Is the positive contribution of point-of-care diagnostics to healthcare effectiveness & efficiency being under-estimated, under-recognised and/or under-funded in Europe?A MindMetre Research Note – December 2016

Early Recognition

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Management Summary

� We live in a world which needs to replace unfettered healthcare availability with the need to improve nations’ healthiness. We have realised that managing escalating demand for healthcare is unsustainable, and strategies need to be developed to improve society’s ‘wellness’ – thereby reducing the need for healthcare services.

� The transition will be gradual, but it is urgent that policymakers have the courage and foresight to reform ways of delivering healthcare that may be established, but are inefficient. Vested interests in the commer-cial healthcare world also need to be dis-mantled, or incentivised to change.

� One area where there appears to be evidence of benefit to patient outcomes and healthcare system efficiency is the im-plementation of point-of-care diagnostics. These techniques can deliver quick results to identify sources of infections among in/outpatients populations, triage sympto-matic patients so that cases can potentially be fast-tracked and prioritised for deeper investigation, thereby improving health outcomes and allowing clinicians to reduce unnecessary laboratory tests.

� In fact, the return on investment from point-of care testing in primary care comes from much more than eliminating unneces-

sary laboratory tests. The clinical benefits derive from shortening the ‘time-to-im-pact’ that is so critical to delivering better patient outcomes. The financial benefits come from reduced hospitals admissions, screening, accommodation, etc

� In addition, although in their early stages, newer point-care-testing technologies appear to be introducing higher sensitivi-ties that more closely approach the labo-ratory test ‘gold standard’. This should, in principle, enhance the benefits of point-of-care testing still further.

� Of course, wider implementation of point-of-care testing needs to be managed by a collaboration with clinicians and general practitioners (who want to deliver fastest/most accurate therapy for patients) and expert laboratorians (who understand how to implement quality and compliance standards)

� This research note reviews current evidence on the topic – both qualitative interviews and recent clinical research. It concludes with recommendations that:

— Policymakers and governments sponsor urgent additional research into the subject to provide a wider evidence base;

— All European countries then consider how their reimbursement regimes can encourage best practice in the applica-tion of point-of-care diagnostics in the primary care setting;

— Guidelines of this best practice be enshrined in official national and supra-national recommendations, both at the acute and the primary care levels.

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Introduction

MindMetre Research conducts regular independent

investigations into issues of healthcare reform, particu-

larly where they may produce better patient outcomes

at the same time as potentially reducing healthcare

costs, whether for in- or out-patient communities.

All healthcare systems in Europe are under financial

pressure, with demand for healthcare rising as popu-

lation longevity increases while funds, although often

ring-fenced, are not growing at a concomitant rate.

Infection outbreaks/spreads as well as nosocomial

(healthcare-acquired) infection threats are becoming

more potent1, particularly as outbreaks are becoming

more difficult to manage and anti-microbial resistance

continues to rise, despite the success of reduction

policies2. Clearly, there is a need to continually look

for better ways of working in Healthcare, in order to

determine whether changes can deliver better health-

care to in-patients and out-patients at the same, or

lower, cost. Those better ways of working require a

collaborative initiative between clinicians/general

practitioners and expert laboratorians who intimately

understand quality and compliance standards.

Point-of-Care Testing – The Issue

This short research note was inspired by qualita-

tive interviews with leading clinicians around Europe

using diagnostic tests at point-of-care. They do so

having become convinced that these point-of-care

tests for respiratory tract infections (RTIs) are making

a significant contribution to a number of outcomes

amongst their patient pool. Those benefits mainly

rest on the power of positive diagnostic test results to

eliminate those with influenza in order to:- concentrate

on, and escalate urgent diagnosis/treatment of, other

infections or conditions; reduce the mis-prescription

of unnecessary and ineffective antibiotics for viral

infections; reduce requests for unnecessary laboratory

tests, especially in the winter season when viral loads

are high; and more rapid and effective cohorting to

reduce healthcare acquired (nosocomial) infection

rates – a key factor in the pressurised acute sector,

particularly during winter months.

