Prospective sero surveillance among healthcare workers vaccinated with ChAdOx1 nCoV-19 Corona vaccine in a tertiary hospital of Kerala, India

BackgroundIndia started Covid-19 vaccination from January 16, 2021 after the approval of two candidate vaccines namely Covishield and Covaxin . We report antibody responses among healthcare workers following two doses of Covishield vaccination in a tertiary care setting. MethodsThis prospective serosurveillance study was done among healthcare workers of Jubilee Mission Medical College, vaccinated during January- March 2021. Blood samples were drawn from 170 participants after their 1st dose and from 156 participants after their 2nd dose of Covishield to measure the specific Ig G antibodies against the recombinant S1 subunit of the S protein of SARS-CoV-2. ResultsThe median level of anti SARS CoV-2 Ig G antibody 28 days after the first dose vaccination is 3.64 S/C (IQR=5.91) and 11.6 S/C (IQR= 5.97) after 14 days of second dose vaccination. Protective levels of anti SARS CoV-2 Ig G antibodies is developed by 25 participants (14.7%) after 28 days of first dose of vaccination and by 109 participants (69.9%) after 14 days of second dose. 18-44 years age group (p=0.027) and absence of comorbidities (p=0.079) are associated with protective IgG levels. ConclusionsRise in specific Ig G is observed after vaccination. Higher antibody response is observed with younger age group and absence of comorbidities, though statistically not significant. The influence of BMI is also not significant.

The accuracy of anthropometric measurements of general and central obesity for the prediction of impaired glucose tolerance among the adult population of South India.

BACKGROUND: The distribution of body fat and its variation is of great importance in determining the pathogenesis of insulin resistance. Central obesity has been recognized as an independent risk factor for diabetes. The objective of the study was to evaluate the predictive accuracy of various anthropometric measures of body fat in determining impaired glucose tolerance (IGT) or prediabetes among South Indian population. METHODOLOGY: This was a community-based comparative cross-sectional study where the anthropometric measures of a representative sample of 171 individuals with glycosylated hemoglobin (HbA1c) in the range for IGT were compared with age- and gender-matched controls with HbA1c in the normal range. The predictive accuracy of the various anthropometric measures of obesity to identify individuals with IGT was estimated using the area under the receiver operating characteristic (ROC) curve. RESULTS: Patients with IGT in both genders had significantly higher BMI, waist circumference (WC), neck circumference (NC), and waist-to-height ratio (WHtR). ROC analysis revealed WHtR in females and NC among males to have the largest area under the curve for predicting IGT. In both genders, WC, WHtR, and NC had better predictive accuracy for prediabetes as compared to BMI and waist-to-hip ratio (WHR). CONCLUSION: It is suggested that the WHtR and WC are better screening tools for prediabetes in comparison to BMI and WHR among the South Indian population.

Possible Effects of Perchlorate Contamination of Drinking Water on Thyroid Health.

BACKGROUND: Perchlorate is an anion that occurs as a contaminant in groundwater. It originates from the improper disposal of ammonium perchlorate, a component of rocket fuel. The objective of this study was to explore whether the exposure to perchlorate in drinking water had an impact on the thyroid function of the population residing near an ammonium perchlorate plant in Kerala. Methodology. Using an ecological study design, we compared the serum levels of thyroid-stimulating hormone, thyroxine, and thyroid peroxidase antibodies among a representative sample of 289 study subjects from the area surrounding the ammonium perchlorate enrichment plant to 281 study subjects in a control area. RESULTS: The perchlorate concentration in the groundwater varied from 1600 ppb to 57,000 ppb in the 10 samples from the contaminated area and was below 24 ppb in all locations in the control area. No significant differences were found in the mean serum TSH concentration and mean T4 levels between the subjects from the contaminated area and the control area. On regression analysis, perchlorate contamination was not found to be a significant predictor of TSH. CONCLUSION: This study did not find any significant association between perchlorate in drinking water and changes in thyroid hormone levels. Our findings indicate the need for further investigation of this hypothesis using urinary perchlorate as a measure of individual exposure.

Incidence and risk factors for intraocular pressure rise after transconjunctival vitrectomy.

