Comparing the diagnostic adequacy of 25-Gauge fork-tip versus franseen versus reverse-bevel-type needles in EUS-guided tissue acquisition: A prospective randomized study with a retrospective control.

Background and Objectives: EUS-guided fine-needle biopsy (FNB) is an established technique for the acquisition of tissue to diagnose lesions of the gastrointestinal tract and surrounding organs. Recently, newer-generation FNB needles have been introduced, including a second-generation reverse-bevel and the third-generation fork-tip and Franseen needles. We aimed to determine if there was any difference between these needles in terms of cytopathological diagnostic yield, sample cellularity, or sample bloodiness. Methods: One hundred twenty-seven consecutive patients undergoing EUS-guided FNB of any solid lesion were randomized to use either a Franseen or fork-tip needle in a 1:1 ratio and were compared with 60 consecutive historical cases performed with reverse-bevel needles. Patient and procedure characteristics were recorded. Cases were reviewed by a blinded cytopathologist and graded based on cellularity and bloodiness. Overall diagnostic yield was calculated for each study arm. Results: One hundred seventy-six cases were eligible for analysis, including 109 pancreatic masses, 24 lymphoid lesions, 17 subepithelial lesions, and 26 other lesions. The final diagnosis was malignancy in 127 cases (72%). EUS-guided FNB was diagnostic in 141 cases (80%) overall and in 89% of cases where malignancy was the final diagnosis. There was no difference in diagnostic yield, sample cellularity, or sample bloodiness between the different needle types. There was no difference in adverse events between groups. Conclusions: EUS-guided FNB performed using 25-gauge Franseen, fork-tip, and reverse-bevel needles resulted in similar diagnostic yield, sample cellularity, and sample bloodiness. Our results may not be extrapolated to larger-caliber needles of the same design.

Health economic evaluations of medical tests: Translating laboratory information into value - A case study example.

Health-care providers and funders are focused on identifying value in all their services and that includes laboratories. This means that in order to gain a share of scarce resources, laboratory professionals must also understand and assess the value of tests and that includes their economic impact. This can be assessed using health economic modelling tools which, when used in conjunction with a detailed value proposition for the test, can translate laboratory information into value. While a variety of health economic assessment tools are available, this review will focus on the use of decision analytic models which essentially compare the outcomes from pathways with and without the new test, the value of which is being assessed. A step-by-step framework is provided to guide laboratory professionals through the essential steps of conducting the evaluation. Initial steps include mapping the clinical pathway, understanding the goal of the evaluation, identifying the key stakeholders and their needs and determining a suitable analytical model. Following collection of the actual data, the validity of the model must be checked, and the robustness of the outcomes tested through sensitivity analysis. The last step is to translate the findings into measures of value which can then inform appropriate decisions by the stakeholders. This review of basic health economic modelling should enable laboratory professionals to have an understanding of how modelling can be applied to tests in their own environment and help deliver their potential value.

Vitamin D testing: Impact of changes to testing guidelines on detection of patients at risk of vitamin D deficiency.

BACKGROUND: Changes were made to the Australian guidelines for vitamin D testing in November 2014 which restricted the patients who could be tested and reimbursed under the Medical Benefits Schedule. A retrospective study was conducted to assess the impact of the changes. METHODS: Data from 588,021 cases tested for vitamin D over the period of 2014 to 2017 were obtained and the results in 149,808 cases tested before the change in guidelines were compared to 438,213 cases tested afterwards. RESULTS: The results showed an initial fall in requests took place after the introduction of changes, but request numbers had returned to pre-change levels by November 2016. Furthermore, following the intervention, there was a significant reduction in the number of cases of vitamin D deficiency (<50 nmol/L) detected after November 2014 (P < 0.001) with odds ratio (OR) calculations showing the strongest effect for the sub-cohort of 0-20 nmol/L (OR = 1.77). For patient vitamin D levels >71 nmol/L, the pattern of detection inverted with more cases of sufficiency being detected after the intervention than before (OR from 0.84 to 0.48, P <0.001). CONCLUSIONS: The failure to show a sustained reduction in vitamin D testing is a common finding with demand management strategies to limit test requesting. More significant is the failure of the intervention to improve the detection of vitamin D deficiency. These failures highlight the need for better tools to manage test requesting including the use of audit and outcomes measurement to guide future interventions.

