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Nevin Manimala Statistics

Validation and update of a prediction model for risk of relapse after cessation of anti-TNF treatment in Crohn’s disease

Eur J Gastroenterol Hepatol. 2022 Oct 1;34(10):983-992. doi: 10.1097/MEG.0000000000002403. Epub 2022 Aug 30.

ABSTRACT

BACKGROUND: Anti-tumor necrosis factor (TNF) therapy is effective for the treatment of Crohn’s disease. Cessation may be considered in patients with a low risk of relapse. We aimed to externally validate and update our previously developed prediction model to estimate the risk of relapse after cessation of anti-TNF therapy.

METHODS: We performed a retrospective cohort study in 17 Dutch hospitals. Crohn’s disease patients in clinical, biochemical or endoscopic remission were included after anti-TNF cessation. Primary outcome was a relapse necessitating treatment. Discrimination and calibration of the previously developed model were assessed. After external validation, the model was updated. The performance of the updated prediction model was assessed in internal-external validation and by using decision curve analysis.

RESULTS: 486 patients were included with a median follow-up of 1.7 years. Relapse rates were 35 and 54% after 1 and 2 years. At external validation, the discriminative ability of the prediction model was equal to that found at the development of the model [c-statistic 0.58 (95% confidence interval (CI) 0.54-0.62)], though the model was not well-calibrated on our cohort [calibration slope: 0.52 (0.28-0.76)]. After an update, a c-statistic of 0.60 (0.58-0.63) and calibration slope of 0.89 (0.69-1.09) were reported in internal-external validation.

CONCLUSION: Our previously developed and updated prediction model for the risk of relapse after cessation of anti-TNF in Crohn’s disease shows reasonable performance. The use of the model may support clinical decision-making to optimize patient selection in whom anti-TNF can be withdrawn. Clinical validation is ongoing in a prospective randomized trial.

PMID:36062493 | DOI:10.1097/MEG.0000000000002403

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Nevin Manimala Statistics

The relationship between sarcopenia and one-year mortality in patients with critical limb ischemia undergoing endovascular therapy below the knee

Vascular. 2022 Sep 3:17085381221124702. doi: 10.1177/17085381221124702. Online ahead of print.

ABSTRACT

OBJECTIVE: Critical limb ischemia (CLI) is a progressive form of peripheral artery disease (PAD). Patients with CLI have poor long-term prognosis. The aim of this study was to investigate the value of sarcopenia in terms of 1-year mortality in patients with below-the-knee lesions who underwent endovascular treatment for CLI.

METHODS: A total of 190 patients with critical limb ischemia who underwent endovascular treatment (EVT) for below-the-knee (BTK) lesions were enrolled in this study. Sarcopenia was defined using the psoas muscle index (PMI). PMI was obtained by calculating the average psoas muscle area (APMA) of the left and right psoas muscles at the third lumbar vertebra level and dividing by the square of the height (cm2/m2). The primary endpoint of the study was 1-year mortality and the secondary endpoint was 1-year amputation. Patients were divided into 2 groups according to presence of sarcopenia.

RESULTS: We detected sarcopenia in 64 patients. The mean age, height, and EF were higher in sarcopenia group. The psoas muscle area, weight, psoas muscle index, body-mass index, albumin level, and GFR were lower in sarcopenia group. The incidence of amputation (11.9% vs 29.7%, p = 0.003) and mortality (15.1% vs 35.9%, p = 0.001) were higher in patients with sarcopenia. Univariate and multivariate logistic regression analyses were used to determine the independent predictors of amputation and mortality. The survival curve for 1-year using the sarcopenia was analyzed using the Kaplan-Meier method, and statistical analysis was performed with the log-rank test. The presence of sarcopenia, glomerular filtration rate level, and low ejection fraction were found to be independent predictors of mortality.

CONCLUSIONS: Sarcopenia was associated with 1-year mortality in patients with CLI undergoing EVT for BTK lesions. Also, patients with sacropenia had higher 1-year amputation rates. Sarcopenia may be a simple method to help patient selection, assessment, and intervention strategy for EVT and may improve patient outcomes.

