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

compliance verification for medical devices and medications

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

no

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

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.)

it applies to everyone. as an example,burn masks or transparent facial orthoses, made to treat hypertrophic scarring require many hours per day for appropriate treatment. patient compliance is an unknown. in fact, patient compliance is unknown for other medical devices such as head gear, neck splints, or external compression device, and for medicine as well.

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

this applies to everyone, every age group, all ethnicities. burns and other injuries do not discriminate.

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

the ability to accurately measure treatment such as pressure therapy or actual delivery of medicine would improve medical research so that treatments could be refined based on compliance data. this would also serve to protect patients from over or under-medicating.

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

none

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)

• Arthritis and nontraumatic joint disorders
• Cancer
• Cardiovascular disease, including stroke and hypertension
• Dementia, including Alzheimer's disease
• Depression and other mental health disorders
• Developmental delays, attention-deficit hyperactivity disorder, and autism
• Diabetes mellitus
• Functional limitations and disability
• Infectious diseases, including HIV/AIDS
• Peptic ulcer disease and dyspepsia
• Pregnancy, including preterm birth
• Pulmonary disease/asthma
• Substance abuse

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Children
• 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
• State Children's Health Insurance Program (SCHIP)
• Other

Importance

Describe why this topic is important.

compliance is measured based on the patient's testimony and is often exaggerated. With the ability to subjectively measure patient compliance, medical treatments can be improved to better treat the patient's ailment and determine which medical treatments work.

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.)

The motivating factor for the compliance device is the custom fit burn orthosis that is made and distributed by our company for the treatment of hypertrophic burns. Efficacy of the devices, like other compression devices, is based on patient compliance which is largely unknown.

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:

At the current time, the treatment period used for medical ailments (i.e. hypertrophic burns, etc.) vary by medical professional and clinic. Having reliable data to back medical treatment results will enable medical professionals to determine which treatments actually work.

Potential Impact

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

Being able to receive accurate information on patient compliance will enable our group to determine the time period of compliance for each patient and have quantitative data for the healing period.

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

2 years

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

There are no health disparities, inequities or impact on vulnerable population associated with this device.

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)

Being able to receive accurate information on patient compliance will enable our group to determine the time period of compliance for each patient and have quantitative data for the healing period.

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