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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 -
Journal of Medical Internet Research Jan 2024A conversational agent powered by artificial intelligence, commonly known as a chatbot, is one of the most recent innovations used to provide information and services... (Review)
Review
BACKGROUND
A conversational agent powered by artificial intelligence, commonly known as a chatbot, is one of the most recent innovations used to provide information and services during the COVID-19 pandemic. However, the multitude of conversational agents explicitly designed during the COVID-19 pandemic calls for characterization and analysis using rigorous technological frameworks and extensive systematic reviews.
OBJECTIVE
This study aims to describe the general characteristics of COVID-19 chatbots and examine their system designs using a modified adapted design taxonomy framework.
METHODS
We conducted a systematic review of the general characteristics and design taxonomy of COVID-19 chatbots, with 56 studies included in the final analysis. This review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to select papers published between March 2020 and April 2022 from various databases and search engines.
RESULTS
Results showed that most studies on COVID-19 chatbot design and development worldwide are implemented in Asia and Europe. Most chatbots are also accessible on websites, internet messaging apps, and Android devices. The COVID-19 chatbots are further classified according to their temporal profiles, appearance, intelligence, interaction, and context for system design trends. From the temporal profile perspective, almost half of the COVID-19 chatbots interact with users for several weeks for >1 time and can remember information from previous user interactions. From the appearance perspective, most COVID-19 chatbots assume the expert role, are task oriented, and have no visual or avatar representation. From the intelligence perspective, almost half of the COVID-19 chatbots are artificially intelligent and can respond to textual inputs and a set of rules. In addition, more than half of these chatbots operate on a structured flow and do not portray any socioemotional behavior. Most chatbots can also process external data and broadcast resources. Regarding their interaction with users, most COVID-19 chatbots are adaptive, can communicate through text, can react to user input, are not gamified, and do not require additional human support. From the context perspective, all COVID-19 chatbots are goal oriented, although most fall under the health care application domain and are designed to provide information to the user.
CONCLUSIONS
The conceptualization, development, implementation, and use of COVID-19 chatbots emerged to mitigate the effects of a global pandemic in societies worldwide. This study summarized the current system design trends of COVID-19 chatbots based on 5 design perspectives, which may help developers conveniently choose a future-proof chatbot archetype that will meet the needs of the public in the face of growing demand for a better pandemic response.
Topics: Humans; Artificial Intelligence; COVID-19; Pandemics; Avatar; Communication
PubMed: 38064638
DOI: 10.2196/43112 -
EXCLI Journal 2023Classic decision theory requires that rational agents show description invariance: which description is chosen should not matter for judgments, preferences, or choices... (Review)
Review
Classic decision theory requires that rational agents show description invariance: which description is chosen should not matter for judgments, preferences, or choices given the descriptions are co-extensive. Framing research has amply demonstrated a failure of description invariance by showing that the choice of the description has a systematic effect on judgments, preferences, and choices. Specifically, framing research has shown that linguistically different descriptions of seemingly equivalent options frequently lead to preference reversals. I summarize the research on framing in situations entailing risk. This includes the characterization of different research designs used, the size and robustness of the framing effects reported for those designs, and the theoretical accounts put forward to explain framing effects. The theoretical accounts are evaluated with respect to their merits, empirically and theoretically. I end by providing the implications of framing research. My central point is that the existence of framing effects points to the adaptiveness of the processes underlying human judgment and choice rather than simply showing human irrationality.
PubMed: 37927347
DOI: 10.17179/excli2023-6169 -
Frontiers in Endocrinology 2022Obesity-related data derived from multiple complex systems spanning media, social, economic, food activity, health records, and infrastructure (sensors, smartphones,... (Review)
Review
Obesity-related data derived from multiple complex systems spanning media, social, economic, food activity, health records, and infrastructure (sensors, smartphones, etc.) can assist us in understanding the relationship between obesity drivers for more efficient prevention and treatment. Reviewed literature shows a growing adaptation of the machine-learning model in recent years dealing with mechanisms and interventions in social influence, nutritional diet, eating behavior, physical activity, built environment, obesity prevalence prediction, distribution, and healthcare cost-related outcomes of obesity. Most models are designed to reflect through time and space at the individual level in a population, which indicates the need for a macro-level generalized population model. The model should consider all interconnected multi-system drivers to address obesity prevalence and intervention. This paper reviews existing computational models and datasets used to compute obesity outcomes to design a conceptual framework for establishing a macro-level generalized obesity model.
