Nandakumar Menon, Regi George, Raman Kataria, Ravi Manoharan, Meredith B Brooks, Alaska Pendleton, Veena Sheshadri, Sudarshana Chatterjee, Wesley Rajaleelan, Jithen Krishnan, Simone Sandler, Saurabh Saluja, David Ljungman, Nakul Raykar, Emma Svensson, Isaac Wasserman, Anudari Zorigtbaatar, Gnanaraj Jesudian, Salim Afshar, John G Meara, Alexander W Peters, Craig D McClain
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引用次数: 0
摘要
背景：在印度农村医疗机构中，非专科毕业的医生（被称为医务人员（MO））通常分担脊柱麻醉护理任务，以缓解劳动力紧张的问题。我们试图评估医务人员的脊柱麻醉失败率是否不低于采用标准化教育课程的麻醉顾问（CA）：我们在印度泰米尔纳德邦和恰蒂斯加尔邦的三家农村医院进行了随机、非劣效试验。年龄在 18 岁以上、围手术期风险较低（ASA I 级和 II 级）的患者被随机分配接受 MO 或 CA 护理。试验前，麻醉医生接受了基于任务的麻醉培训，包括远程讲座、模拟培训以及直接观察麻醉程序和术中护理。主要结果指标是脊髓麻醉失败率，非劣效区为 5%。次要结果指标包括围手术期和术后并发症的发生率：2019年7月12日至2020年6月8日期间，共有422名接受适合脊髓麻醉护理的外科手术的患者被随机分配接受MO（231人，54.7%）或CA护理（191人，45.2%）。MO（7 例，3.0%）的脊柱麻醉失败率不低于 CA（5 例，2.6%）；成功率相差 0.4% (95% CI=0.36-0.43%; p=0.80)。此外，两组患者在术中、术后并发症以及术中疼痛体验方面均无统计学差异：这项研究表明，在低风险手术患者中，由训练有素的医护人员提供的脊髓麻醉护理的失败率并不低于由CA提供的护理。这可能会支持将任务分担作为扩大印度农村医院麻醉护理能力的一种手段的政策措施：NCT04438811.
Task-sharing spinal anaesthesia care in three rural Indian hospitals: a non-inferiority randomised controlled clinical trial.
Background: Task-sharing of spinal anaesthesia care by non-specialist graduate physicians, termed medical officers (MOs), is commonly practised in rural Indian healthcare facilities to mitigate workforce constraints. We sought to assess whether spinal anaesthesia failure rates of MOs were non-inferior to those of consultant anaesthesiologists (CA) following a standardised educational curriculum.
Methods: We performed a randomised, non-inferiority trial in three rural hospitals in Tamil Nadu and Chhattisgarh, India. Patients aged over 18 years with low perioperative risk (ASA I & II) were randomised to receive MO or CA care. Prior to the trial, MOs underwent task-based anaesthesia training, inclusive of remotely accessed lectures, simulation-based training and directly observed anaesthetic procedures and intraoperative care. The primary outcome measure was spinal anaesthesia failure with a non-inferiority margin of 5%. Secondary outcome measures consisted of incidence of perioperative and postoperative complications.
Findings: Between 12 July 2019 and 8 June 2020, a total of 422 patients undergoing surgical procedures amenable to spinal anaesthesia care were randomised to receive either MO (231, 54.7%) or CA care (191, 45.2%). Spinal anaesthesia failure rate for MOs (7, 3.0%) was non-inferior to those of CA (5, 2.6%); difference in success rate of 0.4% (95% CI=0.36-0.43%; p=0.80). Additionally, there were no statistically significant differences observed between the two groups for intraoperative or postoperative complications, or patients' experience of pain during the procedure.
Interpretation: This study demonstrates that failure rates of spinal anaesthesia care provided by trained MOs are non-inferior to care provided by CAs in low-risk surgical patients. This may support policy measures that use task-sharing as a means of expanding anaesthesia care capacity in rural Indian hospitals.
期刊介绍：
BMJ Global Health is an online Open Access journal from BMJ that focuses on publishing high-quality peer-reviewed content pertinent to individuals engaged in global health, including policy makers, funders, researchers, clinicians, and frontline healthcare workers. The journal encompasses all facets of global health, with a special emphasis on submissions addressing underfunded areas such as non-communicable diseases (NCDs). It welcomes research across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialized studies. The journal also encourages opinionated discussions on controversial topics.
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