Historical Control Group Research Articles

Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases, first results from a phase III randomized controlled multicenter trial (the SCANDIUM trial).

LBA9509 Background: Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will ultimately develop in approximately 50% of the patients, with the liver being the most common site. The median survival for patients with liver metastases is about 6-12 months, and there are only few systemic treatment options available that moderately prolong survival. A previous trial using isolated hepatic perfusion (IHP) has suggested a 14-month increase in overall survival, compared with a historical control group consisting of the longest surviving patients in Sweden during the same time period (26 vs. 12 months). Methods: In this multicenter randomized, controlled, phase III trial, patients with previously untreated isolated liver metastasis from uveal melanoma were randomized between 2013 and 2021 to receive IHP or best alternative care (control group). The primary end point is overall survival at 24 months, but here we report the secondary outcomes of response according to RECIST 1.1 criteria, progression-free survival (PFS), hepatic PFS (hPFS) and toxicity. Results: A total of 93 patients were randomized, with three patients in each group being excluded due to either withdrawal of consent or inappropriate enrollment, and a total of 87 patients were assigned to either IHP group (43 patients) or control group (44 patients). In the IHP group, 41 (89%) patients were treated per protocol, and in the control group, 49% of the patients were treated with chemotherapy, 39% with immunotherapy and 9% with localized treatment interventions. In an intention-to-treat analysis, the overall response rate (ORR) in the IHP group was 40% (17/43) compared to 4.5% (2/44) in the control group (p<0.0001). The median hPFS in the IHP group was 9.1 months (95% CI, 5.6 to 13.4 months), compared to 3.3 months (95% CI, 2.9 to 4.0 months) in the control group (p<0.0001). The median PFS in the IHP group was 7.4 months (95% CI, 5.2 to 11.6 months), compared to 3.3 months (95% CI, 2.9 to 3.7 months) in the control group (p<0.0001). There were 14 treatment-related serious adverse events in the IHP group, where vascular complication and infections were the most common side effects, compared to 13 in the control group where immunotherapy related side effects were most common. There was one treatment related death in the IHP group. Conclusions: Treatment with IHP resulted in superior ORR, hPFS and PFS compared to best alternative care among previously untreated patients with isolated uveal melanoma liver metastasis. Clinical trial information: NCT01785316.

Experience and Discussion on Introducing the “Internet Plus” Classroom Into Teaching Physiological Experimentation

The “Internet Plus” education model, enabled by the internet, is a type of “Distance learning” education models. To explore the application of “Internet Plus” education in teaching physiological experimentation at Guilin Medical University, undergraduate clinical medicine students from the 2011 to 2013 classes were used as the historical control group for teaching an experimentation class using the traditional teaching model: “teacher-teaching + student-operation.” Undergraduate clinical medicine students from the 2014 to 2018 classes were used as the teaching reform group and were taught using an “Internet Plus” educational model: “microlectures-previewing + test + feedback + student-operation.” The experimentation operating examination results for the two groups of students were analyzed, questionnaire surveys were administered to students in the experimental group and the relevant teachers, and the survey results were counted. The experimentation operating examination results were significantly higher for the students in the teaching reform group (89.3 points) than for the control group students (84.4 points). The excellent rate was higher (69.8% for the reform group and 54.5% for the control group), whereas the failure rate was lower (1.9% for the teaching reform group and 4.3% for the control group). Additionally,90.1% of the students identified with this reform method, and more than 90% believed that the method improved their interest and confidence in surgical operations during pharmacological and pathophysiological experimentation classes in subsequent courses. All teachers in the physiological experimentation course identified with this teaching method, and 81.8% of the teachers of relevant disciplines in a later stage believed that this learning method was more conducive than traditional teaching to cultivating student interest in learning, proactivity, and other factors. Application of an “Internet Plus” educational model for physiological experimentation teaching can help cultivate hands-on operating abilities and improve the learning interest of students.

Continuous vancomycin infusion versus intermittent infusion in critically Ill patients: The research protocol

Background: Methicillin‐resistant Staphylococcal and Enterococcal infections are important problems in intensive care units (ICUs). Vancomycin is a drug of choice, and continuous administration has long been proposed as an alternative method with better therapeutic benefits. This study aims to examine information on the benefits of continuous vancomycin infusion (CVI) compared with the intermittent vancomycin infusion (IVI) method. Method: A quasi-experimental study with a propensity score-matched historical control involves adult patients in medical or surgical ICUs. In the experimental group, 31 patients for whom vancomycin is indicated will be enrolled to receive CVI for at least 48 hours with therapeutic drug monitoring according to the study protocol. For the historical control group, data of patients who received IVI between January 2018 and October 2020 will be retrospectively reviewed. Capability to achieve serum vancomycin therapeutic target within 48 hours, 96 hours, the incidence of supra- and subtherapeutic level, treatment successfulness, mortality, and incidence of acute kidney injury (AKI) between the two infusion methods will be analyzed before and after one-to-two propensity score matching. Ethics and dissemination: The study was approved by the institutional review boards of Faculty of Medicine Siriraj Hospital, Mahidol University (COA no. Si 027/2021). We plan to disseminate the results in peer-reviewed critical care medicine or infectious disease-related journals and national and international conferences. Trial registration: TCTR20210122005. Registered on January 22, 2021, with Thai Clinical Trials Registry

