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BACKGROUND This systematic review and meta‐analysis aimed to assess the diagnostic test accuracy of blood‐based biomarkers (BBMs) for detecting Alzheimer's disease (AD) pathology in cognitively impaired individuals in specialized care settings. The overarching goal is to inform the development of a clinical practice guideline, led by the Alzheimer's Association, for use in clinical practice. METHODS A systematic search of MEDLINE, Embase, and Cochrane Library was conducted from January 2019 to November 2024. Studies evaluating the diagnostic test accuracy of plasma phosphorylated tau (p‐tau) and amyloid beta (Aβ) tests (p‐tau217, %p‐tau217, p‐tau181, p‐tau231, and Aβ42/Aβ40) compared to reference standard tests (cerebrospinal fluid [CSF] AD biomarkers, amyloid positron emission tomography [PET], or neuropathology) in individuals with cognitive impairment (mild cognitive impairment or dementia) in specialized care settings were included. Pooled diagnostic test accuracy measures were calculated, including sensitivity, specificity, and likelihood ratios. Across a range of pre‐test probabilities, we evaluated how much a positive or a negative test result would lead to a change in the probability of having amyloid positivity (post‐test probability). All analyses were conducted for each test within each biomarker. The Quality Assessment of Diagnostic Accuracy Studies 2 tool was used to evaluate the risk of bias, and the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation approach. RESULTS Across 49 observational studies meeting eligibility criteria, 31 different BBM tests were examined. When evaluated using a single cut‐point, the diagnostic test accuracy varied considerably across tests: the pooled sensitivity ranged from 49.3% (95% confidence interval [CI]: 41.2–57.4) to 91.4% (95% CI: 86.6–94.6), and the pooled specificity ranged from 61.5% (95% CI: 45.6–75.3) to 96.7% (95% CI: 87.8–99.2). Differences in post‐test probability based on a range of pre‐test probabilities varied greatly across tests. Furthermore, the certainty of evidence across tests ranged from moderate to very low. Most included studies were judged to be at high risk of bias, particularly in domains related to patient selection, index test conduct, and reference standard. CONCLUSION This systematic review provides a comprehensive synthesis of the current evidence on the diagnostic accuracy of BBMs for detecting AD pathology in cognitively impaired individuals in specialized care settings. The findings serve as a foundation for an accompanying clinical practice guideline that provides evidence‐based recommendations for BBM use in the clinical diagnostic pathway. Given continuous developments in this rapidly evolving field, ongoing evaluation will be critical to ensure the synthesized evidence and clinical guidelines remain up to date and maintain clinical relevance. Highlights This is the first comprehensive systematic review and meta‐analysis to evaluate the diagnostic accuracy of blood‐based biomarker (BBM) tests specifically in individuals with objective cognitive impairment seen in specialized care settings. Across 49 studies, BBM test performance varied widely. Pooled sensitivity ranged from 49.3% to 91.4% and specificity from 61.5% to 96.7%, depending on the analyte and assay platform. This review followed the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy, the Grading of Recommendations, Assessment, Development, and Evaluation approach to assess the certainty of evidence. This review served as the evidence base for the Alzheimer's Association's new clinical practice guidelines on BBMs, providing structured, evidence‐based guidance for implementing BBMs in the diagnostic workup of suspected Alzheimer's disease. The review underscores that BBM test performance is assay‐ and platform specific and advises clinicians and laboratory directors to interpret results in the context of the specific test used and integrate the results with a comprehensive clinical assessment.