A second inspiration for this research note is the

recent publication in the UK of a government review

of laboratory services3. The report has ramifications

across Europe, in that it takes a critical view of lab-

oratory standards and productivity, and demands

radical actions in the event of insufficient productivity

increases. Given the financial pressure on healthcare

systems across the continent, the UK’s lead may well

steer similar policy moves in France, Germany, Italy,

Spain and other European regimes. This official review

in the UK sets very short timelines for productivity

improvements and encourages trusts to consider

Early Recognition | A MindMetre Research Note – December 2016

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laboratory mergers and consolidation. The MindMetre

paper on the subject presents evidence of the dispro-

portionate positive contribution to overall healthcare

effectiveness made by pathology, including a qual-

itative study of laboratory managers and principal

biochemists, and suggests that investment in labora-

tory services should be increased, not squeezed. This

extends to quality control over point-of-care tests in

the ward, which must be properly managed by labora-

tory professionals.

Nevertheless, all parties in the healthcare in-

frastructure want to reduce waste in the system to

enhance the efficiency of healthcare spending. On this

basis, all parties should also, in principle, be keen to

see point-of-care testing increase, given that various

clinical papers4 have shown that this reduces the need

for samples to be sent unnecessarily to the laboratory

for testing. In fact, it is not just a matter of avoiding

unnecessary tests – effective point-of-care testing

actually delivers savings by eliminating waste at every

point in the patient pathway – fewer acute admissions,

screenings, pre-emptive isolations, accommodation

costs, and so on.

The rising policy trend to use diagnostics to create

more ‘well’ societies (through early, more accurate,

interventions or preventions) is likely to fuel growth in

service demand for diagnostic testing more broadly5.

Moreover, newer point-of-care testing techniques – such

as PCR molecular tests, or immunoassays – are deliv-

ering higher sensitivities than established methods,

coming closer to the laboratory ‘gold-standard’. Given

the wide consensus that established methods are

already delivering strategic benefits6, the growing

acceptance of these newer methods can only serve to

enhance the possible return on investment and speed of

patient ‘impact’ that point-of-care testing delivers.

Qualitative Evidence on the Benefits of Point-of-Care Testing

Before examining recent clinical papers on the

subject of point-of-care testing efficacy, this research

note will summarise the key points from qualitative in-

terviews with leading clinicians from Germany, France

and the UK on the perceived benefits of point-of-care

diagnostics for RTI management.

Respondents from all three countries focused on

the value of rapid point-of-care positive diagnostic

results to manage cohorting of paediatric patients –

especially in the influenza and bronchiolitis ‘season’.

French respondents noted that they benefited from a

reduction in additional examinations when managing

patients, along with a 70% decrease in x-rays and a

47% reduction in blood tests, as well as reductions in

unnecessary hospitalisation and antibiotherapy. A UK

respondent noted a reduction of 80-90 laboratory RTI

test samples per day – which use of point-of-care diag-

nostics qualified as unnecessary. Both UK and German

participants noted the benefit of having test results

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more quickly, very soon after the point of examination,

allowing quick and effective clinical decisions and pre-

venting the spread of nosocomial infections; a positive

diagnosis means patients can be isolated and so the

quicker the diagnosis, the better. Patients diagnosed

as not at risk can be sent home, relieving the burden

on acute care.

Commenting on antimicrobial stewardship in the

primary care setting, all respondents agree that point-

of-care testing (again focusing on positives) prevents

unnecessary administration of antibiotics for respirato-

ry tract infections; moreover, a positive diagnostic test

result also helps dissuade adult patients trying to insist

on antibiotic prescription in the GP’s surgery.

All participants in these qualitative interviews also

agreed that there is a major need for more high quality

research into the total (positive) financial impact

of point-of-care testing for RTIs (and, indeed, other

presenting symptoms), in order to persuade policy-

makers to invest further in frontline diagnostics, and to

underpin that with official guidelines and recommen-

dations encouraging more widespread usage.

