bluuebunny/crossref_metadata_2025_split huggingface dataset:
P544 Point-of-care finger prick test for C-reactive protein, infliximab and adalimumab serum concentrations
Authors: Volkers A , Löwenberg M , Bray K , Bahur B , Braad M , Abeling Y , Gecse K , Duijvestein M , Ponsioen C , D’Haens G 
Published: May 2021

Abstract

Background
Point-of-Care tests (POCTs) allow instant measurement of inflammatory markers and/or drug concentrations. However, currently available POCTs for infliximab (IFX) and adalimumab (ADL) serum concentrations are time consuming. Recently, a new POCT device (ProciseDx, San Diego, CA, USA) was developed which conveniently measures C-reactive protein (CRP), IFX and ADL capillary concentrations within minutes. We aimed to validate this device by comparing POCT results with conventional laboratory tests for serum CRP, IFX and ADL in patients with inflammatory bowel disease (IBD).

Methods
IBD patients requiring routine measurement of serum CRP, IFX or ADL were invited to participate. Along with serum collection, 20μl of capillary blood was obtained via finger prick and dispensed in a cartridge with a buffer, and placed in the POCT device providing results within two to four minutes. Forty patients were needed to validate the CRP POCT, as this assay was already previously validated in a different population. For the IFX and ADL assays, 120 patients using IFX or ADL were required to validate the POCT. Agreement between the laboratory serum assay and POCT was visualized on a scatter diagram and a Bland-Altman plot. Deming regression was calculated to demonstrate agreement. In addition, Pearson’s correlation coefficient was calculated.

Results
Until now, 41 patients have been enrolled for the CRP assay, 120 patients for the IFX and 46 patients for the ADL assay. Two ADL patients were sampled twice (n=48). Significant correlations were found for CRP, IFX and ADL (r=0.98, r=0.88 and r=0.86 respectively, Fig. 1). Deming regression analysis of the CRP assay resulted in a slope of 0.71 (95% CI 0.49 to 0.93) and 1.5 (95% CI -0.44 to 3.50) for the intercept. For the IFX assay, the slope was 1.1 (95% CI 0.83 to 1.3) and the intercept was 1.4 (95% CI -0.47 to 3.4). For the ADL assay, the slope was 0.97 (95% CI 0.64 to 1.3) and the intercept was 2.3 (95% CI -0.64 to 5.2).

Conclusion
A novel POCT using a finger prick approach provides a rapid, user friendly and reliable measurement of CRP, IFX and ADL concentrations within minutes. The capillary CRP was slightly lower than the venous serum CRP, which was consistently observed and considered clinically irrelevant in this cohort.
P566 Impact of induction therapy and clinical remission on resting energy expenditure in children with Crohn’s Disease
Authors: Kornitzer G , Breton J , Poinsot P , Godin D , Grzywacz K , Deslandres C , Groleau V 
Published: May 2021

Abstract

Background
Crohn’s Disease (CD) is known to affect nutritional status and linear growth in affected children. Patients with CD often have decreased oral intake, malabsorption, and increased intestinal losses. Basal metabolic rate may be affected by chronic inflammation and states of anorexia or malnutrition in these patients. In this study, our aim was to compare the effect of different induction regimens in children with CD on resting energy expenditure (REE) and nutritional status.

Methods
We recruited patients under 18 years old with new-onset CD or relapse, diagnosed at our centre over a three-year period from July 2016. Patients included had one of the following induction regimens: corticosteroids, exclusive enteral nutrition (EEN), or anti-TNF therapy (Infliximab). REE was assessed at baseline and 6 to 8 weeks after induction. REE (kcal/d) was measured using an open-circuit indirect calorimeter with computerized metabolic cart (Vmax Encore, Vyaire Medical). Secondary outcomes included anthropometrics and clinical and biochemical response, defined by improved wPCDAI and negative inflammatory markers and fecal calprotectin, respectively.

Results
17 patients were enrolled and 8 patients excluded (loss to follow-up (n=3), therapeutic change (n=3), revised diagnosis (n=2)). 9 patients completed REE assessments (44.4% anti-TNF (n=4), 44.4% EEN (n=4), 11.1% corticosteroid (n=1)). 3 out of 4 patients on anti-TNF had clinical and biochemical response, while only 1 of 4 patients responded to EEN. For patients in the EEN group, mean BMI change was +0.9 (SD 0.4), compared to +0.4 (SD 1.1) in the anti-TNF group. There was no difference in REE change between treatment groups. Data was then pooled based on response to treatment. 100% of non-responders had increased per cent of predicted REE (REEPP), while 75% of responders decreased their REEPP. Mean REEPP change in non-responders was +12.5% (1, 22) vs. -4.3% (-10, 6) in responders.

