Validity and reliability of a novel immunosuppressive adverse effects scoring system in renal transplant recipients

BMC Nephrology

Kathleen M Tornatore³  Gregory E Wilding¹  Joseph D Consiglio¹  Rocco C Venuto²  Ziad Arabi³  Calvin J Meaney⁴ 

[1]Biostatistics

[2] School of Public Health, University at Buffalo, Buffalo, NY, USA

[3]Erie County Medical Center, Buffalo, NY, USA

[4]Medicine, Nephrology Division

[5] School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA

[6]Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, 201 Kapoor Hall, Buffalo, New York 14214, USA

关键词: Cyclosporine;    Tacrolimus;    Mycophenolic acid;    Calcineurin inhibitors;    Renal transplantation;    Adverse effects;    Immunosuppressive agents;   

Others  :  1082674
DOI  :  10.1186/1471-2369-15-88

 received in 2013-11-27, accepted in 2014-05-29,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Meaney et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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