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Background and Aims: Tenecteplase is used as the standard of care treatment for thrombolysis in acute ischemic stroke (AIS) patients within 4.5 h of symptom onset. Documented reports were less certain to claim the benefits of it in an extended window period. EAST-AIS (CTRI/2022/03/040718) trial is designed to determine the success rate of thrombolysis in an extended window period for good clinical outcomes. Study Design: It is a randomized, placebo-controlled trial of tenecteplase administered within 4.5-24 h of stroke onset (with or without large vessel occlusion) based on evidence of salvageable tissue through baseline computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) scan. Criteria of patient inclusion are as follows: patients of both genders (male and female), age >18 years, pre-stroke modified Ranking Scale (mRS) <2, baseline NIHSS >5, CTP showing penumbra--ischemic core ratio >1.8, absolute difference in volume >10 ml, and ischemic core volume <70 ml. The sample size for the study is 100 patients: 50 in the tenecteplase arm (0.25 mg/kg body weight; maximum- 25 mg) and 50 in the placebo arm (controls). Study Outcomes: The study's primary objective is safety endpoints along with the efficacy of tenecteplase assessed using the mRS score at 90 days of stroke onset. Conclusion: The result obtained from EAST-AIS will determine the safety and efficacy of tenecteplase injection administered 4.5-24 h following the symptom onset for AIS patients within the territory of Internal Carotid Artery (ICA), Middle Cerebral Artery (MCA), or Anterior Cerebral Artery (ACA) occlusion. [ABSTRACT FROM AUTHOR]

Background: Dementia is characterized by neurocognitive decline which interferes with daily function and independence. Cognitive stimulation therapy (CST) is an evidence-based cognitive psychosocial intervention for people with dementia. Materials and Methods: A prospective interventional study of single-blind RCT design conducted in the Department of Neurology at ABVIMS and Dr RML Hospital amongst patients with DSM-V major neurocognitive disorder aged more than 50 years. Participants were randomized to CST and control groups using a block-randomized design. The control group participants received treatment as usual while the CST group delivered 45-min virtual group CST sessions for a total of 14 sessions over seven weeks. All participants in both groups were assessed at baseline and eight weeks using the Montreal Cognitive Assessment Scale (MoCA), Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog), neuropsychiatric inventory, instrumental activities of daily living, and Zarit Burden Interview for Caregiver Burden (ZBI) by a rater blind to group randomization. Results: Total MoCA scores improved significantly in the CST group, compared to the control group which showed a statistically significant decrease. The mean total ADAS-Cog score in the CST group improved significantly compared to controls. The Lawton Instrumental Activities of Daily Living Scale showed a statistically significant change in the control group compared to the intervention group. From the comparison of the mean total neuropsychiatric inventory scale, it was observed that there was a statistically significant decrease in the severity of Behavioural and Psychological Symptoms of Dementia (BPSD) symptoms in the CST group. The mean total ZBI score decreased significantly in the CST group favoring less caregiver burden. Conclusion: This study proved that CST has a significant impact on cognitive outcomes in dementia and it also proved its effectiveness in controlling the BPSD outcomes and caregiver burden in dementia. [ABSTRACT FROM AUTHOR]

Background': India is ranked second in the world in terms of tobacco use and tops the list of eight high-burden countries that account for two-thirds of the new tuberculosis (TB) cases globally. As tobacco smoking among TB patients is associated with unsuccessful TB treatment outcomes, effective smoking cessation interventions for TB patients is essential to combat this double pandemic. Aim: The study determined the effectiveness of nicotine replacement therapy (NRT) on smoking reduction and cessation among pulmonary TB patients. Settings and Design: The study included 300 pulmonary TB patients undergoing antitubercular treatment in government health care centers of Dakshina Kannada district in southern India. Materials and Methods: The participants in this two-armed, single-blinded, placebo-controlled, block-randomized trial were divided equally (n = 150) for experimental arm (brief advice + NRT) and control arm (brief advice + placebo). The total duration of treatment and follow-up was 6 months. Unadjusted relative risk (URR) and adjusted relative risk (ARR) were calculated for treatment outcomes at 95% confidence interval (CI). Generalized linear regression analysis was performed upon variables with P value less than 0.2. Results: After 6 months of intervention including follow up, there was a significant reduction in self-reported smoking (ARR = 1.08, 95% CI 1.01-1.17, P = 0.03) in the experimental arm compared with the control arm. Biochemically verified smoking abstinence was not significantly different between the two arms (ARR = 1.01, 95% CI 0.72-1.38, P = 0.97). Conclusion: The study showed statistically significant effectiveness of NRT for self-reported smoking reduction. [ABSTRACT FROM AUTHOR]

