Self-driven solutions and resilience adapted by people with drug-resistant tuberculosis and their caregivers in Bengaluru and Hyderabad, India: a qualitative study.

Background: One-fifth of people with drug-resistance tuberculosis (DR-TB) who were initiated on newer shorter treatment regimen (with injection) had unfavourable treatment outcomes in India as on 2020. Evidence on self-driven solutions and resilience adapted by people with DR-TB (PwDR-TB) towards their multi-dimensional disease and treatment challenges are scarce globally, which we aimed to understand. Methods: In this qualitative study using positive deviance framework, we conducted semi-structured in-depth interviews among consenting adult PwDR-TB (7 women, 13 men) who completed shorter treatment regimen (including injections) with maximum treatment adherence. The study was conducted in the southern districts of Bengaluru and Hyderabad, India between June 2020 and December 2022. Caregivers (14 women, 6 men) and health providers (8 men, 2 women) of PwDR-TB were also interviewed. Interviews were conducted in local language (Kannada, Tamil, Telugu, Urdu and Hindi) and inquired about practices, behaviours, experiences, perceptions and attributes which enabled maximum adherence and resilience of PwDR-TB. Interviews were audio recorded, transcribed, and translated to English and coded for thematic analysis using inductive approach. Findings: Distinctive themes explanatory of the self-driven solutions and resilience exhibited by PwDR-TB and their caregivers were identified: (i) Self-adaptation towards the biological consequences of drugs, by personalised nutritional and adjuvant practices, which helped to improve drug ingestion and therapeutic effects. Also home remedies and self-plans for ameliorating injection pain. (ii) Perceptual adaptation towards drugs aversion and fatigue, by their mind diversion practices, routinisation and normalisation of drug intake process. and constant reinforcement and re-interpretation of bodily signs of disease recovery (iii) Family caregivers intense and participatory care for PwDR-TB, by aiding their essential life activities and ensuring survival, learning and fulfilling special nutritional needs and goal oriented actions to aid drug intake (iv) Health care providers care, marked by swift and timely risk mitigation of side-effects and crisis response (v) Acquired self-efficacy of PwDR-TB, by their decisive family concerns resulting in attitudinal change. Also being sensitised on the detrimental consequences of disease and being motivated through positive examples. Interpretation: Synthesised findings on self-driven solutions and resilience towards the multi-dimensional DR-TB challenges provides opportunity for developing and testing new interventions for its effectiveness in DR-TB care settings globally. Designing and testing personalised cognitive interventions for PwDR-TB: to inculcate attitudinal change and self-efficacy towards medication, developing cognitive reinforcements to address the perception burden of treatment, skill building and mainstreaming the role of family caregivers as therapeutic partners of PwDR-TB, curating self-adaptive behaviours and practices of PwDR-TB to normalise their drug consumptions experiences could be the way forward in building resilience towards DR-TB. Funding: United States Agency for International Development (USAID) through Karnataka Health Promotion Trust (KHPT), Bengaluru, India.

Trend and risk factors of fatal pregnancy termination: A long-term nationwide population-based cross-section survey in Bangladesh.

BACKGROUND: Pregnant women often experience the fatal outcome of their pregnancy both in developed and impoverished countries. Due to strong health systems and services, factual and historical data are available from developed countries. However, the prevalence trend and risk factors of a fatal termination of pregnancy in developing countries like Bangladesh are still lacking. OBJECTIVE: The objective of the current study was to determine the 20 years trend of prevalence and risk factors of fatal pregnancy termination from 1997 to 2018 in Bangladesh. METHOD: This study utilised the publicly available seven consecutive cross-data on Bangladesh Demographic and Health Surveys data since 1997 following identical methods among women of reproductive age. Respondent was asked if they had had a fatal pregnancy termination ever. A Generalised Linear model with a log-Poisson link was used to estimate the relative risk of different predictors for four survey time points (1998, 2004, 2011, 2018). RESULTS: The proportions of fatal pregnancy termination in urban and rural areas were 24% vs. 19% and 24% vs. 22% in 1997 and 2018, respectively. In multivariable analysis, maternal age 30 years and above and obesity were strongly associated in all survey time points. The richest wealth index had a weak association in 1997 but was strongly associated in 2011 and 2018. A significant modest association with secondary complete education level was only observed in 2018. CONCLUSION: The overall proportions of fatal pregnancy termination in Bangladesh remain nearly static; however, its risk factors differed across different survey time points.

