Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial

Introduction ONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours. Methods and analysis This is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher’s exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs. Ethics and dissemination Ethical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations

Privacy-Conflict Resolution for Integrating Personal and Electronic Health Records in Blockchain-Based Systems

Integrating personal health records (PHRs) and electronic health records (EHRs) facilitates the provision of novel services to individuals, researchers, and healthcare practitioners. Simultaneously, integrating healthcare data leads to complexities arising from the structural and semantic heterogeneity within the data. The subject of healthcare data evokes strong emotions due to concerns surrounding privacy breaches. Blockchain technology is employed to address the issue of patient data privacy in inter-organizational processes, as it facilitates patient data ownership and promotes transparency in its usage. At the same time, blockchain technology creates new challenges for e-healthcare systems, such as data privacy, observability, and online enforceabil-ity. This article proposes designing and formalizing automatic conflict resolution techniques in decentralized e-healthcare systems. The present study expounds upon our concepts by employing a running case study centered around preventive and personalized healthcare domains. © 2023, Partners in Digital Health. All rights reserved