Figure I. Relationship between REE and weight at baseline and on follow-up in non-responders.

Figure II. Relationship between REE and weight at baseline and on follow-up in responders.

Conclusion
Our results suggest that induction regimen did not impact REE change on follow-up. In our patients, clinical response to therapy was related to a tendency to decrease REE. Patients who did not achieve remission after induction therapy increased their REE. We suspect that this increase in basal metabolic rate is related to persistent inflammation despite improved nutritional status. Further studies with larger patient populations are needed to infer significance and compare subgroups based on body composition.
P596 Trough concentration of ustekinumab was a useful biomarker for the prediction of treatment-effects in patients with Crohn’s Diseases
Authors: Kato S , Yamaga N , Ishibashi A , Kani K , Yakabi K , Nagoshi S 
Published: May 2021

Abstract

Background
Ustekinumab, anti-IL12/23 antibody have contributed to the good prognosis in patients with Crohn’s disease (CD). However, good biomarkers for the prediction of treatment- effects of ustekinumab (UST) are not clear. We elucidated whether trough concentration of UST could predict the clinical remission and seronegative inflammation in CD patients in clinical practice.

Methods
This was a single-centre prospective observational study approved by the institutional review board of our hospital. Forty CD patients treated by administration of intravenous UST 6 mg/kg and subcutaneous UST 90mg every 8 weeks were enrolled in this study. CDAI, serum CRP and plasma UST trough concentration were evaluated at every visit. All data were examined in total patients, patients with UST induction at remission state after pretreatment (Induction at remission group) and patients with UST induction at active state after pretreatment (Induction at non-remission group). Endpoints were time course changes of clinical remission rate, CDAI, CRP and UST trough concentration until week 40.

Results
In total, 40 participants were included in the final analysis. The mean age and disease duration of the participants were 41.3 and 11.7 years. Of the participants, 65% (26/40) were male, 25% (10/40) used thiopurine, and 30% (12/40) used steroids. TNF-failure of the patients were 65.0% (26/40). Remission rate of total patients significantly increased at week 8 (30, 60, 68, 78, 78, and 73% at every 8 weeks from baseline). Both CDAI and CRP significantly decreased from baseline at week 8. Remission rate of Induction at remission group (n=12) did not significantly decrease from baseline (100, 92, 92, 92, 92, and 83% at every 8 weeks from baseline). Remission rate of Induction at non-remission group (n=28) significantly increased until week 24 from baseline (0, 46, 57, 71, 71, and 68% at every 8 weeks from baseline). Trough concentrations of total patients at week 8, 16, 24 were 3.54, 1.57 and 1.43 μg/mL, respectively. Trough at each week was not significantly different between Induction at remission and at non-remission groups. Immunomodulator use did not affect trough concentration. Cut-off values of prediction for remission at week 8, 16, and 24 were 2.80, 1.28* and 1.12* μg/mL, respectively. Cut-off values of prediction for normal CRP at week 8, 16, and 24 were 3.27, 1.24* and 1.24* mg/mL, respectively (*: Each factor significantly could be detected).

Conclusion
UST trough concentration at subcutaneous injection could predict clinical remission and normal CRP. Pretreatment did not affect UST trough concentration.
P618 Treatment outcomes of patients with Crohn’s disease and complex perianal fistula in five European countries: the PREFACE retrospective study
Authors: Ferrante M , Siproudhis L , Poggioli G , Reinshagen M , Milicevic S , Roset M , Bent-Ennakhi N , D’Ambrosio R , Fernandez-Nistal A , Panes J 
Published: May 2021

Abstract

Background
Presence of fistulas in Crohn’s disease (CD) is an indicator of poor prognosis; 20% of CD patients suffer from perianal fistula. There are few studies specifically designed to assess treatment outcomes in complex perianal fistula (CPF) in CD. This retrospective chart review study describes the outcomes of patients with CPF in CD in five European countries after medical and/or surgical treatment.