A Dual Perspective of Psycho-Social Barriers and Challenges Experienced by Drug-Resistant TB Patients and Their Caregivers through the Course of Diagnosis and Treatment: Findings from a Qualitative Study in Bengaluru and Hyderabad Districts of South India.

Qualitative insights regarding psycho-social barriers and challenges experienced by drug-resistant tuberculosis (DR-TB) patients and their caregivers are understudied in India. We conducted a qualitative study using semi-structured qualitative interviews among treatment-completed DR-TB patients (n = 20) and caregivers (n = 20) in Bengaluru and Hyderabad districts, which represented two different socio-cultural settings in South India. Criterion sampling was used for recruiting the eligible participants who completed treatment with adherence. "Emotional issues and social barriers" were identified to represent a major challenge for patients and caregivers, which occurred acutely after disease diagnosis, characterized by fear and emotional distress due to their perceived loss of life prospects, severity of symptoms, discomfort, and disease denial. Medication intolerance, chronic symptoms, lack of visible signs of treatment progress, loss of weight, and physical concerns caused subsequent fear and distress during the treatment phases for patients along with experiences of stigma. External triggers generated "decisive moments" of hopelessness and life-ending thoughts for patients at the diagnosis and early treatment phase. Medication related challenges included the perceived burden and power of pills which caused emotional distress for patients and intolerance towards caregivers. Pill burden was found as consequential as the side effects of injections. Challenges related to lack of support were another major theme, in which caregivers lacked resources for treatment support and nutrition. Throughout treatment, caregivers and patients expressed concern about a lack of supportive care from family members, sympathy, and intangible social support. Challenges during hospital admission in terms of lack of privacy, quality of services, individual attention, and empathy from health care workers were reported by patients and caregivers. Despite better adherence, DR-TB patients and caregivers experienced considerable emotional and social consequences. Differentiating DR-TB patients and caregivers' issues at different stages of diagnosis and treatment could help improve patient-centered outcomes in India and other high-burden nations.

Mortality Associated with Ambient PM2.5 Exposure in India: Results from the Million Death Study.

BACKGROUND: Studies on the extent to which long-term exposure to ambient particulate matter (PM) with aerodynamic diameter ≤2.5µm (PM2.5) contributes to adult mortality in India are few, despite over 99% of Indians being exposed to levels that the World Health Organization (WHO) considers unsafe. OBJECTIVE: We conducted a retrospective cohort study within the Million Death Study (MDS) to provide the first-ever quantification of national mortality from exposure to PM2.5 in India from 1999 to 2014. METHODS: We calculated relative risks (RRs) by linking a total of ten 3-y intervals of satellite-based estimated PM2.5 exposure to deaths 3 to 5 y later in over 7,400 small villages or urban blocks covering a total population of 6.8 million. We applied using a model-based geostatistical model, adjusted for individual age, sex, and year of death; smoking prevalence, rural/urban residency, area-level female illiteracy, languages, and spatial clustering and unit-level variation. RESULTS: PM2.5 exposure levels increased from 1999 to 2014, particularly in central and eastern India. Among 212,573 deaths at ages 15-69 y, after spatial adjustment, we found a significant RR of 1.09 [95% credible interval (CI): 1.04, 1.14] for stroke deaths per 10-µg/m3 increase in PM2.5 exposure, but no significant excess for deaths from chronic respiratory disease and ischemic heart disease (IHD), all nonaccidental causes, and total mortality (after excluding stroke). Spatial adjustment attenuated the RRs for chronic respiratory disease and IHD but raised those for stroke. The RRs were consistent in various sensitivity analyses with spatial adjustment, including stratifying by levels of solid fuel exposure, by sex, and by age group, addition of climatic variables, and in supplementary case-control analyses using injury deaths as controls. DISCUSSION: Direct epidemiological measurements, despite inherent limitations, yielded associations between mortality and long-term PM2.5 inconsistent with those reported in earlier models used by the WHO to derive estimates of PM2.5 mortality in India. The modest RRs in our study are consistent with near or null mortality effects. They suggest suitable caution in estimating deaths from PM2.5 exposure based on MDS results and even more caution in extrapolating model-based associations of risk derived mostly from high-income countries to India. https://doi.org/10.1289/EHP9538.

