Modified Cutoff Values Research Articles

Utilization of the modified Kama scoring system for predicting bail-out cholecystectomy: a valuable tool in the era of rising laparoscopic surgery prevalence.

Recently, bail-out cholecystectomy (BOC) during laparoscopic cholecystectomy to avoid severe complications, such as vasculobiliary injury, has become widely used and increased in prevalence. However, current predictive factors or scoring systems are insufficient. Therefore, in this study, we aimed to test the validity of existing scoring systems and determine a suitable cutoff value for predicting BOC. We retrospectively assessed 305 patients who underwent laparoscopic cholecystectomy and divided them into a total cholecystectomy group (n = 265) and a BOC group (n = 40). Preoperative and operative findings were collected, and cutoff values for the existing scoring systems (Kama's and Nassar's) were modified using a prospectively maintained database. The BOC rate was 13% with no severe complications. A logistic regression analysis revealed that the Kama's score (odds ratio, 0.93; 95% confidence interval 0.91-0.96; P < 0.01) was an independent predictor of BOC. A cutoff value of 6.5 points gave an area under the curve of 0.81, with a sensitivity of 87% and a specificity of 67%. Kama's difficulty scoring system with a modified cutoff value (6.5 points) is effective for predicting BOC.

Modified quantitative and volumetric response evaluation criteria for patients with hepatocellular carcinoma after transarterial chemoembolization.

This study aimed to investigate the cutoff value of quantitative and volumetric response evaluation criteria for patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE) and compare the performance of the modified criteria to one-dimensional criteria in survival prediction. A retrospective single-center study was performed for treatment-naive patients with HCC who underwent initial TACE between June 2015 and June 2019. Treatment response assessment was performed after the first observation by contrast CT or MRI, with the measurement of diameters by modified Response Evaluation Criteria in Solid Tumors (mRECIST) and volumes by quantitative European Association for Study of the Liver (qEASL). Overall survival (OS) was the primary endpoint of this study. The new cutoff value for volumetric response evaluation criteria was created using restricted cubic splines. The performance of modified qEASL (mqEASL, with the new cutoff value) and mRECIST on survival prediction was compared by Cox regression models in internal and external validation. A total of 129 patients (mean age, 60 years ± 11 [standard deviation]; 111 men) were included and divided into training (n=90) and validation (n=39) cohorts. The cutoff value for the viable volume reduction was set at 57.0%. The mqEASL enabled separation of non-responders and responders in terms of median OS (p<0.001), 11.2 months (95% CI, 8.5-17.2 months) vs. 31.5 months (95% CI, 25.5-44.0 months). Two multivariate models were developed with independent prognostic factors (tumor response, metastasis, portal vein tumor thrombus, and subsequent treatment) to predict OS. Model 2 (for mqEASL) had a greater Harrel's C index, higher time-dependent area under the receiving operator characteristic curve (AUROC), and more precise calibration on 6-month survival rates than Model 1 (for mRECIST). With the modified cutoff value, the quantitative and volumetric response of HCC patients to TACE becomes a precise predictor of overall survival. Further studies are needed to verify this modification before application in clinical practice.

Modification of termination of resuscitation rule with compression time interval in South Korea

This study aimed to validate the predictive performance of the termination of resuscitation (TOR) rule and examine the compression time interval (CTI) as a criterion for modifying the rule. This retrospective observational study analyzed adult out-of-hospital cardiac arrest (OHCA) patients attended by emergency medical service (EMS) providers in mixed urban–rural areas in Korea in 2020 and 2021. We evaluated the predictive performance of basic life support (BLS) and the Korean Cardiac Arrest Research Consortium (KoCARC) TOR rule using the false-positive rate (FPR) and positive predictive value (PPV). We modified the age cutoff criterion and examined the CTI as a new criterion. According to the TOR rule, 1827 OHCA patients were classified into two groups. The predictive performance of the BLS TOR rule had an FPR of 11.7% (95% confidence interval (CI): 5.9–17.5) and PPV of 98.4% (97.6–99.2) for mortality, and an FPR of 3.6% (0.0–7.8) and PPV of 78.6% (75.9–81.3) for poor neurological outcomes at hospital discharge. The predictive performance of the KoCARC TOR rule had an FPR of 5.0% (1.1–8.9) and PPV of 98.9% (98.0–99.8) for mortality, and an FPR of 3.7% (0.0–7.8) and PPV of 50.0% (45.7–54.3) for poor neurological outcomes at hospital discharge. The modified cutoff value for age was 68 years, with an area under the receiver operating characteristic curve over 0.7. In the group that met the BLS TOR rule, the cutoff of the CTI for death was not determined and was 21 min for poor neurological outcomes. In the group that met the KoCARC TOR rule, the cutoff of the CTI for death and poor neurological outcomes at the time of hospital discharge was 25 min and 21 min, respectively. The BLS TOR and KoCARC TOR rules showed inappropriate predictive performance for mortality and poor neurological outcomes. However, the predictive performance of the TOR rule could be supplemented by modifying the age criterion and adding the CTI criterion of the KoCARC.