Methods
Adult patients with CD receiving treatment for a new episode of CPF during the eligibility period (September 2011 to September 2014), in Belgium, France, Germany, Italy and Spain, were included. Index date was defined as date of any medical or surgical CPF treatment initiation. Data was collected from CD diagnosis to at least 3 years after index date (except for deceased or lost to follow-up patients) to describe patient characteristics and treatments used for all CPF episodes since CD diagnosis. Effectiveness outcomes were measured as remission rates based on Fistula Drainage Assessment (FDA) recorded in medical charts for fistula reported at index date (index fistula). Remission rates are expressed as percentage rates on patient level after 6- and 12-months follow-up period. For calculation of treatment outcomes, the most recent FDA prior to the respective timepoint was used.

Results
A total of 372 patients (51% male) with a mean (SD) age of 38 (13) were included by 31 sites. Median time since CD diagnosis was 7 years, and median length of follow-up was 6 years. A total of 498 CPFs were presented at index date and during FU period. Out of the 498 CPFs, 94% were treated with at least one surgical intervention (most frequent: 61% long-term seton placement, 51% surgical drainage) and 82% with at least one medical treatment (most frequent: 40% anti-TNFs, 33% antibiotics, 16% immunosuppressants). After 6 months the remission rate at patient level for index fistula was 28% and after 12 months 35%.

Conclusion
Current standards of care achieved remission in one third of patients with CPF in CD over a period of one year. Improved therapeutic strategies and new treatment options are required to improve outcomes in this manifestation of CD.
P627 Change in urgency among ulcerative colitis patients: Analyses from the SPARC IBD
Authors: Lewis J , Shan M , Xhou X , Naegeli A , Hunter T 
Published: May 2021

Abstract

Background
The objective of this study was to assess the changes in prevalence and severity of fecal urgency in Ulcerative Colitis (UC) patients at 6-months from their enrollment visit.

Methods
Data from patients in the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD) were analyzed. UC patients that had an enrollment visit and 6-month visit were included in these analyses. Fecal urgency at each visit was assessed on a scale ranging from 0 (none) to 4 (severe). The change in urgency status from enrollment visit to 6-months is categorized as Improvement (decrease of 1–3 points), No Change, or Worsening (increase of 1–3 points). Descriptive statistics and contingency tables were created to summarize baseline characteristics by fecal urgency group. Chi-square tests, Fisher’s exact tests, ANOVA and Wilcoxon rank sum tests were conducted to compare the distribution of baseline characteristics between change in urgency groups, with Bonferroni corrections used for multiple comparisons.

Results
Data from 272 UC patients were included in this analysis. 25% of UC patients had an improvement in urgency, 54.4% had no change, 20.6% had a worsening of urgency at 6-months from their enrollment visit.
When compared to patients that had no change in urgency at 6-months, UC patients that had improvement in urgency were more likely to have a higher baseline UCDAI (p&lt;0.0001), mean daily bowel movements (p&lt;0.0001), mean daily liquid bowel movements (P&lt;0.0001), elevated stool frequency relative to their normal when well (p&lt;0.0001), liquid stool consistency (p=0.0418), blood in stools (p=0.0001), abdominal pain (p=0.0065), moderate/severe fecal urgency (p&lt;0.0001), worse general well-being (p&lt;0.0001), moderate/severe Physician Global Assessment (PGA) (p=0.0013), and steroid use (p=0.0287) (Table 1). When compared to patients with worsening urgency at 6-months, UC patients that had an improvement in urgency at 6-months were more likely to have a higher baseline UCDAI (p&lt;0.0001), mean daily bowel movements (p&lt;0.0001), mean daily liquid bowel movement (P&lt;0.0001), more stool frequency relative to their normal when well (p&lt;0.0001), moderate/severe fecal urgency (p&lt;0.0001), worse general well-being (p=0.0053), and moderate/severe PGA (p=0.0022). There were no statistically significant differences in baseline characteristics between UC patients that had a worsening or no change in urgency at 6-months.

Conclusion
Fecal urgency is a common symptom among UC patients. Urgency is not a stable symptom, with nearly 50% experiencing either worsening or improvement over 6-months. Worse disease activity at enrollment in the cohort was associated with improved fecal urgency symptoms over 6-months.
P684 Multiplex Gastrointestinal Pathogen Panel Testing is Associated with Higher Rates of Inflammatory Bowel Disease Therapy Escalation in Patients Hospitalised with Flare
Authors: Verma A , Axelrad J 
Published: May 2021

Abstract

Background
Although the role of Clostridioides difficile infection (CDI) testing in inflammatory bowel disease (IBD) flare is well established, the function of additionally testing for non-CDI enteric infections (EI) via multiplex gastrointestinal pathogen polymerase chain reaction (GI panel) stool tests remains unclear. Patients with PCR-confirmed EI are less likely to have IBD therapy escalated; however, it is unknown whether performing testing itself affects IBD-related decision-making and outcomes. This is vital given the similar clinical presentations of flare and EI. We examined differences in IBD outcomes among patients who – in addition to testing for CDI – were and were not co-tested for EI during hospitalisation for flare.

