Click here to provide additional feedback on this conference.

This document is a compilation of the feedback provided by the attendees of the Co-Morbidity launch conference. Participants were provided with a worksheet that asked them to identify knowledge & manpower gaps; short and long-term goals. Attendees were also encouraged to identify additional issues that must be addressed in order to move the project forward.

Knowledge Gaps

• Mechanism by which psoriasis leads to increased CV risk
• No population data base on psychiatric disease in chronic skin disease; no prospective studies on psych and skin diseases
• Research on biological mechanisms of psychiatric disease in relation to skin disease. Data on the interactions between neural, endocrine and immune systems in the pathophysiology of psychiatric comorbidities.
• More evidence from separate database studies to characterize the relative risk of various systemic illnesses in patients with skin diseases
• Epidemiologic evidence for biologic link between cutaneous inflammatory disease and systemic disease
• Genetic susceptibility
• Types of study designs that facilitate research on the underlying biology of the psych and skin
• The conference served to bring together a good mix of academic, industry and government stakeholders such that co-morbidities could be discussed in an intelligent fashion. While I do not question the existence of Knowledge Gaps, the relative ranking of such gaps was difficult for me to assess. In a world of limited resources, a constant, even overbearing, theme, which gaps are the most important? Which are most common? Those that cause the most morbidity, however defined?
• Current treatments inadequate, and clinical trial data regarding skin treatments are poor
• Chronology of skin disease and co-morbidities (which comes first) Little information about relationship between dermatologic symptoms, psych symptoms, and disability
• Clinical trial data do not reflect real life scenarios; associated comorbidities with various skin diseases.
• Lack of good definition of psoriasis severity
• Which databases exist and how to access them
• Confirmation via additional well controlled epidemiological studies that psoriasis confers independent CV risk
• Basic epidemiologic studies on the relative risk of psychiatric illness in patients with skin disease
• Epidemiologic data on psycho-dermatologic diseases (incidence, prevalence, cost to society in terms of treatment, time off work, etc)
• I work on basic mechanisms of itch and thus am biased towards thinking that it is an important co-morbidity, as patient comfort is impacted. Rarely do the other comorbidities result in death so I take the view that symptoms, such as itch, which are common and difficult to treat and often part of other processes, such as skin picking, is important.
• Very limited knowledge of understanding of cGVHD as it relates to the different types of skin involvement
• Relationship between physical manifestation and mental impact of skin disease
• Little data about base rate prevalence of psych co-morbidities such as depression and anxiety
• The relationship of co-morbidities, does one cause the other or do they share a common cause.
• Lack of data in other populations such as Hispanics
• Pros and cons of types of databases to answer certain questions / limits of databases
• Limited data acquisition on a large scale on QOL as it applies to skin diseases
• Many participants will have their favorite co-morbidity. If not, then they may be interested in, for example, pharmaco-epi in general and work on the area that is most likely to receive funding.
• Synergy of obesity and skin disease
• Any cognitive changes seen in dermatologic conditions?
• True impact of skin disease on patient well-being. The point of Dr Strom that derm suffers an inferiority complex giving rise to the notion among derms that comorbidities are needed to validate the importance of skin disease.
• Knowledge of funding sources

Manpower Gaps

• Lack of interest and training of US dermatologists in psychiatric issues and skin disease-many patients seem to be highly affected by emotional and cognitive aspects. Europe is way ahead of us-we should learn from them.
• We need more dermatologists with interest and expertise in epidemiology (or academic dermatologists for that matter)
• Widespread for any number of reasons - better opportunities perceived elsewhere, difficulties getting derm people turned on to and keeping them in a clinical research environment, etc.
• Few dermatologists with research interest in cGVHD
• Clinician scientists
• Assessments other than self-report require training and expertise
• I do not believe there is a manpower gap. There is a funding gap, that once filled will attract plenty of manpower.
• Statisticians
• Insufficient collaborators from other disciplines working in this area; not enough cross-talk between specialties involving dermatology and others to address how skin effects other organs and how other organs effect skin

Disciplines for Potential Collaboration

• Cardiology
• Epidemiology
• Psychiatry/Psychology
• Health Economics
• Neurology
• Neurobiology
• Ophthalmology
• Nutritionists
• Statistics/Bioinformatics
• Oncology
• Endocrinology
• Orthopedics
• Physiology
• Dentistry

Additional Comments

Pruritus with kidney disease is well-known and thus not part of the conference. The availability of large databases and genomics provides new tools for analysis. Are we going to be looking for needles in haystacks or developing new paradigms? The answer is not known-which is a reason to push ahead-but needs to be thought out well.

Transplant oncology needs to utilize dermatology expertise to better design clinical trial endpoints involving cutaneous cGVHD

Dermatologists require the support of transplant medicine for treatment given the complexity of these patients, other co-morbidities

Health care costs associated with skin diseases

Short-term Goals

• Ask the right question(s)
• Getting companies to share data
• Increase data made available to MedWatch & other adverse drug reaction surveillance systems
• Standardize evaluation of patients with severe adverse cutaneous reactions
• Getting industry design studies a priori within their registries
• Gather centralized source for databases with details of what each offers, and its strengths and weaknesses
• In a sense, this was the focus of the conference. It was clear that opportunities abound. The issue is how and who decide what should be targeted.
• Dermatology participation on current therapeutic trials
• Determine if associations between co-morbidities and skin disease are convincing
• Develop causal models leading to reduced QoL and everyday functioning in people with derm conditions
• Co-morbidities are two-directional: skin reactions are among the most common adverse reactions to drugs AND more toxic drugs are now being used in dermatology
• Identify and largely publicize knowledge gaps so that future researchers have an aid when crafting grants
• Identify appropriate data sources for prospective studies of skin disease and co-morbidities
• Take advantage of and utilize data already available ... with caution
• Focus and create groups based on like interests
• Psych and Derm co-morbidity -- descriptive and analytic