Purpose: To study the incidence and risk factors of raised intraocular pressures (IOPs) in the follow-up of transconjunctival sutureless vitrectomy (TSV). Methods: A retrospective observational study was performed on 635 patients who underwent TSV under a single surgeon. The IOPs were recorded using a calibrated non-contact tonometer at seven postoperative visits, viz., day 1, 7 and 1, 3, 6 months, and 1 day and 1 month following silicone oil removal. Results: IOP rise was seen in 24.25% (154) out of the 635 eyes studied. Among patients under 50 years of age, 37.73% had an IOP rise, compared to 21.55% above 50 years (Odds Ratio 2.206). Among males, 30.32% had an IOP rise, as compared to 15.98% females (OR 2.287). In eyes with retinal detachment, 49.16% had raised IOP (OR 5.435), and 24.05% with proliferative diabetic retinopathy (OR 1.780), as opposed to 15.38% with macular hole and 12.32% with epiretinal membrane. This was statistically significant (P < 0.001). In eyes with silicone oil, 34.9% developed a rise in IOP (OR 2.738) as compared to 11.94% of other surgeries (OR 0.697). This was statistically significant (P < 0.001). Conclusion: We observed an increase in IOP postoperatively, more in those under 50 years, males and patients undergoing surgery for RD and PDR.

Pathological Complete Response in Locally Advanced Breast Cancer after Neoadjuvant Chemotherapy: Survival Outcome and Its Relevance as a Surrogate End Point.

Background Pathological complete response (pCR) to neoadjuvant chemotherapy has emerged as a reliable surrogate marker for improved survival in breast cancer (BC), but its role as a surrogate end point is still controversial. Aims and Objectives The aim of the study is to investigate the clinical course of BC patients with pCR and to evaluate the relevance of pCR as a surrogate end point for survival. Materials and Methods This was a single-institution retrospective analysis done at Amrita Institute of Medical Sciences. Records of BC patients from 2004 to 2014 were analyzed. Disease-free survival (DFS) and overall survival (OS) were compared using the Kaplan-Meier method and log-rank test, respectively. pCR and survival association were evaluated using regression analysis ( R 2 ). Results Of 224 patients included in the study pCR rate was 15.2%. The median duration of follow-up was 61 months (range: 3-151 months). DFS (73.4 vs. 46.1%, p = 0.032) and OS (82.5 vs. 56.4%, p = 0.022) of pCR cohort was significantly higher than non-pCR cohort. Recurrence rate was significantly lower in the pCR cohort at: All distant sites ( p = 0.01 3), visceral sites ( p = 0.007), both bone and visceral sites ( p = 0.007), and nodal sites ( p = 0.007). There was no difference in the bone-only recurrence ( p = 0.3 15). Death rate was significantly lower in pCR cohort ( p = 0.007). The R2 value for pCR as a surrogate for DFS and OS was 0.006 and 0.004, respectively. Conclusion pCR is a favorable prognostic factor associated with improved survival. However, there is no association between pCR and survival.

A Comparison of the Clinical Outcomes in Uterine Cancer Surgery After the Introduction of Robotic-Assisted Surgery.

OBJECTIVE: To compare the rates of intraoperative and postoperative complications of open and robotic-assisted surgery in the treatment of endometrial cancer. METHODS: This retrospective study was performed at a single academic institution from January 2014 to February 2017 in the Department of Gynecology Oncology at Amrita Institute of Medical Science, Kerala, India. The study included patients with clinically early stage uterine malignancy undergoing open or robotic-assisted surgery. Data collected included clinicopathological factors, intraoperative data, length of hospital stay and intraoperative and postoperative (early and late and severity according to Clavien-Dindo classification). Morbidity was compared between two groups. RESULTS: The study included 128 patients, of whom 61 underwent open surgery and 67 underwent robotic-assisted surgery. Mean operative time (P = 0.112), mean estimated blood loss (P < 0.001), number of patients requiring blood transfusion (P < 0.001) and mean length of hospital stay (P < 0.001) were significantly lower in robotic group. None of the patients in robotic group experienced intraoperative hemorrhage (P = 0.010). The early postoperative complications, SSI (P < 0.001), infection (P = 0.002), and urinary complications (P = 0.030) and late postoperative complications lymphoedema (P = 0.002), vault-related complications (1.5% robotic vs. 6.6% open) and incisional hernia (none in robotic vs. 4.9% in open) were significantly lower in robotic group. Grade-II complications (Clavien-Dindo classification) were significantly lower in robotic group (P < 0.001). CONCLUSION: Robotic-assisted surgical staging for uterine cancer is feasible and safe in terms of short-term outcomes and results in fewer complications and shorter hospital stay.

A retrospective analysis of the pattern of care and survival in patients with malignant ovarian germ cell tumors.

