Trial Summary
What is the purpose of this trial?The overarching goal of this study is to develop a direct-to-patient screening approach that will improve early Psoriatic Arthritis (PsA) detection in patients with psoriasis. Previously developed screening questionnaires were intended for use in the setting of a doctor's office to assist providers with referral decisions. However, these screening questionnaires are infrequently used in routine practice because of limitations with time and resources. The study will aim to develop a practical screening strategy that does not require involvement from dermatologists (or other non-rheumatology providers) and can systematically reach a broad range of psoriasis patients, including patients not attending dermatology clinics. The researchers hypothesize that disseminating questionnaires directly to patients outside of a clinic setting (direct-to-patient approach) will educate patients about their PsA risk and improve early PsA diagnoses.
Is the PsA Screening Questionnaire for Psoriatic Arthritis a promising treatment?The PsA Screening Questionnaire is not a treatment but a tool to help identify psoriatic arthritis in people with psoriasis. It is promising because it helps doctors find the condition early, which can lead to better management and care for patients.12367
What safety data exists for PsA screening questionnaires?The available research does not provide specific safety data for the PsA screening questionnaires like ToPAS, PEST, or PASE. These tools are designed to screen for psoriatic arthritis in patients with psoriasis and are evaluated for their effectiveness, sensitivity, and specificity rather than safety. Further validation and comparative studies are ongoing to assess their performance in different populations.12357
What data supports the idea that PsA Screening Questionnaire for Psoriatic Arthritis is an effective treatment?The available research shows that the Psoriasis Epidemiology Screening Tool (PEST) is effective because it is simple and easy to use, with a high sensitivity of 0.94, meaning it correctly identifies 94% of people who have psoriatic arthritis. This makes it a useful tool for general practitioners and dermatologists to identify patients who may need further evaluation. The Toronto Psoriatic Arthritis Screen (ToPAS) and its updated version, ToPAS 2, have also been validated as effective screening tools, helping to distinguish between those with and without psoriatic arthritis. However, the research suggests that these tools still need further refinement and validation to improve their performance.12347
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults over 18 with a diagnosis of psoriasis who haven't been diagnosed with Psoriatic Arthritis. Participants should live close to the study site and have not started any treatment for Psoriatic Arthritis.Inclusion Criteria
I am 18 years old or older.
I have been diagnosed with psoriasis but not with psoriatic arthritis.
Exclusion Criteria
I have psoriasis and a rheumatologist confirmed I also have psoriatic arthritis.
Treatment Details
The study is testing a new way to find out if people with psoriasis might also have Psoriatic Arthritis using a questionnaire that patients can fill out on their own, without needing to visit doctors' offices.
3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention with Standard of Care ReferralExperimental Treatment1 Intervention
Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions to talk with their doctor about a referral to a rheumatologist
Group II: Intervention with Direct Access to RheumatologistExperimental Treatment1 Intervention
Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions on how to directly schedule a rheumatologic evaluation
Group III: ControlActive Control1 Intervention
Psoriasis patients with no prior diagnosis of PsA randomized to not receive an intervention PsA questionnaire
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of UtahSalt Lake City, UT
University of PennsylvaniaPhiladelphia, PA
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Who is running the clinical trial?
Jessica WalshLead Sponsor
References
Toronto Psoriatic Arthritis Screening (ToPAS) questionnaire: a report from the GRAPPA 2009 annual meeting. [2015]The Toronto Psoriatic Arthritis Screening questionnaire (ToPAS) was developed as a tool to screen for psoriatic arthritis (PsA) in patients with psoriasis as well as in the general population. Thus, it differs from PsA-specific screening tools and may be used to screen for PsA in epidemiologic and family investigations. In a presentation at the 2009 annual meeting of GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) in Stockholm, Sweden, the authors described the development, testing, and validation of the ToPAS tool. Results of a comparison of the ToPAS questionnaire with the Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire were also presented. Modification and further validation of the ToPAS are under way.
