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Publicly Available Published by De Gruyter April 21, 2016

Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine

Mario Plebani ORCID logo and Giuseppe Lippi

Laboratory diagnostics has emerged as a critical feature of standard medical practice over the past 100 years. Test results have been recognized as increasingly essential tools for diagnosis and monitoring of human diseases, but also for prevention, risk stratification, early diagnosis and (personalized) therapeutic monitoring [1]. Therefore, there is no doubt that the value of laboratory medicine is unquestioned and that it will play an increasingly dominant role in clinical decision making.

Many scientific reports have used, or are still using, the so-called 70% claim for portending that laboratory data may influence up to 70% of clinical decisions [2], or minor variations around this figure [3]. Mike Hallworth has published an intriguing article years ago, suggesting that the 70% claim is not evidence-based, as this information emerged from “unpublished studies and anecdotal observations” [4]. Determining how laboratory information really impacts diagnoses and therapies is not an easy task and it requires well-designed and expensive studies. This is also due to the fact that laboratory tests are integral elements of everyday clinical practice and cannot be used as surrogates for other sources of information such as clinical history, physical examination and imaging studies. It seems even more challenging to establish a “median value” for the impact of laboratory information (e.g. the 70% claim), as the incremental clinical value in different clinical conditions is so variable. In chest pain patients, for example, the claim should be enhanced up to “100%” due to the crucial role of measuring cardiac troponin(s) for the accurate diagnosis of myocardial infarction, whereas laboratory testing may represent an ancillary and often unessential information in diagnosing patients with bone fractures.

A recent article adds fuel to the fire, demonstrating that approximately 66% of clinical decisions in oncology and cardiology are driven by laboratory information. According to the data published in this study, in vitro diagnostic (IVD) costs account for 2.3% and 1.4% of total healthcare expenditures (HCE) in the US and Germany, respectively [5]. In addition to this evidence, further studies emphasize the increasingly important role of laboratory tests, particularly in improving the diagnostic process and reducing diagnostic errors [68].

It is now virtually undeniable that a correct diagnosis is a pivotal issue in health care, as it both provides an explanation of health problems and generates valuable information for the ensuing clinical management. Diagnostic errors are commonly defined as a failure to provide an accurate and timely explanation of a patient’s health problem or a deficiency in communicating that explanation [9]. Besides jeopardizing patient safety, medical errors impose a huge cost on health care systems, estimated at approximately $19.5 billion per year in the US. Notably, this calculation increases up to nearly $1 trillion per year when quality-adjusted life years (QALYs) are applied to those that die [10], a cost that is approximately five-fold higher than that of heart disease, the most frequent pathology in the US [11]. Further analysis of a 25-year summary of US malpractice claims for diagnostic errors revealed that diagnostic errors account for the largest fraction of claims, the most severe patient harm, as well as the highest total of penalty payouts, up to $38.8 billion [12]. According to these concerning figures, we would all agree that diagnostic quality and safety are now virtually unavoidable in the routine practice of health care [13].

Indeed, many catalysts have become available to increase the accuracy and safety of diagnostic reasoning, entailing technological advances that have made the modern health care instrumentation less vulnerable to mechanical or analytical failures [14], implementation of best-practice recommendations, continuous education of health care operators, systematic analysis of system failure (i.e. root cause analysis), process monitoring and widespread publication of documents for improving the worldwide awareness of the clinical and economic consequences of diagnostic errors [15].

The past decade has seen a considerable outburst of quality and safety measures, but most of these were focused on treatment. Nevertheless, diagnostic errors have been somehow underappreciated and underestimated because their identification is frequently challenging. Major hurdles also exist for filling the gap between the time the error occurs, when it is detected and mitigating the potential adverse consequences for patient’s health [16]. Diagnosis (, edited by Mark L. Graber and Mario Plebani, is an innovative journal aimed at providing a scientific forum to authors and readers interested in improving diagnostic quality. The Journal publishes both basic and applied research in the field of diagnostic quality, along with improvement initiatives, opinions and debates to encourage new thinking on improving this critical aspect of healthcare quality. The main topics covered by the Journal include (a) factors promoting diagnostic quality and safety; (b) factors that contribute to diagnostic errors in medicine; (c) tools for improving the value of diagnosis; (d) training and education related to clinical reasoning and diagnostic skills; (e) advances in laboratory testing and imaging that improve diagnostic capability; and (f) local, national and international initiatives to reduce diagnostic errors [17]. Diagnosis should hence be regarded as a starting point for many medical specialties, for the medical diagnostics industry and for the stakeholders of diagnostic services (e.g. patients, clinicians, policymakers, health care organizations, insurers, payers), thus providing a common ground from which a more productive interaction among the many different parties that have an interest in medical diagnosis may hopefully spark. Overall, the Journal is expected to be home and host for everyone seeking to improve the quality and value of diagnosis, ultimately decreasing the chance that diagnostic errors may occur.

Diagnostic errors are clinically and economically more expensive now than ever before, thus requiring renewed focus and more targeted resources. Failing to actively recognize and address such growing health and economic costs will inevitably translate into a missed opportunity to provide better care and realize better economic performance for the entire health care system [18]. We definitely hope that Diagnosis may be seen as a valuable alternative for both readers and scientists deeply involved in the field of diagnostic quality.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Corresponding author: Professor Mario Plebani, Department of Laboratory Medicine, University-Hospital of Padova, 35128 Padova, Italy, Phone: +390498212792, Fax: +39049663240


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Published Online: 2016-4-21
Published in Print: 2016-7-1

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