Objective
This internet-based survey will capture information about COVID-19 cases among patients with hidradenitis suppurativa (HS) to improve treatment of HS patients.
Background and Significance
The World Health Organization (WHO) declared a pandemic in 2020 caused by COVID-19, an infection caused by a novel coronavirus called SARS-CoV-2. Patients with underlying chronic health conditions and those who are taking immunomodulatory medications are thought to be at increased risk of poor outcomes. Collecting information about COVID-19 outcomes among HS patients, many of who are on immunomodulating medications, will allow clinicians to provide advice and improve the care of such patients.
Study Methods
Pediatric and adult patients with HS who have confirmed or suspected COVID-19 will be identified by treating clinicians. De-identified patient data will be entered into a web-based survey developed and hosted by UCSF using the secure REDCap tool. Data will be hosted on a UCSF server with data and privacy protection procedures in place. A unique computer-generated study identifier will be assigned to each patient at the time of data entry. Data to be collected includes information about HS disease status, immunomodulatory medications, and COVID-19 diagnostics, treatments and outcomes. PHI such as patient names or date of birth will not be collected. Providers entering data into the registry may retain the unique study identifier if they would like to later enter updated case information.
Data will be analyzed for relationships between disease severity and activity, age, comorbidities, medication exposure, and outcomes such as hospital admission, ICU admission, intubation, and death. Care will be taken to account for confounding and to interpret data correctly with respect to correlation and causation. Information will be analyzed and shared regularly in order to inform management of the HS patient population during the COVID-19 pandemic.
The case report form is estimated to take approximately 5-7 minutes to complete. The database contains only de-identified data, in accordance with HIPPA Safe Harbor De-Identification standards.
Human Subjects Research Determination
The UCSF Institutional Review Board has determined that this study constitutes quality improvement/surveillance research, and not human subjects research. The database contains only de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards. Therefore, under federal regulations, this study does not require IRB approval.
This IRB determination is available here. Given exempt status, individual sites should not need to obtain individual IRB approvals, but should check with their local IRBs if there are more stringent procedures in place locally.
Potential Study Risks
This study poses minimal risk. There is a very small risk of a breach of confidentiality of medical record information and associated privacy, which is mitigated by 1) collecting de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards. and 2) assigning a unique coded study identifier to each reported patient.
Potential Study Benefits
We are collecting data with the goal of rapidly improving prevention and treatment of COVID-19 in HS patients. If patients whose data is captured have ongoing COVID-19 related treatment needs when changes to care are implemented, they may receive direct benefit from this study. Otherwise, there will be no direct benefits to patients whose data is captured. The greater HS patient community, however, may benefit from the insights gained through this study.
Potential Future Data Uses
With IRB review, these data may be used in other studies performed by the Global HS COVID-19 Registry or by contributing organizations to evaluate the relationship between HS, immunomodulatory medications, and health outcomes.
Dissemination of Outcomes
The de-identified data collected as part of this study will be maintained at UCSF on a secure server, and updated aggregated data will be shared with the HS community and the public regularly via the hscovid.ucsf.edu website, through listservs and social media, and via scholarly publications. We anticipate that results will be used to inform national and international clinical management of HS patients and may ultimately be published in peer-reviewed journals.
Any questions about the Global HS COVID-19 Registry should be directed to [email protected].