High Risk Of Deterioration Research Articles

What influences ambulance clinician decisions to pre-alert emergency departments: a qualitative exploration of pre-alert practice in UK ambulance services and emergency departments

BackgroundAmbulance clinicians use pre-alerts to inform receiving hospitals of the imminent arrival of a time-critical patient considered to require immediate attention, enabling the receiving emergency department (ED) or other clinical...

Clinical and epidemiological analysis of intestinal infections in a children's infectious diseases hospital, experience in using the PEWS scale

Purpose of the work: to conduct a clinical-epidemiological analysis of intestinal infections in a pediatric infectious diseases hospital and the effectiveness of the PEWS scale.Materials and methods: a retrospective study was conducted at the Moscow City Clinical Hospital «Communarka» and City Clinical Hospital No. 1 in the pediatric infectious disease departments from June 1, 2023, to August 31, 2023. Laboratory, clinical, and anamnestic data were obtained from the medical information system «EMIAS» and the laboratory information system (LIS) «ALISA». The study analyzed 838 medical records of children with acute respiratory infections.Results: when conducting a statistical analysis of indicators in two groups (group 1 — PEWS ≥ 3 points, recorded at least once during the entire period of hospitalization, group 2 — PEWS from 1 to 2 points, recorded at least once during hospitalization period) no significant differences were observed in terms of etiology, age, day of illness, blood test results, and length of hospital stay. All patients had a moderate form of acute respiratory infection, however, patients with PEWS ≥ 3 points required increased attention from medical staff and had a higher risk of deterioration without additional medical intervention, with the most significant risk in predicting deterioration being related to changes in the cardiovascular system. All children were discharged home in satisfactory condition with PEWS = 0.Conclusion: In our conducted research, for the first time in the Russian Federation, the experience of using the PEWS scale in pediatric practice for patients with gastrointestinal infections was applied with the aim of early detection of the risk of clinical deterioration. It can be assumed that the most significant risk in predicting deterioration in the condition of a child with acute gastrointestinal infection, as well as with acute respiratory infection, is predominantly due to disturbances in the cardiovascular system.

Multi-cohort analysis reveals immune subtypes and predictive biomarkers in tuberculosis

Tuberculosis (TB) remains a significant global health threat, necessitating effective strategies for diagnosis, prognosis, and treatment. This study employs a multi-cohort analysis approach to unravel the immune microenvironment of TB and delineate distinct subtypes within pulmonary TB (PTB) patients. Leveraging functional gene expression signatures (Fges), we identified three PTB subtypes (C1, C2, and C3) characterized by differential immune-inflammatory activity. These subtypes exhibited unique molecular features, functional disparities, and cell infiltration patterns, suggesting varying disease trajectories and treatment responses. A neural network model was developed to predict PTB progression based on a set of biomarker genes, achieving promising accuracy. Notably, despite both genders being affected by PTB, females exhibited a relatively higher risk of deterioration. Additionally, single-cell analysis provided insights into enhanced major histocompatibility complex (MHC) signaling in the rapid clearance of early pathogens in the C3 subgroup. This comprehensive approach offers valuable insights into PTB pathogenesis, facilitating personalized treatment strategies and precision medicine interventions.

Evaluation of Changes in Activities of Daily Living and Quality of Life of Patients with Bone Metastasis Who Underwent Conservative Therapy through Bone Metastasis Cancer Boards.

