Volume 6, Issue 4

The medical record continues to be one of the most useful and accessible sources of information to examine the diagnostic process. However, medical record review studies of diagnostic errors have often used subjective judgments and found low inter-rater agreement among reviewers when determining the presence or absence of diagnostic error. In our previous work, we developed a structured data-collection instrument, called the Safer Dx Instrument, consisting of objective criteria to improve the accuracy of assessing diagnostic errors in primary care. This paper proposes recommendations on how clinicians and health care organizations could use the Revised Safer Dx Instrument in identifying and understanding missed opportunities to make correct and timely diagnoses. The instrument revisions addressed both methodological and implementation issues identified during initial use and included refinements to the instrument to allow broader application across all health care settings. In addition to leveraging knowledge from piloting the instrument in several health care settings, we gained insights from multiple researchers who had used the instrument in studies involving emergency care, inpatient care and intensive care unit settings. This allowed us to enhance and extend the scope of this previously validated data collection instrument. In this paper, we describe the refinement process and provide recommendations for application and use of the Revised Safer Dx Instrument across a broad range of health care settings. The instrument can help users identify potential diagnostic errors in a standardized way for further analysis and safety improvement efforts as well as provide data for clinician feedback and reflection. With wider adoption and use by clinicians and health systems, the Revised Safer Dx Instrument could help propel the science of measuring and reducing diagnostic errors forward.

The purpose of this article is to synthesise review evidence, practice and patient perspectives on interventions to reduce diagnostic error in emergency departments (EDs). A rapid review methodology identified nine systematic reviews for inclusion. Six practice interviews were conducted to identify local contextual insights and implementation considerations. Finally, patient perspectives were explored through a citizen panel with 11 participants. The rapid review found evidence for the following interventions: second opinion, decision aids, guided reflection and education. Practitioners suggested three of the four interventions from the academic review: second opinion, decision aids and education. Practitioners suggested four additional interventions: improving teamwork, engaging patients, learning from mistakes and scheduled test follow-up. Patients most favoured interventions that improved communication through education and patient engagement, while also suggesting that implementation of state-wide standards to reduce variability in care and sufficient staffing are important to address diagnostic errors. Triangulating these three perspectives on the evidence allows for the intersections to be highlighted and demonstrates the usefulness of incorporating practitioner reflections and patient values in developing potential interventions.

Background Given an unacceptably high incidence of diagnostic errors, we sought to identify the key competencies that should be considered for inclusion in health professions education programs to improve the quality and safety of diagnosis in clinical practice. Methods An interprofessional group reviewed existing competency expectations for multiple health professions, and conducted a search that explored quality, safety, and competency in diagnosis. An iterative series of group discussions and concept prioritization was used to derive a final set of competencies. Results Twelve competencies were identified: Six of these are individual competencies: The first four (#1–#4) focus on acquiring the key information needed for diagnosis and formulating an appropriate, prioritized differential diagnosis; individual competency #5 is taking advantage of second opinions, decision support, and checklists; and #6 is using reflection and critical thinking to improve diagnostic performance. Three competencies focus on teamwork: Involving the patient and family (#1) and all relevant health professionals (#2) in the diagnostic process; and (#3) ensuring safe transitions of care and handoffs, and “closing the loop” on test result communication. The final three competencies emphasize system-related aspects of care: (#1) Understanding how human-factor elements influence the diagnostic process; (#2) developing a supportive culture; and (#3) reporting and disclosing diagnostic errors that are recognized, and learning from both successful diagnosis and from diagnostic errors. Conclusions These newly defined competencies are relevant to all health professions education programs and should be incorporated into educational programs.

Background The objective of the study was to assess the diagnostic process, access to care and treatment adequacy for primary adrenal insufficiency (PAI) patients from a US-based online registry. Methods The National Adrenal Diseases Foundation (NADF) patient registry from 2015 to 2016 was used for a cross-sectional assessment of PAI patients. Five hundred and forty-one adults met the study inclusion criteria (US residents, age >20, self-reported physician diagnosis of PAI and replacement dosing for cortisol). Issues in diagnosis, comorbid conditions, symptoms, with demographic and socioeconomic characteristics were determined. Disease management assessment included medication dose, patient satisfaction with function, and education. Factors associated with adrenal crisis were noted. Results The cohort was predominantly female (83%), non-Hispanic White (97%), and well-educated (94% > high school education). A majority (57%) of patients reported difficulty with initial diagnosis, while 27% felt that their current steroid replacement was not adequate. Comorbid thyroid disease and other autoimmune conditions were common among PAI patients in the registry. More than three-quarters (78%) of patients used hydrocortisone for glucocorticoid replacement with a mean dose of 24.4 (standard deviation [SD]: 8.7) mg. Mean dose of hydrocortisone has declined over time following current treatment recommendations. Conclusions Timely, accurate diagnosis remains a problem for patients with primary adrenal insufficiency in an affluent, well-educated US cohort. Episodes of adrenal crisis are common and replacement steroid treatment is not always effective for patient function. Comprehensive information about outcomes of care for PAI in the US remains limited and the establishment of a research-specific registry to foster future research may be desirable. Patient registry data is a valuable source of information on diagnostic error and outcomes of care in rare diseases.

