Surveying the Indian research ethics committee response to the COVID-19 pandemic.

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics.

Revolutionizing Medical Education: Can ChatGPT Boost Subjective Learning and Expression?

ChatGPT is an AI tool that can be used to enhance medical education by helping students develop subjective learning and expression skills. These skills are critical in clinical practice, but the current medical education system is heavily focused on objective assessments, such as Multiple Choice Questions (MCQs). Students from non-English speaking backgrounds can particularly struggle with expressing themselves in English, which is the primary language of instruction in many medical schools worldwide. ChatGPT can provide additional language support for these students to help them develop their language skills and communicate effectively. ChatGPT can be used in small group assessments to serve as a benchmark for students to strive for in their medical education. By comparing their answers to ChatGPT's responses, students can identify gaps in their knowledge and work to fill them. ChatGPT can also provide students with feedback on their writing style and language usage, helping them to improve their subjective expression of medical knowledge. Furthermore, ChatGPT can be used to simulate patient encounters for medical students. By interacting with ChatGPT, students can practice taking medical histories and documenting symptoms accurately. In continuing medical education (CME) programs, physicians can also benefit from ChatGPT's capabilities. By using ChatGPT to search for the latest research articles, clinical trials, and treatment guidelines, physicians can stay informed and provide the best care possible to their patients. Overall, ChatGPT has the potential to be a valuable tool in medical education by helping students and physicians develop the essential skills required for clinical practice, such as communication, problem-solving, and critical thinking.

One hundred years since insulin discovery: An update on current and future perspectives for pharmacotherapy of diabetes mellitus.

Diabetes mellitus was considered a fatal malady until the discovery, extraction and commercial availability of insulins. Numerous other classes of drugs ranging from sulfonylureas to sodium-glucose co-transporter-2 inhibitors were then marketed. However, with the prevalence of diabetes mellitus increasing every year, many more drugs and therapies are under investigation. This review article aimed to summarize the significant developments in the pharmacotherapy of diabetes mellitus and outline the progress made by the recent advances, 100 years since insulins were first extracted successfully. Insulin analogues and insulin delivery pumps have further improved glycaemic control in diabetes mellitus. Cardiovascular and renal outcome trials have changed the landscape of diabetology, with some of these drugs also efficacious in nondiabetics. Newer drug delivery systems are being evaluated to improve the efficacy and reduce the dosing frequency and adverse effects of antidiabetics. Some newer drugs with novel mechanisms of action targeting type 1 and type 2 diabetes have also shown promise in recent clinical trials. These drugs include dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1-agonists, glucokinase activators, anti-CD3 monoclonal antibodies and glimins. Their efficacy needs to be evaluated in larger studies.

Assessment of knowledge and attitudes regarding organ donation among doctors and students of a tertiary care hospital.

Organ donation is a lifesaving treatment option for patients with end-organ damage. However, many patients are unable to avail this option due to the low availability of viable organs for transplantation. The availability of donor organs can be improved by increasing awareness and resolving organ donation misconceptions among the general population. It can be assumed that healthcare workers are most aware of the value of organ donation. They are also in a position to influence the willingness of the general population to donate organs after death or sign up for an organ donor card. The knowledge and attitudes of current and future healthcare professionals regarding this subject have neither been evaluated nor considered a topic of priority in the existing Indian medical education program. OBJECTIVES: To evaluate the knowledge, attitudes, and beliefs of licensed medical doctors and undergraduate Bachelor of Medicine and Bachelor of Surgery (MBBS) students and analyze differences between the two groups with respect to the above. METHODOLOGY: A total of 650 doctors and MBBS students from a Tertiary care hospital were included in the study and subjected to a questionnaire with 11 questions. Responses to the questionnaire were analyzed to evaluate knowledge and attitudes regarding organ donation. Statistical analysis was carried out using IBM SPSS Statistics for Windows, version 24. RESULTS AND CONCLUSIONS: About 29.9% of doctors and 49.8% of students knew about the law governing organ donation. The concept of brain death was entirely understood by only 31.7% of doctors and 14.7% of students. Only 16% of doctors and 3.2% of students had filled an organ donor card. About 40.9% of doctors and 51% of students favored the opt-out system, as followed by western nations. Fear of illegal selling or purchase of organs was predominant in 61.9% of doctors and 52.2% of students. The current study reveals that the medical fraternity's knowledge and personal responsibility need improvements. However, the system also needs to be improved to win their trust.

