Perspectives in Clinical Research最新文献

{"title":"Analysis of informed consent documents for compliance with ICMR guidelines for biomedical and health research","authors":"C. Chindhalore, G. Dakhale, S. Gajbhiye, Ashish Vijay Gupta, Shivam V. Khapeka","doi":"10.4103/picr.picr_257_23","DOIUrl":"https://doi.org/10.4103/picr.picr_257_23","url":null,"abstract":"\u0000 \u0000 \u0000 Ethical conduct of research depends on the voluntary expression of consent and adequate disclosure of information about the research in informed consent documents (ICDs).\u0000 \u0000 \u0000 \u0000 The objective of this study was to analyze ICDs of academic studies for compliance with National Ethical Guidelines for Biomedical and Health Research laid down by the Indian Council of Medical Research (ICMR) and to determine the readability of ICDs using the Flesch–Kincaid Grade Level scale and Flesch reading-ease (FRE) score.\u0000 \u0000 \u0000 \u0000 ICDs of academic research projects submitted during 2020–22 were retrieved from the IEC office and analyzed for compliance with ICMR 2017 guidelines. The readability of the documents was assessed by the Flesch–Kincaid Grade Level Scale and FRE score.\u0000 \u0000 \u0000 \u0000 Among 177 protocols analyzed, the most common were epidemiological studies (36.72%), followed by diagnostic studies (28.81%). Vernacular translations of ICDs were present in significantly more studies in 2022 (χ\u0000 2 = 7.18, P = 0.02) as compared to 2020 and 2021. FREs score was 45.75 ± 10.76, and Flesch–Kincaid Grade Level was 8.67 ± 1.44. Content analysis of participant information sheet (PIS) revealed that significantly more PIS submitted in 2022 mentioned expected duration of participation (χ\u0000 2 = 6.95, P < 0.001), benefit to patient/community (χ\u0000 2 = 26.63, P < 0.001), disclosure of foreseeable risk or discomfort (χ\u0000 2 = 21.72, P < 0.001), payment for participation (χ\u0000 2 = 21.72, P < 0.001), and identity of research team and contact details (χ\u0000 2 = 18.58, P < 0.001). Compliance score was significantly better in 2022 as compared to 2020 and 2021.\u0000 \u0000 \u0000 \u0000 Gradually, ICDs became more compliant with ICMR guidelines. Still, there is scope for improvement in ICDs regarding content and readability so that patients can comprehend facts easily to make informed decisions in a real sense.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140731998","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":"Evaluating large language models for selection of statistical test for research: A pilot study","authors":"Himel Mondal, Shaikat Mondal, Prabhat Mittal","doi":"10.4103/picr.picr_275_23","DOIUrl":"https://doi.org/10.4103/picr.picr_275_23","url":null,"abstract":"\u0000 \u0000 \u0000 In contemporary research, selecting the appropriate statistical test is a critical and often challenging step. The emergence of large language models (LLMs) has offered a promising avenue for automating this process, potentially enhancing the efficiency and accuracy of statistical test selection.\u0000 \u0000 \u0000 \u0000 This study aimed to assess the capability of freely available LLMs – OpenAI’s ChatGPT3.5, Google Bard, Microsoft Bing Chat, and Perplexity in recommending suitable statistical tests for research, comparing their recommendations with those made by human experts.\u0000 \u0000 \u0000 \u0000 A total of 27 case vignettes were prepared for common research models with a question asking suitable statistical tests. The cases were formulated from previously published literature and reviewed by a human expert for their accuracy of information. The LLMs were asked the question with the case vignettes and the process was repeated with paraphrased cases. The concordance (if exactly matching the answer key) and acceptance (when not exactly matching with answer key, but can be considered suitable) were evaluated between LLM’s recommendations and those of human experts.\u0000 \u0000 \u0000 \u0000 Among the 27 case vignettes, ChatGPT3.5-suggested statistical test had 85.19% concordance and 100% acceptance; Bard experiment had 77.78% concordance and 96.3% acceptance; Microsoft Bing Chat had 96.3% concordance and 100% acceptance; and Perplexity had 85.19% concordance and 100% acceptance. The intra-class correction coefficient of average measure among the responses of LLMs was 0.728 (95% confidence interval [CI]: 0.51–0.86), P < 0.0001. The test–retest reliability of ChatGPT was r = 0.71 (95% CI: 0.44–0.86), P < 0.0001, Bard was r = −0.22 (95% CI: −0.56–0.18), P = 0.26, Bing was r = −0.06 (95% CI: −0.44–0.33), P = 0.73, and Perplexity was r = 0.52 (95% CI: 0.16–0.75), P = 0.0059.\u0000 \u0000 \u0000 \u0000 The LLMs, namely, ChatGPT, Google Bard, Microsoft Bing, and Perplexity all showed >75% concordance in suggesting statistical tests for research case vignettes with all having acceptance of >95%. The LLMs had a moderate level of agreement among them. While not a complete replacement for human expertise, these models can serve as effective decision support systems, especially in scenarios where rapid test selection is essential.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140729191","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":"Ethics committee accreditation: Journey from voluntariness to essentiality for quality sustenance","authors":"R. Tripathi","doi":"10.4103/picr.picr_45_24","DOIUrl":"https://doi.org/10.4103/picr.picr_45_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140762004","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 and safety of regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis.","authors":"Oki Nugraha Putra, Yulistiani Yulistiani, Soedarsono Soedarsono, Susi Subay","doi":"10.4103/picr.picr_1_23","DOIUrl":"10.4103/picr.picr_1_23","url":null,"abstract":"<p><strong>Background: </strong>Bedaquiline and delamanid have been included in the individualized treatment regimen (ITR) to treat patients with drug-resistant tuberculosis (DR-TB).