First-trimester fasting plasma glucose as a predictor of subsequent gestational diabetes mellitus and adverse fetomaternal outcomes: A systematic review and meta-analysis.

BACKGROUND: The implication of intermediately elevated fasting plasma glucose (FPG) in the first trimester of pregnancy is uncertain. PURPOSE: The primary outcome of the meta-analysis was to analyze if intermediately elevated first-trimester FPG could predict development of GDM at 24-28 weeks. The secondary outcomes were to determine if the commonly used FPG cut-offs 5.1 mmol/L (92 mg/dL), 5.6 mmol/L (100 mg/dL), and 6.1 mmol/L (110 mg/dL) correlated with adverse pregnancy events. DATA SOURCES: Databases were searched for articles published from 2010 onwards for studies examining the relationship between first-trimester FPG and adverse fetomaternal outcomes. STUDY SELECTION: A total of sixteen studies involving 115,899 pregnancies satisfied the inclusion criteria. DATA EXTRACTION AND DATA SYNTHESIS: Women who developed GDM had a significantly higher first-trimester FPG than those who did not [MD 0.29 mmoL/l (5 mg/dL); 95 % CI: 0.21-0.38; P < 0.00001]. First-trimester FPG ≥5.1 mmol/L (92 mg/dL) predicted the development of GDM at 24-28 weeks [RR 3.93 (95 % CI: 2.67-5.77); P < 0.0000], pre-eclampsia [RR 1.55 (95%CI:1.14-2.12); P = 0.006], gestational hypertension [RR1.47 (95%CI:1.20-1.79); P = 0.0001], large-for-gestational-age (LGA) [RR 1.32 (95%CI:1.13-1.54); P = 0.0004], and macrosomia [RR1.29 (95%CI:1.15-1.44); P < 0.001]. However, at the above threshold, the rates of preterm delivery, lower-segment cesarean section (LSCS), small-for gestational age (SGA), and neonatal hypoglycemia were not significantly higher. First-trimester FPG ≥5.6 mmol/L (100 mg/dL) correlated with occurrence of macrosomia [RR1.47 (95 % CI:1.22-1.79); P < 0.0001], LGA [RR 1.43 (95%CI:1.24-1.65); P < 0.00001], and preterm delivery [RR1.51 (95%CI:1.15-1.98); P = 0.003], but not SGA and LSCS. LIMITATIONS: Only one study reported outcomes at first-trimester FPG of 6.1 mmol/L (110 mg/dL), and hence was not analyzed. CONCLUSION: The risk of development of GDM at 24-28 weeks increased linearly with higher first-trimester FPG. First trimester FPG cut-offs of 5.1 mmol/L (92 mg/dL) and 5.6 mmol/L (100 mg/dL) predicted several adverse pregnancy outcomes.

Catastrophic healthcare expenditure and caregiver burden in pediatric chronic kidney disease - a mixed methods study from a low resource setting.

BACKGROUND: Caregivers of children with chronic kidney disease (CKD) in low resource settings must provide complex medical care at home while being burdened by treatment costs often paid out-of-pocket. We hypothesize that caregiver burden in our low resource setting is greater than reported from high income countries and is associated with frequent catastrophic healthcare expenditure (CHE). METHODS: We conducted a mixed-methods study of primary caregivers of children with advanced CKD (stage 3b-5) in our private-sector referral hospital in a low resource setting. We assessed caregiver burden using the Pediatric Renal Caregiver Burden Scale (PRCBS) and measured financial burden by calculating the proportion of caregivers who experienced CHE (monthly out-of-pocket healthcare expenditure exceeding 10% of total household monthly expenditure). We performed a qualitative reflexive thematic analysis of caregiver interviews to explore sources of burden. RESULTS: Of the 45 caregivers included, 35 (78%) had children on maintenance dialysis (25 PD, 10 HD). Mean caregiver burden score was 141 (± 17), greater than previously reported. On comparative analysis, PRCBS scores were higher among caregivers of children with kidney failure (p = 0.005), recent hospitalization (p = 0.03), non-earning caregivers (p = 0.02), caring for > 2 dependents (p = 0.009), and with high medical expenditure (p = 0.006). CHE occurred in 43 (96%) caregivers of whom 37 (82%) paid out-of-pocket. The main themes derived relating to caregiver burden were severe financial burden, mental stress and isolation, and perpetual burden of concern. CONCLUSION: Parents of children with CKD experienced severe caregiver burden with frequent CHE and relentless financial stress indicating an imminent need for social support interventions.

Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy.

