Page 83 - Exploring the Potential of Self-Monitoring Kidney Function After Transplantation - Céline van Lint

INTRODUCTION
Application of a creatinine device for trend monitoring 81
In the last decade significant improvements in kidney transplant outcome have been achieved thanks to advances in the management of immunosuppression [1]. However, patients continue to be at risk for rejection, mainly in the first year after transplantation. The most important parameter for rejection is deterioration of the renal function, measured by the serum creatinine concentration. As early detection of a rejection episode is mandatory to minimize permanent damage to the kidney graft, kidney transplant patients have their serum creatinine checked on average 20 times during the first year post-transplantation. If patients were enabled to monitor kidney function at home, this would have important advantages.
First, home monitoring could improve speed of rejection detection. Second, the high number of necessary outpatient visits could be reduced. This would be an advantage, as the frequent visits are a burden to the recovering patient. Further, it would be beneficial for healthcare as decreasing number of outpatient appointments alleviates the burden to healthcare capacity. Third, transferring part of care to the home setting corresponds to the idea of 4 P Medicine [2]. 4 P Medicine aims at decentralizing healthcare by means of delivering Predictive, Preventive, Personalized and Participatory medicine. It has repeatedly been shown that self-monitoring is of clinical benefit for patients with hypertension [3, 4] and thrombosis [5–7]. Further, several studies in different disease populations show that patients prefer self-monitoring to regular care [7–14] and that patients who self-monitor experience higher levels of quality of life [8, 10, 13, 15] and more empowerment [7, 8, 11, 12, 14] than patients who do not.
Recently, a handheld creatinine meter (StatSensor® Creatinine Xpress-iTM) has become available. It is cleared by the US FDA for hospital use by healthcare professionals and the device is used among radiology patients to detect contrast-induced nephropathy [16–18]. In the future, the availability of this device may offer kidney transplant patients the possibility to self-monitor their blood creatinine levels at home.
However, before an in vitro diagnostic (IVD) device can be advocated for adequate home-based patient care, it must be thoroughly tested to guarantee its robustness and clinical reliability. Two previous studies on the performance of the StatSensor® creatinine meter concluded that its’ results can deviate from centralized enzymatic method values to a small [19] or even large amount [20]. However, in both articles the possible value of StatSensor® for use in clinical practice is recognized, depending on the specific test purpose. The importance of taking the purpose of a test into consideration when evaluating its’ performance has recently been advocated by a multidisciplinary group of the European
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