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OBJECTIVES: To externally validate the International Study Group of Pancreatic Surgery (ISGPS) classification and test its performance for predicting clinically relevant pancreatic fistula (CRPF) for periampullary tumours (P-amps). BACKGROUND: The ISGPS is a simple two-factor, four-tier classification of pancreas-related risk for CRPF after a pancreatoduodenectomy (PD). External validation and performance of the classification specific to P-amps are lacking. P-amps have different disease biology, lesser need for neoadjuvant therapy, softer pancreas, and a higher rate of CRPF, underscoring the importance of site-specific prediction. METHODS: Validation was performed in a cohort of 1422 patients, with CRPF as the primary outcome. Model performance was tested by plotting the receiver operating curve and calibration plots. After analysing the factors predicting CRPF, the model was optimised for P-amps. RESULTS: CRPF rate was 22.2% (315/1422), for P-amps being 25.8%. The ISGPS model performed moderately (AUC=0.632, 95% CI 0.598-0.666, P<0.001), with worse performance for P-amps (AUC=0.605, 95% CI 0.566-0.645, P<0.001). On multivariate analysis, soft pancreas (OR 1.689, 95% CI 1.136-2.512, P=0.010), body mass index ≥23 kg/m2 (OR 2.112, 95% CI 1.464-3.046, P<0.001) and pancreatic duct ≤3 mm (OR 2.113 95% CI 1.457-3.064, P<0.001), emerged as independent predictors and the model was optimised. The adjusted ISGPS for P-amps showed improved discrimination (AUC=0.672, P<0.001, 95% CI 0.637-0.707), with adequate performance on internal validation. CONCLUSION: The adjusted ISPGS performs better than the original ISGPS in predicting CRPF for P-amps. Large-scale multicenter data is needed to generate and validate site-specific predictive models.
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BACKGROUND: Extraskeletal Ewing sarcoma (ESE) is a lesser-known, rarer counterpart of Ewing sarcoma of bone. This single-center study sought to evaluate the prognosticators and outcomes following multimodality therapy in patients with ESE. METHODS: Forty-seven patients with ESE, treated between 2013 and 2018 with a standardized protocol and multimodality therapy using established doxorubicin-based regimens, were followed-up to assess outcomes. RESULTS: Median age at diagnosis was 20 (range 7-56) years, and 57.4% were male. Median tumor size was 7 (range 2-21) cm. The symptom-duration ranged from 1 to 8 (median 4) months. Tumor-site was trunkal in 61.7%, extremity in 23.4%, and head and neck 14.9%. Of the 35 patients with nonmetastatic disease at presentation, 13 underwent upfront surgery. The rest received chemotherapy followed by local treatment, which was surgical in 15 and radiotherapy in 5. At median follow-up of 24 (range 5-98) months, 55.3% patients had experienced events, and 29.8% had died of progressive disease. Three-year event-free survival was 41.1%, and overall survival was 53%. On univariate analysis, trunkal location, upfront surgery, and positive surgical margins were associated with inferior EFS. Trunkal tumors and upfront surgery were also associated with poorer OS. On multivariate analysis, trunkal location and margin-positive resections retained statistical significance for adverse EFS. CONCLUSIONS: Unless clearly resectable upfront, ESE should be downstaged with chemotherapy before local treatment. A margin-negative resection should be the objective when performing surgery. Definitive radiotherapy is an alternative in tumors not amenable for complete excision or when anticipated postoperative morbidity precludes radical surgery.
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Neoplasias Ósseas , Sarcoma de Ewing , Humanos , Masculino , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Feminino , Sarcoma de Ewing/terapia , Sarcoma de Ewing/patologia , Estudos de Coortes , Neoplasias Ósseas/patologia , Prognóstico , Resultado do Tratamento , Terapia Combinada , Estudos Retrospectivos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
Conventional therapies have aimed to try to help individuals suffering with dentine hypersensitivity (DH/DHS). A relatively new approach, laser therapy claims to be beneficial while having immediate and long-lasting effect. Therefore, our analysis aims to explore the immediate and 1-month efficacy of near-infrared laser (NIR) therapy in treating dentinal hypersensitivity. A systematic literature search conducted in databases, and analysis was undertaken utilizing a meta-analysis approach. Randomized controlled clinical trials comparing near-infrared lasers and placebo/no treatment in patients (> 18 years) were included. The risk of bias for included studies was assessed using Cochrane RoB tool (for randomized studies). Random effects meta-analyses model of standardized mean differences and 95% confidence intervals were performed using RevMan 5.4 software. A comprehensive electronic and manual search yielded a total of 1081 potential articles. Following the implementation of the inclusion and exclusion criteria, a total of 6 studies were included in the analysis. Near-infrared laser therapy led to statistical significant reduction in immediate and 1-month follow-up VAS (visual analog scale) scores compared to placebo/no treatment (p < 0.05). Statistical heterogeneity across the studies was high (I2-96%). The findings suggest that near-infrared laser therapy does have a significant immediate effect in reducing dentine hypersensitivity compared to placebo/no treatment. Furthermore, this effect is not diminished and endured at 1-month follow-up.
