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非洲临床研究的障碍:对 27 个非洲国家临床研究人员的定量和定性调查。

Barriers to clinical research in Africa: a quantitative and qualitative survey of clinical researchers in 27 African countries.

机构信息

Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.

Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.

出版信息

Br J Anaesth. 2018 Oct;121(4):813-821. doi: 10.1016/j.bja.2018.06.013. Epub 2018 Jul 19.

Abstract

BACKGROUND

There is a need for high quality research to improve perioperative patient care in Africa. The aim of this study was to understand the particular barriers to clinical research in this environment.

METHODS

We conducted an electronic survey of African Surgical Outcomes Study (ASOS) investigators, including 29 quantitative Likert scale questions and eight qualitative questions with subsequent thematic analysis. Protocol compliant and non-compliant countries were compared according to WHO statistics for research and development, health workforce data, and world internet statistics.

RESULTS

Responses were received from 134/418 of invited researchers in 24/25 (96%) of participating countries, and three non-participating countries. Barriers included lack of a dedicated research team (47.7%), reliable internet access (32.6%), staff skilled in research (31.8%), and team commitment (23.8%). Protocol compliant countries had significantly more physicians per 1000 population (4 vs 0.9, P<0.01), internet penetration (38% vs 28%, P=0.01) and published clinical trials (1461 vs 208, P<0.01) compared with non-compliant countries. Facilitators of research included establishing a research culture (86.9%), simple data collection tools (80%), and ASOS team interaction (77.9%). Most participants are interested in future research (93.8%). Qualitative data reiterated human resource, financial resource, and regulatory barriers. However, the desire to contribute to an African collaboration producing relevant data to improve patient outcomes was expressed strongly by ASOS investigators.

CONCLUSIONS

Barriers to successful participation in ASOS related to resource limitations and not motivation of the clinician investigators. Practical solutions to individual barriers may increase the success of multi-centre perioperative research in Africa.

摘要

背景

需要高质量的研究来改善非洲围手术期患者的护理。本研究的目的是了解在这种环境下进行临床研究的特殊障碍。

方法

我们对非洲外科结局研究(ASOS)的研究人员进行了电子调查,包括 29 个定量李克特量表问题和 8 个定性问题,随后进行主题分析。根据世界卫生组织(WHO)关于研究与开发、卫生人力数据和世界互联网统计数据的统计,比较了符合和不符合方案的国家。

结果

共收到 25 个参与国家中的 134/418 名受邀研究人员的回复,以及 3 个未参与国家的回复。障碍包括缺乏专门的研究团队(47.7%)、可靠的互联网接入(32.6%)、熟练研究人员(31.8%)和团队承诺(23.8%)。符合方案的国家每千人拥有的医生数量明显更多(4 人比 0.9 人,P<0.01)、互联网普及率(38%比 28%,P=0.01)和发表的临床试验数量(1461 篇比 208 篇,P<0.01)均高于不符合方案的国家。研究的促进因素包括建立研究文化(86.9%)、简单的数据收集工具(80%)和 ASOS 团队互动(77.9%)。大多数参与者对未来的研究感兴趣(93.8%)。定性数据再次强调了人力资源、财务资源和监管障碍。然而,ASOS 研究人员强烈表达了为非洲合作做出贡献、产生相关数据以改善患者结局的愿望。

结论

成功参与 ASOS 的障碍与资源限制有关,而不是临床研究人员的积极性。针对个别障碍的实际解决方案可能会增加非洲围手术期多中心研究的成功率。

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