Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: systematic online review and a typology of clinical utility.

OBJECTIVES: The objective of this study is to map the range and variety of direct-to-consumer (DTC) tests advertised online in Australia and analyse their potential clinical utility and implications for medical overuse. DESIGN: Systematic online search of DTC test products in Google and Google Shopping. DTC test advertisements data were collected and analysed to develop a typology of potential clinical utility of the tests at population level, assessing their potential benefits and harms using available evidence, informed by concepts of medical overuse. RESULTS: We identified 484 DTC tests (103 unique products), ranging from $A12.99 to $A1947 in cost (mean $A197.83; median $A148.50). Using our typology, we assigned the tests into one of four categories: tests with potential clinical utility (10.7%); tests with limited clinical utility (30.6%); non-evidence-based commercial 'health checks' (41.9%); and tests whose methods and/or target conditions are not recognised by the general medical community (16.7%). Of the products identified, 56% did not state that they offered pretest or post-test consultation, and 51% did not report analytical performance of the test or laboratory accreditation. CONCLUSIONS: This first-in-Australia study shows most DTC tests sold online have low potential clinical utility, with healthy consumers constituting the main target market. Harms may be caused by overdiagnosis, high rates of false positives and treatment decisions led by non-evidence-based tests, as well as financial costs of unnecessary and inappropriate testing. Regulatory mechanisms should demand a higher standard of evidence of clinical utility and efficacy for DTC tests. Better transparency and reporting of health outcomes, and the development of decision-support resources for consumers are needed.

Improved implementation of medical tests - barriers and opportunities.

Applying the concept of a value proposition to medical testing is just one of the many ways to identify and monitor the value of tests. A key part of this concept focusses on processes that should take place after a test is introduced into routine local practice, namely test implementation. This process requires identification of the clinical pathway, the stakeholders and the benefits or disbenefits that accrue to those stakeholders. There are various barriers and challenges to test implementation. Implementation requires the process of clinical audit which involves measurement of outcomes external to the laboratory but this is not widely performed in laboratory medicine. A second key challenge is that implementation requires liaison with stakeholders outside of the laboratory including clinicians and other healthcare professional such as finance managers. Many laboratories are remote from clinical care and other stakeholders making such liaison difficult. The implementation process is based on data which again will be primarily on processes outside of the laboratory. However the recent enthusiasm for so-called real world data and new data mining techniques may represent opportunities that will facilitate better test implementation. A final barrier is that a range of new tools not currently in the education curriculum of the laboratory professional is required for implementation such as those of preparing a business case to support the introduction of a test and health economic analysis. The professional bodies in laboratory medicine could assist with education in these areas.

Drainage of pancreatic fluid collections using a lumen-apposing metal stent with an electrocautery-enhanced delivery system.

BACKGROUND AND AIM: Our aim was to evaluate the efficacy and safety of a lumen-apposing metal stent with an electrocautery-enhanced delivery system (EDS-LAMS) for endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) in regular clinical practice. METHODS: A retrospective and subsequent prospective analysis was undertaken of all patients who underwent EUS-guided drainage of their PFCs using the EDS-LAMS at 17 tertiary therapeutic endoscopy centers. RESULTS: Two hundred eight cases of EDS-LAMS deployment were attempted in 202 patients (mean age 52.9 years) at time of evaluation. Ninety-seven patients had pancreatic pseudocysts (PPs), 75 walled-off pancreatic necrosis (WOPN), 10 acute peripancreatic fluid collections (APFCs), 6 acute necrotic collections (ANCs), and 14 postoperative collections (POCs). Procedural technical success was achieved in 202/208 cases (97.1%). Maldeployment occurred in 7/208 cases (3.4%). Clinical success was achieved in 142/160 (88.8%) patients (PP 90%, WOPN 85.2%, APFC 100%, ANC 75%, POC 100%). Delayed adverse events included stent migration in 15/202 (7.4%), stent occlusion and infection in 16/202 (7.9%), major bleeding in 4/202 (2%), and buried EDS-LAMS in 2/202 (1%). PFC recurrence occurred in 13/142 (9.2%) patients; 9/202 (4.5%) required surgical or radiological intervention for PFC management after EDS-LAMS insertion. CONCLUSIONS: This large international multicenter study evaluating the EDS-LAMS for drainage of PFCs in routine clinical practice suggests that the EDS-LAMS are safe and effective for drainage of all types of PFCs; however, further endoscopic therapy is often required for WOPN. Major bleeding was a rare complication in our cohort.

