Volume 8, Issue 3

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.

Atrial fibrillation (AF) is the most common sustained arrhythmia, and its prevalence rate is expected to be doubled over the next decades. Despite the wide use of biomarkers in the management of different cardiac diseases such as myocardial infarction and heart failure, utilization of biomarkers in AF management is not routinely recommended by current guidelines. There is also growing evidence that higher levels of cardiac-specific troponin, as an intracellular protein involved in cardiomyocyte contraction, may be associated with the risk of incident and recurrent AF and its complications. In the present paper, we review the association between troponin and AF and propose clinical suggestions for use of troponin in the management of AF patients.

How the clinician interprets the radiology report has a major impact on the patient’s care. It is a crucial cognitive task, and can also be a significant source of error. Because the clinician must secondarily interpret the radiologist’s interpretation of the images, this step can be referred to as a “metainterpretation”. Some considerations for that task are offered from the perspective of a radiologist. A revival of the tradition of discussing cases with the radiologist is encouraged.

Diabetes is one of the most prevalent diseases worldwide, whereby type 1 diabetes mellitus (T1DM) alone involves nearly 15 million patients. Although T1DM and type 2 diabetes mellitus (T2DM) are the most common types, there are other forms of diabetes which may remain often under-diagnosed, or that can be misdiagnosed as being T1DM or T2DM. After an initial diagnostic step, the differential diagnosis among T1DM, T2DM, Maturity-Onset Diabetes of the Young (MODY) and others forms has important implication for both therapeutic and behavioral decisions. Although the criteria used for diagnosing diabetes mellitus are well defined by the guidelines of the American Diabetes Association (ADA), no clear indications are provided on the optimal approach to be followed for classifying diabetes, especially in children. In this circumstance, both routine and genetic blood test may play a pivotal role. Therefore, the purpose of this article is to provide, through a narrative literature review, some elements that may aid accurate diagnosis and classification of diabetes in children and young people.

A positive patient experience has been long recognised as a key feature of a high-quality health service, however, often assessment of patient experience excludes diagnostic care. Experience of diagnostic services and the acceptability of diagnostic tests are often conflated, with lack of clarity about when and how either should be measured. These problems contrast with the growth in the development and marketing of new tests and investigation strategies. Building on the appraisal of current practice, we propose that the experience of diagnostic services and the acceptability of tests should be assessed separately, and describe distinct components of each. Such evaluations will enhance the delivery of patient-centred care, and facilitate patient choice.

Objectives Novel point-of-care antigen assays present a promising opportunity for rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. The purpose of this study was the clinical assessment of the new Roche SARS-CoV-2 Rapid Antigen Test. Methods The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test was evaluated vs. a reverse transcription polymerase chain reaction (RT-PCR) laboratory-based assay (Seegene AllplexTM2019-nCoV) in nasopharyngeal swabs collected from a series of consecutive patients referred for SARS-CoV-2 diagnostics to the Pederzoli Hospital (Peschiera del Garda, Verona, Italy) over a 2-week period. Results The final study population consisted of 321 consecutive patients (mean age, 46 years and IQR, 32–56 years; 181 women, 56.4%), with 149/321 (46.4%) positive for SARS-CoV-2 RNA via the Seegene AllplexTM2019-nCoV Assay, and 109/321 (34.0%) positive with Roche SARS-CoV-2 Rapid Antigen Test, respectively. The overall accuracy of Roche SARS-CoV-2 Rapid Antigen Test compared to molecular testing was 86.9%, with 72.5% sensitivity and 99.4% specificity. Progressive decline in performance was observed as cycle threshold (Ct) values of different SARS-CoV-2 gene targets increased. The sensitivity was found to range between 97–100% in clinical samples with Ct values <25, between 50–81% in those with Ct values between 25 and <30, but low as 12–18% in samples with Ct values between 30 and <37. Conclusions The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test is excellent in nasopharyngeal swabs with Ct values <25, which makes it a reliable screening test in patients with high viral load. However, mass community screening would require the use of more sensitive techniques.

