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Nevin Manimala Statistics

Micelle-enhanced spectrofluorimetric method for the rapid determination of bronchodilator terbutaline and its prodrug bambuterol: Application for content uniformity test

Luminescence. 2022 Apr 13. doi: 10.1002/bio.4257. Online ahead of print.

ABSTRACT

A novel, simple and sensitive spectrofluorimetric approach for determination of terbutaline sulphate (TER) and its prodrug bambuterol (BAM) in their pure and pharmaceutical dosage forms was developed. The suggested approach depends on enhancing the native fluorescence of either TER or BAM at 315 and 297.2 nm after excitation at 277 and 259 nm, respectively, using sodium dodecyl sulphate (SDS) as a micellar media. In the presence of 0.7% w/v SDS, about 1.38-fold and 1.18-fold enhancement is achieved in the relative fluorescence intensity (RFI) of TER and BAM, respectively. The fluorescence-concentration curves were rectilinear over the concentration range of 0.8-16 μg mL-1 , with detection limits (LOD) of 0.252 and 0.26 (μg mL-1), quantitation limits (LOQ) of 0.76 and 0.79 (μg mL-1), determination coefficients (r2) of 0.9981, and slopes of 45.92 and 10.44 for TER and BAM, respectively. The suggested approach was validated in accordance with ICH criteria and was effectively applied in the analysis of the studied drugs in their commercial tablets. The high sensitivity of the proposed approach allows its application in evaluating the content uniformity testing of the studied drugs in their tablets through using the official United States Pharmacopeia criteria (USP). Statistical analogies of the findings with that of the reported methods showed really good harmony and indicated no major differences in precision and accuracy.

PMID:35416388 | DOI:10.1002/bio.4257

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Influence of social networks on cancer survivors’ self-management support: A mixed methods study

Eur J Cancer Care (Engl). 2022 Apr 13. doi: 10.1111/ecc.13578. Online ahead of print.

ABSTRACT

OBJECTIVE: The role of social networks, especially weaker ties (e.g. casual acquaintances and hobby groups), in self-management of long-term consequences of cancer is unexplored. This study aimed to explore the structure of cancer survivors’ social networks and their contribution to self-management support and health-related quality of life (HRQoL).

METHODS: The study used a sequential, exploratory mixed methods design. Phase 1 surveyed 349 lymphoma, colorectal, breast and prostate cancer survivors. Phase 2 analysed 20 semi-structured interviews with respondents recruited from Phase 1.

RESULTS: Phase 1 results suggested participants’ HRQoL increased if they participated in an exercise group, if their self-management skills increased, and social distress and negative illness perception decreased (p < 0.0005 adj. R2 = 0.631). These findings were explored in Phase 2, identifying underlying mechanisms. Four themes were identified: disrupted networks after cancer treatment; navigating formal support and building individual capacity; peer networks and self-management knowledge and linking networks to enable adaptation in recovery.

CONCLUSIONS: This study suggests engagement with community groups, particularly those not directly related to illness management and social interaction with weak ties, make a valuable contribution to self-management support, increase HRQoL and enhance well-being.

PMID:35416341 | DOI:10.1111/ecc.13578

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Invasive cervical cancer audit: what lessons can we learn locally and where would we stand with regard to Duty of Candour?

Cytopathology. 2022 Apr 13. doi: 10.1111/cyt.13128. Online ahead of print.

ABSTRACT

OBJECTIVE: To identify lessons learned locally from the invasive cervical cancer audit. To estimate the impact that the application of “Duty of Candour’ may have upon our future service provision.

METHODS: Retrospective cohort study with interval analysis of all women diagnosed with cervical cancer at STH NHS Foundation Trust between 1st April 2007 to 31st December 2019. Data was collected prospectively with retrospective categorisation by screening history and invasive cervical cancer audit outcomes as satisfactory, satisfactory with learning points, and unsatisfactory. Statistical analysis was performed using Chi Squared test and paired t test.

RESULTS: Cervical cancer was diagnosed in 344 women. Seventy-eight (23%) had no record of prior cervical cytology, 108 (31%) had delayed attendance to the screening programme, 102 (30%) were detected by routine screening, and 56 (16%) were screening programme compliant. Satisfactory management was undertaken in 301 (87.5%) cases; 26 cases (7.5%) were satisfactory with learning points, and 17 cases (5%) were considered as unsatisfactory.

CONCLUSIONS: Seventeen cases were applicable to the ‘Duty of Candour’ process equating to 1.3 cases per year incurring minimal impact upon future service provision. Invasive audit categorisation however is subject to bias with the potential for considerable intra- and inter-observer variation, the authors recommend that a further study is conducted to investigate both consistency and reproducibility of the invasive cervical cancer audit categorisation.

