Impact Of Patient Characteristics Research Articles

#2456 Real world outcomes of Fabry disease in Italian excellence centers: the ground study

Abstract Background and Aims Fabry disease (FD) is an X-linked lysosomal storage disorder with an estimated prevalence from 1:1368 to 1:8882, caused by galactosidase alpha gene (GLA) mutations, resulting in renal, cardiac and central nervous system involvement with significant morbidity and mortality in both sexes. Treatment includes enzyme replacement therapies (ERTs) and chaperone therapy. A better understanding of this disorder from its diagnostic journey, along with the impact of patient characteristics and available treatments on disease prognosis are relevant topics for physicians dealing with FD. The Global buRden and treatment trajectOries in Italian patients with Fabry disease: a retrospective longitUdinal and cross-sectioNal study–GROUND describes a cohort of FD Italian patients, addressing the unmet needs arising from this condition while providing a real-world picture from which further research insights can be derived. Methods This was a retrospective, longitudinal and cross-sectional study. Data about adult patients of either sex living or deceased with a documented FD diagnosis and at least 3 years of follow-up or early occurrence of severe/fatal outcomes were collected. Occurrence of severe/fatal events (renal, cardiac, cerebral events, death) from birth to last follow-up visit was the composite primary outcome. Other outcomes assessed were disease progression measured by FAbry STabilization indEX (FASTEX), occurrence of clinically significant events/FD related symptoms (i.e., renal function decline, detection/worsening of left ventricular hypertrophy (LVH), lysoGb3 increase, new FD symptoms), time from first manifestation to diagnosis, treatment trajectories. Results From June 2021 to June 2022, 199 patients, 73 males and 126 females, including 169 classic and 30 late-onset phenotypes, were enrolled at 8 Italian centers. Median time from onset of FD symptoms to diagnosis was 60.3 months [95% confidence interval (IC) 38.8-89.7], with a median of 0.64 years (range 0-19.29) from diagnosis to beginning of treatment. Chronic pain and angiokeratomas were the most common initial symptoms (18.1% and 13.1% of patients respectively); acroparesthesia and abdominal pain were reported in 12.5% of patients and LVH in 8.5%. Among the 143 missense/nonsense mutations identified, 14 were Variants of Uncertain Significance (VUS). Overall, 82% of patients were treated with 1 FD specific therapy, of whom 24% switched at least one treatment, while 5% definitively stopped. The composite primary outcome was experienced by 31.7% of patients for a total of 85 severe/fatal events. Specifically, 7.5% (n = 15, all treated) patients experienced a renal event; 20.6% of patients had a cardiac event (n = 41, 38/41 treated); 11.1% (n = 22, all but 1 treated) of subjects experienced a cerebral event; fatal events occurred in 7 patients of whom 1 was untreated. In addition, 88.9% of patients reported at least one clinically significant event, among which detection/worsening of LVH was the most common (41.2%). Estimated Glomerular Filtration rate (eGFR) slopes in the last 1-3 years of follow up were −2.07 [Standard Error (SE): 1.38] and −0.76 (SE: 1.75) in classic males and females, respectively. Long-term (i.e., from diagnosis to last available measure) FASTEX identified 31.1% of patients as being unstable. Conclusions In this real-world Italian FD cohort, patients were promptly treated after diagnosis according to existing guidelines, following expert evaluation. Nevertheless, severe clinical events occurred in about 30% of the cohort, mainly among classic treated males, revealing persistent unmet needs such as a better assessment of determinants of disease progression and outcomes, as well as response to treatment and further insights on the potential benefit of new therapeutic options.

Evaluation of Clotting Parameters in Pregnant Women with Placental Blood Clots: Impact of Patient Characteristics and Assessment of Clexane Efficacy

Background: Clexane is used in pregnant women (PW) to minimize placental blood clotting (PBC) and fetal danger. Standard coagulation tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) are critical for anticoagulant medication optimization. As a result, the study's goal was to evaluate the efficacy of clexane as well as adherence to the American Heart Association's recommended limits for routine coagulation tests. Methods: The study included forty normal PW as controls and forty PW with PBC as patients from Al-Mafraq Hospital in Jordan. Patients were administered daily subcutaneous injections of 40 mg of clexane as an anticoagulant, in conjunction with a daily 75 mg aspirin regimen. During the first trimester, 5 ml of venous blood were drawn from each participant. The PT, INR and APTT were measured. This assessment also considered variables including plasma fibrinogen concentration (PFC), age, body mass index (BMI), blood type, and fetal gender. Results: The mean age \(\pm\) SD were 29.6 \(\pm\) 6.2 for the patient group and 28.3 \(\pm\) 5.9 years for the control group. The changes in PT, INR, APTT and PFC between the control and patient groups were statistically significant independent of mother's age, BMI, baby gender, or blood type. Patients displayed inadequate anticoagulation with an INR of 0.8, falling below the recommended therapeutic range of 2-3 for anticoagulant treatment. Surprisingly, by the end of the clinical study, all patients under investigation had safely delivered their babies without difficulties. Conclusion: The observed rise in fibrinogen levels among patients may contribute to PBC formation, necessitating further investigation. Evaluation of the safety and efficacy of a combined 40 mg Clexane and 75 mg aspirin regimen in PW from the Al-Mafraq region, Jordan, is warranted.

