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Nevin Manimala Statistics

Efficacy and safety of photodynamic therapy mediated by 5-aminolevulinic acid for the treatment of cervical intraepithelial neoplasia 2: a single-center, prospective, cohort Study

Photodiagnosis Photodyn Ther. 2021 Aug 1:102472. doi: 10.1016/j.pdpdt.2021.102472. Online ahead of print.

ABSTRACT

Background Photodynamic therapy (PDT) mediated by 5-aminolevulinic acid (5-ALA) is a possible minimally-invasive treatment for cervical intraepithelial neoplasia (CIN). The present study was carried out to investigate the effect of 5-ALA-PDT on CIN2 and the influencing factors of 5-ALA-PDT. Methods Patients diagnosed as CIN2 who met the inclusion criteria were enrolled in this study sequentially from January 2019 to April 2020. Patients were treated by PDT or cryotherapy according to their intentions. The primary endpoint was pathological regression. The secondary endpoint was HPV clearance. Affecting factors of the efficacy of PDT and adverse events were also assessed during treatment. Results A total of 210 patients were enrolled, including 97 patients in PDT group and 101 patients in cryotherapy group, with 12 patients excluded. There was no statistical difference in population characteristics. The pathological regression rate in PDT group was 92.0% (80/87), compared with 81.4% (79/97) in cryotherapy group (P <0.05). The HPV clearance rate was 64.4% (56/87) in PDT group and 57.8% (56/97) in cryotherapy group (P =0.36). The main side effects of PDT were abdominal pain (24.1%, 21/87) and increased vaginal secretions (23.0%, 20/87). On univariate analysis, the risk for lesions persisting at 6 months after PDT was increased by recurrent genital tract inflammation (P =0.004), smoking or passive smoking (P =0.020), and multicentric lesions (P = 0.020). Conclusion PDT can be a safe and efficient treatment for CIN2. Risk factors for persisting HSIL after PDT include recurrent genital tract inflammation, smoking or passive smoking, and multicentric lesions.

PMID:34348187 | DOI:10.1016/j.pdpdt.2021.102472

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Towards lower-dose PET using physics-based uncertainty-aware multimodal learning with robustness to out-of-distribution data

Med Image Anal. 2021 Jul 27;73:102187. doi: 10.1016/j.media.2021.102187. Online ahead of print.

ABSTRACT

Radiation exposure in positron emission tomography (PET) imaging limits its usage in the studies of radiation-sensitive populations, e.g., pregnant women, children, and adults that require longitudinal imaging. Reducing the PET radiotracer dose or acquisition time reduces photon counts, which can deteriorate image quality. Recent deep-neural-network (DNN) based methods for image-to-image translation enable the mapping of low-quality PET images (acquired using substantially reduced dose), coupled with the associated magnetic resonance imaging (MRI) images, to high-quality PET images. However, such DNN methods focus on applications involving test data that match the statistical characteristics of the training data very closely and give little attention to evaluating the performance of these DNNs on new out-of-distribution (OOD) acquisitions. We propose a novel DNN formulation that models the (i) underlying sinogram-based physics of the PET imaging system and (ii) the uncertainty in the DNN output through the per-voxel heteroscedasticity of the residuals between the predicted and the high-quality reference images. Our sinogram-based uncertainty-aware DNN framework, namely, suDNN, estimates a standard-dose PET image using multimodal input in the form of (i) a low-dose/low-count PET image and (ii) the corresponding multi-contrast MRI images, leading to improved robustness of suDNN to OOD acquisitions. Results on in vivo simultaneous PET-MRI, and various forms of OOD data in PET-MRI, show the benefits of suDNN over the current state of the art, quantitatively and qualitatively.

PMID:34348196 | DOI:10.1016/j.media.2021.102187

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Pancreatic Stereotactic Body Radiation Therapy with or without Hypofractionated Elective Nodal Irradiation

Int J Radiat Oncol Biol Phys. 2021 Aug 1:S0360-3016(21)02600-6. doi: 10.1016/j.ijrobp.2021.07.1698. Online ahead of print.

ABSTRACT

PURPOSE/OBJECTIVES: Pancreatic stereotactic body radiation therapy (SBRT) is limited to gross tumor without elective coverage for subclinical disease. Given a better understanding of recurrence patterns, we hypothesized that the addition of elective nodal irradiation (ENI) to pancreatic SBRT would be tolerable and would decrease locoregional progression.

