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Meta-Analysis
. 2022 Sep 12;9(9):CD012854.
doi: 10.1002/14651858.CD012854.pub2.

Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients

Lisa Mellon  1 , Frank Doyle  1 , Anne Hickey  1 , Kenneth D Ward  2 , Declan G de Freitas  3 , P Aiden McCormick  4 , Oisin O'Connell  5 , Peter Conlon  3
Affiliations
Meta-Analysis

Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients

Lisa Mellon et al. Cochrane Database Syst Rev. .

Abstract

Background: Non-adherence to immunosuppressant therapy is a significant concern following a solid organ transplant, given its association with graft failure. Adherence to immunosuppressant therapy is a modifiable patient behaviour, and different approaches to increasing adherence have emerged, including multi-component interventions. There has been limited exploration of the effectiveness of interventions to increase adherence to immunosuppressant therapy.

Objectives: This review aimed to look at the benefits and harms of using interventions for increasing adherence to immunosuppressant therapies in solid organ transplant recipients, including adults and children with a heart, lung, kidney, liver and pancreas transplant.

Search methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 14 October 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection criteria: All randomised controlled trials (RCTs), quasi-RCTs, and cluster RCTs examining interventions to increase immunosuppressant adherence following a solid organ transplant (heart, lung, kidney, liver, pancreas) were included. There were no restrictions on language or publication type.

Data collection and analysis: Two authors independently screened titles and abstracts of identified records, evaluated study quality and assessed the quality of the evidence using the GRADE approach. The risk of bias was assessed using the Cochrane tool. The ABC taxonomy for measuring medication adherence provided the analysis framework, and the primary outcomes were immunosuppressant medication initiation, implementation (taking adherence, dosing adherence, timing adherence, drug holidays) and persistence. Secondary outcomes were surrogate markers of adherence, including self-reported adherence, trough concentration levels of immunosuppressant medication, acute graft rejection, graft loss, death, hospital readmission and health-related quality of life (HRQoL). Meta-analysis was conducted where possible, and narrative synthesis was carried out for the remainder of the results.

Main results: Forty studies involving 3896 randomised participants (3718 adults and 178 adolescents) were included. Studies were heterogeneous in terms of the type of intervention and outcomes assessed. The majority of studies (80%) were conducted in kidney transplant recipients. Two studies examined paediatric solid organ transplant recipients. The risk of bias was generally high or unclear, leading to lower certainty in the results. Initiation of immunosuppression was not measured by the included studies. There is uncertain evidence of an association between immunosuppressant medication adherence interventions and the proportion of participants classified as adherent to taking immunosuppressant medication (4 studies, 445 participants: RR 1.09, 95% CI 0.95 to 1.20; I² = 78%). There was very marked heterogeneity in treatment effects between the four studies evaluating taking adherence, which may have been due to the different types of interventions used. There was evidence of increasing dosing adherence in the intervention group (8 studies, 713 participants: RR 1.14, 95% CI 1.03 to 1.26, I² = 61%). There was very marked heterogeneity in treatment effects between the eight studies evaluating dosing adherence, which may have been due to the different types of interventions used. It was uncertain if an intervention to increase immunosuppressant adherence had an effect on timing adherence or drug holidays. There was limited evidence that an intervention to increase immunosuppressant adherence had an effect on persistence. There was limited evidence that an intervention to increase immunosuppressant adherence had an effect on secondary outcomes. For self-reported adherence, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants classified as medically adherent to immunosuppressant therapy (9 studies, 755 participants: RR 1.21, 95% CI 0.99 to 1.49; I² = 74%; very low certainty evidence). Similarly, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the mean adherence score on self-reported adherence measures (5 studies, 471 participants: SMD 0.65, 95% CI -0.31 to 1.60; I² = 96%; very low certainty evidence). For immunosuppressant trough concentration levels, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants who reach target immunosuppressant trough concentration levels (4 studies, 348 participants: RR 0.98, 95% CI 0.68 to 1.40; I² = 40%; very low certainty evidence). It is uncertain whether an intervention to increase adherence to immunosuppressant medication may reduce hospitalisations (5 studies, 460 participants: RR 0.67, 95% CI 0.44 to 1.02; I² = 64%; low certainty evidence). There were limited, low certainty effects on patient-reported health outcomes such as HRQoL. There was no clear evidence to determine the effect of interventions on secondary outcomes, including acute graft rejection, graft loss and death. No harms from intervention participation were reported.

Authors' conclusions: Interventions to increase taking and dosing adherence to immunosuppressant therapy may be effective; however, our findings suggest that current evidence in support of interventions to increase adherence to immunosuppressant therapy is overall of low methodological quality, attributable to small sample sizes, and heterogeneity identified for the types of interventions. Twenty-four studies are currently ongoing or awaiting assessment (3248 proposed participants); therefore, it is possible that findings may change with the inclusion of these large ongoing studies in future updates.

