Now, more than ever, we live in an intensely information-driven society where ready access to one’s personal medical information is expected; enabling and encouraging patient involvement in their own healthcare.
While all aspects of healthcare delivery are changing, it is the clinical laboratory profession that is at the center of this dynamic due to the massive increase in patient test data generated, and the demand for direct patient access to test ordering and test results. This has led to the increased visibility, importance, and responsibilities of the laboratory within the healthcare profession.
Healthcare providers recognize the need to encourage patients’ engagement in their own health care, for they know that an empowered patient[i]:
*Understands more clearly the issues regarding their health, and its effect on their body
*Feels able to participate in decision-making with their health care providers
*Feels able to make informed choices about treatment
*Has a better understanding of the need to make necessary changes to their lifestyle for managing their condition
*Takes responsibility for their health and actively seeks care when necessary.
*Actively seeks out, evaluates, and makes use of information.
Patient Education Promotes Patient Empowerment
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.
Educating patients about the meaning of their laboratory tests is even more important now, because in the past, individuals had to visit a healthcare facility—a physician’s office, hospital, or clinical laboratory—to have blood or other specimens collected for clinical testing, and they had to wait a period of days to weeks for a call from their doctor with the results.
What has changed?
Direct Access Testing (DAT)[ii]
Direct access testing (DAT), 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. It is critical that these results are accurate and well understood. Laboratory professionals play a vital role in this process.
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[iii]. With these new policies in place, consumers are increasingly involved in guiding the health decisions that affect their lives.
Testing is no longer confined to the laboratory:
Technological innovations have led to testing that can be performed in other settings.
Point of Care Testing (POCT)
Consumers can also identify, order, and buy laboratory services directly in a variety of convenient non-traditional settings, such as retail centers, pharmacies, mobile testing facilities, and wellness centers. These point of care testing (POCT) options provide individuals with immediate access to timely services and results. Many of these tests are performed on waived devices, free from most Federal oversight requirements, by personnel with little or no professional experience.[iv]
Direct to Consumer Testing (DTC)
Many more options exist for today’s consumers. Individuals now can buy over-the-counter test kits that allow them to collect a sample and mail it to a laboratory that performs the test, or, in some cases, conduct the test themselves in their own homes. This is known as Direct to Consumer Testing. This has increased exponentially during the COVID pandemic.
A concern about DTC laboratory testing[v]:
While this can provide valuable information to individuals about their health status in a timely and convenient manner, questions have arisen about whether consumers have enough background knowledge and information to make sound decisions based on their test results.
Consumers might not understand the limitations associated with some tests nor do they necessarily have the knowledge to interpret the tests without input from healthcare professionals. Over the past decade, policymakers have been struggling to balance these concerns with a growing desire of individuals to take a more active role in making decisions affecting their health. Regardless of the method or setting 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’s visits, and when to seek immediate help.
Personalized medicine, defined as the tailoring of medical treatment to the individual characteristics of each patient, is profoundly impacting all aspects 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[vii].
If a person’s genomic information indicates a higher-than-average risk of developing diabetes or a particular form of cancer, that person will be encouraged to choose a lifestyle, and use prophylactic medications to regulate better the aspects of health and wellness over which they have control. The person may benefit in the end 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.
Test Reporting and Interpretation[viii]
Laboratory reports have been developed to provide specific information to highly trained and knowledgeable healthcare providers. As such, the reports typically provide a numeric value and a reference interval, and may also include a brief description of the result. This minimal information, when considered with all other factors such as any symptoms of disease that may be present, is sufficient for healthcare professionals to make clinical decisions.
However, an individual consumer needs far greater context to understand fully the meaning of the test and to determine next steps. For example, an abnormal test result outside the reference interval may or may not indicate an underlying health problem. Alternatively, an individual may be falsely reassured by a test result in the normal range even when signs, symptoms, and trends, warrant medical attention. Finally, consumers may not understand the limitations of the tests and therefore may interpret the results of their tests incorrectly.