Background and Objectives: Changes in activities of daily living (ADL) and quality of life (QOL) of patients with bone metastasis who underwent surgical treatment through Bone Metastasis Cancer Boards (BMCBs), a recent multidisciplinary approach for managing bone metastases, have been reported; however, no reports exist on patients who undergo conservative treatment. In this study, we aimed to evaluate these patients' ADL and QOL and examine the factors influencing changes in these parameters. Materials and Methods: We retrospectively reviewed 200 patients with bone metastases who underwent conservative therapy through BMCBs between 2013 and 2021. A reassessment was conducted within 2-8 weeks after the initial assessment. Patients' background and changes in performance status (PS), Barthel Index (BI), EuroQol five-dimension (EQ-5D) scores, and Numerical Rating Scale (NRS) scores were initially assessed. Furthermore, we categorized patients into two groups based on improvements or deteriorations in ADL and QOL and performed comparative analyses. Results: Significant improvements in EQ-5D (0.57 ± 0.02 versus [vs.] 0.64 ± 0.02), NRS max (5.21 ± 0.24 vs. 3.56 ± 0.21), and NRS average (2.98 ± 0.18 vs. 1.85 ± 0.13) scores were observed between the initial assessment and reassessment (all p < 0.001). PS (1.84 ± 0.08 vs. 1.72 ± 0.08) and BI (83.15 ± 1.68 vs. 84.42 ± 1.73) also showed improvements (p = 0.06, and 0.054, respectively). In addition, spinal cord paralysis (odds ratio [OR]: 3.69, p = 0.049; OR: 8.42, p < 0.001), chemotherapy (OR: 0.43, p = 0.02; OR: 0.25, p = 0.007), and NRS average scores (OR: 0.38, p = 0.02; OR: 0.14, p < 0.001) were independent factors associated with ADL and QOL. Conclusions: Patients with bone metastases who underwent conservative treatment through BMCBs exhibited an increase in QOL without a decline in ADL. The presence of spinal cord paralysis, absence of chemotherapy, and poor pain control were associated with a higher risk of deterioration in ADL and QOL.

Derivation of the Difficult Airway Physiological Score (DAPS) in adults undergoing endotracheal intubation in the emergency department

BackgroundPrediction of serious outcomes among patients with physiological instability is crucial in airway management. In this study, we aim to develop a score to predict serious outcomes following intubation in critically ill adults with physiological instability by using clinical and laboratory parameters collected prior to intubation.MethodThis single-center analytical cross-sectional study was conducted in the Emergency Department from 2016 to 2020. The airway score was derived using the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) methodology. To gauge model’s performance, the train-test split technique was utilized. The discrete random number generation approach was used to divide the dataset into two groups: development (training) and validation (testing). The validation dataset’s instances were used to calculate the final score, and its validity was measured using ROC analysis and area under the curve (AUC). By computing the Youden’s J statistic using the metrics sensitivity, specificity, positive predictive value, and negative predictive value, the discriminating factor of the additive score was determined.ResultsThe mean age of the 1021 patients who needed endotracheal intubations was 52.2 years (± 17.5), and 632 (62%) of them were male. In the development dataset, there were 527 (64.9%) physiologically difficult airways, 298 (36.7%) post-intubation hypotension, 124 (12%) cardiac arrest, 347 (42.7%) shock index > 0.9, and 456 [56.2%] instances of pH < 7.3. On the contrary, in the validation dataset, there were 143 (68.4%) physiologically difficult airways, 33 (15.8%) post-intubation hypotension, 41 (19.6%) cardiac arrest, 87 (41.6%) shock index > 0.9, and 121 (57.9%) had pH < 7.3, respectively. There were 12 variables in the difficult airway physiological score (DAPS), and a DAPS of 9 had an area under the curve of 0.857. The accuracy of DAPS was 77%, the sensitivity was 74%, the specificity was 83.3%, and the positive predictive value was 91%.ConclusionDAPS demonstrated strong discriminating ability for anticipating physiologically challenging airways. The proposed model may be helpful in the clinical setting for screening patients who are at high risk of deterioration.

Comparison of eight prehospital early warning scores in life-threatening acute respiratory distress: a prospective, observational, multicentre, ambulance-based, external validation study