Trial registration: ClinicalTrials.gov NCT02402140 NCT01739803 NCT02639949 NCT00818025 NCT01826721 NCT01709097 NCT03136588 NCT02416479 NCT01859273 NCT02554578 NCT01334333 NCT01450033 NCT01905514 NCT01541384 NCT01398488 NCT02954198 NCT01356277 NCT03247322 NCT01184937 NCT03515330 NCT03848585 NCT02904278 NCT03878329 NCT03691220 NCT03427008 NCT00843960 NCT02251691 NCT02610946 NCT02805842 NCT02866682 NCT03266393 NCT03979365 NCT02282124 NCT02827695 NCT03104868 NCT03540121.

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Conflict of interest statement

  1. Lisa Mellon: no relevant interests were disclosed

  2. Frank Doyle is listed as a co‐applicant on a patent for a method to monitor adherence to medication. This is a statistical method for clinicians to measure adherence and calculate drug dosages and is not related to the topic of this review

  3. Anne Hicke: no relevant interests were disclosed

  4. Kenneth D Ward: no relevant interests were disclosed

  5. Declan G de Freitas: no relevant interests were disclosed

  6. P Aiden McCormick: no relevant interests were disclosed

  7. Oisin O'Connell: no relevant interests were disclosed

  8. Peter Conlon: BioMarin Pharmaceutical (Independent Contractor ‐ Consultant); AstraZeneca (Independent Contractor ‐ Consultant)

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Implementation of medication adherence, Outcome 1: Taking adherence
1.2
1.2. Analysis
Comparison 1: Implementation of medication adherence, Outcome 2: Dosing adherence
1.3
1.3. Analysis
Comparison 1: Implementation of medication adherence, Outcome 3: Timing adherence
1.4
1.4. Analysis
Comparison 1: Implementation of medication adherence, Outcome 4: Drug holidays
2.1
2.1. Analysis
Comparison 2: Subjective adherence, Outcome 1: Self‐reported adherence (proportion)
2.2
2.2. Analysis
Comparison 2: Subjective adherence, Outcome 2: Self‐reported adherence (mean)
3.1
3.1. Analysis
Comparison 3: Objective adherence, Outcome 1: Proportion of immunosuppressant trough concentration levels at target
4.1
4.1. Analysis
Comparison 4: Secondary outcomes, Outcome 1: Acute graft rejection
4.2
4.2. Analysis
Comparison 4: Secondary outcomes, Outcome 2: Graft loss
4.3
4.3. Analysis
Comparison 4: Secondary outcomes, Outcome 3: Death
4.4
4.4. Analysis
Comparison 4: Secondary outcomes, Outcome 4: Hospital readmission
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References