Impact of patient characteristics on heart failure and cardiomyopathy onset related to pregnancy from 1997 to 2019. Swedish nationwide register-based study

Abstract Background The aetiology of heart failure (HF) in young patients is heterogenic. Cardiomyopathies are common causes in young patients, that often unmask in situations of higher physical demands, as pregnancy or delivery, presenting with HF signs and symptoms. Peripartum cardiomyopathy (PPCM) is one form associated with delivery. However, even other, such as dilated or hypertrophic cardiomyopathy may present during pregnancy. Despite major advances in care, there is still a lack of knowledge about factors that trigger heart failure onset during pregnancy and delivery. Aim To evaluate the association of baseline characteristics for HF and cardiomyopathy (CM) onset related to delivery, and investigate incidence rate for HF and cardiomyopathies related to delivery over time. Method All women 18 to 50 years registered in the National Patient Register (NPR) from 1st January 1997 to 31st December 2019 were included. Time of delivery was obtained from the Swedish Medical Birth Register (MBR), time of death from the Cause of Death Register. Women with HF, CM and peripartum cardiomyopathy (PPCM) were identified from the NPR with international classification codes for disease ICD-10: I50, I42, I43 and 090.3, used for the first time 90 days prior or 180 days after delivery, and other comorbidities. Patients were compared with five controls without HF or CM from the Total Population Register matched by age, year of delivery, and county. Linear regression was used to test trend changes in use of ICD codes. The impact of baseline characteristics for onset av HF, CM and PPCM in patient compared to controls is presented as odds ratio (OR). Body mass index (BMI) was registered at the beginning of pregnancy. Results Between 1997 and 2019 we identified 2 347 723 deliveries, and 694 women with HF, CM or PPCM, median age 33 (29; 37) years and 3 465 controls. Out of those 493 (71%) had HF, 201 (29%) had any CM and 195 (28.1%) had PPCM. Over time the incidence rate of all conditions increased significantly, se Figure 1. Median BMI at the start of pregnancy increased significantly over time in patients with HF from 22 (20;28) to 27 (23;32), beta 0.1323 (p = 0.0216). Compared to controls patients with congenital heart disease OR at 18.32 (10.04-33.41), valve disease OR at 22.65 (8.55-60.03), arrythmia OR at 7.45 (4.06-13.67), hypertension OR at 7.89 (4.26-14.63), diabetes mellitus type II OR at 8.07 (2.63-24.74) and gestational diabetes OR at 3.93 (2.54-6.07) (all p<0.001) to for HF, CM or PPCM onset related to delivery, also BMI >22,5 at the beginning of pregnancy, lower education level and income, se Figure 2. Conclusion Over 22 years we observed a significant increase in the incidence rate of HF and CM related to delivery. BMI already >22,5 was associated with higher risk for HF or any CM onset in relation to delivery.

Impact of patient characteristics on innate immune responses and inflammasome activation in ex vivo human lung tissues infected with influenza A virus.

Influenza A virus (IAV) infection poses a persistent global health challenge, necessitating a nuanced grasp of host immune responses for optimal interventions. While the interplay between aging, immunosenescence, and IAV is recognized as key in severe lower respiratory tract infections, the role of specific patient attributes in shaping innate immune reactions and inflammasome activity during IAV infection remains under-investigated. In this study, we utilized an ex vivo infection model of human lung tissues with H3N2 IAV to discern relationships among patient demographics, IAV nucleoprotein (NP) expression, toll-like receptor (TLR) profiles, PD-1/PD-L1 markers, and cytokine production. Our cohort consisted of thirty adult patients who underwent video-assisted thoracoscopic surgery during 2018-2019. Post-surgical lung tissues were exposed to H3N2 IAV for ex vivo infections, and the ensuing immune responses were profiled using flow cytometry. We observed pronounced IAV activity within lung cells, as indicated by marked NP upregulation in both epithelial cells (P = 0.022) and macrophages (P = 0.003) in the IAV-exposed group relative to controls. Notably, interleukin-2 levels correlated with variations in TLR1 expression on epithelial cells and PD-L1 markers on macrophages. Age emerged as a modulating factor, dampening innate immune reactions, as evidenced by reduced interleukin-2 and interferon-γ concentrations (both adjusted P < 0.05). Intriguingly, a subset of participants with pronounced tumor necrosis factor-alpha post-mock infection (Cluster 1) showed attenuated cytokine responses in contrast to their counterparts in Cluster 2 and Cluster 3 (all adjusted P < 0.05). Individuals in Cluster 2, characterized by a low post-mock infection NP expression in macrophages, exhibited reduced variations in both NP and TLR1-3 expressions on these cells and a decreased variation in interleukin-2 secretion in comparison to their Cluster 3 counterparts, who were identified by their elevated NP macrophage expression (all adjusted P < 0.05). Our work elucidates the multifaceted interplay of patient factors, innate immunity, and inflammasome responses in lung tissues subjected to ex vivo H3N2 IAV exposure, reflecting real-world lower respiratory tract infections. While these findings provide a foundation for tailored therapeutic strategies, supplementary studies are requisite for thorough validation and refinement.

Real-World Persistence of Ustekinumab in the Treatment of Inflammatory Bowel Disease.

There is an urgent need to understand the long-term real-world effectiveness of ustekinumab (UST) in the treatment of Crohn's disease (CD), fistulizing CD (FCD), and ulcerative colitis (UC). Persistence on treatment is commonly used as a surrogate measure of real-world treatment response. This study aims to estimate the long-term real-world persistence of UST in adult patients with CD, FCD, and UC. A retrospective study was conducted in patients with CD, FCD, and UC treated with UST through a national patient support program in Canada. Treatment persistence was described using the Kaplan-Meier method, and the impact of patient characteristics on persistence was explored through stratified analyses and multivariable Cox proportional hazards models. Persistence rates for 8724 patients with CD were 82.9%, 71.4%, 64.1%, and 59.7% at 1, 2, 3, and 4years, respectively. Similarly, persistence rates for 276 patients with FCD were 84.1%, 70.9%, 64.9%, and 63.1% at 1, 2, 3, and 4years, respectively. Persistence rates for 1291 patients with UC were 76.5% at 1year and 69.5% at 1.5years. When stratified by prior IBD-indicated biologic experience, persistence was numerically higher in biologic-naïve patients across all disease cohorts. A Cox proportional hazards model confirmed that this difference was significant in patients with CD (hazard ratio: 0.72; confidence interval: [0.65-0.79]). This study estimated long-term persistence in a large population of patients with IBD. At 1year, over three-fourths of patients remained on UST treatment in all disease cohorts, and over half of patients remained on treatment at 4years in CD and FCD patients. Biologic-naïve status was significantly associated with higher persistence in patients with CD.