BACKGROUND: The World Health Organization recommends 1500 to 2000 mg of calcium daily as supplementation, divided into three doses, for pregnant persons in populations with low dietary calcium intake in order to reduce the risk of preeclampsia. The complexity of the dosing scheme, however, has led to implementation barriers. METHODS: We conducted two independent randomized trials of calcium supplementation, in India and Tanzania, to assess the noninferiority of a 500-mg daily dose to a 1500-mg daily dose of calcium supplementation. In each trial, the two primary outcomes were preeclampsia and preterm birth, and the noninferiority margins for the relative risks were 1.54 and 1.16, respectively. RESULTS: A total of 11,000 nulliparous pregnant women were included in each trial. The cumulative incidence of preeclampsia was 3.0% in the 500-mg group and 3.6% in the 1500-mg group in the India trial (relative risk, 0.84; 95% confidence interval [CI], 0.68 to 1.03) and 3.0% and 2.7%, respectively, in the Tanzania trial (relative risk, 1.10; 95% CI, 0.88 to 1.36) - findings consistent with the noninferiority of the lower dose in both trials. The percentage of live births that were preterm was 11.4% in the 500-mg group and 12.8% in the 1500-mg group in the India trial (relative risk, 0.89; 95% CI, 0.80 to 0.98), which was within the noninferiority margin of 1.16; in the Tanzania trial, the respective percentages were 10.4% and 9.7% (relative risk, 1.07; 95% CI, 0.95 to 1.21), which exceeded the noninferiority margin. CONCLUSIONS: In these two trials, low-dose calcium supplementation was noninferior to high-dose calcium supplementation with respect to the risk of preeclampsia. It was noninferior with respect to the risk of preterm live birth in the trial in India but not in the trial in Tanzania. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03350516; Clinical Trials Registry-India number, CTRI/2018/02/012119; and Tanzania Medicines and Medical Devices Authority Trials Registry number, TFDA0018/CTR/0010/5).

Bubble Continuous Positive Airway Pressure Oxygen Therapy in Children Under Five Years of Age with Respiratory Distress in Pediatric Intensive Care Unit.

Background: Continuous positive airway pressure (CPAP) has been used in children with bronchiolitis for a long time. Currently in the low-resource settings, the method of providing oxygen therapy via bubble CPAP (bCPAP) to children with respiratory distress is not standardized and the existing low-flow oxygen therapy has a high mortality rate. Objectives: To study the effectiveness and safety of bCPAP as a respiratory support in children with respiratory distress. Materials and methods: This prospective observational study was conducted in a tertiary care pediatric intensive care unit (PICU) over a period of 3 months. Children with respiratory distress were administered with bCPAP oxygen therapy. Baseline demographic data, such as age, sex, weight, severity of illness was collected. Changes in heart rate, respiratory rate, saturation, respiratory distress score and failure rate after bCPAP therapy were studied. Results: During the study period, 30 children were recruited. Most common cause of respiratory distress requiring bCPAP was pneumonia (66.7%) followed by pleural effusion (20%) and bronchiolitis (13.3%). The median (IQR) CPAP duration and PICU stay in the study was 48 hours (27-48) and 4 days (4-8), respectively. Heart rate and respiratory rate, respiratory distress score improved significantly after CPAP therapy (p < 0.05). CPAP therapy failed in one child and required invasive ventilation. We did not observe any complications due to bCPAP therapy. Conclusion: The use of bCPAP in the treatment of respiratory distress is safe and effective. How to cite this article: Lalitha AV, Pujari CG, Raj JM. Bubble Continuous Positive Airway Pressure Oxygen Therapy in Children Under Five Years of Age with Respiratory Distress in Pediatric Intensive Care Unit. Indian J Crit Care Med 2023;27(11):847-854.

A comparison of conventional and accelerated hypofractionated radiotherapy in definitive chemoradiation for locally advanced head and neck carcinoma: a retrospective cohort study.

