Direct-To-Consumer Healthcare Service Perceptions
According to doctors, DTC (direct-to-consumer) home testing methods are mostly irrelevant tests that do more harm to consumers than good. They feel that patients need proper guidance from physicians rather than relying on these test results and that the tests are not considered to be accurately diagnostic for treatment decisions. Conversely, they note that DTC tests motivate physicians to learn more about genetics and help patients become more aware and engaged in their own health and wellness.
1. Irrelevant Testings with Dubious Results That Cause More Harm
- DTC home testing kits for food allergies, offered by companies like EveryWell, test for Immunoglobulin G (IgG) as a marker.
- However, clinical groups have advised against using IgG tests to evaluate food allergies because, according to physicians, the tests are "irrelevant for the laboratory work-up of food allergy or intolerance and should not be performed in cases of food-related complaints."
- The reason for this response by doctors is due to the use of IgG because it stems from the body’s normal immune response to exposure to many substances, including food. High levels don’t indicate a problem; they simply point to foods a person recently has eaten.
- Dr. Martha Hartz, an allergist, sad this about home allergy test: "It has no relevance to anything. It is just not a test that should be done."
- According to Robert Wood, food allergy tests "are completely useless and do dramatic harm" because they make patients cut nutritious food from their diets which is unnecessary for healthy adults and children.
2. Motivate Physicians to Learn More About Genetic Tests
- DTC kits make patients engaged and in-charge of their own health. People are more aware of their health and wellness and they discuss results and questions with their physicians.
- According to the American Medical Association (AMA), physicians must discuss the risks and benefits of these tests with their patients.
- Increasing popularity and interest among patients in DTC home testings using genetics motivates physicians to learn and be more informative as patients discuss concerns with them.
- According to Dr. Margaux Lazarin, "as physicians, we don't get a lot of genetics training in medical school. The field is rapidly expanding—not just with direct-to-consumer products—and the increased interest will hopefully motivate physicians to learn more about genetics and its influence on the health of our patients as they bring questions and test results into our offices."
3. Patients Rely More on Tests Than Lifestyle Modifications Recommended By Physicians
- People tend to rely more on results from home testing than physician's lifestyle recommendations. Dr. Lazarin stated, "I'm wary of how much emphasis patients put on tests, in general, even if it's something like cholesterol. They often put more weight on the test than the lifestyle modifications we recommend."
- Patients are not usually informed about the limitation of DTC testing. The marketing of DTC health testing kits is often misleading and, in certain cases, there is no sufficient scientific evidence to support the test's claims.
- Patients may get a result from a DTC test and believe they do not have a disease but physicians note that multiple other factors contribute to staying healthy. According to Dr. Stewart Decker, "People forget there are innumerable other factors that contribute to health or that could increase the risk of getting a disease. If a patient has a family history of breast cancer, that's an opportunity to have a conversation about risks. Now a patient with a family history of breast cancer might get this new test, think they are at low risk and never see anyone about it again."
- According to the AMA, DTC lab tests "overstate the impact of particular findings, for which little or no evidence may be available, to support questionable recommendations such as those regarding nutritional choices."
- Anneke Lucassen, president of the British Society for Genetic Medicine, states, "Finding a 'health risk' via these tests often does not mean a person will go on to develop the health problem in question, while 'reassuring' results might be unreliable." Lucassen goes further to state, "the BMJ paper warns genetic tests often prioritize 'breadth over detail,' citing a 23andMe test that checks for a few variants of Brca1 and 2, linked to breast and ovarian cancer risk when there are actually thousands."
4. Proper Guidance Is Compulsory to Interpret DTC Test Results
- Physicians and experts feel that companies that provide DTC tests have an ethical responsibility to provide clear explanations about test results.
- Dr. Lazarin says, "I think direct-to-consumer tests should connect consumers to genetic counselors to answer their questions. If someone has a high-risk test result, who is responsible for explaining that information? If I order a cholesterol test, I'm responsible for making sure the patient knows what their results mean."
- According to Dr. Helen Stokes-Lampard, who chairs the Royal College of GPs, "Genetic testing shouldn't simply be done to satisfy a patient's curiosity about their health, as the results could have very real implications." She goes further to say that DTC test counseling "should be the direct responsibility of the companies that are being paid to perform the tests."
- The reason for these kinds of responses from doctors is due to the complication in guidelines and test methods, and patient tendency to misinterpret results.
- JAMA Viewpoints states that most DTC testing companies "offer these tests widely to the public without any reference to evidence-based guidelines or the appropriateness of testing in their advertisements."
- It is evident from a survey in the Annals of Internal Medicine that most patients do not discuss DTC self-tested results with their doctors. Only 19% of patients shared their DTC results with their primary care physicians. Of those who did tell their physicians they had DTC testing, 35% said they were "very satisfied" with how that discussion went.
5. DTC Lab Test Results Should Not Direct Diagnostic/Treatment Decisions
- DTC results should not be used as a substitute for physician guidance and diagnosis. Most doctors do not recommend DTC kits and think that these tests are useless and a waste of money.
- The AMA states, "A positive result does not always indicate a clinical diagnosis. Instead, it may indicate an increased risk for developing a disease or condition. Similarly, a negative result is not indicative of the absence of disease risk. These concepts can be difficult for consumers to understand without a physician or genetic counselor to fully explain them."
- Dr. Coyle, assistant professor of medicine and medical education, stated that "I wouldn’t recommend to patients that they do [DTC testing] if they asked."
- Dr. Helen Wallace, director of GeneWatch UK, said, "We recommend that [patients] do not buy these tests, which are at best a waste of money."
- The reason for this response is due to the high false-positive rates observed during recent studies. In one 2018 study in Genetics and Medicine, 49 patient samples tested for previously identified genetic variants found in raw DTC data, investigators found a 40% false-positive rate.
- According to the AMA, DTC lab tests are "not set up with the appropriate sensitivity and specificity needed for population screening, which raises the potential for a high rate of false-positive results, and may not cover all risk factors for the condition. [These tests] avoid regulatory oversight, particularly when lacking health or medical claims."