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促进临床试验中的包容性——文献快速回顾及行动建议。

Promoting inclusion in clinical trials-a rapid review of the literature and recommendations for action.

机构信息

Independent Researcher, Leicester, UK.

Centre for Ethnic Health Research, University of Leicester, Leicester General Hospital, Leicester, UK.

出版信息

Trials. 2021 Dec 4;22(1):880. doi: 10.1186/s13063-021-05849-7.


DOI:10.1186/s13063-021-05849-7
PMID:34863265
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8643184/
Abstract

BACKGROUND: Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in research is a prevailing problem due to multi-faceted barriers acting at multiple levels. Therefore, we rapidly reviewed international published literature, in relation to clinical trials, on barriers relating to inclusion, and evidence of approaches that are effective in overcoming these. METHODS: A rapid literature review was conducted searching PubMed for peer-reviewed articles that discussed barriers to inclusion or strategies to improve inclusion in clinical trial research published between 2010 and 2021. Grey literature articles were excluded. RESULTS: Seventy-two eligible articles were included. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. In relation to evidence-based strategies and enablers, two key themes arose: [1] a multi-faceted approach is essential [2]; no single strategy was universally effective either within or between trials. The key evidence-based strategies identified were cultural competency training, community partnerships, personalised approach, multilingual materials and staff, communication-specific strategies, increasing understanding and trust, and tackling logistical barriers. CONCLUSIONS: Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population's particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal development, the need to establish a diverse community advisory panel for ongoing input into the research process, and increasing recruitment of staff from under-served groups. Implementation of these recommendations may help improve representation of under-served groups in clinical trials which would improve the external validity of associated findings.

摘要

背景:如果不纳入不同的研究参与者,就很难理解研究结果如何转化为现实世界。尽管如此,由于多方面的障碍在多个层面上起作用,服务不足群体的人在研究中得不到充分纳入仍然是一个普遍存在的问题。因此,我们迅速审查了与临床试验相关的国际已发表文献,涉及纳入障碍以及克服这些障碍的有效方法的证据。

方法:我们在 PubMed 上进行了快速文献综述,检索了 2010 年至 2021 年间发表的关于纳入临床试验研究障碍或改善纳入策略的同行评议文章。排除灰色文献文章。

结果:共纳入 72 篇合格文章。确定的主要障碍包括语言和沟通障碍、缺乏信任、获得试验机会、入选标准、态度和信念、对临床试验的了解不足以及后勤和实际问题。关于循证策略和促成因素,出现了两个关键主题:[1]多方面的方法是必要的;[2]没有一种策略在试验内或试验间普遍有效。确定的关键循证策略包括文化能力培训、社区伙伴关系、个性化方法、多语言材料和人员、专门的沟通策略、增加理解和信任以及解决后勤障碍。

结论:许多与纳入相关的障碍与影响试验设计和一般医疗保健服务的障碍相同。然而,这些障碍在不同的服务不足群体中的表现可能因每个群体的特定情况、背景和需求而有所不同。基于文献,我们提出了 15 条建议,如果实施这些建议,可能有助于改善临床试验和一般临床研究中的纳入情况。三个主要建议包括通过培训和持续的个人发展提高所有临床试验人员的文化能力和敏感性,需要为持续参与研究过程建立一个多样化的社区咨询小组,并增加服务不足群体人员的招聘。实施这些建议可能有助于改善服务不足群体在临床试验中的代表性,从而提高相关发现的外部有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a6d8/8645083/7809bd6a94e7/13063_2021_5849_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a6d8/8645083/7809bd6a94e7/13063_2021_5849_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a6d8/8645083/7809bd6a94e7/13063_2021_5849_Fig1_HTML.jpg

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本文引用的文献

[1]
A systematic review to identify research priority setting in Black and minority ethnic health and evaluate their processes.

PLoS One. 2021

[2]
The under-representation of BAME patients in the COVID-19 Recovery trial at a major London NHS Trust.

J Infect. 2021-4

[3]
Examining the language demands of informed consent documents in patient recruitment to cancer trials using tools from corpus and computational linguistics.

Health (London). 2022-7

[4]
Exploring the Engagement of Racial and Ethnic Minorities in HIV Treatment and Vaccine Clinical Trials: A Scoping Review of Literature and Implications for Future Research.

AIDS Patient Care STDS. 2020-9

[5]
Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process.

Trials. 2020-8-1

[6]
The impact of ethnicity on clinical outcomes in COVID-19: A systematic review.

EClinicalMedicine. 2020-6-3

[7]
COVID-19 and ethnicity: who will research results apply to?

Lancet. 2020-6-27

[8]
Formative research to design a culturally-appropriate cancer clinical trial education program to increase participation of African American and Latino communities.

BMC Public Health. 2020-6-3

[9]
Characteristics of parental decision-making for children with advanced cancer who are offered enrollment in early-phase clinical trials: A systematic review.

Pediatr Hematol Oncol. 2020-9

[10]
Factors associated with biomedical research participation within community-based samples across 3 National Cancer Institute-designated cancer centers.

Cancer. 2020-1-7

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