Trends in snakebite deaths in India from 2000 to 2019 in a nationally representative mortality study.

The World Health Organization call to halve global snakebite deaths by 2030 will require substantial progress in India. We analyzed 2833 snakebite deaths from 611,483 verbal autopsies in the nationally representative Indian Million Death Study from 2001 to 2014, and conducted a systematic literature review from 2000 to 2019 covering 87,590 snakebites. We estimate that India had 1.2 million snakebite deaths (average 58,000/year) from 2000 to 2019. Nearly half occurred at ages 30-69 years and over a quarter in children < 15 years. Most occurred at home in the rural areas. About 70% occurred in eight higher burden states and half during the rainy season and at low altitude. The risk of an Indian dying from snakebite before age 70 is about 1 in 250, but notably higher in some areas. More crudely, we estimate 1.11-1.77 million bites in 2015, of which 70% showed symptoms of envenomation. Prevention and treatment strategies might substantially reduce snakebite mortality in India.

Factors influencing treatment outcome in hepatitis C virus minority patients at an inner-city hospital: A STROBE-complaint article.

Chronic hepatitis C virus (HCV) infection disproportionately affects African-Americans (AAs) and is a major contributor to liver failure and mortality. Genetic factors may not be the only cause in outcome disparity. We retrospectively investigated whether genetic host factors, viral genotypes, and treatment compliance in AA patients impacted the efficacy and the sustained virological response (SVR) rate of the interferon (IFN)-based treatment regimen. The medical chart review included 76 African-American patients (age ranging from 26 to 76) with varying levels of hepatitis condition. Fifty-seven (75%) of them had a clinically verifiable HCV infection and were followed by a hepatologist for 2 years at Howard University Hospital in Washington, DC. Both comprehensive metabolic profile and complete blood count analyses were performed. Among the 57 patients whose viral and IL28B genotypes were determined, sixty-eight percent (68%) were infected with viral genotype 1 and 71% harbored the CT allele of the IL28B gene. Among the 12 patients who completed treatment with IFN-based dual or triple therapy, 58% had achieved SVR 12 weeks following completion of treatment; 33% had a partial response with under 6000 viral count after 16 weeks of treatment; and there was one patient with viral genotype 1a and CT allele who did not respond to the medications. The results of this study prove that the PEG IFN-based regimen was effective in treating HCV-infected AA patients despite the current availability of new direct-acting antivirals. The major obstacles contributing to a low reduction in HCV infection and outcome in the AA community were avoidance or lack of treatment or compliance; contraindications, medication side effects, non-adherence, and payer eligibility restrictions.

National Burden Estimates of healthy life lost in India, 2017: an analysis using direct mortality data and indirect disability data.

BACKGROUND: Many countries, including India, seek locally constructed disease burden estimates comprising mortality and loss of health to aid priority setting for the prevention and treatment of diseases. We created the National Burden Estimates (NBE) to provide transparent and understandable disease burdens at the national and subnational levels, and to identify gaps in knowledge. METHODS: To calculate the NBE for India, we combined 2017 UN death totals with national and subnational mortality rates for 2010-17 and causes of death from 211 166 verbal autopsy interviews in the Indian Million Death Study for 2010-14. We calculated years of life lost (YLLs) and years lived with disability (YLDs) for 2017 using published YLD-YLL ratios from WHO Global Health Estimates. We grouped causes of death into 45 groups, including ill-defined deaths, and summed YLLs and YLDs to calculate disability-adjusted life-years (DALYs) for these causes in eight age groups covering rural and urban areas and 21 major states of India. FINDINGS: In 2017, there were about 9·7 million deaths and 486 million DALYs in India. About three quarters of deaths and DALYs occurred in rural areas. More than a third of national DALYs arose from communicable, maternal, perinatal, and nutritional disorders. DALY rates in rural areas were at least twice those of urban areas for perinatal and nutritional conditions, chronic respiratory diseases, diarrhoea, and fever of unknown origin. DALY rates for ischaemic heart disease were greater in urban areas. Injuries caused 11·4% of DALYs nationally. The top 15 conditions that accounted for the most DALYs were mostly those causing mortality (ischaemic heart disease, perinatal conditions, chronic respiratory diseases, diarrhoea, respiratory infections, cancer, stroke, road traffic accidents, tuberculosis, and liver and alcohol-related conditions), with disability mostly due to a few conditions (nutritional deficiencies, neuropsychiatric conditions, vision and other sensory loss, musculoskeletal disorders, and genitourinary diseases). Every condition that was common in one part of India was uncommon elsewhere, suggesting state-specific priorities for disease control. INTERPRETATION: The NBE method quantifies disease burden using transparent, intuitive, and reproducible methods. It provides a simple, locally operable tool to aid policy makers in priority setting in India and other low-income and middle-income countries. The NBE underlines the need for many more countries to collect nationally representative cause of death data, paired with focused surveys of disability. FUNDING: Ministry of Health and Family Welfare, Government of India.