1071: QUANTIFYING PASSIVE CLINICAL DECISION SUPPORT AND REDUCING LABORATORY RESULT FATIGUE

Introduction: Clinical decision support (CDS) systems are intended to improve adherence to standard practices, enhance awareness, and increase care quality. Excessive passive decision support, such as laboratory result highlighting, can reduce CDS effectiveness. We quantify result highlighting burden across two institutions, and measure change in highlighting burden when applying published data-driven cutoffs to identify abnormal laboratory values. Methods: This multi-site retrospective study includes patients admitted to the pediatric ICU between 9/2016 and 9/2019. We describe the frequency of abnormal laboratory result highlighting by laboratory group, compared across sites. We use a logistic regression model to analyze the relationship between abnormal result highlighting to selected covariates and report odds ratios. We apply modified cutoff values based on mortality odds ratios (MOR) [Pollack et al, Peds Crit Care Med, 2021], indicating “abnormal” results when MOR >2.0. We re-calculate the frequency of abnormal result highlighting and compare to existing cutoffs. Results: We report a total of 19,087 ICU encounters and 12,507 unique patients. Across all laboratory groups, abnormal result highlighting differed significantly by institution (A: 54% vs B: 50%, p < 0.001). Percent of results with passive alerts was greatest in coagulation studies (A: 77%, B: 36%) and least in basic chemistry panels (A: 47%, B: 43%). In a logistic regression model, the only covariate consistently associated with an abnormal result was “collected < 24 hours from ICU admission,” for which odds of an abnormal result decreased [A: 12% decrease; B: 15% decrease]. When MOR-based cutoffs were applied, abnormal result highlight significantly decreased across all laboratory groups by >14%, except for complete blood counts (A: 14% increase, B: 16% increase). Conclusions: Abnormal result highlighting is a pervasive form of passive decision support that is differentially present across PICUs. Modifying laboratory result thresholds using data-driven MOR-based cutoffs reduces this passive CDS burden, which may better allow providers to identify physiologic signals from data noise. This work represents a first step in improving upon passive CDS to improve patient care quality and safety.

Prediction of Postoperative Sepsis Based on Changes in Presepsin Levels of Critically Ill Patients with Acute Kidney Injury after Abdominal Surgery.

Presepsin (PSP) is a viable biomarker for the detection of bacterial infection, but it lacks accuracy when acute kidney injury (AKI) develops. Herein, we evaluated the diagnostic and prognostic value of PSP in predicting postoperative sepsis after abdominal surgery respective to the degree of AKI. A total of 311 patients who underwent abdominal surgery and were admitted to a surgical intensive care unit were enrolled and classified into non-AKI, mild-AKI (stage 1, stage 2 and stage 3 without renal replacement therapy (RRT)) and severe-AKI (stage 3 with RRT) group, according to the Kidney Disease Improving Global Outcomes criteria. In each group, PSP and other biomarkers were statistically analyzed between non-sepsis and postoperative sepsis at the admission (T0), 24 h (T1), 48 h (T2) and 72 h (T3) after surgery. In non-AKI and mild-AKI group, PSP levels were significantly higher in postoperative sepsis than non-sepsis group, whereas no difference was detected in the severe-AKI group. Cutoff values of PSP in the mild-AKI group for the prediction of postoperative sepsis were 544 pg/mL (AUC: 0.757, p < 0.001) at T0 and 458.5 pg/mL (AUC: 0.743, p < 0.001) at T1, significantly higher than in non-AKI group. In multivariate analysis, predictors of postoperative sepsis in the mild-AKI group were PSP at T2 (odds ratio (OR): 1.002, p = 0.044) and PSP at T3 (OR: 1.001, p = 0.049). PSP can be useful for predicting newly developed sepsis in patients with transient AKI after abdominal surgery with modified cutoff values.

