Pub Date : 2023-01-01Epub Date: 2023-01-06DOI: 10.4103/picr.picr_253_22
Shagufta Bhangu, Fabien Provost, Carlo Caduff
Qualitative research methods are widely used in the social sciences and the humanities, but they can also complement quantitative approaches used in clinical research. In this article, we discuss the key features and contributions of qualitative research methods.
{"title":"Introduction to qualitative research methods - Part I.","authors":"Shagufta Bhangu, Fabien Provost, Carlo Caduff","doi":"10.4103/picr.picr_253_22","DOIUrl":"10.4103/picr.picr_253_22","url":null,"abstract":"<p><p>Qualitative research methods are widely used in the social sciences and the humanities, but they can also complement quantitative approaches used in clinical research. In this article, we discuss the key features and contributions of qualitative research methods.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/63/1c/PCR-14-39.PMC10003579.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and Objectives: Evidence-based medicine (EBM) promotes the integration of updated– best evidence with patient preferences and medical expertise for clinical decision-making. Despite the availability of high-quality evidence such as systematic review and meta-analysis, some clinicians manage their patients based on past experiences and expert opinion. Thus, this study was proposed to assess the knowledge, attitude, and practice of EBM among resident doctors at a tertiary care hospital in India. Participants and Methods: This cross-sectional questionnaire-based study was conducted among senior residents and final-year postgraduates (PGs) who were independently involved in clinical decision-making. By convenience sampling method, the participants were recruited, and the validated EBM Questionnaire (EBMQ) was distributed online for assessing the knowledge, attitude, and practice of EBM. Descriptive statistics were represented as frequency and proportions. Results: A total of 102 resident doctors participated with male preponderance (74.5%). Nearly, 96 (94.1%) participants were already practicing EBM and 21.6% had undergone EBM training. Textbooks (50%) were the most often referred sources for EBM information. Specific EBM databases such as MEDLINE and Cochrane were also utilized by 37.3% of participants. More than 70% of participants understood the terms such as a randomized controlled trial, case–control study, and P value. A higher proportion (80.4%) of participants showed a positive attitude about patient care improved by EBM. Conclusions: The majority of the resident doctors exhibited good knowledge and a positive attitude toward applying EBM in clinical decision-making. Periodic training through workshops or courses and integration of EBM with the PG curriculum would potentially enhance the EBM practice.
{"title":"A cross-sectional study evaluating the knowledge, attitude, and practice of evidence-based medicine among resident doctors of a health-care Institution of National Importance in India","authors":"Vivekraj Navabalan, Indumathi Prabath, Suja Xaviar, Jayanthi Mathaiyan","doi":"10.4103/picr.picr_172_22","DOIUrl":"https://doi.org/10.4103/picr.picr_172_22","url":null,"abstract":"Background and Objectives: Evidence-based medicine (EBM) promotes the integration of updated– best evidence with patient preferences and medical expertise for clinical decision-making. Despite the availability of high-quality evidence such as systematic review and meta-analysis, some clinicians manage their patients based on past experiences and expert opinion. Thus, this study was proposed to assess the knowledge, attitude, and practice of EBM among resident doctors at a tertiary care hospital in India. Participants and Methods: This cross-sectional questionnaire-based study was conducted among senior residents and final-year postgraduates (PGs) who were independently involved in clinical decision-making. By convenience sampling method, the participants were recruited, and the validated EBM Questionnaire (EBMQ) was distributed online for assessing the knowledge, attitude, and practice of EBM. Descriptive statistics were represented as frequency and proportions. Results: A total of 102 resident doctors participated with male preponderance (74.5%). Nearly, 96 (94.1%) participants were already practicing EBM and 21.6% had undergone EBM training. Textbooks (50%) were the most often referred sources for EBM information. Specific EBM databases such as MEDLINE and Cochrane were also utilized by 37.3% of participants. More than 70% of participants understood the terms such as a randomized controlled trial, case–control study, and P value. A higher proportion (80.4%) of participants showed a positive attitude about patient care improved by EBM. Conclusions: The majority of the resident doctors exhibited good knowledge and a positive attitude toward applying EBM in clinical decision-making. Periodic training through workshops or courses and integration of EBM with the PG curriculum would potentially enhance the EBM practice.