Automated versus physician assignment of cause of death for verbal autopsies: randomized trial of 9374 deaths in 117 villages in India.

BACKGROUND: Verbal autopsies with physician assignment of cause of death (COD) are commonly used in settings where medical certification of deaths is uncommon. It remains unanswered if automated algorithms can replace physician assignment. METHODS: We randomized verbal autopsy interviews for deaths in 117 villages in rural India to either physician or automated COD assignment. Twenty-four trained lay (non-medical) surveyors applied the allocated method using a laptop-based electronic system. Two of 25 physicians were allocated randomly to independently code the deaths in the physician assignment arm. Six algorithms (Naïve Bayes Classifier (NBC), King-Lu, InSilicoVA, InSilicoVA-NT, InterVA-4, and SmartVA) coded each death in the automated arm. The primary outcome was concordance with the COD distribution in the standard physician-assigned arm. Four thousand six hundred fifty-one (4651) deaths were allocated to physician (standard), and 4723 to automated arms. RESULTS: The two arms were nearly identical in demographics and key symptom patterns. The average concordances of automated algorithms with the standard were 62%, 56%, and 59% for adult, child, and neonatal deaths, respectively. Automated algorithms showed inconsistent results, even for causes that are relatively easy to identify such as road traffic injuries. Automated algorithms underestimated the number of cancer and suicide deaths in adults and overestimated other injuries in adults and children. Across all ages, average weighted concordance with the standard was 62% (range 79-45%) with the best to worst ranking automated algorithms being InterVA-4, InSilicoVA-NT, InSilicoVA, SmartVA, NBC, and King-Lu. Individual-level sensitivity for causes of adult deaths in the automated arm was low between the algorithms but high between two independent physicians in the physician arm. CONCLUSIONS: While desirable, automated algorithms require further development and rigorous evaluation. Lay reporting of deaths paired with physician COD assignment of verbal autopsies, despite some limitations, remains a practicable method to document the patterns of mortality reliably for unattended deaths. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02810366. Submitted on 11 April 2016.

Nationwide Mortality Studies To Quantify Causes Of Death: Relevant Lessons From India's Million Death Study.

Progress toward the United Nations 2030 Sustainable Development Goals requires improved information on mortality and causes of death. However, causes of many of the fifty million annual deaths in low- and middle-income countries remain unknown, as most of the deaths occur at home without medical attention. In 2001 India began the Million Death Study in 1.3 million nationally representative households. Nonmedical staff conduct verbal autopsies, which are structured interviews including a half-page narrative in local language of the family's story of the symptoms and events leading to death. Two physicians independently assess each death to arrive at an underlying cause of death. The study has thus far yielded information that substantially altered previous estimates of cause-specific mortality and risk factors in India. Similar robust studies are feasible at low cost in other low- and middle-income countries, particularly if they adopt electronic data management and ensure high quality of fieldwork and physician coding. Nationwide mortality studies enable the quantification of avoidable premature mortality and key risk factors for disease, and provide a practicable method to monitor progress toward the Sustainable Development Goals.

