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Opiates are generally used to relieve dyspnoea in advanced diseases such as cancer and lung diseases. However, little is known regarding the safety and efficacy of morphine for refractory dyspnoea in coronavirus disease 2019 (COVID-19) patients. We retrospectively reviewed records of 18 COVID-19-positive patients who were administered morphine for refractory dyspnoea during hospitalisation between May 2021 and June 2021. Details of morphine usage, vital signs, an 11-point dyspnoea numeric rating scale (DNRS) and adverse events at baseline, 24 h and 72 h after the start of treatment were abstracted from records. The final clinical outcome in terms of death or discharge was noted. All patients had severe refractory dyspnoea (DNRS score ≥7) at the time of administration of morphine and had not been relieved from standard care for the past 3 days. In the results, the mean (standard deviation [SD]) age was 47.1 (12) years, male was 13 (72.20%) patients and modified Medical Research Council Grade 4 was present in all 18 patients. The mean (SD) 1st day dose of morphine was 7.03 (1.53) mg and the mean (SD) duration of morphine use was 5.22 (3.00) days. Significant decreases in DNRS, respiratory rate and oxygen saturation were observed 24 h and 72 h after the start of morphine administration. Meanwhile, blood pressure and heart rate were not significantly altered after treatment. The finding of this single-centre retrospective study indicates that morphine may be considered for use in the management of refractory dyspnoea among COVID-19 patients.

Background: The development of acute kidney injury (AKI) in patients infected with COVID-19 has been observed to be associated with poor outcomes. Our study aimed to measure the outcomes of COVID-19 in cancer patients who developed AKI during hospitalization and the predictive baseline clinical and laboratory factors associated with the development of AKI. Materials and Methods: This retrospective cohort study was conducted at a COVID hospital that included only cancer patients with COVID-19 infection. Acute kidney injury (AKI) was defined according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria. The demographic, clinical, laboratory and outcomes data were collected from the hospital electronic database and abstracted from the case files. Results: Thirteen (12.8%) of the total 102 cancer patients developed AKI during hospitalization. Out of 13, 11 (84.6%) patients presented with hypoxemia during admission and required oxygen support. Breathlessness [Odds Ratio (OR) (95% CI): 5.8 (1.1-31.3)] or hypoxemia [OR 22.6 (2.6-194.5)] at the time of presentation and requirement of oxygen support [OR 7.5 (1.4-40.5)] were significantly associated with AKI after adjusting for age, gender, vaccination status and comorbidities. Median baseline values of inflammatory markers were significantly higher among those who developed AKI. Out of 102, 27 (26.5%) patients had in-hospital mortality. Mortality was high among those who developed AKI compared to those who didn’t develop AKI (92.3% vs 16.1%, p-value

Background: Patients with chronic kidney disease (CKD) on maintenance hemodialysis are highly vulnerable to coronavirus disease 2019 (COVID-19) infection and poorer outcomes and mortality. Objectives: The study aimed at identifying the various clinical and biochemical predictors of in-hospital mortality in this particular group of patients. Methods: In this retrospective cohort study, the baseline demographic, clinical, and laboratory data were collected from patients with preexisting CKD on maintenance hemodialysis and with COVID-19 infection. The statistical analysis of the collected data was performed using SPSS version 24 (SPSS Inc, Chicago, IL, USA). Results: The data obtained from 35 patients from the first wave of the pandemic were analyzed. The mortality rate was 23% (8 patients). Analyzing the comparison between survivors and non-survivors revealed that the older age (49 [IQR, 42 – 55] years vs. 70 [IQR, 54 – 74] years, P = 0.016), severe disease at presentation (15% vs. 75%, P = 0.004), and need for invasive mechanical ventilation (0% vs. 75%, P = 0.001) were the factors significantly associated with in-hospital mortality. Among baseline biochemical markers, severe lymphocytopenia (11 [IQR, 7 – 16] vs. 4.2 [IQR, 3 – 8], P = 0.011), high serum glutamic oxaloacetic transaminase (23 [IQR, 15.6 – 48] vs. 80 [IQR, 60- 105], P = 0.001), blood urea (71 [IQR, 28 - 120) vs. 160 (IQR, 142 - 355), P = 0.002) and higher value of inflammatory markers, interleukin-6 (IL-6), and procalcitonin, as well as fibrinogen and low baseline albumin, were also significantly associated with in-hospital mortality. Conclusions: The older age, severe disease at presentation, need for invasive mechanical ventilation, raised baseline IL-6, procalcitonin, serum glutamic oxaloacetic transaminase, blood urea, and lower level of albumin may have been valuable predictors of in-hospital mortality and poor outcomes in patients with COVID-19-infected chronic kidney disease on maintenance hemodialysis.

BackgroundHypoxia in patients with COVID-19 is one of the strongest predictors of mortality. Silent hypoxia is characterized by the presence of hypoxia without dyspnea.. Silent hypoxia has been shown to affect the outcomes in previous studies.Research QuestionAre the outcomes in patients presenting with silent hypoxia different from those presenting with dyspneic hypoxia?Study design and MethodsThis was a retrospective study of a cohort of patients with SARS-CoV-2 infection who were hypoxic at presentation. Clinical, laboratory, and treatment parameters in patients with silent hypoxia and dyspneic hypoxia were compared. Multivariate logistic regression models were fitted to identify the factors predicting mortality.ResultsAmong 2080 patients with COVID-19 admitted to our hospital, 811 patients were hypoxic with SpO2P=0.202). The odds ratio of death was 1.1 (95% CI 0.41-2.97) in the patients with silent hypoxia after adjusting for baseline characteristics, laboratory parameters, treatment, and in-hospital complications, which did not reach statistical significance (P=0.851).InterpretationSilent hypoxia may be the only presenting feature of COVID-19. Since the case fatality rate is comparable between silent and dyspneic hypoxia, it should be recognized early and treated as aggressively. Since home isolation is recommended in patients with COVID-19, it is essential to use pulse oximetry at the home setting to identify these patients.

