TY - JOUR
T1 - Critically important outcomes for infection in trials in kidney transplantation
T2 - An international survey of patients, caregivers, and health professionals
AU - Chan, Samuel
AU - Howell, Martin
AU - Johnson, David W.
AU - Hawley, Carmel M.
AU - Tong, Allison
AU - Craig, Jonathan C.
AU - Cao, Christopher
AU - Blumberg, Emily
AU - Brennan, Daniel
AU - Campbell, Scott B.
AU - Francis, Ross S.
AU - Huuskes, Brooke M.
AU - Isbel, Nicole M.
AU - Knoll, Greg
AU - Kotton, Camille
AU - Mamode, Nizam
AU - Muller, Elmi
AU - Biostat, Elaine M.Pascoe M.
AU - An, Ha Phan Hai
AU - Tedesco-Silva, Helio
AU - White, David M.
AU - Viecelli, Andrea K.
PY - 2022/6
Y1 - 2022/6
N2 - Background: Infections are a common complication following kidney transplantation, but are reported inconsistently in clinical trials. This study aimed to identify the infection outcomes of highest priority for patients/caregivers and health professionals to inform a core outcome set to be reported in all kidney transplant clinical trials. Methods: In an international online survey, participants rated the absolute importance of 16 infections and eight severity dimensions on 9-point Likert Scales, with 7–9 being critically important. Relative importance was determined using a best–worst scale. Means and proportions of the Likert-scale ratings and best–worst preference scores were calculated. Results: 353 healthcare professionals (19 who identified as both patients/caregiver and healthcare professionals) and 220 patients/caregivers (190 patients, 22 caregivers, eight who identified as both) from 55 countries completed the survey. Both healthcare professionals and patients/caregivers rated bloodstream (mean 8.4 and 8.5, respectively; aggregate 8.5), kidney/bladder (mean 7.9 and 8.4; aggregate 8.1), and BK virus (mean 8.1 and 8.6; aggregate 8.3) as the top three most critically important infection outcomes, whilst infectious death (mean 8.8 and 8.6; aggregate 8.7), impaired graft function (mean 8.4 and 8.7; aggregate 8.5) and admission to the intensive care unit (mean 8.2 and 8.3; aggregate 8.2) were the top three severity dimensions. Relative importance (best–worst) scores were consistent. Conclusions: Healthcare professionals and patients/caregivers consistently identified bloodstream infection, kidney/bladder infections, and BK virus as the three most important infection outcomes, and infectious death, admission to intensive care unit and infection impairing graft function as the three most important infection severity outcomes.
AB - Background: Infections are a common complication following kidney transplantation, but are reported inconsistently in clinical trials. This study aimed to identify the infection outcomes of highest priority for patients/caregivers and health professionals to inform a core outcome set to be reported in all kidney transplant clinical trials. Methods: In an international online survey, participants rated the absolute importance of 16 infections and eight severity dimensions on 9-point Likert Scales, with 7–9 being critically important. Relative importance was determined using a best–worst scale. Means and proportions of the Likert-scale ratings and best–worst preference scores were calculated. Results: 353 healthcare professionals (19 who identified as both patients/caregiver and healthcare professionals) and 220 patients/caregivers (190 patients, 22 caregivers, eight who identified as both) from 55 countries completed the survey. Both healthcare professionals and patients/caregivers rated bloodstream (mean 8.4 and 8.5, respectively; aggregate 8.5), kidney/bladder (mean 7.9 and 8.4; aggregate 8.1), and BK virus (mean 8.1 and 8.6; aggregate 8.3) as the top three most critically important infection outcomes, whilst infectious death (mean 8.8 and 8.6; aggregate 8.7), impaired graft function (mean 8.4 and 8.7; aggregate 8.5) and admission to the intensive care unit (mean 8.2 and 8.3; aggregate 8.2) were the top three severity dimensions. Relative importance (best–worst) scores were consistent. Conclusions: Healthcare professionals and patients/caregivers consistently identified bloodstream infection, kidney/bladder infections, and BK virus as the three most important infection outcomes, and infectious death, admission to intensive care unit and infection impairing graft function as the three most important infection severity outcomes.
KW - infections
KW - kidney transplant
KW - outcomes
KW - severity
KW - surveys
KW - trials
UR - http://www.scopus.com/inward/record.url?scp=85127978992&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1092597
UR - http://purl.org/au-research/grants/NHMRC/1098815
U2 - 10.1111/ctr.14660
DO - 10.1111/ctr.14660
M3 - Article
C2 - 35362617
AN - SCOPUS:85127978992
VL - 36
JO - CLINICAL TRANSPLANTATION
JF - CLINICAL TRANSPLANTATION
SN - 0902-0063
IS - 6
M1 - e14660
ER -