The usefulness of NICE guidance in practice Different perspectives of managers, clinicians and patients Amanda Owen-Smith 1, Joanna Coast 2, Jenny Donovan 1 1 Department of Social Medicine, University of Bristol, UK 2 Health Economics Unit, University of Birmingham, UK

The NHS and NICE Monolithic, taxation-funded service Delivery organised through a number of regional funding bodies (Primary Care Trusts) – Expert guidelines on treating particular conditions – Recommendations on using of selected clinical and public health interventions – Technology appraisal guidance (TAGs)- effectiveness and cost-effectiveness of new and existing technologies Central, autonomous body

The NHS and NICE Monolithic, taxation-funded service Delivery organised through a number of regional funding bodies (Primary Care Trusts) – Expert guidelines on treating particular conditions – Recommendations on using of selected clinical and public health interventions – Technology appraisal guidance (TAGs)- effectiveness and cost-effectiveness of new and existing technologies Central, autonomous body

A NICE process? Systematic and accountable Explicit consideration of effectiveness and cost-effectiveness Guidance produced by expert teams Central Healthcare professionals involved at all levels Lay values explicitly integrated

A NICE process? Systematic and accountable Explicit consideration of effectiveness and cost-effectiveness Guidance produced by expert teams Central Healthcare professionals involved at all levels Lay values explicitly integrated An international beacon?

Translating NICE guidance into practice

What’s the evidence? Implementation audits –3 large scale studies - Richards M. Department of Health, 2004; 2006; Sheldon TA et al. BMJ, 2004 –Individual guidelines – e.g. Hitchen BMJ, 2008 (MS); Kmietowicz BMJ, 2009 (Diabetes) Interview studies –HTA implementation often based on cost and availability of funding (Sheldon et al., 2004 – UK; Gallego et al., 2009 – Australia; Gagnon et al., 2006 – Catalonia) –Using guidance is problematic for doctors where it conflicts with individual patient advocacy (Chantler, UK) –Little information on how patients use guidance

A qualitative study Study focussed on experiences of decision-making Study at the community level of provision and two case studies in secondary care (morbid obesity and breast cancer) Sampling purposeful and theoretical In-depth interviewing Analysis using the constant comparative method

Some background information… NICE guidance on MO (2001, 2002, 2006) – Two drugs then surgery for those with BMI =/>40 – Widespread area variation NICE guidance on BC (2002) – Service guideline – Number of TAGs – Herceptin campaign

Contributors Community level study Case study 1 (MO) Case study 2 (BC) Totals Managers9009 Clinical professionals Service users

Views of managers 1 The top priority for funding If it’s a NICE drug … we’ll always have the money – we just have to take it from somewhere else. (manager) Generally well-regarded In the past the NHS would have made rationing decisions based on arbitrary criteria, whereas now it’s actually saying, “we’ve looked at the evidence and the cost per QALY”. (manager)

Views of managers 2 BUT – Lack of consideration of affordability – Non-neutral decision-making? What the health service has to do is make resource allocation decisions, which means choosing between do we do A or do we do B? NICE doesn't do that – NICE says, “with all these drug companies breathing down our necks … manipulating the public and threatening to sue us, should we say yes or no to this drug for this indication?” And they almost always say yes. (Public health consultant)

Managers – experiences in practice Relieves the burden of decision-making Helps to control clinician behaviour? The NICE guidelines make it good because its something written in stone … you’ve got a piece of paper that says … “we pay for this and we don’t pay for that”. (manager)

Views of clinical professionals Not such a prominent issue Few critical of the idea in theory I think it’s [guidance] healthy.(GP) Suspicions around quality / independence of recommendations Where we [GPs] perceive that NICE guidance has come up with politically correct statements, I think we are pretty sceptical and probably ignore it. (GP)

Clinical professionals – practical experience More useful in primary care? Research is moving much faster than our ability to subsequently have bureaucratic organisations like NICE then collate and oversee all the data. (consultant) I’ve got somebody who it [NICE criteria] fits perfectly … no funding … they just haven’t got the money. (nurse) Effect on autonomy? At least if things get NICE approval then we know we don’t have to fight to use the treatment. (consultant)

Views of service users Widespread ignorance / misunderstanding I: Have you ever heard on the media anything about NICE, the National Institute of Clinical Excellence? SU: Who?

Views of service users Widespread ignorance / misunderstanding I: Have you ever heard on the media anything about NICE, the National Institute of Clinical Excellence? SU: Who? NICE … isn't it they test the drug and that's when people go on trials? (service user)

Views of service users 2 Conflicted opinions… I feel in a bit of a state of conflict about NICE … somebody needs to take responsibility … but … it almost pulls into question the value of individuals’ lives, and who has a right to place a value on that? (service user) I don't know how NICE put a price on life.... [But] I can see the dilemma... and I can understand that funds probably do need to be rationed. (service user)

The man who is the face of NICE … if he comes up on the television … I could shout at the screen. … People who watched all the things on the television and read it in the newspaper about Herceptin must have thought ‘oh for God’s sake, why are they going on?’ Which is what I would have thought if it hadn’t applied to me. (service user)

Service users – practical experiences Most don’t know it’s there… If they went to the NICE guidelines they'd say “well hold on, NICE says that I should be able to have it [weight reduction surgery]” … [but] we haven't got the funding”. (consultant)

Service users – practical experiences Most don’t know it’s there… If they went to the NICE guidelines they'd say “well hold on, NICE says that I should be able to have it [weight reduction surgery]” … [but] we haven't got the funding”. (consultant) …and when they do? It made no difference. (service user)

Key messages Theoretical views pretty much in accord BUT in practice… – Much more important to managers than clinicians – Of little consequence to service users – Conflict between individual and population health perspective

Key messages Theoretical views pretty much in accord BUT in practice… – Much more important to managers than clinicians – Of little consequence to service users – Conflict between individual and population health perspective ? Over whether guidance fulfils key NICE objectives – Regional variations in care persist – Not explicit to service users

Further work…

More work on how NICE guidance is actually used Investigate how to increase the availability and utility of NICE guidance to service users More work on theoretical perspectives

Further work… More work on how NICE guidance is actually used Investigate how to increase the availability and utility of NICE guidance to service users More work on theoretical perspectives

Study design – some concerns… Practical concerns – Primary / secondary care? – How to make information available? – Methodology – UK / international? Broader concerns – Is knowing actually acceptable to patients? (Owen-Smith et al., JHSRP, 2010) – How might patients react to knowing? (Owen-Smith et al., Soc Sci Med, 2009)

Study design – some concerns… Practical concerns – Primary / secondary care? – How to make information available? – Methodology – UK / international? Broader concerns – Is knowing actually acceptable to patients? (Owen-Smith et al., JHSRP, 2010) – How might patients react to knowing? (Owen-Smith et al., Soc Sci Med, 2009)