Patient, carer and public involvement at NICE

1. NICElydoes it? Patient, carer and public involvement at NICE Lizzie Amis Patient and Public Involvement Programme (PPIP) National Institute for Health and Clinical Excellence (NICE)

2. What is NICE? • The independent UK organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. • 1999: Set up as a Special Health Authority (part of NHS) – National Institute for Clinical Excellence • 2005: Move from clinical focus to wide public health remit when merged with the Health Development Agency – National Institute for Health and Clinical Excellence • 2009: Launch of NHS Evidence and Quality Standards programmes • 2010: White Paper – Quality Standards in social care

3. Core principles of all NICE guidance • Comprehensive evidence base • Expert input • Patient and carer involvement • Independent advisory committees • Genuine consultation • Open and transparent process • Equalities considerations • Regular review

4. NICE patient and public involvement policy The views of patients and the public matter to NICE. We want to involve them, as well as doctors, nurses, other healthcare professionals and managers in our work. By working with patients, patient organisations and the public, NICE aims to produce guidance that addresses patient/ public issues, reflects their views and meets their healthcare needs.

5. Patient and public involvement: in what? Opportunities for involvement exits for all types of NICE guidance

6. “Levels” of patient/ public involvement at NICE • Direct input: membership of NICE advisory bodies (minimum 2, often 3, sometimes 5) • Consultation with patient and voluntary organisations • Patient/carer experts (personal testimony) • Citizens Council (societal values) • Patient/public versions of NICE guidance

7. Understand the needs and experiences of patients and carers Able to provide a balanced view on patient issues Confidence to work with technical data Able to assess and make decisions relating to clinical and cost effectiveness Confidence to work on a large committee  Willingness to work within NICE processes Time to prepare for/attend meetings Ability to communicate via email Lay members of NICE advisory bodies: experience and skills

8. Stages for patient/public involvement in guidance development Patient/ public participation throughout development and implementation Topic suggestion Referral Scoping Development Consultation Publication Implementation support

9. What information do patients and carers provide to NICE? • The personal impact of their condition • Outcomes patients want the technology to help with • The impact of a technology on outcome, symptoms, physical & social functioning, quality of life • Impact on family, friends and employers • Ease of use, side effects and costs of the technology • Patient preferences • Subgroups who might benefit more/less from the technology • Challenges to professional or researcher views • Areas needing further research Patient evidence is most useful when presented as a summary that balances positive and negative views

10. Testimony from patient experts 1:patient preferences Case study – Targeted biological therapies Some patients prefer self-injecting at home: greater flexibility, fewer costs incurred Some patients however prefer intravenous infusions: fixed regular appointments, problems with ‘sharps’ collections However most people prefer oral administration over both.

11. Testimony from patient experts:adding to the evidence base Case study – Psoriasis Clinical research told us the amount of psoriasis was what most affected the quality of life. Patients told us that the location of the flare-up (e.g. face or joints) was more significant.

12. Consultation with patients groups:adding to the evidence base Case study – Kidney dialysis Committee assumed patients would prefer dialysis at home. Some patients told us they disliked home machines as it meant their illness dominated their lives.

13. Patient feedback on draft guidance: challenging the evidence Case study – Age-related Macular Degeneration (AMD) Vision in one or two eyes: Evidence suggested that loss of sight in one eye impacts little on quality of life. Patient organisations, patients and carers clearly indicated that there were significant negative effects of loss of binocular vision on daily activities and quality of life.

