Neal Maskrey /Jonathan UnderhillNational Prescribing CentreLiverpool UK

neal.maskrey@npc.nhs.uk

Dolphins and cows

why evidence-based practice doesn’t happen as often as it sometimes should

what should we be doing differently?what should we be doing differently?

BTS Asthma guidelines 1997

BTS/SIGN Asthma guidelines 2004, 2005, 2007

The doxazosin arm of ALLHAT?Hypertension 2003; 42: 239-246, Ann Intern Med 2002; 137: 313-320, JAMA 2000; 283: 1967-1975

Increased risk of stroke (RR 1.26), combined CVD (RR 1.20) and heart

failure (RR 1.80) with doxazosin

Prescribing of alpha-blockers in the US following ALLHAT

Stafford RS, et al. JAMA 2004; 291: 54-62

Trends in Prescribing of Alpha-adrenoceptor Blocking Drugs in General Practice in England

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Doxazosin Prazosin Terazosin Others

Copyright PPA 2004

ALLHAT (doxazosin arm) PUBLISHED

ALLHAT (doxazosin arm) PUBLISHED

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Trends in the prescribing of alpha blocking drugs in EnglandTrends in the prescribing of alpha blocking drugs in England

Cox IIsMeReC Briefing 2002; 20

The GI safety of rofecoxib and celecoxib has been assessed in large clinical outcome trials which, on first analysis, show benefits over non-selective NSAIDs in the incidence of serious upper GI complications. However, longer-term GI data from the celecoxib study (CLASS) and cardiovascular adverse event data from the rofecoxib study (VIGOR) have questioned the risk/benefit profile of these new drugs and, until they are better understood, it seems sensible not to use them routinely in large numbers of people.

Trends in Prescribing of NSAIDs in General Practice in England

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Diclofenac Ibuprofen Naproxen Meloxicam Rofecoxib Celecoxib Etoricoxib Others

MeReC Extra 30November 2007

Long-term, randomised controlled trials (RCTs) have demonstrated that coxibs cause a small increased risk of thrombotic events in comparison with placebo. The excess risk was estimated to be about three cases per 1000 users treated for one year. This risk appears to increase with dose and persists throughout treatment.

NSAIDs - GI and CV risk

….following a review of the evidence in October 2006, the Commission on Human Medicines (CHM) advised that there was sufficient evidence to suggest that traditional NSAIDs may also be associated with a small increased risk of thrombotic events when used at high doses and for long-term treatment. Furthermore, they identified that not all traditional NSAIDS carried the same CV risk:

Naproxen 1000mg/day may be associated with a lower risk of thrombotic events than coxibs.

Ibuprofen …..at low doses (e.g. 1200mg/day) …. does not suggest an increase [in] thrombotic risk

Diclofenac 150mg/day has a thrombotic risk profile similar to that of etoricoxib 60/90mg, and possibly other ▼coxibs.

Diclofenac accounted for 46% of all NSAID prescribing …in primary care in England …….If the excess risk for CV events is the same as COX-2 inhibitors (3 per 1000 patients per year) then

approximately 2000 additional approximately 2000 additional or premature CV events per or premature CV events per year could be caused by year could be caused by diclofenac prescribingdiclofenac prescribing, compared with no treatment.

#1

However good the information is, on its own it is usually insufficient to change practice

1. Work harder2. Be more effective3. Be imaginative and try some new things

1. Work harder

1. I’m not working hard enough

2. My workload is just right

3. I’m working too hard

Without innovation, public services costs tend to rise faster than the rest of the economy. Without innovation, the inevitable pressure to contain costs can only be met by forcing already stretched staff to work harder.

Mulgan G & Albury D (2003).

Innovation in the Public Sector.

Strategy Unit, London.

