Observational Diagnostic Study Research Articles

Prospective Validation of Glial Fibrillary Acidic Protein, d ‐Dimer, and Clinical Scales for Acute Large‐Vessel Occlusion Ischemic Stroke Detection

BACKGROUND Large‐vessel occlusion (LVO) ischemic stroke is responsible for significant morbidity and mortality. We have previously described a novel tool for acute LVO detection that combines blood‐based biomarkers (glial fibrillary acidic protein and d ‐dimer) with stroke severity scales to achieve high accuracy. Accordingly, the present study sought to prospectively validate cutoff values that we had previously established for biomarkers and scales. METHODS The TIME (Testing for Identification Markers of Stroke) trial was designed as a prospective observational diagnostic accuracy study. All ambulance‐identified stroke code activations <18 hours from symptom onset were recruited at Brandon Regional Hospital (Brandon, FL) between May 2021 and August 2022. Previously determined cutoff concentrations of plasma glial fibrillary acidic protein (213 pg/mL) and d ‐dimer (600 ng/mL) were used in combination with prehospital stroke scales to detect LVO. We compared rates of LVO detection against a reference standard using computed tomography/magnetic resonance angiography. RESULTS A total of 382 patients with suspected stroke were recruited. The final cohort was composed of 323 patients with suspected stroke with the following distribution: LVO ischemic stroke (n = 29, 9%), non‐LVO ischemic stroke (n = 48, 15%), hemorrhagic stroke (n = 13, 4%), transient ischemic attack (n = 12, 3.9%), and stroke mimics (n = 220, 68.1%). Combining blood‐based biomarkers (glial fibrillary acidic protein and d ‐dimer) with the scale field assessment stroke triage for emergency destination yielded the best performance for LVO detection, with specificity of 94% and sensitivity of 71%. Performance was found to be higher in a subanalysis focusing on patients presenting <6 hours from symptom onset, with 93% specificity and 81% sensitivity. Critically, application of the biomarker and stroke scale algorithms ruled out all patients with hemorrhage. CONCLUSION The present work prospectively validated the potential utility of previously defined glial fibrillary acidic protein and d ‐dimer cutoff levels (ie, 213 pg/mL and 600 ng/mL, respectively), demonstrating their value for discrimination of LVO stroke from differential diagnoses during code stroke workups. (ClinicalTrials.gov number, NCT04292600.)

Abstract PO1-07-05: Preliminary Evaluation in Breast Cancer of PointCheck: a Noninvasive AI-Based Neutropenia Monitoring Device

Abstract Background Febrile neutropenia (FN) is a common complication that can arise in breast cancer patients receiving myelosuppressive chemotherapy and increases the risk of fatal infections. Despite better preventive strategies there are between 140,000 to 200,000 FN-related hospitalizations yearly. Quick detection and awareness of grade III neutropenia (Absolute Neutrophil Count [ANC] < 1,000/µL) or greater can be critical to managing FN and treatment scheduling and dosing in patients with breast cancer. The current gold standard for neutropenia detection is a peripheral blood collection that requires patients to come into the clinic. PointCheck™ is a novel, noninvasive technology that can monitor for grade III neutropenia or greater and enable prompt detection in the home by acquiring microscopy videos of superficial capillaries through the nailfold skin and analyzing those videos with computer vision AI algorithms. To evaluate the usability, diagnostic performance, and preliminary clinical utility of PointCheck™ on FN detection we conducted a multi-center observational usability and diagnostic study. Methods The present study included an overall cohort of 175 diverse cancer patients, with 70 breast cancer patients. The primary endpoint was to achieve a score over 80.8 on a standardized System Usability Scale (SUS). Secondary endpoint was achievement of diagnostic performance with an area under the curve (AUC) above 0.80. We also performed an exploratory analysis on the device's clinical utility. Eligible participants were introduced to the device, watched a tutorial video and were given a user manual. They used the device autonomously under the supervision of the clinical team. Usability data was collected using the SUS, the scoring system that has a scale between 0-100. PointCheck™ measurements were analyzed using AI algorithms and compared to same-day Complete Blood Counts (CBCs) collected within 90 minutes of the measurement to assess accuracy in classifying patients as grade III neutropenic or greater (< 1,000/µL), or non-grade III neutropenic (≥1,000/µL). In the exploratory clinical utility analysis, clinicians provided narrative insights by completing a Likert survey assessing how PointCheck™ would support or impact their clinical decisions. Results 81.4% of breast cancer patients scored above 80.8 on the SUS scale across all sites, with a mean SUS score of 87.7 (SD=13.2). Furthermore, the AI-based PointCheck™ classifier accurately discriminated neutropenia patients with an AUC = 0.90 in the overall cohort. In the exploratory analysis, a majority of clinicians (65.2%) agreed that the device could have helped better evaluate their patients (Table 1). Whereas almost 3 out of 4 clinicians (72.4%), described that the use of PointCheck™ could have avoided preparing a chemotherapy infusion if the patient was not ready due to grade III neutropenia or greater. Conclusions The present study showed that there is a high perception of usability of PointCheck™, indicating an above average user experience and falling within the top 10% of systems. Furthermore, we found that PointCheck™ can accurately detect grade III neutropenia or greater in a large cohort of patients including breast cancer patients. Application of PointCheck™ to clinical practice as a monitoring system can contribute to the early detection of FN and antineoplastic therapy management. Table 1: Clinical Utility Survey Results Citation Format: Juan Garcia-Mosquera, Manuel Alva, Toshiaki Iwase, Ganimete Lamaj, Pablo Tolosa, Rodrigo Sánchez-Bayona, José Pelaez-Escobar, Alberto Pablo-Trinidad, Ryan Benasutti, Aurélien Bourquard, Ian Butterworth, Alvaro Sánchez-Ferro, Carlos Castro-González, José Manuel Pérez-García, Alejandro Martínez-Bueno, Eva Ciruelos, Azadeh Nasrazadani. Preliminary Evaluation in Breast Cancer of PointCheck: a Noninvasive AI-Based Neutropenia Monitoring Device [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-07-05.