Background & objectives: There is limited evidence regarding the accuracy of dengue rapid diagnostic kits despite their extensive use in India. We evaluated the performance of four immunochromatographic Rapid Diagnostic Test (RDTs) kits: Multisure dengue Ab/Ag rapid test (MP biomedicals; MP), Dengucheck combo (Zephyr Biomedicals; ZB), SD bioline dengue duo (Alere; SD) and Dengue day 1 test (J Mitra; JM). Methods: This is a laboratory-based diagnostic evaluation study. Rapid tests results were compared to reference non-structural (NS1) antigen or immunoglobulin M (IgM) enzyme-linked immunosorbent assay (ELISA) results of 241 dengue-positive samples and 247 dengue-negative samples. Sensitivity and specificity of NS1 and IgM components of each RDT were calculated separately and in combination (either NS1 or IgM positive) against reference standard ELISA. Results: A total of 238, 226, 208, and 146 reference NS1 ELISA samples were tested with MP, ZB, SD, and JM tests, respectively. In comparison to the NS1 ELISA reference tests, the NS1 component of MP, ZB, SD, and JM RDTs demonstrated a sensitivity of 71.8%, 85.1%, 77.2% and 80.9% respectively and specificity of 90.1%, 92.8%, 96.1 %, and 93.6%, respectively. In comparison to the IgM ELISA reference test, the IgM component of RDTs showed a sensitivity of 40.0%, 50.3%, 47.3% and 20.0% respectively and specificity of 92.4%, 88.6%, 96.5%, and 92.2% respectively. Combining NS1 antigen and IgM antibody results led to sensitivities of 87.5%, 82.9%, 93.8% and 91.7% respectively, and specificities of 75.3%, 73.9%, 76.5%, and 80.0% respectively. Interpretation & conclusion: Though specificities were acceptable, the sensitivities of each test were markedly lower than manufacturers' claims. These results also support the added value of combined antigen-and antibody-based RDTs for the diagnosis of acute dengue.

Early diagnosis of eye diseases improves outcomes and reduces blindness. However, diagnostic capacity in resource-poor settings is limited by a shortage of trained and equipped healthcare professionals. The Arclight device is a user-friendly, cost-effective diagnostic tool for both anterior and posterior segment eye diseases that requires minimal training. Studies have shown it to be effective for assessing the fundal reflex and performing fundoscopy; however, its accuracy and acceptability for anterior segment eye disease are still unknown. This was a cross-sectional study carried out at Mulago National Super Specialised Hospital, where 21 ophthalmic clinical officers (OCOs) were recruited from surrounding districts. Each participant evaluated eleven patients with anterior segment pathologies and one normal case using the Arclight loupe and a handheld Slit Lamp. The diagnosis and the proportion of correctly identified conditions were recorded. Focus group discussions were held to assess the acceptability of using the devices. Discussions were transcribed verbatim and analysed using latent and manifest content analysis. Of the 21 participants, 13 (61.9%) were female, with a median age of 39 (IQR: 33-49), and had practiced for 6 to 10 years, representing 76.2%. The majority of conditions were correctly identified by both the Arclight (71.2%) and handheld slit lamp (72.3%). Pterygium was the most accurately diagnosed condition (100%) with the Arclight. Based on themes from Sekhon's framework and the Technology Acceptance Model, the Arclight device was found to be highly acceptable and easy for OCOs to use. The performance of the OCOs in diagnosing anterior segment diseases with the Arclight is comparable to that of a handheld Slit lamp. It was also found to be an acceptable device for diagnostic purposes. In conclusion, the Arclight device is a suitable, low-cost alternative to the handheld Slit Lamp, especially in resource-limited settings.

We aimed to evaluate the accuracy of glaucoma screening using fundus photography combined with optical coherence tomography and determine the agreement between ophthalmologists and ophthalmology residents. We used a comprehensive ophthalmologic examination dataset obtained from 503 cases (1006 eyes). Of the 1006 eyes, 132 had a confirmed glaucoma diagnosis. Overall, 24 doctors, comprising two groups (ophthalmologists and ophthalmology residents, 12 individuals/group), analyzed the data presented in three screening strategies as follows: (1) fundus photography alone, (2) fundus photography + optical coherence tomography, and (3) fundus photography + optical coherence tomography + comprehensive examination. We investigated the diagnostic accuracy (sensitivity and specificity). The respective sensitivity and specificity values for the diagnostic accuracy obtained by 24 doctors, 12 ophthalmologists, and 12 ophthalmology residents were as follows: (1) fundus photography: sensitivity, 55.4%, 55.4%, and 55.4%; specificity, 91.8%, 94.0%, and 89.6%; (2) fundus photography + OCT: sensitivity, 80.0%, 82.3%, and 77.8%; specificity, 91.7%, 92.9%, and 90.6%; and (3) fundus photography + OCT + comprehensive examination: sensitivity 78.4%, 79.8%, and 77.1%; specificity, 92.7%, 94.0%, and 91.3%. The diagnostic accuracy of glaucoma screening significantly increased with optical coherence tomography. Following its addition, ophthalmologists could more effectively improve the diagnostic accuracy than ophthalmology residents. Screening accuracy is improved when optical coherence tomography is added to fundus photography.

