neal maskrey / jonathan underhill national prescribing centre liverpool uk [email protected]...
TRANSCRIPT
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Neal Maskrey /Jonathan UnderhillNational Prescribing CentreLiverpool UK
Dolphins and cows
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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?
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BTS Asthma guidelines 1997
BTS/SIGN Asthma guidelines 2004, 2005, 2007
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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
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Prescribing of alpha-blockers in the US following ALLHAT
Stafford RS, et al. JAMA 2004; 291: 54-62
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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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Doxazosin Prazosin Terazosin Others
Trends in the prescribing of alpha blocking drugs in EnglandTrends in the prescribing of alpha blocking drugs in England
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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.
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Trends in Prescribing of NSAIDs in General Practice in England
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Diclofenac Ibuprofen Naproxen Meloxicam Rofecoxib Celecoxib Etoricoxib Others
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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
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….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.
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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.
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#1
However good the information is, on its own it is usually insufficient to change practice
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1. Work harder2. Be more effective3. Be imaginative and try some new things
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1. Work harder
1. I’m not working hard enough
2. My workload is just right
3. I’m working too hard
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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.
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#2
It’s hard to find NHS workers who have substantial spare capacity
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2. Be more effective
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2003 20071994
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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
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• 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
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#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%.
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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
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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.
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#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
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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
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3. Be imaginative
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information management
cognitive psychology
explaining risks and benefits to patients
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information management
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information management
• Volume of published material is unmanageable
• Reading is haphazard• Formal CPD is haphazard
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"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
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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.
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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
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Clinician reading journals
Evidence-based treatment for the patient
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• 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
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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
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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
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So, filtering for relevance
• FFeasible (intervention)• OOutcomes (patient-orientated) • CCommon (condition)• CChange in practice required
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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
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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
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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
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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?
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Reading and critical appraisal MUST (largely) be replaced by reading pre-digested sources of evidence from trusted
sources
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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
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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
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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)
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#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?
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