Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients
Conditions: Adherence, Medication, Transplantation, Kidney
Sponsor: Imperial College London

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
  
 
 
 
 
 
Exploring Immunosuppressant Medication Adherence in Kidney 
Transplant Recipients 
 
 
 
 
Version 5 – 23rd January 2017 
 
 
 
 
MAIN SPONSOR: Imperial College London and Imperial College Healthcare NHS Trust 
FUNDERS: NIHR Imperial Biomedical Research Centre 
STUDY COORDINATION CENTRE: Imperial College London 
NRES reference: 17/WM/0026 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
Prof David Taube, Study Supervisor 
 
 
Imperial College Healthcare NHS Trust 
Transplant Research Group 
 
 
 
 
 
 
 
Study Management Group 
 
Chief Investigator:  
Dawn Goodall 
 
Co-investigators:  
Prof David Taube 
Dr Michelle Willicombe 
Dr Adam Mclean 
 
Statistician:  
N/A 
 
Study Management:  
Imperial College Healthcare NHS Trust Transplant Research and Operations Group 
 
 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
Study Coordination Centre  
 
For general queries, supply of study documentation, and collection of data, please contact: 
 
Study Coordinator: Dawn Goodall 
Address: Renal and Transplant clinic 
 
 
Hammersmith Hospital, W12 0HS 
Tel: 0203 313 4247 
 
 
 
 
 
Mobile: 07962258199  
 
 
 
 
E-mail:  dawn.goodall@imperial.nhs.uk 
 
Clinical Queries 
 
Clinical queries should be directed to Dawn Goodall who will direct the query to the 
appropriate person 
 
 
Sponsor 
 
Imperial College London and Imperial College Healthcare NHS Trust are the main research 
sponsors for this study.  For further information regarding the sponsorship conditions, please 
contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
 
 
Funder 
 
NIHR Imperial Biomedical Research Centre 
 
This protocol describes the Exploring Immunosuppressant Medication Adherence in Kidney 
Transplant Recipients study and provides information about procedures for entering 
participants.  Every care was taken in its drafting, but corrections or amendments may be 
necessary. These will be circulated to investigators in the study.  Problems relating to this 
study should be referred, in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance 
Framework for Health and Social Care (2nd edition). It will be conducted in compliance with 
the protocol, the Data Protection Act and other regulatory requirements as appropriate.  
 
 
 
 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
Table of Contents 
1. 
INTRODUCTION 
5 
1.1 BACKGROUND 
5 
2.  STUDY OBJECTIVES 
6 
3.  STUDY DESIGN 
6 
3.1 STUDY OUTCOME MEASURES 
7 
4. 
PARTICIPANT ENTRY 
7 
4.1 PRE-REGISTRATION EVALUATIONS 
7 
4.2 INCLUSION CRITERIA 
7 
4.3 EXCLUSION CRITERIA 
7 
4.4 WITHDRAWAL CRITERIA 
8 
5. 
ADVERSE EVENTS 
8 
5.1 DEFINITIONS 
8 
5.3 REPORTING PROCEDURES 
8 
6. 
ASSESSMENT AND FOLLOW-UP 
9 
7. 
STATISTICS AND DATA ANALYSIS 
9 
8. 
REGULATORY ISSUES 
9 
8.1 ETHICS APPROVAL 
9 
8.2 CONSENT 
9 
8.3 CONFIDENTIALITY 
9 
8.4 INDEMNITY 
9 
8.5 SPONSOR 
10 
8.6 FUNDING 
10 
8.7 AUDITS AND INSPECTIONS 
10 
9. 
STUDY MANAGEMENT 
10 
10. 
PUBLICATION POLICY 
10 
11. 
REFERENCES 
10 
APPENDICES 
11 
APPENDIX 1. 
PARTICIPANT INFORMATION SHEET 
11 
APPENDIX 2.       CONSENT FORM 
 
 
 
 
 
 
 
  11 
 
 
 
 
 
 
 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
GLOSSARY OF ABBREVIATIONS 
AMR 
Antibody mediated rejection  
DSAb 
Donor specific antibody 
ICRTC 
Imperial College Renal and Transplant Centre 
SOT 
Solid organ transplant 
 
