The document discusses international registers for novel medical procedures and how health technology assessment (HTA) organizations can contribute. It provides examples of NICE providing guidance on procedures with uncertainties about safety and efficacy, requiring "special arrangements" like data collection through clinical registries. International collaboration is important for uncommon procedures. HTA organizations can recommend submitting data to existing registers, manage registry projects, and help ensure active surveillance to develop the evidence.

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)

8. Extracorporeal life support organisation
Acknowledgment: http://www.elso.med.umich.edu/

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