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: In 2019, the Central Drugs Standard Control Organization (CDSCO) introduced the New Drugs and Clinical Trials Rules 2019 (NDCTR), which separated the research guidelines for “Clinical Trials” and “Biomedical and Health Research.” As a result, guidelines issued by Indian Council of Medical Research were stated to apply to academic clinical trials (ACTs). This change is important because academic studies are crucial for scientific advancement and repurposing of approved drugs in health-care industry. However, conducting an ACT can pose challenges. We assessed the level of awareness, knowledge, and challenges faced by investigators. Our aim is to overcome some of these challenges and encourage more academic studies for the betterment of healthcare and scientific knowledge in India. Methodology: The study was conducted in two phases after obtaining approval from the Institutional Ethics Committee (EC) of three tertiary care hospitals in Mumbai. In the first phase, the number of ACTs was assessed from the clinical trial registry India website, while the number of registered and re-registered ECs were assessed from the CDSCO website. The second phase involved assessing investigator awareness and knowledge about ACTs using a prevalidated questionnaire with a content validity index score of 0.93. Results: In 2020, the highest numbers of studies were registered, with the highest numbers of registered and re-registered ECs from Maharashtra. All participants completed the questionnaire and were aware of the need to follow guidelines for clinical trials. Sixty-seven percent of participants knew that the guidelines for ACTs differed from those of sponsored clinical trials, but only 58% were aware of the exact definition of an ACT as per NDCTR, 2019. Eighty-five percent of participants knew who could initiate an ACT, but only 27% knew about the applicability of results of an ACT and 33% had in-depth knowledge about the required approvals, while only 10% knew the archival period. Although 71% of participants had knowledge about serious adverse event reporting, few answered in-depth questions correctly. Only 31 participants reported facing varied challenges. Conclusion: To conduct ACTs effectively and contribute to healthcare and scientific advancement, it is crucial to enhance investigators’ existing knowledge about ACTs.
{"title":"Investigator knowledge, awareness, and registrations of academic clinical trials with the Clinical Trial Registry of India: An observational study","authors":"Shruti Bhide, Saurabh Patil, Amitoj Sohal, Neha Kadhe, Renuka Munshi, Chetan Phirke, Snehal Ambre, Sudhir Pawar, Ruchita Patil","doi":"10.4103/picr.picr_68_23","DOIUrl":"https://doi.org/10.4103/picr.picr_68_23","url":null,"abstract":"Introduction: In 2019, the Central Drugs Standard Control Organization (CDSCO) introduced the New Drugs and Clinical Trials Rules 2019 (NDCTR), which separated the research guidelines for “Clinical Trials” and “Biomedical and Health Research.” As a result, guidelines issued by Indian Council of Medical Research were stated to apply to academic clinical trials (ACTs). This change is important because academic studies are crucial for scientific advancement and repurposing of approved drugs in health-care industry. However, conducting an ACT can pose challenges. We assessed the level of awareness, knowledge, and challenges faced by investigators. Our aim is to overcome some of these challenges and encourage more academic studies for the betterment of healthcare and scientific knowledge in India. Methodology: The study was conducted in two phases after obtaining approval from the Institutional Ethics Committee (EC) of three tertiary care hospitals in Mumbai. In the first phase, the number of ACTs was assessed from the clinical trial registry India website, while the number of registered and re-registered ECs were assessed from the CDSCO website. The second phase involved assessing investigator awareness and knowledge about ACTs using a prevalidated