Evaluating the Sum of Eye and Motor Components of the Glasgow Coma Score As a Predictor of Extubation Failure in Patients With Acute Brain Injury.

OBJECTIVES: To evaluate the association between the pre-extubation sum of eye and motor components of the Glasgow Coma Score (GCS-EM) and odds of extubation failure in patients with acute brain injury being liberated from mechanical ventilation. DESIGN: Secondary analysis of a prospective, multicenter observational study (ClinicalTrials.gov identifier NCT03400904). SETTING: Sixty-three hospital sites worldwide, with patient recruitment from January 2018 to November 2020. PATIENTS: One thousand one hundred fifty-two critically ill patients with acute brain injury, with a median age of 54 years, of whom 783 (68.0%) were male, 559 (48.5%) had traumatic brain injury, and 905 (78.6%) had a GCS-EM greater than 8 before extubation (scores range from 2 to 10). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: GCS-EM was computed in intubated patients on the day of extubation. The main outcome was extubation failure, defined as unplanned reintubation within 5 days of extubation. Analyses used multilevel logistic regression with adjustment for patient characteristics and a random intercept for hospital site. In the primary analysis, GCS-EM was not associated with extubation failure (odds ratio, 1.07 per additional point; 95% CI, 0.87-1.31). Findings were consistent in sensitivity analyses that: 1) used different adjustment covariates, 2) included a verbal estimate to derive an overall GCS, 3) accounted for missing data, 4) considered a 2-day time interval to define extubation failure, 5) accounted for competing risks, and 6) used a propensity score-based model. There was no association between GCS-EM and extubation outcome in subgroups defined by brain injury diagnosis or age. CONCLUSIONS: In this large, contemporary, multicenter cohort of patients with acute brain injury, we found no association between the GCS-EM and odds of extubation failure. However, few patients had a pre-extubation GCS-EM less than or equal to 8, and the possibility of a true prognostic association in patients with low scores is not excluded.

Impact of linked color imaging on the proximal adenoma miss rate: a multicenter tandem randomized controlled trial (the COCORICO trial).

BACKGROUND: Missed lesions are common during standard colonoscopy and are correlated with post-colonoscopy colorectal cancer. Contrast-enhanced technologies have recently been developed to improve polyp detection. We aimed to evaluate the impact of linked color imaging (LCI) on the proximal adenoma miss rate in routine colonoscopy. METHODS: This national, multicenter, tandem, randomized trial compared the outcomes of colonoscopy with white-light imaging (WLI) versus LCI for polyp detection in the right colon. Two consecutive examinations of the right colon (upstream of the hepatic flexure) were made with WLI and LCI by the same operator. First-pass examination by WLI or LCI was randomized 1:1 after cecal intubation. According to statistical calculations, 10 endoscopy units had to include approximately 700 patients. The primary outcome was proximal adenoma miss rate. Secondary outcomes were the proximal miss rates for sessile serrated lesions (SSL), advanced adenomas, and polyps. RESULTS: 764 patients were included from 1 January 2020 to 22 December 2022, and 686 patients were randomized (345 WLI first vs. 341 LCI first). Both groups were comparable in terms of demographics and indications. The proximal adenoma miss rate was not significantly higher in the WLI-first group (36.7%) vs. the LCI-first group (31.8%) (estimated mean absolute difference: 4.9% [95%CI -5.2% to 15.0%], P = 0.34). There was also no significant difference in miss rates for SSLs, advanced adenomas, and polyps in the proximal colon. CONCLUSIONS: In contrast to previous data, this study does not support the benefit of LCI to the proximal adenoma miss rate in routine colonoscopy.

Incidence and Outcomes of Acute Respiratory Distress Syndrome in Brain-Injured Patients Receiving Invasive Ventilation: A Secondary Analysis of the ENIO Study.

