Toxicity profile, adverse drug reactions and drug-drug interactions among geriatric cancer patients under metronomic chemotherapy in a South Indian tertiary care hospital.

OBJECTIVE: The study aims to examine the toxicity profile, pattern of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) in geriatric cancer patients receiving metronomic chemotherapy. PATIENTS AND METHODS: Patients were followed after each cycle till 12 weeks. Haematological parameters such as complete blood count, liver function test and renal function test were recorded from the baseline to the final visit. The Common Terminology Criteria for Adverse Events (CTCAE) scale was used to characterise the toxicity profile. ADRs that the patients had were documented and assessed for its causality, severity and preventability. The Lexicomp drug interaction checker was used to grade DDIs. RESULTS: Of 129 patients, according to CTCAE grading, haemoglobin indicated grade 1 toxicity, while other haematological parameters revealed no toxicity. Although there was a statistically significant difference in ALT, alkaline phosphate, serum creatinine and potassium (p < 0.05), it was not clinically significant. A total of 226 ADRs were documented. Anaemia was the most frequently occurred ADR (14%) and Capecitabine caused the highest number of ADRs. Assessments of causality showed that the majority of cases are "possible" (63%). In evaluating the severity of ADRs, 99% ADRs were "mild" and 61% of ADRs were "probably" preventable. Upon assessing the DDIs, 82% of the prescriptions had "no known interaction". CONCLUSION: Metronomic chemotherapy in geriatric cancer patients exhibited grade 1 toxicity for haemoglobin. Anemia was the most common ADRs. The majority of cases were "possible" in causality, "mild" in severity, and "probably" preventable. The majority of the prescriptions have no known DDIs.

Modeling the recovery time of patients with coronavirus disease 2019 using an accelerated failure time model.

OBJECTIVE: To identify factors associated with recovery time from coronavirus disease 2019 (COVID-19). METHODS: In this retrospective study, data for patients with COVID-19 were obtained between 21 June and 30 August 2020. An accelerated failure time (AFT) model was used to identify covariates associated with recovery time (days from hospital admission to discharge). AFT models with different distributions (exponential, log-normal, Weibull, generalized gamma, and log-logistic) were generated. Akaike's information criterion (AIC) was used to identify the most suitable model. RESULTS: A total of 730 patients with COVID-19 were included (92.5% recovered and 7.5% censored). Based on its low AIC value, the log-logistic AFT model was the best fit for the data. The covariates affecting length of hospital stay were oxygen saturation, lactate dehydrogenase, neutrophil-lymphocyte ratio, D-dimer, ferritin, creatinine, total leucocyte count, age > 80 years, and coronary artery disease. CONCLUSIONS: The log-logistic AFT model accurately described the recovery time of patients with COVID-19.

A Study of Factors Affecting the Length of Hospital Stay of COVID-19 Patients by Cox-Proportional Hazard Model in a South Indian Tertiary Care Hospital.

BACKGROUND: The objective of the study was to identify the factors that alter the length of hospital stay of COVID-19 patients so we have an estimate of the duration of hospitalization of patients. To achieve this, we used a time to event analysis to arrive at factors that could alter the length of hospital stay, aiding in planning additional beds for any future rise in cases. METHODS: Information about COVID-19 patients was collected between June and August 2020. The response variable was the time from admission to discharge of patients. Cox proportional hazard model was used to identify the factors that were associated with the length of hospital stay. RESULTS: A total of 730 COVID-19 patients were included, of which 675 (92.5%) recovered and 55 (7.5%) were considered to be right-censored, that is, the patient died or was discharged against medical advice. The median length of hospital stay of COVID-19 patients who were hospitalized was found to be 7 days by the Kaplan Meier curve. The covariates that prolonged the length of hospital stay were found to be abnormalities in oxygen saturation (HR = 0.446, P < .001), neutrophil-lymphocyte ratio (HR = 0.742, P = .003), levels of D-dimer (HR = 0.60, P = .002), lactate dehydrogenase (HR = 0.717, P = .002), and ferritin (HR = 0.763, P = .037). Also, patients who had more than 2 chronic diseases had a significantly longer length of stay (HR = 0.586, P = .008) compared to those with no comorbidities. CONCLUSION: Factors that are associated with prolonged length of hospital stay of patients need to be considered in planning bed strength on a contingency basis.

Disposable low-cost cardboard incubator for thermoregulation of stable preterm infant - a randomized controlled non-inferiority trial.

