Everyone wants improved health care. On TV, in newspapers and magazines and, of course, on the Internet, we can find a vast amount of information about efforts being made to improve our care. As we listen and read, certain terms keep popping up – terms like health outcomes, evidence-based medicine (EBM), and patient-centered care.

In this article, we offer explanations of these three key terms and their contributions to improving health care and, more specifically, healthcare as practiced through laboratory medicine. Together, these terms describe a range of care that you and your health practitioner may consider in making decisions about testing and treatment options. Understanding these terms, and their sometimes competing priorities, may help you to discuss your testing options with your health practitioner and make informed choices to improve your care.

Read the sections below to review these concepts as well as how they play into making informed decisions about your or a loved one’s health care as well as additional resources.

Key Terms

Health Outcomes: “What Makes You (Feel) Better” Medicine

While everyone might agree that improving health care and patient health are worthy goals, there must be a way to measure progress in reaching them. Medical science has turned to evaluating health outcomes as a means for determining the effectiveness of a medical test, procedure or treatment.

But what do we actually mean by “health outcomes”? The ultimate objectives of medicine are to help people who are sick to get better and to assist healthy people in preventing illness, while “doing no harm,” as the famous phrase from the Hippocratic Oath cautions. Sickness or health, surviving or dying from a disease are examples of outcomes, but so are side effects experienced from treatments. “Health outcome” describes the end result or consequence of an action taken to prevent, manage or cure illness. The evaluation of health outcomes asks the basic question: “Are you better off than before medical intervention?”

Improving health outcomes through laboratory medicine is achieved with the appropriate use of testing. Laboratory tests should provide information that can improve a person’s outcome. Sometimes, however, the evidence isn’t always conclusive as to which tests or frequency of testing improves health outcomes, especially in the use of screening tests intended to prevent illness. [See example below “When Lack of Evidence or Consensus Warrants More Informed Decisionmaking”] Even the most authoritative organizations don’t always agree on the elements of preventive care, such as the most appropriate age to begin routine screening or how often it should be repeated. In some cases, there is no consensus on whether screening with a particular test should be done at all.

Health outcomes rely, at least in part, on ensuring that laboratory tests are as accurate, sensitive and specific as possible, as well as reasonably available. Consider, though, that health outcomes also depend on what the practitioner and patient decide to do with the information supplied by test results. Action, or sometimes inaction, prompted by test results can have a substantial impact on a patient’s health and the quality of care received.

Depending on the circumstances, testing decisions based on your preferences may expand the definition of health outcomes from not only “what makes you better” medicine, but to “what makes you feel better” medicine. While what makes you feel better may not necessarily improve your health status, it may improve your quality of life by reducing your anxiety, for example, and increasing your ability to enjoy yourself. Thus, patient-centered care may improve your health as well as the way you feel about your care.

Evidence-based Medicine (EBM): Foundation for Best Practices

Medical knowledge is accumulating—and changing—with such dizzying speed that doctors, nurses, physician assistants, and other healthcare professionals have found they need new methods to cope with this abundance of information. Novel tests, drugs, procedures, and treatments are ever in development, put through clinical trials, and introduced to market. Studies are frequently published with fresh data that support or modify long-standing beliefs and sometimes lead to substantial changes in the care you receive.

Evidence-based medicine (EBM) is a formalized approach for helping healthcare practitioners harness the knowledge that comes with this information explosion and apply it to their daily practice. EBM helps to determine what scientific data support the best health outcomes. This leads to development of practice guidelines aimed at delivering on the promise of improved outcomes in the greatest number of cases. In laboratory medicine, EBM provides guidance that enables healthcare practitioners to optimize the selection of tests for screening for, diagnosing, and managing a variety of medical conditions.

Since evidence-based medicine primarily relies on research that measures health outcomes for a given population, it is somewhat at odds with individualized or personalized care. EBM-derived best practices are by their nature standardized to apply to as many people as possible. Complicated analyses of how a specific test affects the health outcomes of a given population allow scientists to develop guidelines that establish standards of practice that are most likely to result in favorable outcomes for the vast majority of the general population. Unfortunately, these guidelines aren’t always able to take into account circumstances that are specific to the patient. That is why the skill and experience of the practitioner are needed in interpreting the guidelines, and why it is important for you as the patient to understand and be engaged in your care.

More recently, medical professionals have recognized that patient considerations impact outcomes. As a result, in some sectors of healthcare, there is increasing emphasis on including patient preferences, needs, and values as part of the standard of care.

Patient-centered Care: Emphasizing Patient Values

In the first half of the 20th century, medicine was so patient-centered that your doctor knew your medical history and sometimes even your parents’ and grandparents’ histories. This is different today; often, you must visit a clinic or medical practice where you are sometimes seen by the first available practitioner, regardless of whether the practitioner is familiar with you and your history. Even if you are seen by your regular practitioner, there’s no guarantee that he or she is fully current with your health status.

