Diagnostic efficiency in models for permissible measurement uncertainty

2017 ◽  
Vol 41 (6) ◽  
Author(s):  
Rainer Haeckel ◽  
Werner Wosniok ◽  
Eberhard Gurr
Keyword(s):  
Measurement Uncertainty ◽  
Clinical Chemistry ◽  
Present Report ◽  
Diagnostic Errors ◽  
Diagnostic Error ◽  
European Federation ◽  
Diagnostic Efficiency ◽  
Common Mean ◽  
Analytical Imprecision

AbstractLimits for measurement uncertainty related to analytical imprecision and bias are most appropriately defined by the magnitude of tolerable diagnostic errors. A common mean to characterize the consequence of these errors is the diagnostic efficiency, which, in the case of data from a non-diseased population, is the rate of true-positive results (specificity). Three models have been identified by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) for defining permissible uncertainty limits. Their model 1 is based on diagnostic requirements whereas models 2 and 3 do not primarily consider diagnostic errors. The present report links tolerable diagnostic error, empirical biological variation and the technical state of the art to derive the limits for measurement uncertainty. This approach combines the essential aspects of all three EFLM models and uses the diagnostic error, the clinically most relevant aspect, as the crucial criterion for the characterization of measurement uncertainty limits. The present approach is designed for the sole purpose of quality assurance.

scholarly journals Adding clinical utility to the laboratory reports: automation of interpretative comments

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Wytze Oosterhuis
Keyword(s):  
Clinical Chemistry ◽  
Patient Empowerment ◽  
High Volume ◽  
Laboratory Medicine ◽  
Patient Treatment ◽  
Patient Specific ◽  
European Federation ◽  
Diagnostic Efficiency ◽  
Laboratory Test Results ◽  
Interpretative Comments

Abstract In laboratory medicine, consultation by adding interpretative comments to reports has long been recognized as one of the activities that help to improve patient treatment outcomes and strengthen the position of our profession. Interpretation and understanding of laboratory test results might in some cases considerably be enhanced by adding test when considered appropriate by the laboratory specialist – an activity that was named reflective testing. With patient material available at this stage, this might considerably improve the diagnostic efficiency. The need and value of these forms of consultation have been proven by a diversity of studies. Both general practitioners and medical specialists have been shown to value interpretative comments. Other forms of consultation are emerging: in this time of patient empowerment and shared decision making, reporting of laboratory results to patients will be common. Patients have in general little understanding of these results, and consultation of patients could add a new dimension to the service of the laboratory. These developments have been recognized by the European Federation of Clinical Chemistry and Laboratory Medicine, which has established the working group on Patient Focused Laboratory Medicine for work on the matter. Providing proper interpretative comments is, however, labor intensive because harmonization is necessary to maintain quality between individual specialists. In present-day high-volume laboratories, there are few options on how to generate high-quality, patient-specific comments for all the relevant results without overwhelming the laboratory specialists. Automation and application of expert systems could be a solution, and systems have been developed that could ease this task.

scholarly journals PREDICT: a checklist for preventing preanalytical diagnostic errors in clinical trials

2020 ◽  
Vol 58 (4) ◽  
pp. 518-526 ◽  
Author(s):  
Giuseppe Lippi ◽  
Alexander von Meyer ◽  
Janne Cadamuro ◽  
Ana-Maria Simundic ◽  
_ _
Keyword(s):  
Clinical Trials ◽  
Clinical Chemistry ◽  
Diagnostic Testing ◽  
Diagnostic Errors ◽  
European Federation ◽  
Sample Collection ◽  
Specimen Retrieval ◽  
Sample Management ◽  
Accurate Performance ◽  
High Level

AbstractAlthough the importance of guaranteeing a high level of preanalytical quality in routine diagnostic testing has already been largely acknowledged over the past decades, minor emphasis is currently being placed on the fact that accurate performance and standardization of many preanalytical activities are also necessary prerogatives of clinical trials. Reliable evidence exists that clear indications on how to manage the different preanalytical steps are currently lacking in many clinical trials protocols, nor have detailed authoritative documents been published or endorsed on this matter to the best of our knowledge. To fill this gap, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) will provide here a specific checklist for preventing preanalytical diagnostic errors in clinical trials (PREDICT), especially focused on covering the most important preanalytical aspects of blood sample management in clinical studies, and thus encompassing test selection, patient preparation, sample collection, management and storage, sample transportation, as well as specimen retrieval before testing. The WG-PRE members sincerely hope that these recommendations will provide a useful contribution for increasing the success rate in clinical trials.

