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Curbside Consult with Dr. Jayne 3/2/26

March 2, 2026 Dr. Jayne 3 Comments

Clinical informatics is a broad subspecialty. Board certification requires being knowledgeable across a broad range of domains. The American Board of Preventive Medicine, which along with the American Board of Pathology can grant certification, distills it for its website:

Physicians who practice Clinical Informatics collaborate with other health care and information technology professionals to analyze, design, implement and evaluate information and communication systems that enhance individual and population health outcomes, improve patient care, and strengthen the clinician-patient relationship. Clinical Informaticians use their knowledge of patient care combined with their understanding of informatics concepts, methods, and tools to: assess information and knowledge needs of healthcare professionals and patients; characterize, evaluate, and refine clinical processes; develop, implement, and refine clinical decision support systems; and lead or participate in the procurement, customization, development, implementation, management, evaluation, and continuous improvement of clinical information systems.

The description doesn’t specifically describe patient-facing tools, but it does cover individual health outcomes, improving patient care, and building the patient-physician relationship. These goals are easier to accomplish when clinicians have tools at our disposal that help patients understand their own health situation and provide education and information.

Plenty of other entities are trying to grab our patients’ attention, which can lead to interesting conversations in the exam room as we work to counter medical misinformation or try to lead patients to consider evidence-based care plans.

I was surprised to see a study in Communications Biology this week that looked at direct-to-consumer testing. The results of tests that look at the microbiome of the digestive system varied dramatically among laboratory providers. The authors sent identical stool samples to the vendors, but each identified different bacterial levels, and only three of more than 1,200 bacteria were consistently identified across all the reports.

It wasn’t just variability between single samples that were sent to multiple facilities, but also among identical samples that were sent to the same facility. For one set of samples, the lab identified one submission as “unhealthy,” while two identical submissions were “healthy.”

The authors hoped to better understand the consistency and reliability of direct-to-consumer testing, which is not required to comply with the same level of regulations that traditional clinical laboratories must meet. Many of these tests fall under the category of “wellness” rather than being designed to diagnose a specific condition. Many physicians find the term “wellness” irritating because it has been used to hawk everything from unregulated botanical substances to jade eggs that are to be placed in the vagina to enhance sensuality (they are also an infection risk and may cause pelvic floor dysfunction, so those are a “no” when patients ask.) 

The authors found that bacteria in the genus Clostridium had the most variability in the reports. Three labs failed to detect it in one or more samples, and one reported it at five times the expected level.

The authors attribute the variability to different reference databases, reporting cutoffs, sample processing protocols, testing methods, and quality control standards. One of their goals was to make a point that just because a direct-to-consumer test is popular doesn’t mean that it is accurate, and that patients should understand the limited evidence that is behind such tests.

As a middle school science fair judge, it is an issue when three identical runs of the same experiment give different outcomes. For those who are curious, the paper details how exactly they prepared the identical specimens, all of which were obtained from a single donor.

Some direct-to-consumer tests get a lot of attention and often lead to patients arriving at the office of their primary care physician, asking us to treat something that isn’t actually a problem. I’ve seen multiple people bring in salivary hormone test panels that aren’t evidence-based and also allergy testing results that can be downright dangerous if not handled appropriately.

I enjoy working with patients who are engaged and want to take action, but these visits often lead to lengthy conversations that may not fit in the typical busy primary care schedule. Also, patients are almost universally unaware that at-home tests are not of the same level and quality as those that we would order in the office or during a virtual visit.

The authors call on the industry to take concrete steps to improve the transparency and interpretation of gut microbiome testing. These could also be applied to other types of testing. Specifically, they call on labs to address the idea of clinical validity and whether testing yields data showing correlation or causation with respect to a given health factor.

They also call for improved analytical performance in the testing process, maximizing both accuracy and precision. They go further to recommend that the industry work with testing companies and other stakeholders to create guidelines for testing, which would improve the validity of testing as well as the confidence of consumers who seek it.