Background: Acute respiratory distress syndrome (ARDS) is an important pulmonary complication in brain-injured patients receiving invasive mechanical ventilation (IMV). We aimed to evaluate the incidence and association between ARDS and clinical outcomes in patients with different forms of acute brain injury requiring IMV in the intensive care unit (ICU). Methods: This was a preplanned secondary analysis of a prospective, multicenter, international cohort study (NCT03400904). We included brain-injured patients receiving IMV for ≥ 24 h. ARDS was the main exposure of interest and was identified during index ICU admission using the Berlin definition. We examined the incidence and adjusted association of ARDS with ICU mortality, ICU length of stay, duration of IMV, and extubation failure. Outcomes were evaluated using mixed-effect logistic regression and cause-specific Cox proportional hazards models. Results: 1492 patients from 67 hospitals and 16 countries were included in the analysis, of whom 137 individuals developed ARDS (9.2% of overall cohort). Across countries, the median ARDS incidence was 5.1% (interquartile range [IQR] 0-10; range 0-27.3). ARDS was associated with increased ICU mortality (adjusted odds ratio (OR) 2.66; 95% confidence interval [CI], 1.29-5.48), longer ICU length of stay (adjusted hazard ratio [HR] 0.59; 95% CI, 0.48-0.73), and longer duration of IMV (adjusted HR 0.54; 95% CI, 0.44-0.67). The association between ARDS and extubation failure approached statistical significance (adjusted HR 1.48; 95% CI 0.99-2.21). Higher ARDS severity was associated with incrementally longer ICU length of stay and longer cumulative duration of IMV. Findings remained robust in a sensitivity analysis evaluating the magnitude of unmeasured confounding. Conclusions: In this cohort of acutely brain-injured patients, the incidence of ARDS was similar to that reported in other mixed cohorts of critically ill patients. Development of ARDS was associated with worse outcomes.

Association of Noninvasive Respiratory Support with Extubation Outcomes in Brain-injured Patients Receiving Mechanical Ventilation: A Secondary Analysis of the ENIO Prospective Observational Study.

Rationale: Noninvasive respiratory support using a high-flow nasal cannula (HFNC) or noninvasive positive pressure ventilation (NIPPV) can decrease the risk of reintubation in patients being liberated from mechanical ventilation, but effects in patients with acute brain injury (ABI) are unknown. Objectives: To evaluate the association between postextubation noninvasive respiratory support and reintubation in patients with ABI being liberated from mechanical ventilation. Methods: This was a secondary analysis of a prospective, observational study of mechanically ventilated patients with ABI (clinicaltrials.gov identifier NCT03400904). The primary endpoint was reintubation during ICU admission. We used mixed-effects logistic regression models with patient-level covariates and random intercepts for hospital and country to evaluate the association between prophylactic (i.e., planned) HFNC or NIPPV and reintubation. Measurements and Main Results: 1,115 patients were included from 62 hospitals and 19 countries, of whom 267 received HFNC or NIPPV following extubation (23.9%). Compared with conventional oxygen therapy, neither prophylactic HFNC nor NIPPV was associated with decreased odds of reintubation (respectively, odds ratios of 0.97 [95% confidence interval, 0.54-1.73] and 0.63 [0.30-1.32]). Findings remained consistent in sensitivity analyses accounting for alternate adjustment procedures, missing data, shorter time frames of the primary endpoint, and competing risks precluding reintubation. In a Bayesian analysis using skeptical and data-driven priors, the probabilities of reduced reintubation ranged from 17% to 34% for HFNC and from 46% to 74% for NIPPV. Conclusions: In a large cohort of brain-injured patients undergoing liberation from mechanical ventilation, prophylactic use of HFNC and NIPPV were not associated with reintubation. Prospective trials are needed to confirm treatment effects in this population. Primary study registered with www.clinicaltrials.gov (NCT03400904).

Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome.

BACKGROUND : The diagnosis of cholangiocarcinoma in patients with a biliary stricture without mass syndrome can be obtained by biliary brushing with a sensitivity of ~50 %. We performed a multicenter randomized crossover trial comparing the aggressive Infinity brush with the standard RX Cytology Brush. The aims were to compare sensitivity for cholangiocarcinoma diagnosis and cellularity obtained. METHODS : Biliary brushing was performed consecutively with each brush, in a randomized order. Cytological material was studied with blinding to the brush type used and order. The primary end point was sensitivity for cholangiocarcinoma diagnosis; the secondary end point was the abundance of cellularity obtained with each brush, with cellularity quantified in order to determine if one brush strongly outperformed the other. RESULTS : 51 patients were included. Final diagnoses were cholangiocarcinoma (n = 43; 84 %), benign (n = 7; 14 %), and indeterminate (n = 1; 2 %). Sensitivity for cholangiocarcinoma was 79 % (34 /43) for the Infinity brush versus 67 % (29/43) for the RX Cytology Brush (P = 0.10). Cellularity was rich in 31/51 cases (61 %) with the Infinity brush and in 10/51 cases (20 %) with the RX Cytology Brush (P < 0.001). In terms of quantification of cellularity, the Infinity brush strongly outperformed the RX Cytology Brush in 28/51 cases (55 %), while the RX Cytology Brush strongly outperformed the Infinity brush in 4/51 cases (8 %; P < 0.001). CONCLUSIONS : This randomized crossover trial showed that the Infinity brush is not significantly more effective than the RX Cytology Brush for biliary stenosis without mass syndrome in terms of sensitivity for cholangiocarcinoma diagnosis, but does offer a significantly higher abundance of cellularity.

