Feasibility Trial of a Newly Developed Brief Psychological Trauma Intervention for Children Surviving Sexual Abuse in India.

Given the alarming increase in incidences of child sexual abuse (CSA), the present study was conceived to conduct a feasibility trial for a brief CSA-focused cognitive-behavioral intervention for children. A quasi-experimental single-group pre-post design with convenient sampling was adopted. The intervention module was administered to 20 children aged 7-13 years (M = 10.4, SD = 1.3) with a CSA history. The intervention was spread across a minimum of six required sessions and a maximum of 12 sessions held weekly for approximately 90 to 120 minutes' duration to restore the child's functioning and to assist the child in processing and managing trauma effectively along with initiating the process of growth. Child PTSD Symptom Scale (CPSS), Children's Impact of Events Scale-13 (CRIES-13), Developmental Psychopathology Checklist (DPCL), Multidimensional Scale for Child Sexual Abuse (MSCSA) and Children's Global Assessment Scale (CGAS) were used to measure the impact of the intervention on the children. Estimation of improvement was done using Wilcoxon signed rank test, effect size and subjective feedback from children. Feasibility assessment was done across five parameters: recruitment, data collection, attrition, adherence and improvement. We found that the intervention led to significant improvement in scores of all scales with a large effect size of .50 for MSCSA and CRIES-13 and medium effect size for CGAS, CRIES-13 (Intrusion & Avoidance), CPSS, and DPCL. Feasibility was estimated to be high across all five parameters of the assessment. Thus, the newly developed intervention was found to be helpful in restoring the child's functioning, and assisting the child in processing, and managing trauma effectively.

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention.

BACKGROUND: Collaborative care (CC) is a multicomponent team-based approach to providing mental health care with systematic integration into outpatient medical settings. The 12-month INDEPENDENT CC intervention improved joint disease control measures in patients with both depression and diabetes at 12 and 24 months following randomization. OBJECTIVE: This study investigated the durability of intervention effects on patient outcomes at 36 months following randomization. PARTICIPANTS: Adult patients with poorly controlled T2D and depression in India randomized to CC or usual care. DESIGN: Post hoc analyses of between-group differences in patient outcomes at 36 months post-randomization (N = 331) and maintenance of outcomes from 12 to 36 months (N = 314). MAIN MEASURES: We evaluated combined risk factor improvement since baseline, defined as ≥ 50.0% reduction in Symptom Checklist Depression Scale (SCL-20) scores along with reduction of at least 0.5 percentage point hemoglobin A1C, 5 mmHg systolic blood pressure, or 10 mg/dL low-density lipoprotein cholesterol. Improvements in single risk factors were also examined. KEY RESULTS: There were no between-group differences in improvements since baseline in multiple or single risk factors at 36 months. Patients in the CC group with improved outcomes at 12 months were more likely to maintain a ≥ 50.0% reduction since baseline in SCL-20 scores (CC [54.9%] vs. UC [40.9%]; RR: 1.27 [95% CI: 1.04, 1.56]) and 0.5 percentage point reduction since baseline in hemoglobin A1C (CC [31.9%] vs. UC [19.5%]; RR: 1.64 [95% CI: 1.11, 2.41]) at 36 months. CONCLUSIONS: While improvements since baseline in patient outcomes did not differ between the collaborative care and usual care groups at 36 months, patients who received CC were more likely to maintain improvements in depressive symptoms and glucose levels at 36 months if they had achieved these improvements at the end of active intervention. TRIAL REGISTRATION NUMBER: NCT02022111.

VE-MMODE - A randomized controlled trial of Venlafaxine versus Escitalopram for treatment of mild to moderate depression in persons with epilepsy.