Implementation of medical tests in a Value-Based healthcare environment: A framework for delivering value.

Significant variation in the utilisation of medical tests is known to have an adverse impact on health outcomes and analysis of this variation is an important tool for quality assurance in healthcare. The introduction of a new medical test into a care pathway requires two distinct processes, termed adoption and implementation. One cause of the unwarranted variation in the use of medical tests is poor adoption and implementation. Adoption is the decision to acquire a technology and make it available to the users and is supported with evidence of clinical and cost effectiveness. Implementation is delivering the benefits promised in the business case, based on evidence of the impact of a test on each stakeholder involved in delivering the care pathway. The business case will have identified the benefits delivered to all stakeholders, as set out in a value proposition, and according to the quality domains typically addressed in quality improvement, namely clinical, process and structure (resource utilisation) outcomes. The outcome measures extend beyond those of clinical and cost effectiveness required for adoption. We describe an implementation framework which is designed to document the changes to the care pathway, the resource inputs and the expected outcomes with associated quality metrics.

Structured oropharynx, hypopharynx and larynx assessment during routine esophagogastroduodenoscopy improves detection of pre- and early cancerous lesions: a multicenter, comparative study.

Background and study aims A structured assessment of the oropharynx, hypopharynx and larynx (OHL) may improve the diagnostic yield for the detection of precancerous and early cancerous lesions (PECLs) during routine esophagogastroduodenoscopy (EGD). Thus, we aimed to compare routine EGDs ± structured OHL assessment (SOHLA), including photo documentation with regard to the detection of PECLs. Patients and methods Consecutive patients with elective EGD were arbitrarily allocated to endoscopy lists with or without SOHLA. All detected OHL abnormalities were assessed by an otolaryngologist-head & neck surgeon (ORL-HNS) and the frequency of PECLS detected during SOHLA vs. standard cohort compared. Results Data from 1000 EGDs with and 1000 EGDs without SOHLA were analyzed. SOHLA was successful in 93.3 % of patients, with a median assessment time of 45 seconds (interquartile range: 40-50). SOHLA identified 46 potential PECLs, including two benign subepithelial lesions (4.6 %, 95 % CI: 3.4-6.1) while without SOHLA, no malignant and only one benign lesion was found ( P  < 0.05). ORL-HNS imaging review classified 23 lesions (2.3 %, 95 % CI: 1.5-3.4) as concerning and ORL-HNS clinic assessment was arranged. This identified six PECLs (0.6 %, 95 % CI: 0.2-1.3) including two pharyngeal squamous cell lesions (0.2 %) demonstrating high-grade dysplasia and carcinoma in situ (CIS) and four premalignant glottic lesions (0.4 %) demonstrating low-grade dysplasia and CIS. Conclusion In the routine setting of a gastrointestinal endoscopy practice precancerous and early cancerous lesions of the oropharynx, hypopharynx, and larynx are rare (< 1 %) but can be detected with a structured assessment of this region during routine upper gastrointestinal endoscopy.

Where Is the Value of Laboratory Medicine and How Do You Unlock It?

BACKGROUND: The innovation pathway by which a newly discovered biomarker is developed into a medical test and used in routine clinical practice comprises a number of different processes split between 2 phases. The first follows on from biomarker discovery and involves the development of a robust analytical method, the accumulation of evidence to show its clinical and cost-effectiveness, and then adoption into clinical pathways. The second phase is one of implementation and sustainability, with active performance management to ensure that the test continues to deliver the benefits promised at the time of its adoption. CONTENT: To date there has been much more emphasis on the first phase of discovery and accumulation of evidence to demonstrate effectiveness. Insufficient attention has been paid to the second phase of translating that evidence into routine practice, with little real-world evidence to demonstrate the benefits to all of the stakeholders involved in delivering and receiving care. Changes in healthcare that include a move away from activity-based costing to a more value-based approach require more attention be paid to what happens after a test is adopted, including an understanding of the clinical pathway, the stakeholders within that pathway, and the benefits and "disbenefits" that accrue to these stakeholders. SUMMARY: The value proposition provides a guide for successful implementation of a test. Although it can address both adoption and implementation, it highlights that the requirements for test implementation are quite different to those of adoption, with an emphasis on real-world evidence and outcomes.

The Pursuit of Value in Laboratory Medicine - Progress and Challenges.