Evaluation of fetuin-A and high-sensitivity C-reactive protein levels in gingival crevicular fluid in periodontitis diabetic and nondiabetic patients: an observational diagnostic accuracy study

Introduction Periodontitis is one of the most common chronic inflammatory diseases worldwide although its pathogenesis is still unclear. Diabetes complicates periodontitis changing its grade as a modifying factor. Gingival crevicular fluid (GCF) is regarded now as an important biological fluid especially in periodontal diseases. Hence, the aim of this study was to compare and correlate GCF fetuin-A and high-sensitivity C-reactive protein (hs-CRP) levels in nondiabetic periodontitis patients and diabetic periodontitis patients with healthy participants revealing their possible role in periodontal disease diagnosis. Patients and methods Thirty periodontitis stage III grade B/C patients categorized into two groups according to whether having diabetes mellitus or not were compared to 15 systemically and periodontally healthy participants. Clinical parameters were recorded. Assessment of GCF levels of fetuin-A and hs-CRP were done utilizing an enzyme-linked immunosorbent assay kit. Receiver operating characteristic curve was performed revealing sensitivity, specificity, predictive value, and diagnostic accuracy of both markers. Results GCF fetuin-A levels showed statistically significant difference between the three groups (P < 0.001) with the highest level in healthy group followed by the nondiabetic periodontitis group then the diabetic periodontitis group. While for hs-CRP level, it showed significantly higher results in nondiabetic periodontitis group and the diabetic periodontitis group than in healthy group with no statistically significant difference between both periodontitis groups. Conclusions Both markers have diagnostic ability in discriminating periodontitis against healthy individuals. However, the diagnostic ability in discriminating diabetic patients with periodontitis against nondiabetic periodontitis patients, fetuin-A showed outstanding ability, while the ability of hs-CRP was acceptable.

“Salivary LINC00657 and miRNA-106a as diagnostic biomarkers for oral squamous cell carcinoma, an observational diagnostic study”

BackgroundEarly detection and diagnosis of malignant tumors is critical for improving the survival rate and treatment outcomes of oral cancer. Thus, the current prospective investigation was designed to verify the role, sensitivity, and specificity of salivary LINC00657 and miRNA-106a as diagnostic markers in oral squamous cell carcinoma patients as compared to oral lichen planus (as an example of oral potentially malignant disorders) and normal individuals, and to show LINC00657 relation to miR-106a.MethodsA total of 36 participants were included, subdivided into 3 groups: Group I: 12 patients diagnosed with oral squamous cell carcinoma (OSCC). Group II: 12 patients diagnosed with oral lichen planus (OLP). Group III: 12 systemically free individuals with no oral mucosal lesions. Unstimulated salivary samples were collected from all participants to evaluate level of LINC00657 and miR-106a in different groups using quantitative real-time PCR.ResultsOSCC showed the highest LINC00657 and lowest miR-106a fold change among included groups. Receiver Operating Characteristic (ROC) curve analysis of the two biomarkers for detecting OSCC revealed that LINC00657 had higher diagnostic accuracy (DA) (83.3%) compared to miR-106a (80.4%). As for detecting OLP, ROC analysis showed that miR-106a had higher (DA) (61%) compared to LINC00657 (52.5%). To discriminate OSCC from OLP, the diagnostic accuracy of both markers is the same (75%). Moreover, differentiating OSCC grades II and III, ROC analysis showed that miR-106a had lower (DA) (60%) compared to LINC00657 (DA) (83.3%).ConclusionsSalivary LINC00657 and miR-106a could be promising diagnostic markers for oral squamous cell carcinoma. Salivary LINC00657 may differentiate oral squamous cell carcinoma from oral potentially malignant disorders with considerable diagnostic accuracy. Moreover, low levels of salivary miR-106a could have the potential to indicate malignancy.Trial registrationThe study was retrospectively registered on clinicaltrial.gov with NCT05821179 (first trial registration in 26/3/2023), date of registration: 19/4/2023.