OBJECTIVES: Depression in persons with epilepsy (PWE) goes undiagnosed and untreated. Despite being common, there are no direct efficacy comparisons of available antidepressants in PWE. Our aim was to compare the effectiveness of Venlafaxine (VEN) and Escitalopram (ESCIT) in comorbid depression in PWE. METHODS: In a single-center, prospective, double-blinded randomized controlled trial (RCT) 90 PWE (age ≥18 years) with mild to moderate depression, were randomized in a 1:1 ratio to receive ESCIT (5-20 mg/day) or VEN (37.5-150 mg/day) for 8 weeks. The primary outcome was to study differences in the efficacy, based on the change in scores of the Hamilton depression rating scale (HAM-D) at 8 weeks. Seizure frequency, QOLIE-31, adverse event profile, and medication adherence were secondary outcome measures. RESULTS: Using the NDDI-E scale, we screened 350 PWE, 90 were enrolled. ITT analysis included all participants and the PP analysis included 40 participants to VEN group and 42 to ESCIT group. Baseline mean (±SD) HAM-D scores for both groups were similar (13.53 ± 3.27; 13.02 ± 3.57). The mean difference (95%CI) on HAM-D scores at 8 weeks was found to be significant within both groups (ITT/PP- VEN: 7.75(6.75, 8.79)/7.92 (7.06, 8.78); p < 0.001, ESCIT: 8.21 (7.39, 9.03)/8.23(7.43, 9.04); p < 0.001). However, there was no significant difference in the efficacy of VEN versus ESCIT at 8 weeks. A significant improvement in QOLIE-31 index and seizure frequency was observed from baseline in both the groups. 90% of those on VEN and 92.9% of those using ESCITadhered to the treatment at week 8. Adverse events were more in VEN group than the ESCIT group. CONCLUSIONS: This study found that HAMD scores improved significantly in the ESCIT and VEN groups, despite the fact that there was no clinically meaningful difference observed between the two groups. Trials with a larger sample size and longer duration are required to establish whether ESCIT or VEN is superior.

Prevalence of postpartum depression & anxiety among women in rural India: Risk factors & psychosocial correlates.

BACKGROUND OBJECTIVES: Postpartum depression and anxiety (PPD/A) impact a woman's physical and psychological wellbeing. In the absence of corroboratory evidence from the community setting in India, the present study was undertaken to examine the prevalence, psychosocial correlates and risk factors for PPD/A in the rural community of India. METHODS: This cross-sectional study included 680 women during the postpartum period from a rural community in northern India. Screening for PPD/A was done using Edinburg Postnatal Depression Scale and State and Trait Anxiety Inventory. Diagnostic assessment of screened-positive women was done using Mini-International Neuropsychiatric Interview (MINI). The psychosocial evaluation was done on parameters including women's social support, bonding with the child, functionality, parental stress, interpersonal violence and marital satisfaction. RESULTS: The overall prevalence of PPD/A/both in community women was 5.6 per cent, with a specific prevalence of 2.2 per cent for PPD, 0.74 per cent for PPA and 2.8 per cent for both disorders. Comparative analysis indicated that women with PPD/A/both experienced significantly higher levels of parenting stress, poor lifestyle (prior two weeks), less support from their partner, parents-in-law and parents, less marital satisfaction, high intimate partner violence, poor bonding with infants and higher infant-focussed anxiety. On multivariable logistic regression analysis, higher education, marital satisfaction, support from partners and in-laws were associated with reducing the risk of PPD/A/both. INTERPRETATION CONCLUSIONS: Rural Indian women experience PPD/A/both which causes stress and impacts their functionality, bonding with the infant and relationship with their spouse and parents. Higher education, marital satisfaction and higher support from partners and in-laws reduce the risk of developing PPD/A/both.

Psychosis susceptibility zinc finger protein 804A (ZNF804A) gene polymorphism in schizophrenia patients treated with olanzapine in North Indian population.

PURPOSE: The Zinc finger protein 804A (ZNF804A) is a potential schizophrenia candidate gene that has emerged from genome-wide association studies. The aim of the study is to investigate whether this gene variant influences the response of positive or negative symptoms to antipsychotic drug olanzapine in North Indian schizophrenia patients. MATERIALS AND METHODS: Our study involved 184 unrelated schizophrenia cases (114 males and 70 females; mean age: 52.8 ± 11.6 years) and 300 normal controls (168 males and 132 females; mean age: 54.9 ± 6.9 years). At the start of treatment and after four weeks, we assessed the response of positive and negative symptoms by positive and negative syndrome scale (PANSS). Olanzapine drug level was estimated using HPLC Method and Genotyping was performed using PCR-Snap Shot technique. RESULTS: Significant differences were observed in the genotype distribution (χ2 = 6.10, d.f. = 2, p = 0.04) and allele frequencies (χ2 = 5.14, d.f. = 1, p = 0.02; odds ratio = 0.57, 95% confidence interval =1.09-3.48) between schizophrenia patients and controls group. The improvement of positive and negative schizophrenia symptoms after 4 weeks of treatment with olanzapine was assessed. Patients homozygous for the ZNF804A risk allele for AA show poorer improvement of positive symptoms compared to patients with a protective allele. CONCLUSIONS: Our findings indicate that ZNF804A gene polymorphism plays a significant role in the treatment of schizophrenia, suggesting that ZNF804A may be an effective marker for schizophrenia treatment.

