Completeness of reporting of adverse events in trials of maintenance immunosuppression in kidney transplantation: a systematic review.
Howell M, Yeo R, et al.Nephrology Dialysis Transplantation 2017; 32(9): 1586-1594.
Aims
To evaluate the reporting of adverse events (AEs), specifically drug-related side effects, in published reports of randomized controlled trials (RCTs) of maintenance immunosuppression in kidney transplantation.
Interventions
The Cochrane Kidney and Transplant Specialist Register was searched from January 2003 to December 2015 for all RCTs of maintenance immunosuppression following kidney transplantation published in peer-reviewed journals. Titles and abstracts were reviewed and the full text of all relevant trials retrieved.
Participants
314 reports of 233 trials including 45,896 patients were included in the systematic review.
Outcomes
The primary outcome measured was all drug-related AEs, defined as any undesirable symptom or side effect.
Follow-up
Variable across RCTs, the majority included <24 months of follow-up.
CET Conclusions
The CET recently published a study looking at the quality and consistency of outcome reporting in renal immunosuppression trials (Clin Transplant. 2016;30(11):1440). One aspect that was particularly poor was the reporting and definition of safety outcomes. This systematic review from the Westmead group takes things a lot further, looking at reporting of safety outcomes in more detail. They find that safety outcomes are inconsistently reported and poorly defined with little information about severity. Frequency of reporting does not reflect known side effect profiles, raising the possibility of selective reporting. These findings are important, and add more weight to the use of tools such as the CONSORT-HARM extension and the development of core outcome sets, such as those being developed as part of the SONG-Tx initiative.
Quality notes
Quality assessment not appropriate
Trial registration
None