Gender differences in first authorship of randomized controlled trials from India.

BACKGROUND: It has been established that identity of the trial leadership plays a role in the conduct of the trial. An estimation of the gender composition of RCT leadership in India has not been undertaken. We performed this study to quantify the gender composition of first authors of RCTs published from India for the years 2011 to 2020. METHODS: PubMed database was searched using the keyword "randomized controlled trial". We included studies that were classified as a RCT, had a first author affiliation that belonged to India and were published online between 1st January 2011 to 31st December 2020. The gender of the first authors was determined using Gender-API and manually. RESULTS: Out of the total 4136 RCTs included in our study, the gender of 4056 (98%) first authors were identified. Of the 4056 first authors, 1198 (30%) were women and 2858 (70%) were men. The mean (SD) percentage of yearly distribution of women and men as first authors was 29.53(2.23) and 70.46(2.23), respectively. We did not find any significant change in gender distribution of first authors over the course of ten years [P = 0.78]. CONCLUSION: The persistence of gender disparity in the leadership of RCTs from India demands greater efforts towards inclusion of women as leaders of clinical trials.

Effect of Daily Vitamin D Supplementation on Serum Vitamin D Levels in Children with Epilepsy Receiving Sodium Valproate Monotherapy: A Randomized, Controlled Trial.

OBJECTIVES: To compare the change in serum vitamin D levels and to compare the changes in serum levels of calcium, phosphate, alkaline phosphatase and parathyroid hormone in vitamin D supplemented and unsupplemented groups after 3 mo. METHODS: In this randomized, parallel group, nonblinded, controlled trial, 40 children, 2-12 y of age with newly diagnosed epilepsy, and vitamin D sufficient status, and started on valproate monotherapy, were randomized into the intervention group (n = 20), which was given daily oral 600 IU vitamin D supplementation, and the control group (n = 20), which was not given any supplementation. Changes in the biochemical parameters was measured in the two groups after 3 mo. RESULTS: There was a significant reduction in the median (IQR) vitamin D levels in the control group as compared to an increase seen in the intervention group [-6.64 (-8.4, -2.65) vs. 5.66 (1.81, 7.12); p < 0.001]. In the control group, 37.5% children developed vitamin D insufficiency and 12.5% developed deficiency whereas only 5% of the intervention group developed vitamin D insufficiency (p = 0.005). There was a significant decrease in ionized calcium (p = 0.02), increase in serum phosphate (p = 0.02), and alkaline phosphatase level (p = 0.003) in the unsupplemented group as compared to the supplemented group. CONCLUSION: Vitamin D supplementation can reduce the valproate-associated decline in vitamin D levels and the negative impact on other markers of bone mineral metabolism. TRIAL REGISTRATION: TCTR20200621002, 19.06.2020, retrospectively registered.

Development and implementation of a sustainable COVID-19 training package for healthcare workers: Experience from a teaching hospital of North India.

Background: With the impending threat of future COVID-19 waves, it is imperative that teaching hospitals develop, implement, and evaluate a systematic training program to render HCW elastic in delivering COVID-19 related services. We present our experience in developing, implementing, and evaluating a sustainable and scalable COVID-19 patient management training package for healthcare workers. Materials and Methods: A mixed-methods study design was used. Rapid assessment to understand the need of the trainees and identify the available resources was done followed by planning of the training module and its implementation. The program was evaluated for effectiveness and sustainability. Data analysis was done using descriptive statistics and qualitative data generated from open-ended questions in the feedback forms and the discussions were analyzed using rapid content analysis. Results: A total of 66.8% of the doctors and 18.9% of the nurses were trained by online synchronous mode while 55.0% of the nursing officers and 47.1% of the nursing orderlies and paramedical staff were trained in onsite skill development sessions. Need assessment identified that healthcare workers were ill-prepared to use medical devices such as Bipap machines, ventilators, and oxygen delivery devices. The participants mentioned that the multidisciplinary approach and video-based demonstrations facilitated their online learning while the incremental learning approach, easy-to-understand terminology and hands-on experience facilitated their onsite skill development sessions. Conclusion: The COVID-19 training package developed was multidisciplinary, effective, sustainable, and scalable in a resource-limited setting. We suggest that this model can be adapted by healthcare organizations to develop and implement such training packages for their healthcare workers.