Study on MICs of Tigecycline in Clinical Isolates of Carbapenem Resistant Enterobacteriaceae (CRE) at a Tertiary Care Centre in North India.

INTRODUCTION: Members of family Enterobacteriaceae are the most common Gram-negative bacteria isolated from clinical samples. Those Enterobacteriaceae which have acquired resistance to all ß-lactams antibiotics including the carbapenems are considered as Carbapenem Resistant Enterobacteriaceae (CRE). These CRE isolates are often resistant to most other classes of antimicrobials as well, making their treatment a great challenge. Tigecycline is one of the last resort antimicrobials against such multidrug resistant bacteria. Decreased tigecycline susceptibility mediated by efflux pump systems is being reported in clinical strains of Enterobacteriaceae. Minimum Inhibitory Concentration (MIC) data would prove useful in managing infections by these multidrug resistant bacteria and optimizing use of tigecycline. AIM: To evaluate the MIC values of tigecycline against carbapenem resistant Escherichia coli and Klebsiella pneumoniae isolates. MATERIALS AND METHODS: This prospective study was carried out from January 2015 to December 2015 at the Department of Microbiology, Era's Lucknow Medical College and Hospital (ELMCH), Lucknow, Uttar Pradesh, India. Antimicrobial susceptibility by disk diffusion (Kirby-bauer) was done for 491 E. coli and K. pneumoniae strains isolated from 1606 samples collected from patients admitted in various wards and ICUs. Imipenem, meropenem and ertapenem 10 µg disks were used for testing of sensitivity to carbapenems. In all isolates, Tigecycline 15 µg (Hi-Media) disk was used to screen for tigecycline resistance. In CRE isolates, MICs of tigecycline were determined by E-test (Ezy MIC TM TG strips, Hi Media) and interpreted using European Committee on Antimicrobial Susceptibility Testing (EUCAST) 2016 guidelines. RESULTS: Out of 491 isolates tested, 186 (37.9%) were found to be CRE showing resistance to at least one of the three carbapenems tested and these included 99 E.coli and 87 K. pneumoniae. Sensitivity pattern of these two bacterial isolates shows a high level of resistance to most classes of antimicrobials. MIC testing for tigecycline was carried out in 144 CRE isolates and tigecycline resistance (MIC >2 µg/ml) was seen in 12 (8.3%) isolates (eight K.pneumoniae and four E. coli). Eight other isolates were found to have MIC of 2 µg/ml and thus the overall prevalence of isolates with decreased susceptibility was 20 (13.9%). CONCLUSION: A high prevalence of carbapenem resistance coupled with high tigecycline MICs in clinical isolates of E.coli and K. pneumoniae highlights the judicious use of a combination of antimicrobials. Routine in vitro sensitivity testing to evaluate the clinical utility of tigecycline against such resistant Enterobacteriaceae is warranted.

Can optical diagnosis of small colon polyps be accurate? Comparing standard scope without narrow banding to high definition scope with narrow banding.

AIM: To study the accuracy of using high definition (HD) scope with narrow band imaging (NBI) vs standard white light colonoscope without NBI (ST), to predict the histology of the colon polyps, particularly those < 1 cm. METHODS: A total of 147 African Americans patients who were referred to Howard University Hospital for screening or, diagnostic or follow up colonoscopy, during a 12-mo period in 2012 were prospectively recruited. Some patients had multiple polyps and total number of polyps was 179. Their colonoscopies were performed by 3 experienced endoscopists who determined the size and stated whether the polyps being removed were hyperplastic or adenomatous polyps using standard colonoscopes or high definition colonoscopes with NBI. The histopathologic diagnosis was reported by pathologists as part of routine care. RESULTS: Of participants in the study, 55 (37%) were male and median (interquartile range) of age was 56 (19-80). Demographic, clinical characteristics, past medical history of patients, and the data obtained by two instruments were not significantly different and two methods detected similar number of polyps. In ST scope 89% of polyps were < 1 cm vs 87% in HD scope (P = 0.7). The ST scope had a positive predictive value (PPV) and positive likelihood ratio (PLR) of 86% and 4.0 for adenoma compared to 74% and 2.6 for HD scope. There was a trend of higher sensitivity for HD scope (68%) compare to ST scope (53%) with almost the same specificity. The ST scope had a PPV and PLR of 38% and 1.8 for hyperplastic polyp (HPP) compared to 42% and 2.2 for HD scope. The sensitivity and specificity of two instruments for HPP diagnosis were similar. CONCLUSION: Our results indicated that HD scope was more sensitive in diagnosis of adenoma than ST scope. Clinical diagnosis of HPP with either scope is less accurate compared to adenoma. Colonoscopy diagnosis is not yet fully matched with pathologic diagnosis of colon polyp. However with the advancement of both imaging and training, it may be possible to increase the sensitivity and specificity of the scopes and hence save money for eliminating time and the cost of Immunohistochemistry/pathology.

