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Net costs from three perspectives of using low versus high osmolality contrast medium in diagnostic angiocardiography.

OBJECTIVES: We conducted an economic analysis to assess the extent to which a reduction in adverse drug reactions induced by low osmolality compared with high osmolality contrast media during diagnostic angiocardiography would result in savings to hospitals, society and third-party payers that would offset the substantially higher price of low osmolality contrast medium. BACKGROUND: Substitution of low osmolality for high osmolality contrast media in the approximately 1 million diagnostic angiocardiographic procedures performed each year in the United States could substantially increase health care costs. Cost-effectiveness estimates should include savings that might occur through reduced costs of managing adverse drug reactions. METHODS: In a randomized clinical trial of 505 persons under-going diagnostic angiography with either high osmolality or low osmolality contrast medium, we measured and compared 1) material costs of contrast media, and 2) costs from three perspectives of incremental resources used to manage contrast-related adverse drug reactions. We also performed sensitivity analyses to examine the effect of different assumptions with regard to relative risk, absolute risk and costs of adverse drug reactions on estimates of net cost of use of high osmolality and low osmolality contrast media. RESULTS: One-hundred thirty-seven (54.2%) of 253 patients receiving high osmolality contrast medium and 44 (17.5%) of 252 patients receiving low osmolality contrast medium experienced adverse drug reactions. The average cost (from society's perspective) of resources used to manage adverse drug reactions per patient undergoing angiography was significantly (p = 0.0001) greater for high osmolality (mean $249) versus low osmolality (mean $92) contrast medium. Differential costs (from the hospital's perspective) were $67 greater for high osmolality contrast medium. Charges and professional fees (from the payer's perspective) were $182 greater for high osmolality (mean $312) than for low osmolality (mean $130) contrast medium (p = 0.42, NS). The higher differential and average costs of managing adverse drug reactions with high osmolality contrast medium offset 33% and 75%, respectively, of the $207 difference in mean material costs, but these estimates are sensitive to infrequent high cost cases. CONCLUSIONS: Although low osmolality contrast medium is not cost-saving in diagnostic angiocardiography, its higher price is partially offset by lower management costs of adverse drug reactions. The cost offset for the hospital is lower than that for society and may not be realized by third-party payers. These methods and results may be useful in establishing clinical and payment guidelines for use of alternative contrast media in diagnostic angiocardiography.

Angiocardiography↗

A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty.

OBJECTIVES: A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty. BACKGROUND: Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures. METHODS: A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques. RESULTS: After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, without heparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14). CONCLUSIONS: A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

Aged↗

The influence of diagnostic access bias on the epidemiology of sarcoidosis: a population-based study in Rochester, Minnesota, 1935-1984.

A population-based study was conducted among residents of Rochester, Minnesota from 1935-1984 to examine the influence of diagnostic access bias on the incidence and mode of presentation of clinically recognized sarcoidosis. Immigrants had an elevated risk of sarcoidosis and were more likely to present with asymptomatic sarcoidosis diagnosed on routine screening chest radiographs. Similar patterns were observed for health professionals, a group with markedly greater access to the diagnostic procedures which label them as having sarcoidosis. Sarcoidosis exhibits a spectrum of manifestations, ranging from a totally asymptomatic process discernible only by specific diagnostic scrutiny to a clinically obvious presentation with significant morbidity. For disease entities such as this, apparent patterns of occurrence may depend on differential access in the study population to the maneuvers necessary for diagnosis. Diagnostic access bias, in addition to other diagnostic biases, deserves more careful scrutiny in epidemiologic research.

Adolescent↗

Sensitivity and specificity of diagnostic tests in acute maxillary sinusitis determined by maximum likelihood in the absence of an external standard.

This study shows how to obtain maximum likelihood estimates of test sensitivities and specificities in case of lack of an external standard, using the Expectation Maximisation (EM) algorithm. This method is used to compare four diagnostic tests in patients suspected of acute maxillary sinusitis. Data were analyzed from published studies. Antral aspiration is the test with the highest diagnostic value. The diagnostic value of a positive clinical examination (according to explicit criteria) and of a positive radiograph or ultrasound are comparable. A negative radiograph is of more diagnostic value than a negative clinical examination or ultrasound. The width of the confidence intervals may be too small, due to model deviations which may give incorrect standard errors. However, the estimated likelihood ratios adequately reflect the relative value of the diagnostic tests considered, even when the assumption of independence is dropped.

