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Validity and reliability of a novel immunosuppressive adverse effects scoring
system in renal transplant recipients
#MMPMID24925208
Meaney CJ
; Arabi Z
; Venuto RC
; Consiglio JD
; Wilding GE
; Tornatore KM
BMC Nephrol
2014[Jun]; 15
(?): 88
PMID24925208
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BACKGROUND: After renal transplantation, many patients experience adverse effects
from maintenance immunosuppressive drugs. When these adverse effects occur,
patient adherence with immunosuppression may be reduced and impact allograft
survival. If these adverse effects could be prospectively monitored in an
objective manner and possibly prevented, adherence to immunosuppressive regimens
could be optimized and allograft survival improved. Prospective, standardized
clinical approaches to assess immunosuppressive adverse effects by health care
providers are limited. Therefore, we developed and evaluated the application,
reliability and validity of a novel adverse effects scoring system in renal
transplant recipients receiving calcineurin inhibitor (cyclosporine or
tacrolimus) and mycophenolic acid based immunosuppressive therapy. METHODS: The
scoring system included 18 non-renal adverse effects organized into
gastrointestinal, central nervous system and aesthetic domains developed by a
multidisciplinary physician group. Nephrologists employed this standardized
adverse effect evaluation in stable renal transplant patients using physical
exam, review of systems, recent laboratory results, and medication adherence
assessment during a clinic visit. Stable renal transplant recipients in two
clinical studies were evaluated and received immunosuppressive regimens comprised
of either cyclosporine or tacrolimus with mycophenolic acid. Face, content, and
construct validity were assessed to document these adverse effect evaluations.
Inter-rater reliability was determined using the Kappa statistic and intra-class
correlation. RESULTS: A total of 58 renal transplant recipients were assessed
using the adverse effects scoring system confirming face validity. Nephrologists
(subject matter experts) rated the 18 adverse effects as: 3.1 ± 0.75 out of 4
(maximum) regarding clinical importance to verify content validity. The adverse
effects scoring system distinguished 1.75-fold increased gastrointestinal adverse
effects (p=0.008) in renal transplant recipients receiving tacrolimus and
mycophenolic acid compared to the cyclosporine regimen. This finding demonstrated
construct validity. Intra-class correlation was 0.81 (95% confidence interval:
0.65-0.90) and Kappa statistic of 0.68 ± 0.25 for all 18 adverse effects and
verified substantial inter-rater reliability. CONCLUSIONS: This immunosuppressive
adverse effects scoring system in stable renal transplant recipients was
evaluated and substantiated face, content and construct validity with inter-rater
reliability. The scoring system may facilitate prospective, standardized clinical
monitoring of immunosuppressive adverse drug effects in stable renal transplant
recipients and improve medication adherence.
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