Abstract TP1: Impact Of Patient Characteristics And Covid-19 On Last Known Well To Arrival

Introduction: Stroke is a medical emergency requiring prompt evaluation and treatment. COVID-19 disproportionally burdened certain socioeconomic groups and its impact on patient's hospital arrival and access to emergency services to treat stroke is unknown. This study examines whether there was an impact of patient characteristics and COVID-19 on last known well (LKW) to arrival. Methods: Data from our health system stroke registry comprised of 40 hospitals were used for the analysis. Patients with a diagnosis of Ischemic stroke (ISC) or Intracerebral Hemorrhage (ICH) discharged between Jan 1 2018 - Mar 15 2020 (pre-COVID) and Mar 16 2020 - Apr 10 2022 (pandemic period) were included in the analysis. Inpatient strokes were excluded. Multinomial logistic regression was used to determine the likelihood of presenting to the hospital in the hyperacute phase (&lt;4.5 hours) and the acute phase (4.5 to 24 hours) compared to delayed phase (&gt; 24 hours), adjusting for COVID-19 time period, race/ethnicity, mode of arrival, insurance type, stroke type, age, NIHSS at admit, and medical history. Results: A total of 25,102 patients were included in the analysis, of which 55.7% arrived in hyperacute phase, 37.7% acute phase, and 6.6% delayed phase. ICH patients (AOR 1.10, 95% CI 1.03, 1.18) were more likely than ISC patients to arrive in the hyperacute phase than delayed phase. Asian patients were less likely than white patients to arrive in the hyperacute phase (AOR 0.72, 95% CI 0.58, 0.88) than delayed phase. Patients with a history of dementia (AOR 1.69, 95% CI 1.05, 2.72), depression (AOR 1.19, 95% CI 1.02, 1.39), and afib/flutter (AOR 1.31, 95% CI 1.12, 1.53) were more likely to arrive in the hyperacute phase than delayed phase. Patients with history of diabetes (AOR 0.69, 95% CI 0.61, 0.77), smoking (AOR 0.71, 95% CI 0.60, 0.83) and drug/alcohol abuse (AOR 0.62, 95% CI 0.52, 0.75) were less likely to arrive in the hyperacute phase than delayed phase. COVID-19 time period, history of stroke, and insurance had no impact on time to arrival. Conclusions: While several patient characteristics and medical comorbidities were significantly associated with delay in arrival of stroke patients, the first two years into COVID-19 was not associated with delay in presentation.

Impact of patient characteristics and treatment patterns on outcomes in potentially resectable pancreatic cancer (PC).

681 Background: Treatment of PC remains a challenge, with surgery being the mainstay of potentially curative therapy. Even after surgical resection, however, many patients experience recurrence. There has been a shift toward treating PC as a systemic disease from diagnosis with neoadjuvant chemotherapy (nCT) or chemoradiation (nCRT). This study examines characteristics of real-world patients who were deemed to have resectable (R) or borderline resectable (BR) disease, and how they relate to overall survival (OS). Methods: This is a retrospective analysis of patients in an academic health system who presented for initiation of treatment for PC staged as R or BR. Descriptive data on patient characteristics, performance status (PS), laboratory values, neoadjuvant therapies, recurrence, and mortality were obtained. OS was evaluated using Kaplan-Meier analysis and log-rank tests. Two-sided p-values were calculated. Results: From electronic records at the University of Cincinnati, 129 patients were identified. Median age was 66 with baseline ECOG PS of mostly 0 (86, 67%) or 1 (40, 31%). Primary tumor site was most commonly head of pancreas (104, 81%). Of 129, 55 (43%) patients received surgery upfront; the rest received neoadjuvant therapy (39 nCRT, 35 nCT) with gemcitabine (68%) or 5-fluorouracil (32%) containing regimens. Of those receiving nCRT/nCT, 36 (49%) went on to resection; the rest experienced progression (27, 36%) or toxicities (11, 15%) including death. Of 129, 92 (71%) have died, with median OS of 20.1 months (95% CI 16.4 - 25.0) for the full cohort. On adjusted multivariable analysis, the following were associated with worse OS: failure to undergo resection (HR 5.65, 95% CI 3.17 - 10.09, p&lt;0.0001); receiving &lt;3 cycles nCT (HR 3.00, 95% CI 1.38 - 6.53, p=0.006); baseline CA 19-9 &gt;100 (HR 2.73, 95% CI 1.52 - 4.90, p=0.001); BR disease (HR 2.20, 95% CI 1.27 – 3.81, p=0.005); not receiving RT (HR 1.91, 95% CI 1.04 - 3.53, p=0.038). Regimen choice was not associated with OS. Conclusions: In this real-world PC dataset, surgical resection remains the mainstay of curative therapy. Inadequate nCRT/nCT lead to suboptimal outcomes, likely reflecting patient physiology and disease biology effects. Future trials should focus on maximizing neoadjuvant therapy with the goal of resection.[Table: see text]

Impact of Patient Characteristics on the Outcomes of Patients with Gastrointestinal Cancers Treated with Immune Checkpoint Inhibitors.

