Introducing new medical technologies and techniques into patient care

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Introducing new medical technologies and
techniques into patient care

• Bruce Campbell
• Chair, NICE Interventional Procedures and Medical
  Technologies Advisory Committees
• Royal College of Surgeons of England
• 12th October, 2011

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NICE Guidance

• Technology Appraisals - Clinical and cost
  effectiveness
• Clinical Guidelines - Managing specific
  conditions
• 
  - Link to Quality Standards
• Interventional Procedures - Safety and efficacy
  Not cost
• Public Health
• Medical Technologies device/diagnostic adoption
• Diagnostics

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Aims of IP recommendationsSafety and efficacy of
procedures

• Patients
• Protect patients from harm
• Access to potentially beneficial treatments
• Clinicians
• Training, expertise, teams, facilities
• When uncertain
• More evidence through research/registers

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Interventional Procedures Guidance on safety and
efficacy

• Procedures for treatment or diagnosis
• incision, puncture or entry into body cavity
• ionising, electromagnetic, acoustic energy
• Procedures not specific devices
• Notified by clinicians, manufacturers, others
• First use in the NHS (or private sector)
• New concerns about efficacy or safety
• Is safety or efficacy likely to differ?

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Interventional Procedures Advisory Committee
(IPAC)Orthopaedics - Roger Atkins

• 25 Members - Specialists GP Nurse Lay
  statistician ABHI MHRA patient safety
• Monthly meetings 4 scopes check details
• 4 new
  procedures
• 4 post-consultation
• Public may attend (max 20)
• 406 guidances since 2002 (55 reviews)
• Continual learning and evolution

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Evidence used by the Interventional Procedures
Advisory Committee (IPAC)

• Published studies
• Specialist Medical Advisers (questionnaires)
• Patient Commentators (questionnaires)
• Committee Members knowledge
• Public consultation

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Published evidence

• Peer reviewed articles
• Abstracts only for unique safety data
• Main detailed table (usually 6 - 8 papers)
• RCTs, SRs, largest and most useful studies
• Appendix All other studies

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Specialist Advisers (clinicians)

• Nominated by professional organisations
• Usually three or more
• May have done/not done procedure
• Established / Variation / Novel
• Safety/Efficacy Views / Concerns
• Training and other issues
• Controversies ..... Case selection

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Study of advice from Specialists

• 182 procedures 598 specialist views
• Established? Efficacious? Safe?
• Influenced by
• Being an operator (doing the procedure)
• Not by being a researcher
• Not by having a conflict of interest
• Campbell Int J Tech Assess Health Care 2008 24
  1-4.

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Patient Commentators (since 2006)

• Questions include
• How well procedure worked
• Effect on different specified areas of life
• Pain before/during/after procedure
• Side effects
• Concerns about safety (before and after)
• Would you have again if in same situation?
• Would you recommend to a friend?

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Examples of findings Campbell Quality and
Safety in Healthcare 2010191-6

• Most useful How well it worked Effects on
  different areas of life Would have again?
• Least useful About pain About information and
  consent (these questions now abandoned)
• Most frequent category Supports other evidence
  but no new insights
• Only 0-3 (7)New and original evidence

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What to recommend when evidence for a procedure
is inadequate?

• Possible recommendations
• Do not use - very rare
• Only in research - many problems

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What to recommend when evidence for IP is
inadequate?

• Special Arrangements for
• Governance tell your hospital
• Consent - tell your patients
• Audit/research review your outcomes
• ......if evidence is judged adequate gtgtgt
• normal arrangements

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Interpreting IP recommendations

• Special arrangements
• Open to misinterpretation
• Applied to wide range of procedures
• More text in Other comments
• e.g. The Committee recognised the distress and
  disability caused by ..... If further evidence
  supports efficacy then potential to improve
  quality of life for many patients

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Other recommendations

• Patient selection - specialist teams
• Facilities required
• Training and expertise.....
• Outcomes from further research.....
• Submission to registers.......

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Training Some complicating and confounding
factors

• Differing innate technical skill
• Differing levels of experience
• Differing learning curves
• Differing ways of doing same procedure

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Training workshop consensus Nov 2008

• Specialist organisations define standards,
  skills, strategy, regulation of courses
• NICE recommends adherence to standards
• Supporting framework necessary
• Audit and outcome data important for review,
  dissemination, benchmarking, competency,
  revalidation
• Manufacturers make valuable contributions

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Future review of guidancereducing uncertainty

• Now specify the research outcomes we need (e.g.
  indications, complications, specific benefits,
  QOL, long term)
• Recommendations for data collection as an adjunct
  to other published evidence

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CodingMany new procedures have no code

• Work with the coding centre
• Agreeing codes for new procedures
• Including these on website with guidance
• Pressing for single, specific codes
• Flagging special arrangements procedures

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Examples of registers providing evidence for NICE
IP guidance

• Established registers
• Minimally invasive THR 2010
• Off pump CABG 2011
• Carotid artery stenting 2011
• Developed specifically
• Pectus bar (Nuss procedure) 2009
• NPWT for the open abdomen
• TAVI (aortic valve) part of CCAD

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Registers

• Aspiration
• data on all special arrangements procedures
• ideally an adaptable template and system
• Activity
• Liaising with and developing existing registers
• Continuing strategies for new ones
• Meetings with manufacturers re-PMS data
• Publications and international agenda

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NICE Medical Technologies Evaluation
ProgrammeAim identify gtgtgt evaluation gtgtgt
adoption

• Devices diagnostics notified by manufacturers
• Selection by MTAC - advantages compared with
• current management measurable improvements
• patient outcome or experience
• use of resources facilities, staff, tests
• cost
• sustainability

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We are looking for technologies which offer a
step change
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Medical Technologies Advisory Committee
(MTAC) Routing of selected products

• To other NICE Programmes
• Technology Appraisals, Interventional Procedures,
  Diagnostics
• MTAC Med Tech Guidance
• Advice on adoption ( clinical and cost data)
• and/or Research ( fostering research
  collaborations use with data collection)

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MTAC Guidancelong term aims

• Boost to novel and useful technologies
• Improve research into devices and diagnostics
• Demand for decent evidence in selection and for
  supportive guidance
• Advise when evidence is inadequate
• Foster research on promising products
• Selected products gt observational data

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Impact of MTAC guidance
.... second item on BBC national news (after
Libya) on 29 March 2011
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No surgical innovation without evalution the
IDEAL recommendationsMcCulloch, Altman,
Campbell, et al Lancet 2009 274 1005-12

1. IDEA case reports
2. DEVELOPMENT prospective development studies
3. EXPLORATION research database feasibility RCT
4. ASSESSMENT comparative RCT modifications
5. LONG TERM STUDY register, rare case reports

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Reviewing guidance

• System developed in 2008
• Special arrangements guidance at 3yrs
• Clinical experts asked
• New literature search
• Recent study Median publication interval 5 years
• Changed to normal arrangements 6 of 11
• More patients Longer mean follow-up
• No greater number of RCTs
• Int J Tech Assess Health Care 2011 (in press)