Perspectives in Clinical Research最新文献

{"title":"Procalcitonin-guided antimicrobial stewardship in critically ill patients with sepsis: A pre– post interventional study","authors":"Philip Mathew, S. Vargese, Litha Mary Mathew, Alice David, J. Saji, Ann Mariam Varghese","doi":"10.4103/picr.picr_298_23","DOIUrl":"https://doi.org/10.4103/picr.picr_298_23","url":null,"abstract":"\u0000 \u0000 \u0000 Injudicious usage of antibiotics has led to the emergence of antibiotic resistance which is a major health-care problem in developing countries such as India. Our aim was to show how antibiotic therapy based on serial procalcitonin (PCT) assay can help in antibiotic de-escalation in septic patients.\u0000 \u0000 \u0000 \u0000 A pre–post interventional study was conducted among 300 septic patients admitted to an intensive care unit (ICU). All septic patients admitted 2 months before and 2 months after the introduction of monitoring of PCT were included and they were divided into Group P (with PCT monitoring) and Group C (without PCT monitoring). The proportion of patients for whom antimicrobials were de-escalated, the average time taken to de-escalate antimicrobials, and the average duration of ICU stay were compared. Proportions and averages with standard deviations were calculated to describe the data. A test of proportions was done to compare the proportion de-escalated and a Student’s t-test was done to compare the average duration of antibiotic therapy.\u0000 \u0000 \u0000 \u0000 The proportion of patients in whom de-escalation of antimicrobials was done was 125 (83.33%) in Group P as compared to 92 (61.33%) in Group C. The time taken to de-escalate was 3.04 ± 0.83 days (95% confidence interval [CI] 2.89–3.18) in Group P compared to 4.7 ± 1.4 days (CI 4.41–4.98) in Group C. The duration of ICU stay was also less in Group P - 3.08 ± 0.91 days (CI 3.08–3.38) as compared to Group C - 5.16 ± 2.17 days (4.80–5.51).\u0000 \u0000 \u0000 \u0000 Serial PCT assay-based antimicrobial therapy helped to wean patients with sepsis off antimicrobials earlier thus reducing the duration of ICU stay.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140430582","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}

{"title":"Ethical considerations for real-world evidence studies","authors":"Arun Bhatt","doi":"10.4103/picr.picr_256_23","DOIUrl":"https://doi.org/10.4103/picr.picr_256_23","url":null,"abstract":"\u0000 Real-world evidence (RWE) studies are conducted on patient’s data primarily collected for monitoring of health status of patients. The use of real-world data to generate evidence in academic research or for regulatory submission raises a variety of ethical issues such as privacy, confidentiality, data protection, data de-identification, data sharing, scientific design of study, and informed consent requirements. The investigators–researchers and sponsors should adhere to current standards of ethics whilst planning and conduct of RWE studies. The ethics committees should consider ethical issues specific to RWE studies before approval.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140438416","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}

{"title":"Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital","authors":"Y. Shetty, Prajakta D. Auti, Y. Aithal","doi":"10.4103/picr.picr_213_23","DOIUrl":"https://doi.org/10.4103/picr.picr_213_23","url":null,"abstract":"\u0000 \u0000 \u0000 Over the years, Indian regulations have undergone numerous amendments, including stringent reporting deadlines, relatedness requirements, and compensation obligations for serious adverse event (SAE). A historic change, new drugs and trial rules-2019, was proposed on March 19, 2019. The purpose of the study was to ascertain whether various stakeholders were reporting in accordance with the evolving SAE criteria.\u0000 \u0000 \u0000 \u0000 Data were retrieved after the Ethics Committee’s approval between August 2014 and December 2021. Data gathered before March 19, 2019, were categorized as “BEFORE” data, while the remaining data were categorized as “AFTER.” Utilizing causality, on-site SAE reporting, and the ethics committee review procedure, we evaluated the compliance. The data were evaluated using descriptive statistics, and the Chi-square or Mann–Whitney tests were used to compare the “BEFORE” and “AFTER” groups.\u0000 \u0000 \u0000 \u0000 A total of 77 SAEs were reported in 26 clinical trials, where most clinical trials were phase III. Endocrine projects made up 9/26 (34.61%). In the cardiology studies, the greatest SAE distribution was 21 SAEs/89 participants (23.59%) with approximately 48% of these being vascular. The “AFTER” group noticed a decrease in the total number and length of SAE subcommittee meetings. In the “AFTER” group, there was a significantly higher median number of agenda items/meetings (8 [4.5–10.75]) (P < 0.0001). The median interval between the onset of SAE and the first reporting date, however, was just 1 day (interquartile range: 1–5 days). In nondeath SAEs, there was no significant difference in the compensation paid. In the “AFTER” group, there were no discrepancies in reporting SAE.\u0000 \u0000 \u0000 \u0000 There is acceptable adherence to SAE reporting criteria.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139808223","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}

