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   2022| January-March  | Volume 13 | Issue 1  
    Online since January 6, 2022

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A review of medical device regulations in India, comparison with European Union and way-ahead
Manas Manu, Gaurav Anand
January-March 2022, 13(1):3-11
Indian healthcare sector is a fast-growing industry which is expected to reach $280 billion by 2025. Medical devices market in India is one of the top 20 medical device markets in the world. It is currently valued at $5.2 billion and is expected to reach $50 billion by 2025. However, India does not manufacture many devices indigenously and still imports approximately 70% of its medical devices. Manufacturing and monitoring of medical devices are highly regulated activities. In India, there were no specific medical device regulations and devices were regulated under the Drugs and Cosmetics Act, 1940. To fulfill this gap, Central Drug Standard Control Organization released Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India. Keeping pace with the requirements, these were amended as Medical Devices (Amendment) Rules, 2020, which has come into force in April 2020. These rules cover various aspects of device related regulations, including classification, registration, manufacturing and import, labeling, sales, and postmarket requirements, etc. The rules are a positive step and encompass most of the European Union (EU) approval process, which mandates that the devices are safe and performs its intended function. However, with rapid advancements in medical device technology, much is desired in clarity and revamping of the current regulatory system to harmonize standards to be in-line with advanced regulations like EU.
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The medical science liaison role in Spain: A nationwide survey
Víctor Sastre, Adela Matesanz-Marín, Cristina García, Antonio González del Castillo
January-March 2022, 13(1):48-53
Context and Aims: The Medical Science Liaison's (MSL's) value to the company has evolved into a more strategic role with a wide variety of responsibilities. We conducted an online survey of current MSLs nationwide to assess their profile, activity development, performance evaluation, and career development. Subjects and Methods: A 37-item survey was hosted on SurveyMonkey© and accessible from December 2018 to February 2019. The survey was open to current MSLs from different pharmaceutical companies in Spain and included questions about the participant profile, activity development, performance evaluation, and career development. Statistical Analysis Used: The results were expressed as valid percentages; to establish relationships between the answers to different questions, exclusion and comparison filters were used on the web platform. Results: A total of 179 MSLs responded to the anonymous survey. Off-label information management (79%), relationships with key opinion leaders (76%), continuous medical training for HCPs (70%), involvement in clinical trials/investigator-initiated trials (68%), and elaboration of the National Strategy (67%) were mentioned as the top new competencies. Fifty-eight percent spend an average of 61%–80% of their time out in the field and 68% use remote interactions. Fifty-six percent did not agree that their current performance metrics are a reflection of their true value. Forty-five percent of the participants disagreed when asked if their activity is easily balanced with their personal lives. Conclusions: Based on our findings, we believe that there is a need to consider the MSL's strategic priorities, to define metrics that accurately assess MSL performance, and to find ways to fully maximize their limited time.
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A study to monitor errors in use of inhalation devices in patients of mild-to-moderate bronchial asthma in a tertiary care hospital in Eastern India
Neha Akhoon, DB S. Brashier
January-March 2022, 13(1):17-24
Context: Bronchial asthma is a chronic respiratory disorder which affects over 300 million people worldwide. Inhalation pharmacotherapy is the cornerstone in treatment of asthma, which is administered using inhaler devices. Studies show high prevalence of incorrect technique while inhaler usage, which renders to compromised disease control and increased healthcare cost. Aims: This study was aimed to monitor errors in use of inhalers and explore their relationship with patient characteristics and training given by healthcare providers, in patients suffering from mild to moderate bronchial asthma. Settings and Design: This was an observational cross-sectional study conducted after approval of Institutional ethics committee in a tertiary care hospital. Methods and Material: A total of 207 patients were recruited after they met the inclusion criteria and their informed consent was taken. Data regarding the patients’ socio-demographic information, education status and history of illness were logged on a case record form. Their inhalation techniques were assessed according to the checklist, errors were noted and patients were educated regarding correct technique using ‘teach-back training’ method. Statistical analysis used: Chi-square test, SPSS software. Results: Among the inhalers used, pMDI was most commonly prescribed (58%), followed by DPI (37.7%) and pMDI with spacer (4.3%). Irrespective of the type of inhaler used, overall 75.36% patients included in the study, showed errors in use of inhaler. Prevalence of errors in DPI, pMDI and pMDI with spacers was 78.2 %,77.8% and 22.2% respectively. Our study showed that education status of patient, training by healthcare provider and duration of inhaler use have statistically significant association (p<0.05) with the prevalence of errors in inhaler usage. Conclusion: It is emphasized that dedicated and trained staff should be available for instructing patients and reinforcing by follow up checks should be considered.
