Colorectal Cancer Screening by Fecal Immunochemical Tests (FIT): Considerations on Sampling and Markers (Hb and Hb/Hp Complex) of Fecal Occult Blood (FOB).

BACKGROUND/AIM: Formal demonstration of the efficacy of colorectal cancer (CRC) screening by fecal immunochemical tests (FITs) in reducing CRC incidence and mortality is still missing. The aim of this study was to analyze the impact of sampling and FIT marker in the recently implemented CRC screening program in Finland. PATIENTS AND METHODS: Because only the index test [FIT hemoglobin (Hb)]-positive subjects are verified by the reference test (colonoscopy), the new screening program is subject to verification bias that precludes estimating the diagnostic accuracy (DA) indicators. A previously published study (5) with 100% biopsy verification of colonoscopy referral subjects (called validation cohort, n=300) was used to derive these missing DA estimates. Two points of concern were addressed: i) only one-day sample tested, and ii) only the Hb component (but not Hb/Hp complex) was analyzed by FIT. RESULTS: The estimated DA of one-sample testing for Hb in the screening setting had a very low sensitivity (SE) (12.5%; 95%CI=12.3-12.7) for adenomas, with AUC=0.560 (for CRC, AUC=0.950). Testing three samples for Hb improved SE to 19.4% (95%CI=19.1-19.7%) but had little effect on overall DA (AUC=0.590). For adenomas, one-sample testing for Hb and Hb/Hp complex provided higher SE than three-sample testing for Hb (SE 20.6%; 95%CI=20.3-21.0), and the best SE was reached when two samples were tested for Hb and Hb/Hp complex (SE 47.5%; 95%CI=46.9-48.1%) (AUC=0.730). CONCLUSION: The strategy of the current CRC screening could be significantly improved by testing two consecutive samples by Hb and Hb/Hp complex, instead of stand-alone Hb testing of one sample.

The Diagnostic Accuracy (DA) of ColonView Fecal Immunochemical Test (FIT) in Detecting Colorectal Adenoma (CRA) Can Be Improved by the Diagnostic Models (DM) that Include Triage and Risk Features of CRA.

BACKGROUND/AIM: This study assessed whether the diagnostic accuracy (DA) of ColonView (CV) fecal immunochemical test (FIT) in detecting colorectal adenoma (CRA) can be improved by the diagnostic models (DM) that include triage and risk features of CRA. PATIENTS AND METHODS: A total of 5,090 participants of colorectal neoplasia (CRN) screening were recruited prospectively between January 2014 and December 2016. The CRN cohort of 486 patients included 222 CRA patients and 264 non-CRA patients of whom three consecutive fecal samples were analyzed by two fecal occult blood (FOB) assays (CV FIT test, HemoccultSENSA test). Hierarchical multilevel logistic models were used to test the DA of CV test and DMs, visualised as hierarchical summary receiving operating characteristic (HSROC) curves. RESULTS: In conventional receiving operating characteristic (ROC) analysis, the area under the curve (AUC) values of the age, height, weight, and body mass index (BMI) were 0.60, 0.57, 0.54, and 0.51, respectively. The AUC values for different DMs ranged from 0.69 (for DM without triage I/II and SENSA), and the highest AUC value of 0.70 was reached for DM with all variables included. In HSROC analysis, the AUC values for i) lowR variables, ii) highR variables, and ii) DMs were as follows: i) AUC=0.506, ii) AUC=0.566 and iii) AUC=0.732. The differences in AUC values were: between i) and ii) p=0.008; between i) and iii) p<0.0001; between ii) and iii) p<0.0001. CONCLUSION: The results demonstrated that DMs, particularly those including risk factors, significantly improved the DA of the CV FIT test in detecting CRA compared to traditional low-risk (lowR) and high-risk (highR) features alone. This study provides novel evidence supporting the enhanced diagnostic performance of DMs in combination with CV FIT testing for the detection of CRA.

Triage Process at Endoscopy With ColonView Fecal Immunochemical Test (FIT) Will Enhance Diagnostic Accuracy (DA) of Colorectal Cancer Screening.

