The applicability of Papanicolaou Society of Cytopathology system on reporting endoscopic ultrasound-guided fine needle aspiration cytology specimens of pancreatic lesions in situations with limited availability of ancillary tests. Experience at a single laboratory.

INTRODUCTION: The Papanicolaou Society of Cytopathology (PSC) system of reporting pancreatobiliary cytology is a standardised reporting nomenclature that uses a six-tiered scheme of diagnostic categories utilising routine microscopy and ancillary tests such as biochemical and molecular analysis of cyst fluids and immunochemistry. The objective of this study was to determine the applicability of the PSC system on endoscopic ultrasound-guided fine needle aspiration cytology samples reported at the cytopathology laboratory, Mubarak Al Kabeer Hospital, in Kuwait with special emphasis on situations with limited availability of ancillary tests. METHODS: In total, 132 cases of endoscopic ultrasound-guided fine needle aspiration cytology samples from pancreatic lesions were categorised according to PSC system guidelines after examining the glass slides and reviewing the clinical, imaging and ancillary test findings. These review diagnoses were compared with the diagnoses rendered during initial reporting. Correlation with histopathology reports was done wherever available. RESULTS: In 23 (17.42%) of 132 cases, re-categorisation was necessary between initial and reviewed diagnoses. In 16 cases, re-categorisations were because of non-analogous categories between initial and reviewed diagnosis. In the remaining seven, they were due to identification of newer cytomorphological and imaging findings or because of issues arising from unavailability of sufficient material for ancillary investigations. CONCLUSION: All cases could be categorised using the PSC system with a moderate number of re-categorisations between initial and reviewed diagnoses. In certain circumstances, limited availability of ancillary tests, resulted in non-diagnostic categories whereas in other such circumstances, diagnostic categories could be assigned with certain conceptual modifications to the PSC guidelines.

Towards a common framework for defining ancillary material quality across the development spectrum.

Ancillary materials (AMs) play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that the final product cannot be sterilized, AM quality becomes increasingly critical to the clinical advancement of cell and gene therapies. Despite a lack of direct legislative direction regarding AM quality, internationally harmonized guidance is available from several industry-standard bodies that describe the principles and application of a risk-based approach to AM qualification and related supply-chain risk management. According to a best-practice risk-based approach, AMs must be adequately qualified to a degree that reflects the level of risk the material presents to patient safety and the drug product's specification. This general approach can be implemented in different ways, and balancing quality with cost of goods is critical to the cost-effective manufacture of advanced therapy medicinal products. In some cases, it may be preferable or necessary to use AMs that are produced in compliance with current Good Manufacturing Practice. However, developers may be able to suppress manufacturing costs without undermining safety or regulatory compliance in the case that a material presents a lower risk profile. Despite a great deal of attention and interest in the quality of AMs in the cell and gene therapy space, there is still a need for greater harmonization to create a shared understanding of what constitutes a risk-based approach to AM production and sourcing. In this article, we propose a staged approach to AM quality that achieves a balance between the competing demands of risk mitigation and cost of goods containment at the various stages of AM quality development. Our novel, heuristic framework for communication among AM suppliers, users and regulators aims to bring down development and manufacturing costs and lessen the workload around regulatory compliance.

Full blood count as an ancillary test to support the diagnosis of giant cell arteritis.

BACKGROUND: Temporal artery biopsy is considered the investigation of choice to diagnose definitively giant cell arteritis (GCA) in patients with compatible symptoms. However it is invasive and not completely sensitive. Serum markers, particularly erythrocyte sedimentation rate (ESR), can be supportive, but are not definitive in individual cases. AIMS: To investigate whether indices derived from the full blood count, including neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were associated with a positive biopsy in patients with suspected GCA. METHODS: The clinical and pathological details of 537 patients undergoing temporal artery biopsy at our institution from 1992 to 2015 were reviewed. RESULTS: In univariate analysis high platelets (odds ratio (OR) 4.44, P < 0.001), NLR (OR 1.81, P = 0.02), PLR (OR 3.25, P < 0.001), C-reactive protein (CRP) (OR 3.00, P < 0.001), ESR (OR 3.62, P < 0.001) and increased age (OR 1.03, P = 0.006) were strongly associated with a positive biopsy. In multivariate modelling only high platelets (P < 0.001) and ESR (P = 0.049) maintained significance. CONCLUSIONS: We conclude that the presence of thrombocytosis and high NLR, PLR, ESR and CRP can all be used clinically to support the diagnosis of GCA prior to biopsy. Of particular note, in multivariate modelling the presence of thrombocytosis is a stronger predictor of a positive temporal artery biopsy than ESR. Therefore, careful consideration of the findings in a full blood count can be used to predict the likelihood of a positive temporal artery biopsy in patients with suspected GCA.

