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Journal of Biomaterials Applications Feb 2020Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and...
BACKGROUND
Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and safety has been published.
OBJECTIVE
This systematic review intends to review and assess commercially available polydioxanone implants and their safety and performance in patients.
METHODS
We searched for approved polydioxanone implants in several Food and Drug Administration databases. Then, we performed a literature search for publications and clinical trials where polydioxanone devices were implanted in patients. This search was performed on MEDLINE, Embase, Scopus and other databases. Safety and performance of polydioxanone implants in patients were assessed and compared with the implantation of non-polydioxanone devices, when possible, based on scoring systems developed by the authors that analyse surgical site infection rates, inflammatory reaction rates, foreign body response, postoperative pain and fever.
RESULTS
Food and Drug Administration databases search revealed that 48 implants have been approved since 1981, with 1294 adverse reactions or product malfunction in the last decade and 16 recalls. A total of 49 clinical trials and 104 scientific publications were found. Polydioxanone sutures and meshes/plates had low rates of surgical site infection, inflammatory reaction, foreign body response and postoperative fever. Polydioxanone clips/staples reported high rates of surgical site infection, postoperative fever and pain, with sub-optimal clinical performance and poor safety rates. The remaining implants identified showed high levels of safety and performance. Safety scores of polydioxanone implants and non-polydioxanone alternatives are similar. Polydioxanone monofilament sutures perform better than non-polydioxanone alternatives but performance did not differ with remaining polydioxanone implant types.
CONCLUSIONS
Although polydioxanone clips/staples should be implanted with caution and monitored carefully, in general, safety and performance scores of other polydioxanone implants did not differ from non-polydioxanone alternatives. This review will be a useful reference for researchers and industries developing new polydioxanone medical devices.
Topics: Absorbable Implants; Biocompatible Materials; Device Approval; Humans; Inflammation; Medical Device Recalls; Polydioxanone
PubMed: 31771403
DOI: 10.1177/0885328219888841 -
Sports Health 2022With the current Centers for Disease Control and Prevention recommendations for mask use to minimize transmission of coronavirus 2019 (COVID-19) coupled with concern for...
CONTEXT
With the current Centers for Disease Control and Prevention recommendations for mask use to minimize transmission of coronavirus 2019 (COVID-19) coupled with concern for future pandemics that would require mask wearing, providing data-driven guidance with respect to athletic performance is essential.
OBJECTIVE
The purpose of this study was to perform a systematic review of existing literature on the use of face masks while exercising to assess the physiologic effects of face masks worn during athletic activities.
DATA SOURCES
A systematic review was conducted of studies on face mask use during exercise according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Potential studies were identified through searches of MEDLINE, Embase, Cochrane CENTRAL and CINAHL databases.
STUDY SELECTION
Screening was completed independently by 2 coauthors who sought to identify studies that described the effects of oronasal mask use, if any, on sports/exercise/physical activity, for any age, gender, or level of sport. Articles describing mask effects without exercise, articles published before 1980, and non-English language studies were excluded.
STUDY DESIGN
Systematic review.
LEVEL OF EVIDENCE
Level 3.
DATA EXTRACTION
Data extraction focused on physiologic parameters measured during physical activity performed while wearing a face mask.
RESULTS
Twenty-two articles met all inclusion criteria. Study analysis revealed that the use of masks in healthy volunteers during exercise had no significant effect on physiologic parameters measured including heart rate (HR), respiratory rate (RR), oxygen saturation, and perceived exertion. Of the studies that investigated N95 masks in the healthy adult population, 2 reported modest changes in RR and maximum power output indicative of decreased athletic performance when subjects were exercising at maximum effort. Similar findings were seen in studies of subpopulations including children and pregnant women.
CONCLUSION
Available data suggest that healthy individuals can perform moderate-to-vigorous exercise while wearing a face mask without experiencing changes in HR, RR, and oxygen saturation that would compromise individual safety or athletic performance. In the specific situation in which an N95 mask is worn, maximum power generated may be impaired.
