Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests.

BACKGROUND: Treatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient's HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control (NordiQC) HER2 IHC programme; results were used in an economic BC treatment model. METHODS: Data were obtained from NordiQC HER2 BC surveys performed from 2008 to 2012. False-negative (FN) and false-positive (FP) rates for approved and laboratory-developed IVDs were used to estimate direct costs, loss of survival, productivity benefit and quality-adjusted life-years. In the absence of consistent and accessible clinical and economic data from countries participating in the NordiQC programme, United States productivity data, healthcare costs and patient numbers were used as a surrogate in order to estimate the potential impact of selecting an approved or laboratory-developed IVDs. RESULTS: In total, 1703 tests were performed. Pooled FN rates were 11% for approved IVDs and 25% for laboratory-developed IVDs; FP rates were 0% and 5%, respectively. Using these FP and FN rates in the economic model and applying them to the United States BC population, approved IVD tests would result in better clinical outcomes, i.e., better survival and fewer disease recurrences/progressions, and lower costs, i.e., total direct costs and lost productivity, versus laboratory-developed IVD tests. Every $1 saved by laboratories by using cheaper reagents could potentially result in approximately $6 additional costs to the healthcare system. CONCLUSIONS: The results of this analysis suggest that incorrect HER2 test results have far-reaching clinical and economic consequences.

Nurse workload in implementing a tight glycaemic control protocol in a UK hospital: a pilot time-in-motion study.

AIMS AND OBJECTIVES: The cumulative time that critical care nurses spend implementing a tight glycaemic control (TGC) protocol was estimated in a time-in-motion (TiM) study conducted in a hospital in the UK. BACKGROUND: TGC protocols were introduced to the critical care setting to reduce hyperglycaemic events in high-risk patients. The time burden to critical care nurses of implementing such protocols has not yet been studied in the UK. DESIGN: A prospective TiM pilot study was conducted in an eligible UK intensive care unit by four protocol-trained observers over five consecutive weekdays from 3 to 7 November 2008. Three nurses were also interviewed on site to gather their attitudes and perceptions about the benefits of and time associated with administering a TGC protocol. METHODS: Independent observers shadowed nurses, observing when a blood glucose measurement was taken, when each predefined subtask was completed and the duration of each task. Semistructured interviews with nurses were conducted in-person and one-on-one by a trained study member. RESULTS: Considered together, the episodic median duration of all TGC activities was 6·65 min. Across a total shift, nurses devoted approximately 7% of their time to administering a TGC protocol. Nurses perceived that a TGC protocol is beneficial to patient safety and outcomes in a critical care setting but acknowledged that the tasks can be mildly to moderately tedious. CONCLUSIONS: This TiM analysis indicated that the additional responsibility of implementing a TGC protocol represents a substantive commitment of nursing time in a critical care setting. RELEVANCE TO CLINICAL PRACTICE: The episodic data of our pilot study in the UK contributes further evidence that TGC protocols may be arduous to maintain and constitute a substantial investment of nursing time.

A systematic review of serum biomarkers anti-cyclic citrullinated Peptide and rheumatoid factor as tests for rheumatoid arthritis.

This systematic review assesses the current status of anti-cyclic citrullinated peptide (anti-CCP) and rheumatoid factor (RF) tests in the diagnosis and prognosis of rheumatoid arthritis (RA). We reviewed publications on tests and biomarkers for early diagnosis of RA from English-language MEDLINE-indexed journals and non-MEDLINE-indexed sources. 85 publications were identified and reviewed, including 68 studies from MEDLINE and 17 non-MEDLINE sources. Anti-CCP2 assays provide improved sensitivity over anti-CCP assays and RF, but anti-CCP2 and RF assays in combination demonstrate a positive predictive value (PPV) nearing 100%, greater than the PPV of either of the tests alone. The combination also appears to be able to distinguish between patients whose disease course is expected to be more severe and both tests are incorporated in the 2010 ACR Rheumatoid Arthritis Classification Criteria. While the clinical value of anti-CCP tests has been established, differences in cut-off values, sensitivities and specificities exist between first-, second- and third-generation tests and harmonization efforts are under way. Anti-CCP and RF are clinically valuable biomarkers for the diagnosis and prognosis of RA patients. The combination of the two biomarkers in conjunction with other clinical measures is an important tool for the diagnosis and management of RA patients.