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Procalcitonin-guided antimicrobial stewardship in critically ill patients with sepsis: A pre– post interventional study 脓毒症重症患者在降钙素原指导下的抗菌药物管理:干预前干预后研究
Q2 Medicine Pub Date : 2024-02-26 DOI: 10.4103/picr.picr_298_23
Philip Mathew, S. Vargese, Litha Mary Mathew, Alice David, J. Saji, Ann Mariam Varghese
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. 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. 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). Serial PCT assay-based antimicrobial therapy helped to wean patients with sepsis off antimicrobials earlier thus reducing the duration of ICU stay.
抗生素的滥用导致了抗生素耐药性的出现,这是印度等发展中国家的一个主要医疗保健问题。我们的目的是说明基于系列降钙素原 (PCT) 检测的抗生素疗法如何帮助脓毒症患者降低抗生素耐药性。 我们在重症监护室(ICU)收治的 300 名脓毒症患者中开展了一项干预前-干预后研究。所有在引入 PCT 监测前 2 个月和引入 PCT 监测后 2 个月入院的脓毒症患者都被纳入其中,并被分为 P 组(有 PCT 监测)和 C 组(无 PCT 监测)。比较了不再使用抗菌药物的患者比例、不再使用抗菌药物所需的平均时间以及重症监护病房的平均住院时间。通过计算比例、平均值和标准差来描述数据。采用比例检验比较停用抗菌药物的比例,采用学生 t 检验比较抗生素治疗的平均持续时间。 P组患者中使用抗菌药物的比例为125人(83.33%),C组为92人(61.33%)。P 组的重症监护室住院时间为 3.08 ± 0.91 天(CI 3.08-3.38),而 C 组为 5.16 ± 2.17 天(4.80-5.51)。 基于 PCT 检测的系列抗菌疗法有助于脓毒症患者尽早停用抗菌药物,从而缩短重症监护室的住院时间。
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引用次数: 0
Ethical considerations for real-world evidence studies 真实世界证据研究的伦理考虑因素
Q2 Medicine Pub Date : 2024-02-22 DOI: 10.4103/picr.picr_256_23
Arun Bhatt
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.
真实世界证据(RWE)研究是以患者数据为基础进行的,主要是为了监测患者的健康状况。在学术研究或提交监管申请时,使用真实世界数据生成证据会引发各种伦理问题,如隐私、保密、数据保护、数据去标识化、数据共享、研究的科学设计和知情同意要求等。在规划和开展 RWE 研究时,研究者和赞助商应遵守现行的伦理标准。伦理委员会在批准研究之前,应考虑到 RWE 研究特有的伦理问题。
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引用次数: 0
Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital 现场严重不良事件报告:一家三级医院伦理委员会的七年经验
Q2 Medicine Pub Date : 2024-02-03 DOI: 10.4103/picr.picr_213_23
Y. Shetty, Prajakta D. Auti, Y. Aithal
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. 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. 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. There is acceptable adherence to SAE reporting criteria.
