Methods: A multi-center cross sectional study was conducted for a month in out-patient wards of hospitals in Khobar, Dammam, Makkah, and Madinah, Saudi Arabia. Patients were randomly selected from a registered patient pools at hospitals and the item-subject ratio was kept at 1:20. The tool was assessed for factorial, construct, convergent, known group and predictive validities as well as, reliability and internal consistency of scale were also evaluated. Sensitivity, specificity, and accuracy were also evaluated. Data were analyzed using SPSS v24 and MedCalc v19.2. The study was approved by concerned ethics committees (IRB-129-25/6/1439) and (IRB-2019-05-002).
Results: A total of 282 responses were received. The values for normed fit index (NFI), comparative fit index (CFI), Tucker Lewis index (TLI) and incremental fit index (IFI) were 0.960, 0.979, 0.954 and 0.980. All values were >0.95. The value for root mean square error of approximation (RMSEA) was 0.059, i.e., <0.06. Hence, factorial validity was established. The average factor loading of the scale was 0.725, i.e., >0.7, that established convergent validity. Known group validity was established by obtaining significant p-value <0.05, for the associations based on hypotheses. Cronbach's α was 0.865, i.e., >0.7. Predictive validity was established by evaluating odds ratios (OR) of demographic factors with adherence score using logistic regression. Sensitivity was 78.16%, specificity was 76.85% and, accuracy of the tool was 77.66%, i.e., >70%.
Conclusion: The Arabic version of GMAS achieved all required statistical parameters and was validated in Saudi patients with chronic diseases.
OBJECTIVES: In this study, we aimed to assess the incremental value of V/Q SPECT/CT over conventional V/Q planar scintigraphy and V/Q SPECT, and to determine if Q only-SPECT/CT without the conventional ventilation component could replace the current imaging protocol in diagnosing pulmonary embolism.
METHODS: We retrospectively assessed 73 patients with suspicion of pulmonary embolism who had undergone/Q planar scintigraphy, V/Q SPECT and V/Q SPECT/CT consecutively. Combination of clinical follow-up, laboratory test results and correlative imaging were used as reference standard. Q-only SPECT/CT datasets were then analysed separately without the V-planar, V-SPECT and V-SPECT/CT datasets.
RESULTS: A total of 66 patients fulfilled our initial inclusion and exclusion criteria, with 23 patients as positive for PE and 43 patients ruled out of having PE based on the reference standard. Sensitivity and specificity for V/P planar scintigraphy, V/Q SPECT, and V/Q SPECT-CT were 86.9% and 39.5%, 91.3% and 55.8%, and 100% and 97.6% respectively. Overall, SPECT/CT resulted in significantly higher diagnostic accuracy than planar and SPECT imaging respectively (p<0.05). Q-only SPECT/CT significantly over diagnosed pulmonary embolism in 12 patients (p<0.05).
CONCLUSION: Adding V/Q SPECT/CT to the algorithm of PE significantly improves the sensitivity and specificity. However, by eliminating the ventilation component, the diagnostic accuracy is significantly reduced.
Materials and Methods: Routinely taken lateral cephalograms from 408 subjects aged 10 to 18 years were evaluated retrospectively using the CVM stages described by Baccetti et al. Descriptive statistics, accuracy, sensitivity, specificity, positive and negative predictive values, and likelihood ratios were calculated for stages 2, 3, and 4 of CVM.
Results: Real age increased as the CVM stage gradually increased. The results of 2×2 contingency tables showed that CVM stage 4 produced an accuracy of 71% and 73%, a false positive rate of 7% and 18%, and a post-test probability of 59% and 68% for boys and girls, respectively.
Conclusion: Based on these findings, it can be concluded that the stages of CVM are of limited use for predicting the attainment of the legal age threshold of 14 years. Future studies should investigate whether combinations of skeletal and dental methods could achieve better accuracy and post-test probability.
METHODS: In this prospective study, thyroid nodules were characterized by using the four TI-RADS systems and US-guided FNAC was done for nodule with the highest ACR TI-RADS score. Correlation between TI-RADS and FNAC results were analyzed.
