Effects, costs and implementation of monitoring kidney transplant patients' tacrolimus levels with dried blood spot sampling: A randomized controlled hybrid implementation trial

被引:29
作者
Veenhof, Herman [1 ]
van Boven, Job Frank Martien [1 ]
van der Voort, Anna [1 ]
Berger, Stefan Philip [2 ]
Bakker, Stephanus Johannes Leonardus [2 ]
Touw, Daniel Johannes [1 ,3 ]
机构
[1] Univ Groningen, Univ Med Ctr Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands
[2] Univ Groningen, Univ Med Ctr Groningen, Dept Internal Med, Div Nephrol, Groningen, Netherlands
[3] Univ Groningen, Dept Pharm, Sect Pharmaceut Anal, Groningen, Netherlands
关键词
cost-effectiveness; dried blood spots; implementation; randomized controlled trial; LC-MS/MS; CYCLOSPORINE-A; IMMUNOSUPPRESSANTS; HEMATOCRIT; VALIDATION; EVEROLIMUS; CREATININE; SIROLIMUS;
D O I
10.1111/bcp.14249
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Aims Dried blood spot (DBS) home sampling allows monitoring creatinine levels and tacrolimus trough levels as an alternative for blood sampling in the hospital, which is important in kidney transplant patient follow-up. This study aims to assess whether DBS home sampling results in decreased patient travel burden and lower societal costs. Methods In this single-centre randomized controlled hybrid implementation trial, adult kidney transplant patients were enrolled. The intervention group (n= 25) used DBS home sampling on top of usual care in the first 6 months after transplantation. The control group (n= 23) received usual care only. The primary endpoint was the number of outpatient visits. Other endpoints were costs per patient, patient satisfaction and implementation. Results There was no statistically significant difference in the average number of outpatient visits between the DBS group (11.2, standard deviation: 1.7) and the control group (10.9, standard deviation: 1.4;P= .48). Average costs per visit in the DBS group were not significantly different (euro542, 95% confidence interval euro316-990) compared to the control group (euro533, 95% confidence interval euro278-1093;P= .66). Most patients (n= 19/23, 82.6%) were willing to perform DBS home-sampling if this would reduce the number of hospital visits. Only 55.9% (n= 143/256) of the expected DBS samples were received and 1/5 analysed on time (n= 52/256). Conclusion Adult kidney transplant patients are willing to perform DBS home sampling. However, to decrease patient travel burden and costs in post-transplant care, optimization of the logistical process concerning mailing and analysis of DBS samples is crucial.
引用
收藏
页码:1357 / 1366
页数:10
相关论文
共 29 条
[1]   Longitudinal study on the use of dried blood spots for home monitoring in children after kidney transplantation [J].
Al-Uzri, A. ;
Freeman, K. A. ;
Wade, Jordan ;
Clark, K. ;
Bleyle, L. A. ;
Munar, M. ;
Koop, D. R. .
PEDIATRIC TRANSPLANTATION, 2017, 21 (06)
[2]   World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects [J].
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 310 (20) :2191-2194
[3]  
[Anonymous], 2013, Handleiding iMTA Productivity Cost Questionnaire (iPCQ)
[4]  
[Anonymous], 2012, Tijds gezondheidswetenschappen, DOI [10.1007/s12508-012-0128-3, DOI 10.1007/S12508-012-0128-3]
[5]  
Boons CC, 2019, EUR J CLIN PHARMACOL, P1
[6]   High within-patient variability in the clearance of tacrolimus is a risk factor for poor long-term outcome after kidney transplantation [J].
Borra, Lennaert C. P. ;
Roodnat, Joke I. ;
Kal, Judith A. ;
Mathot, Ron A. A. ;
Weimar, Willem ;
van Gelder, Teun .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2010, 25 (08) :2757-2763
[7]  
Bouwmans C, 2013, Handleiding iMTA Medical cost Questionnaire (iMCQ), iMTA
[8]   Therapeutic Drug Monitoring of Tacrolimus-Personalized Therapy: Second Consensus Report [J].
Brunet, Merce ;
van Gelder, Teun ;
Asberg, Anders ;
Haufroid, Vincent ;
Hesselink, Dennis A. ;
Langman, Loralie ;
Lemaitre, Florian ;
Marquet, Pierre ;
Seger, Christoph ;
Shipkova, Maria ;
Vinks, Alexander ;
Wallemacq, Pierre ;
Wieland, Eberhard ;
Woillard, Jean Baptiste ;
Barten, Markus J. ;
Budde, Klemens ;
Colom, Helena ;
Dieterlen, Maja-Theresa ;
Elens, Laure ;
Johnson-Davis, Kamisha L. ;
Kunicki, Pawel K. ;
MacPhee, Iain ;
Masuda, Satohiro ;
Mathew, Binu S. ;
Millan, Olga ;
Mizuno, Tomoyuki ;
Moes, Dirk-Jan A. R. ;
Monchaud, Caroline ;
Noceti, Ofelia ;
Pawinski, Tomasz ;
Picard, Nicolas ;
van Schaik, Ron ;
Sommerer, Claudia ;
Vethe, Nils Tore ;
de Winter, Brenda ;
Christians, Uwe ;
Bergan, Stein .
THERAPEUTIC DRUG MONITORING, 2019, 41 (03) :261-307
[9]   Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot-Based Methods for Therapeutic Drug Monitoring [J].
Capiau, Sara ;
Veenhof, Herman ;
Koster, Remco A. ;
Bergqvist, Yngve ;
Boettcher, Michael ;
Halmingh, Otto ;
Keevil, Brian G. ;
Koch, Birgit C. P. ;
Linden, Rafael ;
Pistos, Constantinos ;
Stolk, Leo M. ;
Touw, Daan J. ;
Stove, Christophe P. ;
Alffenaar, Jan-Willem C. .
THERAPEUTIC DRUG MONITORING, 2019, 41 (04) :409-430
[10]   Effectiveness-implementation Hybrid Designs Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact [J].
Curran, Geoffrey M. ;
Bauer, Mark ;
Mittman, Brian ;
Pyne, Jeffrey M. ;
Stetler, Cheryl .
MEDICAL CARE, 2012, 50 (03) :217-226