Publications by authors named "Mani Kalaivani"

213 Publications

SARS-CoV-2 Reinfection Rate and Estimated Effectiveness of the Inactivated Whole Virion Vaccine BBV152 Against Reinfection Among Health Care Workers in New Delhi, India.

JAMA Netw Open 2022 01 4;5(1):e2142210. Epub 2022 Jan 4.

Department of Gastroenterology & Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.

Importance: A surge of COVID-19 occurred from March to June 2021, in New Delhi, India, linked to the B.1.617.2 (Delta) variant of SARS-CoV-2. COVID-19 vaccines were rolled out for health care workers (HCWs) starting in January 2021.

Objective: To assess the incidence density of reinfection among a cohort of HCWs and estimate the effectiveness of the inactivated whole virion vaccine BBV152 against reinfection.

Design, Setting, And Participants: This was a retrospective cohort study among HCWs working at a tertiary care center in New Delhi, India.

Exposures: Vaccination with 0, 1, or 2 doses of BBV152.

Main Outcomes And Measures: The HCWs were categorized as fully vaccinated (with 2 doses and ≥15 days after the second dose), partially vaccinated (with 1 dose or 2 doses with <15 days after the second dose), or unvaccinated. The incidence density of COVID-19 reinfection per 100 person-years was computed, and events from March 3, 2020, to June 18, 2021, were included for analysis. Unadjusted and adjusted hazard ratios (HRs) were estimated using a Cox proportional hazards model. Estimated vaccine effectiveness (1 - adjusted HR) was reported.

Results: Among 15 244 HCWs who participated in the study, 4978 (32.7%) were diagnosed with COVID-19. The mean (SD) age was 36.6 (10.3) years, and 55.0% were male. The reinfection incidence density was 7.26 (95% CI: 6.09-8.66) per 100 person-years (124 HCWs [2.5%], total person follow-up period of 1696 person-years as time at risk). Fully vaccinated HCWs had lower risk of reinfection (HR, 0.14 [95% CI, 0.08-0.23]), symptomatic reinfection (HR, 0.13 [95% CI, 0.07-0.24]), and asymptomatic reinfection (HR, 0.16 [95% CI, 0.05-0.53]) compared with unvaccinated HCWs. Accordingly, among the 3 vaccine categories, reinfection was observed in 60 of 472 (12.7%) of unvaccinated (incidence density, 18.05 per 100 person-years; 95% CI, 14.02-23.25), 39 of 356 (11.0%) of partially vaccinated (incidence density 15.62 per 100 person-years; 95% CI, 11.42-21.38), and 17 of 1089 (1.6%) fully vaccinated (incidence density 2.18 per 100 person-years; 95% CI, 1.35-3.51) HCWs. The estimated effectiveness of BBV152 against reinfection was 86% (95% CI, 77%-92%); symptomatic reinfection, 87% (95% CI, 76%-93%); and asymptomatic reinfection, 84% (95% CI, 47%-95%) among fully vaccinated HCWs. Partial vaccination was not associated with reduced risk of reinfection.

Conclusions And Relevance: These findings suggest that BBV152 was associated with protection against both symptomatic and asymptomatic reinfection in HCWs after a complete vaccination schedule, when the predominant circulating variant was B.1.617.2.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.42210DOI Listing
January 2022

SARS-CoV-2 Seroprevalence in Individuals With Type 1 and Type 2 Diabetes Compared With Controls.

Endocr Pract 2021 Dec 14. Epub 2021 Dec 14.

Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India. Electronic address:

Objective: Data for the association between diabetes and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) susceptibility are conflicting. We aimed to evaluate this association using an analytical cross-sectional study design.

Methods: Study participants were recruited from endocrine clinics of our hospital and belonged to 3 groups: group 1 (type 1 diabetes mellitus [T1DM]), group 2 (type 2 diabetes mellitus [T2DM]), and group 3 (controls). All participants submitted blood samples for SARS-CoV-2 S1/S2 immunoglobulin G antibody test (LIAISON; DiaSorin) and were interviewed for a history of documented infection.

Results: We evaluated a total of 643 participants (T1DM, 149; T2DM, 160; control, 334; mean age, 37.9 ± 11.5 years). A total of 324 (50.4%) participants were seropositive for SARS-CoV-2. The seropositivity rate was significantly higher in the T1DM (55.7% vs 44.9%, P = .028) and T2DM (56.9% vs 44.9%, P = .013) groups than in the control group. The antibody levels in seropositive participants with T1DM and T2DM were not significantly different from those in seropositive controls. On multivariable analysis, low education status (odds ratio [OR], 1.41 [95% CI, 1.03-1.94]; P = .035), diabetes (OR, 1.68 [95% CI, 1.20-2.34]; P = .002), and overweight/obesity (OR, 1.52 [95% CI, 1.10-2.10]; P = .012) showed a significant association with SARS-CoV-2 seropositivity. The association between diabetes and SARS-CoV-2 seropositivity was found to further increase in participants with coexisting overweight/obesity (adjusted OR, 2.63 [95% CI, 1.54-4.47]; P < .001).

Conclusion: SARS-CoV-2 seropositivity, assessed before the onset of the national vaccination program, was significantly higher in participants with T1DM and T2DM than in controls. The antibody response did not differ between seropositive participants with and without diabetes. These findings point toward an increased SARS-CoV-2 susceptibility for patients with diabetes, in general, without any differential effect of the diabetes type.
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http://dx.doi.org/10.1016/j.eprac.2021.12.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8669945PMC
December 2021

Bone microarchitecture, bone mineral density and bone turnover in association with glycemia and insulin action in women with prior gestational diabetes.

Clin Endocrinol (Oxf) 2021 Nov 24. Epub 2021 Nov 24.

Department of Endocrinology & Metabolism, All India Institute of Medical Sciences, New Delhi, India.

Objective: The aim of this cross-sectional study was to comprehensively assess bone health in women with prior gestational diabetes mellitus, including bone microarchitecture (TBS), bone mineral density (BMD, DXA) and bone turnover (osteocalcin).

Design, Patients And Measurements: Study participants underwent a detailed anthropometric, biochemical and hormone assessment, including insulin and osteocalcin measurement. BMD was measured at lumbar spine, femur neck and total hip using DXA and TBS derived from lumbar spine DXA images using TBS iNsight software.

Results: A total of 240 women (mean age: 33.3 ± 5.0 years; median postpartum duration: 34 [interquartile range 13.0-54.5] months were evaluated. At the current visit, 115 (47.9%) and 36 (15%) women had prediabetes and diabetes, respectively. Women with dysglycemia (diabetes/prediabetes) had a higher BMD at all three sites, compared to those with normoglycemia; however, the difference was not statistically significant. Women with dysglycemia had a significantly lower TBS (1.32 ± 0.09 vs. 1.35 ± 0.09; p = .038). In the fully adjusted model, the odds ratio for association between diabetes and low TBS was 2.92 (95% confidence interval: 1.20, 7.08; p = .018). Women with dysglycemia had significantly lower serum osteocalcin levels (18.6 ± 8.5 ng/ml vs. 21.5 ± 9.7 ng/ml; p = .018). HOMA-IR (r = -.285, p < .001) was negatively correlated, while Matsuda index (r = .274, p < .001) and disposition index (r = .159, p = .016) were positively correlated with serum osteocalcin levels.

Conclusions: Bone health is affected early in the natural history of diabetes and is associated with an overall low bone turnover state.
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http://dx.doi.org/10.1111/cen.14641DOI Listing
November 2021

Ref.: Ms.No.CLOI-D-21-01786.

Clin Oral Investig 2021 Nov 23. Epub 2021 Nov 23.

Department of Biostatistics, All India Institute of Medical Sciences New Delhi, New Delhi, India.