Application of plan-do-check-act management to improve first-attempt insertion success rates of internal jugular vein catheterization for standardized training residents in an intensive care unit

BackgroundIn the intensive care unit (ICU), internal jugular vein puncture and catheterization are basic rescue operations that physicians need to complete quickly and independently. It is necessary to improve the first-attempt success rate of internal jugular vein catheterization, shorten the catheterization duration and reduce the incidence of complications for standardized training residents (STRs).ObjectiveTo improve first-attempt insertion success rates of internal jugular vein catheterization for STRs.MethodsBased on the PDCA cycle management method and current situation investigation, the PDCA management objectives were set, and the implementation content, monitoring items and continuous improvement plan were formulated. The data of residents who were trained in the ICU of Fangcun Hospital, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, from January 2016 to April 2016 and managed by the PDCA cycle (PDCA group), were compared with the data of residents trained in the same department from August 2015 to November 2015 before the implementation of PDCA (historic control group), the first-attempt success rate of puncture and catheterization, the duration of puncture and catheterization, and the incidence of complications were analysed.ResultsThirty-six cases of internal jugular vein catheterization were performed by the PDCA group, 21 cases (58%) were performed by residents in the third year of standardized training, and 15 cases (42%) were performed by residents in the second year of standardized training. Compared with the historic control group, there was no significant difference in the seniority of residents (X2 = 0.240, P = 0.625) or the ‘majors of the residents (X2 = 1.306, P = 0.835). The first-attempt success rate of puncture in the PDCA group was 94% (34/36), which was significantly higher than that of the historic control group (55% (11/20) (P = 0.001). In the PDCA group, the first-attempt success rate of puncture among third-year standardized training residents was 95% (20/21), and the first-attempt success rate in the second-year was 93% (14/15), which were significantly higher than the corresponding rates of 62% (8/13) and 43% (3/7) respectively, in the historic control group (all P = 0.021). The duration of catheterization was [4 (3,5)] min after PDCA, which was significantly shorter than that in the historic control group [9 (6.25,13.00)] min (Z = − 5.214, P < 0.001). The incidence rate of complications in the PDCA group was 0% (0 /36), which was significantly lower than the rate of 20% (4 / 20) in the historic control group (P < 0.013).ConclusionPDCA cycle management can help improve the first-attempt success rate of internal jugular vein puncture and catheterization, shorten the duration of puncture and catheterization, and reduce the incidence of complications. The idea and method of PDCA cycle management can be applied to other training and management protocols for STRs.

Additional chemotherapy for EGFRm patients with the continued presence of plasma ctDNA EGFRm at week 3 after start of osimertinib first-line treatment (PACE).

TPS9157 Background: Epidermal growth factor receptor (EGFR) – mutated non-small cell lung cancer (NSCLC) is susceptible to EGFR targeting tyrosine kinase inhibitors (TKI), such as the third generation TKI osimertinib. However, response rate and duration vary between patients. Among others, the specific subtype of EGFR-mutation, its co-occurrence with other genetic alterations, and the detection of phosphorylated EGFR (pEGFR) in the plasma, and its clearance upon treatment were previously identified as markers that predict therapy response. A high proportion of patients with early (3-6 weeks after start) pEGFR clearance from plasma show impressive survival upon single-agent TKI. However, failure to achieve early clearance upon Osimertinib is associated with unfavorable outcome. For these patients, treatment concepts are lacking. Here, we report about the initiation of a clinical trial that evaluates the combination of EGFR-directed TKI and platinum-based chemotherapy as an early treatment escalation strategy for this high-risk patient population. Methods: PACE is a prospective multicenter single-arm investigator-initiated phase II trial. Patients with NSCLC harboring L858R or del19 EGFR mutation, who are treated with first-line Osimertinib are subjected to liquid biopsy-based early response assessment three weeks after start of therapy. Failure to clear pEGFR from plasma at this time point triggers treatment escalation with the addition of platinum-based doublet chemotherapy to the Osimertinib treatment. The primary outcome measure of the trial is progression-free survival (PFS), with the objective to assess the efficacy of biomarker-driven escalation of osimertinib therapy with a combination platinum-based regimen. Secondary outcome measures are the overall response rate (ORR), overall survival (OS), and the Quality of life (QLQ-C30, CTCAE-PROs) of the treated patients. In exploratory analyses, we will assess whether specific patterns of co-mutations are associated with early treatment failure (upon TKI) and pEGFR persistence. Fig. 1 illustrates the trial concept. A sample of 46 subjects achieves 80% power at a 0.05 significance level to detect a PFS of 14.4 months in the experimental treatment group when the PFS of the historic control group is 9.1 months; a total of 400 patients need to be screened within the national Network Genomic Medicine. Enrollment started in 12/2021. The clinical trial is supported by AstraZeneca and Guardant. EudraCT registration number: 2019-004757-88 .

