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Nevin Manimala Statistics

Protocol for a randomised controlled trial on impact of comprehensive geriatric and supportive assessment versus standard care in older adults with cancer undergoing curative treatment: The Geriatric Oncology SuPportive clinic for ELderly (GOSPEL) study

J Geriatr Oncol. 2022 Jul 14:S1879-4068(22)00168-0. doi: 10.1016/j.jgo.2022.07.002. Online ahead of print.

ABSTRACT

Cancer affects older adults with varying levels of frailty, but cancer treatment is extrapolated from clinical trials involving predominantly young and robust subjects. Recent geriatric oncology randomised controlled trials (RCT) report that geriatric assessment leading to frailty-guided intervention reduces treatment-related toxicity whilst maintaining survival and improving quality of life (QoL). However, these positive results have not have been consistently reported in the literature. We postulate that the impact of geriatric interventions has been underestimated in these studies with the inclusion of subjects receiving palliative-intent chemotherapy in whom dose reduction is common. Integrating supportive care with current geriatric oncology models may improve the QoL of older adults undergoing treatment. However, no studies as yet have examined such integrated geriatric and supportive models of care. The Geriatric Oncology SuPportive clinic for Elderly (GOSPEL) study is a single-centre, open-label, analyst-blinded RCT evaluating the impact of comprehensive geriatric and supportive care on QoL of older adults with cancer undergoing curative treatment. Older adults aged above 65, with a Geriatric-8 score ≤ 14, with plans for high dose radiotherapy and/or curative chemotherapy will be recruited. The primary QoL outcome is measured using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-ELD14 mobility scale at 12 weeks. Secondary outcomes include overall and disease-free survival, treatment-related adverse events, and hospital admissions. We pre-powered this study to recruit 200 subjects based on the minimally clinically important difference for EORTC QLQ-ELD14 to achieve 80% statistical power (alpha 0.05), assuming 25% attrition. Outcomes will be analysed using intention-to-treat. Intervention consists of multi-domain comprehensive geriatric and supportive care assessments from a multidisciplinary team targeting unmet needs. These include functional decline, falls, incontinence, cognitive impairment, multi-morbidity, polypharmacy, and symptom relief, as well as social and psycho-spiritual concerns. Standard care entails routine oncological management with referral to geriatrics based on the discretion of the primary oncologist. Recruitment has been ongoing since August 2020. Results from the GOSPEL study will increase understanding of the impact of integrated geriatric and supportive care programs in older adults with cancer receiving curative treatment. Trial registration: This study is registered under ClinicalTrials.gov (ID NCT04513977).

PMID:35843845 | DOI:10.1016/j.jgo.2022.07.002

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Nevin Manimala Statistics

An Integrated Care Model to Support Adolescents With Diabetes-related Quality-of-life Concerns: An Intervention Study

Can J Diabetes. 2022 May 22:S1499-2671(22)00128-9. doi: 10.1016/j.jcjd.2022.05.004. Online ahead of print.

ABSTRACT

BACKGROUND: Our aim in this study was to determine whether participating in an integrated stepped care model for adolescents with type 1 diabetes (T1D) would lead to improvements in overall quality of life (QoL), diabetes-related quality of life (DRQoL) and glycated hemoglobin (A1C) levels compared with usual care.

METHODS: A nonrandomized, 2-group, pre/post, delayed-intervention design was used for this study. The Mind Youth Questionnaire (MY-Q) was used to assess QoL and DRQoL. Adolescents attending the diabetes clinic using the stepped care model formed the intervention group (n=77). These adolescents completed the MY-Q, and the identified concerns were discussed and addressed with them by their care team as part of the care model. Adolescents attending a pediatric diabetes clinic on another site completed the MY-Q as a comparison group (n=39), results were not shared with their care team, and they received the standard care.

RESULTS: There were 116 adolescents between 13 to 17 years of age, who completed the MY-Q on 2 occasions. Baseline data were obtained on the first occasion, and, on the second occasion, an average of 12 months later, there was a follow-up assessment. At follow up, adolescents in the intervention group had a significantly higher overall QoL and reported significantly less concerns on DRQoL domains than those in the comparison group. Participation in the intervention group, however, did not lead to improvements in A1C.

CONCLUSION: This study shows that implementing an integrated stepped care model within an interprofessional pediatric diabetes clinic can lead to the improvement of adolescents’ overall QoL and DRQoL.