BackgroundDue to the unprecedented speed of SARS-CoV-2 vaccine development, their efficacy trials and issuance of emergency use approvals and marketing authorizations, additional scientific questions remain that need to be answered regarding vaccine effectiveness, vaccination regimens and the need for booster doses. While long-term studies on the correlates of protection, vaccine effectiveness, and enhanced surveillance are awaited, studies on breakthrough infections help us understand the nature and course of this illness among vaccinated individuals and guide in public health preparedness.MethodsThis observational cohort study aimed at comparing the differences in clinical, biochemical parameters and the hospitalization outcomes of 53 fully vaccinated individuals with those of unvaccinated (1,464) and partially vaccinated (231) individuals, among a cohort of 2,080 individuals hospitalized with SARS-CoV-2 infection.ResultsCompleting the course of vaccination protected individuals from developing severe COVID-19 as evidence by lower proportions of those with hypoxia, abnormal levels of inflammatory markers, requiring ventilatory support and death compared to unvaccinated and partially vaccinated individuals. There were no differences in these outcomes among patients who received either vaccine type approved in India.ConclusionWith a current rate of only 9.5% of the Indian population being fully vaccinated, efforts should be made to improve the vaccination rates as a timely measure to prepare for the upcoming waves of this highly transmissible pandemic. Vaccination rates of the communities may also guide in the planning of the health needs and appropriate use of medical resources.Research in contextEvidence before this studyThe Government of India started vaccinating its citizens from the 16thof January 2021, after emergency use authorization had been received for the use of two vaccines, BBV152, a COVID-19 vaccine based on the whole-virion SARS-CoV-2 vaccine strain NIV-2020-770, (Covaxin) and the recombinant replication-deficient chimpanzee adenovirus vector encoding the spike protein ChAdOx1 nCoV-19 Corona Virus Vaccine (Covishield). These have been approved by the Indian regulatory authority based on randomized controlled studies. In these studies, was found that the vaccines led to more than 90% reduction in symptomatic COVID-19 disease. However, there is scarce evidence of the efficacy of these vaccines in real-world scenarios. A few studies have looked at vaccinated cohorts such as health care workers in whom the vaccines had an efficacy similar to the RCTs. In a study of patients with SARS-CoV-2 infection admitted to a tertiary care hospital in New Delhi, it was found that mortality in fully vaccinated patients was 12.5% as compared to 31.5% in the unvaccinated cohort.Added-value of this studyThis cohort of hospitalized patients with SARS-CoV-2 infection was studied during the peak of the second wave of COVID-19 in India during which the delta variant of concern was the predominant infecting strain and had 26% patients who were partially vaccinated and 71.4% who were unvaccinated. Only 3% of the patients were fully vaccinated and developed a breakthrough infection. At the time of presentation, 13% of the individuals with breakthrough infection and 48·5% in the non-vaccinated group were hypoxic. Inflammatory markers were significantly lower in the completely vaccinated patients with breakthrough infection. The need for use of steroids and anti-viral agents such as remdesivir was also significantly low in the breakthrough infection group. A significantly less proportion of the individuals with breakthrough infection required oxygen supplementation or ventilatory support. Very few deteriorated or progressed to critical illness during their hospital stay. Only 3 individuals (5.7%) out of the 53 who developed breakthrough infection succumbed to illness while case fatality rates were significantly higher in the unvaccinated (22.8%) and partially vaccinated (19.5%) groups. Propensity score weighted multivariate logistic regression analysis revealed lower odds of developing hypoxia, critical illness or death in those who were completely vaccinated.Implications of all the available evidenceThe real-world effectiveness of the vaccines against SARS-CoV-2 seems to be similar to the randomized controlled trials. The vaccines are very effective in reducing the incidence of severe COVID-19, hypoxia, critical illness and death. The reduced need for oxygen supplementation, mechanical ventilation and the requirement of corticosteroids or other expensive medications such as anti-viral drugs could go a long way in redistributing scarce health care resources. All nations must move forward and vaccinate the citizens, as the current evidence suggests that ‘prevention is better than cure’.