Acute Disease↗

Diagnostic accuracy of predicting coronary artery disease related to patients' characteristics.

Patients' demographic and clinical characteristics may affect diagnostic accuracy of cardiologists. We asked a group of experienced cardiologists from three institutions to estimate the pretest probability of coronary artery disease in 257 patients referred for diagnostic coronary angiography and with no history of previous myocardial infarction nor valvular heart disease. Physicians pretest estimates were compared with the diagnostic findings of coronary angiography. We tested the influence of five variables on the accuracy of the pretest estimates: age, sex, chest pain characteristics, rest electrocardiogram and electrocardiographic exercise test result. Cardiologists tended to overestimate the presence of coronary artery disease and this tendency was particularly remarkable in the group of patients showing a negative exercise test. Pretest diagnostic accuracy was 0.72 when the test result was negative and 0.85 when the test result was positive (95% confidence interval of the difference 0.03 to 0.23; p < 0.001). The diagnosis of coronary artery disease was also more accurate for male than for female patients (0.81 vs 0.70; 95% confidence interval of the difference 0.02 to 0.21; p < 0.02). Characteristics of chest pain, age and rest electrocardiogram did not affect the level of pretest diagnostic accuracy. Cardiologists should be cognizant of correctly interpreting a negative exercise test and the clinical data of female patients; in both cases, they should move circumspect of the diagnosis of coronary artery disease.

Age Factors↗

Temporal diagnostic reasoning based on time-objects.

Time is essential in diagnostic problem-solving. However, as with other commonsense tasks, time representation and reasoning is not a trivial undertaking. This probably explains why time has either been ignored or implicitly represented and used in the majority of diagnostic systems, medical or otherwise. Durations, temporal uncertainty and multiple temporal granularities are necessary requirements for medical problem-solving. Most general theories of time proposed in the literature do not address all these requirements, and some do not address any. The paper discusses time representation and reasoning in medical diagnostic problem-solving, building from a generic temporal ontology which covers the above temporal requirements. Much of what is discussed, however, is applicable to non-medical domains as well. It is argued that the diagnostic concepts (patient data, disorders, therapeutic-actions) are naturally modelled as time-objects. The resulting representation treats time as an integral dimension to these concepts, with special status. Time-object-based representations for generic hypotheses (disorders, actions) are discussed and illustrated; in the case of disorders the representation covers both an associational model and a causal-associational model. A central function of diagnostic problem-solving is deciding the compatibility of hypotheses with regard to a patient model. In this respect the paper discusses temporal and contextual screening of triggered hypotheses as well as accountings and conflicts between time-objects.

Artificial Intelligence↗

Acute type-A dissection of the aorta: which diagnostic modes remain for surgical indication?

The natural course of acute type-A dissection of the aorta (AADA) implies a mortality of 50% within the initial 2 days. Preoperative diagnostic tests have to be expeditious while avoiding hypertension and direct manipulation of the aneurysm to prevent aortic rupture. Since 1979, 51 patients have been operated upon for AADA. The diagnosis was established by one or more of the following methods: transthoracic echocardiography (TTE); transesophageal echocardiography (TEE); conventional angiography (CA); intravenous digital subtraction angiography (DSA); and computed tomography with bolus injection of contrast medium (CT). TTE (n = 26) showed a dissection in 72%, suggested an intimal flap in 25%, and missed the diagnosis in 1 case. CT (n = 15) and DSA (n = 10) failed to indicate dissection in 1 case each. CA (n = 27) demonstrated dissection in every case but was the most time-consuming and stressful method. Since the introduction of combined transthoracic and transesophageal echocardiography, no other diagnostic methods have been used. On the basis of this experience, we propose the following diagnostic plan: 1. in AADA, the demonstration of an intimal flap in the ascending aorta by TTE/TEE is an indication for immediate surgery without further diagnostic measures (10 patients: no false-positive findings); 2. if a dissection is suggested by TTE/TEE, then DSA is performed if the supra-aortic branches are suspected to be compromised; CT is preferred if an extrapericardial aortic rupture is suspected; 3. the time-consuming and stressful diagnostic approach of conventional angiography is no longer indicated.

Acute Disease↗

Differences in diagnostic value of four electrocardiographic voltage criteria for hypertrophic cardiomyopathy in a genotyped population.