Modeling repeated self-reported outcome data: A continuous-time longitudinal Item Response Theory model.

Item Response Theory (IRT) models have received growing interest in health science for analyzing latent constructs such as depression, anxiety, quality of life or cognitive functioning from the information provided by each individual's items responses. However, in the presence of repeated item measures, IRT methods usually assume that the measurement occasions are made at the exact same time for all patients. In this paper, we show how the IRT methodology can be combined with the mixed model theory to provide a longitudinal IRT model which exploits the information of a measurement scale provided at the item level while simultaneously handling observation times that may vary across individuals and items. The latent construct is a latent process defined in continuous time that is linked to the observed item responses through a measurement model at each individual- and occasion-specific observation time; we focus here on a Graded Response Model for binary and ordinal items. The Maximum Likelihood Estimation procedure of the model is available in the R package lcmm. The proposed approach is contextualized in a clinical example in end-stage renal disease, the PREDIALA study. The objective is to study the trajectories of depressive symptomatology (as measured by 7 items of the Hospital Anxiety and Depression scale) according to the time from registration on the renal transplant waiting list and the renal replacement therapy. We also illustrate how the method can be used to assess Differential Item Functioning and lack of measurement invariance over time.

Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial.

OBJECTIVE: Endocuff Vision (ECV) is the second generation of a device designed to improve polyp detection. The aim of this study was to evaluate its impact on adenoma detection rate (ADR) in routine colonoscopy. DESIGN: This cluster-randomised crossover trial compared Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy. Two teams of 11 endoscopists each with prior ECV experience, balanced in terms of basal ADR, gender and case volume were compared. In randomised fashion, the teams started with ECV+ or ECV- and switched group after inclusion of half of the cases. The main outcome criterion was ADR difference between ECV+ and ECV-. Subgroup analysis was done for physicians with low and high ADR (< or ≥ 25%). RESULTS: During two periods of 20 and 21 weeks, respectively, the 22 endoscopists included 2058 patients (1032 ECV- vs 1026 ECV+, both groups being comparable). Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm. In the physician subgroup analysis, only high detectors showed a significant ADR increase (from 31% to 41%, p<0.001), while the increase in the low detectors was not significant (from 24% to 30%, p=0.11). ECV had a positive impact in all colonic locations, except for the rectum. No ECV- related complication was reported. CONCLUSION: We observed a significant ADR difference of approximately 10% by the use of ECV. By subgroup analysis, this increase was significant only in physicians classified as high detectors. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03344055).

22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy.

BACKGROUND : Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has been suggested for obtaining high quality tissue samples from pancreatic tumors. We performed a multicenter randomized crossover trial comparing EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle. The aims were to compare the quantity of targeted tissue (pancreas) and diagnostic accuracy for the two needles. METHODS : 60 patients admitted for EUS-FNB in three endoscopy units were included. One pass was performed consecutively with each needle, in a randomized order. Histologic material was studied in a blinded manner with respect to the needle. The primary end point was mean cumulative length of tissue core biopsies per needle pass. RESULTS : Final diagnosis was adenocarcinoma (n = 46; 77 %), neuroendocrine neoplasm (n = 11; 18 %), autoimmune pancreatitis (n = 2), and mass-forming chronic pancreatitis (n = 1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22G Acquire needle at 11.4 mm (95 % confidence interval [CI] 9.0 - 13.8] vs. 5.4 mm (95 %CI 3.8 - 7.0) for the 20G Procore needle (P < 0.001), as was the mean surface area (3.5 mm2 [95 %CI 2.7 - 4.3] vs. 1.8 mm2 [95 %CI 1.2 - 2.3]; P < 0.001). Diagnostic adequacy and accuracy were 100 % and 87 % with the 22G Acquire needle, and 82 % and 67 % with the 20G Procore needle (P = 0.001 and P = 0.02, respectively). CONCLUSIONS : EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.