Facility Delivery, Postnatal Care and Neonatal Deaths in India: Nationally-Representative Case-Control Studies.

OBJECTIVE: Clinical studies demonstrate the efficacy of interventions to reduce neonatal deaths, but there are fewer studies of their real-life effectiveness. In India, women often seek facility delivery after complications arise, rather than to avoid complications. Our objective was to quantify the association of facility delivery and postnatal checkups with neonatal mortality while examining the "reverse causality" in which the mothers deliver at a health facility due to adverse perinatal events. METHODS: We conducted nationally representative case-control studies of about 300,000 live births and 4,000 neonatal deaths to examine the effect of, place of delivery and postnatal checkup on neonatal mortality. We compared neonatal deaths to all live births and to a subset of live births reporting excessive bleeding or obstructed labour that were more comparable to cases in seeking care. FINDINGS: In the larger study of 2004-8 births, facility delivery without postnatal checkup was associated with an increased odds of neonatal death (Odds ratio = 2.5; 99% CI 2.2-2.9), especially for early versus late neonatal deaths. However, use of more comparable controls showed marked attenuation (Odds ratio = 0.5; 0.4-0.5). Facility delivery with postnatal checkup was associated with reduced odds of neonatal death. Excess risks were attenuated in the earlier study of 2001-4 births. CONCLUSION: The combined effect of facility deliveries with postnatal checks ups is substantially higher than just facility delivery alone. Evaluation of the real-life effectiveness of interventions to reduce child and maternal deaths need to consider reverse causality. If these associations are causal, facility delivery with postnatal check up could avoid about 1/3 of all neonatal deaths in India (~100,000/year).

Association between Diverticular Disease and Pre-Neoplastic Colorectal Lesions in an Urban African-American Population.

BACKGROUND: It is unclear whether there is a shared pathway in the development of diverticular disease (DD) and potentially neoplastic colorectal lesions since both diseases are found in similar age groups and populations. AIM: To determine the association between DD and colorectal pre-neoplastic lesions in an African-American urban population. METHODS: Data from 1986 patients who underwent colonoscopy at the Howard University Hospital from January 2012 through December 2012 were analyzed for this study. The presence of diverticula and polyps was recorded using colonoscopy reports. Polyps were further classified into adenoma or hyperplastic polyp based on histopathology reports. Multiple logistic regression was done to analyze the association between DD and colonic lesions. RESULTS: Of the 1986 study subjects, 1,119 (56%) were females, 35% had DD and 56% had at least one polyp. There was a higher prevalence of polyps (70 vs. 49%; OR = 2.3; 95% CI: 1.9-2.8) and adenoma (43 vs. 25%; OR = 2.0; 95% CI: 1.7-2.5) in the diverticular vs. non-diverticula patients. Among patients who underwent screening colonoscopy, the presence of diverticulosis was associated with increased odds of associated polyps (OR = 9.9; 95% CI: 5.4-16.8) and adenoma (OR = 5.1; 95% CI: 3.4-7.8). CONCLUSION: Patients with DD are more likely to harbor colorectal lesions. These findings call for more vigilance on the part of endoscopists during colonoscopy in patients known to harbor colonic diverticula.

A Study of Method Development, Validation, and Forced Degradation for Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Dosage Form by RP-HPLC Method.

