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The Journal of Prosthetic Dentistry Jul 2019Different finish-line designs have been advocated for tooth preparations of ceramic crowns. However, scientific evidence is lacking to help clinicians make a proper... (Meta-Analysis)
Meta-Analysis Review
STATEMENT OF PROBLEM
Different finish-line designs have been advocated for tooth preparations of ceramic crowns. However, scientific evidence is lacking to help clinicians make a proper selection.
PURPOSE
The purpose of this systematic review and meta-analysis was to evaluate the effects of finish-line designs on the marginal and internal adaptations of ceramic crowns.
MATERIAL AND METHODS
This report follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The literature search was conducted in MEDLINE via the PubMed, Embase, and Web of Science databases with no publication year or language limits. In vitro studies comparing the marginal and internal adaptations of ceramic crowns with rounded shoulder and chamfer finish lines were included in the meta-analysis.
RESULTS
Sixteen studies were included in the qualitative synthesis and meta-analyses. Statistical analyses were conducted using the Review Manager Software. Meta-analyses were performed with random-effects models (α=.05). Ceramic crowns with rounded shoulders exhibited significantly better marginal adaptation than those with chamfers (P<.001; mean difference=-7.8; 95% confidence interval=-11.6 to -4.1). Moreover, ceramic crowns with chamfers exhibited significantly better internal adaptation than those with rounded shoulders (P=.020; mean difference=35.0; 95% confidence interval=6.5 to 63.5).
CONCLUSIONS
The difference in marginal adaptation of ceramic crowns using 2 finish-line designs was small, and the clinical significance was low, whereas the results of internal adaptation favored the chamfer finish line.
Topics: Ceramics; Crowns; Dental Marginal Adaptation; Dental Porcelain; Dental Prosthesis Design; Tooth Preparation, Prosthodontic
PubMed: 30782459
DOI: 10.1016/j.prosdent.2018.10.002 -
Journal of Fish Diseases May 2018Design and reporting quality of diagnostic accuracy studies (DAS) are important metrics for assessing utility of tests used in animal and human health. Following... (Review)
Review
Design and reporting quality of diagnostic accuracy studies (DAS) are important metrics for assessing utility of tests used in animal and human health. Following standards for designing DAS will assist in appropriate test selection for specific testing purposes and minimize the risk of reporting biased sensitivity and specificity estimates. To examine the benefits of recommending standards, design information from published DAS literature was assessed for 10 finfish, seven mollusc, nine crustacean and two amphibian diseases listed in the 2017 OIE Manual of Diagnostic Tests for Aquatic Animals. Of the 56 DAS identified, 41 were based on field testing, eight on experimental challenge studies and seven on both. Also, we adapted human and terrestrial-animal standards and guidelines for DAS structure for use in aquatic animal diagnostic research. Through this process, we identified and addressed important metrics for consideration at the design phase: study purpose, targeted disease state, selection of appropriate samples and specimens, laboratory analytical methods, statistical methods and data interpretation. These recommended design standards for DAS are presented as a checklist including risk-of-failure points and actions to mitigate bias at each critical step. Adherence to standards when designing DAS will also facilitate future systematic review and meta-analyses of DAS research literature.
Topics: Animals; Aquatic Organisms; Diagnostic Tests, Routine; Fish Diseases; Fishes; Sensitivity and Specificity
PubMed: 29542822
DOI: 10.1111/jfd.12792 -
Sports Medicine (Auckland, N.Z.) Jul 2023Heat adaptation regimes are used to prepare athletes for exercise in hot conditions to limit a decrement in exercise performance. However, the heat adaptation literature... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Heat adaptation regimes are used to prepare athletes for exercise in hot conditions to limit a decrement in exercise performance. However, the heat adaptation literature mostly focuses on males, and consequently, current heat adaptation guidelines may not be optimal for females when accounting for the biological and phenotypical differences between sexes.
OBJECTIVES
We aimed to examine: (1) the effects of heat adaptation on physiological adaptations in females; (2) the impact of heat adaptation on performance test outcomes in the heat; and (3) the impact of various moderators, including duration (minutes and/or days), total heat dose (°Cmin), exercise intensity (kcalmin), total energy expended (kcal), frequency of heat exposures and training status on the physiological adaptations in the heat.
METHODS
SPORTDiscus, MEDLINE Complete and Embase databases were searched to December 2022. Random-effects meta-analyses for resting and exercise core temperature, skin temperature, heart rate, sweat rate, plasma volume and performance tests in the heat were completed using Stata Statistical Software: Release 17. Sub-group meta-analyses were performed to explore the effect of duration, total heat dose, exercise intensity, total energy expended, frequency of heat exposure and training status on resting and exercise core temperature, skin temperature, heart rate and sweat rate. An explorative meta-regression was conducted to determine the effects of physiological adaptations on performance test outcomes in the heat following heat adaptation.
