Beyond Citation Metrics: A Pilot Scoping Review to Rapidly Characterize Article Impact.

BACKGROUND: Systematic reviews and meta-analyses (SRMAs) support evidence-based practice in laboratory medicine. However, there is little in the literature to address the challenge of globally characterizing the impact of SRMA findings and recommendations. We propose that characterization of citing studies through the structured methods of scoping review provides a meaningful window. CONTENT: A scoping review method characterized the impact of a test utilization SRMA's findings and recommendations through use of a 17-item structured charting template. Following charting, we used descriptive content analysis to identify patterns of utilization, while incorporating current conceptual thinking on healthcare quality improvement. SUMMARY: Rapid scoping reviews support descriptive characterization of SRMA impact and linkage of studies to evolving concepts in the quality improvement literature. The approach may be especially appealing to communities of practice, e.g., to support reflective practice. This pilot suggests that primary studies that have cited the 2018 SRMA have utilized some, but not all, aspects of the 2018 SRMA.

Mapping the Evidence on Rapid Diagnosis of Bloodstream Infections: A Scoping Review.

BACKGROUND: Laboratory and other healthcare professionals participate in developing clinical practice guidelines through systematic review of the evidence. A significant challenge is the identification of areas for analytic focus when the evidence consists of several categories of interventions and outcomes that span both laboratory and clinical processes. The challenge increases when these interventions present as sets of combined interventions. A scoping review may provide a transparent and defensible analytic route forward for systematic reviews challenged in this manner. CONTENT: A scoping review was carried out to characterize the evidence on rapid identification of bloodstream infections. Fifty-five studies previously identified by the supported systematic review were charted in duplicate. Charted records were analyzed using descriptive content analysis and evidence mapping with a 5-step process. SUMMARY: The 5-step analysis culminated in the characterization of 9 different intervention chain configurations that will facilitate the comparison of complex intervention practices across studies. Furthermore, our evidence map indicates that the current evidence base is strongly centered on 3 specific clinical outcomes, and it links these outcomes to the most represented intervention chain configurations. The scoping review effort generated a route forward for the supported systematic review and meta-analysis.

Bringing the clinical laboratory into the strategy to advance diagnostic excellence.

OBJECTIVES: Clinical laboratory testing provides essential data for making medical diagnoses. Generating accurate and timely test results clearly communicated to the treating clinician, and ultimately the patient, is a critical component that supports diagnostic excellence. On the other hand, failure to achieve this can lead to diagnostic errors that manifest in missed, delayed and wrong diagnoses. CONTENT: Innovations that support diagnostic excellence address: 1) test utilization, 2) leveraging clinical and laboratory data, 3) promoting the use of credible information resources, 4) enhancing communication among laboratory professionals, health care providers and the patient, and 5) advancing the use of diagnostic management teams. Integrating evidence-based laboratory and patient-care quality management approaches may provide a strategy to support diagnostic excellence. Professional societies, government agencies, and healthcare systems are actively engaged in efforts to advance diagnostic excellence. Leveraging clinical laboratory capabilities within a healthcare system can measurably improve the diagnostic process and reduce diagnostic errors. SUMMARY: An expanded quality management approach that builds on existing processes and measures can promote diagnostic excellence and provide a pathway to transition innovative concepts to practice. OUTLOOK: There are increasing opportunities for clinical laboratory professionals and organizations to be part of a strategy to improve diagnoses.

Roots of the total testing process.

Laboratory professionals can contribute to improvement of diagnosis in the context of the total testing process (TTP), a multidisciplinary framework complementary to the diagnostic process. While the testing process has been extensively characterized in the literature, needed is accurate identification of the source of the term "total testing process". This article clarifies first appearance of the term in the literature and supplies a formal definition.

A Laboratory Medicine Best Practices Systematic Review and Meta-analysis of Nucleic Acid Amplification Tests (NAATs) and Algorithms Including NAATs for the Diagnosis of Clostridioides (Clostridium) difficile in Adults.

