The doxazosin arm of ALLHAT? Hypertension 2003; 42: , Ann Intern Med 2002; 137: , JAMA 2000; 283: 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
ALLHAT (doxazosin arm) PUBLISHED
Trends in the prescribing of alpha blocking drugs in England
Cox IIs MeReC 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
MeReC Extra 30 November 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 ……. approximately 2000 additional or premature CV events per year could be caused by diclofenac prescribing If the excess risk for CV events is the same as COX-2 inhibitors (3 per 1000 patients per year) then approximately 2000 additional or premature CV events per year could be caused by diclofenac prescribing, compared with no treatment.
#1 However good the information is, on its own it is usually insufficient to change practice
1.Work harder 2.Be more effective 3.Be imaginative and try some new things
1. Work harder 1.Im not working hard enough 2.My workload is just right 3.Im 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 Its hard to find NHS workers who have substantial spare capacity
2. Be more effective
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; 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:
#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 performanc e 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
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: 1768
More reading? Potential journals10,000 Potential new articles per week40,000 Even if 97% are not relevant (no POOs) 1,200 Time to read each article15minutes 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 OA Effect 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 approaches to managing information:Information Mastery requires two different approaches to managing information: ForagingalertedForaging - a method of being alerted to new relevant, valid information when it is published HuntingfindingHunting - a method of finding 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 Validity Work 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:
How can we quickly spot what is NOT important to us? RELEVANT Not RELEVANT – 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 VALID Not VALID – Poor study design – Bias and confounding – Measurement validity – Insufficient power
So, filtering for relevance F Feasible (intervention) O Outcomes (patient-orientated) C Common (condition) C Change in practice required
DOOs can mislead and dont always relate to POOs Ebell M, et al. Am Fam Physician 2004; 69: 548–56 Disease / condition DOOPOO Doxazosin for BPIn Blacks, reduces BPIncreases mortality Lidocaine for arrhythmia after MI Suppresses arrhythmiasIncreases mortality Finasteride for BPHImproves 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 DOOPOO 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 PWT2DKeeps 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 dont know and I dont care
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 Library NICE, (NSFs) EBM DTB MeReC Bandolier Ivy League journals Clinical Evidence InfoPOEMs, Prodigy BestTreatments NPC ref sheets Textbooks Usefulness Medline InfoRetriever, DrCompanion, self-assembly
The five S approach Haynes 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 how can we expect clinicians to be up to date?