NICE and Orthopaedics Bruce Campbell Chair, NICE Interventional Procedures and Medical Technologies Advisory Committees British Orthopaedic Association Dublin 16 th September 2011
The Plan. . . • Origins of NICE and types of guidance • Quality Standards and Pathways • Interventional Procedures (and registers) • Medical Technologies • NHS Evidence • NICE and the Health Bill
Origins of NICE (1999 - 2002) TAs and Clinical Guidelines • “Postcode prescribing” • Variations in practice contrary to evidence • NHS – equal access, good standards, value Interventional Procedures • Bristol cardiac + other high profile affairs • No scrutiny or governance for procedures • Shortcomings of SERNIP
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
Technology Appraisals • Clinical and cost effectiveness – NHS must fund when recommended • Topic selection, scoping • Topics referred to NICE by Ministers – Expensive new drugs – Other potentially high impact treatments • 235 TA guidances to date (August 2011) • 12 in development
Technology Appraisals relating to Orthopaedics • Metal on metal hip resurfacing • Prostheses for THR • Autologous chondrocyte implantation • Drugs for rheumatoid, psoriatic arthritis, ankylosing spondylitis, osteoporosis
Clinical Guidelines • Specific Guideline Development Groups • 127 Clinical Guidelines to date (August 2011) • 52 in development • • Core management of diseases/conditions Describe care pathway Recommendations are advisory Link with Quality Standards. . .
NICE Quality Standards for treatment and prevention of specific conditions • Set of concise statements about care • Relationship to NICE Clinical Guidelines • Aspirational but achievable • Describe good service • Should be measurable to enable audit • Will inform Commissioning (QOF, CQUIN) Topic list and development during 2011 -2 #NOF. . +NQB engagement exercise
NICE Quality Standards Examples VTE Prevention – 7 statements, eg: • All patients risk-assessed using tool on admission • Verbal + written advice offered on discharge Stroke – 11 statements, eg: • Brain imaging within 1 hour of arrival if indicated • Screen for swallowing within 4 hours + plan • Urinary incontinence after 2 weeks > reassessed
NICE Pathways • The new online way to access NICE guidance, linking: Ø All kinds of guidance Ø Quality Standards Ø Audit and other tools • Easy and quick • No more hard copies
Interventional Procedures Guidance on safety and efficacy Procedures notified by anyone • First use in the NHS (or private sector) • New concerns about efficacy or safety • Procedures for treatment or diagnosis: – incision, puncture or entry into body cavity – ionising, electromagnetic, acoustic energy Procedures not specific devices
Interventional Procedures Guidance • 406 guidances since 2002 (55 reviews) • 100 th Committee meeting last week • . . and for orthopaedics. . . .
Lower limb • • • Minimally invasive two-incision THR 112 Minimally invasive total hip replacement 152 Mini-incision knee replacement 117 + 345 Open and arthroscopic femoroacetabular surgery for hip impingement syndrome 203 + 213 Reconstruction for prox femoral deficiency 297 MR unicompartment knee implants knee 317 Intramedullary distraction for leg lengthening 197 Arthroscopic knee washout for OA 230 Distal iliotibial band lengthening for GT pain 375
Upper limb + Foot + etc • • • Artificial MCP and IP joint replacement 110 Artificial trapeziometacarpal joint replacement Total wrist replacement 271 Shoulder resurfacing arthroplasty 354 Radiation therapy for Dupuytren’s 368 • • MTP joint replacement of the hallux 140 Sinus tarsi implant for mobile flatfoot 305 Minimal access surgery for hallux valgus 332 Direct skeletal fixation of limb/digit prostheses using intraosseous transcutaneous implants 270 111
Spinal procedures – open surgery • • • Prosthetic lumbar disc replacement 100 + 306 Prosthetic cervical disc replacement 143 + 341 Direct C 1 lat mass screw cervical stabilisation 146 Interspinous distraction for spinal stenosis 165 + 365 Non-rigid stabilisation for low back pain 183 + 366 Lateral interbody fusion - lumbar spine 321
• • • Percutaneous vertebroplasty 12 Balloon kyphoplasty for compression fractures 20 Endoscopic laser foraminoplasty 31 Percut endoscopic laser thoracic discectomy 61 Percut intradiscal electrothermal therapy 81 + 319 Percut intradiscal RF thermocoagulation 83 Endoscopic division of epidural adhesions 88 + 333 Laser lumbar discectomy 27 + 357 Automated percut mechanical lumbar discectomy 141 Percut disc decompression using coblation 173 Percut endoscopic laser lumbar discectomy 300 Percut endoscopic laser cervical discectomy 303
Miscellaneous “non-operative” • • CT guided thermocoagulation osteoid osteoma 53 Autologous blood injection for tendinopathy 279 ESWT for refractory plantar fasciitis 311 ESWT for refractory Achilles tendinopathy 312 ESWT for refractory tennis elbow 313 ESWT for refractory Greater trochanteric pain 313 Low intensity ultrasound for fracture healing 374
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 specialists Established? Efficacious? Safe? Influenced by: • Being an operator (doing the procedure) • Not by being a researcher • Not by having a conflict of interest 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 Quality and Safety in Healthcare 2010; 19: 1 -6 Campbell B • 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. . . .