Clinical Research Currently Available

Clinical publications on recent point-of-care

technologies may not yet, as research participants

noted, be sufficiently numerous. Neither, however, are

they totally absent. A scan of more recent research

published on the subject reveals a broad agreement

on the benefits of point-of-care testing for RTIs that

has, at times, been knocked off course by a focus

on the subject of test sensitivities, which are seen as

significantly lower than the laboratory ‘gold standard’

when it comes to reliable negatives. Although there is

evidence that sensitivity rates have been significantly

improved7, it is arguable that focusing on this technical

issue misses the point. Most clinical research authors8

seem to agree that, by focusing on the power of rapid

positive diagnostic results to eliminate non-critical

cases and focus healthcare resources where they most

latter, the benefits of point-of-care testing remain very

robust indeed. To spend valuable clinical research time

focusing on negative result sensitivities would seem

to be an academic distraction. Moreover, the clinical

community is desirous that further work is done on

the positive contribution topic. As one recent five

country review9 notes, there are still “few high-quality

studies focusing on patient outcomes (rather than

test accuracy).” It is interesting, therefore, to note that

one UK university hospital trust10 has very recently

attracted funding for a major research programme

on point-of-care testing. The announcement of this

funding observes that, “Point-of-care tests could

greatly improve acute care for patients, enabling viral

infections to be treated effectively before they can get

any worse and manage potential infection of other

patients. Early diagnosis may also help to avoid the

unnecessary use of antibiotics, only effective against

bacterial and fungal infections, a key factor in growing

antibiotic resistance11.”

These benefits of point-of-care testing are cor-

roborated in other recent publications12 on the topic,

which also conclude that a rapid positive diagnosis

of influenza provides the trigger to put alternative

therapies in place, avoid unnecessary antibiotic ad-

ministration, and limit additional diagnostic testing.

In fact, another review of evidence13, published within

“A rapid positive diagnosis of influenza provides the trigger to put alternative therapies in place, avoid unnecessary antibiotic administration, and limit additional diagnostic testing.”

Early Recognition | A MindMetre Research Note – December 2016

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the last three years, observes that even though point-

of-care testing does not offer laboratory sensitivities,

rapidly generated positive test results do offer sig-

nificant benefits:- early measures and interventions

to prevent infection, especially in acute healthcare

settings; early administration of alternative treatments;

and prevention of unnecessary ward closure. All these

‘outcomes’ can be regarded as critical to keeping

pressurised healthcare facilities operating at optimum

efficiency when viral loads are at their highest – namely

in the winter season. The point here is that every

unnecessary bed occupancy or ward closure repre-

sents a damaging loss of facilities for patients who may

be requiring urgent acute treatment. In this sense,

the ramifications of rapid diagnostic at point-of-care

potentially go far beyond the individual patient. More

clinical research is required to accurately model and

validate these wider ramifications.

Another study from 2015 specifically looks at the

effect of rapid influenza diagnostic testing (RIDT)

at point-of-care – particularly its impact on health-

care resource consumption. In line with the clinical

research already cited, the study finds that “When the

RIDT was positive, a significant decrease in the pre-

scriptions of chest X-ray, urine dipstick, laboratory tests

and antibiotic prescription (ceftriaxone) was observed.”

In terms of sensitivities, the same study does specifical-

ly note the power of positive point-of-care test results,

saying, “The comparison of the RIDT results with the

gold standard (IF assay and PCR) show that when the

RIDT was positive, the risk of having a SBI was zero,

and the risk of having influenza was 99%.”

In the paediatric setting (and also with the elderly

and the profoundly immunosuppressed) Respirato-

ry Syncytial Virus (RSV) infections also place severe

pressures on GP/physician surgeries and hospital

resources. A recent study focusing on RSV14 notes that

rapid diagnostic testing for respiratory viruses reduces

both patient hospitalisation time and its associated

financial costs. It also concludes that RSV point-of-care

diagnostic testing enables rapid, effective and accurate

diagnoses in primary care to significantly reduce the

need for acute care referrals, unnecessary antimicrobial

therapy or further diagnostic testing in the laboratory.

