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2021 ◽  
Author(s):  
Pamela Rose Buckley ◽  
Charles R. Ebersole ◽  
Christine Steeger ◽  
Laura Elizabeth Michaelson ◽  
Karl G. Hill ◽  
...  

Objective. Transparency of research methods is vital to science, though incentives are variable, with only some journals and funders adopting transparency policies. Clearinghouses are also important stakeholders; however, to date none have implemented formal procedures that facilitate transparent research. Using data from the longest standing clearinghouse, we examine transparency practices for preventive interventions to explore the role of online clearinghouses in incentivizing researchers to make their research more transparent. Methods. We conducted a descriptive analysis of 88 evaluation reports reviewed in 2018-19 by Blueprints for Healthy Youth Development, when the clearinghouse began checking for trial registrations, and expanded on these efforts by applying broader transparency standards to interventions eligible for an endorsement on the Blueprints website during the study period. Reports were recent, with 84% published between 2010 and 2019. Results. We found few reports had data, code, or research materials that were publicly available. Meanwhile, 40% had protocols that were registered, but only 8% were registered prospectively, while one-quarter were registered before conducting analyses. About one-third included details in a registered protocol describing the treatment contrast and planned inclusions, and less than 5% had a registered statistical analysis plan (e.g., planned analytical methods, pre-specified covariates, etc.). Confirmatory research was distinguished from exploratory work in roughly 40% of reports. Reports published more recently (after 2015) had higher rates of transparency. Conclusions. Preventive intervention research needs to be more transparent. Since clearinghouses rely on robust findings to make well-informed decisions and researchers are incentivized to meet clearinghouse standards, clearinghouses should consider policies that encourage transparency to improve the credibility of evidence-based interventions.


Introduction: The goal of this 2-arm equal preliminary clinical trial was to decide the plaque expulsion efficacy (primary result) and the motivation assessment (auxiliary result) looking at a manual versus an interactive power toothbrush in orthodontic patients. Methods: Sixty teenagers with fixed orthodontic appliances who reported to the Department of Periodontics for routine oral prophylaxis in the both arches were randomized in a 1:1 proportion parallel, randomized, examiner-blindcontrolled clinical preliminary. Qualification criteria included in any event 16 characteristic teeth, 1-6 "center consideration zones," plaque score of ≥1.75, no serious caries, gingivits and periodontitis, no dental prophylaxis, no smoking, no anti-microbials, and no chlorhexidine mouth wash. Subjects were to brush solo with either an interactive power toothbrush (Oral-B Professional Care 6000, D36/EB20) with Bluetooth innovation or a customary manual toothbrush (Oral-B Indicator 35 delicate). Center consideration regions were each brushed for 10 extra seconds like inter-proximal spaces. Plaque removal was surveyed with the utilization of the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) to decide change from standard at 2 weeks followed by 6 weeks. Supervised brushing at screening and post-treatment visits recorded real brushing times. Subject-revealed motivational viewpoints were recorded at screening and week 6. Results: Fifty-nine subjects between 13-17 years finished the investigation. The interactive power toothbrush gave significantly (P\0.001) more noteworthy plaque decrease versus the manual toothbrush at 2 and 6 week as indicated by the entire mouth TMQHPI. The treatment contrast in balanced mean plaque change from standard was 0.777 (95% CI 0.614-0.940) at week 2 and 0.834 (0.686-0.981) at week 6. Mean decreases in the quantity of center consideration regions were likewise significantly more noteworthy (P \0.001) in the power brush bunch at weeks 2 and 6. Brushing times increased significantly at weeks 2 and 6 (P #0.013) versus standard baseline in the interactive powertoothbrush group only.Subject-revealed motivation was significantly increased in the interactive power tooth brush group at week 6 as opposed to screening (P #0.005). Conclusions: An interactive power toothbrush produced increased brushing times and significantly more prominent plaque removal versus a manual brush.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Chengbing Zeng ◽  
Tiantian Zhai ◽  
Jianzhou Chen ◽  
Longjia Guo ◽  
Baotian Huang ◽  
...  