Past, present and future perspectives of therapeutic drug monitoring in India.

Therapeutic drug monitoring (TDM) is the clinical practice of performing drug assays and interpreting results to maintain constant therapeutic concentrations in patients' bloodstream. Conventional TDM was started way back in the 1960s and served to optimise pharmacotherapy by maximising therapeutic efficacy by evaluating efficacy failure and monitoring drug compliance, while minimising adverse events, in drugs with a narrow therapeutic range. Currently, the scope of TDM has been extended to additional indications which are of importance to India. Apart from the conventional indications, TDM can also help combat drug resistance amongst patients treated with antimicrobials, including anti-tubercular drugs and critically ill patients with compromised pharmacokinetics. TDM is also indicated for patients on antiretroviral drugs under specific clinical scenarios and is of high importance to India. Target concentration intervention (TCI) and apriori TDM (by merging TDM with pharmacogenomics) are emerging fields explored in developed nations. The authors sought to assess the evolution of TDM in India and evaluate the potential impact of newer indications in rationalising pharmacotherapy. In the mid-1980s, TDM was presented to India. Despite showing some initial progress, its use is limited to conventional indications. Its utility is also challenged by cost and higher reliance on conventional prescribing practices. However, the newer indications such as antimicrobial resistance, tuberculosis and HIV, with their high prevalence in developing nations, present an opportunity for the growth of TDM in these countries. Indian clinician's awareness and buoyant demands alongside expert contributions from clinical pharmacologists could widen its scope.

Exploring the healing power of singing bowls: An overview of key findings and potential benefits.

Singing bowl sound meditation is an ancient practice that has been used for centuries in Tibetan and Buddhist cultures as a form of healing and relaxation. The practice involves the use of singing bowls, which produce a soothing sound believed to have a powerful effect on the body's energy system, helping to balance the chakras and promote healing. Over the years, several studies have been conducted to explore the effects of singing bowl sound meditation on mood, tension, and well-being. The reasons behind the positive effects of singing bowl sound healings are not fully understood. Possible explanations include alterations in brain waves, binaural beats, and the vibrations of singing bowls interacting with the energy field surrounding the human body, known as the biofield. Studies have shown that singing bowl sound meditation can produce physiological and psychological responses, reducing negative affect and increasing positive affect, as well as improving blood pressure, heart rate, and respiratory rate. Singing bowl sound meditation may be an effective low-cost and low-technology intervention for reducing feelings of tension, anxiety, and depression while promoting spiritual well-being. However, further research is needed to determine the long-term effects of singing bowl sound meditation on physiological and psychological well-being, as well as its potential clinical applications.

IcoSema: unveiling the future of diabetes management from a clinical pharmacology perspective.

IcoSema, a groundbreaking approach to diabetes management, combines insulin icodec and semaglutide to offer a transformative treatment option. Insulin icodec delivers consistent glucose-lowering effects with once-weekly dosing, while semaglutide, a GLP-1 agonist, stimulates insulin secretion and aids in weight loss. This comprehensive article evaluates the potential of IcoSema from a clinical pharmacology perspective, examining the pharmacokinetics, efficacy, safety, compliance and cost-effectiveness of its individual components, as well as considering comparable combination therapies like iGlarLixi and IDegLira. By analysing these crucial factors, the article aims to determine the potential of IcoSema in the field of diabetes management. The combination of insulin icodec and semaglutide has the potential to provide improved glycaemic control, weight management, and simplified treatment regimens, addressing common challenges faced in diabetes management. Safety, compliance and cost considerations are important aspects of evaluating this combination therapy. Ongoing trials investigating IcoSema are expected to provide valuable insights into its efficacy, safety and comparative effectiveness. By addressing concerns such as potential side effects, individual patient response and drug interactions, healthcare providers can optimize treatment outcomes and enhance the management of type 2 diabetes.

