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  1. 1. Hi Brian, It seems to me that we need to take a classic engineering approach: What is the current status of medical imaging for Dermatology? Which requirements are being met and which ones aren't? For the requirements that are not being met: Does it really matter? What are the consequences? Are there any agencies, professional societies, or manufacturers that care enough to invest some resources (time and/or money)? Do these deficiencies fall within the Scope of the DICOM Standards Committee or any other group? What is the probability that we can really make a difference? While you probably don't have all the answers, this should be a good opportunity for you to "Ask the experts" what they recommend as the best path forward. Howard Whither Dermatologic Imaging Standards? Brian C. Madden, Ph. D. Department of Dermatology University of Rochester What is the current status of medical imaging for Dermatology? The current status of diagnostic imaging for dermatology is centered on applications associated with pathology and teledermatology. Histological images used in dermatology suffer the same problems with massive file size as in other specialties. As a result, a compromise is often made where real-time digital video is used for presentation and consultation. Small portions of a given slide will be displayed, not enhanced in any fashion, and not archived. The vast majority of the histology slides used in dermatologic diagnosis have H&E staining. There are occasions where other stains (e.g., for T-cell markers) are occasionally used. Digital imaging has largely been adopted by dermatopathologists because of the reduction in imaging costs and the convenience of electronic display and storage. Again, the issues here are much the same as in other
  2. 2. specialties. References to capture or display functions that are unique to dermatology have not been noted in a review of the literature. There have been no occasions at grand rounds when I have been present where, despite the availability of an electronic format, any visualization aids or diagnostic filters have been used, even for educational purposes. Nonetheless, histology is used as the gold standard for dermatologic diagnosis. Looking at pixels has been accepted as equivalent diagnostic coin as looking at glass and stain. (See details in the Dermatopathology section of the proposal.) Teledermatology is the most common application of digital imaging for diagnosis in dermatology. In real-time teledermatology, the consulting dermatologist has the ability to review patient images as they are acquired and to request additional images while the patient is still present in the originating clinic. The capacity for immediate feedback offsets some of the limitations inherent in the use of video to acquire the diagnostic images. In store-and-forward teledermatology, the still images, together with the exam notes and patient history, form the complete basis for a remote diagnosis. Any problems with the image capture in this situation will often result in a callback, and possibly a delay in treatment. The image quality of the still images is usually appreciably better (better resolution, better control of lighting, and more functional control over the operation of the camera) than that available with real-time video. It is crucial that staff at the originating site are well trained in the imaging techniques they employ (video or still image) and are supplied with cameras appropriate for diagnostic imaging. Teledermatology programs can, and still do, fail with regularity because of poor image quality. (See details in the Teledermatology section of the proposal.) While there are many more promising diagnostic devices and procedures that involve imaging, none have achieved a sufficient following or have displayed an essential functionality needed to establish a consensus as to best practice and to be sanctioned by the appropriate professional societies. (See details in the Waiting in the Wings section of the proposal.) Image functions available through DICOM Secondary Capture and Visible Light utilities are commonly used to insert digital images into the medical record. Unlike for dermatopathology and teledermatology, there is frequently no clear, or even tacit, clinical role for their use. These images, acquired with unvalidated devices under uncontrolled conditions, are entered into the medical record because it is easy to do, essentially free, and there is often only a vague sense of future utility. They also serve as a reminder, of the patient and of the condition. What courses of action or inaction these images are properly constituted to support remain undetermined and undocumented. On the other end, caregivers who have
  3. 3. never seen the patient, are unfamiliar with the acquisition equipment, and are unaware of the acquisition environment are often confronted with a diagnostic quandary where they have insufficient information in hand to form a principled decision. The caregivers usually end up using whatever information is available. The question is should an electronic medical record system support or prohibit this activity? Alternatively, should the system allow for any clinical latitude but provide balance by requiring that the decision be recorded and possibly reviewed? It is going to be much harder to clean all this up later in any attempt to deploy meaningful use once the many hardware systems that have been installed have filled countless patient databases with potentially ill-conceived images. Which requirements are being met and which ones aren’t? There are very few requirements. Most recommendations follow ‘Best Buy’ criteria (i.e., specify whatever devices are currently and inexpensively available on store shelves). Examples may be seen in the AAD and ATA recommendations. In practice, acquisition and display of dermatologic digital images are ad hoc (e.g., SC and VL). This laxity is of concern. Requirements are not arbitrary. There is an absolute scale to be applied here. Anatomical features that need to be discerned to form a proper diagnosis have a physical size. These anatomical structures interact with the incident light in a largely determinate fashion to create the backscatter from the skin that is used to form the diagnostic image. The adequacy of these images for clinical use is not a subjective aesthetic judgment. Statements