The diagnostic value of various classic electrocardiographic (ECG) voltage criteria for hypertrophic cardiomyopathy (HC) has not been established in a genotyped population. This study aimed to determine the most accurate diagnostic definition of classic ECG voltage criteria for detecting carriers of HC. ECG and echocardiographic findings were analyzed in 161 genotyped subjects (97 genetically affected, 64 unaffected) from 20 families with disease-causing mutations in 4 genes. The diagnostic value of 4 voltage criteria (Cornell, Sokolow-Lyon, Romhilt-Estes, and 12-lead QRS voltage) for detecting carriers of HC was investigated. In all subjects, the Romhilt-Estes (point score > or =4) criterion and 12-lead QRS voltage (> or =240 mm) were most sensitive (37% and 36%, respectively), with high specificity (95% each), resulting in the greatest accuracy (60% and 59%, respectively). Using these criteria, in subjects without echocardiographic evidence of left ventricular hypertrophy, voltage abnormalities were found in 22.6% of carriers and 4.7% of noncarriers (p <0.01). In conclusion, these findings suggest that the Romhilt-Estes and the 12-lead QRS voltage criteria may be the most accurate diagnostic definitions for HC on the basis of molecular genetic diagnoses. Furthermore, this study demonstrated that voltage abnormalities may be found in prehypertrophic carriers. Even when genetic testing becomes widely available, it will be difficult to make genetic diagnoses in all patients with HC because of its genetic heterogeneity. Therefore, understanding the diagnostic value of classic ECG voltage criteria may be important in detecting carriers, including those without left ventricular hypertrophy.

Adult↗

The belly-off sign: a new clinical diagnostic sign for subscapularis lesions.

PURPOSE: We describe a new clinical sign for subscapularis lesions that we call the belly-off sign and compare its diagnostic value with standard subscapularis tests (the lift-off test, internal rotation lag sign, and belly-press test/Napoleon sign) in cases of different types of subscapularis lesions. The belly-off sign represents the inability of the patient to maintain the palm of the hand attached to the abdomen with the arm passively brought into flexion and internal rotation. TYPE OF STUDY: Case series. METHODS: This descriptive and explorative study included 60 patients (mean age, 55.3 years) with clinical, surgical, and/or magnetic resonance imaging-confirmed evidence of isolated or combined lesions of the subscapularis musculotendinous unit. In all patients, a complete physical shoulder examination was performed and the results were compared with the intraoperative and magnetic resonance imaging findings. RESULTS: The belly-off sign appeared to be more reliable than any other diagnostic test or sign in detecting isolated partial tears of the subscapularis tendon (group I), combined partial subscapularis and complete supraspinatus tendon tears (group II), and postoperative subscapularis insufficiency with mild atrophy of the upper aspect of the subscapularis muscle (group VII). In cases of complete/near complete subscapularis tears with or without supraspinatus and infraspinatus tendon tears (groups IV, V, and VI), the belly-off sign appeared to be as reliable as the belly-press test, internal rotation lag sign, and lift-off test. For assessing partial subscapularis tendon tears and insufficient external rotators (group III), the belly-off sign was less reliable than any other diagnostic test or sign. CONCLUSIONS: The belly-off sign represents a promising new clinical diagnostic sign for subscapularis lesions. In particular, subtle lesions of the upper subscapularis tendon and postoperative subscapularis insufficiencies can be detected by the belly-off sign in cases of intact external rotators. In cases of an advanced lack of external rotators, the belly-off sign becomes negative and loses its diagnostic value. We therefore conclude that the belly-off sign is attributable to an unbalanced transverse force couple with overwhelming of the external rotators of the shoulder. LEVEL OF EVIDENCE: Level IV, case series with no, or historical, control group.

Adult↗

Improving the diagnostic criteria and procedures for chronic fatigue syndrome.

Since the publication of the case definition for chronic fatigue syndrome (CFS) in 1988 the diagnostic criteria have been revised twice in the U.S. None of the case definitions were derived empirically. As a result, there is concern regarding the sensitivity, specificity, and reliability of the criteria. The goal of the present study was to identify methods for improving the diagnostic criteria for CFS. Three groups of 15 participants each were recruited: participants with (1) CFS, (2) major depressive disorder (MDD), and (3) healthy controls. Using statistical procedures, three methods for improving the diagnostic criteria were explored: identification of new diagnostic symptoms, the use of severity ratings for symptomatology, and the identification of standardized measures that differentiate cases of CFS from other conditions. Results of the present study suggest that these three methods hold promise for improving the sensitivity, specificity, and reliability of the diagnostic criteria for CFS.

