Making Informed Decisions for Better Health

The Spectrum of Care

Overview

As outlined in the previous sections, various factors can influence the decisions made and actions taken by you and your healthcare practitioners regarding testing. No decision can be viewed as entirely clear-cut, and the elements influencing decision-making can be seen as existing along a continuum of possibilities. Balancing these influences according to a given situation can be central to improving healthcare. The scenarios in the following table illustrate some of these factors and address just a few examples of ways that testing decisions may be considered. They are listed according to three general categories along the spectrum of care.

To read more detailed discussions of the examples provided below, expand the sections below.

When Strong Evidence Agrees With Patient Preferences

Sometimes the scientific evidence is abundant and the answers are relatively clear as to whether a test is or is not useful and the testing protocol recommended by the medical community is consistent with a patient’s needs and wishes.

Scientific evidence collected over years of practice indicates that diabetics who maintain a stable blood glucose level (“glycemic control”) experience fewer complications. Good glycemic control is typically defined as an A1c less than 7%. More recently, evidence has supported individualized A1c targets rather than a one-size-fits all approach. A position statement published jointly by the American Diabetes Association and the European Association for the Study of Diabetes in 2012 supports this approach. Specifically, these groups have concluded that diabetics who are newly diagnosed can generally tolerate a lower target and stricter control. People who have lived with the disease for years, on the other hand, may require looser control with a higher A1c target, especially if they are at risk of low blood sugar (hypoglycemia). Adjusting the targets to fit an individual’s requirement leads to better control and improved compliance. In this case, personalizing the testing, interpretation of results and subsequent adjustments to therapy obviously improves healthcare based on the evidence as well as from the patient perspective.

Several major healthcare organizations recommend that individuals age 50 and older undergo screening for colon cancer. The American Cancer Society, the U.S. Preventive Services Task Force, and the American Radiology Association, to name just a few, have guidelines supporting colon cancer screening. Though the advice may differ on which test to use and how often, these groups have found that screening lowers the incidence of this type of cancer and leads to fewer deaths. Recent technological advances have led to several possible testing options for detecting and/or preventing colon cancer. The choices for patients range from the fecal occult blood test (FOBT), an annual, non-invasive test requiring a sample that can be collected at home, to colonoscopy, an invasive imaging procedure that usually requires some level of sedation and may be performed every 5 to 10 years. Though the evidence is clear that screening can save lives, patient preferences can be the key to more people getting screened.

Let’s face it, most people would like to avoid any medical procedures including testing; it is human nature to want to forego any inconvenience or unpleasantness if possible. In this third example, the evidence against testing nicely accommodates this patient preference. Several well-regarded health organizations including the American College of Obstetrics and Gynecology, the U.S. Preventive Services Task Force, and the American Cancer Society have evaluated years of evidence and now conclude that screening women younger than 21 for cervical cancer does not improve outcomes. This is because cervical cancer is rare in this age group. In fact, testing could worsen outcomes when testing results in false positives on Pap smears, leading to unnecessary follow-up testing and procedures. For this specific age group, the harms of testing outweigh the benefit, thus testing is discouraged, and patients younger than 21 are likely to comply because of a natural desire to avoid tests. On the other hand, women older than 21 are strongly urged to get tested.

When Patient Choice Outweighs Proven Advantages of Testing

These are testing situations along the spectrum of care in which patient-centered considerations may be the priority if the patient chooses, regardless of the evidence:

For pregnant women in the U.S., the standard of care is for practitioners to offer screening for fetal chromosomal abnormalities, regardless of personal or medical history. This may be done as part of first trimester and/or second trimester screening tests. Each patient who is confronted with the choice of testing or not will have different needs, values, and preferences and these will override any evidence that supports testing. While one woman will want the test in order to manage her pregnancy, another woman with different values may choose to forgo testing because the results of the test will make no difference in the management of her pregnancy. In this case, the values and needs of the patient override the evidence. Yet, in the patient’s viewpoint, her health care needs have been met and her care is appropriate for her.

Testing for mutations in the BRCA gene may be offered to people who have a family history of breast or ovarian cancer, or close family member with a BRCA mutation. The results of testing can inform women (and some men) about whether they have a significant greater risk of having breast or ovarian cancer over the general population. It does not, however, absolutely determine whether or not they will develop one of these cancers. This information from BRCA testing, however, can give them the power to then make decisions about their care, depending on their preferences and risk tolerances. Options for risk reduction range from greater surveillance (more frequent screenings) to invasive procedures such as removal of breasts (mastectomy) or ovaries. The choice of these options, and indeed about testing itself, is a personal one. Some people who are offered testing may not want it because they know the result would not affect their decision-making or cause them to choose a different course of action. Conversely, other individuals might choose testing to gain information about their genetic predisposition so they can decide whether or not to take action. Opting for predictive BRCA testing for breast cancer is an example of an important health decision and a good illustration of when a well-informed patient is an empowered one. Moreover, a genetic counselor is often a good resource for understanding genetic test results, but perhaps more importantly, can provide guidance when making the decision about whether or not to be tested.