</p><p><strong>Objective: </strong>The objective of this study is to compare the effectiveness of sputum culture conversion and the safety of ITR containing bedaquiline and delamanid.</p><p><strong>Methods: </strong>Data were collected retrospectively from medical records of DR-TB patients who received ITR between January 2020 and December 2021. Patients were divided into bedaquiline and bedaquiline-delamanid groups. Sputum culture was evaluated until 6 months of treatment. Measurement of QTc interval, renal and liver function test, and serum potassium were evaluated to assess safety during the study period. We used Chi-square to analyze a difference in cumulative culture conversion; meanwhile, Wilcoxon and Mann-Whitney tests were used to analyze differences in laboratory data for each and between the two groups, respectively.</p><p><strong>Results: </strong>Fifty-one eligible DR-TB patients met the inclusion criteria, 41 in the bedaquiline and 10 in bedaquiline-delamanid group. 43/51 patients had a positive culture at baseline. After 6 months of treatment, 42/43 DR-TB patients (97.6%) had sputum culture conversion and no difference between the two groups (<i>P</i> ≥ 0.05). QTc interval within normal limit and no patient had a QTc >500 ms during the study period. Creatinine levels significantly differed between the two groups 6 months after treatment (<i>P</i> < 0.05).</p><p><strong>Conclusion: </strong>DR-TB patients who received all oral ITR containing bedaquiline and or delamanid demonstrated favorable sputum conversion with a tolerable safety profile.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11101004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141066027","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":"Impact of accreditation on registered ethics committees in terms of quality and governance in India: A cross-sectional study","authors":"G. Dakhale, M. Kalikar, A. Giradkar","doi":"10.4103/picr.picr_153_23","DOIUrl":"https://doi.org/10.4103/picr.picr_153_23","url":null,"abstract":"\u0000 \u0000 \u0000 Ethics Committee accreditation is a process to assess the performance against a set of standards. Very few studies have shown that process of accreditation results in the improvement of the overall functioning of ECs. in terms of quality and governance. Hence, the present study was planned to evaluate the impact of accreditation on registered EC in terms of quality and governance and to compare functioning of accredited versus non accredited EC in terms of quality and governance.\u0000 \u0000 \u0000 \u0000 This was a cross sectional, observational, questionnaire-based survey conducted on 28 registered Ethics Committee in India after approval from the Institutional Ethics Committee.\u0000 \u0000 \u0000 \u0000 Accredited EC’s (n = 12) were compared for NABH standard for accreditation before and after accreditation in terms of percentage. It was found that majority of the standards related to structure and composition, adherence to specific policies , completeness of review and after approval process were met by majority of EC’s after accreditation. Only a few EC ‘s fulfilled some of the criteria before accreditation. There was a statistically significant difference with reference to adherence to specific policies by accredited and non-accredited EC’s like updating SOP according to changing requirements (P < 0.0237), process for preparing SOP (P < 0.0237), categorization of review process mentioned in SOP (P < 0.0237) procedure to be followed for vulnerable population (P < 0.0103) , process of handling issues related to complaints by participants and other stakeholders violation (P < 0.0103) etc.\u0000 \u0000 \u0000 \u0000 Accreditation results in improving of EC functioning in terms of quality and governance.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140778012","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":"A descriptive study of new drug approvals during 2017-2021 and disease morbidity and mortality patterns in India.","authors":"Urvashi Gupta, Ashwin Kamath, Priyanka Kamath","doi":"10.4103/picr.picr_109_23","DOIUrl":"10.4103/picr.picr_109_23","url":null,"abstract":"<p><strong>Aim: </strong>Studies show the presence of a mismatch between drug research and disease burden. A study conducted in the European Union found that new drug development was restricted to certain diseases. A study of biosimilar approvals in India found that 87% of drugs were for treating noncommunicable diseases. This study aimed to determine the new drugs approved in India from 2017 to 2021 and the top ten causes of morbidity and mortality and detect the presence of any discordance between these.</p><p><strong>Methods: </strong>A descriptive study was conducted using data on new drug approvals accessed from the Central Drugs Standard Control Organization website. The top ten causes of mortality and morbidity in India from 2015 to 2019 were identified from the Global Burden of Diseases database. Descriptive statistics were used to compare the drug approvals and the leading diseases.</p><p><strong>Results: </strong>One hundred twenty-six drugs were approved during the study period. Antineoplastic drugs constituted 19.84% of the approvals, antimicrobials 18.25%, and cardiovascular drugs 9.52%. Ischemic heart disease and chronic obstructive pulmonary disease were the two leading causes of morbidity and mortality. Diarrheal diseases, lower respiratory tract infection, and drug-susceptible tuberculosis were among the top ten causes. Ten antibacterials, including four antitubercular drugs, were approved during this period. Two drugs were approved for rare diseases.