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http://dx.doi.org/10.1007/s00784-021-04298-5DOI Listing
November 2021

Underweight, Overweight, and Anemia among Elderly Persons in a rural area of Ballabgarh, Haryana.

Indian J Community Med 2021 Jul-Sep;46(3):511-514. Epub 2021 Oct 13.

Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India.

Background: Underweight, overweight, and anemia are common public health problems among elderly individuals.

Objectives: The current study was conducted in a rural area of Ballabgarh, Haryana, to estimate the prevalence of underweight, overweight, and anemia among elderly persons and to find their association with sociodemographic variables.

Materials And Methods: A total of 420 elderly persons aged ≥60 years were selected by simple random sampling. Information on variables was collected by an interview schedule. Body mass index (BMI) was calculated from height and arm-span of elderly persons. Hemoglobin was estimated with HemoCue Hb 201 system.

Results: Of the total participants, 33.6% were underweight, 13.8% were overweight, 15.6% were obese, and 37.0% had normal BMI. None of the sociodemographic variables was found to be significantly associated with being underweight. Being female was significantly associated with being overweight/obese. The prevalence of anemia was 36.4%. None of the sociodemographic variables was associated with anemia.

Conclusions: Underweight and anemia are common among elderly persons in rural areas. These need to be addressed through community-based interventions.
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http://dx.doi.org/10.4103/ijcm.IJCM_688_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8575191PMC
October 2021

Prevalence of chronic obstructive pulmonary disease in India: A systematic review and meta-analysis.

Lung India 2021 Nov-Dec;38(6):506-513

Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India.

Background And Objective: The prevalence of chronic obstructive pulmonary disease (COPD) is increasing worldwide. There is a lack of national-level estimates on the magnitude of COPD in India. Hence, we estimated the prevalence of COPD among adults in India.

Methods: We searched PubMed, Embase, Cochrane Library, Google Scholar, and Scopus and included community-based cross-sectional studies reporting data on the prevalence of COPD among adults based on spirometry. A random-effects model was used to estimate the pooled prevalence of COPD.

Results: In the eight identified studies, (pooled sample of 8,569 individuals), the estimated prevalence was 7.4% (95% confidence interval: 5.0%-9.8%), I = 95.4% (P < 0.001). The prevalence was higher among males, in the urban area, and the northern region.

Conclusion: Adequate training and resources should be provided to diagnose COPD at primary health care level for early management. A nationwide population-based survey is indicated to provide reliable estimates of the burden to inform evidence-based community-based interventions.
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http://dx.doi.org/10.4103/lungindia.lungindia_159_21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8614617PMC
November 2021

Prevalence of chronic obstructive pulmonary disease in India: A systematic review and meta-analysis.

Lung India 2021 Nov-Dec;38(6):506-513

Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India.

Background And Objective: The prevalence of chronic obstructive pulmonary disease (COPD) is increasing worldwide. There is a lack of national-level estimates on the magnitude of COPD in India. Hence, we estimated the prevalence of COPD among adults in India.

Methods: We searched PubMed, Embase, Cochrane Library, Google Scholar, and Scopus and included community-based cross-sectional studies reporting data on the prevalence of COPD among adults based on spirometry. A random-effects model was used to estimate the pooled prevalence of COPD.

Results: In the eight identified studies, (pooled sample of 8,569 individuals), the estimated prevalence was 7.4% (95% confidence interval: 5.0%-9.8%), I = 95.4% (P < 0.001). The prevalence was higher among males, in the urban area, and the northern region.

Conclusion: Adequate training and resources should be provided to diagnose COPD at primary health care level for early management. A nationwide population-based survey is indicated to provide reliable estimates of the burden to inform evidence-based community-based interventions.
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http://dx.doi.org/10.4103/lungindia.lungindia_159_21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8614617PMC
November 2021

Depression Among Adolescents in a Rural Area of Haryana, India: A Community-Based Study Using Patient Health Questionnaire-9.

Cureus 2021 Sep 29;13(9):e18388. Epub 2021 Sep 29.

Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, IND.

Introduction: The estimates of prevalence of depression among adolescents in the Indian community are limited; most studies are institution-based. Early identification and management of depression can provide significant health dividends to the affected adolescents, and better health consequences in their adulthood.

Objectives: To determine the prevalence of depression among 10- to 19-year-old residents in a rural area of Haryana, India, and to assess factors associated with adolescent depression.

Methods: A sample of 630 adolescents (between 10 to 19 years of age) residing in the selected area of Ballabgarh (Haryana) were selected using simple random sampling technique. Home visits were made, in which participants were administered the Patient Health Questionnaire (PHQ)-9 to screen for depression. The prevalence and 95%CI were estimated. In addition, a semi-structured interview schedule was administered to identify sociodemographic variables and other factors associated with adolescent depression. Unadjusted and adjusted OR were reported with p-value, using multivariable logistic regression analysis.

Results: The age-adjusted prevalence of depression among adolescents was 20.6% (95% CI: 16.9-24.2). The prevalence in late and early adolescence was 11.7% and 8.9%, respectively. It was higher in girls (22.3%) as compared with boys (19.2%). Mild depression was the most common type identified. On multivariable logistic regression, depression was associated with birth order of four or more (Adjusted OR (AOR)=3.0 (95%CI: 1.4-6.3), p<0.01), presence of long-standing illness in the past three months (AOR=3.0 (95%CI: 1.4-6.1), p<0.01), impaired self-perceived body image (AOR=2.9 (95%CI: 1.8-4.6), p<0.01), and perceived stressful event(s) in the past six months (AOR=4.9 (95%CI: 2.8-8.6), p<0.01).

Conclusion:  One in five adolescents was screened positive for depression, necessitating focus on screening and early identification of depressive symptoms, especially at the primary care level.
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http://dx.doi.org/10.7759/cureus.18388DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8555932PMC
September 2021

Outcome of COVID-19-positive children with heart disease and grown-ups with congenital heart disease: A multicentric study from India.

Ann Pediatr Cardiol 2021 Jul-Sep;14(3):269-277. Epub 2021 Aug 26.

Children's Heart Center, Kokilaben Dhirubhai Ambani Hospital, Mumbai, Maharashtra, India.

Background: Outcome data of children with heart disease who acquired COVID-19 infection are limited.

Aims: We sought to analyze outcome data and identify risk factors associated with mortality in children with heart disease and grown-ups with congenital heart disease (GUCH) who had a laboratory-confirmed COVID-19 infection.

Settings And Design: This is a retrospective, multicentric, observational study.

Materials And Methods: The study included children with heart disease and GUCH population, who presented with either symptomatic or asymptomatic COVID-19 infection to any of the participating centers. COVID-19-negative patients admitted to these centers constituted the control group.

Results: From 24 pediatric cardiac centers across India, we included 94 patients with a median age of 12.5 (interquartile range 3-96) months and 49 (52.1%) patients were males. Majority (83 patients, 88.3%) were children. One-third of the patients ( = 31, 33.0%) had acyanotic congenital heart disease, and 41.5% ( = 39) were cyanotic, with > 80% of the patients being unoperated. Only 30 (31.9%) patients were symptomatic for COVID-19 infection, while the rest were incidentally detected positive on screening. A total of 13 patients died (case fatality rate: 13.8%). The in-hospital mortality rate among hospitalized patients was significantly higher among COVID-19-positive cases (13 of 48; 27.1%) as compared to COVID-negative admissions (9.2%) during the study period ( < 0.001). On multivariate analysis, the independent predictors of mortality among COVID-19-positive cases were severity of illness at admission (odds ratio [OR]: 535.7, 95% confidence interval [CI]: 6.9-41,605, = 0.005) and lower socioeconomic class (OR: 29.5, 95% CI: 1.1-814.7, = 0.046).

