{
  "abstract": "Objective To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.Design This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.Setting Tertiary care hospitals across metropolitan areas in India.Participants Adult trauma patients and residents managing these patients were included.Interventions ATLS or PTC training was provided for residents in the intervention arms.Main outcomes and measures The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.Results Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.Conclusions Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.Trial registration number NCT05417243.",
  "authors": [
    {
      "affiliations": [
        "Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden",
        "Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden"
      ],
      "name": "Martin Gerdin Wärnberg"
    },
    {
      "affiliations": [
        "Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India",
        "Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India"
      ],
      "name": "Debojit Basak"
    },
    {
      "affiliations": [
        "Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden",
        "Department of Internal and Emergency Medicine, Skånes universitetssjukhus Malmö, Malmo, Sweden"
      ],
      "name": "Johanna Berg"
    },
    {
      "affiliations": [
        "Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India",
        "Department of Surgery, Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India"
      ],
      "name": "Shamita Chatterjee"
    },
    {
      "affiliations": [
        "Department of Clinical Science Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden",
        "Department of Reconstructive Orthopedics, Karolinska University Hospital, Stockholm, Sweden"
      ],
      "name": "Li Felländer-Tsai"
    },
    {
      "affiliations": [
        "Department of Surgery, HBT Medical College and Dr RN Cooper Municipal General Hospital, Mumbai, Maharashtra, India"
      ],
      "name": "Geeta Ghag"
    },
    {
      "affiliations": [
        "Division of General Surgery, Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA"
      ],
      "name": "Catherine Juillard"
    },
    {
      "affiliations": [
        "Department of Surgery, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India"
      ],
      "name": "Monty Khajanchi"
    },
    {
      "affiliations": [
        "All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Tamal Khan"
    },
    {
      "affiliations": [
        "Department of Surgery, Maulana Azad Medical College, New Delhi, India"
      ],
      "name": "Anurag Mishra"
    },
    {
      "affiliations": [
        "Department of Surgery, HBT Medical College and Dr RN Cooper Municipal General Hospital, Mumbai, Maharashtra, India"
      ],
      "name": "Vipul Versi Nandu"
    },
    {
      "affiliations": [
        "Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden",
        "Program for Global Surgery and Trauma, The George Institute for Global Health India, New Delhi, India"
      ],
      "name": "Nobhojit Roy"
    },
    {
      "affiliations": [
        "Department of Surgery, Maulana Azad Medical College, New Delhi, India"
      ],
      "name": "Rajdeep Singh"
    },
    {
      "affiliations": [
        "Critical Care, All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Kapil Dev Soni"
    },
    {
      "affiliations": [
        "Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden",
        "Department of Clinical Science Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden"
      ],
      "name": "Lovisa Strömmer"
    }
  ],
  "title": "Feasibility of a cluster randomised trial on the effect of trauma life support training: a pilot study in India",
  "uid": "effad886-99d3-5c2a-b594-814bc880fc0f"
}