{"title":"Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital","authors":"Y. Shetty, Prajakta D. Auti, Y. Aithal","doi":"10.4103/picr.picr_213_23","DOIUrl":"https://doi.org/10.4103/picr.picr_213_23","url":null,"abstract":"\u0000 \u0000 \u0000 Over the years, Indian regulations have undergone numerous amendments, including stringent reporting deadlines, relatedness requirements, and compensation obligations for serious adverse event (SAE). A historic change, new drugs and trial rules-2019, was proposed on March 19, 2019. The purpose of the study was to ascertain whether various stakeholders were reporting in accordance with the evolving SAE criteria.\u0000 \u0000 \u0000 \u0000 Data were retrieved after the Ethics Committee’s approval between August 2014 and December 2021. Data gathered before March 19, 2019, were categorized as “BEFORE” data, while the remaining data were categorized as “AFTER.” Utilizing causality, on-site SAE reporting, and the ethics committee review procedure, we evaluated the compliance. The data were evaluated using descriptive statistics, and the Chi-square or Mann–Whitney tests were used to compare the “BEFORE” and “AFTER” groups.\u0000 \u0000 \u0000 \u0000 A total of 77 SAEs were reported in 26 clinical trials, where most clinical trials were phase III. Endocrine projects made up 9/26 (34.61%). In the cardiology studies, the greatest SAE distribution was 21 SAEs/89 participants (23.59%) with approximately 48% of these being vascular. The “AFTER” group noticed a decrease in the total number and length of SAE subcommittee meetings. In the “AFTER” group, there was a significantly higher median number of agenda items/meetings (8 [4.5–10.75]) (P < 0.0001). The median interval between the onset of SAE and the first reporting date, however, was just 1 day (interquartile range: 1–5 days). In nondeath SAEs, there was no significant difference in the compensation paid. In the “AFTER” group, there were no discrepancies in reporting SAE.\u0000 \u0000 \u0000 \u0000 There is acceptable adherence to SAE reporting criteria.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139868136","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}

{"title":"Effectiveness of partial COVID-19 vaccination on the outcome of hospitalized COVID-19 patients during the second pandemic in India.","authors":"Sajal De, Dibakar Sahu, Diksha Mahilang, Ranganath T Ganga, Ajoy Kumar Behera","doi":"10.4103/picr.picr_48_23","DOIUrl":"10.4103/picr.picr_48_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139572525","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}

{"title":"Challenges of assessing educational intervention in type 1 diabetes mellitus.","authors":"Deepa Chodankar","doi":"10.4103/picr.picr_331_23","DOIUrl":"10.4103/picr.picr_331_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139572523","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}

{"title":"Redefining informed consent form in cell and gene therapy trials.","authors":"Varsha Dalal, Geeta Jotwani, Munna Lal Yadav","doi":"10.4103/picr.picr_244_22","DOIUrl":"10.4103/picr.picr_244_22","url":null,"abstract":"<p><p>Informed consent is a foundation of the ethical conduct of research involving human participants. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that participants are aware of the risks and potential benefits and make a voluntary decision about participating in clinical trial research. The extraordinary scientific advances happening globally, have demonstrated the potential of regenerative therapies in transforming the health of the nation by providing a therapeutic option for diseases that were previously considered incurable. These therapies, which include cells and gene therapy (GT) labeled as Advanced Therapeutic Medicinal Products globally, have complex mechanisms of action. Owing to their highly personalized and intricate nature of these therapies, developing the latter often presents unique challenges above and beyond those encountered for small molecule drugs. We recently looked through some cell and GT clinical trials and realized the lacunae in the informed consent form (ICF) provided by the investigators. Especially in a country like India, where the general understanding and perception of patients is limited regarding clinical trials, it is felt that any lapses in the consent process may jeopardize the informed decision-making and safety of the participants and tarnish the reputation of India globally. The present article highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies and aims to address all the elements of ICF in light of the challenges associated with these innovative therapies.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139570768","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}

