scholarly journals Challenges in diagnostic accuracy studies in primary care: the fecal calprotectin example

2013 ◽  
Vol 14 (1) ◽  
Author(s):  
Gea A Holtman ◽  
Leeuwen Yvonne Lisman-van ◽  
Boudewijn J Kollen ◽  
Johanna C Escher ◽  
Angelika Kindermann ◽  
...  
2012 ◽  
Vol 58 (6) ◽  
pp. 989-998 ◽  
Author(s):  
Liselotte Kok ◽  
Sjoerd G Elias ◽  
Ben J M Witteman ◽  
Jelle G Goedhard ◽  
Jean W M Muris ◽  
...  

Abstract BACKGROUND Fecal biomarker tests that differentiate between organic bowel disease (OBD) and non-OBD in primary care patients with persistent lower-abdomen complaints could reduce the number of unnecessary referrals for endoscopy. We quantified the accuracy of fecal calprotectin and immunochemical occult blood (iFOBT) point-of-care (POC) tests and a calprotectin ELISA in primary care patients with suspected OBD. METHODS We performed biomarker tests on fecal samples from 386 patients with lower-abdomen complaints suggestive for OBD. Endoscopic and histological diagnosis served as reference. RESULTS OBD was diagnosed in 99 patients (prevalence 25.9%); 19 had adenocarcinoma, 53 adenoma, and 27 inflammatory bowel disease. Sensitivity for OBD was 0.64 (95% CI 0.54–0.72) for calprotectin POC, 0.56 (0.46–0.66) for iFOBT POC, and 0.74 (0.65–0.82) for calprotectin ELISA; specificities were 0.53 (0.48–0.59), 0.83 (0.78–0.87), and 0.47 (0.41–0.53), respectively. Negative predictive values (NPVs) were 0.81 (0.74–0.86), 0.85 (0.80–0.88), and 0.84 (0.78–0.89); positive predictive values (PPVs) varied from 0.32 (0.26–0.39) and 0.33 (0.27–0.39) (calprotectin tests) to 0.53 (0.44–0.63) (iFOBT POC). Combining the 2 POC tests improved sensitivity [0.79 (0.69–0.86)] and NPV [0.87 (0.81–0.91)] but lowered specificity [0.49 (0.44–0.55)] and PPV [0.35 (0.29–0.42)]. When adenomas ≤1 cm were considered non-OBD, the NPV of all tests improved to >0.90 [combined POC tests, 0.97 (0.93–0.99)]. CONCLUSIONS Diagnostic accuracy of the tests alone or combined was insufficient when all adenomas were considered OBD. When only adenomas >1 cm were considered OBD, all tests could rule out OBD to a reasonable extent, particularly the combined POC tests. The tests were less useful for inclusion of OBD.


2021 ◽  
pp. 1-11
Author(s):  
Bing-Jie Xiang ◽  
Min Jiang ◽  
Ming-Jun Sun ◽  
Cong Dai

<b><i>Objective:</i></b> Fecal calprotectin (FC) is a promising marker for assessment of inflammatory bowel disease (IBD) activity. However, the utility of FC for predicting mucosal healing (MH) of IBD patients has yet to be clearly demonstrated. The objective of our study was to perform a meta-analysis evaluating the diagnostic accuracy of FC in predicting MH of IBD patients. <b><i>Methods:</i></b> We systematically searched the databases for studies from inception to April 2020 that evaluated MH in IBD. The methodological quality of each study was assessed according to the Quality Assessment of Diagnostic Accuracy Studies checklist. The extracted data were pooled using a summary receiver operating characteristic curve model. Random-effects model was used to summarize the diagnostic odds ratio, sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio. <b><i>Results:</i></b> Sixteen studies comprising 1,682 ulcerative colitis (UC) patients and 4 studies comprising 221 Crohn’s disease (CD) patients were included. The best performance of FC for predicting MH in UC was at cut-off range of 60–75 μg/g with area under the curve (AUC) of 0.88 and pooled sensitivity and specificity of 0.87 and 0.79, respectively. The pooled sensitivity and specificity values of cutoff range 180–250 μg/g for predicting MH in CD were 0.67 and 0.76, respectively. The AUC of 0.79 also revealed improved discrimination for identifying MH in CD with FC concentration. <b><i>Conclusion:</i></b> Our meta-analysis has found that FC is a simple, reliable noninvasive marker for predicting MH in IBD patients. FC cutoff range 60–75 μg/g appears to have the best overall accuracy in UC patients.


