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   2022| April-June  | Volume 13 | Issue 2  
    Online since April 6, 2022

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Awareness, attitude, and practice of materiovigilance among medical professionals at a tertiary care institute of national importance: A cross-sectional study
Bikash Ranjan Meher, Biswa Mohan Padhy, Anand Srinivasan, Rashmi Ranjan Mohanty
April-June 2022, 13(2):94-98
Background: Medical faculty and residents have a key role in the reporting of adverse events associated with medical devices. However, at present, there are no published data regarding their knowledge, attitude, and practice about materiovigilance in India. Materials and Methods: This was a cross-sectional questionnaire-based survey done among medical faculty and residents of a tertiary care institution of national importance. The questionnaire consists of 15 questions pertaining to knowledge, attitude, and practice of materiovigilance. Results: The questionnaire was administered to 138 medical faculty and residents, out of which 105 responded constituting a 76% response rate. The mean knowledge score of medical faculty and residents was 2.09 ± 1.06 and 2.07 ± 1.02, respectively, and the difference between the two groups was not statistically significant (P = 0.9). The majority of the participants (92.63%) believed that medical device can cause adverse events; however, very few of them (20.13%) have reported it during their practice. Conclusion: Requisite knowledge and appropriate attitude are essential for developing healthy practice toward reporting of adverse events associated with medical devices. Our study revealed that the knowledge gap exists among medical professionals about the reporting of adverse events and the materiovigilance program. A continuous effort is required to make them aware of the materiovigilance by conducting various training programs such as continuous medical education and workshops by the coordinators of the medical device adverse events monitoring center.
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A.S.P.I.R.E: A student led initiative to foster a facilitative environment for undergraduate medical research
Alhad Mulkalwar, Ojas Krishnani, Shirish Rao, Raakhi Tripathi
April-June 2022, 13(2):65-69
The uptake of undergraduate research opportunities in India is reported to be disappointing and little is known about the hurdles faced by students in undertaking research activities. As a solution to this issue, a student-led research council named, “A.S.P.I.R.E: Association for Support and Propagation of Innovation, Research and Education,” was formed. Its activities were focused on building a peer-based research environment to learn via module-wise teaching and mentoring sessions, a practical approach to learn evidence-based medicine via journal clubs and maximize the available opportunities via research opportunities database. Research opportunities database is a live dashboard of research projects currently in progress and vacancies therein for undergraduate students, so that they could be a part of the projects in their subjects of interest. Online discussion forums and social media platform were also created to facilitate active discussion and remote learning. 10 peer based teaching sessions and 8 journal clubs have been organized as an outcome of which 46 undergraduate students have undertaken new research activities in a single year. Based on the feedback from both students and faculty members, it can be said that A.S.P.I.R.E, through its systematic and peer-based approach has developed a culture of research and evidence-based medicine among the undergraduate students.
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Completeness of reporting and outcome switching in trials published in Indian journals from 2017 to 2019: A cross-sectional study
Kiran Warrier, CR Jayanthi
April-June 2022, 13(2):77-81
Context: Randomized controlled trials (RCTs) are among the cornerstones for generation of high-quality clinical evidence. However, incomplete or biased reporting of trials can hamper the process of review of trials and their results. Outcome switching, intentional, or otherwise leads to biased reporting and can result in false inferences. Aims: The aim of this study was to analyze the completeness of reporting Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and detect if outcome switching had occurred. Settings and Design: This cross-sectional study was conducted in the department of pharmacology. Methods: Online editions of journals published by the Indian association of medical specialties from 2017 to 2019 were accessed, and the full-text versions of the published RCTs in them were downloaded. Reporting of each item in the CONSORT checklist was recorded. The effect of trial registration and CONSORT endorsement on reporting of key methodological parameters was also determined. Protocols of registered trials were accessed, and the outcome switching was assessed. Statistical Analysis Used: Descriptive statistics were used to summarize the data. Results: Average completeness of reporting has significantly improved from 2017 to 2019. Major areas of underreporting were generalizability, protocol availability, trial registration, date of recruitment, allocation concealment, and the patient flow diagram. CONSORT endorsing journals had worse, whereas registered trials had better reporting of key methodological indicators. No overt switching of outcomes was observed in 84 out of 86 registered trials where trial protocols were available online for comparison. Conclusions: Quality of clinical trial reporting in the Indian medical journals has improved but remains inadequate. CONSORT nonendorsement prevents completeness of trial reporting.