Lessons in clinical reasoning - pitfalls, myths, and pearls: a case of tarsal tunnel syndrome caused by an intraneural ganglion cyst.

OBJECTIVES: Intraneural ganglionic cysts are non-neoplastic cysts that can cause signs and symptoms of peripheral neuropathy. However, the scarcity of such cases can lead to cognitive biases. Early surgical exploration of space occupying lesions plays an important role in identification and improving the outcomes for intraneural ganglionic cysts. CASE PRESENTATION: This patient presented with loss of sensation on the right sole with tingling numbness for six months. A diagnosis of tarsal tunnel syndrome was made. Nerve conduction study revealed that the mixed nerve action potential (NAP) was absent in the right medial and lateral plantar nerves. The magnetic resonance imaging (MRI) found a cystic lesion measuring 1.4×1.8×3.8 cm as the presumed cause of the neuropathy. Surgical exploration revealed a ganglionic cyst traversing towards the flexor retinaculum with baby cysts. The latter finding came as a surprise to the treating surgeon and was confirmed to be an intraneural ganglionic cyst based on the histopathology report. CONCLUSIONS: Through integrated commentary by a case discussant and reflection by an orthopedician, this case highlights the significance of the availability heuristic, confirmation bias, and anchoring bias in a case of rare disease. Despite diagnostic delays, a medically knowledgeable patient's involvement in their own care lead to a more positive outcome. A fish-bone diagram is provided to visually demonstrate the major factors that contributed to the diagnostic delay. Finally, this case provides clinical teaching points in addition to a pitfall, myth, and pearl related to availability heuristic and the sunk cost fallacy.

Revamping Medical Education in India: New Guidelines for Eligibility Qualifications of Medical Faculty.

The National Medical Commission (NMC) in India has introduced new guidelines for the eligibility qualifications of faculty in medical institutions in 2022, aimed at enhancing the quality of medical education and healthcare in the country. The guidelines include an increased minimum publication requirement for promotion to professorship, the consideration of various types of publications, and mandatory courses in biomedical research and medical education technology. The guidelines also recommend reputable indexing databases and journals to improve the quality of research work. The NMC's efforts are expected to promote research collaboration, evidence-based clinical practice, and consistent teaching standards. However, it is essential to ensure that the recommended databases and journals are legitimate and credible. Overall, the NMC's initiatives to improve medical education in India are commendable, and it is hoped that they will lead to significant improvements in the quality of healthcare in the country.

IELTS Band 8 Strategies for Busy Physicians From Non-native English-Speaking Countries.

Non-native English-speaking physicians often encounter challenges when pursuing job and education opportunities in English-speaking countries. This article focuses on the International English Language Testing System (IELTS) exam, which is a requirement for applying to work, study, or obtain a visa in native English-speaking developed countries. The article details how the author, who is a physician from India, employed strategies that resulted in an overall band score of 8, consisting of 8.5 in listening, 9 in reading, 7.5 in writing, and 7.5 in speaking. The author had a moderate level of English proficiency before the 31-day preparation period, which involved one hour of daily practice and four-hour intensive practice for three days. To prepare, the physician used various resources, including Cambridge IELTS 15 and 16 books, two free practice tests from the British Council, a free 14-day course, and two full practice tests from Macquarie University. The author employed diverse strategies to improve their listening skills, such as listening to English content without subtitles, practicing with IELTS-like tests, and listening to tests at faster speeds. To overcome reading challenges, the author completed three reading passages during practice, read medical journals and books, and familiarized themselves with medical terminologies. For the writing section, the author practiced different question types and used language-checking software for feedback. Lastly, for the speaking section, the author practiced various topics, familiarized themselves with the exam format, and recorded themselves to identify and correct errors. This success story demonstrates how non-native English speakers can use a combination of resources and strategies to enhance their skills in all four sections of the IELTS exam at a nominal fee.