多年来,印度的法规经历了多次修订,包括严格的报告期限、关联性要求和严重不良事件(SAE)的赔偿义务。2019 年 3 月 19 日,印度提出了一项历史性变革--《新药和试验规则-2019》。本研究旨在确定各利益相关方是否按照不断变化的 SAE 标准进行报告。 2014年8月至2021年12月期间的数据在伦理委员会批准后进行了检索。2019 年 3 月 19 日之前收集的数据被归类为 "前 "数据,其余数据被归类为 "后 "数据。利用因果关系、现场 SAE 报告和伦理委员会审查程序,我们对合规性进行了评估。我们使用描述性统计对数据进行评估,并使用卡方检验或曼-惠特尼检验对 "前 "组和 "后 "组进行比较。 26 项临床试验共报告了 77 例 SAE,其中大多数临床试验为 III 期临床试验。内分泌项目占 9/26(34.61%)。在心脏病学研究中,SAE 分布最广的是 21 例/89 名参与者(23.59%),其中约 48% 是血管性的。AFTER "组注意到,SAE小组委员会会议的总数和时间长度均有所减少。在 "AFTER "组中,议程项目/会议的中位数明显增加(8 [4.5-10.75])(P < 0.0001)。然而,SAE 发生与首次报告日期之间的中位间隔仅为 1 天(四分位数间距:1-5 天)。在非死亡 SAE 中,支付的赔偿金没有显著差异。在 "AFTER "组中,报告 SAE 的时间没有差异。 对 SAE 报告标准的遵守情况可以接受。
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引用次数: 0
Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital 现场严重不良事件报告:一家三级医院伦理委员会的七年经验
Q2 Medicine Pub Date : 2024-02-03 DOI: 10.4103/picr.picr_213_23
Y. Shetty, Prajakta D. Auti, Y. Aithal
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. 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. 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. There is acceptable adherence to SAE reporting criteria.
多年来,印度的法规经历了多次修订,包括严格的报告期限、关联性要求和严重不良事件(SAE)的赔偿义务。2019 年 3 月 19 日,印度提出了一项历史性变革--《新药和试验规则-2019》。本研究旨在确定各利益相关方是否按照不断变化的 SAE 标准进行报告。 2014年8月至2021年12月期间的数据在伦理委员会批准后进行了检索。2019 年 3 月 19 日之前收集的数据被归类为 "前 "数据,其余数据被归类为 "后 "数据。利用因果关系、现场 SAE 报告和伦理委员会审查程序,我们对合规性进行了评估。我们使用描述性统计对数据进行评估,并使用卡方检验或曼-惠特尼检验对 "前 "组和 "后 "组进行比较。 26 项临床试验共报告了 77 例 SAE,其中大多数临床试验为 III 期临床试验。内分泌项目占 9/26(34.61%)。在心脏病学研究中,SAE 分布最广的是 21 例/89 名参与者(23.59%),其中约 48% 是血管性的。AFTER "组注意到,SAE小组委员会会议的总数和时间长度均有所减少。在 "AFTER "组中,议程项目/会议的中位数明显增加(8 [4.5-10.75])(P < 0.0001)。然而,SAE 发生与首次报告日期之间的中位间隔仅为 1 天(四分位数间距:1-5 天)。在非死亡 SAE 中,支付的赔偿金没有显著差异。在 "AFTER "组中,报告 SAE 的时间没有差异。 对 SAE 报告标准的遵守情况可以接受。
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引用次数: 0
Effectiveness of partial COVID-19 vaccination on the outcome of hospitalized COVID-19 patients during the second pandemic in India. 在印度第二次大流行期间,COVID-19 部分疫苗接种对 COVID-19 住院病人的疗效。
Q2 Medicine Pub Date : 2024-01-01 Epub Date: 2024-01-09 DOI: 10.4103/picr.picr_48_23
Sajal De, Dibakar Sahu, Diksha Mahilang, Ranganath T Ganga, Ajoy Kumar Behera
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引用次数: 0
Challenges of assessing educational intervention in type 1 diabetes mellitus. 评估 1 型糖尿病教育干预措施的挑战。
Q2 Medicine Pub Date : 2024-01-01 Epub Date: 2024-01-09 DOI: 10.4103/picr.picr_331_23
Deepa Chodankar
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引用次数: 0
Designing and validating a research questionnaire - Part 2. 设计和验证研究问卷--第二部分。
Q2 Medicine Pub Date : 2024-01-01 Epub Date: 2024-01-09 DOI: 10.4103/picr.picr_318_23
Priya Ranganathan, Carlo Caduff, Christopher M A Frampton