PMID:35843836 | DOI:10.1016/j.jcjd.2022.05.004

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Nevin Manimala Statistics

Delta variant SARS-CoV-2 infections in pediatric cases during the second wave in India

J Microbiol Immunol Infect. 2022 Jul 2:S1684-1182(22)00092-5. doi: 10.1016/j.jmii.2022.06.001. Online ahead of print.

ABSTRACT

BACKGROUND: During October 2020, Delta variant was detected for the first time in India and rampantly spread across the globe. It also led to second wave of pandemic in India which affected millions of people. However, there is limited information pertaining to the SARS-CoV-2 strain infecting the children in India.

METHODS: Here, we assessed the SARS-CoV-2 lineages circulating in the pediatric population of India during the second wave of the pandemic. Clinical and demographic details linked with the nasopharyngeal/oropharyngeal swabs (NPS/OPS) collected from SARS-CoV-2 cases (n = 583) aged 0-18 year and tested positive by real-time RT-PCR were retrieved from March to June 2021.

RESULTS: Symptoms were reported among 37.2% of patients and 14.8% reported to be hospitalized. The E gene CT value had significant statistical difference at the point of sample collection when compared to that observed in the sequencing laboratory. Out of these 512 sequences 372 were VOCs, 51 were VOIs. Most common lineages observed were Delta, followed by Kappa, Alpha and B.1.36, seen in 65.82%, 9.96%, 6.83% and 4.68%, respectively in the study population.

CONCLUSION: Overall, it was observed that Delta strain was the leading cause of SARS-CoV-2 infection in Indian children during the second wave of the pandemic. We emphasize on the need of continuous genomic surveillance in SARS-CoV-2 infection even amongst children.

PMID:35843834 | DOI:10.1016/j.jmii.2022.06.001

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Nevin Manimala Statistics

Comparison of open and laparoscopic inguinal hernia repair in octogenarians

Asian J Surg. 2022 Jul 14:S1015-9584(22)00890-9. doi: 10.1016/j.asjsur.2022.06.149. Online ahead of print.

ABSTRACT

INTRODUCTION: Although the advantages of laparoscopic inguinal hernia repair in the general population have been reported, its role in octogenarians has yet to be elucidated. This retrospective study was designed to compare the outcomes of open and laparoscopic inguinal hernia repairs in octogenarians.

MATERIALS AND METHODS: The data of octogenarians who underwent laparoscopic (n = 81) or open (n = 121) inguinal hernia repair were collected from January 2017 to December 2019. Statistical analysis variables included basic epidemiological data of patients, surgical procedures, comorbidities, postoperative pain, complications, recurrence, and other data.

RESULTS: There were no significant differences between the two groups in terms of sex, body mass index, recurrent hernias, comorbidities, postoperative complications, and recurrence. The American Society of Anesthesiologists (ASA) class and the proportion of scrotal hernias in the open group were higher than those of the laparoscopic group, whereas the proportion of bilateral hernias in the laparoscopic group was higher than that in the open group. The postoperative pain scores of the laparoscopic group were lower than those of the open group.

CONCLUSIONS: In octogenarians, both laparoscopic and open inguinal hernia repairs are safe and feasible, but an appropriate surgical plan is crucial for obtaining better treatment effect.

PMID:35843826 | DOI:10.1016/j.asjsur.2022.06.149

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Nevin Manimala Statistics

Effect of redo varicocelectomy on semen parameters and pregnancy outcome: An original report and meta-analysis

Andrologia. 2022 Jul 17:e14525. doi: 10.1111/and.14525. Online ahead of print.

ABSTRACT

Recurrence following varicocelectomy is an important cause of treatment failure and persistence of subnormal semen parameters. This original study was combined with a systemic review and meta-analysis aiming to evaluate the efficacy of redo varicocelectomy on male fertility potential and pregnancy outcome. The retrospective study included 32 patients who underwent microsurgical subinguinal varicocelectomy for patients with recurrent varicocele. Changes in semen parameters and hormone profiles before and after surgery were compared. The literature review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and included seven articles in addition to our original report. Results of the original study revealed statistically significant improvements in sperm concentration, progressive motility, total motile sperm count and normal morphology following redo varicocelectomy. The meta-analysis results echoed those reported in our original study and depicted significant improvements in sperm concentration (mean difference [MD] = +20.281 million/ml, p < 0.001), total motility (MD = +9.659%, p = 0.001), total motile sperm count (MD = +23.258 million sperm, p < 0.001) and normal morphology (MD = +4.460%, p < 0.001). Overall pregnancy outcome was reported in seven studies with a rate of 34.6%. No significant changes were noted in any of the collected hormone results both in this original report and in the meta-analysis. In conclusion, redo varicocelectomy has a beneficial role on male fertility potential and can be offered for men with recurrent varicocele as directed by their individual clinical condition.