Effect of convalescent plasma therapy on mortality in moderate-to-severely Ill COVID-19 patients.

INTRODUCTION: The role of plasma therapy in the management of the COVID-19, pandemic has been speculated. However, in view of the varied response regarding its effectiveness from various multicenter studies, there is a need to conduct more single center population-specific studies. We, thus, aimed to assess the role of convalescent plasma therapy in COVID-19 patient management in a single -center. METHODS: This retrospective study was conducted using records of all COVID-19 patients who received plasma therapy over a period of 6 months in a dedicated COVID-19 hospital in Delhi. Information pertaining to transfusion, disease severity, associated comorbidities, the treatment given and patient outcome were recorded. Data was analyzed using SPSSv23. RESULTS: Of the141 patients who received plasma therapy, 62% were discharged after treatment. Mortality was found to be significantly higher in patients > 60 years of age (p < 0.001), those with severe COVID-19 infection (p < 0.05) and pre-existing renal disease (p < 0.05). The admission-transfusion interval was significantly correlated to mortality and was a sensitive parameter for predicting outcome at cut off value of < 5 days (p < 0.001). There was no significant association of mortality with patient blood group, plasma antibody levels or donor hemoglobin levels. CONCLUSIONS: We report improvement and recovery in a large number of patients who received convalescent plasma within the first 5 days of hospitalization with moderate to severe disease. Further research to compare dosage and administration protocols to delineate role of CCP in survival of COVID-19 patients is needed before it is prematurely shelved.

Using the health humanities to impart disability competencies to undergraduate medical students.

BACKGROUND: Disability competencies were included, for the first time, in India's new undergraduate competency-based curriculum as a result of physician-led advocacy in 2019; the regulatory body also recommended the use of the humanities in medicine. OBJECTIVE: To use tools from the health humanities to impart disability competencies and help students appreciate the social and human rights issues associated with disability. METHODS: A module was developed and piloted in the foundation course on the new cohort of students. The tools included storytelling, visual art, poetry, narratives, and Forum Theatre; many facilitators were doctors and patients with disabilities. Learners were introduced to the concept of universal design through a field visit. Quantitative and open-ended feedback was taken from learners after module delivery; reflections were sought after four months. RESULTS: The data revealed that the humanities tools used in the module had the potential to help learners explore struggle and oppression and to expose discriminatory attitudes. Learners were able to think beyond the hegemony of normalcy, and show an understanding of diversity, dignity, autonomy, disableism, social inclusion, equity, and universal design. They admitted to the misconceptions they carried and showed keenness to advocate for change. CONCLUSION: This study piloted a novel disability competencies module using tools from the health humanities and found that learners were able to engage with and show an understanding of the social and human rights issues associated with disability. Conversations by, for, and with people with disabilities must be part of such interventions in developing and delivering disability courses.

Estimating the Volume of Equine Rabies Immunoglobulin (eRIG) Required for Local Infiltration in Soft Tissue Animal Bites in Children Using a Wound Size-Based Approach.

INTRODUCTION: Post-exposure prophylaxis using rabies immunoglobulin (RIG) is universal recommendation for category III exposures. This study was conducted to determine quantity of RIG used to infiltrate animal bite wounds in relation to longest dimension and area of wound. METHODS: Children aged 2-18 years reporting within 7 days of category III animal bite were included. eRIG (300 IU/ml) was used in all subjects. A predesigned proforma was filled for clinical and epidemiological details of subjects. Maximum length and width of wounds was measured by using non-stretchable measuring tape. RIG was infiltrated in wounds as per WHO recommendations and volume infiltrated was noted. RESULTS AND CONCLUSION: A total of 100 subjects were enrolled. The mean (±SD) volume of RIG infiltrated in wounds per unit length was 0.75 (±0.21) ml/cm and per unit area was 3.18 (±1.75) ml/cm2. Regression equations were calculated. Proposed equations y = 0.6x + 0.3, where y is the volume of RIG (ml) and x is the length of the wound (cm) and y = 0.9x + 1.1, where y is the volume of RIG (ml) and x is the area of the wound (cm2) can prove to be a useful tool in RIG volume calculation for primary health care providers.