Gastrointestinal (GI) cancers are a group of malignancies that globally account for a significant portion of cancer incidence and cancer-related death. Survival outcomes for esophageal, gastric, pancreatic, and hepatobiliary cancers remain poor, but new treatment paradigms are emerging with the advent of immune checkpoint inhibitor (ICI) therapy. This review characterizes patient-related prognostic factors that influence the response to ICI therapy. We performed an analysis of the landmark randomized clinical trials in esophageal, gastric, colorectal, hepatocellular, pancreatic, and biliary tract cancers in terms of patient demographic factors. A literature review of smaller retrospective studies investigating patient-related factors was completed. The immunological bases for these associations were further explored. The key predictive factors identified include age, sex, performance status, geography, body mass index, sarcopenia, gut microbiome, various biochemical factors, and disease distribution.

The Impact of Patient Characteristics and Antiplatelet Regimes on Clot Microstructure in Patients Treated for ST Elevation Myocardial Infarction: Clot Microstructure can Evaluate Therapeutic Efficacy.

Unfavourable clot microstructure is associated with adverse outcomes in ST elevation myocardial infarction (STEMI). We investigated the effect of comorbidities and anti-platelet treatment on clot microstructure in STEMI patients using fractal dimension (df), a novel biomarker of clot microstructure derived from the visco-elastic properties of whole blood. Patients with STEMI (n = 187) were recruited sequentially receiving aspirin with Clopidogrel (n = 157) then Ticagrelor (n = 30). Patient characteristics and blood for rheological analysis obtained. We quantified df using sequential frequency sweep tests to obtain the phase angle of the Gel Point which is synonymous with the clot microstructure. Higher df was observed in males (1.755 ± 0.068) versus females (1.719 ± 0.061, p = .001), in patients with diabetes (1.786 ± 0.067 vs 1.743 ± 0.046, p < .001), hypertension (1.760 ± 0.065 vs 1.738 ± 0.069, p = .03) and previous MI (1.787 ± 0.073 vs 1.744 ± 0.066, p = .011) compared to without. Patients receiving Ticagrelor had lower df than those receiving Clopidogrel (1.708 ± 0.060 vs 1.755 ± 0.067, p < .001). Significant correlation with df was found with haematocrit (r = 0.331, p < .0001), low-density lipoprotein (LDL) (r = 0.155, p = .046) and fibrinogen (r = 0.182, p = .014). Following multiple regression analysis, diabetes, LDL, fibrinogen and haematocrit remained associated with higher df while treatment with Ticagrelor remained associated with lower df. The biomarker df uniquely evaluates the effect of interactions between treatment and underlying disease on clot microstructure. STEMI patients with diabetes and elevated LDL had higher df, indicating denser clot. Ticagrelor resulted in a lower df than Clopidogrel signifying a less compact clot.

The Impact of Patient Characteristics on Outcomes of Surgically Managed Vertebral Osteomyelitis in the United States: Insights from a National Database Study.

This study was conducted to assess the patient characteristics, types of treatment, and outcomes of patients who are surgically treated for vertebral osteomyelitis (VO) in the United States. VO can be treated with or without surgical intervention. Surgically treated cases of VO are associated with significant morbidity and mortality, and incur major healthcare costs. There are few studies assessing the characteristics and outcomes of patients with VO who are treated surgically, as well as the overall impact of surgically managed VO on the healthcare system of the United States. Utilizing the Nationwide Inpatient Sample (NIS) database, 44,401 patients were identified who underwent surgical treatment for VO over a fifteen year period. Severity of comorbidity burden was calculated using the Deyo Index (DI). Surgical approach and comorbidities were analyzed in regard to their impact on complications, mortality rate, LOS, and hospitalization charges. The incidence of surgical intervention for patients who had VO increased from 0.6 to 1.1 per U.S. persons over the study period. Surgically treated patients had a mean age of 56 years, were 75.8% white, were 54.5% male, 37.9% carried Medicare insurance, and they had a mean DI of 0.88. Anterior/posterior approach (OR: 3.53), thoracolumbar fusion (OR: 2.69), thoracolumbar fusion (OR: 19.94), and anterior/posterior approach (OR: 64.73) were the surgical factors that most significantly predicted any complication, mortality, increased LOS, and increased hospital charges, respectively (P < 0.001). The mean inflation-adjusted total hospital cost increased from $20,355 to $39,991 per patient over the study period. VO has been steadily increasing in the United States. Incidence and inflation-adjusted costs nearly doubled. Anterior/posterior approach and thoracolumbar fusion most significantly predicted negative outcomes. VO is associated with lengthy and expensive hospital stays resulting in a significant burden to patients and the healthcare system.

A clinical prediction of skin to subarachnoid space depth in parturients undergoing caesarean delivery in a Nigerian population

Few studies on the prediction of skin to subarachnoid space depth (SSD) in African parturients undergoing caesarean delivery are available. We undertook a prospective observational study of 402 parturients scheduled for elective caesarean delivery to determine simple and clinically applicable formulae for predicting skin to SSD. Additionally, the impact of patient characteristics and variables such as age, height, weight, body mass index (BMI), and body surface area on SSD was studied. We employed a Stepwise Multiple Linear Regression Model to predict SSD in normal weight, overweight, and obese parturients using previously described formulae and compared our derived SSDs to these previous formulae for concordance. (Craig, Abe, Stocker, Chong’s modified, Prakash, Ma, Hazarika, Taman and Celik). Mean SSD was 6.62 ± 1.07 cm in the overall population. SSD in normal weight patients was (6.19 ± 0.92 cm), overweight (6.44 ± 0.92 cm) and obese (6.97 ± 1.17 cm). There was a correlation between SSD and BMI (p = 0.001). Formulae for predicting SSD in the overall population, normal weight, overweight and obese parturients were 4.34 + weight × 0.03, 4.43 + weight × 0.03, 4.54 + weight × 0.03 and 3.56 + weight × 0.03, respectively. We also found the Prakash formula to correlate best with our observed SSD. We concluded that SSD correlated well with weight in the overall parturient population and that Prakash’s formula was the most accurate of the other previously described formulae in predicting SSD in this subset of African parturients.

