International registers – how an HTA organisation can contribute.
1. International registers – how an HTA
organisation can contribute
Hannah Patrick
Consultant clinical advisor to the Interventional Procedures Programme,
National Institute for Health and Clinical Excellence
HTAi conference, Bilbao
June 2012
2. The purpose of NICE Interventional
Procedure Guidance
• inform patients and clinicians of
uncertainties in Safety and Efficacy of
novel procedures
• give conditions for safe use eg surgeon
training, specialist centres etc
3. “Special arrangements”
• Inform the clinical governance leads in
their hospitals
• Audit outcomes
• Ensure that patients understand the
uncertainty about the safety and efficacy
4. Arterio–venous extracorporeal
membrane carbon dioxide removal
• Key efficacy outcomes:
– survival without disability
– reduction in mechanical ventilation
– improvement in arterial blood gases
• Key safety issues:
– Bleeding, vascular injury, limb amputation
– Gas/ clot embolism, clotting within the device
5. First assessment (2008)
Special arrangements
Data collection/ research
to provide evidence on
thresholds for
intervention and criteria
for patient selection.
Essentially…use / coverage with
evidence development
6. Second assessment (2011)
Special arrangements
Enter patients into trials,
data collection.
Document patient
selection criteria,
thresholds for
intervention, and clinical
benefits.
Essentially…use / coverage with
evidence development
7. Issues to address in establishing a
register
• 3 professional societies; Clinical
Perfusionists, Cardiothoracic Surgeons,
Intensivists
• Other registers; Novalung, European
register, Extracorporeal Life Support
Organisation (ECMO database)
9. More issues and the way forward
Some hospitals provide ECC02R but not
ECMO
Who should pay and how?
Role of the HTA organisation:
Project management
Recommend data submission
10. Endoscopic balloon dilatation for
subglottic or tracheal stenosis
• Key efficacy outcomes: avoidance of
tracheostomy, improve lung function and
exercise tolerance, reduce stridor
• Key safety issues: laryngeal or airway
scarring, bleeding and inadequate reduction of
papillomas
11. First assessment (2012)
Special arrangements
Data submission to the
International Register for Airway
Stenosis (
www.airwaystenosis.net).
Essentially…use / coverage with
evidence development
12. Radiofrequency cold ablation for
respiratory papillomatosis
• Key efficacy outcomes: reduce frequency of
microlaryngoscopy procedures
• Key safety issues: laryngeal or airway scarring
and bleeding
13. First assessment (2012)
Special arrangements
Data submission to the
International Register for Airway
Stenosis (
www.airwaystenosis.net).
Essentially…use / coverage with
evidence development
14. International Registry for Airway
Stenosis
Issues
- Rare condition affecting children and adults
- Funding of dataset development?
Role of the HTA organisation:
- Recommend data submission
- Project management
15. International collaboration – lessons
learnt
• Especially important for uncommon procedures
• Work through professional societies
• Develop existing databases wherever possible
• Active surveillance essential
• Learn from collaborative initiatives
Notas del editor
The IP programme produces four piece of guidance per month, based on a rapid appraisal of evidence. It is part of the Technology Appraisal programme of NICE but is very different from the part that hits the news in its drug recommendations because we do not assess cost-effectiveness and our guidance is not mandatory. We produce guidance early in the development of new procedures and therefore consider unpublished as well as published information;
Extracorporeal membrane systems mimic gas exchange in the lungs, by eliminating some carbon dioxide from the blood and adding oxygen. The primary aim of AV-ECCO 2 R is to remove excess carbon dioxide: the system does oxygenate blood but to a limited extent only because of the low rate of extracorporeal blood flow.
NICE first assessed this procedure in 2003 The committee reviewed 7 case series (n=215) and a few case reports There was limited evidence of efficacy NICE was concerned about safety NICE decided there was not enough evidence for routine use of the procedure. It stipulated that it should only be used if clinicians informed their hospitals and if patients were told about the uncertainty of the procedure. The guidance also stated that cases should be submitted to a register for subsequent assessment of the procedure when more evidence was available
RCT stopped early as control group did much better than expected and there was therefore insufficient difference between the groups for the target sample size to show a difference in outcomes.
NICE first assessed this procedure in 2003 The committee reviewed 7 case series (n=215) and a few case reports There was limited evidence of efficacy NICE was concerned about safety NICE decided there was not enough evidence for routine use of the procedure. It stipulated that it should only be used if clinicians informed their hospitals and if patients were told about the uncertainty of the procedure. The guidance also stated that cases should be submitted to a register for subsequent assessment of the procedure when more evidence was available
NICE first assessed this procedure in 2003 The committee reviewed 7 case series (n=215) and a few case reports There was limited evidence of efficacy NICE was concerned about safety NICE decided there was not enough evidence for routine use of the procedure. It stipulated that it should only be used if clinicians informed their hospitals and if patients were told about the uncertainty of the procedure. The guidance also stated that cases should be submitted to a register for subsequent assessment of the procedure when more evidence was available