Correlates of bacterial vaginosis among women from North India.

Background: Bacterial vaginosis (BV) is the most prevalent cause of abnormal vaginal discharge among pre-menopausal women and associated with adversities of sexual and reproductive health. The present study aimed to identify potential epidemiological and behavioural risk factors and clinical predictors of BV among women in Delhi, India. Methods: A cross-sectional study was conducted to assess 283 non-pregnant women aged 18-45 years for BV using Nugent's scoring criteria. Information on demographics, sexual behaviours, hygiene practices and clinical symptoms was obtained and evaluated for their association with Nugent-BV status. Results: A positive diagnosis for Nugent-BV was made in 69 (24.4%) participants, 55 (19.4%) were intermediate and 159 (65.2%) were negative for Nugent-BV. Infertility (p = .02) and recent unprotected sexual exposure (p = .02) were strongly associated with Nugent-BV. On the other hand, women who reported regular use of condoms during intercourse were more likely to test negative (p = .03). None of the patient complaints, however, had any significant correlation with Nugent-BV diagnosis. Conclusion: Women in their reproductive years share the highest burden of adversities associated with bacterial vaginosis. History of infertility, recent unprotected sexual exposure and frequent use of condoms were correlates having significant associations with Nugent-BV.

Outcome and Determinants of Neutropenic Enterocolitis in Pediatric Cancer Patients.

BACKGROUND: Neutropenic enterocolitis (NEC) is a dreaded complication of chemotherapy. There is scant literature regarding incidence, clinical features, and determinants. The understanding of gut dysbiosis in NEC and pediatric cancer is evolving. METHODS: Pediatric cancer patients with neutropenia and gastrointestinal symptoms were evaluated for NEC with contrast-enhanced computed tomography abdomen. Clinical, imaging, and laboratory features were analyzed. Fecal samples were analyzed for fecal calprotectin by sandwich enzyme-linked immunoassay and gut microbiota by conventional culture and compared with healthy controls and children without NEC. RESULTS: NEC was diagnosed in 44 children based on clinical and imaging features with incidence of 7.4% (4 had recurrent episodes). Common manifestations included fever (98%), pain abdomen (88%), and diarrhea (83%). Hypoalbuminemia was observed in 78% of patients. Large bowel involvement (94%) with diffuse bowel involvement (63%) and pancolitis (64%) were common. Fecal calprotectin was significantly elevated in NEC group than non-NEC group and healthy controls (median: 87, 53, and 42 µg/g, respectively). A higher degree of gut dysbiosis was observed in children with NEC with higher isolation of Bacteroides and infrequent isolation of Lactobacilli. Mortality rate of 23% was observed. Only the presence of free fluid predicted higher mortality. Though levels of fecal calprotectin and gut dysbiosis were higher in NEC, they did not increase mortality. Isolation of Bacteroides and absence of Lactobacilli predicted a longer duration of intravenous alimentation. CONCLUSIONS: NEC caused significant morbidity and mortality in pediatric cancer patients. Gut dysbiosis was significantly higher in NEC group suggesting a role in pathogenesis and influencing outcome. This highlights the role of targeted interventions towards gut dysbiosis like prebiotics and probiotics.

The role of Plasma Renin Activity in prenatally diagnosed non-obstructed hydronephrosis at risk for surgery-an observational study.

BACKGROUND: Patients with asymptomatic prenatally diagnosed hydronephrosis may progress to needing surgery; no biomarker supporting the identification of these cases is currently available. The aim of the study was to assess the role of Plasma Renin Activity (PRA) as a discriminatory factor to identify patients with asymptomatic prenatally diagnosed hydronephrosis who require close monitoring and are at-risk for surgery. METHODS: The study group consists of 30 children prenatally diagnosed with asymptomatic unilateral hydronephrosis, initially managed with medical follow-up. Pyeloplasty was indicated if patients became symptomatic or if there was a significant drop in split renal function (SRF) during follow-up. An association was sought between PRA and renal parameters in post-hoc analysis. RESULTS: During the mean follow-up of 55.5 ± 8.2 months, 13/30 (43.3%) patients developed delayed drainage and 8/30 (26.6%) underwent pyeloplasty. Mean PRA was higher at presentation in the group which later presented with a drop in differential kidney function ≥ 10%, while it was within the normal range for age in the other patients. Before pyeloplasty, progression to delayed drainage coincided with a drop in SRF and a rise in PRA. While PRA levels normalized after pyeloplasty, SRF improved but did not reach initial values. A mean rise of 68.9% in PRA preceded current indications for surgery by 27.5 ± 9.5 months. CONCLUSIONS: A progressive increase in PRA in children with asymptomatic prenatally diagnosed hydronephrosis reflects obstructive stress in the tubulo-interstitial compartment. This stress is relieved by pyeloplasty and is reflected by a drop in PRA after surgery. PRA can, thus, serve as the discriminatory factor to identify hydronephrosis patients 'at-risk' for surgery even before the current criteria for pyeloplasty are met.