RESULTS
Thirty studies were included in the systematic review; 22 studies were meta-analysed. After heat adaptation, a reduction in resting core temperature (effect size [ES] = - 0.45; 95% confidence interval [CI] - 0.69, - 0.22; p < 0.001), exercise core temperature (ES = - 0.81; 95% CI - 1.01, - 0.60; p < 0.001), skin temperature (ES = - 0.64; 95% CI - 0.79, - 0.48; p < 0.001), heart rate (ES = - 0.60; 95% CI - 0.74, - 0.45; p < 0.001) and an increase in sweat rate (ES = 0.53; 95% CI 0.21, 0.85; p = 0.001) were identified in females. There was no change in plasma volume (ES = - 0.03; 95% CI - 0.31, 0.25; p = 0.835), whilst performance test outcomes were improved following heat adaptation (ES = 1.00; 95% CI 0.56, 1.45; p < 0.001). Across all moderators, physiological adaptations were more consistently observed following durations of 451-900 min and/or 8-14 days, exercise intensity ≥ 3.5 kcalmin, total energy expended ≥ 3038 kcal, consecutive (daily) frequency and total heat dose ≥ 23,000 °Cmin. The magnitude of change in performance test outcomes in the heat was associated with a reduction in heart rate following heat adaptation (standardised mean difference = - 10 beatsmin; 95% CI - 19, - 1; p = 0.031).
CONCLUSIONS
Heat adaptation regimes induce physiological adaptations beneficial to thermoregulation and performance test outcomes in the heat in females. Sport coaches and applied sport practitioners can utilise the framework developed in this review to design and implement heat adaptation strategies for females.
Topics: Male; Humans; Female; Hot Temperature; Thermotolerance; Adaptation, Physiological; Exercise; Body Temperature Regulation
PubMed: 37222863
DOI: 10.1007/s40279-023-01831-2 -
BMC Geriatrics Feb 2021The theme of young family caregivers of older relatives is still partially uncovered, although the phenomenon is increasing worldwide. This Systematic Literature Review... (Review)
Review
BACKGROUND
The theme of young family caregivers of older relatives is still partially uncovered, although the phenomenon is increasing worldwide. This Systematic Literature Review discusses methodological and content issues of ten articles covering this topic, in order to contribute to increase the knowledge and provide suggestions for designing effective support services for adolescent young caregivers. To this purpose, the findings of this review are framed within the caregiving stress appraisal model (renamed CSA model) elaborated by Yates' and collegues, in order to highlight differences between young caregivers and the older ones.
METHODS
Multiple databases including PubMed, Web of Science, Scopus, ProQuest - Psychology Database, CINAHL Complete - EBSCOHost were used to carry out a systematic review of the literature. Additional references were retrieved from experts contacted and research knowledge. The selected articles underwent both methodological appraisal and contents analysis: for every article an appraisal score was calculated and themes and sub-themes were identified.
RESULTS
Out of the ten included studies three were mixed methods, six qualitative and one quantitative. Nine reached a high quality methodological score and one medium. Four main themes emerged from the content analysis: aspects of the caregiving relationship; effects of caregiving; coping strategies; recommendations for services, policy and research.
CONCLUSIONS
Selected studies explored practical features of the relationship between young caregivers and older family members (tasks performed, motivations, coping strategies) and highlighted both positive and negative outcomes on young people's everyday life condition and future development. Nevertheless, these evidences were often limited to small samples that did not allow to make generalizations. More studies are needed including large samples in order to deepen the different aspects of caregiving and design tailored support services.
Topics: Adaptation, Psychological; Adolescent; Aged; Aged, 80 and over; Caregivers; Family; Humans
PubMed: 33546605
DOI: 10.1186/s12877-020-01976-z -
Sports Medicine (Auckland, N.Z.) Dec 2015Locomotor adaptability is based on the implementation of error-feedback information from previous perturbations to predictively adapt to expected perturbations... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Locomotor adaptability is based on the implementation of error-feedback information from previous perturbations to predictively adapt to expected perturbations (feedforward) and to facilitate reactive responses in recurring unexpected perturbations ('savings'). The effect of aging on predictive and reactive adaptability is yet unclear. However, such understanding is fundamental for the design and application of effective interventions targeting fall prevention.
METHODS
We systematically searched the Web of Science, MEDLINE, Embase and Science Direct databases as well as the reference lists of the eligible articles. A study was included if it addressed an investigation of the locomotor adaptability in response to repeated mechanical movement perturbations of healthy older adults (≥60 years). The weighted average effect size (WAES) of the general adaptability (adaptive motor responses to repeated perturbations) as well as predictive (after-effects) and reactive adaptation (feedback responses to a recurring unexpected perturbation) was calculated and tested for an overall effect. A subgroup analysis was performed regarding the factor age group [i.e., young (≤35 years) vs. older adults]. Furthermore, the methodological study quality was assessed.