BACKGROUND/AIM: This study assessed the diagnostic accuracy (DA) of the predictive features of colorectal cancer (CRC, predictCRC), triage process (triage), and ColonView (CV) fecal immunochemical test (FIT) in a CRC screening setting. The diagnostic score models (DMs) including predictCRC with triage and CV test were also calculated. PATIENTS AND METHODS: The study cohort of 544 patients included 58 CRC patients and 486 non-CRC patients who submitted three consecutive fecal samples for analysis, by two fecal occult blood (FOB) assays (CV FIT test, HemoccultSENSA test). Hierarchical multilevel logistic models were used to test the DA (for CRC) of each item of predictCRC (with triage I and II) and DMs, visualized as hierarchical summary receiving operating characteristic (HSROC) curves. RESULTS: The DA of the predictCRC location of neoplasm (Loc), triage I, and triage II showed 49%, 41%, and 93% sensitivity (Se), and 70%, 99.5%, and 88% specificity (Sp), respectively. The PPV+ of triage I (92%) was higher than that of Loc (22%) or triage II test (45%). In the conventional receiver operating characteristic (ROC) analysis, the area under the curve (AUC) values for the different DMs ranged from 0.880 (for DM without triage I and II), whereas the highest AUC value of 0.960 was reached for DM with triage I and II included in the formula. In the HSROC analysis, the AUC values were as follows: i) with all predictCRCs, AUC=0.717 and ii) with DMs, AUC=0.937. In the roccomp analysis, the difference in AUC values between i) and ii) was statistically significant (p<0.0001). CONCLUSION: In the detection of CRC, the DA of the new DMs with triage was far superior to that of DMs without triage. This is the first study to report evidence of improved DA in the detection of CRC using DMs including predictCRC with triage and CV FIT test.

Fecal Immunochemical Test (FIT) in Triage of Bleed-positive (Crab+) and Bleed-negative Colorectal Adenoma (Crab-) Patients in Colorectal Neoplasia Screening.

BACKGROUND/AIM: Fecal immunochemical tests (FITs) are sensitive and specific for detecting colorectal cancer (CRC), but their diagnostic accuracy (DA) in bleed-positive (CRAb+) and bleed-negative colorectal adenomas (CRAb-) has been rarely tested. PATIENTS AND METHODS: A total of n=506 patients were included in the study, each collecting 3 consecutive stool samples for analysis. The stool samples were analyzed by the ColonView FIT (CV) and Hemoccult SENSA tests. A total of 484/5,090 (9.5%) patients returned all 3 samples and were subjected to final analysis. Hierarchical summary receiver operating characteristic (HSROC) analysis with different cut-offs for hemoglobin/haptoglobin (Hb and Hb/Hp) complex was performed to assess the DA of CV. RESULTS: In the HSROC analysis, the AUC values were as follows: i) bleed-positive adenoma patients by visual analysis mode (VA), AUC=0.566, ii) bleed-positive adenoma patients by automatic analysis mode (AA), AUC=0.546, iii) bleed-negative adenoma patients by VA, AUC=0.534 and iv) bleed-negative adenoma patients by AA, AUC=0.589: In roccomp analysis, there were significant differences in AUC values between iii) and iv) p=0.045. CONCLUSION: When stratified by the 'blood in stool' (as b+ or b- endpoint), the DA of the CV test is quite similar for CRAb+ and CRAb-. However, of the two modes (VA/AA) of the CV test, the AA reading gives a slightly higher DA both CRAb+ and CRAb-.

Diagnostic Accuracy of Fecal Immunochemical Test (FIT) in Bleed-positive and Bleed-negative Colorectal Cancer (CRC) Among a Cohort of 5,090 Subjects who Participated in the Colorectal Neoplasia (CRN) Screening in Brazil.