Diagnostic accuracy of using capnography in verification of nasogastric tube placement among adult patients in hospital settings: Protocol of a diagnostic study.

To determine the diagnostic accuracy of end-tidal carbon dioxide (ETCO2) detection using capnography for verifying the correct placement of nasogastric tubes (NGTs) among adult patients in hospital settings. A prospective observational diagnostic study will be conducted. Patients ≥ 18-year-old and requiring the insertion of an NGT will be recruited using a convenience sampling method from 39 general medical and geriatric wards, intensive care units, accident and emergency departments, and subacute/rehabilitation/infirmary wards in 21 acute or subacute/convalescent/extended care hospitals. ETCO2 detection by sidestream capnography, which indicates an airway intubation of an NGT when a capnogram waveform or an ETCO2 level > 10mmHg (1.33 kPa) occurs, will serve as the index test. The reference standards will be the X-ray performed and pH value of gastric aspiration (pH ≤ 5.5) after the index test. Each participant will be included only once. Sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve of capnography will be calculated to assess the diagnostic performance of capnography. The variability in diagnostic accuracy in participants with different characteristics will be explored by using chi-squared or Fisher's exact tests. The time spent and the cost of the tests will be compared using the paired t-test. All statistical tests will be two-sided with a level of significance set at 0.05. This study will provide evidence on the diagnostic accuracy of capnography in verifying NGT placement and its applicability to patients in hospitals settings, since this evidence is limited in the current literature. In addition, it will help identify the optimal combination of tests in verifying the correct placement of NGTs and inform the update of clinical practice guidelines and stakeholders' decisions on the adoption of ETCO2 detection as a routine method for verifying NGT placement. ClinicalTrials.gov ID: NCT05817864.

The utility of heart-type free fatty-acid binding-protein (HFABP) levels for differentiating acute ischemic stroke from stroke mimics.

Heart-type fatty acid-binding protein (HFABP) is found in the myocardium, brain, and some organs and is rapidly released from damaged cells into the circulation in case of ischemia. We aimed to determine the diagnostic utility of HFABP levels in patients suggesting acute ischemic stroke (AIS). This study was a prospective, single-center, observational diagnostic accuracy study with a nested cohort design. The estimated sample size was 126 patients, with a 1:1 case and control ratio. We included all consecutive patients with a lateralizing symptom (motor or sensory) or finding suggesting AIS (139 patients) who presented to ED within 24h of their symptom onset and collected plasma at admission to the ED. After further evaluations, 111 patients (79.8%) were diagnosed with AIS and 28 with other neurological diseases (stroke-mimics). In our study, the median HFABP levels of the cases and controls were 2.6μg/ml and 2.2μg/ml, respectively, without any statistically significant difference (p = 0.120). The diagnostic accuracy of HFABP for AIS was also insignificant at 0.60 (95% CI 0.51-0.68; p = 0.119). Plasma HFABP level is not a marker that can differentiate AIS from other neurological pathologies in patients presenting to the ED, with findings suggesting AIS.

SP4.4 A Prospective Diagnostic study investigating Urinary Biomarkers of AKI in Major Abdominal Surgery (The AKI-BioMAS Study)

Abstract Aims To characterize biomarker performance in predicting Acute Kidney Injury (AKI) in Major Abdominal Surgery using both the Kidney Disease: Improving Global Outcomes (KDIGO) serum creatinine (AKISCr) and urine output (AKIUO) criteria. Post-operative AKI is associated with increased morbidity and mortality. Research assessing AKI biomarkers has focussed on cardiac, vascular and transplant surgery cohorts. Few studies have addressed Major Abdominal Surgery. Methods This prospective observational diagnostic study was conducted on 488 major abdominal surgery patients. Urine was collected four hours post-surgery. Biomarkers measured were NGAL, KIM-1, DKK-3 and IGFBP-7*TIMP-2. Diagnostic performance was assessed utilizing Receiver Operating Characteristic (ROC) curve analysis. Results 242 participants developed AKIUO (49.5%) and 43 AKISCr (8.8%). The area under the receiver operating characteristic curve (AUC) values for stage 1 AKISCr using NGAL was 0.741 (95%CI 0.699-0.770, p<0.001) and 0.871 (95%CI 0.838-.899, p<0.001) for stage 2. AUC values for IGFBP-7*TIMP-2 for stage 1 were 0.655 (95% CI 0.611-0.697, p0.003) and stage 2 0.803 (95%CI 0.764-0.837 p0.002). The AUC for KIM-1 was statistically significant for stage 1 (0.68, 95%CI 0.637-0.722) but not for stage 2. No AUC values for DKK-3 were statistically significant. Biomarkers performed poorly for stage 1 and 2 AKIUO with AUC values of <0.65. Conclusions AKI rates following Major Abdominal Surgery are dependent on criteria used. Given the numerous confounders affecting urine output post-operatively it may be that current AKIUO criteria in patients undergoing Major Abdominal Surgery may be inappropriate. This is reflected in poor diagnostic performance of biomarkers in this context. Biomarkers performed better when assessing AKISCr, with NGAL returning the highest AUC values.