BackgroundThe second wave of the COVID-19 pandemic hit India from early April 2021 to June 2021 and more than 400,000 cases per day were reported in the country. We describe the clinical features, demography, treatment trends, baseline laboratory parameters of a cohort of patients admitted at the All India Institute of Medical Sciences, New Delhi with SARS-CoV-2 infection and their association with the outcome.MethodsThis was a retrospective cohort study describing the clinical, laboratory and treatment patterns of consecutive patients admitted with SARS-CoV-2 infection. Multivariate logistic regression models were fitted to identify the clinical and biochemical predictors of developing hypoxia, deterioration during the hospital stay and death.FindingsA total of 2080 patients were included in the study. The case fatality rate was 19.5%. Amongst the survivors, the median duration of hospital stay was 8 (5-11) days. Out of 853 (42.3%%) of patients who had COVID-19 Acute respiratory distress syndrome at presentation, 340 (39.9%) died. Patients aged 45-60 years [OR (95% CI): 1.8 (1.2-2.6)p =0.003] and those aged >60 years [OR (95%CI): 3.4 (2.3-5.2), p500 mg/dL [OR (95% CI): 3.2 (2.2-4.6), p 0.5 mg/L [OR (95% CI): 3.8 (1.1-13), p=0.037] had higher odds of death. Patients who were admitted in the second week had lower odds of death and those admitted in the third week had higher odds of death.InterpretationThis is the largest cohort of patients admitted with COVID-19 from India reported to date and has shown that vaccination status and early admission during the inflammatory phase can change the course of illness of these patients. Strategies should be made to improve vaccination rates and early admission of patients with moderate and severe COVID-19 to improve outcomes.Research in contextEvidence before this studyThe COVID-19 pandemic has been ravaging the world since December 2019 and the cases in various regions are being reported in waves. We found that the case fatality rates ranging from 1.4% to 28.3% have been reported in the first wave in India. Older age and the presence of comorbidities are known predictors of mortality. There are no reports regarding the effectiveness of vaccination, correlation of mortality with the timing of admission to the health care facility and inflammatory markers in the ‘second wave’ of the COVID-19 pandemic in India.Added-value of this studyThis study reports the real-world situation where patients get admitted at varying time points of their illness due to the mismatch between the availability of hospital beds and the rising number of COVID-19 patients during the pandemic. It reports the odds of developing severe hypoxia necessitating oxygen therapy and death thus helping identify priority groups for admission.Implications of all the available evidenceThis study found increased odds of requiring oxygen support or death in patients older than 45 years of age, with comorbidities, and those who had hyper-inflammation with raised C-reactive peptide, d-dimer or leukocytosis. Patients who were admitted in the second week of illness had lower odds of death as compared to those admitted in the third week implying that treatment with corticosteroids in the second week of the illness during the ‘inflammatory phase’ could lead to reduced mortality. These findings would help triage patients and provide guidance for developing admission policy during times where hospital beds are scarce. Vaccination was found to reduce the odds of deterioration or death and should be fast-tracked to prevent further ‘waves’ of the pandemic.

Use of illegal and prescription drugs has significantly increased in recent years all over the world in most populations. Greater worldwide awareness in this regard has substantially improved the epidemiological understanding of substance use, its risk factors, and impact on life. People with intellectual disabilities constitute 0.5%–1.5% of the world’s population. It can be conjectured that they might be experiencing similar or even a greater burden of substance use in their lives. This article highlights some important aspects of substance use among this population in low- and middle-income countries that need urgent attention.

Studies comparing the utility of dexmedetomidine with other drugs for sedation during medical thoracoscopy are lacking. In this pilot study, we compared dexmedetomidine with midazolam for sedation in thoracoscopy.Consecutive subjects were randomized to receive either dexmedetomidine (n=30) (group D) or midazolam (n=30) (group M). All received fentanyl for procedural analgesia. The primary endpoint was pulmonologist-rated overall procedure satisfaction on the visual analog scale (satisfaction VAS). Key secondary outcomes were pulmonologist-rated cough on VAS (cough VAS), patient-rated faces pain scale scores, change in hemodynamic variables, total additional fentanyl dose, and adverse events during procedure.The satisfaction VAS score (mean±SD) was significantly greater in group D versus group M (7.5±1.4 and 6.5±1.1, respectively) ( P =0.003). The cough VAS scores (mean±SD) were 2.1±1.5 (group D) and 3.1±1.3 (group M) ( P =0.014). The scores (mean±SD) for patient-rated faces pain scale were 2.9±1.8 and 4.2±2.3 ( P =0.019) in group D and group M, respectively. The additional dose of fentanyl administered in group M was significantly greater than in group D ( P =0.001). The responses at the local anesthesia infiltration, skin incision, thoracoscope insertion, and biopsy between both groups were similar. The hemodynamic parameters were comparable in both groups. Also, more patients were willing for repeat thoracoscopy if needed; in the dexmedetomidine group.The findings of this pilot RCT indicate that dexmedetomidine may be more efficacious than midazolam for sedation in patients undergoing medical thoracoscopy. These observations need to be confirmed in an adequately powered RCT.

e12505 Background: In HER2 positive breast cancer, TCH is a safe and efficacious anthracycline free regimen used as both adjuvant and neoadjuvant modality. Three is scarcity of data regarding its long term safety and efficacy from India. Methods: This retrospective study comprised of 210HER2 positive breast cancer female patients treated with TCH [docetaxel (75mg/m2), carboplatin (AUC=6) and trastuzumab (8mg/kg loading followed by 6mg/kg) q 21 days with GSF prophylaxis] protocol for 6 cycles at our centre between Jan 2014 and Dec 2021. All eligible patients received maintenance trastuzumab, hormonal therapy and radiotherapy as per institutional protocol. The information regarding baseline clinico-demographic characteristics, treatment details, outcomes and toxicities were collected and evaluated. Results: The median age was 49 years (23-72), 113 (53.8%) were post-menopausal and 100 (47.6%) were Estrogen receptor/Progesterone receptor positive. Sixty-eight (32.4%) patients were stage I and II, 112 (53.3%) stage III and 30 (14.3%) were oligometastatic. TCH regimen was given as neoadjuvant chemotherapy (NACT) in 130 (61.9%) patients and as adjuvant chemotherapy in 80 (38.1%) patients. Of the patients receiving NACT, 114 (87.6%) patients underwent surgery. Twenty-two (19.3%) patients underwent breast conservation surgery and 92 (80.7%) underwent modified radical mastectomy. Over the study period, 62 (29.5%) patients had progression of the disease and 22 (10.5%) patients died. With a median follow up of 31.9 months, 3-year disease free survival (DFS) was 63.5% and overall survival (OS) was 90.8%. Median DFS was 31 months in patients with node positive disease and was not reached in patients with node positive disease. Of the patients who received NACT, pathologic complete response (pCR) was recorded in 42 (36.8%) patients. Three-year DFS was 59.1% in patients who achieved pCR and 44.8% in those who did not achieve pCR. Any grade 3/4 toxicity was seen in 26.7% patients which caused dose modification in 13.9% patients. The most common grade 3/4 hematological toxicity was anemia (15.1%) and thrombocytopenia (10.4%), while non-hematological toxicity was diarrhea (11.6%). Febrile neutropenia was seen in 4 (1.9%) patients. Four patients (1.9%) had reversible decrease in cardiac left ventricular ejection fraction. Conclusions: Anthracycline free TCH regimen is an effective and safe regimen for use in curative (adjuvant and neoadjuvant) setting for HER2 positive breast cancer in Indian women with outcomes comparable to the anthracycline based regimens reported in literature.

