S CHAN 1, E AU 2, D JOHNSON 1, C HAWLEY 1, A TONG 2, E PASCOE 1, J CRAIG 3, B SAUTENET 4, E BLUMBERG 5, D BRENNAN 6, S CAMPBELL 1, C CAO 1, R FRANCIS 1, B HUUSKES 7, N ISBEL 1, G KNOLL 8, C KOTTON 9, N MAMODE 10, E MULLER 11, N PHAN 12, H TEDESCO-SILVA 13, D WHITE 14, M WOLLEY 15, A VIECELLI 1
1Department of Nephrology, Princess Alexandra Hospital, Woolloongabba, Australia, 2Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia, 3College of Medicine and Public Health, Flinders University, Adelaide, Australia, 4Service de Nephrologie-Hypertension, Dialyses, Transplantation Rénale, Hopital Bretonneau, Université de Tours, Université de Nantes, INSERM SPHERE U 1246, Tours, , France, 5Division of Infectious Diseases, Perelman School of Medicine at the University of Pennsylvania, , Pennsylvania, 6Division of Nephrology, Johns Hopkins School of Medicine, , United States of America, 7Department of Physiology, Anatomy and Microbiology, School of Life Sciences, La Trobe University, Melbourne, Australia, 8Division of Nephrology, Department of Medicine, University of Ottawa, , Canada, 9Transplant and Immunocompromised Host Infectious Diseases Division, Massachusetts General Hospital, Harvard Medical School, Boston, United States of America, 10Department of Transplantation, Guy’s and St Thomas’ NHS Foundation Trust, London, , United Kingdom, 11Department of Surgery, Groote Schuur Hospital, University of Cape Town, , South Africa, 12Kidney Diseases and Dialysis Department, Viet Duc University Hospital,, , Vietnam, 13Division of Nephrology, Hospital do Rim, Universidade Federal de Sao Paulo, , Brazil, 14Dreyfus Health Policy and Research Center, Brooklyn, United States of America, 15Kidney Health Service, Royal Brisbane and Women’s Hospital, Brisbane, Australia
Background:Infection remains a leading cause of death in kidney transplant recipients. This study aimed to assess the scope and consistency of infection outcomes reported in contemporary trials conducted in kidney transplant recipients.
Methods:A literature review of all randomized trials and trial protocols reporting infection outcomes in adult kidney transplant recipients were identified in the Cochrane Kidney and Transplant Specialized Register from January 2014 to July 2019. Characteristics and infection outcomes from the trials were analyzed.
Results: From 102 included trials, 772 outcome measures were extracted and categorized into 216 unique measures with a median of 3.2 outcome measures per trial (range: 1 to 9). Measures were further grouped into 32 outcomes based on site of infection (14 outcomes) and organism (18 outcomes). The most commonly reported site-specific outcome and organism-specific outcome was systemic infection (71% trials) and cytomegalovirus infection (62% trials), respectively. Outcome metric and methods of aggregation included mean, median, proportion, proportional change and number of patients with at least one episode. Across all trials, measures were assessed at 55 different time points with a range of 1 to 11 time points per trial.
Conclusion:Infection outcomes in kidney transplant recipients were frequently reported by site and organism but varied widely in terms of outcome, metrics, method of aggregation and time point of measurement. Establishment of core outcomes for infection based on the shared priorities of patients/caregivers and health professionals may improve the consistency, comparability and usefulness of trial evidence.
Dr Samuel Chan is a PhD candidate working at the Princess Alexandra Hospital in Brisbane, Queensland. He is a staff specialist, nephrology, undertaking his PhD studies in kidney transplant infectious diseases. His PhD is supported by the NHMRC Postgraduate Scholarship and he was recently awarded the NHMRC Sir Gustav Nossal prize, for being the highest ranked recipient in the NHMRC postgraduate scholarship category