References to studies included in this review

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    1. Santana MJ, Feeny D, Jackson K, Schafenacker M, Weinkauf J, Lien D. Using patient-centred care to enhance adherence to medication and exercise in lung transplantation: a randomized controlled clinical trial [abstract no: 445]. In: Canadian Society of Transplantation Annual Scientific Meeting; 2011 Mar 2-5; Quebec, Canada. 2011:34. [CENTRAL: CN-01657760]
Schmid 2017 {published data only}
    1. Hils S, Schmid A, Bogatyreva L, Hauschke D, Kramer-Zucker A, Pisarski P. Telemedical supported aftercare after living kidney transplantation-a single center experience [abstract no: O179]. Transplant International 2015;28(Suppl 4):69. [EMBASE: 72111423]
    1. Hils S, Schmid A, Bogatyreva L, Hauschke D, Pisarski P. Telemedical supported aftercare as an innovative project-study improves the quality of life after living kidney transplantation-a single center experience [abstract no: D2730]. Transplantation 2014;98(Suppl 1):843. [EMBASE: 71546416]
    1. Kaier K, Hils S, Fetzer S, Hehn P, Schmid A, Hauschke D, et al. Results of a randomized controlled trial analyzing telemedically supported case management in the first year after living donor kidney transplantation - a budget impact analysis from the healthcare perspective. Health Economics Review 2017;7(1):1. [MEDLINE: ] - PMC - PubMed
    1. Pisarski P, Hils S, Schmid A, Kramer-Zucker A, Janigen B. Telemedicin as an innovative project-study in adherence improvement after living kidney transplantation at the Transplantation Center Freiburg [abstract no: O162]. Transplant International 2013;26(Suppl 2):73. [EMBASE: 71359226]
    1. Schmid A, Hils S, Kramer-Zucker A, Bogatyreva L, Hauschke D, De Geest S, et al. Telemedically-supported case management of living-donor renal transplant recipients to optimize routine evidence-based aftercare: a single-center randomized controlled trial. American Journal of Transplantation 2017;17(6):1594-605. [MEDLINE: ] - PubMed
SMART 2006 {published data only}
    1. De Geest S, Denhaerynck K, Schafer-Keller P, Bock A, Steiger J. Supporting medication adherence in renal transplantation--the SMART study. Swiss Medical Weekly 2007;137 Suppl 155:125-7S. [MEDLINE: ] - PubMed
    1. De Geest S, Schafer-Keller P, Denhaerynck K, Bock A, Kofer S, Thannberger N, et al. Supporting medication adherence in renal transplantation (SMART): a pilot study [abstract no: PO3.09]. Kidney & Blood Pressure Research 2004;27(5-6):327. [CENTRAL: CN-00615859]
    1. De Geest S, Schafer-Keller P, Denhaerynck K, Thannberger N, Kofer S, Bock A, et al. Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens. Clinical Transplantation 2006;20(3):359-68. [MEDLINE: ] - PubMed
    1. Geest S, Schafer P, Denhaerynck K, Bock A, Steiger J. Supporting medication adherence in renal transplantation (SMART): a randomized controlled trial to improve adherence with immunosuppressive regimen [abstract no: PO-590]. Transplant International 2005;18(Suppl):na.
Suhling 2014 {published data only}
    1. Suhling H, Rademacher J, Zinowsky I, Fuge J, Greer M, Warnecke G, et al. Conventional vs. tablet computer-based patient education following lung transplantation--a randomized controlled trial. PLoS ONE [Electronic Resource] 2014;9(6):e90828. [MEDLINE: ] - PMC - PubMed
    1. Suhling H, Rademacher J, Zinowsky I, Fuge J, Greer M, Warnecke G. Patient education via tablet-pc vs. conventional to improve compliance with immunosuppressive drug regimen after lung transplantation - a randomized controlled trial [abstract no: 2844]. European Respiratory Journal 2013;42(Suppl 57):565S. [EMBASE: 71843332]
Taber 2020 {published data only}
    1. Taber DJ, Posadas MA, Rao V, McGillicuddy J, Rohan V, Nadig SN, et al. The potential for improved medication adherence with a complete once daily immunosuppression regimen in kidney transplant: results of a randomized controlled study [abstract no: FR-PO1177]. Journal of the American Society of Nephrology 2019;30(Abstract Suppl):750-1. [EMBASE: 633769114]
