| Wednesday, May 17, 2017
The healthcare profession, as with every other societal institution, is changing with the times. Technological advances have changed how we diagnose, treat, monitor, and manage disease; political and social forces have changed how these services are regulated and reimbursed, and all three have influenced how these services are delivered. The laboratory profession reflects these changes as well.
An estimated 7-10 billion laboratory tests are performed each year in the United States, and laboratory test results influence approximately 70% of medical decisions. Yet the importance of lab tests reaches much further. They enable physicians and patients to:
- Identify disease and begin treatment earlier than ever before
- Detect and diagnose diseases before symptoms occur
- Individualize care to meet the unique needs of the individual patient
- Identify health threats before infection spreads
- Employ preventive strategies that reduce the need for invasive care
- Monitor patient progress and adjust treatments accordingly
- Foster cost-savings and greater productivity in health delivery
The impact of personalized medicine
The evolving field of personalized medicine -- defined as the tailoring of medical treatment to the individual characteristics of each patient – is profoundly impacting all stages of patient care, including prevention, diagnosis, treatment, and follow up. This approach relies on understanding how a person’s unique molecular and genetic profile makes them susceptible to certain diseases. Scientists advanced the cause of personalized medicine with the decoding of the human genome, the genetic map of the body.
Consequently, this allows medical providers to:
- Shift the emphasis in medicine to prevention and prediction of disease rather than reaction to it;
- Focus on susceptibility to disease, improve disease detection, preempt disease progression;
- Ability to make more informed medical decisions; earlier disease interventions;
- Customize disease-prevention strategies;
- Prescribe more effective drugs and avoid prescribing drugs with predictable side effects;
- Have a higher probability of desired outcomes thanks to better targeted therapies;
- Reduce the time, cost, and failure rate of pharmaceutical clinical trials, and
- Eliminate trial-and-error inefficiencies that inflate health care costs and undermine care
Similarly, genomic medicine is also changing laboratory testing protocols to match specific patient needs. An example is genetic testing for BRCA1 and BRCA2 mutations that can indicate an individual’s risk for developing breast or ovarian cancer.
The results of gene-based molecular diagnostic laboratory tests can then be used to determine the benefits and harms for an individual taking prescribed medications (known as companion diagnostics tests). Information on an individual’s drug metabolism, for example, can yield information on who might benefit most from a drug and those at risk for atypical adverse reactions. Tests can also inform the optimal dose or treatment frequency needed to achieve a desired therapeutic effect in an individual patient. Examples are:
- HER2/neu testing to guide the prescription of the cancer drug Herceptin for breast cancer.
- UGT1A1 testing to guide the dosage of the chemotherapy drug Irinotecan for metastatic colectoral cancer.
Patient–centered healthcare requires patient engagement through patient empowerment
As the healthcare industry starts to reengineer care delivery to accommodate these new advances and demands, providers on the front lines of change are recognizing the need for increasing patients’ engagement in their own health care. This is based on the knowledge that it is impossible to manage the health of a population without getting patients more involved in self-management and the modification of their own risk factors.
An empowered, activated patient:
- understands their health condition and its effect on their body
- feels able to participate in decision-making with their health care professionals
- feels able to make informed choices about treatment
- understands the need to make necessary changes to their lifestyle for managing their condition
- is able to challenge and ask questions of the health care professionals providing their care
- takes responsibility for their health and actively seeks care only when necessary
- actively seeks out, evaluates and makes use of information
Educating patients about the meaning of their laboratory tests promote these goals.
When the patient understands the reasons specific tests are ordered, what the results mean, and how they are utilized in the diagnosis, treatment, and monitoring of their conditions, the more likely it is that the patient will do what is needed to attain and maintain a healthier state.