Psoriasis Epidemiology Screening Tool (PEST): a report from the GRAPPA 2009 annual meeting. [2015]Patients with psoriasis attending general practitioner and dermatology clinics may complain about their joints, but it may be difficult for the nonrheumatologist to distinguish psoriatic arthritis (PsA) from other forms of arthritis. A screening tool for PsA would therefore be useful to both general practitioners and dermatologists and help identify patients for further evaluation by a rheumatologist. Although several screening tools have been developed, the Psoriasis Epidemiology Screening Tool (PEST) has the advantage of simplicity and ease of use. This new instrument consists of 5 simple questions supported by the addition of a manikin for patient markup. During development, the questionnaire has shown a sensitivity of 0.94 and a specificity of 0.78. Further validation of this and the other questionnaires is now required. A "head to head" study of the PEST, ToPAS (Toronto Psoriatic Arthritis Screening questionnaire), and PASE (Psoriatic Arthritis Screening and Evaluation) tools is planned in a secondary-care population with psoriasis. This study is important not only to confirm the comparative performance of the instruments, but also to confirm the high figures for sensitivity in a secondary-care population.
High prevalence of psoriatic arthritis in patients with severe psoriasis with suboptimal performance of screening questionnaires. [2022]The objectives of this study were to: (1) assess the prevalence of psoriatic arthritis (PsA) among Psoriasis (Ps) patients attending dermatology clinics; (2) identify clinical predictors of the development of PsA; and (3) compare the performance of three PsA screening questionnaires: Psoriatic Arthritis Screening and Evaluation (PASE), Psoriasis Epidemiology Screening Tool (PEST) and Toronto Psoriatic Arthritis Screening (ToPAS).
Validation of the Toronto Psoriatic Arthritis Screen Version 2 (ToPAS 2). [2022]We previously developed and performed an initial validation of a screening questionnaire, the Toronto Psoriatic Arthritis Screen (ToPAS), for psoriatic arthritis (PsA). In our original analysis, we found that the index constructed appeared to discriminate well between those with a confirmed diagnosis of PsA and those without PsA in various clinical settings. However, it was suggested that ToPAS would benefit from additional refinement to the questions and the scoring system, because items pertaining to axial involvement were not included in our original index. Subsequently, a second version of ToPAS was developed, ToPAS 2, which incorporated the suggested refinements. We aimed to validate ToPAS 2 as a screening instrument for PsA.
Utilization of the validated Psoriasis Epidemiology Screening Tool to identify signs and symptoms of psoriatic arthritis among those with psoriasis: a cross-sectional analysis from the US-based Corrona Psoriasis Registry. [2020]Despite increasing awareness of the disease, rates of undiagnosed psoriatic arthritis (PsA) are high in patients with psoriasis (PsO). The validated Psoriasis Epidemiology Screening Tool (PEST) is a five-item questionnaire developed to help identify PsA at an early stage.
Validation of the Simple Psoriatic Arthritis Screening (SiPAS) questionnaire in a Turkish psoriatic population. [2021]Screening of psoriatic arthritis (PsA) in patients with psoriasis (PsO) is critical for the prevention of irreversible joint erosions, deformity, and disability. The SiPAS questionnaire is a short, simple and useful tool designed to screen PsA. This study aimed to evaluate validity of the SiPAS questionnaire in Turkish patients with PsO.
Assessment of the Toronto Psoriatic Arthritis Screen 2 as a Screening Tool for Psoriasis. [2022]Psoriasis is a chronic inflammatory disease affecting multiple organ systems and resulting in reduced quality of life for many patients. A screening tool would be useful, particularly in underserviced or research settings with limited access to dermatologists. The Toronto Psoriatic Arthritis Screen, version 2 (ToPAS 2) is a validated screening tool for psoriatic arthritis containing questions specific for psoriasis.