Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

The Association for the Advancement of Wound Care (AAWC) Venous Ulcer Guideline is one of multiple algorithms available for venous leg ulcer management. Approximately one third of recommendations within the guidelines are based on less than two randomized controlled trials. In the supplemental report provided, these recommendations have been identified and provide many questions that have yet to be sufficiently answered in the field of venous leg ulcer management.

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

There are multiple interventions outlined in the attached supplemental document which require further comparison to standard of care. These include the following comparisons with both study arms receiving effective sustained multi-layer compression plus the described interventions:

• bedside sharp debridement versus autolytic debridement effects on venous ulcer healing and pain
• hyperbaric oxygen versus moisture retentive dressings plus compression for the healing of venous ulcers
• laser therapy, negative pressure and multiple topical and systemic pharmaceuticals (described in attached document) versus moisture-retentive dressing effects on venous healing

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

The question applies to all patients with venous leg ulcers.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

There are no specific subgroups that limit the application of the question.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

We are interested in increasing the rate of venous ulcer healing and patient comfort and thereby decreasing patient morbidity and the associated economic and resource strain that venous ulcer management places on the healthcare system.

Describe any health-related risks, side effects, or harms that you are concerned about.

Various risks might be considered for each individual question posed. For example, during further trials for systemic pharmaceutical interventions for venous ulcers, such as Stanozolol and Defibrotide, systemic side effects may also be encountered.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Functional limitations and disability

AHRQ Priority Populations

• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

This topic is extremely relevant because venous leg ulcers affect up to 1.5% of Americans over 60 years of age and lead to healthcare costs of 2.5$ billion annually. Further elucidating the most effective management strategies and including them in the AAWC Venous Ulcer Guideline will provide better patient care, allow providers and patients to devote energy only to the most effective management plans, decrease patient morbidity and hopefully decrease costs.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

A desire to optimize clinical guidelines and use their evidence to guide research has motivated these questions.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

The data results of answering the recommended questions may contradict what many wound care providers have been practicing for many years and improve venous ulcer outcomes by encouraging evidence-based care.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Answers to the multiple questions we pose may directly affect decision making of members of our group. With further research, supporting evidence of long-practiced diagnostic skills, prevention recommendations and interventions may be described. On the other hand, we may find that certain practices that are frequently employed are less efficacious than assumed. For example, autolytic debridement may improve venous ulcer healing and require less local anesthesia than surgical debridement. Results will inform providers of better management strategies.

Describe the timeframe in which an answer to your question is needed.

Because we have devised multiple questions, it is likely that years will pass before all of our answers are provided. However, taken individually, most questions that we pose can be answered within a year's time. Examining reimbursement databases may help prioritize which question to ask first, in order to stop spending healthcare dollars on procedures with inferior outcomes.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

Answers to the multiple questions we pose may directly affect decision making of members of our group. With further research, supporting evidence of long-practiced diagnostic skills, prevention recommendations and interventions may be described. On the other hand, we may find that certain practices that are frequently employed are less efficacious than assumed. For example, autolytic debridement may improve venous ulcer healing and require less local anesthesia than surgical debridement. Results will inform providers of better management strategies.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

Colleague