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Dr. Anne PostulkaChristchurch, NZ, June 2015
Not only for Google: Why does speed matter?
© Cepheid
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Who am I and where do I come from?
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Who else is there?
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For Google
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Speed matters – also in MedTech
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• Definition of speed
• Objectives of speed
• Feasibility of speed
• Benefits of speed
• What does it take
Content
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09:00 10:00 11:00 12:00 13:00 14:00 15:00 16:00 17:00 18:00
Reception Assemble Batch Set up Run assay
Tran
scrib
e
Samples received after 15:00 processed next working day –> TTR minimum 23h plus transport time
Reception Assemble Batch Set up Run assay
Tran
scrib
e
Speed? Let’s talk TAT
TAT: Is it real?
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• Speed is TAT, but above all total time-to-result (TTR)
What does speed mean – for IVDs?
Recommended: the DIY pathway (speed) analysis
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• Definition of speed
• Objectives of speed
• Feasibility of speed
• Benefits of speed
• What does it take
Content
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Reducing TTR = Increasing Medical Value
TIME TO RESULT
Medical Value: Time to Result is crucial
ME
DIC
AL
VA
LU
E
0 12 hrs 1 day 2 days
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«Better, sooner, more convenient: Increasing youth
friendliness of Family Planning Services in New Zealand »
Ms Rose Stewart, National Nursing Advisor, New Zealand
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Potential Patient Impact• Delayed or Wrong Diagnosis• Misuse or Overuse of Antibiotics• Cross-infection• Increased Length of Stay
Potential Economic Impact• Unnecessary Antibiotics Expense• Isolation Expenses• Blocked Bed Expenses
Economic and Medical Cost of Delayed Diagnosis
Time to Test Results Costs Money and LivesTime to Test Results Costs Money and Lives
Articles that look at time to result as crucial to maximizing diagnostic value:1. Lance R. Peterson, M.D., Donna M. Hacek, M.T. (A.S.C.P.), Ari Robicsek, M.D., Case Study: An MRSA
Intervention at Evanston Northwestern Healthcare, printed in The Joint Commission Journal on Quality and Patient Safety Volume 33 Number 12, December 2007
2. Lance R. Peterson, M.D., Rapid Diagnosis of Community-Acquired MRSA, printed in Clinical Updates in Infectious Diseases, Volume Issue 3, October 2008
3. Eli N. Perencevich, MD, MS et al., SHEA Guideline: Raising Standards While Watching the Bottom Line: Making a Business Case for Infection Control, Infection Control and Hospital Epidemiology, Volume 28, Number 10, October 2007
TIME TO TEST RESULT
2 HOURS 24 HOURS 48 HOURS 72 HOURS
CEPHEID PCR
EXPENSE
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Meet the Needs of Patients and Physicians
Short TAT, short TTR, actionable results
‒ Improve access to and value of testing
‒ Avoid disruption of carer-to-patient-interaction
‒ Personalize care (Chris Price, UK)
‒ Patient-centered, outcomes focused medicine
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• Definition of speed
• Objectives of speed
• Feasibility of speed
• Benefits of speed
• What does it take
Content
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Reliable, reproducible results anytime, any place
Integrated Platform and Test
1 2 3
Total Hands-On Time <1 Minute
Insert Cartridge and Start Assay
Insert Swab into Elution Reagent Vial and Break at Score
Vortex and Dispense Sample into Port S
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Random Access 24/7 – the Alternative
09:00 10:00 11:00 12:00 13:00 14:00
Modules
1
2
3
4
5
6
7
8
• In 8 hours: 50-100 real-time results
• Daily capacity ~250 results with 8 modules used 24/7
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Feasibility of speed = near-patient
MRSA Group B StrepInfluenzaCT/NGC.difficileNorovirusTuberculosis…
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Bringing diagnostics closer to patients
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• Definition of speed
• Objectives of speed
• Feasibility of speed
• Benefits of speed
• What does it take
Content
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Medical and Economic Benefits of Speed
• Speed = short TTR = timely diagnosis‒ Does it make a difference for patients?