questionnaire with a content validity index score of 0.93. Results: In 2020, the highest numbers of studies were registered, with the highest numbers of registered and re-registered ECs from Maharashtra. All participants completed the questionnaire and were aware of the need to follow guidelines for clinical trials. Sixty-seven percent of participants knew that the guidelines for ACTs differed from those of sponsored clinical trials, but only 58% were aware of the exact definition of an ACT as per NDCTR, 2019. Eighty-five percent of participants knew who could initiate an ACT, but only 27% knew about the applicability of results of an ACT and 33% had in-depth knowledge about the required approvals, while only 10% knew the archival period. Although 71% of participants had knowledge about serious adverse event reporting, few answered in-depth questions correctly. Only 31 participants reported facing varied challenges. Conclusion: To conduct ACTs effectively and contribute to healthcare and scientific advancement, it is crucial to enhance investigators’ existing knowledge about ACTs.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.4103/picr.picr_242_22
Sanjay Pattanshetty, ViolaSavy Dsouza, JestinaRachel Kurian, K Cauvery, Lada Leyens, Helmut Brand
INTRODUCTION Increased international travel and trade, changes in lifestyle, microbial resistance, and climate change, which allow endemics to proliferate, all contribute to the accelerated spread of infectious diseases (IDs). It is crucial to collaborate through shared knowledge and skills to combat these risks. Prioritizing clinical trials in infectious disease (CTI) in a cooperative and multipronged manner is essential to the successful elimination of threats.[1] Building a strong research and innovation ecosystem is one of the important agendas of the G20 presidency in responding to these global crises (e.g., Ebola and Zika).[2] India gears up for its 2023 G20 presidency, as the global economy teeters on the brink of recession as it recovers from the grip of COVID-19.[3] At this juncture, it is beneficial to obtain a macroscopic overview of the state of collaboration between G20 nations in CTI research. METHODOLOGY Studies published by G20-affiliated authors between 2010 and 2022 were retrieved from PubMed and the Web of Science using relevant search strategies. After data cleaning using thesaurus file, we eliminated duplicates and categorized the collectively represented European Union (EU) member states as “EU” except France, Germany, and Italy, as they are individually represented in G20. The final dataset was used for bibliometric analysis using VOSviewer consisted of metadata of articles extracted from the Web of Science.[4] Coauthorship and co-occurrence analysis was performed as a component of bibliometric analysis. RESULTS Three thousand six hundred and thirty-six articles were included in the study. Between 2013 and 2014, the number of publications with international collaborations increased by 5.8%. The United States of America (USA) had the most publications among the G20 nations (28.2%), followed by the United Kingdom (UK) (10.3%) and Germany at 6.2%. India is ranked 13, accounting for 2.4% of all publications. The use of keywords such as HIV/AIDS, COVID-19, hepatitis, and influenza are relatively frequent. India has collaborated with G20 nations on over 203 clinical trials from 2010 to 2022. India has collaborated closely with the USA, followed by the UK and Australia. DISCUSSION According to the key findings of our study, most clinical trials undertaken in partnership with G20 countries are the USA, the UK, and Germany. Industrialized nations are dominating publications likely as a result of relative research funding capacity and the English proficiency advantage. Rethinking of funding policies in health research to direct and incentivize institutions and researchers can improve.[5] Viral infections such as HIV/AIDS, COVID-19, and hepatitis are frequently occurring keywords indicating that research on these fields is attracting international collaborations. With the emergence of the COVID-19 pandemic, there has been a sharp increase-related research focused on preventing and containing such a pandemic.[6] COVID-19-driven resurge
