Difference In Proportion Of Patients Research Articles

Comparative Efficacy and Safety of Upadacitinib vs. Vedolizumab, Ustekinumab, and Tofacitinib After Induction and Maintenance for Ulcerative Colitis: Three Matching-Adjusted Indirect Comparisons.

Evidence on the comparative efficacy and safety of approved therapies for ulcerative colitis (UC) during induction and maintenance, including upadacitinib (UPA), vedolizumab (VEDO), ustekinumab (UST), and tofacitinib (TOFA), is limited. Using data from phase 3 trials, three placebo (PBO)-anchored matching-adjusted indirect comparisons of the efficacy and safety of UPA versus VEDO, UST, and TOFA (U-ACHIEVE and U-ACCOMPLISH, GEMINI-1, UNIFI, and OCTAVE induction and maintenance trials) have been conducted. Baseline characteristics from UPA trials were weighted separately to match each comparator trial. Induction responders were re-randomized to oral UPA 15 or 30mg, VEDO 300mg intravenously every 8weeks (Q8W), UST 90mg SC Q8W, or oral TOFA 5mg, or PBO in maintenance. Treat-through efficacy outcomes at weeks 44(UST)/46(VEDO)/52(UPA/TOFA) were adjusted by the likelihood of induction response and included clinical response, clinical remission, and endoscopic improvement. Safety outcomes included adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation (except UPA vs. VEDO). Benefit-risk was assessed by numbers needed to treat (NNT)/harm, calculated as the inverse of the difference in proportions of patients achieving each efficacy/safety outcome for UPA versus comparator. The proportions of patients who demonstrated clinical response or endoscopic improvement was greater with UPA 15mg versus VEDO and TOFA (p<0.05). The proportions of patients demonstrating all treat-through efficacy outcomes were significantly greater with UPA 30mg versus VEDO, UST, or TOFA with NNTs 3.2-8.7. No significant differences in proportions of AEs, SAEs, and AEs leading to discontinuation were observed between the two doses of UPA and comparators. In patients with active UC, greater clinical efficacy, and similar safety after 1year of maintenance were observed with UPA versus VEDO, UST, and TOFA, suggesting a favorable benefit-risk profile for UPA. Despite matched baseline characteristics, differences in trial design and endpoints may persist.

A surgical preadmission pharmacist service in a tertiary paediatric hospital: a pilot study

AbstractBackgroundPharmacist surgical preadmission review is common in adult healthcare settings, however there is little evidence of this practice in the paediatric setting. This research describes a pilot surgical preadmission pharmacist service in a paediatric hospital.AimTo evaluate the impact of a surgical preadmission pharmacist service on patient flow and the quality of medication management.MethodA retrospective review (2 months) was conducted to compare an intervention group (1 May 2019–30 June 2019) to historical baseline (1 October 2018–30 November 2018). Children and adolescents (aged 0–18 years) presenting for elective surgery and overnight admission were included. Relevant clinical data and timestamps were extracted from the electronic medical record. Multiple linear regression models were built to examine the difference in outcomes between the control and intervention groups. This project was exempt due to the local policy requirements that constitute research by the Queensland Children's Hospital Human Research Ethics Committee (Reference no: LNR/19/QCHQ/53406). The justification for this exemption was as follows: the study presented no foreseeable risk of patient harm as it involved evaluation of an established standard of clinical care and involved the use of existing collections of records that contain only non‐identifiable patient data.ResultsIn total, 135 patients were included in the baseline and 96 patients were included in the intervention group. The intervention group had statistically significant lower time to best possible medication history (BPMH) by 47.57 h (95% confidence interval [CI] −53.25 to −41.89, p &lt; 0.001). Time to prescription of home medications was significantly reduced in the intervention group by 5.26 h (95% CI −10.45 to −0.08, p = 0.05). There was no difference in proportion of patients with home medications omitted (71–62%, p = 0.38) or requiring modification (14–12%, p = 0.58) between the two groups.ConclusionImplementation of a surgical preadmission pharmacist service in our paediatric hospital demonstrated earlier BPMH documentation and prescription of home medications, without negative effects on perioperative patient flow.

Time trends in the epidemiology of food allergy in England: an observational analysis of Clinical Practice Research Datalink data