PMID:35416340 | DOI:10.1111/cyt.13128

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Integrity and quantity of salivary cell-free DNA as a potential molecular biomarker in oral cancer: A preliminary study

J Oral Pathol Med. 2022 Apr 13. doi: 10.1111/jop.13299. Online ahead of print.

ABSTRACT

INTRODUCTION: Differences in cell-free DNA (cfDNA) fragments have been described as a valuable tool to distinguish cancer patients from healthy individuals. We aim to investigate the concentration and integrity of cfDNA fragments in saliva from oral squamous cell carcinoma (OSCC) patients and healthy individuals in order to explore their value as diagnostic biomarkers.

MATERIALS AND METHODS: Saliva samples were collected from a total of 34 subjects (19 OSCC patients and 15 healthy controls). The total concentration of scfDNA was determined using a fluorometry method and quantitative real-time PCR (qPCR). To evaluate the scfDNA quantity and integrity, qPCR targeting Arthobacter luteus (ALU) sequences at three amplicons of different lengths (60, 115, and 247 bp, respectively) was carried out. ScfDNA integrity indexes (ALU115/ALU60 and ALU247/ALU60) were calculated as the ratio between the absolute concentration of the longer amplicons 115 bp and 247 bp and the total scfDNA amount (amplicon 60 bp).

RESULTS: The total scfDNA concentration (ALU60) was higher in OSCC than in healthy donors, but this trend was not statistically significant. The medians of scfDNA integrity indexes, ALU115/ALU60 and ALU247/ALU60, were significantly higher in OSCC, showing area under the curve (AUC) values of 0.8211 and 0.7018, respectively.

CONCLUSION: Our preliminary results suggest that scfDNA integrity indexes (ALU115/ALU60 and ALU247/ALU60) have potential as non-invasive diagnostic biomarkers for OSCC.

PMID:35416334 | DOI:10.1111/jop.13299

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Prostate cancer awareness among transgender women after gender-affirming surgery

Prostate. 2022 Apr 13. doi: 10.1002/pros.24355. Online ahead of print.

ABSTRACT

BACKGROUND: The prostate gland remains unresected during gender-affirming surgery (GAS) for transgender women (TGW), and may develop malignancies in later life. We sought to evaluate prostate cancer awareness (PCA) among post-GAS TGW.

METHODS: The investigators implemented a cross-sectional study and enrolled a sample of Thai post-GAS TGW without medical background. Predictor variables were categorized as demographic, clinical, operative, or postoperative. The outcome variable was PCA (yes/no). Appropriate statistics were computed, and a p-value ≤ 0.05 was considered statistically significant.

RESULTS: The sample consisted of 100 Thai post-GAS TGW (4% bisexual, 12% bachelor [or higher] graduates, 51% service workers, 64% had monthly net income <40,000 TB [or ca. 1050 Euro], 92% operated by plastic surgeons) with a mean age of 26.2 ± 5.4 years (range: 18-45). On bivariate analysis, PCA was significantly associated with educational level (p = 0.007; adjusted odd ratio [ORadj. ]: 5.85; 95% confidence interval [95% CI]: 1.65-20.69), being operated ≥ 10 years (p = 0.01; ORadj. : 0.16; 95% CI: 0.04-0.76), self-recognition of the remaining prostate gland (p = 0.0001; ORadj. : 0.02; 95% CI: 0-0.12), and emphasis on PCA by the GAS operator (p = 0.01; ORadj. : 0.07; 95% CI: 0.01-0.63). Multiple linear regression analysis revealed a statistically significant, positive correlation (r = 0.78; p = 0.0001) among these four predictors, and continued to confirm the positive effect on PCA in TGW with high education and realization of the prostate gland (r = 0.56; p = 0.04) or information on PCA by the operator (r = 0.68; p = 0.003).

CONCLUSION: The GSA operator should intensively inform TGW about the remnant prostate and the risk of PC, especially those with low and middle levels of education attained.

PMID:35416318 | DOI:10.1002/pros.24355

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Association between RAC1 gene variation, redox homeostasis and type 2 diabetes mellitus

Eur J Clin Invest. 2022 Apr 13:e13792. doi: 10.1111/eci.13792. Online ahead of print.

