Relevant Evaluation Criteria Scenario/Model Outcome
Information Gathering
1. Gather essential information about the patient’s symptoms, including:
a. description of symptom(s) (i.e., nature, onset, duration, severity, associated symptoms) Patient has no symptoms; older brother was recently diagnosed with coronary heart disease and her mother died from this disease. The patient wants to do what she can to avoid heart disease and is particularly interested in “functional foods” because of an article she saw in a magazine.
2. Gather essential patient history information:
a. patient’s identity Mary Romero
b. patient’s age, sex, height, and weight 33-year-old female, 5 ft 4 in, 135 lb
c. patient’s occupation Clerk at a department store
d. patient’s dietary habits Eats breakfast most mornings: usually a cup of coffee and cold cereal with reduced-fat (2%) milk

Lunch: something from the mall’s food court; often a sandwich with potato chips and soft drink

Afternoon snack: typically a candy bar or granola bar

Dinner: meat (beef, pork, or chicken mostly; fish every once in a while when someone has gone fishing); potatoes or pasta most nights; fresh, frozen, or canned vegetable 4-5 times per week; sweet dessert (cake, pie, baked goods) or ice cream 5-6 times a week; typically has a soft drink with dinner, occasionally an alcoholic drink
e. patient’s sleep habits Usually sleeps 7-8 hours per night
f. concurrent medical conditions, prescription and nonprescription medications, and dietary supplements None; birth control pill and multivitamin
g. allergies NKA
h. history of other adverse reactions to medications None
i. other (describe)
Assessment and Triage
3. Differentiate the patient’s signs/symptoms and correctly identify the patient’s primary problem(s). Mrs. Romero has no signs/symptoms of disease but wants to follow a preventive strategy with diet.
4. Identify exclusions for self-treatment. None
5. Formulate a comprehensive list of therapeutic alternatives for the primary problem to determine if triage to a medical practitioner is required, and share this information with the patient. Options include:
(1) Refer Mrs. Romero to her PCP for assessment of heart disease and evaluation of her risk.
(2)  Refer Mrs. Romero to a registered dietitian for comprehensive nutritional assessment and counseling.
(3) Inform Mrs. Romero of foods that have health claims associated with reduced risk of heart disease.
(4) Take no action.
Plan
6. Select an optimal therapeutic alternative to address the patient’s problem, taking into account patient preferences. Mrs. Romero may require a combination of the options.

(1)  Provide basic information and counseling related to functional foods with health claims associated with heart disease. Emphasize authorized and authoritative health claims (Table Authorized and Authoritative Health Claims), because these have strong scientific evidence supporting the claim. The limited evidence for qualified claims and structure-function claims can be presented along with a discussion of where they fit, if at all, in the patient’s overall plan.
(2)  Refer Mrs. Romero for cholesterol screening (or perform screening in the pharmacy) and assessment for heart disease.
(3)  Refer Mrs. Romero to a dietitian if she wants/needs more than basic counseling on nutrition or have her request a referral from her PCP (may be necessary for insurance coverage).
7. Describe the recommended therapeutic approach to the patient. A number of foods with health claims are associated with decreased risk of heart disease. For several foods, there is significant scientific agreement regarding the potential benefits. Using these foods in place of some of your current foods may reduce your risk of heart disease. However, it would also be helpful to know what your risks are, including your cholesterol level.
8. Explain to the patient the rationale for selecting the recommended therapeutic approach from the considered therapeutic alternatives. Given your family history, you should have your cholesterol checked periodically and be evaluated for other risk factors for heart disease.

I can provide you basic information on foods that have health claims related to heart disease and may be of benefit in maintaining heart health. Dietitians are the food and nutrition experts; they can do a comprehensive assessment of your diet and provide more in-depth dietary counseling if you want that.
Patient Education
9. When recommending self-care with non-prescription medications and/or nondrug therapy, convey accurate information to the patient:
a. appropriate dose and frequency of administration (1)  Decreased dietary saturated fat and cholesterol: Recommend not more than 10% of calories from saturated fat and not more than 300 mg cholesterol a day, but less is better. Most people find 1% milk to be more acceptable than nonfat (skim) milk, so you might want to try it in place of 2% milk, or you could try soy milk.
(2)  Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber: Recommend replacement of white breads and pasta with whole grain. Total dietary fiber should be at least 25 g/day (Al for women 19-50 years of age).
(3)  Soluble fiber from oat bran, rolled oats, or whole oat flour in certain foods, or barley: Incorporate these products into the diet as replacement for breads and cereals that are not whole grain.
(4)  Soy protein: 25 g/day is required in conjunction with a diet low in saturated fat and cholesterol. For many people, the major dietary modifications needed to eat this much soy are very difficult to make, especially if all family members are not committed to the changes.
(5)  Plant sterol and stanol esters: Total intake is at least 1.3 g/day of sterol esters or 3.4 g/day of stanol esters, as part of a diet low in saturated fat and cholesterol. You usually need to eat the products at least twice a day to get the recommended amount. Some margarines and orange juice have added plant/stanol esters.
(6)  Whole-grain foods: This health claim overlaps somewhat with that for “grain products that contain fiber” (#2) but does not specify “particularly soluble fiber.” Insoluble fibers are also important in health. Look for whole grain, such as whole wheat, as the first ingredient on labels.
To make these health claims, foods must generally contain a certain amount of the component. Check food labels for these claims and for ingredient amounts.