Although patient-directed stool testing isn’t something you typically hear much about, research like this highlights some of the opportunities for clinical informatics experts to lend their knowledge to the task. We can help identify if a population-level issue  needs to be investigated, perform qualitative and quantitative research to understand the scope of the problem, support researchers as they seek data and information around the topic, and identify how the findings might be used to improve patient care.

We can also configure the tools at our disposal to help identify which patients would benefit from such testing, configure clinical decision support systems based on new evidence, and automate the creation of treatment plans based on the results while delivering effective patient education along the way.

Many of my colleagues think that clinical informatics team members just build order sets and flowsheets in the EHR all day. They don’t necessarily have exposure to all the different types of healthcare technology we can employ and how it can have an impact on the patients and communities that we serve.

As more of us enter the field, we should be able to provide that kind of education and exposure to our specialty. Our colleagues should know what we can do, just as they know how a cardiologist or pulmonologist can contribute to the care team.

What’s the most interesting clinical informatics project your team has done? Has your group built any tools that address direct-to-consumer testing or management of those results? Leave a comment or email me.

Email Dr. Jayne.



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Currently there are "3 comments" on this Article:

  1. A Week in the Life of Clinical Informatics:

    Sunday: patient care.
    Monday: system design.
    Tuesday: iterate on feedback.
    Wednesday: governance meetings, safety, and responsibility.
    Thursday: hard questions about evidence (including from wellness testing).

    If only it were that streamlined.
    In reality, a single day can hold everything from caring for the patient in front of you to helping shape what healthcare might look like 50–100 years from now.

    Clinical informatics requires deep analytical thinking, trust-building, and humility. You have to understand the problem beneath the problem. You have to care enough to feel urgency.

    “Your workflow issue is my issue. Your patient is my patient. Let’s get it right.”

    For those curious about the field, organizations like the American Medical Informatics Association (AMIA) offer a tools (and mentors) – and many of us are happy to talk about the work.

  2. Good DTC discussion a few weeks ago on LinkedIn: https://www.linkedin.com/posts/graham-walker-md_what-if-we-made-a-lot-more-tests-direct-to-consumer-activity-7426998007272861697-ZCGP?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAGYl5gBhHG9z_iLVKPFLIJzVxbfDeN79Is

    Also distinctions between DTC and Direct Access Testing (DAT): https://myadlm.org/cln/cln-daily/2023/direct-to-consumer-laboratory-testing

    There are distinctions between these types of tests and applicable regulations. Also why Congress created CLIA in the late 1960s to focus on test quality: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493

    Some of the key aspects of the topic are:
    1. Distinctions between health professional performed testing versus consumer performed
    2. Trust (from medical/legal perspective) in results from health professionals versus consumer performed
    3. It gets tricky in trying to include some of these data in EHRs as the two in #1 need to be kept distinct.
    4. Not an easy way to integrate into the EHR. Usually patient/consumer messaged or verbal in person visit listed in clinical notes, where they are not very interoperable/usable.
    5. Range of testing scenarios from in lab, laboratory professional performed to Point of care testing by health professional, to same kit performed used to collect the specimen and perform by the consumer to consumer purchased testing and self collected specimen sent to a CLIA lab where testing is perfomed by health professionals. Different levels of trust with each too. As more combinations flood the market, we find consumer purchased kit, and consumer collected specimen paired with smartphone “reading/interpretation” of values and perhaps transmission to a health professional or CDC (like we saw with COVID public health tests).
    6. When consumers are involved no way to know if specimens were collected correctly or even on humans (swab a dog’s nose or dropped a pregnancy test in the toilet invalidating it). Where the IVD vendor does more interpretation it reduces, but doesn’t eliminate these factors.
    7.With at home STD, HIV and other tests that are public health reportables when done by a clinical lab or provider, positive results are public health reportable in most jurisdictions by law. However, not aware of laws for consumer performed testing (even if same kit).
    8. They can be purchased/done 24/7 when many clinics are closed so convenient.
    9. How are these results used for decision making? Is it to go to a health professional for further testing? Is it to stay home and rest and recover from an infectious disease? Is it to avoid a costly ED visit or to get results sooner than waiting for an available appointment (in areas where access is challenging or health professional shortages)?

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