Current Status of Delamanid in the Management of MDR Tuberculosis.

Delamanid is a nitro-dihydro-imidazooxazole compound which was developed by a Japanese company, Otsuka Holdings inc. and has shown in-vitro and in-vivo activity against drug resistant tuberculosis. The drug exerts its anti-mycobacterial activity by inhibition of mycolic acid biosynthesis, leading to defective cell wall formation ultimately leading to bacterial death. Following the promising results in Phase 2 trials, Delamanid received approval in European Union in 2014, following which it was also approved in Japan and Korea in the same year. It was approved in India recently in August, 2017. Though relatively well tolerated, there have been concerns due to QT prolongation associated with the use of Delamanid. WHO has currently recommended use of Delamanid in combination with optimized background regimen in patients with pulmonary TB (conditional recommendation). More data from clinical trials and observational studies is awaited regarding use of Delamanid in children, HIV co-infection, pregnant women and use in combination with Bedaquiline.

Current Burden of Atopic Dermatitis in India: A Systematic Literature Review.

Atopic dermatitis (AD) is a common chronic dermatological condition affecting ~10% of adults and ~20% of the paediatric population in high-income countries. There is a lack of comprehensive understanding of the disease burden of AD in India. In this systematic review, the primary objective was to review epidemiological data on AD in India based on articles published between 2011 and 2021. The secondary objective was to assess the disease burden from economic and quality of life (QoL) perspectives. A literature search was conducted using the PubMed and Google Scholar databases using predefined search strings. Relevant studies published in English on AD between 2011 and 2021 were included. This review included 11 articles, of which nine reported demographic and clinical characteristics. The reported prevalence ranged from 3.1% to 7.21% among the paediatric population, up to 16 years of age. The prevalence of AD ranged from 0.98% to 9.2% in studies including paediatric and adult patients. The cost of medications was reported to be the major contributor to the economic burden associated with AD. Mental illnesses such as depression and anxiety were frequently reported in association with AD. Although AD is a common disorder affecting all age groups, there is a lack of substantial epidemiological data. None of the current studies covers the entire country. Hence, studies with a wider geographic scope covering all aspects of disease burden are required to help clinicians and policymakers to understand the disease burden and devise appropriate preventive and management strategies.

Assessment of the quality and trend of reporting of health economic evaluation research in India.

Objectives: This study was conducted to assess the reporting quality of health economic evaluation studies using Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement along with an analysis of their trend in India.Methods: Following ethical review exemption, PubMed and Google scholar were searched for Indian studies published in 5 years (2014-2019). Keywords used were cost-effectiveness, cost-benefit, cost-utility, and cost-minimization analysis, economic evaluation, and India. CHEERS statement was used to assess the reporting quality and trend was studied using variables like a published year, type of analysis, therapy area, intervention. Data were analyzed using descriptive statistics.Results: Of the 39 studies analyzed, 17 scored less than 18 (represents 75% compliance) with a minimum score of 9 and a maximum of 23. The reporting quality was deficient with respect to heterogeneity characterization (25 studies), discount rate (18 studies), model choice, and assumptions (18 studies). Cost - effectiveness was the most common PE analysis (27 studies). The most commonly studied therapy area was infectious disorders (10) followed by oncology (5), and the commonest intervention was drugs (22).Conclusion: Inadequacy in reporting quality of health economic evaluation studies is evident. The trend revealed cost-effectiveness to be the most commonly performed type of analysis.Expert Opinion: Health economic evaluation research has gained considerable importance in healthcare decision making. Reporting quality is critical to enable efficient interpretation of health economic evaluation research. These studies have many elements, each of which have a significant impact on the conduct and outcome of the study. Hence, it is advisable to refer to any of the available guidelines [eg. CHEERS checklist] while preparing the manuscript so as to ensure all crucial elements of the study have been reported.

Current status of clinical research using artificial intelligence techniques: A registry-based audit.

BACKGROUND AND OBJECTIVES: Artificial intelligence (AI) as a field has recently gained a lot of importance and is expected to revolutionize the health-care scenario in the near future. There have been no studies done worldwide to review the status of research with respect to the use of AI in health care. Hence, we conceptualized this study to get an overview of the clinical studies being conducted in the field of AI, by analyzing those registered on the Food and Drug Administration trial registry website. METHODOLOGY: All the clinical studies conducted in the field of AI registered on the ClinicalTrials.gov website up to September 2019 were reviewed and analyzed. The variables such as geographical distribution, study design, status of study whether ongoing or completed, therapy area, type of intervention tested, type of funding, and year of initiation of study were recorded. The data were analyzed using descriptive statistics using SPSS for Windows, Version 16.0 (SPSS Inc. Chicago, IL, USA). RESULTS: Out of all the studies registered, 156 were related to AI. Of these 156 studies, 84 were interventional and 72 were observational. The most common therapy area under study was oncology with 26.3% studies, followed by cardiology, ophthalmology, psychiatry, and neurology. Devices comprised the most common intervention being studied, accounting to 34% of studies, followed by diagnostics which included 28% of studies. In the first 8 months of 2019 itself, 65 studies had been registered. CONCLUSION: The study revealed an increasing trend in the studies being conducted using AI techniques, with majority being conducted in the area of oncology, with medical devices being the most common intervention being tested.

