Search

There is a need to transition from conventional (on-site) clinical trials (CTs) to trials conducted within the comfort of a patient's home or community (decentralized CT) through e-consent, remote data monitoring, and telemedicine consults. This shift in trial procedures will positively impact recruitment rates, compliance and participant retention, protocol deviations, and delays or missed visits. Home nursing in CTs (HNCTs) will be an important component of this decentralization effort. A few limitations may impact the implementation of HNCT in India. In this regard, the workstream conducted semi-structured qualitative interviews with experts from diverse domains of CT conduct (researchers from academia and industry, clinicians, investigators, nursing staff, patient research advocates, institutional ethics committee, or institutional review board members, legal experts, and trial participants) to collect their understanding, perspectives, and the ground realities about HNCTs in India. The current review puts forth the key areas that would facilitate the establishment of HNCTs in India and provides recommendations for the same. [ABSTRACT FROM AUTHOR]

Background: There is a dearth of studies from India evaluating the awareness of patient safety. This study was performed to gain insight into the Indian patients' awareness about patient safety and evaluate their willingness in promoting the same. Methods: In this cross-sectional study, online interactive sessions pertaining to patient safety and patient safety culture were arranged by clinical pharmacologists for 800 urban patients post-discharge from a tertiary care hospital in India. A validated questionnaire was used, and the responses were analysed using descriptive statistics. Results: A total of 635 patients [mean age, 43.2 ± 10.3 years; 385 (60.6%) males] responded. A total of 93.4% of the patients were aware of the term "patient safety" and 35.3% faced situations where they felt that patient safety was compromised. Of these patients, 64.3% reported to higher authorities when faced with such situations, while the remaining either ignored the issue or had no idea about how to deal with the same. A total of 99.2% of the patients never participated in any patient safety program; nevertheless, 94.5% of them were willing to participate in the same. Accessibility to information about patient care was deemed essential by 58.3% of the patients. Conclusions: Although the overall awareness about patient safety among urban Indian patients is high, there is a lack of awareness about ways of dealing with patient safety issues. Given the high level of interest in participating in patient safety programs, such programs should routinely include patients for optimizing the chances for safer provision of health care. [ABSTRACT FROM AUTHOR]

Introduction and Objective: Ivermectin (IVM) and doxycycline (DOXY) have demonstrated in-vitro activity against SARS-CoV-2, and have a reasonable safety profile. The objective of this systematic review was to explore the evidence in the literature on the safety and efficacy of their use as monotherapy and combination therapy in COVID-19 management.Methods: After prospectively registering the study protocol with the Open Science Framework, we searched PubMed, Google Scholar, clinicaltrials.gov, various pre-print servers and reference lists for relevant records published until 16 February, 2021 using appropriate search strategies. Baseline features and data pertaining to efficacy and safety outcomes were extracted separately for IVM monotherapy, DOXY monotherapy, and IVM + DOXY combination therapy. Methodological quality was assessed based on the study design.Results: Out of 200 articles screened, 19 studies (six retrospective cohort studies, seven randomised controlled trials, five non-randomised trials, one case series) with 8754 unique patients with multiple stages of COVID-19 were included; four were pre-prints and one was an unpublished clinicaltrials.gov document. The comparator was standard care and 'hydroxychloroquine + azithromycin' in seven and three studies respectively, and two studies were placebo controlled; six studies did not have a comparator. IVM monotherapy, DOXY monotherapy and IVM + DOXY were explored in eight, five and five studies, respectively; one study compared IVM monotherapy and IVM + DOXY with placebo. While all studies described efficacy, the safety profile was described in only six studies. Efficacy outcomes were mixed with some studies concluding in favour of the intervention and some studies displaying no significant benefit; barring one study that described 9/183 patients with erosive esophagitis and non-ulcer dyspepsia with IVM + DOXY (without causality assessment details), there were no new safety signals of concern with any of the three interventions considered. The quality of studies varied widely, with five studies having a 'good' methodological quality.Conclusions: Evidence is not sufficiently strong to either promote or refute the efficacy of IVM, DOXY, or their combination in COVID-19 management.Systematic Review Protocol Registration Details: Open Science Framework: https://osf.io/n7r2j . [ABSTRACT FROM AUTHOR]

