Perspectives in Clinical Research最新文献_第5页

Designing and validating a research questionnaire - Part 2. 设计和验证研究问卷--第二部分。

Q2 Medicine

Perspectives in Clinical Research

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。

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

Perspectives in Clinical Research

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。

{"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":"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.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 1","pages":"24-30"},"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}

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

Perspectives in Clinical Research

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。

{"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":"391 ","pages":""},"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}

引用次数: 0

Evaluation of factors that act as barriers in conducting academic trials – An investigator’s perception 评估阻碍学术试验开展的因素--研究人员的看法

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-12-19 DOI: 10.4103/picr.picr_76_23

S. Gajbhiye, G. Dakhale, C. Chindhalore, Ashish Vijay Gupta, E. T. Selvi

Academic trials are essential in investigating health research questions relevant to the society. Only a few leading research institutions in India have been engaged in academic trials. Thus, there is a need to understand what factors dampen the spirit of the academician in conducting academic clinical trials. The aim of the study is to evaluate the investigator’s perception of obstacles to carrying out academic trials and to identify factors that will motivate investigators in conducting academic trials We conducted a prospective observational study in a tertiary care hospital for 6 months. Faculty members working in academic institutes were selected. A structured questionnaire was designed for the study and administered using google forms. Responses were taken on a Likert scale. Validity and reliability assessments were carried out. Mann-Whitney test was applied to assess differences between demographic groups. P <0.05 was considered significant. Most of the participants rated applying for research grants (76%), obtaining funding for the study and making arrangements for compensation for trial-related events (75%) as extremely challenging. We found that the degree of challenge is significantly lower in the faculty members who conducted clinical trials in the past as against those who did not (P = 0.00069). We also found that the degree of challenge is significantly higher in the faculty members with <10 years of experience than those with >10 years of experience (P = 0.00001). Thus, to conclude the challenges faced by investigators were at multiple levels, most common being applying for research grants and making arrangements for the funds for payment towards participation or study-related injury. Faculty members with exposure to conducting clinical trials and with experience of more than 10 years had perceived a reduced degree of challenges.

学术试验对于调查与社会相关的健康研究问题至关重要。印度只有少数领先的研究机构从事学术试验。因此，有必要了解是哪些因素抑制了院士开展临床学术试验的精神。本研究旨在评估研究者对开展学术试验的障碍的看法，并找出能激励研究者开展学术试验的因素。我们在一家三级医院开展了一项为期 6 个月的前瞻性观察研究。研究选取了在学术机构工作的教职员工。研究设计了一份结构化问卷，并使用谷歌表格进行管理。采用李克特量表进行回答。对问卷的有效性和可靠性进行了评估。采用 Mann-Whitney 检验来评估人口统计组之间的差异。P 10 年工作经验（P = 0.00001）。总之，研究人员面临的挑战是多方面的，最常见的是申请研究基金和安排资金用于支付参与研究或与研究相关的伤害。接触过临床试验并拥有 10 年以上经验的教员所面临的挑战程度较低。

{"title":"Evaluation of factors that act as barriers in conducting academic trials – An investigator’s perception","authors":"S. Gajbhiye, G. Dakhale, C. Chindhalore, Ashish Vijay Gupta, E. T. Selvi","doi":"10.4103/picr.picr_76_23","DOIUrl":"https://doi.org/10.4103/picr.picr_76_23","url":null,"abstract":"Academic trials are essential in investigating health research questions relevant to the society. Only a few leading research institutions in India have been engaged in academic trials. Thus, there is a need to understand what factors dampen the spirit of the academician in conducting academic clinical trials. The aim of the study is to evaluate the investigator’s perception of obstacles to carrying out academic trials and to identify factors that will motivate investigators in conducting academic trials We conducted a prospective observational study in a tertiary care hospital for 6 months. Faculty members working in academic institutes were selected. A structured questionnaire was designed for the study and administered using google forms. Responses were taken on a Likert scale. Validity and reliability assessments were carried out. Mann-Whitney test was applied to assess differences between demographic groups. P <0.05 was considered significant. Most of the participants rated applying for research grants (76%), obtaining funding for the study and making arrangements for compensation for trial-related events (75%) as extremely challenging. We found that the degree of challenge is significantly lower in the faculty members who conducted clinical trials in the past as against those who did not (P = 0.00069). We also found that the degree of challenge is significantly higher in the faculty members with <10 years of experience than those with >10 years of experience (P = 0.00001). Thus, to conclude the challenges faced by investigators were at multiple levels, most common being applying for research grants and making arrangements for the funds for payment towards participation or study-related injury. Faculty members with exposure to conducting clinical trials and with experience of more than 10 years had perceived a reduced degree of challenges.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"134 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139172315","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}