Who Conducts Health Economic Evaluations of Laboratory Tests? A Scoping Review.

BACKGROUND: Health economic evaluations (HEEs) are effectively used to inform decision making in healthcare. We sought to assess the level of involvement of laboratory professionals (LPs) in HEEs of laboratory tests. METHODS: A systematic literature search was conducted in Medline (2013 to November 28, 2018) for original articles reporting HEEs of medical laboratory tests. Eligible studies were characterized by indication, utilization, region, setting, study design, primary outcome measures, and sponsorship. Authors were classified based on stated affiliation as clinician, scientist, public health expert, or LP. RESULTS: In total, 140 HEEs were included in the study, of which 24 (17.1%) had contributions from LPs. Studies were primarily focused on infectious disease (n = 68), oncology (n = 23), and cardiovascular disease (n = 16). Cost-utility or cost-effectiveness analyses (n = 117) were the most frequent study types, with effectiveness measured mainly in terms of quality-adjusted life-years (n = 57) and detected cases (n = 41). Overall, 76% of HEEs followed a social or health system perspective, whereas 15% took a hospital viewpoint. Partial or full funding was received from public health organizations or industry in 39% and 16% of studies, respectively. The involvement of LPs was associated with test utilization, secondary care, analytic perspective, and an immediate time horizon (all P < 0.05). Quality of studies was found to be lower in HEEs coauthored by LPs. CONCLUSION: Multidisciplinary collaboration is essential to understanding the complexity of clinical pathways. HEEs are used effectively to inform healthcare decision making. The involvement of LPs in HEEs is low. This implies that laboratory expertise is frequently not considered in decision processes.

Leveraging the real value of laboratory medicine with the value proposition.

Improving quality and patient safety, containing costs and delivering value-for-money are the key drivers of change in the delivery of healthcare and have stimulated a shift from an activity-based service to a service based on patient-outcomes. The delivery of an outcomes-based healthcare agenda requires that the real value of laboratory medicine to all stakeholders be understood, effectively defined and communicated. The value proposition of any product or service is the link between the provider and the needs of the customer describing the utility of the product or service in terms of benefit to the customer. The framework of a value proposition for laboratory medicine provides the core business case that drives key activities in the evolution and maintenance of high quality healthcare from research through to adoption and quality improvement in an established service. The framework of a value proposition for laboratory medicine is described. The content is endorsed by IFCC and WASPaLM.

Setting analytical performance specifications based on outcome studies - is it possible?

The 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine proposed a simplified hierarchy for setting analytical performance specifications (APS). The top two levels of the 1999 Stockholm hierarchy, i.e., evaluation of the effect of analytical performance on clinical outcomes and clinical decisions have been proposed to be replaced by one outcome-based model. This model can be supported by: (1a) direct outcome studies; and (1b) indirect outcome studies investigating the impact of analytical performance of the test on clinical classifications or decisions and thereby on the probability of patient relevant clinical outcomes. This paper reviews the need for outcome-based specifications, the most relevant types of outcomes to be considered, and the challenges and limitations faced when setting outcome-based APS. The methods of Model 1a and b are discussed and examples are provided for how outcome data can be translated to APS using the linked evidence and simulation or decision analytic techniques. Outcome-based APS should primarily reflect the clinical needs of patients; should be tailored to the purpose, role and significance of the test in a well defined clinical pathway; and should be defined at a level that achieves net health benefit for patients at reasonable costs. Whilst it is acknowledged that direct evaluations are difficult and may not be possible for all measurands, all other forms of setting APS should be weighed against that standard, and regarded as approximations. Better definition of the relationship between the analytical performance of tests and health outcomes can be used to set analytical performance criteria that aim to improve the clinical and cost-effectiveness of laboratory tests.

Ion Selective Electrodes (ISEs) and interferences--a review.

Ion Selective Electrodes (ISEs) are used to measure some of the most critical analytes on clinical laboratory and point-of-care analysers. These analytes which include Na(+), K(+), Cl(-), Ca(2+), Mg(2+) and Li(+) are used for rapid patient care decisions. Although the electrodes are very selective, they are not free of interferences. It is important for laboratories to have an understanding of the type and extent of interferences in order to avoid incorrect clinical decisions and treatment.