A pilot multicentre cluster randomised trial to compare the effect of trauma life support training programmes on patient and provider outcomes.

INTRODUCTION: Trauma accounts for nearly 10% of the global burden of disease. Several trauma life support programmes aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programmes on patient outcomes. We describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing advanced trauma life support (ATLS) and primary trauma care (PTC) with standard care. METHODS AND ANALYSIS: We will pilot a pragmatic three-armed parallel, cluster randomised controlled trial in India, where neither of these programmes are routinely taught. We will recruit tertiary hospitals and include trauma patients and residents managing these patients. Two hospitals will be randomised to ATLS, two to PTC and two to standard care. The primary outcome will be all-cause mortality at 30 days from the time of arrival to the emergency department. Our secondary outcomes will include patient, provider and process measures. All outcomes except time-to-event outcomes will be measured both as final values as well as change from baseline. We will compare outcomes in three combinations of trial arms: ATLS versus PTC, ATLS versus standard care and PTC versus standard care using absolute and relative differences along with associated CIs. We will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury and elderly. In parallel to the pilot study, we will conduct community consultations to inform the planning of the full-scale trial. ETHICS AND DISSEMINATION: We will apply for ethics approvals to the local institutional review board in each hospital. The protocol will be published to Clinical Trials Registry-India and ClinicalTrials.gov. The results will be published and the anonymised data and code for analysis will be released publicly.

Assessing the Rates and Reasons of Elective Surgical Cancellations on the Day of Surgery: A Multicentre Study from Urban Indian Hospitals.

BACKGROUND: Cancellations of elective surgeries on the day of surgery (DOS) can lead to added financial burden and wastage of resources for healthcare facilities; as well as social and emotional problems to patients. These cancellations act as barriers to delivering efficient surgical services. Optimal utilisation of the available resources is necessary for resource-constrained low-and-middle-income countries (LMIC). This study investigates the rate and causes of cancellations of elective surgeries on the DOS in various surgical departments across ten hospitals in India. METHODS: A research consortium 'IndSurg' led by World Health Organisation Collaboration Centre (WHOCC) for Research in Surgical Care Delivery in LMICs, India conducted this multicentre retrospective cross-sectional study to analyse the cancellations of elective/planned surgical operations on DOS across urban secondary and tertiary level hospitals. We audited surgical records of a pre-decided period of six weeks for cancellations, documented relevant demographic information and reasons for cancellations. RESULTS: We analysed records from the participating hospitals, with an overall cancellation rate of 9.7% (508/5231) on the DOS for elective surgical operations. Of these, 74% were avoidable cancellations. A majority (30%) of these 508 cancellations were attributed to insufficient resources, 28% due to patient's refusal or failure to show-up, and 22% due to change in patient's medical status. CONCLUSION: We saw a preponderance of avoidable reasons for elective surgery cancellations. A multidisciplinary approach with adequate preoperative patient counselling, timely communication between the patients and caregivers, adequate preoperative anaesthetic assessment, and planning by the surgical team may help reduce the cancellation rate.

A multicenter observational cohort study of 24 h and 30 day in-hospital mortality of pediatric and adult trauma patients - An Indian urban tertiary care perspective.

BACKGROUND/PURPOSE: India with its evolving trauma system needs multicenter studies on trauma outcomes to help determine the need for planning and structuring care better and to bridge the gap between the burden of disease and research. Therefore here we studied 24 h and 30 day mortality in adult and pediatric trauma population presenting to urban tertiary care hospitals. METHODOLOGY: Data from multicenter observational cohort study conducted from July 2013 to December 2015, Towards improved trauma care outcomes in India (TITCO) were used. MAIN FINDINGS: 3381 pediatric and 12,666 adult trauma patients. Unadjusted analyses of mortality were significantly less in pediatric compared to adult group within 24 h (OR 0.513, 99% CI 0.4-0.658, p < 0.001) and 30 days (OR 0.442, 99% CI 0.383-0.511, p < 0.001). In adjusted analyses pediatric group did not have significantly lower odds of 24-h mortality (OR 0.778, 99% CI 0.106-5.717, P = 0.746). At 30 days, pediatric group had 89% lower odds of death compared to adults (OR 0.11, 99% CI 0.017-0.0714, p = 0.002). CONCLUSION: Children had mechanisms of injury different from adults leading to less severe injuries than adults. Children are more likely than adults to survive until 30 days after admission for trauma in urban India. LEVEL OF EVIDENCE: Level II.