Estimates for the prevalence of food allergy vary widely, with a paucity of data for adults. The aim of this analysis was to report trends in the incidence and prevalence of food allergy in England, using a national primary care dataset. We analysed data from Clinical Practice Research Datalink between 1998 and 2018, with linked data to relevant hospital encounters in England. The main outcomes were incidence and prevalence of food allergy, according to three definitions of food allergy: possible food allergy, probable food allergy, and probable food allergy with adrenaline autoinjectors prescription. We also evaluated the difference in proportion of patients prescribed adrenaline autoinjectors by English Index of Multiple Deprivation (IMD), age, and by previous food anaphylaxis, and explored differences in patient encounters (general practice vs emergency department setting). 7 627 607 individuals in the dataset were eligible for inclusion, of whom 150 018 (median age 19 years [IQR 4-34]; 82 614 [55·1%] female and 67 404 [44·9%] male) had a possible food allergy. 121 706 met diagnostic criteria for probable food allergy, of whom 38 288 were prescribed adrenaline autoinjectors. Estimated incidence of probable food allergy doubled between 2008 and 2018, from 75·8 individuals per 100 000 person-years (95% CI 73·7-77·9) in 2008 to 159·5 (156·6-162·3) individuals per 100 000 person-years in 2018. Prevalence increased from 0·4% (23 399 of 6 432 383) to 1·1% (82 262 of 7 627 607) over the same period and was highest in children under 5 years (11 951 [4·0%] of 296 406 in 2018) with lower prevalence in school-aged children (from 11 353 [2·4%] of 473 597 in 2018 for children aged 5-9 years to 6896 [1·7%] of 404 525 for those aged 15-19 years) and adults (42 848 [0·7%] of 5 992 454 in 2018). In those with previous food anaphylaxis, only 2321 (58·3%) of 3980 (975 [64·0%] of 1524 children and young people and 1346 [54·8%] of 2456 adults) had a prescription for adrenaline autoinjector. Adrenaline autoinjectors prescription was less common in those resident in more deprived areas (according to IMD). In the analysis of health-care encounters, 488 604 (97·1%) of 503 198 visits recorded for food allergy occurred in primary care, with 115 655 (88·4%) of 130 832 patients managed exclusively in primary care. These estimates indicate an important and increasing burden of food allergy in England. Our findings that most patients with food allergy are managed outside the hospital system, with low rates of adrenaline autoinjector prescription in those with previous anaphylaxis, highlight a need to better support those working in primary care to ensure optimal management of patients with food allergy. UK Food Standards Agency and UK Medical Research Council.

Shoulder Motion Overestimated by Mallet Scores.

Brachial plexus birth injuries (BPBI) occur in up 0.4 to 4.6 per 1000 live births. Weakness about the shoulder and development of glenohumeral joint contractures are common sequalae of BPBI. Shoulder function in children with BPBI is frequently assessed using the modified Mallet classification to evaluate upper extremity motion deficits. The purpose of this study was to assess the accuracy of the abduction, external rotation, and hand-to-mouth Mallet classification scores in children with BPBI using motion capture. A retrospective study of 107 children with BPBI who underwent motion capture assessment and Mallet scores on the same date were reviewed. Motion capture measurements were used to calculate humerothoracic elevation and external rotation joint angles in the abduction/hand-to-mouth and external rotation positions, respectively. The humerothoracic joint angles were converted to the corresponding Mallet scores. Discrepancies between the Mallet scores determined by clinicians and those determined by motion capture were assessed. For abduction, 24.3% of Mallet scores were misclassified during clinical examination. Of the misclassified scores, 22 were overestimated by 1 point and 4 were underestimated by 1 point compared with motion capture. For external rotation, 72.9% of Mallet scores were misclassified during clinical examination. Only 5 patients had an HT elevation that was less than 40 degrees, with 4 of them (80%) having a Mallet hand-to-mouth score of 4. There were no differences in proportion of patients with HT elevation less than 40 degrees who had a Mallet score of 4 or a Mallet score less than 4. There was better agreement in global abduction Mallet scores compared with external rotation and hand-to-mouth Mallet scores. This difference was likely due to the complex compensatory strategies that patients employ while performing external rotation and hand-to-mouth positions. The inaccuracy of the clinically determined Mallet scores is alarming given that they are frequently utilized to assist with surgical indications and are commonly used as outcome measures. Level IV Case series.

Brain metastases in patients with pleural mesothelioma receiving dual checkpoint blockade compared to single-agent checkpoint blockade or chemotherapy.

e20093 Background: Immunotherapy (IO) has emerged as a treatment option in pleural mesothelioma (PM). Historically, brain metastases (BM) in PM were rare, thus brain imaging is not routine practice or included in guidelines. We characterize the incidence of BMs by type of treatment received. Methods: In this retrospective analysis,adult patients with PM treated at the Hospital of the University of Pennsylvania between 1/1/2015- 8/31/2023 were included. Patient demographic data, treatment, brain imaging and clinical history were extracted from the electronic medical record.A two-tailed Z score with alpha 0.05 was used to determine a difference in proportion of patients with BM by treatment group. Results: 290 patients were included in the study. 154 (53.1%) were treated with chemotherapy (CT), 94 (32.4%) were treated with pembrolizumab (pembro), 39 (13.4%) were treated with ipilimumab + nivolumab (ipi/nivo), and 3 (1.0%) were treated with another IO. A higher proportion of patients treated with ipi/nivo developed BM compared to those treated with pembro alone (4/39, 10.3% vs 2/94, 2.1%; Z score p= 0.038). None of the 154 patients treated with CT developed BM. All BMs were detected due to symptoms. Of the six patients that developed BM, the median age was 72.5 (range 47-80), 83% were male, 67% identified as Caucasian, and there was an even distribution of histology with 33% each of epithelioid, biphasic, and sarcomatoid. All patients received IO most recently or were currently on it when BM developed. Median time to BM from start of immunotherapy was 144.5 days (range 2-913 days). On imaging, all 6 patients had edema surrounding the brain metastases and 4 also showed hemorrhage. Survival after development of BM was poor (Table1). Four patients (67%) underwent surgery for the BM, while all patients received brain radiation. Two patients received whole brain radiation therapy (WBRT), while four patients received stereotactic radiosurgery (SRS) to a median of four brain metastases (range 1-7). Three patients developed subsequent intracranial progression (out-of-field) including one with rapid intracranial progression 20 days post-radiation. Conclusions: In this large retrospective study of patients with PM treated with systemic therapy, BM was most prevalent in those patients receiving ipi/nivo compared to pembro alone and not seen in those receiving chemotherapy. The presence of edema suggests a possible immune infiltrate while on IO (correlative studies in progress). Brain imaging should be considered prior to starting IO in patients with PM. [Table: see text]

Venous thromboembolism testing practices after orthopaedic trauma: prophylaxis regimen does not influence testing patterns.