国际旅行和贸易的增加、生活方式的改变、微生物耐药性和气候变化使地方病得以扩散，所有这些都促进了传染病的加速传播。通过共享知识和技能开展合作，抗击这些风险至关重要。以合作和多管齐下的方式确定传染病临床试验的优先顺序对于成功消除威胁至关重要。[1]建立一个强大的研究和创新生态系统是G20主席国应对这些全球危机(如埃博拉和寨卡病毒)的重要议程之一。[2]印度为2023年G20轮值主席国做准备，目前全球经济正从COVID-19的控制中复苏，处于衰退的边缘。[3]在这个关键时刻，对G20国家在CTI研究中的合作状况有一个宏观的概述是有益的。方法使用相关搜索策略从PubMed和Web of Science检索2010年至2022年间g20成员作者发表的研究。在使用同义词库文件进行数据清理后，我们消除了重复项，并将除法国、德国和意大利以外的欧盟(EU)成员国分类为“EU”，因为它们分别在G20中表示。最终数据集使用VOSviewer进行文献计量分析，该数据集由从Web of Science提取的文章元数据组成。[4]合著和共现分析作为文献计量学分析的一个组成部分。结果共纳入33636篇文献。2013年至2014年，国际合作的出版物数量增长了5.8%。美利坚合众国(USA)在G20国家中拥有最多的出版物(28.2%)，其次是英国(UK)(10.3%)和德国(6.2%)。印度排名第13位，占所有出版物的2.4%。HIV/AIDS、COVID-19、肝炎、流感等关键词的使用频率相对较高。从2010年到2022年，印度与G20国家合作进行了203多项临床试验。印度与美国密切合作，其次是英国和澳大利亚。根据我们研究的主要发现，与G20国家合作开展的大多数临床试验是美国、英国和德国。工业化国家在出版物中占据主导地位，可能是由于相对的研究资金能力和英语熟练程度优势。重新思考卫生研究的资助政策，以指导和激励机构和研究人员可以改善。[5]艾滋病、COVID-19、肝炎等病毒感染是频繁出现的关键词，表明这些领域的研究正在吸引国际合作。随着COVID-19大流行的出现，有关预防和遏制这一大流行的相关研究急剧增加。[6]应对由covid -19导致的这些疾病死灰复燃，需要有适当的政治意愿，开展合作与协作。[7]最近，正在制定战略以鼓励中低收入国家(LMICs)实现其出版潜力，但这些变化没有跟上预防和控制高负担感染的需要。[8]本研究为政策制定者和利益相关者提供了合作临床试验的宏观视角，以加强未来应对ID威胁的研究。未来对协作的研究可以集中在协作的促进因素和障碍上。这需要通过G20等合作实体发挥全球领导作用。财政支持及赞助无。利益冲突没有利益冲突。
{"title":"Collaborative clinical trials on infectious disease among the G20 nations using scientometric analysis","authors":"Sanjay Pattanshetty, ViolaSavy Dsouza, JestinaRachel Kurian, K Cauvery, Lada Leyens, Helmut Brand","doi":"10.4103/picr.picr_242_22","DOIUrl":"https://doi.org/10.4103/picr.picr_242_22","url":null,"abstract":"INTRODUCTION Increased international travel and trade, changes in lifestyle, microbial resistance, and climate change, which allow endemics to proliferate, all contribute to the accelerated spread of infectious diseases (IDs). It is crucial to collaborate through shared knowledge and skills to combat these risks. Prioritizing clinical trials in infectious disease (CTI) in a cooperative and multipronged manner is essential to the successful elimination of threats.[1] Building a strong research and innovation ecosystem is one of the important agendas of the G20 presidency in responding to these global crises (e.g., Ebola and Zika).[2] India gears up for its 2023 G20 presidency, as the global economy teeters on the brink of recession as it recovers from the grip of COVID-19.[3] At this juncture, it is beneficial to obtain a macroscopic overview of the state of collaboration between G20 nations in CTI research. METHODOLOGY Studies published by G20-affiliated authors between 2010 and 2022 were retrieved from PubMed and the Web of Science using relevant search strategies. After data cleaning using thesaurus file, we eliminated duplicates and categorized the collectively represented European Union (EU) member states as “EU” except France, Germany, and Italy, as they are individually represented in G20. The final dataset was used for bibliometric analysis using VOSviewer consisted of metadata of articles extracted from the Web of Science.[4] Coauthorship and co-occurrence analysis was performed as a component of bibliometric analysis. RESULTS Three thousand six hundred and thirty-six articles were included in the study. Between 2013 and 2014, the number of publications with international collaborations increased by 5.8%. The United States of America (USA) had the most publications among the G20 nations (28.2%), followed by the United Kingdom (UK) (10.3%) and Germany at 6.2%. India is ranked 13, accounting for 2.4% of all publications. The use of keywords such as HIV/AIDS, COVID-19, hepatitis, and influenza are relatively frequent. India has collaborated with G20 nations on over 203 clinical trials from 2010 to 2022. India has collaborated closely with the USA, followed by the UK and Australia. DISCUSSION According to the key findings of our study, most clinical trials undertaken in partnership with G20 countries are the USA, the UK, and Germany. Industrialized nations are dominating publications likely as a result of relative research funding capacity and the English proficiency advantage. Rethinking of funding policies in health research to direct and incentivize institutions and researchers can improve.[5] Viral infections such as HIV/AIDS, COVID-19, and hepatitis are frequently occurring keywords indicating that research on these fields is attracting international collaborations. With the emergence of the COVID-19 pandemic, there has been a sharp increase-related research focused on preventing and containing such a pandemic.[6] COVID-19-driven resurge","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01Epub Date: 2021-12-01DOI: 10.4103/picr.PICR_19_21
Saurabh R Patil, Shruti Shripad Bhide
Context: Number of trials in India shows an increasing trend. As these trials will shape clinical practice, their quality is of utmost importance. Among many tools to assess the quality of randomized control trials (RCTs), risk of bias (RoB) is most robust.
