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The importance of focus groups

Written by: Eline te Braake

Conducting focus groups is a common method in qualitative research. It's a good way to investigate certain opinions, current issues, and motivations. The latter, motivations, is often something that arises from the dialogues that not only the researcher has with the participants in a focus group, but which also naturally results from the interaction between the participants in the group. For example, a focus group can very nicely result in finding out 'the question behind the question'. That, in our opinion, should be central to the conduct of any focus group. However, this is not always the case.

‘Reading through’ focus groups

Since we are currently bombarded with the word 'focus group' in the research world, we lose a bit of its actual essence. What often happens in practice is that a list with a number of questions is simply 'read through’. You may wonder what the added value is of holding such a focus group, if the same questions could have been answered in a questionnaire. In addition, people take effort to make time and agree to participate with an intention to share their opinions: to feel heard. Thus, there should also be enough time and space for this during a focus group. Why burden people with a focus group, when we could have put the exact same questions in a questionnaire that they could have filled out from their homes and in their own time? Therefore, it is up to the researcher to reflect whether a focus group is indeed the most suitable method for answering the proposed research question.

The actual added value

But what is the importance of focus groups? What can we get out of it and where is the added value? In our view, the beauty of focus groups lies in that you take the time to sit together, reflect on what is really needed, and find out where the current bottleneck really lies. Something that you can't really determine or plan in advance despite the predetermined protocols. This is also something that doesn't always come up naturally during a focus group. It is therefore up to the researcher to create a safe environment, to give space for dialogue in the group, to find starting points in the conversations that are held, and to ask questions about what is really important to the participants. Only this way, a focus group can lead to new insights that could not have been captured by other methods.

Making use of the dynamics of the group

In addition, a focus group also distinguishes itself from other methods in that it is held in a group. On the one hand, this means that the researcher also has to take into account the dynamics in the group. This entails that everyone should feel comfortable, feel heard, and everyone should have the opportunity to speak. On the other hand, this dynamic can be used in a positive way. Participants learn from each other, recognize themselves in each other’s situation, help each other if something is not understood, and make each other think. As a result, new insights often arise that have been obtained with and through each other.

There is so much to get out of a focus group that are more difficult to achieve with other methods. It's true that organizing and performing a good focus group takes a lot of time, but when done well, it gives so much more meaning to the topics that, according to the participants, really matter!

Do you also want to set up a focus group, but do you need help? Please contact us for the possibilities!

Eline te Braake

Email: e.tebraake@rrd.nl

Tel: 088 087 5734

03/12/2024

First PhD defence of 2024 by Kira Oberschmidt about guidelines for active involvement of stakeholders in eHealth Action Research!

Written by: Marian Hurmuz

Last Friday, the first RRD PhD defence of 2024 took place! Kira Oberschmidt defended her PhD thesis, titled: “Who, When, How: Guiding the active involvement of stakeholders in eHealth Action Research”. Action Research (AR) is a collaborative research approach in which stakeholders play an active role as co-researchers. AR fits the context of eHealth research well, as its key elements can hopefully ensure a better match between the technology being developed or implemented and the needs of relevant stakeholders. Ideally, stakeholders should take on a very active role and shape the research. However, oftentimes, neither the researcher nor the stakeholders are used to working in this way. Therefore, support is needed in terms of sharing knowledge, best practices and lessons learned between projects. Yet, in AR publications explicit reflection and description of these lessons learned is often missing. This makes it difficult for AR projects to learn from each other. Kira has dedicated her PhD to provide guidance for researchers setting up their project, and specifically to support the active involvement of stakeholders. She developed a framework on stakeholder involvement in eHealth AR projects. On Friday the 19th of January (2024), she defended her thesis, which you can find here.