Background: Substance use in workplace leads to adverse effects both on the employees and on the workplace. Existing research focuses on alcohol-related harm, while workplace use of other substances has been neglected. There are no randomized controlled studies of brief interventions in Indian hospital settings. Aim: To evaluate the efficacy of World Health Organization (WHO) alcohol, smoking, and substance involvement screening test (ASSIST)-linked brief intervention (ALBI) for reducing risky patterns of substance use in male workers at a tertiary-care hospital in North India. Material and Methods: The study was conducted in two phases. In Phase-I, a random list of 400 employees was generated from the entire pool of male hospital workers, of which 360 participated. Data on the ASSIST risk categories (mild, moderate, and high) were generated from Phase I. In Phase-II, moderate- or high-risk subjects ('ASSIST screen-positive') were randomized into intervention and control groups, with 35 screen-positive subjects in each group. The intervention group was provided a 15--30-min structured session per ALBI protocol, while the control group was given a 15--30-min general talk on health-related consequences associated with substance use. The subjects were compared on ASSIST score, WHO quality-of-life brief version (WHOQOL-BREF) and readiness to change questionnaire (RCQ) at baseline and at 3-month follow up. Results: The prevalence of moderate-to-high-risk use of tobacco, alcohol, and cannabis in the total sample was 28.6%, 27.5%, and 6.9%, respectively. At 3-months postintervention follow-up of the randomized sample, recipients of ALBI had significant reduction of ASSIST scores for all substances compared to the control group (p < 0.001). More participants receiving ALBI were ready to change to RCQ action stage (p values for tobacco, alcohol, and cannabis <0.001, <0.001 and 0.007, respectively). WHOQOL-BREF scores significantly improved in ALBI group across all domains. Conclusion: ALBI was effective in reducing risky substance use, increasing readiness to change and improving the QOL of the subjects at workplace setting. [ABSTRACT FROM AUTHOR]

Aim: To study the efficacy of intravenous vitamin C in management of moderate and severe COVID-19. Objective: To determine the efficacy of intravenous vitamin C in reducing in-hospital mortality in moderate and severe cases of COVID-19. Design: Parallel, double-blinded randomized controlled trial with placebo. Ethical clearance was obtained from the institutional ethics committee, AIIMS Patna. The trial was registered with the Clinical Trials Registry – India (registration number- CTRI/2020/11/029230.) Setting: A tertiary care centre in Bihar, India Participants: All patients above the age of 18 years both males and females, admitted in ICU with a diagnosis of moderate and severe COVID-19 (on the basis of a positive reverse transcriptase polymerase chain reaction (RT–PCR) report) at our facility during the study period (01/10/2020–31/12/2020) not having any of the exclusion criteria. Intervention: The patients in the intervention arm were given 1 gram (2 ampoules of 2 ml each containing 500 mg of vitamin C mixed in 100 ml normal saline) intravenous vitamin C 8 hourly for four days. The patients in the placebo arm received similar looking ampoules (2 ampoules of 2 ml sterile water for injection mixed in 100 ml normal saline) intravenously 8 hourly for four days. The rest of the treatment was given as per the standard operating procedure (SOP) of the institute with adjustments as per treating team's judgement. Outcome Measures: Primary outcome was reduction in in-hospital mortality. Secondary outcomes were improvement in qSOFA score, pO2/fiO2 ratio, fall in inflammatory markers, need for mechanical ventilation and vasopressors. Results: Regarding primary outcome, 10 (33.3%) patients died in intervention group compared to 13 (43.3%) in placebo. Worth noting from baseline characteristics is that 86.7% in intervention arm were of severe category compared to 66.7% severe category patients in placebo group. Though number of severe cases were more in intervention arm there has been comparatively less mortality in this group. Regarding secondary outcomes, amongst 30 patients in vitamin C group, 11 (36.7%) required invasive mechanical ventilation compared to 14 (46.7%) out of 30 in placebo group but the difference was not statistically significant. Although there were a greater number of moderate cases in placebo group, invasive ventilation requirement (and NIV requirement) was more in this group, thus it could be considered that vitamin C might have a role in reducing the severity of disease. The need for vasopressor therapy was higher in intervention arm 33.3% compared to 26.7% in placebo but not significant statistically. The secondary outcomes of the study such as improvement in organ failure score (qSOFA Score), fall in level of inflammatory markers, improvement in respiratory index (pO2/fiO2 ratio), need for mechanical ventilation and need for vasopressors also shown encouraging results but not up to the statistically significant level due to moderate dosage of the drug and small sample size. Conclusion: In the current study, by the observations and results of the double-blind placebo controlled randomised trial, we concluded that as the primary outcome of the study, there was reduction in In-hospital mortality and need for mechanical ventilation in the vitamin C intervention group compared to placebo, although these results did not reach statistical significance due to small sample size and use of moderate dose of IV vitamin C. The secondary outcomes of the study such as improvement in organ failure score (qSOFA Score), fall in level of inflammatory markers, improvement in respiratory index (pO2/fiO2 ratio), need for mechanical ventilation and need for vasopressors also shown encouraging results but not up to the statistically significant level due to moderate dosage of the drug and small sample size. In summary, high dose of intravenous vitamin C may reduce inflammatory reaction, improve oxygen support status, and reduce mortality in COVID-19 patients, without adverse events. High dose intravenous vitamin C may be a promising therapy for patients of moderate to severe COVID-19. [ABSTRACT FROM AUTHOR]

