Wendy Grevink, auteur op RRD

How to tackle difficulties with implementing health technologies early on? – The importance of service modelling

Written by: Eline te Braake

In recent years, a lot of useful and promising eHealth technologies are developed. However, it is unfortunately still the case that a lot of these technologies are not (successfully) implemented in practice. It appears that daily practice is often very different than the research context. Furthermore, when in use, technology affects the behaviour of people, and vice versa, how people behave and use the technology, affects it’s impact. This can create a gap between the actual daily practice and the purpose of the eHealth technology. As a consequence, several eHealth technologies are only partial used or not at all used in practice. This means that potential end-users will never experience the benefits of these promising eHealth technologies.

How can we prevent this?

At RRD, we want to prevent this problem by looking at the implementation process from an early stage. Meaning that during the development of the eHealth technology, several steps are taken to decrease the chances of implementation failure. One of these steps is service modelling. A service model describes all the tasks, processes and responsibilities that certain people or organisations have or need to perform once the eHealth intervention will be put in daily practice. An important aspect of service modelling is to involve stakeholders; the people or organisations who affect or are affected by the technology. Stakeholders are the experts when it comes to daily practice, they have crucial knowledge about current struggles and strengths in practice which cannot be identified by solely looking at literature. Furthermore, by involving stakeholders, needs and wishes can be aligned which in time may increase the commitment towards future implementation.

Example of service modelling in a project

Recently, RRD developed the service model within the RE-SAMPLE project (Horizon grant no 965315). RE-SAMPLE is a European project that focuses on people with COPD. The goal of RE-SAMPLE is to develop a technology that supports patients and caregivers to manage their COPD and other chronic conditions. The RE-SAMPLE service model is based on 5 rounds of studies with stakeholders from three different countries: Italy, The Netherlands and Estonia.

Although RE-SAMPLE is one project, most of the studies were done for each country separately. It was very important to do this, because there are a lot of differences between the countries in terms of how care is organized. In Italy for example, it became clear that the physician spends most time with the patients, while in the Netherlands, pulmonary nurses see the patient with COPD more often. In the Netherlands, short waiting lists are seen as a strength of current care, while in Estonia, long waiting lists are mentioned as the weakness of current care. These are just small examples of the many differences between the three countries

Taking the differences into consideration, it appeared that one version of the service model cannot be used for all the three pilot sites. This is the reason that differences between countries are made clear in the service model. It might be that different roles and responsibilities are assigned to different stakeholders in a particular country. You can see the final version of the RE-SAMPLE service model with all the different roles, processes, and responsibilities below:

praktijkvoorbeeld_implementatie_van_gezondheidstechnologieën

During the various surveys, much valuable information was gathered to develop the service model. Without stakeholder involvement, current processes, problems in care and preferences regarding future implementation could not be identified. Want to learn more about RE-SAMPLE's service model development? You can see a video below that explains the entire process of service model development in detail.

Would you like to see this process explained in Dutch? Then click on the following link: https://www.youtube.com/watch?v=S-PkshYyHMI

Do you want to learn more about service modelling in general or do you want to know what the options are for your organisation? Feel free to contact RRD! We can potentially help each other out and offer the help you need.

Eline te Braake

Email: e.tebraake@rrd.nl

Tel: 088 087 5734

01/26/2023

Good Clinical Practice guidelines: Our way of work

Written by: Stephanie Jansen-Kosterink

As you can read on our website, Roessingh Research and Development (RRD) conducts scientific research into innovative healthcare technology with a focus on the end-user. Part of our research falls under the heading of medical-scientific research. This type of research is subject to national and international laws and regulations, such as the Medical Research Involving Human Subjects Act (WMO) and the Medical Devices Regulation (MDR).

At RRD, all researchers are in possession of a WMO-GCP registration. In 2015, I was one of the first at RRD to follow an external multi-day training to participate in the WMO-GCP exam. The training was very interesting. Much was known, especially the submission of a research protocol to a medical ethics review committee (MERC), but much was also unknown. What was new to me was the information about conducting medical research, such as the requirements of standard operating procedures (SOPs) for all parts of your research. The exam was very difficult. It had been years since I had taken an exam and the focus was mostly on the details. But luckily, the result was positive and I received my WMO-GCP registration. That was not the end of it. This registration is valid for 3 years, which means that every 3 years a re-registration is needed. The WMO-GCP re-registration deals with the WMO, Good Clinical Practice (GCP) guidelines, ISO14155 standard for research with medical devices and specific matters in the field of research involving human subjects, including the latest changes.