Intermittent versus daily regimen of prednisolone in ambulatory boys with Duchenne muscular dystrophy: A randomized, open-label trial.

INTRODUCTION/AIMS: Corticosteroids prolong ambulation and improve muscle power among boys with Duchenne muscular dystrophy (DMD). However, the optimal steroid regimen remains unclear. Hence, this study was undertaken to compare the efficacy of daily- versus intermittent-steroid regimens in ambulatory boys with DMD. METHODS: In this single-center, open-label randomized trial, 72 children were randomized to receive either daily prednisolone (0.75 mg/kg/day) or intermittent prednisolone (0.75 mg/kg/day, for first 10 days of every month). The primary outcome measure was the difference in average score on manual muscle testing (MMT) at baseline and after 6 mo of steroids. A difference of >0.2 was hypothesized to be significant. Secondary outcomes included changes in timed functions, muscular dystrophy-specific functional-rating scale score, peak torque, average power, and pulmonary function. RESULTS: In the intention-to-treat analysis, the mean (SD) change in MMT scores was 0.17 (0.15) and 0.08 (0.10) for the daily and intermittent steroid groups, respectively. The mean difference between the two interventions was 0.10 (95% confidence interval [CI] = 0.04-0.16; P = .003), which although significant was less than the predefined value of 0.2. Statistically significantly improvements were observed with daily-steroid regimen in the Gowers time (P = .01), nine-metre walk test (P = .02) and average power (P = .02) as compared to intermittent-steroid regimen. A total of 19/32 (52.8%) children in the daily-steroid group and 8/29 (27%) children in the intermittent-steroid group experienced some form of adverse effect (P = .02). DISCUSSION: Over a short-term period, the intermittent-steroid regimen was non-inferior to the daily-steroid regime in preserving muscle strength among children with DMD. However, better improvement of functional measures was observed with daily-steroid administration. The frequency of individual side effects was similar between the two groups.

Histologic Changes in Core-Needle Liver Biopsies From Patients With Acute-on-Chronic Liver Failure and Independent Histologic Predictors of 28-Day Mortality.

CONTEXT.­: The histologic features in patients with acute-on-chronic liver failure (ACLF) are evolving, and histologic indicators of patients' poor prognosis are not yet fully established. OBJECTIVE.­: To evaluate the independent histologic predictors of 28-day mortality in ACLF patients on core-needle liver biopsies. DESIGN.­: Core-needle biopsies from patients with a diagnosis of ACLF (n = 152) as per the European Association for the Study of the Liver criteria were included during 8 years. Liver biopsies from 98 patients with compensated chronic liver disease were included as disease controls for histologic comparison. Features of ongoing changes, such as hepatic necrosis, hepatic apoptosis, cholestasis, hepatocyte degeneration, bile ductular proliferation, Mallory-Denk bodies, steatosis, and extent of liver fibrosis, were analyzed for predicting short-term mortality (28 days). A P value of <.05 was considered significant. RESULTS.­: In our cohort of ACLF patients, the following etiologies for acute decompensation were identified: alcohol, 47 of 152 (30.9%); sepsis, 24 of 152 (15.7%); hepatotropic viruses, 20 of 152 (13.1%); drug-induced liver injury, 11 of 152 (7.2%); autoimmune flare, 9 of 152 (5.9%); mixed etiologies, 5 of 152 (3.2%); and cryptogenic, 36 of 152 (23.6%). On histologic examination, hepatic necrosis (P < .001), dense lobular inflammation (P = .03), cholestasis (P < .001), ductular reaction (P = .001), hepatocyte degeneration (P < .001), and absence of advanced fibrosis stages (P < .001) were identified significantly more othen in ACLF patients than in disease controls on univariate analysis. On multivariate Cox regression analysis, the absence of advanced Ishak histologic activity index fibrosis stages (P = .02) and the presence of dense lobular inflammation (P = .04) were associated with increased 28-day mortality in ACLF patients. After adjusting the clinical causes of acute decompensation, only dense lobular inflammation was found as an independent predictor of short-term mortality (P = .04) in ACLF patients. CONCLUSIONS.­: Dense lobular necroinflammatory activity is a clinically independent histologic predictor of 28-day short-term mortality in patients with ACLF.

