Patient survey to identify reasons for non-adherence and elicitation of quality of life concepts associated with immunosuppressant therapy in kidney transplant recipients

Abstract

BackgroundRenal transplantation (RT) is considered the treatment of choice for end-stage renal disease compared to dialysis, offering better health-related quality of life (HRQoL) and higher survival rates. However, immunosuppressants are essential for the long-term survival of kidney grafts and patients’ non-adherence to their medication leads to poor outcomes. Immunosuppressants can also significantly alter patients’ HRQoL because of their side effects and the complex chronic medication regimen they represent.PurposeTo elicit key concepts related to adherence to immunosuppressant therapy (IT) and reasons for non-adherence in terms of patient reported outcomes, side effects, and the impact of the medication on HRQoL in RT population, including patient preference of once daily over twice-daily immunosuppressive regimen. Results were used to develop an IT-specific conceptual framework and provide suggestions for improving patients’ adherence to IT.Materials and methodsInterviews were conducted with three clinical experts to determine key concepts related to RT and immunosuppressants. Thirty-seven participants in four focus groups were asked to cite important concepts related to adherence and impact of IT on HRQoL and to rate them. Qualitative analysis was conducted to code participants’ responses.ResultsNon-adherence among participants where admitted was unintentional. The reason for this included forgetfulness, interference with lifestyle, being asleep at the time the medication should be taken, change in routine, and impact of side effects. Overall, participants reported that the evening dose was more problematic to remember and that the exclusion of this dose could make them more adherent. Participants also reported that IT impacted on their HRQoL in a number of ways including: placing restrictions on their lifestyle, causing anxiety, or impairing their ability to work.ConclusionThis study provides qualitative evidence about the barriers to IT adherence and the components of HRQoL that are important from the perspective of RT patients. The developed conceptual framework of IT-HRQoL in RT transplants, including social, psychological, and work life domains, can be used to inform the development of a new IT-specific measure of HRQoL in RT patients for use in head-to-head clinical trials or observational studies. Despite limitations associated with the number and the age range of patients recruited, this study suggests that a change in the regimen from twice-daily to once daily among other measures could improve their adherence to IT and their HRQoL by placing less restrictions on their lifestyles.

Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project

“… Information about barriers to medication adherence Do factors/barriers need to change to perform target behavior (based on contextual analysis)? Physical capability Physical skills Being physically able to swallow pills and remember if already taken Emesis, nausea [ 48 , 49 ] a b Poor physical condition [ 50 ] a b NO Physical limitations (e.g. cognitive function) which can’t change YES Limited physical stamina (e.g.…”

“…cognitive function) which can’t change YES Limited physical stamina (e.g. fatigue, nausea) Psychological capability Knowledge Knowledge why intake and timing of immunosuppressants is important Lack of knowledge about medication and consequences [ 48 , 50 – 61 ] a b Wrong information b Ambiguities / vague advise [ 50 , 52 , 53 ] a Unclear, where getting prescription from and which pharmacy [ 49 – 51 , 57 , 62 ] a b YES Lack of knowledge about importance and consequences of medication (non-) adherence Behavioral regulation Apply the knowledge of correct medication intake and timing in every aspect, applying if-then-rules Development of coping strategies for barriers Lack of routine [ 51 , 52 , 55 – 57 , 59 , 63 ] a No sense of autonomy regarding medication intake [ 51 ] History of MNA [ 53 , 64 ] Longer time since transplantation [ 64 ] Current major life event (other priorities) [ 49 , 53 ] Busy lifestyle [ 48 , 49 , 51 , 54 , 57 ] Alcohol and substance abuse [ 51 ] YES Lack of procedural knowledge of medication intake YES Lack of behavioral regulation (e.g. self-monitoring) YES Lack of skills to develop coping strategies facing barriers Memory, attention & decision processes Notice and remember at prescribed time during daily life to take medication Information overload b Forgetfulness [ 48 , ...…”

“…self-monitoring) YES Lack of skills to develop coping strategies facing barriers Memory, attention & decision processes Notice and remember at prescribed time during daily life to take medication Information overload b Forgetfulness [ 48 , 49 , 51 , 52 , 54 – 57 , 65 ] a , poor executive function after transplantation [ 53 , 65 ] Forgetting get a new prescription on time [ 49 , 50 , 54 , 56 , 57 , 60 ] a b YES Limitations in memory, concentration, attention & decision processes ⋄ Lack of awareness / recognition in daily life Cognitive and inter-personal skills Development of habit in correct timing and intake of medication, Skill to ask for help if needed Unable to cope with changed prescription [ 54 ] Lack of psychological skills to fill pill boxes / prepare medication correctly [ 60 ] YES Lack of habit-forming, goal-setting or action-planning skills Physical opportunity Environ-mental context and resources Enough medication available, readily accessible at opportunities, enough reminder clues Not having medicines when being away from home [ 48 , 49 , 54 , 57 ] a Lack of cues [ 48 – 50 , 52 , 55 – 57 , 60 ] a b Time of intake «does not fit» to lifestyle [ 48 – 50 , 56 , 57 , 65 ] a Interruptions in daily routine [ 48 <...>…”

“…Forgetfulness [ 48 , 49 , 51 , 52 , 54 – 57 , 65 ] a , poor executive function after transplantation [ 53 , 65 ]…”

<p>Solid Lipid Nanoparticles of Mycophenolate Mofetil: An Attempt to Control the Release of an Immunosuppressant</p>

“… 6 The majority of SOT recipients require three immunosuppressive agents including a calcineurin inhibitor, a corticosteroid, and a mycophenolic acid (MPA) derivative such as MMF. 7 In recent years MMF has become a vital alternative therapy. Calcineurin inhibitor and corticosteroids are available in once-daily formulations but mycophenolic acid derivatives are given twice a day.…”