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Data-driven overdiagnosis definitions: A scoping review.

Prabodi Senevirathna1, Douglas E V Pires2, Daniel Capurro3

  • 1School of Computing and Information Systems, The University of Melbourne, Melbourne, 3053, Victoria, Australia.

Journal of Biomedical Informatics
|September 28, 2023
PubMed
Summary
This summary is machine-generated.

This review examines how researchers measure overdiagnosis, a common risk when applying new diagnostic technologies to healthy populations. By analyzing 46 studies, the authors highlight the lack of a consistent standard for identifying overdiagnosed patients, which complicates efforts to improve patient safety in digital health.

Keywords:
Clinical trajectoriesDigital overdiagnosisDigital screeningOverdiagnosisclinical informaticsdiagnostic accuracypatient safetysystematic review

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Area of Science:

  • Data-driven overdiagnosis definitions in clinical informatics
  • Health services research and digital health innovation

Background:

Digital health innovations offer significant potential to transform clinical care and patient management strategies. However, the rapid integration of these technologies into healthcare systems presents unique challenges for patient safety. No prior work had resolved the ambiguity surrounding adverse outcomes when applying these tools to asymptomatic populations. Overdiagnosis remains a significant concern as diagnostic capabilities expand through advanced computational approaches. That uncertainty drove the need to evaluate how current literature defines and quantifies this phenomenon. Researchers have struggled to establish uniform metrics for identifying patients who receive unnecessary diagnoses. This gap motivated a systematic investigation into existing quantitative strategies used across various medical fields. Understanding these definitions is vital for ensuring that technological progress does not inadvertently harm patients.

Purpose Of The Study:

The aim of this scoping review is to comprehensively analyze quantification strategies and data-driven definitions for overdiagnosis reported in the literature. Researchers seek to understand how these definitions vary across different clinical contexts and diagnostic approaches. This investigation addresses the challenge of translating digital health innovations into improved patient care without causing unintended harm. The authors focus on the potential adverse effects of applying diagnostic tools to healthier segments of the population. They identify a clear need to evaluate existing methods for estimating the proportion of overdiagnosed patients. This study motivates a deeper look at how current quantitative techniques influence our understanding of diagnostic accuracy. By mapping the available evidence, the team intends to highlight the lack of a consistent standard in the field. The work ultimately serves to inform future efforts in developing more reliable metrics for diagnostic safety.

Main Methods:

The authors performed a scoping systematic review to identify manuscripts describing quantitative strategies for estimating overdiagnosis. Their search approach targeted studies that provided numerical methods for calculating the proportion of affected patients. Researchers established specific inclusion criteria to select relevant literature from a broad range of clinical domains. The team analyzed 46 manuscripts that met these predefined requirements for quantitative rigor. This review process involved examining both prospective and retrospective study designs to capture diverse measurement techniques. Investigators included randomized clinical trials and various simulation models to ensure a comprehensive overview of the field. The study design focused on mapping the landscape of existing definitions rather than conducting a new primary analysis. This systematic approach allowed the authors to categorize the different ways that researchers currently quantify diagnostic outcomes.

Main Results:

The authors identified 46 studies that met their criteria for analyzing quantitative methods of overdiagnosis. These manuscripts covered a wide variety of clinical conditions, with breast and prostate cancer appearing most frequently. The literature reveals that current strategies for quantifying overdiagnosis produce widely diverging results across different studies. Researchers utilized both prospective and retrospective methods to estimate the proportion of overdiagnosed individuals. These quantitative approaches included randomized clinical trials and complex simulation models. The findings demonstrate that there is no standard method currently employed to measure this adverse effect. This lack of uniformity complicates the comparison of diagnostic outcomes across different digital health innovations. The results highlight a significant need for standardized metrics to improve the safety of emerging diagnostic technologies.

Conclusions:

The authors emphasize that current literature lacks a unified standard for quantifying overdiagnosis across clinical settings. This synthesis suggests that the wide variation in reported metrics hinders effective mitigation strategies. Researchers propose that establishing a consistent definition is necessary to improve patient safety in digital health. The review highlights that existing quantitative approaches produce highly inconsistent findings when applied to patient data. Authors observe that the rapid development of diagnostic tools necessitates more rigorous evaluation of potential adverse effects. This analysis indicates that current methodologies for estimating overdiagnosis are fragmented and require standardization. The team concludes that future efforts should prioritize the development of reliable benchmarks for diagnostic accuracy. This work underscores the importance of addressing overdiagnosis to ensure that digital innovations provide genuine clinical benefits.

The researchers propose that overdiagnosis occurs when diagnostic tools identify conditions that would not have caused symptoms or death. This outcome is measured using diverse quantitative strategies, including simulations and randomized clinical trials, which currently yield widely diverging results across different patient populations.

The study focuses on quantitative methods, such as retrospective and prospective analyses, to estimate the proportion of overdiagnosed patients. These tools are used to evaluate clinical conditions, with the authors noting that breast and prostate cancer represent the most frequent subjects in the reviewed literature.

A standard method is necessary because the rapid development of new digital diagnostic tools increases the risk of overdiagnosis. Without a consistent framework, the authors argue that it is difficult to mitigate these adverse effects effectively as technology continues to evolve within clinical environments.

The researchers utilize data from 46 distinct studies to synthesize existing evidence. This data type allows them to compare various quantitative strategies and highlight the lack of consensus in how different clinical trials and simulations define and report overdiagnosis rates.

The authors measure the prevalence of overdiagnosis across a variety of clinical conditions. They observe that the lack of a standardized measurement phenomenon leads to significant discrepancies in how researchers report the impact of diagnostic interventions on healthier segments of the population.

The researchers propose that establishing a standard method for quantifying overdiagnosis is vital for its mitigation. They suggest that this step is required to ensure that the integration of digital diagnostic tools into healthcare does not lead to unintended negative consequences for patients.