225 Ac-PSMA-617-targeted alpha therapy for the treatment of metastatic castration-resistant prostate cancer: A systematic review and meta-analysis.

BACKGROUND: The aim of this systematic review and meta-analysis was to present an overview of the role of 225 Ac-PSMA (prostate-specific membrane antigen)-targeted alpha therapy (TAT) as a salvage treatment option in metastatic castration-resistant prostate cancer. METHODS: A systematic literature review was performed in databases such as Medline, Embase, PubMed, Cochrane Central Register of Controlled Clinical Trials, and the website; www.ClinicalTrials.gov until December 2020. The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. All original articles, including retrospective, prospective, hand-searched articles, and clinical trials, were searched, and appropriate data were included for the analysis. The study's primary endpoint assessed therapeutic efficacy by biochemical response assessment criteria (any prostate-specific antigen [PSA] decline and >50% PSA decline from the baseline) after 225 Ac-PSMA-TAT. The secondary endpoints included assessing overall survival (OS), progression-free survival (PFS), molecular response, and therapy-related adverse events across all the studies. The values were expressed as pooled proportions and demonstrated graphically by forest plots using the random-effects model. RESULTS: After the data extraction and filtration process, a total of three publications, including 141 patients, were included for the final analysis. The pooled proportion of patients demonstrating any PSA decline and greater than 50% PSA decline were 83% (95% confidence interval [CI]: 77%-89%) and 59% (95% CI: 42%-76%), respectively. The pooled proportions for OS was 81% (95% CI: 74%-89%). The pooled proportion of patients who have shown complete molecular response are 17% (95% CI: 5%-29%). The median PFS was 12 months (interquartile range: 8.2-14.4 months). Across the studies, the most common side effects from 225 Ac-PSMA-617 TAT were xerostomia/dry mouth, which pertained to Gr I-II in 63.1% (89 of 141), followed by fatigue in 44.5% (45 of 101) of patients. Grade I-II and III anemia was noted in 48.5% (49 of 101) and 6% (6 of 101), respectively. Grade III leukopenia and thrombocytopenia were negligible: 0.9% (1 of 101) and 0.9% (1 of 101), respectively. Similarly, grade III nephrotoxicity was also observed only in 5 of 101 (5%) patients. CONCLUSION: Treatment with 225 Ac-PSMA-617 TAT demonstrated biochemical response, improved survival, caused low treatment-related toxicity proving a promising salvage treatment option in mCRPC patients.

Visual Cortex Alterations in Early and Late Blind Subjects During Tactile Perception.

Involvement of visual cortex varies during tactile perception tasks in early blind (EB) and late blind (LB) human subjects. This study explored differences in sensory motor networks associated with tactile task in EB and LB subjects and between children and adolescents. A total of 40 EB subjects, 40 LB subjects, and 30 sighted controls were recruited in two subgroups: children (6-12 years) and adolescents (13-19 years). Data were acquired using a 3T MR scanner. Analyses of blood oxygen level dependent (BOLD), functional connectivity (FC), correlation, and post hoc test for multiple comparisons were carried out. Difference in BOLD activity was observed in EB and LB groups in visual cortex during tactile perception, with increased FC of visual with dorsal attention and sensory motor networks in EB. EB adolescents exhibited increased connectivity with default mode and salience networks when compared with LB. Functional results correlated with duration of training, suggestive of better performance in EB. Alteration in sensory and visual networks in EB and LB correlated with duration of tactile training. Age of onset of blindness has an effect in cross-modal reorganization of visual cortex in EB and multimodal in LB in children and adolescents.

A descriptive study of disability in patients presenting with medically unexplained physical symptoms in a medical OPD setting.