BACKGROUND/AIM: This study assessed the diagnostic accuracy (DA) of fecal immunochemical test (FIT) ColonView (CV) and guaiac-based fecal occult blood test (HemoccultSENSA) among bleed-positive (history or signs of intestinal bleeding) and bleed-negative participants (no history or signs of intestinal bleeding) (n=5,090) in colorectal neoplasia (CRN) screening in Brazil. PATIENTS AND METHODS: The eligible patients for the study (n=506) collected three consecutive stool samples, to be analyzed by both assays (CV, SENSA). Finally, 421/5090 (8.3%) patients returned both samples, which were subjected to final analysis. Receiver operating characteristic (ROC) analysis with different cut-offs was performed to assess the DA. RESULTS: The area under curve (AUC) values for i) visually analyzed (VA) CV for bleed-positive CRC, ii) automatically analyzed (AA) CV for bleed-positive CRC, iii) VA CV for bleed-negative CRC, and iv) AA CV for bleed-negative CRC as endpoints were as follows: i) AUC=0.864, ii) AUC=0.933, iii) AUC=0.836, and iv) AUC=0.892. In roccomp analysis, the differences in AUC values were: between i) and ii) p=0.068; between i) and iii) p=0.497; between i) and iv) p=0.488; between ii) and iii) p=0.0058; between ii) and iv) p=0.229; and between iii) and iv) p=0.138. CONCLUSION: This is the first investigation where two modes of CV test, VA, and AA, for bleed-positive and bleed-negative CRC patients were used as the endpoint. The AA reading of the CV test showed higher DA in bleed-positive than in bleed-negative CRC patients.

A Simple Prediction Score for Diagnosis of Acute Pancreatitis.

BACKGROUND/AIM: The diagnostic accuracy (DA) for patients with acute pancreatitis (AcPa) has been rarely evaluated. PATIENTS AND METHODS: In the AcPa study group, there were 22 patients versus 1,311 patients in the non-AcPa group. The clinical history-taking variables (CHT) (n=22), clinical signs & tests details (CST) (n=14), and laboratory analyses (n=3) were recorded in each patient. Meta-analytical techniques were used to detect the summary sensitivity (Se) and specificity (Sp) estimates for each data set; CHT, CST, and diagnostic scores (DS). RESULTS: In receiver operating characteristic (ROC) analysis, the area under curve (AUC) values for i) CHT, ii) CST, and iii) DS were as follows: i) AUC=0.640 (95%CI=0.550-0.730); ii) AUC=0.588 (95%CI=0.520-0.656), and iii) AUC=0.943 (95%CI=0.910-0.976). The differences between these AUC values (roccomp analysis) are as follows: i) versus ii) p=0.155; i) versus iii) p<0.0001; ii) versus iii) p<0.0001. CONCLUSION: The new DS introduced in this study proved to be far superior to both symptoms and signs & tests in its DA for AcPa, as demonstrated by HSROC analysis.

Site-specific Performance of ColonView (CV) Fecal Immunochemical Test (FIT) With Differences Between Proximal and Distal Colorectal Adenoma.

BACKGROUND/AIM: The aim of this study was to assess the diagnostic accuracy (DA) of a ColonView (CV) test in proximal versus distal colorectal adenoma (pCRA versus dCRA). PATIENTS AND METHODS: The colorectal neoplasia (CRN) screening cohort included 5,090 individuals and 506/5,090 (10%) were eligible for the study. Finally, only 127/506 were included in the CRA analysis and hierarchical summary ROC (HSROC) curves were used to show the pooled overall DA of visually analyzed (VA) and automatically analyzed (AA) techniques in pCRA and dCRA detection. RESULTS: The overall specificity (Sp) of the AA technique for the pCRA and dCRA endpoint was 46% and 43%, respectively. The most sensitive AA test in pCRA patients showed 76% sensitivity (Se) versus 58% Se in dCRA patients. In the HSROC analysis, area under the curve (AUC) values were as follows: i) VA in pCRA: AUC=0.503, ii) AA in pCRA: AUC=0.560, iii) VA in dCRA: AUC=0.552 and iv) AA in dCRA: AUC=0.486. In Roccomp analysis, the statistically significant AUC values were available between VA and AA reading modes in pCRA (p=0.044) and in AA reading between pCRA and dCRA (p=0.024). CONCLUSION: As compared with the CRC endpoint, the DA value of the CV test is far inferior for the CRA endpoint, as determined by the AUC values.