The Issue of Re-imbursement

In the primary and acute care settings, it would

appear, from the evidence cited in this research note,

that there is clear evidence that rapid point-of-care

testing for RTIs can have a significant effect on iden-

tifying and escalating potentially more serious infec-

tions (by eliminating non-critical diagnoses), thereby

managing scarce acute resources, especially at times of

high pressure on European healthcare systems in the

RTI ‘season’. There also would seem to be a clear contri-

bution to reducing unnecessary antibiotic prescription –

an important contribution to the current global drive to

improve antimicrobial stewardship in the face of rising

antimicrobial resistance.

Despite this evidence (and clearly it would be

beneficial that this evidence base be more numerous)

“…the ramifications of rapid diagnostic at point-of-care potentially go far beyond the individual patient.”

“There is clear evidence that rapid point-of-care testing for RTIs can have a significant effect on identifying and escalating potentially more serious infections.”

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re-imbursement regimes for point-of-care testing

remain inconsistent across Europe. To the authors of

this research note, this seems a clear policy omission,

especially as the whole mindset of healthcare provision

in Europe has now recognised the need to move

from regimes that struggle with escalating health-

care demand, to ones that use preventative medicine

(and public health education) to create more ‘healthy

societies’ that do not need to consume so much health-

care service15. A significant minority of primary care

practitioners are evidently convinced of the efficacy of

point-of-care testing for the overall healthcare manage-

ment of their patient pool, as they have implemented

such technology whether or not they are specifically

reimbursed for the tests. It is credible to suggest that

the motivation for such pioneers is likely to be financial

as well as Hippocratic. In other words, they may well

believe that using point-of-care testing enables their

practice or department to treat more people, more

effectively for a lower overall burden on the healthcare

system. As an example, one study reports around 30%

usage by German primary care physicians16.

Conclusions and Recommendations

� There is evidence that point-of-care testing for RTIs provides tangible value in better managing pressurised healthcare resources – analytical and clinical – especially at times of high viral load

� Point-of-care testing can also make a signif-icant and critical contribution to reducing the unnecessary prescription of antibiotics, a key factor in the fight against antimicrobi-al resistance through better stewardship

� Therefore, as healthcare systems transform to more sustainable, more preventative

models, it is imperative that policymakers pay more attention to the positive contribu-tion that point-of-care testing can make to improved health outcomes at the same, or lower, cost

� To this end, the clinical research evidential base needs to be seriously extended, taking into account the wider picture of ‘ripple effect’ benefits from point-of-care testing – health outcomes, resource management and financial management. This is increas-ingly the case as newer point-of-care tests gain traction and clinical acceptance. Gov-ernments would be well-advised to make the relatively tiny investment in swelling this evidential base, as the potential benefit for healthcare system affordability and sus-tainability could be very substantial indeed.

� Policymakers (and in some countries, healthcare insurers) should also pay specific attention to the currently available evidence on the subject of point-of-care testing, with a view to seriously considering whether a change in the reimbursement regimes for these tests might drive their usage, facilitate patient triage strategy, and deliver a strong return on investment for national healthcare systems.

� Implementation requires joint collabo-ration between clinicians and/or general practitioners (who want to deliver faster – but accurate – patient therapies) and expert laboratorians who are best placed to govern quality and compliance standards.

Early Recognition | A MindMetre Research Note – December 2016

1. European Centre for Disease Prevention and Control, ; Bundesregierung, DART 2020; Ministère du Travail, de l’Emploi et de la Santé, Plan nationale d’alerte sur les antibiotiques, 2011; Ministry of Health, Social Services and Equality, Spanish Agency of Medicines and Medical Devices, Plan estratégico y de acción para reducir el riesgo de selección y disemi-nación de resistancias a los antibióticos2014; Review on Antimicrobial Resistance, Tackling drug-resistant infection globally, May 2016; WHO, Antimicrobial resistance – global report on surveillance 2014

2. See European Centre for Disease Prevention and Control, European Antomicrobial Resistance Network (EARS Net), various publications

3. Carter Review, Operational productivity and performance in English NHS acute hospitals: Unwarranted variations, February 2016