#2

It’s hard to find NHS workers who have substantial spare capacity

2. Be more effective

2003 20071994

Summary of recommendations

• Incentive scheme for all practices• Better co-ordination of resources promoting rational prescribing• Better information• Education• Audit• Formularies and guidelines• Use skills of community pharmacists• Practice visits should be better targeted, more focussed, effectively

followed up• Summarise information for prescribers• Improve local consensus• Involve and educate patients

• The median effect size overall was approximately 10% improvement in absolute terms. Grimshaw J, et al. Implementing clinical guidelines: current evidence and future implications: Journal of Continuing Education in the health professions 2004; 24: S31-S37.

• The only factors that had a significant relationship with implementation of these important prescribing changes were an innovative approach among the doctors (most practitioners were cautious of change), and fundholding status. Salisbury C, et al. The implementation of evidence-based medicine in general practice prescribing. BJGP 1998; 48; 1849-1852.

• 102 trials of educational interventions in the health care professions published between 1970 and 1993 inclusive. – Dissemination-only strategies, such as conferences or the mailing of

unsolicited materials, demonstrated little or no changes in health professional behaviour or health outcome when used alone.

– More complex interventions, such as the use of outreach visits or local opinion leaders, ranged from ineffective to highly effective but were most often moderately effective (resulting in reductions of 20% to 50% in the incidence of inappropriate performance). Oxman AD, et al. CMAJ 1995; 153: 1423-1431

#3

If it was possible to deliver implementation strategies with 100% effectiveness, the best results we could expect are a shift in the desired direction of 10-50%.

Let it happen Help it happen Make it happen

Educational: based on adult learning

theories. Focus on internal motivation of professionals. Bottom up, PBL, small interactive

groups

Epidemiological: based on rational, cognitive theories;

information. Guideline

development; dissemination via courses, journals,

mailing

Marketing: based on health

promotion and social marketing

theories. Attractive product, adapted to local

needs (after assessment).

Stepwise approach, multiple

channels for communication

Greenhalgh T, et al. NCCSDO. April 2004

Let it happen Help it happen Make it happen

Social interaction: based on social

learning and innovation

theories, social influence and

power theories. Peer review in local networks, outreach visits, opinion leaders, patient mediated

interventions

Behavioural: based on learning theory. Control

performance by audit,

feedback, reminder

systems, £, sanctions.

Organisational: based on

management & system theories. Create structural

and organisational conditions to

improve care. Re-engineering care processes, TQM,

team building, leadership.

Coercive: based on economic, power and

learning theories.

Regulations, budgeting, contracting.

#4

The NHS mostly does things to clinicians, rather than helping them acquire for themselves the knowledge, skills and attitudes to do a better job

The NHS professional bureaucracy

• Front line staff have a large measure of control over decisions

• Hierarchical directives issued by those nominally in control often have limited impact – even resisted

• Negotiation, not imposition• Collegial influences – credibility of professionals at

their core, not simply those in formal positions of “authority”

Mintzberg H. The Structuring of Organisations: a synthesis of research. 1979

3. Be imaginative

information management

cognitive psychology

explaining risks and benefits to patients

information management

information management

• Volume of published material is unmanageable

• Reading is haphazard• Formal CPD is haphazard

"We surveyed one acute medical take in our hospital. In a relatively quiet take, we saw 18 patients with a total of 44 diagnoses. The guidelines that the on call physician should have read remembered and applied correctly for those conditions came to 3679 pages. This number included only NICE, the Royal Colleges and major societies from the last 3 years. If it takes 2 min to read each page, the physician on call will have to spend 122h reading to keep abreast of the guidelines" (for one 24h on-call period).

Allen D, Harkins KJ. Lancet 2005; 365: 1768Allen D, Harkins KJ. Lancet 2005; 365: 1768

More reading?• Potential journals 10,000 • Potential new articles per week 40,000• Even if 97% are not relevant (no POOs) 1,200• Time to read each article 15minutes

• 10h a day, 6 days a week = 240 articles.• So at the end of the first week you are about 4 weeks behind in

your reading.• At the end of the first month, you are 4 months behind in your

reading.• And at the end of the first year you are almost 5 years behind in

your reading.