KEYWORDS 
 
Adherence, Medication, Immunosuppressant, Kidney transplant 
 
STUDY SUMMARY 
 
TITLE Exploring 
Immunosuppressant 
Medication 
Adherence 
in 
Kidney 
Transplant Recipients 
DESIGN Qualitative - Focus groups 
AIMS To 
describe 
the 
beliefs, 
understanding 
and 
experience 
of 
immunosuppressant medication adherence in our current transplant 
patient population 
OUTCOME 
MEASURES 
What 
our 
transplant 
patients’ 
understanding 
is 
of 
the 
terms 
immunosuppressant medication adherence and immunosuppressant 
medication nonadherence. 
How our transplant patients define immunosuppressant medication 
nonadherence 
What importance our transplant patients attach to medication adherence? 
Whether patients understand that medication nonadherence may affect 
the outcome of their kidney transplant 
The common practical and perceptual barriers to medication adherence 
identified by our transplant patients 
Interventions our transplant patients have used to try and improve their 
medication adherence 
Interventions our transplant patients have found effective to improve their 
medication adherence 
Interventions our transplant patients have not found to be effective to 
improve their medication adherence 
The support transplant patients have had with medication adherence 
since their transplant 
The support transplant patients feel could have helped them to better 
adhere to their medicines up to now 
The support our transplant patients feel would help them to adhere better 
to their medicines in the future 
POPULATION Kidney Transplant Recipients 
ELIGIBILITY Kidney Transplant Recipients transplanted and under active follow up at 
ICRTC 
DURATION 7.5 months 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
1. 
INTRODUCTION  
 
1.1 
BACKGROUND 
 
Organs for transplantation remain a scarce and precious resource with over 5000 patients 
currently on the kidney transplant waiting list. A kidney transplant costs approximately 
£17,000 in the first year and £5,000 per subsequent year. If the transplant fails, the patient 
must return to dialysis at an estimated cost of £30,800 per year.  While short term outcomes 
have improved steadily over the last 15-20 years, longer term outcomes haven’t and after 10 
years approximately 30% of kidney transplants have failed.  
 
Nonadherence to immunosuppressive medication is increasingly being associated with 
these poor long term outcomes (1-7) as it has been shown to be a potent risk factor for the 
development of de novo donor specific antibody (DSAb) and antibody mediated rejection 
(AMR) with AMR being a leading cause of kidney transplant failure(8-11). In a prospective 
study undertaken by Sellares et al(8) investigating the causes of kidney transplant failure in 
a series of patients who underwent an indicative biopsy it was shown that 64% of the 
transplants that failed were due to rejection, every rejection loss had evidence of AMR by the 
time of failure and among the rejection losses, 47% were independently identified by their 
clinician as being nonadherent.  
 
Studies have estimated that 30-50% of transplant patients are nonadherent to their 
immunosuppressive medication(1, 3, 5, 12) and that graft loss is seven times more likely in a 
nonadherent compared to an adherent patient(13). Nonadherence to immunosuppression 
can start at any time after the transplant; sometimes within weeks but also after months or 
years(3, 14). A prospective cohort study undertaken by Massey(14, 15). and colleagues 
identified that self-reported nonadherence to immunosuppression medication increased 
significantly between 6 weeks and 6 months post-transplant from 17% to 27% and that by 18 
months, the rate of nonadherence had reached 31% They assessed patient’s perceptions of 
the importance of medication adherence over time and while it was initially high, it decreased 
significantly over time.   
 
In a meta-analysis of adherence rates among solid organ transplant (SOT) recipients, 
nonadherence to immunosuppression medication was shown to be the highest in the kidney 
transplant recipients at 35.6 cases per 100 persons per year (PPY) compared to 14.5 cases 
per 100 PPY for heart recipients and 6.7 cases per 100PPY for liver recipients(16). This 
higher rate of nonadherence in the kidney transplant recipients is possibly because the 
consequences of nonadherence are higher in other SOTs.  Adherence with therapy is one of 
the criteria when listing a patient for transplant and it is possible that recipients of SOTs 
other than the kidney may be subject to more stringent psychosocial selection criteria.  
 
There are many reasons why patients do not adhere to their medication and their barriers to 
adherence can change over time. Adherence is difficult to measure accurately and currently, 
there is no universally agreed standard by which to measure nonadherence post-transplant; 
neither is there a panacea for ‘treating’ medication nonadherence. Many interventions and 
tools can be utilised with patients to improve adherence such as provision of information 
regarding the requirements for treatment, possible adverse effects and likely duration of 
therapy, reducing the complexity of medication regimes, diary cards, alarms and compliance 
aids. To achieve the best outcome, interventions should be tailored to the individual patient 
but in practice, this can be difficult to achieve. Patients who are nonadherent to 
immunosuppressant medication will often be nonadherent to other medicines prescribed for 
them, clinic attendance, diet, exercise, alcohol, smoking and illicit drug use. All of these 
factors will contribute to the overall morbidity and mortality of the patient. 
 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
1.2 
RATIONALE FOR CURRENT STUDY  
 
To describe the beliefs, understanding and experience of immunosuppressant medication 
adherence in our current kidney transplant patient population 
 
2.  STUDY OBJECTIVES 
 
 
To describe our transplant patients’ understanding of the terms immunosuppressant 
medication adherence and immunosuppressant medication nonadherence. 
 