e12594 Background: Dose-dense adjuvant chemotherapy has been shown to be associated with improved long-term survival outcomes in triple-negative breast cancer (TNBC). However, there is a lacuna of data on the benefits of dose-dense neo-adjuvant chemotherapy (NACT) in TNBC particularly with respect to pathological complete response (pCR) rates and with the relapse or overall survival. To our knowledge no studies have been reported regarding the use or benefit of dose-dense NACT (ddNACT) over conventional NACT (cNACT) among Indian women with TNBC. Methods: This retrospective study included, 217 newly diagnosed cases of TNBC, treated with sequential anthracycline and taxane based NACT followed by definitive surgery. Study groups consisted of 137 patients who received 3-weekly conventional chemotherapy (cNACT group) and 80 patients with 2-weekly dose-dense NACT (ddNACT group) with granulocyte-colony-stimulating factor (GCSF) prophylaxis. Primary endpoint of the study was pathological complete response (pCR) rate and secondary endpoints were relapse-free survival (RFS), overall survival (OS) and grade-3/4 chemotoxicities. Fisher’s exact test was used to compare pCR rates. Kaplan-Meier and cox regression survival analysis were used to compare survival outcomes. Results: Median age (Interquartile range) in overall population, cNACT and ddNACT group were 43 (37-50), 44 (37-50) and 42 (36.5-48) years respectively. Baseline parameters were comparable between study groups, except that ddNACT group had higher proportion of premenopausal patients as compared to cNACT group (72.5% vs 55.5%). Majority of the patients presented at advanced stage, with stage-III being predominant, constituted by 97 (70.1%) and 55 (67.5%) patients in cNACT and ddNACT group respectively. No significant difference in pCR rate (32.8% vs 31.3%; p=0.808) was observed across the study groups. In multivariate analysis, dose-dense chemotherapy was no better than conventional chemotherapy for achieving pCR (Odds ratio [OR]: 0.86, 95% confidence interval [CI]: 0.45-1.63; p=0.639 and had no RFS advantage over conventional chemotherapy [Median RFS: Not reached in ddNACT vs 56.1 months in cNACT; Hazard Ratio: 0.83, 95% CI (0.48-1.44)]. OS was also comparable in both the groups with 3-year survival rate of 78.8% (95%CI: 60.9-89.2) in ddNACT group vs 84.3% (95% CI: 74.8-90.4) in cNACT group. Grade-3/4 toxicities were comparable in both groups. Conclusions: This observational study focusing on ddNACT among TNBC patients demonstrated similar pCR and toxicity rates with no significant survival benefits compared to cNACT regimen. Cost-benefits of frequent hospital visits for GCSF administration associated with dose dense therapy need further consideration before implementing such these regimens in lower-middle income countries.

e12593 Background: Capecitabine maintenance has demonstrated a survival benefit in triple-negative breast cancer (TNBC) patients not achieving pathological complete response (pCR) following neo-adjuvant chemotherapy (NACT). However, there is scarcity of data from Indian sub-continent corroborating the benefit of capecitabine maintenance. Methods: This retrospective study comprised of 161 TNBC patients registered at our institute between a period of May 2013 to Dec 2020, who received NACT (sequential anthracycline and taxane) but did not achieve pCR. Capecitabine was added to the institutional protocol since 2017 for maintenance therapy of TNBC patients who didn’t achieve pCR post NACT. Using Kaplan-Meir survival analysis and multivariate cox-proportional hazard models, we analysed differences in the relapse-free survival (RFS) and overall survival (OS) among those who received capecitabine maintenance therapy (n=80) versus those who did not receive it (n=81). Results: Distribution of age, family history, baseline performance score, tumor size, node positivity and clinical stage at time of presentation were comparable between the study groups, except for menopausal status (50% in control vs 33% in capecitabine group). Median(IQR) follow up time was 22.2 (16.2-27.4) months in capecitabine groups vs 19.3 (11.7-35.1) in control group. Twenty-three (28.8%) women in the capecitabine group had a disease-relapse while 45.7% (n=37) had relapsed in control group (p=0.026). Median RFS was 20.4 (17.8-25.9) months in control group while it was not reached in capecitabine group (log rank p=0.007). Adjusted for other baseline clinical characteristics, hazard of disease-relapse was significantly lower in the capecitabine group compared to controls [adjusted Hazard Ratio (aHR), 95% CI: 0.57 (0.34-0.96), p=0.035]. Median OS was not achieved in both the study groups, however, the hazard of death was lower in capecitabine group compared to control [aHR(95%CI): 0.44 (0.20-1.01), p-0.053]. Stratified by menopausal status, effect of capecitabine maintenance on disease relapse and RFS was only significant among the post-menopausal women [aHR (95%CI): 0.24 (0.10-0.59)]. Conclusions: This is the first study from our country, demonstrating a survival benefit with capecitabine maintenance in patients with TNBC not achieving pCR following NACT, particularly in post-menopausal women. It is an important observation as most of our patients present with locally advanced disease where pCR rate is low.

