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

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 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

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

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

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.

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

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

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

RegistersAspiration:

• 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 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 > 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; modifications

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 RCTsInt J Tech Assess Health Care 2011 (in press)