Abstract:Harnessing the patient's "voice" to inform care via qualitative research methods: an important goal, not easily achieved. See the article by Tang et al. on page 3369.
“…3,8 Classifying these patients as nonadherent based solely on CV may result in wasted effort addressing nonadherence and harm from increased immunosuppression exposure. 9 Additionally, wrongly suspecting nonadherence may contribute to mistrust in the patient-provider relationship or reduce patient selfefficacy, which are important to support adherence. 10 It may be prudent to identify those with high CV given the association with poor outcomes.…”
Introduction: High tacrolimus intrapatient variability is associated with poor outcomes following transplantation. A commonly hypothesized cause of this variability is medication non-adherence, but this has not been conclusively demonstrated. Research Question: The purpose of this study was to evaluate the relationship between medication adherence and tacrolimus intrapatient variability. Design: This was a retrospective cohort study of kidney transplant recipients. Adherence was assessed at the 12-month clinic visit as a composite of patient self-report, pharmacist assessment, and lab monitoring frequency. Tacrolimus intrapatient variability was calculated as the coefficient of variation (CV). Linear regression and receiver operating curve (ROC) analysis were used to assess the relationship between adherence and CV. Results: Nonadherence was identified in 37.5% of patients. The median CV was 27.1% for adherent patients and 29.8% for non-adherent patients ( P = 0.051). In the multivariable analysis, the only significant predictor of CV was the incidence of dose changes ( P = 0.002). ROC analysis demonstrated poor discriminant power with an AUC of 0.597. Discussion: The results fail to support a clinically meaningful relationship between medication adherence and tacrolimus CV. There is very little evidence at this time that adherence is the primary contributing factor to tacrolimus intrapatient variability and, by extension, that CV can be used as a surrogate for adherence.
“…3,8 Classifying these patients as nonadherent based solely on CV may result in wasted effort addressing nonadherence and harm from increased immunosuppression exposure. 9 Additionally, wrongly suspecting nonadherence may contribute to mistrust in the patient-provider relationship or reduce patient selfefficacy, which are important to support adherence. 10 It may be prudent to identify those with high CV given the association with poor outcomes.…”
Introduction: High tacrolimus intrapatient variability is associated with poor outcomes following transplantation. A commonly hypothesized cause of this variability is medication non-adherence, but this has not been conclusively demonstrated. Research Question: The purpose of this study was to evaluate the relationship between medication adherence and tacrolimus intrapatient variability. Design: This was a retrospective cohort study of kidney transplant recipients. Adherence was assessed at the 12-month clinic visit as a composite of patient self-report, pharmacist assessment, and lab monitoring frequency. Tacrolimus intrapatient variability was calculated as the coefficient of variation (CV). Linear regression and receiver operating curve (ROC) analysis were used to assess the relationship between adherence and CV. Results: Nonadherence was identified in 37.5% of patients. The median CV was 27.1% for adherent patients and 29.8% for non-adherent patients ( P = 0.051). In the multivariable analysis, the only significant predictor of CV was the incidence of dose changes ( P = 0.002). ROC analysis demonstrated poor discriminant power with an AUC of 0.597. Discussion: The results fail to support a clinically meaningful relationship between medication adherence and tacrolimus CV. There is very little evidence at this time that adherence is the primary contributing factor to tacrolimus intrapatient variability and, by extension, that CV can be used as a surrogate for adherence.
“… 19 , 20 The views of patients and interviews with poor or non-adherent patients have been shown to be essential in providing insight into medication adherence. 13 In the first phase of this study, we assessed the immunosuppressive medication adherence of 31 liver transplant recipients. 21 We determined that 12 patients had poor medication adherence.…”
Section: Methodsmentioning
confidence: 99%
“…11 , 12 With that in mind, exploring factors affecting liver transplant recipients’ immunosuppressive medication adherence positively or negatively is vital. 13 This study aimed to explore the use of immunosuppressive medication experience in liver transplant recipients with poor adherence and the factors affecting the medication adherence. It is expected to contribute to the development of new strategies to improve immunosuppressive medication adherence in liver transplant recipients.…”
Purpose
Preserving graft functions and preventing rejection is closely related to immunosuppressive medication adherence in liver transplant recipients. Therefore, it is essential to determine factors affecting immunosuppressive medication use positively or negatively in liver transplant recipients. This study aimed to explore the use of immunosuppressive medication experience in liver transplant recipients with poor adherence and reveal the factors affecting the medication adherence.