e12601 Background: Neoadjuvant chemotherapy (NACT) with HER2 blockade is preferred approach for treatment of early and locally advanced HER2 positive breast cancer. However, there is a lack of survival data with respect to pathological complete response (pCR) from India. Methods: We retrospectively evaluated 211 HER2 positive female breast cancer patients registered between years 2014 and 2021, who received three different NACT regimens (i) Anthracycline free TCH (n=116) [docetaxel (75mg/m2), carboplatin (AUC = 6) and trastuzumab (8mg/kg loading followed by 6mg/kg) with G-CSF q 21 days], (ii) EC-TH (n=52) [epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) for 4 cycles followed by 4 cycles of docetaxel (85mg/m2)] and (iii) EC-T (n=43, without trastuzumab due to financial constraints). Primary end point was pCR. Secondary end points were disease free survival (DFS), Overall Survival (OS) and safety profile. Results: Median age was 45 years (24-71), 88 (41.7%) were postmenopausal and 104 (49.3%) were ER/PR positive. Twenty-two (10.4%) patients were stage II, 164 (77.7.%) were stage III and 25 (11.9%) were oligometastatic stage IV. Distribution of age, performance status, tumor size and nodal positivity were comparable across the study groups. Pathological CR in trastuzumab containing groups, was higher compared to non-trastuzumab containing group (35.8% vs 20%, p=0.045) and was similar between, TCH and EC-TH groups. Median follow-up was 32.9 months (5.7-108), 3-year DFS and OS were 54.8% and 92.1% respectively. Pathological CR rates and survival outcomes of the three groups are given in table 1. When stratified by pCR status, in the trastuzumab containing groups, achievement of pCR translated to improved DFS (log rank p=0.01). This survival advantage of pCR was not seen in non-trastuzumab containing group. The outcome of trastuzumab containing both regimens were similar. Grade 3/4 toxicities were recorded in 21.6% of TCH, 26.7% of EC-TH and in 25.2% of EC-T groups. Most common toxicities were anemia (16.3%), thrombocytopenia (14.2%) and vomiting (10.2%). Conclusions: Trastuzumab containing regimens impact pCR rates and in turn the survival outcomes among Indian women with HER2 positive breast cancer. Safety and efficacy of anthracycline free TCH regimen is comparable with EC-TH.[Table: see text]

e12549 Background: Prevalence of Triple Negative Breast Cancer (TNBC), which has utterly poor prognosis and higher recurrence rate, is high among Indian women ranging from 20-43% across different regions of India. Previous studies from other countries have shown that pretreatment hemoglobin and hematocrit values influence treatment outcomes among breast cancer patients. Recent 2019-2020 National Family Health Survey (NFHS) of India reported that 66.4% of women suffer from anemia. This study examined the association of pre-treatment hemoglobin levels with survival outcomes among Indian women with TNBC. Methods: We retrospectively analyzed the medical records of 435 women registered at our institute with a diagnosis of TNBC between the years 2013-2021. Pre-treatment hemoglobin levels i.e. either before the start of neoadjuvant chemotherapy (NACT) or prior to surgery among those who received adjuvant chemotherapy were retrieved from the medical records along with clinical and tumor characteristics. Primary outcomes were relapse free survival (RFS) and overall survivals (OS). Cox-regression and Kaplan-Meier survival analysis were used to examine the association of pre-treatment anemia with survival outcomes in these patients. Results: Fifty-one percent (n=221) of the 435 TNBC patients in our study cohort had pretreatment hemoglobin level of

To determine the validity of diagnoses indicative of early-onset dementia (EOD) obtained from an algorithm using administrative data, we examined Veterans Health Administration (VHA) electronic medical records (EMRs).A previously used method of identifying cases of dementia using administrative data was applied to a random sample of 176 cases of Post-9/11 deployed veterans under 65 years of age. Retrospective, cross-sectional examination of EMRs was conducted, using a combination of administrative data, chart abstraction, and review/consensus by board-certified neuropsychologists.Approximately 73% of EOD diagnoses identified using existing algorithms were identified as false positives in the overall sample. This increased to approximately 76% among those with mental health conditions and approximately 85% among those with mild traumatic brain injury (TBI; i.e. concussion). Factors related to improved diagnostic accuracy included more severe TBI, diagnosing clinician type, presence of neuroimaging data, absence of a comorbid mental health condition diagnosis, and older age at time of diagnosis.A previously used algorithm for detecting dementia using VHA administrative data was not supported for use in the younger adult samples and resulted in an unacceptably high number of false positives. Based on these findings, there is concern for possible misclassification in population studies using similar algorithms to identify rates of EOD among veterans. Further, we provide suggestions to develop an enhanced algorithm for more accurate dementia surveillance among younger populations.

Introduction Amyotrophic lateral sclerosis (ALS) is a recognized military service-connected condition. Prior prevalence studies of ALS among U.S. war Veterans were not able to address concerns related to neurodegenerative sequelae of traumatic brain injury (TBI) and disregarded risk heterogeneity from occupational categories within service branches. Materials and Methods We identified the prevalence of definite and possible ALS and cumulative incidence of definite ALS among Post-9/11 U.S. Veterans deployed in support of Post-9/11 conflicts (mean age 36.3) who received care in the Veterans Health Administration during fiscal years 2002–2015. Using a case-control study design, we also evaluated the association of TBI and major military occupation groups with ALS adjusting for demographics and comorbidities. Results The prevalence of ALS was 19.7 per 100,000 over 14 years. Both prevalence and cumulative incidence of definite ALS were significantly higher among Air Force personnel compared to other service branches and among tactical operation officers and health care workers compared to general and administrative officers. Neither TBI nor younger age ( Conclusion This study among a cohort of relatively young Veterans showed a high ALS prevalence, suggesting an early onset of ALS among deployed military service members. The higher prevalence among some military specific occupations highlights the need to determine which occupational exposures specific to these occupations (particularly, Air Force personnel, tactical operations officers, and health care workers) might be associated with early onset ALS.

