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.

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.

Economic Evaluations of Pathology Tests, 2010-2015: A Scoping Review.

BACKGROUND: Concerns about pathology testing such as the value provided by new tests and the potential for inappropriate utilization have led to a greater need to assess costs and benefits. Economic evaluations are a formal method of analyzing costs and benefits, yet for pathology tests, questions remain about the scope and quality of the economic evidence. OBJECTIVE: To describe the extent and quality of published evidence provided by economic evaluations of pathology tests from 2010 to 2015. METHODS: Economic evaluations relating to pathology tests from 2010 to 2015 were reviewed. Eight databases were searched for published studies, and details recorded for the country, clinical focus, type of testing, and consideration of sensitivity, specificity, and false test results. The reporting quality of studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist and cost-effectiveness ratios were analyzed for publication bias. RESULTS: We found 356 economic evaluations of pathology tests, most of which regarded developed countries. The most common economic evaluations were cost-utility analyses and the most common clinical focus was infectious diseases. More than half of the studies considered sensitivity and specificity, but few studies considered the impact of false test results. The average Consolidated Health Economic Evaluation Reporting Standards checklist score was 17 out of 24. Cost-utility ratios were commonly less than $10,000/quality-adjusted life-year or more than $200,000/quality-adjusted life-year. CONCLUSIONS: The number of economic evaluations of pathology tests has increased in recent years, but the rate of increase has plateaued. Furthermore, the quality of studies in the past 5 years was highly variable, and there is some question of publication bias in reporting cost-effectiveness ratios.

Success and complications of an intra-ductal fully covered self-expanding metal stent (ID-FCSEMS) to treat anastomotic biliary strictures (AS) after orthotopic liver transplantation (OLT).

BACKGROUND: Anastomotic biliary strictures (AS) after orthotopic liver transplantation (OLT) belong to the most common biliary complications and cause the biggest morbidity burden after OLT. Metal stents for benign biliary strictures are gaining acceptance with many published series. Traditional metal stent designs seem to have poor durability in AS after OLT. Novel intra-ductal stents are showing promise in these strictures. As a result, we designed a special stent with an antimigration waist and a short stent length with a long removal string that rests in the duodenum for easy removal. PATIENTS AND METHODS: This is a retrospective multi-centre Australian study of AS after OLT treated with a novel intra-ductal fully covered self-expanding metal stent. From August 2008 to October 2014, records from three liver transplant centres were reviewed. RESULTS: Totally 36 ID-FCSEMS were inserted in 31 cases to treat an AS after OLT. The mean age of the patients was 56 years, and 61 % were male. The mean time of AS presentation after OLT was 20.3 months. Eight out of our 31 patients were previously treated using multiple plastic stenting over time without any success. Treatment with the ID-FCSEMS was performed with an average treatment time of 3.8 months. Stricture resolution was achieved in 100 %. All attempted stents removals were successful without any difficulty. Complications were reported in 6.5 %. It was pleasing that only one case of stent migration (2.8 %) was seen. Follow-up showed seven cases of AS recurrence (24.1 %), and all were treated successfully with repeat ERCP and stenting (some metal, some plastic). CONCLUSION: This novel ID-FCSEMS has a high clinical success and low complication rate, and in particular, there was only one case of stent migration. As a result, this stent type is preferred to traditional metal stents for treating AS after OLT.

Internet support for point-of-care testing in primary care.

One of the few and largest randomised controlled trials of point-of-care testing (PoCT) in general practice was conducted in Australia. This trial showed PoCT provided the same or better clinical effectiveness than central laboratory testing for HbA1c, urinary albumin/creatinine ratio, cholesterol and triglyceride measurements but not for the international normalised ratio (INR) or high-density lipoprotein (HDL) cholesterol. For most tests, however, testing in the central laboratory was more cost-effective than PoCT. One factor that contributed to the higher cost of PoCT was the considerable amount of resources devoted to training and monitoring the PoCT operators throughout the trial, many of whom were in remote locations.

How to manage warfarin therapy.

Long-term treatment with warfarin is recommended for patients with atrial fibrillation at risk of stroke and those with recurrent venous thrombosis or prosthetic heart valves. Patient education before commencing warfarin - regarding signs and symptoms of bleeding, the impact of diet, potential drug interactions and the actions to take if a dose is missed - is pivotal to successful use. Scoring systems such as the CHADS2 score are used to determine if patients with atrial fibrillation are suitable for warfarin treatment. To rapidly achieve stable anticoagulation, use an age-adjusted protocol for starting warfarin. Regular monitoring of the anticoagulant effect is required. Evidence suggests that patients who self-monitor using point-of-care testing have better outcomes than other patients.

The role of failure modes and effects analysis in showing the benefits of automation in the blood bank.

BACKGROUND: Failure modes and effects analysis (FMEA) is a risk management tool used by the manufacturing industry but now being applied in laboratories. STUDY DESIGN AND METHODS: Teams from six South Korean blood banks used this tool to map their manual and automated blood grouping processes and determine the risk priority numbers (RPNs) as a total measure of error risk. RESULTS: The RPNs determined by each of the teams consistently showed that the use of automation dramatically reduced the RPN compared to manual processes. In addition, FMEA showed where the major risks occur in each of the manual processes and where attention should be prioritized to improve the process. Despite no previous experience with FMEA, the teams found the technique relatively easy to use and the subjectivity associated with assigning risk numbers did not affect the validity of the data. CONCLUSION: FMEA should become a routine technique for improving processes in laboratories.

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.

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.

Point-of-care testing for patients with diabetes, hyperlipidaemia or coagulation disorders in the general practice setting: a systematic review.

BACKGROUND: Point-of-care testing (PoCT) is increasingly being used in the general practice setting and has the potential to provide improved health outcomes for patients. OBJECTIVES: The aim of the study was to systematically assess the literature relating to the analytical performance, clinical effectiveness, cost and satisfaction of patients and health professionals with PoCT for monitoring patients with diabetes, with hyperlipidaemia or requiring anticoagulant therapy in general practice. METHODS: Systematic review and synthesis of randomized and quasi-randomized trials during 1966-2007 was performed. PubMed, EMBASE, CINAHL, Current Contents, BIDS and the Cochrane Library databases were searched using key terms relating to PoCT for diabetes (glycosylated haemoglobin, urine albumin creatinine ratio), hyperlipidaemia (total cholesterol, triglycerides and high-density lipoprotein) and anticoagulant therapy (international normalized ratio) in the general practice setting. RESULTS: Nine papers from six randomized or quasi-randomized trials were included in the review. Large between-study heterogeneity made pooling of the data inappropriate. In terms of clinical effectiveness, no study found a significant difference between PoCT and pathology laboratory testing. There was a similar lack of data in relation to the analytical performance of PoCT, to cost outcomes and to patient and health professional satisfaction, making conclusions difficult to infer. CONCLUSIONS: This systematic review does not provide robust evidence that PoCT in general practice improves patient health outcomes, that it has comparable analytical quality to pathology laboratory testing, that it is cost-effective compared to usual care or that patients and health professionals find PoCT satisfactory. The number of trials is low, the follow-up of patients is short and many of the trials did not investigate PoCT as a separate intervention.

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.

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.

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.