4. Journal of Clinical Virology, S. Lacroix, B. Vrignauld, E. Avril, A. Moreau-Klein, M. Coste, E. Launay, C. Gras-Le Guen, Impact of rapid influenza diagnostic test on physician estimation of viral infection probability in paediatric emergency department during epidemic period, 2015; Journal of Virological Methods, G.P. Leonardi, A. M. Wilson, M. Dauz, A. R. Zuretti, Evaluation of respiratory syncytial virus (RSV) direct antigen detection assays for use in point-of-care testing, 2015; Journal of Clinical Microbiology, Ferdaus Hassan, Rangaraj Selvarangan, Reply to “New Rapid Diagnostic Tests: a Real Improvement for Clinical Use?”, Feb 2015, Volume 53

5. See, for instance:- Credence Research, Inc. “Global Clinical Laboratory Services Market – Growth, Share, Opportunities, Competitive Analysis, and Forecast, 2016 – 2022,”

6. See, for instance:- Andrew St John and Christopher P Price, Existing and Emerging Technologies for Point-of-Care Testing, Clin Biochem Rev. 2014 Aug; 35(3): 155–167., which notes that “there has been a preoccupation with the expense of a point of care test compared to one performed in the central laboratory. Yet, as several studies have shown, when economic studies of PoCT are performed that consider the complete testing process, including the patient outcomes, the PoCT value proposition is shown to be favourable compared to the central testing model.55,67,68 Successful innovation and the adoption of devices which improve patient outcomes in a cost effective way has to include the process and economic changes that are part of the clinical and cost effectiveness evidence – particularly the disinvestment of redundant resources.”

7. Journal of Clincial Virology, J. Jeremiah Bell, Evan J. Anderson, Wallace H. Greene, Jose R. Romero, Moheet Merchant, Rangaraj Selvarangan, Mul-ticentre clinical performance evaluation of BD Veritor System for Rapid Detection of Respiratory Syncytial Virus, 2014

8. For instance: Journal of Hospital Infection, M. Bouscambert-Duchamp, M. Valette, B. Lina, Rapid bedside tests for diagnosis, management, and prevention of nosocomical influenza, 2015; Journal of Virological Methods, G.P. Leonardi, A. M. Wilson, M. Dauz, A. R. Zuretti, Evaluation of respiratory syncytial virus (RSV) direct antigen detection assays for use in point-of-care testing, 2015; Journal of Clinical Microbiology, Ferdaus Hassan, Rangaraj Selvarangan, Reply to “New Rapid Diagnostic Tests: a Real Improvement for Clinical Use?”, Feb 2015, Volume 53

9. BMJ, J Howick et al, Current and future use of point-of-care testing in primary care, 8 Aug 2014, BMJ Open 2014;4:e005611 doi:10.1136/bmjopen-2014-005611

10. See, for instance:- University Hospital Southampton NHS Trust, Faster tests to fight viral infections, 15 Aug 2016

11. ibid12. Journal of Clinical Microbiology, Ferdaus Hassan, Rangaraj Selvarangan,

Reply to “New Rapid Diagnostic Tests: a Real Improvement for Clinical Use?”, Feb 2015, Volume 53

13. Journal of Hospital Infection, M. Bouscambert-Duchamp, M. Valette, B. Lina, Rapid bedside tests for diagnosis, management, and prevention of nosocomical influenza, 2015

14. ibid15. See, for instance:- European Commission, Horizon 2020, Health,

demographic change and well-being, 25 July 2016; Kings Fund, Making our health and care systems fit for an ageing population, 2014; CDC, C.B. Kemp, Preventing Chronic Disease, 2012;

16. International Electronic Journal of Rural and Remote Health, T, Frese, K. Steger, T. Deutsch, G.L. Schmid, H. Sandholzer, Leipzig Medical School, Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany, 2016, Rural and Remote Health 16: 3552

MindMetre will be continuing to follow this issue with further updates as policy on the topic develops throughout Europe.

Contact: info@mindmetre.com Website: www.mindmetreresearch.com