    1. Taber DJ, Posadas-Salas A, Su Z, Rao V, Rohan V, Nadig S, et al. Preliminary assessment of safety and adherence to a once-daily immunosuppression regimen in kidney transplantation: results of a randomized controlled pilot study. Clinical Transplantation 2020;34(4):e13844. [MEDLINE: ] - PubMed
TACmono 2021 {published data only}
    1. Van Zanten R, De Weerd A, Betjes M, Boer-Verschragen M, Massey E. Medication adherence and fear of rejection after conversion from dual to monotherapy: A randomized controlled trial [abstract no: OP170]. Transplant International 2021;34(Suppl 1):35. [EMBASE: 635968308] - PMC - PubMed
    1. Zanten R, Weerd A, Betjes M, Boer-Verschragen M, Massey EK. Is simplification of immunosuppressive medication a way to promote medication adherence of kidney transplant recipients? Findings from a randomized controlled trial. Transplant International 2021;34(9):1703-11. [MEDLINE: ] - PMC - PubMed
TAKE‐IT 2014 {published data only}
    1. Bignall O, Pai A, Amaral S, Furth S, Bergman N, Goebel J, et al. Differences in reported barriers to immunosuppression adherence among a cohort of pediatric renal transplant recipients from the United States and Canada [abstract no: D161]. American Journal of Transplantation 2016;16(Suppl 3):751. [EMBASE: 611700425]
    1. Boucquemont J, Foster B, TAKE-IT Investigators. Sex and age differences in medication adherence in adolescent and young adult kidney transplant recipients [abstract no: SA-PO404]. Journal of the American Society of Nephrology 2016;27(Abstracts):721A. [CENTRAL: CN-01657535]
    1. Boucquemont J, Foster B. Adherence patterns in adolescent and young adult kidney transplant recipients [abstract no: 229]. American Journal of Transplantation 2016;16(Suppl 3):284. [EMBASE: 611700136]
    1. Boucquemont J, Pai AL, Dharnidharka VR, Hebert D, Furth SL, Foster BJ. Gender differences in medication adherence among adolescent and young adult kidney transplant recipients. Transplantation 2019;103(4):798-806. [MEDLINE: ] - PMC - PubMed
    1. Boucquemont J, Pai AL, Dharnidharka VR, Hebert D, Zelikovsky N, Amaral S, et al. Association between day of the week and medication adherence among adolescent and young adult kidney transplant recipients. American Journal of Transplantation 2020;20(1):274-81. [MEDLINE: ] - PMC - PubMed
TRANSAFE‐Rx 2018 {published data only}
    1. Fleming JN, Gebregziabher M, Posadas A, Su Z, McGillicuddy JW, Taber DJ. 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. American Journal of Health-System Pharmacy 2021;78(14):1287-93. [MEDLINE: ] - PMC - PubMed
    1. Fleming JN, Treiber F, McGillicuddy J, Gebregziabher M, Taber DJ. Improving transplant medication safety through a pharmacist-empowered, patient-centered, mhealth-based intervention: TRANSAFE Rx study protocol. JMIR Research Protocols 2018;7(3):e59. [MEDLINE: ] - PMC - PubMed
    1. Gonzales HM, Fleming JN, Gebregziabher M, Posadas-Salas MA, Su Z, McGillicuddy JW, et al. Pharmacist-led mobile health intervention and transplant medication safety: a randomized controlled clinical trial. Clinical Journal of the American Society of Nephrology: CJASN 2021;16(5):776-84. [MEDLINE: ] - PMC - PubMed
    1. Taber DJ, Fleming JN, Su Z, Mauldin P, McGillicuddy JW, Posadas A, et al. Significant hospitalization cost savings to the payer with a pharmacist-led mobile health intervention to improve medication safety in kidney transplant recipients. American Journal of Transplantation 2021;21(10):3428-35. [MEDLINE: ] - PubMed
    1. Taber DJ, Pilch NA, McGillicuddy JW, Mardis C, Treiber F, Fleming JN. Using informatics and mobile health to improve medication safety monitoring in kidney transplant recipients. American Journal of Health-System Pharmacy 2019;76(15):1143-9. [MEDLINE: ] - PubMed
Urstad 2012 {published data only}
    1. Urstad KH, Oyen O, Andersen MH, Moum T, Wahl AK. The effect of an educational intervention for renal recipients: a randomized controlled trial. Clinical Transplantation 2012;26(3):E246-53. [MEDLINE: ] - PubMed

