Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study.

BACKGROUND: COVID-19 disproportionately impacted patients with cancer as a result of direct infection, and delays in diagnosis and therapy. Oncological clinical trials are resource-intensive endeavors that could be particularly susceptible to disruption by the pandemic, but few studies have evaluated the impact of the pandemic on clinical trial conduct. PATIENTS AND METHODS: This prospective, multicenter study assesses the impact of the pandemic on therapeutic clinical trials at two large academic centers in the Northeastern United States between December 2019 and June 2021. The primary objective was to assess the enrollment on, accrual to, and activation of oncology therapeutic clinical trials during the pandemic using an institution-wide cohort of (i) new patient accruals to oncological trials, (ii) a manually curated cohort of patients with cancer, and (ii) a dataset of new trial activations. RESULTS: The institution-wide cohort included 4756 new patients enrolled to clinical trials from December 2019 to June 2021. A major decrease in the numbers of new patient accruals (-46%) was seen early in the pandemic, followed by a progressive recovery and return to higher-than-normal levels (+2.6%). A similar pattern (from -23.6% to +30.4%) was observed among 467 newly activated trials from June 2019 to June 2021. A more pronounced decline in new accruals was seen among academically sponsored trials (versus industry sponsored trials) (P < 0.05). In the manually curated cohort, which included 2361 patients with cancer, non-white patients tended to be more likely taken off trial in the early pandemic period (adjusted odds ratio: 2.60; 95% confidence interval 1.00-6.63), and substantial pandemic-related deviations were recorded. CONCLUSIONS: Substantial disruptions in clinical trial activities were observed early during the pandemic, with a gradual recovery during ensuing time periods, both from an enrollment and an activation standpoint. The observed decline was more prominent among academically sponsored trials, and racial disparities were seen among people taken off trial.

The prognostic value of stromal and epithelial periostin expression in human breast cancer: correlation with clinical pathological features and mortality outcome.

BACKGROUND: PN is a secreted cell adhesion protein critical for carcinogenesis. In breast cancer, it is overexpressed compared to normal breast, and a few reports suggest that it has a potential role as a prognostic marker. METHODS: Tumour samples obtained at the time of mastectomy from 200 women followed for a median time of 18.7 years (range 0.5-29.5 years) were investigated through IHC with a polyclonal anti-PN antibody using tissue microarrays. Epithelial and stromal PN expression were scored independently according to the percentage of coloured cells; the 60th percentile of PN epithelial expression, corresponding to 1%, and the median value of PN stromal expression, corresponding to 90%, were used as arbitrary cut-offs. The relationships between epithelial and stromal PN expression and clinical-pathological features, tumour phenotype and the risk of mortality following surgery were analysed. Appropriate statistics, including the Fine and Gray competing risk proportional hazard regression model, were used. RESULTS: The expression of PN in tumour epithelial cells was significantly lower than that which was observed in stromal cells (p < 0.000). No specific association between epithelial or stromal PN expression and any of the clinical-pathological parameters analysed was found as it was observed in respect to mortality when these variables were analysed individually. However, when both variables were considered as a function of the other one, the expression of PN in the stromal cells maintained a statistically significant predictive value with respect to both all causes and cancer-specific mortality only in the presence of high epithelial expression levels. No significant differences in either all causes or BCa-specific mortality rates were shown according to epithelial expression for tumours displaying higher stromal PN expression rates. However, the trends were opposite for the higher stromal values and the patients with high epithelial expression levels denoted the group with the worst prognosis, while higher epithelial values in patients with lower stromal expression levels denoted the group with the best prognosis, suggesting that PN epithelial/stromal interactions play a crucial role in breast carcinogenesis, most likely due to functional cross-talk between the two compartments. On the basis of PN expression in both compartments, we defined 4 subgroups of patients with different mortality rates with the group of patients characterized by positive epithelial and low stromal PN expression cells showing the lowest mortality risk as opposed to the groups of patients identified by a high PN expression in both cell compartments or those identified by a low or absent PN expression in both cell compartments showing the worst mortality rates. The differences were highly statistically significant and were also retained after multiparametric analysis. Competing risk analysis demonstrated that PN expression patterns characterizing each of previous groups are specifically associated with cancer-specific mortality. CONCLUSIONS: Although they require further validation through larger studies, our findings suggest that the patterns of expression of PN in both compartments can allow for the development of IHC "signatures" that maintain a strong independent predictive value of both all causes and, namely, of cancer-specific mortality.

Advancing health policy in nursing education through service learning.