Development of a prediction score for evaluation of extubation readiness in neurosurgical patients with mechanical ventilation.

There is no widely accepted consensus on the weaning and extubating protocols for neurosurgical patients, leading to heterogeneity in clinical practices and high rates of delayed extubation and extubation failure-related health complications. In this single-center prospective observational diagnostic study, mechanically ventilated neurosurgical patients with extubation attempts were consecutively enrolled for one year. We surveyed responsive physicians for the reasons for delayed extubation and developed the STAGE (Swallowing, Tongue protrusion, Airway protection reflected by spontaneous and suctioning cough, and Glasgow coma scale Evaluation) score to predict the extubation success for neurosurgical patients already meeting other general extubation criteria. A total of 3171 patients were screened consecutively and 226 patients were enrolled in this study. Rates of delayed extubation and extubation failure were 25% (57/226) and 19% (43/226), respectively. The most common reasons for the extubation delay were weak airway protecting function and poor consciousness. The area under the receiver operating characteristics curve of the total STAGE score associated with extubation success was 0.72 (95% CI: 0.64 to 0.79). Guided by the highest Youden index, the cutoff point for the STAGE score was set at 6 with 59% (95% CI: 51% to 66%) sensitivity, 74% (95% CI: 59% to 86%) specificity, 90% (95% CI: 84% to 95%) positive predictive value, and 30% (95% CI: 21% to 39%) negative predictive value. At STAGE scores ≥ 9, the model exhibited a 100% (95% CI: 90% to 100%) specificity and 100% (95% CI: 72% to 100%) positive predictive value for predicting extubation success. After surveying the reasons for delayed extubation, we developed the STAGE scoring system to better predict the extubation success rate. We believe that this scoring system has promising potential in predicting extubation readiness and may help clinicians avoid delayed extubation and failed extubation-related health complications in neurosurgical patients.

Field evaluation of a point-of-care triage test for active tuberculosis (TriageTB)

BackgroundTo improve tuberculosis (TB) diagnosis, the World Health Organisation (WHO) has called for a non-sputum based triage test to focus TB testing on people with a high likelihood of having active pulmonary tuberculosis (TB). Various host or pathogen biomarker-based testing devices are in design stage and require validity assessment. Host biomarkers have shown promise to accurately rule out active TB, but further research is required to determine generalisability. The TriageTB diagnostic test study aims to assess the accuracy of diagnostic test candidates, as well as field-test, finalise the design and biomarker signature, and validate a point-of-care multi-biomarker test (MBT).MethodsThis observational diagnostic study will evaluate sensitivity and specificity of biomarker-based diagnostic candidates including the MBT and Xpert® TB Fingerstick cartridge compared with a gold-standard composite TB outcome classification defined by symptoms, sputum GeneXpert® Ultra, smear and culture, radiological features, response to TB therapy and presence of an alternative diagnosis. The study will be conducted in research sites in South Africa, Uganda, The Gambia and Vietnam which all have high TB prevalence. The two-phase design allows for finalisation of the MBT in Phase 1 in which candidate host proteins will be evaluated on stored serum from Asia, South Africa and South America and on fingerstick blood from 50 newly recruited participants per site. The MBT test will then be locked down and validated in Phase 2 on 250 participants per site.DiscussionBy targeting confirmatory TB testing to those with a positive triage test, 75% of negative GXPU may be avoided, thereby reducing diagnostic costs and patient losses during the care cascade. This study builds on previous biomarker research and aims to identify a point-of-care test meeting or exceeding the minimum World Health Organisation target product profile of a 90% sensitivity and 70% specificity. Streamlining TB testing by identifying individuals with a high likelihood of TB should improve TB resources use and, in so doing, improve TB care.Trial registrationNCT04232618 (clinicaltrials.gov) Date of registration: 16 January 2020.

Accuracy of Self-Reported COVID-19 Vaccination Status Compared With a Public Health Vaccination Registry in Québec: Observational Diagnostic Study.