INTRODUCTION: Medically unexplained physical symptoms (MUPS) are quite common in the primary care setting. These unexplained symptoms lead to physical, psychological, and functional disability increasing patient and caregiver distress. METHODOLOGY: Cross-sectional study was conducted on a sample of 100 patients attending medicine outpatient department. The data on sociodemographic profile and detailed clinical history were collected. Disability was assessed using the World Health Organization Disability Assessment Schedule 2.0 instrument. Association between qualitative measures was measured by Chi-square test or Fisher's exact test and for qualitative measure t-test or Wilcoxon test was used. RESULTS: Most of the patients were young, from urban settings and belonging to lower socioeconomic strata. A mean of 6.54 symptoms per patient was presented with headache as the most common symptom. Average gross disability score in each domain was 1.6 with a major impact on the social and lifestyle-related domain. CONCLUSION: Patients with MUPS have significant disability especially in the domain of mobility and lifestyle-related activities. The disability is more in females, population dwelling in urban settlements, and population belonging to lower socioeconomic status.

Questionnaire to assess adherence to diet and exercise advices for weight management in lifestyle-related diseases.

BACKGROUND: Lifestyle-related diseases have assumed significant public health problem across the globe including developing nations. High rate of nonadherence to treatment poses challenges to family physicians in its treatment. OBJECTIVE: To develop a valid and reliable questionnaire for assessment of adherence to lifestyle modification advices. MATERIALS AND METHODS: The questionnaire was developed following a systematic, scientifically accepted methodology which included literature review, focused group discussions, detailed interviews, and expert evaluation. Comprehensibility, replicability, face validity, content validity, patient acceptance, and ease of usage of the questionnaire were analyzed. Five-point Likert scale was employed as response options. Cronbach's alpha was calculated to assess internal consistency of overall questionnaire. A cross-sectional survey was then performed on 100 obese patients with nonalcoholic fatty liver disease to validate the questionnaire. RESULTS: The developed questionnaire consists of 14 questions under two domains, 12 items under diet and 2 items under the physical activity domain. Each of these questions is on a 5-point Likert scale. The tool has shown satisfactory validity. It also has adequate reliability and internal consistency with Cronbach's alpha value of 0.9. CONCLUSION: It is a valid and reliable tool which can be used in clinical practice to assess adherence to lifestyle modification advices by family physicians.

Development and Validation of a Questionnaire Assessing Knowledge, Attitude, and Practices about Obesity among Obese Individuals.

AIM: The objective of this study was to develop and validate a knowledge, attitude, and practice (KAP) questionnaire about obesity among obese individuals. MATERIALS AND METHODS: The questionnaire was developed following a standardized protocol that consisted of literature review, focused group discussions, and expert opinion. A cross-sectional survey on 100 obese individuals was carried out to validate the tool. Exploratory factor analysis was performed, using principal component with varimax rotation, to establish the construct validity of the questionnaire. Internal consistency of the questionnaire was tested using Cronbach's α coefficient. RESULTS: KAP questionnaire with 42 items categorized under three domains knowledge, attitude, and practices was developed. The KAP sections have 14, 15, and 13 items, respectively. Independent Cronbach's α for KAP domains were 0.75, 0.75, and 0.63, respectively, indicating good internal consistency. CONCLUSION: The developed questionnaire will be helpful in achieving better understanding of the patients' KAP about obesity. It has satisfactory validity and good internal consistency.

Development of integrated care tool - BRIEF for screening the unmet psychosociomedical needs of older Indians.

BACKGROUND: With demographic shifts, there is an unprecedented increase in noncommunicable diseases, multimorbidity, and geriatric syndromes among older adults, especially in economically weaker sectors. However, there is no socioculturally appropriate tool to screen older adults for age-related health needs, multimorbidity, and geriatric syndromes at their doorstep. Objective: Our objective was to create a self-assessment tool, "integrated care tool" (ICT), and to assess its psychometric properties by applying it on older adults from multiple settings such as hospital, community, and old-age home (assisted living services). METHODS: new questionnaire was developed using standardized procedure including item development, pilot testing, and psychometric validation. After obtaining the institutional ethics committee clearance, data were collected from consenting respondents attending the Outpatient Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, community settings through health camps, and long-term care center, between May 2016 and February 2017. Data were computerized and analyzed by principal component analysis as extraction method and orthogonal varimax as rotation method. RESULTS: The final 30-item questionnaire was arranged into various domains as per rotated component matrix analysis. Overall internal consistency of the final questionnaire, as calculated by Cronbach's alpha, was 0.79, and the measure of sampling adequacy was 0.79. CONCLUSION: ICT-BRIEF is a simple, self-assessment/caregiver-assisted tool to screen the health needs of older adults. This tool can be validated for developing risk score and scaled up to generate a large database to create elderly centered care plans.