e13003 Background: Brain metastasis (BM) is a poor prognostic factor for survival among breast cancer (BC) patients. Very few studies reported in the literature have challenged this premise, suggesting that time to the occurrence of brain metastasis and the survival times following brain metastasis differ significantly between BC subtypes. The purpose of this study was to evaluate the clinico-pathological characteristics associated with brain metastasis free survival (BMFS), survival after brain metastases (SABM) and overall survival among Indian women with BC and BM. Methods: Among 621 patients treated for metastatic BC from 2015 to 2018 at All India Institute of Medical Sciences-New Delhi, 79 (12.7%) patients were identified to have BM. Of these ten individuals have presented with BM at the time of presentation. Survival analysis and Cox proportional hazards models were fitted to explore clinco-pathological factors that are associated with survival outcomes in these individuals. Results: Median age of the sample is 42 years (range:22-64). Triple negative breast cancers (TNBC) accounted for 25.3% and HER2 positive were 49.4% in our sample. Median time for the occurrence of BM from cancer diagnosis was 20.5 months (95% CI:14.7-26.2) in the overall sample, while among TNBC and HER2 positive tumors was 14.1 and 20.6 months respectively. In Cox multivariable model, T4stage [Hazard Ratio (HR) (95%CI): 2.4(1.1-5.3)], having a metastatic disease other than to brain at the time of presentation [HR(95%CI): 2.8(1.5-5.4)] and TNBC [HR(95%CI): 2.7(1.1-6.7)], was observed to be significantly associated with BMFS. Median SABM was 7.9 months (95% CI 5.2–16.2) and the median overall survival from the cancer diagnosis was 32.4 months (95% CI 23.4–40.8). Adjusted for age, only the presence of multiple brain lesions (>2) was significantly associated with SABM [HR (95%CI): 2.4(1.1-5.2)]. However, TNBC [HR (95%CI): 2.9(1.2-7.4)]and baseline metastatic disease [HR (95%CI): 2.2(1.2-4.2)] were significantly associated with overall survival following cancer diagnosis in these individuals. HER2 positivity was not associated with BMFS or SABM in this cohort. Conclusions: In this single-institutional study, clinical T4 stage, TNBC subtype and baseline metastatic disease have shown to be significantly associated with BMFS and overall survival. These results suggest that women in Indian population with these baseline clinico-pathological characteristics at the diagnosis of breast of cancer should be frequently monitored for BM.

e12618 Background: Attainment of pathological complete remission (pCR) with neoadjuvant chemotherapy in triple-negative breast cancer (TNBC) is associated with improved survival outcomes. However, data corroborating this fact is lacking from the Indian subcontinent. Methods: We evaluated 179 cases of TNBC, registered at Dr. B.R.A., I.R.C.H., AIIMS, New Delhi, from a period of May 2013 to July 2020, who were treated with neo-adjuvant chemotherapy (NACT) followed by surgery. Patients with oligometastatic disease who were treated with NACT with curative intent were also included in the analysis. Multivariate logistic regression analysis was done to explore the factors associated with the achievement of pCR. Survival analysis was done to study the correlation of pCR with relapse-free survival (RFS) and overall survival (OS). Results: The median age of our cohort was 43 (18-67) years. Study population comprised 104 (58.1%) pre-menopausal, 67 (37.4%) post-menopausal and 8(4.5%) peri-menopausal patients respectively. Twenty-three patients (12.9%) presented with early breast cancer, 144 (80.5%) were locally advanced and 12 (6.7%) were oligo-metastatic. Forty (22.4%), 127 (71.0%) and 12 (6.7%) patients were at clinical stages-II, III, and IV respectively at the time of presentation as per AJCC 7th edition. The median duration of symptoms was 4 (0.25-36) months. Forty-seven (26.3%) patients underwent breast conservation surgery and 128 (71.5%) patients had modified radical mastectomy. Overall pCR was attained in 29.6%(n=53) of the patients, with rates of 55%(n=22) and 23.6%(n=30) in patients with stage-II and stage-III respectively. Stage-II patients were more likely to achieve pCR after NACT [OR (95% CI: 4.3 (2.0-8.9)] when adjusted for other clinical covariates. Three-year RFS in patients achieving pCR was 94.7%, whereas in patients not achieving pCR was 43.9%, with a hazard of relapse or death significantly less in patients attaining pCR [HR (95% CI): 0.14 (0.06-0.37), p