WHAT IS KNOWN ABOUT THE SUBJECT
To date, there has been no systematic review of the existing literature to provide a clear consensus on whether face mask use significantly impacts athletic performance. Mask use has been demonstrated safe in the workplace; however, the use of face masks during exercise has not been examined on a large scale, particularly with respect to physiologic parameters.
WHAT THIS STUDY ADDS TO EXISTING KNOWLEDGE
This analysis highlights that available data suggest that healthy individuals can perform heavy exercise in face masks with minimal physiologic changes. This is the first systematic review of studies analyzing exercise use wearing masks. With the evidence presented here commonly cited concerns about both safety and performance decrements with mask use during physical activities may be allayed.
Topics: Adult; Athletes; COVID-19; Child; Exercise; Female; Humans; Pandemics; Pregnancy; SARS-CoV-2
PubMed: 35855525
DOI: 10.1177/19417381221111395 -
Otolaryngology--head and Neck Surgery :... Jun 2016To minimize discomfort, time, and costs, vestibular laboratories may perform monothermal caloric irrigations and discontinue testing if responses are symmetric. This... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To minimize discomfort, time, and costs, vestibular laboratories may perform monothermal caloric irrigations and discontinue testing if responses are symmetric. This systematic review aimed to determine the diagnostic accuracy of the monothermal caloric screening test (MCST) for unilateral vestibular dysfunction compared with bithermal caloric testing (BCT).
DATA SOURCES
Ovid-MEDLINE, EMBASE, Scopus, Cochrane CENTRAL, and manual bibliographic searches.
REVIEW METHODS
Inclusion criteria specified concurrent MCST and BCT performance and reporting of test measures (monothermal caloric asymmetry, unilateral weakness). The primary outcomes were between-measure correlation, sensitivity, and specificity. Meta-analysis was performed with hierarchical bivariate and univariate random-effects models. Heterogeneity was assessed with the I(2) statistic.
RESULTS
Fifteen studies (n = 5572 participants) met inclusion criteria. Thresholds varied between studies. Asymmetries calculated by MCST and BCT were strongly correlated, but a subgroup analysis showed no correlation for those with mild unilateral weakness. The sensitivity and specificity of the MCST ranged from 0.54 to 1.00 and 0.25 to 0.96, respectively. Predictably, higher sensitivity resulted from lower cutoff points for the MCST, higher thresholds for the BCT, and additional test positivity criteria. Warm irrigations yielded higher sensitivity than cool. Studies excluding participants with severe unilateral weakness yielded lower sensitivity estimates. After pooling by threshold, temperature, and risk of bias, most performance estimates remained substantially heterogeneous (I(2) > 60%).
CONCLUSION
Accuracy of the MCST is lacking precisely where it is needed most-at the border of normal and abnormal vestibular function. To guide clinical practice, research should include analysis of subgroups with varying levels of function and employ standardized testing parameters.
Topics: Caloric Tests; Electronystagmography; Humans; Sensitivity and Specificity; Vestibular Diseases
PubMed: 26932962
DOI: 10.1177/0194599816630963 -
Sports Medicine (Auckland, N.Z.) Apr 2016The quiet eye (final fixation to a specific target prior to movement initiation) is a perceptual skill robustly associated with expertise and superior performance. The... (Review)
Review
INTRODUCTION
The quiet eye (final fixation to a specific target prior to movement initiation) is a perceptual skill robustly associated with expertise and superior performance. The benefit of the phenomenon has been demonstrated in a range of sporting tasks. The mechanism(s) underpinning this phenomenon are much-debated and are associated with varying assumptions.
OBJECTIVE
This systematic review categorizes previous quiet eye research based on Newell's 1986 model of interacting constraints.
DATA SOURCES
Three electronic databases (Web of Science, Scopus, PubMed) were searched from inception until February 2015. Details of relevant studies were also obtained from one literature review and two book chapters.
ELIGIBILITY CRITERIA AND SYNTHESIS METHODS
To frame the discussion of research evidence concerning the quiet eye, previous studies were evaluated based on a classification of manipulating performer, environment, and task constraints. Additionally, associative studies (without specific constraints), and interacting constraints (affecting more than one constraint) were considered.
