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Case Study
Real world evaluation and implementation
of a diagnostic test for pre-eclampsia
Guy Checketts
The Oxford AHSN
Contents
• Overview of preeclampsia
• Project objectives
• The diagnostic
• Clinical pathway
• Challenges
• Keys to success
• Learning Points
• Workshop
Preeclampsia (PE)
• Multisystem hypertensive disorder affecting 3-5% of all
pregnancies
• Serious cause of maternal and foetal morbidity
• High degree of clinical suspicion
• Low threshold for admission
• Current practice admits ~50%
• High blood pressure
• Headaches
• Impaired liver and kidney function
• Seizures
• Smaller babies / pre-term delivery
• Significant burden on the system 3
Project Objectives
Standardise adoption of preeclampsia testing
7 network hospitals – Thames Valley
• Patient safety and clinical risk management
• Improving capacity
• Reduce (unnecessary) admissions
• Allows focus of scarce resources
• Reduce overall system costs
• Better Births – National Maternity Review (2016)
•Close working relationships with
• Oxford Maternity Steering Group
• Manufacturers
• Maternity, lab and finance functions in partner hospitals
• Local Maternity Systems (LMS) 4
Preeclampsia testing
PE testing detailed under NICE DG23 Guidelines
•Elecsys® is only test currently commercially available (Roche)
• Dual biomarkers - sFlt1:PlGF ratio test
•Triage PlGF test (Alere / Quidel – under development)
• Single biomarker - PlGF
•PROGNOSIS: Multi-centre multi-national trial
• Zeisler et al 2016 N Eng J Med 7;374 13-22
•INSPIRE: Real world evaluation at Oxford JR Hospital
• Confirmed pathway and algorithm
• Vatish et al. Awaiting publication
•NPV >99% woman does not have PE (next 7 days)
•PPV 36.7% woman has PE (next 4 weeks)
5
The clinical pathway – INSPIRE (real world evaluation)
6
56% RISK of PE in 7 days20% RISK of PE in 7 days0.4% RISK of PE in 7 days
<3% risk of PE in 28 days
≤38 39-84 ≥85
Taken from Guidelines:
AHSN Maternity Network Soluble Flt/PlGF Ratio in Management of Suspected Pre Eclampsia. 26/04/2018 MV/SC/LI: V11.0
PE Very unlikely Elevated risk of PE Very high risk of PE
PCR<30 or if N/A
dipstick < 1+ protein;
no signs of end-organ
dysfunction
PCR>30 or if N/A
dipstick ≥ 1+ protein,
OR signs of end-
organ dysfunction
1.No admission unless for
hypertension
2. .Twice weekly BP and
urinanalysis
1.No admission unless for
hypertension
2. Follow local guidelines
1.Consider admission
2.Monitor as if PE
1. Consider admission
2. Senior clinical
review
3. Monitor as if PE
Elecsys®
ratio
Challenges – Finding the “Sweet Spot” for adoption
(Most challenges result in a delay)
7
• Identify the correct stakeholders - share of voice varies
• Multiple functions adds complexity
• Different departmental drivers – alignment?
• Relative priority
• Within a department / between departments
• Funding - cash-releasing or not?
• Guidelines? NICE or Local?
• Getting a “Yes” doesn’t mean “Yes”
• Adoption? Training and standardisation
• Each hospital is unique – one size does not fit all
Key to success…
• Identify and engage with key internal stakeholders early
• Clinical, Labs, Finance, HR, etc. Follow the breadcrumbs…
• Multidisciplinary meetings and common agreement
• Confirm clinical need and local drivers (Patient safety / other?)
• Mapping clinical pathways – where are the savings?
• Current / future / financial / capacity
• Real world evaluation
• Clinical & health economic
• Stakeholder engagement
• Approval
• Identify “true” costs and benefits
• Training and standardisation
• Metrics pre / post adoption 8
What it means to the end user
“Pre-eclampsia is a major cause of maternal and fetal morbidity
worldwide and places significant economic and capacity burdens
on maternity systems. Through standardisation of sFlt-1:PlGF
testing on the ELECSYS platform we will be able to make
significant improvements to patient safety and the level of
service offered to women”
Dr Manu Vatish, Senior Clinical Fellow in Obstetrics
Oxford University Hospitals
9
Thank you
Questions? 10
Workshop
Action Planning for Adoption
11
What can you do now to facilitate adoption?
Manufacturer, clinical, lab…
12
Drivers
•Clinical? Financial?
•Audit / Quality
•Guidelines
Obstacles and Risks
•Cost
•Resource / priority
•Resistance to change
Information required
•Real-world performance vs.
clinical evidence
•Baseline metrics
•Other?