References to studies excluded from this review

Chisholm 2002 {published data only}
    1. Chisholm MA, Mulloy LL, Jagadeesan M, Martin BC, DiPiro JT. Effect of clinical pharmacy services on the blood pressure of African-American renal transplant patients. Ethnicity & Disease 2002;12(3):392-7. [MEDLINE: ] - PubMed
Hilbrands 1993 {published data only}
    1. Hilbrands LB, Demacker PN, Hoitsma AJ, Stalenhoef AF, Koene RA. The effects of cyclosporine and prednisone on serum lipid and (apo)lipoprotein levels in renal transplant recipients. Journal of the American Society of Nephrology 1995;5(12):2073-81. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Demacker PN, Hoitsma AJ. Cyclosporin and serum lipids in renal transplant recipients. Lancet 1993;341(8847):765-6. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Hoitsma AJ, Koene KA. Randomized, prospective trial of cyclosporine monotherapy versus azathioprine-prednisone from three months after renal transplantation. Transplantation 1996;61(7):1038-46. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Hoitsma AJ, Koene RA. Costs of drugs used after renal transplantation. Transplant International 1996;9(Suppl 1):S399-402. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Hoitsma AJ, Koene RA. Effect of immunosuppressive therapy on quality of life after renal transplantation [abstract]. Journal of the American Society of Nephrology 1994;5(3):1011. [CENTRAL: CN-00615875]
Korus 2020 {published data only}
    1. Korus M, Cruchley E, Calic M, Gold A, Anthony SJ, Parekh RS, et al. Assessing the acceptability and efficacy of teens taking charge: Transplant-A pilot randomized control trial. Pediatric Transplantation 2020;24(1):e13612. [MEDLINE: ] - PubMed
    1. Korus M, Cruchley E, Gold A, Stinson J, Parekh R, Anthony S. A self-management website for teenagers who have undergone kidney or liver transplantation: A feasibility randomized controlled pilot trial [abstract no: 401.3]. Pediatric Transplantation 2017;21(Suppl 1):33-4. [EMBASE: 616208183]
Mitchell 2018 {published data only}
    1. Mitchell Y, Volpendesta J, Vongspanich-Dray J. Evaluation of efficiency and patient perception of solid organ transplant medication education after pharmacist-created video education [abstract no: 206]. American Journal of Kidney Diseases 2018;71(4):567. [EMBASE: 621595826]
    1. Mitchell Y, Volpendesta J, Vongspanich-Dray J. Evaluation of efficiency and patient perception of solid organ transplant medication education after pharmacist-created video education [abstract no: A385]. American Journal of Transplantation 2018;18(Suppl 4):608. [EMBASE: 622280687]
Moro 2008 {published data only}
    1. Moro JA, Almenar L, Martnez-Dolz L, Aguero J, Sanchez-Lazaro I, Iglesias P, et al. Support program for heart transplant patients: initial experience. Transplantation Proceedings 2008;40(9):3039-40. [MEDLINE: ] - PubMed
NCT03515330 {published data only}
    1. Henderson M. A pilot study of mDOT for immunosuppressant adherence in adult liver transplant recipients [A pilot study of mobile directly observed therapy (mDOT) for immunosuppressant adherence in adult liver transplant recipients]. www.clinicaltrials.gov/show/NCT03515330 (first received 3 May 2018).
NCT03848585 {published data only}
    1. Söderdahl G. Medicine adherence and effects on transplants with Pilloxa's electronic pillbox [Improvement of medicine adherence and the following positive effects on transplants in patients after organ transplantation with Pilloxa's electronic pillbox]. www.clinicaltrials.gov/ct2/show/NCT03848585 (first received 21 February 2019).
Tzvetanov 2014 {published data only}
    1. Tzvetanov I, D'Amico G, West-Thielke P, Johnsen M, Hahaj G, Heller R, et al. An innovative rehabilitation program for obese kidney transplant recipients: impact of return to work rates [abstract no: D2729]. Transplantation 2014;98(Suppl 1):843. [EMBASE: 71546415] - PubMed
    1. Tzvetanov I, West-Thielke P, D'Amico G, Johnsen M, Ladik A, Hachaj G, et al. A novel and personalized rehabilitation program for obese kidney transplant recipients. Transplantation Proceedings 2014;46(10):3431-7. [MEDLINE: ] - PubMed