ABSTRACT

Increased production of reactive oxygen species (ROS) and oxidative stress are known to play a key role in the pathogenesis of type 2 diabetes (T2D), however, the relationship between genes encoding a multi-subunit ROS-generated enzyme NADPH oxidase and disease susceptibility remains unexplored. The present pilot study investigated whether single nucleotide polymorphisms (SNP) at the RAC1 gene (Rac family small GTPase 1), a molecular switcher of NADPH oxidase, are associated with the risk of T2D, glucose metabolism, and redox homeostasis. DNA samples from 3206 unrelated Russian subjects (1579 T2D patients and 1627 controls) were genotyped for six common SNPs rs4724800, rs7784465, rs10951982, rs10238136, rs836478, and rs9374 of RAC1 using the MassArray-4 system. SNP rs7784465 was associated with an increased risk of T2D (P=0.0003) and significant differences in the RAC1 haplotypes occurred between the cases and controls (P=0.005). Seventeen combinations of RAC1 genotypes showed significant associations with T2D risk (FDR<0.05). Associations of RAC1 polymorphisms with T2D were modified by environmental factors such as sedentary lifestyle, psychological stresses, a dietary deficit of fresh fruits/vegetables, and increased carbohydrate intake. RAC1 polymorphisms were associated with biochemical parameters in diabetics: rs7784465 (P=0.015) and rs836478 (P=0.028) with increased glycated hemoglobin, rs836478 (P=0.005) with increased fasting blood glucose, oxidized glutathione (P=0.012), and uric acid (P=0.034). Haplotype rs4724800A-rs7784465C-rs10951982G-rs10238136A-rs836478C-rs9374G was strongly associated with increased levels of hydrogen peroxide (P<0.0001). Thus, polymorphisms in the RAC1 gene represent novel genetic markers of type 2 diabetes, and their link with glucose metabolism and disease pathogenesis is associated with the changes in redox homeostasis.

PMID:35416295 | DOI:10.1111/eci.13792

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Complications Following Surgery for Adult Scheuermann’s Kyphosis: A 2-Year Follow-Up in 22 Patients

Turk Neurosurg. 2021 Oct 22. doi: 10.5137/1019-5149.JTN.35974-21.2. Online ahead of print.

ABSTRACT

AIM: Our objective was to determine the rate of postoperative complications following surgery for Scheuermann’s kyphosis (SK) and ascertain whether restoration to an ideal Roussouly spine type reduced the incidence of postoperative proximal junctional kyphosis (PJK).

MATERIAL AND METHODS: We retrospectively screened all patients undergoing SK surgery at our institution (2010-2017) and excluded patients with less than two years of follow-up. Postoperative complications were identified as early or late and minor or major. Successful restoration of Roussouly spine type was assessed and patients were classified as “restored” or “non-restored.” Associations between ideal Roussouly restoration and postoperative PJK were evaluated using logistic regression analysis.

RESULTS: The study included 22 patients with a median age of 23 (IQR, 20.0-43.8) years. Postoperative complications developed in 17 (77%) of these cases. All 17 patients developed minor complications; seven (32%) patients also exhibited major complications. PJK was diagnosed in 55% of the patients with an 18% overall two-year revision rate. Forty-four percent of the patients in the restored group developed PJK compared to 83% in the non-restored group (p=0.162). Multivariable logistic regression analysis revealed a trend towards an increased incidence of PJK in the non-restored group, albeit without statistical significance (OR, 9.4; 95% CI, 0.7-122.5, p=0.087).

CONCLUSION: Our study revealed that 77% of patients undergoing surgery for SK developed at least one complication with a two-year revision rate of 18%. PJK was detected less frequently in patients who were restored to their ideal Roussouly spine type, although this finding did not achieve statistical significance.

PMID:35416264 | DOI:10.5137/1019-5149.JTN.35974-21.2

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Longer distance races and slower running pace are associated with exercise associated collapse. SAFER XXV study in 153208 distance runners

J Sports Med Phys Fitness. 2022 Apr 12. doi: 10.23736/S0022-4707.22.13107-5. Online ahead of print.

ABSTRACT

BACKGROUND: Exercise associated collapse (EAC) is a common medical encounter at distance running events. Risk factors associated with EAC are not well documented. The objective is to determine the overall incidence of EAC and identify risk factors associated with EAC in 21.1km and 56km runners.

METHODS: A cross-sectional analysis of 153208 race starters from the Two Oceans Marathon races (2008-2015). All EACs on race day were documented by medical staff. Risk factors associated with EAC investigated included demographics, race distance (21.1km vs. 56km), running speed, race experience and race day environmental data (wet-bulb globe temperature [WBGT], humidity, wind speed). Incidence (per 1000 starters; 95%CIs) and incidence ratios (95%CIs) were calculated.