Conclusions: Children with heart disease are at a higher risk of death when they acquire COVID-19 infection. Systematic preventive measures and management strategies are needed for improving the outcomes.
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http://dx.doi.org/10.4103/apc.apc_134_21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8457291PMC
August 2021

Impact of COVID-19 pandemic on pediatric cardiac services in India.

Ann Pediatr Cardiol 2021 Jul-Sep;14(3):260-268. Epub 2021 Aug 26.

Department of Pediatrics, Division of Pediatric Cardiology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

Background: COVID-19 pandemic has disrupted pediatric cardiac services across the globe. Limited data are available on the impact of COVID.19 on pediatric cardiac care in India.

Aims: The aims are to study the impact of COVID-19 pandemic on the care of children with heart disease in India in terms of number of outpatient visits, hospitalizations, catheter-based interventions, and cardiac surgeries.

Settings And Design: This is a retrospective, multicentric, observational study.

Methods: We collected monthly data on the number and characteristics of outpatient visits, hospitalizations, catheter-based interventions, and cardiac surgeries and major hospital statistics, over a period of 5 months (April to August 2020), which coincided with the first wave of COVID-19 pandemic in India and compared it with data from the corresponding months in 2019.

Results: The outpatient visits across the 24 participating pediatric cardiac centers decreased by 74.5% in 2020 ( = 13,878) as compared to the corresponding period in 2019 ( = 54,213). The reduction in the number of hospitalizations, cardiac surgeries, and catheterization procedures was 66.8%, 73.0%, and 74.3%, respectively. The reduction in hospitalization was relatively less pronounced among neonates as compared to infants/children (47.6% vs. 70.1% reduction) and for emergency surgeries as compared to elective indications (27.8% vs. 79.2%). The overall in-hospital mortality was higher in 2020 (8.1%) as compared to 2019 (4.8%), with a higher postoperative mortality (9.1% vs. 4.3%).

Conclusions: The current COVID-19 pandemic significantly impacted the delivery of pediatric cardiac care across India with two-third reduction in hospitalizations and cardiac surgeries. In an already resource-constrained environment, the impact of such a massive reduction in the number of surgeries could be significant over the coming years. These findings may prove useful in formulating strategy to manage subsequent waves of ongoing COVID-19 pandemic.
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http://dx.doi.org/10.4103/apc.apc_133_21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8457266PMC
August 2021

Impact of SARS-CoV-2 on Progression of Glycemic and Cardiometabolic Variables and Changes in Insulin Indices: A Longitudinal Study.

Diabetes Ther 2021 Nov 5;12(11):3011-3023. Epub 2021 Oct 5.

Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, 110029, India.

Introduction: We aimed to evaluate whether SARS-CoV-2 infection is associated with beta cell dysfunction and progression of glycemic and cardiometabolic variables in an established cohort.

Methods: Study participants (n = 352, 46.9% men) underwent a detailed evaluation at two time points: (a) pre-COVID (2016-19) and (b) peri-COVID (2020-21). At the second visit, SARS-CoV-2 infection was determined on the basis of a quantitative S1/S2 IgG antibody test (DiaSorin Liaison) and/or a documented history of infection.

Results: A total of 159 (45.2%) participants were seropositive for SARS-CoV-2, of whom 122 (76.7%) had mild/asymptomatic infection. Progression in body mass index (BMI) category [34 (21.4%) vs. 22 (11.4%), p = 0.011] was seen in a significantly higher proportion of the participants in the infected group compared to the non-infected group. Progression in glycemic and insulin indices [homeostasis model assessment of insulin resistance (HOMA-IR), Matsuda index, and oral disposition index (oDI)] categories was also evident in a larger proportion of participants in the infected group; however, the difference was not statistically significant. On logistic regression analysis, the association between SARS-CoV-2 infection and BMI category progression was statistically significant [fully adjusted OR 2.14 (95% CI, 1.18-3.90; p = 0.013)].

Conclusion: In this longitudinal study, predominant mild/asymptomatic SARS-CoV-2 infection was associated with increase in BMI, but not with worsening of beta cell function and insulin resistance, nor glycemic progression.
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http://dx.doi.org/10.1007/s13300-021-01158-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8491756PMC
November 2021

Myoinositol metformin pretreatment in GnRH-antagonist cycle for women with PCOS undergoing IVF: a double-blinded randomized controlled study.

Gynecol Endocrinol 2021 Sep 30:1-8. Epub 2021 Sep 30.

Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.

Objective: To study the effects of myoinositol (Myo) in comparison to metformin (Met), in reducing the risk of OHSS and improving ART outcome in PCOS women undergoing IVF.

Design: Double-blinded randomized controlled trial (CTRI/2018/05/014196).

Setting: ART Clinic, AIIMS, New Delhi patients: 102 infertile PCOS women undergoing IVF cycles were enrolled after evaluating for eligibility and allotted as 50 in group 1 (Myo) and 52 in group 2 (Met) after randomization.

Interventions: Recruited patients received Myo 2 g twice daily (group 1) and Met 850 mg twice daily (group 2). Pre- and post-treatment clinical (menstrual pattern, BMI), hormonal profile (LH, FSH, testosterone, prolactin [PRL], and AMH), biochemical parameters (HOMA IR, fasting glucose, and insulin), ovarian with antral follicle count (AFC) and side effect profile were assessed. After 3 months of therapy, patients were recruited for IVF cycle by antagonist protocol was involving controlled ovarian stimulation, cycle monitoring, oocyte recovery, insemination of oocytes and follow up with fertilization, cleavage, transfer of good grade cleavage embryos, or blastocysts pregnancy outcomes and OHSS incidence and medications was continued until the day of OPU.

Main Outcome Measures: Primary outcome was OHSS and clinical pregnancy rate including spontaneous, IVF, and cumulative pregnancy rate including FET. Secondary outcome was ART outcomes and the change in biochemistry and hormonal profile between groups and inter group after medications at 12 weeks.

Results: Incidence of OHSS (Myo 5 (10.0) ( = 50), Met 10 (20.0) ( = 50) .07) was not statistically different between groups. Clinical pregnancy rate (Myo 18 (36.0) ( = 50), Met 9 (18.0) ( = 50) .04) cumulative pregnancy rate including FET (Myo 16 (43.2) ( = 37) Met 10) 22.7) ( = 44) .05) and spontaneous conception (prior to IVF) Myo 13 (26.0) ( = 50), Met 6 (12.0) ( = 50) .07) was significantly high in Myo group. No between group difference in ovarian stimulation outcomes including duration and dosage of gonadotropins, E2, P4 levels, number of follicles >14 mm on day of trigger. Number of oocytes retrieved and grade of maturity were similar between groups. Fertilization, cleavage and number of good grade embryos were significantly higher in Myo group. However, implantation rate and number of embryos for freezing were similar between groups. Myo had improvement in fasting insulin, HOMA, Sr.AMH, and SHBG suggesting decreased insulin resistance.

Conclusions: Myo is equally beneficial as Met in reducing the risk of OHSS and has better ART outcome in PCOS women undergoing antagonist cycles.
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http://dx.doi.org/10.1080/09513590.2021.1981282DOI Listing
September 2021

Efficacy and safety of fecal transplantation versus targeted therapies in ulcerative colitis: network meta-analysis.

Future Microbiol 2021 10 30;16:1215-1227. Epub 2021 Sep 30.

Department of Gastroenterology & Human Nutrition, All India Institute of Medical Sciences, New Delhi, 110029, India.

