Komfo Anokye Teaching Hospital, Kumasi, Ghana.
Komfo Anokye Teaching Hospital, Kumasi, Ghana; Kwame Nkrumah University of Science & Technology, Kumasi, Ghana.
J Neurol Sci. 2023 May 15;448:120641. doi: 10.1016/j.jns.2023.120641. Epub 2023 Mar 31.
One out of every four strokes is a highly preventable recurrent stroke. However, while low-and-middle-income countries (LMICs) experience a disproportionate global burden of stroke, individuals in these regions seldomly participate in pivotal clinical trials, which form the basis for international expert consensus guideline recommendations.
To evaluate a contemporary and globally prominent expert consensus secondary stroke prevention guideline statement for the participation of clinical trial subjects recruited from LMICs in formulating key therapeutic recommendations.
We examined the 2021 American Heart Association/American Stroke Association Guideline for the Prevention of Stroke in Patients with Stroke and TIA. All randomized controlled trials (RCTs) cited in the Guideline were independently reviewed by two authors for study populations and participating countries with a focus on trials for vascular risk factor control and management by underlying stroke mechanism. We also reviewed all cited systematic reviews and meta-analyses for the original RCTs.
Among 320 secondary stroke prevention clinical trials, 262 (82%) focused on vascular risk control addressing diabetes (n = 26), hypertension (n = 23), obstructive sleep apnea (n = 13), dyslipidaemia (n = 10), lifestyle (n = 188) and obesity (n = 2); and 58 focused on stroke mechanism management including atrial fibrillation (n = 10), large vessel atherosclerosis (n = 45) and small vessel disease (n = 3). Overall, 53 of 320 studies (16.6%) had contributions from LMICs ranging from 55.6% for dyslipidemia, 40.7% for diabetes, 26.1% for hypertension, 15.4% for OSA, 6.4% for lifestyle, 0% for obesity, and by mechanism: 60.0% for atrial fibrillation, 22.2% large vessel atherosclerosis and 33.3% for small vessel disease trials. Only 19 (5.9%) of the trials had participatory contributions from a country in sub-Saharan Africa (South Africa only).
Compared to their global burden of stroke, LMICs are underrepresented in key clinical trials used in formulating a prominent global stroke prevention guideline. While current therapeutic recommendations are likely applicable to practice settings throughout the world, greater involvement of patients from LMIC settings will enhance the contextual relevance and generalizability of recommendations to these disparate populations.
每四个中风患者中就有一个是可高度预防的复发性中风。然而，尽管中低收入国家（LMICs）承受着不成比例的全球中风负担，但这些地区的个人很少参与关键性临床试验，而这些临床试验是国际专家共识指南推荐的基础。
评估 2021 年美国心脏协会/美国中风协会关于中风和 TIA 患者中风预防的指南中，从 LMICs 招募临床试验受试者参与制定关键治疗建议的当代和全球知名专家共识二级中风预防指南声明。
我们检查了 2021 年美国心脏协会/美国中风协会关于中风和 TIA 患者中风预防的指南。两位作者独立审查了指南中引用的所有随机对照试验（RCT），重点关注血管风险因素控制和管理的试验，并根据潜在的中风机制对研究人群和参与国家进行审查。我们还审查了原始 RCT 的所有引用的系统评价和荟萃分析。
在 320 项二级中风预防临床试验中，262 项（82%）专注于血管风险控制，涉及糖尿病（n=26）、高血压（n=23）、阻塞性睡眠呼吸暂停（n=13）、血脂异常（n=10）、生活方式（n=188）和肥胖（n=2）；58 项专注于中风机制管理，包括心房颤动（n=10）、大动脉粥样硬化（n=45）和小血管疾病（n=3）。总体而言，320 项研究中有 53 项（16.6%）来自 LMICs，其中血脂异常占 55.6%，糖尿病占 40.7%，高血压占 26.1%，OSA 占 15.4%，生活方式占 6.4%，肥胖占 0%，按机制划分：心房颤动占 60.0%，大动脉粥样硬化占 22.2%，小血管疾病占 33.3%。只有 19 项（5.9%）试验来自撒哈拉以南非洲（仅南非）的国家有参与性贡献。
与中风的全球负担相比，LMICs 在用于制定重要全球中风预防指南的关键临床试验中代表性不足。虽然当前的治疗建议可能适用于全球的实践环境，但更多来自 LMIC 环境的患者参与将提高建议对这些不同人群的背景相关性和普遍性。
