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印度医护人员对临床试验的认知与看法:一项全印横断面调查。

Knowledge and perception of health-care professionals on clinical trials in India: A pan-Indian cross-sectional survey.

机构信息

Head of Department of Ophthalmology and Chief of Vitreo-Retinal Services, Amrita Institute of Medical Sciences (AIMS), Kochi, Kerala, India.

Director and Head of Department of Opthalmology, Regional Institute of Ophthalmology, RIO Thiruvanthapuram, Kerala, India.

出版信息

Indian J Ophthalmol. 2023 Jul;71(7):2866-2872. doi: 10.4103/IJO.IJO_3048_22.

Abstract

PURPOSE

The purpose of the study was to evaluate the knowledge and perception of health-care professionals (HCPs), such as doctors/surgeons, pharmacists, nurses, optometrists, and lab technicians, on clinical trials (CTs) in India.

METHODS

The study was a pan-Indian cross-sectional survey initiated by the Indian Ophthalmology Clinical Trial Network (IOCTN) by using a previously validated questionnaire for three months of data collection. An online survey was used to record information regarding demographics, CT knowledge, and CT perception among HCPs.

RESULTS

A total of 630 responses were recorded from HCPs: 207 doctors and surgeons, 159 pharmacists, and 264 laboratory technicians, nurses, and optometrists across India. Over 90% of HCPs had a clear knowledge on the purpose of CTs, the informed consent (IC) process, ethical approval by the Drugs Controller General of India (DCGI). About 80% and 90% were aware of confidentiality of patients, voluntariness of participation, and good clinical practice. Surprisingly, less than 50% had lesser knowledge regarding monetary incentives of CT participants (CTPs). A slightly positive perception was observed regarding the potential benefits of CTPs, compensation related to injury, and importance of obtaining IC. Less than 50% had a negative perception that monetary compensation to CTPs led to bias and deprivation of standard treatments. However, no significant difference was observed between other aspects of demographics and perception regarding CTs.

CONCLUSION

We observed doctors and surgeons to be having the highest regarding CTs, followed by pharmacists. The survey highlighted the necessity of scheduling awareness programs among the HCPs, which would improve their misconceptions and perception of CTs while interacting with patients for CT enrollment.

摘要

目的

本研究旨在评估印度的医疗保健专业人员(如医生/外科医生、药剂师、护士、验光师和实验室技术员)对临床试验(CT)的知识和认知。

方法

这项研究是由印度眼科临床试验网络(IOCTN)发起的一项全印度横断面调查,为期三个月,使用了之前经过验证的问卷来收集数据。采用在线调查记录了 HCP 关于人口统计学、CT 知识和 CT 认知的信息。

结果

共记录了来自印度各地的 630 名 HCP 的回复:207 名医生和外科医生、159 名药剂师以及 264 名实验室技术员、护士和验光师。超过 90%的 HCP 对 CT 的目的、知情同意(IC)过程、印度药品管制总局(DCGI)的伦理批准有清晰的认识。约 80%和 90%的人知道患者的保密性、参与的自愿性和良好的临床实践。令人惊讶的是,不到 50%的人对 CT 参与者(CTP)的金钱激励了解较少。对 CTP 的潜在益处、与伤害相关的补偿以及获得 IC 的重要性,观察到了略微积极的看法。不到 50%的人认为金钱补偿 CTP 会导致偏见和剥夺标准治疗的负面看法。然而,在其他方面的人口统计学和对 CT 的看法方面没有观察到显著差异。

结论

我们观察到医生和外科医生对 CT 的了解最多,其次是药剂师。这项调查强调了在 HCP 中安排意识计划的必要性,这将有助于改善他们与患者互动以招募 CT 时的误解和 CT 认知。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10a5/10491074/fbf3d51fe75a/IJO-71-2866-g001.jpg

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