References to studies awaiting assessment

NCT02904278 {published data only}
    1. Shellmer D. Novel mobile device application to improve adherence [Randomized, controlled trial of a novel mobile device application to improve adherence in children greater than 11 years of age after cardiac transplantation (CTOTC-10)]. www.clinicaltrials.gov/show/NCT02904278 (first received 16 September 2016).
NCT03878329 {published data only}
    1. Shah S. Telemedicine based remote home monitoring after liver transplantation (TelehealthOLT). www.clinicaltrials.gov/show/nct03878329 (first received 18 March 2019).

References to ongoing studies

Ganjali 2019 {published data only}
    1. Ganjali R, Taherzadeh Z, Ghorban Sabbagh M, Nazemiyan F, Mamdouhi F, Tabesh H, et al. Effect of an interactive voice response system on self-management in kidney transplant recipients: Protocol for a randomized controlled trial. Medicine 2019;98(6):e14291. [MEDLINE: ] - PMC - PubMed
Halleck 2017 {published data only}
    1. Halleck F, Georgi S, Khadzhynov D, Lehner L, Schrezenmeier E, Durr M, et al. Prescribed medications, adherence and smartphone use in kidney transplant recipients: Evaluating the potential of a mobile app to enhance medication adherence [abstract no: OS178]. Transplant International 2017;30(Suppl 2):69. [EMBASE: 618770482]
    1. Halleck F, Georgi S, Khadzhynov D, Schmidt D, Schrezenmeier E, Lehner L, et al. A mobile app to improve medication adherence in kidney transplant recipients-analysis of a prospective interventional study [abstract no: B202]. American Journal of Transplantation 2018;18(Suppl 4):699-700. [EMBASE: 622279560]
    1. Staeck O, Georgi S, Khadzhynov D, Lehner L, Schrezenmeier E, Schmidt D, et al. Use of a mobile app to improve medication adherence in kidney transplant recipients-A prospective interventional study [abstract no: SAO014]. Nephrology Dialysis Transplantation 2018;33(Suppl 1):i320-1. [EMBASE: 622605515]
iMALT 2018 {published data only}
    1. Shemesh E. Improving medication adherence in adolescents who had a liver transplant (iMALT) [Improving medication adherence in adolescents who had a liver transplant]. www.clinicaltrials.gov/show/nct03691220 (first received 1 October 2018).
Langlee 2019 {published data only}
    1. Henderson M, Saha A, Langlee J, Lees L, Helfer D, Waldram MM, et al. Mobile directly observed therapy for immunosuppression adherence in adult kidney transplant recipients: a pilot randomized controlled trial [abstract no: 232.1]. Transplantation 2019;103(11 Suppl 1):S42. [EMBASE: 629910110]
    1. Langlee J, Lees L, Saha A, Helfer D, Waldram M, Love A, et al. A pilot study of the mDOT platform for immunosuppression adherence in adult kidney transplant recipients [abstract no: D324]. American Journal of Transplantation 2019;19(Suppl 3):1153-4. [EMBASE: 628454855]
    1. Saha A, Langlee J, Lees L, Brown A, Motter J, Sung H, et al. Mobile directly observed therapy for immunosuppression medication adherence in kidney transplant patients [abstract no: P-108]. American Journal of Transplantation 2020;20(Suppl 2):61-2. [EMBASE: 631496771]
MARS 2020 {published data only}
    1. Beck DK, Rechards M, Tielen M, Ismail S, Van der Wetering J, Gelder T, et al. Promoting medication adherence and self management among kidney transplant recipients (MARS-trial): development and first experiences [abstract no: P-6.14]. Transplantation 2020;104(Suppl 3):S303. [EMBASE: 633381194]
    1. Beck DK, Tielen M, Rechards M, Timman R, Boonstra C, Versteegh J, et al. Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol. BMC Nephrology 2020;21(1):374. [MEDLINE: ] - PMC - PubMed
NCT00843960 {published data only}
    1. Kugler C. Medication adherence enhancement in heart transplant recipients: a randomized clinical trial. www.inclinicaltrials.com/medication-adherence/nct00843960/ (first received 12 February 2009).
NCT02251691 {published data only}
    1. Lee CY. Influence of once-daily versus twice-daily immunosuppressant on renal transplant [The influence of once-daily versus twice-daily immunosuppressive regimen on drug compliance in patients after renal transplantation]. www.clinicaltrials.gov/ct2/show/NCT02251691 (first received 29 September 2014).
NCT02610946 {published data only}
    1. Tran H. Do technology Apps improve compliance in adolescent renal transplant recipients? www.clinicaltrials.gov/ct2/show/NCT02610946 (first received 20 November 2015).
NCT02805842 {published data only}
    1. Mor E, Yussim A. Incidence of non adherence to treatment with once-daily formulation of tacrolimus (Advagraf) [Evaluation of incidence of non adherence to treatment with once-daily formulation of tacrolimus (ADVAGRAF) in kidney transplant recipients]. www.clinicaltrials.gov/ct2/show/NCT02805842 (first received 20 June 2016).
NCT02866682 {published data only}
    1. Bunnapradist S. Prospective study comparing brand and generic immunosuppression on transplant outcomes, adherence, & immune response in kidney transplant recipients [Prospective study comparing brand and generic immunosuppression on transplant outcomes, adherence, & immune response]. www.clinicaltrials.gov/ct2/show/NCT02866682 (first received 15 August 2016).
NCT03266393 {published data only}
    1. Pearl M. Envarsus XR® in adolescent renal transplant recipients (EnvarsusXR) [A prospective, randomized, single-center, pilot study of envarsus X® to examine safety, medication adherence, and patient reported outcomes in adolescent renal transplant recipients]. www.clinicaltrials.gov/show/NCT03266393 (first received 30 August 2017).
NCT03979365 {published data only}
    1. Stegall M. Envarsus XR compared to immediate release tacrolimus (SIMPLE) [A prospective, randomized, multicenter, open-label, pilot study to investigate medication adherence & patient reported symptom occurrence & interference w/ daily life comparing Envarsus XR® & immediate release tacrolimus in adult renal transplant recipients (SIMPLE)]. www.clinicaltrials.gov/ct2/show/NCT03979365 (first received 7 June 2019).