Detection of early signs of right ventricular systolic impairment in unoperated Ebstein's anomaly by cardiac magnetic resonance feature tracking.

Cardiovascular magnetic resonance feature-tracking analysis (CMR-FT) provides a quantitative assessment of myocardial contraction with potential for diagnostic and prognostic ability in a wide spectrum of diseases. Ebstein's anomaly (EA) is a rare congenital heart disease characterized by apical displacement of the tricuspid valve. However, it is also considered a disorder of development affecting the global right ventricular myocardium. Aim of our study is to describe the complex contractile mechanics of the functional right ventricle (RV) in patients affected by EA through CMR-FT. Fifty surgery-free EA patients who had undergone a complete CMR protocol at our institution between January 2017 and December 2020 were selected for the retrospective study. A historical control group of twenty-five healthy subjects was also included. CMR-FT analysis was performed at a dedicated workstation by manually tracing RV endo- end epicardial borders on steady-state-free-precession (SSFP) cine images. Strain values were calculated. Apical displacement of the tricuspid valve (TV) was measured on a 4-chamber cine image from the right atrio-ventricular junction to the functional annulus of the TV. EA patients presented significantly impaired RV global radial strain (GRS) and global circumferential strain (GCS) compared to controls (P<0.0001 and P=0.0008, respectively). In a subgroup analysis, GRS was significantly compromised in patients with a severely displaced TV (>16 mm/m2) compared to milder forms (P=0.03) and to controls (P<0.0001). Among EA patients with a preserved ejection fraction, 12 (48%) vs. 6 (24%) controls had reduced both GRS and GCS. The contractile pattern of the functional RV in EA is characterised by prevalent alterations in the short-axis direction as indicated by reduced GRS and GCS. Strain values might be reduced prior to routine used functional parameters like RV ejection fraction (RVEF) and can possibly serve as an early predictor of myocardial dysfunction in EA patients.

Matched external control analysis of event-free survival (EFS) in patients with high-risk neuroblastoma (HRNB) receiving eflornithine (DFMO) maintenance.

10010 Background: Long term survival in HRNB patients remains a challenge with relapse as the primary cause of mortality. DFMO has been evaluated as a chemopreventative therapy in a single arm study designed to compare EFS outcomes with published rates for the Phase 3 Children’s Oncology Group ch14.18 immunotherapy trial, ANBL0032. In order to address the limitations associated with comparison to a historical control group, we used ANBL0032 patient-level data and propensity-score matching (PSM) to simulate a randomized study comparing EFS of patients treated with DFMO after ch14.18 (treated) to ANBL0032 patients who did not subsequently receive DFMO (control). Methods: A phase 2 trial enrolled a total of 140 HRNB patients in remission at the completion of disease treatment from 2012 to 2016. Patients received 2 years of continuous treatment with DFMO 750 ±250 mg/m2 BID and were followed for up to 7 years. ANBL0032 enrolled a total of 1328 HRNB patients from 2001 to 2015 who were assigned to treatment with ch14.18 immunotherapy and followed for up to 10 years. With FDA input, we defined selection rules to identify like groups of treated and control patients eligible for matching, covariates of potential prognostic importance, and matching algorithm details. PSM was used to balance cohorts on their baseline demographic and characteristics, matching each treated patient with the 3 most closely scored control patients with an exact match on MYCN. The Kaplan-Meier method and Cox regression analyses were used to compare EFS (primary) and overall survival (OS) (key secondary) endpoints. Multiple sensitivity analyses were performed to further investigate the primary comparison. Results: A total of 92 treated patients and 852 control patients met selection criteria, with 91 and 516, respectively, having complete covariate data required for the analysis. Eighty-seven (94.6%) of the treated group had verified participation in ANBL0032 immediately prior to enrollment in the DFMO trial. EFS from end of immunotherapy was significantly improved in the matched DFMO group (n=90) vs. control group (n=270), with a hazard ratio of 0.48 (95% CI: 0.27, 0.85) and a p-value of 0.0114. Four-year EFS was 84.4% (95% CI 75.2, 90.5) in the DFMO group versus 72.8% (95% CI 67.0, 77.7) in the control group. OS rates were also higher for DFMO group in the matched population, with a hazard ratio of 0.36 (95% CI: 0.16, 0.79) and a p-value of 0.0105. EFS sensitivity analyses demonstrated consistent results, including those challenging selection criteria for the control population. Conclusions: Patients in remission after standard upfront therapy treated with DFMO had approximately half the risk of relapse compared to matched control patients. The PSM comparisons represent the most statistically robust findings to date supporting the benefit of DFMO as a maintenance treatment for HRNB. Clinical trial information: NCT02395666, NCT00026312.