A myriad of early warning scores (EWSs) exist, yet there is a need to identify the most clinically valid score to be used in prehospital respiratory assessments to estimate short-term and midterm mortality, intensive-care unit admission, and airway management in life-threatening acute respiratory distress. This is a prospective, observational, multicentre, ambulance-based, external validation study performed in 44 ambulance services and four hospitals across three Spanish provinces (ie, Salamanca, Segovia, and Valladolid). We identified adults (ie, those aged 18 years and older) discharged to the emergency department with suspected acute respiratory distress. The primary outcome was 2-day all-cause in-hospital mortality, for all the patients or according to prehospital respiratory conditions, including dyspnoea, chronic obstructive pulmonary disease (COPD), COVID-19, other infections, and other conditions (asthma exacerbation, haemoptysis, and bronchoaspirations). 30-day mortality, intensive-care unit admission, and invasive and non-invasive mechanical ventilation were secondary outcomes. Eight EWSs, namely, the National Early Warning Score 2, the Modified Rapid Emergency Medicine Score, the Rapid Acute Physiology Score, the Quick Sequential Organ Failure Assessment Score, the CURB-65 Severity Score for Community-Acquired Pneumonia, the BAP-65 Score for Acute Exacerbation of COPD, the Quick COVID-19 Severity Index, and the Modified Sequential Organ Failure Assessment (mSOFA), were explored to determine their predictive validity through calibration, clinical net benefit as determined through decision curve analysis, and discrimination analysis (area under the curve of the receiver operating characteristic [AUROC], compared with Delong's test). Between Jan 1, 2020, and Nov 31, 2022, 902 patients were enrolled. The global 2-day mortality rate was 87 (10%); in proportion to various respiratory conditions, the rates were 35 (40%) for dyspnoea, nine (10%) for COPD, 13 (15%) for COVID-19, 28 (32%) for other infections, and two (2%) for others conditions. mSOFA showed the best calibration, a higher net benefit, and the best discrimination (AUROC 0·911, 95% CI 0·86-0·95) for predicting 2-day mortality, and its discrimination was statistically significantly more accurate (p<0·0001) compared with the other scores. The performance of mSOFA for predicting 2-day mortality was higher than the other scores when considering the prehospital respiratory conditions, and was also higher for the secondary outcomes, except for non-invasive mechanical ventilation. Our results showed that mSOFA outperformed other EWSs. The inclusion of mSOFA in prehospital decision making will entail a quick identification of patients in acute respiratory distress at high risk of deterioration, allowing prioritisation of resources and patient care. Gerencia Regional de Salud, Public Health System of Castilla y León (GRS Spain). For the Spanish translation of the abstract see Supplementary Materials section.

Decline in muscle strength and physical function after fracture in men - the prospective STRAMBO study.

Studies on muscle strength and physical function after fracture are focused on short follow-ups and adjacent anatomical region. We compared loss of muscle strength and physical function in men after fracture with normal ageing-related decline. In 823 men aged 60-87, measurements of grip strength and clinical tests (chair stands, balance) were performed every 4years for 12years. In 155 men with incident fracture, we compared the status after vs. before the fracture. In men without fracture (controls), we compared the status on the first follow-up (4years) vs. baseline. In men with fracture, grip strength decreased more than in the controls (41%, 0.28SD, P < .01). Men with fracture had higher risk of incident deterioration on the five chair-stand test vs. the controls (OR = 2.45, P < .001). They had higher risk of incident inability to stand for 10s with closed eyes vs. the controls (OR = 4.80, P < .01). They also had higher risk of deterioration on the tandem walk than the controls: forwards (OR = 2.04, P < .01), backwards (OR = 2.25, P < .005). The rapid physical decline was not limited to the region of the fracture site. In men who had incident non-upper limb fractures, grip strength decreased more (32%, P < .05) vs. the controls. In men who had incident non-lower limb fractures, the risk of decline in the tests of the lower limbs was higher vs. controls (chair stands, OR = 2.73, P < .001). The risk of decline was higher in men with clinical fractures which occurred >1year before the next visit vs. controls (tandem walk forwards, OR = 2.98, P < .005). Overall, in older men, fractures were associated with greater loss of muscle strength and physical function vs. normal ageing. This accelerated decline was also found in the anatomical regions remote from the fracture site. Thus, programs to decrease or reverse the post-fracture decline could have beneficial effects on subsequent fracture risk.

Evaluation of Nutritional Status in Cancer Patients Underwent Radiotherapy: The Results of Biochemical, Body Composition with Bioelectrical Impedance Analysis, Anthropometric Measurements, and Patient-Generated Subjective Global Assessment

Aim: This study aims to evaluate the nutritional status and the effect of radiotherapy (RT) on nutrition in all ambulatory cancer patients. Material and Method: In this prospective observational study 105 cancer patients with various diagnoses treated between 2013 and 2014 were evaluated. All patients were ≥18 years old and had Karnofsky Performance Status ≥70. Anthropometric measurements, body composition with bioelectric impedance, and patient-generated Subjective Global Assessment (PG-SGA) tools were used. The height, weight, body mass index (BMI), triceps skin fold thickness, mid-upper arm circumference, hemoglobin, and serum albumin levels were determined twice before and after RT. Additionally, nutrition-related symptoms and short-term weight loss results were determined by PG-SGA questionnaires. Results: The patients’ median age was 53 years (range, 18-82 years). At initial evaluation 74 patients were well nourished using the PG-SGA global rating. Malnutrition developed in totally 33 of these 74 patients after RT. The PG-SGA results after RT were significantly worse than before treatment. PG-SGA revealed no significant relationship between nutritional status prior to RT and the parameters including gender, age, mean weight, BMI, disease duration, pre-RT hemoglobin and albumin levels. Post-RT evaluation showed a significant relationship between deterioration (PG-SGA B-C) and mean weight, BMI, serum albumin, hemoglobin levels, and concomitant chemotherapy. Gastrointestinal and head and neck cancer patients had the most deterioration after RT. The patients' weight, BMI, fat-free mass, total body water, and the percentage weight loss at the end of RT were significantly lower than the initial assessment. Conclusion: It is considerable to use multiple tools for nutritional monitoring. Patients who received RT to the head and neck and upper abdomen region had a high risk of deterioration after treatment. These patients should be monitored carefully during all treatment periods.

