Background: The evaluation and selection of immunosuppressive drug regimens in kidney transplantation is increasingly focussed on long term patient and graft survival. An understanding of the effect of immunosuppressive regimens on the quality of life (QoL) of kidney transplant recipients is needed in clinical decision making. This study aims to review the availability and reliability of QoL outcomes reported in randomized controlled trials (RCTs).
Methods: We conducted a systematic review to identify RCTs of immunosuppressive drugs in kidney transplantation that included at least one QoL outcome, defined as any patient-reported outcome providing a quantitative measure of some aspect of physical, emotional or social well-being. Electronic databases were searched to December 2011 to identify RCTs that reported any quantitative measure of QoL. We assessed the risk of bias of QoL outcomes using a standard 11-item checklist and calculated the standardised mean differences (SMD) for each QoL outcome.
Results: Of the 1,945 eligible reports identified, 37 (1.9%) included at least one QoL outcome from 4800 participants and 25 unique trials. Twenty instruments (14 generic, 6 specific) were used. The most common were SF36 (10 trials, 44%) and gastrointestinal specific instruments (5 trials, 23%). A high-risk of bias was found in 21 trials (91.3%), mainly due to selective reporting, lack of assessment of meaningful differences, and consideration of the adequacy of the instrument. Of the 96 QoL comparisons, 91 (95%) favoured the intervention with 35 (38%) being statistically significant (P≤0.05). The pooled SMD for trials with a moderate or high risk of bias (0.36 [95% CI:0.30,0.40]) was significantly higher (P<0.001) than trials with a low risk of bias (0.18 [95% CI:0.14,0.23]).
Conclusion: QoL assessments are rarely reported in trials of immunosuppression in kidney transplantation. They rely on generic instruments and show a high risk of bias. In order to inform patient-centred clinical decision making, assessment of the impact of immunosuppressive drug regimens on QoL should focus on specific outcomes relevant to patient experiences.
To cite this abstract in AMA style:Howell M, Howard K, Wong G, Turner R, Craig J, Tong A. Quality of Life Outcomes Reported in Randomized Controlled Trials of Immunosuppressive Drug Regimens in Kidney Transplantation: [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/quality-of-life-outcomes-reported-in-randomized-controlled-trials-of-immunosuppressive-drug-regimens-in-kidney-transplantation/. Accessed December 1, 2020.
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