A drug utilisation pattern in non-dialysis patients of diabetic nephropathy in a government-run tertiary care hospital in South-Asia.

OBJECTIVES: The objective of the present study was to evaluate the Drug utilisation pattern in patients of diabetic nephropathy (stage 1-4) in a tertiary care hospital in South-Asia. METHODS: A cross-sectional observational study was conducted in the nephrology out-patient-department of a tertiary care hospital in South-Asia. WHO core prescribing, dispensing, and patient care indicators were evaluated, and adverse drug reactions (ADRs) encountered by the patients were analysed for causality, severity, preventability, and outcome. RESULTS: The most commonly prescribed antidiabetics in diabetic nephropathy patients were insulin (17.42%), followed by metformin (4.66%). Current drugs of choice SGLT-2 inhibitors were prescribed in a lesser frequency than expected. Loop diuretics and calcium channel blockers (CCBs) were the preferred antihypertensives. The use of ACE inhibitors (1.26%) and ARBs (3.45%) for hypertension was restricted to Stage 1 and 2 nephropathy. The patients were on 6.47 drugs on average. 30.70% of drugs were prescribed by generic names, 59.07% of the drugs were prescribed from the national essential drugs list and 34.03% of the prescribed drugs were supplied by the hospital. CTCAE grade 1 (68.60%) and grade 2 (22.09%) ADR severity was the highest. CONCLUSIONS: Prescribing patterns in patients of diabetic nephropathy were adapted from relevant medical evidence, affordability and availability of the drugs. Generic prescribing, availability of drugs and ADR preventability in the hospital have a broad scope for improvement.

A Pilot, Open-Label, Proof-of-Concept Study To Evaluate the Efficacy and Safety of Asthiposhak® Tablets in Participants Suffering From Asthikshaya or Osteopenia.

Introduction Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to debilitating bone fractures. This study aimed to assess the efficacy of Asthiposhak® Tablets in individuals with Asthikshaya (osteopenia) by measuring changes in the bone mineral density (BMD) score before and after the intervention, specifically between visit 1 (baseline) and visit 8 (after 180 days of treatment). Methods The single-arm study involved the screening of participants for Asthikshaya (osteopenia) using baseline investigations, which included a bone mineral density (BMD) assessment through a dual-energy X-ray absorptiometry (DEXA) scan. A total of 36 participants were enrolled in the study, who took two Asthiposhak Tablets three times a day with lukewarm water, for a period of 180 days. Safety assessments, along with evaluations of BMD (DEXA Scan), Ayurvedic Symptom Score, and serum biochemical markers, were conducted through blood investigations. Efficacy and safety data were analyzed using 'intention-to-treat' analysis. Descriptive statistics were used to express data in percentages, mean ± SD, or median (IQR). Data at different intervals were compared using paired t-tests or Wilcoxon signed-rank tests. One-way analysis of variance (ANOVA) with Bonferroni correction tested the significance between visits for the Ayurvedic Symptom Score, and Friedman's two-way analysis of variance by ranks measured differences in vital parameters. The significance level used was p<0.05. Results Out of the initially recruited 36 participants, 30 successfully completed the study, consisting of 12 males and 18 females, with an age range of 40 to 70 years and a mean age of 51.33 years. After 180 days of treatment with Asthiposhak Tablets, a statistically significant (p<0.05) improvement in hip and spine BMD (T-score) was observed. Additionally, significant reductions in the mean Total Ayurvedic Symptom Score were noted at both 90 and 180 days of treatment compared to day 0. Moreover, the levels of bone-specific alkaline phosphatase and osteocalcin, serum bone markers, showed statistically significant (p<0.05) reduction after 180 days of treatment compared to day 0. Importantly, all safety variables, including laboratory investigations, remained within the normal range following the 180-day treatment with Asthiposhak Tablets. Conclusion Asthiposhak Tablets exhibited significant efficacy in enhancing both BMD (T-score) and Ayurvedic Symptom Score, thereby substantiating their osteoprotective potential in individuals with Asthikshaya (osteopenia). Furthermore, the tablets were found to reduce the levels of biochemical markers, such as serum bone-specific alkaline phosphatase and osteocalcin, suggesting their anti-resorptive action.