RESULTS: The overall incidence of EAC was 1.50 (95% CI 1.31-1.71). Longer race distance (IR: 2.1; 1.6-2.7; p<0.0001) and slower running speed (IR: 1.3; 1.1-1.5; p=0.0017) were significant risk factors associated with EAC. The incidence of EAC was higher in female vs. male 21.1km race starters (IR=2.25; 1.47-3.46; p=0.0229). Age and environmental conditions were not associated with EAC (p>0.05) in a cool and temperate environment.

CONCLUSIONS: About 1 in 667 race starters (21.1km and 56km) develop EAC. Longer race distance, slower running speed and female sex (in 21.1km starters) are significant risk factors associated with EAC. Race medical directors can identify race entrants that may be at risk of developing EAC, develop prevention strategies and better prepare medical care at these events.

PMID:35415992 | DOI:10.23736/S0022-4707.22.13107-5

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An Index Predicting Histological Acute Cholecystitis in Patients Undergoing an Urgent Laparoscopic Cholecystectomy

Isr Med Assoc J. 2022 Apr;24(4):241-245.

ABSTRACT

BACKGROUND: It is important to predict acute cholecystitis (AC) before a laparoscopic cholecystectomy because inflammation of the gallbladder predicts the need for open conversion and subsequent morbidity after a laparoscopic cholecystectomy.

OBJECTIVES: To create an index based on clinical, laboratory, and ultrasound criteria on admission that will predict AC on pathological examination in patients presenting acutely.

METHODS: We retrospectively reviewed consecutive cases of emergency laparoscopic cholecystectomies conducted by three experienced surgeons between 1 October 2014 and 31 January 2018. Independent variables were age, sex, presenting symptoms, admission laboratory tests, and ultrasound findings. The outcome variable was AC on histological examination. An index was created from all variables that added significantly to the logistic regression analysis.

RESULTS: Eight variables that contributed significantly to the model, included age, male sex, vomiting on admission, an increased proportion of neutrophils, a normal aspartate aminotransferase test, a normal serum amylase test result, a thick gall bladder wall, and pericholecystic fluid. An index of ≤ 2 to ≥ 8 created from those variables had a graded risk for AC of 1.8% to 92.0% with a c-statistic of 0.86 (95% confidence interval 0.81-0.91). Operating time and bleeding increased in those with a higher index.

CONCLUSIONS: An index including age, sex, symptoms, and selected laboratory results as well as ultrasound characteristics had an excellent graded risk in the prediction of histological AC that was associated with operating time and an increased risk of bleeding during the operation.

PMID:35415983

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The association between lung cancer stigma and race: A descriptive correlational study

Health Expect. 2022 Apr 12. doi: 10.1111/hex.13495. Online ahead of print.

ABSTRACT

BACKGROUND: Stigma is a formidable burden for survivors of lung cancer that can reduce the quality of life (QOL), resulting in physical, social and psychological challenges. This study investigates associations between stigma and depression, QOL and demographic and health-related characteristics, including race.

DESIGN: An adapted conceptual model derived from the Cataldo Lung Cancer Stigma Scale guided this descriptive correlation study assessing stigma in African American and Caucasian survivors of lung cancer. Self-reported, written surveys measuring depression, QOL, lung cancer stigma and demographics were administered. Statistical analysis was conducted to assess associations between stigma and depression, stigma and QOL and stigma and race, while adjusting for demographic characteristics.

RESULTS: Participants (N = 56) included 30 Caucasian and 26 African American survivors of lung cancer recruited from a cancer registry of an American College of Surgeons-accredited programme, a survivors’ support club and an ambulatory oncology practice in the southeastern United States. Statistical analysis yielded (1) a significant moderate positive association between depression and lung cancer stigma; (2) a significant moderate negative association between QOL and lung cancer stigma; and (3) significant relationships between race and lung cancer stigma, specifically higher degree of stigma among African Americans compared to Caucasians.

CONCLUSION: Stigma affects many aspects of survivors’ lives. Healthcare professionals need to consider how health-related stigma may further complicate the physical burdens, psychological distresses and social challenges that accompany the disease, especially among African American survivors. Additional enquiry and interventions are needed to assist with mitigating the negative effects of stigma on survivors and their family members and friends.

PATIENT OR PUBLIC CONTRIBUTION: Fifty-six survivors of lung cancer participated in this descriptivecorrelation study. They completed written surveys measuring depression, QOL, and lung cancer stigma, plus an investigator-developed demographic information form.

PMID:35415934 | DOI:10.1111/hex.13495