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

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引用次数: 0

摘要

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。

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Home nursing in clinical trials: Result from semi-structured qualitative interviews

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.

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来源期刊

Perspectives in Clinical Research Medicine-Medicine (all)

CiteScore

2.90

自引率

0.00%

发文量

审稿时长

36 weeks

期刊介绍： This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.