Kira’s thesis covers the following topics:

Reviewing literature to identify what is currently known about AR in eHealth projects (context of these projects, definition of AR, how to conduct AR, best practices and lessons learned from AR in eHealth projects).
Studying novice action researchers’ attitude towards AR.
Investigating how champions see their role and whether this changes over the course of AR projects.
Investigating the motivation of stakeholders participation in long-term, time-consuming research projects like AR.
Identifying how to involve participants unplanned and spontaneously.
Studying the alignment of interests and needs of different stakeholders in a project, in terms of what they want to achieve from the project.
Providing a structured way for researchers to reflect together with project partners
Investigating the important elements of stakeholder skill training to enable them to be involved and to enable them to interact with each other.
Describing an iterative method to involve patients, their perspectives and lived experiences in research

Taking into account all the recommendations made in her thesis, Kira developed a framework for stakeholder engagement in eHealth AO projects. This framework describes important issues to consider in such a project. Her framework is available on our website: https://www.rrd.nl/ar-framework/

We are very proud of Kira and her hard work at RRD! And we are happy that Kira continues working at RRD for the next steps in her career!

01/23/2024

Involving your end-users: how important is this?

Written by: Marian Hurmuz

Involving your end-users is getting more and more important in research. Also in the field of health research there is a need for a human centered focus. You can incorporate this by integrating social sciences and humanities (SSH) in your research! At RRD, our research focuses on the end-users. In this news article, I will tell why it is important to involve end-users and give an example of what we do to improve our relationships with our end-users.

Engagement of stakeholders

Through continuous engagement with end-users and other important stakeholders, we can learn a lot from their experiences regarding the topic we are studying. It is important to involve these stakeholders as soon as possible in your research. By engaging with them, you are able to take into account their actual needs and wishes and the processes in which the health technology will be used. It is very unpleasant to develop a great solution, which does not fit those needs or processes. Besides, the unpleasant feeling, it is of course also a waste of scarce resources.

The knowledge you gather in the early stage of your research, helps you to identify how to incorporate the health technology in the best way possible into the daily lives of the end-users and healthcare organisations. It is important to test and evaluate this with end-users to see whether you translated their needs correctly or changes are needed. This will help you to come to sustainable implementation of your health technology.

Giving something back to your stakeholders

Feedback is of course not a one-way pathway. When you want to build a relationship with your end-users or other stakeholders, you need to frequently interact with them. It is important that they do not forget about you and your research. Furthermore, they also need to feel that they are valuable to you. One of things we do at RRD to give them this feeling, is to share our early results of the studies with them. We noticed that they really appreciated this! It also led to some unprompted feedback if something is lacking in the results or interpreted wrongly.

When you share your findings with your stakeholders, you do not only ask for information from them, but you also give something back to them! This can encourage stakeholders to be actively involved in your research and more willing to help you out during your research.

For example, within the RE-SAMPLE project (Horizon grant no 965315), we have created feedback videos sharing our initial findings. As an example you will find one of these videos below.

Would you like to see this video in Dutch? Click on the following link: https://www.youtube.com/watch?v=IZQ9FWMFVSw

Are you struggling with integrating social sciences and humanities (SSH) in your research? We are always open to have a talk to help you out!

Marian Hurmuz

Email: m.hurmuz@rrd.nl

Tel: 088 087 5771

10/05/2023

Conducting your graduation assignment at RRD?

Written by: Yfke Dotinga

Hi! My name is Yfke Dotinga and during the past eight months, I have been doing research for my graduation assignment at Roessingh Research and Development (RRD). In this post, I want to share my experiences of conducting a graduation assignment at RRD.

My assignment

My research was conducted as part of the RE-SAMPLE project (Horizon grant no 965315) for the development of an eHealth tool for people with COPD. My research focused on aligning the technology with the goals and needs of the end user. For the development of health technologies, it is very important to involve the user in the design process. Therefore, I took an iterative approach with participation of the users both at the start and end phase of my research. Based on these conversations, I conducted a thorough analysis to map their values and proposed design examples of how the effective engagement could be increased. This way, we hope to optimize the support of people with COPD in their self-management and to improve their quality of life.

Thanks to great support and the enthusiasm of Christiane Grünloh and co-researchers Eline te Braake, Marian Hurmuz and Stephanie Jansen-Kosterink, I really enjoyed working on my contribution to the RE-SAMPLE project. I finalised my assignment and successfully defended my master thesis in May!