Subtype of Achalasia and Integrated Relaxation Pressure Measured Using the Starlet High-resolution Manometry System: A Multicenter Study in Japan.

Background/AimsManoScan and Sandhill high-resolution manometry (HRM) systems are used worldwide; however, the diagnosis of achalasia on the Starlet HRM system is not fully characterized. Furthermore, the impact of calcium channel blockers and nitrites in treating achalasia has not been investigated using HRM. Management of recurrent cases is a priority issue, although few studies have examined patient characteristics.MethodsWe conducted a multicenter, large-scale database analysis. First, the diagnosis of treatment-naive achalasia in each HRM system was investigated. Next, patient characteristics were compared between type I-III achalasia, and the impact of patient characteristics, including calcium channel blocker and nitrite use for integrated relaxation pressure (IRP) values, were analyzed. Finally, patient characteristics with recurrent achalasia were elucidated.ResultsThe frequency of type I achalasia with Starlet was significantly higher than that with ManoScan and Sandhill HRM systems. In achalasia, multivariate analysis identified male sex, advanced age, long disease duration, obesity, type I achalasia, and sigmoid type as risk factors related to normal IRP values (< 26 mmHg). Calcium channel blockers and nitrites use had no significant impact on the IRP values, although achalasia symptoms were indicated to be alleviated. In recurrent cases, the IRP value was significantly lower, and advanced age, long disease duration, and sigmoid type were more common than in treatment-naive patients.ConclusionsWe should cautiously interpret the type of achalasia and IRP values in the Starlet HRM system. Symptoms of recurrent cases are related to disease progression rather than IRP values, which should be considered in decision making.

Nurse staffing levels in critical care: The impact of patient characteristics.

Intensive care is one of the most resource-intensive forms of care because seriously ill patients are cared for in units with high staffing levels. Studies show that the number of registered nurses (RNs) per patient and nurse education level affects patient outcome. However, there is a lack of studies that consider how nurses/patient ratio with an advanced educational level of specialized nurses in intensive care, affect the intensive care performed in different patient populations. To investigate if differences in patient characteristics and nurse-patient ratio have an impact on the quality of care. This is a retrospective observational study with a review of all patients >15 years receiving care at two general intensive care units with different nurse/patient ratio (unit A, 1:1 nurse/patient ratio and unit B, 0.5:1 nurse/patient ratio). There was no significant difference in the initial severity of illness between the units. However, younger patients, male patients and patients requiring surgery entailed a higher workload and a longer intensive care unit (ICU) stay despite a 1:1 critical care nurse/patient ratio. A small difference, but not significant, with more unplanned re-intubations occurred at unit A compared with unit B. The differences in the nurse/patient ratio did not reflect a difference in the severity of illness among admitted patients but might be explained by patient characteristics with different needs. Health care managers should consider not only the number of nurses but also their educational level, specific competencies and skills mix and nursing-sensitive measures to provide high-quality ICU care in settings with different patient characteristics. Nursing-sensitive patient outcomes should be considered in relation to nurse/patient ratio, as important to measure to ensure a high quality of patient care in the ICU.

Update of a prognostic survival model in head and neck squamous cell carcinoma patients treated with immune checkpoint inhibitors using an expansion cohort

BackgroundImmune checkpoint inhibitors (ICI) treatment in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) offers new therapeutic venues. We have previously developed a predictive survival model in this patient population based on clinical parameters, and the purpose of this study was to expand the study cohort and internally validate the model.MethodsA single institutional retrospective analysis of R/M HNSCC patients treated with ICI. Clinical parameters collected included p-16 status, hemoglobin (Hb), albumin (Alb), lactate dehydrogenase (LDH), neutrophil, lymphocyte and platelet counts. Cox proportional hazard regression was used to assess the impact of patient characteristics and clinical variables on survival. A nomogram was created using the rms package to generate individualized survival prediction.Results201 patients were included, 47 females (23%), 154 males (77%). Median age was 61 years (IQR: 55-68). P-16 negative (66%). Median OS was 12 months (95% CI: 9.4, 14.9). Updated OS model included age, sex, absolute neutrophil count, absolute lymphocyte count, albumin, hemoglobin, LDH, and p-16 status. We stratified patients into three risk groups based on this model at the 0.33 and 0.66 quantiles. Median OS in the optimal risk group reached 23.7 months (CI: 18.5, NR), 13.8 months (CI: 11.1, 20.3) in the average risk group, and 2.3 months (CI: 1.7, 4.4) in the high-risk group. Following internal validation, the discriminatory power of the model reached a c-index of 0.72 and calibration slope of 0.79.ConclusionsOur updated nomogram could assist in the precise selection of patients for which ICI could be beneficial and cost-effective.

Comparison of Cesarean Deliveries in a Multicenter U.S. Cohort Using the 10-Group Classification System.