Development of a Brief Psychological Trauma Intervention for Child Sexual Abuse in India.

Despite the alarming increase in incidences of child sexual abuse (CSA) in India, intervention research remains preliminary and generic. Although Cognitive Behavior Therapy (CBT) has been found to be consistently effective in addressing the adverse consequences of CSA, none of the cultural adaptations of CBT have been evidenced in India so far. Hence, the present study was conceived to develop a CSA-focused brief CBT intervention for children between 7 and 13 years of age. Intervention development progressed through four steps: 1) a systematic review of literature; 2) a qualitative study, including focused group discussions, conducted with 19 mental health professionals; 3) development of the intervention; 4) expert evaluation and finalization. We developed the intervention with three key elements: restoring the child's functioning, assisting the child in processing, and managing trauma effectively and initiating the process of growth. The intervention predominantly followed the CBT framework while integrating culturally specified techniques. The intervention contains 8 modules and 18 sub-modules structured around three phases of intervention. The intervention is spread across a minimum of 6 required sessions and a maximum of 12 session held twice weekly for approximately 90-120 min duration. A list of 35 activities corresponding to each phase and sub-module of the present intervention has been designed as an intervention workbook. In conclusion, the newly developed intervention is a manualised, culturally competent, psychological intervention developed within the CBT framework for children aged 7-13 years with experience of CSA. The next phases include piloting intervention for feasibility.

Association of Common Mental Disorders with Diabetes Mellitus - Evidence from Community-based Matched Case-Control Study in North India.

BACKGROUND: Diabetes mellitus (DM) and depression are major public health problems globally. Evidence of linkage of common mental disorders (CMDs) including depression and anxiety disorders with DM is sparsely reported from community-based settings. OBJECTIVE: The present study aimed to study the association between CMDs and DM among adult population (>30 years) residing in a rural area of North India. MATERIALS AND METHODS: A community-based case-control study was conducted in 28 villages of Ballabgarh block of Faridabad district of Haryana. Cases (diabetes) were recruited from the community with at least 1 year of diabetes. Age- and sex-matched two neighborhood controls were selected from the same community. Diabetic status was confirmed using glycated hemoglobin. CMDs such as depression and anxiety disorders were screened using PRIME-MD Hindi version. Conditional logistic regression was used to study the relationship between diabetes and CMDs. RESULTS: Total 211 cases (diabetic) and 273 controls (nondiabetic) were approached for the study, of which 173 cases and 175 controls were analyzed. Cases and controls were comparable with respect to age, sex, and socioeconomic status. CMDs were found more among cases as compared to controls (67.5% vs. 37.5%) (P < 0.001). On conditional logistic regression analysis, CMDs were significantly higher among diabetes cases (adjusted odds ratio - 3.2, 95% confidence interval: 1.9-5.2). CONCLUSION: Strong evidence of coexistence of CMDs and DM from this population-based study necessitates the need of incorporation of management of CMDs into diabetes control program in India.

Assessment of Psychological Well-being Among Medical Professionals Working with Patients Who Suffer from Physical Trauma: An Observational Study from India.

Background: Healthcare providers working with victims of physical trauma are exposed to significant human suffering at work. This may place them at risk of burnout, secondary traumatic stress (STS), and other psychological disturbances. This study aimed to evaluate the professional quality of life and psychological well-being among trauma professionals. Methodology: This was a cross-sectional study conducted among 153 staff members (nursing officers, resident doctors, and faculty) of a Level 1 trauma center in North India. The Professional Quality of Life (ProQoL-5) and Depression, Anxiety, and Stress (DASS-21) Scales were used. Results: More than 50% of the participants had a moderate risk of burnout and STS. In addition, 54% of participants reported having anxiety, 40% stress, and 36% depressive symptoms. Depression, anxiety, and stress were all strongly predicted by burnout and STS. Conclusion: Psychological distress symptoms were seen in a significant portion of professionals working in the trauma center. Workplace interventions for the promotion of psychological well-being among trauma professionals are recommended. How to cite this article: Gupta S, Bhatia G, Sagar R, Sagar S. Assessment of Psychological Well-being Among Medical Professionals Working with Patients Who Suffer from Physical Trauma: An Observational Study from India. Indian J Crit Care Med 2023;27(7):493-502.

