Management and was recently adapted and formalized in specific terms for assisting pharmaceutical companies efforts towards market and operational excellence. However, despite some impressive success stories, the pharmaceutical industry have not yet fully embraced QbD, particularly in routine commercial manufacturing (Rantanen and Khinast, 2015; Puñal Peces et al., 2016). In this review, we aim to analyse the current state of implementation of QbD methodologies and tools in the pharmaceutical industry, extracting patterns and trends and identifying gaps and opportunities that may be considered to improve QbD adoption. For this purpose, a critical analysis of 60 research papers was performed, whose contents were classified, compared and summarized at different abstraction levels. Our analysis reveals the following tools as the frequently adopted for conducting each activity: Risk Assessment (RA) - Ishikawa Diagram, Failure Mode and Effects Analysis (FMEA) and Risk Estimation Matrix (REM); Screening Design of Experiments (DoE) - 2-level Full and Fractional Factorial Designs; Optimisation DoE - Central Composite Design (CCD). Emerging trends include the growing interest in quantifying and managing the impact of raw materials' attributes variability on process and product, as well as the development of Retrospective QbD approaches (rQbD) in complement to standard QbD.
Topics: Drug Industry; Humans; Pharmaceutical Preparations; Research; Risk Assessment; Technology, Pharmaceutical
PubMed: 31862299
DOI: 10.1016/j.ejpb.2019.12.007 -
IEEE Transactions on Pattern Analysis... Nov 2022Dynamic neural network is an emerging research topic in deep learning. Compared to static models which have fixed computational graphs and parameters at the inference...
Dynamic neural network is an emerging research topic in deep learning. Compared to static models which have fixed computational graphs and parameters at the inference stage, dynamic networks can adapt their structures or parameters to different inputs, leading to notable advantages in terms of accuracy, computational efficiency, adaptiveness, etc. In this survey, we comprehensively review this rapidly developing area by dividing dynamic networks into three main categories: 1) sample-wise dynamic models that process each sample with data-dependent architectures or parameters; 2) spatial-wise dynamic networks that conduct adaptive computation with respect to different spatial locations of image data; and 3) temporal-wise dynamic models that perform adaptive inference along the temporal dimension for sequential data such as videos and texts. The important research problems of dynamic networks, e.g., architecture design, decision making scheme, optimization technique and applications, are reviewed systematically. Finally, we discuss the open problems in this field together with interesting future research directions.
Topics: Algorithms; Neural Networks, Computer
PubMed: 34613907
DOI: 10.1109/TPAMI.2021.3117837 -
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