It was a challenge to gain acceptance of the SCAPIS project throughout the organisations at both Linköping University and Region Östergötland. However, in June 2018, the last study participants will be received – and the number of persons who have agreed to take part in Linköping Municipality was the highest in the country. Carl Johan Östgren, the local research manager, even says that lives have been saved, and that more people wanted to take part than was possible.
The concept for the unique, gigantic research project SCAPIS – Swedish CArdioPulmonary bioImage Study – was formed in 2007, but in Linköping active planning started in 2013, following the pilot study for the national project the year before.
– As we didn't have our own clinical trials unit at that time, we were a bit less well equipped than other university hospitals,” says Carl Johan Östgren, and adds that Linköping therefore had to start from scratch by creating a new unit.
Elisabeth Logander of Region Östergötland, the project manager, had a big coordinating role to play, and found good help from several sources in her work with personnel recruitment.
– Irene Rydberg helped a lot with premises issues, says Carl Johan Östgren, highlighting Linköping University’s property coordinator, who works within Campus US and in close contact with the property owner, Region Östergötland, at Linköping University Hospital.
– We have been lucky with our personnel at all levels.
From the group that met regularly before the study started, Carl Johan Östgren mentions Eva Swahn, Study Physician, and also Jan Engvall, Adjunct Professor in Cardiovascular Medicine, and Anders Persson, Professor of Medical Imaging Science and head of the CMIV Centre for Medical Imaging Science and Visualisation at Linköping University.
How should the organisation be designed? This was one of the questions the top management team wrestled with before the implementation of the project gained acceptance. Linköping prepared carefully – which Carl Johan Östgren believes was a success factor.
– For a long time, there was uncertainty and worry about financing. Nobody wanted to risk exceeding the budget.
Financial worries existed particularly at local level, but the Swedish Heart-Lung Foundation (main funding body for the national SCAPIS) and the Knut and Alice Wallenberg Foundation gave an external grant totalling 60 million SEK to SCAPIS Linköping. In addition, the local project received some co-funding from Region Östergötland and Linköping University.
– High risk, high gain, says Carl Johan Östgren.
– We had to get our own CAT scanner, which we are now selling back to the Region.
SCAPIS Linköping received its first study participants on 1 October 2015. Carl Johan Östgren praises the experienced study physician Eva Swahn, who he thinks dealt with the study participants in a particularly professional and skilled manner. When people received bad news, she made sure they received the correct treatment, without unnecessarily long referral routes.
– Nationally, 50 per cent on average of those asked agreed to take part in SCAPIS, but in Linköping the figure was 58 per cent, the highest in the country, says Carl Johan Östgren.
The letter with the offer to take part in the study was sent to around 10 000 randomly selected inhabitants aged between 50 and 64 years, out of an age group population of 24 500 in Linköping Municipality. Carl Johan Östgren says that the reactions were uniformly positive.
– The participants have just been grateful. Nobody has been dissatisfied, instead they felt it was meaningful and fun to take part. People have even asked if there was a list for reserves, saying ‘Please include me, I have lots of interesting diseases’, but then the random sampling doesn't work that way, instead the selection was via the Swedish Population Register.
The purpose of SCAPIS was neither to treat disease nor to save lives in the short run, even if this has also become the case during the course of the study. Carl Johan Östgren appreciates that life-threatening conditions that have been possible to treat were discovered in at least a handful of persons in Linköping.
– Some cases have been recognised in TV and the papers, he says.
The ”Scapists”, as the study participants in SCAPIS became known, have all received a thorough health check-up of the heart, vascular system and lungs, as well as status levels for blood sugar and cholesterol. The data increases the chances of preventing, discovering and treating cardiovascular disease and COPD in the future. Carl Johan Östgren also emphasises the local add-on investigations carried out.
– The add-on investigations are so unique that we will stand out just because of them, he says, adding that the open application procedure formed the basis for the investigations carried out.
SCAPIS Mikro is the name of one of SCAPIS Linköping’s add-on investigations. The Department of Medical Technology at Linköping University in collaboration with Perimed AB has developed a new bio-optical system, EPOS – Enhanced Perfusion and Oxygen Saturation system. The advanced light technology measures the micro-circulation of the skin in a unique way, which opens up opportunities to study the relationship between impaired micro-circulation and cardiovascular disease and diabetes in a completely new way. Other add-on investigations have also included pulse wave speed measurement to check vascular rigidity, ultrasound investigations of the heart, and cortisol levels have been measured in hair clippings to study long-term stress in relation to both working life and lifestyle conditions as biological heart blood vessel risk factors. The study participants also took blood pressure measurements at home; a method that has proved to give more reliable measurements than the high figures obtained at surgeries in the presence of medical personnel, known as “white-coat hypertension”. Women in particular displayed higher blood pressure measurements in surgeries than in the home environment, and the measurements from this add-on investigation provides SCAPIS Linköping with one of the world’s largest data sets from home blood pressure measurement.
– We wanted to use the full potential of SCAPIS, says Carl Johan Östgren, who thinks that the implementation phase has gone very well.
The next phase will consist of processing and making available the data collected. The vision has been, and remains, to build up an infrastructure and a database that are easily accessible and simple to use for researchers.
– I am sure of that, because it has already happened. In Linköping, for example, SCAPIS became an ice-breaker that forced a technology development, which had been procured but not implemented before. Now, it could wait no longer. Carl Johan Östgren alludes to the automated sample handling of the Biobank Facility, with associated secure tracing in a “LIMS system”.
Its manager, Lena Thunell, is another of the personnel members from whom SCAPIS Linköping has benefitted so much. In an email comment, she writes that SCAPIS has been “a very important pioneering study at the start of ‘healthcare-integrated bio-banking’ in Linköping”.
– Soon we will have 5058 Scapists, says Carl Johan Östgren, when we meet at his office at the end of May 2018.
– Well, we did take on a few more than the 5 000 we originally planned. On 1 June, the final Scapist will enter the study in Linköping, on 12 June the project will be celebrated with a party, and on 1 July the unit will close. But SCAPIS is sure to continue to deliver, long after several of us have retired...
SCAPIS Linköping is a collaboration between Linköping University and Region Östergötland. There is a long tradition of collaboration and cooperation between Linköping University and Region Östergötland, in particular within health and medical care. This collaboration has also been developed in part within the framework for Clinical Studies Sweden, where the Swedish Research Council and Sweden’s six healthcare regions collaborate, and where Forum Southeast is the node for the south-eastern healthcare region. Forum Southeast consists of the Research Unit at Kalmar County Council, Futurum in Region Jönköping and Forum Östergötland at Linköping University, Linköping University Hospital. Forum Southeast works with regional coordination and contributes to national collaboration – all to facilitate the implementation of clinical studies.
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