Students at RRD

Students are offered a desk in a room with other interns/graduation students, with good company for the coffee breaks. We created the habit to go for a daily lunch walk through Ledeboerpark and we planned some activities together like ice skating, going out for diner and doing a board game night together. It was very nice to have other students around with similar assignments and struggles!

Furthermore, it was interesting to hear about other the projects and to occasionally serve as test subject in the motion lab. All in all, I have learned a lot during my graduation assignment, and I am satisfied with my time at RRD. So, thanks for all your support!

Do you want to follow an intern at RRD or conduct a graduation assignment (bachelor or master) at RRD? Check our vacancies and internships page!

Yfke Dotinga

06/06/2023

ISPO in Mexico!

Written by: Corien Nikamp

I had solemnly promised to write a blog post after a week in Mexico because of the World Congress of the International Society of Prosthetics and Orthotics in Guadalajara. With 2 symposia, 2 orals and chair a session of chairing, it promised to be a busy congress. Yesterday, our 9-day stay in Guadalajara was, not at all at our request, extended by one day because of a broken "part" of the plane. That meant an extra night with a voucher in a hotel, an early flight still to Atlanta and a 9-hour stop at the airport. So plenty of time to write this blog, in between a few games of 30-seconds with colleagues from Groningen (Enschede won 😊).

Together with RRD'ers Erik Prinsen and Martin Tenniglo, our trip began last Friday with a flight from Amsterdam to Mexico City. Colleague Martin soon made contact with a bunch of fellow Chinese passengers and was spontaneously offered local Chinese delicacies. It most closely resembled strange-colored sausages stuffed with egg or corn that would keep until the end of time, so I politely declined and stuck with the KLM meal. After an otherwise prosperous flight, we landed in Mexico City Friday evening local time and after choosing the wrong line 3 times, we had the right stamps in our passports and could proceed to our capsule hotel. The corridor with sleeping compartments looked most like a spaceship and I was looking forward (by now NL time deep into the night) to a nice bed.

Exploring downtown Guadalajara

After a night of no sleep on a mattress that was too thin with the bus station next door, we were able to get back to the right terminal at 5:00 a.m. local time, refreshed and ready to catch our flight to Guadalajara. All on schedule, so we finally reached our hotel around noon. After lunch at a local picturesque restaurant, Erik unfortunately had to go do important ISPO-NL chairman things, so Martin and I took a cab downtown to avoid falling asleep. That turned out to be a very good choice. On the way we feasted our eyes on how traffic moves in this metropolis of millions (how about cargo jamming?).

We visited the widely known cathedral and spent hours in a neighborhood with all kinds of markets, stores and eateries, so we bought some souvenirs. We immediately got a good impression of local Mexican life and it became clear to me that we (or at least I) take children's birthdays a little too lightly in the Netherlands. Stores full of decorations, balloon, garlands, plates/cutlery/straws/cups in all colors of the rainbow, piñatas and candy with all the E numbers you can think of in quantities of at least several kilos.

After a jet-lagged night of sleep, Martin and I woke up fairly refreshed and then signed up for a "Tequilla tour". A bus tour of about an hour led by Hector "the protector" as our local guide, we visited an agave plantation and local bar, after which we visited one of the most famous Tequilla breweries in Tequilla. A fun day where, as a non-Tequilla drinker, I especially enjoyed the outward and return drive to get an impression of the country.

ISPO Congress

On Monday, right after the opening ceremony, the program included a symposium by Erik, Martin and myself, in which we told how we at Roessingh Diagnostic Center approach (scientifically) treatment of stiff knee gait after CVA. Well attended and nice reactions so a good start of the congress. On Tuesday I went straight back to work because I was allowed to chair a session, and then continued with a symposium by Erik and myself, together with Prof. Nerrolyn Ramstrand from Jönköping, Sweden. Again a well-attended session with nice discussions, in which we talked about our experiences doing gait image analyses: what is the effect of the number of measurements you use for your results, and how could you present the results?