A lot has changed in healthcare over the years, and one of the biggest transformations has been the evolving role of the patient in this new patient-doctor relationship. While this new relationship provides an opportunity for you to be an active participant in your care, it also involves more responsibility on your part, asking you to be more knowledgeable about your own health history, more assertive in asking questions, and more vocal in discussing your preferences when it comes to care.

This new role has been characterized in healthcare circles as “patient-centered care.” According to the Institute of Medicine (IOM), patient-centered care means “providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions.” What this means for you as a patient is that when you are fully engaged in your care, you can have a frank and informative discussion with your doctor and be more involved in the decisions regarding your care.

You can expect that your practitioner will advise you according to the latest evidence-based guidelines and will help you understand what this means for your personal care. You, in turn, can be fully engaged when you are prepared to ask questions when you don’t understand something and are willing to discuss your concerns and hopes regarding diagnosis and treatment and your quality of life. Together, you and your practitioner can determine the care you need to achieve the best health outcome by finding the right balance between evidence-based guidelines and your personal values.

The Spectrum of Care


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.

Making Sense of it All

Informed decisions and deciding what is right for you

Most people will agree that technological innovations have led to great strides in helping sick people get well and in preventing illness in the first place. EBM encourages use of those new procedures that have been shown to be of most benefit to the majority of patients, and patient-centered care filters these practices in an attempt to provide the optimal care for each individual.

So, when we say that today’s healthcare is patient-centered, evidence-based, and focused on improved health outcomes, it kind of makes us want to scratch our heads and say, “Well, hasn’t it always been this way?” In a manner of speaking, yes, but in a much less organized and formalized system of care that was often limited by the experience of the individual physician and that did not benefit from the scientific analysis of best practices.

It is important to remember that the newest fields of modern medicine, which we’ll define here to include laboratory medicine, radiological medicine (x-rays, MRIs, etc.), and pharmaceutical medicine, are still young and maturing. After decades of explosive growth and dramatically positive impacts on health outcomes, medical scientists have only just begun to effectively manage the explosion of knowledge that they have gained.

As healthcare has become a more routine and, in some cases, costlier part of our daily lives, the medical community has even greater incentive to standardize the lessons learned and how to apply those best practices to the individual patient. EBM and patient-centeredness are two of the yardsticks used by the medical community to measure the value of medical care, such as testing and treatments, and to verify their effectiveness in improving health outcomes.

In some respects, EBM and patient-centered care represent two ends of a spectrum. You and your healthcare provider must learn to balance EBM with patient-centered care. The conversation you have with your practitioner should evaluate options based on standardized guidelines and the proven benefits and harms, but also take into account everything from your personal and medical history to your philosophical and religious views, cultural background, personal risk tolerance, and the specific circumstances in which you are making your decisions. To help illustrate these concepts, we provided several real-world examples of laboratory tests along this spectrum in the section above, The Spectrum of Care.

Regardless of the particular situation, patients who are well-informed and educated about their own health and the related decisions they face have an advantage in ensuring that priorities are balanced to improve their personal health outcomes. Though the illustrations presented here vary according to the rigor of evidence, in each case the opportunity for involvement of the patient is vital. Moving forward, medicine will require more from patients in determining the course of their testing and treatments.

Getting the conversation started: Questions to ask your healthcare practitioner

When testing is ordered, you should feel comfortable in finding out why the test needs to be done, how it will be done, and what the healthcare practitioner expects to learn from it. Here are some examples of questions you might wish to ask your practitioner to get the conversation started:

  • What information do you expect to gain from this test? How could it change the course of my care?
  • What are the risks and benefits of testing?
  • What are the risks and benefits of acting on the results (undergoing treatment)?
  • What is the evidence that supports this screening and how does it fit my situation?
  • What do I need to know or do before the test?
  • What happens during and after the test?
  • What are normal results? What do abnormal results mean?
  • What factors may affect the results?
  • What course of action may be next, after the test?
  • If results are not normal, what are the next steps?

So that you don’t forget to ask during your visit, be sure to write your questions down before you go.

To create a list of questions specific for your situation, see the Agency for Healthcare Research and Quality’s Question Builder.

Your health care practitioner is the best person to look to for answers. No matter how brief the answers may be, asking your physician, physician’s assistant, or nurse is likely to provide you with the answer most specific to your situation. After you hear from them, you can decide to follow up and get more details from a published source of information.

Several leading health organizations have resources on the their websites that can help you become an informed patient with regard to your particular condition and feel more comfortable when talking to your health care practitioner:

Time constraints, comfort in asking questions, confidence in understanding the answers, or simply forgetting to ask the important questions will sometimes compel many people to look for health and medical information from sources other than their health care practitioners. There is a wealth of information available on the Internet that you can use to help guide your understanding of laboratory testing and the concepts described in this article. However, anyone can create a website or a blog, so it’s important to get information from reliable and reputable sources, such as government agencies, professional associations, major healthcare organizations, and universities.

Testing.com provides information on specific laboratory tests. You can access these by using the menus or the search feature at the top of any page.

Below are listed several other websites of varying levels of patient friendliness that address the topics covered in this article. They may be a good place to start when beginning to search for additional information on the web.


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