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Task-sharing spinal anaesthesia care in three rural Indian hospitals : A non-inferiority randomised controlled clinical trial

Menon, Nandakumar ; George, Regi ; Kataria, Raman ; Manoharan, Ravi ; Brooks, Meredith B. ; Pendleton, Alaska ; Sheshadri, Veena ; Chatterjee, Sudarshana ; Rajaleelan, Wesley and Krishnan, Jithen , et al. (2024) In BMJ Global Health 9(8).
Abstract

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,... (More)

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. Trial registration number NCT04438811.

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@article{171ff816-80ed-4ede-b841-21c2e9c76be4,
  abstract     = {{<p>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 &amp; 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. Trial registration number NCT04438811.</p>}},
  author       = {{Menon, Nandakumar and George, Regi and Kataria, Raman and Manoharan, Ravi and Brooks, Meredith B. and Pendleton, Alaska and Sheshadri, Veena and Chatterjee, Sudarshana and Rajaleelan, Wesley and Krishnan, Jithen and Sandler, Simone and Saluja, Saurabh and Ljungman, David and Raykar, Nakul and Svensson, Emma and Wasserman, Isaac and Zorigtbaatar, Anudari and Jesudian, Gnanaraj and Afshar, Salim and Meara, John G. and Peters, Alexander W. and Mcclain, Craig D.}},
  issn         = {{2059-7908}},
  keywords     = {{Global Health; Health services research; Health systems; Public Health; Randomised control trial}},
  language     = {{eng}},
  number       = {{8}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Global Health}},
  title        = {{Task-sharing spinal anaesthesia care in three rural Indian hospitals : A non-inferiority randomised controlled clinical trial}},
  url          = {{http://dx.doi.org/10.1136/bmjgh-2023-014170}},
  doi          = {{10.1136/bmjgh-2023-014170}},
  volume       = {{9}},
  year         = {{2024}},
}