PMID:35842930 | DOI:10.1111/and.14525

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Nevin Manimala Statistics

Preoperative determination of pathological grades of primary single HCC: development and validation of a scoring model

Abdom Radiol (NY). 2022 Jul 17. doi: 10.1007/s00261-022-03606-1. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to establish a reliable diagnostic score model for the preoperative determination of pathological grade in HCC based on gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid (Gd-EOB-DTPA) enhanced MRI and biochemical indicators.

METHODS: In this retrospective study, we analyzed 139 patients with HCC who underwent Gd-EOB-DTPA MRI between 2014 and 2020, including an establishment cohort of 76 patients and a validation cohort of 63 patients. Based on the imaging features demonstrated on Gd-EOB-DTPA MRI images and biochemical indicators of the establishment cohort, a scoring model based on logistic regression was developed, and compared with postoperative pathological findings in terms of effective determination of pathological grade. The validity of the scoring model was assessed by ROC curves and an independent external validation cohort.

RESULTS: Three parameters related to pathological grades were identified, including maximum diameter of the tumor, peritumoral hypointensity in the hepatobiliary phase, and [alkaline phosphatase (U/L) + gamma glutamyl transpeptidase (U/L)]/ lymphocyte count (× 109/L) (AGLR) ratios. Based on these three parameters, a scoring model was developed. ROC curve showed that a score of > 5 was set as the threshold for determining pathological grades with accuracy, sensitivity, specificity, PPV, and NPV of 89.5%, 75.0%, 95.1%, 85.7%, and 90.7%, respectively.

CONCLUSION: The study provided the groundwork for a promising and easily implementable scoring model for preoperative determination of HCC pathological grades, for which further validation should be pursued.

PMID:35842888 | DOI:10.1007/s00261-022-03606-1

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Nevin Manimala Statistics

Evaluation of choroidal thickness and ocular manifestations in lipoid proteinosis

Int Ophthalmol. 2022 Jul 17. doi: 10.1007/s10792-022-02422-2. Online ahead of print.

ABSTRACT

PURPOSE: To assess choroidal thickness in patients with lipoid proteinosis versus healthy subjects using enhanced depth imaging optical coherence tomography.

METHODS: Twenty eyes of 20 patients and the same number of age and sex-matched healthy individuals were enrolled. Comprehensive ocular examinations including measurement of best-corrected visual acuity, spherical equivalent values of refractive errors, and axial length were performed. Choroidal thickness at three points (subfoveal, 500 µm nasal and temporal regions) were measured automatically using MATLAB software.

RESULTS: The mean age was 15.68 ± 5.98 years in the patient group and 16.48 ± 5.69 years in the control group. Mean choroidal thickness was statistically significantly thicker at each point in patients with lipoid proteinosis compared to the healthy controls: subfoveal, temporal and nasal choroidal thickness measurements were 425.65 ± 51.42, 380.20 ± 69.66, 334.05 ± 49.98 µm in the study group; 346.15 ± 47.76, 330.15 ± 44.35, 298.95 ± 44.21 µm in the control group, respectively (P < 0.05).

CONCLUSION: Patients with lipoid proteinosis have thicker choroid compared to control eyes. Hyalin deposition and ensuing potential inflammation in the disease process may explain this finding.

PMID:35842887 | DOI:10.1007/s10792-022-02422-2

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Nevin Manimala Statistics

A novel approach for assessment of antitrypanosomal activity of sesquiterpene lactones through additive and non-additive molecular structure parameters

Mol Divers. 2022 Jul 17. doi: 10.1007/s11030-022-10495-5. Online ahead of print.