The pressure on healthcare budgets including laboratory medicine is relentless and the focus on activities and costs remains the dominant funding model of laboratory medicine everywhere. The limitations of this model are well documented and for a decade or more laboratory professions worldwide have started looking at alternative models where the value of laboratory medicine and its impact on patient outcomes are the predominant driving force. There are multiple ways to determine the value of a medical test, particularly if one takes into consideration its impact upon the complete clinical pathway. Thus various approaches to value determination are being explored by a number of international organisations. These organisations will be reviewed below, including one which uses the concept of a value proposition that describes in detail how a test should be implemented by measuring its clinical, operational and economic impact. All approaches for determination of value require professional leadership. There is a need for research of varying types including that related to translating global evidence into local practice, a key challenge facing laboratory medicine and healthcare generally. Another challenge is to think and act beyond the silo of the laboratory to achieve greater collaboration with those colleagues more directly involved in patient care.

A value proposition for natriuretic peptide measurement in the assessment of patients with suspected acute heart failure.

There is robust clinical trial evidence supporting the role of natriuretic peptides [NPs] in the assessment of patients presenting with suspected acute heart failure [AHF]. Despite the fact that clinical guidelines have for some time advocated NP measurement, the availability and uptake of NP testing in acute care services remains patchy and incomplete. The reasons for this are multifactorial but are underpinned by compartmentalised management and budget structures within complex healthcare delivery organisations. This paper outlines a value proposition for NP testing in the acute care setting which crosses the continuum of services and budgets. It articulates the expected benefits to each stakeholder in terms of efficiency of processes, clinical outcomes and cost effectiveness. It describes a pathway to implementation and suggests metrics that may be used to measure the effectiveness of introduction of NP testing. It is hoped that the value proposition will facilitate the uptake of NT testing fostering collaboration between laboratory, clinical, management and finance teams and by informing the development of business cases.

The value proposition for point-of-care testing in healthcare: HbA1c for monitoring in diabetes management as an exemplar.

Point-of-care testing (POCT) is a key enabling technology for disruptive and transformative innovation in healthcare, allowing tests to be performed quickly and close to the patient. This results in faster clinical decision making and new, more efficient models of care, with clinical, process and economic benefits potentially accruing to all stakeholders. Recognised barriers to the adoption of new technology such as POCT include poor understanding of current practice and thus the unmet need, the challenges of process change, and reluctance to disinvest in redundant resources resulting from improved pathway efficiency. Major contributors to this problem include a background of funding, organisation and management of healthcare that fails to recognise the complexity of a multiple stakeholder health economy seeking to become more outcomes-based and value driven. We examine the concept of a structured value proposition as a generic tool to achieve better adoption of POCT using as an example, the evidence that is available for the rapid measurement of glycated haemoglobin (HbA1c) in the management of diabetes. We highlight the key components of the value proposition, identifying the impact of the test result on all stakeholders and the metrics which are required to define current practice (e.g. a laboratory-based HbA1c testing service), in order to develop the business case and the implementation plan required to demonstrate effective adoption of a POCT-based service. We conclude that the value proposition helps to identify the potential benefits to be gained from using POCT, and the stakeholders to whom they accrue.

Practical guide for identifying unmet clinical needs for biomarkers.

The development and evaluation of novel biomarkers and testing strategies requires a close examination of existing clinical pathways, including mapping of current pathways and identifying areas of unmet need. This approach enables early recognition of analytical and clinical performance criteria to guide evaluation studies, in a cyclical and iterative manner, all the time keeping the clinical pathway and patient health outcomes as the key drivers in the process. The Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM TE-WG) https://www.eflm.eu/site/page/a/1158 has published a conceptual framework of the test evaluation cycle which is driven by the clinical pathway, inherent to which is the test purpose and role within the pathway that are defined by clinical need. To supplement this framework, the EFLM TE-WG has also published an interactive checklist for identifying unmet clinical needs for new biomarkers; a practical tool that laboratories, clinicians, researchers and industry can equally use in a consistent manner when new tests are developed and before they are released to the market. It is hoped that these practical tools will provide consistent and appropriate terminology in this diverse field and offer a platform that facilitates greater consultation and collaboration between all stakeholders. The checklist should assist the work of all colleagues involved in the discovery of novel biomarkers and implementation of new medical tests. The tool is aligned with the IOM recommendations and the FDA and CE regulating body's requirements.

High-sensitivity cardiac troponin I and risk of incident atrial fibrillation hospitalisation in an Australian community-based cohort: The Busselton health study.

