Category: Nevin Manimala

J Magn Reson Imaging. 2023 Feb 13. doi: 10.1002/jmri.28642. Online ahead of print.

ABSTRACT

BACKGROUND: Assessment of the activity of Graves’ ophthalmopathy (GO) is difficult. Existing methods need improvement.

PURPOSE: Investigate the application of multiparametric magnetic resonance imaging (MRI) in GO.

STUDY TYPE: Retrospective.

POPULATION: A total of 235 GO patients (age: 38.8 ± 13.4 years; 90 male; 96 active patients).

FIELD STRENGTH/SEQUENCE: Short-tau inversion recovery (STIR) fast spin echo, multiecho spin echo T2 mapping and 3D T1-weighted fast field echo sequences at 3.0 T.

ASSESSMENT: Two physicians assessed the mean and maximum signal intensity ratio of extraocular muscles to white matter (SIR), T2 relaxation time (T2RT), extraocular muscle area (EMA), fat fraction (FF), retrobulbar fat volume (RFV), and extraocular muscle volume (EMV). Clinical activity score (CAS) ≧ 3 was in active stage.

STATISTICAL TESTS: The optimal cut-off point of diagnostic efficacy was selected using receiver operating characteristic (ROC) curve analysis and evaluated using area under the curve (AUC), compared using Student’s t test, analysis of variance or Kruskal-Wallis H test. The correlation used Pearson correlation analysis. The discriminant equation used a binary logistic regression analysis. P < 0.05 was considered statistically significant.

RESULTS: The SIRmean, SIRmax, T2RTmean, T2RTmax, EMA, and EMV in active GO patients were significantly higher than those in inactive and were positively correlated with CAS (r = 0.276, 0.228, 0.438, 0.388, 0.502, and 0333, respectively). The FFmax of active patients was significantly lower than that of inactive patients and was negatively correlated with CAS (r = -0.44). Logistic regression analysis indicated that T2RTmean was independently associated with GO active periods and had good diagnostic performance (area under ROC curve = 0.736, sensitivity 70.7%, specificity 69.3%). T2RTmean ≧ 74.295 could be a diagnostic cut-off for judging GO activity (sensitivity 55.3%).

CONCLUSION: SIR, T2RT, EMV, and FF can quantitatively assess the activity and severity of GO and can potentially provide a basis for clinical judgment and selection of treatment options.

EVIDENCE LEVEL: 4.

TECHNICAL EFFICACY: Stage 2.

PMID:36780178 | DOI:10.1002/jmri.28642

JAMA Netw Open. 2023 Feb 1;6(2):e2255779. doi: 10.1001/jamanetworkopen.2022.55779.

ABSTRACT

IMPORTANCE: During the COVID-19 pandemic, children and adolescents were massively infected worldwide. In 2022, reinfections became a main feature of the endemic phase of SARS-CoV-2, so it is important to understand the epidemiology and clinical impact of reinfections.

OBJECTIVE: To assess the incidence, risk, and severity of pediatric SARS-CoV-2 reinfection.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used epidemiologic data of documented SARS-CoV-2 infections from the surveillance database of the Institute for Public Health of Vojvodina. A total of 32 524 children and adolescents from Vojvodina, Serbia, with laboratory-confirmed SARS-CoV-2 infection between March 6, 2020, and April 30, 2022, were followed up for reinfection until July 31, 2022.

MAIN OUTCOMES AND MEASURES: Incidence rates of documented SARS-CoV-2 reinfection per 1000 person-months, estimated risk of documented reinfection 90 days or more after laboratory confirmation of primary infection, reinfection severity, hospitalizations, and deaths.

RESULTS: The study cohort included 32 524 children and adolescents with COVID-19 (mean [SD] age, 11.2 [4.9] years; 15 953 [49.1%] male), including 964 children (3.0%) who experienced documented reinfection. The incidence rate of documented reinfections was 3.2 (95% CI, 3.0-3.4) cases per 1000 person-months and was highest in adolescents aged 12 to 17 years (3.4; 95% CI, 3.2-3.7). Most reinfections (905 [93.9%]) were recorded in 2022. The cumulative reinfection risk was 1.3% at 6 months, 1.9% at 9 months, 4.0% at 12 months, 6.7% at 15 months, 7.2% at 18 months, and 7.9% after 21 months. Pediatric COVID-19 cases were generally mild. The proportion of severe clinical forms decreased from 14 (1.4%) in initial episodes to 3 (0.3%) in reinfections. Reinfected children were approximately 5 times less likely to have severe disease during reinfection compared with initial infection (McNemar odds ratio, 0.2; 95% CI, 0.0-0.8). Pediatric reinfections rarely led to hospitalization (0.5% vs 1.3% during primary infections), and none resulted in death.