PURPOSE: The study evaluates accelerated hypofractionated radiotherapy (AHRT) compared to conventional fractionation radiotherapy (CFRT) in patients with locally advanced head and neck cancer (LAHNC) receiving definitive chemoradiation therapy. MATERIALS AND METHODS: The study includes a retrospective cohort analysis of 120 patients. CFRT arm (n = 65) received 2 Gy per fraction to a dose of 70 Gy over 7 weeks in a three-volume approach, whereas the AHRT arm (n = 55) received 2.2 Gy per fraction to a dose of 66 Gy in 6 weeks with a two-volume approach. The primary outcome was overall survival (OS). RESULTS: With a median follow-up of 18.9 months, 23 patients died in the AHRT arm, and 45 deaths in the CFRT arm. The median OS was 23.4 and 37.63 months in the CFRT and AHRT arms, respectively (hazard ratio [HR] = 0.709; 95% confidence interval [CI], 0.425-1.18; p = 0.189). The median time to loco-regional control was 33.3 months in the CFRT arm and was not reached in the patient group receiving AHRT (HR = 0.558; 95% CI, 0.30-1.03; p = 0.065). The median progression-free survival was 15.9 months in the CFRT arm and 26.9 months in the AFRT arm (HR = 0.801; 95% CI, 0.49-1.28; p = 0.357). Out of 11 acute toxic deaths, eight were in the CFRT arm. CONCLUSION: The study showed a trend towards benefit in terms of locoregional control in the AHRT arm and similar OS. A longer follow-up of patients receiving AHRT is required to assess the benefit.

Long Term Outcomes in Idiopathic Inflammatory Myositis: An Observational Epidemiologic Study over 15 Years.

Background: We report a longitudinal observational cohort of idiopathic inflammatory myositis (IIM) focusing on the long-term clinical outcome and associated parameters. Methods: IIM patients were classified as per Bohan and Peter criteria. In those with ≥ 24 months of follow-up; the treatment response, functional outcomes, and damage at last follow-up were recorded. Complete clinical response and clinical remission as defined by Oddis et al., was used to define outcomes at last follow-up. Results: The cohort consists of 175 patients, mean age 40.9 (+12.6) years, M:F 1:3.3; and the major subsets were dermatomyositis (44.6%), overlap myositis (25.7%), antisynthetase syndrome (6.3%), polymyositis (14.3%), and juvenile DM/OM (8.6%). Ninety-four patients have followed up for 24 months or more, with the median (IQR) of 65(35,100.7) months. Of them, 74.1% and 11.8% had complete and partial clinical responses respectively at the last follow-up. In our cohort 40.2% were off-steroids and 13.8% were in clinical remission at the last follow-up. Complete clinical response was associated with better functional outcomes and lesser damage as determined by HAQ-DI of 0[OR10.9; 95%CI (3.3,160)], MRS [OR 3.2; 95%CI (1.4,7.3)] and lesser MDI [OR 1.7; 95% CI (1.1,2.7)] respectively as compared to partial response (unadjusted analysis). Baseline parameters and IIM subsets did not significantly influence the functional outcome and damage. The mortality rate in our cohort is 24/175 (13.7%), the disease-specific mortality rate being 9.1%. Large majority of deaths were early, associated with active disease. Conclusion: We report good long-term outcomes in all major myositis subsets. Partial clinical response to treatment is associated with worse functional outcomes and damage accrual. Death occurs early in association with active disease.

The effect of l-arginine supplementation on amelioration of oxygen support in severe COVID-19 pneumonia.

BACKGROUND & AIMS: l-Arginine (l-Arg) has been shown to help reduce respiratory support requirements in coronavirus disease 2019 (COVID-19), in an Italian study. We investigated the effect of l-Arg supplementation on the reduction in respiratory support for patients with severe COVID-19 pneumonia in an Indian population. METHODS: A parallel-group, triple-blinded, randomized controlled trial (RCT) was conducted on patients with severe COVID-19 pneumonia on oxygen (O2) support. Patients received either 3 g of oral l-Arg or placebo, daily under supervision, until they were off O2 support, or for a maximum of 10 days, whichever was earlier. The primary outcome was cessation in O2 support. Other outcomes were time to cessation of O2 support, duration of hospitalization, and incidence of adverse thrombotic events. RESULTS: We did an intention-to-treat analysis on 74 patients who were randomized into l-Arg (n = 38) or placebo group (n = 36). There were no significant differences between the two groups in the outcomes. At end of the study, 28 patients (73.6%) in l-Arg and 26 patients (72.2%) in the placebo group were weaned off oxygen support. The median number of days to the cessation of O2 support estimated using Kaplan Meir survival analysis, was 3 days in the l-Arg group (95% confidence interval [CI]: 1.2, 4.7) and 5 days in the placebo group (95% CI, 4.1,5.8); P = 0.27. CONCLUSION: In this group of patients with severe COVID-19 pneumonia, l-Arg supplementation did not show any significant difference in outcomes when compared to placebo supplementation.

Role of Biomarkers and Its Trend to Predict the Outcome of COVID-19 Patients: A Retrospective Study.

