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.
Subject(s)
Burns/therapy , Patient Selection , Physician-Patient Relations , Quality Improvement/organization & administration , Attitude of Health Personnel , Humans , Informed Consent , Prospective StudiesABSTRACT
BACKGROUND: The morbidity and mortality from donation of a right hepatic lobe for living donor liver transplantation (LDLT) is an important issue for this procedure. We report the prevalence of severe psychiatric postoperative complications from the Adult-to-Adult Living Donor Liver Transplantation Cohort study (A2ALL), which was established to define the risks and benefits of LDLT for donors and recipients. METHODS: Severe psychiatric complications were evaluated in all donors from the A2ALL study who were evaluated between 1998 and February 2003. RESULTS: Of the 392 donors, 16 (4.1%) had one or multiple psychiatric complications, including three severe psychiatric complications (suicide, accidental drug overdose, and suicide attempt). CONCLUSIONS: Despite extensive preoperative screening, some donors experience severe psychiatric complications, including suicide, after liver donation. Psychiatric assessment and monitoring of liver donors may help to understand and prevent such tragic events.