Abstract
Numerous physical examination instruments are used to assess and measure severity of psoriasis and psoriatic arthritis (PsA) in practice and in clinical trials. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has developed several online training modules used by GRAPPA members and investigators participating in psoriasis and PsA research. At the 2011 GRAPPA meeting, attendees were updated on the ongoing development of the training modules. Several Internet-based multimedia presentations for psoriasis and PsA assessments have been completed. Available psoriasis modules include the Psoriasis Area and Severity Index (PASI) and Body Surface Area, one 5-point and two 6-point Physician Global Assessments, the original and modified Nail Psoriasis Severity Index, the Palmar-Plantar Pustular Psoriasis Area and Severity Index, the Psoriasis Scalp Severity Index, and the Total Plaque Severity Score. Rheumatology modules that demonstrate evaluation of swollen and tender joints, enthesitis, and dactylitis are now available, and an axial disease evaluation module is near completion. Each video includes the background and rationale for each measure, demonstration videos of select examinations, diagrams, and photographs to emphasize teaching points, and for most dermatology modules, an optional test to assess competence. Preliminary data generated by a pilot study of pre- and post-education PASI scoring by experienced and naive physicians and patient assessors were presented, revealing improved accuracy of scoring after viewing the PASI video. Attendees agreed that additional patient examples with more diverse skin types and psoriasis phenotypes, translation to languages other than English, and further validation studies are needed.
The clinical features and severity of psoriasis and psoriatic arthritis (PsA) can be rigorously assessed in research and in clinical practice by a variety of measurement scales. Although many instruments, such as the Psoriasis Area and Severity Index (PASI) and tender and swollen joint counts, are widely used, accessible and standardized training modules for these and other measures have not been widely available. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), comprising dermatologists and rheumatologists with expertise in evaluating psoriatic disease, in collaboration with KIT Digital (formerly Accela Communications), Southborough, MA, USA, have created several online videos intended to train clinicians and researchers on physician assessment instruments used to assess severity of psoriasis and PsA. At the GRAPPA 2011 annual meeting in Naples, Italy, an update was provided on the development and current use of these training modules.
The rationale for developing this resource resides in the need and demand for standardized and accessible training regarding psoriasis and PsA trial endpoints. In general, there is relatively little standardization of training regarding most disease measures. Most medical providers obtain instruction in performing disease measures from a combination of on-the-job training from senior investigators and at investigator meetings. However, there is little training opportunity with newer instruments, such as those that measure enthesitis and dactylitis, which are not widely used. The inherent limitations of the instruments, variations in training, and limited experience with newly introduced measures are just a few of the challenges faced by trial sponsors. The GRAPPA videos provide exposure to newer assessment tools as well as standardized demonstration of established tools such as the PASI.
Since the GRAPPA video project was started in 2009 updates from previous meetings have reported on progress of the current array of videos1,2. Briefly, each module consists of an instructional video where an expert in the field provides background information on the measure and actively demonstrates examination using photographs and video footage of assessments performed on volunteer patients. Most of the dermatology modules include a certification portion emphasizing comprehension of the instrument. Each module was developed in collaboration with KIT Digital, which streams the training modules on the Internet. GRAPPA members are able to access the dermatology modules through the GRAPPA website using their login and password (http://grappanetwork.org/). 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 currently available dermatologic assessment modules include the PASI3, with training in body surface area (BSA) using a handprint method (one handprint = 1%)4; the Psoriasis Scalp Severity Index5; Physician Global Assessment with both a 5-point (0−4) and 6-point (0−5) scale6; the original and modified Nail Psoriasis Severity Index7,8; the Palmar-Plantar Pustular Psoriasis Area and Severity Index9; and the Total Plaque Severity Score, which is intended for scoring target lesions. Recently available rheumatology training modules include demonstration of tender and swollen joints used in the American College of Rheumatology criteria, Disease Activity Score, and other composite arthritis scores10, and evaluations of enthesitis and dactylitis. An axial disease module is in development11,12,13.
The prototype module, which reviews the PASI and BSA, has been the most widely accessed. Over 700 individuals have viewed the video and completed the 16.5 minute instructional video and certification portion on performing PASI/BSA assessments. Details of the registration, navigation, and certification processes have been described1,2. In brief, following registration, a password-protected video can be accessed, and then 3 sets of patient photographs are made available for scoring and comparison to scores of a consensus panel. Following completion of the scoring segment, a certificate can be printed. Registration, viewing time, and scores can be verified via KIT Digital’s web response system, which allows licensed users (such as industry sponsors who require training compliance) to download these data.
Although formal validation studies have not yet been conducted, pilot data presented at this meeting suggest the PASI training video is effective at improving the accuracy of PASI scoring. A study being conducted by April Armstrong, MD, MPH, at the University of California, Davis, USA, showed that after viewing the training module, PASI-naive dermatologists and patients with psoriasis assigned PASI scores that were closer to those of experienced PASI users. Final analysis of this study is under way.
In summary, although there are inherent limitations to online video training of psoriasis and PsA measures, the GRAPPA training modules have been of continued interest to both experienced and inexperienced evaluators and industry sponsors. In addition to completion of the rheumatology modules and validation studies, several modifications and improvements to existing modules have been suggested. Additional patient examples to increase the range of disease severity and of skin types are needed. Translation or subtitling in languages other than English is of interest to the international community. The online platform would also lend itself well to continuing medical education modules. Suggested topics included reviewing available PsA screening instruments (e.g., Psoriatic Arthritis Epidemiology Screening Tool, Psoriatic Arthritis Screening Evaluation, and Toronto Psoriatic Arthritis Screening)14,15,16 and online education for clinicians interested in improving their physical examination skills.