MATERIALS/METHODS: We conducted a retrospective 1:2 propensity-matched cohort study to compare toxicity and locoregional progression among patients treated with pancreatic SBRT with or without ENI. In the SBRT+ENI cohort, an elective target volume was delineated per RTOG guidelines and treated to 25 Gy in 5 fractions alongside 40 Gy in 5 fractions to gross disease. The primary outcome was the cumulative incidence of locoregional progression, with death as a competing risk.

RESULTS: Among 135 candidate controls treated with SBRT alone, 100 were propensity-matched to 50 patients treated with SBRT+ENI. All patients completed SBRT. Median potential radiographic follow-up was 28 months. The incidence of late and serious acute toxicity were similar between matched cohorts. However, SBRT+ENI was associated with a statistically significant increase in acute grade 1-2 nausea (60% vs. 20%, p<0.001). The 24-month cumulative incidences of locoregional progression with and without ENI were 22.6% (95% confidence interval [CI]: 10.0-35.1%) vs. 44.6% (95% CI: 34.8-54.4%, multivariable-adjusted hazard ratio 0.39, 95% CI 0.18-0.87, p=0.021). This was stable in sensitivity analyses of uniform prescription dose, multiagent chemotherapy, and resectability. There were fewer peripancreatic (0% vs. 7%), porta hepatis (2% vs. 7%), and peri-aortic/aortocaval (5% vs. 12%) recurrences after SBRT+ENI, but no difference in survival.

CONCLUSIONS: Pancreatic SBRT+ENI was tolerable and did not increase late or serious acute toxicity relative to a matched cohort undergoing SBRT alone, but did increase acute grade 1-2 nausea. The addition of ENI to SBRT was associated with decreased locoregional progression but not improved survival. Further studies are warranted to determine if ENI offers meaningful benefit.

PMID:34348171 | DOI:10.1016/j.ijrobp.2021.07.1698

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Prediction models: stepwise development and simultaneous validation is a step back

J Clin Epidemiol. 2021 Aug 1:S0895-4356(21)00235-3. doi: 10.1016/j.jclinepi.2021.07.019. Online ahead of print.

NO ABSTRACT

PMID:34348179 | DOI:10.1016/j.jclinepi.2021.07.019

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Status of dysphagia after ischemic stroke: A Korean nationwide study

Arch Phys Med Rehabil. 2021 Aug 1:S0003-9993(21)01313-7. doi: 10.1016/j.apmr.2021.07.788. Online ahead of print.

ABSTRACT

OBJECTIVE: To identify the incidence of dysphagia after ischemic stroke and determine factors affecting the presence of dysphagia.

DESIGN: Retrospective case-control study. This was an interim analysis of a prospective multicenter Korean stroke cohort.

SETTING: Acute care university hospitals.

PARTICIPANTS: Patients (N=6000) with first-ever acute ischemic stroke. Patients were divided into two groups according to the presence or absence of dysphagia confirmed at 7 days after onset using the American Speech-Language-Hearing Association National Outcomes Measurement System (ASHA-NOMS) scale, which was determined after conducting screening or standardized tests.

INTERVENTIONS: Not applicable.

MAIN OUTCOME MEASURES: Age at stroke onset, body mass index (BMI), premorbid modified Rankin Scale (mRS), brainstem lesions, National Institutes of Health Stroke Scale (NIHSS), post-stroke mRS, and ASHA-NOMS swallowing level at post-stroke day 7 were evaluated.

RESULTS: Among ischemic stroke patients, 32.3% (N=1940) had dysphagia at 7 days after stroke onset. At discharge, 80.5% (N=1561) still had dysphagia. The prediction model for the presence of dysphagia identified age at onset, underweight (BMI < 18.5 kg/m2), premorbid mRS, brainstem lesions, and NIHSS as independent predictors. The odds ratio (OR) for the presence of dysphagia significantly increased with underweight (OR [95% confidence interval]: 1.6684 [1.27-2.20]), increased age at onset (1.0318 [1.03-1.04]), premorbid mRS (1.1832 [1.13-1.24]), brainstem lesions (1.6494 [1.39-1.96]), and NIHSS (1.2073 [1.19-1.23]).

CONCLUSIONS: The incidence of dysphagia after ischemic stroke was 32.3%. The prediction model for the presence of dysphagia identified age, low BMI, premorbid disabilities, brainstem lesions, and NIHSS as predictive factors.

PMID:34348122 | DOI:10.1016/j.apmr.2021.07.788

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Is Google Trends a useful tool for tracking mental and social distress during a public health emergency? A time-series analysis

J Affect Disord. 2021 Jul 9;294:737-744. doi: 10.1016/j.jad.2021.06.086. Online ahead of print.