Topics: Humans; Obesity; Diet; Exercise; Machine Learning
PubMed: 36313777
DOI: 10.3389/fendo.2022.1027147 -
Journal of Affective Disorders Mar 2024Understanding predictors of suicidal ideation (SI) is crucial for preventing suicides. Given Europe's high suicide rates and the complex nature of SI, it is essential to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Understanding predictors of suicidal ideation (SI) is crucial for preventing suicides. Given Europe's high suicide rates and the complex nature of SI, it is essential to also examine social determinants like education as potential risk factors for SI in this region. This systematic review and meta-analysis investigates the association between formal/vocational education and SI in Europe.
METHODS
Electronic databases (PubMed, Web of Science, PsycINFO, PSYNDEX) were searched until November 2022. Included studies involved European populations examining associations between education and SI. Pooled Odds Ratios (OR) with 95 % confidence intervals (CI) were calculated using random-effects models. Heterogeneity was assessed with the heterogeneity variance τ and I statistic; subgroup analyses were performed based on study characteristics. Risk of bias was assessed using an adaption of the Newcastle-Ottawa Scale.
RESULTS
From 20,564 initial studies, 41 were included in the meta-analysis (outlier-adjusted, 96,809 study participants). A negative, insignificant association (OR = 0.86, 95 % CI: 0.75; 1.00) was observed between education and SI, with significant heterogeneity (τ = 0.09, I = 73 %). Subgroup analyses indicated that population type, age group, categorization of education, timeframe of SI assessment, and study quality significantly moderated the effect size.
LIMITATIONS
Heterogeneity across studies limits generalizability. The cross-sectional design precludes establishing causal relationships, and social desirability bias may have underestimated the association between education and SI.
CONCLUSIONS
This systematic review and meta-analysis suggests a trend towards a protective effect of education on the emergence of SI in Europe. Future research, preferably with longitudinal study design examining various covariates, should systematically consider educational inequalities in SI.
Topics: Humans; Suicidal Ideation; Suicide; Longitudinal Studies; Cross-Sectional Studies; Europe
PubMed: 38199415
DOI: 10.1016/j.jad.2024.01.040 -
Trials Mar 2021In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions... (Review)
Review
BACKGROUND
In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics should be evaluated to determine the potential performance of a specific trial design remain and are often further complicated by the complexity of such trial designs.
METHODS
A systematic search was conducted to review existing software for the design of platform trials, whereby multi-arm multi-stage trials were also included. The results of this search are reported both on the literature level and the software level, highlighting the software judged to be particularly useful.
RESULTS
In recent years, many highly specialized software packages targeting single design elements on platform studies have been released. Only a few of the developed software packages provide extensive design flexibility, at the cost of limited access due to being commercial or not being usable as out-of-the-box solutions.
CONCLUSIONS
We believe that both an open-source modular software similar to OCTOPUS and a collaborative effort will be necessary to create software that takes advantage of and investigates the impact of all the flexibility that platform trials potentially provide.
Topics: Clinical Trials as Topic; Research Design; Software
PubMed: 33663579
DOI: 10.1186/s13063-021-05130-x -
Clinical Orthopaedics and Related... Dec 2014Total disc replacement was clinically introduced to reduce pain and preserve segmental motion of the lumbar and cervical spine. Previous case studies have reported on... (Review)
Review
BACKGROUND
Total disc replacement was clinically introduced to reduce pain and preserve segmental motion of the lumbar and cervical spine. Previous case studies have reported on the wear and adverse local tissue reactions around artificial prostheses, but it is unclear how design and biomaterials affect clinical outcomes.
QUESTIONS/PURPOSES
Which design and material factors are associated with differences in clinical wear performance (implant wear and periprosthetic tissue response) of (1) lumbar and (2) cervical total disc replacements?
METHODS
We performed a systematic review on the topics of implant wear and periprosthetic tissue response using an advanced search in MEDLINE and Scopus electronic databases. Of the 340 references identified, 33 were retrieved for full-text evaluation, from which 16 papers met the inclusion criteria (12 on lumbar disc replacement and five on cervical disc replacement; one of the included studies reported on both lumbar and cervical disc replacement), which involved semiquantitative analysis of wear and adverse local tissue reactions along with a description of the device used. An additional three papers were located by searching bibliographies of key articles. There were seven case reports, three case series, two case-control studies, and seven analytical studies. The Methodological Index for Non-randomized Studies (MINORS) Scale was used to score case series and case-control studies, which yielded mean scores of 10.3 of 16 and 17.5 of 24, respectively. In general, the case series (three) and case-control (two) studies were of good quality.