More Americans today die from hepatitis C than from HIV, according to the Centers for Disease Control and Prevention (CDC), and the rise in deaths disproportionately affects people born from 1945 through 1965, so-called “baby boomers.” Over 3.2 million Americans are living with chronic HCV infection, which can cause long-term liver damage, and two-thirds were born from 1945 through 1965. Without treatment, it is estimated that as many as half with chronic infection will develop cirrhosis and/or liver cancer, both of which can be fatal. The virus is usually spread through sharing needles or other equipment when injecting drugs but may also be transmitted through other means, including snorting drugs or risky sexual behavior such as having multiple sex partners. Before 1992, when widespread screening of the blood supply began in the U.S., HCV was also commonly spread through blood transfusions and organ transplants. Many people who may have contracted the virus 40 years ago are unaware of their condition as it is a slow-progressing disease and can be relatively asymptomatic for decades until late, incurable complications develop. Detecting infections early through screening allows for treatment with newly-available drugs that are safe and effective. In 2012, the CDC undertook a study to determine whether routine age-based screening would raise the rate of cure. The study concluded that routine screening of all individuals born from 1945 through 1965, regardless of risk factors, would significantly reduce deaths. Nevertheless, some individuals in this age group may perceive their risk of having HCV to be so low that there is no benefit in undergoing screening. Though the evidence shows that this population in general would benefit from screening, each individual must make a decision on whether screening would be useful for him or her.

When Lack of Evidence or Consensus Warrants More Informed Decision-making

These are the areas along the continuum of care where the available evidence for use of a test is not clear-cut or the significance of its use is disputed or questioned. In this situation, the patient-centered view may take precedence.

An example of a situation in which there is a lack of consensus on the available evidence is screening asymptomatic men for prostate cancer using the test for prostate-specific antigen (PSA). The evidence regarding this test consists of data from large, long-term studies that indicate that screening with PSA is no better than standard care in lowering death rates from prostate cancer. That, coupled with the possible harms from false-positive results and unnecessary, possibly painful follow-up procedures, have led some in the medical community to advise against the use of the test. In contrast, some other health experts say that this population-based evidence should not apply to individuals, that each patient, armed with facts on pros and cons of testing, should be allowed to make an informed decision. In this scenario, the decision to test or not can rest squarely with the patient. While some patients will welcome the autonomy, others may choose to rely on the advice of their healthcare practitioner and, in each situation, the level of risk that is acceptable to the patient enters into the picture.

For women who are considering breast cancer screening through the use of mammography, there is some consensus from healthcare professionals, but there are enough differences that women must consider their options carefully. The American Cancer Society and the American College of Obstetricians and Gynecologists recommend annual screening for those of average risk beginning at 40 years of age. However, the U.S. Preventive Services Task Force (USPSTF) says that for women at average risk and who are under age 50, the decision when to start regular screening mammography should be an individual one, taking into consideration such factors as a woman’s risk tolerance. The USPSTF also recommends less frequent screening for women over age 50, advising that mammography be done every other year. While mammography can detect breast cancer in the earliest stages when it is most treatable, it can also lead to false-positive results and unnecessary follow-up procedures, including sometimes biopsies. Thus, a woman must decide for herself, with the help of her health practitioner, what her tolerances are for risk if she forgoes testing and possibly misses early cancer or undergoes testing and possibly gets a false-positive result.

The high-sensitivity CRP test detects low levels of inflammation in the body. It is promoted by some as a test for determining a person’s risk level for CVD, heart attacks, and strokes. This is because it is now believed that a persistent low level of inflammation plays a major role in atheroslcerosis, the narrowing of blood vessels associated with cardiovascular disease. A number of risk factors have been linked to the development of CVD, but a significant number of people who have few or no identified risk factors will also develop CVD. This fact has lead researchers to look for additional risk factors that might be either causing CVD or that could be used to determine lifestyle changes and/or treatments that could reduce a person’s risk of CVD. Studies have shown that measuring CRP with a highly sensitive assay can help identify the risk level for CVD in apparently healthy people. It is thought that normal but relatively high levels of CRP in otherwise healthy individuals can predict the future risk of a heart disease, even when cholesterol levels are within an acceptable range. Clinical trials that involve measuring hs-CRP levels are currently underway in an effort to better understand its role in cardiovascular events. These studies may eventually lead to guidelines on its use in screening and treatment decisions. Meanwhile, a healthcare practitioner may suggest the test as a means to provide additional information of an individual’s risk, but a patient may choose to forego it until studies provide more evidence of its usefulness.