in the literature refer to capture for ‘educational purposes’. The question arises then why not archive the training images images elsewhere than in the patient record? Use this process as an opportunity to de-identify the patient images and documentation – be HIPAA compliant. By my limited understanding of the law (e.g., state mandates for the archiving at the originating site of all data transmitted during a telemedicine session or requirements by the Joint Commission for quality assurance testing of clinical devices and procedures), appreciable amounts of legislative and regulatory guidance have not been included in the existing guidelines that are currently backed by the appropriate professional societies, or are left out of existing clinical business practice. For the requirements not being met: Part of the difficulty is arriving at a method of assessment that captures critical failures. Combining a wide variety of conditions in an assessment where the consequences of being wrong may vary greatly can, on the average, be made to look adequately successful. The preference for
  4. 4. outcome summaries over analytical modeling of capture, display and diagnostic requirements makes it difficult to isolate problem areas. (See second excerpted paragraph below.) Additionally, the inclusion of images in the medical record without regulation should be examined. This practice has crept into use from a mindset that existed when face-to-face exams were the universal norm. In the digital age, this is no longer true. The question is what should be done to ensure that the images being captured and entered into the patient record are adequate to fulfill the requirements of the purposes for which the images are actually being used – both by the caregiver who captured them and any subsequent use thereafter? Does it really matter? What are the consequences? Let me present two paragraphs from the Conclusions section of the proposal. The first raises the question of consequence from a business point of view. The second addresses the complexity of the dermatologic diagnostic decision space and has to do with the level of care, and the definition of clinical success. The view of the individual clinician is very different from that of the enterprise: There are an additional number of issues that must be resolved before digital dermatology can responsibly move into the clinic. In particular, we must understand whether diagnostic performance would improve if better imaging and analysis systems were available to the dermatologist. In addition, we should determine whether the improvement in diagnostic accuracy would lead to savings at least equal to the cost of the hardware. Or, alternatively, is it the case that dermatologic costs are so low that when viewed in the context of the healthcare budget as a whole, that the status quo is both adequate and appropriate, and the required resources should be spent elsewhere? In my mind, this is still an open question. And how do we go about assessing this process?: Early on, much of the performance data for dermatologic digital imaging was anecdotal. As more studies were run, problems remained with performance metrics even when the patient populations were larger. The problems stem from these studies not addressing the effect that the large spectrum of dermatologic diseases has on the validity of performance measures. There is a wide variety in the cases that come through the clinic door – some are acute, some chronic; some are cosmetic, some life-threatening. This diversity reflects the long-tailed disease
  5. 5. prevalence distribution of the presented cases. There has been no clear consensus on how to determine what the expected endpoint is given the heterogeneity of the cases, or even what constitutes a successful diagnosis. Should an overlap in the differentials be considered sufficient or does an accurate measure of performance require an explicit single match. Sometimes it doesn’t matter to the course of treatment, sometimes it does; some treatments have broad effects, some are very specific. Weighted equally, the number of cases that do not require exceptional diagnostic performance wash out those that do, but it is the latter group of patients that is generally at greater risk. Curing a case of acne is not the same as curing a case of melanoma – not to the individual patients, and not to the proper evaluation of the healthcare system. While the mortality in dermatology is low, there still is considerable morbidity. In 2006 in the VA (VISN 2), there were over 12,000 patient- visits for dermatology. At that time in VISN 2, there was often over a 90 day delay to receive dermatologic care. In one VA newsletter during that period, I remember reading that in Louisiana (before Katrina) you could get a hip replacement faster than get a dermatology appointment (both took over a year). There is a need to improve access to dermatologic specialty care. Digital images of diagnostic quality enable a large class of mid-level clinical staff to leverage the skills of a specialist by allowing remote supervision. This is the next stage of telemedical advancement over simply using the specialist as a remote consultant. This is a major change from the initial promotion of telemedicine, and teledermatology in particular, centered around addressing inequities brought on by the unequal geographical distribution of specialty services. (See the Distributed Specialty Care Model presentation.) What if you were a patient? I would be concerned. I am. As we espouse evidence-based medicine as the paradigm of future medicine, is there room for the inclusion of images without pedigree in the electronic medical record? Shouldn’t we be setting the groundwork for a more rigorous representation of digital imagery? Or should we allow short-term convenience to set these ill-conceived practices in stone? The bottom line is that dermatology is not radiology. There are different trades involved. The economics are different. The medicine is different. Dermatology, however, is not alone in many of these differences. The use of devices to monitor patients at home is at the core of low-cost methods to improve quality of life for a longer-living population. Ways must be found to protect the patient while adapting the existing twentieth century business model into the coming twenty-first century paradigm. (See details in the Business Model section of the proposal.)