To describe how our transplant patients define immunosuppressant medication 
nonadherence 
 
To establish what importance our transplant patients attach to medication adherence 
 
To determine whether our transplant patients understand that medication 
nonadherence may affect the outcome of their kidney transplant 
 
To establish the common practical and perceptual barriers to medication adherence 
identified by our transplant patients 
 
To identify the types of interventions that our transplant patients have used to try and 
improve their medication adherence 
 
To identify the types of intervention that our transplant patients have found effective 
to improve their medication adherence 
 
To identify the types of intervention that our transplant patients have not found to be 
effective to improve their medication adherence 
 
To determine the support our transplant patients have had with medication 
adherence since their transplant 
 
To determine what support our transplant patients feel could have helped them to 
better adhere to their medicines up to now 
 
To determine what support our transplant patients feel would help them to adhere 
better to their medicines in the future 
 
3.  STUDY DESIGN 
 
This study will collect qualitative data from a series of focus groups with kidney transplant 
recipients to explore their beliefs, understanding and experience of immunosuppressant 
medication adherence. The focus groups will also explore with the participants the support 
that they have received to facilitate their immunosuppressant medication adherence and 
what support they feel should be available to them and to others to optimise 
immunosuppressant medication adherence in all our transplant patients. The outcomes of 
the focus groups will be used to inform clinical practice in addition to a prospective trial 
aimed at improving immunosuppressant medication adherence though regular, intensive, 
pharmacist led, tailored medication adherence support. 
 
Five focus groups will be undertaken. Each focus group will include six patients and will last 
for approximately one to one and a half hours. All the patients will be kidney transplant 
patients who were transplanted and are followed up at Imperial College Renal and 
Transplant Centre (ICRTC).   
 
Patients will be recruited for the study through adverts placed in the transplant out-patient 
clinic at Imperial College Healthcare NHS Trust and in the Kidney Patient's Association 
newsletter. Any patients who express an interest in the study having seen the recruitment 
adverts will be directed to Dawn Goodall, The Chief Investigator. Dawn Goodall or another 
member of the research team, all of whom are members of the direct transplant clinical 
healthcare team will approach patients while in clinic to discuss participation in the study with 
them. The chief investigator, who is a member of the transplant clinical care team, will also 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
identify potential participants from the Imperial College Renal and Transplant Centre registry 
of current maintenance transplant patients and will telephone patients to invite them to 
participate. The participants will be selected to ensure a mix of patients by clinical and 
demographic criteria. 
 
The focus groups will take place on the Hammersmith Hospital site. Each focus group will be 
audio and video recorded. Field notes will be taken during the focus groups to record key 
data or events identified by the lead researcher. 
 
Each focus group will be transcribed and the content coded. A preliminary analysis will be 
made after each focus group to inform, adapt and develop the questions for the following 
focus group. Codes from each focus group will be categorised and themes identified. 
Analysis will be in content and narrative format. 
 
An informed consent will be obtained from every participant prior to inclusion in the study. No 
investigations, treatment or assessments of patients will be undertaken as part of this study. 
 
3.1 
STUDY OUTCOME MEASURES 
 
 
What our transplant patients’ understanding is of the terms immunosuppressant 
medication adherence and immunosuppressant medication nonadherence. 
 
How our transplant patients define immunosuppressant medication nonadherence 
 
What importance our transplant patients attach to medication adherence? 
 
Whether patients understand that medication nonadherence may affect the outcome 
of their kidney transplant 
 
The common practical and perceptual barriers to medication adherence identified by 
our transplant patients 
 
Interventions our transplant patients have used to try and improve their medication 
adherence 
 
Interventions our transplant patients have found effective to improve their medication 
adherence 
 
Interventions our transplant patients have not found to be effective to improve their 
medication adherence 
 
The support transplant patients have had with medication adherence since their 
transplant 
 
The support transplant patients feel could have helped them to better adhere to their 
medicines up to now 
 
The support our transplant patients feel would help them to adhere better to their 
medicines in the future 
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
 
Kidney Transplant Recipients transplanted and under active follow up at ICRTC. 
 