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Sensibilidade da Dentina , Terapia a Laser , Terapia com Luz de Baixa Intensidade , Sensibilidade da Dentina/tratamento farmacológico , Sensibilidade da Dentina/radioterapia , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: Given the current lack of an approved and effective treatment or vaccine for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), repositioning old drugs for use as an antiviral treatment is an interesting strategy because knowledge about these drugs' safety profile, posology, and drug interactions is already known. Chloroquine and hydroxychloroquine, widely used as antimalarial and autoimmune disease drugs, have recently been reported as a potential broad-spectrum antiviral drug. BACKGROUND: The in vitro antiviral activity of chloroquine has been identified since the late 1960s. However, antiviral mechanisms of chloroquine remain speculative. Several clinical trials have been conducted to test the efficacy and safety of chloroquine or hydroxychloroquine in the treatment of COVID-19-associated pneumonia. The quality of the studies and the outcomes are evaluated in this systematic review and meta-analysis. REVIEW RESULTS: Literature review revealed 23 clinical studies. Only 9 of 23 studies were randomized controlled trials. Of nine randomized controlled trials, only study by Skipper et al. was deemed to be at low risk of bias. All studies evaluated variedwith different outcomes. Mechanical ventilation and virological clearance were the only common outcomes evaluated in more than two studies. Virological clearance odds ratio (OR) was 1.25 (95% confidence interval [CI] of 0.57-2.73; Chi2 = 0.83; I2 = 0%). GRADE quality of evidence was downgraded by three levels to very low due to concerns about the risk of bias, inconsistency, and imprecision. For mechanical ventilation, OR was 1.09 (95% CI 0.80-1.50; Chi2 = 0; I2 = 0). GRADE quality of evidence was downgraded by two levels to low due to concerns about the risk of bias and imprecision. There was no statistically significant difference between the groups for these two outcomes. CONCLUSION: As per the available evidence, based on our review, we conclude that hydroxychloroquine/chloroquine has not shown to be beneficial when used for the treatment of patients with COVID-19 pneumonia. HOW TO CITE THIS ARTICLE: Shetty RM, Namachivayam A. Evidence for Chloroquine/Hydroxychloroquine in the Treatment of COVID-19. Indian J Crit Care Med 2021;25(4):441-452.
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BACKGROUND: Patients admitted to intensive care and on mechanical ventilation, are administered sedative and analgesic drugs to improve both their comfort and interaction with the ventilator. Optimizing sedation practice may reduce mortality, improve patient comfort and reduce cost. Current practice is to use scales or scores to assess depth of sedation based on clinical criteria such as consciousness, understanding and response to commands. However these are perceived as subjective assessment tools. Bispectral index (BIS) monitors, which are based on the processing of electroencephalographic signals, may overcome the restraints of the sedation scales and provide a more reliable and consistent guidance for the titration of sedation depth.The benefits of BIS monitoring of patients under general anaesthesia for surgical procedures have already been confirmed by another Cochrane review. By undertaking a well-conducted systematic review our aim was to find out if BIS monitoring improves outcomes in mechanically ventilated adult intensive care unit (ICU) patients. OBJECTIVES: To assess the effects of BIS monitoring compared with clinical sedation assessment on ICU length of stay (LOS), duration of mechanical ventilation, any cause mortality, risk of ventilator-associated pneumonia (VAP), risk of adverse events (e.g. self-extubation, unplanned disconnection of indwelling catheters), hospital LOS, amount of sedative agents used, cost, longer-term functional outcomes and quality of life as reported by authors for mechanically ventilated adults in the ICU. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, ProQuest, OpenGrey and SciSearch up to May 2017 and checked references citation searching and contacted study authors to identify additional studies. We searched trial registries, which included clinicaltrials.gov and controlled-trials.com. SELECTION CRITERIA: We included all randomized controlled trials comparing BIS versus clinical assessment (CA) for the management of sedation in mechanically ventilated critically ill adults. DATA COLLECTION AND ANALYSIS: We used Cochrane's standard methodological procedures. We undertook analysis using Revman 5.3 software. MAIN RESULTS: We identified 4245 possible studies from the initial search. Of those studies, four studies (256 participants) met the inclusion criteria. One more study is awaiting classification. Studies were, conducted in single-centre surgical and mixed medical-surgical ICUs. BIS monitor was used to assess the level of sedation in the intervention arm in all the studies. In the control arm, the sedation assessment tools for CA included the Sedation-Agitation Scale (SAS), Ramsay Sedation Scale (RSS) or subjective CA utilizing traditional clinical signs (heart rate, blood pressure, conscious level and pupillary size). Only one study was classified as low risk