Ethical challenges posed by clinical trials in preterm labor: a case study.

This paper explores the ethical implications of a randomized double-blind clinical trial aimed to determine effectiveness and safety of an oxytocin receptor antagonist versus a betamimetic in the treatment of preterm labor, presented to a teaching hospital affiliated with a private university in Santiago, Chile. Though this trial protocol fulfills one of the conditions under which pregnant women could be enrolled in a clinical trial-the intervention has the potential to benefit the pregnant woman (by reducing adverse effects associated to salbutamol administration) and her fetus (if the new drug prolongs pregnancy)-there are some specific ethical issues raised. First, when to obtain consent is an important issue for clinical trials involving acute and unforeseen conditions that affect pregnant woman, e.g. preterm labor. Second, research must address the risk/benefit ratio for these two interdependent individuals, providing a good prospect of low risk and adequate benefit for both of them. Thirdly, specifically when a study is sponsored by a high-income country and conducted in a low- or middle-income country, decisions regarding ancillary care provisions for research participants should be made in advance. Lastly, researchers must consider the requirements for paternal consent based on cultural contexts.

Evaluation of the time required for overhead tasks performed by physicians, medical physicists, and technicians in radiation oncology institutions: the DEGRO-QUIRO study.

OBJECTIVE: Developments in radiation oncology in recent years have highlighted the increasing deployment of personnel resources for tasks not directly related to patients. These tasks include patient-related activities such as treatment planning, reviewing files, and administrative duties (e.g., invoicing for services, documentation). The aim of the present study, part of the QUIRO project of the German Society of Radiation Oncology (DEGRO), was to describe, on the basis of valid data, the deployment of personnel resources in radiation oncology centers for "overhead" tasks. METHODS: Questionnaires were used to analyze the percentages of time needed for various tasks. The target group comprised physicians, medical physics experts (MPE), and medical technical radiology assistants (MTRA). A total of 760 personnel from 65 radio-oncology centers in the German inpatient and outpatient sector participated (32 % physicians, 23 % MPE, and 45 % MTRA). RESULTS: High percentages of overhead tasks during working time were measured for each of the three personnel groups considered (physicians, MPE, and MTRA). Patient-related efficiency, i.e., the percentage of working time associated directly or indirectly with the patient, was highest among MTRA and lowest among MPE. Particular features could be seen in the activity profiles of personnel in university clinics. Duties in the areas of research and teaching resulted in a greater percentage of overhead tasks for physicians and MPE. Irrespective of function (physician, MPE, or MTRA), a managerial role resulted in lower patient-related efficiency, as well as a narrower time budget for direct patient care compared with non-managerial employees. CONCLUSION: Using the data gathered, it was possible to systematically investigate the time required for overhead tasks in radio-oncological centers. Overall, relatively high time requirements for a variety of overhead tasks were measured. These time requirements, generated for example by administrative duties or research and teaching, are currently not taken into adequate consideration in terms of remuneration or personnel capacity planning.

An urgent need to understand and address the safety and well-being of hospital "sitters".

BACKGROUND: Hospital sitters provide continuous observation of patients at risk of harming themselves or others. Little is known about sitters' occupational safety and well-being, including experiences with patient/visitor-perpetrated violence (type II). METHODS: Data from surveys, focus groups, individual interviews at six U.S. hospitals were used to characterize the prevalence of and circumstance surrounding type II violence against sitters, as well as broader issues related to sitter use. RESULTS: Sitter respondents had a high 12-month prevalence of physical assault, physical threat, and verbal abuse compared to other workers in the hospital setting. Sitters and other staff indicated the need for clarification of sitters' roles regarding patient care and sitter well-being (e.g., calling for assistance, taking lunch/restroom breaks), training of sitters in personal safety and de-escalation, methods to communicate patient/visitor behaviors, and unit-level support. CONCLUSIONS: The burden of type II violence against hospital sitters is concerning. Policies surrounding sitters' roles and violence prevention training are urgently needed.

Acute rhinosinusitis in children.

Acute rhinosinusitis in children is a common disorder that is characterized by some or all of the following symptoms: fever, rhinorrhea, nasal congestion, cough, postnasal drainage, and facial pain/headache. It often starts as an upper respiratory tract infection that is complicated by a bacterial infection in which the symptoms worsen, persist, or are particularly severe. The accurate diagnosis of acute rhinosinusitis is challenging because of the overlap of symptoms with other common diseases, heavy reliance on subjective reporting of symptoms by the parents, and difficulties related to the physical examination of the child. Antibiotics are the mainstay of treatment. There is no strong evidence for the use of ancillary therapy. Orbital and intracranial complications may occur and are best treated early and aggressively. This article reviews the diagnosis, pathophysiology, bacteriology, treatment, and complications of acute rhinosinusitis in children.