To determine venous thromboembolism (VTE) testing patterns in an orthopaedic trauma population and to evaluate for differences in VTE surveillance by prophylaxis regimen through a secondary analysis of the ADAPT trial. Prospective randomized trial. Level I trauma center. Three hundred twenty-nine adult (18 years and older) trauma patients presenting with an operative extremity fracture proximal to the metatarsals/carpals or any pelvic or acetabular fracture requiring VTE prophylaxis. VTE imaging studies recorded within 90 days post injury. Percentage of patients tested for VTE were compared between treatment groups using Fisher's exact test. Subsequently, multivariable regression was used to determine patient factors significantly associated with risk of receiving a VTE imaging study. Sixty-seven patients (20.4%) had VTE tests ordered during the study period. Twenty (29.9%) of these 67 patients with ordered VTE imaging tests had a positive finding. No difference in proportion of patients tested for VTE by prophylaxis regimen (18.8% on aspirin vs. 22.0% on LMWH, P = 0.50) was observed. Factors associated with increased likelihood of VTE testing included White race (adjusted odds ratio [aOR]: 2.61, 95% CI: 1.26-5.42), increased Injury Severity Score (aOR for every 1-point increase: 1.10, 95% CI: 1.05-1.15), and lower socioeconomic status based on the Area Deprivation Index (aOR for every 10-point increase: 1.14, 95% CI: 1.00-1.30). VTE surveillance did not significantly differ by prophylaxis regimen. Patient demographic factors including race, injury severity, and socioeconomic status were associated with differences in VTE surveillance. Level I, Therapeutic.

Pediatric Congenital Anterior Skull Base Encephaloceles and Surgical Management: A Comparative Review of 22 Patients Treated Transnasally, Transcranially, or Combined Approach With a Review of the Literature.

Anterior basal encephaloceles are considered a rare entity and are often associated with midline cerebral abnormalities. Those with a large skull base defect and herniation of brain parenchyma in the neonate or young infant present unique challenges for surgical management. We analyzed the neurosurgical administrative and operative databases between 1986 and 2022 to determine clinical presentation, operative approach, and outcome of basal encephaloceles. Over the 36-year period, 27 pediatric anterior basal encephaloceles were managed, of which 22 had full documentation and images allowing comprehensive review. Mean age at presentation was 5 years (SD 4.94). The majority were transethmoidal encephaloceles (59%), followed by the transsphenoidal-sphenoethmoidal type (32%). Overall, 91% were managed surgically by a transcranial, endoscopic, or combined approach. Four children required subsequent procedures, predominantly for persistent cerebrospinal fluid leak. No significant differences in proportion of patients requiring interval/revision surgery after initial conservative, endoscopic endonasal, or transcranial surgery was identified. Neither age at surgery nor size of the defect on computed tomography scan was associated with the need for revision surgery. Size of cranial defect was significantly smaller in the endoscopic group ( P = .01). There was a historic tendency for younger children with larger defects to have a transcranial approach. With the addition of endoscopic skull base expertise, smaller defects in older children were more recently treated endoscopically. Basal encephaloceles are rare and complex lesions and are optimally managed within a skull base multidisciplinary team able to provide multiple approaches. Large skull base defects with brain parenchymal involvement often require a transcranial or combined transcranial-endoscopic approach.

Proportion of intensive care unit patients receiving sedation after rapid sequence intubation with rocuronium

BackgroundRocuronium has a longer duration of action than the sedative effects of induction agents used during rapid sequence intubation (RSI), introducing a potential window for inadequate sedation. When rocuronium is used for paralysis in the emergency department, delays in sedation have been observed, but have not been described in intensive care units (ICUs). ObjectivesThe primary objective is the proportion of patients in the ICU who received sedation within 15 minutes after intubation using rocuronium. Secondary objectives include (1) time to sedation (minutes), (2) time to sedation between ICUs (minutes), (3) time to sedation between provider specialties (minutes), (4) time to sedation by Glasgow coma scale (GCS), and (5) first-hour versus second-hour Sedation Intensity Score (SIS) after RSI. MethodsThis is a retrospective review at a single academic tertiary care center of patients intubated in an ICU between July 2019 and August 2020. Inclusion criteria were age 18 to 89 years, intubation using rocuronium, and intubation in an ICU. Exclusion criteria were sedative exposure before intubation, no charted induction agent or charting delays from paralytic, incomplete charting, intubation outside an ICU, intubation during cardiac arrest, pregnancy, or incarceration. ResultsA total of 192 intubations using rocuronium were included and 77 (40.1%) received sedation within 15 minutes of induction agent administration. There was no difference in proportion of patients receiving sedation by GCS ≤ 8 and GCS > 8 before intubation (38.1% vs. 41.1%, P = 0.69). Using a SIS to describe amount of sedative administered, more sedation was administered in the second hour after intubation than the first hour (median score 5.5 [interquartile range {IQR} 0–20] vs. 4.5 [IQR 0–12.5], P < 0.001). ConclusionIn this single-center analysis, a large proportion of patients intubated in ICUs with rocuronium did not receive additional sedation within 15 minutes of induction, exposing them to risk of awareness while paralyzed.

