Study reveals economic impact related to specimen complications in prostate biopsies

Specimen provenance complications (SPCs) attributed to economic burden

The Journal of Urology included a study focused on the economic impact of specimen provenance complications (SPCs) related to prostate biopsy procedures and diagnosis. The data set revealed that on average 1 of every 200 prostate biopsy patients is misdiagnosed due to their biopsy specimens being switched with or contaminated by those of another patient. In addition to the life-changing afflictions of false-negative and false-positive patients, the study reports an estimated $880 million wasted annually on unnecessary healthcare and medical-legal expenditures related to the mix-ups.

An important note are the millions of additional biopsies that are performed each year to diagnose breast, colon, lung, and other cancers that are not included in this study, all of which encompass a similar workflow as prostate specimens.


Journal of Urology Study
The full study titled The Clinical and Economic Implications of Specimen Provenance Complications in Diagnostic Prostate Biopsies appeared in the April edition of the Journal of Urology, and can be accessed online at www.jurology.com.

Summary of Abstract

OVERVIEW:

More than 1 in every 200 prostate biopsy patients is misdiagnosed due to undetected specimen provenance complications. Inaccurate diagnoses of prostate cancer can result from transposition or contamination of patients’ biopsy specimens, known, as Type I and Type II specimen provenance complications (SPCs), respectively. False diagnoses due to SPCs often result in adverse clinical and economic consequences associated with unnecessary and/or delayed treatment. This is the first study seeking to quantify the societal economic and clinical implications of SPCs among prostate biopsies in the United States.

MATERIALS AND METHODS:

A comprehensive, systematic review of the published literature was performed to approximate the effect of SPCs on direct medical costs, patients’ quality-adjusted life years (QALYs), and medico-legal costs (MLCs). Data were extracted from published studies on SPC rates, prostate cancer treatment distribution, efficacy, and costs, patient quality of life at various states of treatment disutility, and litigation/settlement costs following false diagnosis of prostate biopsies.

The authors performed a combinatorial analysis to estimate the total number of SPCs expected among an annual cohort of prostate biopsy patients, and the subset of those SPCs which are likely to be clinically meaningful. Factors considered included previously reported data relating to clinical setting distribution, SPC rates by setting, and distribution of positive vs negative histopathology results. SPC’s likely to be observed as visible “floaters” within the standard histopathology workflow were further excluded from the clinically meaningful subset.

RESULTS:

These analyses estimate that 0.46% of all prostate biopsies are subject to clinically meaningful transpositions (Type I errors); 0.27% resulting in false-positive, and 0.20% in false-negative misdiagnoses. An additional 0.11% of biopsies result in false-positive misdiagnosis due to undetected contamination (Type II errors). In total, SPCs can be expected to lead to misdiagnosis and significant patient harm in at least 0.57% of all prostate biopsies, or 1.13 in every 200 patients.

Among an estimated 806,251 primary and secondary prostate biopsies performed annually in the United States, 20,322 (2.52%) are projected to involve SPCs, resulting in 4,570 (0.57%) clinically meaningful false diagnoses. The total burden of SPCs was projected to exceed $879.9 million, or $3,776 per positive cancer diagnosis, comprised as follows:

Wasted direct medical treatment costs: $145.8 million ($626 per diagnosis)

Net monetized cost of 634 QALYs lost: $39.3 million ($169 per diagnosis)

Medical legal expenditures: $694.8 million ($2,981 per diagnosis)

CONCLUSIONS:

The societal economic burden of SPCs in the case of diagnostic prostate biopsy alone was estimated to be $879.9 million annually, and is likely to be similarly large in other disease states. Furthermore, as molecular diagnostics increasingly become a component of differential diagnosis and therapy selection in the era of precision medicine, the compounding impact of SPCs perpetuated from histopathology to molecular pathology cannot be ignored. These findings may be useful as policy-makers, health organizations, and researchers seek approaches to reduce medical errors and waste resulting from false diagnoses.


 

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