Monsenso app used for research project promoting psychological resilience and nature connectedness in university students

Monsenso app used for research project promoting psychological resilience and nature connectedness in university students

The two-day Autumn School event with GoGreenRoutes hosted at the Hamilton Institute, Maynooth University (October 12th – 13th), saw the launch of a new configuration of our mobile application designed to promote psychological resilience and nature connectedness in university students across six participating European cities. Both mental health and nature are currently under threat globally, yet the optimal solution may be to address both challenges together with benefits for well-being and the natural environment.

The six-week digital programme focuses upon cultivating key psychological skills and enhancing participants’ relationship with the natural world through engagement with bespoke psychoeducational materials and a suite of nature-based activities. The programme will be made available to a range of students in GoGreenRoutes ‘Cultivating’ Cities, Limerick, Lahti, Umeå, Tallinn, Versailles and Burgas, over the coming six-month period.

The programme development has been led by the Institute of Child Education and Psychology, Europe (Ireland) and Monsenso (Denmark), and this process has been carefully conducted with the end user in mind. Programme content is based upon cutting-edge research in the promotion of psychological resilience and the need to cultivate the relationship between humans and nature.

Participating users of the research project will consist of university students in each of the six cities, who will embark upon an experiential six-week learning journey wherein one specific domain of psychological resilience will be addressed each week. A selection of five suggested nature-centered activities is provided in the application for each of the six resilience domains, with users retaining a sense of autonomy as to determining which of the activities are most suitable to their needs and preferences.

Participant engagement with the programme will be monitored on an ongoing weekly basis, and the efficacy of the programme will be assessed based upon the impact noted in users’ psychological resilience, nature connectedness, psychological wellbeing, pro-environmental attitudes and behaviours, sleep quality, and levels of outdoor activity across the six-week engagement period.

The first rollout of the programme will commence in mid-November and the implementation process will continue in the six European cities until April 2024.

For more information about the research project, visit

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

With the rise of patient-centered medicine and accelerated approvals, health technology assessment (HTA) bodies and payers are looking to real-world evidence (RWE) to strengthen evidence packages and reduce uncertainties at the time of launch.

Increasingly, stakeholders are recognizing the importance of RWE that incorporates patients’ real-world experiences in understanding what treatments work, and for whom, in clinical practice.

Real-world evidence is generated through applying data science to real-world data (RWD), or data “relating to patient health status or the delivery of healthcare routinely collected from EHRs, claims, registries, patient-reported outcomes, devices/applications, etc.” Decision-makers are exploring how this evidence can supplement clinical trials and provide additional context on the effectiveness of therapies.

There is some overlap between patient experience data, which provides information about a patient’s experience with a disease or condition, and real-world data (RWD), however, they are not one and the same. For example, patient-reported outcomes (PROs) collected in an electronic health record (EHR) would be considered both RWD and patient experience data, however, lab test results in the medical record would be considered only RWD. As personalized medicine continues to gain traction, decision-makers like ICER, FDA, NPC, EMA, EUNetHTA, and EHDEN are calling for patients’ voices to be included in the drug development and assessment process. Such information – direct input from patients on how they feel and function is often lacking from RWD sources, and FDA and EMA identified such missing data as problematic for interpretation.

We spoke with Ashley Jaksa MPH, Scientific Partnerships Lead, Aetion and Chung Yen Looi, DPhil Partnerships Director, Monsenso, about the evolving landscape of patient experience data and how biopharma organizations can incorporate the patient voice into their RWD and RWE programs.

Q: Ashley, can you tell our readers a little more about what Aetion does? 

AJ: Aetion is a healthcare technology company that uses routinely collected health care data to generate RWE on the safety and effectiveness of medical treatments and technologies. We were founded by Harvard epidemiologists to develop a way to conduct scalable and transparent RWD analyses at the highest level of scientific rigour. Our RWE analytics platform helps biopharma organizations, regulators, HTAs, payers, and other researchers generate RWE to inform decisions on the safety, effectiveness, and value of medical interventions across the product lifecycle. Our platform is data fluent, meaning it can analyze almost any type of RWD, and we often work with our customers and partners to identify the most fit-for-purpose data set for their research question.

Q: Why is the patient experience important for biopharma to understand, and where in the drug development lifecycle is it most important to integrate patients’ voices? 

CL: I think we can all agree that pharma and its stakeholders want to develop safe and effective drugs and bring them to market, to improve patients’ lives. As such, asking patients directly about how a drug impacts their lives is critical. Without the patient voice, we will never know how patients experience therapies in the real world, and how medical interventions could make a meaningful difference to their lives. Capturing and incorporating the patient voice across the product lifecycle can help biopharma companies to better understand the real-world impact of their drug, treatment responders, and meaningful endpoints based on a wider, representative population, in a quick and cost-effective way. 

AJ: Similar to RWE, patient experience data is important in almost all stages of the product lifecycle—not just as a post-marketing exercise. For example, understanding the treatment pathways and patient experiences on first-line therapies can help shape what comparators and outcomes should be captured in future randomized controlled trials to differentiate the drug in the market.

