e r a c y r a m i r P 6 Consider additional problems and risk factors for promoting health. 7 List all the treatm ent options, and seek out relevant systematic reviews, guidelines, clinical trials, etc (evidence-based bedside medicine). 8 Incorporate the patient \200\231s view on the balance of risks and bene \201 ts, harmo- nizing his view of priorities, with your own assessment of urgency. 9 Arrange follow-up and communicate with all of the health care team. 10 Arrange for purchase of all necessary car e, weighing up cost implications for your other patients and the community, welcoming accou ntability for all acts and omissions, and for the effi cient use of resources \200\224with jus- ti \201 cations based on explicit criteria, transparency, and principles of au- tonom y, non-male \201 cence, bene \201 cence, and distributive justice. The alternative Look the patient in the eye. Look the disease in the eye, and then do your best. The synthesis The alternative looks promising \200\224even attractive, when com- pare d with the 10 impossibilities above. But note that the alternative only looks attractive be cause it is vague. \200\230Do your best \200\231 is not very helpful ad- vise \200\224and once we start unpacking this \200\230best \200\231 we start to get a list like the 10 impo ssibilities. \200\230Professionalism \200\231 sums up part of what being a good doctor ent ails \200\224ie \200 Self-regulation \200 Self-actuating and self-monitoring of standar ds of care. \200 Altruism \200 Commitment to service \200 Specialist knowledge and te ch- nical skills re \202 ecting but not determined by society \200\231s values \200 Cons istently working to high standards of probity and quality (no bribes, no favoritism, but a dynamic concern for distributive justice). \200 Self-determination vis vis the range a nd pattern of the kinds of problems it is right for it to attempt to solve. For a further d iscussion, see On Being a Doctor: Rede \201 ning Medical Professionalism for Better Patien t Care (King \200\231s Fund). Trying to achieve authenticity is a meta-goal, and may be a better mast to nail your colors to than the 10 impossibilities above not because it is easier but be- cause paying attenti on to authenticity may make you a better doctor, whereas striving for all 10 of the impossi bilities may make you perform less well (too many con \202 icting ideals). With inauthenti c consultations you may be chasing remunerative activities, quality points, protocols, or s imply be trying to clear the waiting room, at any cost, while the patient is trying to twis t your arm into giving antibiotics or a medical certi \201 cate. Authentic consultations a re those where there are no barriers; just 2 humans without status exploring and sharing hy potheses and beliefs and deciding what to do for the best (along the lines de- scribed in d etail on p531) \200\224with no ulterior motives and no con \202 icts of interest. Authenti c consultations know and tell the truth where possible, and where this is not possible, the truth is worked towards \200\224diligently and fearlessly. Prevention The bene \201 ts of preventive activities are often uncertain: the only certain ty is that harm will be caused to some people. The discipline of quater- nary prevention (B OX) aims to minimize this. Prevention through the human life cycle Pre-conception (p2). Is she using folic acid supple- ments? Is she rubella immune? If not, vaccinate, and ensure ef f ective contraception for 1 month after vaccination. Is she diabetic? If so, optimize glyc aemic control as early as possible (p3, 24). Child: Vaccination (p151); hearing; safety les sons; developmental tests (p218); heart disease, p156. Preventing myocardial infarcts: See the UK National Service Framework for heart disease. 69 Smoking trebles risk above the rate for men who have never smoked. Systolic BP >148mmHg (40% of men) doubles risk,1 and if ser um choles- terol is in top 20% of the observed range, risk trebles. Help to stop smoking (p 512), and treat- ing hypertension (OHCM p134) & dyslipidaemia (OHCM p704) are the main inte rventions. GPs/ practice nurses have a central role in preventing cardiac deaths, eg by scr eening for \200\200BP, and en- couraging less smoking \200\224and giving statins (not base d on a particular cholesterol level, but ac- cording to overall risk of MI and stroke).2 Pr eventing breast cancer deaths: Education and \200\230breast awareness \200\231. Mammograph y ( \200\230neg- ligible \200\231 radiation): cancer pick-up rate \211\210 5/1000 \200 \230healthy \200\231 women. Yearly 2-view images in post- menopausal women might \200\201m ortality by 40%, but the price is serious but needless alarm caused: ( 10 false +ve results for each true +ve result). The NHS off ers 3-yrly single views to those between 47 and 73 years old (older wom- en may be screened too). Prevention in the reproductive years (p488): Safe sex education (start at pu- berty; teaching to use condoms need not increase rates of sexual activity); fam- ily planning (p296 \200\223306), antenatal/prenatal care (p2, eg fo lic acid), screening for cervical cancer (p270), blood pressure, rubella serology. Preventi ng oxidative damage by free radicals: Antioxidants, eg vitamin E, C, carotenoids, \202 av enoids, and selenium (OHCM p693) may have a role. 71 Old age: \200\230Keep \201 t \200 \231, pre-retirement classes, bereavement counseling, falls clinic. The main aim is to adop t the measures above, to ensure that there is an old age. Side eff ects No intervention is without side eff ects, and when carried out in large populations the problems may outweigh the bene \201 ts. Smoking and prevention: p512. Seat belts and prevention: p791 482 \200 Examples of prevention Primary prevention: (preventing occurrence) \200 Vaccination \200 Quit smoking advice \200 Binge drinking advice \200 Healthy eating advice \200 Safe (r) sex advice (HIV) \200 Hypertension screening \200 Preconception folic acid to prevent spina bi \201 da Fluoride in water (caries) Secondary prevention: (screening for 1st stages) \200 Cervical cytology \200 Mammography \200 Proteinuria in pre-eclampsia \200 Microalbuminuria in DM \200 Colonoscopy for polyps \200 Densitometry (osteoporosis) \200 Diet advice in impaired fast- e r a c y r a m ing glycaemia Tertiary prevention: (preventing complications) \200 Aspirin after a stroke \200 Retina l photography in dm \200 Hip protectors after falls \200 \200\230Don \200\231t go bare foot \200\231 (diabetes) \200 Vitamin D in osteoporosis Metaprevention (or quaternary pre vention): \201\201 Preventing medicalization \201\201 Prioritizing preventive i r P options \201\201 Shielding from over-zealous prevention, eg no ACE-i for heart protection if prone to postural hypotension/falls. 70 1 Reversible with antihypertensives and a statin (even if cholesterol \200\230normal or lo w \200\231); ASCOT study. 72 2 The Heart Protection Study (HPS) indicates that if a patient has vascular risk factors, eg family history, obesity, sedentary life, smoking, \200\200B P, DM) statins can be of bene \201 t even if lipid levels are considered OK. In HPS (N=20, 000) overall risk of MI & stroke was \200\201 by 30% in those on simvastatin 40mg/24h. Sta tins also \200\201 risk of getting angina, the need for angioplasty/bypass, and amputation s. Advantages hold good for women and men, and those over 70. 73 The AFCAPS/TEXCAPS study s hows that treatment can \200\201 adverse coronary events even in the primary prevention of patients with normal cholesterol levels and no risk factors (past MI etc). 74 \200\22376 This page intentionally left blank Barriers to prevention Genetic barriers Not everyone responds to preventive measures. Some of us, because of our genes, are \200\230immune \200\231 to the bene \201 ts of exercise, for example. As genetic advances occur, our habitual blanket advice of \200\234take more exercise \200\235 looks increasingly old fashioned. What we should really do is get to know our patients psychologically and genetically, and tailor advice such as \200\234for you, diet advice is more important than exercise \200\235. In one study, in the 8 exercising peo ple showing the largest \200\200 in insulin sensitivity, 51 genes were expressed in muscle s at double the levels of the 8 people who showed the least improvement after exercise. 77 Cognitive barriers (See BOX.) When, if ever, we contemplate cataclysmic but preventable ill health in ourselves, we may either believe that \200\234It won \200\231t hap- pen to me \200\235 or we deliberately dare fate to make it happen to us. To some people, over-zealous and sanctimonious-sounding hectoring from bodies such as the UK Health Development Agency creates barriers to prevention, inciting anger and rejection by those who resent their taxe s being spent by some State Nanny who assumes that all her charges are \200\230backward 5- year-olds \200\231 who can- not be trusted to think for themselves. 78 So people are now pr oud to announce that \200\234 \200 I eat everything, as much butter and fried foods as I can get \200 I smoke 40 \200\22360 cigarettes a day \200 To eat corn \202 akes, you \200\231ve got to have sugar on them, and lots of cream, otherwise there is no point in eat ing them \200 As long as you keep smoking cigarettes, and drink plenty of whisky, you \200\231ll go on for ever \200\235. 