Frequently asked questions.
Yes, REC approval was granted on 15th April 2020 (REC ref 20/YH/0135; IRAS Project ID 282395).
COVID-19 is a notifiable disease in my country. How does using PsoProtect fit in with my duty to report COVID-19 cases?
PsoProtect only uses de-identified data, and is completely separate from any duty to process or share confidential patient information for the purpose of managing the COVID-19 outbreak in your country.
Since only de-identified data is permitted in PsoProtect, General Data Protection Regulation (GDPR, a regulation in European Union law) technically does not apply. However, since GDPR is held up as a worldwide gold standard for best practice regarding data protection and privacy, we have nevertheless followed GDPR principles:
Data fields included in the PsoProtect survey have been carefully selected to prevent traceability of the collected data to the identities of individual people. The only people with knowledge of patient identity are the healthcare professionals entering data at local sites.
The data collected within PsoProtect is housed in secure servers that are built and hosted by UKCloud, in compliance with best practice (GDPR Article 32: technical and organisational data protection measures). The data is collected and processed solely for the purpose of scientific and medical research undertaken in the public interest (GDPR Article 6/9: legal basis for processing), and all resulting outcomes will apply robust aggregation techniques before being publicised and shared for the advancement of scientific and medical knowledge and its translation into clinical practice.
Please read our Data Privacy Notice.
Since only de-identified data is permitted in PsoProtect, no specific consent is required.
An unbiased Access Committee will review applications to access the de-identified data stored in the PsoProtect database. Specific permission to access and process datasets held within the PsoProtect database can be granted by the Access Committee. The Access Committee will take care to ensure that no combination of data fields will render patients identifiable. Datasets with de-identified data can be sent via secure email or password encrypted files. Please contact us for further information.
All research projects using PsoProtect data will be required to submit progress reports to the Access Committee, and to notify the committee in advance of any publication or sharing of results. The PsoProtect team will maintain a publicly accessible register of research projects using data from the database, which will be displayed on our website.
Applications for access to the data are not open to commercial organizations.
The PsoProtect database is based on a web-based REDCap platform. The NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust holds a licence to develop and host REDCap surveys. Study data entered within PsoProtect will be monitored according to the study protocol. PsoProtect is deployed onto virtual servers managed by the Product Team. The Product Team is responsible for ensuring successful, regular backups and availability of the PsoProtect database.
PsoProtect is funded by the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and the Psoriasis Association. The study is coordinated by an expert steering committee comprising clinical academics, epidemiologists and data scientists.
Yes, we encourage reporting of both adult and paediatric cases.
PsoProtect stores the following types of de-identified data:
- Psoriasis disease characteristics, comorbidities and systemic treatment for psoriasis at onset of COVID-19
- COVID-19 characteristics and disease course
- COVID-19 outcome
Since clinicians are advised to complete the case report form once the outcome of COVID-19 is known, only one data collection and entry point is required per patient.
PsoProtect is working closely with existing psoriasis pharmacovigilance registries to support timely and detailed reporting of COVID-19 cases. Please download your completed case report form and associated PsoProtect ID and share this with your pharmacovigilance registry, if appropriate.
- If your patient is registered to BADBIR (UK and Ireland): Please forward your completed PsoProtect case report form with the patient’s NHS number or BADBIR ID to the BADBIR Pharmacovigilance Team: firstname.lastname@example.org. If a case is reported to PsoProtect but the case report form is not available, please contact BADBIR with the patient’s NHS number or BADBIR ID, PsoProtect ID and name/email address of the reporting clinician. BADBIR can then request a copy of the PsoProtect CRF.
How does PsoProtect involve people with psoriasis and members of the public in its activities and output?
From the outset, patients and patient organisations have been deeply integrated in the design and set-up of PsoProtect. To raise awareness of this project and for future dissemination of results, PsoProtect has partnered with the major psoriasis patient and public involvement (PPI) organisations globally including the NPF (National Psoriasis Foundation), PAPAA (Psoriasis and Psoriatic Arthritis Alliance) and PA (Psoriasis Association). Any patient organisation interested in partnering with PsoProtect is welcome to contact us.
PsoProtectMe is an online self-report survey for people with psoriasis. People with psoriasis are invited to complete the survey, whether or not they have had symptoms of COVID-19. The information collected in PsoProtectMe will help to improve our understanding of patients’ experiences, symptoms and health behaviours during the pandemic.
Please continue to report your cases of COVID-19 in psoriasis using the PsoProtect case report form only.
What should I do if I need to change the information I have submitted or if my organisation requests that I delete my entry?
Please contact us via email (email@example.com) if you need to change any of the information you have submitted to PsoProtect, or if your organisation requests that you delete your entry. Please let us know your PsoProtect case reference and the date of your submission.