4.2 
INCLUSION CRITERIA 
 
Kidney transplant recipients transplanted and under the active follow up of ICRTC. 
Speak and understand English 
18 years and above 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
 
 
4.3 
EXCLUSION CRITERIA 
 
Unable to speak and understand English 
Below 18 years 
 
4.4 
WITHDRAWAL CRITERIA 
 
Patient unwilling to continue participation in the focus groups 
 
 
5. 
ADVERSE EVENTS 
 
5.1 
DEFINITIONS   
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
 
Results in death 
 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
 
 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
 
Results in persistent or significant disability or incapacity 
 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death 
or hospitalisation but may jeopardise the subject or may require intervention to prevent one 
of the other outcomes listed in the definition above, should also be considered serious. 
 
5.3 
REPORTING PROCEDURES 
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded.   
 
5.3.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  
However, relapse and death due to kidney transplantation, and hospitalisations for elective 
treatment of a pre-existing condition do not need reporting as SAEs. 
 
All SAEs should be reported to the West Midlands – Edgbaston REC where in the opinion of 
the Chief Investigator, the event was: 
 
‘related’, ie resulted from the administration of any of the research procedures; 
and 
 
‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
Fax 0208 383 8543, attention Dawn Goodall 
Please send SAE forms to: Dawn Goodall 
Tel: 0208 383 4247 (Mon to Fri 09.00 – 17.00) 
 
6. 
ASSESSMENT AND FOLLOW-UP  
 
If, as a result of the discussion, any patient realises that they are not taking their medicines 
as well as they thought, support will be available for them in the transplant outpatient’s clinic. 
The pharmacist who is running the focus groups will help the patient to organise this.  
 
 
7. 
STATISTICS AND DATA ANALYSIS 
 
Each focus group will be transcribed by the Chief Investigator and the content coded. A 
preliminary analysis will be made after each focus group to inform, adapt and develop the 
questions for the following focus group. Following completion of all the focus groups, the 
Chief Investigator will undertake a full analysis of all the focus groups. Codes from each 
focus group will be categorised and themes identified. All analysis will take place at Imperial 
College Healthcare NHS Trust. 
 
Data and all appropriate documentation will be stored for a minimum of 5 years after the 
completion of the study, including the follow-up period.   
 
 
8. 
REGULATORY ISSUES 
 
8.1 
ETHICS APPROVAL 
The Chief Investigator has obtained approval from the West Midlands - Edgbaston Research 
Ethics Committee and the HRA.  The study will be conducted in accordance with the 
recommendations for physicians involved in research on human subjects adopted by the 
18th World Medical Assembly, Helsinki 1964 and later revisions. 
 
8.2 
CONSENT  
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that specified in the protocol at any 
stage if he/she feels it is in the participant’s best interest, but the reasons for doing so should 
be recorded.  In these cases the participants remain within the study for the purposes of 
follow-up and data analysis.  All participants are free to withdraw at any time from the 
protocol treatment without giving reasons and without prejudicing further treatment. If a 
patient gives consent and participates in a focus group but then loses capacity, the contents 
of the focus group and their contribution to it will still be used in full. 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
 
8.3 
CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. The chief investigator and other members of 
the research team are members of the healthcare team caring for the participants therefore 
have access to their personal information. Confidential patient information will be stored only 
on the hospital computer systems. Non-anonymised data will be available to study clinicians 
only.  All electronic data will be pseudonymised (ie each patient = unique number). The 
unique number will be allocated to the patient at the time of recruitment. The identifier will be 
stored securely on the hospital computer system.  Written consent forms will be stored in the 
study file which will be stored securely on the hospital premises. A copy will be scanned and 
recorded on their electronic patient record. The focus groups will be audio and video 
recorded and transcribed by Dawn Goodall, the Chief Investigator. The transcription will take 
place as soon as possible after the focus group has taken place and the aim will be to 
complete the transcription within 2 weeks. The recordings will be destroyed following 
transcription and checking. Participants will not be identified by name in the transcriptions. 
Quotes will be included in the writing up of the study to illustrate themes that emerge from 
the qualitative analysis however they will be anonymised and participants will not be 
identified. 
 
8.4 
INDEMNITY 
Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and 
insurance cover with NHS Litigation Authority for NHS Trusts in England, which apply to this 
study  
 
8.5 
SPONSOR 
Imperial College London and Imperial College Healthcare NHS Trust will act as the main 
sponsors for this study.  Delegated responsibilities will be assigned to the NHS trusts taking 
part in this study.   
 
8.6 
FUNDING 
NIHR Imperial Biomedical Research Centre are funding this study.  Each participant will be 
given a £25 incentive to attend the focus groups in addition to their travel expenses. 
Refreshments will be provided at each focus group. 
 