Patient education regarding lab testing can be provided in many ways, including through:
- The physician directly
- Laboratory staff and other ancillary healthcare providers who have the education to provide this information, such as nurses, and pharmacists
- Reference laboratories, where patients can visit directly or receive information via mail or online
- Government information sites such as the FDA, and the CDC
- Private laboratory information sites, such as Lab Tests Online; or Health Network Laboratories;
- Laboratory testing information provided online by major medical clinics and hospitals
- Health insurance companies
- Laboratory profession sites such as the American Association for Clinical Chemistry (AACC); the American Society for Microbiology (ASM), and the American Society for Clinical Pathology (ASCP)
- Laboratory Accreditation organizations, such as the American College of Physicians (CAP), COLA and The Joint Commission
Additional catalysts driving the need for patient education about lab testing
Direct Access aka Direct-To-Consumer Testing
Direct-to-Consumer (DTC) testing permits consumers to order laboratory tests directly from a laboratory without necessarily having to work with their healthcare provider. These test results may be used to monitor an existing health condition, identify a previously unknown medical disorder, or provide data regarding personal health characteristics. DTC laboratory testing is a key element of ongoing efforts to increase individuals’ engagement in managing their healthcare, and it is critical that DTC test results are accurate and well understood.
Currently almost 40 states and the District of Columbia permit consumers to order some or all of their laboratory tests directly— without the involvement of a physician. Similarly, the federal government joined this trend by issuing a regulation directing clinical laboratories to provide individuals with access to their test data upon request. With these new policies in place, consumers are increasingly involved in guiding the health decisions that affect their lives.
To this list of uses for direct-to-consumer testing we can now add at home DNA testing that provides information on an individual’s genetic disposition or risk for certain medical diseases or conditions. This knowledge may help individuals make decisions about lifestyle choices.
The first DNA Test company that the FDA has authorized to provide this information is “23 and Me.” This testing does not include checks for genes that predispose people to cancer; rather, it looks instead for DNA variation involved in ten other conditions, such as Parkinson’s, Late-onset Alzheimer’s and Celiac disease.
Regardless of the method by which patients order their own tests, they must have the correct and complete information to understand what the results mean; when it is necessary to follow up with physician visits; and when to seek immediate help.
Point-of-care testing (POCT) and the rise of retail medicine
Testing is also no longer confined to the laboratory. Technological innovations have led to testing that can be performed in other healthcare settings. Medical decisions are made at the patient’s bedside, in the emergency room or clinic, at the workplace, in an exam room of a physician’s office, in pharmacies, and in retail centers, such as Target and Walmart. Increasingly, these decisions are based on simple tests performed at the point-of-care, using devices that are “waived” from most federal oversight requirements, and are thus designated as waived tests.
Advances in technology have made this testing both simpler and more robust, and this has contributed significantly to the shift in testing from the more complex testing methodologies to the simpler waived methods. Many tests can now be performed using compact or hand held devices by personnel with no professional experience and training.
Thus, it has become more important than ever to provide education on laboratory diagnostic testing to the public.
Wellness and Prevention Strategies
As referenced earlier, personalized medicine, tailored to the individuality of each patient based on genomic and molecular testing, focuses strongly on wellness and disease prevention. If a person's genomic information indicates a higher-than-average risk of developing diabetes or a particular form of cancer, that person may choose a lifestyle, or sometimes be prescribed medications, to better regulate the aspects of health and wellness over which he or she has control. The person may benefit in the long run from making preventive lifestyle choices that will help counteract the biological risk.
To have successful patient management of these potential health issues, there must be buy-in by the patient to the necessary regimens, including appropriate laboratory testing. Educating the patient on how these tests work, what the results mean in terms of potential for developing these diseases, and the ramifications that can follow are vital. Patient education is the building block for successful healthcare management.
Education is the modern response to enabling patient empowerment in the face of an evolving healthcare environment, driven by the rapid pace of technological change. Patient education must be provided if practitioners are to stay competitive, provide the best value-based healthcare, and promote long-term partnerships with their patients. A key component of patient empowerment is ensuring that patients have access to the most complete education possible about their lab tests to both understand and be partners in their own health care.