A Pilot, Prospective, Randomized-Controlled Study to Evaluate the Efficacy and Safety of Arsha Hita™ in the Treatment of Anal Fissures.

Introduction Anal fissures are tears in the anal canal that cause pain, bleeding, and spasms. They can be treated with non-operative options such as sitz baths, local anesthetics, topical nitrates, oral fiber, and calcium channel blockers, but some patients require surgery. Topical nitrates have side effects such as severe headaches, while topical calcium channel blockers can cause itching. There is a need to explore alternative treatments with fewer side effects. This proof-of-concept pilot study aimed to compare the efficacy and safety of a combination of Arsha Hita™ tablets and ointment (Shree Dhootapapeshwar Limited, Mumbai Maharastra, India) (test treatment) with a combination of lidocaine 1.5% w/w + nifedipine 0.3% w/w cream for local application and Isabgol powder (6 g) orally as an active comparator (standard treatment), which is the standard treatment of anal fissures as per the Association of Colon and Rectal Surgeons of India (ACRSI) guidelines. Methodology This study was a single-center, prospective, randomized-controlled study conducted in Karnataka, India. Participants were screened for anal fissures and randomized to receive either standard treatment (Group A) or test treatment (Group B) for 14 days, and were re-evaluated after two, four, and six weeks. The study assessed signs and symptoms related to anal fissures, such as pain post-defecation on Visual Analog Scale (VAS), bleeding per anus grading, wound healing grade, stool consistency, and stool frequency. Compliance, inter-current illness, and concomitant therapy were noted at each visit. The study used independent sample t-tests to compare variables at baseline and chi-square or Fisher's exact tests to compare the number/proportion of participants achieving primary and secondary endpoints. Mann-Whitney U test was used to compare median composite scores at baseline and Visit 4, and Friedman's two-way analysis of variance was used to compare median composite scores across the four visits (p < 0.05 was considered significant). Descriptive analysis was used to assess VAS, bleeding, and healing grades. Results The study included 53 participants with anal fissures, of which 25 out of 27 allocated in Group A (two drop-outs) received standard treatment, and all 26 allocated in Group B received Arsha Hita treatment. At the end of the study, 11 participants in Group B achieved a 90% reduction in composite scores compared to only three patients in Group A (p<0.05). Both groups showed improvement in pain on defecation, severity of bleeding, healing of anal fissure wound, and participant's and physician's global impression score. Group B had significantly better results in terms of VAS score, resolution of per-anal bleeding, and physician's global impression score (p<0.05). There were no adverse events in either group during the six-week treatment period. Conclusion The pilot study provides evidence that the combination of Arsha Hita tablets and Arsha Hita ointment may be more effective and safer for treating anal fissures than the standard treatment. The test treatment group experienced greater pain relief, complete resolution of per-anal bleeding, and better global impression scores than the standard treatment group. These findings suggest the need for further research through larger, randomized controlled trials to determine the efficacy and safety of Arsha Hita in treating anal fissures.

Neuroinflammation and oxidative stress in schizophrenia: are these opportunities for repurposing?