Aims: To understand the quality of trials being carried out in India in terms of RoB.
Settings and design: We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology.
Subjects and methods: We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0.
Statistical analysis used: Descriptive statistics were used.
Results: 158 trials published in seven journals were evaluated in six different domains. Overall evaluation for 97% (153) trials was "high risk," while 3% (5) were in "some concerns" category, with no trials categorized as "low risk. 74% articles showed a high risk of bias in the domain of 'selection of reported results. Nearly half articles scored "low risk" in domains of "missing data" and "deviations in assignment to intervention." The study results showed a slowly increasing trend of average RoB over the last 10 years.
Conclusions: The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.
{"title":"Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology.","authors":"Saurabh R Patil, Shruti Shripad Bhide","doi":"10.4103/picr.PICR_19_21","DOIUrl":"10.4103/picr.PICR_19_21","url":null,"abstract":"<p><strong>Context: </strong>Number of trials in India shows an increasing trend. As these trials will shape clinical practice, their quality is of utmost importance. Among many tools to assess the quality of randomized control trials (RCTs), risk of bias (RoB) is most robust.</p><p><strong>Aims: </strong>To understand the quality of trials being carried out in India in terms of RoB.</p><p><strong>Settings and design: </strong>We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology.</p><p><strong>Subjects and methods: </strong>We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0.</p><p><strong>Statistical analysis used: </strong>Descriptive statistics were used.</p><p><strong>Results: </strong>158 trials published in seven journals were evaluated in six different domains. Overall evaluation for 97% (153) trials was \"high risk,\" while 3% (5) were in \"some concerns\" category, with no trials categorized as \"low risk. 74% articles showed a high risk of bias in the domain of 'selection of reported results. Nearly half articles scored \"low risk\" in domains of \"missing data\" and \"deviations in assignment to intervention.\" The study results showed a slowly increasing trend of average RoB over the last 10 years.</p><p><strong>Conclusions: </strong>The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/c8/PCR-14-16.PMC10003580.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9095566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01Epub Date: 2021-10-23DOI: 10.4103/picr.picr_16_21
Krishna Undela, Parthasarathi Gurumurthy, M S Sujatha
Purpose: In view of the raising rate of adverse birth outcomes (ABOs) across the globe, this study was conducted to assess the impact of medical conditions and medications received during pregnancy on ABOs.
Materials and methods: A prospective case-control study was conducted at the Department of Obstetrics and Gynecology of a tertiary care hospital over a period of 3 years from July 2015 to June 2018. Liveborn and stillborn neonates included in the study were categorized into cases and controls based on the presence or absence of composite ABOs, respectively. Binary logistic regression analysis was used to identify the risk factors for ABOs among medical conditions and medications received by mothers during their current pregnancy.