The ColonView (CV) Quick Test for Fecal Occult Blood Shows Significantly Higher Diagnostic Accuracy in Detecting Distal than Proximal Colorectal Cancer.

AIM: The present study compared the accuracy of ColonView (CV) quick test in detecting proximal versus distal colorectal cancer (CRC). A traditional guaiac-based fecal occult blood test (gFOBT) (Hemoccult SENSA) was used as a reference. PATIENTS AND METHODS: A cohort of 368 colonoscopy-referral patients were asked to collect 3 consecutive fecal samples, to be analyzed by both assays (CV, SENSA). Receiver operating characteristic (ROC) analysis was used to find the optimal cut-off values for both Hb and Hb/Hp of the CV test. Summary hierarchical ROC (HSROC) curves were used to visualize the pooled overall accuracy of visually analysed (VA) and automatically analyzed (AA) reading modes in proximal and distal CRC detection. RESULTS: The overall specificity (Sp) of the AA reading mode for the proximal CRC and distal CRC endpoint was 73% and 76%, respectively. For proximal CRC, the two most sensitive AA tests showed 90% sensitivity (Se), while for distal CRC, the two most sensitive AA tests showed 100% Se. In the HSROC analysis, the AUC values were as follows: i) VA in proximal CRC: 0.765, ii) AA in proximal CRC: 0.878, iii) VA in distal CRC: 0.955 and iv) AA in distal CRC: 0.961. In roccomp analysis, AUC values were significantly different in: VA vs. AA in proximal CRC p=0.009; VA in proximal vs. VA in distal CRC p<0.0001; VA in proximal vs. AA in distal CRC p<0.0001; AA in proximal vs. VA in distal CRC p=0.021; AA in proximal CRC vs. AA in distal CRC p=0.006. CONCLUSION: The applicability of the CV test (a new-generation FIT) in CRC screening was confirmed. The AA reading was superior to VA (or SENSA) in its diagnostic accuracy in detecting proximal CRC patients. Distal CRCs were more accurately detected than proximal CRCs by both reading modes.

The Automatically Analyzed (AA) ColonView (CV) Quick Test for Fecal Occult Blood Shows Higher Diagnostic Accuracy in Detection of Colorectal Adenoma than Visually Analyzed Tests.

BACKGROUND/AIM: The present study compared the accuracy of visually analyzed (VA) and automatically analyzed (AA) ColonView (CV) quick test; a new-generation fecal immunochemical test (FIT) for hemoglobin (Hb) and hemoglobin/haptoglobin (Hb/Hp) (Biohit Oyj, Helsinki, Finland) in subjects participating in colorectal neoplasia (CRN) detection in Brazil. A traditional guaiac-based fecal occult blood test (gFOBT) test (HemoccultSENSA) was used as a reference. PATIENTS AND METHODS: A cohort of 509 colonoscopy-referral patients were asked to collect three consecutive fecal samples, to be analyzed by both CV and SENSA. RESULTS: In ROC analysis for the AA reading, the optimal cut-off value for CV Hb was ≥8.0912 and that for CV Hb/Hp was ≥1.8983. With these cut-offs, the sensitivity (Se), specificity (Sp), and efficiency of CV AA in detecting colorectal adenoma (CRA) were: 64.2%/78.6%, 53.4%/35.3%, and 58.6%/56.5%, for Hb and Hb/Hp, respectively. In the HSROC analysis, the AUC values for i) VA and ii) AA modes were as follows: i) AUC=0.551 (95%CI=0.500-0.602), ii) AUC=0.606 (95%CI=0.550-0.662). The difference between these AUC values was statistically significant (p=0.0160). CONCLUSION: The present study confirms the previous results on the applicability of the ColonView quick test in CRN screening. Of the two optional reading modes, the AA reading showed significantly better diagnostic accuracy as compared to the VA reading (or SENSA), in detecting the CRA endpoint in colonoscopy-referral patients.

The New Generation Immunochemical Test for Fecal Occult Blood (ColonView Quick Test) Shows a High Diagnostic Accuracy in Colorectal Cancer Detection.