Using a novel ambulatory monitoring system to support patient safety on an acute infectious disease ward during an unfolding pandemic.

To gain staff feedback on the implementation and impact of a novel ambulatory monitoring system to support coronavirus patient management on an isolation ward. Qualitative service evaluation. Semi-structured interviews were conducted with 15 multidisciplinary isolation ward staff in the United Kingdom between July 2020 and May 2021. Interviews were audio-recorded, transcribed and analysed using thematic analysis. Adopting Innovation to Assist Patient Safety was identified as the overriding theme. Three interlinked sub-themes represent facets of how the system supported patient safety. Patient Selection was developed throughout the pandemic, as clinical staff became more confident in choosing which patients would benefit most. Trust In the System described how nurses coped with discrepancies between the ambulatory system and ward observation machines. Finally, Resource Management examined how, once trust was built, staff perceived the ambulatory system assisted with caseload management. This supported efficient personal protective equipment resource use by reducing the number of isolation room entries. Despite these reported benefits, face-to-face contact was still highly valued, despite the risk of coronavirus exposure. Hospital wards should consider using ambulatory monitoring systems to support caseload management and patient safety. Patients in isolation rooms or at high risk of deterioration may particularly benefit from this additional monitoring. However, these systems should be seen as an adjunct to nursing care, not a replacement. Nurses valued ambulatory monitoring as a means of ensuring the safety of patients at risk of deterioration and prioritizing their workload. The findings of this research will be useful to all those developing or considering implementation of ambulatory monitoring systems in hospital wards. This manuscript follows the Consolidated criteria for Reporting Qualitative Research (COREQ) guidelines with inclusion of relevant SQUIRE guidelines for reporting quality improvement. No Patient or Public Contribution.

Kathleen's journey: improving mental health outcomes for women with bipolar affective disorder

For most women, pregnancy and the postpartum period are times of great joy and expectation. However, for women with a diagnosis of bipolar affective disorder, there is an exceptionally high risk of deterioration in their mental health. There is the real possibility of developing postpartum psychosis, possibly requiring acute psychiatric admission and being separated from their baby. This can have devastating consequences for a woman, her baby, the family and society. Multiple services/disciplines across primary, secondary and tertiary care settings need to work together to enhance outcomes for these women. In Ireland, a relatively new collaborative way of working is emerging, as specialist perinatal mental health teams are developed. This case review aims to illustrate the complexities of and potential in collaborative team working to support a woman with a pre-existing a mental health disorder, and her family, during pregnancy. This was done through a specialist perinatal mental health teams collaboration co-ordinated by a clinical nurse specialist.

Tobacco Smoking and Pack-Years Are Associated With Frailty Among People With HIV.

Tobacco smoking increases frailty risk among the general population and is common among people with HIV (PWH) who experience higher rates of frailty at younger ages than the general population. We identified 8608 PWH across 6 Centers for AIDS Research Network of Integrated Clinical Systems sites who completed ≥2 patient-reported outcome assessments, including a frailty phenotype measuring unintentional weight loss, poor mobility, fatigue, and inactivity, and scored 0-4. Smoking was measured as baseline pack-years and time-updated never, former, or current use with cigarettes/day. We used Cox models to associate smoking with risk of incident frailty (score ≥3) and deterioration (frailty score increase by ≥2 points), adjusted for demographics, antiretroviral medication, and time-updated CD4 count. The mean follow-up of PWH was 5.3 years (median: 5.0), the mean age at baseline was 45 years, 15% were female, and 52% were non-White. At baseline, 60% reported current or former smoking. Current (HR: 1.79; 95% confidence interval: 1.54 to 2.08) and former (HR: 1.31; 95% confidence interval: 1.12 to 1.53) smoking were associated with higher incident frailty risk, as were higher pack-years. Current smoking (among younger PWH) and pack-years, but not former smoking, were associated with higher risk of deterioration. Among PWH, smoking status and duration are associated with incident and worsening frailty.