引用次数: 0

An observational study to evaluate the awareness of drug treatment, prescription pattern, adverse drug reactions, and adherence in patients of major depressive disorder 一项旨在评估重度抑郁症患者对药物治疗的认识、处方模式、药物不良反应和依从性的观察性研究

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-12-06 DOI: 10.4103/picr.picr_113_23

U. Parmar, Pranali Puradkar, Kranti Kadam, Firoz M. Tadavi, Snehalata Gajbhiye, Shirish Joshi, Amitoj Sohal

Due to the paucity of studies in and out of India that dealt with treatment awareness of major depressive disorder (MDD), we decided to assess the awareness of MDD patients, and since adherence and awareness are linked to each other, we assessed adherence too. Prescription pattern studies identify changes in prescriptions due to poor initial response or adverse drug reactions (ADRs), which may result in dose reduction or switching medications and delay remission. Therefore, the study assessed the ADR pattern. A cross-sectional questionnaire-based study was carried out on 200 MDD patients with treatment records for at least 3 months after getting approval from the Institutional Ethics Committee and consent from the patients. The data obtained were entered in Microsoft Excel and analyzed using descriptive statistics. The mean age was 44.65 ± 12.02 years, and females were 70%. Maximum patients (98%) were aware of the consequence of stopping the drugs suddenly, and only 12.5% were aware of the onset of response to treatment. Escitalopram was the most common antidepressant prescribed (43.77%), and 67 ADRs out of 136 were attributable to it. Weakness and fatigue were the most common ADRs. The majority (97) of the ADRs were possibly related to antidepressants, and 65% of patients showed optimal adherence to medications. This study sheds light on the treatment awareness and adherence of MDD patients in India and highlights the need for educating patients about treatment response. It also emphasizes the importance of monitoring ADRs and adjusting prescription patterns accordingly to improve treatment outcomes.

由于印度国内外关于重度抑郁症(MDD)治疗意识的研究很少，我们决定评估MDD患者的意识，并且由于依从性和意识是相互关联的，我们也评估了依从性。处方模式研究确定由于初始反应差或药物不良反应(adr)而改变处方，这可能导致剂量减少或转换药物和延迟缓解。因此，本研究评估了不良反应模式。经机构伦理委员会批准并征得患者同意后，对200例治疗记录至少3个月的MDD患者进行横断面问卷调查研究。得到的数据在Microsoft Excel中输入，并使用描述性统计进行分析。平均年龄44.65±12.02岁，女性占70%。大多数患者(98%)意识到突然停药的后果，只有12.5%的患者意识到治疗反应的开始。艾司西酞普兰是最常见的抗抑郁药(43.77%)，136例不良反应中有67例可归因于艾司西酞普兰。虚弱和疲劳是最常见的不良反应。大多数不良反应(97例)可能与抗抑郁药有关，65%的患者表现出最佳的药物依从性。这项研究揭示了印度重度抑郁症患者的治疗意识和依从性，并强调了对患者进行治疗反应教育的必要性。它还强调了监测不良反应和相应调整处方模式以改善治疗结果的重要性。