There are also health claims with less vigorous supporting data for which evidence suggests a benefit but research is not conclusive (does not prove a benefit; therefore, these claims may not be as effective or the claim might be changed if new studies are reported. Because the following foods are otherwise healthy foods when used in moderation, they can still be safely incorporated into your diet.
(1)  Walnuts and several other types of nuts: 1.5 ounces a day; remember that nuts are a concentrated source of calories, so use judiciously.
(2) Omega-3 fatty acids: specifically eicosapentaenoic acid (EPA) and docosa-hexaenoic acid (DHA), found in salmon, lake trout, herring, and other oily fish.
(3)  Monounsaturated fats from olive oil; 23 g/day (2 tablespoons) in place of a similar amount of saturated fat. A number of salad dressings and a few soft margarines now include olive oil.
(4) Canola oil, unsaturated fatty acids; 19 g/day (1.5 tablespoons) in place of a similar amount of saturated fat. Some cooking oil, a number of salad dressings, a few soft margarines, and some baked goods include canola oil.
b. maximum number of days the therapy should be employed No limit; preferably, these foods will be incorporated as part of an ongoing healthful diet for life.
c. product administration procedures These foods can replace other foods in your diet so that the total calories do not increase. The more “healthful” fats must replace saturated fats and not increase the total fat intake. You will need to read food labels carefully to be sure you are getting whole grains, low-saturated fats, low cholesterol, and sterol/stanol esters in the product. Also look for the amount of soy or soluble fiber.
d. expected time to onset of relief These steps are preventive at this time; for elevated cholesterol, dietary changes typically are effective within a few weeks.
e. degree of relief that can be reasonably       expected Mild-to-moderate decrease in total and low-density lipoprotein cholesterol.You should be able to decrease “borderline” high cholesterol to within an acceptable range, but these foods alone would probably not be enough if you had significantly elevated cholesterol, especially considering the history of heart disease in the family.
f. most common side effects Rapid increases in fiber content of the diet can cause gas and bloating, so it is best to gradually increase the fiber in your diet. Replace 1-2 servings of white bread and pasta with whole-grain products every few days until the refined foods are totally replaced. Also add extra fiber by gradually replacing the low-fiber cereals with a whole-grain cereal or oatmeal. Fruits and vegetables can be increased gradually as well to replace snacks and desserts. Be sure to take plenty of water when eating a high-fiber diet.
g. side effects that warrant medical intervention should they occur Moderate-to-severe abdominal pain, nausea, vomiting; these side effects may be signs of bowel obstruction or diverticulitis.
h. patient options in the event that condition Dietary changes for Mrs. Romero are preventive, unless her cholesterol is worsens or persists                      elevated at the time it is checked. Cholesterol levels should be monitored periodically; if cholesterol increases to an unacceptable level despite these dietary changes, it may be necessary for Mrs. Romero to consider drug (statin) therapy.
i. product storage requirements              See food label.
j. specific nondrug measures                N/A
10. Solicit follow-up questions from patient. Where can I find more information on dietary changes and diet plans to prevent heart disease? May I use dietary supplements instead of changing to functional foods? Most information on the Internet is advertising for dietary supplements.
11. Answer patient’s questions. The Food and Drug Administration Web site (www.fda.gov) includes information on health claims and food labels that you might find helpful. You could consider making an appointment with a registered dietitian who could help develop some menus that incorporate foods you like and provide more specific plans for substituting healthier foods. Your health plan may contract with a dietitian. If not, the American Dietetic Association can provide the name(s) of private consultants and the contact information for a dietitian. The phone number for referrals is on their Web site (www.eatright.org). In general, foods are better than supplements. Many studies have shown beneficial effects from a diet containing fiber-rich foods and whole grains but not with isolated supplements. Psyllium, found in products like Metamucil, fits criteria for a health claim related to soluble fiber and risk of congestive heart disease, and could be used to increase soluble fiber. It also has the added benefit of reducing constipation, as do fibers from whole grains.