Purpose of the Study

You are invited to participate in an observational study that aims to investigate the natural history, treatment practices, health impact, and patient-reported outcomes (PROs) related to psoriasis. By participating, you will help us gain insights into symptoms, disease progression, treatment outcomes, quality of life, work productivity, and healthcare gaps related to psoriasis.

Can I participate?

You are eligible to participate if you meet the follow criteria:

• You are an adult in the US over the age of 18

• At some point in your life you have been told by a doctor that you have psoriasis

What Will Happen During the Study

If you agree to participate, you will be asked to:

1. Enroll in the Study: You will be asked to electronically sign a copy of this informed consent form, enrolling you in the study.

2. Authorize a Connection to your Providers’ Patient Portals: You will be asked to contribute personal information relating to your health history to the study through a platform called Unite. Unite is a free online research platform that makes it easy for individuals to centralize and view their medical history data across different providers and share it for research. The Unite platform is integrated with thousands of healthcare provider patient portals (the ones you have used may be called something like MyHealth, MyChart, etc.), enabling you to connect, import, and view your electronic health records (EHR) data from multiple providers in one integrated view. To contribute your medical history data to the study, you will simply use Unite’s search tool to search for the name of the healthcare providers that may have records related to your psoriasis, and follow the on-screen steps to authorize the import-only connection that will allow the Unite platform to import your records.  The process typically takes 30 seconds or less per provider. Once you authorize the connection, the Unite platform will initiate the process of retrieving your records from the provider’s system, which typically completes in about 1 minute. After the import is complete, you will see a screen describing the data that was imported. These data typically include information relating to: 

• Measurements and assertions (lab data, device measurements, clinical assessment tool scores, etc.)

• Diagnoses

• Conditions

• Problems

• Procedures

• Family history

• Detected issues (drug-drug interactions, duplicate therapies, etc.)

• Imaging results (x-ray, CT, MRI, etc.)

• Medications and administrations

• Responses to questionnaires administered by your health team (social history, patient intake forms, research questionnaires, case report forms, etc.)

• Records of samples taken

• Diagnostic reports

• Allergies

• Providers and members of care team

• other information of this kind

3. Complete Patient-Reported Outcomes (PRO) Questionnaires: You will be asked to complete several brief questionnaires every 3 months via the Unite Portal to assess your symptoms, quality of life, work productivity, and treatment satisfaction. These questionnaires include:

• Psoriasis Symptoms and Signs Diary (PSSD): 11 questions that assess symptom severity and impact over the past 7 days.

• Dermatology Life Quality Index (DLQI): 10 questions that evaluate the impact of psoriasis on your quality of life over the past week.

• Patient Benefit Index (PBI): 50 questions that measure achievement of therapy goals from your perspective.

• Work Limitations Questionnaire (WLQ): 25 questions that assess the impact of psoriasis on your work productivity.

• Scalp-Specific Itch Numeric Rating Scale (NRS): 1 question that measures the severity of scalp itching over the past 24 hours.

These questionnaires will be administered upon enrollment and every three months thereafter throughout your participation in the study. The data you provide will help us understand the relationship between your patient-reported outcomes and clinical data from your EHR.

Ongoing Data Collection:

You may be asked to authorize the connection with a given provider to be maintained in the background for up to 1 year so that the system can periodically check for new records and update the data in your Unite Portal account. If the connection with one of your providers has expired, you may be asked to reconnect it so that your Unite data can be refreshed. Throughout the study, you will be able to use your Unite Portal account to view any data that was imported from any providers you have previously connected. You may also be asked to provide additional information or complete questionnaires via the Unite Portal.

Compensation

As compensation for your time and effort, you will receive a $10 Amazon gift card upon the first successful retrieval of your EHR data. Additionally, you will receive a $5 Amazon gift card for each round of PRO questionnaires you complete throughout the study until you have completed at least 4 rounds.

Duration

The recruitment phase is estimated to last 6-12 months to reach our target of 1000 participants. Your participation may continue as long as you are willing to contribute both EHR and PRO data to the study. Data collection and analysis will be ongoing throughout the study.

Risks

The risks associated with participation are minimal. The primary risk is a potential breach of confidentiality, which will be mitigated by our robust data security measures. Additionally, the completion of PRO questionnaires may involve minor discomfort or inconvenience due to the time required to answer the questions.

Benefits

While there may be no immediate benefit to you, your participation will contribute to a better understanding of psoriasis, including how it affects patients' lives from both a clinical and patient-reported perspective. This may lead to improved treatment options and quality of life for the patient community in the future.

Future Research

The data collected in this study, including your EHR and PRO data, may be used for future research studies. These studies may focus on psoriasis or other health conditions, treatments, or outcomes identified in your medical history. The data may be stored and used indefinitely for these purposes. If you choose to withdraw from future research, you may notify the study team at any time. However, any data that has already been de-identified and included in research datasets will not be removed.

Confidentiality

Your data, including both electronic health records (EHR) and patient-reported outcomes (PRO) data, will be secured and kept confidential. Data will be encrypted both in transit and at rest. Data from this study may be used for future research studies, may focus on psoriasis or other health conditions, treatments, or outcomes that are observed in the data collected. We may share de-identified data (data that has been stripped of any information that could reveal the identity of a participant) with third parties with whom we may partner, such as academic research collaborators, commercial life sciences organizations, and health technology providers. Information that could identify you will never be shared without your explicit consent. The data in your Unite account will be stored indefinitely unless and until you delete your Unite Portal account. Regardless of your participation status in the study, the data in your Unite account will be handled according to Unite’s Privacy Policy and Terms of Use. 

Voluntary Participation and Withdrawal

Your participation in this study is voluntary. You may withdraw from the study at any time without penalty.  You may continue to use your Unite account even after you have withdrawn from the study. Any data collected prior to your withdrawal will remain in the study dataset, and any data that has already been de-identified and included in further research datasets will not be removed. To withdraw, notify the study team through the Unite Portal or by email to psoriasisstudy@unitegenomics.com.