My registration was still valid until January 2023 and re-registration was required again. Wednesday 7 December, I was invited to Heeze and during the train journey to the south of the Netherlands I completed the WMO-GCP re-registration e-learning of the Tapas Group. I arrived at the certification questions when the train finally arrived at Eindhoven CS. Fortunately, all questions were correct and my registration was a fact!

Much of the research we conduct at RRD is scientific, but not always medical. Nevertheless, we choose to approach all our research in the first instance as medical-scientific. When we are sure that the research does not fall under the WMO, we always verify this with the METC East Netherlands. Even if it does not fall under the WMO, we continue to follow the GCP guidelines.

Are preparing research yourself, such as testing an intervention or a medical device? We will be happy to help you to draw up the research protocol and supervise the medical ethics review!

Stephanie Jansen-Kosterink

Email: s.jansen@rrd.nl

Tel: 088 087 5717

01/19/2023

PhD defense Robert Schulte: Up to one's knees in data

Written by: Marian Hurmuz

Data-driven intent recognition using electromyography (EMG) has the potential to make actuated prosthesis more intuitive. Although electromyography has its challenges, it also forms an opportunity to realize more intuitive control of prostheses through intent recognition. Robert Schulte aimed to investigate data-driven intent recognition strategies in the lower-limb using EMG. Last week Thursday (8th of December, 2022), Robert defended his PhD thesis, which you can find here Finding.

His thesis covers the following topics:

Developing and validating a synchronisation method for wearable motion capture and EMG measurement systems.
Collecting a large database of kinematic and EMG data, MyPredict, containing 55 participants measured in 85 measurement moments.
Investigating the use of genetic algorithms to construct optimised feature sets to be used in lower limb prosthetic control.
Investigating whether concept drift is an issue in lower limb pattern recognition.
Comparing three adaptation approaches to circumvent the concept drift: entropy-based, based on backward prediction, and a combination of the two.
Comparing three modelling frameworks to estimate knee torque in non-weight-bearing situations: convolutional neural network (CNN), neuromusculoskeletal model (NMS), and a hybrid model of both.

Robert ends his thesis by concluding that data-driven intent recognition has the potential to make prostheses more intuitive, thereby possibly leading to better prosthesis control.

We are very proud of Robert and his hard work at RRD! With ending his PhD, there is no end to working with data. Robert started working at Datavibes in Gouda as a Data Engineer/Data Scientist. He continues working with data, but now in a less scientific environment. We wish him the best of luck in his future career!

12/15/2022

Involving citizens and patients in research from " how to " to " how? like this! "

Written by: Christiane Grünloh, Ria Wolkorte, Rita Schriemer

As soon as the calls for research arise, the topic of citizen and patient involvement comes up. Without a letter of support from a patient organization or interest group, your application has little chance. And once you have received the letter of support, how do you properly secure the involvement? Participation is not only a matter of ticking off by patients, but also of sparking researchers. Within ICMS (see description below), three colleagues from their own field are working on implementing active and meaningful involvement. Together they spread their knowledge, experience AND conviction.

The principles of value-driven care and Shared Decision Making are self-evident in the clinic. Can we say the same of the research that precedes healthcare? Are patients, citizens or end-users involved in ICMS studies? The answer is yes. But it can be even better. If it were up to these colleagues, it will become the gold standard that members of the public, be it patients, citizens or end-users of healthcare and technology are involved in all research we do in ICMS. And not just as a participant or tester, but that they have a voice in the design and choices made in the research. Christiane Grünloh (Roessingh Research and Development), Ria Wolkorte (University of Twente) and Rita Schriemer (Sint Maartenskliniek/Radboudumc) share their point of view.