scholarly journals Generation and Characterization of dickkopf3 Mutant Mice

2006 ◽  
Vol 26 (6) ◽  
pp. 2317-2326 ◽  
Author(s):  
Ivan del Barco Barrantes ◽  
Ana Montero-Pedrazuela ◽  
Ana Guadaño-Ferraz ◽  
Maria-Jesus Obregon ◽  
Raquel Martinez de Mena ◽  
...  
Keyword(s):  
Thyroid Hormone ◽  
Clinical Chemistry ◽  
Lung Ventilation ◽  
Immunoglobulin M ◽  
Mutant Mice ◽  
Phenotypic Analysis ◽  
Thyroid Hormone Metabolism ◽  
Hormone Binding Protein ◽  
Deficient Mice

ABSTRACT dickkopf (dkk) genes encode a small family of secreted Wnt antagonists, except for dkk3, which is divergent and whose function is poorly understood. Here, we describe the generation and characterization of dkk3 mutant mice. dkk3-deficient mice are viable and fertile. Phenotypic analysis shows no major alterations in organ morphology, physiology, and most clinical chemistry parameters. Since Dkk3 was proposed to function as thyroid hormone binding protein, we have analyzed deiodinase activities, as well as thyroid hormone levels. Mutant mice are euthyroid, and the data do not support a relationship of dkk3 with thyroid hormone metabolism. Altered phenotypes in dkk3 mutant mice were observed in the frequency of NK cells, immunoglobulin M, hemoglobin, and hematocrit levels, as well as lung ventilation. Furthermore, dkk3-deficient mice display hyperactivity.

Handshake antimicrobial stewardship as a model to recognize and prevent diagnostic errors

Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Justin B. Searns ◽  
Manon C. Williams ◽  
Christine E. MacBrayne ◽  
Ann L. Wirtz ◽  
Jan E. Leonard ◽  
...  
Keyword(s):  
Antimicrobial Stewardship ◽  
Interrater Reliability ◽  
Diagnostic Errors ◽  
Diagnostic Error ◽  
Primary Treatment ◽  
Treatment Team ◽  
Children's Hospital ◽  
Children’S Hospital ◽  
The Impact ◽  
Made In

AbstractObjectivesFew studies describe the impact of antimicrobial stewardship programs (ASPs) on recognizing and preventing diagnostic errors. Handshake stewardship (HS-ASP) is a novel ASP model that prospectively reviews hospital-wide antimicrobial usage with recommendations made in person to treatment teams. The purpose of this study was to determine if HS-ASP could identify and intervene on potential diagnostic errors for children hospitalized at a quaternary care children’s hospital.MethodsPreviously self-identified “Great Catch” (GC) interventions by the Children’s Hospital Colorado HS-ASP team from 10/2014 through 5/2018 were retrospectively reviewed. Each GC was categorized based on the types of recommendations from HS-ASP, including if any diagnostic recommendations were made to the treatment team. Each GC was independently scored using the “Safer Dx Instrument” to determine presence of diagnostic error based on a previously determined cut-off score of ≤1.50. Interrater reliability for the instrument was measured using a randomized subset of one third of GCs.ResultsDuring the study period, there were 162 GC interventions. Of these, 65 (40%) included diagnostic recommendations by HS-ASP and 19 (12%) had a Safer Dx Score of ≤1.50, (Κ=0.44; moderate agreement). Of those GCs associated with diagnostic errors, the HS-ASP team made a diagnostic recommendation to the primary treatment team 95% of the time.ConclusionsHandshake stewardship has the potential to identify and intervene on diagnostic errors for hospitalized children.

scholarly journals How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Pieter Vermeersch ◽  
Glynis Frans ◽  
Alexander von Meyer ◽  
Seán Costelloe ◽  
Giuseppe Lippi ◽  
...  
Keyword(s):  
Quality Management System ◽  
Clinical Chemistry ◽  
European Federation ◽  
Consensus Recommendation ◽  
Iso 15189 ◽  
Consensus Document ◽  
Analytical Phase ◽  
Total Testing Process ◽  
Analytical Requirements ◽  
Analytical Requirement

Abstract The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technical auditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements. The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISO requirements described in ISO15189:2012, members of EFLM WG-PRE agreed by consensus on minimal recommendations and best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement in their quality management system to adequately address the pre-analytical requirement described in ISO15189:2012. The best-in-class solution describes the current state-of-the-art in fulfilling a particular pre-analytical requirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.