Targeted population screening of late onset Pompe disease in unspecified myopathy patients for Korean population

We performed targeted population screening of late onset Pompe disease (LOPD) in unspecified myopathy patients, because early diagnosis is difficult due to its heterogeneous clinical features. We prospectively enrolled 90 unrelated myopathic patients who had one or more signs out of five LOPD-like clinical findings (proximal weakness, axial weakness, lingual weakness, respiratory difficulty, idiopathic hyperCKemia). Acid alpha glucosidase activity was evaluated with dried blood spot and mixed leukocyte simultaneously. For a final diagnosis of LOPD, 16 patients with decreased enzyme activity were genotyped by GAA molecular analysis. We found two patients with LOPD (2.2%), and the remaining 14 patients had at least one G576S or E689K mutation, known as the pseudodeficiency allele. Acid alpha glucosidase activity of LOPD patients was significantly lower than that of patients with at least one pseudodeficiency allele (p = 0.017). This study is the first LOPD screening study for targeted Korean population, and more generally, an Asian population. Our findings suggest that for diagnosis of LOPD in Asian population, modified cutoff value of acid alpha glucosidase activity with dry blood spot considering that of patients having heterozygote pathogenic variants or pseudodeficiency alleles may reduce time and cost requirements and increase the comfort of patients.

Evaluation of alpha-fetoprotein as a screening marker for hepatocellular carcinoma in hepatitis prevalent areas

The objective of this study was to establish modified cutoff values of serum alpha-fetoprotein (AFP) according to hepatitis status. While AFP is used as a serum marker in the diagnosis or monitoring of hepatocellular carcinoma (HCC), its use as a screening method to the general population is controversial. We evaluated its screening performance in a hepatitis prevalent East Asian population, and suggest different cutoff values according to the individual’s hepatitis status. We evaluated the performance of AFP as a screening test in 48,123 consecutive Koreans during the period from March, 2012 to August, 2013 who underwent routine health checks at a single institution. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated with fixed cutoff and with modified cutoffs according the individual’s hepatitis status. A total of 24 out of 48,123 subject (0.05%) were newly diagnosed with HCC after screening. Among the 1,874 subject with positive hepatitis B virus surface antigen (HBsAg), 17 (0.91%) developed HCC, compared with two out of 393 (0.51%) individuals with hepatitis C virus antibody (anti-HCV). Five out of 45,855 (0.01%) subject with neither HBsAg nor anti-HCV developed HCC. Compared to the performance of a fixed cutoff, specificity, PPV, and NPV improved without sacrificing sensitivity when applying modified cutoff. In conclusion, our findings suggest that AFP with modified cutoffs according to the individual’s hepatitis status might be a useful screening marker for HCC in hepatitis prevalent areas.

THE VALIDITY OF THE MOOD DISORDER QUESTIONNAIRE FOR SCREENING BIPOLAR DISORDER: A META-ANALYSIS.

We conducted a meta-analysis to review the diagnostic accuracy of the Mood Disorder Questionnaire (MDQ) among patients with mood disorders. We used a bivariate random effects model to calculate summary sensitivity and specificity. Twenty-one studies were included. At the standard or modified cutoff value of 7, summary sensitivity was .62 and summary specificity was .85. When we pooled 11 studies including both patients with bipolar disorder (BD) and those with unipolar depression, the summary sensitivity was .76 and summary specificity was .81. However, among the six studies that excluded patients with known BD, the summary sensitivity was significantly reduced to .37 and summary specificity was .88. There were no significant differences on the diagnostic accuracy of the MDQ between studies from Eastern and Western countries after adjusting for various clinical correlates. The overall diagnostic accuracy of the MDQ was relatively good. However, when the MDQ is applied among patients with depression without previous diagnoses of BD, its sensitivity was significantly reduced. This suggests that when the MDQ is applied among this population, its optimal cutoff value should be adjusted to enhance its sensitivity.