Long-term Goals

• Creation of prospective studies of large, representative cohorts of psoriasis patients
• Coordinated efforts by industry, medicine and insurers
• I think once we have a better idea of whether there is an increased risk of cardiovascular disease in patients with psoriasis, we can think about an interventional study. My opinion is that it is premature to do so.
• Foster collaborative effects to address knowledge gaps
• Enhanced funding/research interests into the pathogenesis of cGVHD
• Design of clinical interventions by the Derm community
• Show that intervention in skin disease can improve co-morbid states
• Show that intervention in co-morbid states can improve skin disease
• Treatment studies to determine how to reduce eventual co-morbidities: treat derm, treat psych
• I believe that a great way to move this field forward would be if a consortium of clinical researchers were put together, funded by industry for clinical trials and use of database. To some degree the Med Derm Sociaty has tried this, but, again, funding is key.
• Do interventions on derm diseases (psoriasis) affect cardiovascular morbidity/mortality? Same but for psych morbidity

Project Barriers

• Funding
• Rare diseases
• Rare reactions
• Protected Time; evolving to a risk-adverse environment
• Lack of effective interventions
• Fear of litigation
• Aside from people and money, the critical components are vision, critical mass, desire and focus to get it done. Same as for anything else.
• Very difficult to design cGVHD clinical trials: complex disease, highly morbid pts., rarity of disease
• Many skin diseases considered cosmetic by key stakeholders
• Lack of appreciation of the magnitude of morbidity associated with derm conditions
• Registry and other data can be misleading
• Epidemiology expertise among those interested in psych/derm overlap
• Adequately trained individuals to carry out research projects
• Lack of a collaborative project because of different IRB's

Collaboration Barriers

• Funding
• Having colleagues take skin diseases seriously--willingness to bridge two specialties
• Barriers appear to be minimal or modest, as long as you supply your own funds, although the VA system seems particularly amenable to working with investigators.
• Time consuming for dermatologists to care for these patients
• Collaboration requires on-site expertise of both dermatology and transplant medicine as well as other sub-specialties (academic center)
• Red tape at academic institutions
• Coordinating across IRBs
• Difficult people
• Need to perform sophisticated assessments across sites

Current Funding Source/Adequacy

• NIH - inadequate - funding levels are too low
• NPF, ASA, DF: Inadequate - grants are too small to address meaningful questions
• Foundations--moderately adequate
• Multi-center trials would require increased funding for infrastructure; we could utilize existing resourced in the cGVHD community to do this once a derm-directed therapy is available
• I am at intramural NIH, funding challenge is primarily imposed by whether Pharma will/will not provide drug; the NIH Clinical Pharmacy is no longer automatically covering the cost of study medications
• NIH: One NIH training grant with 2 slots for pharmacoepidemiology
• Pharmaceutical industries- Much competition for funding

Potential Funding Sources

• Pharma
• CDC
• Foundations
• Private Donors
• That’s a problem
• NPF

Other topics that fall under broad rubric of co-morbidity

An article defining this field of research to be published in JID

Promotion, highlight of abstracts on co-morbidity at annual meeting

How skin diseases can cause other morbidities (e.g. ? pso and cvd) How treatment of skin disease can lead to morbidities (e.g. biologics and infection) How other morbidities or treatments can lead to skin disease (e.g. obesity a risk factor for Pso, gadolidium a rf for NSF)

Inform young dermatologists that there are interesting and important questions to address, and encourage them to pursue epidemiologic training. Strengthen the career path for these individuals with mentoring.

Put together a comprehensive (but not exhaustive) list of knowledge gaps and outline possible ways of addressing them.

Establishing a framework of targets along with the “who”, “why” and “how” of doing so. I very much enjoyed being allowed to participate in the conference. All that I have written here should be interpreted in a positive light. It will however take dedication on the part of a team, large or small, to implement 'something'.

I personally consider the neuro-psych-skin area to be particularly important. Neuroscience is booming and collaborations here-whether they involve imaging, basic research, genomics etc.-with dermatology could be particularly illuminating.

Consider a cGVHD/derm oncology interest group listserv which would foster interest/collaboration between dermatologists who evaluate and treat cancer patients

Develop a research agenda for co-morbidities and skin disease; Develop a platform for collaboration

Try to develop collaborations organized by specific derm condition; try to use standard methods to study co-morbidities across derm conditions

I will like to see a major collaborative effort between institutions and researchers to create a multicenter study. -Identify and get some funding

Neurologic diseases and the skin; Oral manifestations of skin diseases

Being able to maintain focus. I think that it is also very important to try to capture data from existing post marketing studies. I have either helped to design or serve on oversight boards for 3 large post marketing psoriasis studies and two in AD. I have not been able to get the companies to talk to either other nor the FDA to agree that they should. The power in 20,000 study subjects is much greater than that seen in 1 to 5,000.

I think that it is very important to realize that we need to be focused. We cannot study all of Dermatology. We also need to realize that the term co-morbidity is cumbersome and meaningless. I think that we are talking about health states associated with skin findings or cutaneous illnesses.