Rapid transition to online teaching program during COVID-19 lockdown: Experience from a medical college of India.

BACKGROUND: COVID-19 pandemic has forced medical colleges around the world to shift to online teaching. There is hardly any evidence regarding such rapid transitions to online teaching, especially from resource-poor settings. We share our experience of developing an online teaching program based on teachers' and students' feedback. MATERIALS AND METHODS: A mixed methods study was conducted during the COVID-19 lockdown period in a public-funded medical institute of India. Online feedback was obtained 3 weeks after the beginning of emergency remote teaching. The responses by the students and teachers shaped the final online teaching program which reinforced the perceived strengths and addressed the weaknesses. Observations were made for the proportion of scheduled lectures delivered through digital platform and students' attendance in the 1st week and last week of the study period. RESULTS: Feedback was obtained from 367 students and 56 teachers. Around three-fourths of the students (76.7%) and teachers (73.2%) were satisfied with online teaching. The themes generated for benefits of online teaching were similar for both students and teachers, but the perceived challenges differed. Students found online teaching more stressful, and teachers were apprehensive of the new technology and lack of a controlled environment. CONCLUSIONS: A rapid transition to development and implementation of an online teaching program was found to be feasible and acceptable to the primary stakeholders. Not only the content but student engagement and supportive environment for both students and teachers are essential requirements in the context of an online undergraduate teaching program.

Basics of Statistical Comparisons.

All study designs in medical research, barring descriptive studies, involve comparative analysis to achieve its objective/s. Comparisons between groups based on outcomes, or risk factors, or interventions, are the basis of hypotheses in evidence-based medicine. Statistical tests support in making criterion-based decisions about the validity of the hypothesis. A basic knowledge of statistical comparisons helps medical researchers to apply valid statistical tests. Novice medical researchers struggle to decide when, and which statistical test must be applied. There is a need to further reduce the mathematical jargon in statistics related publications for medical researchers. In this article, we aim to provide the readers with practical pointers about the applied aspects of basic statistical comparisons in medical research.

Covid-19 Pandemic: Resumption of Orthopedic Care and Medical Education.

Covid-19 is a respiratory disease caused by coronavirus 2 (SARS-CoV-2) first identified in Wuhan, China (December 2019). The disease rapidly crossed the barrier of countries, continents and spread globally. Non-pharmaceutical measures such as social distancing, face mask, frequent hand washing and use of sanitizer remained the best available option to prevent the spread of disease. OPD, IPD admissions, elective O. Ts were curtailed. Orthopedic care was only limited to emergency and semi-urgent procedures like necrotizing fasciitis, open fracture, and compartment syndrome. These measures were taken to preserve infrastructure and manpower to manage covid-19 pandemic. The children were thought to have a low susceptibility to covid-19 as compared to an adult. Deferring the patient during pandemic has led to high orthopedic disease burden, morbidity and disease-related sequelae, hence elective care must be resumed with modified hospital infrastructure. Resumption of elective/emergent orthopedic care should be slow, phasic and strategic, much similar to unlocking. Cases must be stratified depending on covid status and severity. Dedicated O.Ts with neutral/negative pressure and HEPA filter for covid positive and suspected patients are to be used. All symptomatic and suspected patients should be investigated for covid-19 by RT-PCR, blood counts and CT scan. Regional anaesthesia should be preferred to General anaesthesia. Power drill/saw/burr/pulse lavage should be minimized to avoid aerosol generation. Postoperatively continuous surveillance and monitoring to be done for covid related symptoms. Medical institutes rapidly shifted to the online mode of education. Blended learning (virtual & physical) and imparting skills have to be continued in post covid phase with equitable distribution of teaching hours to students of different years.

Rapid transition to online practical classes in preclinical subjects during COVID-19: Experience from a medical college in North India.