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.

有效性和可靠性是指研究工具的准确性和一致性。在本系列的上一篇文章中,我们探讨了研究问卷的编制。在本文中,我们将讨论确定研究问卷有效性和可靠性的方法。
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引用次数: 0
Redefining informed consent form in cell and gene therapy trials. 重新定义细胞和基因治疗试验中的知情同意书。
Q2 Medicine Pub Date : 2024-01-01 Epub Date: 2023-07-28 DOI: 10.4103/picr.picr_244_22
Varsha Dalal, Geeta Jotwani, Munna Lal Yadav

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.

知情同意是开展涉及人类参与者的研究的道德基础。基于尊重人的伦理原则,知情同意的目标是确保参与者了解风险和潜在益处,并自愿决定是否参与临床试验研究。全球范围内取得的非凡科学进步证明了再生疗法在改变国民健康状况方面的潜力,它为以前被认为是不治之症的疾病提供了一种治疗选择。这些疗法包括细胞和基因疗法(GT),在全球被称为高级治疗药物产品,具有复杂的作用机制。由于这些疗法具有高度个性化和错综复杂的性质,因此开发这些疗法往往会遇到比小分子药物更独特的挑战。我们最近查看了一些细胞和 GT 临床试验,发现研究者提供的知情同意书(ICF)中存在缺陷。特别是在印度这样一个国家,患者对临床试验的理解和认识普遍有限,因此我们认为,同意过程中的任何疏漏都可能危及参与者的知情决策和安全,并有损印度在全球的声誉。本文强调了就细胞和基因疗法的各个方面对患者和公众进行适当教育的必要性,并旨在根据与这些创新疗法相关的挑战,探讨《国际功能、残疾和健康分类》的所有要素。
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引用次数: 0
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. 治疗性患者教育计划对摩洛哥非斯市 1 型糖尿病儿童和青少年血糖控制和生活质量的影响。
Q2 Medicine Pub Date : 2024-01-01 Epub Date: 2023-09-11 DOI: 10.4103/picr.picr_80_23
Hanaâ Ait-Taleb Lahsen, Mohammed El Amine Ragala, Hanane El Abed, Btissame Zarrouq, Karima Halim

Context: 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.

Aims: 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.

Settings and design: It is a quasi-experimental study.

Materials and methods: 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.

Statistical analysis used: Parametric and nonparametric tests were used and statistical significance determined by P < 0.05.

Results: At 3 months' follow-up, both global and dimensional QOL mean scores improved significantly (P ≤ 0.0001), whereas glycosylated hemoglobin (HbA1c) decreased (10.28% vs. 10.62%), tough with no statistical significance (P = 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], P = 0.001) and postprandial blood glucose levels (2, 50 g/L [1.90-3.27] vs. 2, 95 g/L [2.07-3.99], P = 0.001) after 3 months; with no significant change in their minimum.

Conclusion: 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.

背景:1 型糖尿病(T1DM)是一种慢性疾病,主要见于儿童或青少年,其中幼儿的发病率显著增加。为了帮助他们有效控制病情,养成健康的生活方式,必须对他们进行有组织的治疗性患者教育(TPE):这是一项准实验研究:100 名 8-18 岁的 T1DM 儿童和青少年参加了摩洛哥非斯一家医院中心儿科的 TPE 干预活动。测量了血糖指标,并通过有效问卷评估了 QOL:采用参数和非参数检验,统计意义以 P < 0.05 为准:随访 3 个月后,总体和维度 QOL 平均得分均有显著改善(P ≤ 0.0001),而糖化血红蛋白(HbA1c)有所下降(10.28% 对 10.62%),但无统计学意义(P = 0.160)。此外,3 个月后,餐前最高血糖水平(2,11 g/L [1.51-2.58] vs. 2,37 g/L [1.81-3.21],P = 0.001)和餐后血糖水平(2,50 g/L [1.90-3.27] vs. 2,95 g/L [2.07-3.99],P = 0.001)均有明显改善;餐后最低血糖水平无明显变化:尽管 TPE 干预在改善患者 QOL 方面比 HbA1c 更有效,但值得努力为 T1DM 儿科患者实施定期的 TPE 项目,并对其进行调整,以达到更好的患者血糖指标水平。
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引用次数: 0
Artificial intelligence at the pen’s edge: Exploring the ethical quagmires in using artificial intelligence models like ChatGPT for assisted writing in biomedical research 笔尖上的人工智能:探索在生物医学研究中使用 ChatGPT 等人工智能模型辅助写作的伦理困境
Q2 Medicine Pub Date : 2023-12-19 DOI: 10.4103/picr.picr_196_23
Hunny Sharma, Manisha M Ruikar
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.
聊天生成预训练转换器(ChatGPT)是一种由人工智能(AI)驱动的会话语言模型。它是一种复杂的语言模型,采用深度学习方法,根据自然语言输入生成类人文本输出。这篇叙述性综述旨在阐明在卫生保健和医疗领域使用 ChatGPT 等人工智能模型进行写作辅助的伦理问题。目前,所有像 ChatGPT 这样的人工智能模型都处于起步阶段;存在生成内容不准确、缺乏上下文理解、动态知识差距、辨别力有限、缺乏责任和问责制、隐私、数据安全、透明度和偏见问题、缺乏细微差别和原创性等风险。其他问题,如作者身份、无意抄袭、伪造和编造内容,以及被标记为人工智能生成内容的威胁,都凸显了监管合规、透明度和披露的必要性。如果能主动考虑并解决这些合法问题,那么人工智能模型作为写作辅助工具的潜在应用可能会带来丰厚的回报。
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引用次数: 0
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Perspectives in Clinical Research
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