Background Though incidental pulmonary nodules are common, rates of guideline-recommended surveillance and associations between surveillance and mortality are unclear. In this study, we describe adherence (categorized as complete, partial, late and none) to guideline-recommended surveillance among patients with incidental 5–8 mm pulmonary nodules and assess associations between adherence and mortality. Methods This was a retrospective cohort study of 551 patients (≥35 years) with incidental pulmonary nodules conducted from September 1, 2008 to December 31, 2016, in an integrated safety-net health network. Results Of the 551 patients, 156 (28%) had complete, 87 (16%) had partial, 93 (17%) had late and 215 (39%) had no documented surveillance. Patients were followed for a median of 5.2 years [interquartile range (IQR), 3.6–6.7 years] and 82 (15%) died during follow-up. Adjusted all-cause mortality rates ranged from 2.24 [95% confidence interval (CI), 1.24–3.25] deaths per 100 person-years for complete follow-up to 3.30 (95% CI, 2.36–4.23) for no follow-up. In multivariable models, there were no statistically significant associations between the levels of surveillance and mortality (p > 0.16 for each comparison with complete surveillance). Compared with complete surveillance, adjusted mortality rates were non-significantly increased by 0.45 deaths per 100 person-years (95% CI, −1.10 to 2.01) for partial, 0.55 (95% CI, −1.08 to 2.17) for late and 1.05 (95% CI, −0.35 to 2.45) for no surveillance. Conclusions Although guideline-recommended surveillance of small incidental pulmonary nodules was incomplete or absent in most patients, gaps in surveillance were not associated with statistically significant increases in mortality in a safety-net population.

Background Diagnostic error in cerebral venous thrombosis (CVT) has been understudied despite the harm associated with misdiagnosis of other cerebrovascular diseases as well as the known challenges of evaluating non-specific neurological symptoms in clinical practice. Methods We conducted a retrospective cohort study of CVT patients hospitalized at a single center. Two independent reviewers used a medical record review tool, the Safer Dx Instrument, to identify diagnostic errors. Demographic and clinical factors were abstracted. We compared subjects with and without a diagnostic error using the t-test for continuous variables and the chi-square (χ 2 ) test or Fisher’s exact test for categorical variables; an alpha of 0.05 was the cutoff for significance. Results A total of 72 CVT patients initially met study inclusion criteria; 19 were excluded due to incomplete medical records. Of the 53 patients included in the final analysis, the mean age was 48 years and 32 (60.4%) were women. Diagnostic error occurred in 11 cases [20.8%; 95% confidence interval (CI) 11.8–33.6%]. Subjects with diagnostic errors were younger (42 vs. 49 years, p = 0.13), more often women (81.8% vs. 54.8%, p = 0.17), and were significantly more likely to have a past medical history of a headache disorder prior to the index CVT visit (7.1% vs. 36.4%, p = 0.03). Conclusions Nearly one in five patients with complete medical records experienced a diagnostic error. Prior history of headache was the only evaluated clinical factor that was more common among those with an error in diagnosis. Future work on distinguishing primary from secondary headaches to improve diagnostic accuracy in acute neurological disease is warranted.

Background The use of alternative sample matrices may be an advantageous perspective when the laboratory falls short of serum or lithium-heparin plasma for performing clinical chemistry and/or immunochemistry testing. This study was aimed at exploring whether some tests may be performed in citrate plasma as an alternative to lithium-heparin plasma. Methods Paired lithium-heparin and citrate plasma samples collected from 55 inpatients were analyzed on Roche Cobas 8000 for 28 different clinical chemistry and immunochemistry parameters. Data obtained in citrate plasma were adjusted for either the dilution factor or using an equation corresponding to the linear regression calculated by comparing unadjusted lithium-heparin and citrate plasma values. Results Except for magnesium (+17%) and sodium (+11%), unadjusted values of all remaining analytes were significantly lower in citrate than in lithium-heparin plasma, with bias ranging between −6.4% and −25.9%. The correlation between lithium-heparin and citrate plasma values was generally excellent (i.e. >0.90). The adjustment of citrate plasma values for the dilution factor (i.e. 1.1) was only effective in harmonizing the results of albumin and lipase, whilst the concentration of all other analytes remained significantly different between the two sample matrices. The adjustment of plasma citrate values using corrective formulas was instead effective in harmonizing all parameters, with no results remaining statistically different between the two sample matrices. Conclusions Citrate plasma may be used in exceptional circumstances for clinical chemistry and immunochemistry testing as a replacement for lithium-heparin plasma, provided that citrate plasma values are adjusted by using validated corrective equations.