79 Psychological barriers All of us at times are prone to promote our own destruction as keenly as we promote our own survival. Knowing that alcoh ol may bring about our own destruction gives the substance a certain appeal, when we are in certain frames of mind \200\224particularly if we do not know the sordid details of what d eath by alcohol entails. It provides an alluring means of escape without entailing too head long a rush into the seductive arms of death. Gambling and taking risks are all part of thi s ethos. Logistic barriers A general practice needs to be highly organized to be in a state of perpetual readiness to answer questions like \200\234Who has not had their BP checked for 3 years \200\235? or \200\234Who has not turned up to their request to attend for scre ening \200\235? or \200\234Who has stopped sending in for their repeat prescriptions for a ntihypertensives? \200\235. UK IT systems have advanced a lot in the last years, enabling p atient alerts to pop-up, allowing for opportunistic preventive activi- ties. The price of t his is that patient-centered activities are crowded out, and that, with many preventive act ivities off ered, no guidance on prioritizing indi- vidual intervention is upcoming. See qu aternary prevention, p482. 484 e r a c y r a m i r P Another example of logistical barriers is providing a sequence of working fridges in the distribution of vaccines to rural tropical areas. Political barriers It is n ot unknown for governments to back out of preven- tive obligations as if in \202 uenced by groups who would lose if prevention were successful. Some countries are keener to buy tank s than vaccines. Ethical barriers If child bene \201 ts were available only to those child ren who had had MMR vaccine, more mumps would be prevented (an unpopular ap- proach!). Fina ncial barriers Practices must pay for extra staff to do eff ective screen- ing. Angioplasty (for example) prevents some consequences of heart disease, but is too expensive to use on everybody whom it might bene \201 t. Motivation barriers As we rush out of morning surgery to attend the latest vascular disaster we use up energy which might have been spent on stu dy- ing patients \200\231 notes in the evening to screen to prevent the next one. Changing from a crisis-led work pattern to strategic prevention is one way that practice nurses can lead the way. They are particularly successful at the meticulous, repetitive tasks on which all good prevention depends. 485 Metaphysics at the bedside \200\224and the world \200\231s worst patient We often \201 nd ourselves sitting on beds trying to persuade wayward people to courses of preventive actio n which will clearly bene \201 t them, usually at some distant time in the future. We thin k this very clarity should be enough to persuade the person to act. But, as we dismally sta mp our feet on the bare boards of our impatience, we resign ourselves to the fact that acti on will not follow. Why is this so often the case? The best answer to this question comes from the world \200\231s worst patient and our own g reatest poet: great not because of his mastery of his world, but because, as the world used him, often cruelly, and as his London doctors gave him up as a hopeless addict, he took on all our petty confusions and made them human, compelling, and universal. Samuel Taylor Col eridge answers our question thus: R Holmes Coleridge volume 2; page 225 e r a c y r a m i r P \200\230To love our future Self is almost as hard as to love our Neighbor \200\224it is in deed only a difference of Space & Time. My Neighbor is my other Self, \200\230othered \200 \231 by Space \200\224my old age is to my youth an other Self, \200\230othered \200\231 by Time \200 \200\231 By being consumed by the \201 res of his addictions this poet becomes the wick in the lam p we can now use to illuminate our patients \200\231 frailties, and hence our own. Russian roulette Coleridge accurately reveals us to ourselves when we are indiff erent to our other selves, whether \200\230othered \200\231 by space or time. He also understood a deeper pr oblem: those who go beyond indiff erence, ambiva- lently seeking their own destruction \200 \224as if playing Russian roulette with the barrel full every time while at the same time n ot wanting to die. Some peo- ple \200\231s attitude to HIV is like this \200\224when safe s ex messages are not so much ignored as trounced, or one person off ers HIV to another as an erotic gift. 77 This exempli \201 es a phenomenon which is a human universal: to know wha t is good, healthy, and sensible \200\224and do the opposite. We note that both Dos- toevsk y and Graham Greene are said to have played Russian roulette \200\224and we conclude that t his is a way of living as much as a way of dying: one lives while the barrel spins. Unless one understands something of this mentality, our preventive activities will always tend to smack of Girl Guide piety. So when we catch ourselves trying to inculcate the principles of preventive medicine into t he surly, silent, and self-destructive adolescent sitting beside us we should stop what we are doing and try to tap into the volcano. Screening This entails systematic testing of a population or a sub-group for signs of ill- ness \200\224which may be of established disease (pre-symptomatic, eg small breast cancers) , or symptomatic (eg unreported hearing loss in the elderly). Modi \201 ed Wilson criteria for screening (1 \200\22310 spells IATROGENIC)1 486 \200 (Summary: screening tests must be cost-eff ective.) 