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

Humans Anesthesia, Spinal India Female Male Adult Hospitals, Rural Middle Aged Anesthesiologists
Global Health Health services research Health systems Public Health Randomised control trial

Journal

BMJ global health
ISSN: 2059-7908
Titre abrégé: BMJ Glob Health
Pays: England
ID NLM: 101685275

Informations de publication

Date de publication:
16 Aug 2024
Historique:
received: 06 10 2023
accepted: 09 07 2024
medline: 18 8 2024
pubmed: 18 8 2024
entrez: 17 8 2024
Statut: epublish

Résumé

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. 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. 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. 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. NCT04438811.

Sections du résumé

BACKGROUND 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 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 RESULTS
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 CONCLUSIONS
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 BACKGROUND
NCT04438811.

Identifiants

DOI: 10.1136/bmjgh-2023-014170 PMID: 39153752
pubmed: 39153752
pii: bmjgh-2023-014170
doi: 10.1136/bmjgh-2023-014170
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04438811']

Types de publication

Journal Article Randomized Controlled Trial Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Auteurs

Nandakumar Menon (N)

ASHWINI Gudalur Adivasi Hospital, Gudalur, Tamil Nadu, India.

Regi George (R)

Tribal Health Initiative, Sittilingi, Tamil Nadu, India.

Raman Kataria (R)

Jan Swasthya Sahyog, Bilaspur, Chhattisgarh, India.

Ravi Manoharan (R)

Tribal Health Initiative, Sittilingi, Tamil Nadu, India.

Meredith B Brooks (MB)

Boston University School of Public Health, Boston, Massachusetts, USA.
Department of Global Health, Harvard Medical School, Boston, Massachusetts, USA.
ORCID: 0000-0001-8431-5517

Alaska Pendleton (A)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Vascular and Endovascular Surgery, University of Rochester, Rochester, New York, USA.

Veena Sheshadri (V)

ASHWINI Gudalur Adivasi Hospital, Gudalur, Tamil Nadu, India.

Sudarshana Chatterjee (S)

Jan Swasthya Sahyog, Bilaspur, Chhattisgarh, India.

Wesley Rajaleelan (W)

ASHWINI Gudalur Adivasi Hospital, Gudalur, Tamil Nadu, India.
Department of Anesthesia and Perioperative Medicine, University of Ottawa, Ottawa, Ontario, Canada.

Jithen Krishnan (J)

ASHWINI Gudalur Adivasi Hospital, Gudalur, Tamil Nadu, India.

Simone Sandler (S)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.

Saurabh Saluja (S)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Surgery, Weill Cornell Medical College, New York, New York, USA.

David Ljungman (D)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Surgery at the Institute of Clinical Sciences, University of Gothenburg, Goteborg, Sweden.

Nakul Raykar (N)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.

Emma Svensson (E)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Clinical Sciences Lund, Lund University, Lund, Sweden.

Isaac Wasserman (I)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Otolaryngology - Head and Neck Surgery, Massachusetts Eye & Ear Infirmary, Boston, Massachusetts, USA.

Anudari Zorigtbaatar (A)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.
ORCID: 0000-0002-5050-8967

Gnanaraj Jesudian (G)

Karunya Rural Community Hospital, Coimbatore, Tamil Nadu, India.
ORCID: 0000-0002-7444-5892

Salim Afshar (S)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Plastic and Oral Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.

John G Meara (JG)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Plastic and Oral Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.

Alexander W Peters (AW)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA.
Department of Surgery, Weill Cornell Medical College, New York, New York, USA.

Craig D McClain (CD)

Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts, USA craig.mcclain@childrens.harvard.edu.
Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.
ORCID: 0000-0002-3462-9638

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Task-sharing spinal anaesthesia care in three...
questionsmedicales.fr › Anesthésie et analgésie › Anesthésie › Anesthésie de conduction › Rachianesthésie › Task-sharing spinal anaesthesia care in three...
questionsmedicales.fr › Régions géographiques › Asie › Asie de l'Ouest › Asie du Sud › Inde › Task-sharing spinal anaesthesia care in three...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Task-sharing spinal anaesthesia care in three...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Établissements de santé › Hôpitaux › Hôpitaux ruraux › Task-sharing spinal anaesthesia care in three...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Task-sharing spinal anaesthesia care in three...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Personnel de santé › Médecins › Anesthésiologistes › Task-sharing spinal anaesthesia care in three...