PURPOSE: To summarize the main findings on the subject of neuroinflammation and oxidative stress in patients with Schizophrenia (SCZ). METHODS: A narrative review of all the relevant papers known to the authors was conducted. RESULTS: SCZ is a chronic, debilitating, neuropsychiatric disorder associated with an immense and adverse impact on both the patient and the caregiver, and impairs the overall quality of life. The current modality of treatment involves the use of antipsychotics to balance the disturbances in the neurotransmitters in the dopaminergic and serotonin pathways in the brain, which have a role to play in SCZ. Contemporary management of SCZ focuses mainly on symptomatic control due to the lack of effective curative treatments.Despite the optimum use of antipsychotics, there is a considerable proportion of the patient population who are poor responders. This has necessitated the exploration of new etiopathologies in order to evolve new modalities of treatment. This narrative review, conducted over a period of 3 months, throws light on the large-scale evidence pointing toward neuroinflammation and oxidative stress as key etiopathological markers that merit further consideration in SCZ, and may even be the basis for devising novel pharmacotherapies for SCZ. CONCLUSIONS: This review discusses the various plausible hypotheses, viz., cytokine hypothesis of peripheral inflammation, acute-phase reactants in SCZ, microglial hypothesis of central inflammation, neurogenesis in relation to neuroinflammation, and oxidative stress in SCZ. It also highlights the many opportunities available for repurposing already marketed drugs with anti-inflammatory and antioxidant properties with a view to devising more effective and comprehensive therapies to manage SCZ.

A Cost-Variation Analysis of Drugs Available in the Indian Market for the Management of Diabetic Nephropathy.

Background Diabetic nephropathy is associated with polypharmacy and increased out-of-pocket expenditure for the patients. Multiple brands of each prescribed drug are available in the market. Hence, there is a need to evaluate the cost variation of the available brands of prescribed drugs. Methodology All drugs prescribed to the 282 patients with diabetic nephropathy from our previous cross-sectional observational drug utilization study were included. Data regarding the cost of various brands of the prescribed drugs were obtained from Current Index of Medical Specialities (CIMS) android application version 3.1.2 and Indian online pharmacies. The percentage price variation and cost ratio for these drugs were determined. A correlation analysis was conducted between the number of brands and percentage price variation. Results A high percentage price variation (>1,000%) and cost ratio (>10) was observed for 19 out of 39 drugs that were evaluated. The highest price variations were seen with amlodipine (16,799%), metformin (11,240%), and glimepiride (10,525%). The highest cost ratios were seen with amlodipine (168), metformin (113.40%), and glimepiride (106.25%). There was a negligible correlation between the number of brands and percentage price variation. Conclusions The above findings indicate that drug price variations need to be monitored more strictly. The present study may aid physicians in understanding the degree of price variation among medications used for the treatment of diabetic nephropathy, thereby necessitating the selection of a P-drug to increase the affordability of drugs for patients.

Validity and Reliability of a Questionnaire Measuring Knowledge, Attitude, and Practice Regarding Dementia Among General Population and Healthcare Workers in Urban India.

Objective: The present study aimed to validate a questionnaire and measure the previous knowledge, attitude, and practice (KAP) of the general population and healthcare professionals regarding the debilitating disorder of dementia. Design: A questionnaire including 27 items was compiled by the authors and was circulated via the online platform. Setting:A questionnaire-based survey was conducted using the online modality. Participants: A convenience sampling method was used to recruit participants aged 18 and above from all walks of life. Measurements: Test-retest reliability, item analysis, and Cronbach's alpha were calculated for the compiled questionnaire. The responses of the participants were assessed using descriptive statistics and the chi-square test. Results: A total of 503 responses were collected. The internal consistency (Cronbach's alpha=0.70) was acceptable and the test-retest reliability (0.823) was good. Eighty-one percent (408/503) of participants had heard the word dementia. Seven percent (27/408) of the participants who had heard the word dementia did not have any knowledge about the symptoms of dementia. Thirty-three percent (136/408) of participants believed that dementia could not be prevented. Almost half, i.e., 46% (187/408) of participants, considered dementia as a normal part of aging. Conclusions: The present study provides a fully validated questionnaire, which could prove helpful in research as it permits generating high-quality data and reducing measurement error. Knowledge of dementia among the general participants seems to be moderate and prompts towards the development of advocacy programs.