The Challenge of Long-term Progressive Conditions to

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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)