RESULTS
This review emphasizes that the quiet eye is beneficial for performing aiming tasks and that Newell's constraints model provides a useful framework for organizing knowledge in this area.
CONCLUSION
Despite the robust research on the value of the quiet eye, several gaps in current knowledge exist regarding the mechanism of the quiet eye effect.
Topics: Athletic Performance; Eye Movements; Fixation, Ocular; Humans; Motor Skills; Movement; Psychomotor Performance; Task Performance and Analysis
PubMed: 26712511
DOI: 10.1007/s40279-015-0442-4 -
Journal of Strength and Conditioning... Jun 2018Van De Walle, GP and Vukovich, MD. The effect of nitrate supplementation on exercise tolerance and performance: a systematic review and meta-analysis. J Strength Cond... (Meta-Analysis)
Meta-Analysis Review
Van De Walle, GP and Vukovich, MD. The effect of nitrate supplementation on exercise tolerance and performance: a systematic review and meta-analysis. J Strength Cond Res 32(6): 1796-1808, 2018-The purpose of this article was to systematically review the current literature and evaluate the overall efficacy of nitrate supplementation on exercise tolerance and performance by meta-analysis. Studies were eligible for inclusion if they met the following criteria: (a) were an experimental trial published in an English peer-reviewed journal; (b) compared the effects of inorganic nitrate consumption with a non-bioactive supplement control or placebo; (c) used a quantifiable measure of exercise performance; and (d) was carried out in apparently healthy participants without disease. A total of 29 studies were identified that investigated the effects of nitrate supplementation on exercise tolerance or performance in accordance with the criteria outlined. Analysis using time to exhaustion as the outcome variable revealed a significant effect of nitrate supplementation on exercise tolerance (ES = 0.28; 95% confidence interval [CI]: 0.08-0.47; p = 0.006) compared with placebo. Analysis using time to complete a specific distance as the outcome variable revealed no significant effect of nitrate supplementation on exercise performance (ES = -0.05; 95% CI: -0.28 to 0.17; p = 0.64) compared with placebo. Nitrate supplementation is likely to improve exercise tolerance and capacity that may improve exercise performance. More research is required to determine the optimal dose and duration of nitrate supplementation. It would also be important to consider the type of athlete performing the exercise and the duration, intensity, and mode of the exercise performed because these factors are likely to influence the efficacy of nitrate supplementation.
Topics: Athletic Performance; Clinical Trials as Topic; Dietary Supplements; Exercise; Exercise Tolerance; Humans; Nitrates
PubMed: 29786633
DOI: 10.1519/JSC.0000000000002046 -
International Journal of Molecular... Jun 2023Various papers have introduced the use of positron emission tomography (PET) with [Ga]Ga-radiolabeled fibroblast-activation protein inhibitor (FAPi) radiopharmaceuticals... (Meta-Analysis)
Meta-Analysis Review
Various papers have introduced the use of positron emission tomography (PET) with [Ga]Ga-radiolabeled fibroblast-activation protein inhibitor (FAPi) radiopharmaceuticals in different subtypes of gastric cancer (GC). Our aim was to assess the diagnostic performance of this novel molecular imaging technique in GC with a systematic review and meta-analysis. A straightforward literature search of papers concerning the diagnostic performance of FAP-targeted PET imaging was performed. Original articles evaluating this novel molecular imaging examination in both newly diagnosed GC patients and GC patients with disease relapse were included. The systematic review included nine original studies, and eight of them were also eligible for meta-analysis. The quantitative synthesis provided pooled detection rates of 95% and 97% for the assessment of primary tumor and distant metastases, respectively, and a pooled sensitivity and specificity of 74% and 89%, respectively, for regional lymph node metastases. Significant statistical heterogeneity among the included studies was found only in the analysis of the primary tumor detection rate (I = 64%). Conclusions: Beyond the limitations of this systematic review and meta-analysis (i.e., all the included studies were conducted in Asia, and using [F]FDG PET/CT as a comparator of the index test), the quantitative data provided demonstrate the promising diagnostic performance of FAP-targeted PET imaging in GC. Nevertheless, more prospective multicentric studies are needed to confirm the excellent performances of FAP-targeted PET in this cluster of patients.