Background: Biomarkers have been extensively studied and used in the diagnosis and management of various diseases. The trend of biomarkers helps in prognosticating and managing critically ill patients. In resource-limited settings, the availability and feasibility of using these biomarkers are challenging.Our study aimed to see the trend of biomarkers and their effect on intensive care unit (ICU) mortality in coronavirus disease-2019 (COVID-19) patients. Materials and methods: A retrospective observational study was done from 1 April 2020 to 30 September 2020. The primary objective was to evaluate the trend of biomarkers in patients with COVID-19 pneumonia and their effect on ICU mortality. The secondary objectives were the duration of mechanical ventilation and length of ICU stay. Results: A total of 380 patients were included. The mean age was 54.9 (SD = 11.1) and 67% were males. The mean age, acute physiology and chronic health evaluation II (APACHE II) score was 29.54 (5.8). Among the biomarkers, total count (TC), ferritin, and procalcitonin (PCT) were higher in non-survivors than in survivors in bivariate analysis. The final multivariable logistic regression model showed age, APACHE II score, length of ICU stay, neutrophil:lymphocyte (NL) ratio, and ferritin as covariates. Among these variables, ferritin was the only biomarker [odds ratio (OR): 1.80, 95% confidence interval (CI) 1.17-2.77] with the APACHE II score (OR: 1.15, 95% CI 1.01-1.30) found to be significant. Conclusion: Ferritin was the only significant biomarker with higher values in non-survivors than in survivors. The trend of biomarkers was not found to be useful in predicting outcome of the patients. How to cite this article: Havaldar AA, Lobo V, Sushmitha EAC, Kumar VM, Raj JM, Thomas T. Role of Biomarkers and Its Trend to Predict the Outcome of COVID-19 Patients: A Retrospective Study. Indian J Crit Care Med 2022;26(9):1031-1035.

Epidemiology of Acute Respiratory Distress Syndrome in Pediatric Intensive Care Unit: Single-center Experience.

Background: Acute respiratory distress syndrome (ARDS) is characterized by dysregulated inflammation resulting in hypoxemia and respiratory failure and causes both morbidity and mortality. Objectives: To describe the clinical profile, outcome, and predictors of mortality in ARDS in children admitted to the Pediatric intensive care unit. Materials and methods: This is a single-center retrospective study conducted at a tertiary referral hospital in a 12-bed PICU involving children (1 month to 18 years) with ARDS as defined by Pediatric Acute Lung Injury Consensus Conference (PALICC) guidelines, over a period of 5 years (2016-2020). Demographic, clinical, and laboratory details at onset and during PICU stay were collected. Predictors of mortality were compared between survivors and non-survivors. Results: We identified 89 patients with ARDS. The median age at presentation was 76 months (12-124 months). The most common precipitating factor was pneumonia (66%). The majority of children (35.9%) had moderate ARDS. Overall mortality was 33% with more than half belonging to severe ARDS group (58%). On Kaplan-Meier survival curve analysis, the mean time to death was shorter in the severe ARDS group as compared to other groups. Multiorgan dysfunction was present in 46 (51.6%) of the cases. Non-survivors had higher mean pediatric logistic organ dysfunction (PELOD2) on day 1. PRISM III at admission, worsening trends of ventilator and oxygenation parameters (OI, P/F, MAP, and PEEP) independently predicted mortality after multivariate analysis. Conclusion: High PRISM score predicts poor outcome, and worsening trends of ventilator and oxygenation parameters (OI, P/F, MAP, and PEEP) are associated with mortality. How to cite this article: Pujari CG, Lalitha AV, Raj JM, Kavilapurapu A. Epidemiology of Acute Respiratory Distress Syndrome in Pediatric Intensive Care Unit: Single-center Experience. Indian J Crit Care Med 2022;26(8):949-955.

Demographics and Clinical Characteristics of COVID-19-vaccinated Patients Admitted to ICU: A Multicenter Cohort Study from India (PostCoVac Study-COVID Group).

