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Has the therapeutical ceiling been reached in Crohn’s disease randomized controlled trials? A systematic review and meta-analysis

United European Gastroenterol J. 2023 Mar 6. doi: 10.1002/ueg2.12366. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: The availability of biological agents for inflammatory bowel disease has increased over the past years. In this systematic review and meta-analysis, we aimed to explore time trends in clinical response and clinical remission rates in Crohn’s disease (CD) patients treated with biologics while discussing the need for new strategies.

METHODS: MEDLINE, Cochrane, and ISI Web of Science databases were searched for randomized placebo-controlled trials with biological agents in moderate-to-severe CD patients. Sub-group and meta-regression analyses compared treatment and placebo by calculating the pooled odds ratios of clinical remission and clinical response, across time categories and publication year. We also estimated the proportion of patients achieving clinical remission and clinical response by comparing both groups according to the publication year.

RESULTS: Twenty-five trials were included in the systematic review, which enrolled 8879 patients between 1997 and 2022. The clinical remission and clinical response odds, in induction and maintenance, have been constant over time, as no statistically significant differences were found between time categories (interaction p-values: clinical remission [induction, p = 0.19; maintenance, p = 0.24]; clinical response [induction, p = 0.43; maintenance, p = 0.59]). In meta-regression analyses, publication year did not influence these outcomes (clinical remission [induction, OR 1.01{95% CI 0.97-1.05}, p = 0.72; clinical response [induction, OR 1.01{95% CI 0.97-1.04]; p = 0.63; maintenance, OR 1.03{95% CI 0.98-1.07}; p = 0.21]), with the exception of clinical remission in maintenance studies, which presented a decreased effect (odds ratio 0.97{95% CI 0.94-1.00}, p = 0.03]).

CONCLUSIONS: Our review highlights that the odds of clinical outcomes in CD patients receiving biological treatment relative to placebo have been stable in the last decades.

PMID:36876515 | DOI:10.1002/ueg2.12366

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Early Use of Extracorporeal Membrane Oxygenation for Traumatically Injured Patients: A National Trauma Database Analysis

Am Surg. 2023 Mar 6:31348231161082. doi: 10.1177/00031348231161082. Online ahead of print.

ABSTRACT

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) in acute trauma patients is a poorly characterized event. While ECMO most commonly has been deployed for advanced cardiopulmonary or respiratory failure following initial resuscitation, growing levels of evidence for out of hospital cardiac arrest support early ECMO cannulation as part of resuscitative efforts. We sought to perform a descriptive analysis evaluating traumatically injured patients, who were placed on ECMO, during their initial resuscitation period.

METHODS: We performed a retrospective analysis of the Trauma Quality Improvement Program Database from 2017 to 2019. All traumatically injured patients who received ECMO within the first 24 hours of their hospitalization were assessed. Descriptive statistics were used to define patient characteristics and injury patterns associated with the need for ECMO, while mortality represented the primary outcome evaluated.

RESULTS: A total of 696 trauma patients received ECMO during their hospitalization, of which 221 were placed on ECMO within the first 24 hours. Early ECMO patients were on average 32.5 years old, 86% male, and sustained a penetrating injury 9% of the time. The average ISS was 30.7, and the overall mortality rate was 41.2%. Prehospital cardiac arrest was noted in 18.2% of the patient population resulting in a 46.8% mortality. Of those who underwent resuscitative thoracotomy, a 53.3% mortality rate was present.

CONCLUSION: Early cannulation for ECMO in severely injured patients may provide an opportunity for rescue therapy following severe injury patterns. Further evaluation regarding the safety profile, cannulation strategies, and optimal injury patterns for these techniques should be evaluated.

PMID:36876475 | DOI:10.1177/00031348231161082

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Effectiveness of online teaching during the COVID-19 pandemic on practical manual therapy skills of undergraduate physiotherapy students

J Man Manip Ther. 2023 Mar 6:1-9. doi: 10.1080/10669817.2023.2179285. Online ahead of print.

ABSTRACT

OBJECTIVES: This study includes two separate parts: the objective for part A was to evaluate the practical manual therapy skills of undergraduate physiotherapy students who had learned manual therapy techniques either online or in classroom depending on the phases of the pandemic. The objective for part B was to evaluate in a randomized prospective design the effectiveness of video-based versus traditional teaching of a manual therapy technique.

DESIGN: Cross-sectional cohort study (part A) and randomized controlled trial (part B).

SETTING: University of Luebeck, undergraduate physiotherapy students in years 1-3.