1 The condition screened for should be an important one. 2 There should be an acceptable tr eatment for the disease. 3 Diagnostic and treatment facilities should be available. 4 A rec ognizable latent or early symptomatic stage is required. 5 Opinions on who to treat as pati ents must be agreed. 6 The test must be of high discriminatory power (below), valid (measur ing what it purports to measure, not surrogate markers which might not cor- relate with rea lity) and be reproducible \200\224with safety guaranteed (see BOX). 7 The examination must be acceptable to the patient. 8 The untreated natural history of the disease must be known. 9 A simple inexpensive test should be all that is required. 10 Scre ening must be continuous (ie not a \200\230one-off \200\231 aff air). Informed consent: R ees \200\231 rule Before off ering screening, we have a duty to quantify for patients the c hance of being disadvantaged by it; \200\224from anxiety (may be devastating, while waiting for a false +ve result to be sorted out) and the eff ects of subsequent tests (eg bleeding after biopsy after an abnormal cervical smear), as well as the chances of bene \201 t. We are all guilty of exag- gerating bene \201 ts and avoiding discussion of controversial ar eas with patients. Comparing a test with some gold standard Patients with e r a c y r a m i r P Patients with- out condition False +ve (B) condition True +ve (A) Subjects appear to have the condition Subjects appear not to have the condition TEST RESULT False \200\223ve (C) True \200\223ve (D) Sensitivity: How reliably is the test +ve in the disease? A/A+C Speci \201 city: How relia bly is the test \200\223ve in health? D/D+B Unproven/ineff ective screening2 Partly eff ective screening Mental test score (dementia, p 353) Cervical smears (if >25yrs, p270) Mammography (after menopause)80 Urine stix (diabetes ; kidney disease) Finding smokers (+quitting advice) Antenatal procedures (p8) Looking for malignant hypertension (lesser hypertension is problematic) Fecal occult bloods (colorectal ca) PSA screening for prostate ca (det- ects too many harmless cancers?) Elderly visiting to de tect disease3 Why screen in primary care? If screening is to be done at all, it makes economic sense to d o it in primary care. In the UK, \211 1 million people see GPs each weekday, providing gre at facilities for opportunistic \200\230case- \201 nding \200\231 (90% of patients consul t over a 5 yrs). Provided the GP \200\231s records are adequate, the last 10% are then aske d to attend for special screening sessions. Private clinics do limited work, but there is n o evidence that their multiphasic biochemical analyzes are eff ective procedures, and NHS r esources are wasted chasing false +ves. 1 \200\207For an excellent critique of the Wilson criteria, see Gray J 2004 Br J Gen Pract 501 : 292 \200\2238. 2 There is evidence that some screening causes morbidity (mortality-a wareness and hypochondriasis \200\200) \200\224so why is screening promulgated? Because it is easier for governments to be optimistic than to be rigorous? 3 In one study (N=43,000 pa tients >75yrs old) neither in-depth assessment nor a targeted approach focused on those wit h \211 3 problems off ered gains in survival or quality of life. 81 487 Why should safety be guaranteed? \200\207Nothing in this world is guaranteed \200\224least of all the data on which state- ments about safety are made. It is only an ill-educated po pulation who would demand this impossible criterion. In mammography the dose of ra- diation is tiny \200\224but one of the reasons for doing it at intervals of >1yr is to reduce radi ation exposure. Safety is not guaranteed. 82,83 Also, each popu- lation of women contains a very radiosensitive subgroup: those bearing a mutation of the gene BRCA1 or BRCA2. In thes e, repeated X-ray use must de \201 nitely be avoided. 84 But if genetic testing and counse ling were to be a prequel to mammography, then counseling would be needed. There are some p eople who de \201 nitely should not have this can of worms opened \200\224 to \201 nd th ese may need psychological screening \200 .thus safety issues can lead to a an in \201 nit e regress \200\224and what started out as a good idea gets swamped. A better approach is to accept some risk \200\224and try to limit it, where practicable. \200\207The great thing is to teach people how to evaluate risk, and how to han- dle dangerous things safely \200 \224rather than just shun them. . s e d u t i t a l p g n i n e e r c s e r a c y r a m i r P g n i t c u r t s n o c e D Problems with screening Take a healthy person, screen them, turn them into a patient, and t hen kill them. From a report on cervical screening: \200\234By off ering screening to 