Background: The current evidence for occupational therapy practice, teaching, and research is replicated and implemented significantly from high-income countries in India. Therefore, a systematic review and an evaluation of existing evidence for occupational therapy (OT) to reduce disabilities including impairments, activity limitations, and participation restriction in persons with disabilities (PWD) in India are warranted. Objectives: The objective of this review was to evaluate the effectiveness of OT interventions for reducing disabilities in PWD in India. Study Design: Systematic review. Methods: We searched the Cochrane CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, AMED, and Web of Science. A hand search was also carried out in selected Indian journals, OT-specific databases, and repositories, such as Indian Journal of Occupational Therapy, Indian Journal of Physiotherapy and Occupational Therapy, OT Seekers, World Federation of Occupational Therapy Bulletin, Asia Pacific Occupational Therapists Regional Group, and clinical trials registers. The search was restricted to published studies conducted in India during 2000-2021. We included randomized controlled trials (RCTs) of an occupational therapy intervention delivered by OTs for PWD, where the effects of the intervention were evaluated using any relevant disability outcome measure. Studies without access to full text were excluded. Two review authors independently completed screening, and one author reviewed the full text of the screened studies. Another pair of authors extracted data from included studies for prespecified disability outcomes, and two authors assessed the risk of bias in the included studies. Results: We identified seven RCTs of occupational therapy interventions for PWD in India with 305 participants in total. All seven studies were very different in terms of their objective, participants, comparison, and outcomes. Allocation concealment and blinding and risk of bias were high in five trials. All the trials reported impairment outcomes with a statistically significant difference between the experimental arm and the control arm in terms of their primary outcomes except one. Given the sample size and the risk of bias in each of the included trials, the effect size has to be understood and interpreted with utmost caution. Conclusion: Overall, this review establishes the paucity of evidence for occupational therapy for PWD in India. Building the capacity for rigorous and relevant scientific research in occupational therapy would enable bridging the gaps in evidence for occupational therapy in India. [ABSTRACT FROM AUTHOR]

Background: Family caregivers of operated neurosurgery patients function as informal extensions of the health system. But they are untrained and unprepared for their new role. It has been felt that their problems related to care provision can be resolved by appropriate training. Aim: This study aimed to compare the impact of self-instruction manual-based training of family caregivers of operated neurosurgery patients on their knowledge regarding care provision and care practices. Setting: Tertiary care hospital setting located in North India. Design: Randomized controlled trial. Materials and Methods: A randomized controlled trial was done among the operated neurosurgery patients and their caregiver dyads (n = 90). They were randomly allocated to receive either self-instruction manual and one-to-one training (TP1) or self-instruction manual only (TP2). Block randomization method was used. Sequentially numbered sealed envelope was used for allocation concealment. Monthly follow-up was done for 3 months. The primary outcome measure was knowledge gain of the caregivers. Statistical Analysis Used: Chi-square test, Student's t-test, paired t-test, repeated measures analysis of variance, and Bonferroni's correction were used. Results: The attrition rate was 15.5%. Intention-to-treat analysis was followed. Caregivers in the TP1 group had significant knowledge gain (95% confidence interval of mean difference 9.4–14.5, P < 0.05). The number of caregivers who had followed correct caregiving practices was significantly more in the TP1 group. Conclusion: Training of caregivers by providing information along with one-to-one training is an effective strategy for improving the knowledge and skills of caregivers regarding care provision of the operated neurosurgery patients. [ABSTRACT FROM AUTHOR]