  6. 6. Are there agencies, professional societies, or manufacturers that care enough to invest some resources (time and/or money)? In the coming few days I will be meeting with people at the FDA (DIAM), NIH (NCI, NIBIB), NIST (IT Laboratory) and the VA (VistA Imaging). While these people are healthcare research fellow travelers, I do not believe they are in a position to bankroll the required research and validation in any more than a collaborative capacity. Nor do I believe that some of the medical societies yet appreciate the opportunities and requirements that face them. I do believe that there is a new class of stakeholder that is a recent addition to the triad of vendor, clinician and SDO. These newcomers are Enterprise IT vendors. They ply IT services and system integration (not chips, algorithms and imaging) and are becoming increasingly aware that they are vulnerable to the weakest links in the medical informatics chain. I believe that the professional dermatologic medical societies will come to support this initiative. Effort must be taken to demonstrate the benefits accrued by validating the use of images in the patient record – how it contributes to their bottom line. This will require that more of the next generation of tools and functions be in hand than are currently available. Do these deficiencies fall within the Scope of the DICOM Standards Committee or any other group? All of the proposals presented here fall well under the umbrella of creating “standards for communication of biomedical, diagnostic and therapeutic information in disciplines that use digital images and associated data”. Many developing technologies overlap with existing Working Group activities and would benefit from any interaction. (See details in the Waiting in the Wings section of the proposal). What is the probability we can really make a difference? There is a long list of people who do not share my views. I don’t have skin in the game, as Warren Buffet would say. My net income is not going to be affected by implementing these changes. On the other hand, the AAD and ATA are not impartial arbiters, either. They act as physician advocacy groups. When, five years ago, I went to my first ATA Dermatology SIG meeting, there was a vote taken not 10 minutes into the session that only an MD could chair the group. This was a move by some clinicians to protect their turf. This initiative was in stark contrast to the Ophthalmology SIG session which I attended the day before. There they pleaded from the podium for more technologists to take leadership roles in their SIG (of
  7. 7. course they had just stepped back from the precipice of having a very large and incredibly helpful diabetic retinopathy project crash and burn because they hadn’t done their due technical diligence in demonstrating the clinical equivalence of film and digital images). In order to implement some of the necessary changes, we will need to consider alternative paradigms of support and validation. The professional societies will always have the responsibility for defining best clinical practice, however, they may not be the prime motivators for technological change or the surveyors of the path to the new healthcare system. Addendum: What is the least that should be done? The very least that should be done is to create GUIs for teledermatology (assess, visualize and correct motion and focus blur and provide color management) and dermatopathology (assess, visualize and correct focus blur associated with the incongruence of the capture plane with the that of the tissue plane due to the many orders of magnitude difference between the lateral dimensions and depth, and provide color management). Create a photographic label that embodies targets that covers the needs of the basic metrics and provides for many of the advanced functions to come. Dermatology is the tip of the spear when it comes to the use of color in diagnostic decision making. This is not the use of pseudocolor or CGI, but rather the integration of a chromatic dimension in the essential representation of benign and diseased tissue. I make the argument here that dermatology is the right venue to establish the proper fundamentals for the advanced techniques to come. I have 40 years of experience in vision research and development. I know quite a few of the best researchers in the business, and I can get them to contribute to the development of a proper Diagnostic Imaging Chain model.