2014 ◽  
Vol 12 (4) ◽  
pp. 404-412 ◽  
Author(s):  
Montserrat Llordés ◽  
Angeles Jaén ◽  
Pere Almagro ◽  
Josep Luis Heredia ◽  
Josep Morera ◽  
...  

2018 ◽  
Vol 72 (11) ◽  
pp. e13253
Author(s):  
Ángel Herráiz-Adillo ◽  
Olga Piñar-Serrano ◽  
Julián Ángel Mariana-Herráiz ◽  
Vicente Martínez-Vizcaíno ◽  
Diana Patricia Pozuelo-Carrascosa ◽  
...  

2020 ◽  
Vol 134 (9) ◽  
pp. 764-768
Author(s):  
T Ito ◽  
S Matsuyama ◽  
T Shiozaki ◽  
D Nishikawa ◽  
H Akioka ◽  
...  

AbstractObjectiveVertigo and dizziness are frequent symptoms in patients at out-patient services. An accurate diagnosis for vertigo or dizziness is essential for symptom relief; however, it is often challenging. This study aimed to identify differences in diagnoses between primary-care physicians and specialised neurotologists.MethodIn total, 217 patients were enrolled. To compare diagnoses, data was collected from the reference letters of primary-care physicians, medical questionnaires completed by patients and medical records.ResultsIn total, 62.2 per cent and 29.5 per cent of the patients were referred by otorhinolaryngologists and internists, respectively. The cause of vertigo or dizziness and diagnosis was missing in 47.0 per cent of the reference letters. In addition, 67.3 per cent of the diagnoses by previous physicians differed from those reported by specialised neurotologists.ConclusionTo ensure patient satisfaction and high quality of life, an accurate diagnosis for vertigo or dizziness is required; therefore, methods or materials to improve the diagnostic accuracy are needed.


2018 ◽  
Vol 23 (suppl_1) ◽  
pp. e37-e37
Author(s):  
Vinusha Gunaseelan ◽  
Patricia Parkin ◽  
Imaan Bayoumi ◽  
Patricia Jiang ◽  
Alexandra Medline ◽  
...  

Abstract BACKGROUND The Canadian Paediatric Society (CPS) recommends that every Canadian physician caring for young children provide an enhanced 18-month well-baby visit including the use of a developmental screening tool, such as the Nipissing District Developmental Screen (NDDS). The Province of Ontario implemented an enhanced 18-month well-baby visit specifically emphasizing the NDDS, which is now widely used in Ontario primary care. However, the diagnostic accuracy of the NDDS in identifying early developmental delays in real-world clinical settings is unknown. OBJECTIVES To assess the predictive validity of the NDDS in primary care for identifying developmental delay and prompting a specialist referral at the 18-month health supervision visit. DESIGN/METHODS This was a prospective longitudinal cohort study enrolling healthy children from primary care practices. Parents completed the 18-month NDDS during their child’s scheduled health supervision visit between January 2012 and February 2015. Using a standardized data collection form, research personnel abstracted data from the child’s health records regarding the child’s developmental outcomes following the 18-month assessment. Data collected included confirmed diagnoses of a development delay, specialist referrals, family history, and interventions. Research personnel were blind to the results of the NDDS. We assessed the diagnostic test properties of the NDDS with a confirmed diagnosis of developmental delay as the criterion measure. The specificity, sensitivity, positive predictive value, and negative predictive value were calculated, with 95% confidence intervals. RESULTS We included 255 children with a mean age of 18.5 months (range, 17.5–20.6) and 139 (55%) were male. 102 (40%) screened positive (1+ flag result on their NDDS). A total of 48 (19%) children were referred, and 23 (9%) had a confirmed diagnosis of a developmental delay (speech and language: 14; gross motor: 4; autism spectrum disorder: 3; global developmental delay: 1; developmental delay: 1). The sensitivity was 74% (95% CI: 52–90%), specificity was 63% (95% CI: 57–70%), positive predictive value was 17% (95% CI:10–25%), and the negative predictive value was 96% (95% CI: 92–99%). CONCLUSION For developmental screening tools, sensitivity between 70%-80% and specificity of 80% have been suggested. The NDDS has moderate sensitivity and specificity in identifying developmental delay at the 18-month health supervision visit. The 1+NDDS flag cut-point may lead to overdiagnosis with more children with typical development being referred, leading to longer wait times for specialist referrals among children in need. Future work includes investigating the diagnostic accuracy of combining the NDDS with other screening tools.


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