Aims: To estimate the proportion of contemporary RCTs of primary immunosuppression in kidney transplantation reporting specified patient and graft-related outcomes, objectively measure reporting quality and identify trial characteristics associated with full outcome reporting.
Methods: Databases were searched, 2000-2012. Presence and completeness of outcome reporting, and trial characteristics were abstracted. Completeness of reporting was assessed from statistical descriptions of events. Logistic regression identified factors associated with complete reporting. Results were expressed as proportions and odds ratios (OR) with corresponding 95% confidence intervals.
Results: 180 first reports of RCTs were identified. 78% reported patient death, 77% graft loss, 66% serum creatinine and 61% eGFR. For death, complete reporting increased for trials which had greater than 100 participants (OR 2.6[1.5-4.7]), declared pharmaceutical sponsorship (OR 2.8[1.2-6.7]) and which were published in general medical versus transplant or nephrology-specific journals (OR 1.8[1.2-2.8]). Pharmaceutical sponsorship was the only factor associated with complete outcome reporting of graft loss (OR 2.9[1.5-5.4]). Full reporting of serum creatinine was not associated with any trial characteristic. eGFR was more fully reported in recently published trials (OR 1.2[1.1-1.4]), and those declaring industry sponsorship (OR 2.2[1.1-4.8]). Journal impact factor, CONSORT statement endorsement, trial location and main intervention comparison had no effect on odds of complete reporting for any outcome.
Conclusions: Selective and incomplete reporting of outcomes bias interpretation of RCT results. Consequently, robust estimates of intervention effects are often lacking. Declared pharmaceutical sponsorship was the characteristic most frequently associated with complete outcome reporting. International consensus on reporting standards and outcome domains in trials of immunosuppression in kidney transplantation is urgently required to address these deficiencies and improve the reliability of estimates of benefits and harms of interventions.
To cite this abstract in AMA style:Masson P, Duthie F, Kelly P, Higgins G, Craig J, Webster A. Outcome Reporting in Randomised Controlled Trials (RCTs) of Primary Immunosuppression in Kidney Transplantation [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/outcome-reporting-in-randomised-controlled-trials-rcts-of-primary-immunosuppression-in-kidney-transplantation/. Accessed December 1, 2020.
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