Journal article
Improving Research Enrollment of Severe Burn Patients
Journal of burn care & research, Vol.38(5), pp.E807-E813
09/01/2017
DOI: 10.1097/BCR.0000000000000489
PMCID: PMC5576502
PMID: 28846992
Abstract
Enrolling severely burn injured patients into prospective research studies poses specific challenges to investigators. The authors describe their experience of recruiting adults with >= 20% TBSA burns or inhalation injury admitted to a single academic burn unit into observational research with minimally invasive specimen collection. The authors outline iterative changes that they made to their recruitment processes in response to perceived weaknesses leading to delays in enrollment. The primary outcome was the change in days to consent for enrolled patients or cessation of recruitment for nonenrolled patients before and after the interventional modifications. The authors assessed change in overall enrollment as a secondary outcome. Study enrollment was approximately 70% in both 4-month study periods before and after the intervention. Following the intervention, time to consent by surrogate decision maker decreased from a median of 26.5 days (interquartile range [IQR] 14-41) to 3 days (IQR 3-6) (P = .004). Time to initial consent by patient changed from a median of 15 days (IQR 2-30) to 3 days (IQR 2-6) (P = .27). Time to decline for nonenrolled patients decreased from a median of 12 days (IQR 6.5-27) to 1.5 days (IQR 1-3.5) (P = .026). Both the findings of the study and a brief literature review suggest that careful design of the recruitment protocol, increased experience of the study team, and broad time windows for both approach and enrollment improve the efficiency of recruiting critically injured burn patients into research.
Details
- Title: Subtitle
- Improving Research Enrollment of Severe Burn Patients
- Creators
- Anne M. Lachiewicz - University of North Carolina at Chapel HillFelicia N. Williams - University of North Carolina at Chapel HillShannon S. Carson - University of North Carolina at Chapel HillJessica M. Trexler - University of North Carolina at Chapel HillCarrie A. Nielsen - University of North Carolina at Chapel HillDavid van Duin - University of North Carolina at Chapel HillDavid J. Weber - University of North Carolina at Chapel HillShannon D. Williams - University of North Carolina at Chapel HillSamuel W. Jones - University of North Carolina at Chapel HillBruce A. Cairns - University of North Carolina at Chapel Hill
- Resource Type
- Journal article
- Publication Details
- Journal of burn care & research, Vol.38(5), pp.E807-E813
- DOI
- 10.1097/BCR.0000000000000489
- PMID
- 28846992
- PMCID
- PMC5576502
- NLM abbreviation
- J Burn Care Res
- ISSN
- 1559-047X
- eISSN
- 1559-0488
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 7
- Grant note
- Steris Inc. KL2TR001109 / National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA GlaxoSmithKline Scynexis KL2TR001109 / NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Advancing Translational Sciences (NCATS) National Center for Advancing Translational Sciences; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Advancing Translational Sciences (NCATS) K08GM109106-03 / NIGMS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of General Medical Sciences (NIGMS) K08GM109106 / NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of General Medical Sciences (NIGMS)
- Language
- English
- Date published
- 09/01/2017
- Academic Unit
- Surgery
- Record Identifier
- 9984755386902771
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