Results: Among 1214 neonates included in the study, 556 (45.8%) were identified with composite ABOs, the majority were low birth weight (320 [26.4%]) and preterm birth 300 (24.7%). After adjusting for confounding factors, it was identified that hypertension (adjusted odds ratio [aOR] 7.3), oligohydramnios (aOR 3.9), anemia (aOR 3.2), nifedipine (aOR 10.0), nicardipine (aOR 5.3), and magnesium sulfate (aOR 5.3) were the risk factors for overall and specific ABOs like preterm birth and low birth weight. It was also identified that the early detection and management of hypertension with antihypertensives like labetalol and methyldopa can reduce the risk of preterm birth by 93% and 88%, respectively.
Conclusion: Medical conditions such as hypertension, oligohydramnios, and anemia and medications such as nifedipine, nicardipine, and magnesium sulfate during pregnancy were identified as the risk factors for overall and specific ABOs like preterm birth and low birth weight.
{"title":"Impact of medical conditions and medications received during pregnancy on adverse birth outcomes: A hospital-based prospective case-control study.","authors":"Krishna Undela, Parthasarathi Gurumurthy, M S Sujatha","doi":"10.4103/picr.picr_16_21","DOIUrl":"10.4103/picr.picr_16_21","url":null,"abstract":"<p><strong>Purpose: </strong>In view of the raising rate of adverse birth outcomes (ABOs) across the globe, this study was conducted to assess the impact of medical conditions and medications received during pregnancy on ABOs.</p><p><strong>Materials and methods: </strong>A prospective case-control study was conducted at the Department of Obstetrics and Gynecology of a tertiary care hospital over a period of 3 years from July 2015 to June 2018. Liveborn and stillborn neonates included in the study were categorized into cases and controls based on the presence or absence of composite ABOs, respectively. Binary logistic regression analysis was used to identify the risk factors for ABOs among medical conditions and medications received by mothers during their current pregnancy.</p><p><strong>Results: </strong>Among 1214 neonates included in the study, 556 (45.8%) were identified with composite ABOs, the majority were low birth weight (320 [26.4%]) and preterm birth 300 (24.7%). After adjusting for confounding factors, it was identified that hypertension (adjusted odds ratio [aOR] 7.3), oligohydramnios (aOR 3.9), anemia (aOR 3.2), nifedipine (aOR 10.0), nicardipine (aOR 5.3), and magnesium sulfate (aOR 5.3) were the risk factors for overall and specific ABOs like preterm birth and low birth weight. It was also identified that the early detection and management of hypertension with antihypertensives like labetalol and methyldopa can reduce the risk of preterm birth by 93% and 88%, respectively.</p><p><strong>Conclusion: </strong>Medical conditions such as hypertension, oligohydramnios, and anemia and medications such as nifedipine, nicardipine, and magnesium sulfate during pregnancy were identified as the risk factors for overall and specific ABOs like preterm birth and low birth weight.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d1/79/PCR-14-10.PMC10003577.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9095568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.4103/picr.picr_184_23
Arun Bhatt
The International Council for Harmonisation has released a draft version E6(R3) of the Good Clinical Practice Guideline for public consultation. The objective of the revamped guideline is to make the new provisions applicable across diverse clinical trial types and settings and to remain relevant as technological and methodological advances occur. E6(R3) includes profound changes in the structure and content of E6(R2) version, which will impact all the trial conduct processes from planning to reporting. This guideline’s focus on principles, digital technology, ethics, and quality will increase the responsibilities of the ethics committees, the investigator, and the sponsor. This brief review discusses the impact of the guideline on trial conduct and the challenges of implementation in India.
{"title":"The revamped Good Clinical Practice E6(R3) guideline: Profound changes in principles and practice!","authors":"Arun Bhatt","doi":"10.4103/picr.picr_184_23","DOIUrl":"https://doi.org/10.4103/picr.picr_184_23","url":null,"abstract":"The International Council for Harmonisation has released a draft version E6(R3) of the Good Clinical Practice Guideline for public consultation. The objective of the revamped guideline is to make the new provisions applicable across diverse clinical trial types and settings and to remain relevant as technological and methodological advances occur. E6(R3) includes profound changes in the structure and content of E6(R2) version, which will impact all the trial conduct processes from planning to reporting. This guideline’s focus on principles, digital technology, ethics, and quality will increase the responsibilities of the ethics committees, the investigator, and the sponsor. This brief review discusses the impact of the guideline on trial conduct and the challenges of implementation in India.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.4103/picr.picr_272_22
Gaurav Anand, Divya Sadhna
Electronic health records (EHRs) constitute vital statistics, current health condition, ongoing therapies, and patient data; hence, their interoperability could be useful for epidemiologic and clinical research. Fast Healthcare Interoperability Resources (FHIR) and blockchain are currently “in-use” and tested for exchange of such data. The annual scientific production of publications for both FHIR and blockchain shows steady growth. The data interoperability and electronic data interchange have been introduced in the field of EHR in 2020, hence inferring that data interoperability is relatively a new domain. The thematic mapping suggested “interoperability” of EHR is well-developed and important for the structure of the research field.