BACKGROUND/AIM: The present study compared the accuracy of visually analyzed (VA) and automatically analyzed (AA) ColonView (CV) quick test; a new-generation immunochemical test (FIT) for Hb and Hb/Hp (Biohit Oyj, Helsinki, Finland) in subjects participating in colorectal cancer (CRC) detection in Brazil. A traditional gFOBT test (HemoccultSENSA) was used as a reference. PATIENTS AND METHODS: A cohort of 368 colonoscopy-referral patients were asked to collect 3 consecutive fecal samples, to be analysed by both assays (CV, SENSA). RESULTS: In receiver operating characteristic (ROC) analysis for the AA reading, the optimal cut-off value for CV Hb AA (test AA 3) was ≥117 and that for CV Hb/Hp AA (test AA 4) was ≥48. In the hierarchical summary receiver operating characteristic (HSROC) analysis for pooled accuracy of CV with AA and VA reading, the AUC values for i) VA and ii) AA were as follows: i) AUC=0.859 (95%CI=0.839-0.879), ii) AUC=0.931 (95%CI=0.920-0.942). The difference between these AUC values (Roccomp analysis) was statistically significant (p=0.0024). CONCLUSION: The present study confirms the previous studies on the applicability of the ColonView quick test (a new-generation FIT) in CRC screening.

A Diagnostic Score (DS) in the Difficult Diagnosis of Non-specific Abdominal Pain (NSAP).

BACKGROUND/AIM: The diagnostic scores (DSs) for patients with non-specific abdominal pain (NSAP) have been rarely evaluated. PATIENTS AND METHODS: In the NSAP study group there were 614 patients (268 females and 346 males) versus 719 patients in the non-NSAP group including 368 females and 351 males. The clinical symptoms (n=22), signs and tests (n=14) and laboratory analyses (n=3) were recorded in each patient. Meta-analytical techniques were used to detect the summary sensitivity (Se) and specificity (Sp) estimates for each data set (symptoms, signs and tests as well as DS models). RESULTS: In receiver operating characteristic (ROC) analysis, the area under curve (AUC) values for i) symptoms ii) signs and tests and iii) DS were as following: i) AUC=0.542 (95% CI=0.512-0.572); ii) AUC=0.625 (95% CI=0.550-0.700), and iii) AUC=0.874 (95% CI=0.850-0.898). The differences between these AUC values are as following: between i and ii, p=0.097; between i and iii, p<0.0001 and between ii and iii, p<0.0001. CONCLUSION: This is the first study to provide evidence that DS may help in the difficult diagnosis of NSAP.

A Diagnostic Score for Reliable Confirmation of Acute Renal Colic Among Patients With Acute Abdominal Pain.

BACKGROUND/AIM: Diagnostic scores (DSs) for confirmation of acute renal colic (ARCO) have rarely been evaluated. PATIENTS AND METHODS: A cohort of 1,333 patients with acute abdominal pain (AAP) were studied, including 59 patients with confirmed ARCO. The most significant diagnostic findings (in multivariate logistic regression analysis) were used to construct DS formulas for the diagnosis of ARCO. Meta-analytical techniques were used to detect the summary sensitivity and specificity estimates for each data set (clinical symptoms, signs and tests, as well as DS formulas). RESULTS: In hierarchical summary receiver operating characteristic analysis (HSROC), the values for area under the curve (95% confidence interval) for i) clinical symptoms ii) signs and tests, and iii) DS were 0.650 (0.612-0.688), 0.724 (0.680-0.768) and 0.962 (0.940-0.984), respectively. In HSROC analysis of the area under the curve values, differences were significant between i) and iii) (p<0.0001) and between ii) and iii) (p<0.0001). CONCLUSION: The present study is the first to provide evidence suggesting that the DS can be used for clinical confirmation of ARCO in patients with AAP, with a high diagnostic accuracy without radiological or laboratory analyses.

A Diagnostic Score for Acute Small Bowel Obstruction.

