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We have known for decades that early detection is the key to early disease treatment, before it can turn into something really nasty.
But since then, we have learned that overdiagnosis, which consists of diagnosing diseases that are not harmful to them, is overdevelopment. Overdiagnosis is often followed by excessive treatment, in which procedures or other therapies are proposed that will not benefit the patient and may cause harm.
The chance discovery of a small thyroid cancer in a person's neck, for example, may result in total thyroidectomy (withdrawal) and thyroid hormone replacement for life. But it is very unlikely that this cancer caused any damage if it had been left alone. And studies have revealed a dramatic increase in thyroid cancer worldwide, with no change in death rates.
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Overdiagnosis can also start with a new, more sensitive test. Such tests can increase the number of people clbadified as "sick" and refer them to additional invasive tests such as biopsies, surgeries and medications.
After the introduction of a new test for pulmonary embolism, for example, more people were diagnosed with these blood clots in the lungs and started taking anticoagulant drugs. Some have suffered from complications such as intestinal and cerebral hemorrhages. And although more people have been diagnosed and treated for pulmonary embolism, the number of people who died is unaffected.
But overdiagnosis is difficult to detect. The collection of data may take years to prove that the new way of diagnosing a disease, based on the new test, is problematic compared to the old one.
To speed up the detection process, we have put together a list of five markers indicating that overdiagnosis is possible. The markers, published today in the journal Annals of Internal Medicine, may help researchers, health authorities, clinicians and even patients determine whether new tests are candidates for overdiangose. Here they are as a set of questions:
- Does the new test offer additional diagnostic potential?
- is the new diagnostic test actually more people?
- do the extra people diagnosed have benign or safe forms of the disease?
- are more people being treated?
- the disadvantages of being treated outweigh the benefits?
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A better way to detect heart disease? Not enough
When we applied these questions to a new blood test for acute heart disease – the extremely sensitive cardiac troponin (HS-cTn) – we found that we had answered yes to most of them.
This new test was evaluated during a major test in Scotland. The trial found that among the patients presenting to the hospital with a possible heart attack, the new test (HS-cTn) allowed more people to be told that they had suffered a heart muscle injury.
Ronald Rampsch / Shutterstock
This has also led more people to undergo additional tests, such as coronary angiogram (type of X-ray imaging), to the prescription of anti-platelet (anticoagulants) and to other drugs to prevent heart disease. The risks of coronary angiography are rare, but include heart attacks, strokes, arrhythmias, infections, and bleeding. Bleeding is a major side effect of antiplatelet medications.
Surprisingly, the new test does not mean that fewer people died of heart attacks in the following year, as expected, despite the increased number of people being treated. This possibility, or other longer-term benefits, was not excluded from the trial, so we could not answer the last question with confidence.
The new test, HS-cTn, was introduced in Australia in 2010 and is now widely used in Australia, Europe and the United States. But we still do not know if its use improves the lives of patients.
We can not say for sure if this new test leads to overdiagnosis, but there are enough red flags to indicate that this could be a problem. We need to further evaluate the new test.
More control of new tests needed
Although we have used the example of HS-cTn, the same reserves and uncertainties apply to the introduction of many new tests.
New tests are generally not subject to the same standards of evidence of benefit as drugs, before being allowed (and often promoted) in the marketplace. It's time to change the rules.
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The potential disadvantages, as well as the benefits, must be taken into account before new tests are used in routine clinical practice. At a minimum, processes need to be put in place to collect and control the data needed to answer the five questions.
Regulators should only allow the provisional use of the test in the years immediately following its availability. for a limited period, for example, or in research contexts.
The additional funding would depend on the evidence that the test is generally beneficial rather than harmful to patients once the benefits and harms are established.
Without these safeguards, the introduction of new tests will continue to put patients at risk because of the tests and treatments they are waiting for, this will help them.
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