Goldsmith, P. M. et al. (2017) Impact of intrapatient variability (IPV) in tacrolimus trough levels on long-term renal transplant function: multicentre collaborative retrospective cohort study protocol. BMJ Open, 7(7), e016144. (doi: 10.1136/bmjopen-2017-016144) (PMID:28756385) (PMCID:PMC5642769)
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Abstract
Introduction: High intrapatient variability (IPV) in tacrolimus trough levels has been shown to be associated with higher rates of renal transplant failure. There is no consensus on what level of IPV constitutes a risk of graft loss. The establishment of such a threshold could help to guide clinicians in identifying at-risk patients to receive targeted interventions to improve IPV and thus outcomes. Methods and analysis: A multicentre Transplant Audit Collaborative has been established to conduct a retrospective study examining tacrolimus IPV and renal transplant outcomes. Patients in receipt of a renal transplant at participating centres between 2009 and 2014 and fulfilling the inclusion criteria will be included in the study. The aim is to recruit a minimum of 1600 patients with follow-up spanning at least 2 years in order to determine a threshold IPV above which a renal transplant recipient would be considered at increased risk of graft loss. The study also aims to determine any national or regional trends in IPV and any demographic associations. Ethics and dissemination: Consent will not be sought from patients whose data are used in this study as no additional procedures or information will be required from participants beyond that which would normally take place as part of clinical care. The study will be registered locally in each participating centre in line with local research and development protocols. It is anticipated that the results of this audit will be disseminated locally, in participating NHS Trusts, through national and international meetings and publications in peer-reviewed journals.
| Item Type: | Articles |
|---|---|
| Keywords: | Nephrology, transplant medicine, transplant surgery. |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Clancy, Mr Marc and Ghita, Ryan |
| Authors: | Goldsmith, P. M., Bottomley, M. J., Okechukwu, O., Ross, V. C., Ghita, R., Wandless, D., Falconer, S. J., Papachristos, S., Nash, P., Androshchuk, V., and Clancy, M. |
| College/School: | College of Medical Veterinary and Life Sciences College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing |
| Journal Name: | BMJ Open |
| Publisher: | BMJ Publishing Group |
| ISSN: | 2044-6055 |
| ISSN (Online): | 2044-6055 |
| Published Online: | 28 July 2017 |
| Copyright Holders: | Copyright © 2017 The Authors |
| First Published: | First published in BMJ Open 7(7): e016144 |
| Publisher Policy: | Reproduced under a Creative Commons license |
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