Comparison of extended totally extra peritoneal (eTEP) vs intra peritoneal onlay mesh (IPOM) repair for management of primary and incisional hernia in terms of early outcomes and cost effectiveness-a randomized controlled trial.

BACKGROUND: There are no randomized controlled trials comparing the eTEP with IPOM repair and this randomized study was designed to compare the two techniques in terms of early pain, cost effectiveness, and quality of life. METHOD: This was a prospective randomized trial with intention to treat analysis. The primary outcome was immediate post-operative pain scores. Operative time, conversions, peri operative morbidity, hospital stay, return to daily activities, incremental cost effectiveness ratio and quality of life (WHO-QOL BREF) were secondary outcomes. RESULTS: Sixty patients were randomized equally. Early post-operative pain scores and seroma rates were significantly lower and with a significantly earlier return to activity in eTEP group (p value < 0.05). With negative costs and positive effects, eTEP group was 2.4 times more cost effective. CONCLUSION: eTEP repair is better in terms of lesser early post-operative pain, earlier return to activities and cost effectiveness in small and medium size defects.

A prospective randomized comparison of sexual function and semen analysis following laparoscopic totally extraperitoneal (TEP) and transabdominal pre-peritoneal (TAPP) inguinal hernia repair.

BACKGROUND: With standardization of laparoscopic technique of groin hernia repair, the focus of surgical outcome has shifted to lesser studied parameters like sexual function and fertility. METHODS: This prospective randomized study was conducted in a single surgical unit at a tertiary care hospital. A sample size of 144 was calculated with 72 in each group (Group 1 TEP and Group 2 TAPP). Primary outcomes measured included comparison of sexual function using BMFSI, qualitative semen analysis and ASA levels between patients undergoing TEP or TAPP repair. Semen analysis and ASA was measured pre-operatively and 3 months post-operatively. RESULTS: A total of 145 patients were randomized into two groups, TAPP (73) and TEP (72) patients. Both the groups were comparable in terms of demographic profile and hernia characteristics with majority of the patients in both the groups having unilateral inguinal hernia (89.0% in TAPP group and 79.2% in TEP group). Both the groups showed statistically significant improvement in overall sexual function score (BMFSI) at 3 months; however, there was no inter group difference. Both the groups were also comparable in terms of ASA and qualitative semen analysis. CONCLUSION: Both TEP and TAPP repair are comparable in terms of sexual function and effect on semen analysis. Laparoscopic repair improves the overall sexual functions in patients with groin hernia.

A three-arm randomized study to compare sexual functions and fertility indices following open mesh hernioplasty (OMH), laparoscopic totally extra peritoneal (TEP) and transabdominal preperitoneal (TAPP) repair of groin hernia.

BACKGROUND: With evolving technology, the focus of groin hernia repair has shifted to sexual function and fertility outcomes. METHODS: This three-arm randomized study was conducted in tertiary care hospital from 1st July 2017 to 30th March 2019. Consecutive patients of groin hernia were randomized into 3 groups, TAPP (Group 1), TEP (Group 2), and OMH (Group 3). Demographic profile and hernia characteristics were assessed preoperatively. Sexual functions (using BMSFI) and fertility (using surrogate fertility indices, viz., semen analysis and anti-sperm antibodies (ASA)) were assessed preoperatively at 3 months after the surgery. RESULTS: A total of 121 patients were included in the study with 41 patients in TAPP (Group 1) and 40 each in TEP (Group 2) and OMH (Group3) group. All the 3 groups were comparable in terms of demographic profile, hernia characteristics, intra-operative and early post-operative outcomes. Significant improvement was found in most of the domains of BMSFI score in the study population (p value < 0.001) with no intergroup difference. There was significant increase of anti-sperm antibody level in OMH group as compared to TAPP and TEP (p = 0.001), however, the levels were within normal limit. CONCLUSIONS: In conclusion, this study has shown that inguinal hernia repair whether open or laparoscopic (TEP or TAPP) leads on to improvement in sexual functions and fertility indices and can have a significant impact on pre-op counseling of the patient in terms of choice of repair, depending on the available expertise in a given center.

