Perceived usefulness of trauma audit filters in urban India: a mixed-methods multicentre Delphi study comparing filters from the WHO and low and middle-income countries.

OBJECTIVE: To compare experts' perceived usefulness of audit filters from Ghana, Cameroon, WHO and those locally developed; generate context-appropriate audit filters for trauma care in selected hospitals in urban India; and explore characteristics of audit filters that correlate to perceived usefulness. DESIGN: A mixed-methods approach using a multicentre online Delphi technique. SETTING: Two large tertiary hospitals in urban India. METHODS: Filters were rated on a scale from 1 to 10 in terms of perceived usefulness, with the option to add new filters and comments. The filters were categorised into three groups depending on their origin: low and middle-income countries (LMIC), WHO and New (locally developed), and their scores compared. Significance was determined using Kruskal-Wallis test followed by Wilcoxon rank-sum test. We performed a content analysis of the comments. RESULTS: 26 predefined and 15 new filter suggestions were evaluated. The filters had high usefulness scores (mean overall score 9.01 of 10), with the LMIC filters having significantly higher scores compared with those from WHO and those newly added. Three themes were identified in the content analysis relating to medical relevance, feasibility and specificity. CONCLUSIONS: Audit filters from other LMICs were deemed highly useful in the urban India context. This may indicate that the transferability of defined trauma audit filters between similar contexts is high and that these can provide a starting point when implemented as part of trauma quality improvement programmes in low-resource settings.

Comparison of emergency department trauma triage performance of clinicians and clinical prediction models: a cohort study in India.

OBJECTIVE: The aim of this study was to evaluate and compare the abilities of clinicians and clinical prediction models to accurately triage emergency department (ED) trauma patients. We compared the decisions made by clinicians with the Revised Trauma Score (RTS), the Glasgow Coma Scale, Age and Systolic Blood Pressure (GAP) score, the Kampala Trauma Score (KTS) and the Gerdin et al model. DESIGN: Prospective cohort study. SETTING: Three hospitals in urban India. PARTICIPANTS: In total, 7697 adult patients who presented to participating hospitals with a history of trauma were approached for enrolment. The final study sample included 5155 patients. The majority (4023, 78.0%) were male. MAIN OUTCOME MEASURE: The patient outcome was mortality within 30 days of arrival at the participating hospital. A grid search was used to identify model cut-off values. Clinicians and categorised models were evaluated and compared using the area under the receiver operating characteristics curve (AUROCC) and net reclassification improvement in non-survivors (NRI+) and survivors (NRI-) separately. RESULTS: The differences in AUROCC between each categorised model and the clinicians were 0.016 (95% CI -0.014 to 0.045) for RTS, 0.019 (95% CI -0.007 to 0.058) for GAP, 0.054 (95% CI 0.033 to 0.077) for KTS and -0.007 (95% CI -0.035 to 0.03) for Gerdin et al. The NRI+ for each model were -0.235 (-0.37 to -0.116), 0.17 (-0.042 to 0.405), 0.55 (0.47 to 0.65) and 0.22 (0.11 to 0.717), respectively. The NRI- were 0.385 (0.348 to 0.4), -0.059 (-0.476 to -0.005), -0.162 (-0.18 to -0.146) and 0.039 (-0.229 to 0.06), respectively. CONCLUSION: The findings of this study suggest that there are no substantial differences in discrimination and net reclassification improvement between clinicians and all four clinical prediction models when using 30-day mortality as the outcome of ED trauma triage in adult patients. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02838459).

On-admission blood pressure and pulse rate in trauma patients and their correlation with mortality: Cushing's phenomenon revisited.

BACKGROUND: Injury-induced alteration in initial physiological responses such as hypertension and heart rate (HR) has a significant effect on mortality. Research on such associations from our country-India is limited. The present study investigates the injury-induced early blood pressure (BP) and HR changes and their association with mortality. MATERIALS AND METHODS: The data were selected from Towards Improved Trauma Care Outcomes collected from October 1, 2013, to July 24, 2014. Patients above 18 years of age with documented systolic BP (SBP) and HR were selected. BP was categorized into hypotension (SBP <90 mmHg), hypertension (SBP >140 mmHg), and normal (SBP 90-140 mmHg). HR was categorized into bradycardia (HR <60 beats/min [bpm]), tachycardia (HR >100 bpm), and normal (HR 60-100 bpm). These categories were compared with mortality. RESULTS: A total of 10,200 patients were considered for the study. Mortality rate was 24%. Mortality among females was more than males. Patients with normal BP and HR had 20% of mortality. Mortality in patients with abnormal BP and HR findings was 36%. Mortality was higher among hypotension-bradycardia patients (80%) followed by hypertension-bradycardia patients (58%) and tachycardia hypotension patients (48%). Elderly patients were at higher risk of deaths with an overall mortality of 35% compared to 23% of adults. CONCLUSION: The study reports that initial combination of hypotension-bradycardia had higher mortality rate. Specific precautions in prehospital care should be given to trauma patients with these findings. Further prospective study in detail should be considered for exploring this abnormality.