Conversion of non-inferiority margin from hazard ratio to restricted mean survival time difference using data from multiple historical trials.

The restricted mean survival time measure has gained a lot of interests for designing and analyzing oncology trials with time-to-event endpoints due to its intuitive clinical interpretation and potentially high statistical power. In the non-inferiority trial literature, restricted mean survival time has been used as an alternative measure for reanalyzing a completed trial, which was originally designed and analyzed based on traditional proportional hazard model. However, the reanalysis procedure requires a conversion from the non-inferiority margin measured in hazard ratio to a non-inferiority margin measured by restricted mean survival time difference. An existing conversion method assumes a Weibull distribution for the population survival time of the historical active control group under the proportional hazard assumption using data from a single trial. In this article, we develop a methodology for non-inferiority margin conversion when data from multiple historical active control studies are available, and introduce a Kaplan-Meier estimator-based method for the non-inferiority margin conversion to relax the parametric assumption. We report extensive simulation studies to examine the performances of proposed methods under the Weibull data generative models and a piecewise-exponential data generative model that mimic the tumor recurrence and survival characteristics of advanced colon cancer. This work is motivated to achieve non-inferiority margin conversion, using historical patient-level data from a large colon cancer clinical database, to reanalyze an internationally collaborated non-inferiority study that evaluates 6-month versus 3-month duration of adjuvant chemotherapy in stage III colon cancer patients.

Maternal and Neonatal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Immunoglobulin G Levels After the Pfizer-BioNTech Booster Dose for Coronavirus Disease 2019 (COVID-19) Vaccination During the Second Trimester of Pregnancy.

To evaluate maternal and neonatal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) antibody levels at birth after a third (booster) dose of the Pfizer-BioNTech messenger RNA (Pfizer) coronavirus disease 2019 (COVID-19) vaccine during the second trimester of pregnancy, and compare them with those in women who received two vaccine doses during the second trimester. We conducted a prospective cohort study of women admitted to the delivery ward at a single center who received the third Pfizer COVID-19 vaccine dose (booster group) at 17-30 weeks of pregnancy and who did not have previous SARS-CoV-2 infection. Maternal and neonatal antibody levels were measured on admission for delivery and in the umbilical cord blood after birth. Antibody levels for the booster group were compared with those in a historical control group of pregnant women who received their second vaccine dose (two-dose group) within the same gestational age window. Between October 2021 and February 2022, antibody levels were measured in 121 women and 109 neonates at a mean±SD of 15.3±3.9 weeks after booster vaccination. Neonatal titers measured two times higher than maternal titers, with inverse correlation between maternal and neonatal titers at birth and time interval from third vaccination. The two-dose group included 121 women and 107 neonates, with antibody levels measured at a mean±SD of 14.6±2.6 weeks after the second dose. Median [interquartile range] maternal antibody titers were higher in the booster group (4,485 [2,569-9,702] AU/mL) compared with the two-dose group (1,122 [735-1,872] AU/mL) (P<.001). Furthermore, neonatal antibody titers were higher in the booster group (8,773 [5,143-18,830] AU/mL) compared with the two-dose group (3,280 [2,087-5,754] AU/mL) (P<.001). Maternal and neonatal SARS-CoV-2 IgG antibody titers after second-trimester maternal Pfizer COVID-19 vaccination were significantly higher after the booster dose compared with the two-dose vaccination series. Although there is uncertainty as to whether antibody levels correlate with protection, these data support the importance of booster vaccination during pregnancy to restore maternal and neonatal protection against COVID-19.

High flow nasal cannula outside the ICU provides optimal care and maximizes hospital resources for patients with multiple rib fractures

BackgroundHigh flow nasal cannula (HFNC) use reduces work of breathing and improves oxygenation for patients with hypoxemic respiratory failure. Limited prior work has explored protocolized use of HFNC for trauma patients outside the Intensive Care Unit (ICU). The purpose of this study is to describe and evaluate use of HFNC for patients with rib fractures when therapy was standard of care on all floors of the hospital. MethodsIn 2018, the study hospital expanded use of HFNC (AIRVO; Fisher Paykel, Auckland, NZ) to all floors of the hospital, making it available in the ICU, Emergency Department (ED), and on general inpatient floors. The study group included adult patients with three or more rib fractures who received HFNC at any location in the hospital (Phase 2: January 2018-December 2019). The study group was compared to a historical control group when HFNC was available only in the ICU (Phase 1: March 2013-July 2015). Patients were excluded from the study if they received invasive mechanical ventilation prior to HFNC. Primary outcomes were mechanical ventilation rates, ICU days, length of hospitalization, and mortality. ResultsDuring the study period, 63 patients received HFNC, with 35% of patients (n = 22) receiving the duration of therapy outside the ICU. When compared to the control group (N = 63), there were no significant differences in total hospital days (9 vs. 9, p=.64), mechanical ventilation (19% vs. 13%, p=.47), or mortality (3% vs. 5%, p = 1.00). Twenty-seven percent of patients (n = 17) in the study group avoided the ICU during hospitalization. ConclusionsFindings suggest that HFNC therapy can be safely initiated and managed on all hospital floors for patients with multiple rib fractures. Making the therapy available outside the ICU may reduce healthcare resource use without adversely affecting patient outcomes.