Buildings' impact on effective hospital services--the means of the property management role in Norwegian hospitals.

PURPOSE: The purpose of this paper is to assess the status of the physical assets of Norwegian hospital facilities in terms of technical condition, building performance, usability and adaptability, thereby comprehending the main challenges for property management as part of facilities management (FM) within hospitals of the Norwegian Specialist Health-Care Services and permitting a discussion on a more strategic property management role. DESIGN/METHODOLOGY/APPROACH: The research is based on an action research approach using data collection from surveys, schemes and questionnaires, literature studies, documentation analysis and workshops with an active research team involvement with stakeholders. In-depth interviews were undertaken with owner representatives, property management representatives and health-care deliverers, and a GAP analysis allowed a study of the quality of property management (as part of the FM). FINDINGS: A severe technical backlog was documented together with a strong demand for structural upgrading, which was roughly estimated to be approximately 30-35 billion NOK in 2012 (3.75-4.4 billion euros). Improvements are necessary in all areas of FM delivery within limited economic frameworks, even though several examples of good property management (as part of FM delivery) were found. A gap exists between the general strategy concerning hospital assets and the property management role, particularly with regard to the translation of change in user needs into changed facilities. A need for an increasing professionalization of the role is pressing, turning attention from operational costs and control to potential added value. This requires a shift of focus from the property manager in order to implement visions and goals for the health-care sector, which involves several actions such as an improved communication between stakeholders and technically improved skills, thus ensuring the recruitment and capability of property management staff and improved measurement processes. PRACTICAL IMPLICATIONS: This paper give two major recommendations: first, a stronger integration of the property management role as part of the FM delivery with the executive management of the Health Authorities and Regional and Local Health Trusts; and second, a nationally coordinated strategy for the development of property management in the Specialist Health-Care Services (called Strategic FM). The authors believe that developing a pool of competencies at the national level is necessary to develop the tools, methods and standardized measurements to enable a change in the use of the terms of added value and sustainability. Ultimately, this will enhance the assets of the healthl sector, and this paper suggests a model that allows for this development. ORIGINALITY/VALUE: This paper shows a model for property management as a strategic role in a holistic process involving all stakeholders from both the bottom up and the top down. The authors believe this process will engage the stakeholders in agreeing upon a clear vision and set of goals for the health-care service assets.

Top 4 sources of savings in support services.

Examples of ways that a hospital can reduce support-service costs include: Incorporating more comprehensive performance metrics as part of its contract renewal process for food services. Managing equipment service contracts centrally and reexamining existing contracts. Converting from heavy-weight to lighter-weight linens. Providing rigorous training for environmental services staff on critical touch points in patient room cleaning.

The application of hospitality elements in hospitals.

In the last decade, many hospital designs have taken inspiration from hotels, spurred by factors such as increased patient and family expectations and regulatory or financial incentives. Increasingly, research evidence suggests the value of enhancing the physical environment to foster healing and drive consumer decisions and perceptions of service quality. Although interest is increasing in the broader applicability of numerous hospitality concepts to the healthcare field, the focus of this article is design innovations, and the services that such innovations support, from the hospitality industry. To identify physical hotel design elements and associated operational features that have been used in the healthcare arena, a series of interviews with hospital and hotel design experts were conducted. Current examples and suggestions for future hospitality elements were also sought from the experts, academic journals, and news articles. Hospitality elements applied in existing hospitals that are addressed in this article include hotel-like rooms and decor; actual hotels incorporated into medical centers; hotel-quality food, room service, and dining facilities for families; welcoming lobbies and common spaces; hospitality-oriented customer service training; enhanced service offerings, including concierges; spas or therapy centers; hotel-style signage and way-finding tools; and entertainment features. Selected elements that have potential for future incorporation include executive lounges and/or communal lobbies with complimentary wireless Internet and refreshments, centralized controls for patients, and flexible furniture. Although the findings from this study underscore the need for more hospitality-like environments in hospitals, the investment decisions made by healthcare executives must be balanced with cost-effectiveness and the assurance that clinical excellence remains the top priority.

Hospital quality and the cost of inpatient surgery in the United States.