A 94% of the responders knew all the preliminary symptoms of COVID-19 while 92% of participants knew and practiced preventive measures to avoid COVID-19 infection. As a response to the global distress, the World Health Organisation (WHO), on 30 th January 2020, declared COVID-19 a Public Health Emergency Of International Concern (PHEIC) and encouraged nations affected by COVID-19 to coordinate and investigate to understand the virus, contain the threat and to decrease the risk of further spread [7]. Endemic b. Epidemic c. Pandemic d. Not known Correct (331) Incorrect (0) Not determined (24) 93% Which of the following do you think are the symptoms of COVID-19 a. Fever b. Sneezing and coughing c. Difficulty in breathing d. All of the above Correct (333) Incorrect (0) Not determined (22) 94% What will you do if the above symptoms are developed in a person a. [Extracted from the article]

Background: Children who possess a good knowledge and practice of personal hygiene measures such as hand washing have lower incidence of communicable diseases. This study was done to assess the status of personal hygiene and the morbidity pattern among the children of a government school. Material & Methods: A cross-sectional observational study was conducted among 3rd and 6th standard students of a government school situated at Liluah, Howrah district of West Bengal, India over a period of 2 weeks in August, 2017 with the help of a questionnaire. Results of the study were analysed with relevant statistical methods. Results: The importance of hand washing with soap after defecation and before meals was known to 100% and 98% students respectively, however was practised by 98% and 76% students respectively. There is significant association between knowledge and practice of hand washing with soap after meals (P value 0.04146). Brushing teeth, washing feet and taking daily bath (80.77%) are the most common practices. Most common morbidities were fever with cough (17.3%), worm infestation (13.5%) and dental caries. Conclusion: Personal hygiene practices like hand washing, trimming nails regularly, etc can reduce the incidence of many preventable diseases among children, leading them to a healthy life. [ABSTRACT FROM AUTHOR]

Background: Covid19 pandemic has resulted in drastic changes in human lives across the globe in the form of lockdown and an uncertain future. Information regarding the COVID-19-related anxiety and well-being among the public in India is very limited, especially from the state of West Bengal. We conducted this e-survey among the general population of West Bengal to assess the anxiety levels and the well-being status during lockdown. This information would be helpful to guide family physicians to screen patients for anxiety from the primary care level. Aims: The main aim of this questionnaire based study was to assess the levels of anxiety and well-being status among the public including the frontline workers in West Bengal, India. Materials and Methods: A prospective study was conducted with a validated e-questionnaire after Institutional Ethics committee approval, from 18th April, 2020 to 3rd May, 2020. The questionnaire had 12 questions which included the Generalized Anxiety disorder (GAD)-7 scale and the WHO-5 scale (5 question-items) to assess the well-being of the participants. The survey link was distributed through the social networking sites of WhatsApp, LinkedIn, Facebook and Twitter and e-mails within West Bengal. Microsoft Excel (version 2016) was used to analyse the data. Results: A total of 355 responses were received 15.49% responders were observed to have anxiety and 37.74% participants had low well-being scores. Majority of healthcare workers (89.47%) were seen to have anxiety and a significant (52.03%) had a low well-being status. Conclusions: We report the presence of anxiety and low well-being among the general population of West Bengal. It is important to understand the current psychological status of the public for the family physicians as many would visit them with vague symptoms. There is a dire need to screen all patients including front line workers visiting primary care physicians for mental health to ensure better clinical outcome. [ABSTRACT FROM AUTHOR]

