Evidence map›Paper›PMID 33821958›Full record

Trial reportAmerican journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists2021

Impact of a pharmacist-led, mHealth-based intervention on tacrolimus trough variability in kidney transplant recipients: A report from the TRANSAFE Rx randomized controlled trial.

James N Fleming, Mulugeta Gebregziabher, Aurora Posadas, Zemin Su, John W McGillicuddy, David J Taber

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 7 pooled it
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 7 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Effect of pharmacist interventions in chronic kidney disease: a meta-analysis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Digital Health Interventions by Clinical Pharmacists: A Systematic Review.International journal of environmental research and public health · 2022
    Pooled it
  8. Article
  9. Article
  10. Article
  11. Review
  12. The expanded role of the transplant pharmacist: A 10-year follow-up.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2023
    Article
  13. Article
  14. Review
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

James N FlemingDepartment of Surgery, Medical University of South Carolina, Charleston, SC, USA.
Mulugeta GebregziabherDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.ORCID 0000-0002-4826-481X
Aurora PosadasDepartment of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Zemin SuDepartment of Medicine, Medical University of South Carolina, Charleston, SC, USA.
John W McGillicuddyDepartment of Surgery, Medical University of South Carolina, Charleston, SC, USA.
David J TaberDepartment of Surgery, Medical University of South Carolina, Charleston, SC, USA.
Medical University of South Carolina · US

Funding

Improving Transplant Med Safety through a Pharmacist-Led, mHealth-Based ProgramR18HS023754 · AHRQ · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI TABER, DAVID J. · 2017 to 2019
$1.5M
Agency for Healthcare Research and Quality R18HS023754AHRQ HHS R18 HS023754
6 · The paper itself

Abstract

purposeNonadherence is a leading cause of death-censored allograft loss in kidney transplant recipients. Strong associations have tied tacrolimus intrapatient variability (IPV) to degree of nonadherence and high tacrolimus IPV to clinical endpoints such as rejection and allograft loss. Nonadherence is a dynamic, complex problem best targeted by multidimensional interventions, including mobile health (mHealth) technologies.

methodsThis was a secondary planned analysis of a 12-month, parallel, 2-arm, semiblind, 1:1 randomized controlled trial involving 136 adult kidney transplant recipients. The primary aims of the TRANSAFE Rx study were to assess the efficacy of a pharmacist-led, mHealth-based intervention in improving medication safety and health outcomes for kidney transplant recipients as compared to usual care.

resultsPatients were randomized equally to 68 patients per arm. The intervention arm demonstrated a statistically significant decrease in tacrolimus IPV over time as compared to the control arm (P = 0.0133). When analyzing a clinical goal of tacrolimus IPV of less than 30%, the 2 groups were comparable at baseline (P = 0.765), but significantly more patients in the intervention group met this criterion at month 12 (P = 0.033). In multivariable modeling, variables that independently impacted tacrolimus IPV included time, treatment effect, age, and warm ischemic time.

conclusionThis secondary planned analysis of an mHealth-based, pharmacist-led intervention demonstrated an association between the active intervention in the trial and improved tacrolimus IPV. Further prospective studies are required to confirm the mutability of tacrolimus IPV and impact of reducing tacrolimus IPV on long-term clinical outcomes.

Indexed as

Kidney TransplantationTelemedicineAdultGraft RejectionHumansImmunosuppressive AgentsPharmacistsTacrolimusImmunosuppressive AgentsTacrolimusadherencekidney transplantmHealthtacrolimustelemedicine

Identifiers

PMID33821958
PMCPMC8599187
OpenAlexW3141736172

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.