Adult↗

Electrochemical biosensors: towards point-of-care cancer diagnostics.

Wide-scale point-of-care diagnostic systems hold great promise for early detection of cancer at a curable stage of the disease. This review discusses the prospects and challenges of electrochemical biosensors for next-generation cancer diagnostics. Electrochemical biosensors have played an important significant role in the transition towards point-of-care diagnostic devices. Such electrical devices are extremely useful for delivering the diagnostic information in a fast, simple, and low cost fashion in connection to compact (hand-held) analyzers. Modern electrochemical bioaffinity sensors, such as DNA- or immunosensors, offer remarkable sensitivity essential for early cancer detection. The coupling of electrochemical devices with nanoscale materials offers a unique multiplexing capability for simultaneous measurements of multiple cancer markers. The attractive properties of electrochemical devices are extremely promising for improving the efficiency of cancer diagnostics and therapy monitoring. With further development and resources, such portable devices are expected to speed up the diagnosis of cancer, making analytical results available at patient bedside or physician office within few minutes.

Biomarkers, Tumor↗

The diagnostic impact of contrast-enhanced MRI in management of breast disease.

For effective use, the diagnostic impact of contrast-enhanced breast MRI (CE MRI) needs to be quantified. This is a retrospective study of 441 women who have undergone CE MRI of the breast from 1 July 1997 to 25 March 2002. Indications for CE MRI studies were diagnostic in 176, monitoring chemotherapy in 126 and study of MRI screening for breast cancer (MARIBS) cases in 139. CE MRI results were confusing or incorrect in 6% of the diagnostic group, 13% of the chemotherapy group and 9% of the MARIBS group. In 18 of 38 of these cases CE MRI stimulated further tests to clarify a clinical query. CE MRI resulted in an increase in confidence or change in clinical plan in 46% of the diagnostic group, 72% of the chemotherapy group and 80% of the MARIBS group. In 44 of 283 of these, CE MRI caused a beneficial change in the clinical plan based on conventional radiology. CE MRI results in a positive diagnostic impact above conventional imaging in a clinically important proportion of patients, but gives some false calls in a smaller proportion (8.6%).

Adult↗

Sensitivity, specificity and other diagnostic measures with multiple sites per unit.

Medical researchers often study the performance of diagnostic tools. The performance of the diagnostic tool is evaluated by calculating sensitivity, specificity and similar measures. Sensitivity is defined as the probability of a positive diagnostic test in a patient with the illness or injury for which the test serves as a diagnostic tool. Specificity is the probability of a negative diagnostic test in a patient free of the disease or injury. For some conditions, the test is applied to several anatomic locations or at different times in a patient and each test can be positive or negative. The findings of the tests performed on the same patient are correlated and any summary measure should account for this correlation. We propose a summary measure for the subject that combines the results from all tests performed on the same patient while accounting for the correlation. The measure is easily calculated and requires no specific statistical software. We also provide an estimate of the standard error and confidence intervals. The method is illustrated with a study, conducted at the University of California, Davis School of Medicine, of the sensitivity of magnetic resonance (MR) imaging and plain film (PF) radiography in detecting injuries in the cervical spine, such as fractures and soft tissue injuries.

California↗

Diagnostic and prognostic role of cardiac troponin I (cTnI) measured on the DPC Immulite.