Why NICE needs registers when the evidence is inadequate “Special Arrangements” for: • Governance • Consent • Audit/research – review your outcomes. . BUT no predictable increase in evidence base Collect data on each procedure >>> evidence for NICE review
Registers for new procedures our aspiration…… • • • Procedures with inadequate evidence Small relevant dataset To address explicit uncertainties Time-limited to answer questions (exceptions) Data on all patients treated (link to funding) Timely analysis and review of data Common template > decreasing difficulty and cost
Why pursue the agenda for registers? • Routinely collected NHS data inadequate – No codes for many new procedures/technologies – Safety and efficacy data negligible • Controlled research trials problematic – Need for data may not be adequate question – Obstacles and delay in arranging – “Only in research” may stop use
How helpful are data from registers? Would we not be better doing RCTs? Not a substitute for good research……… • Provide in “in use”/“real world” information • Data need to be relevant and complete Can support or challenge published data • Safety data > uncommon adverse events • Valuable pilot data for planning research BUT • Problems with funding, design, submission
Registers for new procedures We continue to: • Recommend existing registers when suitable • Liaise with national registers and specialist groups to adapt registers • Seek ways of creating simple new registers • Improve coding of new procedures • Press the agenda for national data collection • Pursue international agenda
Orthopaedics and data collection The NJR. . . and more
IP evaluation of minimally invasive THR (2010) – NJR data 19, 041 minimally invasive (from 344, 953) Safety Outcomes (minimally invasive vs others) • Calcar crack 0. 5% vs 0. 4% • Pelvic penetration <0. 1% vs 0. 2% • Shaft fracture <0. 1% vs <0. 1% • Shaft penetration <0. 1% vs <0. 1% • Trochanteric fracture 0. 2% vs 0. 2% • Other 0. 2% vs 0. 2%
Non Arthroplasty Hip Surgery Register (NAHSR) Recommended in NICE IP guidance on Open (203, 403) and Arthroscopic (213, and in press) femoroacetabular surgery for hip impingement syndrome • Enter all patients when register available • Long term outcomes an important purpose • Details of patient selection (for this + any research)
Reviewing guidance System developed in 2008: • “Special arrangements” guidance at ~3 yrs • 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
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
Orthopaedics and novel Med Tech products • None notified yet • There must be lots in development • Scope very broad • Please consider with manufacturers
NHS Evidence www. evidence. nhs. uk • Latest evidence in health and social care • Breadth of information • Adjust to your needs • Sources accredited
Health and Social Care Bill: impact on NICE Range and status of NICE guidance unaffected • NHS still to take account of NICE recommendations Key partnership with NHS Commissioning Board • NICE Quality Standards for commissioning guidance New role in social care • Quality Standards for social care on topics at the health and social care interface (eg dementia, medicines management) Move from SHA to Non-departmental Public Body • Enables move into social care • Underlines political independence
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