Christiane: “For the three of us, the need to get people actively involved in your research is crystal clear. It is necessary if you want to create impact. You only have impact if your research is relevant. You will achieve relevance if your research addresses the most important questions and problems of the target group. Or when the outcomes, technological or social, contribute to the quality of life.” Ria: “We involve patients in the daily practice of science. They help make decisions.” All three of them do this within their own disciplines and in ways that are customary in their field. Rita: “In clinical research we call this patient involvement. Citizen Science is the term and approach applied to health research at the UT. At Roessingh Research and Development we speak of Human Centered Design.”

Christiane: “These are different concepts and interpretations for approaches that have the same point of departure, namely that the people for whom you conduct your research are also the people with whom you conduct the research.”

Patient Involvement in clinical and fundamental research

Rita: “In clinical research, it is increasingly becoming the standard to actively involve patients in research. Where people were first only involved as participants, patients now also contribute within other phases of the research. This can already be done at the time of the application. Patients can contribute to the relevance of the study and comment on the layman summary. But if you start the interaction earlier, their input can lead to focus differences because certain areas are more relevant to them in daily life than others. We recently experienced this in an application for osteoarthritis research. Two highly engaged patients even attended the interview with the funding organisation. For them, the main reason for committing to the study was the research's holistic view of the disease. They know better than anyone that their condition involves a combination of medical, biological, social, movement and behavioural aspects.

Basic researchers often think that their field of expertise or research is too difficult for laymen, or that involving outsiders is of little use. Nevertheless, the PhD students on rheumatism research at the Sint Maatenskliniek and at the experimental rheumatology lab at Radboudumc all have a patient representative who follows most of the research process. They then have to explain to him or her in layman's terms what they are investigating, how they do that and what the results of the investigations are. In our experience there is a role for patients in every research phase. Patients and members of the public can contribute ideas at different levels and in different research phases. These partnerships are highly valued by both parties.”

Citizen Science

Citizen science is mainly known from ecological research, for example, counting birds. But this view is too limited. Citizen science has been widely applied in health research in recent years. People with a chronic condition are often already looking for solutions to make their lives more pleasant. It is precisely this motivation and self-inquiry that you can use in research. Ria: “In Twente we started working with a group of people with rheumatoid arthritis according to the principles of citizen science. Actively involving citizens in your research means a different division of roles than the traditional one between patient and researcher. With the people involved we made agreements about data management and open science. Who owns the data and who can access it? Only the researcher? Or is the data also from the participating citizen themselves. How should access be arranged? These were nice conversations with clear agreements, which do normally not take place with the participants in research.

Based on the choice of people with rheumatoid arthritis, our research theme was formulated quite loosely around fatigue. Together with the participants, whom we call co-researchers, we have further shaped this. We found that it was precisely the capriciousness and unpredictability of fatigue that they wanted to understand better. As researchers, we turned this into a research question “Which factors are associated with experienced fatigue in people with rheumatoid arthritis?”. The co-researchers then decided that it was important to take a longer-term look at the degree of fatigue and factors that can influence it. To this end, they determined the maximum number of measurement moments (namely: 1) per 24 hours, as well as the duration of the measurement (namely: 21 days). This is more limited than we as researchers had in mind, but the feasibility of the research was also important to us. However, it is not only the researcher or the citizens who decide, it is a collaborative process As researchers, we naturally continue to look at what is scientifically justified, and we remain responsible for that. But there is much more a principle of joint decision-making and transparency.”

Participative health technology design

To develop technology that has a high usability and creates positive user experiences, , it is important to know what needs and goals people have, what their characteristics are, what tasks they have and in what context they will use the solutions. This is the starting point for creating initial ideas for possible solutions, which are then continuously tested and improved together with the users.

Christiane: “We recently started a study about eHealth for people with COPD. One important goal for the clinical researchers is to develop a prediction model that predicts when symptoms are getting worse for the patient. To do this, patients have to collect data for a longer period, for example, with a wearable and by answering questionnaires . But by talking with patients, we learned that people also want something in return for providing their data. They also expect feedback from their personal measurements. Data collection alone is not helpful to them, but rather can be a burden, especially for patients with low energy. This is important to take into account when developing the app, because otherwise people will stop using it in the long run and then clinical researchers will not have enough data for their prediction model. We already know these kinds of comments from human-centered design, or from action research, yet I keep seeing this blind spot. For me, research without the active input of end-users and stakeholders is unconceivable. In this way, we bring together all the relevant perspectives and expertise, and learn about the needs of the different user groups, to create health technologies that are useful for all of them.”