PMID:36062475 | DOI:10.1177/17085381221124702

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Induction of robust humoral immunity against SARS-CoV-2 after vaccine administration in previously infected haematological cancer patients

Br J Haematol. 2022 Sep 5. doi: 10.1111/bjh.18429. Online ahead of print.

NO ABSTRACT

PMID:36062472 | DOI:10.1111/bjh.18429

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Nevin Manimala Statistics

MRI pattern in acute optic neuritis: Comparing multiple sclerosis, NMO and MOGAD

Neuroradiol J. 2022 Sep 3:19714009221124308. doi: 10.1177/19714009221124308. Online ahead of print.

ABSTRACT

BACKGROUND: Several MRI findings of optic neuritis (ON) have been described and correlated with specific underlying etiologies. Specifically, optic nerve enhancement is considered an accurate biomarker of acute ON.

OBJECTIVE: To identify differences in MRI patterns of optic nerve enhancement in certain demyelinating etiologies presenting with acute ON.

METHODS: Retrospective analysis of enhancement patterns on fat-suppressed T1-weighted images from patients presenting clinical and radiological acute ON, treated at our institution between January 2014 and June 2022. Location and extension of enhancing optic nerve segments, as well as presence of perineural enhancement were evaluated in three predetermined demyelinating conditions. Fisher’s exact test and chi2 were calculated.

RESULTS: Fifty-six subjects met eligibility criteria. Mean age was 31 years (range 6-79) and 70% were females. Thirty-four (61%) patients were diagnosed with multiple sclerosis (MS), 8 (14%) with neuromyelitis optica (NMO), and 14 (25%) with anti-myelin oligodendrocyte glycoprotein disease (MOGAD). Bilateral involvement was more frequent in MOGAD, compared to MS and NMO (43 vs 3% and 12.5% respectively, p = 0.002). MS patients showed shorter optic nerve involvement, whereas MOGAD showed more extensive lesions (p = 0.006). Site of involvement was intraorbital in 63% MS, 89% NMO, 90% MOGAD (p = 0.051) and canalicular in 43% MS, 33% NMO and 75% MOGAD (p = 0.039). Intracranial or chiasmatic involvement and presence of perineural enhancement were not statistically different between entities.

CONCLUSION: In the setting of acute ON, patients presenting MOGAD were more likely to show bilateral, longitudinally extended and anterior (intraorbital and canalicular) optic nerve involvement compared to patients with MS or NMO.

PMID:36062458 | DOI:10.1177/19714009221124308

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Nevin Manimala Statistics

Comparison of Appendicitis Scoring Systems in Childhood Appendicitis

Turk Arch Pediatr. 2022 Sep;57(5):532-537. doi: 10.5152/TurkArchPediatr.2022.22076.

ABSTRACT

OBJECTIVE: Appendicitis scoring systems have been developed as a diagnostic tool to improve the decision-making process in patients with suspected appendicitis.The aim of the study was to compare the results of the Alvarado, The Pediatric Appendicitis Score, modified Pediatric Appendicitis Score, Lintula, and Tzanakis scoring systems in childhood appendicitis. We also aimed to see whether our rates of correct diagnosis and negative appendectomy could change, if we had made decisions using the scoring systems.

MATERIALS AND METHODS: The patients who underwent appendectomy because of suspected appendicitis between June 2019 and June 2020 were evaluated prospectively. The patients were divided into appendicitis and non-appendicitis groups according to histopathological findings. The obtained data were used to calculate the scores for the scoring systems and statistical analyses.

RESULTS: In the study, 141 patients were included. The negative appendectomy rate was 14.8%. The lowest negative appendectomy rate (6.38%) was obtained with the Lintula scoring system. Tzanakis scoring system had the highest accuracy rate (85.1%) compared to the other scoring systems.