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Drug use evaluation of cephalosporins in a tertiary care hospital
Yashashri C Shetty, PS Manjesh, Widhi Churiwala, Sakshi M Jain, Vishal K Singh
January-March 2022, 13(1):38-42
Background: Infectious disease burden in India is among the largest in the world. Cephalosporins are being used extensively in the current scenario, both empirically and as definitive treatment. With this information, we tried to evaluate the prescription pattern of drugs for infections in medicine and general surgical wards of a tertiary care hospital and evaluate the utilization of cephalosporins in the same. Methodology: The study was conducted for a duration of 3 months in a tertiary care hospital after approval from the Institutional Ethics Committee, and permission of the respective heads of the surgery and medicine departments was obtained. After satisfying the inclusion criteria, participants' demographic details and the prescription notes by the treating doctor were noted and analyzed. The WHO prescription indicators were analyzed and the prescriptions were evaluated for the completeness of them. The utilization of cephalosporins was evaluated based on the institutional standard treatment guideline (STG) – Guidelines for Antimicrobial Therapy and Prophylaxis, 2014. Data were analyzed using descriptive statistics. Results: A total of 600 patients were recruited, of which 350 were male and 250 were female. A total of 4341 drugs were prescribed. On an average, 7 drugs per prescription were found. The generic drugs prescribed were 27% (1163). Among the drugs prescribed, 19% (850) were antibiotics, of which 36.94% (314) were cephalosporins and 81% (3491) were other drugs. Ninety-four percent (565) prescriptions were incomplete (in terms of dose, frequency, duration, or dosage form). After referring to the STG, we found that cephalosporins were prescribed empirically in 40% (126) cases, of which medicine prescriptions accounted for it the most. Conclusion: Cephalosporins are extensively prescribed in medicine and surgery wards of the tertiary care hospital.
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A retrospective cross-sectional descriptive study to critically appraise the quality of reporting of health economic evaluations conducted in the Indian setting
Sandeep Kumar Gupta, Ravi Kant Tiwari, Raj Kumar Goel
January-March 2022, 13(1):25-32
Background: The reporting quality of economic research could benefit from enhanced quality assurance procedures. At present, there are small numbers of health economic researches being conducted with Indian context or setting. There is not much clarity about the reporting quality of health economic researches being conducted with Indian context or setting. Objective: The primary objective is to of this study was to appraise the quality of reporting of health economic evaluations conducted in the Indian setting and published between January 2014 and December 2018. Materials and Methods: This was a retrospective, cross-sectional, descriptive analysis. The MEDLINE in PubMed, Google Scholar, and Science Direct were systematically searched to search for economic evaluations. The consolidated health economic evaluation reporting standards statement checklist was utilized to assess the quality of reporting of the included studies. For grading the quality of the included health economic assessments, the Quality of Health Evaluation Studies (QHES) instrument was used. Results: Thirty studies fulfilled the inclusion criteria and were included in the study. The mean QHES score was 80.26 (standard deviation = 8.06). Twenty-five (83.33%, 95% confidence interval [CI]: 0.66–0.92) of the article mentioned perspective of the study. Twenty-nine (96.66%, 95% CI: 0.83–0.99) of the article described the effects of uncertainty for all input parameters. Twenty (66.66%, 95% CI: 0.48–0.80) of the article reported all funding sources. Conclusions: Overall, the quality of reporting of the included health economic studies was good, which reemphasizes their usefulness in supporting the decision-making procedure about better medicine. The finding of this study will be a small step toward ensuring robust and high-quality health economics data in India.
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The critical appraisal of randomized controlled trials published in an Indian journal to assess the quality of reporting: A retrospective, cross-sectional study
Sandeep Kumar Gupta, Ravi Kant Tiwari, Raj Kumar Goel
January-March 2022, 13(1):33-37
Background: Although randomized controlled trials (RCTs) are the highest levels of evidence, they might not necessarily be of good quality. Hence, RCTs should always be appraised critically. Critical appraisal is the corroboration of evidence by methodically studying its validity, reliability, and applicability. Objective: The primary objective of this study was to do a critical appraisal of the RCTs published in Indian Journal of Pharmacology (IJP) from 2011 to 2016. The secondary objective was to scrutinize how adequately the published RCTs adhere to the Consolidated Standards of Reporting Trials (CONSORT) declaration. Materials and Methods: The present study included all RCTs published as full-text articles in IJP from January 2011 to December 2016. The identified RCTs were critically appraised using the critical appraisal checklist based on CONSORT 2010 guidelines and its extensions. Results: According to this analysis, 75% (95% confidence interval [CI]: 0.56–0.87) of the articles had given details about the sample size calculation. Nearly 89.29% (95% CI: 0.72–0.96) of the articles described the method for generating random allocation sequence, but only 35.71% (95% CI: 0.20–0.54) of the articles described allocation concealment method. Almost 35.71% (95% CI: 0.20–0.54) of the trials reported results as per the principle of the intention to treat (ITT). Nearly 21.43% (95% CI: 0.10–0.39) of the studies reported CIs in the present study. Conclusion: Allocation concealment method, analysis of the data based on the ITT principle, and reporting CIs were found to be underreported in this study. There should be more emphasis on reporting of allocation concealment, ITT analysis, and CI.
