Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Dec 1;91(6):1018-1024.
doi: 10.1097/TA.0000000000003360.

Outcome measures used in clinical research evaluating prehospital blood component transfusion in traumatically injured bleeding patients: A systematic review

Harriet Tucker  1 , Pascale Avery, Karim Brohi, Ross Davenport, Joanne Griggs, Anne Weaver, Laura Green
Affiliations

Outcome measures used in clinical research evaluating prehospital blood component transfusion in traumatically injured bleeding patients: A systematic review

Harriet Tucker et al. J Trauma Acute Care Surg. .

Abstract

Background: Trial outcomes should be relevant to all stakeholders and allow assessment of interventions' efficacy and safety at appropriate timeframes. There is no consensus regarding outcome measures in the growing field of prehospital trauma transfusion research. Harmonization of future clinical outcome reporting is key to facilitate interstudy comparisons and generate cohesive, robust evidence to guide practice. The objective of this study was to evaluate outcome measures reported in prehospital trauma transfusion trials.

Methods: Data Sources, Eligibility Criteria, Participants, and InterventionsWe conducted a scoping systematic review to identify the type, number, and definitions of outcomes reported in randomized controlled trials, and prospective and retrospective observational cohort studies investigating prehospital blood component transfusion in adult and pediatric patients with traumatic hemorrhage. Electronic database searching of PubMed, Embase, Web of Science, Cochrane, OVID, clinical trials.gov, and the Transfusion Evidence Library was completed in accordance with Preferred Reporting Items for Meta-analyses guidelines.Study Appraisal and Synthesis MethodsTwo review authors independently extracted outcome data. Unique lists of salutogenic (patient-reported health and wellbeing outcomes) and nonsalutogenic focused outcomes were established.

Results: A total of 3,471 records were identified. Thirty-four studies fulfilled the inclusion criteria: 4 military (n = 1,566 patients) and 30 civilian (n = 14,398 patients), all between 2000 and 2020. Two hundred twelve individual non-patient-reported outcomes were identified, which collapsed into 20 outcome domains with varied definitions and timings. All primary outcomes measured effectiveness, rather than safety or complications. Sixty-nine percent reported mortality, with 11 different definitions. No salutogenic outcomes were reported.

Conclusion: There is heterogeneity in outcome reporting and definitions, an absence of patient-reported outcome, and an emphasis on clinical effectiveness rather than safety or adverse events in prehospital trauma transfusion trials. We recommend stakeholder consultation and a Delphi process to develop a clearly defined minimum core outcome set for prehospital trauma transfusion trials.

Level of evidence: Scoping systematic review, level III.

PubMed Disclaimer

References

    1. Sauaia A, Moore FA, Moore EE, Moser KS, Brennan R, Read RA, Pons PT. Epidemiology of trauma deaths: a reassessment. J Trauma . 1995;38(2):185–193.
    1. Holcomb JB, del Junco DJ, Fox EE, et al; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg . 2013;148(2):127–136.
    1. Cannon JW. Prehospital damage-control resuscitation. N Engl J Med . 2018;379:387–388.
    1. Sperry JL, Guyette FX, Brown JB, et al. Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock. N Engl J Med . 2018;379(4):315–326.
    1. Moore HB, Moore EE, Chapman MP, et al. Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial. Lancet . 2018;392(10144):283–291.

Publication types

MeSH terms