We conducted this network meta-analysis to compare the efficacy and safety of targeted pharmacotherapies and fecal microbial transplantation (FMT). Nineteen studies were included and there was only one head-to-head randomized controlled trial (adalimumab vs vedolizumab). All interventions, including FMT, were superior to a placebo in inducing clinical remission (except adalimumab - odds ratio 1.66; 95% CI: 0.97-2.85), clinical response and endoscopic remission. FMT was comparable with other agents in achieving all efficacy outcomes. Infliximab was ranked highest in inducing clinical remission (surface under the cumulative ranking, 0.8). There was no difference in safety outcomes between FMT and other targeted therapies. FMT is as efficacious and as safe as other targeted therapies in inducing clinical remission, clinical response and endoscopic remission. Further studies to assess the long-term benefits are needed in order to reach a definitive conclusion.
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http://dx.doi.org/10.2217/fmb-2020-0242DOI Listing
October 2021

Axillary ultrasonography combined with pre-operative wire localisation of clipped node in nodal restaging after neoadjuvant chemotherapy in node positive breast cancer patients: a pilot study.

Br J Radiol 2021 Nov 7;94(1127):20210788. Epub 2021 Sep 7.

Department of Surgical Oncology, All India Institute of Medical Sciences, New Delhi, India.

Objective: To evaluate the role of axillary ultrasonography (axUS) and ultrasound-guided pre-operative wire localisation of pre-treatment positive clipped node (CN) for prediction of nodal response to neoadjuvant chemotherapy (NACT) in node positive breast carcinoma patients.

Methods And Materials: A prospective study was conducted between June 2018 and August 2020 after Ethics Committee approval. Breast carcinoma patients (cT1-cT4b) with palpable axillary nodes (cN1-cN3) and suitable for NACT were recruited after written informed consent. Single, most suspicious node was biopsied and clipped. Nodal response to NACT was assessed on axUS. Wire localisation of CN was performed prior to axillary lymph node dissection (ALND). Diagnostic performances of axUS and CN excision were assessed.

Results: Of the 69 patients evaluated, 32 patients (mean age, 43.5 ± 11.8 years; females, 31/32 [97%]; pre-menopausal, 18/32 [56.3%]) with metastatic nodes who received NACT were included. Nodal pathological complete response rate was 34.4% (11/32) overall and 70% (7/10) in patients with ≤2 suspicious nodes on pre-NACT axUS. False-negative rates (FNRs) of axUS and CN excision were 4.8% and 28.6% respectively. Combination of post-NACT axUS and CN excision had an FNR of 4.8% overall and 0% in patients with ≤2 suspicious nodes on pre-NACT axUS.

Conclusion: Combination of AxUS and ultrasound-guided wire localisation of pre-treatment positive CN has high diagnostic accuracy for nodal restaging after NACT in node positive breast cancer patients.

Advances In Knowledge: Addition of axUS assessment to wire localisation of CN reduces its FNR for detecting residual metastasis after NACT.
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http://dx.doi.org/10.1259/bjr.20210788DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8553197PMC
November 2021

Changing pattern of admissions for acute myocardial infarction in India during the COVID-19 pandemic.

Indian Heart J 2021 Jul-Aug;73(4):413-423. Epub 2021 Jun 18.

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India.

Aim: Studies on the changes in the presentation and management of acute myocardial infarction (AMI) during the COVID-19 pandemic from low- and middle-income countries are limited. We sought to determine the changes in the number of admissions, management practices, and outcomes of AMI during the pandemic period in India.

Methods & Results: In this two-timepoint cross-sectional study involving 187 hospitals across India, patients admitted with AMI between 15th March to 15th June in 2020 were compared with those admitted during the corresponding period of 2019. We included 41,832 consecutive adults with AMI. Admissions during the pandemic period (n = 16414) decreased by 35·4% as compared to the corresponding period in 2019 (n = 25418). We observed significant heterogeneity in this decline across India. The weekly average decrease in AMI admissions in 2020 correlated negatively with the number of COVID cases (r = -0·48; r = 0·2), but strongly correlated with the stringency of lockdown index (r = 0·95; r = 0·90). On a multi-level logistic regression, admissions were lower in 2020 with older age categories, tier 1 cities, and centers with high patient volume. Adjusted utilization rate of coronary angiography, and percutaneous coronary intervention decreased by 11·3%, and 5·9% respectively.

Conclusions: The magnitude of reduction in AMI admissions across India was not uniform. The nature, time course, and the patient demographics were different compared to reports from other countries, suggesting a significant impact due to the lockdown. These findings have important implications in managing AMI during the pandemic.
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http://dx.doi.org/10.1016/j.ihj.2021.06.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424286PMC
November 2021

Early evaluation of the aortic root after Nicks' procedure.

JTCVS Tech 2020 Dec 13;4:85-96. Epub 2020 Aug 13.

Cardiothoracic Sciences Centre, All India Institute of Medical Sciences, New Delhi, India.

Objectives: To determine the influence of surgical techniques adopted to avoid suture line disruption, periprosthetic leakage, patch dislodgement, pericardial patch aneurysm formation, and the long-term stability of aortic root enlargement (ARE) during aortic valve replacement (AVR).

Methods: One hundred fifteen patients undergoing AVR or combined aortic and mitral valve replacements with Nicks' posterior ARE between 1997 and 2019 underwent long-term echocardiographic and angio-computed tomographic evaluation. Age was 11-72 years (AVR: median, 30; interquartile range, 21-47 years; AVR and mitral valve replacement: median, 27.5; interquartile range, 20-37.5 years). The aortotomy was closed using autologous pericardial patch and Teflon-buttressed sutures.

Results: Hospital mortality was 1.7% (n = 2), with 4 (3.5%) late deaths. At a mean follow-up of 123.11 ± 77.67 months, the survival probability from Kaplan-Meier was 93.25 ± 0.03%. No cases of severe prosthesis-patient mismatch (PPM) were observed, and only 2 patients had moderate PPM. Median aortic root diameters at the level of sinus of Valsalva and sinotubular junction were 32 (29-35) mm and 33 (30-36) mm, respectively, at discharge, and were 33 (30-36) mm, and 33 (31-37) mm, respectively, at latest follow-up, with no cases of late pericardial patch aneurysm.

Conclusions: ARE is a safe adjunct to AVR in patients with a small aortic annulus to prevent PPM. Retention of a pericardial collar and Teflon-buttressed sutures is an expedient, safe, and effective technique in reducing bleeding at the enlarged ventriculo-aortic junction. Autologous pericardial patch aortoplasty is not associated with late aneurysm/pseudoaneurysm formation.
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http://dx.doi.org/10.1016/j.xjtc.2020.08.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305724PMC
December 2020

Efficacy of Daily Supplementation of Milk Fortified With Vitamin D2 for Three Months in Healthy School Children: A Randomized Placebo Controlled Trial.

Indian Pediatr 2021 Sep 23;58(9):820-825. Epub 2021 Jul 23.

Department of Homeopathy, BR Sur Homeopathic college, New Delhi.

Objective: To evaluate the efficacy of daily supplementation of 200 mL milk fortified with 240 IU of vitamin D2 (ergocalciferol).

Design: Double-blind randomized controlled trial.

Settings: School-based study in Delhi between October and December, 2019.

Participants: 235 healthy children aged 10-14 years.

Intervention: Daily supplementation of 200 mL milk fortified with 240 IU of ergocalciferol in intervention group (n=119) and 200 mL of plain milk in control group (n =116) for 3 months.

Outcome Measures: Change in serum 25 hydroxy vitamin D (25(OH)D), parathyroid hormone (PTH), bone formation and resorption markers, and urinary calcium creatinine ratio (U-Ca/CrR).

