The impact of patient navigation on the delivery of diagnostic breast cancer care in the National Patient Navigation Research Program: a prospective meta-analysis.

Patient navigation is emerging as a standard in breast cancer care delivery, yet multi-site data on the impact of navigation at reducing delays along the continuum of care are lacking. The purpose of this study was to determine the effect of navigation on reaching diagnostic resolution at specific time points after an abnormal breast cancer screening test among a national sample. A prospective meta-analysis estimated the adjusted odds of achieving timely diagnostic resolution at 60, 180, and 365 days. Exploratory analyses were conducted on the pooled sample to identify which groups had the most benefit from navigation. Clinics from six medical centers serving vulnerable populations participated in the Patient Navigation Research Program. Women with an abnormal breast cancer screening test between 2007 and 2009 were included and received the patient navigation intervention or usual care. Patient navigators worked with patients and their care providers to address patient-specific barriers to care to prevent delays in diagnosis. A total of 4675 participants included predominantly racial/ethnic minorities (74 %) with public insurance (40 %) or no insurance (31 %). At 60 days and 180 days, there was no statistically significant effect of navigation on achieving timely diagnostic care, but a benefit of navigation was seen at 365 days (aOR 2.12, CI 1.36-3.29). We found an equal benefit of navigation across all groups, regardless of race/ethnicity, language, insurance status, and type of screening abnormality. Patient navigation resulted in more timely diagnostic resolution at 365 days among a diverse group of minority, low-income women with breast cancer screening abnormalities. Trial registrations clinicaltrials.gov Identifiers: NCT00613275, NCT00496678, NCT00375024, NCT01569672.

Clinical performance and safety of adapters for intradermal delivery with conventional and autodisable syringes.

Although the number of vaccines and diagnostic tests currently delivered intradermally is limited, this route of administration offers potential advantages due to the high concentration of antigen-presenting cells in the skin. One factor which may in part be limiting development and use of intradermal (ID) administration is concern about the ease and reliability of the needle and syringe-based Mantoux technique. A phase I clinical study was conducted to evaluate two ID adapters that have been developed as injection-delivery aids to increase the safety, simplicity, and reliability of ID injection: a prototype autodisable, intradermal (ADID) adapter for autodisable (AD) syringes, and a marketed side-merge adapter (SMA). Thirty healthy adult volunteers each received six injections of 0.1 mL of sterile saline solution. Each adapter was used to give injections into the upper deltoid, forearm, and suprascapular regions of each volunteer. The needle-bevel orientation during injection was random. Injection performance was determined by measuring wheal size and fluid leakage. Wheals were similar in size for the ADID adapter (mean 9.9 ± 0.17 mm) and SMA (mean 9.8 ± 0.15 mm). In all of the injections completed with the SMA, and 98% of those completed with the ADID, fluid leakage was less than 10% of the intended injection volume. Minor skin abrasions were the only adverse events. Based on self-reporting of pain, injections were well tolerated (mean pain score of 2 on a 0-10 scale). ID delivery using the SMA and ADID adapters appears safe and effective.