As in accreditation, so in medicine: overly sensitive testing leads to overdiagnosis and overtreatment

Wiener et al. describe the harms that arise from overly sensitive diagnostic testing.  We have seen previously how inspection for compliance with ISO 17025 and 15189 are is an inappropriate screening methodology using a sampling method that is often over-sensitive.

Overdiagnosis, unnecessary treatment, worry, stress and wasted expenses are the consequences of these poor choices whether managing patients, departments…or countries.

Harms to patients and cost to health systems from overdiagnosis

The main harm from overdiagnosis is unnecessary treatment, which in the case of pulmonary embolism means anticoagulation—a leading cause of medication related death.34 Because of ongoing controversy about duration of therapy, exposure to unnecessary and dangerous anticoagulation may be lifelong. In some studies, complications of anticoagulation are more common than the problem treatment is meant to prevent: recurrent venous thromboembolism. Notably, in the largest case series of patients given anticoagulants for isolated subsegmental pulmonary embolism (n=93), the risk of major bleeding was 5.3% but the risk of recurrent venous thromboembolism was only 0.7%.24 In our study, in parallel with the increased incidence of pulmonary embolism, we found presumed anticoagulation complications for US patients admitted to hospital with pulmonary embolism to have increased from 3.1 to 5.3 per 100 000 (P<0.001) between 1998 and 2006.26

Overdiagnosis also causes patients harm from inconvenience and anxiety. The current standard of care (warfarin) requires frequent blood tests, dietary changes, and constant fear of bleeding or clotting if the international normalised ratio is not in the target range. Patients may also be harmed by the fear and anxiety from being unnecessarily told that they have a potentially life threatening disease.23 In addition, health insurers may charge them higher premiums because they have a “pre-existing condition.”

Overdiagnosis and overtreatment are also costly to health systems. The mean charge associated with admission for pulmonary embolism in the US increased from roughly $25 000 (£17 000; €19 000) to $44 000 between 1998 and 2006.35 The mean cost of subsequent warfarin anticoagulation, associated laboratory tests, and clinic visits was $2694.36 The recent introduction of newer anticoagulants (dabigatran, rivaroxaban) will decrease the need for testing, but the drugs are substantially more expensive than warfarin ($3000 v $48 a year37)...”


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