Wednesday I had a quieter day with only sessions to attend myself. In the evening the convention party was scheduled. A beautiful location on a ranch outside the booth and Mexican music and dancing as entertainment, so we turned a blind eye to the fact that the food was cold and the drinks ran out after 1.5 hours. I then had to present on the last convention day in the morning as the 1st session after the party, so didn't have high expectations for attendance, but that turned out to be all right. On "kingsday" we turned out to have a Dutch party in our session. Two foreign speakers did not show up, leaving 4 presentations from Amsterdam and Enschede, "orange above" that is. In this session, after several previous ISPO congresses in which I talked about the results of my PhD study, I found it super fun to present about the implementation of the EVO consultation in the Roessingh. So the circle is complete!

In the afternoon, we had one last presentation, about the 1st final results of our iHand study, in which we look at the effects of a soft-rubber glove during use in the home situation. It was nice to also be able to highlight this kind of rehabilitation technology during ISPO. With this session, a full conference week is over. It took a lot of preparation time, but resulted in a fun week of meeting old acquaintances and new contacts. Apart from the congress, what will stay with me from Mexico? Traffic with a "sporty driving style" and lights on cars as if they were fairground rides, holes in the pavement, loud music, rubbish on the streets, 30+⁰C, good food and friendly people, who by 5-10 minutes mean 20-30 minutes.

The next ISPO congress will take place in Stockholm in 2025, and with an invitation to sit on the "World Congress Scientific Committee" for 2025 in my pocket, preparations for the next edition have already begun! Hopefully in a moment we will have some last games of 30-seconds and then get a seat on the flight to Amsterdam, then we will be back home after 10 intense days.

One last beautiful mural I came across in town!

Regards, Corien

Corien Nikamp, PhD

E-mail: c.nikamp@rrd.nl

Tel: 088 087 5762

05/02/2023

Measuring walking - are we doing it right?

Written by: Erik Prinsen, Corien Nikamp, Nerrolyn Ramstrand

Ever since Muybridge studied walking by making a series of photographs, gait analysis has become widely available to study walking. Instrumented gait analysis in particular has been essential in increasing our understanding of how individuals regain walking function after a stroke or amputation. It has also been used to quantify how we can influence walking ability with technology. Despite its wide application, there is no consensus on the best way to conduct an instrumented gait analysis, nor how to present its results. While the majority of trials have investigated straight-line overground walking, one may also question whether this is the most clinically relevant environment. So, are we measuring walking in the right way? This question is the main topic of a symposium that is organized by dr. Corien Nikamp and dr. Erik Prinsen from Roessingh Research and Development in Enschede, the Netherlands, together with Prof. dr. Nerrolyn Ramstrand from Jönköping University, Jönköping, Sweden. This symposium is part of the World Congress of the International Society of Prosthetic and Orthotics to be held from 24-27 April in Guadalajara, Mexico. In this blog, we are offering a sneak peek into the contents of this symposium.

When performing an instrumented gait analysis, many choices must be made. Which variables are of interest for my specific case? How much data am I going to collect? How am I going to present the data? These questions will be tackled during the symposium.

How much data am I going to collect?

While there has been research investigating differences between biomechanical models, few studies have investigated the influence of the number of steps that are included in the analysis. This notion is not new, as Zahedi et al. in their 1987 paper in Prosthetic and Orthotics International already concluded that “it is first necessary to quantify the degree of repeatability due to the method of measurement and step to step variation, before attempting biomechanical comparison.” To our knowledge, however, step-to-step variation has not been studied in individuals with an amputation.

Therefore, Roessingh Research and Development conducted pilot experiments in which we asked three individuals with a transfemoral amputation to come to our lab five times while we collected around 200 strides using instrumented gait analysis. This allowed us to compare variability of gait within a measurement session but also between measurement sessions. Results of this pilot study showed that including a limited number of steps (up to 20 steps) can lead to differences up to 10% in walking speed when comparing across sessions. It also showed that during a measurement session, individuals tend to start at a higher walking speed which levels off towards the end of a session. This pilot study gave indications that the gait pattern of individuals with an amputation is more variable than we initially thought. It also suggests that we may need to include more strides than is common practice at this moment, or at least be aware of the potential risks of analyzing limited number of steps. During the symposium we will delve into the results in much more detail and open the floor to discuss experiences of other researchers.