Rapid Antiretroviral Therapy Program: Development and Evaluation at a Veterans Affairs Medical Center in the Southern United States.

Early HIV viral suppression (VS) improves individual health outcomes and decreases onward transmission. We designed an outpatient clinic protocol to rapidly initiate antiretroviral therapy (ART) in a large Veterans Health Administration (VA) HIV clinic. A pre-post evaluation was performed using a retrospective cohort study design for new diagnoses of HIV infection from January 2012 to February 2020. Time-to-event analyses were performed using the Cox proportional hazards model with the intervention group as the main exposure adjusted for integrase inhibitor usage, baseline viral load, age, gender, and race. Most of the patients were men (historical control: 94.8%, n = 55; Rapid Start: 94.8%, n = 55) and Black or African American persons (historical control: 87.9%, n = 51; Rapid Start: 82.8%, n = 48). More patients initiated treatment with an integrase inhibitor-based regimen in the Rapid Start group (98.3%, n = 57) compared with the historical control group (39.7%, n = 23). Compared with controls, the Rapid Start patients were significantly more likely to achieve VS at any given time during the study period (hazard ratio 2.65; p < 0.001). Median days (interquartile range) from diagnosis to VS decreased from 180.5 (102.5-338.5) to 62 (40-105) (p < 0.001), first appointment to VS decreased from 123 (68.5-237.5) to 45 (28-82) (p < 0.001), referral to first visit decreased from 20 (10-43) to 1 (0-3) (p < 0.001), and from first visit to ART dispense date decreased from 27.5 (3-50) to 0 (0-0) (p = 0.01). Prioritizing immediate ART initiation can compress the HIV care continuum from diagnosis to linkage to VS. Implementation of the Rapid Start Protocol should be considered at all VA facilities providing HIV care.

Effect of stapled versus layered skin closure on surgical site occurrences after abdominal wall reconstruction.

The effect of skin closure technique on surgical site occurrences (SSO) after open abdominal wall reconstruction (AWR) with retromuscular polypropylene mesh placement is largely unknown. We hypothesize that layered subcuticular skin closure with cyanoacrylate skin adhesive is protective of surgical site infection compared to standard stapled closure. A retrospective review utilizing the Abdominal Core Health Quality Collaborative (ACHQC) database of all patients at Prisma Health-Upstate. All patients with open abdominal wall reconstruction (AWR) of midline incisional hernia defects with retromuscular polypropylene mesh placement from January 2013 to February 2020 were included. Patient demographics, comorbidities, type of hernia repair with mesh location, method of skin closure, and SSOs were collected. Skin closure method was divided into two groups, reflecting a temporal change in practice: staples (historical control group) versus subcuticular suture with cyanoacrylate skin adhesive with/without polymer mesh tape (study group). Primary endpoint was SSI and SSO. Secondary endpoints were SSO or SSI requiring procedural intervention (SSOPI/SSIPI). Standard statistical methods were utilized. A total of 834 patients were analyzed, with 263 treated with stapled skin closure and 571 with subcuticular and adhesive closure. On univariate analysis, the incidence of SSI was significantly lower in the study group (11.8 vs 6.8%; p = 0.002), as was the need for SSIPI (11.8 vs 6.7%; p = 0.015). Rate of SSO was not significantly different between groups (28.1 vs 27.2%), but the rate of SSO requiring intervention was lower in the study group (14.1 vs 9.3%; p = 0.045). Layered skin closure technique, including subcuticular closure and adhesive, may reduce the risk of surgical site infection after open AWR. A prospective randomized trial is planned to confirm these findings.

Innovative Tele-Instruction Approach Impacts Basic Life Support Performance: A Non-inferiority Trial.