BACKGROUND: COVID-19 pandemic compelled medical schools to opt for online mode in medical education. The competency-based curriculum started in India last year onwards allotted more hours to practical teaching than lectures. As the lockdown extended, there was a need to shift laboratory teaching to online mode. We describe our experience of developing and implementing a framework to rapidly shift practical lab teaching of preclinical subjects to online mode. METHODS: A mixed method study was conducted during the COVID-19 lockdown period in a public funded medical institute of India. A framework utilizing the principles of small group teaching using the available resources was developed and implemented. Online feedback was obtained from students, while in-depth telephonic interview was conducted for teachers. RESULTS: A Demonstrate-Engage-Assess framework for online Practical teaching of Preclinical subjects (DEAPP) was developed and implemented. Feedback was obtained from 103 first year students and six teachers from preclinical subjects. Around 62%-80% students were satisfied with online practical teaching or agreed with benefits of various online tools used in the teaching sessions. Teachers found the framework more planned, and resource efficient, while students found it to be more engaging, enjoyable, and motivated for learning. No face-to-face interaction, non-experiential learning, and adaptation to newer technology were the main barriers perceived in online practical laboratory teaching. CONCLUSION: DEAPP framework was found to be feasible for rapid online transition of practical lab teaching and reported by the students and teachers as engaging, enjoyable and motivated learning.

Module to facilitate self-directed learning among medical undergraduates: Development and implementation.

CONTEXT: Currently, self-directed learning (SDL) is emphasized in medical institutions all over the world. The skills of SDL enable one to be a lifelong learner, a necessity to cope up with fast-expanding medical knowledge. AIMS: This study aims to develop and implement an "SDL" module for medical undergraduates and find out their perception about the same. SETTINGS AND DESIGN: A cross-sectional study using a mixed-method design (having both qualitative and quantitative components) was conducted in the Department of Community Medicine, UCMS, Delhi, India. METHODS: A module was developed following an extensive literature review and focus group discussions with the teaching staff of the institute. First-semester undergraduate students were invited to participate in the study and asked for feedback using a semi-structured questionnaire. STATISTICAL ANALYSIS: Quantitative data were expressed in mean, range, and frequency. For qualitative data, thematic analysis was performed. RESULTS: The module was implemented with 160 students, in November for 10 hour distributed over 5 weeks. Feedback could be obtained from 130 students. Sixty-seven percent of students were satisfied and 66% reported as motivated to study the allotted topic further. Qualitative analysis showed that though the students liked the learning process based on this module, they also felt facilitators could have been more active in imparting knowledge and skills. CONCLUSIONS: To make learners equipped with the ability to learn throughout a professional learning course, SDL as a learning tool should be introduced in the medical undergraduate curriculum.

Effect of Faculty Training on Quality of Multiple-Choice Questions.

BACKGROUND: Multiple-choice question (MCQ) is frequently used assessment tool in medical education, both for certification and competitive examinations. Ill-constructed MCQs impact the utility of the assessment and thus the fate of examinee. We conducted this study to ascertain whether a short training session for faculty on MCQ writing results in desired improvement in their item-writing skills. METHODS: A 1-day workshop on constructing high-quality MCQs was conducted for the faculty as a before-after design, following training session of 3 h duration. 28 participants wrote preworkshop (n = 133) and postworkshop (n = 137) MCQs, which were analyzed and compared for 17 item-writing flaws. A mock test of 100 MCQs (selected by stratified random sampling from all the MCQs generated during the workshop) was conducted for MBBS-passed students for item analysis. RESULTS: Item-writing flaws reduced following the training (15% vs. 27.7%, P < 0.05). Improvement mainly occurred in quality of options; heterogeneity dropped from 27.1% prior to the workshop to 5.8% postworkshop. The proportion of MCQs failing the cover test remained similarly high (68.4% vs. 60.6%), and there was no improvement in writing of the stem before and after the workshop. The item analysis did not reveal any significant improvement in facility value, discriminating index, and proportion of nonfunctioning distractors. CONCLUSION: A single, short-duration faculty training session is not good enough to correct flaws in writing of the MCQs. There is a need of focused training of the faculty in MCQ writing. Courses with a longer duration, supplemented by repeated or continuous faculty development programs, need to be explored.