{"title":"Electronic health record interoperability using FHIR and blockchain: A bibliometric analysis and future perspective","authors":"Gaurav Anand, Divya Sadhna","doi":"10.4103/picr.picr_272_22","DOIUrl":"https://doi.org/10.4103/picr.picr_272_22","url":null,"abstract":"Electronic health records (EHRs) constitute vital statistics, current health condition, ongoing therapies, and patient data; hence, their interoperability could be useful for epidemiologic and clinical research. Fast Healthcare Interoperability Resources (FHIR) and blockchain are currently “in-use” and tested for exchange of such data. The annual scientific production of publications for both FHIR and blockchain shows steady growth. The data interoperability and electronic data interchange have been introduced in the field of EHR in 2020, hence inferring that data interoperability is relatively a new domain. The thematic mapping suggested “interoperability” of EHR is well-developed and important for the structure of the research field.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01Epub Date: 2023-01-06DOI: 10.4103/picr.picr_247_22
Sanish Davis
One of the central missions of the World Medical Association (WMA) in its role as the global organization of physicians is to ensure the highest possible standard of ethical clinical practice and medical research. The WMA’s Declaration of Helsinki (DoH) was first adopted in 1964. In its close to 60-year lifetime, the Declaration has been revised seven times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research.
{"title":"Declaration of Helsinki: Can it still serve as a North star for ethics in regulatory trials?","authors":"Sanish Davis","doi":"10.4103/picr.picr_247_22","DOIUrl":"10.4103/picr.picr_247_22","url":null,"abstract":"One of the central missions of the World Medical Association (WMA) in its role as the global organization of physicians is to ensure the highest possible standard of ethical clinical practice and medical research. The WMA’s Declaration of Helsinki (DoH) was first adopted in 1964. In its close to 60-year lifetime, the Declaration has been revised seven times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/eb/37/PCR-14-1.PMC10003581.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9101540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01Epub Date: 2022-11-02DOI: 10.4103/picr.picr_2_22
Sonopant G Joshi, Abhijeet Ashok Safai, Samir Sumant Barve
A sudden upsurge in COVID-19 research during the pandemic in 2020 brought a tremendous workload over Ethics Committees (ECs). Altered lifestyles and changes in research-related approaches due to the pandemic posed a completely different scenario to ECs,[1] and compelled them to adopt new administrative and functional modalities.[2] In addition, the Indian Council of Medical Research (ICMR) released special guidelines for ethical review of research studies during the pandemic.[3] This study aimed at exploring the functioning and experiences of a selected EC from India during the pandemic.
{"title":"Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic.","authors":"Sonopant G Joshi, Abhijeet Ashok Safai, Samir Sumant Barve","doi":"10.4103/picr.picr_2_22","DOIUrl":"10.4103/picr.picr_2_22","url":null,"abstract":"A sudden upsurge in COVID-19 research during the pandemic in 2020 brought a tremendous workload over Ethics Committees (ECs). Altered lifestyles and changes in research-related approaches due to the pandemic posed a completely different scenario to ECs,[1] and compelled them to adopt new administrative and functional modalities.[2] In addition, the Indian Council of Medical Research (ICMR) released special guidelines for ethical review of research studies during the pandemic.[3] This study aimed at exploring the functioning and experiences of a selected EC from India during the pandemic.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ab/35/PCR-14-43.PMC10003585.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9101535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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