Actions
•Real-world evaluation
•Stakeholder engagement
•Project management
•Budget impact
Feedback: One sentence on a key thought from your discussion

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Real World Evaluation and implementation of a diagnostic test for pre-eclampsia

  • 1. Case Study Real world evaluation and implementation of a diagnostic test for pre-eclampsia Guy Checketts The Oxford AHSN
  • 2. Contents • Overview of preeclampsia • Project objectives • The diagnostic • Clinical pathway • Challenges • Keys to success • Learning Points • Workshop
  • 3. Preeclampsia (PE) • Multisystem hypertensive disorder affecting 3-5% of all pregnancies • Serious cause of maternal and foetal morbidity • High degree of clinical suspicion • Low threshold for admission • Current practice admits ~50% • High blood pressure • Headaches • Impaired liver and kidney function • Seizures • Smaller babies / pre-term delivery • Significant burden on the system 3
  • 4. Project Objectives Standardise adoption of preeclampsia testing 7 network hospitals – Thames Valley • Patient safety and clinical risk management • Improving capacity • Reduce (unnecessary) admissions • Allows focus of scarce resources • Reduce overall system costs • Better Births – National Maternity Review (2016) •Close working relationships with • Oxford Maternity Steering Group • Manufacturers • Maternity, lab and finance functions in partner hospitals • Local Maternity Systems (LMS) 4
  • 5. Preeclampsia testing PE testing detailed under NICE DG23 Guidelines •Elecsys® is only test currently commercially available (Roche) • Dual biomarkers - sFlt1:PlGF ratio test •Triage PlGF test (Alere / Quidel – under development) • Single biomarker - PlGF •PROGNOSIS: Multi-centre multi-national trial • Zeisler et al 2016 N Eng J Med 7;374 13-22 •INSPIRE: Real world evaluation at Oxford JR Hospital • Confirmed pathway and algorithm • Vatish et al. Awaiting publication •NPV >99% woman does not have PE (next 7 days) •PPV 36.7% woman has PE (next 4 weeks) 5
  • 6. The clinical pathway – INSPIRE (real world evaluation) 6 56% RISK of PE in 7 days20% RISK of PE in 7 days0.4% RISK of PE in 7 days <3% risk of PE in 28 days ≤38 39-84 ≥85 Taken from Guidelines: AHSN Maternity Network Soluble Flt/PlGF Ratio in Management of Suspected Pre Eclampsia. 26/04/2018 MV/SC/LI: V11.0 PE Very unlikely Elevated risk of PE Very high risk of PE PCR<30 or if N/A dipstick < 1+ protein; no signs of end-organ dysfunction PCR>30 or if N/A dipstick ≥ 1+ protein, OR signs of end- organ dysfunction 1.No admission unless for hypertension 2. .Twice weekly BP and urinanalysis 1.No admission unless for hypertension 2. Follow local guidelines 1.Consider admission 2.Monitor as if PE 1. Consider admission 2. Senior clinical review 3. Monitor as if PE Elecsys® ratio
  • 7. Challenges – Finding the “Sweet Spot” for adoption (Most challenges result in a delay) 7 • Identify the correct stakeholders - share of voice varies • Multiple functions adds complexity • Different departmental drivers – alignment? • Relative priority • Within a department / between departments • Funding - cash-releasing or not? • Guidelines? NICE or Local? • Getting a “Yes” doesn’t mean “Yes” • Adoption? Training and standardisation • Each hospital is unique – one size does not fit all
  • 8. Key to success… • Identify and engage with key internal stakeholders early • Clinical, Labs, Finance, HR, etc. Follow the breadcrumbs… • Multidisciplinary meetings and common agreement • Confirm clinical need and local drivers (Patient safety / other?) • Mapping clinical pathways – where are the savings? • Current / future / financial / capacity • Real world evaluation • Clinical & health economic • Stakeholder engagement • Approval • Identify “true” costs and benefits • Training and standardisation • Metrics pre / post adoption 8
  • 9. What it means to the end user “Pre-eclampsia is a major cause of maternal and fetal morbidity worldwide and places significant economic and capacity burdens on maternity systems. Through standardisation of sFlt-1:PlGF testing on the ELECSYS platform we will be able to make significant improvements to patient safety and the level of service offered to women” Dr Manu Vatish, Senior Clinical Fellow in Obstetrics Oxford University Hospitals 9
  • 12. What can you do now to facilitate adoption? Manufacturer, clinical, lab… 12 Drivers •Clinical? Financial? •Audit / Quality •Guidelines Obstacles and Risks •Cost •Resource / priority •Resistance to change Information required •Real-world performance vs. clinical evidence •Baseline metrics •Other? Actions •Real-world evaluation •Stakeholder engagement •Project management •Budget impact Feedback: One sentence on a key thought from your discussion