Yoga-An Alternative Form of Therapy in Patients with Blunt Chest Trauma: A Randomized Controlled Trial.

BACKGROUND: Yoga as alternative form of therapy has shown positive impact on pulmonary functions, exercise capacity, behavioral changes, and inflammation in non-trauma patients. However, the efficacy of Yoga has not been studied in chest trauma patients. METHODS: This randomized controlled trial was conducted at level-1 Trauma Centre. Isolated chest injury patients were randomized into either standard physiotherapy or Yogatherapy groups. Patients in physiotherapy group received conventional chest physiotherapy and Yogatherapy group received a set of Yogic exercises in addition to conventional chest physiotherapy. Primary outcome measure was changes in pulmonary function tests (PFT) at 4 weeks of discharge. Secondary outcomes were changes in quality of life (QoL), respiratory muscle strength and endurance, chest wall mobility, and levels of cytokines at 4 weeks. Data were analyzed using STATA v14.0. RESULTS: A total of 89 eligible patients were randomized to physiotherapy (n = 46) and Yoga therapy (n = 43) groups. Demographic characteristics were comparable in both the groups. There were statistically significant improvements in PFT in the Yogatherapy group compared with physiotherapy with an increase in Forced vital capacity (p = 0.02) and Forced expiratory volume (p = 0.01) at 4 weeks. In addition, there were significant improvement in physical component of QoL, respiratory muscle endurance (p = 0.003) and axillary cirtometry (p = 0.009) in the Yogatherapy group. However, no statistically significant difference in the trends of cytokine markers seen between the groups. CONCLUSION: Yoga was found to be effective in improving pulmonary functions and QoL in patients with chest trauma. (Trial registered at ctri.nic.in/clinicaltrials/login.php, numberREF/2016/05/011,287).

Frontal lobe metabolic alterations characterizing Parkinson's disease cognitive impairment.

BACKGROUND AND PURPOSE: Diagnosis of Parkinson's disease (PD) cognitive impairment at early stages is challenging compared to the stage of PD dementia where functional impairment is apparent and easily diagnosed. Hence, to evaluate potential early stage cognitive biomarkers, we assessed frontal lobe metabolic alterations using in vivo multi-voxel proton magnetic resonance spectroscopic imaging (1H-MRSI). METHOD: Frontal metabolism was studied in patients with PD with normal cognition (PD-CN) (n = 26), with cognitive impairment (PD-CI) (n = 27), and healthy controls (HC) (n = 30) using a single slice (two-dimensional) 1H-MRSI at 3 T. The acquired spectra were post-processed distinctly for voxels corresponding to the bilateral middle/superior frontal gray matter (GM) and frontal white matter (WM) regions (delineated employing neuromorphometrics atlas) using the LC-Model software. RESULT: Significant (post hoc p < 0.016) reduction in the concentration of N-acetyl aspartate (NAA) in the middle and superior frontal GMs and total choline (tCho) and total creatine (tCr) in the frontal WM was observed in PD-CI compared to PD-CN and HC, while that in HC and PD-CN groups were comparable. The NAA and tCr/tCho metabolite concentrations showed significant (p < 0.05) positive correlations with cognitive test scores in the frontal GM and WM, respectively. The receiver operating curve (ROC) analysis revealed significant (p < 0.05) "area under curve" for NAA/tNAA in the frontal GM and tCho in the frontal WM. CONCLUSION: The frontal metabolic profile is altered in cognitively impaired PD compared with cognitively normal PD. Neuronal function loss (NAA), altered energy metabolism (Cr), and cholinergic (Cho) neural transmission are implicated in PD cognitive pathology. Frontal neuro-metabolism may promisingly serve as PD cognitive biomarker.

Cortical thickness and gyrification index measuring cognition in Parkinson's disease.