A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous quantification of paracetamol and ibuprofen in their combined dosage form especially to get some more advantages over other methods already developed for this combination. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity, and system suitability. Forced degradation study was validated according to International Conference on Harmonisation (ICH). For this, an isocratic condition of mobile phase comprising phosphate buffer (pH 6.8) and acetonitrile in a ratio of 65:35, v/v at a flow rate of 0.7 mL/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 µm, Phenomenex Inc.) column at ambient temperature was maintained. The method showed excellent linear response with correlation coefficient (R (2)) values of 0.999 and 1.0 for paracetamol and ibuprofen respectively, which were within the limit of correlation coefficient (R (2) > 0.995). The percent recoveries for two drugs were found within the acceptance limit of (97.0-103.0%). Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) ≤ 2.0. Forced degradation of the drug product was carried out as per the ICH guidelines with a view to establishing the stability-indicating property of this method and providing useful information about the degradation pathways, degradation products, and how the quality of a drug substance and drug product changes with time under the influence of various stressing conditions. The degradation of ibuprofen was within the limit (5-20%, according to the guideline of ICH), while paracetamol showed <20% degradation in oxidation and basic condition.

Rare Manifestation of a Rare Disease, Acute Liver Failure in Adult Onset Still's Disease: Dramatic Response to Methylprednisolone Pulse Therapy-A Case Report and Review.

Adult onset Still's disease (AOSD) is a rare systemic inflammatory disorder of unknown etiology. It is characterized by daily fevers, arthralgias or arthritis, typical skin rash, and leukocytosis. Hepatic involvement is frequently observed in the course of AOSD with mildly elevated transaminases and/or hepatomegaly. Fulminant hepatic failure, occasionally requiring urgent liver transplantation, is a rare manifestation of AOSD. Here, we present a case of 22-year-old woman with no significant medical history who initially came with fever, arthralgias, myalgias, generalized weakness, and sore throat. Laboratory data showed mildly elevated transaminases and markedly elevated ferritin levels. She was diagnosed with AOSD based on Yamaguchi diagnostic criteria and was started on prednisone. Three months later, while she was on tapering dose of steroid, she presented with fever, abdominal pain, jaundice, and markedly elevated transaminases. Extensive workup excluded all potential causes of liver failure. She was diagnosed with AOSD associated acute liver failure (ALF). Intravenous (IV) methylprednisolone pulse therapy was started, with dramatic improvement in liver function. Our case demonstrated that ALF can present as a complication of AOSD and IV mega dose pulse methylprednisolone therapy can be employed as a first-line treatment in AOSD associated ALF with favorable outcome.

A novel use of early radiation therapy in the treatment of hyperbilirubinemia in a patient with primary hepatic lymphoma and chronic hepatitis C.

Lymphomas arising in the liver are extremely rare. Here, we describe a case of Hepatitis C virus infection with primary hepatic lymphoma (PHL) presenting with hyperbilirubinemia. A 45-year-old African American male presented with abdominal pain, pruritus, and itching for two days. CT of abdomen and pelvis with contrast showed numerous masses in the liver. The liver biopsy was consistent with diffuse large B cell lymphoma (DLBCL). Conventional chemotherapy was avoided initially because of hyperbilirubinemia. Hence, radiation therapy was given initially to reduce his bilirubin levels and tumor size. The patient was able to complete six cycles of rituximab combined with cyclophosphamide, adriamycin, vincristine, and prednisone (R-CHOP) chemotherapy and achieved a complete response verified by positron emission tomography-computed tomography (PET-CT). PHL should be considered when there are numerous space occupying liver lesions seen on imaging. Hyperbilirubinemia may be a reason for delay in treatment for some of these patients. Hence, the role of radiation therapy prior to treatment with R-CHOP is an alternative to management for stage IV diffuse large B cell lymphoma.

BMI and the risk of colorectal adenoma in African-Americans.