Results: The mean (SD) baseline serum 25(OH) D level in control and fortification groups was 11.9 (3.8) and 11.4 (3.6) ng/mL (P=0.23), respectively. The serum 25(OH)D levels did not increase post-intervention with the dose used for fortification, but were significantly higher in intervention group as compared to control group [10.8 (3.4) vs 6.7 (3.5) ng/mL; P<0.001]. A higher proportion of secondary hyperparathyroidism was observed post-intervention in control (39%) than in intervention group (13.3%); P<0.001. Serum carboxy-terminal telopeptide levels were similar in both groups but the serum procollagen type1 N-terminal propeptide levels were higher in the control than intervention group (P<0.007), following supplementation.

Conclusions: Supplementation of milk fortified with approximately 240 IU vitamin D2 for three months did not achieve sufficient serum 25(OH)D levels in Indian children with vitamin D deficiency during winter.
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September 2021

Characteristics of Gut Microbiome After Traumatic Brain Injury.

J Neurosurg Anesthesiol 2021 Jul 8. Epub 2021 Jul 8.

Department of Neuroanaesthesiology and Critical Care Department of Laboratory Medicine, Jai Prakash Narayan Apex Trauma Center Department of Biostatistics, All India Institute of Medical Sciences (AIIMS), New Delhi Department of Anaesthesia and Intensive Care, Government Medical College, Chandigarh, India.

Background: Preclinical studies have reported significant changes in the gut microbiome after traumatic brain injury (TBI). We hypothesized that TBI induces the growth of Proteobacteria in the human gut. Our primary outcome was to study the profile of the human fecal microbiome after TBI and the secondary outcome was to identify colonization with colistin-resistant and multidrug-resistant pathogens.

Methods: Consecutive patients with moderate-severe TBI admitted to the neurotrauma-intensive care unit within 48 hours of injury were enrolled into this observational study. Samples from rectal swabs obtained on days 0, 3, and 7 after admission were assessed for microbial growth and antibiotic resistance. Demographic data and variables such as hypotension, blood transfusion, surgery, start of nasogastric feeding, use of antibiotics, length of hospital stay and mortality were noted.

Results: One hundred one patients were enrolled into this study; 57 (56.4%) underwent surgery, 80 (79.2%) required blood transfusion, 15 (14.9%) had an episode of hypotension, 37 (36.6%) received enteral feed within the first 3 days, and 79 (78.2%) received antibiotics. Rectal microbiological samples were collected from 101, 95, and 85 patients on days 0, 3, and 7, respectively. All organisms isolated at the 3 time-points belonged to the Proteobacteria phylum, with Enterobacteriaceae forming the largest group. Colistin-resistant organisms were found in 17 (16.8%) of 101 patients and multidrug-resistant organisms in 25 (64.1%) of the 39 patients in whom isolates were tested against the entire panel of antimicrobials.

Conclusion: TBI is associated with widespread colonization with Proteobacteria as early as 48 hours after injury. Colonization with colistin and multidrug-resistant organisms highlights the importance of the judicious use of antibiotics.
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http://dx.doi.org/10.1097/ANA.0000000000000789DOI Listing
July 2021

Supportive Management of IgA Nephropathy With Renin-Angiotensin Blockade, the AIIMS Primary IgA Nephropathy Cohort (APPROACH) Study.

Kidney Int Rep 2021 Jun 26;6(6):1661-1668. Epub 2021 Feb 26.

Department of Pathology, All India Institute of Medical Sciences, New Delhi, India.

Introduction: Renin-angiotensin system (RAS) blockade using angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) is first-line therapy for IgA nephropathy (IgAN). There is a paucity of information on the predictors and magnitude of response to this treatment.

Methods: In a prospective study, treatment-naive patients with IgAN with urinary protein ≥ 1 g/d and estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m received supportive treatment including ACEi (ramipril) or ARB (losartan) in patients intolerant to ACEi, and optimal blood pressure (BP) control to ≤130/80 mm Hg, with a follow-up of 6 months. The primary outcome was remission of proteinuria. Complete remission (CR) was defined as proteinuria < 0.5 g/d and partial remission (PR) as proteinuria < 1g/d with at least a 50% decline from the baseline with stable renal function (≤ 25% reduction in eGFR).

Results: A total of 96 patients were analyzed, with a mean age of 33.3 ± 10.2 years, baseline eGFR 74.0 ± 30.9 ml/min per 1.73 m, and urinary protein 2.6 ± 1.2 g/d. In all, 71.9% patients received ≥ 75% of the maximum approved dose of ACEi/ARB. Remission was observed in 36.5% (CR, 6.3%) patients at 3 months and in 55.2% (CR, 31.3%) at 6 months. Patients who failed to achieve remission had lower baseline eGFR ( = 0.002) and serum albumin levels (< 0.001), asymptomatic hyperuricemia ( < 0.001), and higher proteinuria ( = 0.076). E1 (= 0.053) and T1/T2 ( = 0.009) lesions were more frequent on histology. The ACEi/ARB had to be discontinued in 17 (17.7%) patients. These patients were older (= 0.085) with lower eGFR ( < 0.002) and serum albumin levels ( = 0.001) and more E1 ( = 0.012) and T1/T2 ( = 0.001) lesions on histology.

Conclusion: Meticulous supportive therapy with optimal use of ACEi/ARB achieved remission in half of IgAN patients in this study. Increasing the treatment duration to 6 months improved remission rates. Patients with severe clinical and histological disease were less likely to tolerate and respond to treatment with RAS blockade.
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http://dx.doi.org/10.1016/j.ekir.2021.02.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207308PMC
June 2021

Association of cognitive impairment with sleep quality, depression and cardiometabolic risk factors in individuals with type 2 diabetes mellitus: A cross sectional study.

J Diabetes Complications 2021 08 28;35(8):107970. Epub 2021 May 28.

Department of Endocrinology & Metabolism, All India Institute of Medical Sciences, New Delhi, India.

Aim: The aim of this study was to evaluate the association of cognitive impairment with sleep quality, depression, and cardiometabolic risk factors among participants with type 2 diabetes mellitus.

Methods: Subjects underwent clinical interview to capture socio-demographic details, medical history, sleep quality, presence of depression, along with anthropometric and biochemical measurements. A detailed neuropsychological assessment [Montreal cognitive assessment scale (MoCA), Trail making A and B, Digit span, Spatial span, Letter Number Sequencing] was done. Cognitive impairment was defined as MoCA score of <23.

Results: Participants (n=250, 50% women, 63.6% middle-age) had a mean (±SD) age of 53.6 (±9.1) years and HbA1c of 55.1±6.8mmol/mol (7.2±0.6%). Cognitive impairment was present in 57 (22.8%) participants. In the middle-age subgroup, cognitive impairment was higher (23.9%) than those in the fourth decade (6.3%), but comparable (24.0%) to the older age (60-70years) individuals. Diabetes-related vascular complications [Odds ratio (95% CI) 2.03 (1.05, 3.94)]; hypertension [2.00 (1.04, 3.84)], depression [2.37 (1.24, 4.55)] and lower education [2.73 (1.42, 5.23)] had a significant association with cognitive impairment on multivariate logistic regression analysis.

Conclusion: The high burden of cognitive impairment calls for an urgent need to establish longitudinal cohorts in midlife to understand this population's cognitive trajectories and see the influence of various bio-psychosocial variables.
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http://dx.doi.org/10.1016/j.jdiacomp.2021.107970DOI Listing
August 2021

Effect of Percutaneous Tracheostomy on Optic Nerve Sheath Diameter [TONS Trial].

Indian J Crit Care Med 2021 Apr;25(4):382-387

Department of Neuroanaesthesiology and Critical Care, AIIMS, New Delhi, India.