OBJECTIVE: Cortical dynamics is driven by cortico-cortical connectivity and it characterizes cortical morphological features. These brain surface features complement volumetric changes and may offer improved understanding of disease pathophysiology. Hence, present study aims to investigate surface features; cortical thickness (CT) and gyrification index (GI) in Parkinson's disease (PD) patients of normal cognition (PD-CN), cognitively impaired patients with PD (PD-CI) in comparison with cognitively normal healthy controls (HC) to better elucidate cognition linked features in PD. METHOD: Anatomical MRI (3DT1) was carried out in 30 HC (56.53 ± 8.42 years), 30 PD-CN (58.8 ± 6.07 years), and 30 PD-CI (60.3 ± 6.43 years) subjects. Whole brain ROI based parcellation using Desikan-Killiany (DK-40) atlas followed by regional CT and GI differentiation [with 'age' and 'total intracranial volume' (TIV) correction], multiple linear regression (with 'age', 'TIV', and 'education' correction) with clinical variables, ROC analysis, and CT-GI correlation across the groups was used for data analysis. RESULTS: Widespread cortical thinning with regional GI reduction was evident in PD-CI with respect to other two groups (HC and PD-CN), and with absence of such alterations in PD-CN compared to HC. Frontal, parietal, and temporal CT/GI significantly correlated with cognition and presented classification abilities for cognitive state in PD. Mean regional CT and GI were found negatively correlated across groups with heterogeneous regions. CONCLUSION: Fronto-parietal and temporal regions suffer cognition associated cortical thinning and GI reduction. CT may serve better discriminator properties and may be more consistent than GI in studying cognition in PD. Heterogeneous surface dynamics across the groups may signify neuro-developmental alterations in PD.

Substance use and its associated factors among school students.

Background: . There is lack of comprehensive data on substance use and associated factors among school students in Delhi, India. Methods: . We used a cluster sampling method based on sections of classes in schools to conduct this study in two government-run schools in Delhi. All enrolled students from 8th, 9th and 11th grades participated (n = 405). The WHO Student Drug Use questionnaire was administered in a single session for a class section for assessing substance use. Results: . The participation rate was 90.6%. The rates of past 12 months' use of tobacco, alcohol, cannabis and inhalants were 22%, 12.1%, 12.1% and 8.6%, respectively, while rates for 'sedatives and tranquillizers' were 4.9%, opium 2.7% and other opioids 1.2%. Lifetime use of heroin was reported by two students and use in the past 12 months by one student. Multiple substance use was high. Higher age was associated with the use of alcohol and cannabis. According to logistic regression model results, use by a family member significantly increased the probability of using tobacco (adjusted odds ratio [AOR] 11.3; 95% confidence interval (CI) 3.4-37.8) and alcohol (AOR 3.75; 95% CI 5.1-1059.3). Similarly, use by peers significantly increased the probability of tobacco (AOR 7.7; 95% CI 2.0-29.8) and cannabis use (AOR 5.7; 95% CI 1.5-21.5). Having poor harm perception significantly increased the chances of inhalant use by students (AOR 5.5; 95% CI 1.5-20.1). Conclusion: . The study results bring to attention the prevalent and important problem of substance use among schoolchildren. We recommend that (i) intervention strategies for school settings are important and need to factor in the use of illicit substances (cannabis); (ii) psychosocial intervention by trained school counsellors in school settings is the mainstay for intervention for cannabis and inhalants; and (iii) heroin users should be referred to healthcare facilities for detoxification.

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 .).

Lithium acts to modulate abnormalities at behavioral, cellular, and molecular levels in sleep deprivation-induced mania-like behavior.

BACKGROUND: Ample amount of data suggests role of rapid eye movement (REM) sleep deprivation as the cause and effect of mania. Studies have also suggested disrupted circadian rhythms contributing to the pathophysiology of mood disorders, including bipolar disorder. However, studies pertaining to circadian genes and effect of lithium treatment on clock genes are scant. Thus, we wanted to determine the effects of REM sleep deprivation on expression of core clock genes and determine whether epigenetics is involved. Next, we wanted to explore ultrastructural abnormalities in the hippocampus. Moreover, we were interested to determine oxidative stress, tumor necrosis factor-α (TNF-α), and brain-derived neurotrophic factor levels in the central and peripheral systems. METHODS: Rats were sleep deprived by the flower pot method and were then analyzed for various behaviors and biochemical tests. Lithium was supplemented in diet. RESULTS: We found that REM sleep deprivation resulted in hyperactivity, reduction in anxiety-like behavior, and abnormal dyadic social interaction. Some of these behaviors were sensitive to lithium. REM sleep deprivation also altered circadian gene expression and caused significant imbalance between histone acetyl transferase/histone deacetylase (HAT/HDAC) activity. Ultrastructural analysis revealed various cellular abnormalities. Lipid peroxidation and increased TNF-α levels suggested oxidative stress and ongoing inflammation. Circadian clock genes were differentially modulated with lithium treatment and HAT/HDAC imbalance was partially prevented. Moreover, lithium treatment prevented myelin fragmentation, disrupted vasculature, necrosis, inflammation, and lipid peroxidation, and partially prevented mitochondrial damage and apoptosis. CONCLUSIONS: Taken together, these results suggest plethora of abnormalities in the brain following REM sleep deprivation, many of these changes in the brain may be target of lithium's mechanism of action.