ABSTRACT

BACKGROUND: Google Trends data are increasingly used by researchers as an indicator of population mental health, but few studies have investigated the validity of this approach during a public health emergency.

METHODS: Relative search volumes (RSV) for the topics depression, anxiety, self-harm, suicide, suicidal ideation, loneliness, and abuse were obtained from Google Trends. We used graphical and time-series approaches to compare daily trends in searches for these topics against population measures of these outcomes recorded using validated self-report scales (PHQ-9; GAD-7; UCLA-3) in a weekly survey (n = ~70,000) of the impact COVID-19 on psychological and social experiences in the UK population (21/03/2020 to 21/08/ 2020).

RESULTS: Self-reported levels of depression, anxiety, self-harm/suicidal ideation, self-harm, loneliness and abuse decreased during the period studied. There was no evidence of an association between self-reported anxiety, self-harm, abuse and RSV on Google Trends. Trends in Google topic RSV for depression and suicidal ideation were inversely associated with self-reports of these outcomes (p = 0.03 and p = 0.04, respectively). However, there was statistical and graphical evidence that self-report and Google searches for loneliness (p < 0.001) tracked one another.

LIMITATIONS: No age/sex breakdown of Google Trends data available. Survey respondents were not representative of the UK population and no pre-pandemic data were available.

CONCLUSION: Google Trends data do not appear to be a useful indicator of changing levels of population mental health during a public health emergency, but may have some value as an indicator of loneliness.

PMID:34348169 | DOI:10.1016/j.jad.2021.06.086

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Nevin Manimala Statistics

Learning from patient safety incidents involving acutely sick adults in hospital assessment units in England and Wales: a mixed methods analysis for quality improvement

J R Soc Med. 2021 Aug 4:1410768211032589. doi: 10.1177/01410768211032589. Online ahead of print.

ABSTRACT

OBJECTIVE: Six per cent of hospital patients experience a patient safety incident, of which 12% result in severe/fatal outcomes. Acutely sick patients are at heightened risk. Our aim was to identify the most frequently reported incidents in acute medical units and their characteristics.

DESIGN: Retrospective mixed methods methodology: (1) an a priori coding process, applying a multi-axial coding framework to incident reports; and, (2) a thematic interpretative analysis of reports.

SETTING: Patient safety incident reports (10 years, 2005-2015) collected from the National Reporting and Learning System, which receives reports from hospitals and other care settings across England and Wales.

PARTICIPANTS: Reports describing severe harm/death in acute medical unit were identified.

MAIN OUTCOME MEASURES: Incident type, contributory factors, outcomes and level of harm were identified in the included reports. During thematic analysis, themes and metathemes were synthesised to inform priorities for quality improvement.

RESULTS: A total of 377 reports of severe harm or death were confirmed. The most common incident types were diagnostic errors (n = 79), medication-related errors (n = 61), and failures monitoring patients (n = 57). Incidents commonly stemmed from lack of active decision-making during patient admissions and communication failures between teams. Patients were at heightened risk of unsafe care during handovers and transfers of care. Metathemes included the necessity of patient self-advocacy and a lack of care coordination.

CONCLUSION: This 10-year national analysis of incident reports provides recommendations to improve patient safety including: introduction of electronic prescribing and monitoring systems; forcing checklists to reduce diagnostic errors; and increased senior presence overnight and at weekends.

PMID:34348052 | DOI:10.1177/01410768211032589

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Relation between Bone Density and Primary Stability in the Posterior Mandibular Region in Patients Undergoing Dental Implant Treatment: A Retrospective Study

J Long Term Eff Med Implants. 2021;31(2):71-79. doi: 10.1615/JLongTermEffMedImplants.2021035972.

ABSTRACT

Tooth loss has become one of the most raising issues to be brought up in dentistry, by both patients and dentists. Teeth are considered to be important in case of function and esthetics. Compromise to the dentition would raise social disturbances for the individual. Dental implants are surgical fixtures or artificial tooth roots that are placed into the jawbone. It is one of the best methods of tooth replacement. When considering implants, the dentist must approach it with a multidisciplinary treatment plan. They should consider factors such as age, gender, habit, systemic diseases, oral hygiene, placement site and technique, bone width and bone height, bone density, etc. complications for implant surgery would include bleeding, infections, pain, breakage, etc. A single center retrospective study was done in an institutional setting. The data for the study was retrieved from the college’s patient records management software. All patients undergoing implant surgery in the posterior mandibular region were considered. The patients age, gender, implant site, bone width, and bone height were taken into account as variables. The data received was analyzed using SPSS. A total of 737 patients were considered in the study, 383 being male patients and remaining 354 being female patients. the right and left molar teeth were more commonly replaced in comparison to premolars. The association between the primary stability and bone density was statistically significant (p < 0.05). Within the limitations of the study, males had better bone density than females and D2 bone density was predominantly seen in both males and females and between the age group between 26 to 40 years. D2 bone density is seen in both left and right molar regions. Primary stability was associated with the implant length, width and bone density.