The accuracy of self-reported vaccination status is important to guide real-world vaccine effectiveness studies and policy making in jurisdictions where access to electronic vaccine registries is restricted. This study aimed to determine the accuracy of self-reported vaccination status and reliability of the self-reported number of doses, brand, and time of vaccine administration. This diagnostic accuracy study was completed by the Canadian COVID-19 Emergency Department Rapid Response Network. We enrolled consecutive patients presenting to 4 emergency departments (EDs) in Québec between March 24, 2020, and December 25, 2021. We included adult patients who were able to consent, could speak English or French, and had a proven COVID-19 infection. We compared the self-reported vaccination status of the patients with their vaccination status in the electronic Québec Vaccination Registry. Our primary outcome was the accuracy of the self-reported vaccination status (index test) ascertained during telephone follow-up compared with the Québec Vaccination Registry (reference standard). The accuracy was calculated by dividing all correctly self-reported vaccinated and unvaccinated participants by the sum of all correctly and incorrectly self-reported vaccinated and unvaccinated participants. We also reported interrater agreement with the reference standard as measured by unweighted Cohen κ for self-reported vaccination status at telephone follow-up and at the time of their index ED visit, number of vaccine doses, and brand. During the study period, we included 1361 participants. At the time of the follow-up interview, 932 participants reported at least 1 dose of a COVID-19 vaccine. The accuracy of the self-reported vaccination status was 96% (95% CI 95%-97%). Cohen κ for self-reported vaccination status at phone follow-up was 0.91 (95% CI 0.89-0.93) and 0.85 (95% CI 0.77-0.92) at the time of their index ED visit. Cohen κ was 0.89 (95% CI 0.87-0.91) for the number of doses, 0.80 (95% CI 0.75-0.84) for the brand of the first dose, 0.76 (95% CI 0.70-0.83) for the brand of the second dose, and 0.59 (95% CI 0.34-0.83) for the brand of the third dose. We reported a high accuracy of self-reported vaccination status for adult patients without cognitive disorders who can express themselves in English or French. Researchers can use self-reported COVID-19 vaccination data on the number of doses received, vaccine brand name, and timing of vaccination to guide future research with patients who are capable of self-reporting their vaccination data. However, access to official electronic vaccine registries is still needed to determine the vaccination status in certain susceptible populations where self-reported vaccination data remain missing or impossible to obtain. Clinicaltrials.gov NCT04702945; https://clinicaltrials.gov/ct2/show/NCT04702945.

Optimising computer aided detection to identify intra-thoracic tuberculosis on chest x-ray in South African children.

Diagnostic tools for paediatric tuberculosis remain limited, with heavy reliance on clinical algorithms which include chest x-ray. Computer aided detection (CAD) for tuberculosis on chest x-ray has shown promise in adults. We aimed to measure and optimise the performance of an adult CAD system, CAD4TB, to identify tuberculosis on chest x-rays from children with presumptive tuberculosis. Chest x-rays from 620 children <13 years enrolled in a prospective observational diagnostic study in South Africa, were evaluated. All chest x-rays were read by a panel of expert readers who attributed each with a radiological reference of either 'tuberculosis' or 'not tuberculosis'. Of the 525 chest x-rays included in this analysis, 80 (40 with a reference of 'tuberculosis' and 40 with 'not tuberculosis') were allocated to an independent test set. The remainder made up the training set. The performance of CAD4TB to identify 'tuberculosis' versus 'not tuberculosis' on chest x-ray against the radiological reference read was calculated. The CAD4TB software was then fine-tuned using the paediatric training set. We compared the performance of the fine-tuned model to the original model. Our findings were that the area under the receiver operating characteristic curve (AUC) of the original CAD4TB model, prior to fine-tuning, was 0.58. After fine-tuning there was an improvement in the AUC to 0.72 (p = 0.0016). In this first-ever description of the use of CAD to identify tuberculosis on chest x-ray in children, we demonstrate a significant improvement in the performance of CAD4TB after fine-tuning with a set of well-characterised paediatric chest x-rays. CAD has the potential to be a useful additional diagnostic tool for paediatric tuberculosis. We recommend replicating the methods we describe using a larger chest x-ray dataset from a more diverse population and evaluating the potential role of CAD to replace a human-read chest x-ray within treatment-decision algorithms for paediatric tuberculosis.

Negative predictive value of the FebriDx host response point-of-care test in patients presenting to a single Australian emergency department with suspected COVID-19: an observational diagnostic accuracy study

ObjectivesTo determine the negative predictive value (NPV) of the FebriDx point-of-care host response device in patients presenting with symptoms suggestive of COVID-19 infection in a mostly immunised Australian emergency department...

Point-of-Care Assessment of Direct Oral Anticoagulation in Acute Ischemic Stroke: Protocol for a Prospective Observational Diagnostic Accuracy Study.

Treatment of ischemic stroke with recombinant tissue plasminogen activator for intravenous thrombolysis (IVT) must be delivered within a narrow time window after symptom onset. This effective hyperacute treatment can be administered after ruling out active anticoagulation with direct oral anticoagulants (DOACs). Whenever this is impractical, e.g., due to aphasia, plasmatic DOAC levels are measured with a consequent delay in the IVT decision-making process ranging from 30 to 60 minutes of time. This study will test the hypothesis that hyperacute point-of-care assessment of clotting time in the patient's whole blood has sufficient diagnostic accuracy to determine immediately whether stroke patients are pretreated with DOAC. This will be a prospective single-center diagnostic accuracy study in 1,850 consecutive acute ischemic stroke patients at a tertiary stroke center in Saxony, Germany. Presence of active anticoagulation with DOAC will be determined by point-of-care quantification of clotting time via whole blood viscoelastic testing (ClotPro) using Russell venom viper and ecarin assay compared with high-performance liquid chromatography-tandem mass spectrometry as the reference standard. Viscoelastic point-of-care assessment of clotting time in whole blood might improve swift delivery of time-sensitive hyperacute treatment with IVT in stroke patients.