OBJECTIVE: To evaluate the diagnostic and prognostic role of the Immulite cTnI assay for the detection of acute coronary syndromes (ACS). POPULATION: 150 males and 63 females with a median age of 63 years, range 28 to 88, and an interquartile range of 18 years were admitted within 24 h of chest pain and non-ST segment elevation ACS were studied. The median onset of symptoms was 3 h (range 0-23). METHODS: Venous samples were taken on admission (t = 0) and at 24 h (t = 24). The serum samples were assayed for CK, CK-MB and cTnT on an Elecsys 1010 (Roche Diagnostics, Lewes, UK). The cTnT assay CV was 5.5% at 0.32 microg/l and 5.4% at 6.0 microg/l, and the detection limit was 0.01 microg/l with an upper limit of 25 microg/l. For cTnI using the Immulite (DPC, Gwynedd, Wales), the detection limit was 0.1 microg/l, and the upper limit was 180 microg/l. Final diagnostic categorization was performed by both WHO and European Society of Cardiology criteria using cTnT as the diagnostic cardiac biomarker. Patients were followed for the major adverse cardiac events (MACE), endpoints cardiac death, AMI or need for urgent revascularization. ROC curves were constructed using final diagnosis. Outcome prediction was assessed by ROC curves and Kaplan-Meier survival curves. RESULTS: Both methods had equivalent diagnostic efficiency using WHO criteria for AMI. When ESC criteria were used the AUC for admission and 24 h cTnT and cTnI values were 0.945 vs. 0.910, P = 0.20 and 0.998 vs. 0.937, P = 0.005, respectively. Both methods predicted outcome as either death or MI or MACE and were not significantly different. CONCLUSION: The Immulite cTnI assay can be used for diagnosis and risk stratification in patients admitted with non-ST segment elevation acute coronary syndromes.

Adult↗

Diagnostic accuracy of fracture detection in suspected non-accidental injury: the effect of edge enhancement and digital display on observer performance.

AIM: To compare the effect of varying degrees of edge enhancement and method of digital image display on fracture detection in suspected non-accidental injury (NAI). MATERIALS AND METHODS: Fifty radiographs from post-mortem skeletal surveys in 13 children with suspected NAI were selected. Images were obtained using a Fuji 5000R computed radiography system. Hard copies were printed with edge enhancement factors 0, 0.5 and 1.2. Images (edge enhancement 0.5) were also displayed on a 1K(2) monitor. Six observers independently evaluated all 200 images for the presence of abnormality. Observers also scored each image for visualization of soft tissues, visualization of trabecular markings and overall image quality. The paired Student's t-test and location receiver operating curve (ROC) analysis were used to compare quality scores and diagnostic accuracy of each display method. Individual and pooled true-positive rates (sensitivity) were determined. For the purposes of ROC analysis, histology was taken as the gold standard. RESULTS: There was no difference in duration of hard and soft-copy reading sessions (p=0.76). After image manipulation soft-copy radiographs scored significantly better for image quality than hard copy (p<0.0001). Pooled observer sensitivity (at a specificity of 90%) was below 50% for all display methods. Diagnostic accuracy varied significantly between observers. Diagnostic accuracy of individual observers was not affected by display method. CONCLUSION: In suspected NAI, diagnostic accuracy of fracture detection is generally low. Diagnostic accuracy appears to be affected more by observer-related factors than by the method of digital image display.

Child Abuse↗

Diagnosis of angiomyolipoma using computed tomography-region of interest < or =-10 HU or 4 adjacent pixels < or =-10 HU are recommended as the diagnostic thresholds.

AIM: To study and compare the diagnostic accuracy of region of interest (ROI) density measurement and pixel mapping [computed tomography (CT) density of individual pixels] for the diagnosis of renal angiomyolipoma (AML) using CT. MATERIALS AND METHODS: A study group of histologically proven AMLs was compared with a control group of histologically proven renal cell cancers, normal renal parenchyma, and simple renal cysts. The mean tissue density (ROI circle) and a pixel density map were recorded. The diagnostic accuracy of various thresholds of ROI and pixel mapping values were compared using receiver operating characteristic curves. RESULTS: Twenty-two AMLs, 16 renal cell carcinomas (RCCs), 30 simple cysts, and 30 sites of renal parenchyma were evaluated. The mean (+/-1 SD) density of the AMLs was significantly lower [-15.2(20.8) units] than the three control groups [+36.0(8.1) units, +5.4(3.4) units and +22.2(46.5) units for RCC, renal cyst and parenchyma respectively; p < 0.001 (analysis of variance)]. The sensitivities and specificities of the ROI diagnostic thresholds of < or =0 units, < or =-10 units and < or =-20 units were 77 and 97%, 73 and 100% and 50 and 100%, respectively. Using pixel mapping [diagnostic thresholds of either a line of 4 pixels < or =-10 units or a square of 4 pixels < or =-10 units] the sensitivity improves to 86% with a specificity of 97%. CONCLUSION: Although a ROI threshold value of < or =-10 units has a very high specificity (100% in the present study) the sensitivity is modest at only 73%. Pixel mapping is more sensitive for recognizing small clusters of fat. In practice, both methods can be recommended for the analysis of suspected AMLs. ROI density measurement is convenient when analysing large areas of suspected fat and < or =-10 units should be used as the diagnostic threshold. When faced with small lucent areas or indeterminate values after ROI analysis, pixel mapping is recommended using a line of 4 pixels < or =-10 units or a square of 4 pixels < or =-10 units as the discriminating thresholds.