PMID:34348015 | DOI:10.1615/JLongTermEffMedImplants.2021035972

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Effect of different levels of SVV on the endothelial glycocalyx of patients undergoing colorectal surgery: A randomised clinical trial

Exp Physiol. 2021 Aug 4. doi: 10.1113/EP089348. Online ahead of print.

ABSTRACT

NEW FINDINGS: What is the central question of the study? Massive infusion can destroy the endothelial glycocalyx (EG). We compared the serum concentrations of EG components, atrial natriuretic peptide (ANP), and the outcomes of patients with different levels of stroke volume variation (SVV). What is the main finding and its importance? With a decrease in SVV, the serum concentrations of EG components and ANP increased, while the oxygenation index decreased. When the intraoperative SVV was maintained at 7-10%, the patients had better postoperative recovery and shorter postoperative hospital stays. Therefore, it is better to maintain the SVV value between 7% and 10%.

ABSTRACT: Dynamic hemodynamic parameters, such as stroke volume variation (SVV), can be used for volume monitoring. However, studies have only determined the SVV threshold but not the optimal level. The endothelial glycocalyx (EG) plays an important role in maintaining vascular permeability. Moreover, rapid and massive infusion can lead to the degradation, shedding, and destruction of the EG. We aimed to explore the effects of different SVV values (11-14%, 7-10%, or 3-6%) on the EG in 54 patients who were scheduled for elective colorectal tumour surgery and identify the optimal perioperative fluid therapy strategy. The concentrations of EG degradation products (heparin sulphate, hyaluronic acid, syndecan-1) and atrial natriuretic peptide (ANP) were higher when the SVV was maintained between 3% and 6% after fluid therapy compared to before infusion (p < 0.05). Comparison of postoperative complications and hospitalisation time among the three SVV levels was not statistically significant (p >0.05). The postoperative hospitalisation time in group M was shorter than that in group L. When the SVV was maintained between 7% and 10%, patients had shorter postoperative recovery time compared to patients whose SVV was maintained at other levels. High fluid volume with increasing EG degeneration and ANP levels may be related to postoperative outcomes. This article is protected by copyright. All rights reserved.

PMID:34347918 | DOI:10.1113/EP089348

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Frequency of auto-antibodies of type 1 diabetes in adult patients with celiac disease

J Clin Lab Anal. 2021 Aug 4:e23941. doi: 10.1002/jcla.23941. Online ahead of print.

ABSTRACT

Both celiac disease (CD) and type 1 diabetes (T1D) are autoimmune diseases resulting from a complex interplay between genetic susceptibility and environmental factors.

AIM: In this retrospective study, we determined the frequency of auto-antibodies of T1D in adult patients with active CD.

MATERIALS AND METHODS: Eighty adult patients with active CD were included in our study. Ninety healthy blood donors (HBD) served as control group. Anti-glutamic acid decarboxylase IgG antibodies (GAD-Ab), anti-tyrosine phosphatase IgG antibodies (IA2-Ab), and anti-zinc transporter IgG antibodies (Zn-T8-Ab) were determined by enzyme-linked immunosorbent assay (ELISA) for patients and control group. For statistical analysis, we used Chi-square or Fisher’s exact test.

RESULTS: Out of 80 patients, 10 (12.50%) had auto-antibodies of T1D vs. only one in control group (1.11%) (p = 0.003). Simultaneous presence of GAD-Ab, IA2-Ab, and Zn-T8-Ab was found in one patient (1.25%). Nine patients had only GAD-Ab. IA2-Ab and Zn-T8-Ab were absent in all HBD. The frequency of GAD-Ab was significantly higher in CD patients than in HBD (12.5% vs 1.11%, p = 0.003).

CONCLUSION: The present study has shown that CD is associated with a high frequency of auto-antibodies of T1D. Screening for T1D in this population, at risk for other autoimmune diseases, may be useful.

PMID:34347922 | DOI:10.1002/jcla.23941