METHOD: In part A, physiotherapy students who had learned manual therapy either online (during the pandemic) or in classroom (prior to and after the lock down periods of the pandemic) were videotaped while performing two manual techniques on the knee joint and on the lumbar spine. Recordings were analyzed independently by two blinded raters according to a 10-item list of criteria. Inter-rater reliability was assessed using Cohen’s kappa for each item. Performance across cohorts was analyzed using analysis of variance. In part B, students were randomized to learn a new technique on the cervical spine either from a lecturer or from the same lecturer on a video recording (independent variable). Practical performance of the technique was analyzed by two raters blinded to group allocation according to a 10-item list of criteria (dependent variable). Results were analyzed statistically by using ANCOVA with year of study as a covariate.

RESULTS: Sixty-three and 56 students participated in part A and part B of the study, respectively. The inter-rater reliability for video analyses for both parts of the study was moderate (k = 0.402 to 0.441). In part A, there was no statistically significant difference across years of study for the practical performance of the technique on the back F(2,59) = 2.271; p = 0.112 or the knee joint F(2,59) = 3.028; p = 0.056. In part B, performance was significantly better when learned from a lecturer and practiced on a peer than when learned from a video and practiced on a rescue dummy (p < 0.001).

CONCLUSION: Practical skill performance can be acquired from videos but immediate skill reproduction is significantly better when the technique is presented by a lecturer in classroom and practiced on peer students.

PMID:36876463 | DOI:10.1080/10669817.2023.2179285

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A Peer-led Kinesthetic Forearm and Wrist Anatomy Workshop: A Multiple Cohort Study

Anat Sci Educ. 2023 Mar 6. doi: 10.1002/ase.2268. Online ahead of print.

ABSTRACT

An understanding of forearm and wrist anatomy is necessary for the diagnosis and treatment of various injuries. Evidence supports the use of peer-assisted learning (PAL) as an effective resource for teaching basic science courses. First-year medical students across three class years participated in an optional PAL kinesthetic workshop wherein participants created anatomically accurate paper models of forearm and wrist muscles. Participants completed pre- and post-workshop surveys. Participant and non-participant exam performances were compared. Participation ranged from 17.3-33.2% of each class; participants were more likely to identify as women than men (p<0.001). Participants in cohorts 2 and 3 reported increased comfort with relevant content after the workshop (p<0.001). Survey responses for cohort 1 were omitted due to low response rates; however, exam performances were assessed for all three cohorts. Cohort 2 participants scored higher than non-participants on forearm and wrist questions on the cumulative course exam (p=0.010), while the opposite was found for cohort 3 (p=0.051). No other statistically significant differences were observed. This is the first study to examine quantitative and qualitative results for a PAL intervention repeated for three separate cohorts. Although academic performance varied, two cohorts reported increased comfort with relevant course material after the workshop. Results of this study support the need for further exploration of PAL workshops as an instructional method in teaching anatomy, and highlight the challenges associated with repeating interventions over multiple years. As more studies attempt replication across multiple years, these challenges may be addressed, thereby informing PAL best practices.

PMID:36876457 | DOI:10.1002/ase.2268

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Unlicensed assistive personnel’s care for persons with or at risk of delirium: a scoping review protocol

JBI Evid Synth. 2023 Mar 7. doi: 10.11124/JBIES-22-00248. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this review is to describe the nature and extent of the literature regarding unlicensed assistive personnel’s involvement in delivering care to persons with or at risk of delirium.

INTRODUCTION: Initiatives that promote the involvement of unlicensed assistive personnel in providing additional supervision and care to persons with or at risk of delirium have been developed. Since no standardized approach guides unlicensed assistive personnel’s involvement with persons with or at risk of delirium, and since inconsistent training and expectations may pose a threat to the safety and quality of care, it is essential to clarify their role with persons with or at risk of delirium.

INCLUSION CRITERIA: This review will consider articles published in peer-reviewed journals, dissertations, theses, book chapters, and conference papers in French or English. Quantitative, qualitative, or mixed method studies that report on the development, implementation, or evaluation of the role of unlicensed assistive personnel in contexts of delirium will be included. We will consider editorials and opinion papers only if they report on the development, implementation, or evaluation of the role of unlicensed assistive personnel.

METHODS: Records will be identified via CINAHL, ProQuest Dissertations & Theses Global, Embase, MEDLINE, APA PsycINFO, and Web of Science. Two independent reviewers will select studies and extract data using a piloted form. Data will be synthesized narratively, using descriptive statistics and a tabular format. A consultation phase will include approximately 24 unlicensed assistive personnel and registered nurses who will be invited to comment on the review findings.