e12556 Background: There is an ambiguity of data regarding the predictive and prognostic significance of pre-treatment-derived neutrophil-lymphocyte-ratio (DNLR) to attain pathologic complete response (pCR) after neo-adjuvant chemotherapy (NACT) and survival in patients with triple-negative breast cancer (TNBC). Methods: In this ambispective study, conducted at Dr. B.R.A., I.R.C.H., AIIMS, New Delhi, 328 patients of TNBC registered from a period of May 2013 to June 2020, who received treatment with curative intent were included. Patients with oligometastatic TNBC who received NACT with curative intent were also included in the analysis. Survival analysis to evaluate the correlation of pre-treatment DNLR with relapse-free survival (RFS) and overall survival (OS) was done. Logistic regression analysis was done to evaluate the association of DNLR with pCR among the subset of the sample who completed NACT and underwent surgery. Results: The median age of our cohort was 45 (18-74) years. Study cohort comprised of 165 (50.3%) pre-menopausal, 150 (45.7%) post-menopausal and 12 (3.7%) peri-menopausal patients respectively. Stage distribution as per AJCC 7th edition was stage-I 8 (2.4%), stage-II 127 (38.7%), stage-III 171(52.1%), and stage-IV 22 (6.7%) patients respectively. The median duration of symptoms was 3 (0.25-36) months. One seventy-three (52.7%) patients received NACT and underwent surgery, out of which 52 (30.1%) patients achieved pCR. Median DNLR in the overall population was 1.7 (0.4-10.1) and the median derived lymphocyte count of 2290 (370-11700) with < 5%(n = 14) having baseline lymphopenia( < 1000). Based on the maximum sensitivity and specificity, a DNLR cut-off point of 1.77 in the overall population and 1.88 among those patients who underwent surgery following NACT were used to categorize low and high DNLR. Median RFS was 73.5 months in our sample, whereas median OS was not reached. The 3-year RFS and OS rates were 65.8% (59.0-71.8) and 85.1% (79.5-89.2%) respectively. High DNLR( > 1.77) was not associated with RFS [HR (95%CI): 1.36 (0.90-2.06)] and OS [HR (95% CI): 0.97 (0.52-1.81)]. In a subset analysis of patients (173) undergoing surgery following NACT, high DNLR ( > 1.88) was not found to be associated with pCR [OR (95% CI): 0.81 (0.42-1.57)]. Conclusions: Pre-treatment DNLR is an easily available inflammatory marker. Indian patients of TNBC usually have raised baseline lymphocyte count, hence, pre-treatment DNLR may not be a reliable predictor of pCR and survival outcomes in these patients. Association of DNLR at various treatment and post-treatment time points with survival outcomes needs further exploration.

In 24 April 2013, Rana Plaza - a high-rise building in Bangladesh where garments were being made for the Western markets collapsed. In this study, we report on the surviving workers' physical strength, self-efficacy, and disability level one year after the disaster.This cross-sectional study took place at the Centre for the Rehabilitation of the Paralysed (CRP) which provided care for more than 600 victims. For this study, upper extremity strength among the survivors was assessed by dynamometer hand grip (HG) and lower extremity strength by five time sit to stand test (FTSST). The WHODAS tool measured level of disability and General Self-Efficacy questionnaire measured self-efficacy. Post-traumatic stress disorder (PTSD) prevalence was determined by the PCL-scale.The study recruited 181 injured workers. The mean disability score among them was 49.8 (SD 17.5) and mean self-efficacy score was 24.9 (SD 6.9). In multivariate models, after adjusting for age, gender, education, injury profile, employment, marital status and job category, self-efficacy was found to be higher among those who scored above median HG test score [β= -2.32 (95% CI: -4.63, -0.01)] and FTSST performance score [β= -2.69 (95% CI: -4.93, -0.46)]. The disability level was found to be significantly associated with PTSD score [β = 0.84 (95% CI: 0.62, 1.06)] and self-efficacy score [β= -0.45 (95% CI: -0.78, -0.13)].There is an immense need to develop and deliver effective post-injury recovery, rehabilitation and return-to-work programs for injured workers in resource poor countries. Implications for Rehabilitation The study findings suggest that one year after the factory disaster in Bangladesh, the injured workers are suffering from a high degree of disability, low physical performance and reporting low self-efficacy. The national and international stakeholders including Western buyers, aid agencies, NGOs, worker advocacy groups, consumer associations and the government of Bangladesh can be updated on the progress made so far. There is an immense need to develop and deliver effective post-injury recovery, rehabilitation and return-to-work programs for injured workers in resource poor countries. International organizations like ILO, WHO, World Bank can help developing countries in building these capacities.

Globally, burns are among some of the most devastating injuries and account for more than 265,000 deaths worldwide. In Bangladesh alone, nearly 3000 people die annually from burn-related injuries. This study was conducted at the National Institute of Burn and Plastic Surgery in Dhaka, Bangladesh in June of 2016. Data included conducting surveys of hospitalized burn patients (N=66) and a chart review of deceased burn patients (N=88). In addition to reporting on the demographic profile of patients, information was also obtained on clinical measures during hospitalization. For non-fatal burns, high risk groups included young adult males (early 30s) of lower socioeconomic status. Among children, the most vulnerable group was found to be children less than eight years old. The most common non-fatal types of burn injuries were flame (35%), electrical (31%) and scald (24%). Discharged patients had an average hospital stay of around 30days with half of all patients requiring surgical intervention, thus indicating the severity of those cases and the need for resource-intensive care. Among the discharged patient population, factors significantly associated with a longer duration of hospital stay included severity of injury, not having received prior treatment before admission and whether or not patients required surgery during hospitalization. Among the mortality cases, the high-risk groups also included young adult males and children of around eight years of age. The average total body surface area (TBSA) sustained in these cases was 46.4%, with 65% of deaths attributable to complications from flame burns. These findings highlight the frequency and severity of burn injuries, identify vulnerable population groups and list common causes of burns in this large developing country of 160 million people. Furthermore, these findings may be applicable to the epidemiology and outcome of burns in similar low and middle income countries.