Material and Methods
The study was conducted as a qualitative study with phenomenological approach. Seven adult liver transplant recipients were included in this study, who had poor adherence to immunosuppressive medication. Data was collected via in-depth personal interviews. Data analysis was conducted through inductive content analysis with three steps of preparation, organization, and reporting phases.
Results
Content analysis revealed four main categories, nine categories and 31 sub-categories. Four main categories emerged from the interview data: medication adherence perception, types of medication non-adherence, factors affecting medication adherence negatively and factors affecting medication adherence positively.
Conclusion
This study explored that there are several factors affecting immunosuppressive medication adherence among liver transplant recipients, both positively and negatively. In order to achieve liver transplant recipients’ total adherence to immunosuppressive medication, the factors affecting medication adherence positively and negatively should be understood. The study results are expected to contribute developing strategies to improve immunosuppressive medication adherence in liver transplant recipients.
“…because outcome data could not be collected 9 ), this results in excluding the most non-adherent patients—even if they do enroll—from data analysis. 26,27…”
Section: Background/aimsmentioning
confidence: 99%
“…because outcome data could not be collected 9 ), this results in excluding the most nonadherent patients-even if they do enroll-from data analysis. 26,27 Procedures that can be used with highly adherent patients may not be appropriate for truly non-adherent patients. For example, non-adherent patients may struggle to consistently use electronic monitoring devices, so employing those devices in research may exclude significantly non-adherent patients.…”
Background/aims Medication non-adherence is a leading cause of transplant rejection, organ loss, and death; yet no rigorous controlled study to date has shown compelling clinical benefits from an adherence-improving intervention. Non-adherent patients are less likely to participate in trials, and therefore, most studies enroll a majority of adherent patients who do not stand to benefit from the intervention, as they do not have the condition (non-adherence) under investigation. The improving Medication Adherence in adolescent Liver Transplant recipients trial specifically targets non-adherent patients to investigate whether a remote intervention to improve adherence results in reduced incidence of biopsy-confirmed rejection. Methods Improving Medication Adherence in adolescent Liver Transplant is a randomized single-blind controlled multisite, multinational National Institutes of Health-funded trial involving 13 pediatric transplant centers in the United States and Canada. An innovative, objective adherence biomarker—the Medication Level Variability Index, which is the standard deviation of a series of medication blood levels for each patient, is used to identify non-adherent patients at risk for rejection. The index is computed using electronic health record information for all potentially eligible patients based on repeated reviews of the entire clinic’s roster. Identified patients, after consent, are randomized to intervention versus control (treatment as usual) arms. The remote intervention is delivered for 2 years by trained interventionists who reside in various locations in the United States. The primary outcome is the incidence of biopsy-confirmed acute cellular rejection, as confirmed by a majority vote of three pathologists who are masked to the study allocation and clinical information. Discussion Improving Medication Adherence in adolescent Liver Transplant includes several innovative design elements. The use of a validated, objective adherence index to survey a large cohort of transplant recipients allows the teams to avoid bias inherent in both convenience sampling and referral-based recruitment and enroll only patients whose computed index indicates substantially increased risk of rejection. The remote intervention paradigm helps to engage patients who are by definition hard to engage. The use of an objective, masked medical (rather than behavioral) outcome measure reduces the likelihood of biases related to clinical information and ensures broad acceptance by the field. Finally, monitoring for potential adverse events related to increased medication exposure due to the adherence intervention acknowledges that a successful intervention (increasing adherence) could have detrimental side effects via increased exposure to and potential toxicity of the medication. Such monitoring is almost never attempted in clinical trials evaluating adherence interventions.
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