Adult↗

Evaluation of three Aspergillus antibody assays for screening of chronic pulmonary aspergillosis: prospective diagnostic accuracy study.

OBJECTIVES: Chronic pulmonary aspergillosis (CPA) is a frequent complication of pulmonary tuberculosis (PTB), particularly in high-burden settings where access to reliable serological diagnostics remains limited. We evaluated the diagnostic performance of two immunochromatographic technology (ICT) lateral flow assays (LFAs) and an ELISA for CPA screening among patients with active or previously treated PTB. METHODS: In this two-year prospective multicentre diagnostic evaluation, serum from adults with prior or active PTB was tested using the Era Biology Aspergillus IgG ICT LFA, LDBio Aspergillus IgG/IgM ICT LFA, and Bordier Aspergillus fumigatus IgG ELISA. CPA diagnosis was established using a consensus composite reference standard incorporating clinical, immunological, radiological, and microbiological criteria. The Bordier ELISA was used as part of the immunological component of the consensus CPA diagnosis, with a cutoff optical density of &#x2265;1.0. Diagnostic accuracy, agreement statistics, receiver operating characteristic analysis, and latent class analysis (LCA) were performed. RESULTS: Among 340 participants, 24 (7.06%) had CPA. Proportion of participants with positive antibody tests among all tested individuals were 6.76% for LDBio ICT LFA, 20.0% for Era Biology ICT LFA, and 11.47% for Bordier ELISA. Against consensus CPA diagnosis, Bordier ELISA showed 87.50% sensitivity and 94.30% specificity, LDBio ICT LFA 58.33% sensitivity and 97.15% specificity, and Era Biology LFA 66.67% sensitivity and 83.54% specificity. LCA estimated CPA prevalence at 7.72%. LCA-derived sensitivities and specificities were 86.58% and 99.92% for LDBio ICT LFA, 83.39% and 85.31% for Era Biology LFA, and 79.10% and 94.19% for Bordier ELISA. CONCLUSIONS: The Bordier ELISA showed high sensitivity and specificity, while the LDBio ICT LFA demonstrated very high specificity with strong LCA-derived performance. These findings support the use of ELISA for laboratory diagnosis and ICT as a point-of-care screening tool for CPA in resource-limited settings. Era Biology Aspergillus IgG LFA demonstrated moderate sensitivity and acceptable diagnostic performance, indicating its potential utility as a supplementary screening assay for CPA in settings where rapid, point-of-care testing is required.

Humans↗

Cost-effectiveness of different diagnostic strategies to assess gastro-oesophageal reflux disease in patients with unexplained chronic persistent cough in Italy.

BACKGROUND: Chronic persistent cough is a common and disabling disorder and gastro-oesophageal reflux disease is considered to be the third leading cause, after asthma and postnasal drip. Therefore, patients with unexplained chronic persistent cough usually undergo a stepwise evaluation to establish the existence of a reflux disease. AIM: To identify the most cost-effective diagnostic approach to assess gastro-oesophageal reflux disease in patients with unexplained chronic persistent cough. METHODS: Direct and indirect costs associated with six diagnostic strategies using 24-h oesophageal pH-metry, oesophago-gastroduodenoscopy and the proton pump inhibitors test in different sequences, were evaluated using a decision tree model. If the first test was positive, the diagnostic work-up was stopped, if negative the patient proceeded to the second test, and so on. Clinical data from an observational prospective trial conducted in 51 patients with unexplained chronic persistent cough were used in the economic model. RESULTS: All six strategies had the same clinical effectiveness (78.4%). The diagnostic work-up with the lowest cost was the proton pump inhibitors test followed by pH-metry and then oesophago-gastroduodenoscopy with a total cost of euro 211.08 (direct euro 142.93, indirect euro 68.15). CONCLUSIONS: This study shows that the lowest cost is the strategy where proton pump inhibitors test is performed as first investigation. Implementation of this diagnostic work-up may lead to cost savings in the management of patients with chronic persistent cough.

Chronic Disease↗