An Audit of Clinical Studies Involving Elderly Population Registered in Clinical Trials Registry of India.

CONTEXT: The elderly in India form a heterogeneous subset of the population with significant disease burden variations. However, there are no data available regarding the type of research studies conducted in an elderly population in India. AIMS: The aim of this study was to analyze the research studies conducted in the elderly population in India based on data from the Clinical Trials Registry of India (CTRI). SETTINGS AND DESIGN: This was an "audit" of available data on the CTRI website. PARTICIPANTS AND METHODS: Following exemption from the Institutional Ethics Committee, all studies in the elderly population registered in CTRI from its inception (July 2007 to August 2019) were reviewed. Data captured with respect to geographical distribution, study designs used, therapy area, trial registration, and funding. STATISTICAL ANALYSIS USED: The variables were analyzed using descriptive statistics using SPSS version 16.0. RESULTS: Out of a total of 21,400 studies in CTRI, a total of 99 (0.46%) studies involved only elderly patients. Of these studies, 60 (60.6%) were interventional, whereas 39 (39.4%) were observational. Of all the interventional studies, 17 (28%) tested drugs, 26 (43%) tested a lifestyle intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and physiotherapy. Postgraduate theses constituted 60 (60.6%) studies. Eighty-seven (87.9%) were academic projects, eight (8.1%) were government-funded studies, and only four (4%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was the central nervous system, followed by community medicine and orthopedics. CONCLUSIONS: This study depicts the underrepresentation of the geriatric population in clinical studies.

A review of clinical studies involving pregnant women registered in the Clinical Trials Registry of India.

CONTEXT AND AIMS: Pregnant women undergo physiological changes which influence the efficacy as well as safety of medications used. Very few drugs are tested and approved for medical conditions during pregnancy, and less pharmacokinetic data are available to form clinical treatment guidelines. There was no data available regarding the type of research studies conducted in pregnancy in India. Hence, we conducted this study to analyze the type of research studies in pregnancy registered in the Clinical Trials Registry of India (CTRI). SUBJECTS AND METHODS: Following exemption from review by the Institutional Ethics Committee, all studies in pregnant women registered in CTRI from its inception in July 2007 to June 2018 were reviewed. Data were captured with respect to geographical distribution, trimester of pregnancy, study designs used, therapy area, and funding. STATISTICAL ANALYSIS USED: The variables were analyzed using descriptive statistics using SPSS version 16.0. RESULTS: Out of a total of 14,911 studies in CTRI, a total of 285 (1.91%) studies involved pregnant women. Of these studies, 199 (69.8%) were interventional, whereas 86 (30.1%) were observational. Of all the interventional studies, 119 (60%) tested drugs, 47 (24%) tested a nondrug intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and vaccines. Postgraduate theses constituted 140 (49.1%) studies, 79 (27.7%) were academic projects, 27 (9.4%) were government-funded studies, and only 16 (5.6%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was anesthesia, followed by hypertension and induction of labor. CONCLUSIONS: This study depicts underrepresentation of pregnant women in clinical studies and more evidence needs to be generated with respect to drug safety and pharmacokinetics.

Use of Topical Steroids in Dermatology: A Questionnaire Based Study.

CONTEXT: Topical steroids, the most widely prescribed drugs in dermatology are being increasingly misused. AIMS: This study was conducted to assess knowledge and practices regarding the use of topical steroids and to analyze prescriptions containing topical steroids. SUBJECTS AND METHODS: Following approval from the institutional ethics committee, participants were recruited as per the selection criteria and divided into those treated in the institution and those having outside prescription. They were administered a pre-validated questionnaire to assess knowledge and practices regarding the use of topical steroids. STATISTICAL ANALYSIS USED: Comparison of awareness between two patient categories was done using Chi-square test. Prescription variables were analyzed using descriptive statistics. Significance of P value was set at 0.05. RESULTS: Out of 400 patients, 167 had external prescriptions whereas 233 were institutional patients. Only 5.5% of all patients knew about the type of drug prescribed whereas 31.25% were aware of the indication. A total of 33.75% of the patients knew topical steroids required a prescription and 5.6% said they were aware that topical steroid use was associated with side effects. Side effects were reported by 96 patients. Awareness regarding knowledge, indication, and need for prescription were significantly better in institutional patients whereas knowledge about side effects was lacking in both groups. Psoriasis was the most common indication overall whereas tinea was the most common indication (51.5%) among externally prescribed. CONCLUSIONS: Although this study showed that institutional patients had comparatively better knowledge than community-treated patients, there is a need to create more awareness among patients overall and implement measures to stop irrational prescribing practices in the community.