The impact of telemonitoring on correct drug use, complications and quality of life among patients with multiple myeloma (ITUMM): A study protocol for an open-label, parallel-group, randomized controlled trial.

INTRODUCTION: Multiple myeloma (MM) is the second most common hematologic malignancy. MM is associated with significant morbidity due to its end-organ destruction and is a disease of the older population. Although survival rates for MM have improved over the last decade, due to an increase in treatment options, the disease remains incurable. Expensive (oral) agents are widely used in MM patients; however, tools for supporting patients in complex treatment regimens are scarce. To investigate if a tool will support MM patients and healthcare professionals, the MM e-coach was developed and tested. The aim of this study is to study the impact of telemonitoring on adherence, complications and quality of life in patients with MM (ITUMM study). METHODS: A two-arm open-label parallel-group randomized controlled trial will be conducted between March 2021 and June 2024 to compare the telemonitoring (MM e-coach) with standard MM care. This study aimed to recruit 150 patients with recently diagnosed multiple myeloma (RDMM), starting first or second line of treatment. Blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. Secondary outcomes are patient reported outcomes: GFI, EQ-5D-5L, EORTC-QLQ-C30, SDM-Q-9, MARS-5, single item questions, PREMs, adverse events, OS and PFS. Patient reported outcomes were developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM patients from time of RDMM until 12 months post-diagnosis. Online measurements will be performed at baseline (0), 3, 6, 9 and 12 months. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Ethics Committee of the Isala klinieken in The Netherlands (No. 201111) at 25 February 2021. Study results will be disseminated to the relevant healthcare communities by publication in peer-reviewed journals, and at scientific and clinical conferences. STUDY REGISTRATION NUMBER: ClinicalTrials.gov number: NCT05964270 and ABR number: NL75771.075.20.

Comparison of the CollaboRATE and SDM-Q-9 questionnaires to appreciate the patient-reported level of shared decision-making.

OBJECTIVE: To compare CollaboRATE and SDM-Q-9 questionnaires when appreciating patient-perceived level of shared decision-making (SDM) in doctor-patient consultations. METHODS: Data were harvested from five separate studies on SDM, conducted in three university and one large community hospital in the Netherlands, using Dutch versions of both questionnaires. CollaboRATE and SDM-Q-9 scores were expressed as percentages. Correlation was assessed using Spearman's Rho coefficient. Bland&Altman analysis was used to assess the degree of agreement. Top scores were calculated to assess possible ceiling effects. RESULTS: The five studies included 442 patients. Median CollaboRATE scores (88.9%, IQR 81.5-100%) were significantly higher (p < 0.001) than SDM-Q-9 scores (80.0%, IQR 64.4-100%). Correlation was moderate (Rho=0.53, p < 0.001). A systematic, 12.5-point higher score was found across the range of scores when using CollaboRATE. Top scores for CollaboRATE and SDM-Q-9 were present in 37.5% and 17% of questionnaires, respectively. CONCLUSIONS: Overall, CollaboRATE and SDM-Q-9 questionnaires showed a high level of patient-perceived SDM. However, CollaboRATE only moderately correlated with SDM-Q-9 and had a stronger ceiling effect. PRACTICE IMPLICATIONS: When choosing a SDM-measurement tool, its benefits and limitations should be weighed. These metrics should be combined with objective scores of SDM, as these may differ from the patients' subjective interpretation.

[Updated Dutch law demands shared decision-making]. / Meer 'samen beslissen' nodig door aangescherpte Wgbo.

In January 2020, the Dutch law on the medical treatment agreement was updated. In this update, shared decision-making is explicitly mentioned as a prerequisite during doctor-patient encounters. This entails explicit exploration of the patient's wishes, views and preferences and their integration in medical decision-making. There is growing interest in shared decision-making from patient advocacy and professional societies, the government, and healthcare insurers. However, both care professionals and patients are not yet used to applying this in their encounters. Creating awareness, training and organisational changes are essential aspects to foster shared decision-making. Various (umbrella) organisations in healthcare have developed (digital) tools for both care professionals and patients to support shared decision-making. This article addresses these tools to nudge all stakeholders towards shared decision-making.

Ixazomib, Daratumumab, and Low-Dose Dexamethasone in Frail Patients With Newly Diagnosed Multiple Myeloma: The Hovon 143 Study.

PURPOSE: Frail patients with newly diagnosed multiple myeloma have an inferior outcome, mainly because of a high discontinuation rate due to toxicity. We designed a phase II trial specifically for frail patients, evaluating the efficacy and tolerability of ixazomib-daratumumab-low-dose-dexamethasone (Ixa-Dara-dex). METHODS: Sixty-five patients, who were frail according to the International Myeloma Working Group frailty index, were treated with nine induction cycles Ixa-Dara-dex followed by maintenance with Ixa-Dara for a maximum of 2 years. RESULTS: The overall response rate on induction therapy was 78%. After a median follow-up of 22.9 months, median progression-free survival (PFS) was 13.8 months and 12-month overall survival (OS) was 78%. Median PFS and 12-month OS were 21.6 months and 92% in patients who were frail based on age > 80 years alone, versus 13.8 months and 78%, and 10.1 months and 70% in patients who were frail based on additional frailty parameters either ≤ 80 or > 80 years of age, respectively. In 51% of patients, induction therapy had to be discontinued prematurely, of which 6% because of noncompliance to study treatment, 9% because of toxicity, and 9% because of death (8% within 2 months, of which 80% because of toxicity). Quality of life improved during induction treatment, being clinically meaningful already after three induction cycles. CONCLUSION: Ixa-Dara-dex lead to a high response rate and improved quality of life. However, treatment discontinuation because of toxicity and early mortality, negatively influencing PFS and OS, remains a concern in frail patients. The outcome was heterogeneous across frail subpopulations. This should be taken into account in the design and interpretation of future studies in frail patients, to pave the way for more precise treatment guidance.

Developing a patient portal for haematology patients requires involvement of all stakeholders and a customised design, tailored to the individual needs.

BACKGROUND: Electronic patient portals are increasingly being implemented, also in (haemato) oncology. However, portal usage is low and depends on user and provider engagement. We explored wishes, expectations and thoughts of patients with a haematologic malignancy and their physicians with regard to the electronic patient portal. METHODS: Based on insights from literature and a focus group discussion we built a 44-item questionnaire. This questionnaire was spread amongst patients with a haematologic malignancy at the outpatient clinic that was not yet exposed to patient portal facilities. Haematologists completed a questionnaire based on literature. RESULTS: Patients were interested in many different types of access to information and portal functionalities. However, their opinions varied about the provision of access to the portal to other people, the role of the physician, possibilities for communication via the portal and timing of access. The physicians acknowledged the relevance of the electronic patient portal, but had some worries about the patients' autonomous information handling, organizational and technical issues. Patients frequently expressed to be open about the potential of the patient portal to orchestrate their care. Nevertheless, most physicians appreciated their supporting role towards the patient. CONCLUSIONS: Patients and physicians appreciated the electronic patient portal. Both groups need to be involved in further portal development to improve engagement by meeting patients' wishes, taking into account organizational and professional issues and managing expectations for both parties. To fit various patient profiles, portal design should be flexible and individualized. Further research should focus on the perceived added value and the impact on patient related outcome measures of portals.