Learning from 2523 trauma deaths in India- opportunities to prevent in-hospital deaths.

BACKGROUND: A systematic analysis of trauma deaths is a step towards trauma quality improvement in Indian hospitals. This study estimates the magnitude of preventable trauma deaths in five Indian hospitals, and uses a peer-review process to identify opportunities for improvement (OFI) in trauma care delivery. METHODS: All trauma deaths that occurred within 30 days of hospitalization in five urban university hospitals in India were retrospectively abstracted for demography, mechanism of injury, transfer status, injury description by clinical, investigation and operative findings. Using mixed methods, they were quantitatively stratified by the standardized Injury Severity Score (ISS) into mild (1-8), moderate (9-15), severe (16-25), profound (26-75) ISS categories, and by time to death within 24 h, 7, or 30 days. Using peer-review and Delphi methods, we defined optimal trauma care within the Indian context and evaluated each death for preventability, using the following categories: Preventable (P), Potentially preventable (PP), Non-preventable (NP) and Non-preventable but care could have been improved (NPI). RESULTS: During the 18 month study period, there were 11,671 trauma admissions and 2523 deaths within 30 days (21.6%). The overall proportion of preventable deaths was 58%, among 2057 eligible deaths. In patients with a mild ISS score, 71% of deaths were preventable. In the moderate category, 56% were preventable, and 60% in the severe group and 44% in the profound group were preventable. Traumatic brain injury and burns accounted for the majority of non-preventable deaths. The important areas for improvement in the preventable deaths subset, inadequacies in airway management (14.3%) and resuscitation with hemorrhage control (16.3%). System-related issues included lack of protocols, lack of adherence to protocols, pre-hospital delays and delays in imaging. CONCLUSION: Fifty-eight percent of all trauma deaths were classified as preventable. Two-thirds of the deaths with injury severity scores of less than 16 were preventable. This large subgroup of Indian urban trauma patients could possibly be saved by urgent attention and corrective action. Low-cost interventions such as airway management, fluid resuscitation, hemorrhage control and surgical decision-making protocols, were identified as OFI. Establishment of clinical protocols and timely processes of trauma care delivery are the next steps towards improving care.

Validation of international trauma scoring systems in urban trauma centres in India.

INTRODUCTION: In the Lower-Middle Income Country setting, we validate trauma severity scoring systems, namely Injury Severity Score (ISS), New Injury Severity Scale (NISS) score, the Kampala Trauma Score (KTS), Revised Trauma Score (RTS) score and the TRauma Injury Severity Score (TRISS) using Indian trauma patients. PATIENTS AND METHODS: From 1 September 2013 to 28 February 2015, we conducted a prospective multi-centre observational cohort study of trauma patients in four Indian university hospitals, in three megacities, Kolkata, Mumbai and Delhi. All adult patients presenting to the casualty department with a history of injury and who were admitted to inpatient care were included. The primary outcome was in-hospital mortality within 30-days of admission. The sensitivity and specificity of each score to predict inpatient mortality within 30days was assessed by the areas under the receiver operating characteristic curve (AUC). Model fit for the performance of individual scoring systems was accomplished by using the Akaike Information criterion (AIC). RESULTS: In a registry of 8791 adult trauma patients, we had a cohort of 7197 patients eligible for the study. 4091 (56.8%)patients had all five scores available and was the sample for a complete case analysis. Over a 30-day period, the scores (AUC) was TRISS (0.82), RTS (0.81), KTS (0.74), NISS (0.65) and ISS (0.62). RTS was the most parsimonious model with the lowest AIC score. Considering overall mortality, both physiologic scores (RTS, KTS) had better discrimination and goodness-of-fit than ISS or NISS. The ability of all Injury scores to predict early mortality (24h) was better than late mortality (30day). CONCLUSION: On-admission physiological scores outperformed the more expensive anatomy-based ISS and NISS. The retrospective nature of ISS and TRISS score calculations and incomplete imaging in LMICs precludes its use in the casualty department of LMICs. They will remain useful for outcome comparison across trauma centres. Physiological scores like the RTS and KTS will be the practical score to use in casualty departments in the urban Indian setting, to predict early trauma mortality and improve triage.