Together we can make research more relevant and better. And beyond that, patient involvement, citizen science and human-centered design keep the conversations between science and society going.

Involving citizens, patients and end-users is not "rocket science", but it does require a certain responsibility and care from the researcher. If you have questions about this, we can aid, educate and guide you towards involvement in your design and implementation of the research. You will see that it is very rewarding and becomes self-evident. Would you like to know more about how to involve people in your research? We are happy to think along with you at an early stage!

f.l.t.r: Ria Wolkorte, Rita Schriemer, Christiane Grünloh

Ria Wolkorte r.wolkorte@utwente.nl

Rita Schriemer r.schriemer@maartenskliniek.nl

Christiane Grünloh c.grunloh@rrd.nl

ICMS (Interdisciplinary Consortium for clinical Movement Sciences & technology) is a unique partnership between the Sint Maartenskliniek (a specialized hospital entirely focused on movement disorders), the Radboud University Medical Centre, the Radboud University, the University of Twente, Roessingh Research & Development (RRD), Roessingh Rehabilitation Centre working together with science driven companies (national and international).

11/28/2022

Ankle-foot orthoses in rehabilitation after stroke: Off to the Norwegian fjords!

Written by: Corien Nikamp

Sometimes you receive those emails that you almost send toward the trash because it's yet another invitation to a magazine or conference article, but at the last minute you read them more carefully. Thank goodness for that! At the beginning of this year, that was also the case. I received an email from someone at the Norwegian Association of Orthotic and Prosthetic Designers, NITO. She remembered my presentations on the use of ankle-foot orthoses (EVOs) after stroke, at the International Society for Prosthetics and Orthotics (ISPO) World Congress in Kobe, Japan in 2019. We had not heard of Covid-19 then, so that congress sometimes seems to be from another time. However, she had not forgotten about the congress and my presentations and invited me to their annual congress in November to tell about my PhD study, including the latest developments, in front of the Norwegian audience. Invitations like that don't come along every week, of course, so last weekend I went to Trondheim.

Trondheim

It was a very successful weekend. Trondheim is not an unfamiliar area for me because of previous conferences. With a waterfront hotel and views of the fjords not a bad prospect for a short visit.

I went through the queue in 20 minutes at Schiphol airport where I calculated 4 hours, so the trip to Trondheim went without any stress. If you then have to give your presentation on Sunday morning, but a gala dinner with subsequent party is scheduled on Saturday evening, it’s wait and see whether there will be an audience. But the Norwegians proved an interested audience and the room was very well filled.

Presentation about early AFO-provision

In my presentation, I discussed the different effects of early AFO-provision after stroke that I investigated in a longitudinal randomised study performed at Roessingh Research and Development (RRD). Since I had 45 minutes, I was able to go into detail about the different effects we studied: effects on functional outcome measures, gait pattern, muscle activation patterns and falls. In my presentations, I always find it important to return to the original question from clinicians at Roessingh, Centre for Rehabilitation that prompted my PhD study at the time:

Can I help this patient this soon after a stroke by giving him/her an AFO to support walking, or is it better to wait a while longer?"

Summarising almost 10 years of study in 45 minutes with 4 main points?

Yes, there are benefits by providing an AFO early after a stroke. Functional tasks can be performed faster at a higher level (independent walking, gait speed, balance, etc.), but the final level does not differ from later provision.
AFOs support drop-foot after stroke, but early provision does not affect movement patterns around hip and pelvis (neither does later provision).
Long-term use of AFOs does not affect muscle activation patterns and thus does not evoke “muscle disuse”.
Falls often occur when the AFO is not worn. So pay attention to what instructions you give to patients.

Implementation of scientific research into the clinic

I continued the presentation with the latest developments: how do we ensure implementation of the results into the clinic? Based on the results of my PhD study, I set to work with doctors and therapists from Roessingh, Centre for Rehabilitation and Roessingh Rehabilitation Technology, to bring the answers provided by the study back into practice. In doing so, we have set up a new consultation service that will make it possible to check in the first weeks after a stroke whether someone might benefit from an AFO and then provide it quickly. Also with regard to instructions for the patient and his/her relatives, more attention is now paid to the difference between walking with and without an AFO and the increased risk of falling.