BACKGROUND/AIM: The diagnosis of acute small bowel obstruction (ASBO) may be difficult and the decision to operate is based on clinical findings. So far, the diagnostic scores (DSs) for ASBO detection have been rarely evaluated. PATIENTS AND METHODS: A cohort of 1,333 acute abdominal pain (AAP) patients with 54 ASBO patients, were included in the study. The most significant diagnostic findings (in multivariate logistic regression analysis) were used to construct DS formulas for ASBO diagnosis with location of pain at diagnosis (LP+) and without location of pain at diagnosis (LP-). Meta-analytical techniques were used to calculate the summary sensitivity (Se) and specificity (Sp) estimates for each data sets (history-taking, findings, and DS formulas). RESULTS: In SROC analysis, the AUC values for i) clinical history-taking, ii) diagnostic findings and tests, iii) DSLP- and iv) DSLP+ were as follows: i) AUC=0.638 (95%CI=0.600-0.676); ii) AUC=0.694 (95%CI=0.630-0.724), iii) AUC=0.962 (95%CI=0.940-0.986), and for iv) AUC=0.971 (95%CI=0.952-0.988). In roccomp analysis for the AUC values, the differences are significant as follows: between i) and ii) p=0.312; between i) and iii) p<0.0001; between i) and iv) p<0.0001; between ii) and iii) p<0.0001; between ii) and iv) p<0.0001; and between iii) and iv) p=0.317. CONCLUSION: The present study is the first to provide data that the DS could be used for clinical diagnosis of ASBO without radiological or laboratory analyses, to reach a high diagnostic accuracy in AAP patients.

A Diagnostic Score (DS) Is a Powerful Tool in Diagnosis of Acute Appendicitis in Elderly Patients With Acute Abdominal Pain.

BACKGROUND/AIM: Although acute appendicitis (AA) in elderly patients is different from AA in younger patients, the accuracy of diagnostic scores (DSs) in detecting AA is rarely considered. PATIENTS AND METHODS: A cohort of 470 AAP (acute abdominal pain) patients older than 50 years, including 224 women (53.7%) and 193 men (46.3%), were included in the study. The most significant diagnostic predictors were used to construct DS formulas for AA diagnosis with (Tax+) and without body temperature (Tax-). Meta-analytical techniques were used to calculate the summary Se and Sp estimates for each data sets (history-taking, findings, and DS formulas). RESULTS: In SROC analysis, the AUC values for i) symptoms ii) signs and tests iii) DSTax- and iv) DSTax+ were as follows: i) AUC=0.658 (95%CI=0.601-0.709); ii) AUC=0.751 (95%CI=0.701-0.800), iii) AUC=0.977 (95%CI=0.942-1.000), and for iv) AUC=0.980 (95%CI=0.956-1.000). Using roccomp analysis for these AUC values, the differences were significant as follows: between i) and ii) p=0.0358; between i) and iii) p<0.0001; between i) and iv) p<0.0001; between ii) and iii) p<0.0001; between ii) and iv) p<0.0001; and between iii) and iv) p=0.682. CONCLUSION: Similar to younger AA patients, the DS formula was superior to both the clinical history-taking and findings, and therefore, the use of DS should be an important part of the diagnostic decision tree of AA also in the elderly patients presenting with AAP.

Pediatric Acute Appendicitis Score in Children With Acute Abdominal Pain (AAP).

AIM: The aim of the study was to compare the accuracy of common clinical findings, laboratory tests and diagnostic score (DS) in diagnosis of clinically confirmed acute appendicitis (AA) in children. PATIENTS AND METHODS: A cohort of 188 children under the age of 15 years presenting with acute abdominal pain (AAP) were included in the study. The clinical history (n=21), signs (n=14) and tests (n=3) were recorded in each child. RESULTS: The significant independent diagnostic predictors (disclosed by multivariate logistic regression model) were used to construct the DS formulas for AA diagnosis. These formulas were tested at six different cut-off levels to establish the most optimal diagnostic performance for clinically confirmed AA. In the receiver operating characteristic curve (ROC) comparison test, there was a statistically significant difference (p=0.0055) in the area under curve (AUC) values between i) clinical history and symptoms (AUC=0.594), and ii) signs and laboratory tests (AUC=0.734), whereas both were significantly inferior (p=0.0001) to the AUC value of the DS (AUC=0.952). CONCLUSION: In diagnosis of clinically confirmed AA in children, the DS formula is superior to both the clinical history/symptoms and signs/lab tests, justifying the use of DS as an integral part of the diagnostic algorithm of AA in all children presenting with AAP.