Potter 2016 {published data only}
    1. Bodzin A, Becker Y, Josephson M, Witkowski P, Lockwood M, Potter L, et al. Randomized controlled study evaluating adherence monitoring with electronic feedback on reducing renal allograft rejection [abstract no: 281]. American Journal of Transplantation 2016;16(Suppl 3):302. [EMBASE: 611700054]
    1. Kane B, Lockwood M, Bodzin A, Potter L, Lourenco L, Millis JM. Randomized controlled study evaluating adherence monitoring with electronic feedback on reducing renal allograft rejection [abstract no: 626.1]. Transplantation 2016;100(7 Suppl 1):S430. [EMBASE: 613004919]
    1. Kane B, Lockwood M, Potter L, Lourenco L, Bodzin A, Covington D, et al. Prospective randomized controlled study evaluating the relationship between electronic adherence data and tacrolimus concentration data [abstract no: C73]. American Journal of Transplantation 2016;16(Suppl 3):626. [EMBASE: 611699014]
    1. Lockwood M, Potter L, Kane B, Bodzin A, Lourenco L, Millis JM. Prospective randomized controlled study evaluating the impact of an electronic feedback system (EFS) on medication adherence in solid organ transplantation [abstract no: 626.1]. Transplantation 2016;100(7 Suppl 1):S430. [EMBASE: 613004893]
    1. Lockwood M, Potter L, Kane B, Lourenco L, Bozdin A, Millis J. Prospective randomized controlled study evaluating the impact of an electronic feedback system on medication adherence in solid organ transplantation [abstract no: 547]. American Journal of Transplantation 2016;16(Suppl 3):394. [EMBASE: 611698886]
Rocafort 2015 {published data only}
    1. Rocafort P, Rodriguez De Bittner M, Gopalikrishnan M, Lewin J, Thompson N, Swarthout M, et al. Implementation of a transition of care educational and behavioral intervention to improve medication adherence in kidney transplant patients [abstract no: 23]. Journal of the American Pharmacists Association 2015;55(2):e121. [EMBASE: 71970802]
Schmid‐Mohler 2019 {published data only}
    1. Schmid-Mohler G, Fehr T, Muller T, Witschi P, Biotti B, Wuthrich RP, et al. Study to measure the effect of an advanced nursing practice program on weight gain, physical activity and medication intake in patients in the first year after kidney transplantation [abstract no: P252]. Transplant International 2015;28(Suppl 4):450. [EMBASE: 72112245]
    1. Schmid-Mohler G, Zala P, Graf N, Witschi P, Mueller TF, Wuthrich RP, et al. Comparison of a behavioral versus an educational weight management intervention after renal transplantation: a randomized controlled trial. Transplantation Direct 2019;5(12):e507. [MEDLINE: ] - PMC - PubMed
Shellmer 2014 {published data only}
    1. Shellmer D, DeVito Dabbs A, Dew M, Feingold B, Mazariegos G, Shapiro R. A randomized controlled trial of a dyadic mobile health application to promote medication adherence among solid organ adolescent transplant patients [abstract no: A484]. Transplantation 2014;98(Suppl 1):237-8. [EMBASE: 71544245]
    1. Shellmer DA, DeVito Dabbs A, Dew M, Mazariegos G. Teen Pocket Path: A randomized pilot of a mobile health application to improve adherence among adolescent solid organ transplant recipients [abstract no: 67]. Journal of Heart & Lung Transplantation 2014;33(4 Suppl 1):S32. [EMBASE: 71404775] - PubMed
SMASK 2019 {published data only}
    1. McGillicuddy J, Chandler J, Sox L, Mueller M, Nemeth L, Baliga P, et al. "Smartphone Medication Adherence Saves Kidneys" for kidney transplantation recipients: protocol for a randomized controlled trial. JMIR Research Protocols 2019;8(6):e13351. [MEDLINE: ] - PMC - PubMed
    1. McGillicuddy JW, Chandler JL, Sox LR, Taber DJ. Exploratory analysis of the impact of an mhealth medication adherence intervention on tacrolimus trough concentration variability: post hoc results of a randomized controlled trial. Annals of Pharmacotherapy 2020;54(12):1185-93. [MEDLINE: ] - PMC - PubMed
    1. McGillicuddy JW, Sox L, Chandler J, Treiber F, Taber D. Impact of an mHealth, electronic pillbox intervention on tacrolimus variability in kidney transplantation: results of a prospective randomized clinical trial [abstract no: D314]. American Journal of Transplantation 2019;19(Suppl 3):1149-50. [EMBASE: 628454375]
TAKE‐IT 2021 {published data only}
    1. Serper M, Ladner DP, Curtis LM, Nair SS, Hur SI, Kwasny MJ, et al. Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients. Contemporary Clinical Trials 2021;103:106294. [MEDLINE: ] - PMC - PubMed
TRANSNephro 2014 {published data only}22988897
    1. Kreuzer M, Prufe J, Bethe D, Vogel C, Grosshennig A, Koch A, et al. The TRANSNephro-study examining a new transition model for post-kidney transplant adolescents and an analysis of the present health care: study protocol for a randomized controlled trial. Trials [Electronic Resource] 2014;15(1):505. [MEDLINE: ] - PMC - PubMed
    1. Kreuzer M, Prufe J, Oldhafer M, Bethe D, Dierks ML, Muther S, et al. Transitional care and adherence of adolescents and young adults after kidney transplantation in Germany and Austria: a binational observatory census within the TRANSNephro trial. Medicine 2015;94(48):e2196. [MEDLINE: ] - PMC - PubMed
Trofe‐Clark 2017 {published data only}
    1. Trofe-Clark J, Gbemudu W, Ryan S, Sawinski D, Lim M, Goral S, et al. Assessments of literacy, cognitive function and transplant medication knowledge in renal transplant recipients [abstract no: C132]. American Journal of Transplantation 2017;17(Suppl 3):659. [EMBASE: 615705042]
U‐REAACT 2019 {published data only}
    1. Amaral S, Schwartz L, Zelikovsky N, Psihogios A, Rodig N, Reason J, et al. U-REAACT: Using mobile health to promote medication adherence in youth with kidney transplants [abstract no: 400.7]. Pediatric Transplantation 2019;23(Suppl 1). [EMBASE: 627772915]
VECTOR 2019 {published data only}
    1. Mansell H, Rosaasen N, West-Thielke P, Wichart J, Daley C, Mainra R, et al. Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol. BMJ Open 2019;9(3):e025495. [MEDLINE: ] - PMC - PubMed