Prevalence of Non-Exclusive Breastfeeding and Associated Out-of-Pocket Expenditure on Feeding and Treatment of Morbidity Among Infants Aged 0-6 Months in an Urban Slum.

OBJECTIVE: To estimate the prevalence of non-exclusive breastfeeding (NEBF) and quantify the out-of-pocket expenditure (OOPE) associated with NEBF and treatment of morbidity among infants up to six months of age. METHODS: Community based in an urban slum, among 172 mother-infant dyads selected by systematic random sampling. Current breast-feeding practices and OOPE over last one month was recorded using a pre-validated, interviewer administered schedule. Independent sample t-test subsequent to bootstrapping was used to test the statistical significance of the difference in mean out of pocket expenditure between NEBF and exclusively breastfeeding (EBF) infants. The main outcome measures was non-exclusive breastfeeding rate and out of pocket expenditure associated with infant feeding and treatment of morbidity. RESULTS: 67 (38.9%) infants were found to be non- exclusively breastfed. The median (IQR) total monthly OOPE incurred on non-breastmilk feeding and healthcare was found significantly higher among NEBF infants vs EBF infants [440 (80-982) vs [0 (0-290); P<0.001]. The median (IQR) monthly OOPE incurred on healthcare was also significantly higher among NEBF infants than EBF infants [INR 140 (0-540) vs 0(0-150); P=0.002]. CONCLUSION: The prevalence of NEBF was high, and it was associated with higher financial burden on the families.

Evaluation of a faculty development workshop aimed at development and implementation of a competency-based curriculum for medical undergraduates.

INTRODUCTION: Faculty development to implement competency-based medical education (CBME) is urgently needed as the Medical Council of India has implemented the competency-based curriculum this year onwards. OBJECTIVES: To evaluate a 2-day faculty development workshop in terms of: (a) increase in knowledge about CBME terminology and concepts, (b) self-reported capacity to develop and implement a competency-based module in their respective disciplines, and (c) satisfaction of the participants. METHODOLOGY: A single arm interventional study using mixed methods was carried out in which faculty members were purposively identified and requested to volunteer for a two-day faculty development workshop on the development and implementation of CBME. The workshop was evaluated (open-ended and Likert scored items) by the participants for self-reported gain in knowledge, gain in their confidence to develop and implement CBME, and level of satisfaction with respect to the components of the workshop. Quantitative data was analyzed by Wilcoxon signed rank test and Kruskal-Wallis test. Qualitative data was analyzed by doing content analysis and emerging themes have been presented. RESULTS: Eleven faculty members attended a capacity building workshop for developing and implementing a competency-based curriculum for medical undergraduates. There was a significant improvement in their self-reported knowledge and attitude regarding the competency-based curriculum. New concepts learned fell into four domains: modification of the existing curriculum toward competency-based curriculum, knowledge of CBME, teaching-learning and assessment methods, and beneficial to the students. The participants were highly satisfied with the workshop in its current form. CONCLUSION: A two-day faculty development workshop can increase the knowledge and understanding of competency-based medical education and can be an important first step in the journey to more specialized training.

Prevalence of Pet Dog Ownership in an Urban Colony of East Delhi and Awareness Regarding Canine Zoonotic Diseases and Responsible Pet Ownership among Dog Owners.

BACKGROUND: India has lowly prioritized pet-associated zoonosis as a public health priority because data regarding the same and the susceptible population involved are sparse. OBJECTIVE: To find the proportion of pet dog ownership in a settled urban colony of East Delhi and to assess awareness regarding canine zoonotic diseases and responsible pet ownership. METHODS: This was a cross-sectional descriptive study of 700 participants in an urban colony of East Delhi. RESULTS: The proportion of pet dog owners was 5.4%. Only one-third (34.2%) of the respondents were aware that pets are a source of disease. A majority of pet owners (86.8%) identified rabies as a disease caused by the bite of only stray dogs. The proportion of responsible pet owners was 39.4%. Only one-tenth of surveyed households had registered their pet with the local municipal authorities, despite such registration being a compulsory requirement by law. CONCLUSION: This study provides us with a better understanding of the lacunae in awareness of zoonotic diseases and its preventive measures among pet owners. All pet owners have a responsibility to ensure that their pets are healthy and free from disease.