Background Plasma glucose levels provide the cornerstone of diabetes evaluation, and so it is crucial that clinical laboratories provide accurate and reliable plasma glucose results. To prevent in vitro glycolysis, citrate is used. Here, we present the first study on the 75-g oral glucose tolerance test (OGTT) using the currently available new citrate-containing tubes in liquid and granular forms and the previous sodium fluoride (NaF) for the diagnosis of carbohydrate metabolism disorders and gestational diabetes mellitus (GDM) according to the American Diabetes Association (ADA) guidelines. Methods The 75-g OGTT was performed in 147 volunteers, 83 of whom were pregnant women. Blood was collected in NaF/K 3 ethylenediaminetetraacetic acid (EDTA) and NaF/Na 2 EDTA/citrate in liquid form in tubes in Brescia and in NaF/K 2 Ox and NaF/Na 2 EDTA/citrate in granular form in Vicenza. Glucose was measured within 3–4 h from the OGTT. The mean biases were calculated and compared with the desirable bias (<± 2.1%). Results OGTT glucose concentrations were higher in citrate tubes when compared to NaF-containing tubes. When citrate tubes were used, GDM increased to 12.5 and 11.7% in Brescia and Vicenza, respectively. Impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and diabetes mellitus (DM) increased to 36.7, 6.7 and 3.4%, respectively, in Brescia. In Vicenza, an increase of 47 and 1.9% in IFG and IGT, respectively, was found. Conclusions OGTT glucose measurement in citrate-containing tubes was shown to be more effective than those containing only NaF in diagnosing carbohydrate disorders. This new glycolysis inhibitor seems to be a necessary preanalytical tool for accurate and reliable plasma glucose results.

Background Defects in human cognition commonly result in clinical reasoning failures that can lead to diagnostic errors. A metacognitive structured reflection on what clinical findings fit and/or do not fit with likely and “can’t miss” diagnoses may reduce such errors. Case presentation A 57-year-old man was sent to the emergency department from clinic with chest pain, severe shortness of breath, weakness, and cold sweats. Further investigation revealed multiple risk factors for coronary artery disease, sudden onset of exertional dyspnea, and chest pain that incompletely resolved with rest, mild tachycardia and hypoxia, an abnormal electrocardiogram (ECG), elevated serum cardiac biomarkers, and elevated B-type natriuretic peptide (BNP) in the absence of left-sided heart failure. He was treated for acute coronary syndrome (ACS), discharged, and quickly returned with worsening symptoms that eventually led to a diagnosis of submassive pulmonary embolism (PE). Conclusions Through integrated commentary on the diagnostic reasoning process from clinical reasoning experts at two institutions, this case underscores the importance of frequent assessment of fit along with explicit explanation of dissonant features in order to avoid premature closure and diagnostic error. A fishbone diagram is provided to visually demonstrate the major factors that contributed to the diagnostic error. A case discussant describes the importance of diagnostic schema as an analytic reasoning strategy to assist in the creation of a differential diagnosis, problem representation to summarize updated findings, a Popperian analytic approach of attempting to falsify less-likely hypotheses, and matching pertinent positives and negatives to previously learned illness scripts. Finally, this case provides clinical teaching points in addition to a pitfall, myth, and pearl specific to premature closure.

Background Kimura is an uncommon inflammatory cause of pediatric head and neck masses due to eosinophilic infiltration of unclear etiology. Kimura can present similarly to infectious lymphadenitis, a much more common pediatric complaint. This case explores the role of anchoring bias when faced with an illness that at first appears to fit a common illness script that led to a delayed diagnosis. Case presentation A 7-year-old boy presented with acute onset of pre-auricular lymphadenopathy and fevers initially thought to be most consistent with infectious cervical lymphadenopathy. Despite treatment with broad spectrum antibiotics and multiple evaluations for underlying abscess requiring surgical drainage, the patient did not improve and remained febrile. Eventually, excisional lymph node biopsy was obtained and a pathologic diagnosis of Kimura disease was made. Conclusions This case illustrates an uncommon pediatric diagnosis which presented similarly to infectious cervical lymphadenitis without additional laboratory features consistent with Kimura. We highlight the role of anchoring bias and care fragmentation leading to repeat imaging and delayed biopsy in the eventual diagnosis of a rare illness.