Psychometric Properties of the BAASIS: A Meta-analysis of Individual Participant Data.

BACKGROUND: Nonadherence to immunosuppressives, a risk factor for poor posttransplant outcomes, can be assessed by self-report using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS). Available in written and interview versions, and previously validated on content, the BAASIS is widely used in research and clinical practice. The aim of this study was to investigate its psychometric properties. METHODS: Using a literature search and our BAASIS database, this meta-analysis identified completed studies in adult transplant recipients whose data were usable to examine the BAASIS' reliability and 3 validity aspects: (1) relationships with other variables (electronic monitoring, other self-report scales, tacrolimus blood-level variability, collateral report, depressive symptoms, psycho-behavioral constructs, and interventions); (2) response processes; and (3) internal structure. Testing used random-effects logistic regressions. RESULTS: Our sample included 12 109 graft recipients from 26 studies. Of these 26, a total of 20 provided individual participant data. Evidence of the BAASIS' stability over time supports its reliability. Validity testing of relationships with other variables showed that BAASIS-assessed nonadherence was significantly associated with the selected variables: electronically monitored nonadherence ( P < 0.03), other self- and collaterally-reported nonadherence ( P < 0.001), higher variability in tacrolimus concentrations ( P = 0.02), higher barriers ( P < 0.001), lower self-efficacy ( P < 0.001), lower intention ( P < 0.001), and higher worries ( P = 0.02). Nonadherence also decreased after regimen change interventions ( P = 0.03). Response process evaluation indicated good readability and slightly higher nonadherence with the written version. Structurally, items on taking and timing shared variability. CONCLUSIONS: The BAASIS shows good validity and reliability as a self-report instrument to assess medication nonadherence in transplantation.

Medication adherence terminology - the first consensual translation using the Delphi method.

BACKGROUND: The terminology of adherence (or compliance) describing the patients medication taking behavior is often used inconsistently and fragmented in the literature. Therefore, the English original of so-called ABC Taxonomy was developed to classify and unify the terminology. The aim of this paper was to establish the first consensual translation of Czech terminology dealing with the issue of medication taking behavior using Delphi method. METHODS: In the period from February to May 2021, a three-round anonymous online Delphi questionnaire survey was conducted. The questionnaire contained items for translations of seven terms and their definitions based on the ABC Taxonomy, while the resulting consensus was established by a predefined degree of agreement of the respondents. RESULTS: Out of 106 contacted panelists representing different healthcare professions, 46 (43.4%) answered in the first round. Sufficient consensus ( 85%) was reached for the translation of two definitions. In the second round, 32 respondents managed to establish a consensus (> 75%) of one term and four definitions and 24 respondents in the third round established a mild (> 50%) to strong (> 95%) consensus for all remaining terms and definitions. The set of terms related to medication taking for the Czech language was as follows: adherence k léčbě, zahájení léčby, zavedení léčby, přerušení léčby, setrvání na léčbě, management adherence and obory související s adherencí. CONCLUSION: The consensual translations of all Czech terms and definitions related to medication adherence can contribute to greater harmonization and comparability of scientific papers as well as to enhance the communication between scientific and clinical community. However, this consensus needs to be confirmed by a larger number of experts dealing with adherence issue, including the involvement of professional societies.

Comparison of different methods to assess tacrolimus concentration intra-patient variability as potential marker of medication non-adherence.

Background and objective: Non-adherence to tacrolimus commonly manifests as low drug concentrations and/or high intra-patient variability (IPV) of concentrations across multiple measurements. We aimed to compare several methods of tacrolimus IPV calculation and evaluate how well each reflects blood concentration variation due to medication non-adherence in kidney transplant recipients. Methods: This Czech single-center retrospective longitudinal study was conducted in 2019. All outpatients ≥18 years of age, ≥3 months post-transplant, and on tacrolimus-based regimens were approached. After collecting seven consecutive tacrolimus concentrations we asked participating patients to self-report adherence to immunosuppressants (BAASIS© scale). The IPV of tacrolimus was calculated as the medication level variability index (MLVI), the coefficient of variation (CV), the time-weighted CV, and via nonlinearly modeled dose-corrected trough levels. These patient-level variables were analyzed using regression analysis. Detected nonlinearities in the dose-response curve were controlled for by adding tacrolimus dosing and its higher-order terms as covariates, along with self-reported medication adherence levels. Results: Of 243 patients using tacrolimus, 42% (n = 102) reported medication non-adherence. Non-adherence was associated with higher CVs, higher time-weighted CVs, and lower dose-corrected nonlinearly modeled trough levels; however, it was not associated with MLVIs. All of the significant operationalizations suggested a weak association that was similar across the applied methods. Discussion and conclusion: Implementation non-adherence was reflected by higher CV or time-weighted CV and by lower blood concentrations of tacrolimus. As an additional tool for identifying patients at risk for non-adherence, simple IPV calculations incorporated into medical records should be considered in everyday clinical practice.

Reimbursed medication adherence enhancing interventions in 12 european countries: Current state of the art and future challenges.