History-taking, Clinical Signs, Tests and Scores for Detection of Non-organic Dyspepsia (NOD) Among Patients With Acute Abdominal Pain (AAP).

Background/Aim: The diagnostic accuracy of history-taking, clinical signs and tests and diagnostic scores (DSs) for patients with non-organic dyspepsia (NOD) have been rarely evaluated. Patients and Methods: A cohort of 1333 patients presenting with acute abdominal pain (AAP) were studied, including 50 patients with confirmed NOD. The most significant diagnostic variables (in multivariate logistic regression analysis) were used to construct six different DS models and their diagnostic accuracy was compared with clinical symptoms and signs and tests. Meta-analytical techniques were used to detect the summary sensitivity (Se) and specificity (Sp) estimates for each data set (symptoms, signs and tests as well as DS models). Results: In hierarchical summary receiver operating characteristic (HSROC) analysis, the area under curve (AUC) values for i) symptoms ii) signs and tests iii) DS were as follows: i) AUC=0.608 [95% confidence interval (CI)=0.550-0.666]; ii) AUC=0.621 (95% CI=0.570-0.672) and iii) AUC=0.877 (95% CI=0.835-0.919). The differences between these AUC values (roccomp analysis) are as follows: between i) and ii) p=0.715; between i) and iii) p<0.0001; between ii) and iii) p<0.0001. Conclusion: The present study is the first to provide evidence that the DS could be used in diagnosis of NOD. The major advantage of our DS is that this model does not need radiology or endoscopy to reach high diagnostic accuracy.

Performance of a Diagnostic Score in Confirming Acute Cholecystitis Among Patients With Acute Abdominal Pain.

BACKGROUND/AIM: Although acute cholecystitis (AC) is quite a frequent clinical cause of acute abdominal pain (AAP), the accuracy of a diagnostic score (DS) in confirming AC is rarely considered. The aim of the study was to conduct a detailed analysis comparing the accuracy of common clinical findings, laboratory tests and DS in AC diagnosis. PATIENTS AND METHODS: A cohort of 1,333 patients presenting with AAP were included in the study. The clinical history and diagnostic symptoms (n= 21), signs (n=14) and laboratory tests (n=3) were recorded in each patient. RESULTS: The significant independent diagnostic predictors (disclosed by multivariate logistic regression model) were used to construct the DS formulas for AC diagnosis. These formulas were tested at five different cut-off levels to establish the most optimal diagnostic performance for clinically confirmed AC. In the ROC comparison test, there was no statistically significant difference in the AUC values of i) clinical history and symptoms (AUC=0.542), and ii) signs & laboratory tests (AUC=0.580), whereas both were significantly inferior (p=0.0001) to the AUC value of the DS (AUC=0.962). CONCLUSION: In the diagnosis of clinically confirmed AC, the DS formula is superior to clinical symptoms and signs, justifying the use of DS as an integral part of the diagnostic algorithm of AC in all patients presenting with AAP.

Leucocyte Count Does Not Improve the Diagnostic Performance of a Diagnostic Score (DS) in Distinguishing Acute Appendicitis (AA) from Nonspecific Abdominal Pain (NSAP).