We sought to (1) use the Robson 10-Group Classification System (TGCS), which classifies deliveries into 10 mutually exclusive groups, to characterize the groups that are primary contributors to cesarean delivery frequencies, (2) describe inter-hospital variations in cesarean delivery frequencies, and (3) evaluate the contribution of patient characteristics by TGCS group to hospital variation in cesarean delivery frequencies. This was a secondary analysis of an observational cohort of 115,502 deliveries from 25 hospitals between 2008 and 2011. The TGCS was applied to the cohort and each hospital. We identified and compared the TGCS groups with the greatest relative contributions to cohort and hospital cesarean delivery frequencies. We assessed variation in hospital cesarean deliveries attributable to patient characteristics within TGCS groups using hierarchical logistic regression. A total of 115,211 patients were classifiable in the TGCS (99.7%). The cohort cesarean delivery frequency was 31.4% (hospital range: 19.1-39.3%). Term singletons in vertex presentation with a prior cesarean delivery (group 5) were the greatest relative contributor to cohort (34.8%) and hospital cesarean delivery frequencies (median: 33.6%; range: 23.8-45.5%). Nulliparous term singletons in vertex (NTSV) presentation (groups 1 [spontaneous labor] and 2 [induced or absent labor]: 28.9%), term singletons in vertex presentation with a prior cesarean delivery (group 5: 34.8%), and preterm singletons in vertex presentation (group 10: 9.8%) contributed to 73.2% of the relative cesarean delivery frequency for the cohort and were correlated with hospital cesarean delivery frequencies (Spearman's rho = 0.96). Differences in patient characteristics accounted for 34.1% of hospital-level cesarean delivery variation in group 2. The TGCS highlights the contribution of NTSV presentation to cesarean delivery frequencies and the impact of patient characteristics on hospital-level variation in cesarean deliveries among nulliparous patients with induced or absent labor. · We report on the cesarean delivery frequencies in a multicenter U.S. . · NTSV gestations (groups 1 and 2) are a primary driver of cesarean deliveries.. · Patient characteristics contributed most to hospital variation in cesarean deliveries in group 2..

Prospective Study of Low-Radiation and Low-Iodine Dose Aortic CT Angiography in Obese and Non-Obese Patients: Image Quality and Impact of Patient Characteristics.

The purpose of this study was to prospectively analyse image quality and radiation dose of body mass index (BMI)-adapted low-radiation and low-iodine dose CTA of the thoracoabdominal aorta in obese and non-obese patients. This prospective, single-centre study included patients scheduled for aortic CTA between November 2017 and August 2020 without symptoms of high-grade heart failure. A BMI-adapted protocol was used: Group A/Group B, BMI < 30/≥ 30 kg/m2, tube potential 80/100 kVp, total iodine dose 14.5/17.4 g. Intraindividual comparison with the institutional clinical routine aortic CTA protocol was performed. The final study cohort comprised 161 patients (mean 71.1 ± 9.4 years, 32 women), thereof 126 patients in Group A (mean BMI 25.4 ± 2.8 kg/m2) and 35 patients in Group B (34.0 ± 3.4 kg/m2). Mean attenuation over five aortoiliac measurement positions for Group A/B was 354.9 ± 78.2/262.1 ± 73.0 HU. Mean effective dose for Group A/B was 3.05 ± 0.46/6.02 ± 1.14 mSv. Intraindividual comparison in 50 patients demonstrated effective dose savings for Group A/B of 34.4 ± 14.5/25.4 ± 14.1% (both p < 0.001), and iodine dose savings for Group A/B of 54/44.8%. Regression analysis showed that female sex and increasing age were independently associated with higher vascular attenuation. In conclusion, BMI-adapted, low-radiation and low-iodine dose CTA of the thoracoabdominal aorta delivers diagnostic image quality in non-obese and obese patients without symptoms of high-grade heart failure, with superior image quality in females and the elderly.

Abstract P3-18-06: Satisfaction and physical wellbeing after breast conserving therapy: Clinical predictors and reference values using the BREAST-Q