Background: Emergency authorization and approval were given for the coronavirus disease-19 (COVID-19) vaccines. The efficacy reported after phase III trials were 70.4% and 78% for Covishield and Covaxin, respectively.In this study, we aim to analyze the risk factors, which were associated with mortality in critically ill COVID-19-vaccinated patients admitted into intensive care unit (ICU). Materials and methods: This study was conducted from April 1, 2021 to December 31, 2021 across five centers in India. Patients who had received either one or two doses of any of the COVID vaccines and developed COVID-19 were included. The ICU mortality was a primary outcome. Results: A total of 174 patients with COVID-19 illness were included in the study. The mean age was 57 years standard deviation (SD 15). Acute physiology, age and chronic health evaluation (APACHE II) score and the sequential organ failure assessment (SOFA) score were 14 (8-24.5) and 6 (4-8), respectively. Multiple variable logistic regression showed patients who have received a single dose [odds ratio (OR): 2.89, confidence interval (CI): 1.18, 7.08], neutrophil:lymphocyte (NL) ratio (OR: 1.07, CI: 1.02,1.11), and SOFA score (OR: 1.18, CI: 1.03,1.36) were associated with higher mortality. Conclusion: The mortality in the vaccinated patients admitted to the ICU was 43.68% due to COVID illness. The mortality was lower in patients who had received two doses. How to cite this article: Havaldar AA, Prakash J, Kumar S, Sheshala K, Chennabasappa A, Thomas RR et al. Demographics and Clinical Characteristics of COVID-19-vaccinated Patients Admitted to ICU: A Multicenter Cohort Study from India (PostCoVac Study-COVID Group). Indian J Crit Care Med 2022;26(11):1184-1191.

Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania.

BACKGROUND: Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality, as well as preterm birth, the leading cause of death for children under 5 years globally. The World Health Organization currently recommends that pregnant women receive high-dose calcium supplementation (1500-2000 mg elemental calcium) for prevention of preeclampsia in populations with low dietary calcium intake. Trials of low-dose calcium supplementation (< 1000 mg elemental calcium/day) during pregnancy have also shown similar reductions in the risk of preeclampsia; however, no trials to date have directly compared low-dose to the standard high-dose calcium supplementation. Our objective is to assess the non-inferiority of low-dose as compared to standard high-dose calcium supplementation in pregnancy. METHODS/DESIGN: We will conduct two independent trials in Bangalore, India (n = 11,000 pregnancies), and Dar es Salaam, Tanzania (n = 11,000 pregnancies). The trial designs are individually randomized, parallel group, quadruple-blind, non-inferiority trials of low-dose calcium supplementation (500 mg elemental calcium/day) as compared to standard high-dose calcium supplementation (1500 mg elemental calcium/day) among nulliparous pregnant women. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized calcium regimen from randomization until the time of delivery. The co-primary outcomes are (i) preeclampsia and (ii) preterm birth; we will test non-inferiority of the primary outcomes for low-dose as compared to the standard high-dose supplementation regimen in each trial. The trials' secondary outcomes include gestational hypertension, severe features of preeclampsia, pregnancy-related death, third trimester severe anemia, fetal death, stillbirth, low birthweight, small-for-gestational age birth, and infant death. DISCUSSION: The trials will provide causal evidence on the non-inferiority of low-dose as compared to the standard high-dose supplementation in India and Tanzania. A single tablet, low-dose calcium supplementation regimen may improve individual-level adherence, reduce programmatic costs, and ultimately expand implementation of routine calcium supplementation in pregnancy in populations with low dietary calcium intake. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03350516 ; registered on 22 November 2018. Clinical Trials Registry-India identifier: CTRI/2018/02/012119 ; registered on 23 February 2018. Tanzania Medicines and Medical Devices Authority Trials Registry identifier: TFDA0018/CTR/0010/5 ; registered on 20 December 2018.

Late toxicities in locally advanced head and neck squamous cell carcinoma treated with intensity modulated radiation therapy.

PURPOSE: The study aims to report late toxicities in locally advanced head-and-neck squamous cell carcinoma (LAHNSCC) treated with intensity-modulated radiation therapy (IMRT). MATERIALS AND METHODS: A retrospective study was conducted on 103 patients of LAHNSCC treated with IMRT. We analyzed the cumulative incidence of late xerostomia, dysphagia, and aspiration at an interval of 6-month, 1-year, 2-year, and 3-year from the start of IMRT. RESULTS: At a median follow up of 4.2 years (interquartile range, 3.5 to 6 years), the cumulative incidence of grade ≥2 late xerostomia was 5.5%, dysphagia was 6.9%, and aspiration was 11.1%. Logistic regression showed that Dmean of ≥26 Gy to parotids had higher risk of xerostomia (hazard ratio [HR] = 5.19; 95% confidence interval [CI], 1.90-14.22; p = 0.001). Late dysphagia was associated with Dmean of ≥45 Gy to pharyngeal constrictors (PC) (HR = 7; 95% CI, 1.84-26.61; p =0.004), ≥55 Gy to larynx (HR = 3.25; 95% CI, 1.15-9.11; p = 0.025), and adjuvant RT (HR = 5.26; 95% CI, 1.85-14.87; p = 0.002). Aspiration was associated with Dmean of ≥45 Gy to larynx (HR = 6.5; 95% CI, 1.93-21.88; p = 0.003), Dmean of ≥55 Gy to PC (HR = 3.54; 95% CI, 1.25-9.98; p = 0.017), and patients having late dysphagia (HR = 4.37; 95% CI, 1.55-12.31; p = 0.005). CONCLUSION: IMRT is a feasible radiation delivery technique in LAHNSCC with a decreased late toxicity profile.

