TY - JOUR
T1 - Scope and Consistency of Cancer Outcomes Reported in Randomized Trials in Kidney Transplant Recipients
AU - Au, Eric H.
AU - Wong, Germaine
AU - Tong, Allison
AU - Teixeira-Pinto, Armando
AU - van Zwieten, Anita
AU - Dobrijevic, Ellen
AU - Ahn, Curie
AU - Blosser, Christopher D.
AU - Davidson, Bianca
AU - Francis, Anna
AU - Jhaveri, Kenar D.
AU - Malyszko, Jolanta
AU - Mena-Gutierrez, Alejandra
AU - Newell, Kenneth A.
AU - Palmer, Sarah
AU - Scholes-Robertson, Nicole
AU - Silva Junior, Helio Tedesco
AU - Craig, Jonathan C.
PY - 2023/2
Y1 - 2023/2
N2 - Introduction: Cancer is an important outcome in kidney transplantation, but the scope and consistency of how cancer is defined and reported in trials involving kidney transplant recipients has not been evaluated. This study aimed to assess the range and variability of cancer outcomes in trials involving kidney transplant recipients. Methods: The ClinicalTrials.gov database was searched from February 2000 to July 2021 to identify all randomized controlled trials (RCTs) in adult kidney transplant recipients, and which included cancer as a specified outcome. The definition of cancer, types of cancer (if any), timepoint(s) of measurement and method of aggregation were extracted for each cancer outcome. Results: Of the 819 trials in kidney transplantation, only 84 (10%) included 1 or more cancer outcomes. Of these, 72 of 84 (86%) trials included cancer as a secondary outcome and 12 of 84 (14%) considered cancer as a primary outcome. The most frequent description of cancer was “malignancy” (n = 44, 43%), without reference to diagnostic criteria, histology, grade, or stage. The 2 most common cancer types were posttransplant lymphoproliferative disorder (PTLD) (n = 20, 20%) and nonmelanoma skin cancer (n = 10, 10%). Several methods of aggregation were identified, including incidence or rate (n = 47, 46%), frequency or proportion (n = 30, 29%), and time to event (n = 5, 5%). Approximately half the cancer outcomes were measured at a single time point (n = 44, 52%). Conclusion: Cancer is an infrequently reported outcome and is inconsistently defined in trials of kidney transplant recipients. Consistent reporting of cancer outcomes using standardized definitions would provide important information on the impact of cancer in patients after kidney transplantation.
AB - Introduction: Cancer is an important outcome in kidney transplantation, but the scope and consistency of how cancer is defined and reported in trials involving kidney transplant recipients has not been evaluated. This study aimed to assess the range and variability of cancer outcomes in trials involving kidney transplant recipients. Methods: The ClinicalTrials.gov database was searched from February 2000 to July 2021 to identify all randomized controlled trials (RCTs) in adult kidney transplant recipients, and which included cancer as a specified outcome. The definition of cancer, types of cancer (if any), timepoint(s) of measurement and method of aggregation were extracted for each cancer outcome. Results: Of the 819 trials in kidney transplantation, only 84 (10%) included 1 or more cancer outcomes. Of these, 72 of 84 (86%) trials included cancer as a secondary outcome and 12 of 84 (14%) considered cancer as a primary outcome. The most frequent description of cancer was “malignancy” (n = 44, 43%), without reference to diagnostic criteria, histology, grade, or stage. The 2 most common cancer types were posttransplant lymphoproliferative disorder (PTLD) (n = 20, 20%) and nonmelanoma skin cancer (n = 10, 10%). Several methods of aggregation were identified, including incidence or rate (n = 47, 46%), frequency or proportion (n = 30, 29%), and time to event (n = 5, 5%). Approximately half the cancer outcomes were measured at a single time point (n = 44, 52%). Conclusion: Cancer is an infrequently reported outcome and is inconsistently defined in trials of kidney transplant recipients. Consistent reporting of cancer outcomes using standardized definitions would provide important information on the impact of cancer in patients after kidney transplantation.
KW - cancer
KW - kidney transplant
KW - outcomes
KW - randomized controlled trials
UR - http://www.scopus.com/inward/record.url?scp=85143853597&partnerID=8YFLogxK
U2 - 10.1016/j.ekir.2022.10.032
DO - 10.1016/j.ekir.2022.10.032
M3 - Article
AN - SCOPUS:85143853597
VL - 8
SP - 274
EP - 281
JO - Kidney International Reports
JF - Kidney International Reports
SN - 2468-0249
IS - 2
ER -