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.

Traumatic transfers: calibration is adversely affected when prediction models are transferred between trauma care contexts in India and the United States.

OBJECTIVE: We evaluated the transferability of prediction models between trauma care contexts in India and the United States and explored updating methods to adjust such models for new contexts. STUDY DESIGN AND SETTINGS: Using a combination of prospective cohort and registry data from 3,728 patients of Towards Improved Trauma Care Outcomes in India (TITCO) and from 18,756 patients of the US National Trauma Data Bank (NTDB), we derived models in one context and validated them in the other, assessing them for discrimination and calibration using systolic blood pressure, heart rate, and Glasgow coma scale as candidate predictors. RESULTS: Early mortality was 8% in the TITCO and 1-2% in the NTDB samples. Both models discriminated well, but the TITCO model overestimated the risk of mortality in NTDB patients, and the NTDB model underestimated the risk in TITCO patients. CONCLUSION: Transferability was good in terms of discrimination but poor in terms of calibration. It was possible to improve this miscalibration by updating the models' intercept. This updating method could be used in samples with as few as 25 events.

Clastogenic and mutagenic effects of bisphenol A: an endocrine disruptor.

Bisphenol A (BPA) is a well-known endocrine disruptor (ED) which represents a major toxicological and public health concern due to its widespread exposure to humans. BPA has been reported to induce DNA adduct and aneuploidy in rodents. Recent studies in humans depicted its association with recurrent miscarriages and male infertility due to sperm DNA damage indicating that BPA might have genotoxic activity. Hence, the present study was designed to determine genotoxic and mutagenic effects of BPA using in-vivo and in-vitro assays. The adult male and female rats were orally administered with various doses of BPA (2.4 µg, 10 µg, 5mg and 50mg/kgbw) once a day for six consecutive days. Animals were sacrificed, bone marrow and blood samples were collected and subjected to series of genotoxicity assay such as micronucleus, chromosome aberration and single cell gel electrophoresis (SCGE) assay respectively. Mutagenicity was determined using tester strains of Salmonella typhimurium (TA 98, TA 100 and TA 102) in the presence and absence of metabolically active microsomal fractions (S9). Further, we estimated the levels of 8-hydroxydeoxyguanosine, lipid per-oxidation and glutathione activity to decipher the potential genotoxic mechanism of BPA. We observed that BPA exposure caused a significant increase in the frequency of micronucleus (MN) in polychromatic erythrocytes (PCEs), structural chromosome aberrations in bone marrow cells and DNA damage in blood lymphocytes. These effects were observed at various doses tested except 2.4 µg compared to vehicle control. We did not observe the mutagenic response in any of the tester strains tested at different concentrations of BPA. We found an increase in the level of 8-hydroxydeoxyguanosine in the plasma and increase in lipid per-oxidation and decrease in glutathione activity in liver of rats respectively which were exposed to BPA. In conclusion, the data obtained clearly documents that BPA is not mutagenic but exhibit genotoxic activity and oxidative stress could be one of the mechanisms leading to genetic toxicity.

Polyethylene sebacate: genotoxicity, mutagenicity evaluation and application in periodontal drug delivery system.

The objective of the present study is to evaluate Polyethylene sebacate (PES) for its toxicity profile including oral toxicity, genotoxicity and mutagenicity. PES was synthesised, and characterised by gel permeation chromatography, FTIR, (1)H-NMR, differential scanning calorimetry and X-ray diffraction. Oral toxicity studies revealed PES to be nontoxic up to 3000 mg/kg body weight with no significant changes in serum biochemistry. The standard battery of genotoxicity tests including micronucleus test, chromosomal aberration and comet assay revealed PES as nongenotoxic. Mutagenicity of PES was evaluated using the Ames microplate format mutagenicity assay sample kit using TA98 and TA100 strains of Salmonella typhimurium, both in presence and absence of Aroclor 1254 induced rat liver S9. Ames assay confirmed PES to be nonmutagenic. Periodontal implants of PES of varying roxithromycin/PES ratios and different diameter were prepared. A decrease in in vitro drug release was seen with increase in diameter of the implants. Release rates, however, increased with increase in PES concentration, and were attributed to decreased crystallinity of roxithromycin, confirmed by the DSC thermographs and XRD spectra. Roxithromycin release from the implants followed Higuchi kinetics and exhibited controlled release. The results suggest PES as a safe polymer for biomedical and pharmaceutical applications.