{"title":"An observational study to evaluate the awareness of drug treatment, prescription pattern, adverse drug reactions, and adherence in patients of major depressive disorder","authors":"U. Parmar, Pranali Puradkar, Kranti Kadam, Firoz M. Tadavi, Snehalata Gajbhiye, Shirish Joshi, Amitoj Sohal","doi":"10.4103/picr.picr_113_23","DOIUrl":"https://doi.org/10.4103/picr.picr_113_23","url":null,"abstract":"\u0000 \u0000 \u0000 Due to the paucity of studies in and out of India that dealt with treatment awareness of major depressive disorder (MDD), we decided to assess the awareness of MDD patients, and since adherence and awareness are linked to each other, we assessed adherence too. Prescription pattern studies identify changes in prescriptions due to poor initial response or adverse drug reactions (ADRs), which may result in dose reduction or switching medications and delay remission. Therefore, the study assessed the ADR pattern.\u0000 \u0000 \u0000 \u0000 A cross-sectional questionnaire-based study was carried out on 200 MDD patients with treatment records for at least 3 months after getting approval from the Institutional Ethics Committee and consent from the patients. The data obtained were entered in Microsoft Excel and analyzed using descriptive statistics.\u0000 \u0000 \u0000 \u0000 The mean age was 44.65 ± 12.02 years, and females were 70%. Maximum patients (98%) were aware of the consequence of stopping the drugs suddenly, and only 12.5% were aware of the onset of response to treatment. Escitalopram was the most common antidepressant prescribed (43.77%), and 67 ADRs out of 136 were attributable to it. Weakness and fatigue were the most common ADRs. The majority (97) of the ADRs were possibly related to antidepressants, and 65% of patients showed optimal adherence to medications.\u0000 \u0000 \u0000 \u0000 This study sheds light on the treatment awareness and adherence of MDD patients in India and highlights the need for educating patients about treatment response. It also emphasizes the importance of monitoring ADRs and adjusting prescription patterns accordingly to improve treatment outcomes.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"50 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138595496","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}

引用次数: 0

Home nursing in clinical trials: Result from semi-structured qualitative interviews 临床试验中的家庭护理：半结构化定性访谈的结果

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-12-06 DOI: 10.4103/picr.picr_218_22

Pooja Sharma, S. Bhowmick, Kedar Nayak, Soma Bhattacharjee, Sandeep Lahiry

There is a need to transition from conventional (on-site) clinical trials (CTs) to trials conducted within the comfort of a patient’s home or community (decentralized CT) through e-consent, remote data monitoring, and telemedicine consults. This shift in trial procedures will positively impact recruitment rates, compliance and participant retention, protocol deviations, and delays or missed visits. Home nursing in CTs (HNCTs) will be an important component of this decentralization effort. A few limitations may impact the implementation of HNCT in India. In this regard, the workstream conducted semi-structured qualitative interviews with experts from diverse domains of CT conduct (researchers from academia and industry, clinicians, investigators, nursing staff, patient research advocates, institutional ethics committee, or institutional review board members, legal experts, and trial participants) to collect their understanding, perspectives, and the ground realities about HNCTs in India. The current review puts forth the key areas that would facilitate the establishment of HNCTs in India and provides recommendations for the same.

有必要通过电子同意、远程数据监测和远程医疗咨询，从传统的(现场)临床试验(CT)过渡到在患者家中或社区舒适地进行的试验(分散式CT)。试验程序的这种转变将对招募率、依从性和参与者保留率、方案偏差、延迟或错过就诊产生积极影响。ct的家庭护理将是这种权力下放工作的重要组成部分。一些限制可能会影响在印度实施HNCT。在这方面，工作流程与来自CT行为不同领域的专家(来自学术界和产业界的研究人员、临床医生、调查人员、护理人员、患者研究倡导者、机构伦理委员会或机构审查委员会成员、法律专家和试验参与者)进行了半结构化的定性访谈，以收集他们对印度hnct的理解、观点和实际情况。目前的审查提出了有助于在印度建立高毒性国家工作队的关键领域，并为此提出了建议。

{"title":"Home nursing in clinical trials: Result from semi-structured qualitative interviews","authors":"Pooja Sharma, S. Bhowmick, Kedar Nayak, Soma Bhattacharjee, Sandeep Lahiry","doi":"10.4103/picr.picr_218_22","DOIUrl":"https://doi.org/10.4103/picr.picr_218_22","url":null,"abstract":"\u0000 There is a need to transition from conventional (on-site) clinical trials (CTs) to trials conducted within the comfort of a patient’s home or community (decentralized CT) through e-consent, remote data monitoring, and telemedicine consults. This shift in trial procedures will positively impact recruitment rates, compliance and participant retention, protocol deviations, and delays or missed visits. Home nursing in CTs (HNCTs) will be an important component of this decentralization effort. A few limitations may impact the implementation of HNCT in India. In this regard, the workstream conducted semi-structured qualitative interviews with experts from diverse domains of CT conduct (researchers from academia and industry, clinicians, investigators, nursing staff, patient research advocates, institutional ethics committee, or institutional review board members, legal experts, and trial participants) to collect their understanding, perspectives, and the ground realities about HNCTs in India. The current review puts forth the key areas that would facilitate the establishment of HNCTs in India and provides recommendations for the same.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"79 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138596031","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}