The evidence base for the optimal laboratory diagnosis of Clostridioides (Clostridium) difficile in adults is currently unresolved due to the uncertain performance characteristics and various combinations of tests. This systematic review evaluates the diagnostic accuracy of laboratory testing algorithms that include nucleic acid amplification tests (NAATs) to detect the presence of C. difficile The systematic review and meta-analysis included eligible studies (those that had PICO [population, intervention, comparison, outcome] elements) that assessed the diagnostic accuracy of NAAT alone or following glutamate dehydrogenase (GDH) enzyme immunoassays (EIAs) or GDH EIAs plus C. difficile toxin EIAs (toxin). The diagnostic yield of NAAT for repeat testing after an initial negative result was also assessed. Two hundred thirty-eight studies met inclusion criteria. Seventy-two of these studies had sufficient data for meta-analysis. The strength of evidence ranged from high to insufficient. The uses of NAAT only, GDH-positive EIA followed by NAAT, and GDH-positive/toxin-negative EIA followed by NAAT are all recommended as American Society for Microbiology (ASM) best practices for the detection of the C. difficile toxin gene or organism. Meta-analysis of published evidence supports the use of testing algorithms that use NAAT alone or in combination with GDH or GDH plus toxin EIA to detect the presence of C. difficile in adults. There is insufficient evidence to recommend against repeat testing of the sample using NAAT after an initial negative result due to a lack of evidence of harm (i.e., financial, length of stay, or delay of treatment) as specified by the Laboratory Medicine Best Practices (LMBP) systematic review method in making such an assessment. Findings from this systematic review provide clarity to diagnostic testing strategies and highlight gaps, such as low numbers of GDH/toxin/PCR studies, in existing evidence on diagnostic performance, which can be used to guide future clinical research studies.

Determining qualitative effect size ratings using a likelihood ratio scatter matrix in diagnostic test accuracy systematic reviews.

Background Diagnostic test accuracy (DTA) systematic reviews (SRs) characterize a test's potential for diagnostic quality and safety. However, interpreting DTA measures in the context of SRs is challenging. Further, some evidence grading methods (e.g. Centers for Disease Control and Prevention, Division of Laboratory Systems Laboratory Medicine Best Practices method) require determination of qualitative effect size ratings as a contributor to practice recommendations. This paper describes a recently developed effect size rating approach for assessing a DTA evidence base. Methods A likelihood ratio scatter matrix will plot positive and negative likelihood ratio pairings for DTA studies. Pairings are graphed as single point estimates with confidence intervals, positioned in one of four quadrants derived from established thresholds for test clinical validity. These quadrants support defensible judgments on "substantial", "moderate", or "minimal" effect size ratings for each plotted study. The approach is flexible in relation to a priori determinations of the relative clinical importance of false positive and false negative test results. Results and conclusions This qualitative effect size rating approach was operationalized in a recent SR that assessed effectiveness of test practices for the diagnosis of Clostridium difficile. Relevance of this approach to other methods of grading evidence, and efforts to measure diagnostic quality and safety are described. Limitations of the approach arise from understanding that a diagnostic test is not an isolated element in the diagnostic process, but provides information in clinical context towards diagnostic quality and safety.

Metacognition and evidence analysis instruction: an educational framework and practical experience.

The role of metacognitive skills in the evidence analysis process has received little attention in the research literature. While the steps of the evidence analysis process are well defined, the role of higher-level cognitive operations (metacognitive strategies) in integrating the steps of the process is not well understood. In part, this is because it is not clear where and how metacognition is implicated in the evidence analysis process nor how these skills might be taught. The purposes of this paper are to (a) suggest a model for identifying critical thinking and metacognitive skills in evidence analysis instruction grounded in current educational theory and research and (b) demonstrate how freely available systematic review/meta-analysis tools can be used to focus on higher-order metacognitive skills, while providing a framework for addressing common student weaknesses. The final goal of this paper is to provide an instructional framework that can generate critique and elaboration while providing the conceptual basis and rationale for future research agendas on this topic.

Hepatitis C virus infection: detection and treatment.

Hepatitis C virus (HCV) is a blood-borne virus that infects the liver. HCV affects millions of Americans, and poses a serious public health threat with sequelae such as cirrhosis, hepatocellular carcinoma, and liver failure. This paper reviews means of transmission, characteristics of the various risk groups, and clinical presentations of both the acute and chronic stages of HCV infection. Diagnostic methods, including screening and confirmatory tests, along with relevant clinical and physiologic findings are also described. Additionally, treatment strategies, in particular combination therapy with interferon alpha-2b and ribavirin, are discussed. Contraindications, side effects, and monitoring of this therapeutic modality are considered. Finally, prospective treatments are presented.