Abstract Background: BREAST-Q is a widely accepted patient reported outcome measure (PROM) for breast surgery patients. BREAST-Q has been challenging to implement for clinical practice, due to insufficient understanding of clinical factors influencing BREAST-Q scores and lack of reference values for score interpretation. As a result, the clinical applicability of the BREAST-Q is limited, and benefits of routine PROM implementation on care quality have not been realized for breast surgery patients. This study finds predictors impacting long-term scores for the BREAST-Q Breast Conserving Therapy (BCT) module and determines reference values to guide score interpretation in clinical practice. Methods: A retrospective review of BCT patients at Memorial Sloan Kettering Cancer Center was conducted. All patients completed at least one BREAST-Q in 2018-2020. Patient characteristics were collected, including age, BMI, race, smoking status, chemotherapy, radiation therapy (RT), and axillary surgery (sentinel lymph node biopsy, axillary lymph node dissection). BREAST-Q was collected routinely during clinical visits as part of standard of care. Linear regression measured the impact of patient characteristics on 1 year and 2 year BREAST-Q scores. Median scores at baseline and 2 weeks, 6 months, 1 year, and 2 years after surgery were determined for RT and No RT patients. Pearson’s Chi-square and Student t-tests were used for categorical and continuous variables, respectively. Based on prior literature, a minimal clinically important difference of 4 points was used (scale 0-100). Results: 1866 BCT patients were included. Average age was 58.9(11.4) with BMI of 27.9(6.4). Patients were primarily white (76.8%) and non-smokers (89.7%); 36.8% had chemotherapy, 74.7% had axillary surgery, and 73.3% had RT. Regression analysis showed age and race as significant predictors of Satisfaction with Breast and Physical Wellbeing scores (Table 1). RT was a clinically significant predictor for Physical Wellbeing, reducing scores by 4.5 points at 1 year and 4.6 points at 2 years. Reference values were then created for RT and No RT patients. (Table 2). Conclusions: This study found factors impacting satisfaction and physical wellbeing after BCT using BREAST-Q scores of a longitudinal cohort of women and presented references values for score interpretation. Separate reference values were created based on RT as it is a significant predictor of BREAST-Q scores and omission of RT is increasingly offered to older women with low-risk breast cancer, given no survival benefit. These reference values can be incorporated into a user-friendly application or integrated into electronic medical records to help patients and physicians interpret BREAST-Q scores in a clinically meaningful way. Future research should assess the impact of early interventions targeting BCT patients below the 25th percentile (e.g. referrals to plastic surgeons or physical therapy) on BREAST-Q scores. Table 1.Multivariate analysis of BREAST-Q score predictors at 1 year and 2 years after surgerySatisfaction with BreastPhysical Wellbeing1 year2 year1 year2 yearScore changeSEp-valueScore changeSEp-valueScore changeSEp-valueScore changeSEp-valueAge0.1533.907p=0.0020.1280.068p=0.0610.2800.041p &amp;lt; 0.0010.2930.054p &amp;lt; 0.001BMI0.0190.0483p=0.821-0.2200.119p=0.065-0.0120.073p=0.867-0.1380.093p=0.141RaceWhiteReference--Reference--Reference--Reference--Black-7.3462.018p &amp;lt; 0.001-11.4652.876p &amp;lt; 0.001-7.4821.748p &amp;lt; 0.001-6.6512.259p=0.003Asian-1.4631.936p=0.450-1.5842.842p=0.578-2.2221.677p=0.185-0.3472.248p=0.878Other-3.7162.998p=0.2150.7904.451p=0.859-7.4672.575p=0.004-4.1963.495p=0.230Unknown1.4962.804p=0.5946.2213.914p=0.1120.2342.410p=0.923-1.9253.074p=0.531Smoking StatusNeverReference--Reference--Reference--Reference--Previous-1.2161.174p=0.300-1.4221.603p=0.375-1.5821.013p=0.119-1.0301.259p=0.414Current-1.7752.584p=0.492-3.3293.946p=0.399-3.8962.238p=0.082-8.0853.099p=0.009Unknown6.7652.384p=0.0059.4784.054p=0.1120.7612.064p=0.7136.1623.183p=0.531ChemotherapyNoReference--Reference--Reference--Reference--Yes-0.7401.148p=0.5190.3961.603p=0.805-3.3750.993p &amp;lt; 0.001-1.8101.262p=0.152Radiation TherapyNoReference--Reference--Reference--Reference--Yes-0.8961.293p=0.488-2.8961.830p=0.114-4.4951.118p &amp;lt; 0.001-4.6431.435p=0.001Axillary SurgeryNoReference--Reference--Reference--Reference--Yes-0.3581.319p=0.786-1.8711.948p=0.337-3.9091.140p &amp;lt; 0.001-3.6461.526p=0.017 Table 2.BREAST-Q reference values at 2 weeks, 6 months, 1 year, and 2 years after surgeryBaseline2 Weeks6 Months1 Year2 YearsRTSatisfaction with Breastsn=445-n=485n=1223n=65325th percentile53-63615950th percentile64-78757275th percentile82-100100100Physical Wellbeingn=483n=843n=486n=1228n=65125th percentile726060606650th percentile857176717675th percentile10082898989Psychosocial Wellbeingn=445-n=487n=1221n=65125th percentile62-66646650th percentile71-83838375th percentile87-100100100Sexual Wellbeingn=417-n=430n=1108n=58025th percentile46-48484850th percentile62-66666675th percentile70-798484No RTSatisfaction with Breastsn=172-n=186n=439n=22925th percentile48-67.5636350th percentile64-88827875th percentile82-100100100Physical Wellbeingn=184n=323n=188n=442n=23025th percentile726066717650th percentile897176828975th percentile1008289100100Psychosocial Wellbeingn=174-n=187n=437n=23025th percentile64-71666950th percentile74-87878775th percentile93-100100100Sexual Wellbeingn=161-n=158n=387n=19925th percentile43-535354.550th percentile62-66666675th percentile74-919191 Citation Format: Jacqueline J Chu, Jonas A Nelson, Paula Garcia, Babak J Mehrara, Andrea L Pusic, Monica Morrow, Mary L Gemignani, Audree B Tadros. Satisfaction and physical wellbeing after breast conserving therapy: Clinical predictors and reference values using the BREAST-Q [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-18-06.

The Impact of Patient Characteristics on Diagnostic Test Performance.

Diagnostic tests can detect diseases, monitor responses, and inform treatments. They are vital to the effective management of disease. There have been significant advances in the engineering of new diagnostic technologies. These technologies may forgo sample extraction, simplify readout, or automate processing. Many researchers design these diagnostics based on test performance in a limited sample subset. This approach ignores the intertwined relationship between patient characteristics and diagnostic test results. Yet, it is important to understand the clinical decision-making workflow and how the disease manifests in order to optimally design diagnostic tests. This review article explores the three aspects of incorporating patient characteristics to maximize diagnostic performance. 1) Characterize patient populations using patient demographics, disease prevalence, and other unique features. 2) Use the characteristics of the patient population to establish design requirements. 3) Determine the best use case since each case has different performance and target requirements. In this framework the clinical, technological, and unmet needs of a patient population shape the diagnostics design requirements. Following these steps will lead to maximal diagnostic performance and poise new diagnostics for real world use.