Safety of hydroxychloroquine in healthcare workers for COVID-19 prophylaxis.

BACKGROUND & OBJECTIVES: Hydroxychloroquine (HCQ), reported to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in in vitro studies, has been recommended for prophylaxis of COVID-19 in healthcare workers (HCWs). The objective of this study was to assess short-term adverse events (AEs) of HCQ in HCWs. METHODS: This cross-sectional study among consenting HCWs taking prophylaxis and working in hospitals with COVID-19 patients used online forms to collect details of HCWs, comorbidities, prophylactic drugs used and AEs after the first dose of HCQ. Verification of dose and AEs was done by personal contact. Multivariate logistic regression analysis was done to determine the effect of age, gender and dose of HCQ on AE. RESULTS: Of the 1303 HCWs included, 98.4 per cent (n=1282) took HCQ and 66 per cent (n=861) took 800 mg as first day's dose. Among the 19.9 per cent (n=259) reporting AEs, 1.5 per cent (n=20) took treatment for AE, none were hospitalized and three discontinued HCQ. Gastrointestinal AEs were the most common (172, 13.2%), with less in older [odds ratio (OR) 0.56, 95% confidence interval (CI) 0.35-0.89], with more in females (OR 2.46, 95% CI 1.78-3.38) and in those taking a total dose of 800 mg on day one compared to a lower dose. Hypoglycaemia (1.1%, n=14), cardiovascular events (0.7%, n=9) and other AEs were minimal. INTERPRETATION & CONCLUSIONS: HCQ prophylaxis first dose was well tolerated among HCWs as evidenced by a low discontinuation. For adverse effects, a small number required treatment, and none required hospitalization. The study had limitations of convenience sampling and lack of laboratory and electrocardiography confirmation of AEs.

Associations of cereal grains intake with cardiovascular disease and mortality across 21 countries in Prospective Urban and Rural Epidemiology study: prospective cohort study.

OBJECTIVE: To evaluate the association between intakes of refined grains, whole grains, and white rice with cardiovascular disease, total mortality, blood lipids, and blood pressure in the Prospective Urban and Rural Epidemiology (PURE) study. DESIGN: Prospective cohort study. SETTING: PURE study in 21 countries. PARTICIPANTS: 148 858 participants with median follow-up of 9.5 years. EXPOSURES: Country specific validated food frequency questionnaires were used to assess intakes of refined grains, whole grains, and white rice. MAIN OUTCOME MEASURE: Composite of mortality or major cardiovascular events (defined as death from cardiovascular causes, non-fatal myocardial infarction, stroke, or heart failure). Hazard ratios were estimated for associations of grain intakes with mortality, major cardiovascular events, and their composite by using multivariable Cox frailty models with random intercepts to account for clustering by centre. RESULTS: Analyses were based on 137 130 participants after exclusion of those with baseline cardiovascular disease. During follow-up, 9.2% (n=12 668) of these participants had a composite outcome event. The highest category of intake of refined grains (≥350 g/day or about 7 servings/day) was associated with higher risk of total mortality (hazard ratio 1.27, 95% confidence interval 1.11 to 1.46; P for trend=0.004), major cardiovascular disease events (1.33, 1.16 to 1.52; P for trend<0.001), and their composite (1.28, 1.15 to 1.42; P for trend<0.001) compared with the lowest category of intake (<50 g/day). Higher intakes of refined grains were associated with higher systolic blood pressure. No significant associations were found between intakes of whole grains or white rice and health outcomes. CONCLUSION: High intake of refined grains was associated with higher risk of mortality and major cardiovascular disease events. Globally, lower consumption of refined grains should be considered.

Fatigue and its correlates in Indian patients with systemic lupus erythematosus.