Background: Elective percutaneous tracheostomy [PCT] is the widely performed procedure in neurocritically ill patients as an airway management choice in neurocritical care unit [NICU]. Intracranial pressure [ICP] is a vital parameter to be monitored in these patients while undergoing any surgical procedure including PCT. Optic nerve sheath diameter [ONSD], being a surrogate of ICP, can be done bedside and carries less complications than invasive ICP monitoring. The aim of our study was to assess the effect of PCT on ONSD at different stages of PCT.

Materials And Methods: A total of 158 patients with various intracranial pathologies scheduled for PCT in NICU were screened for eligibility in our study. We assessed mean values of ONSD, HR, MBP, and SpO for changes over various time points during PCT using generalized estimating equation (GEE). A value of <0.05 was considered significant.

Results: A total of 135 patients who underwent PCT were analyzed for the study. The values of ONSD changed significantly at different stages of PCT procedure compared to baseline. The baseline ONSD value was 0.39 ± 0.05 cm. ONSD rose significantly to 0.40 ± 0.06 cm during positioning, 0.41 ± 0.06 cm during skin incision, 0.42 ± 0.07 cm during dilatation of tract, 0.41 ± 0.07 cm during insertion of tracheostomy, and 0.41 ± 0.06 cm at the end of the procedure.

Conclusions: PCT leads to a significant rise of ONSD values during all stages of PCT. The available evidences point toward detrimental rise in ICP during PCT. ICP can be monitored noninvasively by measuring ONSD using bedside ultrasound.

How To Cite This Article: Kapoor I, Wanchoo J, Mahajan C, Singhal V, Roy H, Kumar S, . Effect of Percutaneous Tracheostomy on Optic Nerve Sheath Diameter [TONS Trial]. Indian J Crit Care Med 2021;25(4):382-387.
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http://dx.doi.org/10.5005/jp-journals-10071-23783DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8138650PMC
April 2021

Burden of falls among elderly persons in India: A systematic review and meta-analysis.

Natl Med J India 2020 Jul-Aug;33(4):195-200

Centre for Community Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.

Background: . Falls are one of the leading causes of death and disability among elderly persons. In India, there is paucity of data on the prevalence of falls, particularly among community-dwelling elderly persons. To estimate healthcare costs related to falls and formulation of fall prevention strategies, there is a need of reliable estimates of magnitude of falls. We aimed to provide a community-based pooled estimate of the burden of falls among elderly persons in India.

Methods: . A systematic literature search was done manually as well as electronically through PubMed, Google Scholar, Cochrane library, IndMed, Embase and WHO databases. Community-based original studies conducted in India were included. No restriction for the date was used. Meta-analysis was done using the random effects model.

Results: . Sixteen studies were included in the review and meta-analysis. These studies included a total of 14 844 elderly persons, of which 2707 reported falling. The pooled prevalence of falls was found to be 31% (95% CI 23%-39%). There was significant heterogeneity between the studies (I = 98.08%, p<0.01).

Conclusion: . There is a high prevalence of falls among elderly persons in India. However, the available studies have considerable methodological variations and are of limited quality. Realistic estimates are required for designing programmes for prevention of falls and for rehabilitation.
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http://dx.doi.org/10.4103/0970-258X.316253DOI Listing
October 2021

Effects of ambient air pollution on emergency room visits of children for acute respiratory symptoms in Delhi, India.

Environ Sci Pollut Res Int 2021 Sep 21;28(33):45853-45866. Epub 2021 Apr 21.

Indian Council of Medical Research, New Delhi, 110029, India.

The present study explored the association between daily ambient air pollution and daily emergency room (ER) visits due to acute respiratory symptoms in children of Delhi. The daily counts of ER visits (ERV) of children (≤15 years) having acute respiratory symptoms were obtained from two hospitals of Delhi for 21 months. Simultaneously, data on daily concentrations of particulate matter (PM and PM), nitrogen dioxide (NO), sulfur dioxide (SO), carbon monoxide (CO), and ozone (O) and weather variables were provided by the Delhi Pollution Control Committee. K-means clustering with time-series approach and multi-pollutant generalized additive models with Poisson link function was used to estimate the 0-6-day lagged change in daily ER visits with the change in multiple pollutants levels. Out of 1,32,029 children screened, 19,120 eligible children having acute respiratory symptoms for ≤2 weeks and residing in Delhi for the past 4 weeks were enrolled. There was a 29% and 21% increase in ERVs among children on high and moderate level pollution cluster days, respectively, compared to low pollution cluster days on the same day and previous 1-6 days of exposure to air pollutants. There was percentage increase (95% CI) 1.50% (0.76, 2.25) in ERVs for acute respiratory symptoms for 10 μg/m increase of NO on previous day 1, 46.78% (21.01, 78.05) for 10 μg/m of CO on previous day 3, and 13.15% (9.95, 16.45) for 10 μg/m of SO on same day of exposure. An increase in the daily ER visits of children for acute respiratory symptoms was observed after increase in daily ambient air pollution levels in Delhi.
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http://dx.doi.org/10.1007/s11356-021-13600-7DOI Listing
September 2021

Intraobserver and interobserver variations in cortical transit time measurement in children with pelviureteric junction obstruction.

World J Nucl Med 2021 Jan-Mar;20(1):38-45. Epub 2020 Sep 14.

Department of Pediatric Surgery, All India Institute of Medical Sciences, New Delhi, India.

Cortical transit time (CTT) has recently been shown to be a useful parameter in the management of children with pelviureteric junction obstruction (PUJO). The aim of this study was to assess intraobserver and interobserver variations in the qualitative and quantitative assessment of CTT in children with PUJO. A retrospective study was performed, and Tc-MAG3 renogram images of all children with PUJO performed from January 2016 to December 2017 were retrieved. The images were assessed by three observers at two different time points. CTT was qualified as delayed if CTT was more than 3 min else; it was noted as normal. The intraobserver and interobserver variations in the results of the CTT of the normal kidney and affected kidney both before and after surgery were studied. The kappa statistic was used to compare the interobserver variation of qualitative interpretation of CTT. The Bland-Altman plot was used to evaluate the intraobserver and interobserver variations of the quantitative interpretation of CTT. A total of 57 Tc-MAG3 renal scintigraphies were evaluated. Overall, 114 renal units were evaluated with 51 normal renal units and 63 renal units with PUJO. Of these, 63 renal units with PUJO, 31 renal units had been operated upon, whereas the remaining 32 renal units had no intervention at the time of the study. The kappa statistic in the normal, affected operated, and affected unoperated kidneys was interpreted as almost perfect, substantial to almost perfect, and moderate to substantial level of agreement, respectively. The Bland-Altman plot revealed a large mean difference and wide 95% limits of agreement in affected kidneys (both operated and unoperated). The study concludes that the qualitative CTT interpretation in the affected renal unit which is most commonly used in recent studies is a reliable and reproducible parameter in children with PUJO. The quantitative measurement had wide inter- and intraobserver variation for clinical use.
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http://dx.doi.org/10.4103/wjnm.WJNM_37_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8034798PMC
September 2020

The association of Candida and antifungal therapy with pro-inflammatory cytokines in oral leukoplakia.

Clin Oral Investig 2021 Nov 4;25(11):6287-6296. Epub 2021 Apr 4.

Department of Biostatistics, All India Institute of Medical Sciences New Delhi, New Delhi, India.

Objectives: To study the association of Candida and antifungal therapy with pro-inflammatory cytokines (PIC) in oral leukoplakia (OL).

Materials And Methods: A prospective observational study where immunocompetent adult subjects with OL (30 homogenous (HL), 30 non-homogenous (NHL)) and 30 age and sex-matched healthy controls (C) with no predisposing factors for oral Candida infection were recruited. Sterile cotton swabs and ophthalmic sponges were used to sample the lesion surface in OL and buccal mucosa in C, for direct microscopy and culture for Candida and to determine levels of PIC (IL-6, IL-8. IL-17, TNF-α) by ELISA, respectively. Sampling for PIC was repeated at same sites in OL, 2 weeks after antifungal therapy.