The story struck a chord with the Norwegian audience. Many approving faces during the presentation, nice questions afterwards and several conversations with orthotists asking where they can find the publications.

At RRD and Roessingh we hope to contribute to improve rehabilitation care in the field of AFOs after stroke.

Curious about more details on how we shaped the consultation hour, or how we can apply knowledge related to healthcare technology innovation and implementation at RRD to your own issue? Get in touch with us!

Corien Nikamp, PhD

Email: c.nikamp@rrd.nl

Tel: 088 087 5762

11/18/2022

Province, Municipality and Twente Board invest in powerful MedTech Twente cluster in 2030

Growth boost for medical technology through investment in cluster organization

The kickoff of MedTech Twente 2030 marks an important follow-up step toward further growth and internationalization of Twente's medical technology cluster. The project focuses on a growing and powerful business cluster in the region and strengthens the ecosystem in three areas: community building for knowledge sharing and cooperation within the region, cooperation with other European clusters and international profiling and positioning. The plan is also a catalyst for the creation of multiple action agendas, to get Twente into the top European medtech regions by 2030. The kick-off of MedTech Twente 2030 took place during the MedTech Business Day, part of the first MedTech Twente Week. In the presence of cluster partners, entrepreneurs and business representatives, administrators from the Province of Overijssel, the Municipality of Enschede and the Twente Board explained why they are investing in the cluster. Some medtech companies also told about their developments and the importance of strong cooperation in and profiling of the region on MedTech.

Investment in ecosystem results in growing international position of MedTech Twente

Eddy van Hijum, Deputy Provincial Executive of Overijssel: "Together we are investing in the growth of medtech companies in the region. After the previous honors for specific medtech projects, now comes this strengthening of mutual cooperation within the MedTech Cluster and external profiling. This is going to help advance the cluster as a whole and specific companies, resulting in positive effects on welfare and prosperity in the region.

Jeroen Diepemaat, alderman for the economy of the municipality of Enschede confirms that prognosis, and sees business activity growing fast in Twente, including at Kennispark Twente. "In various places medtech companies are building and establishing themselves on the innovation campus and realizing their ambitions. I am proud that we can support all these developments with a powerful cluster organization."

Victor Jan Leurs adds. "For optimal Gross Twents Happiness, health of residents is a very important component. Future care is under heavy pressure and medical technology is one of the solutions to keep care accessible and affordable for everyone. Our region and companies belong to the national top and can play a major role in this in the long term."

Driving forces behind the regional cluster are Oost NL, University of Twente, Hogeschool Saxion, World Trade Center Twente, Roessingh Research and Development, Health Valley, Kennispark Twente, Twente Board and Novel-T. "In mid-2020, on behalf of the various stakeholders, we offered Mona Keijzer, then State Secretary for Economic Affairs, a first action agenda with targeted investment proposals for the regional MedTech cluster. It is fantastic to see the traction since then, realized from a collaboration between entrepreneurs, governments and knowledge institutions and focused on growing companies. I am looking forward to the next phase!" said Jaap Beernink, CEO Novel-T.

MedTech Twente Week

The first edition of the MedTech Twente Week took place from November 2 to 4, 2022. The success of the TechMed Event has been expanded into a broad multi-day program for researchers, corporates, startups, medics, students and investors, among others. There is plenty of focus on medical technology research, bringing MedTech innovations to the market and implementing them, accelerating MedTech business and making new connections. Together, we are strengthening our future health care with medical technology.

11/03/2022

Making advances in technology for healthy ageing matter: RRD at Ageing Well Week 2022

Written by: Lena Brandl

More than 40 parallel workshops, 30 poster presentations, and 50 exhibitors from industry, science, and communities dedicated to making healthy ageing possible gave rise to the Ageing Well Week 2022 in Gdańsk, Poland. Gdańsk is a buzzling city with a rich history, including its key role in the solidarity and oppositionist movements. It has therefore only been natural for the city to host the Ageing Well Week 2022, according to the city’s mayor, Aleksandra Dulkiewicz. The challenges that a rapidly ageing world population poses can only be met by a unified and solidary world community.