Fatigue is a disabling yet poorly understood symptom in patients with systemic lupus erythematosus (SLE). Many variables influence fatigue including physical function, pain, fibromyalgia and psychiatric comorbidity. Literature is conflicted on its association with disease activity. To assess fatigue and its correlates among patients with SLE. Existent data from validation of Hindi LupusPRO study were utilized for this study. SLE patients were enrolled and underwent assessments of disease activity and damage (SELENA-SLEDAI and SLICC/ACR Damage Index (SDI)). Depression (Patient Health Questionnaire-9 (PHQ-9)), anxiety (Generalized Anxiety Disorder-7 (GAD-7)), fatigue (Fatigue Severity Scale (FSS)) and fibromyalgia were evaluated. Physical function and bodily pain were assessed using Short Form 36 (SF-36). Statistical analysis was done using the STATA version 14. A total of 140 females and 4 males with SLE with a mean age of 32.48 (SD 7.26) years were recruited. Median duration of illness was 3 years (IQR-4). Fatigue (FSS ≥ 4) was present in 74 (51.39%) participants. Prevalence of depression (PHQ-9 ≥ 10) and anxiety (GAD-7 ≥ 10) were 25% and 22.9%, respectively. Concomitant fibromyalgia was present in 8 participants (5.56%). Higher fatigue scores correlated with greater disease activity, shorter disease duration, worse physical function, bodily pain, depression and anxiety. On stepwise regression, disease duration, disease activity, bodily pain, depression and anxiety were independent predictors of fatigue (R2 = 0.35, p < 0.001). Fatigue is seen in over half of Indian patients with SLE and is independently associated with disease activity, disease duration, pain and psychiatric comorbidity. Multidisciplinary approach is indicated to address fatigue in SLE. Key Points • Fatigue is common in patients in Indian patients with SLE • Higher disease activity, shorter duration of disease, pain and psychiatric comorbidity were associated with fatigue.

Prevalence and Risk Factors of Hypovitaminosis-D in Children with Cognitive and Movement Disorders.

OBJECTIVES: To document the prevalence of hypovitaminosis-D in children with intellectual and movement disorders and to identify the risk factors in vitamin D deficient children. METHODS: This is a cross-sectional study on 90 children with neurodevelopmental disabilities. The prevalence of hypovitaminosis-D and the risk factors such as sun exposure, age-appropriate mobility, diet, skin color and anti-epileptic medications were examined in children with cognitive disorders and movement disorders. RESULTS: The mean serum vitamin D level in children with cognitive disability (n = 46) was found to be 26.7 ± 16.3 ng/L and in the children with movement disability (n = 44) it was 27.9 ± 10.5 ng/L. Though the risk factors were found in greater numbers in children in the deficient group (vitamin D < 30 ng/L), the difference between the two groups was not significant. Of the 90 children, 86 (95.5%) had at least one sign of vitamin D deficiency. Lowest levels of vitamin D were seen in autistic spectrum disorder and learning disabilities in the Cognitive Disability group and hemiplegia in the Movement Disability group. CONCLUSIONS: The prevalence of vitamin D deficiency in children with neurodevelopmental disabilities was 72.2%, with 76.1% in the cognitive disability group and 68.2% in the movement disability group. The risk factors were more common in vitamin D deficient children.

Comparison of the 2017 EULAR/ACR criteria with Bohan and Peter criteria for the classification of idiopathic inflammatory myopathies.

Bohan and Peter is the oldest criteria for the classification of idiopathic inflammatory myopathies (IIM). Recently, 2017 EULAR/ACR criteria were introduced which were validated against a control group. The objective of this study was to assess the performance of the 2017 EULAR/ACR criteria in retrospective cohort of adult and juvenile idiopathic inflammatory myopathies and compare with Bohan and Peter criteria. This was a retrospective study of patients clinically diagnosed to have IIM in a tertiary care center in the last 10 years. Only patients with a minimum follow-up of 6 months and response to steroids and immunosuppression were included in the study. Performance of both the criteria in the cohort was assessed and compared with clinical diagnosis. Hundred and eleven patients (87 females) were included in the study. Eleven patients had juvenile onset. Ninety-three patients (83.8%) were classified as probable/definite myositis using the Bohan and Peter criteria. Eighty-nine (80.2%) patients were classified as having probable/definite inflammatory myositis using the new criteria. Agreement between the two criteria was weak in our cohort (κ-0.331). Complete details of muscle biopsy were available in 52 patients. In this subgroup, 96% were classified by Bohan and Peter and 80.8% by EULAR/ACR criteria. Bohan and Peter classified 73% and EULAR/ACR 82% of patients when biopsy was excluded (n = 111). Both criteria classified over 90% of the patients with dermatomyositis. Forty-two patients were clinically diagnosed as polymyositis, of these 32 patients had myositis overlap syndrome. Bohan and Peter classified 66.7% and EULAR/ACR classified 64.3% in this subset. Bohan and Peter criteria had high sensitivity in the presence of muscle biopsy compared with EULAR/ACR. The performance of the EULAR/ACR criteria was similar to Bohan and Peter in the absence of muscle biopsy. Both criteria had poor sensitivity in polymyositis.