Background: Medication non-adherence jeopardises the effectiveness of chronic therapies and negatively affects financial sustainability of healthcare systems. Available medication adherence-enhancing interventions (MAEIs) are utilised infrequently, and even more rarely reimbursed. The aim of this paper was to review reimbursed MAEIs across selected European countries. Methods: Data on reimbursed MAEIs were collected from European countries at the ENABLE Cost Action expert meeting in September 2021. The identified MAEIs were analysed and clustered according to their characteristics, direct vs. indirect relation to adherence, and the targeted adherence phase. Results: Out of 12 contributing countries, 10 reported reimbursed MAEIs, 28 in total, of which 20 were identified as MAEIs targeting adherence directly. Reimbursed MAEIs were most often performed by either doctors (n = 6), nurses (n = 6), or pharmacists (n = 3). The most common types of MAEIs were education (n = 6), medication regimen management (n = 5), and adherence monitoring feedback (n = 4). Only seven reimbursed MAEIs were technology-mediated, whereas 11 addressed two interlinked phases of medication adherence, i.e., implementation and persistence. Conclusion: Our review highlights the scarcity of reimbursed MAEIs across the selected European countries, and calls for their more frequent use and reimbursement.

Medication adherence interventions in transplantation lack information on how to implement findings from randomized controlled trials in real-world settings: A systematic review.

BACKGROUND: Growing numbers of randomized controlled trials (RCTs) are showing the effectiveness of interventions to improve medication adherence in transplantation recipients. However, real-world implementation is still a major challenge. This systematic review assesses the range of information available in RCTs supporting these interventions' clinical adoption in adult transplant populations. METHODS: We included RCTs of interventions that a) targeted any phase of medication adherence in solid organ or allogeneic stem cell transplantation recipients and b) were published between January 2015 and November 2020. We excluded study protocols, conference abstracts and studies focusing only on pediatric populations. We identified relevant database and trial registries as well as traced references backward and citations forward. Implementation-relevant information was evaluated using adapted versions of Peters' ten criteria: 1. healthcare/organizational context; 2. social/economic/policy context; 3. patient involvement; 4. other stakeholder involvement; 5. sample representativeness; 6. trial conducted in a real-world-setting; 7. presence of feasibility study; 8. implementation strategy; 9. process evaluation; 10. implementation outcomes, using a stoplight color-rating system. RESULTS: Screening 17'004 titles/abstracts resulted in 23 eligible RCTs, including 2'339 patients (n = 19-209/study). All included studies focused on the implementation phase of medication adherence. The best-reported criteria were feasibility study (43%), representative sample (17%) and conducted in a real-world-setting (17%). Least reported were context (9%), implementation strategies (4%), process evaluation (4%). CONCLUSIONS: RCTs testing medication adherence interventions tend to report limited implementation-relevant information. This hinders their translation to real-world transplant settings. Integrating implementation science principles early in the conceptualization of RCTs would fuel real-world-translation, reducing research waste.

Changes in Beliefs About Post-Transplant Immunosuppressants Over Time and Its Relation to Medication Adherence and Kidney Graft Dysfunction: A Follow-Up Study.

PURPOSE: The main aim was to evaluate the changes in beliefs about immunosuppressants over a 3-year period in patients after kidney transplantation. The second aim was to investigate the relationship between beliefs, medication adherence, and selected clinical outcomes such as graft functioning. PATIENTS AND METHODS: This observational follow-up study was conducted in the outpatient post-transplant clinic at the University Hospital Hradec Kralove in the Czech Republic. Adult patients, at least 4 weeks after kidney transplantation, were invited for the structured interview, which was followed by a self-administered questionnaire survey during their regularly scheduled visits at the clinic. Appropriate paired tests were used to compare two measurements of beliefs about immunosuppressants by BMQ-CZ© in 2016 (baseline) and in 2019 (follow-up). Self-reported adherence was measured by two validated tools (MARS-CZ© and BAASIS©) capturing implementation and discontinuation phases. A generalized linear model was used to investigate the relation between beliefs and the consecutive estimated glomerular filtration rate. RESULTS: The study involved 134 patients. Over time, their perceived treatment necessity beliefs of immunosuppressants decreased, while their treatment-related concerns increased. Overall self-reported non-adherence (ie, taking, dosing and discontinuation of immunosuppressants) was reported by 12% of the patients in both observation periods. In the follow-up period, timing non-adherence was reported by 52 (38.8%) patients. Higher baseline treatment concerns were associated with poor adherence whereas higher baseline treatment necessity beliefs corresponded with better kidney functioning, even after adjusting for age. CONCLUSION: Higher treatment necessity beliefs corresponded with better kidney functioning, whereas higher treatment concerns were related to non-adherence to immunosuppressants at the beginning of the observed period. Still, most patients accepted their medicines that do not come without risk. Nevertheless, decreasing treatment necessity beliefs on one hand, and increasing treatment concerns on the other, should be considered in clinical practice.

Review of Czech literature focused on terminology of medication adherence.

BACKGROUND: Medication taking terminology is often used incorrectly or inconsistently in the world literature and the meaning of the terms is interchanged. The aim of the work was to map the Czech literature and find out whether Czech authors use terminology related to medication adherence and whether they are consistent in defining it. METHODS: Based on the methodological instructions for the translation of the so-called ABC Taxonomy introduced by International Society for Medication Adherence (ESPACOMP), a search of Czech literature published until September 22nd, 2021 in the databases ProLékaře.cz, BMČ, PubMed, and Solen was prepared. Morphological variants of keywords were used for the search: compliance, adherence, initiation, implementation, discontinuation, persistence, concordance. RESULTS: A total of 125 Czech publications from 1998 to 2021 were identified, of which 79 defined specific terms. These included: adherence, persistence, compliance, concordance; the terms for compliance and adherence were interchanged in 14 publications. Publications focused on the treatment of specific diseases were the most common. Only five sources dealt with the issue of medication adherence as a theme without relation to a specific nosological unit. CONCLUSION: Inconsistency in the use of terms related to medication adherence has proven to be a very common phenomenon in the Czech literature. It is, therefore, necessary to establish a consensus on this terminology in order to unify Czech literature.