Lower vs Higher Oxygenation Target and Days Alive Without Life Support in COVID-19

Supplemental oxygen is ubiquitously used in patients with COVID-19 and severe hypoxemia, but a lower dose may be beneficial. To assess the effects of targeting a Pao2 of 60 mm Hg vs 90 mm Hg in patients with COVID-19 and severe hypoxemia in the intensive care unit (ICU). Multicenter randomized clinical trial including 726 adults with COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 11 ICUs in Europe from August 2020 to March 2023. The trial was prematurely stopped prior to outcome assessment due to slow enrollment. End of 90-day follow-up was June 1, 2023. Patients were randomized 1:1 to a Pao2 of 60 mm Hg (lower oxygenation group; n = 365) or 90 mm Hg (higher oxygenation group; n = 361) for up to 90 days in the ICU. The primary outcome was the number of days alive without life support (mechanical ventilation, circulatory support, or kidney replacement therapy) at 90 days. Secondary outcomes included mortality, proportion of patients with serious adverse events, and number of days alive and out of hospital, all at 90 days. Of 726 randomized patients, primary outcome data were available for 697 (351 in the lower oxygenation group and 346 in the higher oxygenation group). Median age was 66 years, and 495 patients (68%) were male. At 90 days, the median number of days alive without life support was 80.0 days (IQR, 9.0-89.0 days) in the lower oxygenation group and 72.0 days (IQR, 2.0-88.0 days) in the higher oxygenation group (P = .009 by van Elteren test; supplemental bootstrapped adjusted mean difference, 5.8 days [95% CI, 0.2-11.5 days]; P = .04). Mortality at 90 days was 30.2% in the lower oxygenation group and 34.7% in the higher oxygenation group (risk ratio, 0.86 [98.6% CI, 0.66-1.13]; P = .18). There were no statistically significant differences in proportion of patients with serious adverse events or in number of days alive and out of hospital. In adult ICU patients with COVID-19 and severe hypoxemia, targeting a Pao2 of 60 mm Hg resulted in more days alive without life support in 90 days than targeting a Pao2 of 90 mm Hg. ClinicalTrials.gov Identifier: NCT04425031.

Education to improve timeliness of shingles diagnosis in primary care: a cluster randomised study within a trial with nested qualitative study.

Herpes zoster (shingles) is normally diagnosed clinically. Timely diagnosis is important so that antiviral treatment can be started soon after rash onset. To assess whether a practice-level educational intervention, aimed at non-clinical patient-facing staff, improves the timely assessment of patients with shingles. This was a cluster randomised study within a trial (SWAT) with nested qualitative study in general practices in England. Practices were cluster randomised 1:1, stratified by centre and minimised by practice list size and Index of Multiple Deprivation score. Intervention practices were sent educational materials, highlighting the common presenting features of shingles and what action to take if suspected. The primary and secondary outcomes were the mean proportion of patients per practice seen within 72 and 144 h of rash onset, respectively. Comparison between groups was conducted using linear regression, adjusting for randomisation variables. Semi-structured interviews with practice staff in intervention practices explored views and opinions about the intervention. In total, 67 practices were enrolled; 34 randomised to the intervention and 33 to the control. The mean difference in proportion of patients seen within 72 and 144 h was -0.132 (95% confidence interval [CI] = -0.308 to 0.043) and -0.039 (95% CI = -0.158 to 0.080), respectively. In intervention practices, 90.9% reported distributing the educational materials; however, engagement with these was suboptimal. Twelve participants were interviewed, and the poster component of the intervention was said to be easiest to implement. Our educational intervention did not improve the timely assessment of patients with shingles. This may be the result of poor intervention engagement.

Nicardipine or Nitroprusside for Postoperative Blood Pressure Control in Infants After Surgery for Congenital Heart Disease: Single-Center Retrospective Noninferiority and Cost Analysis, 2016-2020.

Postoperative hypertension frequently occurs after surgery for congenital heart disease. Given safety concerns when using calcium channel blockers in infants along with the cost and side-effect profile of nitroprusside, we retrospectively assessed our experience of using nicardipine and nitroprusside for postoperative blood pressure control in infants who underwent surgery for congenital heart disease. We also investigated the cost difference between the medications. This study was a single-center retrospective, pre-post chart review of patients who had surgery for congenital heart disease between 2016 and 2020. The primary aim was a noninferiority comparison of achievement of blood pressure goal at 1-hour post-initiation of an antihypertensive agent. Secondary comparisons included achievement of blood pressure goal at 2 hours after medication initiation, Vasoactive-Inotropic Score (VIS), and blood transfusion, crystalloid volume, and calcium needs. Academic quaternary-care center. Infants under 1 year old who required treatment for hypertension with nitroprusside ( n = 71) or nicardipine ( n = 52) within 24 hours of surgery for congenital heart disease. None. We failed to identify any difference in proportion of patients that achieved blood pressure control at 1-hour after medication initiation (nitroprusside 52% vs. nicardipine 54%; p = 0.86), with nicardipine noninferior to nitroprusside within a 15% margin. Of patients who did not achieve control at 1-hour post-medication initiation, receiving nicardipine was associated with blood pressure control at 2 hours post-medication initiation (79% vs. 38%; p = 0.003). We also failed to identify an association between antihypertensive types and mean VIS scores, blood transfusion volumes, crystalloid volumes, and quantities of calcium administered. Index cost of using nitroprusside was 16 times higher than using nicardipine, primarily due to difference in wholesale cost. In our experience of achieving blood pressure control in infants after surgery for congenital heart disease (2016-2020), antihypertensive treatment with nicardipine was noninferior to nitroprusside. Furthermore, nicardipine use was significantly less expensive than nitroprusside. Our contemporary practice is therefore to use nicardipine in preference to nitroprusside.