Exploring the nurses' experiences in recognising and managing clinical deterioration in emergency patients: A qualitative study

BackgroundEmergency Department (ED) patients are particularly at a high risk of deterioration. The frontline nurses are key players in identifying and responding to deterioration events; however, few studies have sought to explore the whole process of recognition and management of clinical deterioration by emergency nurses. ObjectivesThe aim of this study was to explore the experiences of emergency nurses and provide a whole picture of how they recognise and manage clinical deterioration. MethodsA qualitative descriptive study involving 11 senior nurses and seven junior nurses was conducted in the ED of a 3000-bed tertiary general hospital using semistructured interviews. The interviews were transcribed and thematically analysed. FindingsFour salient themes emerged from the data analysis. The first, 'early recognition and response', revealed the importance of vital signs assessment in recognising and responding to clinical deterioration. The second, 'information transfer', depicted the skills and difficulties of transferring information in escalations of care. The third, 'abilities, education, and training', presented the abilities that emergency nurses should have and their perspectives on training. The fourth, 'support culture', described the major role of senior nurses in collaboration with colleagues in the ED. ConclusionsThis study explored the experiences of emergency nurses in recognising and managing clinical deterioration. The findings illuminate the need to support the critical role of emergency nurses, with an emphasis on their abilities and continuous interprofessional collaboration training to improve the recognition and management of clinical deterioration.

Pediatric ED Saves: Analyzing the ED Screen of Direct Admissions.

The study includes patients who received the institutional screen between June 1, 2019, and May 31, 2020. We placed charts into three groups: group 1 (stable), group 2 (unstable), and group 3 (stable then transferred to pediatric intensive care unit within 6 hours). We assessed effectiveness by calculating sensitivity, specificity, and predictive values. We used comparative analysis between groups to identify patients safe for DA and those at high risk for deterioration. The screen was 80% sensitive and 100% specific, predicting 97.7% of stable patients. Of the 652 charts reviewed, 384 met the inclusion criteria. Group 1 (31.60, 26.45%, 5.23%) had lower respiratory rate, respiratory diagnosis, and oxygen requirement compared to group 2 (45.00, 78.13%, 15.63%) and group 3 (44.50, 75.00%, 50.00%). For SpO2, group 1 (98.70) was higher than group 2 (96.03). For the Pediatric Early Warning Score, group 2 (1.72) was higher than group 1 (0.31) and group 3 (0.63). The institutional screen is an effective tool to identify patients presenting as DA needing immediate emergency department intervention and/or pediatric intensive care unit care. The screen benefits patients with a respiratory diagnosis, oxygen requirement, high respiratory rate or low SpO2.

Indicators of patient deterioration in poorly resourced private hospitals: Which vital sign to watch? A retrospective case–control study

BackgroundPatient vital signs are a measure of wellness if monitored regularly and accurately. Staff shortages in poorly resourced regional hospitals often result in inadequate patient monitoring, putting patients at risk of undetected deterioration. ObjectiveThis study aims to explore the pattern and completeness of vital sign monitoring and the contribution of each vital sign in predicting clinical deterioration events in resource-poor regional/rural hospitals. MethodUsing a retrospective case–control study design, we compared 24 h of vital sign data from deteriorating and nondeteriorating patients from two poorly-resourced regional hospitals. Descriptive statistics, t-tests, and analysis of variance are used to compare patient-monitoring frequency and completeness. The contribution of each vital sign in predicting patient deterioration was determined using the Area Under the Receiver Operator Characteristic curve and binary logistical regression analysis. ResultsDeteriorating patients were monitored more frequently (9.58 [7.02] times) in the 24-h period than nondeteriorating patients (4.93 [2.66] times). However, the completeness of vital sign documentation was higher in nondeteriorating (85.2%) than in deteriorating patients (57.7%). Body temperature was the most frequently omitted vital sign. Patient deterioration was positively linked to the frequency of abnormal vital signs and the number of abnormal vital signs per set (Area Under the Receiver Operator Characteristic curve: 0.872 and 0.867, respectively). No single vital sign strongly predicts patient outcomes. However, a supplementary oxygen value of >3 L/min and a heart rate of >139 beats/min were the best predictors of patient deterioration. ConclusionGiven the poor resourcing and often geographical remoteness of small regional hospitals, it is prudent that the nursing staff are made aware of the vital signs that best indicate deterioration for the cohort of patients in their care. Tachycardic patients on supplementary oxygen are at high risk of deterioration.