ABSTRACT

Human African trypanosomiasis (HAT) or sleeping sickness is a protozoan neglected tropical disease, which is the main health worry in more than 20 countries in Africa. A novel approach is presented to predict the antitrypanosomal activity of sesquiterpene lactones (STLs) in terms of biological activity (pIC50). The largest reported data set of pIC50 for Trypanosoma brucei rhodesiense (Tbr) as one form of HAT are used to derive and test the new model. The new model is based on five additive and two non-additive molecular structural parameters in several frameworks where it can be easily applied through a computer code. It is derived and tested based on 125 and 31 experimental data, respectively, with different types of statistical parameters. The high reliability of the novel model is compared with the best available QSAR models, which use “classical” molecular descriptors, and 3D pharmacophore features. The values of R2 (correlation coefficient), root mean squared error (RMSE), and RMSEP (root mean square error of prediction) of the new model are 0.77, 0.38, and 0.35, respectively. Meanwhile, R2, RMSE, and RMSEP of comparative QSAR models based on complex descriptors are in the ranges 0.71-76, 0.46-0.4, and 0.51-0.44, respectively. The predictive results of the novel approach confirm its high simplicity, reliability, precision, accuracy, and goodness-of-fit.

PMID:35842884 | DOI:10.1007/s11030-022-10495-5

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Nevin Manimala Statistics

Plasma nervonic acid levels were negatively associated with attention levels in community-living older adults in New Zealand

Metabolomics. 2022 Jul 16;18(8):54. doi: 10.1007/s11306-022-01908-5.

ABSTRACT

The global population is aging. Preserving function and independence of our aging population is paramount. A key component to maintaining independence is the preservation of cognitive function. Metabolomics can be used to identify biomarkers of cognition before noticeable deterioration. Our study investigated the plasma metabolome of 332 community-living New Zealanders between 65 and 74 years of age, using gas chromatography-mass spectrometry. Six cognitive domains were assessed. Of the 123 metabolites identified using an in-house mass spectral libraries of standards, nervonic acid had a significant, inverse association with the attention domain (P-value = 1.52E– 4; FDR = 0.019), after adjusting for covariates (apolipoprotein E -ε4 genotype, sex, body fat percentage (standardised by sex), age, education, deprivation index, physical activity, metabolic syndrome, polypharmacy, smoking status, and alcohol intake) and multiple testing. Attention is defined as the ability to concentrate on selected aspects of the environment while ignoring other stimuli. This is the first study to identify nervonic acid as a potential biomarker of attention in older adults. Future research should confirm this association in a longitudinal study.

PMID:35842880 | DOI:10.1007/s11306-022-01908-5

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Nevin Manimala Statistics

Burden of pilonidal disease and improvement in quality of life after treatment in adolescents

Pediatr Surg Int. 2022 Jul 17. doi: 10.1007/s00383-022-05175-2. Online ahead of print.

ABSTRACT

PURPOSE: Pilonidal Disease (PD) affects adolescents in different aspects. We hypothesized that patients with different gender, ethnicity, and age have different quality of life (QOL) measurements which could improve with minimally invasive treatment (MIT).

METHODS: 131 PD patients underwent MIT (laser epilation ± trephination) from 2019 to 2021. Patients’ demographics were recorded. Before and after MIT, patients received QOL questionnaire consisting of four categories: daily activities, sports participation, school/work attendance, and socializing. Data were analyzed using Student and multivariate t test. P < 0.05 was considered statistically significant.

RESULTS: 101 (51 male, 50 female) patients were included. 30 patients with incomplete data were excluded. 54% of patients were < 18 years old. 47.5% were Hispanic. Median symptom duration prior to presentation was 5.4 (1.3-15) months. Prior to MIT, patients’ ability to perform daily activities, participate in sports, attend school/work, and socialize was moderately or severely impacted in 66%, 57%, 45%, and 23% of respondents, respectively; after MIT, only 7%, 8%, 2%, and 4% were affected (p < 0.01). Recurrence rate was 6%. Pre-MIT, older patients and non-Hispanics reported worse impact on their QOL. Symptom duration or PD recurrence did not correlate with patient’s pre- or post-MIT QOL.

CONCLUSION: Patients’ ethnicity and age impacted QOL in PD. All patients’ QOL significantly improved with MIT. Considering the importance of socializing, playing sports, and school/work attendance in adolescents, our study highlights importance of early treatment of PD.

PMID:35842877 | DOI:10.1007/s00383-022-05175-2