Modeling Early Gambling Behavior Using Indicators from Online Lottery Gambling Tracking Data: Longitudinal Analysis.

BACKGROUND: Individuals who gamble online may be at risk of gambling excessively, but internet gambling also provides a unique opportunity to monitor gambling behavior in real environments which may allow intervention for those who encounter difficulties. OBJECTIVE: The objective of this study was to model the early gambling trajectories of individuals who play online lottery. METHODS: Anonymized gambling-related records of the initial 6 months of 1152 clients of the French national lottery who created their internet gambling accounts between September 2015 and February 2016 were analyzed using a two-step approach that combined growth mixture modeling and latent class analysis. The analysis was based upon behavior indicators of gambling activity (money wagered and number of gambling days) and indicators of gambling problems (breadth of involvement and chasing). Profiles were described based upon the probabilities of following the trajectories that were identified for the four indicators, and upon several covariates (age, gender, deposits, type of play, net losses, voluntary self-exclusion, and Playscan classification-a responsible gambling tool that provides each player with a risk assessment: green for low risk, orange for medium risk and red for high risk). Net losses, voluntary self-exclusion, and Playscan classification were used as external verification of problem gambling. RESULTS: We identified 5 distinct profiles of online lottery gambling. Classes 1 (56.8%), 2 (14.8%) and 3 (13.9%) were characterized by low to medium gambling activity and low values for markers of problem gambling. They displayed low net losses, did not use the voluntary self-exclusion measure, and were classified predominantly with green Playscan tags (range 90%-98%). Class 4 (9.7%) was characterized by medium to high gambling activity, played a higher breadth of game types (range 1-6), and had zero to few chasing episodes. They had high net losses but were classified with green (66%) or orange (25%) Playscan tags and did not use the voluntary self-exclusion measure. Class 5 (4.8%) was characterized by medium to very high gambling activity, played a higher breadth of game types (range 1-17), and had a high number of chasing episodes (range 0-5). They experienced the highest net losses, the highest proportion of orange (32%) and red (39%) tags within the Playscan classification system and represented the only class in which voluntary self-exclusion was present. CONCLUSIONS: Classes 1, 2, 3 may be considered to represent recreational gambling. Class 4 had higher gambling activity and higher breadth of involvement and may be representative of players at risk for future gambling problems. Class 5 stood out in terms of much higher gambling activity and breadth of involvement, and the presence of chasing behavior. Individuals in classes 4 and 5 may benefit from early preventive measures.

Comparison of 20-gauge Procore® and 22-gauge Acquire® needles for EUS-FNB of solid pancreatic masses: an observational study.

Background and Aims: Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) has been proposed to obtain high-quality tissue samples for pancreatic tumors. We performed an observational study to compare EUS-FNB with a 20-gauge Procore® needle versus a 22-gauge Acquire® needle. Our primary endpoint was the quantity of the obtained tissue, as defined by the mean cumulative length of tissue core biopsies per needle pass. Methods: Sixty-eight EUS-FNB were consecutively performed on patients with a pancreatic mass. The choice of needle depended on availability at the time of admission: 34 punctures were performed with each needle. Histological material was studied in a blinded manner with respect to the needle, and the cumulative length of tissue core biopsies per needle pass was determined. Intraobserver and interobserver variability of this criterion was then evaluated. Results: There were no between-group differences. Histological diagnosis was achieved and core biopsy specimens were obtained in 28 out of 34 patients (82%) in the 20-gauge Procore® group and in 33 out of 34 patients (97%) in the 22-gauge Acquire® group (p = .1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22-gauge Acquire® needle with 8.2 ± 4.2 mm versus 4.2 ± 3.8 mm for the 20-gauge Procore® needle (p < .01). No intra and inter-observer variability of this criterion was observed. Conclusions: Our results suggest significant differences, with a mean cumulative length of tissue core biopsies per needle pass significantly higher with the 22-gauge Acquire® needle. This simple criterion seems reliable and reproducible.

