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Clinical trial data collection still relies on a manual entry from information available in the medical record. This process introduces delay and error risk. Automating data transfer from Electronic Health Record (EHR) to Electronic Data Capture (EDC) system, under investigators’ supervision, would gracefully solve these issues. The present paper describes the design of the evaluation of a technology allowing EHR to act as eSource for clinical trials. As part of the EHR2EDC project, for 6 ongoing clinical trials, running at 3 hospitals, a parallel semi-automated data collection using such technology will be conducted focusing on a limited scope of data (demographic data, local laboratory results, concomitant medication and vital signs). The evaluation protocol consists in an individual participant data prospective meta-analysis comparing regular clinical trial data collection to the semi-automated one. The main outcome is the proportion of data correctly entered. Data quality and associated workload for hospital staff will be compared as secondary outcomes. Results should be available in 2020. [ABSTRACT FROM AUTHOR]

Background: An online interactive information portal is a type of eHealth application in which a group of people with a common interest use social software to gather information and to interact by asking questions and provide information. The present study uses an interactive information portal to explore communication and information needs regarding early diagnosis or disease interception in the area of breast cancer. Method: Eight online interactive information portals were developed for women belonging to two age groups, one group younger than age 45 and one group age 45 or older (in total 16 communities). In each portal, the participants had to perform four activities: (1) Read a message, combining either a positive or negative message framing with emotional or rational message components and the message being endorsed either by an experience expert (an (ex)-patient) or a gynecologist (hence, the eight portals per age group); (2) Select additional information, the participants were asked to choose more information by selecting one out of eight different topics; (3) Raise a question, women were asked to raise one or more questions related to breast cancer (free text). They could either address the question to an experience expert, a general practitioner or a gynecologist; (4) Share your opinion, the participant was asked to share her opinion, either by adding an opinion under an existing discussion thread or initiating a new discussion topic, in free text. Results: Most participants prefer a positive, emotional message endorsed by a gynecologist. There is a substantial difference between the questions raised by younger and older women, and they also ask different questions to general practitioners, gynecologists or experience experts. Half the questions were asked to a gynecologist, followed by an experience expert, while few women address their questions to a general practitioner. Rational messages trigger more discussion in the online community than emotional ones. Especially in older women, emotional messages trigger more negative sentiments. Conclusions: The results provide insights into women's information preferences and responses to information in an online interactive portal for breast cancer prevention information. The results can inform the medical profession and public policy organizations to more efficiently engage women in an early diagnosis and breast cancer screening context. [ABSTRACT FROM AUTHOR]

In order to activate women to participate in breast cancer screening programs, a good understanding is needed of the personal characteristics that influence how women can be activated to search for more information, consult friends and doctors, and participate in breast cancer screening programs. In the current study, we investigate the effect of six personal characteristics that have in previous research been identified as important triggers of health behavior on breast cancer screening activation: Health awareness, Need for Cognition, Affect Intensity, Breast cancer knowledge, Topic involvement, and the Perceived breast cancer risk. We test the effect of these factors on four activation variables: intention of future information seeking, forwarding the message to a friend, talking to a doctor, and actual breast cancer screening attendance. Additionally, we try to unravel the process by means of which the antecedents (the six personal characteristics) lead to activation. To that end, we test the mediating role of perceived breast cancer threat, perceived efficacy of screening, and the evoked breast cancer anxiety as mediators in this process. The data were collected by means of a cross-sectional survey in a sample of 700 Flemish (Belgium) women who were invited to the free-of-charge breast cancer population screening. Screening attendance of this sample was provided by the government agency in charge of the organisation of the screening. Health awareness, affects intensity, topic involvement, and perceived risk have the strongest influence on activation. Breast cancer anxiety and perceived breast cancer threat have a substantial mediation effect on these effects. Efficacy perceptions are less important in the activation process. Increased health awareness and a higher level of perceived risk lead to less participation in the free of charge population based breast screening program. Implications for theory and practice are offered. The limitation of the study is that only a standard invitation message was used. In future research, other types of awareness and activation messages should be tested. Additionally, the analysis could be refined by investigating the potentially different activation process in different subgroups of women. [ABSTRACT FROM AUTHOR]