of bias, the other three studies were classified as high risk.There was no evidence of a difference in one study (N = 50) that measured ICU LOS (Median (Interquartile Range IQR) 8 (4 to 14) in the CA group; 12 (6 to 18) in the BIS group; low-quality evidence).There was little or no effect on the duration of mechanical ventilation (MD -0.02 days (95% CI -0.13 to 0.09; 2 studies; N = 155; I2 = 0%; low-quality evidence)). Adverse events were reported in one study (N = 105) and the effects on restlessness after suction, endotracheal tube resistance, pain tolerance during sedation or delirium after extubation were uncertain due to very low-quality evidence. Clinically relevant adverse events such as self-extubation were not reported in any study. Three studies reported the amount of sedative agents used. We could not measure combined difference in the amount of sedative agents used because of different sedation protocols and sedative agents used in the studies. GRADE quality of evidence was very low. No study reported other secondary outcomes of interest for the review. AUTHORS' CONCLUSIONS: We found insufficient evidence about the effects of BIS monitoring for sedation in critically ill mechanically ventilated adults on clinical outcomes or resource utilization. The findings are uncertain due to the low- and very low-quality evidence derived from a limited number of studies.
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Anestesia , Monitores de Consciência , Estado Terminal , Unidades de Terapia Intensiva , Respiração Artificial , Adulto , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial/efeitos adversos , Respiração Artificial/estatística & dados numéricos , Resultado do TratamentoRESUMO
Deep learning (DL) offers promising performance in computer vision tasks and is highly suitable for dental image recognition and analysis. We evaluated the accuracy of DL algorithms in identifying and classifying dental implant systems (DISs) using dental imaging. In this systematic review and meta-analysis, we explored the MEDLINE/PubMed, Scopus, Embase, and Google Scholar databases and identified studies published between January 2011 and March 2022. Studies conducted on DL approaches for DIS identification or classification were included, and the accuracy of the DL models was evaluated using panoramic and periapical radiographic images. The quality of the selected studies was assessed using QUADAS-2. This review was registered with PROSPERO (CRDCRD42022309624). From 1,293 identified records, 9 studies were included in this systematic review and meta-analysis. The DL-based implant classification accuracy was no less than 70.75% (95% confidence interval [CI], 65.6%-75.9%) and no higher than 98.19 (95% CI, 97.8%-98.5%). The weighted accuracy was calculated, and the pooled sample size was 46,645, with an overall accuracy of 92.16% (95% CI, 90.8%-93.5%). The risk of bias and applicability concerns were judged as high for most studies, mainly regarding data selection and reference standards. DL models showed high accuracy in identifying and classifying DISs using panoramic and periapical radiographic images. Therefore, DL models are promising prospects for use as decision aids and decision-making tools; however, there are limitations with respect to their application in actual clinical practice.
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BACKGROUND: Long-chain polyunsaturated fatty acids (LCPUFA) are critical for the maturation of the brain and retina. Retinopathy of prematurity (ROP) is a preventable cause of blindness in preterm infants. LCPUFA have anti-inflammatory, antioxidant, and antiangiogenesis effects. Supplementation of enteral LCPUFA might mitigate the incidence of ROP in these infants. Available limited randomized studies showed promising results. We aimed to assess the effect of enteral supplementation of LCPUFA on ROP in preterm infants. METHODS: We followed PRISMA guidelines and searched MEDLINE, Cumulative Index of Nursing and Allied Health Literature, Embase, and Cochrane Registry from 1990 to 2021 for the studies that examined the effects of enteral LCPUFA and ROP in preterm infants. We included the studies that satisfied the predefined inclusion criteria. RevMan 5.3 software derived the forest plot of pooled relative risk. We assessed the quality of all the included studies using GRADE recommendations. RESULTS: Nine studies were eligible for the meta-analysis involving 2,482 infants. Of the nine RCTs, six studies provided LCPUFA (DHA/AA) as a separate intervention in different concentrations, and three studies provided formula milk enriched with LCPUFA. In addition, five studies recruited infants below 32 weeks of gestational age. Supplementation of LCPUFA did not reduce the incidence of severe ROP (RR 0.71, 95% CI: 0.50-1.01, 5 studies, 1,822 infants) with very low CoE or any ROP (RR 0.95, 95% CI: 0.73-1.12, 6 studies, 1,177 infants) with very low CoE or ROP requiring treatment (RR 0.92, 95% CI: 0.62-1.38, 4 studies, 1,395 infants) with very low CoE. Regarding safety outcomes, enteral LCPUFA did not increase the risk of necrotizing enterocolitis or mortality. DISCUSSION/CONCLUSION: Supplementation of enteral LCPUFA to preterm infants did not reduce ROP incidence; however, there was a trend toward benefit in mitigating severe form of ROP. More well-designed, large, randomized controlled studies are warranted.