PMID:36876454 | DOI:10.11124/JBIES-22-00248

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Years of life lost due to unintentional drug overdose relative to the leading underlying causes of death in the United States: a comparative analysis of excess mortality 2017-2019

J Addict Dis. 2023 Mar 6:1-5. doi: 10.1080/10550887.2023.2173929. Online ahead of print.

ABSTRACT

The present study aims to compare Years of Life Lost for unintentional drug overdose and the leading underlying causes of death in the United States annually from 2017 to 2019. Years of Life Lost provide valuable context to incident deaths when comparing the relative mortality burden of underlying causes of death. Prior research has shown unintentional drug overdose was the third leading cause of Years of Life Lost in the state of Ohio in 2017. However, this finding has yet to be replicated at the national level in the US. Death statistics for 2017-2019 were accessed via CDC WONDER. Years of Life Lost were calculated for unintentional drug overdose and each of the top five causes of incident deaths in the US during the study period. Unintentional drug overdose caused nearly seven million Years of Life Lost in the US during the three-year period of study and was the fourth leading cause of Years of Life Lost after cancer, heart disease and other accidents. Incidence alone provides an incomplete picture of the effect of unintentional drug overdose on overall mortality burden in the US. Years of Life Lost give critical context to the overdose crisis, underscoring unintentional drug overdose as a leading cause of premature mortality.

PMID:36876385 | DOI:10.1080/10550887.2023.2173929

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Changes in parents’ attitudes towards childhood vaccines during the course of COVID-19 pandemic

Pediatr Int. 2023 Mar 5:e15520. doi: 10.1111/ped.15520. Online ahead of print.

ABSTRACT

BACKGROUND: Concerns about the safety and adverse reactions of rapidly developed vaccines against COVID-19 contributed to parents’ vaccine hesitancy and this situation created an opportunity for anti-vaccine campaigners. The aim of this study is to examine the changes in parents’ attitudes towards childhood vaccines during the course of COVID-19 pandemic.

METHODS: In this cross-sectional study, parents of children who applied to the outpatient clinic of pediatric department of Trakya University Hospital between August 2020 and February 2021 were recruited into two study groups according to COVID-19 peak time in Türkiye. Group 1 included parents who applied after first peak of COVID-19 pandemic and Group 2 included parents of children who applied after second peak. The WHO’s 10-item Vaccine Hesitancy Scale was applied to each group.

RESULTS: 610 parents agreed to participate in the study. Group 1 and 2 consisted of 160 and 450 parents, respectively. While the number of parents who were hesitant about childhood vaccines was 17 (10.6 %) in Group 1, it was 90 (20 %) in Group 2. Statistically significant difference was found between the two groups (p = 0.008). The WHO’s 10-item Vaccine Hesitancy Scale mean score was found to be higher in Group 2 (23.7 ± 6.9) than Group 1 (21.3 ± 7.3) (p < 0.001). The WHO’s 10-item Vaccine Hesitancy Scale mean scores (20.0 ± 6.5) of parents who experienced COVID-19 infection themselves or their family or acquaintances had significantly lower than those who did not (24.7 ± 6.9) (p < 0.001).

CONCLUSIONS: The hesitant attitudes towards childhood and COVID-19 vaccines were low in parents who somehow encountered COVID-19 or were worried about the devastating effects of this disease. On the other hand, it has been shown that as the COVID-19 pandemic progresses, parents’ hesitations towards childhood vaccines increase.

PMID:36872424 | DOI:10.1111/ped.15520

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What impacts students’ satisfaction the most from Medicine Student Experience Questionnaire in Australia: a validity study

J Educ Eval Health Prof. 2023;20:2. doi: 10.3352/jeehp.2023.20.2. Epub 2023 Jan 18.

ABSTRACT

PURPOSE: This study evaluated the validity of student feedback derived from Medicine Student Experience Questionnaire (MedSEQ), as well as the predictors of students’ satisfaction in the Medicine program.

METHODS: Data from MedSEQ applying to the University of New South Wales Medicine program in 2017, 2019, and 2021 were analyzed. Confirmatory factor analysis (CFA) and Cronbach’s α were used to assess the construct validity and reliability of MedSEQ respectively. Hierarchical multiple linear regressions were used to identify the factors that most impact students’ overall satisfaction with the program.

RESULTS: A total of 1,719 students (34.50%) responded to MedSEQ. CFA showed good fit indices (root mean square error of approximation=0.051; comparative fit index=0.939; chi-square/degrees of freedom=6.429). All factors yielded good (α>0.7) or very good (α>0.8) levels of reliability, except the “online resources” factor, which had acceptable reliability (α=0.687). A multiple linear regression model with only demographic characteristics explained 3.8% of the variance in students’ overall satisfaction, whereas the model adding 8 domains from MedSEQ explained 40%, indicating that 36.2% of the variance was attributable to students’ experience across the 8 domains. Three domains had the strongest impact on overall satisfaction: “being cared for,” “satisfaction with teaching,” and “satisfaction with assessment” (β=0.327, 0.148, 0.148, respectively; all with P<0.001).