Abstract Background This study aimed to evaluate the predictive potential of contrast-enhanced computed tomography (CT)-based imaging biomarkers (IBMs) for the treatment outcomes of patients with oesophageal squamous cell carcinoma (OSCC) after definitive concurrent chemoradiotherapy (CCRT). Methods Altogether, 154 patients with OSCC who underwent definitive CCRT were included in this retrospective study. All patients were randomised to the training cohort (n = 99) or the validation cohort (n = 55). Pre-treatment contrast-enhanced CT scans were obtained for all patients and used for the extraction of IBMs. An IBM score, was constructed by using the least absolute shrinkage and selection operator with Cox regression analysis, which was equal to the log-partial hazard of the Cox model in the training cohort and tested in the validation cohort. IBM nomograms were built based on IBM scores for individualised survival estimation. Finally, a decision curve analysis was performed to estimate the clinical usefulness of the nomograms. Results Altogether, 96 IBMs were extracted from each contrast-enhanced CT scan. IBM scores were constructed from 11 CT-based IBMs for overall survival (OS) and 8 IBMs for progression-free survival (PFS), using the LASSO-Cox regression method in the training cohort. Multivariate analysis revealed that IBM score was an independent prognostic factor correlated with OS and PFS. In the training cohort, the C-indices of IBM scores were 0.734 (95% CI 0.664–0.804) and 0.658 (95% CI 0.587–0.729) for OS and PFS, respectively. In the validation cohort, C-indices were 0.672 (95% CI 0.578–0.766) and 0.666 (95% CI 0.574–0.758) for OS and PFS, respectively. Kaplan–Meier survival analysis showed a significant difference between risk subgroups in the training and validation cohorts. Decision curve analysis confirmed the clinical usefulness of the IBM score. Conclusions The IBM score based on pre-treatment contrast-enhanced CT could predict the OS and PFS for patients with OSCC after definitive CCRT. Further multicentre studies with larger sample sizes are warranted.


2020 ◽  
Author(s):  
Chengbing Zeng ◽  
Tiantian Zhai ◽  
Jianzhou Chen ◽  
Longjia Guo ◽  
Baotian Huang ◽  
...  

Abstract Background: This study aimed to evaluate the predictive potential of contrast-enhanced computed tomography (CT)-based imaging biomarkers (IBMs) for the treatment outcomes of patients with oesophageal squamous cell carcinoma (OSCC) after definitive concurrent chemoradiotherapy (CCRT).Methods: Altogether, 154 patients with OSCC who underwent definitive CCRT were included in this retrospective study. All patients were randomised to the training cohort (n=99) or the validation cohort (n=55). Pre-treatment contrast-enhanced CT scans were obtained for all patients and used for the extraction of IBMs. An IBM score, was constructed by using the least absolute shrinkage and selection operator with Cox regression analysis, which was equal to the log-partial hazard of the Cox model in the training cohort and tested in the validation cohort. IBM nomograms were built based on IBM scores for individualised survival estimation. Finally, a decision curve analysis was performed to estimate the clinical usefulness of the nomograms.Results: Altogether, 96 IBMs were extracted from each contrast-enhanced CT scan. IBM scores were constructed from 11 CT-based IBMs for overall survival (OS) and 8 IBMs for progression-free survival (PFS), using the LASSO-Cox regression method in the training cohort. Multivariate analysis revealed that IBM score was an independent prognostic factor correlated with OS and PFS. In the training cohort, the C-indices of IBM scores were 0.734 (95%CI, 0.664–0.804) and 0.658 (95%CI, 0.587–0.729) for OS and PFS, respectively. In the validation cohort, C-indices were 0.672 (95%CI, 0.578–0.766) and 0.666 (95%CI, 0.574–0.758) for OS and PFS, respectively. Kaplan-Meier survival analysis showed a significant difference between risk subgroups in the training and validation cohorts. Decision curve analysis confirmed the clinical usefulness of the IBM score.Conclusions: The IBM score based on pre-treatment contrast-enhanced CT could predict the OS and PFS for patients with OSCC after definitive CCRT. Further multicentre studies with larger sample sizes are warranted.


2020 ◽  
Author(s):  
Chengbing Zeng ◽  
Tiantian Zhai ◽  
Jianzhou Chen ◽  
Longjia Guo ◽  
Baotian Huang ◽  
...  

