A real-world investigation into prescribing patterns and effectiveness of ceftolozane/tazobactam among critically ill patients from SPECTRA.

Background: Ceftolozane/tazobactam (C/T) real-world use was examined in a global population of critical care patients treated in intensive care unit settings.

Methods: The Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam Real-world Analysis (SPECTRA) is a multinational, retrospective observational study of 617 adults treated with C/T conducted between 2016 and 2020. Population-associated clinical, treatment-related, and microbiologic characteristics, resource utilization, and clinical outcomes were assessed in critical care patients.

Unveiling results and insights from multinational, multicenter Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam Real-world Analysis (SPECTRA).

Objectives: Antibacterial-resistant gram-negative hospital-acquired infections result in significant morbidity and mortality. In clinical trials, ceftolozane/tazobactam (C/T) has been effective against these infections; however, real-world findings are limited.

Methods: SPECTRA was a global, retrospective, observational inpatient study of adults treated with C/T for ≥48 h, conducted between 2016 and 2020.

Intrathecal daptomycin use in a challenging case of ventriculitis.

Treatment of ventriculitis caused by enterococci can be challenging, and antibiotic options are limited. We describe a case of device-related ventriculitis caused by vancomycin-resistant , refractory to initial antibiotics. Our management approach included intrathecal daptomycin.

'It makes life so much easier'-experiences of users of the MicroGuide™ smartphone app for improving antibiotic prescribing behaviour in UK hospitals: an interview study.

Objectives: To understand the impact on prescribing behaviour of an antimicrobial therapy guidelines smartphone app, in widespread use in hospitals in the UK.

Methods: Twenty-eight doctors and five nurse prescribers from four purposively selected hospitals in the UK participated in behavioural theory-informed semi-structured interviews about their experiences of using the MicroGuide™ smartphone app. Data were analysed using a thematic content analysis.

Multicentre study of the activity of ceftolozane/tazobactam and other commonly used antibiotics against isolates from patients in the UK.

Objectives: To evaluate the activity of ceftolozane/tazobactam and other commonly used antipseudomonal antibiotics against geographically spread isolates in the UK using disc susceptibility testing.

Methods: The activity of ceftolozane/tazobactam and nine other commonly used antipseudomonal antibiotics was evaluated. Isolates were collected between January 2015 and April 2018.

The heterogeneous causal effects of neonatal care: a model of endogenous demand for multiple treatment options based on geographical access to care.

Neonatal units in the UK are organised into three levels, from highest Neonatal Intensive Care Unit (NICU), to Local Neonatal Unit (LNU) to lowest Special Care Unit (SCU). We model the endogenous treatment selection of neonatal care unit of birth to estimate the average and marginal treatment effects of different neonatal designations on infant mortality, length of stay and hospital costs. We use prognostic factors, survival and hospital care use data on all preterm births in England for 2014-2015, supplemented by national reimbursement tariffs and instrumental variables of travel time from a geographic information system.

Estimating the effectiveness and cost-effectiveness of establishing additional endovascular Thrombectomy stroke Centres in England: a discrete event simulation.

Background: We have previously modelled that the optimal number of comprehensive stroke centres (CSC) providing endovascular thrombectomy (EVT) in England would be 30 (net 6 new centres). We now estimate the relative effectiveness and cost-effectiveness of increasing the number of centres from 24 to 30.

Methods: We constructed a discrete event simulation (DES) to estimate the effectiveness and lifetime cost-effectiveness (from a payer perspective) using 1 year's incidence of stroke in England.

Opportunities for antimicrobial stewardship in patients with acute bacterial skin and skin structure infections who are unsuitable for beta-lactam antibiotics: a multicenter prospective observational study.

Purpose: The objective of this prospective, observational study was to describe the treatment, severity assessment and healthcare resources required for management of patients with acute bacterial skin and skin structure infections who were unsuitable for beta-lactam antibiotic treatments.

Methods: Patients were enrolled across five secondary care National Health Service hospitals. Eligible patients had a diagnosis of acute bacterial skin and skin structure infection and were considered unsuitable for beta-lactam antibiotics (e.

Comparative healthcare-associated costs of methicillin-resistant Staphylococcus aureus bacteraemia-infective endocarditis treated with either daptomycin or vancomycin.

Complex infection with methicillin-resistant Staphylococcus aureus (MRSA) is associated with high healthcare and societal costs; thus, evaluation of the costs and health benefits of interventions is an important consideration in a modern healthcare system. This study estimated the cost consequences of the use of daptomycin compared with vancomycin for the first-line treatment of patients with proven MRSA-induced bacteraemia-infective endocarditis (SAB-IE) with a vancomycin minimum inhibitory concentration (MIC) >1mg/L in the UK. A decision model was developed to assess total healthcare costs of treatment, including inpatient, outpatient and drug costs.