The AFPI-CAR policy paper on identifying basic framework of possible roadmap for one health.

Zoonotic diseases are an important public health problem. Keeping this in way, a panel reviewed the discussion around "one health" strategy of the WHO in combating zoonotic diseases during Seventh annual conference of Consortium Against Rabies (CAR) with the theme of "Zoonoses: Thinking beyond Rabies" held on 14th and 15th June 2019. The panel came out a manuscript discussing the need, background, and rationale for basic framework of possible roadmap for one health. BACKGROUND ­ABOUT CAR: CAR has been established with the aim to serve as a platform for the control of the rabies menace in India. It will evolve into a full fledged struggle against rabies in the country. The association comprises of medical professionals, veterinary doctors, and public health persons. The idea behind CAR is to bring the best minds in the country for research and information dissemination in the field of rabies. ABOUT ACADEMY OF FAMILY PHYSICIANS OF INDIA AFPI: AFPI is the official association of family physicians in India. Dedicated to provide professional leadership, conduct healthcare advocacy, policy development and a change in health system within the domain of family medicine, and larger public health system in the country, the academy is the recipient of the Healthcare Leadership Award 2012 in the category of Healthcare Governance and Public Administration. THE WHITE PAPER DEVELOPMENT PROCESS: More than 100 medical experts, veterinary doctors, and public health persons from across the country and belonging to the fields of internal medicine, family medicine, public health, veterinary sciences, nursing science and environmental science and representing reputed medical institutions, government funded research institutions, and policy making bodies participated in discussions on topic of "one health" made during 7th Annual national conference of CAR with the theme of "Zoonoses: Thinking beyond Rabies" held on 14th and 15th June 2019. The panel steering the discussion included leading expert from ICMR, medical colleges, veterinary college, family medicine, private practitioners, and health program managers. The panel committee had prepared a draft document well in advance of the conference, which was communicated to all participants for feedback and comments. The panel was steered by ICMR expert. The discussion of the panellist was presented to the consensus group and unanimously adopted. A writing group worked on the manuscript, which was again circulated by email to all for any comments and suggestions before final publication.

Development and implementation of a competency-based module for teaching research methodology to medical undergraduates.

CONTEXT: Research experience helps an undergraduate student to understand published works, to learn teamwork, and even to consider research as a career. Few medical institutions have attempted to engage undergraduates in research experience. Competency-based medical education has emerged as a core strategy to educate and assess medical students worldwide. AIMS: This study aims to develop and implement a competency-based research methodology training module for undergraduate students and find out students' perception about this. SETTINGS AND DESIGN: A cross-sectional study of mixed design was undertaken in the Department of Community Medicine, UCMS, Delhi, India. METHODOLOGY: A competency-based research training module was developed and implemented with 4th semester undergraduate students posted in the department. Students' feedback about the module was obtained. STATISTICAL ANALYSIS USED: For quantitative variables, means, ranges, medians, and percentages were calculated. To find out students' perception about the posting a qualitative analysis was done. RESULTS: The module was implemented with 25 students posted in the department in May 2017. However, feedback was obtained from 23 students. About 83% of the students reported as highly satisfied with the posting, 61% of the students mentioned that after completion of this posting, they felt motivated to do further research. A qualitative analysis of the feedback showed that students found the project helped them to enhance their knowledge and develop skills. CONCLUSIONS: Competency-based research methodology training can serve as a tool for teaching research methodology to undergraduate students.

The 3-Question Approach: A Simplified Framework for Selecting Study Designs.

Conventional algorithms for selecting study designs are difficult to use for a novice researcher, especially the postgraduate students. An inherent limitation of using the existing algorithms is the requirement of a priori knowledge of the characteristics of various study designs. We propose a simple and novel 3-question approach to select study designs. The questions are asked in a stepwise manner with answers in 'yes' or 'no'. The responses to each of these questions lead the researcher towards choosing the appropriate study design. We believe that this 3-question approach would be useful for unexperienced researchers in selecting study designs, besides serving as a tool to teach-learn selection of study designs.