Background: The traditional teaching learning methods involve a one way process of transmission of knowledge leaving the students lacking behind in creative abilities. Medical schools need to change their teaching strategies to keep the interest of students and empower them for future self- learning and critical thinking. Objective: To assess the impact of mind mapping technique in information retrieval among medical college students in Puducherry. Methods: A pilot study was conducted using experimental study design among sixth semester MBBS students (n = 64) at a medical college in Puducherry, India. One group (n = 32) followed the text reading method and another group (n = 32) followed the mind mapping technique to learn the same passage given to them. The knowledge about the topic was assessed using a pre designed questionnaire at baseline, day 0 and day 7. The knowledge gain is the primary outcome variable and is compared between two groups. The feedback regarding the teaching methods was obtained from the participants. Results: Mean knowledge score in the text group was lesser than the mind map group at baseline (2.6 Vs 3.5; p = 0.08). On Day 0, the mean score in text group was slightly lesser than the mind map group (8.7 Vs 9.0; p = 0.26). On Day 7, the mean score in mind map group is significantly more than the text group (8.9 Vs 8.5; p = 0.03). Conclusion: The mind mapping technique is an innovative and effective method in remembering things better than the routine way of reading texts. [ABSTRACT FROM AUTHOR]

Introduction: Advances in treatment and disease prevention occur frequently in urology. Urologists must identify a framework within which to evaluate these therapeutic innovations. Materials and Methods: The evidence-based approach to critical appraisal is described using an example from the urological literature. A three-part assessment of the trial validity, treatment effect, and applicability of results will permit the urologist to critically incorporate medical and surgical advances into practice. Results: Validity of clinical trials hinges upon balancing patient prognosis at the initiation, execution, and conclusion of the trial. Readers should be aware of not only the magnitude of the estimated treatment effect, but also its precision. Finally, urologists should consider all patient-important outcomes as well as the balance of potential benefits, harms, and costs, and patient values and preferences when making treatment decisions. Conclusion: Use of this framework for critical appraisal will lead to a more evidence-based application of new therapies for patients. Incorporation of a more evidence-based practice within urology will lead to an increase in the quality of patient care. [ABSTRACT FROM AUTHOR]

Introduction: This paper describes a fictitious study of a fictitious drug. A companion paper in this issue of the Indian J Psychiatry critically examines this paper and provides author, reader, reviewer, and researcher perspectives on problems related to the design and conduct of a clinical trial; on issues related to the analysis of data; on how to write a research paper; and on how to critically read or review a journal article. Readers are invited to appraise this paper and then compare their assessment with that presented in the companion paper. Background: This study sought to compare the safety and efficacy of placeboxetine (PB) hydrochloride extended release capsules with sertraline hydrochloride in patients diagnosed with major depressive disorder in 15 general hospitals in south India. Materials and Methods: In a prospective, open-label, 15-center, randomized controlled clinical trial, consecutive outpatients diagnosed with major depressive disorder of at least moderate severity were randomized 1:1 to receive flexible doses of either PB or sertraline once each morning. Patients were evaluated every two weeks, until the study endpoint, using the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Rating Scale (MADRS). Safety was determined through assessments of vital signs, adverse events, study discontinuation rates, hematological parameters, metabolic parameters, electrocardiography, and other measures. Results: Ten patients dropped out of the study from each treatment arm. There was a significant, marked improvement in HAM-D and MADRS scores in each group by the treatment endpoint. There was no significant difference between PB and sertraline groups on either HAM-D or MADRS at any visit. The response rate was 90% with PB and 92% with sertraline. The remission rate was 70% with PB and 75% with sertraline. All laboratory parameters were within normal limits in all patients. There were no serious adverse events. Conclusions: Placeboxetine is as safe and effective as sertraline in Indian patients with major depressive disorder. [ABSTRACT FROM AUTHOR]

Objective: To assess the role of non-invasive positive pressure ventilation (NIPPV) for management of Indian patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Materials and Methods: Forty patients (mean age 57.6 ± 10.8 years; M:F 31:9) with AECOPD with pH <7.35, admitted to the intensive care unit were included. Patients were randomized to receive NIPPV (N, n = 20) with conventional therapy or conventional therapy (C, n = 20) alone at admission. NIPPV was given through the nasal mask. Incidence of need of endotracheal intubation (ETI) was the primary efficacy variable. Hospital mortality, duration of hospital stay and change in clinical and blood gas parameters were the secondary outcome variables. Results: Mean pH at baseline for N and C groups were similar (7.23 ± 0.07) whereas PaCO2 was 85.4 ± 14.8 and 81.1 ± 11.6 mm of Hg, respectively. At one hour, patients in N group had greater improvement in pH (P = 0.017) as well as PaCO2 (P = 0.04) which corroborated with clinical improvement. Whereas need of ETI was reduced in patients who received NIPPV (3/20 vs 12/20, P = 0.003), in-hospital mortality was similar (3/20 and 2/20, P = NS). The mean duration of hospital stay was significantly shorter in N group (9.4 ± 4.3 days) as compared to C group (17.8 ± 2.6 days); P = 0.001. Conclusions: In patients with AECOPD, NIPPV leads to rapid improvement in blood gas parameters and reduces the need for ETI. [ABSTRACT FROM AUTHOR]