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Doenças do Prematuro , Retinopatia da Prematuridade , Inibidores da Angiogênese , Antioxidantes , Ácidos Graxos Insaturados , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Retinopatia da Prematuridade/prevenção & controleRESUMO
OBJECTIVE: Conventional nonsurgical periodontal therapy, i.e., scaling and root planing (SRP), is not sufficient to completely eradicate the microorganisms present in dental plaque biofilm due to the incapability of instruments to reach the inaccessible areas of a tooth with anatomical variations. Hence, to increase the effectiveness of SRP, many adjunctive treatment strategies are proposed, including photodynamic therapy (PDT). Therefore, the purpose of this study was to determine the clinical and microbiological efficacy of PDT using Indocyanine green (ICG) as a novel photosensitizer for the treatment of chronic periodontitis. MATERIALS AND METHODS: Twenty individuals who fulfilled the eligibility criteria were enrolled for this randomized controlled clinical trial using split-mouth design. Treatment sites from each individual were randomly allocated into two groups: SRP was done for the sites of the control group and an additional session of PDT using ICG was performed for the sites of the test group. Subgingival plaque samples were collected from both the sites and sent for quantitative analysis of Treponema denticola, Porphyromonas gingivalis, and Tannerella forsythia using real-time polymerase chain reaction (RT-PCR) technique. Probing pocket depth (PD), clinical attachment loss (CAL), and count of all the three microorganisms were assessed at baseline and after 3 months. RESULTS: After 3 months, PD and CAL showed statistically significant improvement in the test sites (P < 0.001) compared to the control sites. However, the differences in the microbiological parameters were statistically nonsignificant between the groups. CONCLUSION: ICG as a photosensitizer may enhance the outcomes of SRP and can be used for PDT for the nonsurgical management of periodontal diseases.
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INTRODUCTION: Machine learning in computer-assisted diagnostics improves sensitivity of image analysis and reduces time and effort for interpretation. Compared to standard mammograms, a thermal scan is easily scalable and is a safer screening tool. We evaluate the performance of Thermalytix (an automated thermographic screening algorithm) compared with other standard breast cancer screening modalities. METHODS: A prospective multicentre study was conducted to assess the non-inferiority of sensitivity of Thermalytix (test device) to that of standard modalities in detecting malignancy in subjects who show possible symptoms of suspected breast cancer. Standard screening modalities and Thermalytix were obtained and interpreted independently in a blinded fashion. A receiver operating characteristic (ROC) curve was constructed to identify the best cut-off point, non-inferiority margin of ≥10% to demonstrate the non-inferiority. RESULTS: We recruited 258 symptomatic women who first underwent a thermal scan, followed by mammogram and/or ultrasound. At Youden's Index of ROC curve, the test device had a sensitivity of 82.5% (95% CI 73.2 to 91.9) and specificity of 80.5% (95% CI 75.0 to 86.1) as compared with diagnostic mammogram, which had sensitivity of 92% (95% CI 80.7 to 97.8) and specificity of 45.9% (95% CI 34.3 to 57.9) when BI-RADS 3 (Breast Imaging-Reporting and Data System) was considered as test-positive. The overall area under the curve (AUC) was 0.845. For women aged <45 years, the test device had a sensitivity and specificity of 87.0% (95% CI 66.4 to 97.2) and 80.6% (95% CI 72.9 to 86.9), respectively. For women aged ≥45 years, the sensitivity and specificity were 80.5% (95% CI 65.1 to 91.2) and 86.5% (95% CI 78.0 to 92.6, respectively). CONCLUSION: We evaluated Thermalytix, a new AI-based modality for detecting breast cancer. The high AUC in both women under 45 years and above 45 years shows the potential of Thermalytix to be a supplemental diagnostic modality for all ages. Further evaluation on larger sample size is needed. TRIAL REGISTRATION NUMBER: CTRI/2017/10/0 10 115.