International registers – how an HTAorganisation can contributeHannah PatrickConsultant clinical advisor to the Interventi...
The purpose of NICE Interventional        Procedure Guidance• inform patients and clinicians of  uncertainties in Safety a...
“Special arrangements”• Inform the clinical governance leads in  their hospitals• Audit outcomes• Ensure that patients und...
Arterio–venous extracorporealmembrane carbon dioxide removal• Key efficacy outcomes:  – survival without disability  – red...
First assessment (2008)                     Special arrangements                                                   Data c...
Second assessment (2011)                     Special arrangements                                                    Ente...
Issues to address in establishing a               register• 3 professional societies; Clinical  Perfusionists, Cardiothora...
Extracorporeal life support organisation   Acknowledgment: http://www.elso.med.umich.edu/
More issues and the way forwardSome hospitals provide ECC02R but not ECMO Who should pay and how?Role of the HTA organisat...
Endoscopic balloon dilatation for     subglottic or tracheal stenosis• Key efficacy outcomes: avoidance of  tracheostomy, ...
First assessment (2012)                        Special arrangements                                                      ...
Radiofrequency cold ablation for      respiratory papillomatosis• Key efficacy outcomes: reduce frequency of  microlaryngo...
First assessment (2012)                       Special arrangements                                                       ...
International Registry for Airway                StenosisIssues- Rare condition affecting children and adults- Funding of ...
International collaboration – lessons                  learnt• Especially important for uncommon procedures• Work through ...
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International registers – how an HTA organisation can contribute.

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  • 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 We produce guidance early in the development of new procedures and therefore consider unpublished as well as published information;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
  • International registers – how an HTA organisation can contribute.

    1. 1. International registers – how an HTAorganisation can contributeHannah PatrickConsultant clinical advisor to the Interventional Procedures Programme,National Institute for Health and Clinical ExcellenceHTAi conference, BilbaoJune 2012
    2. 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. 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. 4. Arterio–venous extracorporealmembrane 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. 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. 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. 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. 8. Extracorporeal life support organisation Acknowledgment: http://www.elso.med.umich.edu/
    9. 9. More issues and the way forwardSome hospitals provide ECC02R but not ECMO Who should pay and how?Role of the HTA organisation: Project management Recommend data submission
    10. 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. 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. 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. 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. 14. International Registry for Airway StenosisIssues- Rare condition affecting children and adults- Funding of dataset development?Role of the HTA organisation:- Recommend data submission- Project management
    15. 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

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