RESULTS: Out of 244 thyroid nodules, 100 nodules with either size <1 cm (43 nodules) non-diagnostic or inconclusive FNAC results (57 nodules) were excluded. Seven nodules (4.9%) were confirmed to be malignant on FNAC. K TI-RADS showed 100% sensitivity and NPV but the lowest specificity (40.2%). EU TI-RADS had the highest specificity (83.2%) but the lowest sensitivity (57.1%) and NPV (97.4%). ACR TI-RADS had an average sensitivity (85.7%) and NPV (98.6%). The specificity of ACR TI-RADS (51.1%) was lower than EU TI-RADS but higher than K TI-RADS. AI TI-RADS showed higher specificity (61.8% vs 51.1%, p
MATERIALS AND METHODS: A retrospective study was carried out on 318 subjects with hypochromic anaemia, which comprised 162 IDA and 156 thalassaemia trait subjects with α-thalassemia, β-thalassemia and HbE trait. Optimal cut-off value, sensitivity and specificity of M/H ratio for thalassaemia trait discrimination was determined using Receiver Operating Characteristic (ROC) analysis.
RESULTS: Subjects with thalassaemia trait showed higher MicroR compared to IDA ( p< 0.001) while subjects with IDA demonstrated higher Hypo-He than thalassaemia trait (p < 0.001). M/H ratio was significantly higher in thalassaemia trait compared to IDA, with medians of 3.77 (interquartile range: 2.57 - 6.52) and 1.73 (interquartile range: 1.27 - 2.38), respectively (p < 0.001). M/H ratio ≥ 2.25 was the optimal cut-off value for discriminating thalassaemia trait from IDA in hypochromic anaemia, with the area under ROC curve (AUC) of 0.83, sensitivity of 80.8% and specificity of 71.6%.
CONCLUSIONS: M/H ratio is a useful discriminant index to distinguish thalassaemia trait from IDA in hypochromic anaemia prior to diagnostic analysis for thalassaemia confirmation. High M/H ratio is suggestive of thalassaemia trait than of IDA. However, more studies are required to establish the role of M/H ratio as a screening tool for thalassaemia discrimination in hypochromic anaemia.
METHODS: The concordance rate, sensitivity and specificity of the duplex ddPCR assay were determined and compared to nested PCR and duplex qPCR.
RESULTS: The duplex ddPCR assay had higher analytical sensitivity (P. vivax = 10 copies/µL and P. knowlesi = 0.01 copies/µL) compared to qPCR (P. vivax = 100 copies/µL and P. knowlesi = 10 copies/µL). Moreover, the ddPCR assay had acceptable clinical sensitivity (P. vivax = 80% and P. knowlesi = 90%) and clinical specificity (P. vivax = 87.84% and P. knowlesi = 81.08%) when compared to nested PCR. Both ddPCR and qPCR detected more double infections in the samples.
CONCLUSIONS: Overall, the ddPCR assay demonstrated acceptable efficiency in detection of P. knowlesi and P. vivax, and was more sensitive than nested PCR in detecting mixed infections. However, the duplex ddPCR assay still needs optimization to improve the assay's clinical sensitivity and specificity.
AIM: The objective of this study was to compare the diagnostic accuracy of mRDT CareStatTM with microscopy.
SETTING: This study was conducted in the paediatric primary care clinic of the Federal Medical Centre, Asaba, Nigeria.
METHODS: A cross-sectional study for diagnostic accuracy was conducted from May 2016 to October 2016. Ninety-eight participants were involved to obtain a precision of 5%, sensitivity of mRDT CareStatTM of 95% from published work and 95% level of confidence after adjusting for 20% non-response rate or missing data. Consecutive participants were tested using both microscopy and mRDT. The results were analysed using EPI Info Version 7.
RESULTS: A total of 98 children aged 3-59 months were enrolled. Malaria prevalence was found to be 53% (95% confidence interval [CI] = 46% - 60%), whilst sensitivity and specificity were 29% (95% CI = 20% - 38%) and 89% (95% CI = 83% - 95%), respectively. The positive and negative predictive values were 75% (95% CI = 66.4% - 83.6%) and 53% (95% CI = 46% - 60%), respectively.
CONCLUSION: Agreement between malaria parasitaemia using microscopy and mRDT positivity increased with increase in the parasite density. The mRDT might be negative when malaria parasite density using microscopy is low.
OBJECTIVE: The present study aimed to measure the agreement between BAT and immunoassay in diagnosis of penicillin allergy.