Cortisol total/CRP ratio for the prediction of hospital-acquired pneumonia and initiation of corticosteroid therapy in traumatic brain-injured patients.

BACKGROUND: To propose a combination of blood biomarkers for the prediction of hospital-acquired pneumonia (HAP) and for the selection of traumatic brain-injured (TBI) patients eligible for corticosteroid therapy for the prevention of HAP. METHODS: This was a sub-study of the CORTI-TC trial, a multicenter, randomized, double-blind, controlled trial evaluating the risk of HAP at day 28 in 336 TBI patients treated or not with corticosteroid therapy. Patients were between 15 and 65 years with severe traumatic brain injury (Glasgow coma scale score ≤ 8 and trauma-associated lesion on brain CT scan) and were enrolled within 24 h of trauma. The blood levels of CRP and cortisoltotal&free, as a surrogate marker of the pro/anti-inflammatory response balance, were measured in samples collected before the treatment initiation. Endpoint was HAP on day 28. RESULTS: Of the 179 patients with available samples, 89 (49.7%) developed an HAP. Cortisoltotal&free and CRP blood levels upon ICU admission were not significantly different between patients with or without HAP. The cortisoltotal/CRP ratio upon admission was 2.30 [1.25-3.91] in patients without HAP and 3.36 [1.74-5.09] in patients with HAP (p = 0.021). In multivariate analysis, a cortisoltotal/CRP ratio > 3, selected upon the best Youden index on the ROC curve, was independently associated with HAP (OR 2.50, CI95% [1.34-4.64] p = 0.004). The HR for HAP with corticosteroid treatment was 0.59 (CI95% [0.34-1.00], p = 0.005) in patients with a cortisoltotal/CRP ratio > 3, and 0.89 (CI95% [0.49-1.64], p = 0.85) in patients with a ratio < 3. CONCLUSION: A cortisoltotal/CRP ratio > 3 upon admission may predict the development of HAP in severe TBI. Among these patients, corticosteroids reduce the occurrence HAP. We suggest that this ratio may select the patients who may benefit from corticosteroid therapy for the prevention of HAP.

Impact of Low-Dose Hydrocortisone on the Incidence of Atrial Fibrillation in Patients With Septic Shock: A Propensity Score-Inverse Probability of Treatment Weighting Cohort Study.

PURPOSE: Atrial fibrillation (AF) is common in the intensive care unit (ICU), notably in patients with septic shock for whom inflammation is an already identified risk factor. The aim of this study was to evaluate the effect of low-dose hydrocortisone on AF occurrence in patients with septic shock. METHODS: We performed a prospective nonrandomized observational study in 5 academic ICUs in France. From November 2012 to June 2014, all patients ≥16 years having septic shock were included, except those who had a history of AF, had a pacemaker, and/or experienced AF during hospitalization before the onset of shock or in whom the onset of shock occurred prior to admission to the ICU. Hydrocortisone was administered at the discretion of the attending physician. The incidence of AF was compared among patients who received hydrocortisone, and the effect of low-dose hydrocortisone on AF was estimated using the inverse probability treatment weighting method based on propensity scores. RESULTS: A total of 261 patients were included (no-hydrocortisone group, n = 138; hydrocortisone group, n = 123). Atrial fibrillation occurred in 57 (22%) patients. Atrial fibrillation rates were 33 (24%) and 24 (19%) in no-hydrocortisone patients and hydrocortisone patients, respectively. In the weighted sample, the proportion of patients who developed AF was 28.8% in the no-hydrocortisone group and 16.8% in the hydrocortisone group (difference: -11.9%; 95% confidence interval: -23.4% to -0.5%; P = .040). CONCLUSION: In patients with septic shock, low-dose hydrocortisone was associated with a lower risk of developing AF during the acute phase.

Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study.

Background and study aims Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones. Methods Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed. Results There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group (P < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; P < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; P = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones. Conclusions Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.Trial registered at ClinicalTrials.gov (NCT02592811).

A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).

Background and study aims: The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice. Patients and methods: The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding. Results: A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy. Conclusion: These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02595853).

Exhausted implanted pulse generator in sacral nerve stimulation for faecal incontinence: What next in daily practice for patients?