CONCLUSION: MedSEQ has good construct validity and high reliability, reflecting students’ satisfaction with the Medicine program. Key factors impacting students’ satisfaction are the perception of being cared for, quality teaching irrespective of the mode of delivery and fair assessment tasks which enhance learning.

PMID:36872423 | DOI:10.3352/jeehp.2023.20.2

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Effect of sodium-glucose transporter 2 inhibitor empagliflozin on proteinuria and kidney function progression in patients with non-diabetic glomerulonephritis: a pilot superiority randomized controlled trial

Int Urol Nephrol. 2023 Mar 6. doi: 10.1007/s11255-023-03539-8. Online ahead of print.

ABSTRACT

BACKGROUND: Amelioration of proteinuria is one of main treatment targets in patients with glomerulonephritis, yet the remission rates are suboptimal.

AIM OF THE STUDY: To examine the effect of the sodium-glucose transporter 2 inhibitor (empagliflozin) on proteinuria and kidney function progression, in patients with glomerulonephritis not due to diabetic kidney diseases.

SUBJECTS AND METHODS: Fifty patients were recruited. The entry criteria were diagnosis of glomerulonephritis, and proteinuria (proteinuria ≥ 500 mg⁄g) in spite of the use of the maximal tolerated dose of RAAS blocking agents together with specific immunosuppression treatment regimens. Group 1 (Empagliflozin arm): 25 patients who received 25 mg of empagliflozin once daily for 3 months as add-on to their regular treatment protocol (RAAS blockers and immunosuppression). Group 2 (Placebo arm): 25 patients treated with RAAS blockers and immunosuppression. The primary efficacy endpoints were the change in creatinine eGFR, and proteinuria 3 months after starting treatment.

RESULTS: Progression of proteinuria was lower with empagliflozin as compared to placebo (odds ratio, 0.65; 95% CI, 0.55 to 0.72, p = 0.002). Decline in eGFR was lower with empagliflozin as compared to placebo; however, this was statistically not significant (odds ratio, 0.84; 95% CI, 0.82 to 1.2, p = .31). The percentage change in proteinuria was greater with empagliflozin as compared to placebo (median, – 77 (- 97-105) vs – 48 (- 80-117).

CONCLUSION: Empagliflozin has a favorable effect on amelioration of proteinuria in patients with glomerulonephritis. Empagliflozin has tendency to preserve kidney function in patients with glomerulonephritis as compared to placebo; however, longer term studies are required.

PMID:36872420 | DOI:10.1007/s11255-023-03539-8

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Impact of changing PI-RADS cutoff on prostate cancer detection by MRI cognitive fusion biopsy in biopsy-naïve patients

J Egypt Natl Canc Inst. 2023 Mar 6;35(1):5. doi: 10.1186/s43046-023-00165-4.

ABSTRACT

BACKGROUND: Multi-parametric magnetic resonance imaging may improve the detection of prostate cancer. The aim of this work is to compare between PI-RADS 3-5 and PI-RADS 4-5 as a threshold for targeted prostatic biopsy.

METHODS: This is a prospective clinical study that included 40 biopsy-naïve patients referred for prostate biopsy. Patients underwent prebiopsy multi-parametric (mp-MRI), followed by 12-core transrectal ultrasound-guided systematic biopsy and cognitive MRI/TRUS fusion targeted biopsy from each detected lesion. The primary endpoint was to assess the diagnostic accuracy of the PI-RAD 3-4 versus PI-RADS 4-5 lesion by mpMRI for prostate cancer detection in biopsy-naive men.

RESULTS: The overall prostate cancer detection rate and the clinically significant cancer detection rate were 42.5% and 35%, respectively. Targeted biopsies from PI-RADS 3-5 lesions showed a sensitivity of 100%, specificity of 44%, positive predictive value of 51.7%, and negative predictive value of 100%. Restricting targeted biopsies to PI-RADS 4-5 lesions resulted in a decrease in sensitivity and negative predictive value to 73.3% and 86.2%, respectively, while specificity and positive predictive value were increased to 100% for both parameters which was statistically significant (P value < 0.0001 and P value = 0.004, respectively).

CONCLUSIONS: Limiting the TBs to PI-RADS 4-5 lesions improves the performance of mp-MRI in the detection of prostate cancer especially aggressive tumors.

PMID:36872409 | DOI:10.1186/s43046-023-00165-4