</p><p><strong>Conclusion: </strong>Our study showed that the drugs approved were largely in line with the prevalent disease burden, and there was no significant discordance observed. Some diseases, such as ischemic stroke/intracranial hemorrhage, require further efforts in bringing forth newer pharmacotherapy options.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11101002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141066025","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":"Handling missing data in research","authors":"P. Ranganathan, Sally Hunsberger","doi":"10.4103/picr.picr_38_24","DOIUrl":"https://doi.org/10.4103/picr.picr_38_24","url":null,"abstract":"\u0000 Missing data are an inevitable part of research and lead to a decrease in the size of the analyzable population, and biased and imprecise estimates. In this article, we discuss the types of missing data, methods to handle missing data and suggest ways in which missing data can be minimized.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140787580","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":"Impact of education on knowledge and attitude related to pharmacovigilance and reporting of adverse drug reactions among community pharmacists in Yemen: A pre- and postinterventional study","authors":"Khalifah Abdulwahid, Nur Aizati Athirah Daud, Y. Al-Worafi, Mohamed Azmi Ahmad Hassali","doi":"10.4103/picr.picr_160_23","DOIUrl":"https://doi.org/10.4103/picr.picr_160_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140771067","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":"Artificial intelligence in pharmacovigilance – Opportunities and challenges","authors":"Mira Kirankumar Desai","doi":"10.4103/picr.picr_290_23","DOIUrl":"https://doi.org/10.4103/picr.picr_290_23","url":null,"abstract":"\u0000 Pharmacovigilance (PV) is a data-driven process to identify medicine safety issues at the earliest by processing suspected adverse event (AE) reports and extraction of health data. The PV case processing cycle starts with data collection, data entry, initial checking completeness and validity, coding, medical assessment for causality, expectedness, severity, and seriousness, subsequently submitting report, quality checking followed by data storage and maintenance. This requires a workforce and technical expertise and therefore, is expensive and time-consuming. There has been exponential growth in the number of suspected AE reports in the PV database due to smart collection and reporting of individual case safety reports, widening the base by increased awareness and participation by health-care professionals and patients. Processing of the enormous volume and variety of data, making its sensible use and separating “needles from haystack,” is a challenge for key stakeholders such as pharmaceutical firms, regulatory authorities, medical and PV experts, and National Pharmacovigilance Program managers. Artificial intelligence (AI) in health care has been very impressive in specialties that rely heavily on the interpretation of medical images. Similarly, there has been a growing interest to adopt AI tools to complement and automate the PV process. The advanced technology can certainly complement the routine, repetitive, manual task of case processing, and boost efficiency; however, its implementation across the PV lifecycle and practical impact raises several questions and challenges. Full automation of PV system is a double-edged sword and needs to consider two aspects – people and processes. The focus should be a collaborative approach of technical expertise (people) combined with intelligent technology (processes) to augment human talent that meets the objective of the PV system and benefit all stakeholders. AI technology should enhance human intelligence rather than substitute human experts. What is important is to emphasize and ensure that AI brings more benefits to PV rather than challenges. This review describes the benefits and the outstanding scientific, technological, and policy issues, and the maturity of AI tools for full automation in the context to the Indian health-care system.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140375278","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":"Exploring the bioethical implications of using artificial intelligence in writing research proposals","authors":"S. Shivananda, V. Doddawad, C. S. Vidya, J. Chandrakala","doi":"10.4103/picr.picr_226_23","DOIUrl":"https://doi.org/10.4103/picr.picr_226_23","url":null,"abstract":"\u0000 Artificial intelligence (AI) has great potential to assist researchers in writing research proposals, by generating hypotheses, identifying literature, and suggesting methods for data collection and analysis. However, the use of AI in research proposal writing raises important bioethical implications, including the unintentional propagation of bias and questions about the role of human expertise and judgment in the research process. This paper explores the ethical implications of using AI in research proposal writing and proposes guidelines for the responsible and ethical use of AI in this context. The paper will review the potential benefits and challenges associated with using AI in research proposal writing, discuss the role of human expertise and judgment, and propose guidelines for promoting transparency and accountability in developing and using AI systems. Ultimately, addressing the bioethical issues related to AI in research proposal writing will require ongoing dialogue and collaboration between stakeholders, as well as a commitment to transparency, accountability, and ethical principles.","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":"140430872","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}