Background and Objective: The world is currently experiencing the Coronavirus Disease-19 (COVID-19) pandemic. There is no approved drug for the definitive treatment of the disease. Various drugs are being tried for the treatment of COVID-19, including hydroxychloroquine (HCQ). This study was performed to systematically review the therapeutic role of HCQ in COVID-19 from the available literature. Methods: PubMed, Embase, ClinicalTrials.gov, ICTRP (WHO), Cochrane Library databases, and two pre-print servers (medRxiv.org and Research Square) were searched for clinical studies that evaluated the therapeutic role of HCQ on COVID-19 until 10 May 2020. The available studies were critically analyzed and the data were extracted. Results: A total of 663 articles were screened and 12 clinical studies (seven peer-reviewed and published studies and five non-peer-reviewed studies from pre-print servers) with a total sample size of 3543 patients were included. Some of the clinical studies demonstrated good virological and clinical outcomes with HCQ alone or in combination with azithromycin in COVID-19 patients, although the studies had major methodological limitations. Some of the other studies showed negative results with HCQ therapy along with the risk of adverse reactions. Conclusion: The results of efficacy and safety of HCQ in COVID-19, as obtained from the clinical studies, are not satisfactory, although many of these studies had major methodological limitations. Stronger evidence from well-designed robust randomized clinical trials is required before conclusively determining the role of HCQ in the treatment of COVID-19. Clinical prudence is required in advocating HCQ as a therapeutic armamentarium in COVID-19. [ABSTRACT FROM AUTHOR]

Background: We compared the mortality rate of patients with moderate to severe COVID-19 who were vaccinated and who were not. Material And Methods: In this retrospective observational study, we collected data of patients who were admitted with moderate to severe COVID-19.The vaccination status and co morbidities of the patients were documented. The incidence and in-hospital mortality of COVID-19 patients was assessed. Univariate analysis was performed to determine the risk factors of in-hospital mortality. Result: Of 294 patients, 5.1% (n=15) received Covaxin™ and 26.5% (n=78) received Covishield™; 68.4%(n=201) patients were un vaccinated. Of patients who were vaccinated and contracted COVID-19, 24.8%(n=73) had taken the first dose and 6.8%(n=20) had taken the second dose of either vaccine. The inhospital mortality rate was 13.6% (n=40). No significant association was found with the type of vaccine and the in-hospital mortality (p=0.23). Significant associations with in-hospital mortality were found with the interval before COVID-19 disease and vaccination (OR, 3.02; p=0.01); and the presence of diabetes mellitus (OR, 2.13; p=0.02), cardiovascular diseases (OR, 2.11; p<0.001), and malignancy (OR: 2.33; p=0.0325). Conclusion: The mortality rate of unvaccinated patients with moderate to severe COVID-19 was high. There was no significant difference in the effectiveness of Covaxin™ and Covishield™ in terms of the incidence of COVID-19 and in-hospital mortality. Diabetes mellitus, cardiovascular diseases, and malignancies had a significant association with in-hospital mortality in patients with moderate to severe COVID-19. [ABSTRACT FROM AUTHOR]

The article discusses the strategies for reduction of weight of patients prior to total joint arthroplasty. An overview of various studies showing obesity as an independent factor for osteoporosis and the increased arthroplasty-related risks associated with obesity. Cited strategies for weight control include behavioral counseling, bariatric surgery, and pharmacotherapy.

Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors' collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifi es that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the functioning of the ECs to safeguard the safety of patients during clinical trials remains questionable. There is a definite need for immediate intervention in the form of mandatory training hours for EC members about pharmacovigilance activities and reporting timelines to ensure clinical trial subject safety in the long run. [ABSTRACT FROM AUTHOR]

Objectives: Adverse drug reactions (ADRs) to psychotropic agents are common and can lead to noncompliance or even discontinuation of therapy. There is paucity of such data in the Indian context. We deemed it worthwhile to assess the suspected ADR profile of psychotropic drugs in an ambulatory setting in a public teaching hospital in Kolkata. Materials and Methods: A longitudinal observational study was conducted in the outpatient department (OPD) of the concerned psychiatry unit. Twenty consecutive patients per day, irrespective of their psychiatric diagnosis, were screened for suspected ADRs, 2 days in a week, over 15 months. Adverse event history, medication history and other relevant details were captured in a format as adopted in the Indian National Pharmacovigilance Programme. Causality was assessed by criteria of World Health Organization-Uppsala Monitoring Center (WHO-UPC). Results: We screened 2000 patients (68.69% males, median age 34.4 years), of whom 429 were suspected of having at least one ADR; 84 cases had insufficient evidenceabout causality (WHO-UMC causality status "unlikely") and were excluded from further analysis. Thus, 17.25% (95% confidence interval: 15.59-18.91%) of our study population reported ADRs with at least "possible" causality. Of 352 events recorded, 327 (92.90%) were "probable" and the rest "possible". None was labeled "certain" as rechallenge was not performed. Patients received a median of 3.2 psychotropic drugs each. Thirty-three different kinds of ADRs were noted, including tremor (19.60%), weight gain (15.34%) and constipation (14.49%). Among the incriminated drugs, antipsychotics represented the majority (57.10%), with olanzapine topping the list. Conclusions: This study offers a representative profile of ADRs to be expected in psychiatry out-patients in an Indian public hospital. Establishment of a psychotropic drug ADR database can be a worthy long-term goal in the Indian context. [ABSTRACT FROM AUTHOR]