Modification of Cutoff Values for HE4, CA125, the Risk of Malignancy Index, and the Risk of Malignancy Algorithm for Ovarian Cancer Detection in Jakarta, Indonesia

CA125 and HE4 are used in calculating Risk of Malignancy Algorithm (ROMA); and Risk of Malignancy Index (RMI). However, studies showed that normal levels of CA125, and HE4 differ among ethnicities such as between Asians and Caucasians, thus affecting the accuracy of the RMI score and ROMA in predicting ovarian malignancy. This study aimed to determine whether new or modified cutoff values for Ca- 125, HE4, the RMI score, and ROMA resulted in a better prediction of malignancy compared with the previous or standard ones. Serum level of CA125 and HE4 from 128 patients with diagnosis of ovarian tumor that had been collected before surgery at Cipto Mangunkusumo General Hospital (CMH) in Jakarta from November 2010 until May 2011 were reviewed and analysed. The standard cutoff values of these biomarkers, RMI, and ROMA were modified by using logistic regression model. The modified cutoff values were compared to the standard cutoff values in terms of sensitivity, specificity, and accuracy. The modified cutoff value of CA125, HE4, RMI score and ROMA were 165.2 U/mL, 103.4 pM, 368.7, 28/54. The sensitivity and specificity of the modified cutoff values CA125, HE 4, RMI score and ROMA in differentiating benign from malignant and borderline were 67% and 75,4%; 73.1% and 85.2%; 73.1% and 80.3%; and 77.6% and 86.9%. While the sensitivity and specificity of the standard cutoff value of CA125; HE4; RMI score; and ROMA were 91% and 24.6%; 83.6% and 65%; 80.6% and 65.6%; and 91.0% and 42.6%. The accuracy of modified cutoff values compared with standard cutoff values were: 71.2% vs 59.3%, 78.9% vs 75% vs, 76.5% vs 73.4%, and 82% vs 67.9%. The new or modified cutoff values of Ca125, HE4, RMI score and ROMA resulted in higher accuracy compared to the previous or standard ones, at the cost of reduced sensitivity.

The impact of new epidemiological cutoff values on Candida glabrata resistance rates and concordance between testing methods

Interpretive criteria for Candida susceptibility testing were recently revised with the establishment of species-specific epidemiological cutoff values (ECV). To assess the effect of modified cutoff values on Candida glabrata resistance rates and agreement between testing methods, we tested the susceptibility of 598 clinical isolates to fluconazole, itraconazole, voriconazole, posaconazole, caspofungin, and amphotericin B using CLSI M27-A3 and E-test methods. The caspofungin MICs clustered above the ECV and below the CLSI cutoff (MIC50, 0.5 μg/mL). Applying the ECV reduced the proportion of itraconazole-nonsusceptible strains from 83% to 0.3% but minimally affected resistance rates of other drugs. Categorical agreement between broth microdilution and E-test was increased for itraconazole and reduced for voriconazole and caspofungin. The current caspofungin ECV may not reproducibly differentiate resistant and susceptible C. glabrata strains in hospitals with varying MIC distributions.

Compare HBsAg cutoff index values of borderline or initially weakly reactive samples with neutralization results for electrochemiluminescence immunoassay in China

To set up arbitrary cutoff values and to determine whether arbitrary cutoff values can be predictive of confirmed positive results by compare cutoff index (COI) values of the borderline or initially reactive samples (0.9≤COI<7.0) with HBsAg confirmation test. 238 HBsAg borderline or initially reactive sera or plasma with 0.9≤COI<7.0 were collected from the clinical patients in West China Hospital of Sichuan University. Each sample must be re-determined in duplicate with Elecsys HBsAg II assay according to manufacturers’ instructions. All repeated reactive samples were confirmed with HBsAg neutralization assay. HBV viral loads were tested if necessary. 116 out of 238 (48.7%) samples, deemed as weakly reactive (WR) samples, were found COIs <2.0. 12.1% (11 out of 91) of WR samples did not pass confirmation in repeated reactive samples. Statistical analysis indicated that much more WR samples were found in HBsAg negative group (100%) than those in repeatedly reactive group (42.7%) (P<0.05). In the 116 WR samples (COI<2.0), 25 samples were HBsAg negative and 11 did not pass the neutralization. 36 WR samples were discovered electrochemiluminescence immunoassay HBsAg negative or confirmed negative. Furthermore, four HBsAg negative and one confirmed negative samples were found HBV DNA existed. 36 WR samples harbored with anti-HBc and anti-Hbe. By setting up modified cutoff values to 1.455 or 1.785, the positive predicted value (PPV) could be improved from 95.2 to 99.4% or 100% in this study. Evaluation of HBsAg prevalence through Elecsys HBsAg II overestimated the true positive, especially in WR samples.Adjusted COIs decreased the need of HBsAg neutralization test, to same degree. Key words: hepatitis B surface antigen (HBsAg), confirmation test,Electrochemiluminescence immunoassay (ECLIA), weakly reactive.