Surgery for Drug-Resistant Epilepsy in Children.

BACKGROUND: Neurosurgical treatment may improve seizures in children and adolescents with drug-resistant epilepsy, but additional data are needed from randomized trials. METHODS: In this single-center trial, we randomly assigned 116 patients who were 18 years of age or younger with drug-resistant epilepsy to undergo brain surgery appropriate to the underlying cause of epilepsy along with appropriate medical therapy (surgery group, 57 patients) or to receive medical therapy alone (medical-therapy group, 59 patients). The patients in the medical-therapy group were assigned to a waiting list for surgery. The primary outcome was freedom from seizures at 12 months. Secondary outcomes were the score on the Hague Seizure Severity scale, the Binet-Kamat intelligence quotient, the social quotient on the Vineland Social Maturity Scale, and scores on the Child Behavior Checklist and the Pediatric Quality of Life Inventory. RESULTS: At 12 months, freedom from seizures occurred in 44 patients (77%) in the surgery group and in 4 (7%) in the medical-therapy group (P<0.001). Between-group differences in the change from baseline to 12 months significantly favored surgery with respect to the score on the Hague Seizure Severity scale (difference, 19.4; 95% confidence interval [CI], 15.8 to 23.1; P<0.001), on the Child Behavior Checklist (difference, 13.1; 95% CI, 10.7 to 15.6; P<0.001), on the Pediatric Quality of Life Inventory (difference, 21.9; 95% CI, 16.4 to 27.6; P<0.001), and on the Vineland Social Maturity Scale (difference, 4.7; 95% CI, 0.4 to 9.1; P=0.03), but not on the Binet-Kamat intelligence quotient (difference, 2.5; 95% CI, -0.1 to 5.1; P=0.06). Serious adverse events occurred in 19 patients (33%) in the surgery group, including hemiparesis in 15 (26%). CONCLUSIONS: In this single-center trial, children and adolescents with drug-resistant epilepsy who had undergone epilepsy surgery had a significantly higher rate of freedom from seizures and better scores with respect to behavior and quality of life than did those who continued medical therapy alone at 12 months. Surgery resulted in anticipated neurologic deficits related to the region of brain resection. (Funded by the Indian Council of Medical Research and others; Clinical Trial Registry-India number, CTRI/2010/091/000525 .).

Atypical morphology of anogenital warts is not a marker of atypical histology or of infection to the high-risk human papillomavirus genotypes.

BACKGROUND: The clinical morphology of anogenital warts may vary from flat, filiform, papular, or verrucous to giant condyloma acuminatum. Clinically atypical-looking genital warts may alarm the clinician because of their suspected malignant potential, which may cause anxiety, often leading to aggressive interventions. OBJECTIVE: To study if clinically atypical-looking anogenital warts are more likely to be premalignant or malignant as compared to typical warts. METHOD: Data of 41 (37 males, 4 females) patients with anogenital warts was retrospectively analyzed. After a detailed literature review and in-house discussions, criteria for anogenital warts with typical and atypical clinical morphology were defined. Clinical photographs were independently reviewed by three dermatologists, and human papillomavirus (HPV) genotyping results, histological evaluation, and immunohistochemical analysis for p53 expression were evaluated. RESULTS: Fifteen (36.6%) anogenital warts were classified as atypical by at least two of three blinded dermatologists. The histological examination showed mitotic figures in 31/41 (75.6%) specimens, dysplasia in 14/41 (44.1%) specimens, and p53 positivity in 34/41 (82.9%) specimens. There was no significant difference in the high-risk HPV genotyping (P = 0.67), frequency of dysplastic changes on histology (P = 0.19), and immunohistochemistry with p53 (P = 0.08) between clinically typical and atypical-appearing anogenital warts. Similarly, no significant difference was found in the frequency of dysplastic changes (P = 0.67) or p53 expressions (P =0.41) based on the HPV genotypes. CONCLUSIONS: The atypical clinical morphology of anogenital warts may not be a marker of increased malignant potential. High-risk HPV genotypes do not have a statistically significant association with dysplasia or positive immunohistochemistry with p53.