Request for participation in STUDY

NORWAY SPRINT

This is a request to you to participate in a research project that involves testing a new treatment strategy for psoriatic arthritis. The main aim of the study is to investigate whether treatment that is guided both by normal clinical examination (including blood tests) as well as the imaging examinations MR and ultrasound gives better control of disease activity than adjusting the treatment based on clinical examination. You are being asked because you are being monitored at a rheumatology department that is participating in the study and because your doctor believes that you should start with a disease-modifying drug.

What does the study entail?

You will be followed up for 2 years after inclusion in the study. All patients are followed up regularly with clinical examinations and blood tests, a total of 12 visits over the course of 2 years. All are examined with MRI and X-ray at the start, 1 and 2 years. Half of those who join the study will be drawn to receive follow-up also with ultrasound at each examination, for the other half this examination will be carried out 3 times (start, 1 year and 2 years). All patients are treated with medicines that are approved and in common use in Norway and in accordance with European recommendations. In half of the patients, the results from the MRI and ultrasound examination are also used to choose the first treatment, and to determine changes in the treatment during the follow-up. If you do not wish to participate in the study, you will be followed up according to normal procedure at the department where you have the follow-up.

In the project, we will also collect and register information about you. We will record findings from clinical examination and blood tests. You will also be asked to fill in questionnaires about your state of health, including questions about you and your background that may be relevant to psoriatic arthritis. Clinical information will normally be noted in your electronic hospital record and relevant information from your patient record at the hospital will be used in the study.

Possible advantages AND disadvantages

If you choose to participate in the study, you will receive closer follow-up than is routine at most rheumatology departments today, and the follow-up will ensure good quality and standardized assessment of treatment effect and side effects. In this way, your therapist will have a good starting point to decide whether your treatment is effective. If you end up in the patient group where treatment is also determined by findings on ultrasound and MRI, you may be able to step up treatment more quickly. This may entail a somewhat increased risk of side effects, but may also lead to faster and better treatment of the disease. The disadvantage of participating in the study is primarily that the follow-up leads to somewhat increased time consumption, as more extensive investigations will be carried out than is usual. There is no particular risk from the examinations in the study.

Voluntary participation and possibility to withdraw consent

Participation in the study is voluntary. If you wish to participate, you sign the declaration of consent on the last page. You can withdraw from the study at any time and without giving any reason without this having consequences for your further treatment.

If you agree to participate in the study, you have the right to access the information registered about you. You also have the right to have any errors in the information we have registered corrected. You also have the right to access the security measures when processing the information. If you withdraw from the study, no more information or more material will be collected from you, and if you specifically request it, collected information will be deleted. The right to demand destruction, deletion or disclosure does not apply if the material or information has been anonymised or published. This access can also be restricted if the information has been included in carried out analyses, or if the material has been processed.

If you later wish to withdraw or have questions about the study, you can contact study staff at the center where you are being monitored.

HERE YOU FIND THE CONTACT INFORMATION FOR YOUR LOCAL STUDY CENTER IN THE CONSENT YOU OBTAIN AT THE HOSPITAL

What happens to the samples and INFORMATION about you?

The samples taken from you, and the information recorded about you, must only be used as described in the purpose of the study.

All the information and samples will be processed without names and national identification numbers or other directly identifying information. A code links you to your information and tries through a list of names. The list that can link your name to the code will only be kept at the hospital and only personnel responsible for the study will have access to it.

In addition, information necessary for analyzes of side effects, medical events and health economic calculations can be obtained from the following sources: 1) The history database FD-Trygd from the Central Statistics Office 2) Norwegian Patient Register 3) Municipal patient and user register (IPLOS) 4) KUHR database 5) Prescription register 6) Cause of death register 7) Cancer register 8) National cardiovascular register 9) Notification system for infectious diseases (MSIS). In all relevant links mentioned above, data will be de-identified. The information will be deleted 5 years after the final report for the study has been written and no later than 1 January 2041. We would like to have the opportunity to contact you again later for follow-up studies and ask for your permission to do so.

Publication of results is a necessary part of the research process. All publication must be done so that individual participants cannot be recognised, but we are obliged to inform you that we cannot rule out that this may happen.

GENETIC STUDIES

Blood samples will be taken for freezing which can later be used for DNA research. Only genetic factors that are relevant for psoriatic arthritis are examined, and permission will be specifically sought from the Regional Ethics Committee before the examinations are carried out. The surveys will only be done at group level, and you will not receive individual feedback about the results. If you do not want genetic tests to be carried out on blood samples from you, you can make a reservation against this at the end of this form.

Approval

The Regional Committee for Medical and Healthcare Research Ethics has assessed the study, and has given prior approval [Insert case no. at REK (20xx/yyyy)]

According to the new Personal Data Act, the controller for your personal data, Diakonhjemmet Sykehus and project manager, Siri Lillegraven, has an independent responsibility to ensure that the processing of your data has a legal basis. We process the information based on the EU's personal data protection regulation article 6 a and 9 no. 2 a and your consent.

You have the right to complain about the processing of your information to the Norwegian Data Protection Authority.

Contact details

HERE YOU FIND THE CONTACT INFORMATION FOR YOUR LOCAL STUDY CENTER IN THE CONSENT YOU OBTAIN AT THE HOSPITAL

Further information about the study can be found in chapter A - in-depth explanation of what the study entails.

Further information on biobanking, privacy, finances and insurance can be found in chapter B – Privacy, biobanking, finances and insurance.

Declaration of consent follows chapter B.  – Signed by the person who agrees to participate in the study. The person who has informed about the study can confirm that the information has been provided.

The declaration of consent has been removed in this version that is published online.