OBJECTIVE: The identification of individuals at risk of atrial fibrillation (AF) remains a challenge. We investigated whether high-sensitive cardiac troponin I (hs-cTnI) is an independent predictor of incident atrial fibrillation (AF) hospitalisation in an Australian community-based cohort. METHODS: Serum hs-cTnI was measured in 1641 men and 2189 women in the Busselton Health Study 1994/1995 Cohort aged 25-84 years at baseline. Data on incident AF hospitalisation over 20 years follow-up were obtained by data linkage. RESULTS: Hs-cTnI was detectable (>1.2 ng/L) in 65.5% of participants (males 81.4%, females 53.6%) at baseline. There were 179 (10.9%) AF events in men and 208 (9.5%) in women. In the multivariable-adjusted model, hs-cTnI was a significant predictor of AF event with hazard ratio 1.21 (95% CI 1.11-1.32, P < 0.001) in the whole cohort, 1.17 (95% CI 1.01-1.35, P = 0.037) in men and 1.22 (95% CI 1.08-1.37, P = 0.001) in women for a doubling of baseline hs-cTnI. In women, a graded and significant increase in risk of AF was observed across hs-cTnI categories from ≥1.3 ng/L, whereas in men only the highest category (≥6.0 ng/L) had significantly increased risk compared with individuals with hs-cTnI ≤1.2 ng/L. Addition of categorical hs-cTnI to standard risk factors for AF improved risk estimation in females (C-statistic increment 0.006, P = 0.04) but not males (increment 0.005, P = 0.12) and net reclassification improvement was not significant in either sex. CONCLUSIONS: High-sensitive cTnI level is an independent predictor of incident AF hospitalisation in a community-based cohort but does not improve risk stratification.

Developing a value proposition for high-sensitivity troponin testing.

Laboratories are looking for ways that they can identify and deliver value through their service rather than just provide high quality test results. One way to demonstrate value has been described in the form of a value proposition where the application of a laboratory test is described explicitly in terms of the process of care and the patient outcomes. We have applied this concept to the use of high sensitivity troponin assays for the assessment of patients with suspected acute coronary syndrome. From a previously described framework we use a checklist to describe the various steps in the complete intervention or clinical pathway, demonstrating how the test should be used, highlighting key evidence in the literature that supports the intervention and list some of the measures which can be used to assess how well the intervention is being adopted and implemented. While the value proposition concept is based on the foundations of evidence based medicine it also requires collaboration between the laboratory and other stakeholders including clinicians to ensure that appropriate resources are applied across the complete clinical pathway in order to ensure its effectiveness.

High-sensitivity cardiac troponin I and risk of cardiovascular disease in an Australianpopulation-based cohort.

OBJECTIVE: High-sensitivity cardiac troponin I (hs-cTnI) is an emerging biomarker for cardiovascular risk. We examined hs-cTnI as a predictor of mortality and cardiovascular outcomes in an Australian population-based cohort and evaluated if a sex difference exists. METHODS: Serum hs-cTnI was measured in the Busselton Health Study 1994/1995 Cohort (n=3939). Outcome measures were total and cardiovascular mortality, cardiovascular disease (CVD) and coronary heart disease (CHD) events, heart failure and stroke. RESULTS: Hs-cTnI was detectable (>1.2 ng/L) in 66.1% of participants (males 81.8%, females 54.4%) at baseline. There were 886 deaths (including 361 from CVD) and 940 CVD events during 20-year follow-up. Adjusting for Framingham Risk Score variables, hs-cTnI was a significant predictor of total mortality (HR (95% CI): 1.16 (1.09 to 1.24)), CVD mortality (1.33 (1.23 to 1.44)), CVD events (1.18 (1.11 to 1.25)), CHD events (1.11 (1.03 to 1.20)), heart failure (1.44 (1.31 to 1.58)) and stroke (1.13 (1.03 to 1.24)) per doubling of hs-cTnI at baseline. HRs remained significant in CVD-free individuals at baseline (n=3215), except for CHD events. There were no significant interactions between sex and hs-cTnI as a predictor of outcomes. Compared with individuals with hs-cTnI ≤1.2 ng/L, men with hs-cTnI ≥6.0 ng/L and women with hs-cTnI ≥4.0 ng/L had an HR of 2.18 (1.42 to 3.37) and 1.84 (1.30 to 2.62), respectively, for any CVD event, which persisted in the CVD-free subgroup. CONCLUSIONS: Cardiac troponin I, measured with a high-sensitive assay, is an independent predictor of fatal and non-fatal CVD events and may help identify at-risk individuals in a general population.