Conformity between modified Swallowing Outcome After Laryngectomy questionnaire and Flexible Endoscopic Evaluation of Swallowing in laryngeal carcinoma patients after total laryngectomy

Background:One of the impacts in anatomic laryngeal and phariyngeal changes after total laryngectomy (TL) is oropharyngeal dysphagia (OPD). The detection of neopharyngeal residue as a sign of OPD can be performed by videofluoroscopy (VFS) and flexible endoscopic evaluation of swallowing (FEES). The availability of these tools in rural areas is still limited, thus the treatment of OPD is not maximal. There is a need for a more practical tool, including the modified swallowing outcomes after laryngectomy (SOAL) questionnaire.Methods:This was an analytic observational diagnostic study with a cross-sectional approach. Samples were obtained in Otorhinolaryngology Oncology Clinic and Outpatient Clinic of Dr. Soetomo General Academic Hospital, Surabaya, Indonesia, who filled SOAL modified questionnaire followed by FEES. Samples were obtained within 3 months from 10 May to 10 August 2021. The number of samples obtained through simple random sampling was 16 post-TL patients from a total population of 17 patients who met the inclusion and exclusion criteria. The conformity test between modified SOAL questionnaire and FEES was analyzed using McNemar comparison test and Kappa association test.Results:McNemar test showed no significant difference between both assessment tools (p > 0.05), and the Kappa test showed an association between both tools (p < 0.05). The results of this study stated that there was conformity between modified SOAL questionnaire and FEES in patients after TL in all types of food bolus had Kappa score of >0.81, showing a reliable association between these tools. Kappa test also showed that out of all three types of boluses, the soft bolus had the highest conformity with a Kappa score of 0.875, followed by thick bolus with 0.839, and watery bolus with 0.818.Conclusion:There was a conformity between the results of the modified SOAL questionnaire and FEES in head and neck surgery patients after TL.

Incremental Value of 18 F-FDG-Labeled Leukocytes PET/CT Over 18 F-FDG PET/CT Scan in the Detection of Occult Infection.

Differentiating infection and sterile inflammation is the main clinical concern of clinicians as they are closely related to each other. Although 18 F-FDG PET/CT imaging is widely used, its main disadvantage is its lack of specificity to discriminate aseptic from septic inflammation. 18 F-WBC PET/CT scan is a promising tool for the accurate diagnosis of infection owing to its high specificity. The aim of the present study is to determine the utility of 18 F-WBC PET/CT in the diagnosis of occult infections and to assess its incremental value over routine 18 F-FDG PET/CT scan. This prospective observational diagnostic accuracy study included 33 patients with fever of unknown origin or suspected periprosthetic infection and raised C-reactive protein and total leukocyte count. All the patients underwent both 18 F-WBC PET/CT scan and 18 F-FDG PET/CT scan using a standard protocol on 2 different days. Images of both the scans were evaluated by both visual analyses based on uptake intensity and quantitative grading based on lesion-to-background SUV max values. For interpretation of FDG PET/CT images, visual scoring of grade 0 (undetectable or no uptake), grade 1a (less than liver uptake), grade 1b (equivalent to liver uptake), grade 2 (higher than liver uptake), and grade 3 (higher than cerebellum uptake) was used. 18 F-WBC PET/CT images were also interpreted visually as grade 0 (undetectable or no uptake), grade 1a (significantly less than lumbar vertebrae or liver uptake for truncal lesions, and in case of extremity lesion slightly higher than neighboring soft tissue uptake or less than neighboring bone marrow uptake), grade 1b (equivalent to liver or lumbar vertebrae uptake for truncal lesions, and in case of extremity lesion significantly higher than neighboring soft tissue uptake or higher than neighboring bone marrow uptake), grade 2 (higher than liver or bone marrow uptake), and grade 3 (higher than twice the liver or bone marrow uptake). Similarly, a quantitative grading was also done based on lesion-to-background SUV max using a circular region of interest manually drawn. For both 18 F-FDG and 18 F-WBC PET/CT, the lesion-to-background ratio of <1.5 was recorded as grade 0, 1.5-2.5 as grade 1a, 2.5-3.5 as grade 1b, 3.5-4.5 as grade 2, and >4.5 as grade 3. Final diagnosis was made by histopathological, microbiological analysis, or clinical-radiological workup. Twenty-nine foci of suspected infection were found in 25/33 patients by either 18 F-FDG PET/CT or 18 F-WBC PET/CT scan. No abnormal uptake of either 18 F-FDG or 18 F-FDG WBC scan was seen in 8 patients. There was a concordance of 18 F-FDG PET/CT and 18 F-WBC PET/CT in 28 sites each using grade 1b of visual and quantitative analysis, respectively. Of the 29 suspicious infected foci, 18 were proven positive for infection (14/18 sites by the histopathological/microbiological culture and the rest 4/18 sites by clinical/radiological workup). Culture of aspirates or biopsy from 11/29 suspicious sites was proven noninfective. Seven of 11 suspicious sites were proven noninfective by clinical/radiological workup. The mean clinical follow-up was 8 months (1-15 months).Overall significantly higher diagnostic accuracy was demonstrated with 18 F-WBC PET/CT in comparison to 18 F-FDG PET/CT for the detection of infection ( P < 0.05). The highest diagnostic accuracy of 18 F-WBC PET/CT scan was reported with both grade 1b of visual as well as of quantitative analysis (lesion-to-background SUV max , 2.5-3.5) and grade 2 for both visual and quantitative analysis for 18 F FDG PET/CT. 18 F-WBC PET/CT has a higher diagnostic accuracy over 18 F-FDG PET/CT for the diagnosis of occult infection.