Abstract Background: This study aimed to evaluate the predictive potential of contrast-enhanced computed tomography (CT)-based imaging biomarkers (IBMs) for the treatment outcomes of patients with oesophageal squamous cell carcinoma (OSCC) after definitive concurrent chemoradiotherapy (CCRT).Methods: Altogether, 154 patients with OSCC who underwent definitive CCRT were included in this retrospective study. All patients were randomised to the training cohort (n=99) or the validation cohort (n=55). Pre-treatment contrast-enhanced CT scans were obtained for all patients and used for the extraction of IBMs. An IBM score was constructed by using the least absolute shrinkage and selection operator with Cox regression analysis in the training cohort and tested in the validation cohort. IBM nomograms were built based on IBM scores for individualised survival estimation. Finally, a decision curve analysis was performed to estimate the clinical usefulness of the nomograms.Results: Altogether, 96 IBMs were extracted from each contrast-enhanced CT scan. IBM scores were constructed from 11 CT-based IBMs for overall survival (OS) and 8 IBMs for progression-free survival (PFS), using the LASSO-Cox regression method in the training cohort. Multivariate analysis revealed that IBM score was an independent prognostic factor correlated with OS and PFS. In the training cohort, the C-indices of IBM scores were 0.734 (95%CI, 0.664–0.804) and 0.658 (95%CI, 0.587–0.729) for OS and PFS, respectively. In the validation cohort, C-indices were 0.672 (95%CI, 0.578–0.766) and 0.666 (95%CI, 0.574–0.758) for OS and PFS, respectively. Kaplan-Meier survival analysis showed a significant difference between risk subgroups in the training and validation cohorts. Decision curve analysis confirmed the clinical usefulness of the IBM score.Conclusions: The IBM score based on pre-treatment contrast-enhanced CT could predict the OS and PFS for patients with OSCC after definitive CCRT. Further multicentre studies with larger sample sizes are warranted.


2020 ◽  
Author(s):  
Chengbing Zeng ◽  
Tiantian Zhai ◽  
Jianzhou Chen ◽  
Longjia Guo ◽  
Baotian Huang ◽  
...  

Abstract Background: This study aimed to evaluate the predictive potential of contrast-enhanced computed tomography (CT)-based imaging biomarkers (IBMs) for the treatment outcomes of oesophageal squamous cell carcinoma (OSCC) patients after definitive concurrent chemoradiotherapy (CCRT). Methods: Altogether, 154 patients with OSCC who underwent definitive CCRT were included in this retrospective study. All patients were separated randomly to a training cohort (n=99) and the validation cohort (n=55). Pre-treatment contrast-enhanced CT scans were obtained for all patients and used for the extraction of IBMs. An IBM score was constructed by using the least absolute shrinkage and selection operator with Cox regression analysis in the training cohort and tested in the validation cohort. IBM nomograms were built based on IBM scores for individualized survival estimation. Finally, a decision curve analysis was performed to estimate the clinical usefulness of the nomograms. Results: Altogether, 96 IBMs were extracted from each contrast-enhanced CT scan. The IBM score constructed by 11 CT-based IBMs, using LASSO-Cox regression method in training cohort. The multivariate analysis revealed that IBM score was the independent prognostic factor correlated with overall survival (OS) and progression-free survival (PFS). In the training cohort, the C-indices of IBM scores were 0.734 (95%CI, 0.664–0.804) and 0.678 (95%CI, 0.607–0.745) for OS and PFS, respectively. In the validation cohort, C-indices were 0.672 (95%CI, 0.578–0.766) and 0.662 (95%CI, 0.573–0.751) for OS and PFS, respectively. Kaplan-Meier survival analysis showed significantly different between risk subgroups in training and validation cohort. The decision curve showed the clinical usefulness of IBM score. Conclusions: The IBM score based on pre-treatment contrast-enhanced CT could predict the OS and PFS for patients with OSCC after definitive CCRT. Further multicentre studies with larger sample sizes are warranted.


2020 ◽  
Author(s):  
Chengbing Zeng ◽  
Tiantian Zhai ◽  
Jianzhou Chen ◽  
Longjia Guo ◽  
Baotian Huang ◽  
...  