CONTEXT: Payers, policy makers, and professional organizations have launched a variety of initiatives aimed at improving hospital quality with inpatient surgery. Despite their obvious benefits for patients, the likely impact of these efforts on health care costs is uncertain. In this context, we examined relationships between hospital outcomes and expenditures in the US Medicare population. METHODS: Using the 100% national claims files, we identified all US hospitals performing coronary artery bypass graft, total hip replacement, abdominal aortic aneurysm repair, or colectomy procedures between 2005 and 2007. For each procedure, we ranked hospitals by their risk- and reliability-adjusted outcomes (complication and mortality rates, respectively) and sorted them into quintiles. We then examined relationships between hospital outcomes and risk-adjusted, 30-day episode payments. RESULTS: There was a strong, positive correlation between hospital complication rates and episode payments for all procedures. With coronary artery bypass graft, for example, hospitals in the highest complication quintile had average payments that were $5353 per patient higher than at hospitals in the lowest quintile ($46,024 vs $40,671, P < 0.001). Payments to hospitals with high complication rates were also higher for colectomy ($2719 per patient), abdominal aortic aneurysm repair ($5279), and hip replacement ($2436). Higher episode payments at lower-quality hospitals were attributable in large part to higher payments for the index hospitalization, although 30-day readmissions, physician services, and postdischarge ancillary care also contributed. Despite the strong association between hospital complication rates and payments, hospital mortality was not associated with expenditures. CONCLUSIONS: Medicare payments around episodes of inpatient surgery are substantially higher at hospitals with high complications. These findings suggest that local, regional, and national efforts aimed at improving surgical quality may ultimately reduce costs and improve outcomes.

Responsibilities to plan for ancillary care pose ethical challenges for nutrition research in the community setting.

Investigators who conduct nutrition research in the community setting, particularly among underserved populations, face the ethical question of whether and how to respond to participants' unmet health needs. The research ethics literature conceptualizes this question as one of ancillary care (AC): what is the nature and extent of researchers' ethical responsibilities, if any, to provide or facilitate health care that research participants need but that is not necessary to ensure the safety or scientific validity of the research? In this paper, we highlight 3 ethical challenges involved in the planning of AC responses for nutrition research conducted in the community setting: influence of provision of AC on primary study outcomes as an issue of trial design; whether to extend the provision of AC beyond research participants to nonparticipants with the same health needs; and how best to train field workers who may be the most likely members of the study team to encounter the health needs anticipated among participants. Although the global ethical discussion of AC is gaining in depth, breadth, and practical influence, it remains relatively uninformed by perspectives specific to nutrition research. Our objective is to encourage nutrition researchers to engage proactively in the emerging ethical discussion of AC, so that their relevant experiences and concerns can be taken into account in the eventual formation of ethical guidelines and policies.

Effectiveness of a hospital school mathematics literacy program.

To receive treatment for cancer, patients in Brazil often travel to larger hospitals that may be located far away from their families and communities. Pediatric patients miss time in the classroom and may achieve educational milestones later than other students. They may also struggle with some educational topics after receiving certain types of cancer treatment. The Hospital School at the GRAACC helps to close this education gap by providing educational support to school-age students receiving treatment for cancer. In addition to providing educational services during treatment, teachers at the hospital school, Mobile School - Specific Student (EMAE). The objective of this preliminary study is to build knowledge about the impact of school enrollment on mathematics literacy in hospitalized cancer patients undergoing treatment. We followed 15-year-old patients (n = 54) with at last 1 year inside the hospital school for a period of 8 years (2001-2008). Study participants were affected by a variety of diseases including bone tumors (n = 39), Hodgkin lymphoma (n = 08) and non-Hodgkin lymphoma (n = 07). The level of participants' mathematical literacy was regularly assessed by reviewing the results of formative assessments completed by students. Using that information, students were grouped into categories according to mathematics literacy levels established by the Programme for International Student Assessment (PISA). The formative assessment is based on the analysis of all the material produced by the student and the EMAE teacher across the years of the study, including the recordings of working meetings that were held with all the teachers every class day.

Providing comfort and support to older people.

This article reports on a scheme run by Age UK at Hillingdon Hospital, Middlesex, to help support emergency department (ED) staff with the care of older people. The A&E support-worker team assists patients with non-clinical activities, such as going to the toilet, eating meals and finding out care-related information. The support-worker scheme has been running for nine years and its success has prompted Age UK to consider expanding it nationally. It comes at a time when there is a growing focus on the care Solder patients receive in hospitals.

Language services in hospitals: discordance in availability and staff use.