引用次数: 0

Trends of different inflammatory markers and clinical outcomes in hospitalized COVID-19 patients COVID-19 住院患者不同炎症指标的变化趋势和临床结局

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-11-15 DOI: 10.4103/picr.picr_123_23

Srikanth Krishnamurthy, Nandagopal Velayuthaswamy, Jaymohan Unnithan, Nagarajan Srinivasan, Shobana Balasubramaniam, Ramesh Jagannathan

引用次数: 0

ChatGPT in medical writing: A game-changer or a gimmick? 医学写作中的 ChatGPT：改变游戏规则还是噱头？

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-11-15 DOI: 10.4103/picr.picr_167_23

Shital Sarah Ahaley, Ankita Pandey, Simran Kaur Juneja, Tanvi Suhane Gupta, Sujatha Vijayakumar

OpenAI’s ChatGPT (Generative Pre-trained Transformer) is a chatbot that answers questions and performs writing tasks in a conversational tone. Within months of release, multiple sectors are contemplating the varied applications of this chatbot, including medicine, education, and research, all of which are involved in medical communication and scientific publishing. Medical writers and academics use several artificial intelligence (AI) tools and software for research, literature survey, data analyses, referencing, and writing. There are benefits of using different AI tools in medical writing. However, using chatbots for medical communications pose some major concerns such as potential inaccuracies, data bias, security, and ethical issues. Perceived incorrect notions also limit their use. Moreover, ChatGPT can also be challenging if used incorrectly and for irrelevant tasks. If used appropriately, ChatGPT will not only upgrade the knowledge of the medical writer but also save time and energy that could be directed toward more creative and analytical areas requiring expert skill sets. This review introduces chatbots, outlines the progress in ChatGPT research, elaborates the potential uses of ChatGPT in medical communications along with its challenges and limitations, and proposes future research perspectives. It aims to provide guidance for doctors, researchers, and medical writers on the uses of ChatGPT in medical communications.

OpenAI 的 ChatGPT（生成预训练转换器）是一个聊天机器人，它能以对话的口吻回答问题并执行写作任务。在发布后的几个月内，多个领域都在考虑这款聊天机器人的各种应用，包括医学、教育和研究等领域，这些领域都涉及医学交流和科学出版。医学作家和学者使用多种人工智能（AI）工具和软件进行研究、文献调查、数据分析、参考文献和写作。在医学写作中使用不同的人工智能工具有很多好处。但是，在医学交流中使用聊天机器人会带来一些重大问题，如潜在的不准确性、数据偏差、安全性和道德问题。不正确的观念也限制了聊天机器人的使用。此外，如果使用不当或用于不相关的任务，ChatGPT 也可能具有挑战性。如果使用得当，ChatGPT 不仅能提升医学撰稿人的知识水平，还能节省时间和精力，将其用于需要专家技能的更具创造性和分析性的领域。本综述介绍了聊天机器人，概述了 ChatGPT 的研究进展，阐述了 ChatGPT 在医学交流中的潜在用途及其挑战和局限性，并提出了未来的研究展望。它旨在为医生、研究人员和医学撰稿人在医学交流中使用 ChatGPT 提供指导。

{"title":"ChatGPT in medical writing: A game-changer or a gimmick?","authors":"Shital Sarah Ahaley, Ankita Pandey, Simran Kaur Juneja, Tanvi Suhane Gupta, Sujatha Vijayakumar","doi":"10.4103/picr.picr_167_23","DOIUrl":"https://doi.org/10.4103/picr.picr_167_23","url":null,"abstract":"OpenAI’s ChatGPT (Generative Pre-trained Transformer) is a chatbot that answers questions and performs writing tasks in a conversational tone. Within months of release, multiple sectors are contemplating the varied applications of this chatbot, including medicine, education, and research, all of which are involved in medical communication and scientific publishing. Medical writers and academics use several artificial intelligence (AI) tools and software for research, literature survey, data analyses, referencing, and writing. There are benefits of using different AI tools in medical writing. However, using chatbots for medical communications pose some major concerns such as potential inaccuracies, data bias, security, and ethical issues. Perceived incorrect notions also limit their use. Moreover, ChatGPT can also be challenging if used incorrectly and for irrelevant tasks. If used appropriately, ChatGPT will not only upgrade the knowledge of the medical writer but also save time and energy that could be directed toward more creative and analytical areas requiring expert skill sets. This review introduces chatbots, outlines the progress in ChatGPT research, elaborates the potential uses of ChatGPT in medical communications along with its challenges and limitations, and proposes future research perspectives. It aims to provide guidance for doctors, researchers, and medical writers on the uses of ChatGPT in medical communications.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139275181","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}