The next step to making technology for healthy ageing matter

After 14 years of practice-oriented research about health technologies for the increasingly ageing world population, the most important topic of this final edition of the Ageing Well Week was how the community can accomplish the transition of health technologies to the market. Put differently, how can we ensure that the repertoire of evidence-based health technologies gets into the hands of those to whom we dedicated our efforts: the ageing population?

Since this is a question RRD cares about deeply, we joined the event and the ongoing discussions about enabling ageing well. RRD presented two posters about our work in the AAL project LEAVES (Project No. AAL-2019-6-168-CP). Within the LEAVES project, together with 8 consortium partners, RRD has developed an online grief intervention to support older adults in processing the loss of their spouse:

The first poster, by Stephanie Jansen-Kosterink, demonstrated the preliminary results about technology acceptance and potential health effects of the LEAVES service.
The second poster, by Lena Brandl, discussed older adults’ use and appreciation of a monitoring system to guide users of LEAVES to offline support (if their situation deteriorates while working with the online grief service).

Our presented work was met with curiosity and praise for giving attention to a common, yet unfortunately, largely unrecognized aspect of healthy ageing: processing the loss of loved ones.

Do you want to take a look at our work presented at the Ageing Well Week 2022? You can find the poster about technology acceptance and potential health effects (preliminary results) of LEAVES here and the poster about older adults’ use and appreciation of a monitoring system here.

Do you have thoughts or ideas about how the health technology community can achieve their goals towards solving the challenges of the ageing world population through digital health solutions? We are happy to discuss, exchange ideas and collaborate to bring healthy ageing within everyone’s grasp!

Lena Brandl

Email: l.brandl@rrd.nl

Tel: 088 087 5768

11/03/2022

Involving stakeholders as co-researchers: Taking a first step in how to train them

Written by: Kira Oberschmidt

For almost three years now, RRD has been involved in the Pharaon project (Horizon 2020, grant agreement No. 857188). In Pharaon, we use action research to integrate technologies for smart and healthy ageing. At the end of the project, RRD is going to provide guidelines for action research that can be used in other projects.

In our work, we notice that the involvement of non-researcher stakeholders (for example patients and healthcare professionals) becomes increasingly important. Especially in participatory projects that make use of approaches like action research or citizen science, simply involving these stakeholders as participants is not enough. Instead, they should take on a more active and empowered role. However, as there are not formally trained as researchers, more knowledge and preparation might be required.

We see that stakeholder skill training is occasionally mentioned in literature as a way of preparing stakeholders to become co-researchers. However, little practical information about such training is given. This left us wondering:

What is being taught?
Who are the recipients of the training?
When do training activities take place?
What are identified training needs (why do we need this training)?
How is the training set up and which methods are used?

Workshop at NordiCHI 2022

To answer these questions, we decided to invite researchers with an interest in stakeholder skill training to a workshop. This session took part on 9 October 2022, as part of the pre-conference program at NordiCHI 2022. NordiCHI is a biannual, international conference on Human-Computer Interaction This took place in Aarhus, Denmark this year. The topic of this year’s event was Participative computing for sustainable futures.

During the workshop, our group of organisers engaged in some very interesting discussions with the participants. For example we talked about:

How to find a common language between stakeholders?
How can we identify training needs?
Is training even the correct term for such activities?

While working in smaller groups we also took some time to identify barriers and facilitators of good stakeholder skill training. (We were unable to settle on a better term, so for now we kept calling it ‘training’). While there are still a lot of open questions, it was nice to see that many participants took inspiration and ideas for their own practice from the session.

We look forward to continue this discussion with others. Would you like to learn more about this topic? Feel free to reach out to Kira or Christiane.

