Aim: To evaluate the completeness of reporting of adverse events in randomized controlled trials (RCTs) of maintenance immunosuppression in kidney transplantation.

Background: Side effects of maintenance immunosuppression have a major effect on quality of life and non-adherence of kidney transplant recipients.

Methods: The Cochrane Renal Group Register was searched (2003 to 2013) to identify RCTs reporting adverse events specific to drug related side effects. Reporting was appraised using the harms-extension of the CONSORT checklist.

Results: Of the 223 trials, 156 (70%) reported adverse events, and 107 of these trials (69%) complied with fewer than 11 of the 23 items in the harms-extension CONSORT checklist. Identification and justification of adverse events were reported in only 24 (15%) and 17 (11%) trials respectively, and assessment of severity in 25 (16%) trials. In total, 35 types of adverse events were reported. Gastrointestinal problems were most commonly reported (70%), followed by pain (34%), peripheral edema (30%) and skin complaints (22%). In 92 trials involving calcineurin inhibitors, 22% and 3% reported the common side effects of tremors and paraesthesia respectively and none reported anxiety, aggression or mood swings. For mTOR inhibitors (n=23 trials), 32% and 23% reported the common side effects of skin complaints and headaches respectively. In 89 (57%) trials, adverse events were used to support either positive or negative conclusions.

Conclusions: Reporting of adverse events in RCTs of maintenance immunosuppression in kidney transplantation is inadequate. Common side effects are rarely reported. Despite this, adverse events influenced conclusions in over half of the trials. Reporting of adverse events in RCTs should adhere to CONSORT and reflect adverse events that are commonly experienced or important to patients. This can inform patient-centred clinical decision-making.

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