CONCLUSIONS AND RELEVANCE: This cohort study found that the SARS-CoV-2 reinfection risk remained substantially lower for children and adolescents compared with adults as of July 2022. Pediatric infections were mild, and reinfections were even milder than primary infections.

PMID:36780157 | DOI:10.1001/jamanetworkopen.2022.55779

Med Phys. 2023 Feb 13. doi: 10.1002/mp.16308. Online ahead of print.

ABSTRACT

BACKGROUND: Hematologic toxicity (HT) is a common adverse tissue reaction during radiotherapy for rectal cancer patients, which may lead to various negative effects such as reduced therapeutic effect, prolonged treatment period and increased treatment cost. Therefore, predicting the occurrence of HT before radiotherapy is necessary but still challenging.

PURPOSE: This study proposes a hybrid machine learning model to predict the symptomatic radiation hematologic toxicity in rectal cancer patients using the combined demographic, clinical, dosimetric, and Radiomics features, and ascertains the most effective regions of interest (ROI) in CT images and predictive feature sets.

METHODS: A discovery dataset of 240 rectal cancer patients, including 145 patients with hematologic toxicity (HT) symptoms and a validation dataset of 96 patients (63 patients with HT) with different dose prescription were retrospectively enrolled. Eight ROIs were contoured on patient CT images to derive Radiomics features, which were then respectively combined with the demographic, clinical and dosimetric features to classify patients with HT symptoms. Moreover, the survival analysis was performed on risky patients with HT in order to understand the HT progression.

RESULTS: The classification models in ROIs of bone marrow and femoral head exhibited relatively high accuracies (accuracy = 0.765 and 0.725) in the discovery dataset as well as comparable performances in the validation dataset (accuracy = 0.758 and 0.714). When combining the two ROIs together, the model performance was the best in both discovery and validation datasets (accuracy = 0.843 and 0.802). In the survival analysis test, only the bone marrow ROI achieved statistically significant performance in accessing risky HT (C-index = 0.658, p = 0.03). Most of the discriminative features were Radiomics features, and only gender and the mean dose in Irradvolume was involved in HT.

CONCLUSIONS: The results reflect that the Radiomics features of bone marrow is significantly correlated with HT occurrence and progression in rectal cancer. The proposed Radiomics-based model may help the early detection of radiotherapy induced HT in rectal cancer patients and thus improve the clinical outcome in future. This article is protected by copyright. All rights reserved.

PMID:36780152 | DOI:10.1002/mp.16308

JAMA Intern Med. 2023 Feb 13. doi: 10.1001/jamainternmed.2022.6787. Online ahead of print.

ABSTRACT

IMPORTANCE: Drug expenditures in the US are higher than in any other country and are projected to continue increasing, so US health systems may benefit from evaluating international regulatory and reimbursement decision-making of new drugs.

OBJECTIVE: To evaluate regulatory decisions and health technology assessments (HTAs) in Australia, Canada, and the UK regarding new drugs approved by the US Food and Drug Administration (FDA) in 2017 through 2020, as well as to estimate the US cost per patient per year for drugs receiving negative recommendations.

DESIGN AND SETTING: In this cross-sectional study, recommendations issued by agencies in Australia, Canada, and the UK were collected for new drugs approved by the FDA in 2017 through 2020. All data were current as of May 31, 2022.

EXPOSURES: Authorizations and HTAs in selected countries.

MAIN OUTCOMES AND MEASURES: All FDA-approved drugs were matched by active ingredient to decision summary reports published by drug regulators and HTA agencies in Australia, Canada, and the UK. Regulatory approval concordance and reasons for negative recommendations were assessed using descriptive statistics. For drugs not recommended by an international agency, the annual US drug cost per patient was estimated from FDA labeling and wholesale acquisition costs.

RESULTS: The FDA approved 206 new drugs in 2017 through 2020, of which 162 (78.6%) were granted marketing authorization by at least 1 other regulatory agency at a median (IQR) delay of 12.1 (17.7) months following US approval. Conversely, 5 FDA-approved drugs were refused marketing authorization by an international regulatory agency due to unfavorable benefit-to-risk assessments. An additional 42 FDA-approved drugs received negative reimbursement recommendations from HTA agencies in Australia, Canada, or the UK due to uncertainty of clinical benefits or unacceptably high prices. The median (IQR) US cost of the 47 drugs refused authorization or not recommended for reimbursement by an international agency was $115 281 ($166 690) per patient per year. Twenty drugs were for oncology indications, and 36 were approved by the FDA through expedited regulatory pathways or the Orphan Drug Act.

CONCLUSIONS AND RELEVANCE: This cross-sectional study assessed reasons for which drugs recently approved by the FDA were refused marketing authorization or not recommended for public reimbursement in other countries. Drugs with limited international market presence may require close examination by US health care professionals and health systems.