RESULTS
The review process yielded 18 studies [1009 participants, 613 older adults (70 ± 4 years)], which used various kinds of locomotor tasks and perturbations. The WAES for the general locomotor adaptability was 1.21 [95% confidence interval (CI) 0.68-1.74, n = 11] for the older and 1.39 (95% CI 0.90-1.89, n = 10) for the young adults with a significant (p < 0.05) overall effect for both age groups and no significant subgroup differences. Similar results were found for the predictive (older: WAES 1.10, 95% CI 0.37-1.83, n = 8; young: WAES 1.54, 95% CI 0.11-2.97, n = 7) and reactive (older: WAES 1.09, 95% CI 0.22-1.96, n = 5; young: WAES 1.35, 95% CI 0.60-2.09, n = 5) adaptation featuring significant (p < 0.05) overall effects without subgroup differences. The average score of the methodological quality was 67 ± 8 %.
CONCLUSIONS
The present meta-analysis provides elaborate statistical evidence that locomotor adaptability in general and predictive and reactive adaptation in particular remain highly effective in the elderly, showing only minor, not statistically significant age-related deficits. Consequently, interventions which use adaptation and learning paradigms including the application of the mechanisms responsible for an effective predictive and reactive dynamic stability control may progressively improve older adults' recovery performance and, thus, reduce their risk of falling.
Topics: Accidental Falls; Adaptation, Physiological; Aged; Humans; Walking
PubMed: 26487633
DOI: 10.1007/s40279-015-0413-9 -
Prehospital and Disaster Medicine Dec 2014An increasing number of people are affected worldwide by the effects of disasters, and the United Nations International Strategy for Disaster Reduction (UNISDR) has... (Review)
Review
An increasing number of people are affected worldwide by the effects of disasters, and the United Nations International Strategy for Disaster Reduction (UNISDR) has recognized the need for a radical paradigm shift in the preparedness and combat of the effects of disasters through the implementation of specific actions. At the governmental level, these actions translate into disaster and risk reduction education and activities at school. Fifteen years after the UNISDR declaration, there is a need to know if the current methods of disaster education of the teenage population enhance their knowledge, knowledge of skills in disasters, and whether there is a behavioral change which would improve their chances for survival post disaster. This multidisciplinary systematic literature review showed that the published evidence regarding enhancing the disaster-related knowledge of teenagers and the related problem solving skills and behavior is piecemeal in design, approach, and execution in spite of consensus on the detrimental effects on injury rates and survival. There is some evidence that isolated school-based intervention enhances the theoretical disaster knowledge which may also extend to practical skills; however, disaster behavioral change is not forthcoming. It seems that the best results are obtained by combining theoretical and practical activities in school, family, community, and self-education programs. There is a still a pressing need for a concerted educational drive to achieve disaster preparedness behavioral change. School leavers' lack of knowledge, knowledge of skills, and adaptive behavioral change are detrimental to their chances of survival.
Topics: Adaptation, Psychological; Adolescent; Disaster Planning; Disasters; Health Education; Health Knowledge, Attitudes, Practice; Humans
PubMed: 25327571
DOI: 10.1017/S1049023X14001083 -
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 -
Science and Engineering Ethics Aug 2022In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new...
In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary "consent design toolkit" and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.
Topics: Ethics, Medical; Humans; Informed Consent; Research Personnel
PubMed: 36042065
DOI: 10.1007/s11948-022-00398-x -
European Journal of Clinical... May 2011Despite representing a fundamental step towards the efficacious and safe utilisation of drugs in the paediatric population, the conduct of clinical trials in children... (Review)
Review
PURPOSE
Despite representing a fundamental step towards the efficacious and safe utilisation of drugs in the paediatric population, the conduct of clinical trials in children poses several problems. Methodological issues and ethical concerns represent the major obstacles that have traditionally limited paediatric research. The randomised clinical trial, mainstay of clinical studies to assess the effects of any therapeutic intervention, shows some weaknesses that make it scarcely applicable to the paediatric population. Alternative and innovative approaches to clinical trial design in small populations have been developed in the last few decades with the aim of overcoming the limits related to small samples and to the acceptability of the trial.
METHODS
This systematic review describes a variety of alternative designs to assess efficacy and safety in the paediatric population, including their applicability, advantages, disadvantages and real case examples. Approaches include sequential and adaptive designs, Bayesian methods and other innovative approaches.
RESULTS
By limiting the sample size and increasing acceptability, these methods may rationally limit the amount of experimentation in children to what is achievable, necessary and ethical
CONCLUSION
Thanks to their features, these methods represent a reliable way of ultimately improving paediatric care.
Topics: Bayes Theorem; Child; Humans; Pediatrics; Randomized Controlled Trials as Topic; Research Design; Therapies, Investigational
PubMed: 21301825
DOI: 10.1007/s00228-011-0990-y -
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