ObjectiveThe interpretation of electrophysiological findings may lead to misdiagnosis in polyneuropathies. We investigated the electrodiagnostic accuracy of three supervised learning algorithms (SLAs): shrinkage discriminant analysis, multinomial logistic regression, and support vector machine (SVM), and three expert and three trainee neurophysiologists.MethodsWe enrolled 434 subjects with the following diagnoses: chronic inflammatory demyelinating polyneuropathy (99), Charcot-Marie-Tooth disease type 1A (124), hereditary neuropathy with liability to pressure palsy (46), diabetic polyneuropathy (67), and controls (98). In each diagnostic class, 90% of subjects were used as training set for SLAs to establish the best performing SLA by tenfold cross validation procedure and 10% of subjects were employed as test set. Performance indicators were accuracy, precision, sensitivity, and specificity.ResultsSVM showed the highest overall diagnostic accuracy both in training and test sets (90.5 and 93.2%) and ranked first in a multidimensional comparison analysis. Overall accuracy of neurophysiologists ranged from 54.5 to 81.8%.ConclusionsThis proof of principle study shows that SVM provides a high electrodiagnostic accuracy in polyneuropathies. We suggest that the use of SLAs in electrodiagnosis should be exploited to possibly provide a diagnostic support system especially helpful for the less experienced practitioners.

Background Recently, health professional education uses visual art observation to promote various observation-related technical skills. This article maps the studies on such interventions, scrutinizes what they measured as observational skills, and discusses their effectiveness. Methods Following the PRISMA Extension for Scoping Reviews, a scoping review was conducted. Publications from 2001 on were identified by searching four databases and by hand searching. The author screened each publication using the pre-designed eligibility criteria: participants were novice healthcare learners enrolled in visual art observation training; the study aimed to evaluate the effect of the intervention on technical skills related to observation; the skills were objectively measured. The author extracted relevant information from the included papers without additional inquiry into the study authors. The extracted information was illustrated in both a tabular and descriptive format. Results 3,157 publications were identified, of which 18 articles were included. Few studies had valid and reliable experiments. The relatively valid evidence is that the participants listed more elements or signs for artistic or medical images. Conclusions Sound evidence is lacking for all the technical skills intended to be fostered. Observation skills for artistic images have not been demonstrated to transfer to technical skills. Nor do the studies show that they promoted accurate diagnoses and reduced misdiagnoses. Additionally, the evidence on verbalizing skills is not isolated from the impact of discussions and is unclear regarding its transfer to actual communication. For the others, there are not enough valid studies on technical skills. This is true for studies that directly examine promoting accurate diagnosis or reducing misdiagnosis. Moreover, there may be promising alternatives to visual art observations for cultivating such technical skills, but no comparative studies were conducted.

The effectiveness of magnetic resonance imaging for diagnosing lateral epicondylitis severity is controversial. We aimed to verify whether individual evaluations of the common extensor tendon and lateral collateral ligament would improve the severity diagnostic accuracy of magnetic resonance imaging for lateral epicondylitis. We obtained coronal images of the lateral elbow in three groups: healthy, clinically mild, and clinically severe. We used our scoring system for evaluation using combined and individual methods. We developed the receiver operating characteristic curve for diagnosis using the scores of the healthy and mild groups and that for severity diagnosis using the scores of the mild and severe groups. The scores, in decreasing value, were those of the severe, mild, and healthy groups, with a significant difference in both methods. The curve for diagnosis showed an area under the curve of 0.85 for the combined evaluation and 0.89 for the individual evaluation, without a significant difference between the methods (p = 0.23). The curve for severity diagnosis showed an area under the curve of 0.69 for combined and 0.81 for individual evaluation, with a significant difference between the methods (p = 0.046). Individual evaluation of the common extensor tendon and lateral collateral ligament improved the severity diagnostic accuracy of lateral epicondylitis.