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis.

Recognizing Success in the Chaplain Profession: Connecting Perceptions With Practice.

The current investigation examines the communicative hallmarks of successful chaplaincy work as articulated by professional chaplains providing spiritual care at the end-of-life. Data grounded in qualitative interviews with 32 chaplains of various denominations and lengths of service reveals a challenge in gauging success when working with dying patients and families. Chaplains reported nonverbal hallmarks of success consist of (a) intrapersonal sense of accomplishment, (b) progress in fulfilling patient needs, and (c) meaningful connection with patients.

National characteristics and variation in Arabic handwriting.

From each of four Arabic countries; Morocco, Tunisia, Jordan and Oman, 150 participants produced handwriting samples which were examined to assess whether national characteristics were discernible. Ten characters, which have different configurations depending upon their position in the word, along with one short word, were classified into distinguishable forms, and these forms recorded for each handwriting sample. Tests of independence showed that character forms used were not independent of country (p<0.

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites.

Talking about end-of-life preferences in marriage: applying the theory of motivated information management.

The theory of motivated information management (TMIM) provides one framework to examine information-seeking behaviors, especially in conversations involving sensitive or difficult information such as preferences for end-of-life (EOL) care. The spouse plays a significant role in decision making surrounding EOL care. Consequently, individuals need information about spouses' EOL preferences in order to ensure carrying out those desires.

Using daptomycin in hospitalised patients with cSSTI caused by Staphylococcus aureus has an impact on costs.

Background: The aim was to assess the cost impact of daptomycin compared to vancomycin treatment in patients hospitalised for complicated skin and soft-tissue infection (cSSTI) with suspected methicillin-resistant Staphylococcus aureus infection in the UK.

Methods: A decision model was developed to estimate the costs associated with cSSTI treatment. Data on efficacy, treatment duration and early discharge from published clinical trials were used, with data gaps on standard clinical practice being filled by means of clinician interviews.

Translating spiritual care in the chaplain profession.

Chaplains provide a much-needed service to patients and families requiring spiritual care in the healthcare setting. Despite evidence documenting improvements quality of life for patients using spiritual services, chaplains experience challenges in translating the benefits they provide into concepts understood by patients, team members, and administrators. A qualitative study using interviews with 19 chaplains found that translation problems occur in three main areas: (a) justifying the role to patients and families, (b) determinations of what constitutes a "productive" employee, and (c) effective collaboration with other members of the health care team.

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.

4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters.

The effect of material choice on biofilm formation in a model warm water distribution system.

Water distribution systems (WDS) are composed of a variety of materials and may harbour potential pathogens within surface-attached microbial biofilms. Biofilm formation on four plumbing materials, viz. copper, stainless steel 316 (SS316), ethylene propylene diene monomer (EPDM) and cross-linked polyethylene (PEX), was investigated using scanning electron microscope (SEM)/confocal microscopy, ATP-/culture-based analysis, and molecular analysis.

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.

"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"

Permanent draft genome sequence of Vibrio tubiashii strain NCIMB 1337 (ATCC19106).

Vibrio tubiashii NCIMB 1337 is a major and increasingly prevalent pathogen of bivalve mollusks, and shares a close phylogenetic relationship with both V. orientalis and V. coralliilyticus.

Identification of the class characteristics in the handwriting of Polish people writing in English.

An investigation was carried out to identify the class characteristics of Polish people writing in English and to specifically identify those characteristics that separate Polish handwriting from English handwriting. In the first stage, 40 Polish and 40 English handwriting samples were collected and systematically examined. In total, 31 features were identified that occurred in ≥25% of the Polish handwriting samples and therefore considered class characteristics.

An evaluation of the long-term effects of total plantar fasciotomy--a preliminary study.

Background: Plantar fascia release for chronic plantar fasciitis has given excellent pain relief and rapid return to activities with few reported complications. Cadaveric studies have led to the identification of some potential post-operative problems, commonly weakness of the medial longitudinal arch (MLA) and pain in the lateral midfoot.

Methods: Eight total plantar fasciotomy patients (five bilateral and three unilateral) were evaluated subjectively and objectively with regards to surgical outcome and biomechanical change.

An evidence base for patient-centered cancer care: a meta-analysis of studies of observed communication between cancer specialists and their patients.

Objective: In the context of patients visiting cancer specialists, the objective is to test the association between both patient-centered communication (including Affective Behavior and Participation Behavior) and Instrumental Behavior and patients' post-visit satisfaction with a variety of visit phenomena.

Methods: Meta-analysis of 25 articles representing 10 distinct data sets.

Results: Both patient-centered- and instrumental behavior are significantly, positively associated with satisfaction, with patient-centered communication having a relatively stronger association.