Laboratory professionals can play a vital role in all aspects of this consumer-driven process, including educating individuals about the benefits and limitations associated with tests and assisting in the selection of the most appropriate test for that particular person. In addition, highly trained and experienced laboratorians can assist in the interpretation of test results and can provide consumers guidance on whether additional testing is required to confirm or clarify results, directing them to medical professionals for any necessary follow-up care. Patients can also access reliable information electronically.
Resources for Educating Patients about their Test Results
In summation, patient education about lab test results can be provided in many ways, through
· The physician directly
· The 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[ix]; or Health Network Laboratories[x]
· 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
Patient’s Preferences for Receiving Laboratory Test Results[xi]
An important consideration when setting up a system for educating patients about their lab test results is an awareness of preferences for receipt of these results. In a study conducted in 2015 to identify these preferences, all 200 patients in this study preferred online delivery. Also, 82.5% (n = 165) preferred to receive both normal and abnormal test results this way. The main reason for receiving results online was timesaving, which was reported by 77% of participants, followed by lowering the chance of missing the results (31%). About 40% of participants thought e-mail notification was more secure than accessing the results through a facility website. Findings showed that although patients wanted to benefit from online services for receiving their test results, they were concerned about confidentiality and security. Before using online technologies, security measures necessary to protect patient privacy and to gain the trust of patients should be assured.
The ongoing COVID pandemic, in particular, and ongoing societal health issues in general, have highlighted the importance of direct patient education about their test results. This is true whether for testing performed in the traditional setting of a physician office laboratory, a hospital, or a clinic; or a non-traditional setting such as a pharmacy, a shopping mall, or at home. Patient education about their test results must be provided as a support for effective patient empowerment in the face of a rapidly changing healthcare environment. Patient education is vital for providing the best value-based healthcare, and to promote long-term partnerships between physicians and their patients.
[i] Patients Want to Make Their Own Informed Choices. We Need to Let Them. Al-Agba, Niran S. Medpagetoday’s KevinMD.com. Sept. 30, 2016. https://www.kevinmd.com/blog/20126/09/patients-want-make-informed-choices-need-let .html
[ii] Direct-To-Consumer Laboratory Testing. AACC Position Statement. July 2015. https://www.aacc.org/~/media/files/position-statements/directtoconsumerlaboratorytesting2.pdf?la=en
[iv]Some of the information for this bl was gleaned from “Good Laboratory Practices for Waived Testing Sites: Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory Improvement Amendments of 1988 and Recommendations for Promoting Quality Testing,” which appeared in the CDC’s MMWR, Reports and Recommendations, November 11, 2005. The material in the MMWR report originated in the Coordinating Center for Health Information and Service, Steven L. Solomon, MD, Director; National Center for Health Marketing, Jay M. Bernhardt, PhD, Director; and the Division of Public Health Partnerships, Robert Martin, Ph.D Director.
[v] Direct-To-Consumer Laboratory Testing. AACC Position Statement. July 2015. https://www.aacc.org/~/media/files/position-statements/directtoconsumerlaboratorytesting2.pdf?la=en
[vi] USNews/Duke Medicine: Overview of Personalized Medicine 2011. https://health.usnews.com/health-conditions/cancer/personalized-medicine/overview
[viii] Direct-To-Consumer Laboratory Testing. AACC Position Statement. July 2015. https://www.aacc.org/~/media/files/position-statements/directtoconsumerlaboratorytesting2.pdf?la=en
[ix] Lab Tests Online. 2015 American Association for Clinical Chemistry. https://labtestsonline.org [x] Health Network Laboratories. 2015. https:// www.healthnetworklabs.com/Pages/patienteducation.aspx.
[xi] Patient’s Preferences for Receiving Laboratory Test Results. Sabahi, A., Ahmadian, L., Mirzaee, M., and Khajouei, R.. The American Journal of Managed care. April 19, 2017. https://www.ajmc.com/journals/issue/2017/2017-vol23-n4/patients-preferences-for-receiving-laboratory-test-results