RESULTS
In lumbar regions, metal-on-polymer devices with mobile-bearing designs consistently generated small and large polymeric wear debris, triggering periprosthetic tissue activation of macrophages and giant cells, respectively. In the cervical regions, metal-on-polymer devices with fixed-bearing designs had similar outcomes. All metal-on-metal constructs tended to generate small metallic wear debris, which typically triggered an adaptive immune response of predominantly activated lymphocytes. There were no retrieval studies on one-piece prostheses.
CONCLUSIONS
This review provides evidence that design and biomaterials affect the type of wear and inflammation. However, clinical study design, followup, and analytical techniques differ among investigations, preventing us from drawing firm conclusions about the relationship between implant design and wear performance for both cervical and lumbar total disc replacement.
Topics: Biocompatible Materials; Biomechanical Phenomena; Cervical Vertebrae; Foreign-Body Reaction; Humans; Intervertebral Disc; Lumbar Vertebrae; Metals; Polymers; Prosthesis Design; Prosthesis Failure; Stress, Mechanical; Total Disc Replacement; Treatment Outcome
PubMed: 25002211
DOI: 10.1007/s11999-014-3751-2 -
Calcified Tissue International Oct 2021It is acknowledged that the COVID-19 pandemic has caused profound disruption to the delivery of healthcare services globally. This has affected the management of many... (Review)
Review
It is acknowledged that the COVID-19 pandemic has caused profound disruption to the delivery of healthcare services globally. This has affected the management of many long-term conditions including osteoporosis as resources are diverted to cover urgent care. Osteoporosis is a public health concern worldwide and treatment is required for the prevention of further bone loss, deterioration of skeletal micro-architecture, and fragility fractures. This review provides information on how the COVID-19 pandemic has impacted the diagnosis and management of osteoporosis. We also provide clinical recommendations on the adaptation of care pathways based on experience from five referral centres to ensure that patients with osteoporosis are still treated and to reduce the risk of fractures both for the individual patient and on a societal basis. We address the use of the FRAX tool for risk stratification and initiation of osteoporosis treatment and discuss the potential adaptations to treatment pathways in view of limitations on the availability of DXA. We focus on the issues surrounding initiation and maintenance of treatment for patients on parenteral therapies such as zoledronate, denosumab, teriparatide, and romosozumab during the pandemic. The design of these innovative care pathways for the management of patients with osteoporosis may also provide a platform for future improvement to osteoporosis services when routine clinical care resumes.
Topics: Bone Density Conservation Agents; COVID-19; Humans; Osteoporosis; Osteoporotic Fractures; Pandemics; SARS-CoV-2; Teriparatide
PubMed: 34003337
DOI: 10.1007/s00223-021-00858-9 -
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 -
Journal of Alzheimer's Disease : JAD 2023Drug development in Alzheimer's disease (AD) over the past two decades has had high rates of failure. Novel trial designs, such as adaptive designs, have the potential...
BACKGROUND
Drug development in Alzheimer's disease (AD) over the past two decades has had high rates of failure. Novel trial designs, such as adaptive designs, have the potential to improve the efficiency of drug development in AD.
OBJECTIVE
To evaluate the design characteristics, temporal trends, and differences in design between sponsor types in phase II trials of investigational agents in AD.
METHODS
Phase I/II, II, and II/III trials for AD with drug or other biological interventions registered from December 1996 to December 2021 in ClinicalTrials.gov were included. Descriptive statistics were used to summarize trial characteristics. Linear, logistic, and multinomial regression models assessed temporal trends and differences between sponsor types in design characteristics.
RESULTS
Of N = 474 trials identified, randomized parallel group design was the most common design (72%). Only 12 trials (2.5%) used an adaptive design; adaptive features included early stopping rules, model-based dose-finding, adaptive treatment arm selection, and response adaptive randomization. The use of non-randomized parallel-group and open-label single arm designs increased over time. No temporal trend in the use of adaptive design was identified. Trials sponsored by industry only were more likely to use a randomized parallel-group design and have a larger estimated sample size than trials with other sponsor types.
CONCLUSION
Our systematic review showed that very few phase II trials in AD used an adaptive trial design. Innovation and implementation of novel trial designs in AD trials can accelerate the drug development process.
Topics: Humans; Alzheimer Disease; Research Design; Sample Size; Clinical Trials, Phase II as Topic
PubMed: 37840500
DOI: 10.3233/JAD-230660