BACKGROUND/AIM: Although, acute appendicitis (AA) and nonspecific abdominal pain (NSAP) are the most common diagnoses among secondary care patients with acute abdominal pain, the diagnostic performance of leucocyte count (LC) in DS (Diagnostic Score) model is rarely considered. PATIENTS AND METHODS: As an extension of the World Organisation of Gastro-Enterology Research Committee (OMGE) acute abdominal pain study, 1,333 patients presenting with acute abdominal pain were included in the study. The clinical history and diagnostic symptoms (n=22), signs (n=14) and tests (n=3) in each patient were recorded in detail, and the collected data were related with the final diagnoses of the patients. RESULTS: In the ROC comparison test, there was no statistically significant difference in the performance of DSLC- (DS without LC) and DSLC+ (DS with LC). The highest sensitivities of the DSLC- and DSLC+ tests for detecting AA were 86% (95%CI=81-90%) and 87% (95%CI=82-91%), respectively. The highest specificities of the DSLC- and DSLC+ tests for detecting AA were 98% (95%CI=97-99%) and 98% (95%CI=96-99%), respectively. CONCLUSION: DS could assist the clinician in differentiating AA from NSAP and other causes of acute abdominal pain. Importantly, LC does not improve the diagnostic performance of a DS in AA.

Gender-specific Performance of a Diagnostic Score in Acute Appendicitis.

BACKGROUND/AIM: Although a negative appendectomy in female patients with acute abdominal pain (AAP) can be twice as frequent as in male patients, the accuracy of diagnostic scores (DSs) in acute appendicitis (AA) is rarely considered among patients with AAP. The aim was to study the gender-specific performance of a DS in AA. PATIENTS AND METHODS: As an extension of the World Organisation of Gastro-Enterology Research Committee (OMGE) AAP study, 1,333 patients presenting with AAP were inclu ded in the study. The clinical history and diagnostic symptoms (n=22), signs (n=14) and laboratory tests (n=3) were recorded in each patient. RESULTS: The most significant diagnostic predictors were used to construct DS formulas for AA diagnosis, separately for both genders. The formulas were tested at 6 different cut-off levels to find the best diagnostic performance for AA in females and males. The highest specificities of the DSLC- [DS without leucocyte count (LC)] and DSLC+ (DS with LC) scores in detecting AA were 98% (95% CI=97-99%) and 98% (95% CI=96-99%), respectively. In the ROC comparison test, there was no statistically significant difference in the performance of DSLC- and DSLC+ in female and male patients. CONCLUSION: Our gender-specific DS reached very high AUC values for AA (0.948-0.956) in both genders, and there was no statistically significant difference in the AUC values of DSLC- and DSLC+ between women and men with AAP.

Fecal Occult Blood Tests in Colorectal Cancer Screening: Systematic Review and Meta-analysis of Traditional and New-generation Fecal Immunochemical Tests.

BACKGROUND/AIM: Noninvasive fecal occult blood tests (FOBTs) are recommended by current guidelines for colorectal cancer (CRC) screening. Our aim was to assess the diagnostic performance of traditional guaiac-based FOBTs (gFOBT) and new-generation immunochemical FOBTs (iFOBT) in CRC screening by carrying out a systematic review and meta-analysis. PATIENTS AND METHODS: PubMed, Embase, Cochrane Library, and Web of Science were searched for eligible articles published before February 17, 2020. Three independent investigators conducted study assessment and data extraction. Diagnosis-related indicators for use of FOBTs in the detection of CRC (as the endpoint) in a screening setting were summarized, and further stratified by the type of FOBT (gFOBT vs. iFOBT). STATA software was used to conduct the meta-analysis. Pooled sensitivities and specificities were calculated using a random-effects model. Hierarchical summary receiver operating characteristic curves were plotted and area under the curves (AUC) were calculated. RESULTS: The electronic search identified 573 records after duplicates were removed, of which 75 full-text articles were assessed for eligibility. Finally, a total of 31 studies were eligible for the meta-analysis. In the ROC comparison test, there was a statistically significant difference in the performance of gFOBT and iFOBT tests, with AUC=0.77 (95% confidence intervaI=0.75-0.79) and AUC=0.87 (95% confidence intervaI=0.85-0.88), respectively (p=0.0017). In formal meta-regression, test brand did not prove to be a significant study-level covariate that would explain the observed heterogeneity between the studies. CONCLUSION: New-generation iFOBTs were found to have a significantly higher diagnostic performance as compared with gFOBTs, advocating the use of only fecal immunochemical tests in all newly implemented CRC screening programs.