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A narrative review of the challenges, ethical frameworks, and guidelines in the setting of COVID-19 healthcare and research
Naheeda Hamza, Uma Kulkarni
April-June 2022, 13(2):70-76
The coronavirus disease (COVID)-19 pandemic has ever since its outbreak been perplexing healthcare generally at all levels. There is a need to identify, analyze and address the bioethical dilemmas that have emerged during the pandemic. This paper presents a narrative review of the published literature on the ethical issues, frameworks, and guidelines in COVID-19-related healthcare and research. An electronic search was conducted on PubMed, Google Scholar, and Science Direct using the search terms “COVID- 19”[AND] ethical issues, clinical trials, resource allocation, ethical guidelines, vaccine allocation. Articles between 2019 and 2020 focusing on ethics were included and analyzed. Fifteen full-text articles in English, one workshop summary, and 5 guidelines were identified and are discussed under the following themes: global response to the pandemic, allocation of resources, conduct of clinical trials, and fair distribution of vaccines and individual patient care. Despite the global and collaborative response to guide the healthcare sector throughout the pandemic, there have been some worrying repercussions in the form of increased vulnerabilities, precarious imbalances in resources, priority settings, exclusion of individuals or groups, exhaustions of healthcare professionals, impaired individual patient care, slowing down of non-covid research as well as scientific, ethical and logistic challenges in COVID and non-COVID research. These can be ethically justifiable only considering the seriousness and urgency of the pandemic. This paper presents some tenacious challenges that must be addressed if ethical reflection is to be effectively implemented in response to this pandemic.
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Research, residents, and registrars – getting it right
Shruti Saha, Nithya Jaideep Gogtay
April-June 2022, 13(2):63-64
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An exploration of profile, perceptions, barriers, and predictors of research engagement among resident doctors: a report from CHARTING study
Martin Igbokwe, Oladimeji Adebayo, Oluwaseyi Ogunsuji, Gbenga Popoola, Rereloluwa Babalola, Sebastine Oseghae Oiwoh, Anuoluwapo Mojisola Makinde, Adebayo Makinde Adeniyi, Kehinde Kanmodi, Wasinda Francis Umar, Ayanfe Omololu, Ibiyemi Oduyemi, Abdulmajid Ibrahim Yahya, Aliyu Sokomba
April-June 2022, 13(2):106-113
Purpose/Aims: This research aimed to study the profile, perceptions, barriers, and predictors of Nigerian resident doctors' level of engagement in scientific research. Methods: This study was a descriptive cross-sectional quantitative survey of 438 resident doctors in Nigeria. This study forms a part of the big CHARTING Study, the protocol of which was published in “Nigeria Journal of Medicine 2019;28:198-205.” Results: Three hundred and eighteen (72.8%) respondents were male and 119 (27.2%) were female. There were 229 (52.4%) registrars and 208 (47.6%) senior registrars, while residents in surgical versus nonsurgical specialties were 190 (44.5%) and 237 (55.5%), respectively. Three hundred and sixty-eight (85%) respondents had participated previously in research; 67 (15.6%) and 72 (16.6%) had their papers published in local or international journals, respectively; and only 46 (10.6%) had held first authorship positions in peer-reviewed journal publications. The significant barriers to research identified among them included lack of funding, lack of free time, inadequate training/knowledge on research methodology, and the onerous nature of clinical research. The independent predictor of previous engagement with research was years on current job (P = 0.007). This was similar to finding for the first authorship of a peer-reviewed article among the respondents (0.017). Conclusion: This study concludes that publication and grantsmanship rates were very low among the surveyed resident doctors, despite their high rate of engagement in research projects. There is a need for increased research capacity building among resident doctors in Nigeria.
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Knowledge, attitude, and practice survey on antimicrobial use and resistance among Indian clinicians: A multicentric, cross-sectional study
Suparna Chatterjee, Avijit Hazra, Raja Chakraverty, Nusrat Shafiq, Ashish Pathak, Niyati Trivedi, Balakrishnan Sadasivam, Ashish Kumar Kakkar, Ratinder Jhaj, Rajni Kaul, Nilima Kshirsagar
April-June 2022, 13(2):99-105
Purpose: This multicentric questionnaire-based study was undertaken to address the lack of systematic background data on the knowledge, attitudes, and practices among Indian physicians related to antimicrobial use and resistance. Materials and Methods: A validated structured study questionnaire was used for capturing respondent particulars, antimicrobial prescribing habits, knowledge of antimicrobial resistance (AMR), ways of choosing and learning about antibiotics, agreement or disagreement with certain perceptions regarding antibiotics, selection of antibiotics in specific settings, and suggestions regarding rationalizing antimicrobial use in the practice setting. Summary statistical analysis of the pooled data was done. Results: Five hundred and six respondents with a mean (standard deviation) age of 31.4 (8.71) years participated in the study. Three hundred and twenty-seven were medical and 179 surgical discipline clinicians. Overall, the theoretical knowledge about antimicrobials was satisfactory, but areas of concern were noted in the attitude and practice domains. A substantial proportion of participants failed to identify the correct choice of antibiotics in the case-based scenarios. 38.33% reported not attending a single continuing medical education on antimicrobials during the past year. Statistically significant differences were not observed in the KAP quotient scores between medical and surgical discipline respondents. Conclusions: Despite satisfactory background knowledge regarding the rational use of antimicrobials and AMR patterns, there are discrepancies in the physicians' prescribing attitude and thus strengthen the case for instituting specific interventions to improve antimicrobial prescribing.