14. 30 members of the public Use deliberative methods to consider societal and ethical issues for all NICE guidance. For example: Should NICE take age into account? Should the NHS pay a premium for treatments for people with rare conditions? Should NICE take severity into account in the QALY calculation? Council’s views underpin social value judgements used by NICE advisory bodies The Citizens Council:Advising on Social Value judgements

15. Social Value judgment principles developed from Citizen Council reports • Age: patients should not be denied, or have restricted access to, NHS treatment simply because of their age • Self inflicted illness: NICE … should avoid denying care to patients with conditions that are, or may be, self-inflicted (in part or in whole). [Unless] self-inflicted cause(s) of the condition influence the clinical or cost effectiveness of the use of an intervention • Rare conditions: NICE considers that it should evaluate drugs to treat rare conditions, known as ‘orphan drugs’, in the same way as any other treatment

16. All clinical guidance produced in versions for patients and the public, known as “Understanding NICE Guidance” Plain English translation of guidance, not detailed patient information Includes key patient support organisations for further information Outputs for patients and the public Patient/ carer organisations

17. Patient/carer/public concerns with NICE’s processes • Lack of research evidence on patient/carer views, experiences and preferences • Quality of life measures often determined by professionals and don’t reflect issues of most importance to patients • The weighting NICE places on evidence from patient submissions and patient experts • Process doesn’t take account of wider societal costs • Technical language and modelling are difficult to engage/challenge • NICE ‘blight’/ variability in access to NICE recommended technologies/ Political priorities dominate

18. What do patient organisations say? (1) • “NICE plays a critical role in ensuring that NHS treatment is equitable, cost effective and of a uniformly high standard.”  • “NICE listened carefully to patient representations […] and changed their technology appraisals as a consequence”  • “NICE has provided a valuable conduit to address issues surrounding South Asian health, a conduit that before the inception of NICE never existed.”  Source: patient group submissions to the cross party parliamentary Health Select Committee

19. What do patient organisations say? (2) • “The views of patients and the public may not always be given as much weighting as the more traditional sources of evidence.”  • “Evidence from people with experience of the drugs is used as pointers to consider further published research rather than as evidence in its own right” • “Committee meetings can be intimidating for patient experts […] dominated by technical discussion of health economics.”  • “Clinical trial design should be re-evaluated to ensure that appropriate evidence is presented to NICE.”  Source: patient group submissions to the cross party parliamentary Health Select Committee

20. But what do individual patients and carers think? • Varied patient organisation feedback about the patient expert process • Unknown what individuals think: Patient Experts (TAs) and Guideline Development Group (GDG) lay members… …so PPIP conducted two evaluations of their experiences

21. What do individual patient experts say about NICE’s Technology Appraisals? Positive  • “Felt my presence worthwhile not just tolerated. My contribution listened to with interest. Treated with consideration.” • “I thought it was a very well-thought out process, and feel honoured to have been a part of it.” Concerns  • “I felt totally out of my depth and excluded when the technical/statistical information was shared.” • “Patient organisations by and large know how NICE works […] The question is whether NICE […] has developed a similar understanding of patients and patient organisations.”

22. What do individual GDG lay members say about NICE’s clinical guidelines? Positive  • “Those of us with the condition are the REAL experts – nobody other than us can say just how it feels to have the condition. Others, no matter how brilliant, cannot have that insight” • “We were the group’s conscience!” Concerns  • “Whilst the gathering and analysis of research based on quantitative data might be described as ‘good’, insufficient worth was afforded to published qualitative studies – in fact they were ignored”

23. In the spotlight…

24. Develop and support processes for patient involvement Identify topic-relevant patient groups Oversee recruitment/ support lay members of advisory bodies Advise patient groups and individual patients on how to engage in NICE processes Survey patient views Evaluate involvement opportunities Support materials: Recruitment packs Guide for patient groups Fact-sheets and consent forms for patient experts PPIP support for patient input to NICE guidance

25. PPIP resources • Ten staff members (one part-time, one on maternity leave) • Strategic input from PPIP lead • 1-2 project managers link to each section of NICE • 2 admin (PPIP Coordinators)

26. More information Patient and Public Involvement at NICE: www.nice.org.uk/getinvolved/patientandpublicinvolvement Patient guidance collection: www.nice.org.uk/patientsandpublic/index.jsp

27. Contact details Lizzie Amis Patient & Public Involvement Programme National Institute for Health and Clinical Excellence (NICE) Tel: 020 7045 2056 Email: lizzie.amis@nice.org.uk Website: www.nice.org.uk