Efficacy and Safety of Rivaroxaban in Patients with CAT: A Pooled Meta-Analysis of 3 Randomized Controlled Trials

Introduction: CALLISTO, a comprehensive programme of research on cancer-associated thrombosis (CAT) , included 3 randomized trials of rivaroxaban versus low molecular weight heparin (LMWH) for the treatment of venous thrombosis in patients with solid and haematological cancers (SELECT-D, CASTA-DIVA and CONKO-11). A meta-analysis of these studies was conducted to improve the precision of current estimates of the efficacy and safety of rivaroxaban in this patient group and investigate how patient characteristics impact the treatment effects.Methods: The primary endpoint was the cumulative incidence of venous thromboembolism (VTE) recurrence at the end of the treatment period (≥3 months). Other endpoints included major bleeding (MB), a composite of MB or clinically relevant non-major bleeding (clinically relevant bleeding [CRB]) and deaths from any cause. All endpoints were assessed by 8 pre-defined subgroup analyses: age, gender, creatinine clearance, type of index VTE, index VTE localization, cancer localization, performance status and presence of metastases (Prospero submission 266227). Patient-level data were used in this analysis.The cumulative incidences of VTE recurrence, CRB were estimated using the Kalbfleisch and Prentice model, while the Kaplan-Meier model was used to estimate the incidence of death. Comparisons between rivaroxaban and LMWH for VTE recurrence, MB and CRB were assessed by sub-distribution hazard ratios (SubHR) and 95% confidence intervals (CI), whereas hazard ratios and 95% CIs were used for the all-cause death endpoint. The pooled treatment effect size of each study was estimated using fixed-effect and random-effects models.Results: When considering the prevention of VTE recurrence in the 3 randomized trials (N=804), an overall reduction of 48% was observed with rivaroxaban compared with LMWH (SubHR = 0.52, 95% CI 0.28─0.98). The estimation appeared to be homogeneous across subgroups of patients. In comparison with LMWH, rivaroxaban was associated with an increased risk of CRB (SubHR = 2.03, 95% CI 1.34─3.09), without significant difference in MB (SubHR = 1.24, 95% CI 0.60─2.57), and no difference was observed for death.Conclusions: This pooled analysis suggests that rivaroxaban may be an alternative treatment option for the prevention of VTE recurrence in cancer patients with VTE. The gain in statistical power has shown significant benefit, as well as some risk associated with rivaroxaban treatment in this complex patient population. The impact of patient characteristics on these treatment effects will be presented at the meeting. DisclosuresLaporte: Bayer Healthcare: Other: personal fees and non-financial support; Pfizer: Other: non-financial support; LEO Pharma: Other: non-financial support. Marshall: Bayer: Research Funding. Young: BMS/Pfizer Alliance: Honoraria; Leo Pharma: Honoraria; Chugai: Honoraria; Bayer: Honoraria, Research Funding. Riess: Bristel Myers Squibb: Honoraria; Bayer: Honoraria, Research Funding; Daiichi Sankyo: Honoraria; ASPEN: Honoraria; Leo Pharma: Honoraria; Pfizer: Honoraria. Sinn: BMS: Honoraria, Research Funding; Incyte: Honoraria, Research Funding; Pfizer: Honoraria; Servier: Consultancy, Honoraria, Research Funding; Astra Zenica: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; MSD: Consultancy, Research Funding; Sanofi: Consultancy; Bayer: Research Funding. Girard: Bayer Healthcare: Other: Personal fees, Research Funding; LEO Pharma: Other: Perconal fees, Research Funding. Sanchez: BAYER: Other: reports grants, personal fees and non-financial suppor; BMS: Other: grants, personal fees and non-financial support; PFIZER: Other: personal fees and non-financial support; BOEHRINGER INGELHEIM: Other: personal fees and non-financial support; CHIESI: Other: personal fees; BOSTON SCIENTIFICS: Other: grants and personal fees.

Disease burden and treatment sequence of polymyositis and dermatomyositis patients in Japan: a real-world evidence study

Introduction/objectivesSince new consensus on polymyositis (PM) and dermatomyositis (DM) were released in Japan, an updated evidence on treatment landscape and PM/DM burden was essential. This study evaluates treatment burden and overall treatment cost of PM/DM-related inpatient and outpatient visits, treatments, and procedures/patient/year.MethodThis retrospective, observational study analyzed insurance claims from Japan Medical Data Center (JMDC) database. Patients with at least one PM/DM diagnosis/one dispensation of treatment between 1 January 2009 and 31 December 2019 were enrolled. Patient characteristics, treatment patterns and sequence, treatment choices, healthcare resource utilization (HCRU), and related costs were assessed. Chi-square test and linear regression model were used to assess impact of patient characteristics on treatment choice.ResultsPatients (836/4,961) receiving a relevant treatment were analyzed. Heart disease (35%), interstitial lung disease (27%), and diabetes mellitus (26%) were frequently identified as comorbidities. Concomitant dispensation of immunosuppressants and systemic steroids was largely found in first and second line of treatment (LoT) while systemic steroids remained as single dominant treatment across all LoTs. HCRU was very low for inpatient visits (0.68 [1.43]) or rehabilitation (4.74 [14.57]). The mean (SD) number of inpatient visits decreased from first (1.23 [2.32]) to third year (0.11 [0.54]). Total mean (SD) healthcare cost per patients per year was ¥ 3,815,912 (7,412,241), with overall drug dispensation compounding to 80% of total cost.ConclusionsHigh concomitant immunosuppressant and systemic steroid prescriptions in first LoT recommend early optimal treatment to manage PM/DM. Although inpatient costs are low, outpatient dispensation costs increase overall economic burden.Key Points• Japan faces treatment challenges in the prognosis of polymyositis (PM) and dermatomyositis (DM) and thus, we assessed the real-world treatment landscape, practice, patterns, and healthcare resource utilization as an evidence to support healthcare outcome improvement and treatment burden reduction.• Systemic steroids were the dominant preferred choice of treatment, but it increases the overall cost of the treatment due to the resultant comorbidities considering possible side-effects promotion.• Thus, an increased awareness towards the disease management among patients and medical doctors is required for better management goals based on this real-world practice evidence.