BackgroundSustaining Basic Life Support (BLS) training during the COVID-19 pandemic bears substantial challenges. The limited availability of highly qualified instructors and tight economic conditions complicates the delivery of these life-saving trainings. Consequently, innovative and resource-efficient approaches are needed to minimize or eliminate contagion while maintaining high training standards and managing learner anxiety related to infection risk.MethodsIn a non-inferiority trial 346 first-year medical, dentistry, and physiotherapy students underwent BLS training at AIXTRA—Competence Center for Training and Patient Safety at the University Hospital RWTH Aachen. Our objectives were (1) to examine whether peer feedback BLS training supported by tele-instructors matches the learning performance of standard instructor-guided BLS training for laypersons; and (2) to minimize infection risk during BLS training. Therefore, in a parallel group design, we compared arm (1) Standard Instructor Feedback (SIF) BLS training (Historical control group of 2019) with arm (2) a Tele-Instructor Supported Peer-Feedback (TPF) BLS training (Intervention group of 2020). Both study arms were based on Peyton's 4-step approach. Before and after each training session, objective data for BLS performance (compression depth and rate) were recorded using a resuscitation manikin. We also assessed overall BLS performance via standardized instructor evaluation and student self-reports of confidence via questionnaire. Non-inferiority margins for the outcome parameters and sample size calculation were based on previous studies with SIF. Two-sided 95% confidence intervals were employed to determine significance of non-inferiority.ResultsThe results confirmed non-inferiority of TPF to SIF for all tested outcome parameters. A follow-up after 2 weeks found no confirmed COVID-19 infections among the participants.ConclusionTele-instructor supported peer feedback is a powerful alternative to in-person instructor feedback on BLS skills during a pandemic, where infection risk needs to be minimized while maximizing the quality of BLS skill learning.Trial registrationhttps://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00025199, Trial ID: DRKS00025199.

Effect of intravenous acetaminophen on postoperative outcomes in hip fracture patients: a systematic review and narrative synthesis.

Hip fractures are debilitating in older adults because of their impact on quality of life. Opioids are associated with adverse effects in this population, so oral acetaminophen is commonly prescribed to minimize opioid use. Intravenous (iv) acetaminophen has been reported to have superior efficacy and bioavailability than oral acetaminophen. Nevertheless, its effect on postoperative outcomes in emergency hip fractures is unclear. This systematic review assessed the effect of iv acetaminophen on postoperative outcomes in older hip fracture patients. We searched multiple databases from inception to June 2021 for studies on adults > 50 yr of age undergoing emergency hip fracture surgery who received iv acetaminophen (or paracetamol) and that reported postoperative outcomes. Relevant titles, abstracts, and full texts were screened based on the eligibility criteria. The Newcastle-Ottawa scale was used to assess the quality of the selected papers. Of 3,510 initial studies, four met the inclusion criteria. One was a prospective cohort study and three were retrospective cohort studies. All four studies used historical control groups. Three studies reported a significantly lower mean opioid dose with iv acetaminophen than with oral acetaminophen. Three studies also reported a significantly shorter hospital stay. One study each reported a significant decrease in the number of missed physical therapy sessions, the need for one-to-one supervision, and episodes of delirium. There is very limited low-level evidence that iv acetaminophen improves preoperative and postoperative analgesia and shortens hospital stay in older hip fracture patients. Nevertheless, our results should be interpreted with caution since there are no prospective randomized trials investigating whether iv acetaminophen improves postoperative outcomes in this patient population. PROSPERO (CRD42021198174); registered 15 August 2021.

Additional saturday occupational therapy for adults receiving inpatient physiotherapy rehabilitation: a prospective cohort study

BackgroundThe first aim of this study was to investigate the impact of providing an additional four hours of Saturday occupational therapy to patients receiving Saturday physiotherapy in an inpatient setting on length of stay, functional independence, gait and balance. The second aim was to conduct an economic evaluation to determine if the introduction of a Saturday occupational therapy service in addition to physiotherapy resulted in a net cost savings for the rehabilitation facility.MethodsA prospective cohort study with a historical control was conducted in an Australian private mixed rehabilitation unit from 2015–2017. Clinical outcomes included the Functional Independence Measure (Motor, Cognitive, Total), gait speed (10 Meter Walk test) and five balance measures (Timed Up and Go test, Step test, Functional Reach, Feet Together Eyes Closed and the Balance Outcome Measure of Elder Rehabilitation). Economic outcomes were rehabilitation unit length of stay and additional treatment costs.ResultsA total of 366 patients were admitted to the rehabilitation unit over two 20-week periods. The prospective cohort (receiving Saturday occupational therapy and physiotherapy) had 192 participants and the historical control group (receiving Saturday physiotherapy only) had 174 participants. On admission, intervention group participants had higher cognitive (p < 0.01) and total (p < 0.01) Functional Independence Measure scores. Participation in weekend therapy by the intervention group was 11% higher, attending more sessions (p < 0.01) for a greater length of time (p < 0.01) compared to the historical control group.After controlling for differences in admission Functional Independence Measure scores, rehabilitation length of stay was estimated to be reduced by 1.39 (p = 0.08) days. The economic evaluation identified potential cost savings of AUD1,536 per patient. The largest potential savings were attributed to neurological patients AUD4,854. Traumatic and elective orthopaedic patients realised potential patient related cost savings per admission of AUD2,668 and AUD2,180, respectively.ConclusionsImplementation of four hours of Saturday occupational therapy in addition to physiotherapy results in a more efficient service, enabling a greater amount of therapy to be provided on a Saturday over a shorter length of stay. Provision of multidisciplinary Saturday rehabilitation is potentially cost reducing for the treating hospital.