Sensitivity and specificity of the new Geriatric Dehydration Screening Tool: An observational diagnostic study

Objectives: The aim of this study was to evaluate the diagnostic accuracy of the Geriatric Dehydration Screening Tool–Modified (GDST-M) in detecting dehydration in older people and, if possible, to simplify the tool and make it easier to use.Methods: This was a monocentric diagnostic accuracy study. We involved people ≥65 y of age with a Mini Mental State Evaluation (MMSE) score >24 and who were hospitalized in five medical wards of a large teaching hospital in Milan (Italy). We administered the GDST-M to hospitalized older people who met the inclusion criteria and compared outcomes with the values of serum osmolarity to evaluate their dehydration status and the accuracy of the tool.Results: A total of 299 older people were recruited, of which 202 were dehydrated and 97 were hydrated. The GDST-M, with a cutoff value of 6, showed a sensitivity of 61.9% and a specificity of 47.2%. Multiple correspondence analysis and cluster analysis enabled extraction of 9 items from the 23 items present in the GDST-M. The new tool had a moderate diagnostic accuracy in detecting dehydration in older people aged over 75 y, with a sensitivity of 63.4% and a specificity of 69.6%.Conclusions: The short form of the tool is simple and contains minimally invasive assessments of low fluid intake dehydration in older people. The new GDST could also be easily used by lay people after a short training session.

The Risk of Endometrial Malignancy and Other Endometrial Pathology in Women with Abnormal Uterine Bleeding: An Ultrasound-Based Model Development Study by the IETA Group

Objectives: The aim of this study was to develop a model that can discriminate between different etiologies of abnormal uterine bleeding. Design: The International Endometrial Tumor Analysis 1 study is a multicenter observational diagnostic study in 18 bleeding clinics in 9 countries. Consecutive women with abnormal vaginal bleeding presenting for ultrasound examination (n = 2,417) were recruited. The histology was obtained from endometrial sampling, D&C, hysteroscopic resection, hysterectomy, or ultrasound follow-up for >1 year. Methods: A model was developed using multinomial regression based on age, body mass index, and ultrasound predictors to distinguish between: (1) endometrial atrophy, (2) endometrial polyp or intracavitary myoma, (3) endometrial malignancy or atypical hyperplasia, (4) proliferative/secretory changes, endometritis, or hyperplasia without atypia and validated using leave-center-out cross-validation and bootstrapping. The main outcomes are the model’s ability to discriminate between the four outcomes and the calibration of risk estimates. Results: The median age in 2,417 women was 50 (interquartile range 43–57). 414 (17%) women had endometrial atrophy; 996 (41%) had a polyp or myoma; 155 (6%) had an endometrial malignancy or atypical hyperplasia; and 852 (35%) had proliferative/secretory changes, endometritis, or hyperplasia without atypia. The model distinguished well between malignant and benign histology (c-statistic 0.88 95% CI: 0.85–0.91) and between all benign histologies. The probabilities for each of the four outcomes were over- or underestimated depending on the centers. Limitations: Not all patients had a diagnosis based on histology. The model over- or underestimated the risk for certain outcomes in some centers, indicating local recalibration is advisable. Conclusions: The proposed model reliably distinguishes between four histological outcomes. This is the first model to discriminate between several outcomes and is the only model applicable when menopausal status is uncertain. The model could be useful for patient management and counseling, and aid in the interpretation of ultrasound findings. Future research is needed to externally validate and locally recalibrate the model.

Comparison of Ultrasound and Tumor Marker CA125 in Diagnosis of Adnexal Mass Malignancies.