Topics: Humans; Positron Emission Tomography Computed Tomography; Stomach Neoplasms; Prospective Studies; Neoplasm Recurrence, Local; Positron-Emission Tomography; Radiopharmaceuticals; Fluorodeoxyglucose F18; Gallium Radioisotopes
PubMed: 37373285
DOI: 10.3390/ijms241210136 -
Advanced Journal of Emergency Medicine 2019Nurses are the largest group of health service providers with a vital role in assisting victims during disasters. They must be therefore appropriately prepared to... (Review)
Review
CONTEXT
Nurses are the largest group of health service providers with a vital role in assisting victims during disasters. They must be therefore appropriately prepared to respond to health requirements in these situations.
EVIDENCE ACQUISITION
Three articles were ultimately extracted from a comprehensive search conducted in the present systematic review and meta-analysis in Google Scholar, SID, Magiran, Scopus, PubMed and Web of Science using English keywords and their Persian equivalents. The I index was used to evaluate the heterogeneity between the studies, and the analyses were performed in STATA 14.
RESULTS
This review was conducted on 586 nurses working in hospitals. The final meta-analysis included three articles. The matched mean scores of knowledge, attitude and performance concerning disaster preparedness were respectively found to be 43.49 (95% CI: 37.67-49.31, P=0.581, I=0.0%), 68.81 (95% CI: 63.04-70.58, p=0.913, I=0.0%) and 56.19 (95% CI: 53.95-58.42, P=0.001, I=86.2%).
CONCLUSION
The present findings suggested moderate levels of knowledge and performance and good attitudes associated with preparedness in disasters in the Iranian nurses. These parameters can be therefore improved to desirable levels and the overall preparedness for coping with disasters boosted in nurses by training nurses and performing hospital drills.
PubMed: 31633097
DOI: 10.22114/ajem.v0i0.204 -
The American Journal of Emergency... Feb 2023Spurred by the Coronavirus infectious disease 2019 pandemic, aerosol containment devices (ACDs) were developed to capture infectious respiratory aerosols generated by... (Review)
Review
BACKGROUND
Spurred by the Coronavirus infectious disease 2019 pandemic, aerosol containment devices (ACDs) were developed to capture infectious respiratory aerosols generated by patients at their source. Prior reviews indicated that such devices had low evidence of effectiveness, but did not address how ACDs should be evaluated, how well they should perform, nor have clearly defined performance standards. Towards developing design criteria for ACDs, two questions were posed: 1) What characteristics have guided the design of ACDs? 2) How have these characteristics been evaluated?
METHODS
A scoping review was performed consistent with PRISMA guidelines. Data were extracted with respect to general study information, intended use of the device, device design characteristics and evaluation.
RESULTS
Fifty-four articles were included. Evaluation was most commonly performed with respect to device aerosol containment (n = 31, 61%), with only 5 (9%), 3 (6%) and 8 (15%) formally assessing providing experience, patient experience and procedure impact, respectively. Nearly all of the studies that explored provider experience and procedure impact studied intubation. Few studies provided a priori performance criteria for any evaluation metric, or referenced any external guidelines by which to bench mark performance.
CONCLUSION
With respect to aerosol containment, ACDs should reduce exposure among HCP with the device compared with the absence of the device, and provide ≥90% reduction in respirable aerosols, equivalent in performance to N95 filtering facepiece respirators, if the goal is to reduce reliance on personal protective equipment. The ACD should not increase awkward or uncomfortable postures, or adversely impact biomechanics of the procedure itself as this could have implications for procedure outcomes. A variety of standardized instruments exist to assess the experience of patients and healthcare personnel. Integration of ACDs into routine clinical practice requires rigorous studies of aerosol containment and the user experience.
