Oxygen Sensor-Guided Fine Needle Biopsy Studies of Human Cancer Xenografts in Mice.

An oxygen sensor-mounted fine-needle biopsy tool was used for in vivo measurement of oxygen levels in tumor xenografts. The system provides a means of measuring the oxygen content in harvested tumor tissue from specific locations. Oxygen in human tumor xenografts in a murine model was observed for over 1 min. Tissues were mapped in relation to oxygen tension (pO2) readings and sampled for conventional cytological examination. Careful modeling of the pO2 readings over 60 seconds yielded a diffusion coefficient for oxygen at the sensor tip, providing additional diagnostic information about the tissue before sampling. Oxygen level measurement may provide a useful adjunct to the use of biomarkers in tumor diagnosis.

Development of a pO2-Guided Fine Needle Tumor Biopsy Device.

Tumor biopsies are an important aspect of oncology providing a guide for medical treatment and evaluation of disease progression. Highly heterogenous tumors have complex regions of active cancer cells interdigitated with necrotic tissue and healthy noncancerous tissue. The reliable access to tumor tissue pathology is therefore challenging and usually requires multiple needle insertions with accompanying patient discomfort and risk of infection. Oxygen levels provide a means of detecting and evaluating tumor tissue with levels reduced by 2-fold to 22-fold, depending on the type of organ. However, if the biopsy needle is placed in an area of normal tissue, there is always a chance that no diagnostic cells will be acquired for meaningful pathology and molecular analysis. While not the case in all tumors, there are cases where the in vivo oxygen levels differ with tumor cells having a value of pO2 lying between the anoxic necrotic tissue and normoxic normal tissue. The level of oxygen in tumor cells can also vary with time as related to complex biochemical pathways. The efficacy of radiation therapy is also sensitive to oxygen levels in tumors. Lower levels of oxygen present greater resistance to treatment. To address these concerns, a pO2-guided biopsy needle (OGBN) was developed to determine oxygen levels and fluctuations in highly resolved regions of tumors, in order to aide in determining the optimal region for cell sampling help in determining medical treatment options.

Prognostic performance of proteomic testing in advanced non-small cell lung cancer: a systematic literature review and meta-analysis.

OBJECTIVE: Timely assessment of patient-specific prognosis is critical to oncology care involving a shared decision-making approach, but clinical prognostic factors traditionally used in NSCLC have limitations. We examine a proteomic test to address these limitations. METHODS: This study examines the prognostic performance of the VeriStrat blood-based proteomic test that measures the inflammatory disease state of patients with advanced NSCLC. A systematic literature review (SLR) was performed, yielding cohorts in which the hazard ratio (HR) was reported for overall survival (OS) of patients with VeriStrat Poor (VSPoor) test results versus VeriStrat Good (VSGood). A study-level meta-analysis of OS HRs was performed in subgroups defined by lines of therapy and treatment regimens. RESULTS: Twenty-four cohorts met SLR criteria. Meta-analyses in five subgroups (first-line platinum-based chemotherapy, second-line single-agent chemotherapy, first-line EGFR-tyrosine kinase inhibitor (TKI) therapy, and second- and higher-line TKI therapy, and best supportive care) resulted in statistically significant (p ≤ .001) summary effect sizes for OS HRs of 0.42, 0.54, 0.41, 0.52, and 0.50, respectively, indicating increased OS by about two-fold for patients who test VSGood. No significant heterogeneity was seen in any subgroup (p > .05). CONCLUSIONS: Advanced NSCLC patients classified VSGood have significantly longer OS than those classified VSPoor. The summary effect size for OS HRs around 0.4-0.5 indicates that the expected median survival of those with a VSGood classification is approximately 2-2.5 times as long as those with VSPoor. The robust prognostic performance of the VeriStrat test across various lines of therapy and treatment regimens has clinical implications for treatment shared decision-making and potential for novel treatment strategies.

Hunter and New England HealthPathways: a 4-year journey of integrated care.

Objective This paper describes the 4-year journey of Hunter and New England HealthPathways - a password-protected web-based portal designed to provide localised evidence-informed clinical and referral information to support general practice at the point of care. Methods A process evaluation was conducted in 2013, with a case study comparison performed in 2014 to assess impact of HealthPathways on patient referral and access to specialist care, followed by a review in 2016 of utilisation of the online portal to assess whether healthcare providers continued to access HealthPathways. Results Increased utilisation was correlated with an increase in the number of pathways published online. Clinical leadership and the process of developing pathways built relationships between primary care and specialist teams. Case studies indicated that a comprehensive approach to pathway implementation accompanied by service redesign resulted in higher pathway use and improved access to specialist care. Senior management support and a formal partnership between major health care providers led to strong governance of HealthPathways and the delivery of other integrated care initiatives. There was significant growth in utilisation over the 4 years, increasing to an average of 6679 sessions per month in 2016 and more general practices reported use of HealthPathways. Conclusions HealthPathways is a vehicle for building strong foundations to support system change and integrated care. The critical elements for acceptability, growth and sustainability are the strong relationships between primary care and specialist clinicians, as well as formal partnerships that are built from the processes used to develop HealthPathways. What is known about the topic? HealthPathways and similar web-based evidence-informed guidelines aimed at improving system integration are increasing in Australia. There are few published papers that describe approaches to inform the ongoing implementation of such programs. What does this paper add? This paper describes iterative methodology for evaluating complex programs, such as HealthPathways, that identifies the critical factors required to build sustainable models of integrated care. What are the implications for practitioners? The 4-year experience of Hunter and New England HealthPathways provides an approach to improve the implementation, sustainability and spread of similar programs and associated integrated care initiatives.

Managing the intersection of medical and pharmacy benefits.

BACKGROUND: Because of the unique features of specialty pharmaceuticals and insurance plans, specialty pharmaceutical products can be paid through the pharmacy benefit or the medical benefit. While most pharmacists are very comfortable with the conventions of reimbursement in the pharmacy benefit, they are less familiar with the processes for payment in the medical benefit. OBJECTIVE: To review the 2 parallel processes for payment of specialty pharmaceuticals, the pharmacy benefit and the medical benefit, and to compare and contrast these 2 processes. SUMMARY: The medical benefit and pharmacy benefit processes for payment of specialty pharmaceuticals use different claim forms, product coding systems, pricing conventions, and contracts. Even though the services delivered can be identical, the financial aspects of paying for these services are quite different. CONCLUSION: Pharmacists who are interested in entering the specialty pharmacy arena, either as a provider or manager of providers, need to understand the payment processes for specialty pharmaceuticals through both the pharmacy and medical benefits.