Objective: Atypical antipsychotics are increasingly drugs of first choice in schizophrenia. Amisulpride, a new atypical antipsychotic, is reported to be effective for both positive and negative symptoms of schizophrenia in Western countries but Indian experience is limited. The aim of the present study was therefore to conduct a trial of amisulpride versus olanzapine in Indian schizophrenia patients. Methods: Eighty adult patients of either sex were randomized to receive standard doses of the two drugs orally, in a single blind manner, for 12 weeks, with follow up at 4 and 8 weeks. Effectiveness was assessed by changes in scores on the Brief Psychiatric Rating Scale (BPRS), Scale for Assessment of Positive Symptoms (SAPS), Scale for Assessment of Negative Symptoms (SANS), and physician-administered Clinical Global Impression (CGI) scale. Tolerability was assessed by treatment-emergent adverse drug reactions (ADRs). Results: Evaluable were 39 patients on amisulpride and 38 on olanzapine. The groups were comparable at baseline with respect to demographics, illness duration and rating scores. Final BPRS score was lower for olanzapine (33.2 ± 9.44) than for amisulpride (37.7 ± 9.67). SAPS and SANS scores and CGI rating improved individually in both arms but remained comparable between groups throughout the study period, but olanzapine reduced SAPS score to a greater extent. ADRs were encountered in 67.5% and 47.5% of patients (p = 0.113) on amisulpride and olanzapine, respectively. Tremor and insomnia were more frequent with amisulpride, while olanzapine caused more weight gain and sedation. No serious ADRs occurred. Conclusions: Amisulpride, although comparable to olanzapine on some measures, did not match the improvement seen with the latter drug in BPRS and SAPS scores. Despite differences in ADR profiles, overall tolerability was satisfactory for both drugs. In Indian patients, amisulpride should therefore be an alternative to olanzapine to a limited extent, such as when weight gain and sedation are undesirable. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented which raises concerns on the inadequate curriculum for nurses on patient safety and pharmacovigilance in eastern India.

A response by Gairik Sengupta and colleagues to a letter to the editor regarding the adverse drug reaction monitoring in psychiatry out-patient in the previous issue of the journal, is presented.

Background: Laparoscopic cholecystectomy is the gold standard method of treatment for acute cholecystitis. Controversy exists regarding its timing. Though interval cholecystectomy after 4 to 6 weeks of resolution of acute inflammation was the standard of care there has been recent trend of early cholecystectomy within 72 hours of symptom onset. The objective of the study is to compare the results between these two approaches. Methods: We carried out a prospective study for one year duration at department of surgery Peerless Hospital with 50 patients, keeping 25 patients in each group (based on admission in even and odd days of week). The statistical analysis was done using 'SPSS' with a p-value < 0.05 to be significant. Results: Our results suggest that though early laparoscopic cholecystectomy was technically difficult than interval approach, there was advantage of significantly lower total hospital stay and early return to activity without much difference between operating time and postoperative complications. This is also economically more acceptable in our overcrowded hospital. Conclusion: Based on these results we believe that early laparoscopic cholecystectomy within 72 hours of symptom onset is the preferred and safe method for treating acute cholecystitis than interval laparoscopic cholecystectomy. [ABSTRACT FROM AUTHOR]