Surgical management of vocal cord nodules in children: Trends and outcomes

ObjectivesVocal cord nodules (VCNs) are the most common cause of dysphonia in school-aged children, with potential negative impacts on quality of life including diminished self-esteem and academic performance. The standard of care for VCNs is conservative management which ranges from voice hygiene to speech therapy with a focus on voice otherwise known as voice therapy, with surgical excision reserved for refractory cases. Thus, few studies have analyzed outcomes of surgical management of VCNs. The purpose of this study is to assess the prevalence and efficacy of surgical excision of VCNs when compared to speech therapy. MethodsChildren with VCNs seen at a single tertiary care institution between 2015 and 2020 were identified by ICD-9 code 478.5 and ICD-10 code J38.2. Demographics, objective voice assessment, intervention, and follow-up assessment data were reviewed. Frequencies, medians, and interquartile ranges were calculated. Time to resolution and improvement were assessed by Cox proportional hazards model. Univariate logistic regression was performed. A P value of <0.05 was considered statistically significant. ResultsThree hundred sixty-eight patients diagnosed with VCNs were identified. 169 patients received intervention for VCNs, with 159 (43.2 %) receiving speech therapy alone and 5 (1.4 %) receiving surgery alone. On bivariate analysis, there was no significant difference in demographic features between treatment groups, however speech therapy patients did have a longer follow-up time. 154 patients underwent objective voice assessment at the time of VCN diagnosis. Among these patients, 95 (61.7 %) received speech therapy and 59 (40.3 %) received no intervention. Speech therapy patients had significantly higher pVHI scores, however there was no significant difference in CAPE-V Overall Severity scores or computerized voice assessment analysis. On Cox proportional hazards analysis, surgical intervention was associated with faster resolution and faster improvement of dysphonic symptoms. On binary logistic regression, surgery was associated with a significantly greater proportion of patients reporting resolution of dysphonic symptoms, however there was no significant difference in proportion of patients reporting improvement of dysphonia. ConclusionFor most patients with VCNs, conservative measures such as voice hygiene and speech therapy remain first line, however certain patients may benefit from the rapid improvement and resolution of symptoms that surgical intervention may provide.

A Randomized Comparison of Liposomal Daunorubicin/Daunorubicin Combined with Low-Dose Cytarabine and Etoposide or High-Dose Cytarabine and Fludarabine in Induction Treatment of Pediatric AML Using MRD-Based Risk Stratification in the NOPHO-DBH AML 2012 Protocol

Background: In pediatric acute myeloid leukemia (AML), measurable residual disease (MRD) by flow cytometry (FCM) after induction therapy has emerged as one of the strongest prognostic factors. We designed a phase III study (NOPHO-DBH AML2012) using an intensified response-guided induction with mainly MRD based risk stratification. All high-risk patients were treated with allogeneic stem cell transplantation (SCT). The study contained two randomized questions: 1) a randomized comparison of mitoxantrone and liposomal daunorubicin (DNX) in first induction which is reported elsewhere and 2) the comparison of AD(x)E (low dose cytarabine, DNX, etoposide) and FLAD(x) (fludarabine, high dose cytarabine, DNX [60 mg/m 2 x III]) which was proven effective in refractory/relapsed AML in the second induction course Patients and methods: The study was population-based and conducted in the Nordic countries, Belgium, Hong Kong and the Netherlands (NOPHO-DBH collaboration). Between March 2013 and November 2017, 194 were randomized 1:1 to AD(x)E or FLAD(x). At this time DNX became unavailable and randomization was paused. After almost 18 months, when it became clear that the shortage was permanent, randomization was resumed (February 2019-July 2021) but with daunorubicin substituting DNX. In total 306 patients were included (152 AD(x)E, 154 FLAD(x)). Randomization was stratified according to treatment arm and response to course 1. The primary endpoint was the proportion with MRD &amp;lt;0.1% after the second induction. Patients with MRD ≥ 0.1% after course 2 or MRD ≥ 15% after course 1 or with FLT3-ITD and NPM1 wild type were assigned high-risk (HR) and consolidated with SCT whereas standard-risk (SR) received 3 chemotherapy courses ( CBFB:: MYH11 2 courses) (Fig 1). Estimates of overall survival (OS) and event-free survival (EFS) from date of diagnosis and given at 5 years were calculated by the Kaplan-Meier method and given as percentage± standard error with differences tested by log rank test. Results: Patient and disease characteristics were similar between treatment arms (Table 1). For all 306 randomized patients EFS was 66.8±2.8% and OS 80.5±2.4%. 232 (76%) had SR with EFS of 71.1±3.1% and OS 86.9±2.3% whereas 56 (18%) had HR with EFS 67.5±6.3% and OS 70.1±6.3%. Median observation time for patients without events was 68 months. There was no difference in proportion of patients with MRD &amp;lt; 0.1% in the randomized groups with 112/152 (74%) for AD(x)E and 120/154 (78%) for FLAD(x). CR rates were 93.4% for AD(x)E and 96.1% for FLAD(x). Survival outcomes for AD(x)E and FLAD(x) were very similar with EFS 67.9±3.8 vs 65.9±3.9 ( P=.93) and OS 82.0±3.2 vs 79.1±3.4 ( P=.60) (fig 1). Univariate Cox regression on all factors in table 1 showed statistical significance for RUNX1:: RUNX1T1 associated with better EFS (Hazard ratio[HzR] 0.26 CI 0.10-0.70) and “other” aberrations with worse EFS (HzR 2.21 CI 1.49-3.27). For OS, both RUNX1:: RUNX1T1 (HzR 0.12 CI 0.02-0.84) and CBFB:: MYH11 (HzR 0.12 CI 0.02-0.88) showed better outcome while the group “other” aberrations had increased HzR (1.77 CI 1.03-3.0). In multivariable analysis, RUNX1:: RUNX1T1 and CBFB:: MYH11 were the only factors significantly associated with EFS and OS (lower HzR) . One patient in each arm died from toxicity after course 2. There was a trend for increased toxicity in patients treated with FLAD(x), with 134 grade 3 (CTCAE4.0) toxicities registered after course 2 compared to 103 for AD(x)E and 37 vs 27 grade 4 toxicities. Also, 18 patients in the FLAD(x) group required ICU treatment compared to 9 for AD(x)E. Conclusion. Risk stratification based on MRD FCM and response-guided induction as used in the NOPHO-DBH AML 2012 protocol resulted in one of the best cure rates reported in newly diagnosed pediatric AML. The stratification allowed 75% of patients to receive standard-risk treatment without SCT in primary therapy. Patient with suboptimal response (ie our HR group) benefitted from SCT in first remission. Perhaps surprisingly, given the efficacy in relapsed AML, FLAD(x) did not improve outcome compared to AD(x)E. Since toxicity was higher we have opted to retain ADE in the upcoming protocol.