8.7 
AUDITS  
The study may be subject to inspection and audit by Imperial College London under their 
remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS 
Research Governance Framework for Health and Social Care (2nd edition).  
 
 
9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through Imperial College NHS 
Healthcare Trust Transplant Research and Operations Group.   
 
 
10. 
PUBLICATION POLICY 
 
The aim is to publish the outcome of the study in a high impact, peer reviewed journal. 
 
 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
23
rd January 2017 
 
 
 
11. 
REFERENCES 
 
 
1. 
Kidney Disease: Improving Global Outcomes Transplant Work G. KDIGO clinical 
practice guideline for the care of kidney transplant recipients. American journal of 
transplantation : official journal of the American Society of Transplantation and the American 
Society of Transplant Surgeons. 2009;9 Suppl 3:S1-155. 
2. 
De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S. Interventions to 
improve medication-adherence after transplantation: a systematic review. Transplant 
international : official journal of the European Society for Organ Transplantation. 
2009;22(8):780-97. 
3. 
Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, et al. Nonadherence 
consensus conference summary report. American journal of transplantation : official journal 
of the American Society of Transplantation and the American Society of Transplant 
Surgeons. 2009;9(1):35-41. 
4. 
Denhaerynck K, Steiger J, Bock A, Schafer-Keller P, Kofer S, Thannberger N, et al. 
Prevalence and risk factors of non-adherence with immunosuppressive medication in kidney 
transplant patients. American journal of transplantation : official journal of the American 
Society of Transplantation and the American Society of Transplant Surgeons. 2007;7(1):108-
16. 
5. 
Morrissey PE, Flynn ML, Lin S. Medication noncompliance and its implications in 
transplant recipients. Drugs. 2007;67(10):1463-81. 
6. 
Prendergast MB, Gaston RS. Optimizing medication adherence: an ongoing 
opportunity to improve outcomes after kidney transplantation. Clinical journal of the 
American Society of Nephrology : CJASN. 2010;5(7):1305-11. 
7. 
Schafer-Keller P, Steiger J, Bock A, Denhaerynck K, De Geest S. Diagnostic 
accuracy of measurement methods to assess non-adherence to immunosuppressive drugs 
in kidney transplant recipients. American journal of transplantation : official journal of the 
American Society of Transplantation and the American Society of Transplant Surgeons. 
2008;8(3):616-26. 
8. 
Sellares J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, et al. 
Understanding the causes of kidney transplant failure: the dominant role of antibody-
mediated rejection and nonadherence. American journal of transplantation : official journal of 
the American Society of Transplantation and the American Society of Transplant Surgeons. 
2012;12(2):388-99. 
9. 
Roberts DM, Jiang SH, Chadban SJ. The treatment of acute antibody-mediated 
rejection in kidney transplant recipients-a systematic review. Transplantation. 
2012;94(8):775-83. 
10. 
Wiebe C, Gibson IW, Blydt-Hansen TD, Karpinski M, Ho J, Storsley LJ, et al. 
Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post 
kidney transplant. American journal of transplantation : official journal of the American 
Society of Transplantation and the American Society of Transplant Surgeons. 
2012;12(5):1157-67. 
11. 
Hughes s, De Freitas, D, Worthington, J., Strickland-Hodge, B. Preventing donor-
specific antibodies after transplant. Clinical Pharmacist. 2014(Jan / Feb 2014). 
12. 
Organisation WH. ADHERENCE TO LONG-TERM THERAPIES 
Evidence for action. World Health Organisation; 2003. Report No.: WHO/MNC/03.01. 
13. 
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. 

Exploring medication adherence in Kidney transplant recipients V5                                                          IRAS Project ID 208878 
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rd January 2017 
 
14. 
Massey EK, Tielen M, Laging M, Timman R, Beck DK, Khemai R, et al. 
Discrepancies between beliefs and behavior: a prospective study into immunosuppressive 
medication adherence after kidney transplantation. Transplantation. 2015;99(2):375-80. 
15. 
Massey EK, Tielen M, Laging M, Beck DK, Khemai R, van Gelder T, et al. The role of 
goal cognitions, illness perceptions and treatment beliefs in self-reported adherence after 
kidney transplantation: a cohort study. Journal of psychosomatic research. 2013;75(3):229-
34. 
16. 
Dew MA, DiMartini AF, De Vito Dabbs A, Myaskovsky L, Steel J, 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. 
 
 
 
 
 
11. APPENDICES 
 
Participant Information Sheet 
Consent form 
Recruitment poster