Effect of exercise on pain in knee OAEffect of exercise on pain in knee OA Roddy E, et al. Ann Rheum Dis 2005; 64: 544-8

Clinician reading journals

Evidence-based treatment for the patient

• Information Mastery requires two different Information Mastery requires two different approaches to managing information:approaches to managing information:• ForagingForaging - a method of being alertedalerted to new relevant,

valid information when it is published• HuntingHunting - a method of findingfinding information when it is

needed

• NPC would add a third:- NPC would add a third:- • Hot-synchingHot-synching – clinicians rapidly checking once or, at

the most, twice a year that their key approaches for the management of conditions they see commonly still match the best evidence

Usefulness = Relevance x ValidityWork

What are the criteria used when looking for the best answer or important evidence?

Slawson DC and Shaughnessy AF. J Am Board Fam Pract 1999; 12: 444-449

How can we quickly spot what is NOT important to us?

• Not RELEVANTRELEVANT– Upstream to clinical decisions being made, e.g. animal or in vitro

studies– Study populations and / or settings do not reflect question type,

practice population and settings • Not VALIDVALID

– Poor study design– Bias and confounding– Measurement validity– Insufficient power

So, filtering for relevance

• FFeasible (intervention)• OOutcomes (patient-orientated) • CCommon (condition)• CChange in practice required

DOOs can mislead and don’t always relate to POOsEbell M, et al. Am Fam Physician 2004; 69: 548–56

Disease / condition

DOO POO

Doxazosin for BP In Blacks, reduces BP Increases mortality

Lidocaine for arrhythmia after MI

Suppresses arrhythmias Increases mortality

Finasteride for BPH Improves urinary flow rate

No clinically important change in patient symptom scores

Arthroscopic surgery for OA knee

Improves appearances after debridement

No change in function or symptoms at 1 year

Sleeping infants on their stomach or side

Based on anatomy and physiology, will decrease risk of aspiration

Increase in SIDS

Disease / condition

DOO POO

Vitamin E for heart disease

Reduces levels of free radicals

No change in mortality

HRT for CHD prevention

Reduces LDL, increases HDL

No decrease in CV or all cause mortality, increase in CV events over 60 years

Insulin for PWT2D Keeps blood glucose below 6.7mmol/L

No reduction in mortality

Sodium fluoride for fracture prevention

Increases bone density

Does not reduce fracture rate

Lidocaine prophylaxis after MI

Suppresses arrhythmias

Increases mortality

Beta blockers for heart failure

Reduce cardiac output

Reduce mortality

If the answer to any of those is “no”

I don’t know I don’t know and I don’t and I don’t

carecare

After checking it is relevant, is the answer likely to be valid?

• How to quickly spot the fatal flaws:– Is it a high level of evidence?– Is it statistically significant?– Is it clinically significant?:

• Do you understand what the the numbers tell you?• Absolute vs. relative risk vs. NNT

– Was there enough people in the study for long enough?

– Was the allocation concealed?

Reading and critical appraisal MUST (largely) be replaced by reading pre-digested sources of evidence from trusted

sources

Be an Information Master!

Slawson DC and Shaughnessy AF

Cochrane LibraryNICE, (NSFs)

EBM DTB MeReCBandolier

“Ivy League” journals

Clinical EvidenceInfoPOEMs, ProdigyBestTreatments NPC ref sheets

Textbooks

Usefulness

Medline

InfoRetriever, DrCompanion, self-assembly

The five S approachHaynes RB. Evidence-Based Medicine 2006;11:162-4

NPCi therapeutics floors, Clinical Evidence, CKS (PRODIGY), etc

NPCi blogs and podcasts, EBM, ACP Journal Club, etc

Cochrane reviews, HTAs, NICE full guidelines, etc

information management

• Stop reading journals (to stay up to date)• Read trusted summaries of evidence• Concentrate CPD on the conditions you see

commonly (c30 for a GP = two thirds of problems presenting)

#5

Information management is nowhere near being a key component of undergraduate or postgraduate curricula – yet without it howcan we expect clinicians to be up to date?

Comments / Questions