Results: Candida was associated with 55.3% of NHL, 23.3% of HL and 13.3% of C. The oral secretary levels of PIC were raised in NHL as compared to HL and C. The levels of IL-6, IL-8, TNF-α (p<0.001) and IL-17 (p<0.01) were significantly raised in Candida positive NHL while IL-6 (p<0.05) and TNF-α (p<0.01) were significantly raised in Candida positive HL before antifungal treatment. After antifungal treatment, there was significant reduction in PIC in Candida positive NHL and HL.

Conclusions: Candida infection contributes to the inflammatory milieu in Candida associated OL which increases the risk of carcinogenesis. Antifungal therapy reduces the PIC in Candida associated OL.

Clinical Relevance: Identification and elimination of predisposing factors for Candida infection, like cessation of harmful habits, maintenance of oral/denture hygiene, surveillance for Candida and antifungal therapy at intervals, are recommended in OL.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT04712929.
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http://dx.doi.org/10.1007/s00784-021-03927-3DOI Listing
November 2021

Therapeutic implications of phenotypes, virulence factors and antifungal sensitivity in Oral leukoplakia.

J Oral Biol Craniofac Res 2021 Apr-Jun;11(2):354-360. Epub 2021 Mar 19.

Oral Medicine & Radiology Centre for Dental Education Research All India Institute of Medical Sciences New Delhi India.

Objectives: To determine the association of phenotypes, virulence factors, antifungal sensitivity and clinical response to Fluconazole in Oral leukoplakia (OL).

Methods: Sterile swabs were obtained from oral lesions in immunocompetent subjects [30 Homogenous (HOL), 31 Non- Homogenous (NHOL] and normal buccal mucosa in 30 age and sex-matched healthy controls (C). phenotypes, virulence factors (Secreted Aspartyl Proteinase (SAP), Phospholipase (PL), Biofilm formation (BF) and antifungal sensitivity were determined. Clinical features (Size, Erythema, thickness, oral burning sensation (VAS scores) before and after Fluconazole therapy in OL were recorded by two calibrated observers.

Results: was associated with OL (p ​< ​0.01). was the most common phenotype sensitive to Fluconazole. SAP, PL and BF activity was significantly high in NHOL. Strong positive correlation was seen between SAP, and PL activity and pre-treatment VAS scores in NHOL. There was significant reduction in VAS scores, size of lesion [HOL (p ​< ​0.001) NHOL (p ​< ​0.05)], erythematous areas (67.8%) in NHOL and thickness of lesions (42.6%) in both types OL after Fluconazole therapy with substantial inter-observer agreement. Non (NAC) species had similar virulence profiles but resistant to Fluconazole and showed minimal clinical improvement.

Conclusions: Virulence activity of in OL increases severity of lesions. Fluconazole is effective against virulent , causes clinical improvement and down-staging from high -risk NHOL to low-risk HOL which can reduce risk of malignant transformation. Detection of highly virulent NAC infection and antifungal sensitivity is recommended in OL recalcitrant to Fluconazole therapy.
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http://dx.doi.org/10.1016/j.jobcr.2021.03.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7994788PMC
March 2021

Consensus Statement on Analgo-sedation in Neurocritical Care and Review of Literature.

Indian J Crit Care Med 2021 Feb;25(2):126-133

Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.

Aim And Objective: Our main objective in developing this consensus is to bring together a set of most agreed-upon statements from a panel of global experts that would act as a guide for clinicians working in neurocritical care units (NCCUs).

Background: Given the physiological benefits of analgo-sedation in the NCCU, there is little information on their tailoring in the NCCU. This lack of evidence and guidelines on the use of sedation and analgesia in patients with neurological injury leads to a variation in clinical care based on patient requirements and institutional protocols.

Review Results: Thirty-nine international experts agreed to be a member of this consensus panel. A Delphi method based on a Web-based questionnaire developed with Google Forms on a secure institute server was used to seek opinions of experts. Questions were related to sedation and analgesia in the neurocritical care unit. A predefined threshold of agreement was established as 70% to support any recommendation, strong, moderate, or weak. No recommendations were made below this threshold. Responses were collected from all the experts, summated, and expressed as percentage (%). After three rounds, consensus could be reached for 6 statements related to analgesia and 5 statements related to sedation. Consensus could not be reached for 10 statements related to analgesia and 5 statements related to sedation.

Conclusion: This global consensus statement may help in guiding practitioners in clinical decision-making regarding analgo-sedation in the NCCUs, thereby helping in improving patient recovery profiles.

Clinical Significance: In the lack of high-level evidence, the recommendations may be seen as the current best clinical practice.

How To Cite This Article: Prabhakar H, Tripathy S, Gupta N, Singhal V, Mahajan C, Kapoor I, . Consensus Statement on Analgo-sedation in Neurocritical Care and Review of Literature. Indian J Crit Care Med 2021;25(2):126-133.
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http://dx.doi.org/10.5005/jp-journals-10071-23712DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7922463PMC
February 2021

A retrospective comparative study of outcome with surgical excision and repair versus nonsurgical and ablative treatments for basal cell carcinoma.

Indian J Dermatol Venereol Leprol 2021 May-Jun;87(3):348-356

Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.

Background: There are few studies on basal cell carcinoma (BCC) from India. Long-term follow-up is available in only one study and the aesthetic outcome of treatment has not been evaluated in Indian patients.

Aims: In this retrospective study on BCC, we compared treatment failure, recurrence rates and aesthetic outcomes on long-term follow-up between surgical excision and repair, and nonsurgical and ablative treatments.

Methods: Records of patients with BCC treated in the dermatologic surgery clinic over the past 10 years were analyzed. Patients with histopathologically confirmed BCC who could be contacted were evaluated for recurrence, treatment failure, overall satisfaction and aesthetic outcomes by global aesthetic improvement scale.

Results: Out of 98 patients, 72 were contactable. Four patients received both nonsurgical and ablative treatments and surgical excision and repair sequentially and were excluded. The mean age of patients was 57.9 ± 15.8 years (24-90 years) and the male: female ratio was 1.6:1. The most common site involved was the face (72.1%) followed by trunk and scalp, and the most common type of BCC was the pigmented superficial type (33.8%), followed by the pigmented noduloulcerative type (16.2%). There was no significant difference between the groups in the number of high-risk cases. The mean follow-up period was 37.1 ± 31.4 (range, 4-120) months. Fifty one patients were treated with surgical excision and repair, and 17 with nonsurgical and ablative treatments (9-imiquimod, 5-cryotherapy, 4-radiotherapy). Treatment failure was seen in 5 (7.4%) patients, all in the nonsurgical and ablative treatments group (P = 0.0006). Recurrence was seen in 2 (2.9%) patients, both in the surgical excision and repair group (P > 0.05). Mean patient satisfaction was significantly higher with surgical excision and repair, though there was no significant difference in the Global Aesthetic Improvement Scale between the groups.

Limitations: The sample size was low. Only telephonic and pictorial assessments were done where the patient could not come for follow-up.

Conclusions: Surgical excision and repair was associated with better outcomes than nonsurgical and ablative treatments. Treatment failures and adverse events were high with nonsurgical and ablative treatments. The recurrence rate was low.
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http://dx.doi.org/10.25259/IJDVL_170_19DOI Listing
November 2021

Paravertebral anaesthesia with or without sedation versus general anaesthesia for women undergoing breast cancer surgery.

Cochrane Database Syst Rev 2021 Feb 25;2:CD012968. Epub 2021 Feb 25.

Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.