PURPOSE: The efficacy of sacral nerve stimulation in faecal incontinence relies on an implanted pulse generator known to have a limited lifespan. The long-term use of sacral nerve stimulation raises concerns about the true lifespan of generators. The aim of the study was to assess the lifespan of sacral nerve stimulation implanted pulse generators in daily practice, and the outcome of exhausted generator replacement, in faecal incontinent patients. METHODS: Faecal incontinent patients with pulse generators (Medtronic Interstim™ or InterstimII™) implanted in a single centre from 2001 to 2014 were prospectively followed up. Generator lifespan was measured according to the Kaplan-Meier method. Patients with a generator explanted/turned off before exhaustion were excluded. Morbidity of exhausted generator replacement and the outcome (Cleveland Clinic Florida Faecal Incontinence (CCF-FI) and Faecal Incontinence Quality of Life (FIQL) scores) were recorded. RESULTS: Of 135 patients with an implanted pulse generator, 112 (InterstimII 66) were included. Mean follow-up was 4.9 ± 2.8 years. The generator reached exhaustion in 29 (26%) cases. Overall median lifespan of an implanted pulse generator was approximately 9 years (95% CI 8-9.2). Interstim and InterstimII 25th percentile lifespan was 7.2 (CI 6.4-8.3) and 5 (CI 4-not reached) years, respectively. After exhaustion, generators were replaced, left in place or explanted in 23, 2 and 4 patients, respectively. Generator replacement was virtually uneventful. CCF-FI/FIQL scores remained unchanged after generator replacement (CCF-FI 8 ± 2 vs 7 ± 3; FIQL 3 ± 0.6 vs 3 ± 0.5; p = ns). CONCLUSION: In this study, the implanted pulse generator observed median lifespan was 9 years. After exhaustion, generators were safely and efficiently replaced. The study also gives insight into long-term needs and costs of sacral nerve stimulation (SNS) therapy.

Power and sample size determination for group comparison of patient-reported outcomes using polytomous Rasch models.

The analysis of patient-reported outcomes or other psychological traits can be realized using the Rasch measurement model. When the objective of a study is to compare groups of individuals, it is important, before the study, to define a sample size such that the group comparison test will attain a given power. The Raschpower procedure (RP) allows doing so with dichotomous items. The RP is extended to polytomous items. Several computational issues were identified, and adaptations have been proposed. The performance of this new version of RP is assessed using simulations. This adaptation of RP allows obtaining a good estimate of the expected power of a test to compare groups of patients in a large number of practical situations. A Stata module, as well as its implementation online, is proposed to perform the RP. Two versions of the RP for polytomous items are proposed (deterministic and stochastic versions). These two versions produce similar results in all of the tested cases. We recommend the use of the deterministic version, when the measure is obtained using small questionnaires or items with a few number of response categories, and the stochastic version elsewhere, so as to optimize computing time.

Power and sample size determination for the group comparison of patient-reported outcomes using the Rasch model: impact of a misspecification of the parameters.

BACKGROUND: Patient-reported outcomes (PRO) are important as endpoints in clinical trials and epidemiological studies. Guidelines for the development of PRO instruments and analysis of PRO data have emphasized the need to report methods used for sample size planning. The Raschpower procedure has been proposed for sample size and power determination for the comparison of PROs in cross-sectional studies comparing two groups of patients when an item reponse model, the Rasch model, is intended to be used for analysis. The power determination of the test of the group effect using Raschpower requires several parameters to be fixed at the planning stage including the item parameters and the variance of the latent variable. Wrong choices regarding these parameters can impact the expected power and the planned sample size to a greater or lesser extent depending on the magnitude of the erroneous assumptions. METHODS: The impact of a misspecification of the variance of the latent variable or of the item parameters on the determination of the power using the Raschpower procedure was investigated through the comparison of the estimations of the power in different situations. RESULTS: The power of the test of the group effect estimated with Raschpower remains stable or shows a very little decrease whatever the values of the item parameters. For most of the cases, the estimated power decreases when the variance of the latent trait increases. As a consequence, an underestimation of this variance will lead to an overestimation of the power of the group effect. CONCLUSION: A misspecification of the item difficulties regarding their overall pattern or their dispersion seems to have no or very little impact on the power of the test of the group effect. In contrast, a misspecification of the variance of the latent variable can have a strong impact as an underestimation of the variance will lead in some cases to an overestimation of the power at the design stage and may result in an underpowered study.

