Trends in Long-Term Ventilation Care in U.K. Children and Young People-Further Consideration Required for Pediatric Critical Care Services.

OBJECTIVES: The objective was to compare specific data from the 2020 National Confidential Enquiry into Patient Outcome and Death (NCEPOD) report "Balancing the Pressures" with two previous U.K. studies and to examine changes in the pediatric population requiring long-term ventilation (LTV) as well as the types delivered. We believe that the new data presented will facilitate future service planning. DESIGN: A subset of confidential enquiry data derived from a study by a nationally funded quality improvement organization (NCEPOD: www.ncepod.org.uk ) was compared with two previous U.K. datasets. SETTING: Healthcare providers across England, Wales, and Northern Ireland-inpatient and community settings. PATIENTS: Children and young people (CAYP) 0-16 years old receiving LTV between April 1, 2016, and March 31, 2018. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: When comparing the NCEPOD data with that last published in the United Kingdom, the number of CAYP requiring LTV more than doubled between 2008 and 2018 (933-2,093). There has also been a particular increase in the proportion of children that were under two when they were commenced on LTV (26-39.2%). Children are now more likely than previously to be receiving LTV to manage upper airway obstruction and CNS conditions. There has also been an approximate doubling of those receiving LTV over the whole 24-hour period (9.4-18.4%). CONCLUSIONS: The increased numbers and changing characteristics of babies and children requiring LTV over the last 3 decades in the United Kingdom have implications for all healthcare sectors but particularly for providers of critical care services.

Development of a guideline for the management of the unanticipated difficult airway in pediatric practice.

BACKGROUND: Most airway problems in children are identified in advance; however, unanticipated difficulties can arise and may result in serious complications. Training for these sporadic events can be difficult. We identified the need for a structured guideline to improve clinical decision making in the acute situation and also to provide a guide for teaching. OBJECTIVE: Guidelines for airway management in adults are widely used; however, none have been previously devised for national use in children. We aimed to develop guidelines for the management of the unanticipated difficult pediatric airway for use by anesthetists working in the nonspecialist pediatric setting. METHOD: We reviewed available guidelines used in individual hospitals. We also reviewed research into airway management in children and graded papers for the level of evidence according to agreed criteria. A Delphi panel comprising 27 independent consultant anesthetists considered the steps of the acute airway management guidelines to reach consensus on the best interventions to use and the order in which to use them. If following the literature review and Delphi feedback, there was insufficient evidence or lack of consensus, regarding inclusion of a particular point; this was reviewed by a Second Specialist Group comprising 10 pediatric anesthetists. RESULTS: Using the Delphi group's deliberations and feedback from the Second Specialist Group, we developed three guidelines for the acute airway management of children aged 1-8 years. CONCLUSIONS: This paper provides the background, available evidence base, and justification for each step in the resultant guidelines and gives a rationale for their use.

Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute's Community Cancer Centers Program.

BACKGROUND: This study examined racial/ethnic differences among patients in clinical trial (CT) enrollment, refusal rates, ineligibility, and desire to participate in research within the National Cancer Institute's Community Cancer Centers Program (NCCCP) Clinical Trial Screening and Accrual Log. METHODS: Data from 4509 log entries were evaluated in this study. Four logistic regression models were run using physical/medical conditions, enrollment into a CT, patient eligible but declined a CT, and no desire to participate in research as dependent variables. RESULTS: Age ≥ 65 years (OR = 1.51, 95% CI = 1.28-1.79), males (OR = 2.28, 95% CI = 1.92-2.71), and non-Hispanic black race (OR = 1.53, 95% CI = 1.2-1.96) were significantly associated with more physical/medical conditions. Age ≥ 65 years was significantly associated with lower CT enrollment (OR = 0.83, 95% CI = 0.7-0.98). Males (OR = 0.78, 95% CI = 0.65-0.94) and a higher grade level score for consent form readability (OR = 0.9, 95% CI = 0.83-0.97) were significantly associated with lower refusal rates. Consent page length ≥ 20 was significantly associated with lower odds of "no desire to participate in research" among CT decliners (OR = 0.75, 95% CI = 0.58-0.98). CONCLUSIONS: There were no racial/ethnic differences in CT enrollment, refusal rates, or "no desire to participate in research" as the reason given for CT refusal. Higher odds of physical/medical conditions were associated with older age, males, and non-Hispanic blacks. Better management of physical/medical conditions before and during treatment may increase the pool of eligible patients for CTs. Future work should examine the role of comorbidities, sex, age, and consent form characteristics on CT participation.

Multianalyte liquid biopsy to aid the diagnostic workup of breast cancer.

Breast cancer (BC) affects 1 in every 8 women in the United States and is currently the most prevalent cancer worldwide. Precise staging at diagnosis and prognosis are essential components for the clinical management of BC patients. In this study, we set out to evaluate the feasibility of the high-definition single cell (HDSCA) liquid biopsy (LBx) platform to stratify late-stage BC, early-stage BC, and normal donors using peripheral blood samples. Utilizing 5 biomarkers, we identified rare circulating events with epithelial, mesenchymal, endothelial and hematological origin. We detected a higher level of CTCs in late-stage patients, compared to the early-stage and normal donors. Additionally, we observed more tumor-associated large extracellular vesicles (LEVs) in the early-stage, compared to late-stage and the normal donor groups. Overall, we were able to detect reproducible patterns in the enumeration of rare cells and LEVs of cancer vs. normal donors and early-stage vs. late-stage BC with high accuracy, allowing for robust stratification. Our findings illustrate the feasibility of the LBx assay to provide robust detection of rare circulating events in peripheral blood draws and to stratify late-stage BC, early-stage BC, and normal donor samples.

