- Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
For venous thromboembolism (VTE) prophylaxis of high risk hospitalized medical patients, a randomized controlled non-inferiority clinical trial should be undertaken to compare standard anticoagulant treatment with a potentially low VTE risk diet.
- 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:
With 2,800 hospitalized high VTE risk patients, low molecular weight heparin should be compared with a low VTE risk diet (Mediterranean, vegetarian, or vegan).
- 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.)
Hospitalized medical service patients who
- have high VTE risk based on American College of Chest Physician guidelines (>/= 2 VTE risk factors),
- are > 18 years old,
- are either male or female, and
- have no contraindications for anticoagulant prophylaxis.
- Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
Outcomes can be assessed overall and according to age, sex, VTE risk factors, medical diagnosis (e.g., advanced cancer, congestive cardiac failure, etc.)
- Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
The primary efficacy endpoint would be survival at 60 days from entry into the trial.
The primary safety endpoint would be overall bleeding (i.e., minor and major bleeding) The hypothesis is that patients randomized to a low VTE risk diet would have non-inferior survival (i.e., RR < 1.5 allowing 50% tolerance) and less bleeding (RR < 1.0)
- Describe any health-related risks, side effects, or harms that you are concerned about.
The major risks for those randomized to standard anticoagulation prophylaxis with low molecular weight heparin would be bleeding and rebound hypercoagulation. The low VTE risk diet would not be expected to do harm.
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)
- Cancer
- Cardiovascular disease, including stroke and hypertension
- Diabetes mellitus
- Infectious diseases, including HIV/AIDS
- Pulmonary disease/asthma
- AHRQ Priority Populations
- Low income groups
- Minority groups
- Women
- 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
- Other
Importance
- Describe why this topic is important.
Worldwide, an estimated 20,000 people with major bleeding related to anticoagulant prophylaxis die per year. Between 5,000 and 40,000 people worldwide die of rebound hypercoagulation per year primarily related to anticoagulation prophylaxis of medical and surgical patients. If a low VTE risk diet is non inferior in efficacy and safety outcomes, these deaths and non-fatal complications of anticoagulant prophylaxis could be avoided.
- 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 have extensively researched the evidence-basis of anticoagulant prophylaxis and treatment of VTE and found that the medical literature does not support either the safety or efficacy of this medical intervention.
- 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:
ACCP guidelines call for using anticoagulant prophylaxis for high VTE risk hospitalized patients and for anticoagulants for patients with deep venous thrombosis or pulmonary emboli. My peer-reviewed published articles challenging the safety and efficacy of anticoagulants have not been rebutted by any anticoagulation medicine experts. The proposed trial would be a scientific way to resolve the question of the safety and efficacy of anticoagulant prophylaxis for medical patients.
Potential Impact
- How will an answer to your research question be used or help inform decisions for you or your group?
Yes. I would not prescribe anticoagulant prophylaxis for hospitalized medical patients with high VTE risk. Instead, I would prescribe a low VTE risk diet.
- Describe the timeframe in which an answer to your question is needed.
About 6 million hospitalized patients receive anticoagulant prophylaxis per year in the USA. This proposed randomized trial requires 2,800 subjects to have 80% chance of proving non inferiority of a low VTE risk diet if indeed a low VTE risk diet is non inferior. With a multi-institutional collaborative trial, this could be accomplished within two years.
- Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.
Patient with terminal illnesses (e.g., cancer, congestive heart failure) are particularly prone to fatal pulmonary emboli due to rebound hypercoagulation due to anticoagulant prophylaxis. All patients receiving prophylactic anticoagulants have an increased bleeding risk and all are impacted by the cost and inconvenience.
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)
Yes. I would not prescribe anticoagulant prophylaxis for hospitalized medical patients with high VTE risk. Instead, I would prescribe a low VTE risk diet.
- Are you making a suggestion as an individual or on behalf of an organization?
Individual
- Please tell us how you heard about the Effective Health Care Program
On line search