Abstract 13134: Comparative Analysis of Implantable Loop Recorder Devices

Implantable loop recorders ILR are used for diagnosis and evaluation of Atrial fibrillation and Syncope. The devices mainly utilize RR variability to determine an episode of AF.Diagnosis of bradycardia is based on rate and absence of any R wave. Presence of a P wave is not a prerequisite.In this Retrospective study we used recorded electrogram characteristics obtained with two ILRs. Hypothesis-The R wave amplitude and clarity of P wave facilitates correct diagnosis of AF and any heart block .This would also infuence any undersensing and oversensing Methods-The two ILRs were Medtronic Reveal I &amp; Biomonitor III.The Biomonitor is 77.5x8.6 x4.4 mm whereas LINQ I is 44.8x7.2x4 mm. Main difference in the two is that BioMonitor III has larger sensing area ( 77.5 vs 44.8). Results 106 patients were included in this analysis 53 patients had Medtronic Reveal I and the remaining 53 patients had a BioMonitor III. We compared the amplitude of the R wave, presence of P wave, Undersensing and Oversensing of recorded events. Group I = patients who had Medtronic reveal I, 19 Males, 34 Females, mean age 74+11 BMI=28.83±6.8 Indication was AF in 38 &amp; syncope in 15. Mean R wave was 0.48 mV±0.38, Clear P waves were noted in 16/53. Oversensing noted in 8/53, Undersensing in 4/53. Group I I = patients with BioMonitor III 27 Males, 26 Females,Mean age 73+10 Mean BMI 29.20±5.35. Indication was AF in 37 &amp; syncope in 16.Mean R wave was 0.65 mV±0.37. Clear P waves noted in 33/53. Oversensing noted in 8/53, Undersensing in 0/53. Group II( BM III) had significantly greater R wave amplitude (p=0.02), the presence of a P wave in sinus rhythm was in significanly greater number of patients (p=0.009) There was no significant difference in proportion of patients with oversensing in the two groups ( p=0.09 ) However undersensing was seen in significanly less No of patients in Group II as compared to Group I ( p= 0.04). The two groups are matched for age sex, BMI , indication for implantation. Conclusions 1 In ILRs the recordings obtained with a Biomonitor III ( larger recording area ) had significantly greater amplitude of R wave and a greater proportion of patients with a clear P wave as compared to a Medtronic Reveal 1 ILR 2. Undersensing is also less seen with the Biomonitor ILR which may be related to the R wave amplitude.