METHOD: BAT was performed using penicillin G (Pen G), penicillin V (Pen V), penicilloyl-polylysine (PPL), minor determinant mix (MDM), amoxicillin (Amx) and ampicillin (Amp) in 25 patients. Immunoassay of total IgE (tIgE) and specific IgE (sIgE) antibodies to Pen G, Pen V, Amx and Amp were quantified. Skin prick test (SPT) using PPL-MDM, Amx, Amp and Clavulanic acid were also performed.
RESULTS: Minimal agreement was observed between BAT and immunoassay (k=0.25). Of two BAT-positive patients, one patient is positive to Amx (59.27%, SI=59) and Amp (82.32%, SI=82) but sIgE-negative to all drug tested. This patient is also SPT-positive to both drugs. Another patient is BAT-positive to Pen G (10.18%, SI=40), Pen V (25.07%, SI=100) and Amp (19.52%, SI=79). In sIgE immunoassay, four patients were sIgE-positive to at least one of the drugs tested. The sIgE level of three patients was between low and moderate and they were BAT-negative. One BAT-positive patient had a high level of sIgE antibodies (3.50-17.5kU/L) along with relatively high specific to total IgE ratio ≥0.002 (0.004-0.007).
CONCLUSIONS: The agreement between BAT and immunoassay is minimal. Performing both tests provides little increase in the sensitivity of allergy diagnosis work-up for immediate reactions to penicillin.
OBJECTIVES: The aim of this study was to cross-culturally adapt and validate the Malay MALMAS (M-MALMAS) in Malaysia.
METHODS: Adults with type 2 diabetes, who could understand Malay, were recruited between May 2016 and February 2017 from a primary care clinic in Kuala Lumpur, Malaysia. The M-MALMAS and the Malay version of the Morisky Medication Adherence Scale (MMAS-8) were administered at baseline to test for convergent validity. Four weeks later, the M-MALMAS was re-administered. Predictive validity of the M-MALMAS was assessed by correlating the medication adherence scores with levels of glycated haemoglobin (HbA1c).
RESULTS: In total, 100 of 104 people agreed to participate (response rate = 96.2%). The overall Cronbach's α and McDonald's Ω for the M-MALMAS was 0.654 and 0.676, respectively (mean = 0.665). At test-retest, no significant difference was found for all items. The median total score interquartile range (IQR) of the M-MALMAS was 7.0 (6.0-8.0) and this was significantly correlated to the median total score of the Malay MMAS-8 [median (IQR) = 7.0 (5.8-8.0), p
METHODS: We conducted an individual patient data meta-analysis. We fit bivariate random-effects models to assess diagnostic accuracy.
RESULTS: 16 742 participants (2097 major depression cases) from 54 studies were included. The correlation between PHQ-8 and PHQ-9 scores was 0.996 (95% confidence interval 0.996 to 0.996). The standard cutoff score of 10 for the PHQ-9 maximized sensitivity + specificity for the PHQ-8 among studies that used a semi-structured diagnostic interview reference standard (N = 27). At cutoff 10, the PHQ-8 was less sensitive by 0.02 (-0.06 to 0.00) and more specific by 0.01 (0.00 to 0.01) among those studies (N = 27), with similar results for studies that used other types of interviews (N = 27). For all 54 primary studies combined, across all cutoffs, the PHQ-8 was less sensitive than the PHQ-9 by 0.00 to 0.05 (0.03 at cutoff 10), and specificity was within 0.01 for all cutoffs (0.00 to 0.01).
CONCLUSIONS: PHQ-8 and PHQ-9 total scores were similar. Sensitivity may be minimally reduced with the PHQ-8, but specificity is similar.
OBJECTIVES: We evaluated the relative sensitivity for HPV detection of self-collection compared with practitioner-collected cervical specimens in the context of the Australian National Cervical Screening Program (NCSP).
STUDY DESIGN: 303 women aged ≥18 years attending a single tertiary referral centre took their own sample using a flocked-swab, and then had a practitioner-collected sample taken at colposcopy. All samples were tested at a single laboratory on the six PCR-based HPV assays which can be utilised in the NCSP; Roche cobas 4800 and cobas, Abbott RealTime, BD Onclarity, Cepheid Xpert, and Seegene Anyplex.
RESULTS: HPV16/18 results had high observed agreement between self- and practitioner-collected samples on all assays (range: 0.94-0.99), with good agreement for non-HPV16/18 oncogenic HPV types (range: 0.64-0.73).
CONCLUSIONS: Self-collection for HPV-based cervical screening shows good concordance and relative sensitivity when compared to practitionercollected samples across assays in the NCSP.