Objectives Coronavirus disease (COVID-19) blindness, that is, the excessive consideration of the disease in diagnosis, has reportedly led to delayed diagnosis of some diseases. We compared several clinical measures between patients admitted for bacteremia during the two months of the COVID-19 pandemic and those admitted during the same period in 2019. We hypothesized that the pandemic has led to delayed treatment of bacteremia. Methods This retrospective observational study compared several measures undertaken for patients who visited the emergency unit in two hospitals between March 1 and May 31, 2020, during the COVID-19 pandemic and whose blood cultures tested positive for bacteremia with those for corresponding patients treated during the same period in 2019. The primary measure was time from consultation to blood culture/antimicrobials. Results We included 29 eligible patients from 2020 and 26 from 2019. In 2020, the time from consultation to antimicrobial administration was significantly longer than in 2019 (mean [range], 222 [145–309] min vs. 139 [102–179] min, p=0.002). The frequency of chest computed tomography (CT) was significantly higher in 2020 (96.6 vs. 73.1%, p=0.021). Significant differences were not observed in the time to blood culture or chest CT preceding the blood culture between the two periods. Conclusions Our findings suggested that due to the COVID-19 epidemic/pandemic, focusing on the exclusion of its infection using CT scans leads to an overall delay in the diagnosis and treatment of bacteremia. Medical providers must be aware of COVID-19 blindness and evaluate patients objectively based on rational criteria and take appropriate action.

Objectives Endometriosis is characterized by a long interval between onset of symptoms and diagnosis. Detailed information about the patients’ perspective on the diagnostic delay of endometriosis is scarce. The aim of this study was to identify strengths and weaknesses in the diagnostic process of endometriosis from the patients’ perspective. Methods Qualitative study with semi-structured focus groups. Participants were women between 18 and 45 years old with a recently confirmed diagnosis. The focus groups were audio recorded and fully transcribed. Grounded theory methodology was applied for data analysis. Results Six focus groups were organized, in which 23 women participated. Mean time from start of symptoms to diagnosis was 8.5 years. Dominant themes were knowledge about normal menstruation and endometriosis, being believed and acknowledged by medical staff, and collaboration between health care providers including fast referral to a gynaecologist. Barriers to a timely referral and diagnosis were young age, normalization of symptoms and a lack of awareness in general practitioners. Facilitating factors included adequate knowledge and skills of the general practitioner, a desire for pregnancy and persisting in a request for specialist consultation by the patient. Conclusions The diagnostic process of endometriosis is hampered by delayed consultation, inadequate appraisal of symptoms by general practitioners and the interaction between patients and medical professionals. Efforts should be made to increase public awareness and to provide medical staff with sufficient knowledge and skills to adequately acknowledge presented symptoms.

Objectives The diagnostic process is a vital component of safe and effective emergency department (ED) care. There are no standardized methods for identifying or reliably monitoring diagnostic errors in the ED, impeding efforts to enhance diagnostic safety. We sought to identify trigger concepts to screen ED records for diagnostic errors and describe how they can be used as a measurement strategy to identify and reduce preventable diagnostic harm. Methods We conducted a literature review and surveyed ED directors to compile a list of potential electronic health record (EHR) trigger (e-triggers) and non-EHR based concepts. We convened a multidisciplinary expert panel to build consensus on trigger concepts to identify and reduce preventable diagnostic harm in the ED. Results Six e-trigger and five non-EHR based concepts were selected by the expert panel. E-trigger concepts included: unscheduled ED return to ED resulting in hospital admission, death following ED visit, care escalation, high-risk conditions based on symptom-disease dyads, return visits with new diagnostic/therapeutic interventions, and change of treating service after admission. Non-EHR based signals included: cases from mortality/morbidity conferences, risk management/safety office referrals, ED medical director case referrals, patient complaints, and radiology/laboratory misreads and callbacks. The panel suggested further refinements to aid future research in defining diagnostic error epidemiology in ED settings. Conclusions We identified a set of e-trigger concepts and non-EHR based signals that could be developed further to screen ED visits for diagnostic safety events. With additional evaluation, trigger-based methods can be used as tools to monitor and improve ED diagnostic performance.

Objectives Few 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. Methods Previously 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. Results During 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. Conclusions Handshake stewardship has the potential to identify and intervene on diagnostic errors for hospitalized children.

Background A quality improvement initiative at our institution resulted in a new process for prospectively identifying pediatric hospital medicine (PHM) patients with uncertain diagnoses (UD). This study describes the clinical characteristics and healthcare utilization patterns of patients with UD. Methods This single center cross-sectional study included all PHM patients identified with UD during their admission. A structured chart review was used to abstract patient demographics, primary symptoms, discharge diagnoses, and healthcare utilization patterns, including consult service use, length of stay (LOS), escalation in care, and 30-day healthcare reutilization. Appropriate descriptive statistics were used for categorical and continuous variables. Results This study includes 200 PHM patients identified with UD. Gastrointestinal symptoms were the primary finding in 45% of patients with UD. Consult service use was highly variable, with a range of 0–8 consult services for individual patients. The median LOS was 1.6 days and only 5% required a rapid response team evaluation. As for reutilization, 7% of patients were readmitted within 30 days. Conclusions This descriptive study highlights the heterogeneity of patients with uncertain diagnoses. Ongoing work is needed to further understand the impact of UD and to optimize the care of these patients.