Early Competing Deaths in Locally Advanced Head-and-Neck Cancer.

INTRODUCTION: The competing (noncancer) deaths have increased with aggressive treatment approach and better disease control in locally advanced head-and-neck cancer. AIM: The aim of this study is to find incidence, cause and predictors of early competing mortality in locally advanced head-and-neck cancer patients undergoing combined modality therapy. SUBJECTS AND METHODS: In this retrospective study, a total of 125 locally advanced head-and-neck patients treated from January 2013 to June 2017 were analyzed. The total number of deaths, cause, and the time of death from the start of therapy was recorded. To study the risk factors of competing deaths, univariate and multivariate logistic regression was applied. Data were analyzed using SPSS v. 24 software. RESULTS: A total of 51 deaths (31 cancer deaths and 20 competing deaths) recorded at a median follow-up of 16 months (1-62 months). The incidence of early competing mortality was 12% (n = 15) with a median time of 2.7 months from treatment initiation. Sepsis was major cause of early competing death (n = 13). On univariate and multivariate logistic regression analysis, competing death was significantly associated with pharyngeal (oropharynx, hypopharynx, and larynx) site primary (odds ratio [OR] = 3.562; 95% confidential interval [CI] = 1.207-10.517; P = 0.016), and Stage IVA/IVB disease (OR = 5.104; 95% CI = 1.123-23.202; P = 0.021). CONCLUSION: Competing deaths is one of the multifaceted problems in locally advanced head-and-neck cancer patients. Sepsis being single most cause of early competing deaths in Stage IVA/IVB pharyngeal and laryngeal cancer.

Corneal Allogenic Intrastromal Ring Segments (CAIRS) Combined With Corneal Cross-linking for Keratoconus.

PURPOSE: To describe a new technique for the treatment of keratoconus using corneal allogenic intrastromal ring segments (CAIRS). METHODS: CAIRS trephined from donor cornea using a double-bladed trephine were implanted into mid-depth femtosecond laser-dissected channels in the cornea of patients with keratoconus in the 6.5-mm optic zone, followed by accelerated corneal cross-linking (A-CXL)-either conventional or contact lens-assisted CXL (A-CACXL), depending on minimum corneal thickness. RESULTS: Twenty patients (24 eyes) with stage 1 to 4 keratoconus (Amsler-Krumeich grading) were included. Mean follow-up was 11.58 ± 3.6 months (range: 6 to 18 months). There was significant improvement in uncorrected (2.79 ± 2.65 lines; range: 0 to 8 lines) and corrected (1.29 ± 1.33 lines; range: 0 to 5 lines) distance visual acuity, spherical equivalent, simulated maximum keratometry, steepest keratometry, topographic astigmatism, anterior and posterior best fit spheres, and mean power in the 3- and 5-mm zones. No eye showed progression during the entire follow-up. All segments remained well positioned and no segment-induced complications were seen. No other major intraoperative or postoperative complications were observed. CONCLUSIONS: This pilot study indicates that CAIRS with CXL may be a simple, safe, and effective option for treating keratoconus. Further studies are recommended to determine long-term outcomes. [J Refract Surg. 2018;34(5):296-303.].

Sequential segmental terminal lenticular side-cut dissection for safe and effective small-incision lenticule extraction in thin lenticules.

Small-incision lenticule extraction may be associated with complications such as partial lenticular dissection, torn lenticule, lenticular adherence to cap, torn cap, and sub-cap epithelial ingrowth, some of which are more likely to occur during low-myopia corrections. We describe sequential segmental terminal lenticular side-cut dissection to facilitate minimally traumatic and smooth lenticular extraction. Anterior lamellar dissection is followed by central posterior lamellar dissection, leaving a thin peripheral rim and avoiding the lenticular side cut. This is followed by sequential segmental dissection of the lenticular side cut in a manner that fixates the lenticule and provides sufficient resistance for smooth and complete dissection of the posterior lamellar cut without undesired movements of the lenticule. The technique is advantageous in thin lenticules, where the risk for complications is high, but can also be used in thick lenticular dissection using wider sweeps to separate the lenticular side cut sequentially.