OBJECTIVE: The objective of this study is to evaluate the pattern of care and survival outcome in patients with malignant ovarian germ cell tumors (MOGCTs). MATERIALS AND METHODS: Between January 2004 and August 2017, 50 patients with MOGCT were identified at Amrita Institute of Medical Sciences and 48 included in analyses. Histologic subtypes were as follows: dysgerminoma 11; immature teratoma 16; yolk sac tumor 3; and mixed germ cell tumor 18. 31 (64.6% patients belonged to Stage I and 17 (35.4%) patients were advanced stage (Stage II-IV). RESULTS: Median follow-up period was 34 months (range: 1-241 months). The 5- and 10-year disease-free survival (DFS) and overall survival (OS) for the entire cohort were 87.5% and 94.4%, respectively. DFS and OS of incomplete surgery Stage I patients 28.6% and 68.6%, respectively, were significantly lower than completely staged patients 100%. Out of 8 incomplete surgery patients, 5 recurred of which 2 died of disease within 4 and 9 months of recurrence. There was no survival difference with comprehensive surgical staging (CSS) and pediatric surgical staging (PSS) in Stage I MOGCT (DFS and OS 100%). Stage I dysgerminoma kept on active surveillance after PSS had equivalent survival of 100%. There was no survival difference in advanced stage MOGCT treated with primary debulking surgery and neoadjuvant chemotherapy (NAC) followed by fertility-sparing surgery (DFS and OS 100%). CONCLUSION: Incomplete surgery in Stage I MOGCT was associated with poor survival. There was no survival difference with CSS and PSS. NAC followed by surgery could be a reasonable option for patients of advanced stage MOGCT.

A retrospective evaluation of the perioperative drug use and comparison of its cost in robotic vs open surgery for endometrial cancer.

To compare the usage and cost of analgesics (opioid and non-opioids), antiemetics, and IV fluids and its associated costs in robotic vs open staging surgery for endometrial cancer (EC). This retrospective study was performed at a single academic institution from January 2014 to June 2017 in the department of Gynecology Oncology at Amrita Institute of Medical Science, Kerala, India. The study included women with biopsy confirmed clinically early stage endometrial cancer or atypical hyperplasia, who underwent robotic-assisted or open staging surgery. Data on surgical time, blood loss, post-anaesthesia care unit (PACU) stay, and length of hospital (LOH) stay; analgesic, antiemetic, and IV fluid use were collected for three distinct periods: intra-operative, PACU, and ward. Direct medicine and material costs associated with the administration of intravenous (IV) fluids, analgesics, and antiemetics were collected. All parameters were compared between two surgical groups. The study included 133 (54 open and 79 robotic-assisted) patients. As compared to open surgery, robotic-assisted surgery was associated with significantly reduced: surgical time (p = 0.007), estimated blood loss (p < 0.001), PACU stay (p < 0.001), LOH stay (p < 0.001); IV fluids (crystalloid and colloid; p < 0.001); opioids (p < 0.001), non-opioids (intravenous acetaminophen, oral acetaminophen, diclofenac; all p < 0.001); incidence of post-operative nausea and vomiting and the requirement of rescue antiemetics (p < 0.001). EC staging using robotic-assisted surgery was associated with significantly lower medicine and material costs attributed to IV fluids, analgesia, and antiemetics (p < 0.001). As compared to open surgery, robotic surgery was associated with the total saving of $107.7 ($19.5 in IV fluids, $49.2 in analgesics, $1.33 in antiemetics, and $37.8 in material). Robotic-assisted surgical staging for endometrial cancer is associated with decreased requirement and expenditure attributable to post-operative pain, post-operative nausea and vomiting, and maintenance and replacement fluid therapy.

Stereotactic body radiation therapy for early-stage primary lung cancer, is an active breath coordinator necessary? An audit from a tertiary cancer care center.

CONTEXT: The hypofractionated stereotactic body radiation therapy (SBRT) has emerged as a safe and effective treatment modality for early-stage nonsmall cell lung carcinoma. AIMS: An audit SBRT in primary lung cancer treated in our center with and without an active breath coordinator (ABC) was undertaken to evaluate its impact on target volumes and clinical outcomes. SETTINGS AND DESIGN: This was an observational study. MATERIALS AND METHODS: Nine patients with lung carcinoma were treated from January 2014 to August 2016. Five patients were simulated using ABC and four patients with free breathing. Volumetric modulated arc therapy plans were generated using Monaco treatment planning software. Three patients were treated with a dose of 54 Gy in three fractions and six patients with a dose of 48 Gy in four fractions. STATISTICAL ANALYSIS USED: The statistical analysis was performed using Kaplan-Meier survival. RESULTS: The mean planning target volumes (PTV) in ABC and free breathing groups were 42.19cc and 60.17cc, respectively. The mean volume of lung receiving 20, 10, and 5 Gy (V20, V10and V5) in ABC group were 5.37cc, 10.49cc, and 18.45cc whereas in free breathing 6.63cc, 12.74cc, and 20.64cc, respectively. At a median follow-up of 18 months, there were three local recurrences. No significant toxicity occurred in our series. CONCLUSION: Our initial results show that SBRT is well tolerated with good local control. Although the PTV volume and irradiated normal lung volume was higher in this group compared to ABC group, this did not translate to any added clinical toxicity.