• Where is the evidence?
• And hey: What does it cost?
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Evidence? An example.
Introduction of the first random access PCR test for the diagnosis of C.difficile Infection.
Objective of project:
Answer 2 questions.
1. Do rapid results make a difference for patients (outcomes)?
2. How does the impact translate into costs (or gains) for the hospital?
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“Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile” 1/2
Study design‒ Prospective interventional study‒ 2 acute care hospitals in Swansea, Wales, UK ‒ More than 1,000 consecutive patients enrolled from March to Sept. 2011
ResultsTime to reportable result for Xpert C. difficile was on average 1.53h:
‒ 21h faster than reference method for positive samples
‒ 45h faster for negative samples
Length of stay‒ PCR positive patients were discharged ~4.88 days earlier &‒ PCR neg. patients ~7.03 days earlier compared to reference method.
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“Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile” 2/2
• Micro-costing results: ‒ Testing cost per sample was £36.18 for PCR, £7.53 for CCNA positive, and
£8.78 for CCNA-negative samples
• With routine use of real-time PCR on all patients in one year would potentially save 38,247 bed days in ABMUHB.
• Cost of extended LOS has been identified as main cost driver in CDI.
• Extrapolation: Investing 80 NZD in rapid PCR could provide:‒ Clinically useful result within 1-2 hours ‒ Reduced LOS‒ Cost-savings 740 NZD/day; 1,640 NZD per patient
• Conclusion (authors)‒ A rapid molecular test for C. difficile in an acute hospital setting produced
quick results that led to a decrease in LOS compared to historic CCNA control patients. This could result in considerable savings through reduced excess inpatient days.
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Bode, NL and D
Lonneke G.M. Bode, M.D., Jan A.J.W. Kluytmans, M.D., Ph.D., Heiman F.L. Wertheim, M.D., Ph.D.,Diana Bogaers, I.C.P., Christina M.J.E. Vandenbroucke-Grauls, M.D., Ph.D., Robert Roosendaal, Ph.D.,Annet Troelstra, M.D., Ph.D., Adrienne T.A. Box, B.A.Sc., Andreas Voss, M.D., Ph.D., Ingeborg van der Tweel, Ph.D.,Alex van Belkum, Ph.D., Henri A. Verbrugh, M.D., Ph.D., and Margreet C. Vos, M.D., Ph.D.
ConclusionsThe number of surgical-site S. aureus infections acquired in the hospital can be reducedby rapid screening and decolonizing of nasal carriers of S. aureus on admission.
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Bode et al, NEJM: Conclusions
• HAI: ‒ “The results of our trial provide solid evidence of the preventive effect of
S. aureus decolonization and a good estimate of the size of this effect: the risk of hospital-associated S. aureus infections was reduced by nearly 60% (3,4% vs. 7,7%))”.
• LOS: ‒ “The mean duration of hospitalization was significantly shorter in the
mupirocin-chlorhexidine group than the placebo group (12.2 vs. 14.0 days)”
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Benefits of Speed: Summary
• The value of rapid results – Is it worth it ‒ Does it make a difference for patients?‒ Does it cost more (ROI)?
• Fast (and precise) results mean‒ Optimal patient management and therapy‒ Avoiding useless and/or harmful interventions‒ Reducing transmission for infectious diseases and HAIs ‒ Improving Antimicrobial Stewardship‒ Positively impact overall disease burden with reducing LOS,
related (total) costs, isolation days, expensive cleaning etc.pp
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• Definition of speed
• Objectives of speed
• Feasibility of speed
• Benefits of speed
• What does it take
Content
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• Put the patient in the center
• Change the patient’s journey
• Plan new pathway and process
• Transform communication
• Manage and lead change
What does it take? Change management!
Because it’s the right thing to do.
“Ärmel aufkrempeln, zupacken, aufbauen”
Roll up your sleeves, get a good grip, go!
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Speed matters: For patients and their doctors.
Take-home message
And for Joe, too!
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Thank you.