Improving the quality of hospital care provided to people aged 11-25 years with a mental health condition.

The National Confidential Enquiry into Patient Outcome and Death undertook a detailed analysis of data from 1269 patients aged 11-25 years, admitted to hospital with intentional injury, affective disorder, or eating disorders, to assess the quality of physical and mental healthcare provided. This article summarises the findings and associated recommendations relevant for the general hospital setting.

Balancing the pressures: a review of the quality of care provided to children and young people aged 0-24 years who were receiving long-term ventilation.

Assessing the quality of care for patients receiving long-term ventilation is complex given the diversity of this population (0-24 years in this case) and their differing requirements for treatment. This article details how and why such reviews are necessary.

Safeguarding children: why an issue for pediatric anesthetists?

Child maltreatment and the responsibility of heath care professionals to assist in prevention and diagnosis is currently center stage in the United Kingdom. This subject has a very large literature base. Anesthetists were one of the first groups to have specific guidance on this subject, and key competencies are now part of the core curriculum for our trainees. This article seeks to briefly define maltreatment and provide statistics that outline the scale of the problem, and includes discussion of risk factors and recognition. We have focused on physical abuse and have provided a separate section on abusive head trauma, which is of particular importance to anesthetists. We also discuss the process of management, with some detail around Child Death Review procedures.

Notes from a Small Island: Lessons from the UK NCEPOD Tracheotomy Report.

The spotlight in the care of tracheotomy patients has turned in recent years onto multidisciplinary care, scrutinizing the patient journey from initial treatment decisions through tracheotomy to postprocedural care. The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) conducted a national study into tracheostomy care in the United Kingdom, reporting the most comprehensive analysis of in-patient care to date. Key findings highlight recurrent deficiencies in the organization of care, staff training, and support and the inconsistent use of monitoring and safety equipment. The NCEPOD study findings are translatable to Western health care systems and serve to highlight important safety initiatives from exemplar institutions and national and international quality improvement projects. This commentary provides a forum to disseminate this essential information internationally.

Reimbursement and patient assistance programs for oral chemotherapy agents.

Oncology nurses increasingly are being asked about medication insurance coverage for oral chemotherapy agents and other medications. In small clinic and office settings, nurses often are key providers of this information. Nurses need to be informed about Medicare's medication reimbursement guidelines and able to identify resources for patients. Resources may include pharmaceutical manufacturers, patient medication assistance programs, and medication discount programs. This article reviews these resources and provides tips to use them optimally in busy oncology practices.

Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual.

PURPOSE: Screening logs have the potential to help oncology clinical trial programs at the site level, as well as trial leaders, address enrollment in real time. Such an approach could be especially helpful in improving representation of racial/ethnic minority and other underrepresented populations in clinical trials. METHODS: The National Cancer Institute Community Cancer Centers Program (NCCCP) developed a screening log. Log data collected from March 2009 through May 2012 were analyzed for number of patients screened versus enrolled, including for demographic subgroups; screening methods; and enrollment barriers, including reasons for ineligibility and provider and patient reasons for declining to offer or participate in a trial. User feedback was obtained to better understand perceptions of log utility. RESULTS: Of 4,483 patients screened, 18.4% enrolled onto NCCCP log trials. Reasons for nonenrollment were ineligibility (51.6%), patient declined (25.8%), physician declined (15.6%), urgent need for treatment (6.6%), and trial suspension (0.4%). Major reasons for patients declining were no desire to participate in trials (43.2%) and preference for standard of care (39%). Major reasons for physicians declining to offer trials were preference for standard of care (53%) and concerns about tolerability (29.3%). Enrollment rates onto log trials did not differ between white and black (P = .15) or between Hispanic and non-Hispanic patients (P = .73). Other races had lower enrollment rates than whites and blacks. Sites valued the ready access to log data on enrollment barriers, with some sites changing practices to address those barriers. CONCLUSION: Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.

Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

PURPOSE: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual. METHODS: EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials. RESULTS: Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure. CONCLUSION: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

Informed consent and patients with cancer: role of the nurse as advocate.

Informed consent is an ongoing process, and oncology nurses are important advocates to identify information gaps and patient concerns during this process. This article discusses the rights of research participants from a regulatory perspective. Two case scenarios are presented and discussed to describe how nurses can ensure that patients are truly informed and understand the clinical trial process.

An age-old problem: care of older people undergoing surgery.

The National Confidential Enquiry into Patient Outcome and Death last specifically reported on the provision of care for older patients having surgery 11 years ago (National Confidential Enquiry into Patient Outcome and Death, 1999). This was followed by the first National Service Framework for Older People (Department of Health, 2001).