  8. 8. Brian C. Madden, Ph. D. Bona Fides For over eleven years I have conducted research in the department of dermatology at the University of Rochester. To prepare for this work, during my first three years in the department I took part in the Resident Core Curriculum, attending lectures, Kodachromes, journal club and grand rounds. Currently, as a faculty member, I have concentrated on applying various imaging methods to clinical and basic research related to the study of skin. To accomplish this research, I have established The Skin Appearance Laboratory in the Medical Center. The focus in the lab for the last three years has been on dermatologic standards (ATA, DICOM). I have also worked on extending the functionality of existing devices, in vivo confocal microscopy and dermoscopy, to increase their clinical effectiveness, as well as the design of new instruments and procedures. Among these activities was a new procedure for body mapping (for which a patent was obtained), and the discovery of a new mechanism for melanosome transfer from melanocytes to keratinocytes through filopodia. New research projects on the photorealistic simulation of skin images and the composition of photographic portraiture are queued up. Overlapping this work, I was employed as the Director of VISN 2 Telemedicine at the Department of Veterans Affairs. There I worked on developing and deploying a new model of teledermatology – one based on extending dermatologic specialty services through the use of Distributed Specialty Care. Before returning to Rochester, I was a research associate at the robotics lab at the University of Pennsylvania. There I produced some of the first work in extending the intensity range of images by constructing floating point pixels. I also worked on the design of a robotic head which was integrated with a robotic arm to create a 3D redundant binocular tracking system, PennEyes. The redundant tracking and calibration work was also applied to an autonomous undersea vehicle developed at Wood’s Hole Oceanographic Institute. In support of the burgeoning community of binocular roboticists, a binocular head resource page was created. As my first foray into telemedicine, a book chapter described the potential for the use of the Active Vision paradigm in projecting medical information over arbitrary large distances. Prior to UPenn, I worked in Advanced Computing Technology at Boeing Helicopters as an artificial intelligence specialist. There I wrote Boeing’s 5-year technology forecasts for robotics and for image processing. I developed a pilot study using a robotic gantry to assist in composite mark-up and I went down to NIST 3 days a week for dimensioning and tolerancing applications.
  9. 9. Prior to Boeing, I was a graduate student at the Center for Visual Science at the University of Rochester. There I worked on projects that ranged from retinal cellular recording to perceptual scaling. With my officemate, I developed a method of using Wiener kernel analysis to characterize the response properties of single cells in visual cortex. My thesis was a computational model of visual acuity based on physiological and psychophysical data. This theory resolved a question that had been around since the 1850’s concerning the extreme positional sensitivity of the visual system to Vernier stimuli. The first four years I received an NIH fellowship and I was subsequently employed at Xerox and Kodak (and Xerox). At Xerox, I worked on psychophysical models for text, graphics and halftones. At Kodak, I worked on modeling the characteristics of film, and back at Xerox, I incorporated the effects of array scanners into a model of the transfer function of the visual system. Before CVS, I did research on the structure of natural programming languages (cookbook recipes) at IBM Research. Before that, I worked at a small start-up designing digital electronics. My first job after college was as a design engineer at Digital Equipment Corporation. There I designed the hardware interfaces to control machine tools using a PDP8/L. I also worked on the redesign of the PDP-14 computer. My introduction to both vision and clinical research came in the Visual Perception Laboratory at Tufts University when I was an undergraduate. The work involved treating children with strabismus, and on supporting the underlying research that drove the treatment. My very first employment was during the summer after my junior year in high school. Working at RCA Aerospace Communications and control Division, I wrote programs to simulate the thermal properties of the Lunar Rover in the transit and deployed configurations.
  10. 10. WG-19 Proposal Outline: Introduction Skin Imaging and Dermatology Diagnosis Dermatopathology Teledermatology Modalities Waiting in the Wings Characterization and Validation Business Model Working Group 19 Conclusions