Impact of intrapatient variability (IPV) in tacrolimus trough levels on long-term renal transplant function: multicentre collaborative retrospective cohort study protocol.

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.

Live related donors in India: Their quality of life using world health organization quality of life brief questionnaire.

CONTEXT: Organ selling is now legally banned in India. Numerous studies have documented that organ vendors have a poor quality of life (QOL) following kidney donation. AIMS: This study was designed to assess the QOL of living related donors in India. SETTINGS AND DESIGN: This study was a single-center prospective study. MATERIALS AND METHODS: The QOL of 106 consecutive related kidney donors was compared before and 6 months after the donation using the World Health Organisation Quality of Life Brief Questionnaire. STATISTICAL ANALYSIS USED: STATA 9.0 (College Station, Texas) was used and a p value less than 0.05 was considered significant. RESULTS: The response rate was 94.3% and the mean age was 43.2±11.95 years. Females constituted 73% of the population. Our study showed a significant improvement in the QOL among three of the four domains. The surgical technique (86- mini open donor nephrectomy, and 14 laparoscopic donor nephrectomy), education status, and marital status did not make any difference in the change in the QOL. CONCLUSIONS: Despite a number of our donors being unemployed and not being well educated, live related kidney donation improves the QOL of donors.