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Introducing new medical technologies and techniques into patient care

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.

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Introducing new medical technologies and techniques into patient care

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  1. 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

  2. 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

  3. 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

  4. 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?

  5. Interventional Procedures Advisory Committee (IPAC)Orthopaedics - Roger Atkins • 25Members - 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

  6. Evidenceused by the Interventional Procedures Advisory Committee (IPAC) • Published studies • Specialist Medical Advisers (questionnaires) • Patient Commentators (questionnaires) • Committee Members’ knowledge • Public consultation

  7. 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

  8. 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

  9. 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.

  10. 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?

  11. 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”

  12. What to recommend when evidence for a procedure is inadequate? Possible recommendations: • Do not use - very rare • Only in research - many problems

  13. 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”

  14. 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

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

  16. Training: Some complicating and confounding factors • Differing innate technical skill • Differing levels of experience • Differing “learning curves” • Differing ways of doing same procedure

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. NICE Medical Technologies Evaluation ProgrammeAim: identify >>> evaluation >>> adoption Devices & diagnosticsnotified by manufacturers Selection by MTAC - advantages compared with “current management”: measurable improvements • patient outcome or experience • use of resources – facilities, staff, tests • cost • sustainability

  23. We are looking for technologies which offer a “step change”

  24. 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)

  25. 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

  26. Impact of MTAC guidance .... second item on BBC national news (after Libya) on 29 March 2011

  27. No surgical innovation without evalution: the IDEAL recommendationsMcCulloch, Altman, Campbell, et al Lancet 2009; 274: 1005-12 • IDEA: case reports • DEVELOPMENT: prospective development studies • EXPLORATION: research database; feasibility RCT • ASSESSMENT: comparative RCT; modifications • LONG TERM STUDY: register, rare case reports

  28. 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)

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