Transcript The Challenge of Long-term Progressive Conditions to
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 12 th October, 2011
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
Aims of IP recommendations
Safety 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
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?
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
Evidence
used by the Interventional Procedures Advisory Committee (IPAC)
• Published studies • Specialist Medical Advisers (questionnaires) • Patient Commentators (questionnaires) • Committee Members’ knowledge •
Public consultation
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
S
pecialist 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
Study of advice from Specialists
182 procedures: 598 specialist views
Established? Efficacious? Safe?
• •
Influenced by:
• Being an operator (doing the procedure)
Not Not
by being a researcher by having a conflict of interest Campbell Int J Tech Assess Health Care 2008; 24: 1-4.
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?
Examples of findings
Campbell Quality and Safety in Healthcare 2010;19:1-6 • •
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”
What to recommend when evidence for a procedure is inadequate?
Possible recommendations:
•
Do not use
- very rare •
Only in research
- many problems
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 >>>
“normal arrangements”
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
Other recommendations
• Patient selection - specialist teams • Facilities required • Training and expertise.....
• Outcomes from further research.....
• Submission to registers.......
Training: Some complicating and confounding factors
• Differing innate technical skill • Differing levels of experience • Differing “learning curves” • Differing ways of doing same procedure
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
Future review of guidance:
reducing 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
Coding
Many 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
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) NPWT for the open abdomen TAVI (aortic valve)
2009 – part of CCAD
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
NICE Medical Technologies Evaluation Programme Aim: identify >>> evaluation >>> 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
We are looking for technologies which offer a “step change”
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)
MTAC Guidance
long 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 > observational data
Impact of MTAC guidance
.... second item on BBC national news (after Libya) on 29 March 2011
No surgical innovation without evalution: the IDEAL recommendations
McCulloch, 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; modification
s 5. LONG TERM STUDY:
register, rare case reports
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)