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Observational designs for real-world evidence studies
Santosh Ramesh Taur
January-March 2022, 13(1):12-16
In the era of evidence-based medicine, real-world evidence (RWE) studies have opened avenues to utilize real-world data (RWD) effectively for improving clinical decision-making. However, the transformation of RWD into a meaningful RWE can only be achieved when the researcher asks the right clinical question, selects the right RWD source for variables of interest, uses the right study design, and applies the right statistical analysis. The generated RWE needs to have internal as well as external validity to be actionable. The “fit-for-purpose” observational study designs include descriptive, case–control, cross-sectional, and cohort. This article focuses on the advantages and disadvantages including the inherent bias of each study design. The RWE study decision guide has also been provided to aid the selection of appropriate study designs.
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Knowledge, attitudes, and perception of 398 cancer patients toward participation in clinical trials: A single-center study from New Delhi, India
Vishal Kumar Biswkarma, Nitesh Rohatgi, Rajesh Saxena, SK Gupta
January-March 2022, 13(1):43-47
Background and Objective: Clinical trials are considered to be the gold standard research methodology for evaluating the efficacy and safety of healthcare interventions. Materials and Methods: A cross-sectional study was conducted using standardized self-administered questionnaires prepared by the research team and statistician. The questionnaires were offered to cancer patients presented at a tertiary care center. Results: We surveyed 398 cancer patients, 193 (48.5%) males and 205 (51.5%) females with a mean (±standard deviation) 55.39 (±13.59) of age in years. Out of total, only 59 (14.82%) had the prior knowledge of the clinical trial. Forty-three (10.80%) participants were willing to participate in clinical trials. Conclusion: Cancer patients had preconceived notions and myths that linger in our society that clinical trial participation will harm them. The researchers/oncologists need to explore the rationale, objectives, and benefits of taking part in clinical trials and make it easy to understand by cancer patients.
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Clinical trials and Consolidated Standards of Reporting Trials: Continuing concerns of compliance in COVID-19 era
Arun Bhatt
January-March 2022, 13(1):1-2
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Non-inferiority trials
Priya Ranganathan, CS Pramesh, Rakesh Aggarwal
January-March 2022, 13(1):54-57
Studies sometimes aim to show that a new intervention is not substantially worse than the existing standard of care while offering some benefits, for example, lower cost, decreased toxicity, or easier administration. Such studies are called non-inferiority (NI) trials. In this article, we look at some aspects of NI trials.
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Identifying barriers to report adverse drug reactions using the Delphi method: Experience from an institute of national importance of India
Bikash Ranjan Meher, Rashmi Ranjan Mohanty
January-March 2022, 13(1):58-59
Background: Spontaneous reporting of suspected adverse drug reaction (ADR) is an essential component of pharmacovigilance program, however, under reporting is a major drawback of it. Medical professionals cite many reasons for their inability to report suspected ADRs. Objective: This study aimed to seek consensus among resident doctors regarding barriers to report ADRs. Method: A two-round Delphi consensus study was conducted among resident doctors of a tertiary care institute of India. The participants used a five-point Likert scale to indicate each question of an initial questionnaire whether it should be considered a barrier for reporting ADR. The items for which ≥80% of all respondents agreed or strongly agreed were accepted as barrier for reporting ADR. Results: Forty-five participants completed the Delphi survey. Out of 25 questions participants unanimously selected 9 items such as unavailability of reporting form, complexity in filling reporting form and lack of motivation as barriers for reporting ADR. Conclusion: Using a Delphi method, this study identified a set of statements perceived as barriers by participants for reporting ADR
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Virtual ethics committee meeting during the COVID-associated lockdown – Madras Diabetes Research Foundation Experience
Subramani Poongothai, Ramasamy Aarthy, Mokkapati Lalasa, Kannikan Viswanathan, Viswanathan Mohan
January-March 2022, 13(1):60-61
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