BACKGROUND: Incubators and radiant warmers are essential equipment in neonatal care, but the typical 1,500 to 35,000 USD cost per device makes it unaffordable for many units in low and middle-income countries. We aimed to determine whether stable preterm infants could maintain thermoregulation for 48 h in a low-cost incubator (LCI). METHODS: The LCI was constructed using a servo-heater costing 200 USD and cardboard infant-chamber. We conducted this open-labeled non-inferiority randomized controlled trial in a tertiary level teaching hospital in India from May 2017 to March 2018. Preterm infants on full feeds and receiving incubator or radiant warmer care were enrolled at 32 to 36 weeks post-menstrual age. We enrolled 96 infants in two strata (Strata-1< 33 weeks, Strata-2 ≥ 33 weeks at birth). Infants were randomized to LCI or standard single-wall incubator (SSI) after negative incubator cultures and monitored for 48 h in air-mode along with kangaroo mother care. The incubator temperature was adjusted manually to maintain skin and axillary temperatures between 36.5 °C and 37.5 °C. During post-infant period after 48 h, SSI and LCI worked for 5 days and incubator temperatures were measured. The primary outcome was maintenance of skin and axillary temperatures with a non-inferiority margin of 0.2 °C. Failed thermoregulation was defined as abnormal axillary temperature (< 36.5 °C or >37.5 °C) for > 30 continuous-minutes. Secondary outcomes were incidence of hypothermia and required incubator temperature. Trial registration details: Clinical Trial Registry - India (CTRI/2015/10/006316). FINDINGS: Prior to enrollment 79(82%) infants were in radiant warmer and 17(18%) infants were in incubator care. Median weight at enrollment in Strata-1 and Strata-2 for SSI vs. LCI was 1355(IQR 1250-1468) vs. 1415(IQR 1280-1582) and 1993(IQR 1595-2160) vs. 1995(IQR 1632-2237) grams. Mean skin temperature in Strata-1 and Strata-2 for SSI vs. LCI was 36.8 °C ± 0.2 vs. 36.7 °C ± 0.18 and 36.8 °C ± 0.22 vs. 36.7 °C ± 0.19. Mean axillary temperature in Strata-1 and Strata-2 for SSI vs. LCI was 36.9 °C ± 0.19 vs. 36.8 °C ± 0.16 and 36.8 °C ± 0.2 vs. 36.8 °C ± 0.19. Mixed-effect model done for repeated measures of skin and axillary temperatures showed the estimates were within the non-inferiority limit; -0.07 °C (95% CI -0.11 to -0.04) and -0.06 °C (95% CI -0.095 to -0.02), respectively. Failed thermoregulation did not occur in any infants. Mild hypothermia occurred in 11 of 48(23%) of SSI and 16 of 48(33%) of LCI, OR 1.28 (95%CI 0.85 to 1.91). Incubator temperature in LCI was higher by 0.7 °C (95%CI 0.52 to 0.91). In the post-infant period SSI and LCI had excellent reliability to maintain set-temperature with intra-class correlation coefficient of 0.93 (95%CI 0.92 to 0.94) and 0.96 (95%CI 0.96 to 0.97), respectively. INTERPRETATION: Maintenance of skin and axillary temperature of stable preterm infants in LCI along with kangaroo mother care was non-inferior to SSI, but at a higher incubator temperature by 0.7 °C. No adverse events occurred and LCI had excellent reliability to maintained set-temperature. FUNDING: Food and Drug Administration (Award number P50FD004895).

Prognostic scoring system and risk stratification in patients with emphysematous pyelonephritis: an 11-year prospective study at a tertiary referral centre.

OBJECTIVES: To define pre-morbid, clinical, laboratory, and imaging features and identify prognostic factors associated with morbidity and mortality in patients with emphysematous pyelonephritis (EPN) and develop a prognostic scoring system for improving management outcomes. PATIENTS AND METHODS: From January 2009 to December 2019, we performed a prospective study of all patients with a suspected diagnosis of EPN referred to a specialist tertiary centre in South India. All patients who underwent non-contrast computed tomography of the abdomen and those diagnosed with EPN were included in this study. Demographic parameters, imaging, haematological and microbiology results were recorded. Patients were divided into three groups: Group 1, patients who survived without any intervention; Group 2, those who survived with surgical intervention; and Group 3, those who died with or without intervention. A prognostic scoring system was developed from 18 different parameters and risk stratification was developed. The scores were correlated with overall prognosis. RESULTS: Data from 131 patients with EPN enrolled in the study were analysed: Group 1 (n = 22), Group 2 (n = 102) and Group 3 (n = 7). By using univariate analysis, 10 factors were identified to be significantly associated with prognosis. Diabetes mellitus was the most common comorbidity. Shock at initial admission indicated a poor prognosis and warranted immediate attention (P < 0.001). CONCLUSIONS: A multi-disciplinary approach, a high index of clinical suspicion, an early diagnosis and administration of culture-specific antibiotics with identification of prognostic indicators and risk stratification, allows prompt and appropriate medical and surgical treatments that could improve EPN management outcomes.

Prevalence of Vascular Complications Among Type 2 Diabetic Patients in a Rural Health Center in South India.

Introduction: Vascular complications are the major cause of morbidity in patients with diabetes mellitus. Screening for these complications is crucial in early detection and tertiary prevention. Hence, this study aimed at finding the prevalence of micro and macrovascular complications and their associated factors in type 2 diabetes mellitus patients in a rural health center by using simple and easily available tools. Methodology: This hospital based cross sectional study was conducted in Rural Health and Training Centre (RHTC) of Sri Ramachandra medical college from Jan 2017 to Aug 2017. All type 2 diabetes patients registered at RHTC were included in the study. By the use of questionnaire, clinical examination and laboratory investigations, the prevalence of macro and microvascular complications and associated factors were ascertained. Multiple logistic regression was used to identify factors associated with vascular complications of diabetes. Results: The study included 390 type 2 diabetes patients. The overall prevalence of macrovascular and microvascular complications in our study population was 29.7% and 52.1%, respectively. Among the macrovascular complications, both coronary artery disease (CAD) and peripheral vascular disease (PVD) had a prevalence rate of 15.1%. Among the microvascular complications, peripheral neuropathy (44.9%) had the highest prevalence followed by nephropathy (12.1%) and diabetic foot (7.2%). Multiple logistic regression analyses showed high HbA1c level, lower education, high postprandial blood sugar, hypertension, abdominal obesity were significantly associated with increased risk of vascular complications of diabetes. Conclusion: This study demonstrated the increased prevalence of vascular complications in Type 2 diabetes patients in rural India. Regular screening to identify those patients at risk could prevent further progression of complications.