{"title":"Designing and validating a research questionnaire - Part 2.","authors":"Priya Ranganathan, Carlo Caduff, Christopher M A Frampton","doi":"10.4103/picr.picr_318_23","DOIUrl":"10.4103/picr.picr_318_23","url":null,"abstract":"<p><p>Validity and reliability refer to the accuracy and consistency of a research tool. In the previous article in this series, we examined the development of a research questionnaire. In this article, we discuss the methods of determining the validity and reliability of a research questionnaire.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810057/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139572524","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}

{"title":"Effects of therapeutic patient education program on glycemic control and quality of life among children and adolescents with type 1 diabetes mellitus in Fez city, Morocco.","authors":"Hanaâ Ait-Taleb Lahsen, Mohammed El Amine Ragala, Hanane El Abed, Btissame Zarrouq, Karima Halim","doi":"10.4103/picr.picr_80_23","DOIUrl":"10.4103/picr.picr_80_23","url":null,"abstract":"<p><strong>Context: </strong>Type 1 diabetes mellitus (T1DM) is a chronic disease, mainly observed in children or youth, with a significantly increased incidence in young children. Structured therapeutic patient education (TPE) is a must to help them manage their disease effectively and lead a healthy lifestyle.</p><p><strong>Aims: </strong>This study aimed to assess the effects of a structured TPE program on glycemic markers and quality of life (QOL) of T1DM children and adolescents in Fez city, Morocco.</p><p><strong>Settings and design: </strong>It is a quasi-experimental study.</p><p><strong>Materials and methods: </strong>One hundred T1DM children and adolescents, aged 8-18, participated in a TPE intervention at the pediatric department in a hospital center in Fez, Morocco. Glycemic markers were measured and QOL was assessed by a validated questionnaire.</p><p><strong>Statistical analysis used: </strong>Parametric and nonparametric tests were used and statistical significance determined by <i>P</i> < 0.05.</p><p><strong>Results: </strong>At 3 months' follow-up, both global and dimensional QOL mean scores improved significantly (<i>P</i> ≤ 0.0001), whereas glycosylated hemoglobin (HbA1c) decreased (10.28% vs. 10.62%), tough with no statistical significance (<i>P</i> = 0.160). Furthermore, a significant improvement was observed in the maximum preprandial (2, 11 g/L [1.51-2.58] vs. 2, 37 g/L [1.81-3.21], <i>P</i> = 0.001) and postprandial blood glucose levels (2, 50 g/L [1.90-3.27] vs. 2, 95 g/L [2.07-3.99], <i>P</i> = 0.001) after 3 months; with no significant change in their minimum.</p><p><strong>Conclusion: </strong>Although this TPE intervention was more effective in improving patients' QOL than their HbA1c, it is worth striving to implement regular TPE programs for T1DM pediatric patients and adjust them to achieve a better patients' glycemic markers levels.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139570723","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}

{"title":"Artificial intelligence at the pen’s edge: Exploring the ethical quagmires in using artificial intelligence models like ChatGPT for assisted writing in biomedical research","authors":"Hunny Sharma, Manisha M Ruikar","doi":"10.4103/picr.picr_196_23","DOIUrl":"https://doi.org/10.4103/picr.picr_196_23","url":null,"abstract":"Chat generative pretrained transformer (ChatGPT) is a conversational language model powered by artificial intelligence (AI). It is a sophisticated language model that employs deep learning methods to generate human-like text outputs to inputs in the natural language. This narrative review aims to shed light on ethical concerns about using AI models like ChatGPT in writing assistance in the health care and medical domains. Currently, all the AI models like ChatGPT are in the infancy stage; there is a risk of inaccuracy of the generated content, lack of contextual understanding, dynamic knowledge gaps, limited discernment, lack of responsibility and accountability, issues of privacy, data security, transparency, and bias, lack of nuance, and originality. Other issues such as authorship, unintentional plagiarism, falsified and fabricated content, and the threat of being red-flagged as AI-generated content highlight the need for regulatory compliance, transparency, and disclosure. If the legitimate issues are proactively considered and addressed, the potential applications of AI models as writing assistance could be rewarding.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139171713","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}