Effect of perioperative fluid volume restriction on the incidence of complications following pancreaticoduodenectomy.

Perioperative fluid restriction has been suggested to reduce morbidity and length of stay. The purpose of this study was to compare the morbidity following pancreaticoduodenectomy (PD) between fluid restriction group and conventional management group. Seventy-two patients were enrolled for perioperative fluid restriction of PD. During the operation, main fluid was infused at a rate of less than 8mL/kg/hr. Until POD#3, 10% dextrose and Hartmann's solution were administered at rates of 40 mL/h and {(1.5*body weight) - 42} mL/h, respectively. The historical control group consisted of 139 patients. We compared the rates of major complication (Clavien-Dindo grade III to V) and clinically relevant postoperative pancreatic fistula (CR-POPF), length of hospital stays (LOS), amount of urine output, and the rate of acute kidney injury (AKI). The rates of major complication (19.0% versus 18.7%; p > 0.999), CR-POPF (15.5% versus 15.1%; p > 0.999), and LOS (19 days [range: 10-52] versus 19 days [range: 11-75]; p=0.514) were comparable in the study and the control group, respectively. Amount of urine output during the operation and from POD#1 to POD#3 was more than minimal amount (0.5mL/kg/hr) in the both groups. Incidence rate of AKI in the study group was not higher than the control group (Stage I: 1.7% versus 2.9%, p > 0.999; stage II: 0% versus 1.4%, p > 0.999). There was no decrease in incidence of morbidity including POPF following PD with perioperative fluid restriction. Fluid restriction was feasible because it did not reduce urine output and did not increase incidence of AKI.

Evaluation of adverse events in small‐breed dogs treated with maropitant and a single dose of doxorubicin

BackgroundThe recommended doxorubicin (DOX) dose for small dogs is 1 mg/kg. Recent data suggest that DOX‐induced gastrointestinal (GI) toxicosis can be reduced with maropitant treatment.ObjectivesTo investigate the incidence of adverse events (AEs) in small‐breed dogs administered a single 25 mg/m2 DOX followed by administration of maropitant (DOX25). The primary aim was to assess myelo‐ and GI toxicoses for 2 weeks after DOX administration. The secondary aim was to compare the incidence and grades of AEs found in the DOX25 group with a historical control group (DOX 1 mg/kg without administration of antiemetic or antidiarrheal medications).AnimalsNineteen small‐breed tumor‐bearing dogs.MethodsA prospective, observational study of tumor‐bearing dogs, weighing 5 to 10 kg, administered a single 25 mg/m2 dose of DOX IV, followed by administration of maropitant for the next 5 days.ResultsInappetence, vomiting, and diarrhea were found in 7/19, 2/19, and 6/19 of the DOX25 dogs, respectively. Neutropenia and thrombocytopenia was 12/19 and 3/19, respectively. Most AEs were grades 1 and 2, except for grades 3 and 4 inappetence and neutropenia in 3 and 4 dogs, respectively. Furthermore, febrile neutropenia occurred in 3/19 dogs in the DOX25 group. All AEs between the DOX25 and historical control groups were not significantly different.Conclusions and Clinical ImportanceVomiting and diarrhea were deemed acceptable with 25 mg/m2 DOX followed by maropitant treatment in 5 to 10 kg dogs; however, additional supportive care might be needed for dogs with inappetence and neutropenia.

Financial incentives to increase stool collection rates for microbiome studies in adult bone marrow transplant patients.

In order to study the role of the microbiome in hematopoietic stem cell transplantation (HCT), researchers collect stool samples from patients at various time points throughout HCT. However, stool collection requires active subject participation and may be limited by patient reluctance to handling stool. We performed a prospective study on the impact of financial incentives on stool collection rates. The intervention group consisted of allogeneic HCT patients from 05/2017-05/2018 who were compensated with a $10 gas gift card for each stool sample. The intervention group was compared to a historical control group of allogeneic HCT patients from 11/2016-05/2017 who provided stool samples before the incentive was implemented. To control for possible changes in collections over time, we also compared a contemporaneous control group of autologous HCT patients from 05/2017-05/2018 with a historical control group of autologous HCT patients from 11/2016-05/2017; neither autologous HCT group was compensated. The collection rate was defined as the number of samples provided divided by the number of time points we attempted to obtain stool. There were 35 allogeneic HCT patients in the intervention group, 19 allogeneic HCT patients in the historical control group, 142 autologous HCT patients in the contemporaneous control group (that did not receive a financial incentive), and 75 autologous HCT patients in the historical control group. Allogeneic HCT patients in the intervention group had significantly higher average overall collection rates when compared to the historical control group allogeneic HCT patients (80% vs 37%, p<0.0001). There were no significant differences in overall average collection rates between the autologous HCT patients in the contemporaneous control and historical control groups (36% vs 32%, p = 0.2760). Our results demonstrate that a modest incentive can significantly increase collection rates. These results may help to inform the design of future studies involving stool collection.