Kira Oberschmidt

Email: k.oberschmidt@rrd.nl

Tel: 088 087 5767

Christiane Grünloh

Email: c.grunloh@rrd.nl

Tel: 088 087 5723

10/26/2022

Extending CE certification under the Medical Device Regulation (MDR) to a new 'intended use' - A real-world example

In recent years, Roessingh Research and Development (RRD) has worked intensively to coordinate a multi-center intervention study. This intervention consisted of a soft-robotic glove, called Carbonhand, which was developed to support hand function for patients with reduced hand pinch strength. Bioservo, the manufacturer of Carbonhand and sponsor of the study, had the intended goal of extending CE certification of the system within the MDR to a new medical application. Carbonhand already had a CE for its operation as an aid in daily tasks. However, the new "intended use" is focused on the therapeutic effect of Carbonhand, or improving hand function after long-term use of the system as an aid during daily activities. RRD was therefore asked to design and conduct a clinical evaluation that could demonstrate whether or not that therapeutic effect is there.

For this, RRD set up an appropriate research protocol according to the Good Clinical Practice (GCP) guideline, an international ethical and scientific quality standard (ISO14155) for the design, recording and reporting of human-related research. In addition, RRD realized the approval at the Medical Ethics Review Committee (METC), we realized cooperation with 8 Dutch (rehabilitation) centers and trained all involved in the application of the Carbonhand system and the implementation of the research protocol. A monitor from an external party was involved to check the implementation of the GCP guideline and all collected data.

Intensive cooperation leads to success

Within this study 63 participants were included with reduced hand squeezing strength, independent of underlying diagnosis, who used the Carbonhand during a period of 6 weeks at home while performing daily activities. Three baseline measurements took place beforehand, followed by a post-measurement (within 1 week of intervention) and a follow-up measurement (4 weeks after the end of the intervention). Despite intervention of the COVID-19 pandemic, we managed to conduct the study successfully, not least due to the intensive and pleasant cooperation with the participating centers. On Tuesday, September 27, the final measurement took place and the data collection was officially completed. Of course, we could not have reached this milestone without the commitment of the clinical centers: Roessingh Center for Rehabilitation, University Medical Center Groningen, Isala clinics, Rijndam rehabilitation center, Reade center for rehabilitation and rheumatology, Hoogstraat rehabilitation, Sint Maartenskliniek with the location Canisius Wilhelmina Hospital, Klimmendaal.

In the coming period we will focus on the analysis of all outcome measures. Interim results were promising, now we need to see if this remains so after analysis of all data. If you are interested in the results of the study, keep a close eye on our news page for the latest developments.

Do you recognize the above process as a medical device manufacturer and have a similar issue? RRD is happy to advise and support you in the design and implementation of your clinical evaluation under the MDR!

Anke Kottink-Hutten
E-Mail: a.kottink@rrd.nl

Tel: 088 087 5733

10/18/2022

RE-SAMPLE: First meeting with all partners in the Netherlands

Written by: Marian Hurmuz

After a year and a half, the time had come: the ten European partners in the RE-SAMPLE project met together in the Netherlands at the University of Twente's DesignLab. This meeting was organized for three main reasons:

Sharing knowledge with the various project partners.
Brainstorming on topics the project will focus on over the next six months.
Working on the team spirit within the project! So that we all have our noses in the same direction.

Everyone was very happy that this could take place face-to-face. This way, we were able to organize many interactive group sessions.

The four-year RE-SAMPLE project (Horizon 2020, grant agreement No. 965315) focuses on people with COPD and other chronic conditions. The goal of RE-SAMPLE is to develop a technology that supports patients and their caregivers.

Workshops during the meeting

The meeting lasted two days during which energizing workshops were held by various partners. These workshops included:

The observational cohort within RE-SAMPLE. During this workshop, we had fun looking at how to involve more COPD experts in the cohort and reduce the burden on the COPD experts in the cohort.
Coaching. In this workshop, we went into groups to think about relevant coaching topics for the technology we are developing.
The Social Return on Investment (SROI) method. This workshop was organized by RRD. We worked with 4 groups to capture the main activities and outcomes of different stakeholders involved within RE-SAMPLE (click here for more information on the SROI method).

Social activities

In addition to these workshops, we also had time for social activities to get to know each other better. This started with a graffiti workshop!!! We were given a crash course in spraying graffiti and then we all got to create our own design. See below some examples of these designed. Afterwards a dinner was arranged at De Tropen in Enschede to close the evening with drinks and dishes. After 1.5 years of working online, it was really nice to meet the people in RE-SAMPLE in person.

10/11/2022