OBJECTIVES: Prevalence and risk factors of PTSD among injured garment workers who survived a major factory collapse. METHODS: Survivors receiving treatment or rehabilitation care at one year post event were surveyed, which included Post Traumatic Stress Disorder Checklist Specific version. RESULTS: The respondents consisted of 181 people with a mean age of 27.8 years and a majority had less than high school education (91.2%). Multivariable logistic regression found that the odds of having PTSD was higher among married (OR: 3.2 [95% CI: 1.3-8.0]), those who used to work more than 70 hr/week (OR: 2.4 [1.1-5.3]), workers who used to hold higher job positions (OR: 2.6 [1.2-5.6]) or who had a concussion injury (OR: 3.7 [1.4-9.8]). Among the respondents, 83.4% remained unemployed, and only 57.3% (63 people) reported receiving a quarter or less of what they were promised as compensation. CONCLUSIONS: Probable PTSD was prevalent among surviving workers of the Rana Plaza building collapse in Bangladesh. Language: en

Background: Depression is a growing health issue in both developed and developing countries. General unawareness at the population level, lack of training among health care providers and scarcity of resources including treatment opportunities may conceal the real burden of depression in developing countries, and more epidemiological studies on its prevalence and risk factors are critically needed. Aim: This study reports the prevalence of depression and its associated risk factors among female garment factory workers in Bangladesh – a major supplier country of clothes for the Western market. This research should generate useful evidence for national and international stakeholders who have an interest in improving health, safety and well-being of outsourced factory workers. Methods: A survey was conducted on a sample of 600 lower socio-economic status working women including garment workers. This survey collected data on demographic and health profile of these workers. The primary outcome was depression as measured by Patient Health Questionnaire 9. It also obtained data on traumatic life events and post-traumatic stress disorder. Results: The prevalence of depression was 23.5%: 20.9% among garment workers and 26.4% among others. Part-time employment (odds ratio-OR): 2.36, 95% confidence interval (95% CI): 1.01–5.51), chronic pain (OR: 1.67, 95% CI: 1.01–2.78), two or more traumatic life events (OR: 6.43, 95% CI: 2.85–14.55) and dysuria (OR: 2.50, 95% CI: 1.02–6.15) were found to be significantly associated with depression among these workers in multivariate regression model. Depression prevalene lowered by 11% among these workers for every additional monthly earning of 1,000 taka (US$12). Conclusion: Depression is a multifaceted health issue with many personal, social, economic and health determinants and consequences. This study demonstrates that the prevalence of moderate-to-severe depression among working women in Bangladesh is quite high. Prevention and treatment of depression in developing countries and societies can reduce suffering, lower incidence of suicide, and prevent economic loss. Creating awareness on outsourced workers’ poor mental health may help in developing initiatives to protect and preserve their well-being.

Evidence produced by studies using ICD-9 codes to identify dementia suggests that mild traumatic brain injury (mTBI) can accelerate age-related neurodegeneration and dementia risk. However, ICD-9 codes are unreliable in identifying early onset dementia (

The goal of this multiphased research is to develop methods to comprehensively determine the economic impact of hearing impairment and noise-induced hearing injury among active duty U.S. Service Members. Several steps were undertaken to develop a framework and model for economic burden analysis: (1) a literature review identifying studies reporting the cost of health conditions and injuries in the Department of Defense, (2) consultation with a panel of subject matter experts who reviewed these cost items, and (3) discussions with DoD data stewards and review of relevant data dictionaries and databases. A Markov model was developed to represent the cumulative economic effect of events along the career span, such as retraining after hearing impairment and injury, by synthesizing inputs from various sources. The model, as developed and proposed in this study, will be a valuable decision-making tool for the DoD to identify high-risk groups, take proactive measures, and develop focused education, customized equipping, and return-to-duty and reintegration programs, thereby maximizing the retention of skilled, experienced, and mission-ready Service Members.

e13093 Background: Though studies have examined geographic disparities in breast cancer mortality among United States (U.S.) counties, county-level risk factors were not accounted for. The aim of this study is to efficiently map the spatial association between female breast cancer mortality rates & socioeconomic attributes across U.S. counties for identifying high risk geographical clusters in terms of socioeconomic attributes. Methods: County-specific age standardized breast cancer mortality rates for women ≥20 years in the U.S. were obtained for 3,109 counties in 48 contiguous states from Surveillance Epidemiology and End Results program from 1990-2012. County-level attributes such as percentages of Hispanic white, Non-Hispanic white, Non-Hispanic black, < high school education, below 200% poverty, urban, foreign born, language isolation, women aged ≥ 40 years with mammography within last 2 years, and median household income were gathered from U.S. decennial census. Factor analysis condensed county attributes into three factor covariates namely Hispanic immigrants, health care access among urban high socioeconomic population, and non-Hispanic black unemployment. Spatiotemporal analysis was carried out by structured additive regression model to incorporate spatial functions & Markov chain Monte Carlo simulation techniques. Results: Moran’s index suggested existence of spatial dependence for breast cancer mortality among U.S. counties. As mammography screening, %urban population, % with high socioeconomic status and non-Hispanic black unemployment increased in counties of the Southwest region, Rocky mountain region and those in the western border of Midwest region of U.S, risk of breast cancer mortality increased significantly above the national average. As the Hispanic immigrant culture increased, counties of Midwest region of U.S had significantly higher mortality rates compared to national average. Conclusions: These initial results describe socio-economic, cultural, and healthcare access factors for observed geographic variations in female breast cancer mortality, and in turn, could support a stronger theoretical basis for public health policy.

Although studies have examined the relation between military-related noise and hearing, comprehensive data to calculate rates of hearing loss across all Services and to determine economic impact are lacking. The goal of the multiphase Department of Defense (DoD) Epidemiologic and Economic Burden of Hearing Loss (DEEBoHL) project is to examine rates of hearing impairment and noise-induced hearing injury, relevant noise exposures, and to determine the economic burden of these outcomes to the DoD and Service Members. The DoD Hearing Center of Excellence is supporting the following Phase I specific aims, among active duty Service Members to (1) calculate rates of hearing impairment and noise-induced hearing injury, and (2) develop a framework for the DoD to conduct comprehensive economic burden studies for hearing impairment and noise-induced hearing injury. The study is led by a multidisciplinary team from The University of Texas School of Public Health, The University of Texas Health Science Center at San Antonio, and The Geneva Foundation, with guidance from experts who make up the study advisory board. In this article, we focus on an overview of the DEEBoHL study, the methods for the first aim of this effort, and describe future plans for the study.