PMID:36780147 | DOI:10.1001/jamainternmed.2022.6787

CNS Drugs. 2023 Feb 13. doi: 10.1007/s40263-022-00982-6. Online ahead of print.

ABSTRACT

BACKGROUND: STRIVE was a prospective, 4-year, multicenter, observational, open-label, single-arm study of natalizumab treatment in anti-JC virus antibody-negative patients with early relapsing-remitting multiple sclerosis (RRMS).

OBJECTIVE: Study objectives examined the effects of natalizumab on cognitive processing speed, confirmed disability improvement (CDI), and patient-reported outcomes (PROs).

METHODS: Clinical and PRO secondary endpoints were assessed annually over 4 years in STRIVE. The Symbol Digit Modalities Test (SDMT) was used as a measure of cognitive processing speed. PROs were assessed using the Multiple Sclerosis Impact Score (MSIS-29) and the Work Productivity and Activity Impairment Questionnaire (WPAI).

RESULTS: At all four annual assessments, the proportion of patients in the intent-to-treat (ITT) population (N = 222) who exhibited clinically meaningful improvement in their SDMT score from baseline (i.e., change ≥ 4 points) ranged from 41.9 to 54.0%. The cumulative probability of CDI at 4 years in patients in the ITT population with a baseline Expanded Disability Status Scale score ≥ 2 (N = 133) was 43.9%. Statistically significant reductions in the mean change from screening in the MSIS-29 physical and psychological scores, indicating improved quality of life, were observed over all 4 years (P ≤ 0.0012 for all). A statistically significant decrease from screening in the impact of MS on regular activities, signifying an improvement in this WPAI measure, was also observed over all 4 years of the study.

CONCLUSION: These results further extend our knowledge of the effectiveness, specifically regarding improvements in cognitive processing speed, disability and PROs, of long-term natalizumab treatment in early RRMS patients.

CLINICALTRIALS: GOV: NCT01485003 (5 December 2011).

PMID:36780107 | DOI:10.1007/s40263-022-00982-6

Oral Radiol. 2023 Feb 13. doi: 10.1007/s11282-023-00673-y. Online ahead of print.

ABSTRACT

OBJECTIVE: To analyze the challenges and impacts of COVID-19 on the routine of Brazilian oral radiologists regarding changes in biosafety protocols, number of patients and staff, the flow of acquisition, and availability of images.

METHODS: Structured digital questionnaires with questions related to the impacts of the COVID-19 pandemic on Oral Radiology were applied and analyzed. Descriptive statistical analysis was used to describe the items included in the survey, and means and standard deviations were calculated to describe continuous variables and frequency percentages to describe categorical data.

RESULTS: A high number of Brazilian oral radiologists continued to work in the pandemic period, with little or no change in their working hours. Digital flow and teleradiology are in most of their workplaces and the changes imposed by the pandemic will be incorporated and permanent, according to most of the participants in this study.

CONCLUSIONS: The COVID-19 pandemic brought important impacts on radiology clinics, with changes in the flow of patients, in the service and in the type of exam performed. In addition, adaptation to biosafety standards became necessary, with a significant increase in spending on personal protective equipment.

PMID:36780102 | DOI:10.1007/s11282-023-00673-y

Ir J Med Sci. 2023 Feb 13. doi: 10.1007/s11845-023-03308-7. Online ahead of print.

ABSTRACT

PURPOSE: This research was conducted to determine the effect of COVID-19 on fear, anxiety, and sleep in nursing students.

METHODS: The sample of the study consisted of 1222 students in the 2019-2020 academic year who were members of the student nurses association. The data were collected online via Google Form between June and August 2020 using the student information form containing socio-demographic characteristics, the Generalized Anxiety Disorder 7-Item (GAD-7) Scale, the fear of COVID-19 scale, and the Bergen Insomnia Scale.

RESULTS: In our study, the mean score of the fear of COVID-19 scale of nursing students was 18.23 ± 6.31, and it was determined that 51.8% had sleep problems and 70.9% had anxiety (39.9% mild, 20.8% moderate, and 10.2% severe). In simple linear regression analysis, the fear of COVID-19 was found to be statistically significant and positively correlated with anxiety (β: 0.383, p = 0.001), and the fear of COVID-19 (β: 0.120, p = 0.001) and anxiety (β: 0.346, p = 0.001) was found to be statistically significant and positively correlated with sleep.

CONCLUSION: In our study, there is a relationship between nursing students’ fear of COVID-19 and anxiety and sleep quality. Accordingly, it is recommended to train students in effective methods for coping with the fear of COVID-19, and to take initiatives to reduce related anxiety and sleep problems.

PMID:36780096 | DOI:10.1007/s11845-023-03308-7

Pediatr Surg Int. 2023 Feb 13;39(1):119. doi: 10.1007/s00383-023-05395-0.