Additional references

Adam 2003
    1. Adam R, McMaster P, O'Grady JG, Castaing D, Klempnauer JL, Jamieson N, et al. Evolution of liver transplantation in Europe: report of the European Liver Transplant Registry. Liver Transplantation 2003;9(12):1231-43. [MEDLINE: ] - PubMed
Anyanwu 2002
    1. Anyanwu AC, McGuire A, Rogers CA, Murday AJ. An economic evaluation of lung transplantation. Journal of Thoracic & Cardiovascular Surgery 2002;123(4):411-8. [MEDLINE: ] - PubMed
Bangalore 2007
    1. Bangalore S, Kamalakkannan G, Parkar S, Messerli FH. Fixed-dose combinations improve medication compliance: a meta-analysis. American Journal of Medicine 2007;120(8):713-9. [MEDLINE: ] - PubMed
Butler 2004
    1. Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation 2004;77(5):769-76. [MEDLINE: ] - PubMed
Davies 2010
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Davis 2015
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Dayer 2013
    1. Dayer L, Heldenbrand S, Anderson P, Gubbins PO, Martin BC. Smartphone medication adherence apps: potential benefits to patients and providers. Journal of the American Pharmacists Association: JAPhA 2013;53(2):172-81. [MEDLINE: ] - PMC - PubMed
De Bleser 2009
    1. De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S. Interventions to improve medication adherence after transplantation: a systematic review. Transplant International 2009;22(8):780-97. [MEDLINE: ] - PubMed
De Geest 2018
    1. De Geest S, Zullig LL, Dunbar-Jacob J, Helmy R, Hughes DA, Wilson IB, et al. ESPACOMP Medication Adherence Reporting Guideline (EMERGE). Annals of Internal Medicine 2018;169(1):30-5. [MEDLINE: ] - PMC - PubMed
Denhaerynck 2005
    1. Denhaerynck K, Dobbels F, Cleemput I, Desmyttere A, Schafer-Keller P, Schaub S, et al. Prevalence, consequences, and determinants of nonadherence in adult renal transplant patients: a literature review. Transplant International 2005;18(10):1211-33. [MEDLINE: ] - PubMed
Denhaerynck 2018
    1. Denhaerynck K, Berben L, Dobbels F, Russell CL, Crespo-Leiro MG, Poncelet AJ, et al. Multilevel factors are associated with immunosuppressant nonadherence in heart transplant recipients: The international BRIGHT study. American Journal of Transplantation 2018;18(6):1447-60. [MEDLINE: ] - PMC - PubMed
Dew 2007
    1. Dew MA, DiMartini AL, De Vito Dabbs A, Myaskovsky L, Steel L, Unruh M, et al. Rates and Risk factors for nonadherence to the medical regimen after adult solid organ transplantation. Transplantation 2007;83(7):858-73. [MEDLINE: ] - PubMed
Dew 2009
    1. Dew MA, Dabbs AD, Myaskovsky L, Shyu S, Shellmer DA, DiMartini AF, et al. Meta-analysis of medical regimen adherence outcomes in pediatric solid organ transplantation. Transplantation 2009;88(5):736-46. [MEDLINE: ] - PMC - PubMed
DiMatteo 2012
    1. DiMatteo MR, Haskard-Zolnierek KB, Martin LR. Improving patient adherence: a three-factor model to guide practice. Health Psychology Review 2012;6(1):74-91. [DOI: 10.1080/17437199.2010.537592] - DOI
ERA‐EDTA 2015
    1. ERA-EDTA Registry. ERA-EDTA Registry Annual Report 2015. Academic Medical Center, Department of Medical Informatics, Amsterdam, the Netherlands, 2015. www.era-edta-reg.org/files/annualreports/AnnRep2015.pdf (accessed 31 March 2022).
Fine 2009
    1. Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, et al. Nonadherence consensus conference summary report. American Journal of Transplantation 2009;9(1):35-41. [MEDLINE: ] - PubMed
Foroutan 2019
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