Psoriasis Symptom Inventory
Gain insight from assessing symptom severity in chronic plaque psoriasis
The Psoriasis Symptom Inventory (PSI) is a self-administered patient-reported outcome (PRO) measure that is intended for use in assessing symptom severity in chronic plaque psoriasis. Developed in accordance with the U.S. Food and Drug Administration’s (FDA) Guidelines for Content Validity and Instrument Performance, this eight-item symptom severity scale was initially developed to assess patient-perceived symptom severity as an endpoint in clinical trials. Clinician feedback during the development process indicated a high interest in the usefulness of this measure in standard care settings. The PSI has been used in multiple clinical trials and has supported one label claim with the FDA.
Depending on the needs of your study design, we offer the PSI using both a:
- paper/pencil “past 7-day” recall version for standard care settings (which can also be used for tablet or hand-held ePRO administration)
- “past 24 hours” recall version (collecting seven days of data and generating a weekly score) that was designed and tested for use with ePRO devices for clinical trial endpoints
Licensing information
As the contracted agency approved by the PSI copyright holder (Amgen) to license and distribute the PSI, we uphold our responsibility to protect the integrity of the PSI as it is distributed for use. This includes developing translations, adaptations and preparation for use in ePRO platforms.
All requests to use the PSI in research require a fully executed user licensing agreement before use, and use is granted for a single study only. License fees vary depending on the type of user making the request and the nature of the research. To inquire about terms and fees for licensure to use the PSI, please click on your affiliation below to access the correct form to submit with your inquiry. You will be contacted by a project manager with information relevant to your needs.
Required procedure for using the PSI with ePRO platforms:
- Initial screen format is reviewed and approved
- Microsoft Word files of translations are provided. or translations are loaded directly into the ePRO vendor’s tool
- Programmed screen reports are reviewed against base translation
- Verification letter is issued once screens are error-free
Translations available
Current lists of the available languages:
Past seven-day language list
Available in paper-pencil and ePRO formats
| Language | Country |
|---|---|
| Bulgarian | Bulgaria |
| Czech | Czech Republic |
| Danish | Denmark |
| Dutch | Belgium |
| Dutch | Netherlands |
| English | Australia |
| English | Canada |
| English | UK |
| English | Ireland |
| French | Belgium |
| French | Canada |
| French | France |
| French | Switzerland |
| German | Austria |
| German | Germany |
| German | Switzerland |
| Greek | Greece |
| Hungarian | Hungary |
| Italian | Italy |
| Latvian | Latvia |
| Lithuanian | Lithuania |
| Polish | Poland |
| Portuguese | Brazil |
| Russian | Latvia |
| Russian | Russia |
| Spanish | Chile |
| Spanish | Spain |
| Spanish | US |
| Swedish | Sweden |
Past 24 hours language list
Available in paper-pencil and ePRO formats
| Language | Country |
|---|---|
| Bulgarian | Bulgaria |
| Czech | Czech Republic |
| Danish | Denmark |
| Dutch | Belgium |
| Dutch | Netherlands |
| English | Australia |
| English | Canada |
| English | UK |
| French | Belgium |
| French | Canada |
| French | France |
| French | Switzerland |
| German | Austria |
| German | Germany |
| German | Switzerland |
| Greek | Greece |
| Hungarian | Hungary |
| Italian | Italy |
| Latvian | Latvia |
| Lithuanian | Lithuania |
| Norwegian | Norway |
| Polish | Poland |
| Portuguese | Brazil |
| Portuguese | Portugal |
| Russian | Estonia |
| Russian | Latvia |
| Russian | Lithuania |
| Russian | Russia |
| Slovak | Slovakia |
| Spanish | Chile |
| Spanish | Mexico |
| Spanish | Spain |
| Spanish | US |
| Swedish | Finland |
| Swedish | Sweden |
| Turkish | Turkey |
While the list of available translations is extensive, the process for any additional translations needed is outlined below:
- We must conduct all translation work using our preferred vendors who have a history with this COA
- Standardized methods for COA translation are followed and certification letters are provided
- The PSI developers will conduct the developer review to ensure any new translations are conceptually equivalent across all translations
- Please provide a list of required translations (country and language for each) on your submission form, and you will be provided with a cost estimate and timeline with our reply to the details of your project
Explore available PSI resources
Move forward with confidence. We have a library of resources available, including a reference list of more than 20 professional publications and scientific presentation citations showing the PSI’s use and performance. In addition, with each completed license for the PSI, you will receive a PSI User Manual providing an overview of the development and validation studies for the PRO, describing the scoring method and providing scoring syntax.
FDA label language
SILIQ™ (brodalumab) injection, for subcutaneous use
Initial U.S. Approval: 2017
14 Clinical studies
At week 12, compared to subjects in the placebo group, a greater proportion of subjects in SILIQ 210 mg Q2W group achieved a Psoriasis Symptom Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item (itch, redness, scaling, burning, stinging, cracking, flaking, pain).