Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A single-centre, observational study

BACKGROUND In May 2020, WHO recognized the role of extensive immunization for interrupting the transmission of the SARS-CoV-2 virus. The development of such vaccines in clinical trials relies upon participants who are expected to be vested in the research process. Assessment of participant factors such as motivation and satisfaction are hence important to gauge perspective and ensure successful conduct and completion of these trials. METHODS We administered a validated three-domain questionnaire to and documented the binary categorical responses (yes/no) of participants (after informed consent) who had taken both doses of COVOVAX™ in a phase 3 trial at our institute. Association of the dependent variables (participant responses) with the independent variables (participant demographics and socioeconomic strata) was computed using Chi-square test at 5% significance. In case of a significant association, Bonferroni post-hoc test was applied for multiple comparisons. RESULTS Of the 78 participants who were administered the questionnaire, two-thirds were highly satisfied with their experience at our site. Gaining access to a new vaccine was a primary motivation overall (74%) and also in graduates (p=0.03) and middle-class population (p=0.002), whereas the lower-middle class population (p<0.0001) and those educated till secondary school (p=0.003) took part due to the long wait for government-approved vaccines. CONCLUSION Participants in a Covid-19 vaccine trial at Mumbai were largely satisfied with the care given to them though altruism did not feature as a primary reason for participation.

Medical case reports published in PubMed-indexed Indian journals in 2015: Adherence to 2013 CARE guidelines

In 2013, an independent group of researchers developed the CARE guidelines, a checklist to standardise reporting of case reports. This study assesses adherence to CARE guidelines among PubMed-indexed Indian medical journals in 2015 and the extent of endorsement of these guidelines by the journals. Case reports published in 2015 in journals indexed by PubMed, belonging to the medical stream, currently active, and that had an impact factor were included for analysis. Case series and journals that were published from India but for another country were excluded. Total adherence score and classification of adherence as “excellent”, “very good”, “good”, and “poor” as also adherence to individual components of the checklist were the outcome measures. A total of 162 journals were identified by the search strategy, of which 36 satisfied the selection criteria. In these 36 journals, 1178 case reports were published. We tested the association between the type of journal and impact factor with adherence by using the chi-squared test and generated crude odds ratios. All analyses were done at 5% significance. Based on the total percent score, no case report had excellent adherence, and 19% had good, 70.7% average, and 10% poor adherence, respectively. Among the sub-items, the best adherence was seen in the clinical findings [97.9%], followed by keywords [88.5%], and introduction [71.5%]. The items with extremely poor adherence were patient perspective [0%], informed consent [2.8%], and timeline [4.6%]. Journals with an impact factor of more than 1 had better adherence, relative to those with an impact factor lower than 1. Only one journal’s website mentioned the CARE guidelines. Greater awareness needs to be created among authors, peer reviewers, and editors about using these guidelines. As informed consent is a metric of autonomy, all stakeholders must ensure its reporting.

The revised guidelines of the Medical Council of India for academic promotions: Need for a rethink.

Measuring academic achievements is never an easy task. This is particularly so when individuals are assessed for promotions in several fields with differing job descriptions. Assessment by peers is time-consuming and may be prone to bias; thus, objective criteria are required to minimize these concerns. The Medical Council of India (MCI) has laid down guidelines for appointments and promotions of teachers in medical institutions in India. Among the criteria used for promotions, publication of research is an essential requirement. Though the need for this requirement has been debated, it is believed that the quality of teaching improves when medical teachers are involved in research. Many countries have made it mandatory for their medical faculty to do research; some other countries incentivize the conduct and publication of research. Reports have also lamented that the physician–scientist might become an endangered species.1,2 Thus, linking publications with promotions might benefit both the individual and society. The flip side is that the time spent on research might take teachers away from teaching or clinical duties, particularly in under-staffed specialty departments. Further, the quality of research is likely to be poor when the resources and training in research are lacking.3 Poor quality may even discredit research as a professional activity. Insistence on a certain amount of published research to maintain teaching credentials may lead to the phenomenon of ‘publish or perish’.4 Finally, it is important to consider that biomedical research may, at times, be relevant to nonbiomedical journals and criteria for awarding credit to such publications should also be devised.

The revised guidelines of the Medical Council of India for academic promotions: need for a rethink.

Measuring academic achievements is never an easy task. This is particularly so when individuals are assessed for promotions in several fields with differing job descriptions. Assessment by peers is time-consuming and may be prone to bias; thus, objective criteria are required to minimise these concerns.

The Revised Guidelines Of The Medical Council Of India For Academic Promotions -Need for a rethink-

This editorial is being published simultaneously in the Indian Heart Journal, Indian Journal of Anaesthesia, Indian Journal of Gastroenterology, Indian Journal of Medical Ethics, Indian Journal of Medical Microbiology, Indian Journal of Occupational and Environmental Medicine, Indian Journal of Pathology and Microbiology, Indian Journal of Pharmacology, Indian Journal of Physiology and Pharmacology, Indian Journal of Urology, Indian Pediatrics, International Journal of Health Research & Medicolegal Practice, Journal of Anaesthesiology Clinical Pharmacology, Journal of Ayurveda and Integrative Medicine, Journal of Clinical and Scientific Research, Journal of Conservative Dentistry, Journal of Family Medicine and Primary Care, Journal of Indian Academy of Forensic Medicine, Journal of Mahatma Gandhi Institute of Medical Sciences, Journal of Postgraduate Medicine, National Journal of Integrated Research in Medicine, and The National Medical Journal of India. It may also be published in forthcoming issues of other journals. This editorial is not endorsed by all members of the IAMJE.[Aggarwal R NJIRM 2015; 6(6): 1-5]

Use of computerized tests to evaluate psychomotor performance in children with specific learning disabilities in comparison to normal children.