Chapter A - in-depth explanation of what the study entails

Background information about the study

Modern treatment strategies for arthritis involve close follow-up and that the treatment is directed towards a predetermined treatment goal. The treatment is adapted to the disease activity, so that it is stepped up in the case of high disease activity until the patient achieves remission - that is, a condition without or with minimal symptoms and signs of inflammation. This concept is well developed for rheumatoid arthritis and has shown very good results. Psoriatic arthritis is a disease with great variation in disease expression and it can be difficult to assess disease activity during a normal clinical examination. The purpose of the study is to investigate whether one gets better results from treatment if the doctor has information from MRI and ultrasound in addition to the usual clinical examination.

Overview of study visits, examinations and expected time spent

All included patients will be examined at the start of the study, once per month for the first 4 months, then every other month until 12 months and every 4 months thereafter. Some will need further investigations, e.g. when changing treatment.

Expected time spent depends on what is done on each individual study visit. As a general rule, you must count on approx. 1 hour for blood sampling, filling in questionnaires and clinical examination. Annually, there will be an extended visit and then time will be added for diagnostic imaging examinations, which will take approx. 10 minutes for X-ray examinations, approx. 60 minutes for an MRI examination and approx. 30 minutes for ultrasound. The participants who are followed by ultrasound at each examination will have approx. 30 minutes longer examination time also at the other examination times. The participants in this study will, as far as possible, be followed up by the same team of nurses and doctors on all study visits. Below is an overview of what happens at each survey time.

*Performed at each examination in half of the patients

Advantages, disadvantages and potential side effects

The advantages and disadvantages of participating in the study are described in the first part of the consent form. All the preparations included in the study are approved and have marketing authorization in Norway. If you choose not to participate in the study, your further treatment will be determined by your attending physician. In total, approx. 200 patients will be included in the study, distributed among 10-12 study centres.

Possible consequences of new knowledge

If new information becomes available during the study period and is of such a nature that it may affect your participation in the study, you will be informed of this as soon as possible. You will also be informed of decisions or situations that may lead to the study ending sooner than planned as soon as possible.

Chapter B - Privacy, biobanking, finances and insurance

What information about you is collected?

Information recorded about you is age, sex, height, weight, education, occupational status, possible risk factors, use of medication, possible side effects, other diseases, results from clinical examination and health information questionnaires, results from imaging examinations and results from blood and urine tests .

In addition, information necessary for analyzes of side effects and health economic calculations can be obtained from the following sources: 1) The FD-Trygd historical database from Statistics Sweden. This database contains information about social assistance, movements in the social security system and the labor market, diagnoses, as well as other relevant background information. 2) Administrative and medical information related to the use of specialist healthcare services from the Norwegian Patient Register. 3) The municipal patient and user register (IPLOS) database which contains data on municipal nursing and care services. 4) The KUHR database which contains information on work capacity and consumption of healthcare services 5) The prescription register which contains information on the prescription of medicines 6) The cause of death register which contains information on deaths such as cause, time and place 7) The cancer register which contains information on all cases of cancer 8) National cardiovascular register containing information on people with cardiovascular disease 9) Notification system for infectious diseases (MSIS) which contains information on a number of Notifiable infectious diseases such as tuberculosis.

Clinical information will normally be noted in the electronic hospital record. In addition, the information will also be recorded electronically in a data storage program for research so that it can be analyzed later. Relevant information from patient records at the hospital will also be used in the study.

Representatives from Diakonhjemmet Hospital and control authorities at home and abroad can be given study information and given access to relevant parts of your record. The purpose will be to check that the study information matches the corresponding information in your journal and thus that the study information is valid and can be used in research. Everyone who gets access to information about you has a duty of confidentiality.

What happens to samples taken from you?  

A blood sample taken from you must be stored in a research biobank associated with the Diakonhjemmet Hospital. Professor Espen Haavardsholm, head of the Department for Research and Innovation at Diakonhjemmet Hospital, is responsible for the biobank. The biobank is planned to last until 15 September 2035. After this, the material will be destroyed/deleted according to internal guidelines. The biological material can only be used after approval from the Regional Committee for Medical and Health Research Ethics (REK). The biobank ceases at the end of the study.

COOPERATION WITH OTHER RESEARCH GROUPS AT HOME AND ABROAD

In some cases, it may be relevant to analyze collected samples and data in collaboration with other research groups in Norway and abroad. In such cases, the data will be de-identified, i.e. without name, social security number or other directly identifiable information. This applies to all collected data and samples, including genetic analyses. By participating in the study, you agree that information collected in the study can be transferred abroad as part of research collaboration and publication in line with the purpose of the study. Diakonhjemmet Sykehus is responsible for the transfer of information taking place in accordance with Norwegian law and the EU's privacy legislation (GDPR). The code that links you to your personally identifiable information will not be disclosed.

Financing

The study and the biobank are financed by Diakonhjemmet Sykehus through research funds from Health South-East and the Research Council. The project manager and others working with the project have no form of financial gain linked to the project. The clinical examination is part of the usual business at the departments, and blood tests, diagnostic imaging and clinical examinations that are perceived as appropriate for your medical condition will usually be carried out regardless of whether you participate in the study or not. The same applies to drug treatment. You will therefore pay normal deductibles, but you will not pay for any additional examinations which are not part of normal clinical practice and which are carried out under the auspices of the study. This will particularly apply to X-rays and MRI examinations.

Insurance

You are insured in accordance with the Patient Injury Compensation Act.

Information about the outcome of the study

The outcome of the study will be presented in international journals and at international congresses. After the results of the study have been published, all participants will be sent a summary with information about the outcome of the study. In addition, a popular science presentation of the results will be presented in national patient journals.

IN THE ORIGINAL VERSION HERE IS A SIGNATURE PAGE THAT HAS BEEN REMOVED FOR ONLINE PUBLICATION