Topics: Humans; Respiratory Aerosols and Droplets; COVID-19; Personal Protective Equipment; Intubation, Intratracheal; Equipment Design
PubMed: 36435005
DOI: 10.1016/j.ajem.2022.11.007 -
BMC Medical Informatics and Decision... Jun 2020Early warning scores (EWS) have been developed as clinical prognostication tools to identify acutely deteriorating patients. In the past few years, there has been a...
BACKGROUND
Early warning scores (EWS) have been developed as clinical prognostication tools to identify acutely deteriorating patients. In the past few years, there has been a proliferation of studies that describe the development and validation of novel machine learning-based EWS. Systematic reviews of published studies which focus on evaluating performance of both well-established and novel EWS have shown conflicting conclusions. A possible reason is the heterogeneity in validation methods applied. In this review, we aim to examine the methodologies and metrics used in studies which perform EWS validation.
METHODS
A systematic review of all eligible studies from the MEDLINE database and other sources, was performed. Studies were eligible if they performed validation on at least one EWS and reported associations between EWS scores and inpatient mortality, intensive care unit (ICU) transfers, or cardiac arrest (CA) of adults. Two reviewers independently did a full-text review and performed data abstraction by using standardized data-worksheet based on the TRIPOD (Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) checklist. Meta-analysis was not performed due to heterogeneity.
RESULTS
The key differences in validation methodologies identified were (1) validation dataset used, (2) outcomes of interest, (3) case definition, time of EWS use and aggregation methods, and (4) handling of missing values. In terms of case definition, among the 48 eligible studies, 34 used the patient episode case definition while 12 used the observation set case definition, and 2 did the validation using both case definitions. Of those that used the patient episode case definition, 18 studies validated the EWS at a single point of time, mostly using the first recorded observation. The review also found more than 10 different performance metrics reported among the studies.
CONCLUSIONS
Methodologies and performance metrics used in studies performing validation on EWS were heterogeneous hence making it difficult to interpret and compare EWS performance. Standardizing EWS validation methodology and reporting can potentially address this issue.
Topics: Adult; Benchmarking; Early Warning Score; Heart Arrest; Humans; Intensive Care Units; Prognosis; Prospective Studies
PubMed: 32552702
DOI: 10.1186/s12911-020-01144-8 -
European Journal of Radiology Mar 2017To perform a systematic review and meta-analysis of the sensitivity and positive predictive value (PPV) of CT for preoperative parathyroid localization in patients with... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To perform a systematic review and meta-analysis of the sensitivity and positive predictive value (PPV) of CT for preoperative parathyroid localization in patients with primary hyperparathyroidism (pHPT), and subsequently compare the different protocols and their performance in different patient groups.
MATERIALS AND METHODS
We performed a search of the Embase, Pubmed and Cochrane Library databases to identify studies published between January 1, 2000 and March 31, 2016 investigating the diagnostic value of CT for parathyroid localization in patients with biochemical diagnosis of pHPT. Performance of CT was expressed in sensitivity and PPV with pooled proportion using a random-effects model. Factors that could have affected the diagnostic performance were investigated by subgroup analysis.
RESULTS
Thirty-four studies evaluating a total of 2563 patients with non-familial pHPT who underwent CT localization and surgical resection were included. Overall pooled sensitivity of CT for localization of the pathological parathyroid(s) to the correct quadrant was 73% (95% CI: 69-78%), which increased to 81% (95% CI: 75-87%) for lateralization to the correct side. Subgroup analysis based on the number of contrast phases showed that adding a second contrast phase raises sensitivity from 71% (95% CI: 61-80%) to 76% (95% CI: 71-87%), and that adding a third phase resulted in a more modest additional increase in performance with a sensitivity of 80% (95% CI: 74-86%).
CONCLUSION
CT performs well in localizing pathological glands in patients with pHPT. A protocol with two contrast phases seems to offer a good balance of acceptable performance with limitation of radiation exposure.
Topics: Adenoma; Databases, Factual; Female; Humans; Male; Middle Aged; Parathyroid Glands; Parathyroid Neoplasms; Reproducibility of Results; Sensitivity and Specificity; Tomography, X-Ray Computed
PubMed: 28189196
DOI: 10.1016/j.ejrad.2017.01.004