The role of asymmetric dimethylarginine (ADMA) in COVID-19: association with respiratory failure and predictive role for outcome

We aimed to assess the potential role of Asymmetric dimethylarginine (ADMA) in conditioning respiratory function and pulmonary vasoregulation during Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) infection. Within 72 h from admission, samples from 90 COVID-19 patients were assessed for ADMA, SDMA, L-arginine concentrations. In addition to classical statistics, patients were also clustered by a machine learning approach according to similar features. Multivariable analysis showed that C-reactive protein (OR 1.012), serum ADMA (OR 4.652), white blood cells (OR = 1.118) and SOFA (OR = 1.495) were significantly associated with negative outcomes. Machine learning-based clustering showed three distinct clusters: (1) patients with low severity not requiring invasive mechanical ventilation (IMV), (2) patients with moderate severity and respiratory failure whilst not requiring IMV, and (3) patients with highest severity requiring IMV. Serum ADMA concentration was significantly associated with disease severity and need for IMV although less pulmonary vasodilation was observed by CT scan. High serum levels of ADMA are indicative of high disease severity and requirement of mechanical ventilation. Serum ADMA at the time of hospital admission may therefore help to identify COVID-19 patients at high risk of deterioration and negative outcome.

P157 Severe cystic fibrosis in the CFTR modulator era still exists! The implementation of a novel ‘high risk’ multidisciplinary team approach

Despite the introduction of highly effective CFTR modulators (CFTRm), a significant proportion of people with CF (pwCF) exist with severe disease and/or at risk of deterioration. Here we report on a quality improvement initiative to ensure pwCF at higher risk of deterioration are identified early, monitored appropriately, and have an MDT action plan in place.

Risk of in-hospital Deterioration for Children with Single Ventricle Physiology.

Children with single ventricle physiology (SV) are at high risk of in-hospital morbidity and mortality. Identifying children at risk for deterioration may allow for earlier escalation of care and subsequently decreased mortality.We conducted a retrospective chart review of all admissions to the pediatric cardiology non-ICU service from 2014 to 2018 for children < 18 years old. We defined clinical deterioration as unplanned transfer to the ICU or inpatient mortality. We selected children with SV by diagnosis codes and defined infants as children < 1 year old. We compared demographic, vital sign, and lab values between infants with and without a deterioration event. We evaluated vital sign and medical therapy changes before deterioration events.Among infants with SV (129 deterioration events over 225 admissions, overall 25% with hypoplastic left heart syndrome), those who deteriorated were younger (p = 0.001), had lower baseline oxygen saturation (p = 0.022), and higher baseline respiratory rate (p = 0.022), heart rate (p = 0.023), and hematocrit (p = 0.008). Median Duke Pediatric Early Warning Score increased prior to deterioration (p < 0.001). Deterioration was associated with administration of additional oxygen support (p = 0.012), a fluid bolus (p < 0.001), antibiotics (p < 0.001), vasopressor support (p = 0.009), and red blood cell transfusion (p < 0.001).Infants with SV are at high risk for deterioration. Integrating baseline and dynamic patient data from the electronic health record to identify the highest risk patients may allow for earlier detection and intervention to prevent clinical deterioration.

Patient-reported outcomes of maintenance rucaparib in patients with recurrent ovarian carcinoma in ARIEL3, a phase III, randomized, placebo-controlled trial

