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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: 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: 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]

Byline: Gairik. Sengupta, Subhrojyoti. Bhowmick, Avijit. Hazra, Ananya. Datta, Musfikur. Rahaman Sir, We thank the authors' for their several pertinent observations on our article. As rightfully observed, a more exhaustive [...]

Byline: Gairik. Sengupta, Subhrojyoti. Bhowmick, Avijit. Hazra, Ananya. Datta, Musfikur. Rahaman Objectives : Adverse drug reactions (ADRs) to psychotropic agents are common and can lead to noncompliance or even discontinuation [...]

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]

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]