Ultra-early initiation of postoperative rehabilitation in the post-anaesthesia care unit after major thoracic surgery: case-control study.

BackgroundPhysiotherapy is a major cornerstone of enhanced rehabilitation after surgery (ERAS) and reduces the development of atelectasis after thoracic surgery. By initiating physiotherapy in the post-anaesthesia care unit (PACU), the aim was to evaluate whether the ultra-early initiation of rehabilitation (in the first hour following tracheal extubation) would improve the outcomes of patients undergoing elective thoracic surgery.MethodsA case–control study with a before-and-after design was conducted. From a historical control group, patients were paired at a 3:1 ratio with an intervention group. This group consisted of patients treated with the ultra-early rehabilitation programme after elective thoracic surgery (clear fluids, physiotherapy, and ambulation). The primary outcome was the incidence of postoperative atelectasis and/or pneumonia during the hospital stay.ResultsAfter pairing, 675 patients were allocated to the historical control group and 225 patients to the intervention group. A significant decrease in the incidence of postoperative atelectasis and/or pneumonia was found in the latter (11.4 versus 6.7 per cent respectively; P = 0.042) and remained significant on multivariate analysis (OR 0.53, 95 per cent c.i. 0.26 to 0.98; P = 0.045). A subgroup analysis of the intervention group showed that early ambulation during the PACU stay was associated with a further significant decrease in the incidence of postoperative atelectasis and/or pneumonia (2.2 versus 9.5 per cent; P = 0.012).ConclusionsUltra-early rehabilitation in the PACU was associated with a decrease in the incidence of postoperative atelectasis and/or pneumonia after major elective thoracic surgery.

MP40-08 NOVEL ENDOSCOPIC MANAGEMENT FOR LOCALIZED UPPER URINARY TRACT CARCINOMA USING A PHOTODYNAMIC DIAGNOSIS-GUIDED DUAL LASER ABLATION TECHNIQUE: 3-YEAR FOLLOW-UP RESULTS

You have accessJournal of UrologyCME1 May 2022MP40-08 NOVEL ENDOSCOPIC MANAGEMENT FOR LOCALIZED UPPER URINARY TRACT CARCINOMA USING A PHOTODYNAMIC DIAGNOSIS-GUIDED DUAL LASER ABLATION TECHNIQUE: 3-YEAR FOLLOW-UP RESULTS Takashi Yoshida, Tadashi Matsuda, Chisato Ohe, and Hidefumi Kinoshita Takashi YoshidaTakashi Yoshida More articles by this author , Tadashi MatsudaTadashi Matsuda More articles by this author , Chisato OheChisato Ohe More articles by this author , and Hidefumi KinoshitaHidefumi Kinoshita More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002600.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Radical nephroureterectomy (RNU) is the gold standard treatment for localized upper tract urothelial carcinoma (UTUC); however, ureteroscopic surgery (URS) has become a more common treatment option for low-risk cases (<2 cm, low grade, and low stage) or imperative cases (solitary kidneys, bilateral tumors, or impaired renal function). Our group has demonstrated URS using the photodynamic diagnosis-guided dual laser ablation (PDD-DLA) technique (Yoshida T et al. Eur Urol Open Sci. 2021). In this analysis, we evaluated its long-term efficacy in patients with UTUC undergoing PDD-DLA. This study aimed to compare the efficacy of PDD-DLA versus the conventional holmium laser ablation (HLA) to evaluate oncological outcomes. METHODS: The study included ten consecutive patients with UTUC who underwent PDD-DLA between 2017 and 2019, and 16 consecutive patients who underwent HLA between 2006 and 2016 as a historical control group. The primary endpoint for the study was disease progression (defined as a relapsing tumor that could not be continued with a conservative approach and/or distant metastases). Secondary endpoints were to evaluate UTUC recurrence-free survival (RFS) and intravesical recurrence-free survival (IVRFS). The Kaplan-Meier method with log-rank test was used for survival analysis. RESULTS: The baseline characteristics were well balanced between the PDD-DLA and HLA groups in terms of tumor size, tumor grade, and multifocality. The disease progression-free rate was significantly higher among patients treated with PDD-DLA than in the HLA group (median survival: not reached vs. 33.9 months; p=0.025). The UTUC-RFS rate was not significantly different between the two groups (median survival: 21.0 vs. 8.8 months; p=0.139), The IVRFS rate was better in the PDD-DLA group when compared with those treated with HLA (median survival: not reached vs. 22.9 months; p=0.029). CONCLUSIONS: PDD-DLA was beneficial as a kidney-sparing surgery for UTUC with a 3-year follow-up. Furthermore, PDD-DLA prevented IVR when compared with the conventional method. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e676 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Takashi Yoshida More articles by this author Tadashi Matsuda More articles by this author Chisato Ohe More articles by this author Hidefumi Kinoshita More articles by this author Expand All Advertisement PDF DownloadLoading ...