Abstract Background: This study aimed to evaluate the predictive potential of contrast-enhanced computed tomography (CT)-based imaging biomarkers (IBMs) for the treatment outcomes of oesophageal squamous cell carcinoma (OSCC) patients after definitive concurrent chemoradiotherapy (CCRT).Methods: A total of 151 ESCC patients who underwent definitive CCRT were included in this retrospective study. All patients were separated randomly to a training cohort (n=97) and the validation cohort (n=54). Pre-treatment contrast-enhanced CT scans were obtained for all patients and used for the extraction of IBMs. An IBM score was constructed by using the least absolute shrinkage and selection operator with logistic regression analysis in training cohort and tested in the validation cohort. IBMsnomograms were built based on IBM score. The concordance index (C-index) was used to assess the performance of the nomograms. Finally, decision curve analysis was performed to estimate the clinical usefulness of the nomograms.Results: A total of 96 IBMs were extracted from each contrast-enhanced CT scan. The IBM score were consisted of 13 CT-based IBMs and were significantly correlated with 3-year overall survival (OS) and 3-year progression-free survival (PFS). Multivariate analysis revealed that IBM score was the independent prognostic factor. In the training cohort, the IBM score yielded an area under the curves (AUCs) of 0.802 (95% CI: 0.713–0.891, p<0.001) and 0.742 (95% CI: 0.620–0.889, p<0.001) in terms of 3-year OS and 3-year PFS, respectively. In validation cohort, the AUCs were 0.761(95% CI: 0. 639–0.900, p<0.001) and 0.761(95% CI: 0.629–0.893, p=0.001) for 3-year OS and 3-year PFS,respectively. Kaplan-Meier survival analysis showed significantly different between risk subgroups in training and validation cohort. The nomograms were built based on the IBM score showed good discrimination. In the training cohort, with the C-indices of IBMsnomograms were 0.732 (95%CI, 0.661–0.803) and 0.670(95%CI, 0.595–0.745) for OS and PFS, respectively. In the validation cohort C-indices were 0.677(95%CI, 0.583–0.771) and 0.678(95%CI, 0.591–0.765) for OS and PFS, respectively. The decision curve showed the clinical usefulness of nomograms.Conclusions: TheIBM score based on pre-treatment contrast-enhanced CT could predict the 3-year OS and 3-year PFS for OSCC patients after definitive CCRT. Further multicenter studies with larger sample sizes are warranted.


QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
N A Abdelaziz ◽  
T M Abdalla ◽  
Y A Thabet ◽  
S M Fawzy

Abstract Aim of the Work This prospective analysis was planned for patients with chronic central serous retinopathy (CSR) more than three months who receive oral Eplerenone for treatment. It is aimed to reduce &resolve sub retinal fluid with improving anatomical and physiological visual functions. Patient &Methods sixteen eyes with untreated chronic Central Serous Chorioretinopathy patients who recruited from the ophthalmic clinic. Main intervention is medication by standard dose of Eplerenone, 50mg once daily. Investigated by Optical Coherence Topography at base line, one month after treatment and three months later. Over the course of the study, patients were monitored for side effects, visual and anatomical response to the medication. Results Significant difference in BCVA is found that was 0.675 ±0.2696 at base line to 0.48125±0.2287 after one month after treatment and to 0.04375±0.07274 three months after treatment, (p = 0.000). Sub retinal fluid measurements were improved significantly between each two visits as horizontal fluid volume is improved from 2137 ±987.93 at base line to1559.875 ±677.60 after one month after treatment and to 0 three months after treatment. Vertical fluid volume is improved from 203.125 ±118.73 at base line to122±49.876 after one month after treatment and to 0 three months after treatment. Central sub field thickness were improved significantly between each two visits as it is improved from 372.375 ±92.994 at base line to331.8125 ±90.283 after one month after treatment and to 250.25±25.970 three months after treatment. Contrast sensitivity improved significantly between each two visits as it is improved from 8.7625 ±4.029 at base line to 5.1968±3.227after one month after treatment and to 1.4968±0.4750 three months after treatment. Choroidal thickness was improved significantly between each two visits as it was improved from 267.9375 ±67.451 at base line to222±52.262 after one month after treatment and to 174.0625±23.713 three months after treatment. 100% of the patients complained from positive scotoma at base line, Improved to 44% of the patients complained from positive scotoma one month after treatment, improved to 0% three months after treatment. Conclusion Eplerenone therapy resulted in significant anatomic and visual improvements in eyes with chronic central serous Chorioretinopathy.


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