Background:CA125 is the most used tumor marker for ovarian cancer monitoring and diagnosis. This study aimed to evaluate the capacity to predict malignancy in women with adnexal tumors using CA125 measurement and ultrasound criteria before the pathological examination.Materials and Methods:This observational diagnostic study was conducted on 300 patients with obvious diagnosis of adnexal mass consists of ovarian masses, fallopian tubes, and masses within the broad ligament referring to Alzahra and Beheshti Hospitals from 2018 to 2019. Ultrasound examinations were done before surgery and malignancy risk was investigated by the ADNEX criterion. Sensitivity, specificity, positive and negative likelihood ratio (likelihood ratio [LR]+ and LR−), and area under the curve (AUC) were calculated.Results:From 284 patients, 260 masses were categorized in benign, 18 were in borderline, and 18 masses were malignant. The mean age of patients with malignant tumors was significantly higher than the others (P = 0.01). Differences in the level of CA-125 were not statistically significant (P = 0.78). Furthermore, the proportion of ascites in the malignant group (16.3%) was significantly higher than the others (P = 0.003). The AUC in ADNEX model (cutoff ≥9%) for differentiation of benign and malignant tumors was 0.75 (95% confidence interval [CI]: 0.69–0.80) with a sensitivity of 0.63 (95% CI: 0.41–0.81) and a specificity of 0.80 (95% CI: 0.74–0.84). Receiver operating characteristic analysis for CA-125 revealed that this variable is not capable for discrimination between benign and malignant tumors as the AUCs of the aforementioned variable were 0.60, 0.60, and 0.52 for the whole patients, premenopause, and postmenopause categories.Conclusion:CA-125 marker, along with other ultrasound findings, can be more accurate in identifying the malignancy of the adnexa tumor.

Highlighting multidetector computed tomography capabilities in assessing trauma to the retroperitoneal region: a cross-sectional study

ObjectivesThe main objective of this study was to evaluate the different injury types of retroperitoneal trauma regarding their multidetector computed tomography (MDCT) findings.BackgroundTraumatic injuries of the abdomen are one of the most common causes of morbidities and mortalities worldwide. Retroperitoneal traumatic injuries occur in a minority of abdominal trauma; however, they cause higher mortality rates compared with other types of abdominal trauma.Patients and methodsWe conducted a cross-sectional observational diagnostic study on patients admitted for emergent radiological examination following abdominal trauma. History, clinical examination, laboratory investigations, and MDCT were done to detect retroperitoneal injuries and assess their severity.ResultsA total of 21 (70%) patients had renal injuries, two had ureteric injuries, three had pancreatic injuries, two had vascular injuries, two had psoas muscle injuries, and two had a pelvic bone injury. The MDCT showed that 30 patients had at least one retroperitoneal injury. Perinephric hematoma was the most common MDCT finding (42%) in patients with renal injuries. Associated injuries were seen in around one-third of study participants, including pleural effusion and splenic and hepatic injuries. According to the surgical retroperitoneal zones, zone II showed the highest frequency (80%). The final management of our cases were classified as follows: 13 patients were treated conservatively, whereas 19 patients had surgical management.ConclusionMDCT is considered the imaging modality of choice in diagnosing and staging cases with retroperitoneal traumatic injuries. MDCT should be used as a follow-up technique to detect cases missed by the initial CT scan.

Abstract 12356: Prevalence and Patterns of Injury Detected by Head-to-Pelvis Sudden Death Computed Tomography Following Cardiopulmonary Resuscitation

Introduction: Patients resuscitated from out-of-hospital cardiac arrest (OHCA) frequently have skeletal and visceral injuries identifiable by computed tomography, although the prevalence, types of injury, and potential effects on clinical outcomes are poorly characterized. Methods: We assessed the prevalence of resuscitation-attributable injury in a prospective, observational diagnostic utility study of a head-to-pelvis sudden death computed tomography (SDCT) protocol after successful resuscitation from OHCA. SDCT was performed within six hours of arrival at two academic medical centers. CT data were independently analyzed by two blinded radiologists. Primary outcomes included total injuries and time-critical injuries (such as organ laceration). Exploratory outcomes were clinical associations with injury and survival to discharge. Results: Among 104 patients with OHCA (mean age 56 ± 15 years, 31% female), 59% of events were witnessed and 60% had bystander CPR. Initial rhythms were pulseless electrical activity (38%), ventricular tachycardia/fibrillation (29%), and asystole/unknown (33%). Mean CPR time was 15.4 ± 10.6 minutes; mechanical chest compression systems were used in 27% of cases. The prevalence of injury was high (80%; Table), including 19 patients (18%) with time-critical findings. Compared to patients without injury, patients with injury had numerically lower BMI (24.2 ± 7.7 vs. 26.7 ± 8.0), higher use of mechanical CPR (29% vs. 19%), longer CPR time (16.1 ± 11.0 vs. 12.3 ± 8.5 min), and lower survival to discharge (40% vs. 52%), although none were significant (p= NS for all). Conclusion: In patients resuscitated from OHCA, head-to-pelvis SDCT identified injury in most patients, with nearly one in five with time-critical findings and nearly one half with extensive ribcage injuries that may affect ventilation. These data suggest that SDCT has additional diagnostic utility and treatment implications beyond evaluating causes of OHCA.