引用次数: 0

Pharmaceutical sponsors and contract research organization’s perception toward genetic data reuse for future research 医药赞助商和合同研究组织对未来研究中基因数据再利用的看法

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-11-15 DOI: 10.4103/picr.picr_220_22

R. Devarinti, M. S. Ganachari

Pharmaceutical sponsors and Contract research organization plays vital role in the preparation and implementation of clinical trials and give rise to ethical predicaments that pertain to various aspects such as general or genetic consent, optional research, storage and utilization of genetic data and specimens, as well as disclosure of research findings to study participants. The current investigation is to assess the knowledge, attitudes, and practices of Clinical Research Organizations and Pharmaceutical Sponsors in relation to re-use of genetic research data for future research. A cross-sectional study conducted on pharmaceutical sponsor and their representatives from the metro cities, India. The present research encompassed N=50 of pharmaceutical sponsors and contract research organizations. Among these, 84% evinced cognizance regarding the re-use of genetic data in clinical trials. Furthermore, 62% of pharmaceutical sponsors and contract research organizations articulated apprehensions with respect to ethical and legal quandaries might arise due to the re-use of genomic data. A considerable proportion of participants are a willingness to share and reuse genetic data for future studies. However, it is observed that the perception towards practice is low, particularly in relation to the return of genetic results and ethical concerns while storing genetic samples. There are presently no universally accepted international Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in place for the management of genetic sampling and data at the global level. In India, however, ICMR regulations exist to provide direction for the use of biological materials and datasets in research.

医药赞助商和合同研究组织在临床试验的准备和实施过程中发挥着重要作用，并在各方面引发了伦理困境，如一般或遗传同意、选择性研究、遗传数据和标本的储存和利用，以及向研究参与者披露研究结果等。目前的调查旨在评估临床研究机构和药品赞助商对在未来研究中重复使用基因研究数据的认识、态度和做法。研究对象为印度大城市的医药赞助商及其代表。本研究涉及 50 家医药赞助商和合同研究组织。其中，84% 的人对在临床试验中重复使用基因数据表示认可。此外，62% 的药品赞助商和合同研究组织对基因组数据再利用可能引发的伦理和法律问题表示担忧。相当一部分参与者愿意在今后的研究中共享和再利用基因数据。然而，我们注意到，人们对实践的认识并不高，特别是在基因结果的返还和基因样本储存的伦理问题上。目前，国际人用药品技术要求协调会议（ICH）还没有制定全球普遍接受的基因采样和数据管理准则。不过，印度有 ICMR 法规，为在研究中使用生物材料和数据集提供指导。

{"title":"Pharmaceutical sponsors and contract research organization’s perception toward genetic data reuse for future research","authors":"R. Devarinti, M. S. Ganachari","doi":"10.4103/picr.picr_220_22","DOIUrl":"https://doi.org/10.4103/picr.picr_220_22","url":null,"abstract":"Pharmaceutical sponsors and Contract research organization plays vital role in the preparation and implementation of clinical trials and give rise to ethical predicaments that pertain to various aspects such as general or genetic consent, optional research, storage and utilization of genetic data and specimens, as well as disclosure of research findings to study participants. The current investigation is to assess the knowledge, attitudes, and practices of Clinical Research Organizations and Pharmaceutical Sponsors in relation to re-use of genetic research data for future research. A cross-sectional study conducted on pharmaceutical sponsor and their representatives from the metro cities, India. The present research encompassed N=50 of pharmaceutical sponsors and contract research organizations. Among these, 84% evinced cognizance regarding the re-use of genetic data in clinical trials. Furthermore, 62% of pharmaceutical sponsors and contract research organizations articulated apprehensions with respect to ethical and legal quandaries might arise due to the re-use of genomic data. A considerable proportion of participants are a willingness to share and reuse genetic data for future studies. However, it is observed that the perception towards practice is low, particularly in relation to the return of genetic results and ethical concerns while storing genetic samples. There are presently no universally accepted international Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in place for the management of genetic sampling and data at the global level. In India, however, ICMR regulations exist to provide direction for the use of biological materials and datasets in research.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"3 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139272302","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}