CONCLUSION: The present scoring systems may assist in establishing the diagnosis of appendicitis and reducing negative appendectomy rates. The Lintula scoring system has the lowest negative appendectomy rate due to its higher specificity compared to Alvarado, Pediatric Appendicitis Score, modified Pediatric Appendicitis Score, and Tzanakis scoring systems. Tzanakis scoring system has the highest accuracy rate in the diagnosis of appendicitis, and thus we believe that it may be used as an alternative scoring system for children.

PMID:36062441 | DOI:10.5152/TurkArchPediatr.2022.22076

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Nevin Manimala Statistics

Mid-regional pro-adrenomedullin as a predictor of in-hospital mortality in adult patients with COVID-19: a single-centre prospective study

Anaesthesiol Intensive Ther. 2022 Sep 5:46843. doi: 10.5114/ait.2022.115367. Online ahead of print.

ABSTRACT

BACKGROUND: To determine the predictive value of mid-regional pro-adrenomedullin (MR-proADM) compared to routine clinical and laboratory parameters in patients with COVID-19.

METHODS: A total of 135 adult patients hospitalized with COVID-19 were included in a prospective single-centre study. In addition to routine parameters, the levels of MR-proADM in blood plasma were measured on the day of hospitalization. The patients were divided into 2 groups: those who survived and were discharged (n = 115, 85%) and those who did not survive (n = 20, 15%). Data are presented as median and interquartile range.

RESULTS: The non-survivors had a statistically significantly greater age (73.4 [63.5-84.8] vs. 62.2 [50.3-71.4] years, P = 0.001), a lower level of haemoglobin oxygen saturation (91 [87-92] vs. 92 [92-93]%, P < 0.001), lower lymphocyte level (13 [7-30] vs. 21 [15-27]%, P = 0.03), higher lactate dehydrogenase (338 [273-480] vs. 280 [233-383] EU L-1, P = 0.04) and aspartate aminotransferase levels (49 [28-72] vs. 33 [23-47] EU L-1, P = 0.03), a higher National Early Warning (NEWS) score (7 [7- 8] vs. 6 [5-7] points, P < 0.001), and higher procalcitonin (0.16 [0.11-0.32] vs. 0.1 [0.07-0.18] ng mL-1, P = 0.006) and MR-proADM levels (1.288 [0.886-1.847] vs. 0.769 [0.6-0.955] nmol L-1, P < 0.001). MR-proADM had the highest predictive value for death during hospital stay (cut-off: 0.895 nmol L-1, AUC ROC 0.78 [95% CI: 0.66-0.90], sensitivity 75%, specificity 69%, OR 6.58 [95% CI: 2.22-19.51]).

CONCLUSIONS: Compared with other indicators, MR-proADM has the highest predictive value for in-hospital mortality in patients with COVID-19.

PMID:36062419 | DOI:10.5114/ait.2022.115367

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Nevin Manimala Statistics

Prognostic Value of Ankle-Brachial Index in Prediction of Cardiovascular Events in an Asian Population with Multiple Atherosclerotic Risk Factors

Angiology. 2022 Sep 3:33197221124772. doi: 10.1177/00033197221124772. Online ahead of print.

ABSTRACT

We aimed to evaluate the incremental prognostic value after incorporation of the ankle-brachial index (ABI) into the 10-year pool cohort equation (PCE) risk model in patients with multiple risk factors (MRFs). A total of 4332 MRFs patients were divided into 2 groups as ABI ≤.9 or >.9. The primary outcome was hard cardiovascular events (hCVE: including cardiovascular death, myocardial infarction, or ischemic stroke) over a median follow-up of 36 months. The Cox proportional hazards survival model, C-statistic, and net reclassification indices (NRI) were used. The occurrence of the primary outcome in the ABI ≤.9 group (3.7%) was significantly greater than in the ABI > .9 group (1.3%), P < .001. ABI is an independent predictor of hCVE in addition to the variables in the standard risk model (age, gender, and smoking status). ABI modestly improved the C-index when added to the PCE risk model (PCE .70 vs ABI+PCE .74). The addition of ABI to the PCE risk model did not significantly improve the classification of patients (NRI -.029; 95% CI: -.215 to .130). Despite ABI being one of the independent predictors of hCVE, integration of ABI into the PCE model did not improve the efficacy of risk reclassification in patients with MRFs.