Knowledge of health policy is an increasingly important aspect of nursing practice and education, especially as nurses strive to improve the rapidly changing health care delivery system. At the same time, many educators, researchers, foundations, and government officials are touting the benefits of service learning. In particular, service learning offers ways to enhance partnerships between academia and community agencies and to extend learning beyond the traditional classroom. We present a model for educating nurses as advanced practice nurses in health policy that links service learning with a framework for the political development of nurses. Under the rubric of service learning, the curriculum is based on the overlap among health policy, the role of the nurse as consultant, and community-based care. After discussing the importance of health policy for graduate nursing education and reviewing the essentials of service learning, we describe a three-semester graduate sequence in health policy service learning. The focus is on the clinical and classroom components of both individual and group practica and their relationship to stages of nursing's political development. The article concludes with evaluation considerations and the implications of our work for nursing theory, research, practice, and education.

Home care in Changsha: a work in progress.

Economic growth and reforms have created the need to develop new models for the delivery of health care to the 1.3 billion population of China. Many Chinese people are responsible for funding their own hospitalizations and when the funds are no longer available, they must leave the hospital. As a result, home care is being considered as an alternative for patients to receive the health care they need in a more cost-efficient manner.

A tool to assess homebound status.

Although this specific instrument focuses solely on helping the home care nurse determine homebound status, this type of instrument can be developed for the other criteria used in assessing a client for Medicare-eligible home care services. For example, a similar instrument can be developed to assess whether a patient meets the criteria for part-time intermittent care or skilled care using the Medicare definitions as a guide to tool development. As we move into a time when there is more scrutiny of home care for compliance to Medicare regulations and increased productivity to assure cost effectiveness, instruments like this are essential for careful documentation that allows the agency to demonstrate accountability. In addition, home care agencies are expecting new home care nurses to know and be able to apply the Medicare regulations after a brief orientation. Instruments like this can shorten the orientation process and provide support for the home care nurse in the field.

Third-party reimbursement for home care of clients with diabetes.

Home health care has increasingly become an integral component of the health care continuum for clients. The concept of providing care to a client in the home setting seems relatively straightforward. What has grown increasingly complex is the reimbursement structure under which services are provided. Adding to the complexity are the frequent changes in the regulations that govern the reimbursement for home care. This paper describes the current state of the third-party regulations that govern the reimbursement for the client with diabetes receiving home care.

Home care nursing orientation model: content and strategies.

Orientation for the home healthcare nurse consists of specific content areas that are organized into a comprehensive program. The teaching strategies used to deliver the content are just as important as the information included in the orientation program.

Home care nursing orientation model. Justification and structure.

An orientation program for new nurses in a home care agency can be an effective tool that increases job satisfaction, alleviates a potentially high employee attrition rate, boosts morale, and thereby improves overall quality of patient care.

Identification of 19-norprogesterone in pregnant rat urine.

The existence of biosynthetic pathways leading to the formation of 19-nor-androgens and corticoids have been established in animals and humans. The exact biologic function of the products of these pathways in vivo has yet to be established; however, it has been shown that they possess pronounced biologic activity when administered exogenously. This report describes the identification of 19-nor-progesterone isolated from the urine of pregnant rats. The procedures used included isolation as the underivatized material and methoxime derivative by thin-layer and high-performance chromatography. The identity was further confirmed by gas chromatography/mass spectral analysis of the isolated product as the 3,20-bis-methoxime derivative. The spectra obtained from the urinary product and the authentic 19-norprogesterone-3,20-bis-methoxime were identical. A possible biologic role for 19-norprogesterone or its precursors is discussed.

Temporal relationships among the excretory patterns of 2-hydroxyestrone, estrone, estradiol, and progesterone during pregnancy in the rat.

The urinary excretion pattern of 2-hydroxyestrone, estradiol, estrone, and progesterone was examined in rats during early, mid, and late pregnancy. Progesterone increased from early to mid pregnancy and declined significantly 2 to 3 days prior to parturition, corresponding to changes observed in blood levels by others. 2-Hydroxyestrone, the major estrogen in rat urine, increased significantly 4 days prior to delivery and remained elevated until it further increased sharply the day of parturition. Urinary estradiol and estrone levels showed little change until the day of parturition, when they increased significantly. Multiple correlation analysis of the data implied that 2-hydroxyestrone and estradiol were negatively correlated at the time of implantation. The results suggest that catechol estrogens, through their effect on prostaglandin synthesis, may participate in the process of implantation as well as in the mechanism involved in the onset of labor.