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PJ Online homeThe Pharmaceutical Journal
Vol 280 No 7493 p298
15 March 2008

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Health tests need to be evaluated

Sebastian Czapnik/Dreamstime.com

Diagnostic testing

Diagnostic testing: concerns raised over use of NHS monies to reassure the worried well

Diagnostic health tests should be evaluated and regulated in a similar way to medicines, according to a report published this week.

The Royal College of Pathologists and the PHG Foundation (a public health and genetics charity) are calling for information about the performance and usefulness of tests — ranging from cholesterol testing kits to genetic tests — to be stored in a publicly accessible database, equivalent to the British National Formulary.

Healthcare professionals should then be encouraged to use only the tests with sufficient evidence of clinical performance.

Commenting on the report’s launch, Evan Harris MP said: “At a time when the NHS cannot afford even all those carefully evaluated tests and treatments that are known to save or improve lives, it cannot be right for there to be a free-for-all on tests which are of dubious value and require the NHS to spend scarce resources investigating or reassuring the worried well.”

The report says that, despite NHS laboratories having sophisticated systems to ensure the analytical accuracy of tests, no system is in place to ensure the clinical effectiveness of individual tests. It says that this system is analogous to “having a pharmaceutical industry with tight control of the chemical purity of drugs, but with no formal requirement for evidence that a drug benefits patients”.

As well as helping healthcare professionals to order tests that are proven to be useful and cost-effective, a new regulatory system will help protect the public who purchase these tests over the counter or via the internet.

There are concerns that these tests are sold with heavy marketing, but that patients are not aware of the risks. To help address this, a new patient guide, “Making sense of testing”, has been published by the charity Sense About Science.

The guide highlights that the market for home tests used by the “worried well” is now worth £99m a year.

The guide also explains that tests are only one part of diagnosis, and in some cases can cause harm. It says that many of the tests available are not researched or adequately regulated, and describes concepts such as false negative and false positive results.

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