Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO study): study protocol for a prospective, multicentre, single-arm trial.

BACKGROUND: Dose reduction of tyrosine kinase inhibitors (TKI) in patients with chronic myeloid leukaemia (CML) with an optimal response to TKIs may support cost-effective medication use by maintaining therapeutic effectiveness while reducing adverse events and medication costs. As the choice for dose reduction depends on patients' individual needs and preferences, a patient-centred approach is warranted. Therefore, a study to evaluate the effectiveness of patient-guided dose reduction in patients with CML who are in a major or deep molecular response is designed. METHODS: This study is a prospective, multicentre, single-arm study. 147 patients with CML (aged ≥ 18 years) in chronic phase, who are treated with imatinib, bosutinib, dasatinib, nilotinib or ponatinib, and have reached at least major molecular response (defined as having BCR-ABL levels < 0.1% for an uninterrupted period of 6 months) are eligible. Patients will use an online patient decision aid and a shared decision making consultation will be held, after which patients who choose to will receive a personalised, lower TKI dose. Primary outcome is the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response. For this, BCR-ABL1 levels will be analysed from blood samples drawn at baseline, 6 weeks after dose reduction and 3-monthly thereafter. Secondary outcomes include the proportion of patients with intervention failure at 6 and 18 months after dose reduction. Other outcomes include differences before and after dose reduction regarding the number and severity of patient-reported side effects; quality of life; beliefs about medicines; and medication adherence. Patients' level of decisional conflict and regret after choosing dose reduction will be assessed, as will the decisional process experienced by patients and healthcare providers. DISCUSSION: Outcomes of this trial using a personalised approach will provide clinical and patient-reported data to guide future dose reduction of TKIs in CML. If the strategy appears to be effective, it may be implemented as another valid option to offer next to standard of care to prevent potential unnecessary exposure to higher TKI doses in this selected group of patients. TRIAL REGISTRATION: EudraCT number 2021-006581-20.

Inpatients Self-Administration of Medication: Stakeholders' views and prerequisites.

AIMS AND OBJECTIVES: To identify stakeholders' views on inpatient Self-Administration of Medication and corresponding prerequisites for successful implementation. BACKGROUND: Self-Administration of Medication allows capable patients to manage their medication regimen throughout hospitalisation. It is assumed to facilitate continuity of care, increase medication safety and patient empowerment. To enable sustainable implementation stakeholders should support it. Knowledge about stakeholders' views regarding Self-Administration of Medication is currently lacking. DESIGN: A qualitative study was conducted among stakeholders using semi-structured interviews. METHODS: Using purposive and snowball sampling fourteen representatives from Dutch healthcare associations, organisations and authorities were interviewed between April and July 2019. These stakeholders were asked to reflected on Self-Administration of Medication and its implementation. Data were examined using inductive thematic content analysis and reported following the COREQ checklist. RESULTS: Most stakeholders were positive towards Self-Administration of Medication and foresaw benefits in terms of the following: improvements to patient-centred care, contributions to sustainable use of healthcare assets and the need and opportunity for change. Critical concerns included reflecting potential risks for patient safety, concerns about implementation feasibility and questions regarding implementation necessity. Stakeholders highlighted prerequisites pertaining to the implementation process in which the following two themes emerged: (1) initiate a supported change and (2) perform research for best practices and identification of benefits. Other prerequisites concerned distinct levels within healthcare including individual patients (i.e. adequate communication), hospital organisation (i.e. to establish a workflow to secure medication safety) and healthcare system (i.e. to facilitate multidisciplinary collaboration in healthcare). CONCLUSION: Stakeholders were predominantly positive about Self-Administration of Medication. For successful and sustainable implementation of Self-Administration of Medication, prerequisites identified in this study should be met. RELEVANCE TO CLINICAL PRACTICE: This study provided knowledge about stakeholders' views which could foster implementation and evaluation of Self-Administration of Medication, which may, in turn, promote effective deployment and patient empowerment.