Characteristics and Outcomes of Culture-Positive and Culture-Negative Pediatric Sepsis

To compare the outcomes of pediatric severe sepsis and septic shock among patients with culture-positive and culture-negative sepsis and to determine if there are differentiating markers of disease severity between these 2 populations during their initial presentation and emergency department (ED) stay. Retrospective cohort study of patients ≤21years of age who presented to the ED of a single children's hospital with severe sepsis or septic shock from June 1, 2017 to June 5,2019. There were 235 patients who met criteria for severe sepsis or septic shock. Of these, 139 (59.1%) had culture-negative sepsis and 96 (40.9%) had culture-positive sepsis. In the adjusted multivariable model, children with culture-negative sepsis had more intensive care unit (ICU)-free days than those with culture-positive sepsis (27.3 vs 24.1; adjusted median differences [aMD] -2.6 [-4.4, -0.8]). There were no differences in mortality or hospital-free days. On initial presentation, there were no differences in fever, hypothermia, tachycardia, tachypnea, or hypotension between the 2 groups. There were no differences in proportion of patients receiving the following interventions: intravenous (IV) antibiotics, IV fluids, vasoactive medications, CPR, intubation, or time from arrival to provision of these interventions. Culture-negative sepsis constitutes a substantial proportion of pediatric severe sepsis and septic shock. In this study, patients with culture-negative and culture-positive sepsis presented similarly on arrival to the ED and received similar treatments while there. Patients with culture-negative sepsis had more ICU-free days than those with culture-positive sepsis, although differences in hospital length of stay (LOS) and mortality were not observed.

Preconditioning program reduces the incidence of prolonged hospital stay after lung cancer surgery: Results from the Move For Surgery randomized clinical trial.

Lung cancer resection is associated with high rates of prolonged hospital stay. It is presumed that preconditioning with aerobic exercise can shorten the postoperative duration of hospital stay, but this has not yet been demonstrated in trials after lung cancer surgery. The aim of this study was to perform a RCT to determine whether Move For Surgery (MFS), a home-based and wearable technology-enhanced preconditioning program before lung cancer surgery, is associated with a lower incidence of prolonged hospital stay when compared to usual preoperative care. Patients undergoing lung resection for early-stage non-small cell lung cancer were enrolled before surgery into this blinded, single-site RCT, and randomized to either the MFS or control group in a 1 : 1 ratio. Patients in the MFS group were given a wearable activity tracker, and education about deep breathing exercises, nutrition, sleep hygiene, and smoking cessation. Participants were motivated/encouraged to reach incrementally increasing fitness goals remotely. Patients in the control group received usual preoperative care. The primary outcome was the difference in proportion of patients with hospital stay lasting more than 5 days between the MFS and control groups. Of 117 patients screened, 102 (87.2 per cent) were eligible, enrolled, and randomized (51 per trial arm). The majority (95 of 102, 93.1 per cent) completed the trial. Mean(s.d.) age was 67.2(8.8) years and there were 55 women (58 per cent). Type of surgery and rates of thoracotomy were not different between arms. The proportion of patients with duration of hospital stay over 5 days was 3 of 45 (7 per cent) in the MFS arm compared to 12 of 50 (24 per cent) in the control arm (P = 0.021). MFS, a home-based and wearable technology-enhanced preconditioning program before lung cancer surgery, decreased the proportion of patients with a prolonged hospital stay. Registration number: NCT03689634 (http://www.clinicaltrials.gov).

Association between acute adverse reactions to iodinated contrast media and anxiety in patients undergoing contrast-enhanced CT examination.

As the use of iodinated contrast media has become more widely with advances in imaging, several guidelines have suggested that anxiety increases the risk of acute adverse reactions associated with iodinated contrast media. This study aims to evaluate the impact of anxiety on the occurrence of acute adverse reactions (AAR) to iodinated contrast media in patients undergoing contrast-enhanced CT examinations. Inpatients who underwent contrast-enhanced CT examinations at the Third Xiangya Hospital between February and October 2021 were prospectively recruited. Prior to the imaging examinations, all patients completed the Generalized Anxiety Disorder Scale-7 (GAD-7) assessment before the imaging examinations to determine the severity of anxiety, which was categorized as mild, moderate, or severe. Based on the occurrence of AAR, patients were classified into an AAR group and a non-AAR group. The difference in anxiety was compared between the 2 groups. Multivariate logistic regression analysis was used to identify independent risk factors associated with AAR. To ensure comparability between the 2 groups, propensity score matching (PSM) was utilized to align the clinical characteristics. Subsequently, the difference in anxiety within the matched groups was analyzed. The study comprised 880 patients, with 80 patients in the AAR group and 800 patients in the non-AAR group. There was a significant difference in proportion of patients with mild-severe anxiety between the 2 groups (75% in the AAR group and 36% in the non-AAR group, P<0.001). Additionally, differences were also observed in occupation, income, underlying diseases, and allergy history (all P<0.001). The results of multivariate logistic regression analysis revealed that patients' income, allergy history, and anxiety were independent risk factors for AAR to iodinated contrast media (all P<0.05). Following PSM, each matched group included 66 cases, and no significant differences in clinical characteristics were observed between the 2 groups (all P>0.05). However, the proportion of patients with mild-severe anxiety remained significantly higher in the AAR group compared to the non-AAR group (75% in the AAR group and 31% in the non-AAR group, P<0.001). Anxiety is associated with an increased risk of AAR to iodinated contrast media in patients undergoing contrast-enhanced CT examinations, suggesting the clinical importance of screening for anxiety before imaging examinations.

Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location: A Nonrandomized Clinical Trial

ObjectivesThis study aimed to investigate the correlation between the vertebral level of paddle placement and abdominal wall stimulation (AWS) after differential target multiplexed spinal cord stimulation (SCS) to improve the safety and effectiveness of SCS for patients with chronic pain, particularly those with low back pain (LBP). Materials and MethodsThe Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location study was a nonrandomized clinical trial that included 24 patients with SCS for persistent spinal pain syndrome (PSPS) type 2 (trial ID: NCT05565469). The intervention involved increasing stimulation amplitude to a maximum tolerable value and obtaining numerical rating scores for AWS. The primary outcome measure was the association between AWS, the neurostimulator tip, and conus medullaris location, whereas the secondary outcome was the pre-postinterventional difference in proportion of patients experiencing AWS. Patient demographics and postoperative imaging were assessed. Statistical analyses involved descriptive statistics, a descriptive logistic regression, and a McNemar test. ResultsThe results of the study showed that seven (29%) of the 24 patients experienced AWS either previously or during interventional stimulation. However, there was no significant correlation found between AWS and the location of the neurostimulator tip or conus medullaris, and there was no difference in the pre-postinterventional proportion of patients experiencing AWS. ConclusionsThe study concludes that a relatively high proportion of patients who received SCS for PSPS type 2 experienced or previously experienced AWS. There was no significant correlation found between the location of the neurostimulator tip and the occurrence of AWS. This suggests that AWS may not be solely dependent on the stimulation itself and emphasizes the need to consider other factors. Nonetheless, this study provides important insights into the occurrence of AWS in patients receiving SCS for PSPS type 2 and highlights the need for further research in this area. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT05565469.

Impact of Ambulatory Care Pharmacist-Led Management on Hemoglobin A1c Values among Patients with Uncontrolled Diabetes in a Primary Care Clinic vs Usual Care over Two Years.

Background: Literature has shown the positive impact of ambulatory care pharmacists on diabetes management, yet additional research on clinical outcomes compared to traditional care models is warranted. Objective: The objective of this study is to evaluate the impact of an ambulatory care pharmacist on glycemic control over two years compared to patients who received usual care. Methods: This retrospective cohort study matched patients with a baseline hemoglobin A1c (HgbA1c) ≥8% managed by the ambulatory care pharmacist to patients who received usual care. The primary outcome was the mean change in HgbA1c over two years. The secondary outcomes were to evaluate the difference in (1) the proportion of patients achieving HgbA1c <8%, (2) the proportion of patients achieving blood pressure <130/80mmHg, (3) mean LDL, (4) the proportion of patients prescribed SGLT2 inhibitors, GLP-1RA, and sulfonylureas, and (5) severe hypoglycemia after two years. Results: Data for 180 patients was analyzed over two years. The mean HgbA1c was 10% at baseline vs 8.2% after two years (adjusted mean change -1.92) among pharmacist-managed patients, compared to 9.9% vs 9% respectively for usual care patients (adjusted mean change -0.98) (p=0.004). Among pharmacist-managed patients, 53.5% achieved HgbA1c <8% compared with 34.2% of usual care patients (p=0.014). There were no statistically significant differences in proportion of patients at goal blood pressure, mean LDL, or hypoglycemia between the two groups. After two years, 18.3% of pharmacist-managed and 5.8% of usual care patients were on an SGLT2 inhibitor (p=0.008), and 46.7% of pharmacist-managed and 9.2% of usual care patients were on a GLP-1RA (p<0.001). No difference was found in sulfonylurea utilization. Conclusion: Patients with HgbA1c >8% managed by an ambulatory care pharmacist had twice the HgbA1c reduction and significantly more utilization of GLP-1RA and SGLT2 inhibitors as compared to controls provided usual care.

Cost consequence analysis of waiting for lumbar disc herniation surgery

The economic repercussions of waiting for lumbar disc surgery have not been well studied. The primary goal of this study was to perform a cost-consequence analysis of patients receiving early vs late surgery for symptomatic disc herniation from a societal perspective. Secondarily, we compared patient factors and patient-reported outcomes. This is a retrospective analysis of prospectively collected data from the CSORN registry. A cost-consequence analysis was performed where direct and indirect costs were compared, and different outcomes were listed separately. Comparisons were made on an observational cohort of patients receiving surgery less than 60 days after consent (short wait) or 60 days or more after consent (long wait). This study included 493 patients with surgery between January 2015 and October 2021 with 272 patients (55.2%) in the short wait group and 221 patients (44.8%) classified as long wait. There was no difference in proportions of patients who returned to work at 3 and 12-months. Time from surgery to return to work was similar between both groups (34.0 vs 34.9 days, p = 0.804). Time from consent to return to work was longer in the longer wait group corresponding to an additional $11,753.10 mean indirect cost per patient. The short wait group showed increased healthcare usage at 3 months with more emergency department visits (52.6% vs 25.0%, p < 0.032), more physiotherapy (84.6% vs 72.0%, p < 0.001) and more MRI (65.2% vs 41.4%, p < 0.043). This corresponded to an additional direct cost of $518.21 per patient. Secondarily, the short wait group had higher baseline NRS leg, ODI, and lower EQ5D and PCS. The long wait group had more patients with symptoms over 2 years duration (57.6% vs 34.1%, p < 0.001). A higher proportion of patients reached MCID in terms of NRS leg pain at 3-month follow up in the short wait group (84.0% vs 75.9%, p < 0.040). This cost-consequence analysis of an observational cohort showed decreased costs associated with early surgery of $11,234.89 per patient when compared to late surgery for lumbar disc herniation. The early surgery group had more severe symptoms with higher healthcare utilization. This is counterbalanced by the additional productivity loss in the long wait group, which likely have a more chronic disease. From a societal economic perspective, early surgery seems beneficial and should be promoted.