scholarly journals Use of patient complaints to identify diagnosis-related safety concerns: a mixed-method evaluation

2021 ◽  
pp. bmjqs-2020-011593
Author(s):  
Traber D Giardina ◽  
Saritha Korukonda ◽  
Umber Shahid ◽  
Viralkumar Vaghani ◽  
Divvy K Upadhyay ◽  
...  
Keyword(s):  
Medical Record ◽  
Clinical Care ◽  
Diagnostic Testing ◽  
Diagnostic Errors ◽  
Diagnostic Error ◽  
Diagnostic Process ◽  
Healthcare Organisation ◽  
Safety Concerns ◽  
Patient Complaints ◽  
Malpractice Claims

BackgroundPatient complaints are associated with adverse events and malpractice claims but underused in patient safety improvement.ObjectiveTo systematically evaluate the use of patient complaint data to identify safety concerns related to diagnosis as an initial step to using this information to facilitate learning and improvement.MethodsWe reviewed patient complaints submitted to Geisinger, a large healthcare organisation in the USA, from August to December 2017 (cohort 1) and January to June 2018 (cohort 2). We selected complaints more likely to be associated with diagnostic concerns in Geisinger’s existing complaint taxonomy. Investigators reviewed all complaint summaries and identified cases as ‘concerning’ for diagnostic error using the National Academy of Medicine’s definition of diagnostic error. For all ‘concerning’ cases, a clinician-reviewer evaluated the associated investigation report and the patient’s medical record to identify any missed opportunities in making a correct or timely diagnosis. In cohort 2, we selected a 10% sample of ‘concerning’ cases to test this smaller pragmatic sample as a proof of concept for future organisational monitoring.ResultsIn cohort 1, we reviewed 1865 complaint summaries and identified 177 (9.5%) concerning reports. Review and analysis identified 39 diagnostic errors. Most were categorised as ‘Clinical Care issues’ (27, 69.2%), defined as concerns/questions related to the care that is provided by clinicians in any setting. In cohort 2, we reviewed 2423 patient complaint summaries and identified 310 (12.8%) concerning reports. The 10% sample (n=31 cases) contained five diagnostic errors. Qualitative analysis of cohort 1 cases identified concerns about return visits for persistent and/or worsening symptoms, interpersonal issues and diagnostic testing.ConclusionsAnalysis of patient complaint data and corresponding medical record review identifies patterns of failures in the diagnostic process reported by patients and families. Health systems could systematically analyse available data on patient complaints to monitor diagnostic safety concerns and identify opportunities for learning and improvement.

Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

2015 ◽  
Vol 53 (8) ◽  
Author(s):  
Marc H.M. Thelen ◽  
Florent J.L.A. Vanstapel ◽  
Christos Kroupis ◽  
Ines Vukasovic ◽  
Guilaime Boursier ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Position Paper ◽  
European Federation ◽  
Medical Field ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Flexible Scope ◽  
Scientific Disciplines

AbstractThe recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

Lessons in clinical reasoning – pitfalls, myths, and pearls: the contribution of faulty data gathering and synthesis to diagnostic error

Diagnosis ◽  
2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Martin A. Schaller-Paule ◽  
Helmuth Steinmetz ◽  
Friederike S. Vollmer ◽  
Melissa Plesac ◽  
Felix Wicke ◽  
...  
Keyword(s):  
Patient Safety ◽  
Clinical Reasoning ◽  
Data Gathering ◽  
Diagnostic Errors ◽  
Diagnostic Error ◽  
Care Physician ◽  
Diagnostic Process ◽  
Myasthenic Crisis ◽  
Hospital Organization ◽  
Substantial Impact

Abstract Objectives Errors in clinical reasoning are a major factor for delayed or flawed diagnoses and put patient safety at risk. The diagnostic process is highly dependent on dynamic team factors, local hospital organization structure and culture, and cognitive factors. In everyday decision-making, physicians engage that challenge partly by relying on heuristics – subconscious mental short-cuts that are based on intuition and experience. Without structural corrective mechanisms, clinical judgement under time pressure creates space for harms resulting from systems and cognitive errors. Based on a case-example, we outline different pitfalls and provide strategies aimed at reducing diagnostic errors in health care. Case presentation A 67-year-old male patient was referred to the neurology department by his primary-care physician with the diagnosis of exacerbation of known myasthenia gravis. He reported shortness of breath and generalized weakness, but no other symptoms. Diagnosis of respiratory distress due to a myasthenic crisis was made and immunosuppressive therapy and pyridostigmine were given and plasmapheresis was performed without clinical improvement. Two weeks into the hospital stay, the patient’s dyspnea worsened. A CT scan revealed extensive segmental and subsegmental pulmonary emboli. Conclusions Faulty data gathering and flawed data synthesis are major drivers of diagnostic errors. While there is limited evidence for individual debiasing strategies, improving team factors and structural conditions can have substantial impact on the extent of diagnostic errors. Healthcare organizations should provide the structural supports to address errors and promote a constructive culture of patient safety.