Objectives Rudeness exposure has been shown to inhibit diagnostic performance. The effects of rudeness on challenging a handed-off diagnostic error has not been studied. Methods This was a randomized controlled study of attending, fellow, and resident physicians in a tertiary care pediatric ICU. Participants underwent a standardized simulation that started with the wrong diagnosis in hand-off. The hand-off was randomized to neutral vs. rude. Participants were not informed of the randomization nor diagnostic error prior to the simulation. Perspective taking questionnaires were administrated for each participant. Primary outcome was challenging diagnostic error post-simulation. Secondary outcomes included rate and frequency of diagnostic error challenge during simulation. Results Among 41 simulations (16 residents, 14 fellows, and 11 attendings), the neutral group challenged the diagnostic error more than the rude group (neutral: 71%, rude: 55%, p=0.28). The magnitude of this trend was larger among resident physicians only, although not statistically significant (neutral: 50%, rude: 12.5%, p=0.11). Experience was associated with a higher percentage of challenging diagnostic error (residents: 31%, fellows: 86%, attendings: 82%, p=0.003). Experienced physicians were faster to challenge diagnostic error (p<0.0003), and experience was associated with a greater frequency of diagnostic error challenges (p<0.0001). High perspective taking scores were also associated with 1.63 times more diagnostic error challenges (p=0.007). Conclusions Experience was strongly associated with likelihood to challenge diagnostic error. Rudeness may disproportionally hinder diagnostic performance among less experienced physicians. Perspective taking merits further research in possibly reducing diagnostic error momentum.

Objectives In 2018, the ACGME (Accreditation Council for Graduate Medical Education) made a change to the maximum permissible number of consecutive nights a resident trainee can be on “night float,” from six to seven nights. To our knowledge, although investigators have studied overall discrepancy rates and discrepancy rates as a function of shift length or perceived workload of a particular shift, no study has been performed to evaluate resident-faculty discrepancy rates as a quality/performance proxy, to see whether resident performance declines as a function of the number of consecutive nights. Our hypothesis is that we would observe a progressive increase in significant overnight resident – attending discrepancies over the 7 days’ time. Methods A total of 8,488 reports were extracted between 4/26/2019 to 8/22/2019 retrospectively. Data was obtained from the voice dictation system report server. Exported query was saved as a .csv file format and analyzed using Python packages. A “discrepancy checker” was created to search all finalized reports for the departmental standard heading of “Final Attending Report,” used to specify any significant changes from the preliminary interpretation. Results Model estimates varied on different days however there were no trends or patterns to indicate a deterioration in resident performance throughout the week. There were comparable probabilities throughout the week, with 2.17% on Monday, 2.35% on Thursday and 2.05% on Friday. Conclusions Our results reveal no convincing trend in terms of overnight report discrepancies between the preliminary report generated by the night float resident and the final report issued by a faculty the following morning. These results are in support of the ACGME’s recent change in the permissible number of consecutive nights on night float. We did not prove our hypothesis that resident performance on-call in the domain of report accuracy would diminish over seven consecutive nights while on the night float rotation. Our results found that performance remained fairly uniform over the course of the week.

Objectives Malnutrition is an unfavorable prognostic factor associated with an increase in mortality, hospital stays, readmissions and resources consumption. The aim was to screen primary care patients for risk of malnutrition by using the control nutritional (CONUT) score, calculated through total lymphocytes count, serum albumin and total cholesterol, when the three markers were requested, and to compare results between primary care centers (PCC). Methods The clinical laboratory located in a 370-bed suburban University Community Hospital serves the Health Department inhabitants (2,34,551), attended in nine PCC. The laboratory information system (LIS) automatically calculated the CONUT score in every primary care patient over 18 years old, when all three laboratory markers were ordered by the General Practitioner. For all primary care patients, we collected demographic data, CONUT index and PCC. We classified results by PCC, and compared them. Results The clinical laboratory received 74,743 requests from primary care. The CONUT score was calculated in 7,155 (12.28%) patients. Nine hundred seventy-six (13.6%) were at risk of malnutrition according to the CONUT score, mainly male (p<0.01) and over 65 (p<0.01). Detected cases of malnutrition were all mild, except 48 patients (4.9%) with moderate, and one (0.1%) with severe risk. The percentage of patients at risk of malnutrition was not significantly different among PCC, with the exception of one with patients at lower malnutrition risk. Conclusions It is possible to use CONUT score as a front-line population-wide laboratory marker to screen for the risk for malnutrition in primary care patients that was lower in one PCC.

