A wide range of new diagnostic technologies developed in recent years to detect diseases earlier may also be leading to unnecessary treatments and misdiagnosis, according to the findings of a new report. 

In an analysis published this week in The BMJ, researchers from Norway and the U.S. looked at four case studies involving new healthcare diagnostic technology. They warn that the technology breakthroughs have a potential to help many patients, but may also cause more harm than good, by increasing the frequency of false alarms and over treatment. As a result, care is needed to minimize harm.

The authors point to the new health technology Immunosignature as an example. The product is not approved by the FDA, but focuses on ways to predict disease by analyzing a patient’s antibodies and how they bind to certain peptides. HealthTell claims Immunosignature has the potential to offer “continuous monitoring of healthy people to detect disease early.” They indicate the tech can reduce medical costs and first studies show a high sensitivity for multiple diseases.

However, authors of the analysis warn there is no evidence of improved patient outcomes. In fact, the test produces false positives at a minimum of 1 to 2 percent of the time, and they believe that may be a gross underestimate. False positives often lead to over diagnosis and unnecessary treatment.

Similarly, Zephyr Technology is developing a patch to monitor vital signs, including heart rate, respiratory rate, activity, and posture. The patch then sends the data to a monitoring device, such as a smartphone or computer. The tech is approved by the FDA, and the manufacturer says that it can potentially detect falls, cardiac events, and bed sores before they form. However, it costs about $1,500 for the system alone and data on the accuracy of the monitoring is unclear, which may cause false alarms, unnecessary worries, and unnecessary clinic visits.

A clinical trial found monitoring of pulmonary impedance in patient with heart failure caused three times as many doctors visits and more admissions to the hospital that were unnecessary.

Researchers warn that while technology has the potential to transform medicine from treating disease to promoting health, it should also be looked at and used cautiously.

“Efforts to detect disease early can always be accompanied by unintended harms. These include false alarms and indeterminate findings that can worry patients, drive more testing, increase clinical workload, and distract clinicians from more important work,” they warn. “Overdiagnosis can lead to unnecessary treatments.”

The analysis recommends that patients ask questions first, before jumping on board with new tests. If they receive a positive, what will the patient do differently? If the answer is nothing, then do not use the test. Similarly, if a positive result will lead to distress, unnecessary testing or unnecessary treatment, do not do the test. In either case, prepare for misleading feedback, which can often result in unnecessary over treatment..

Study authors also call on technology companies to focus more on those at high risk, to make the tests more effective. They should also focus on developing tests that highlight real health problems.

Tags: Medical Device, Misdiagnosis