Assessment for familial pattern and association of polymorphisms in KIAA0319 gene with specific reading disorder in children from North India visiting a tertiary care centre: A case-control study.

Genetic association studies have identified KIAA0319 gene as a possible susceptibility locus for reading disorder; however, very few studies are available from India. The study was planned to investigate the familial pattern and association of KIAA0319 polymorphisms among children with reading disorder visiting a tertiary centre in North India. This is a case-control, familial, and genetic association study on 30 children diagnosed with reading disorder (ICD-10) and 30 matched healthy controls and their families. The Aggregate Neurobehavioral Student Health and Educational Review System was administered on parents of probands and controls for reading problems in their siblings, and Adult Reading Questionnaire was administered for parents of both groups. The blood sample was taken from probands, and DNA was isolated. Four KIAA0319 coding sequence single nucleotide polymorphisms (SNPs; rs4504469, rs6935076, rs2038137, and rs2179515) were genotyped using SNaPshot single nucleotide extension. The incidence of reading problem was significantly higher in families of probands as compared with families of controls. There were no significant differences in both groups regarding the frequency of alleles of four SNPs. The reading disorder showed a significant familial pattern, but KIAA0319 gene did not appear to be a susceptibility factor. Future replications with larger samples and whole genome studies are warranted.

Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial.

Importance: Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented. Objective: To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression. Design, Setting, and Participants: Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018. Interventions: Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months. Main Outcomes and Measures: The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol. Results: Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0). Conclusions and Relevance: Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings. Trial Registration: ClinicalTrials.gov Identifier: NCT02022111.

Primary vs delayed primary closure in patients undergoing lower limb amputation following trauma: A randomised control study.

Lower limb crush injury is a major source of mortality and morbidity in trauma patients. Complications, especially surgical site infections (SSIs) are a major source of financial burden to the institute and to the patient as it delays rehabilitation. As such, every possible attempt should be made to reduce any complications. We, thus, aimed to compare the outcomes in early vs delayed closure of lower extremity stumps in cases of lower limb crush injury requiring amputation, so as to achieve best possible outcome. A randomised controlled study was conducted in the Division of Trauma Surgery & Critical Care at Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi from 1 September 2018 to 30 June 2019 and included patients undergoing lower limb amputation below hip joint. Patients were randomised in two groups, in one group amputation stump was closed primarily, while in the second group delayed primary closure of stump was performed. We compared rate of SSI, length of hospital stay, and number of surgeries in both the groups. Fifty-six patients with 63 amputation stumps were recruited in the study. Mean age of patients in the study was 34 years, of which about 95% patients were males. The most common mechanism of injury was road traffic injury in 66% of patients. Mean injury severity score was 12.28 and four patients had diabetes preoperatively. Total 63 extremities were randomised with 30 cases in group I and 33 cases in group II as per computer-generated random number. Above knee amputations was commonest (57.14%) followed by below knee amputations (33.3%). Two patients died in the current study. In group I, In-hospital infection was detected in 7 cases (23.3%) and in group II 9 cases (27.3%) had SSI during hospital admission (P > .05). Mean hospital stay in group I was 10.32 ± 7.68 days and in group II was 11 ± 8.17 days (P > .05). Road traffic injuries and train-associated injuries are a major cause of lower limb crush injuries, leading to limb loss. Delayed primary closure of such wounds requires extra number of surgical interventions than primary closure. There is no difference in extra number of surgical interventions required in both the groups. Thus, primary closure can be safely performed in patients undergoing lower limb amputations following trauma, provided that a good lavage and wound debridement is performed.