Does missing data matter in the revised Patients' Attitudes Towards Deprescribing questionnaire? A systematic review and two case analyses.

BACKGROUND: The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire was developed to capture beliefs and perceptions of patients about deprescribing. In general, handling of missing data is underreported in survey studies. Underlying mechanisms related to missing data may impact the findings from survey studies. OBJECTIVES: The aim of this study was to assess the missing data in studies using the rPATD questionnaire through a systematic review and datasets from two studies. METHODS: First, this review updated a systematic review on the rPATD (and other versions). We searched Medline via OVID, EMBASE, Scopus, Web of Science until 31st January 2023. Missing data reporting and methods to handle them were collected. Second, data from two deprescribing studies were analyzed using three methods of missing data handling: complete case analysis, personal mean substitution, and multiple imputation. We compared the scores from each domain and the associations of the domains with two questions from the rPATD to highlight how using different methods can influence the interpretation of study findings. RESULTS: We identified 49 studies: 31 (63 %) from this study and 18 (37 %) from the original systematic review. The question or domain with the most missing data could be identified in 9 studies (18.4 %). Missing data management was reported in 19 studies (38.8 %). In one case analysis, the "Burden" domain was significantly associated with the question "I would like to try stopping one of my medicines to see how I feel without it" using complete case analysis (p = 0.044) or multiple imputation (p = 0.038), but not when using personal mean substitution (p = 0.057). CONCLUSIONS: Missing data and methods used to handle missing data were underreported in studies using the rPATD questionnaire. The methods should be chosen carefully as our analyses from two distinct studies suggest that they may impact the interpretation of the findings from the questionnaire.

Spatial attention to social information in poker: A neuropsychological study using the Posner cueing paradigm.

Background and aims: This research aimed to characterize social information processing abilities in a population of regular nondisordered poker players compared to controls. Methods: Participants completed the Posner cueing paradigm task including social cues (faces) to assess attention allocation towards social stimuli, including the effect of the presentation time (subliminal vs supraliminal) and of the emotion displayed. The study included two groups of participants: 30 regular nondisordered poker players (those who played at least three times a week in Texas Hold'em poker games for at least three months) and 30 control participants (those who did not gamble or gambled less than once a month, whatever the game). Results: The group of regular nondisordered poker players displayed an enhancement of the inhibition of return during the Posner cueing task. This means that in valid trials, they took longer to respond to the already processed localization in supraliminal conditions compared to controls. However, our results did not evidence any particular engagement or disengagement attention abilities toward specific types of emotion. Discussion and Conclusions: These results suggest that regular nondisordered poker players displayed social information processing abilities, which may be due to the importance to efficiently process social information that can serve as tells in live poker. The observed enhancement of the inhibition of return may permit poker players to not process a localization that has already processed to save attentional resources. Further research regarding the establishment of the IOR in other forms of gambling and with non-social cues needs to be performed.

Gambling and COVID-19: Swedish national gambling data from a state-owned gambling sports and casino operator.

Background and aims: The lockdown of sports and gambling venues during the coronavirus disease 2019 (COVID-19) pandemic caused a fear of increased gambling on other online gambling types, with a risk for transfer to more addictive gambling than otherwise. This study aimed to estimate changes in gambling activity during COVID-19-affected periods among all gamblers at a Swedish state-owned gambling operator and to analyse observable sex differences. Methods: This study included gambling tracking data from the Swedish state-owned gambling operator Svenska Spel Sports & Casino (sports betting, online bingo, casino and poker). All individuals (n = 616,245) who gambled at least once from February 10 to July 19, 2020, were included. The study period was divided into four periods according to their expected level of COVID-19 impact on gambling opportunities: one pre-COVID period and three COVID-affected periods (sports cancellation, emerging return of sports, substantial return of sports). Results: Sports betting experienced an apparent decrease, followed by a gradual normalization and an end level substantially below prepandemic levels. For online bingo, gambling levels increased upon sports interruption and then decreased with the return to normality in sports events but remained higher than baseline levels. We observed a similar trend for online poker during the interruption of sports, but with a lower level than baseline levels when sports events normalized. We noticed a trend favouring online casinos during the sports interruption period regarding gambling intensity but not wagering levels. Discussion and conclusions: Dramatic changes in the content of the gambling market may divert some gamblers to other gambling types, but maintained effects could not be demonstrated.