Methods
We conducted a retrospective cohort study of IBD patients hospitalised with flare and tested for CDI at an urban academic medical centre. We collected data on demographics, IBD disease severity, IBD therapy, and antibiotic therapy. Patients were cohorted by co-testing for EI using a GI panel. The primary outcome was escalation of IBD therapy within 24 hours of emergency department presentation. Each IBD therapy was also studied separately. Secondary outcomes were antibiotic therapy, length of stay, and colectomy.

Results
Of 134 patients, 66 (49.3%) were co-tested and 7 (10.6%) had an EI detected. Disease severity and CDI rates were comparable between groups (Table 1). Co-tested patients were more likely to receive a new IBD therapy (92.4% vs. 75.0%, p=0.006), specifically intravenous (IV) steroids (89.4% vs. 36.8%, p=&lt;0.001; Table 2). Patients who were not co-tested were more likely to have their existing IBD therapy continued on admission. Co-tested patients were less likely to undergo colonoscopy during admission and had lower rates of prolonged antibiotic therapy (&gt;10 days; 4.5% vs. 14.7%, p=0.047), although prolonged antibiotic use was comparable between groups after excluding patients treated for CDI (5.1% co-tested vs. 1.8% not co-tested, p=0.276). Colectomy rates and length of stay were comparable between groups.

Conclusion
Co-testing for non-CDI enteric pathogens by GI panel was associated with a greater degree of inpatient IBD flare management – especially IV steroids. Patients not co-tested were more likely to stay on their existing IBD therapy regimen despite similar flare severities at presentation. Given the low pathogen detection rates, early negative testing for EI may promote provider confidence in intensifying IBD therapy. Early clinical improvement after therapy escalation may obviate the need for colonoscopy in these patients. Use of the GI panel may affect IBD decision-making during relapse, and should be considered in all IBD patients hospitalised with flare.
Ultrasound-guided genicular nerves block: an analgesic alternative to local infiltration analgesia for total knee arthroplasty
Authors: Pietrantoni Pierangela , Cuñat Tomás , Nuevo-Gayoso Montserrat , Martín Nuria , Tió Montserrat , Basora Misericordia , Sastre Sergi , Sala-Blanch Xavier 
Published: May 2021

BACKGROUND
Standard analgesic strategies for total knee arthroplasty employ local infiltration analgesia. Blockade and radiofrequency ablation of the genicular nerves are effective treatments for patients with chronic pain because of knee osteoarthritis.

OBJECTIVE
To test the noninferiority of the analgesic effect of genicular nerves block in comparison with local infiltration analgesia after 24 h of total knee arthroplasty.

DESIGN
Prospective cohort study.

SETTING
Perioperative setting.

PATIENTS
Thirty-five patients scheduled for total knee arthroplasty were prospectively included in the study and compared with 35 patients in a retrospective cohort.

INTERVENTION
Genicular nerve blocks in the prospective cohort were compared with local infiltration analgesia in the retrospective cohort.

MAIN OUTCOME MEASURES
The pain numeric rating scale and the cumulative opioid consumption in oral morphine equivalents during the first 24 h.

RESULTS
We conducted propensity score-matched analyses of patients using acute postoperative pain-related risk covariates. After one-to-one propensity score matching, 21 patients were included in the local infiltration analgesia group and 21 in the genicular nerve block group. The median difference in numeric rating score at rest at 24 h was −0.99 [95% confidence interval (CI), −1.99 to 0.5, P = 0.012] on the unmatched cohort and −1.9 (95% CI, −2 to 0, P = 0.002) on the matched cohort (meeting the noninferiority criteria, Δ=1). The median difference in cumulative opioid consumption was 2.5 mg (95% CI, −13.5 to 2.5, P < 0.001) for the unmatched cohort and 4.99 mg (95% CI, −11.5 to 2.5, P < 0.001) on the matched group (meeting the noninferiority criteria, Δ = 21 mg).

CONCLUSION
Local infiltration analgesia and genicular nerve block are comparable in terms of analgesic results. Therefore, genicular nerves block is an alternative to local infiltration analgesia in patients undergoing total knee arthroplasty.

TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT04024319.
Trends in combat casualty care following the publication of clinical practice guidelines
Authors: Nadler Roy , Tsur Avishai M. , Lipsky Ari M. , Benov Avi , Sorkin Alex , Glassberg Elon , Chen Jacob 
Published: May 2021

BACKGROUND
The current study explores the trends in the application of combat casualty care following the publication of clinical practice guidelines (CPGs) in five domains for 13 years.

METHODS
The Israel Defense Forces Trauma Registry was used to assess practice and adherence to guidelines in five domains: (a) crystalloid transfusions, (b) tranexamic acid use, (c) freeze-dried plasma use, (d) chest decompression, and (e) airway management. All patients injured between January 2006 and December 2018 were included in the analysis. Trends were analyzed and presented monthly using linear regression and were compared using the Chow test.

RESULTS
The mean ± SD crystalloid volume transfused decreased from 1,179 ± 653 mL in 2006 to 466 ± 202 mL in 2018 (B = 0.016, 0.006–0.044). The proportion of patients with an indication treated with tranexamic acid dropped from 8% (238 of 2,979 patients) to 2.5% (60 of 2,356 patients) following the stricter guideline's publication. Freeze-dried plasma administration in indicated casualties rose from 12.5% in 2013 to 48% in 2018 (B = 1.63, 1.3–2.05). The overall proportion of casualties undergoing chest decompression rose from 1% (61 of 6,036 casualties) to 1.5% (155 of 10,493 casualties) following the release of a new CPG in 2012 (p = 0.013). There were no significant trends in intubation ratios before (B = 0.987, 0.953–1.02) or after 2012 (B = 10.2, 0.996–1.05).

CONCLUSION
Some aspects demonstrate the desired trends in response to new CPGs; in others, initial improvement is achieved but followed by stagnation. In some medical care aspects, completely unexpected and undesirable trends are observed. Every change and update in CPGs should be based on reliable data. The effect of every change must be monitored carefully to ensure adequate adherence to lifesaving guidelines.

LEVEL OF EVIDENCE
Epidemiological study, level IV.
Safety and efficacy of low-titer O whole blood resuscitation in a civilian level I trauma center
Authors: Kemp Bohan Phillip M. , McCarthy Patrick M. , Wall Morgan E. , Adams Alexandra M. , Chick Robert C. , Forcum Jason E. , Radowsky Jason S. , How Remealle A. , Sams Valerie G. 
Published: May 2021

BACKGROUND
Military experience has shown low-titer O whole blood (LTOWB) to be safe and beneficial in the resuscitation of hemorrhaging trauma patients. However, few civilian centers use LTOWB for trauma resuscitation. We evaluated the early experience and safety of a LTOWB program at a level 1 civilian trauma center.

METHODS
We retrospectively reviewed our trauma registry from January 2018 to June 2020 for patients admitted in shock (defined as ≥1 of the following: heart rate, >120 beats per minute; systolic blood pressure, <90 mm Hg; or shock index, >0.9) who received blood products within 24 hours. Patients were grouped by resuscitation provided: LTOWB (group 1), component therapy (CT; group 2), and LTOWB-CT (group 3). Safety, outcomes, and variables associated with LTOWB transfusion and mortality were analyzed.

RESULTS
216 patients were included: 34 in Group 1, 95 in Group 2, and 87 in Group 3. Patientsreceiving LTOWB were more commonly male (p<0.001) and had a penetrating injury (p=0.005). Groups 1 and 3 had higher median ISS scores compared to Group 2 (19 and 20 vs 17; p=0.01). Group 3 received more median units of blood product in the first 4h (p<0.001) and in the first 24h (p<0.001). There was no difference between groups in 24h mortality or transfusion-related complications (all p>0.05). Arrival ED SBP was associated with LTOWB transfusion (odds ratio [OR] 0.98, 95% confidence interval [CI] 0.95-1.00, p=0.03). ED lactate was independently associated with 24h mortality. (OR 1.27, CI 1.02-1.58, p=0.03). LTOWB transfusion was not associated with mortality (p=0.49). Abstract.

CONCLUSION
Severely injured patients received LTOWB-CT and more overall product units but had similar 24 h mortality when compared with the LTOWB or CT groups. No increase in transfusion-related complications was seen after LTOWB transfusion. Low-titer O whole blood should be strongly considered in the resuscitation of trauma patients at civilian centers.

LEVEL OF EVIDENCE
Retrospective, therapeutic, level IV.