PMID:36062408 | DOI:10.1177/00033197221124772

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Nevin Manimala Statistics

Diagnostic accuracy and adequacy of peripheral pulmonary nodules samples obtained by transthoracic needle aspiration

Cytopathology. 2022 Sep 5. doi: 10.1111/cyt.13176. Online ahead of print.

ABSTRACT

OBJECTIVE: The objectives of our study were to examine the adequacy of samples and accuracy of transthoracic needle aspiration (TTNA) in patients with peripheral pulmonary nodule (PPN) diagnosis.

METHODS: The retrospective study included 248 patients who underwent TTNA of PPN and subsequent diagnostic-therapeutic surgical procedure during a 5-year period. The material was processed at the Department of Pathology and Molecular Diagnostics. The following were analyzed: adequacy of cytological samples for diagnosis and molecular testing, tumor localization and dimensions, and its cytological and histopathological characteristics.

RESULTS: The adequacy of the cytological samples was 93.15%. The proportion of adequate-diagnostic samples was higher in patients in whom the largest diameter of the lesion was >4cm, and this difference shows statistical significance. Tumor localization wasn’t a statistically significant factor for the adequacy of samples for cytological analysis. Cytological samples of lung adenocarcinoma had high projected adequacy for EGFR analyses of 91.55%, and it doesn’t depend on the size and location of the lesion. The most commonly diagnosed lung tumor was adenocarcinoma (45.51%). Patients with cytological diagnosis of NSCLS-NOS, after histopathological analyses, had adenocarcinoma in most cases (53.85%). The overall accuracy of TTNA in the diagnosis of PPN was 71%. The method’s accuracy was 75.24% for malignant tumors, while it was 28.57% for benign tumors. The accuracy of cytological analysis for the histological type of tumor was 84.18%.

CONCLUSION: TTNA with cytological analysis is an effective and highly sensitive method in determining the etiology of PPN.

PMID:36062401 | DOI:10.1111/cyt.13176

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Methodological integrity assessment in the mobile paradigm literature: A lesson for understanding opportunistic use of researcher degrees of freedom in psychology

Child Dev. 2022 Sep 5. doi: 10.1111/cdev.13850. Online ahead of print.

ABSTRACT

The mobile paradigm has played a fundamental role in memory development research. One key characteristic of the mobile paradigm literature is that across decades, researchers have faithfully followed a particular methodological protocol with its own unique definitions of learning and memory. To investigate the extent to which these methodological choices affected the results, the literature (77 publications and 505 statistical tests) was evaluated for four frequently encountered research biases. The results suggested that research using the paradigm was conducted with scientific rigor. However, methodological choices along with unique operational definitions of learning and memory accounted for more than half of the findings. Thus, the literature has been contaminated by methodological artifacts due to the opportunistic use of researcher degrees of freedom.

PMID:36062399 | DOI:10.1111/cdev.13850

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Identifying surrogate markers in real-world comparative effectiveness research

Stat Med. 2022 Sep 5. doi: 10.1002/sim.9569. Online ahead of print.

ABSTRACT

In comparative effectiveness research (CER), leveraging short-term surrogates to infer treatment effects on long-term outcomes can guide policymakers evaluating new treatments. Numerous statistical procedures for identifying surrogates have been proposed for randomized clinical trials (RCTs), but no methods currently exist to evaluate the proportion of treatment effect (PTE) explained by surrogates in real-world data (RWD), which have become increasingly common. To address this knowledge gap, we propose inverse probability weighted (IPW) and doubly robust (DR) estimators of an optimal transformation of the surrogate and the corresponding PTE measure. We demonstrate that the proposed estimators are consistent and asymptotically normal, and the DR estimator is consistent when either the propensity score model or outcome regression model is correctly specified. Our proposed estimators are evaluated through extensive simulation studies. In two RWD settings, we show that our method can identify and validate surrogate markers for inflammatory bowel disease (IBD).

PMID:36062392 | DOI:10.1002/sim.9569