ABSTRACT

PURPOSE: Despite constantly improving developments in ventriculo-peritoneal shunt systems, most patients with hydrocephalus require revision or replacement at some point of time. Therefore, this study aimed to analyse parameters that are associated with shunt dysfunction.

METHODS: In this retrospective study, we included 81 patients aged 0-17 who were treated at our institution. Demographic data, etiology of the hydrocephalus, type of valve implanted, reason for any revision procedures, any complications and survival time of the ventriculo-peritoneal shunts were detected. Statistical analysis was performed using SPSS. The significance level was set at p ≤ 0.05.

RESULTS: Over a mean study period of 18 years, we analyzed 226 valves subjected to 146 revision operations in 81 patients. The etiology of the hydrocephalus (p = 0.874) and the age of the child at the time of VP shunt implantation (p = 0.308) did not have any impact on the shunt survival time. However, the type of the valve significantly changed the survival time of the shunt (p = 0.030). Pressure differential valves presented a longer survival time than gravitational valves.

CONCLUSION: The majority of patients in this study needed at least one replacement of the initial shunt system. Pressure differential valves may be beneficial for the survival time of the shunt system.

PMID:36780089 | DOI:10.1007/s00383-023-05395-0

Environ Sci Pollut Res Int. 2023 Feb 13. doi: 10.1007/s11356-023-25637-x. Online ahead of print.

ABSTRACT

Even if Archaea deliver important ecosystem services and are major players in global biogeochemical cycles, they remain poorly understood in freshwater ecosystems. To our knowledge, no studies specifically address the direct impact of xenobiotics on the riverine archaeome. Using environmental DNA metabarcoding of the 16S ribosomal gene, we previously demonstrated bacterial communities significant shifts linked to pollutant mixtures during an extreme flood in a typical Mediterranean coastal watercourse. Here, using the same methodology, we sought to determine whether archaeal community shifts coincided with the delivery of environmental stressors during the same flood. Further, we wanted to determine how archaea taxa compared at different seasons. In contrast to the bacteriome, the archaeome showed a specific community in summer compared to winter and autumn. We also identified a significant relationship between in situ archaeome shifts and changes in physicochemical parameters along the flood, but a less marked link to those parameters correlated to river hydrodynamics than bacteria. New urban-specific archaeal taxa significantly related to multiple stressors were identified. Through statistical modeling of both domains, our results demonstrate that Archaea, seldom considered as bioindicators of water quality, have the potential to improve monitoring methods of watersheds.

PMID:36780079 | DOI:10.1007/s11356-023-25637-x

J Endocrinol Invest. 2023 Feb 13. doi: 10.1007/s40618-023-02032-4. Online ahead of print.

ABSTRACT

INTRODUCTION: Primary hyperparathyroidism (PHPT) caused by parathyroid tumours is mostly sporadic, with a genetic cause identified in 5-10% of cases. Familial parathyroid tumours can be included in complex syndromes, such as multiple endocrine neoplasia (MEN) type 1, 2A and 4 or hyperparathyroidism-jaw tumour syndrome (HPT-JT).

OBJECTIVE: Characterisation of the familial parathyroid tumours followed-up at our centre and comparison of the different clinicopathological manifestations between the syndromes.

METHODS: Retrospective analysis of 48 patients with familial parathyroid tumours harbouring RET (n = 11), CDC73 (n = 20) and MEN1 (n = 17) germline mutations was performed.

RESULTS: Cases of PHPT in MEN2A syndrome presented with lower serum PTH (sPTH) and serum calcium (sCa) levels at diagnosis (sPTH = 108.0 (IQR 53.3) pg/mL, sCa = 10.6 ± 1.1 mg/dL) than MEN1 (sPTH = 196.9 (IQR 210.5) pg/mL, sCa = 11.7 ± 1.2 mg/dL) (p = 0.01, p = 0.03, respectively) or HPT-JT cases (sPTH = 383.5 (IQR 775.8) pg/mL, sCa = 12.9 ± 1.8 mg/dL) (p = 0.01; p < 0.001, respectively). There was a statistical difference in sCa levels between MEN1 and HPT-JT (p = 0.02), but not between sPTH (p = 0.07). The predominant first manifestation of the syndrome in MEN1 was gastroenteropancreatic neuroendocrine tumour (GEP-NET) in 47.1% of the cases, in MEN2A was medullary thyroid cancer (90.9%) and in HPT-JT was PHPT in 85% patients. In MEN1 syndrome, the number of affected parathyroid glands was significantly higher than in MEN2A (p < 0.001) and HPT-JT (p = 0.01).

CONCLUSION: The first manifestation of the syndrome in MEN1 cases was GEP-NET and not PHPT. Although presenting at similar ages, patients with MEN2A exhibit less severe biochemical and clinical PHPT at diagnosis than the other familial syndromes.

PMID:36780067 | DOI:10.1007/s40618-023-02032-4