How am I going to present the data?

Another choice that needs to be made is how we are going to present the data. A common way to present the data is using a stride time-normalization. When analysing human walking graphs of the joint kinematics (angles) are typically presented from initial contact to initial contact with an indication where the step-to-swing phase transition is, indicated at the instant of foot-off. While this may work on an individual level, it may lead to problems when presenting data of the group, or when presenting longitudinal data. This is particularly the case when there is variance in where the step-to-swing phase transition is located. This variance may lead to a situation that data of individuals that are still in the stance phase is combined or compared with data of individuals that are already in the swing phase for a part of the stride.

A thorough analysis of data Roessingh Research and Development gathered in a longitudinal study of stroke survivors showed that this does occur and it can seriously skew the graphs of joint kinematics. Furthermore, this trial showed that normalizing joint kinematics on the sub-phases of double limb support phases, single limb support phase and swing phase prevents skewing of graphs giving a much better representation of the joint angle. During the symposium we will show these data so you can see how data are skewed with your own eyes and how sub-phase time normalization alters the graphs giving a better representation.

What data am I going to present?

The final topic of this symposium is the question of which data to present. As mentioned before, many studying comparing different technologies have looked at joint kinematics or joint kinetics. While these are variables of interest, the relation between differences on these variables and the overall functioning of its user is not always straightforward. Therefore, looking at overall variables such as balance or cognitive load during walking might be more interesting.

One way of looking at cognitive load is measuring the blood flow in the frontal cortex of the brain, as measured with functional near-infrared spectroscopy. Jönköping University has extensive experience in collecting these data in individuals with an amputation. Their data showed that the cognitive load of walking with prostheses with advanced capabilities, such as auto-adaptive components, is lower when compared to walking with mechanically passive prostheses. They also demonstrated that patterns of brain activity may change in the absence of changes in walking speed or step length. These results are of high clinical interest as they clearly show the potential of more advanced prosthetic components on the overall functioning of individuals with an amputation, and the potential of cognitive load as an interesting outcome measure in gait research. In this symposium we will show you the magnitude of these differences and we will discuss the meaning of these results for individuals with an amputation and the prosthetics field in general.

Do you want to know more?

Did we spike your interest and are you attending the ISPO World Congress? You can attend our symposium on Tuesday 25th of April from 14.45 – 16.00 hr in the Main room. In case you are not attending, but you are interested? Please feel free to reach out to us!

Erik Prinsen
E-mail: e.prinsen@rrd.nl
Tel: +3188 087 5761

04/04/2023

PhD defences of Marit Zandbergen and Luca Marotta: The use of inertial measurement units (IMUs) in running

Written by: Marian Hurmuz

In the first week of February, two former RRD colleagues defended their PhD thesis! Their focus was on the running population. Marit Zandbergen defended her PhD thesis “Moving forwards by going outside: Inertial measurement unit-based monitoring of running biomechanics”. While running is a popular sport and has many health benefits, there is also a high risk of developing running-related injuries. Running biomechanics could be of help to monitor the risk of injury. However, it is unclear which biomechanics need to be taken into account. Marit worked on this topic during her PhD by aiming to increase our understanding of running biomechanics as measured in- and outside the laboratory and to explore the challenges regarding wearable motion analysis during running in a sport-specific setting. On Thursday, the 2nd of February, 2023, she defended her PhD thesis, which you can find here.

Her thesis covers the following topics:

Investigating the effects of running-induced fatigue on running kinematics.
Measuring running gait (i.e. running speed, stride frequency) in a fatiguing outdoor run.
Assessing the strength of the relationship between peak tibial acceleration and maximal tibial compression force in running.
Investigating whether the quasi-cyclical nature of running can be used to acquire drift-free 3D orientation of a body segment using a single gyroscope.
Identifying how the 3D orientation and displacement of a single IMU on the lower leg can be estimated using the quasi-cyclical nature of running.