PurposeTo compare NFOSI-18 Disease Related Symptoms – Physical (DRSP), Total score, and side effect bother between maintenance rucaparib (600 mg twice daily) vs. placebo in the phase III ARIEL3 trial. MethodsARIEL3 (NCT01968213) included patients with ovarian carcinoma who responded to second-line or later platinum-based chemotherapy. The NFOSI-18 DRS-P and Total scales were secondary endpoints. The NFOSI-18 contains a side effect impact item (GP5): “I am bothered by side effects of treatment.” We compared treatment arms on change from baseline of DRS-P and Total scores using mixed models with repeated measures (MRMM). Time to first and confirmed deterioration of NFOSI-18 DRS-P and Total scales were analyzed using Cox regression. We also calculated the proportion of patients reporting moderate to high side effect bother on GP5. ResultsIn the intention-to-treat (ITT) cohort, mean change from baseline favored the placebo. Compared to placebo, rucaparib was associated with higher risk of deterioration [e.g., 4-point deteriorator definition hazard ratio (HR): 1.85; 95% CI: 1.46, 2.36; median time to first deterioration on DRSP: 1.9 vs. 7.0 months]. Confirmed deterioration results resembled those for first deterioration. Proportions of patients reporting moderate/high side effect bother on GP5 fluctuated around 20% across treatment cycles. Results in BRCA mutant and homologous recombination deficient cohorts were generally similar to those from the ITT cohort. ConclusionThis placebo-controlled study in the maintenance therapy setting provides a unique view of the impact of PARP inhibition on the patient-reported outcomes that are commonly used in ovarian cancer clinical trials. Information regarding the adverse side effect impact of PARP inhibitors should be weighed against their clinical benefit.

Performance of Early Warning Scoring Systems Regarding Adverse Events of Unanticipated Clinical Deterioration in Complementary and Alternative Medicine Hospitals

PurposeThis study aims to examine the performance of early warning scoring systems regarding adverse events of unanticipated clinical deterioration in complementary and alternative medicine hospitals. MethodsA medical record review of 500 patients from 5-year patient data in two traditional Korean medicine hospitals was conducted. Unanticipated clinical deterioration events included unexpected in-hospital mortality, cardiac arrest, and unplanned transfers to acute-care conventional medicine hospitals. Scores of the Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), and National Early Warning Score 2 (NEWS2) were calculated. Their performance was evaluated by calculating areas under the receiver-operating characteristic curve for the event occurrence. Multiple logistic regression analyses were performed to determine the factors associated with event occurrence. ResultsThe incidence of unanticipated clinical deterioration events was 1.1% (225/21101). The area under the curve of MEWS, NEWS, and NEWS2 was .68, .72, and .72 at 24 hours before the events, respectively. NEWS and NEWS2, with almost the same performance, were superior to MEWS (p = .009). After adjusting for other variables, patients at low-medium risk (OR = 3.28; 95% CI = 1.02–10.55) and those at medium and high risk (OR = 25.03; 95% CI = 2.78–225.46) on NEWS2 scores were more likely to experience unanticipated clinical deterioration than those at low risk. Other factors associated with the event occurrence included frailty risk scores, clinical worry scores, primary medical diagnosis, prescribed medicine administration, acupuncture treatment, and clinical department. ConclusionsThe three early warning scores demonstrated moderate-to-fair performance for clinical deterioration events. NEWS2 can be used for early identification of patients at high risk of deterioration in complementary and alternative medicine hospitals. Additionally, patient, care, and system factors need to be considered to improve patient safety.

Does end stage renal disease increase severity of COVID-19?

Background: End stage renal disease (ESRD) patients are vulnerable to contract corona virus disease-19 (COVID-19), and they have higher risk of deterioration and mortality rate compared to general population. There are studies on COVID-19 in end stage renal disease (ESRD) patients showing the low rates of deterioration, most of which did not develop into severe pneumonia. Objective: Compare the clinical, laboratory, and radiological findings in COVID-19 patients with and without ESRD and to identify the mortality risk factors in those with ESRD. Methods: We conducted a cross-sectional study involving 87 COVID-19 patients, consisted of 43 ESRD and 44 non-ESRD. Data taken included age, gender, the amount of co-morbid, oxygen saturation when they first arrived, COVID 19 symptoms (mild/moderate/severe-critical), and the data of patients who died. Result: Severe-critical clinical manifestations of COVID-19 were more common in those with ESRD vs those without (p=0.012). However, the mortality was not significantly different. Absolute neutrophil count and neutrophil-lymphocyte ratio (NLR) were significantly higher in those with ESRD. As many as 24% COVID patients died, in which 11% are ESRD patients, and 13% non-ESRD. Multivariate analysis showed that NLR ≥1 had 1.3 times higher death risk compared to NLR&lt;1. Conclusion: Severe-critical clinical manifestations of COVID-19 were more commonly found in ESRD patients. The mortality rate was not significantly different between the ESRD and non-ESRD. In COVID-19 patients with ESRD, NLR ≥1 had 1.3 times higher death risk compared to NLR&lt;1. High NLR is a risk factor for higher mortality in ESRD patients.