Abstract
Changes in severity of psoriasis and psoriatic arthritis (PsA) are assessed in clinical trials by a variety of physical examination instruments. At the 2010 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), members were updated on the development and availability of modules that teach these instruments. Web-based interactive multimedia presentations for psoriasis assessments have been completed, including modules for Psoriasis Area and Severity Index and Body Surface Area, 5-point and 6-point Physician Global Assessment, the original and modified Nail Psoriasis Severity Index, the Palmar-Plantar Pustular Psoriasis Area and Severity Index, and the Psoriasis Scalp Severity Index. Rheumatology modules will include assessment of tender and swollen joints, and evaluations of enthesitis, dactylitis, and axial disease. Each module will include the background and rationale for each tool, demonstration video of each examination, diagrams and photographs to emphasize teaching points, and an optional examination at the end. The rheumatology modules have been recorded but were not yet available for review at the meeting. The dermatology modules are currently in use by pharmaceutical and biotechnology companies engaged in research on treatments for psoriasis and PsA. The next phase of this project includes analysis of interobserver reliability, translation into languages other than English for international users, and other proposed studies.
The clinical features and severity of psoriasis and psoriatic arthritis (PsA) are assessed through physical examination measures by trial investigators and by clinicians in everyday practice. Widely accessible, standardized training modules for these measures have not been generally available. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), comprising dermatologists and rheumatologists with expertise in evaluating psoriatic disease, has worked with KIT Digital (formerly Accela Communications; Southborough, MA, USA) to create several multimedia tutorials intended to train the user on clinical measures of psoriasis, psoriatic nail disease, and PsA commonly used in the study setting. At the 2010 GRAPPA meeting in Miami, FL, USA, attendees were updated on the development and availability of these tools.
The rationale for this project resides in the need for training of psoriasis and PsA trial endpoints. For the most part, investigators must obtain instruction on these assessments during clinical fellowships or at investigator meetings. Trial sponsors provide education on efficacy assessment in order to meet the expectations of regulatory agencies. For most psoriasis studies, lead investigators typically provide either slide-based presentations at live investigator meetings or via Web-based teleconferences. Sponsors of PsA studies frequently employ live-patient demonstrations to ensure that joint counts are performed accurately, but newer assessments for enthesitis and dactylitis have not been widely used or taught.
GRAPPA contracted KIT Digital to produce Web-based training modules. The instructional portion of each module contains a video of an expert in the field who provides background information on the measure and actively demonstrates the examination using photographs and via video with actual patients. Most of the dermatology modules have an examination portion that allows demonstration of comprehension of the instrument (“certification” portion). The currently available dermatologic assessment modules include: Psoriasis Area and Severity Index (PASI)1 with training in body surface area (BSA) using a handprint method (one handprint = 1%)2, the Psoriasis Scalp Severity Index3, Physician Global Assessment (PGA) with both a 5-point (0—4) and 6-point (0—5) scale4, the original and modified Nail Psoriasis Severity Index (NAPSI)5,6, and the Palmar-Plantar Pustular Psoriasis Area and Severity Index (PPPASI)7. The rheumatology training modules are not yet available online, but will include assessment of tender and swollen joints used in the American College of Rheumatology criteria, Disease Activity Score, and other composite arthritis scores8, and evaluations of enthesitis, dactylitis, and axial disease9,10,11.
GRAPPA members are able to access the dermatology modules through the GRAPPA website (http://grappanetwork.org/) using their login and password; pharmaceutical sponsors who have a licensed agreement to use the modules have the option of developing a customized landing page and password-protected entry as well as customized training modules for individual study requirements.
The PASI/BSA module is the prototype. After completing the registration process, users are able to view the 16.5 minute instructional video on performing PASI/BSA assessments. Once the entire module has been viewed, users may navigate backward and forward to review portions of the video as desired. When ready, users may move to the certification portion, which consists of patient examples for practice scoring. In order to receive credit for completion, one must provide scoring for each of these examples. As users enter their scores and click “submit,” graphs that provide the distribution of consensus scores by experienced dermatologists can be viewed. This allows the user to compare his or her scoring to that of others. After all scores have been entered, a Certificate of Completion can be printed for documentation of training. Currently, 2 pharmaceutical sponsors are under license agreement to use these educational modules for training investigators on efficacy endpoints for clinical trials.
The next phase of this project will involve validation of these training modules to determine their effectiveness in improving comprehension and competence of those performing these assessments. Project managers are able to download user data, which will allow inter- and intrarater reliability to be assessed and provide descriptive statistics for current industry users. This offers a benefit over traditional training offered at investigator meetings, where effectiveness of the educational measures and investigator reliability cannot readily be measured.
Given that opportunities for training in these physical examination assessments are scarce outside the clinical trial setting, these modules may prove useful in other arenas, such as training for clinicians who enter patients in longterm clinical registries, online standardized training for dermatology residents and rheumatology fellows, and online education for clinicians interested in improving their physical examination skills when evaluating patients in clinical practice. GRAPPA plans to translate the videos into other languages for international users and is interested in developing additional modules, including assessment tools such as surveys or composite measures and topics of continuing medical education.