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group developed an approach to assess the quality of evidence of diagnostic tests. Its use in Cochrane diagnostic test accuracy reviews is new. We applied this approach to three Cochrane reviews with the aim of better understanding the application of the GRADE criteria to such reviews. We selected reviews to achieve clinical and methodological diversities. At least three assessors independently assessed each review according to the GRADE criteria of risk of bias, indirectness, imprecision, inconsistency, and publication bias. Two teleconferences were held to share experiences. For the interpretation of the GRADE criteria, it made a difference whether assessors looked at the evidence from a patient-important outcome perspective or from a test accuracy standpoint. GRADE criteria such as inconsistency, imprecision, and publication bias were challenging to apply as was the assessment of comparative test accuracy reviews. The perspective from which evidence is graded can influence judgments about quality. Guidance on application of GRADE to comparative test reviews and on the GRADE criteria of inconsistency, imprecision, and publication bias will facilitate the operationalization of GRADE for diagnostics.

Background Dual-energy absorptiometry (DXA) is the current reference standard for assessing pediatric osteoporosis; however due to its areal nature, it has limitations. Thus, quantitative ultrasound (QUS), a modality free of ionizing radiation, has been proposed as a potential surrogate for DXA. Objective To semi-quantitatively assess the diagnostic accuracy of QUS for evaluating pediatric osteoporosis according to the U.S. Preventive Services Task Force guidelines. Materials and methods We retrieved articles on the diagnostic accuracy of quantitative US for assessing abnormal bone quality or quantity in patients of mean age ≤19 years from MEDLINE, EMBASE and Cochrane Library CCTR databases. Evidences were analyzed for reliability, construct and criterion validity, and responsiveness of quantitative US, according to the following questions: (1) How reliable is the acquisition of QUS measurements? (2) Is QUS diagnostically accurate to characterize bone strength and quality in osteoporotic children? (3) Is QUS sensitive to detect changes in bone status over time? (4) Is QUS able to predict future skeletal fractures/degeneration? Three reviewers independently evaluated the quality of reporting and methodological quality using the Standards for Reporting of Diagnostic Accuracy (STARD) and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tools. Results Out of 262 retrieved references (215 unique), we included 28 studies (1,963 patients; 807 reported boys and 761 girls, others unspecified; reported mean age, 0–19 years). The mean quality of reporting score was “excellent” in 24/28 (86%) studies; 11/28 (39%) studies had “adequate” research design quality. Conclusion There is no evidence of the diagnostic value of QUS at the present time despite the overall excellent and adequate research design quality of primary studies. Although QUS can produce reliable measurements, insufficient evidence has been reported to support other clinimetric properties of this technique.

Chest pain is one of the most common reasons for contacting the emergency medical services (EMS). About 15% of these chest pain patients have a high-risk condition, while many of them have a low-risk condition with no need for acute hospital care. It is challenging to at an early stage distinguish whether patients have a low- or high-risk condition. The objective of this study has been to develop prediction models for optimising the identification of patients with low- respectively high-risk conditions in acute chest pain early in the EMS work flow. This prospective observational cohort study included 2578 EMS missions concerning patients who contacted the EMS in a Swedish region due to chest pain in 2018. All the patients were assessed as having a low-, intermediate- or high-risk condition, i.e. occurrence of a time-sensitive diagnosis at discharge from hospital. Multivariate regression analyses using data on symptoms and symptom onset, clinical findings including ECG, previous medical history and Troponin T were carried out to develop models for identification of patients with low- respectively high-risk conditions. Developed models where then tested hold-out data set for internal validation and assessing their accuracy. Prediction models for risk-stratification based on variables mutual for both low- and high-risk prediction were developed. The variables included were: age, sex, previous medical history of kidney disease, atrial fibrillation or heart failure, Troponin T, ST-depression on ECG, paleness, pain debut during activity, constant pain, pain in right arm and pressuring pain quality. The high-risk model had an area under the receiving operating characteristic curve of 0.85 and the corresponding figure for the low-risk model was 0.78. Models based on readily available information in the EMS setting can identify high- and low-risk conditions with acceptable accuracy. A clinical decision support tool based on developed models may provide valuable clinical guidance and facilitate referral to less resource-intensive venues.