Through early diagnosis of symptoms, the Alzheimer's disease process can be decelerated. The main concern is to encourage the population at risk to take responsible actions at the earliest stage of the onset of the disease. Persuasive communication is essential to achieve this. In an experimental study, the evaluation of awareness messages for early diagnosis containing weak and strong arguments and negative and positive images was performed on a sample of older Belgians. The mediating role of affective responses and message thoughts was explored. Strong arguments led to a more positive evaluation of the message than weak arguments directly and indirectly via the positive effect they had on message affect and thoughts, which, in turn, positively affected message evaluation. A negative message image led to a more positive message evaluation than a positive one. This effect was not mediated by either message affect or message thoughts. [ABSTRACT FROM AUTHOR]

Purpose: Regulatory authorities including the Food and Drug Administration and the European Medicines Agency are encouraging to conduct clinical trials using routinely collected data. The aim of the TransFAIR experimental comparison was to evaluate, within real-life conditions, the ability of the Electronic Health Records to Electronic Data Capture (EHR2EDC) module to accurately transfer from EHRs to EDC systems patients' data of clinical studies in various therapeutic areas., Methods: A prospective study including six clinical trials from three different sponsors running in three hospitals across Europe has been conducted. The same data from the six studies were collected using both traditional manual data entry and the EHR2EDC module. The outcome variable was the percentage of data accurately transferred using the EHR2EDC technology. This percentage was calculated considering all collected data and the data in four domains: demographics (DM), vital signs (VS), laboratories (LB) and concomitant medications (CM)., Results: Overall, 6143 data points (39.6% of the data in the scope of the TransFAIR study and 16.9% when considering all data) were accurately transferred using the platform. LB data represented 65.4% of the data transferred; VS data, 30.8%; DM data, 0.7% and CM data, 3.1%., Conclusions: The objective of accurately transferring at least 15% of the manually entered trial datapoints using the EHR2EDC module was achieved. Collaboration and codesign by hospitals, industry, technology company, supported by the Institute of Innovation through Health Data was a success factor in accomplishing these results. Further work should focus on the harmonisation of data standards and improved interoperability to extend the scope of transferable EHR data., Competing Interests: Competing interests: The EIThealth funds the EHR2EDC project in which the experimentation described in the article took place. EIT reimburse hospitals for the expenses related to the project.And Sanofi, Janssen and ICON provided partial financial support to hospital consortium partners to attend workshops, covering travel and meal related-costs., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

The complexity and heterogeneity of cancers leads to variable responses of patients to treatments and interventions. Developing models that accurately predict patient's care pathways using prognostic and predictive biomarkers is increasingly important in both clinical practice and scientific research. The main objective of the ATHENA project is to: (1) accelerate data driven precision medicine for two use cases - bladder cancer and multiple myeloma, (2) apply distributed and privacy-preserving analytical methods/ algorithms to stratify patients (decision support), (3) help healthcare professionals deliver earlier and better targeted treatments, and (4) explore care pathway automations and improve outcomes for each patient. Challenges associated with data sharing and integration will be addressed and an appropriate federated data ecosystem will be created, enabling an interoperable foundation for data exchange, analysis and interpretation. By combining multidisciplinary expertise and tackling knowledge gaps in ATHENA, we propose a novel federated privacy preserving platform for oncology research.

Clinical trial data collection still relies on a manual entry from information available in the medical record. This process introduces delay and error risk. Automating data transfer from Electronic Health Record (EHR) to Electronic Data Capture (EDC) system, under investigators' supervision, would gracefully solve these issues. The present paper describes the design of the evaluation of a technology allowing EHR to act as eSource for clinical trials. As part of the EHR2EDC project, for 6 ongoing clinical trials, running at 3 hospitals, a parallel semi-automated data collection using such technology will be conducted focusing on a limited scope of data (demographic data, local laboratory results, concomitant medication and vital signs). The evaluation protocol consists in an individual participant data prospective meta-analysis comparing regular clinical trial data collection to the semi-automated one. The main outcome is the proportion of data correctly entered. Data quality and associated workload for hospital staff will be compared as secondary outcomes. Results should be available in 2020.