  1,854 118 -
Impact of educational interventions on utilization patterns of anticancer agents in patients with breast cancer at the specialty oncology care setting in South India
Aakanksha Sharma, Himanshu Patel, Gurumurthy Parthasarathi
April-June 2022, 13(2):82-89
Aims/Objectives: This study was conducted to assess the utilization patterns of anticancer agents in patients with breast cancer and to provide practice recommendations/educational interventions to optimize medication use in patients with breast cancer. Materials and Methods: This was an ambispective study conducted for a period of 3 years at a private, specialty oncology care hospital in South India. In the initial phase, the selection of anticancer agents, dosage of anticancer agents, and management of chemotherapy-induced nausea and vomiting (CINV) were reviewed retrospectively (using paper medical records) with respect to the National Cancer Comprehensive Network guidelines. The administration of anticancer agents and anti-emetics were reviewed with respect to the hospital drug administration policies. The deviations from the standards were reported, and practice recommendations/educational interventions were developed. Treatment patterns were reevaluated prospectively after providing educational interventions. Descriptive statistics were used to report and compare the results from both phases. Results: During retrospective phase, we observed 80% compliance in the selection of anticancer drugs, 74% compliance in drug dosing, and 63.5% compliance in the administration of anti-cancer agents. After the implementation of educational interventions, we observed 85% compliance in the selection of anticancer agents, 82.3% in their dosing, and 86.9% compliance in the administration of anticancer agents. For the management of CINV, we observed 75% compliance in the selection of drugs (vs. 53% during preintervention), 92% compliance in their dosing (vs. 90% during preintervention), 85.1% compliance in the administration of anti-emetics (vs. 50% during preintervention), and 80% compliance in the management of delayed CINV (vs. 60% during preintervention). Conclusions: Treatment patterns of breast cancer were improved with respect to treatment standards after educational interventions to oncology care team.
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Adoption of the World Health Organization access, watch reserve index to evaluate and monitor the use of antibiotics at a tertiary care hospital in India
Alka Bansal, Rajni Sharma, Ravi Prakash
April-June 2022, 13(2):90-93
Background: The World Health Organization classification of antibiotics classifies key antibiotics into access, watch, and reserve (AWaRe) categories. Categorization provides a novel metrics called “AWaRe index” to study and monitor antibiotic consumption globally and within the same setting over time. Aim: The aim of this study is to compare the use of antibiotics in 2 years using the AWaRe index tool. Materials and Methods: A retrospective study was conducted in SMS Hospital, Jaipur to collect data regarding total antibiotics consumed between January 2017 and December 2018 from drug distribution centers in hospital premises using the AWaRe classification. Data were then compared on yearly basis. Results: In 2017, 53.31% of antibiotics consumed belonged to access, 40.09% to watch, and 3.40% to reserve category, respectively, as compared to 41.21%, 46.94%, and 8.15%, respectively, in 2018. Conclusion: Increased use of watch (17%) and reserve antibiotics (140%) over 1 year with the same infection scenario in a similar setting indicates resistance in evolution.
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Functioning of Institutional Ethics Committees During the COVID-19 pandemic: An opinion survey
Shatavisa Mukherjee, Shambo Samrat Samajdar, Rohan Tripathi, Santanu Kumar Tripathi
April-June 2022, 13(2):118-119
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Equivalence trials
Priya Ranganathan, CS Pramesh, Rakesh Aggarwal
April-June 2022, 13(2):114-117
In an equivalence trial, researchers aim to show that a new intervention is more or less similar to an existing standard of care, i.e., the two are “equivalent”. In this article, we discuss some aspects of the design, analysis, interpretation and reporting of equivalence trials.
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Erratum: Common pitfalls in statistical analysis: Measures of agreement
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April-June 2022, 13(2):120-120
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