Marit ends her thesis by recommending others to monitor running biomechanics in a sport-specific setting and to shift their focus from investigating kinematic quantities on a group level to forces underlying them on a subject-specific level. Moving outside by using the methods she proposed in her thesis, is the next step in increasing our understanding of running biomechanics!

On the next day, the 3rd of February, 2023, it was Luca Marotta’s time to defend his PhD thesis “Development of inertial sensor-based methods to assess physical fatigue in running applications”. As already explained, runners have a high injury risk. Monitoring physical fatigue could benefit runners, but quantitative identification of physical fatigue was lacking in literature. So, Luca focused on this by aiming to assess whether physical fatigue can be identified in running using IMUs. During Luca’s defence, one of the committee members even asked the paranymphs to be part of a small experiment. The paranymphs had to keep one arm straight ahead during the defence. This fun experiment showed that people could also get fatigued when they are not moving.

In Luca’s thesis the focus was of course in fatigue while moving, i.e. running. You can find his thesis here , and it includes the following topics:

Assessing whether biomechanical changes measured with IMUs can help accurately detecting fatigue states in running.
Identifying whether different triaxial IMUs with different sampling frequencies track similar relative changes in peak accelerations in treadmill running.
Measuring the extent to which physical fatigue can be identified using IMU data in an outdoor running session and identifying the optimal combination of sensor locations and features.
Assessing to which extent an algorithm trained on IMU data detecting fatigue can be generalised to different running intensities and scenarios.

Luca concludes his thesis by stating that machine learning models can identify running-induced fatigue with reasonable accuracy regardless of running intensity. Future research should focus on using fatigue information extracted from IMUs as a mean to provide feedback to the runner and ultimately improve training loads and decrease the risk of injuries!

We are very proud of both Marit and Luca for their hard work at RRD the past few years and for successfully defending their PhD theses! We wish them both the best of luck in their future career!

02/14/2023

Reeping what you sow: final plenary meeting LEAVES project

Written by: Lena Brandl

36 months, nine consortium partners, three countries, one common goal: supporting older adults after spousal bereavement. Loss is a common occurrence in life and grief is a normal and healthy reaction to loss. Yet, grief is overwhelming at times and one can find oneself feeling lost. Together with eight international partners in Portugal, Switzerland and in the Netherlands, RRD has spent the last three years developing an online service for older mourners to support them in processing the loss of their partner.

It has been an exciting journey, including many many hours discussing, creating and evaluating, together with older adults, grief professionals and our fellow consortium partners.

At DOMUSDELA, Eindhoven, The Netherlands, the consortium of AAL project LEAVES (Project No. AAL-2019-6-168-CP) gathered to streamline its recent efforts one final time, including:

discussing the progress of the evaluation study of LEAVES in Switzerland;
documenting the insights from the evaluation studies conducted in Portugal and the Netherlands in the second half of 2022 and preparing these results for (scientific) publication; and
finalizing a business case for future exploitation of the LEAVES intervention for spousal bereavement.

We also took some time to look back to where LEAVES began, including:

how we transformed a purely text-based grief intervention to a more dynamic, dialogue-based format, combined with readings, writing exercises and activity suggestions to foster self-care;
How we developed an algorithm to detect and communicate when LEAVES users might be better off involving offline support in their grieving process; and
how Luisa, our initial peer virtual coach for LEAVES, became Sun, the final sun-shaped virtual coach in the service. The virtual coach introduces the content of the application to LEAVES-users. During the project, we learned that for some older adults a virtual coach designed as a peer (an older adult who has lost their partner) is confusing. Some older adults who participated in early prototype tests of LEAVES were misled to think that Luisa is a real person which is why we ultimately abandoned the idea of a peer virtual coach.

AAL project LEAVES has entered its final stage of reporting and tying up loose ends and RRD fondly looks back to three years of fruitful collaboration with our LEAVES consortium partners. Now we look ahead to the final review of the project in April 2023.

Lena Brandl

Email: l.brandl@rrd.nl

Tel: 088 087 5768

02/07/2023

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