Lessons in clinical reasoning ‒ pitfalls, myths and pearls: a case of recurrent pancreatitis

Diagnosis ◽  
2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Vita Jaspan ◽  
Verity Schaye ◽  
Andrew S. Parsons ◽  
David Kudlowitz
Keyword(s):  
Acute Pancreatitis ◽  
Clinical Reasoning ◽  
Cognitive Biases ◽  
Diagnostic Errors ◽  
Diagnostic Error ◽  
First Episode ◽  
Gut Flora ◽  
Case Presentation ◽  
Early Hypothesis ◽  
Elevated Transaminases

Abstract Objectives Cognitive biases can result in clinical reasoning failures that can lead to diagnostic errors. Autobrewery syndrome is a rare, but likely underdiagnosed, condition in which gut flora ferment glucose, producing ethanol. It most frequently presents with unexplained episodes of inebriation, though more case studies are necessary to better characterize the syndrome. Case presentation This is a case of a 41-year old male with a past medical history notable only for frequent sinus infections, who presented with recurrent episodes of acute pancreatitis. In the week prior to his first episode of pancreatitis, he consumed four beers, an increase from his baseline of 1–2 drinks per month. At home, he had several episodes of confusion, which he attributed to fatigue. He underwent laparoscopic cholecystectomy and testing for genetic and autoimmune causes of pancreatitis, which were non-revealing. He was hospitalized 10 more times during that 9-month period for acute pancreatitis with elevated transaminases. During these admissions, he had elevated triglycerides requiring an insulin drip and elevated alcohol level despite abstaining from alcohol for the prior eight months. His alcohol level increased after consumption of complex carbohydrates, confirming the diagnosis of autobrewery syndrome. Conclusions Through integrated commentary on the diagnostic reasoning process, this case underscores how overconfidence can lead to premature closure and anchoring resulting in diagnostic error. Using a metacognitive overview, case discussants describe the importance of structured reflection and a standardized approach to early hypothesis generation to navigate these cognitive biases.

Checklists to prevent diagnostic errors: a pilot randomized controlled trial

Diagnosis ◽  
2015 ◽  
Vol 2 (3) ◽  
pp. 163-169 ◽  
Author(s):  
John W. Ely ◽  
Mark A. Graber
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Error Rate ◽  
Primary Care Physicians ◽  
Diagnostic Errors ◽  
Diagnostic Error ◽  
Diagnostic Process ◽  
Emergency Physicians ◽  
Mean Error ◽  
Premature Closure

AbstractMany diagnostic errors are caused by premature closure of the diagnostic process. To help prevent premature closure, we developed checklists that prompt physicians to consider all reasonable diagnoses for symptoms that commonly present in primary care.We enrolled 14 primary care physicians and 100 patients in a randomized clinical trial. The study took place in an emergency department (5 physicians) and a same-day access clinic (9 physicians). The physicians were randomized to usual care vs. diagnostic checklist. After completing the history and physical exam, checklist physicians read aloud a differential diagnosis checklist for the chief complaint. The primary outcome was diagnostic error, which was defined as a discrepancy between the diagnosis documented at the acute visit and the diagnosis based on a 1-month follow-up phone call and record review.There were 17 diagnostic errors. The mean error rate among the seven checklist physicians was not significantly different from the rate among the seven usual-care physicians (11.2% vs. 17.8%; p=0.46). In a post-hoc subgroup analysis, emergency physicians in the checklist group had a lower mean error rate than emergency physicians in the usual-care group (19.1% vs. 45.0%; p=0.04). Checklist physicians considered more diagnoses than usual-care physicians during the patient encounters (6.5 diagnoses [SD 4.2] vs. 3.4 diagnoses [SD 2.0], p<0.001).Checklists did not improve the diagnostic error rate in this study. However further development and testing of checklists in larger studies may be warranted.

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