Abstract
Importance Trauma causes over four million deaths annually, the majority of these in low- and middle-income countries. Implementing trauma quality improvement programs may improve outcomes, and though extensively used, high-quality evidence of their effectiveness is scarce.
Objective To assess if implementing a trauma quality improvement program using on audit filters improves trauma patients’ outcomes.
Design A controlled interrupted time-series study, the Trauma Audit Filter Trial (TAFT).
Setting A prospective, multi-center study across four tertiary care hospitals in urban India.
Participants Adult patients admitted to participating hospitals with a history of trauma, defined as having any of the external causes listed in block V01-Y36, chapter XX of the International Classification of Disease version 10 as reason for admission.
Intervention In the intervention arm, comprised of two hospitals, we implemented a trauma quality improvement program using audit filters after an observation period of one year. The remaining two hospitals, the control arm, continued baseline data collection during the entire study period, 2017 - 2022, with no intervention made.
Main Outcomes All-cause mortality (in-hospital and at 30 days). For time series analysis, we applied segmented regression with a generalized additive model (GAM) to assess the effect on in-hospital mortality. We performed secondary analysis applying difference-in-differences analysis with linear regression to assess the effect on in-hospital and 30-day mortality. The study was not adequately powered to do time series analysis on 30-day mortality.
Results We included 10143 patients, median age 35 (IQR 26 – 50), 83% men. Using time series analysis, we observed a significant reduction in in-hospital mortality (32% vs 24%; OR 0.57, 95% CI 0.41-0.79, p<0.001) in the intervention arm, with no significant change in the control arm. Using difference-in-differences analysis we found a significant reduction in 30-day mortality (39% vs 26%; −0.15 95% CI −0.19 to −0.11, p<0.001) and in-hospital mortality (32% vs 24%; −0.11 95% CI −0.15 to −0.07, p<0.001). However, external factors such as the opening of a dedicated trauma center at one intervention hospital and the COVID-19 pandemic may have influenced these results.
Conclusion Implementing a trauma quality improvement program using audit filters may reduce mortality. More research is needed to confirm these findings across different settings and to understand what makes these programs efficient, useful and sustainable in terms of improving outcomes.
Question Does implementation of a trauma quality improvement program using audit filters improve mortality in adult trauma patients?
Findings In this prospective, multi-center, controlled interrupted time series including 10143 patients across four tertiary care hospitals in urban India we found a significant reduction of all-cause 30 day and in-hospital mortality after implementation of a trauma quality improvement program using audit filters.
Meaning Implementation of trauma quality improvement programs, using audit filters, may reduce mortality. However, these programs require local adaptation, and their effectiveness is dependent on setting, context and the maturity of the health care system.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
NCT03235388
Funding Statement
This work was supported by the Swedish Research Council (2016-02041)
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Informed consent to take part of the intervention was not deemed applicable, as it was a hospital level intervention. We were granted waivers of informed consent for recording vital signs, demographic parameters and in-hospital outcomes. We obtained written consent for telephonic follow-up. Ethical approvals were granted by the Swedish Ethical Review Authority, approved 2017-06-07 2017/930-31/2, as well as at all local ethical review boards for each participating hospital: Maulana Azad Medical College, MAMC - approved 2017-07-19 F.1/IEC/MAMC/(57/02/2017/No113. SSKM/IPGME&R, Kolkata - approved 2017-08-21, IPGME&R/IEC/2017/396. JJ Hospital, Mumbai - approved 2017-08-22, No.IEC/Pharm/CT/111/A/2017. St Johns, Bangalore - approved 2017-08-24, 160/2017.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data Availability
All data in the present study consists of sensitive patient information. To protect the privacy of the participants, this data cannot be released outside the scope of this research collaboration in its current form. We are in the process of creating an anonymised version of this data, which we aim to release openly. This anonymized dataset will be published alongside a data descriptor paper to facilitate open-access use.