Despite efforts to advance effective patient-provider communication, many patients' language needs continue to be unmet or inappropriately addressed by healthcare providers (Wielawski 2010; Patek et al. 2009; Wilson-Stronks and Galvez 2007). This study presents a picture of the language resources currently provided by hospitals and those resources practitioners actually use. Questionnaire data were collected from 14 hospitals in Florida's Palm Beach, St. Lucie, and Martin counties on availability, staff awareness, and staff use of linguistic resources and services. Inconsistencies were identified between the language tools, services, and resources hospitals provide and those staff use. In addition, a large majority of staff respondents still rely upon someone accompanying the patient for communication with patients who have limited English proficiency, despite evidence that this practice contributes to miscommunication and serious medical errors (Flores et al. 2003; Flores 2005; HHS OMH 2001; Patek et al. 2009). Hospitals that use bilingual staff as interpreters often do not test the competency of these staff, nor do they assess the utilization or effectiveness of the tools and resources they provide. Hospitals can improve the cultural and linguistic care they provide if they (1) address the practice of using ad hoc interpreters, (2) effectively disseminate information to hospital staff regarding how and when to access available resources, and (3) collect patient population data and use it to plan for and evaluate the language services they provide to their patients.

An overview of Afghan National Army critical care capabilities.

BACKGROUND: The North Atlantic Treaty Organization created the International Security Assistance Force to help support the growth in capacity and capability of Afghan National Army (ANA). OBJECTIVE: This article describes the current critical care capabilities of the ANA, which was supported by embedded medical mentors to help build up Afghanistan's medical infrastructure after the fall of the Taliban. DESIGN: We reviewed the experiences of deployed medical mentors in ANA hospitals to report the progress and limitations of the North Atlantic Treaty Organization medical mentoring mission. RESULTS: From October 2008 through November 2009, the continued development of ANA Intensive Care Unit capabilities has decreased mortality from 26.3% to 5.1% despite an increase in admissions from 19 to 78 per month. CONCLUSIONS: Significant progress was made in the critical care capabilities of the ANA critical care physicians. The medical mentoring mission is an effective weapon in building the health care capacity of the ANA medical system.

A hospital-based patient and family education center: if you build it, will they come?

Librarians located in a 560-bed, inner city academic medical center with 25,000 + admissions per year planned and opened a Patient and Family Education Center (PFEC) in the lobby of a new patient care pavilion. A review of use in the first 19 months revealed that expected needs were being met while a variety of unexpected needs were identified. Ongoing use continues to be monitored by a detailed log of patron visits maintained by library staff. This article describes the evolution of the Patient and Family Education Center, outreach to the hospital community, and plans for the future.

The Use of Ancillary Services Under a Bundled Care Versus a Fee-For-Service Payment Model.

OBJECTIVES: Colocated services in a team-based integrated practice unit (IPU) optimize care of pelvic floor disorders. Our goal was to compare ancillary service utilization in a multidisciplinary IPU between patients covered by a bundled payment model (BPM) versus a traditional fee-for-service model (FFSM). METHODS: Medical records of women attending an IPU for pelvic floor disorders with colocated services, including nutrition, social work, psychiatry, physical therapy, and subspecialty care between October 2017 and December 2018, were included in this retrospective chart review. All patients were offered treatment with ancillary services according to standardized care pathways. Data extracted included patient demographics, pelvic floor disorder diagnoses, baseline severity measures, payment model, and ancillary services used. Univariate and multivariate logistic regression identified variables predicting higher uptake of ancillary services. RESULTS: A total of 575 women with pelvic floor disorders presented for care during the study period, of which 35.14% attended at least 1 appointment with any ancillary services provider. Ancillary service utilization did not differ between patients in the BPM group and those in the FFSM group (36.22 vs 33.47%; P = 0.489). Social work services were more likely to be used by the BPM compared with the FFSM group (15.95 vs 6.28%; P < 0.001). The diagnosis of fecal incontinence was associated with a higher chance of using any ancillary service (odds ratio, 4.91; 95% confidence interval, 1.81-13.33; P = 0.002). CONCLUSIONS: One third of patients with pelvic floor disorders receiving care in an IPU used colocated ancillary services. Utilization does not differ between payment models.

Ancillary care duties: the demands of justice.

Ancillary care is care that research participants need that is not essential to make the research safe or scientifically valid and is not needed to remedy injuries that eventuate as a result of the research project itself. Ancillary care duties have recently been defended on the grounds of beneficence, entrustment, utility and consent. Justice has also been mentioned as a possible basis of ancillary care duties, but little attention has been paid to this approach. In this paper, the author seeks to rectify this omission by arguing that ancillary care duties can be based on a principle of justice as rectification.