Stereotactic body radiation therapy for hepatocellular carcinoma: Experience from a tertiary cancer care center in India.

AIM: The aim of this retrospective study is to assess the toxicity and tumor response of stereotactic body radiation therapy (SBRT) protocol for hepatocellular carcinoma (HCC) in our institution. BACKGROUND: Hepatocellular cancer is one of the leading cancers among men in India. In recent years, SBRT has emerged as a promising tool in the treatment of HCC. MATERIALS AND METHODS: Ten patients diagnosed as HCC with Barcelona Clinic Liver Cancer Stage B and C, treated with SBRT technique from January 2013 to December 2016, were included in this study. SBRT was delivered using 6 MV photons with volumetric modulated arc therapy. Acute and late toxicities were graded, and tumor response was assessed using response evaluation criteria in solid tumors criteria. Kaplan-Meier curves were generated for progression-free survival (PFS) and overall survival (OS). RESULTS: The median age was 61.5 (52-69) years. The radiation dose ranged from 35 Gy to 60 Gy. All patients obtained partial response during assessment at 3 months after completion of treatment. The median PFS is 8 months (95% confidence interval [CI] - 5.22-10.77 months). The median OS is 51 months (95% CI - 17.64-65.10 months). The OS at 1 and 2 years is 75% and 57%, respectively. CONCLUSIONS: SBRT is well tolerated by our patients. The 1- and 2-year OS of 75% and 57% is consistent with other prospective and retrospective SBRT studies from the literature.

Prevalence of Depression in Breast Cancer Patients and its Association with their Quality of Life: A Cross-sectional Observational Study.

BACKGROUND: Breast cancer is the leading cause of cancer death among women worldwide. In India, the incidence rate of breast cancer is found to be 25.8/10,000 females. The statistics for Kerala, India, is 30.5 in urban areas and 19.8 in rural areas. Cancer and treatment-related symptoms are major stressors in patients with breast cancer undergoing treatment for the disease. Depression is a prevalent psychological symptom perceived by breast cancer patients, and it also impacts the quality of life (QOL) in these patients. We aimed to assess the prevalence of depression and its association with QOL of patients with breast cancer undergoing treatment for breast cancer. MATERIALS AND METHODS: This cross-sectional study enrolled 270 patients diagnosed with breast cancer (>18 years) and undergoing active treatment in a tertiary care center in Kerala, India. Depression was assessed using the Patient Health Questionnaire 9 and International Classification of Diseases, Tenth Edition Research guidelines. We measured the QOL and its domains using the WHOQOL-BREF. RESULTS: The average age of women in research was 53.56 years. Of the 270 patients, 21.5% had depression. Among patients with depression, 22% had moderately severe to severe depression. Patients with depression experienced overall a poor QOL. Twenty-two patients reported their overall QOL was "poor" and 34 patients reported to be dissatisfied with their health. There was an association between depression and domains of QOL. Patients with depression had lower scores in all domains when compared to those without depression. CONCLUSION: Depression and poor QOL is common among breast cancer patients.

Immunolocalization of osteopontin in dysplasias and squamous cell carcinomas arising from oral epithelium.

BACKGROUND: Early detection of oral squamous cell carcinoma (OSCC) remains one of the most efficient ways to ensure patient survival and improved quality of life. Although specific biomarkers related to OSCC have been investigated, a useful biomarker that assesses the transition potential of potentially malignant lesion to OSCC remains to be found. Osteopontin (OPN) has been recognized as an important factor in tumorigenesis and their expression in OSCC have been investigated earlier. In the present study, evaluation of OPN expression in premalignant and malignant lesions has been carried out to assess their possible role as a biomarker in the early diagnosis and prognosis of OSCC. OBJECTIVES: The objective of this study is to evaluate the role of OPN as a biomarker in the diagnosis and prognosis of OSCC. MATERIALS AND METHODS: The study group consisted of archival paraffin-embedded blocks of ten cases each of varying grades of OSCC, oral epithelial dysplasias and epithelial hyperplasias. Sections were subjected to immunohistochemical staining for the biomarker OPN. RESULTS: A positive OPN expression was noticed in epithelial dysplasias and SCC arising from the oral epithelium. A progressive increase in the intensity of staining was seen with increasing grades of dysplasias and a decrease in OPN expression with an increase in grades was observed in OSCC. CONCLUSION: The expression of OPN in full thickness of epithelium in severe dysplasias, carcinoma in situ, and in the superficial epithelium of OSCC suggest the possibility of considering OPN expression in full epithelial thickness in dysplasias as an indicator for malignant transformation.