Efficacy of dorzolamide in improving ocular blood flow in patients with open-angle glaucoma: The Indian carbonic anhydrase inhibitor trial

Purpose: Impaired ocular blood flow is an important risk factor in the pathogenesis of open?angle glaucoma (OAG). Studies have reported that dorzolamide 2% may be effective in improving ocular blood flow (OBF) in OAG patients. The objective of this study was to determine the efficacy of dorzolamide 2% (DORZOX, Cipla Ltd.) in improving retrobulbar blood flow in an Indian setting. Methods: The study was conducted as an interventional pilot project in 24 healthy subjects and 19 OAG patients. Baseline OBF measurements were done for all glaucoma patients with color Doppler imaging (CDI). Baseline ocular perfusion pressure (OPP) was calculated for all participants. Glaucoma patients were given dorzolamide 2% thrice daily for 12 weeks. The primary efficacy endpoints were mean changes in the CDI parameters of the retrobulbar vessels and OPP posttreatment. The secondary endpoint was mean change in the intraocular pressure (IOP) and adverse events, if any. Results: In comparison to healthy subjects, glaucoma patients displayed significantly reduced baseline OPP (P = 0.002). Treatment with dorzolamide 2% for 12 weeks led to a significant increase in OPP (P < 0.001) and a significant increase in end diastolic velocity (EDV) in all major ophthalmic arteries like ophthalmic artery (OA), central retinal artery (CRA), and short posterior ciliary artery (SPCA) (P < 0.001, P = 0.04, and P = 0.0075, respectively). A significant reduction in the intraocular pressure (IOP; P = 0.007) was observed posttreatment, with no adverse events reported. Conclusion: Dorzolamide 2% significantly improved parameters such as the EDV and OPP in major ophthalmic arteries. This pilot study shows promising results on using dorzolamide for treating Indian patients with OAG

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.

An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period.

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

An analysis of invitations for article submission received via emails

Predatory journals charge publication fees from authors and publish without an adequate peer review, and often do not provide editorial and/or publishing services. Our objective was to evaluate e-mail solicitations received by authors in a defined time period to identify attributes of these solicitations as a metric to identify legitimacy of the journal. All e-mails seeking article submission received between January 1 and September 30, 2019, were evaluated. Each e-mail along with its respective webpage was evaluated for the journal’s and publisher’s names, mention of peer review, any assurance of publication, a mention of article processing charges (APC), composite invites [in the e-mail] and mention of peer review, the presence and functionality of archives, presence of manuscript management tab, mention of APC [on the webpage]. Descriptive statistics were used for the analysis. Of the 135 e-mails screened, 100 were finally included in the analysis. We found that 72% of the journals and/ or publishers were included in Beall’s list. According to our criteria, a total of 85% of the solicitations were from journals that we identified as “presumed predatory”. Our study has identified assurance of publication, rapid turnaround time, ambiguous information in the email and webpage, false claims of indexing as some descriptors which may help young authors and researchers assess a journal’s legitimacy.

A critical analysis of the COMPASS trial with respect to benefit-risk assessment using the numbers needed to treat: Applicability and relevance in Indian patients with stable cardiovascular disease

The recently published Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial evaluated the hypothesis that rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary prevention. In India, stable cardiovascular disease occurs in a much younger age group relative to the rest of the world. Our critical analysis of COMPASS trial showed that the younger age group appeared to derive greater benefit from the rivaroxaban + aspirin combination (relative to aspirin alone) as seen with number needed to treat metrics as compared to the older age group.

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.

Authors' reply.

We thank Dr Rupa V., Dr Nagoba B.S. and their colleagues for their comments on our editorial.1,2 Both the groups generally agree with our propositions, with Rupa and colleagues suggesting some changes. Credit for authorship is a balancing act between giving credit to all those who deserve it versus avoiding the scourge of ‘gift authorship’. Our editorial recommends credit to all the authors in order to encourage interdepartmental research and to prevent junior researchers from being denied their due which Nagoba and colleagues agree with. Any restriction in this context as suggested by Rupa and colleagues has a potential for harm—with credit being limited to the senior authors, who may be in a stronger position to influence their relative position in the authorship list. One wonders whether in India we have carried the ‘one size fits all’ approach too far in the name of ‘being objective’––and whether a subjective decision by a selection committee based on an individual’s actual contribution (e.g. the volume of work reported in a paper, the multidisciplinary nature of the work, and the expertise of a particular author) may be the way forward. We wish to reiterate that our editorial, written on behalf of the Indian Association of Medical Journal Editors, focused mainly on issues related to the publication process, and not on the criteria for faculty promotions, which is an entirely different debate. However, we emphasize that credit based on impact factor, as suggested by Rupa and colleagues, will pose a fresh set of challenges, given that the concept, application and the potential for manipulation of this measure have been the subject of widespread critique and debate in the literature.

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.

Demographics of animal bite victims & management practices in a tertiary care institute in Mumbai, Maharashtra, India.

Background & objectives: Rabies is an important public health problem worldwide and more than 55,000 people die annually of the disease. The King Edward Memorial Hospital, Mumbai, is a tertiary referral centre where a rabies clinic runs 24 hours. In view of lack of information about the demographics of the disease in an urban environment the present study was carried out. Methods: Data on 1000 consecutive animal bite victims presenting to the institute in 2010 were collected over a 15 wk period. An electronic database was specially created for capturing information and was modelled on the information available from the WHO expert consultation on rabies, 2005. Economic burden from the patients’ perspective was calculated using both direct and indirect costs. Results: The victims were largely males (771 subjects). The dog was the major biting animal (891, 89.1%).Bites were mainly of Category III (783, 78.3%). One twenty three subjects used indigenous treatments only for local wound care. Of the Category III bites, only 21 of 783 (2.7%) patients were prescribed human rabies immunoglobulin (HRIG) which was primarily for severe bites or bites close to or on the face. A total of 318 patients did not complete the full Essen regime of the vaccine. The median cost to the patient per bite was ` 220 (3.5 USD). Interpretation & conclusions: Our findings showed that the use of HRIG was low with less than 2 per cent of the Category III patients being prescribed it. As vaccine and HRIG continue to remain expensive, the intradermal vaccine, shorter regimes like the Zagreb regime and monoclonal antibodies may offer safer and cost-effective options in the future. Further studies need to be done in different parts of the country.