引用次数: 0

GENESIS-Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students research in health care: A research modeling experience from a newly established medical college GENESIS--以指导、教育、联网和赋权为基础的学生医疗保健研究智能倡议：一所新成立医学院的研究模式经验

Q2 Medicine

Perspectives in Clinical Research

Pub Date : 2023-11-10 DOI: 10.4103/picr.picr_88_23

Priyansh Nathani, Shreya Goyal, Yash Junnarkar, Khushi Prajapati

The importance of undergraduate medical research has been undermined in Indian medical education. Various studies show there is a drastic difference between the research output of Indian medical graduates in comparison to Western counterparts. With all the challenges identified, a student-oriented research committee was formed –Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students (GENESIS) research in health care – A research modeling experience from a newly established medical college. The structure was established to serve the needs of students in the field of research. Problems were identified with the help of a survey, and steps were taken to address the issues through its 4-pronged strategy that includes conducting regular journal clubs. Journal clubs follow a peer-to-peer learning strategy and provide an open stage for discussion. Second, a research tracker which helps in increasing the sustainability of a research project. The third strategy includes a research live matchmaker which helps in bridging the gap between the students and the faculties. Lastly, involving alumni in the initiative will help students get guidance and acts as a gateway to opportunities at the national level. For maintaining the integrity and sustainability of the initiative, the involvement of students from all the batches is made sure. Inputs from faculties and administration are taken on a regular basis. Interinstitutional collaborations and regular assessment and evaluation are done to ensure positive outcomes. With its focus on peer-to-peer mentoring and attempt to eliminate the barriers for research enthusiasts, GENESIS has the potential to make a lasting impact in promoting research culture in colleges.

在印度的医学教育中，本科生医学研究的重要性被削弱了。多项研究表明，印度医学毕业生的研究成果与西方同行相比差距巨大。在确定了所有挑战之后，一个以学生为导向的研究委员会成立了--医疗保健领域的指导、教育、网络和赋权型学生智能倡议（GENESIS）研究--一所新成立医学院的研究示范经验。建立该结构的目的是满足学生在研究领域的需求。通过调查发现了问题，并通过四管齐下的战略（包括定期举办期刊俱乐部）采取措施解决这些问题。期刊俱乐部采用点对点学习策略，为讨论提供了一个开放的舞台。其次，研究跟踪器有助于提高研究项目的可持续性。第三个策略包括研究现场配对，这有助于缩小学生与教师之间的差距。最后，让校友参与这一举措将有助于学生获得指导，并成为获得国家级机会的门户。为了保持活动的完整性和可持续性，确保所有批次的学生都参与进来。定期听取学院和行政部门的意见。为确保取得积极成果，还开展了机构间合作，并定期进行评估和评价。GENESIS 注重同侪指导，努力消除研究爱好者的障碍，因此有可能在促进高校研究文化方面产生持久影响。

{"title":"GENESIS-Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students research in health care: A research modeling experience from a newly established medical college","authors":"Priyansh Nathani, Shreya Goyal, Yash Junnarkar, Khushi Prajapati","doi":"10.4103/picr.picr_88_23","DOIUrl":"https://doi.org/10.4103/picr.picr_88_23","url":null,"abstract":"The importance of undergraduate medical research has been undermined in Indian medical education. Various studies show there is a drastic difference between the research output of Indian medical graduates in comparison to Western counterparts. With all the challenges identified, a student-oriented research committee was formed –Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students (GENESIS) research in health care – A research modeling experience from a newly established medical college. The structure was established to serve the needs of students in the field of research. Problems were identified with the help of a survey, and steps were taken to address the issues through its 4-pronged strategy that includes conducting regular journal clubs. Journal clubs follow a peer-to-peer learning strategy and provide an open stage for discussion. Second, a research tracker which helps in increasing the sustainability of a research project. The third strategy includes a research live matchmaker which helps in bridging the gap between the students and the faculties. Lastly, involving alumni in the initiative will help students get guidance and acts as a gateway to opportunities at the national level. For maintaining the integrity and sustainability of the initiative, the involvement of students from all the batches is made sure. Inputs from faculties and administration are taken on a regular basis. Interinstitutional collaborations and regular assessment and evaluation are done to ensure positive outcomes. With its focus on peer-to-peer mentoring and attempt to eliminate the barriers for research enthusiasts, GENESIS has the potential to make a lasting impact in promoting research culture in colleges.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139281492","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}

引用次数: 0