For doctors

TREATswitzerland in brief

1. target setting

As there is currently no structured and detailed data on the treatment of atopic dermatitis (AD) in Switzerland, a register is intended to remedy this situation. It will provide data on the medical care of patients with AD for healthcare research and enable studies on the efficacy and safety of approved AD therapies in daily life.

The main objective of the TREATswitzerland registry project is to create a disease-focused, prospective cohort of patients with moderate and severe AD.

The primary goal is to document the medical care of patients with moderate and severe AD in order to evaluate the treatment in terms of its effectiveness and appropriateness.

Further goals of the AD register are

• Assessing the psychosocial impact of AD;
• The provision of up-to-date epidemiological data that allows risk factors for favorable or unfavorable disease progression and comorbidities to be investigated; and
• The establishment of a research network and the promotion of clinical research projects.

2. implementation

The TREATswitzerland register study is under the auspices of the SGDV. It is set up and managed by the main study center, the University Clinic for Dermatology and Venereology of the Inselspital, Bern University Hospital.

Study centers are to be set up throughout Switzerland at university hospitals, cantonal hospitals and in medical practices, where patients with AD will be cared for and included in the registry.

Study centers participating in TREATswitzerland are:

• University Clinic for Dermatology Inselspital Bern
  Prof. Dr. med. Dagmar Simon

• Dermatology & Skin Care Clinic, Ennetbürgerstrasse 36, 6374 Buochs
  PD Dr. med. Ahmad Jalili

• University Hospital Basel, Petersgraben 4, 4031 Basel
  Prof. Dr. med. Karin Hartmann, Head of Allergology

• PLAZA Clinics, Oberlandstrasse 100, 8610 Uster
  Dr. med. Tobias Plaza

• Lucerne Cantonal Hospital, Center for Dermatology and Allergology, 6000 Lucerne 16
  Prof. Dr. med. Christoph Brand

• HOCH Health Eastern Switzerland, Cantonal Hospital St. Gallen, Clinic for Dermatology, Venereology and Allergology
  Rorschacherstrasse 95, 9007 St. Gallen
  Dr. med. Ieva Saulite

• Cantonal Hospital Fribourg / HFR Hôpital Cantonal de Fribourg, Dermatology
  Chem. des Pensionnats 2/6, 1752 Villars-sur-Glâne
  Dr. med. Basile Page

• Centre hospitalier universitaire vaudois / CHUV, Dermatologie Beaumont 29
  1011 Lausanne
  Dr. med. Teofila Caplanusi

• Zurich City Hospital Europaallee Institute of Dermatology and Venereology
  Gustav-Gull-Platz 5, 8004 Zurich
  Dr. med. Siegfried Borelli

• Hôpitaux universitaires de Genève (HUG), dermatologie et vénéroéologie
  Rue Gabrielle Perret-Gentil 4, 1205 Genève
  Prof. Dr. med. Wolf-Henning Boehncke
  

3. study design

TREATswitzerland is a prospective, national multicenter registry for adolescents and adults (patients aged 12 years and older) suffering from moderate to severe AD.

Inclusion criteria:

1. Age ≥ 12 years
2. Moderate to severe AD defined as
3. AD according to the diagnostic criteria of the UK Working Party

4. number of cases

The aim is to include 700 patients and observe them for at least 2 years.

5. visits

6. study criteria

Questionnaires on demographics and AD:

• Medical history (general, AD-specific)
• Examination and documentation of skin status (severity: SCORAD, EASI, global assessment of the examiner, body surface area)
• Documentation of the prescribed therapy, reasons for the treatment decision, adverse drug reactions of AD therapy

Patient questionnaires:

• Socio-demographic characteristics
• History of AD, adherence to therapy
• Quality of life (DLQI, CDLQI)
• AD symptoms (POEM, pruritus NRS, sleep disorders NRS)
• Disease progression of AD (number of weeks with complete/good disease control in the last 12 weeks)
• Impairment of the ability to work/educate due to illness
• Symptoms of depression (CES-D)
• Fatigue (FSS)
• Benefits and needs in therapy (PBI; Patient Benefit Index), satisfaction with treatment.

7. organization

The registry study started in June 2022.

8. procedure

If possible, the register visits should be carried out together with the regular check-ups. This is a non-interventional study. The treatment of patients is determined according to their condition and severity of AD and is the responsibility of the treating dermatologist at the study center.

If serious side effects of the therapy occur, these must be reported to Swissmedic by the treating physicians at the study center via BASEC within 7 days (HRO Art. 21).

The following steps are necessary before each patient is included:

• Review of the inclusion criteria
• Obtaining the patient’s consent

The data for the TREATswitzerland register is collected electronically. The REDcap® data collection used for this purpose is operated by SwissRDL at the Institute of Social and Preventive Medicine at the University of Bern.

At the study center, the data from the visit/medical examination can be entered and saved online in the TREATswitzerland Register database.

During the visit, patients are given access to the questionnaires via a QR code, which they can complete directly on a tablet.

9. management

The AD Register TREATswitzerland is managed by the Swiss Society of Dermatology and Venereology (SGDV) (sponsor). The cooperation between TREATswitzerland and the study centers is regulated by agreements.

The principal investigator of the study is Prof. Dr. med. Dagmar Simon, Inselspital, University Hospital Bern.

Project support is provided by a scientific advisory board made up of representatives from the study centers. It coordinates and decides on the further use of the register data for research purposes and their publication.

10. publication

The register data will be analyzed and published as follows:

• Annual report on demographic data and treatments to the SGDV
• Annual report on demographic data and treatments to the sponsors as well as company-specific information on the type and number of treatments with their drugs. The transfer of data is contractually regulated between SGDV and the industry partners.
• Scientific publications.

Study director
Prof. Dr. med. Dagmar Simon