Regarding the amount of cardiac rhythm device´s recalls, FDA warning letters to manufactures and Product Performance Report information (based on Advamed guide) available, it would be interesting to develop guides that answer the question…

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

Regarding the amount of cardiac rhythm device´s recalls, FDA warning letters to manufactures and Product Performance Report information (based on Advamed guide) available, it would be interesting to develop guides that answer the question of which product and manufacturer offers the best safety and quality performance so physician and patient can make a better decision.

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:

1.Pacemakers between manufactures 2.ICD between manufactures 3.CRT devices between manufactures 4.Leads between manufactures

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.)

Any patient

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

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

Improvement in healthcare safety, quality and cost decisions.

1.Safety seen as:

Recalls: number, class and trend over time
FDA Warning Letters 2.Quality seen as:
% cumulative probability survival
Consistence in longevity estimates vs. real performance

3.Cost benefit seen as:

Relationship between product price vs. quality and safety

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

Safety problems with cardiac rhythm devices such as: 1.Loss of therapy 2.Premature battery depletion 3.Deterioration on quality of life 3.Increase on follow-ups

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)

Cardiovascular disease, including stroke and hypertension

AHRQ Priority Populations: None

Federal Health Care Program: None

Importance

Describe why this topic is important.

1.Because Healthcare expenditure in this Cardiac Rhythm diseases is high and the impact on Mortality and Quality of Life is important.

2.Heart failure and AF incidence are increasing and they have a direct relation with devices.

3.Patient deserves to be informed on issues related to safety and quality of the products they are going to receive.

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.)

I am concerned that Cardiac Rhythm Market would be based only in price as it is happening in Latinamerica.

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:

It could be important both for clinicians, policy-makers and patients. Up today, there is no strong evidence on these questions in order to make better decisions.

Potential Impact

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

1.It would guide my decision for both manufacture and product choice

2.It would give better information for business negotiation with providers

3.I would be happy to pay more for evidenced safety and quality performance products

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

Taking into account the availability of information (Product Performance Reports and FDA information), I believe a reasonable timeframe would be less than 3 months.

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

Older and poor patients tend to receive less innovative and quality technology and devices

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