OBJECTIVES: Obesity is associated with the activation of the molecular pathways that increase the risk of colorectal cancer. Increasing body mass index may accelerate the development of adenomatous polyps, the antecedent lesion of colorectal cancer. The aim of this study was to assess the BMI effect on the risk of colonic polyp and adenoma in African-American. METHODS: The records of 923 patients who underwent colonoscopy were examined. Demographic and clinical data were collected before colonoscopy. Polyp and adenoma diagnosis were confirmed by pathology examinations. RESULTS: Overall, 43% of the patients were male, median age was 57 years and 77% had BMI ≥ 25.0 kg/m(2) . The frequency of colorectal polyps and adenomas were 61 and 35%, respectively. BMI ≥ 25.0 (OR = 1.61, 95% CI = 1.14-2.26), smoking (OR = 1.61, 95% CI = 1.15-2.26) and history of colon polyps (OR = 1.64, 95% CI = 1.09-2.47) were associated with higher risk of colon polyp. BMI ≥ 25.0 (OR = 1.81, 95% CI = 1.24-2.62), age (OR = 1.04, 95% CI = 1.02-2.05 for each year), male gender (OR = 1.38, 95% CI = 1.02-1.86), and smoking (OR = 1.73, 95% CI = 1.23-2.42) were associated with higher risk of colon adenoma. CONCLUSION: Male and overweight African-Americans are at higher risk of colorectal adenoma. The findings of this study could be applied for risk stratification and modifying the colorectal cancer prevention including screening guideline in African Americans.

Prevalence of colorectal neoplasia among young African Americans and Hispanic Americans.

BACKGROUND: The disproportionately higher incidence of and mortality from colorectal cancer (CRC) among African Americans (AA) led the American College of Gastroenterology to recommend screening starting at age 45 in 2005. AIM: The purpose of this study was to determine the prevalence of colorectal neoplasia among 40-49-year-old inner city AA and Hispanic Americans (HA). METHODS: We reviewed the medical records of 2,435 inner city AA and HA who underwent colonoscopy regardless of indication and compared the prevalence of colorectal neoplasia between AA and HA patients. We used logistic regression models to calculate odds ratios (OR) and 95 % confidence intervals (CI). RESULTS: There were 2,163 AAs and 272 HA. There were 57 % women in both groups. A total of 158 (7 %) AA and 9 (3 %) HA (P = 0.014) underwent the procedures for CRC screening. When compared to HAs, AAs had higher prevalence of any polyp (35 vs. 18 %, OR = 2.53; 95 % CI 1.82-3.52). Overall, AA had higher prevalence of colorectal neoplasia (adenoma and cancer) when compared to HAs (16 vs. 10 %; OR = 1.68; 95 % CI 1.10-2.56). CONCLUSION: We observed a higher frequency of colorectal neoplasia among 40-49-year-old AAs as compared to HAs suggesting an increased susceptibility to CRC risk in this population.

Timing of procedure and compliance with outpatient endoscopy among an underserved population in an inner-city tertiary institution.

PURPOSE: Anecdotal evidence suggests that patient compliance with colonoscopy is poorer with Monday procedures and better during the winter months because "there is not much else to do." We examined patients' compliance with scheduled outpatient endoscopy by time of the day, days of the week, and seasons of the year. METHODS: We included 2873 patients who were scheduled for endoscopy from September 2009 to August 2010. Compliant patients were those who showed up for their procedures whereas noncompliant patients were those who did not show up without canceling or rescheduling their procedures up to 24 hours before their scheduled procedures. We used logistic regression models to evaluate the association between the timing of the scheduled procedure and compliance. RESULTS: A total of 574 (20%) patients did not show up. There was no difference in compliance by time of day of the procedures. However, when compared with patients scheduled for procedures on Monday, there was a trend towards improved compliance as the week progressed, becoming significant on Friday (odds ratio 1.46; 95% confidence interval 1.06-2.00). There was also better compliance in the warmer months. CONCLUSIONS: Noncompliance with outpatient endoscopy is substantial among underserved populations with limited predictive pattern of compliance by the timing of the procedures.

Retransplantation for donor-derived neuroendocrine tumor.

Although tumor transmission through liver transplantation (LT) is a rare occurrence, the consequences can be devastating, even when a very aggressive management approach is adopted. We report the case of a donor-derived small cell neuroendocrine tumor (NET) in a patient who underwent LT for cholangiocarcinoma. Despite locoregional therapy, chemotherapy and ultimately retransplantation, the patient died from metastases. The high grade nature of the NET was the most important determinant of prognosis in this case. Our experience suggests that retransplantation for donor-derived NET should only be considered when tumor biology is favorable.