Background & objectives: Children with specific learning disabilities (SpLD) have an unexplained difficulty in acquiring basic academic skills resulting in a significant discrepancy between their academic potential and achievements. This study was undertaken to compare the performance on a battery of six psychomotor tests of children with SpLD and those without any learning disabilities (controls) using computerized tests. Methods: In this study, 25 children with SpLD and 25 controls (matched for age, socio-economic status and medium of instruction) were given three training sessions over one week. Then children were asked to perform on the six computerized psychomotor tests. Results were compared between the two groups. Results: children with SpLD fared significantly worse on finger tapping test, choice reaction test, digit picture substitution test and card sorting test compared to the controls (p<0.05). Interpretation & conclusions: Children with SpLD have impairment of psychomotor skills like attention, sensory-motor coordination and executive functioning. Further research is needed to evaluate if the remedial education plan results in improvement in psychomotor performance of children with SpLD on these selected tests.

Principles of sample size calculation.

In most areas in life, it is difficult to work with populations and hence researchers work with samples. The calculation of the sample size needed depends on the data type and distribution. Elements include consideration of the alpha error, beta error, clinically meaningful difference, and the variability or standard deviation. The final number arrived at should be increased to include a safety margin and the dropout rate. Over and above this, sample size calculations must take into account all available data, funding, support facilities, and ethics of subjecting patients to research.

Off-label drug use in a pediatric intensive care unit.

Objective. To determine the extent and nature of off-label drug use in children admitted to a Pediatric Intensive Care Unit (PICU) Methods. This prospective exploratory study was conducted in a tertiary care hospital in a metropolitan city in India after obtaining clearance from the institutional ethics committee. Subjects admitted in PICU from February-August 2006 were enrolled in the study. In addition to the demographic data and diagnosis, details of drugs prescribed (name, dose and route and frequency of administration) were obtained from hospital records. British National Formulary 2005 was used to determine if the prescriptions were off-label and if so, they were categorized as off-label for age, indication, dosage or frequency and route of administration. Descriptive statistics was used to determine the proportion of off-label drug use. Fischer’s exact test was used to determine if there was significant difference (P<0.05) in off-label use between patients with multiple system affection and those with single system affection and between those requiring artificial ventilatory support and those not requiring it. Results. Three hundred subjects received 2237 analyzable prescriptions. Of these 1579 (70.58%) prescriptions were offlabel in nature. Off-label drug use was prevalent in all age-groups and in all systemic afflictions. The proportion of off-label drug use was not influenced by severity of illness, as judged by involvement of multiple systems or need for ventilatory support. The list of off-label drugs used included old as well as new molecules. Most commonly used drugs in PICU were also the most common off-label drugs. Conclusion. Off-label drug use is highly prevalent in PICU settings.

A retrospective analysis of adverse events in the elderly in a tertiary referral center in Mumbai (Bombay), India.

Background : Adverse events (AEs) account for significant morbidity and mortality in elderly. Inappropriate medication usage has been regarded as an important factor contributing to AEs in them. Beers criteria are a set of standard criteria for guiding drug prescription in elderly. Objective : To estimate the burden of AEs in the elderly in India and use of Beers criteria for assessing appropriateness of drug prescription in them. Materials and Methods : Data on AEs collected by our tertiary referral center for the years 2005 and 2006 was analyzed. The term 'elderly individuals' was defined as those aged ≥58 years. An AE was defined as any untoward medical occurrence with a medicinal product in a patient or a clinical investigation, whether or not causally related. Results : In 2005, 321 AEs were reported, and in 2006 there were 673. Of them, those in the elderly constituted 60 (18.9%) and 44 (11.8%) AEs in the 2 years, respectively. About 7 (11.6%) of the AEs in elderly in 2005 were due to medications fulfilling Beers criteria but none in 2006. Two thirds of the AEs in both years were found to be due to antidiabetics, oral anticoagulants and antiplatelets and drugs with a narrow therapeutic index. Warfarin, digoxin and insulin accounted for a quarter of the AEs. Conclusions : Some commonly used medications account for a major proportion of AEs in elderly. Prospective studies of similar nature could further help us assess the burden of AEs in elderly.

Off-label drug use in children.

OBJECTIVE: To determine the extent and nature of off-label drug use in children admitted to a pediatric general ward in a tertiary health care centre METHODS: Consecutive patients aged 1 mo-12 years admitted to the general wards in a tertiary care center in Mumbai over a two-month period were prospectively enrolled in the study. British National Formulary [BNF] version 2005 was used to ascertain if the drug use was "off-label". The off-label use was categorized as: administration of a greater/lesser dose, administration at a higher/lower frequency than indicated, administration for indications not described, administration of a drug not licensed for use in that age group and/ or use of alternative routes of administration. Descriptive statistics was used for calculating the off-label drug use. RESULTS: Two thousand prescriptions received by 600 subjects (M:F= 1.47:1) were analyzed. One thousand and forty-five (50.62%) prescriptions were off-label. The off-label drug use rate was 1.74+/-1.56 per patient. The maximum rate of off-label drugs was in infants (2.33/patient). 'alteration in dosage' was by far the commonest reason for off-label use; followed by 'age' and 'indication'. Furosemide (i. v.), diazepam (i.v), cefotaxime (i.v), ethambutol (tab) and prednisolone (tab) were the five commonest off-label drugs used in the study population. CONCLUSIONS: Off-label drug use was highly prevalent in general pediatric ward of a tertiary care hospital in India.