international registers – how an hta organisation can contribute
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International registers – how an HTA organisation can contribute.TRANSCRIPT
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
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
“Special arrangements”
• Inform the clinical governance leads in their hospitals
• Audit outcomes
• Ensure that patients understand the uncertainty about the safety and efficacy
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
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
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
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)
Extracorporeal life support organisationAcknowledgment: http://www.elso.med.umich.edu/
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
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
First assessment (2012)
Special arrangements
Data submission to the International Register for Airway
Stenosis (www.airwaystenosis.net).
Essentially…use / coverage with evidence development
Radiofrequency cold ablation for respiratory papillomatosis
• Key efficacy outcomes: reduce frequency of microlaryngoscopy procedures
• Key safety issues: laryngeal or airway scarring and bleeding
First assessment (2012)
Special arrangements
Data submission to the International Register for Airway
Stenosis (www.airwaystenosis.net).
Essentially…use / coverage with evidence development
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
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