Background: Breast cancer is one of the most common cancers among women. Surgical removal of the cancer is the mainstay of treatment; however, tumour handling during surgery can cause microscopic dissemination of tumour cells and disease recurrence. The body's hormonal response to surgery (stress response) and general anaesthesia may suppress immunity, promoting tumour dissemination. Paravertebral anaesthesia numbs the site of surgery, provides good analgesia, and blunts the stress response, minimising the need for general anaesthesia.

Objectives: To assess the effects of paravertebral anaesthesia with or without sedation compared to general anaesthesia in women undergoing breast cancer surgery, with important outcomes of quality of recovery, postoperative pain at rest, and mortality.

Search Methods: On 6 April 2020, we searched the Specialised Register of the Cochrane Breast Cancer Group (CBCG); CENTRAL (latest issue), in the Cochrane Library; MEDLINE (via OvidSP); Embase (via OvidSP); the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal; and ClinicalTrials.gov for all prospectively registered and ongoing trials.

Selection Criteria: We included randomised controlled trials (RCTs) conducted in adult women undergoing breast cancer surgery in which paravertebral anaesthesia with or without sedation was compared to general anaesthesia. We did not include studies in which paravertebral anaesthesia was given as an adjunct to general anaesthesia and then this was compared to use of general anaesthesia.

Data Collection And Analysis: Two review authors independently extracted details of trial methods and outcome data from eligible trials. When data could be pooled, analyses were performed on an intention-to-treat basis, and the random-effects model was used if there was heterogeneity. When data could not be pooled, the synthesis without meta-analysis (SWiM) approach was applied. The GRADE approach was used to assess the certainty of evidence for each outcome.

Main Results: Nine studies (614 participants) were included in the review. All were RCTs of parallel design, wherein female patients aged > 18 years underwent breast cancer surgery under paravertebral anaesthesia or general anaesthesia. None of the studies assessed quality of recovery in the first three postoperative days using a validated questionnaire; most assessed factors affecting quality of recovery such as postoperative analgesic use, postoperative nausea and vomiting (PONV), hospital stay, ambulation, and patient satisfaction. Paravertebral anaesthesia may reduce the 24-hour postoperative analgesic requirement (odds ratio (OR) 0.07, 95% confidence interval (CI) 0.01 to 0.34; 5 studies, 305 participants; low-certainty evidence) compared to general anaesthesia. Heterogeneity (I² = 70%) was attributed to the fixed dose of opioids and non-steroidal analgesics administered postoperatively in one study (70 participants), masking a difference in analgesic requirements between groups. Paravertebral anaesthesia probably reduces the incidence of PONV (OR 0.16, 95% CI 0.08 to 0.30; 6 studies, 324 participants; moderate-certainty evidence), probably results in a shorter hospital stay (mean difference (MD) -79.39 minutes, 95% CI -107.38 to -51.40; 3 studies, 174 participants; moderate-certainty evidence), and probably reduces time to ambulation compared to general anaesthesia (SWiM analysis): percentages indicate vote counting based on direction of effect (100%, 95% CI 51.01% to 100%; P = 0.125; 4 studies, 375 participants; moderate-certainty evidence). Paravertebral anaesthesia probably results in higher patient satisfaction (MD 5.52 points, 95% CI 1.30 to 9.75; 3 studies, 129 participants; moderate-certainty evidence) on a 0 to 100 scale 24 hours postoperatively compared to general anaesthesia. Postoperative pain at rest and on movement was assessed at 2, 6, and 24 postoperative hours on a 0 to 10 visual analogue scale (VAS). Four studies (224 participants) found that paravertebral anaesthesia as compared to general anaesthesia probably reduced pain at 2 postoperative hours (MD -2.95, 95% CI -3.37 to -2.54; moderate-certainty evidence). Five studies (324 participants) found that paravertebral anaesthesia may reduce pain at rest at 6 hours postoperatively (MD -1.54, 95% CI -3.20 to 0.11; low-certainty evidence). Five studies (278 participants) found that paravertebral anaesthesia may reduce pain at rest at 24 hours postoperatively (MD -1.19, 95% CI -2.27 to -0.10; low-certainty evidence). Differences in the methods of two studies (119 participants) and addition of clonidine to the local anaesthetic in two studies (109 participants), respectively, contributed to the heterogeneity (I² = 96%) observed for these two outcomes. Two studies (130 participants) found that paravertebral anaesthesia may reduce pain on movement at 6 hours (MD-2.57, 95% CI -3.97 to -1.17) and at 24 hours (MD -2.12, 95% CI -4.80 to 0.55; low-certainty evidence). Heterogeneity (I² = 96%) was observed for both outcomes and could be due to methodological differences between studies. None of the studies reported mortality related to the anaesthetic technique. Eight studies (574 participants) evaluated adverse outcomes with paravertebral anaesthesia: epidural spread (0.7%), minor bleeding (1.4%), pleural puncture not associated with pneumothorax (0.3%), and Horner's syndrome (7.1%). These complications were self-limiting and resolved without treatment. No data are available on disease-free survival, chronic pain, and quality of life. Blinding of personnel or participants was not possible in any study, as a regional anaesthetic technique was compared to general anaesthesia. Risk of bias was judged to be serious, as seven studies had concerns of selection bias and three of detection bias.

Authors' Conclusions: Moderate-certainty evidence shows that paravertebral anaesthesia probably reduces PONV, hospital stay, postoperative pain (at 2 hours), and time to ambulation and results in greater patient satisfaction on the first postoperative day compared to general anaesthesia. Paravertebral anaesthesia may also reduce postoperative analgesic use and postoperative pain at 6 and 24 hours at rest and on movement based on low-certainty evidence. However, RCTs using validated questionnaires are needed to confirm these results. Adverse events observed with paravertebral anaesthesia are rare.
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http://dx.doi.org/10.1002/14651858.CD012968.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8521097PMC
February 2021

Depression among adolescents in a rural community of north India: A cross-sectional study.

J Family Med Prim Care 2020 Nov 30;9(11):5671-5677. Epub 2020 Nov 30.

Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India.

Background: There is a paucity of literature on depression among adolescents in the north Indian community.

Objectives: The aim of this study was to estimate the prevalence of depression among adolescents residing in a rural community of north India, and to determine associated factors, psychiatric comorbidities, and functional impairment.

Methods: A simple random sample of 630 adolescents aged 10-19 years was drawn. Participants were enrolled in house-to-house visits, and screened for depression using the nine-item version of Patient Health Questionnaire (PHQ-9). Diagnostic confirmation and assessment of psychiatric comorbidities was done using Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) for 10-17-year-old adolescents, and MINI for 18 year olds. Prevalence was reported with 95% confidence interval. Multivariable logistic regression analysis was done to determine the association of depression with socio-demographic and other factors. Children's Global Assessment Scale (CGAS) was used to assess functional impairment.

Results: The prevalence of depression was 3.7% (95% CI: 2.3-5.2) ( = 583), comparable in both sexes. Over half the participants with depression had psychiatric comorbidities; the most common were conduct disorder, oppositional defiant disorder, and attention deficit hyperactivity disorder; nearly two-fifth had suicidal ideas/attempt. About two-third of participants with depression had functional impairment. Depression was associated with perceived frequent conflicts at home [adjusted odds ratio (aOR) = 4.0 (95% CI: 1.0-16.0), = 0.049], and perceived stressful event (s) in past six months [aOR = 7.0 (95% CI: 2.4-20.3), < 0.01], which were predominantly related to academics.

Conclusion: Study results indicate the need to strengthen diagnostic and therapeutic/rehabilitative mental health services in adolescent age group. Low-stress lifestyle could be a promising approach to sidestep depressive symptoms.
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http://dx.doi.org/10.4103/jfmpc.jfmpc_1152_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7842477PMC
November 2020
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