Objectives The mortality rate associated with community-acquired pneumonia is still considered high as it occupies a leading position among all infectious diseases. The primary purpose of this study is to evaluate the implementation of the respiratory bacterial culture sampling in the clinical practice of the Russian Federation’s therapeutic departments and its impact on inpatient care. Methods The study included 1,344 patients with community-acquired pneumonia. The analysis of the obtained data was performed using the statistical software package SPSS 23.0 (IBM SPSS Statistics). The description of quantitative indicators was carried out with an indication of the median (25; 75 percentile). Qualitative with an indication of the absolute and relative frequencies n (%). Results It was noted that a third of the sample did not pass through the first stage (bacterioscopy). We noticed the predominance of oropharyngeal flora in the results. The sputum collection was carried out on average 3 (1; 5) days after the start of hospitalization, while antibiotic therapy was prescribed to all patients on the first day, the results of the bacteriological study were ready on average 6 (4; 8th) calendar days after hospitalization, while in 20 (1.5%) cases, the patient was already discharged. Due to the inefficiency of the starting regimen, antimicrobial agents have changed in 84 (6.3%) patients and averaged 5.5 (4.0; 10.0) days from the start of hospitalization. Conclusions The violation of the technique and the time of sputum collection resulted in a reduction in the method’s value.

Objectives Shear wave elastography (SWE) quantitatively determines the nature of the breast lesions. Few previous studies have compared the diagnostic value of this modality with other imaging techniques. The present study aimed to compare the diagnostic value of SWE with that of magnetic resonance imaging (MRI) in detecting the nature of the breast masses. Methods In this cross-sectional study, 80 patients with breast lumps who had Breast Imaging Reporting and Data System (BI-RADS) score of three or higher based on mammography and/or screening ultrasonography, underwent 3D SWE and MRI. The lesions were classified according to MRI BI-RADS scoring; Mean elasticity (Emean) and elasticity ratio (Eratio) for each lesion were also determined by SWE. The results of these two modalities were compared with histopathologic diagnosis as the gold standard method; diagnostic value and diagnostic agreement were then calculated. Results Of the masses, 46.2% were histopathologically proven to be malignant. The Emean for benign and malignant masses was 34.04 ± 19.51 kPa and 161.92 ± 58.14 kPa, respectively. Both modalities had diagnostic agreement with histopathologic results (p<0.001). Kappa coefficient was 0.87 for SWE and 0.42 for MRI. The sensitivity of both methods was 94.59% (95% CI: 81.81–99.34), while the specificity and accuracy were 48.84% [95% CI: 33.31–64.54] and 70.0% [95% CI: 58.72–79.74] for MRI, and 93.02% [95% CI: 80.94–98.54] and 93.75% [95% CI: 86.01–97.94] for SWE. Conclusions SWE has better diagnostic value in terms of determining the nature of the breast masses. SWE can increase the diagnostic function of differentiating benign masses from malignant ones.

Objectives To probe the reference biomarkers used to manage chest pain (CP) by Italian internists. Methods Two hundred and fifty-seven doctors registered as members of the Federation of Associations of Hospital Doctors on Internal Medicine of the Campania Region (FADOI-Campania) were surveyed by means of Google Forms platform. Each participant was asked to report his/her sex, age, and location and hospital size (beds in hospital) in which he/she worked. Furthermore, they were asked to indicate the reference biomarker he/she usually employed in the management of patients with CP, choosing from four possible answers. In line with national and international guidelines, cardiac troponins are the gold standard biomarkers. Results Eighty-two internists (30 females) completed the survey. Interestingly, only 30.5% of participants indicated the cardiac troponins as reference biomarker. Moreover, internists working in medium-sized hospitals appeared to prefer the simultaneous measurement of cardiac troponins and Creatine Kinase MB Isoenzyme. Conclusions Given the economic impact of performing inappropriate examinations and the frequency of the CP symptom and associated diseases, rethinking pathways in a multidisciplinary and shared fashion can promote optimization and appropriateness, and therefore stop wastefulness.

We describe the case of Jessica Barnett, an adolescent girl whose repeated episodes of syncope and near-syncope were ascribed to a seizure or anxiety disorder. The correct diagnoses (congenital long QT syndrome; arrythmogenic right ventricular cardiomyopathy) were established by autopsy and genetic studies only after her death at age 17. The perspective of the family is presented, along with an analysis of what went right and what went wrong in Jessica’s diagnostic journey. Key lessons in this case include the value of family as engaged members of the diagnostic team, that a ‘hyperventilation test’ should not be used to exclude cardiac origins of syncope or pre-syncope, and the inherent challenges in the diagnosis of the long QT syndrome.