Q: How can incorporating the patient voice improve market access?

CL: Patient voice is a powerful way to demonstrate the impact of a drug on patients’ quality of life to payers and HTA bodies, particularly for cost-effectiveness evaluations. Some biopharma organizations have used PRO measures on daily functioning and health-related quality of life as their primary and secondary endpoints in clinical and real-world studies, while others have directly linked PROs to their drug reimbursement contracts. Patient voice contributions can help biopharma companies differentiate their product from similar drugs for coverage, especially for payers who are tying reimbursement to the value to patients based on outcomes and have longer-term responsibilities for their populations.  Some of the common myths are that “payers don’t care about PRO evidence, PROs only matter if they make it to the label, and that PROs should only be collected in Phase IV.” The facts are that not all payers are alike. Some pay a lot of attention to PRO evidence. Payers will consider all data from pivotal trials, whether or not it is on the package insert, and coverage decisions will be made on pivotal trials, so waiting until Phase IV to collect PROs would be too late.

Q: What are the common barriers in generating high-quality, patient-centric RWE?

AJ: I think the common barriers to generating RWE and patient-centric RWE are very similar; researchers must ensure that the data exists, that the data is capturing the relevant underlying medical concept, and that it is generated in a way that limits bias and confounding. Traditional RWD sources, like claims and EHRs, often have limited patient-centric data. This is a challenge for researchers attempting to incorporate this information into their studies. However, groups like Friends of Cancer Research and data providers like Monsenso are working to ensure this information is being collected. Once it is collected, it is essential to validate that these data and algorithms are actually measuring what we are intending to measure. Finally, researchers must be cognizant of bias and confounding and control for this as much as possible through study design and analytic methods. 

CL: Adding to Ashley’s points, I think data privacy and security, patients’ burden of contributing to research, and standardized methodology to analysis and interpretation are common barriers. It may seem like a no-brainer to ensure that patient data is managed in a secure way, but a recent study showed that almost a third of health apps out there collect patient data without privacy policy, and about one in five data transmissions occurred on insecure communication protocols. Furthermore, as patients are already suffering from their disease or conditions, contributing to research could add to their burden, which is why data capture platforms should be designed in a way that is easy-to-use and that provides valuable insights to patients. Finally, there is a lack of standardization in analysis and interpretation—which is why companies like Aetion are important to ensure that critical questions are answered, data sets are relevant, and standards are followed to derive and present meaningful insights that will inform decision-making.

Q: How can biopharma generate high-quality, patient-centric RWE for decision-makers? 

AJ: In addition to addressing the common barriers mentioned above, we think it is important to follow a principled approach to study design and execution. The main reasons why decision-makers like regulators and HTAs/payers dismiss RWE are due to deficient data selection and insufficient methodology. Following principled epidemiologic methods of selecting fit-for-purpose data, avoiding common methodological mistakes, and ensuring the protocol and results are clearly communicated are essential to ensuring the decision-makers trust the evidence. This planning and execution of RWE studies is not easy; it takes forethought. Biopharma manufacturers should be considering RWE at every stage of the product lifecycle, and proactively planning for how RWE studies will be incorporated into each product’s launch. 

Q. What is the cost-benefit for biopharma of generating patient-centric RWE? 

CL: Relative to the costs of bringing a new drug to market – which could go up to billions of dollars and take over a decade, with limited success ratesthe costs associated with collecting patient-centric RWE is insignificant. In return, patient-centric evidence could provide significant savings and valuable insights as early as possible to ensure that new drugs are truly driven by patients’ unmet needs, that they impact outcomes that matter to patients, and, ultimately, that they have the greatest chance of reaching the market and making a meaningful difference to patients. 

AJ: RWE can provide value for biopharma organizations across the product lifecycle—from eliminating costs typically incurred during clinical trials to accelerating time to market. Using a validated RWE platform can take this a step further, allowing companies to run more efficient, credible studies and reach insights faster than they could with traditional line programming. By ensuring patient-centric outcomes are collected in clinical data sources, then incorporating patient-centric RWE across drug development and commercialization programs, biopharma organizations can unlock insights that deliver value not only for their company but for patients as well. 

Q: Lastly, for our readers who are not familiar with Monsenso, Looi can you kindly tell a little more about what Monsenso does? 

CL: of course, Monsenso is a digital health company that enables patient-centric care and research. We’re a spinout from the IT University of Copenhagen based on the groundbreaking research of Professor Lars Kessing and Dr. Mads Frost on bipolar disorder and depression. We were founded in 2013 and have been listed on Nasdaq First North in Denmark since 2020. Our solution enables pharma companies to collect self-reported and device-generated data directly from patients in a simple, scalable, secure, and cost-effective way. Our cloud-based platform connects patients and investigators via an app and a web portal, respectively, to collect data in real-time across clinical development, post-market studies, and clinical practice to inform decision-making. Our platform can integrate with wearable devices and sensors, and combine with other RWD sources to provide a more holistic view of the impact of a drug on patients’ lives.

Monsenso leads mental health component of H2020 funded WellCo Virtual Coach for Behavioural Changes

Monsenso leads mental health component of H2020 funded WellCo Virtual Coach for Behavioural Changes

Monsenso’s mHealth solution will lead the mental health component of a new ICT solution designed to help users maintain or improve their physical, cognitive, mental, and social well-being. 

Copenhagen, Denmark – 6 February 2018 Monsenso is proud to be a consortium partner in the international team consisting of SME companies, universities, and research centres for the Horizon 2020 funded WellCo project.

Led by Spanish ICT company Hi-Iberia, the WellCo project will deliver a radically new ICT solution focused on encouraging users to adopt and maintain healthier behavioural choices to help improve their long-term physical, cognitive, mental, and social well-being. The study will mostly be working with older participants.

“WellCo’s aim is to change behaviours and promote a healthy living that will be translated in better quality of life for seniors. One of the main factors is to ensure the acceptance and maintenance of the healthy behaviors promoted by WellCo. The WellCo application will try to make use of the technology as a tool to personalize and tailor these recommendations to the specific needs and preferences of each user.” says Inmaculada Luengo of Hi-Iberia.

The solution will consist of many components, including a comprehensive assessment, personalised advice, and supervised guidance & follow-up for users. WellCo interventions will be guided by an affective aware virtual coach that, through using state of the art technologies in AI (artificial intelligence), will interactively guide and empower users towards important behavioural changes.

Monsenso’s mHealth solution will help contribute experience and knowledge to the project, by providing comprehensive routine monitoring and detailed data collection for assessing the participant’s behaviour.

“We play a leading role in the development of the user assessment and in the design of the virtual coach, and we will also be involved in the prototyping and dissemination components,” says Thomas Lethenborg, CEO of Monsenso. “We are excited to see how we can build on our remote monitoring and sensor data functionality, in order to contribute to collecting longitudinal data to help improve the mental health of participants.”

The virtual coach will be tested in trial in Trento in Italy, Castilla y León in Spain, Copenhagen and the Southern Denmark area in Denmark. There will be a minimum of 150 end-users included in the study. The study will be continuously supported by a multidisciplinary team of experts and users’ close caregivers to ensure the effectiveness and accuracy of the guided wellness interventions.

Other Danish Involvement in the Project 

In Denmark, the University of Copenhagen and The University of Southern Denmark will be working alongside Monsenso in the study.

The University of Copenhagen will contribute to the study with the Quality of Life Lab, which explores the development and evaluation of personal behavioural health metrics by examining how sensor data can be used as a minimally obtrusive method to accurately and longitudinally measure an individual’s behaviour. The lab will also examine how an individual’s quality of life naturally unfolds over time; within this context, the lab will also examine which behavioural change methods can be used to improve the individual’s overall quality of life.

“It is very exciting to be involved in this study and to see how sensor data and remote monitoring can work together to offer a better, more informed, detailed picture of individual’s behaviours for the assessment and improvement of their quality of life and overall well-being.” says Katarzyna Wac, Quality of Life Lab leader and Associate Professor at the University of Copenhagen.

The solution will be implemented, demonstrated, and piloted at The University of Southern Denmark.

“We will be very interested to see how this project effects our elderly patients and their wellbeing, and how much more data and information can be extracted with the use of remote monitoring and sensor data tools,” says Torben Uhrenholt of The University of Southern Denmark.

The Monsenso solution is currently being used in Region South Denmark Clinics.

Consortium Members 

The consortium consists of:

  • 3 SME companies: H-Iberia, a Spanish ICT solution supplying company, Connected Care from The Netherlands and Monsenso
  • Two universities: The University of Copenhagen and The University of Southern Denmark
  • One research center: Jozef Stefan Institute (Slovenia) and two end-user organisations Fondazione Bruno Kessler (Italy) and Gerencia Servicios Sociales Castilla y León (Spain)

The project has launched on December 4th in Madrid and will continue until the end of 2020.

Click here to read the press release in Danish.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the grant agreement No.769765.

About Monsenso: Monsenso is an innovative technology company based in Denmark that offers a comprehensive mHealth solution to optimise the treatment of mental disorders. Our mission is to assist healthcare providers, researchers and individuals in coping with and overcoming the burden of mental illness. Our solution provides a detailed overview of the patient’s mental health through the automatic collection of behavioural data and routine self-monitoring. Our team is committed to developing complete and effective solutions that fit seamlessly within the lives of individuals, in order to increase the quality and efficacy of their treatment.

For additional information, please contact:
Thomas Lethenborg
+45 30 25 15 26

Torben Uhrenholt
IT Project Leader

Katarzyna Wac
Quality of Life Lab Leader and Associate Professor at the University of Copenhagen
The University of Copenhagen