250, 000 we have helped a few, harmed thousands, disappointed many, used 1.5m each year, and k ept a few lawyers in work. \200\235 Typical problems are: \200 Those most at risk do not present for screening, thus increasing the gap between the healthy and the unhealthy \200\224the inverse care law. \200 The \200\230wor ried well \200\231 overload services by seeking repeat screening. \200 Services for inves tigating those testing positive are inadequate. \200 Those who are false positives suff e r stress while awaiting investigation, . t s e b s t i t a e n i c i d e m c i n e g o r t a I and remain anxious about their health despite reassurance. \200 A negative result may be regarded as a license to take risks. \200 True positives, though treated, may begin to se e themselves as of lower worth than hitherto. \200\207Remember: with some screening programs of dubious value, it may be healthier not t o know. Primary care and shared-care clinics Examples of single-issue clinics which are conducted i n primary care \200 Well-woman/well-man clinic \200 Elderly \200\230non-attending \200 \231 patients \200 Giving-up-smoking clinic (p512) \200 Joint clinics with a consultant who shares care (eg orthopedics: see polyclinicset al, p475) Advantages of single-issue cl inics \200 Management protocol + action plan for self-care \200 Check-lists prevent omi ssions \200 Co-operation cards allow shared care \200 Flow charts to identify trends \200 Help from specialist practice nurse \200 Fewer outpatient referrals (eg \200\201by 20%) \200 GPs can improve clinical skills87 \200 Better co-operation with hospitals \200 Improved dialog with specialists87 Activities in well-woman clinics \200 Smoking an d alcohol advice \200\226 \200 Cervical smear; breast awareness/mammograms \200 Safer s ex advice for HIV \200\226 \200 Screening: osteoporosis; DM; atrial \201 brillation88 \200 Family planning/sterilization \200\226 \200 Antenatal/postnatal care (+pre-concepti on, p2) \200 Protecting skin from sun; regular skin self-exam \200\226 \200 Diet, weigh t & blood pressure \200\226 \200 MMR and tetanus vaccination \200\226 (p151) Breast exami nation/teaching breast self-examination in nurse clinics There is disagreement about whethe r this is desirable, and, if so, whether we can delegate this to nurses. Some (but not all) studies report that cancers in those having this protocol are detected earlier, with impro ved survival, com- pared with mammography alone. But UK DoH advice is against breast palpa- tion in asymptomatic women, even if on the Pill/HRT. The DoH advises against delegation to nurses, but in some practices it may only be nurses whom wom- en \201 nd acceptable \200 \224so validating nurse training is a key issue. Well-men Women live longer, so why should they get all the prevention? Nurses can do all the well-woman activities \200\226starred a bove in well-man clin- ics (substitute testicular self-examination PSA (prostate speci \201 c antigen) tests for breast awareness). One such clinic yielded \211 25% obese, 14% w ith diastolic BP \211 100mmHg, 66% needing tetanus vaccination, and 29% needing smoking ad vice; see the OXCHECK study, p495 and the National Service Frame- work for ischaemic heart disease (OHCM p79). 89 Diabetes Education/encouragement is the most important activity. Gro up sessions are best: passive dependency is minimized and people (patients) help and motiva te each other. Traditional one-to-one care even when optimized, is associated with progress ive decline in knowledge, problem-solving ability, and quality of life. Group-engendered co gnitive and psychosocial skills associate with more favorable clinical outcomes \200\224inc luding falling BMI and HbA1c.90 n=120 488 \200 Antenatal clinic \200 Cardiac1 and hypertension clinic \200 Citizen \200\231s advice cl inic85 \200 Diabetes clinic \200 Asthma86 and COPD clinics. Disadvantages \200 Extra time needed \200 Extra training needed \200 Not holistic \200 Not \202 exible \200 Value often unproven \200 Access to hospital technology \200\201 \200 Traveling time by consultants to outreach clinics is wasteful \200 Untargeted diseases get ignored e r a c y r a m i r P Discussion of HRT issues. Advantages over outpatient clinics: patients see the same person each time; weekly appointm ents are possible if needed; telephone advice is easily avail- able. Mini-clinics are cheap er and ?better than outpatient clinics. 91 Even insulin-dependent diabetics can be managed wholly in primary care from presentation (i f no ketoacidosis). There are dangers in adhering too closely to protocols (p490). However, the vital test is retinal photography or dilated fundoscopy (p412 & p446). Other vital are as are BP control (<145/85, lower if microalbuminuria), diet, exercise, and smoking advice, statins (for all) and round-the-clock blood glucose monitoring, with checks on U&E and HbA 1c. Liaison with community consultant-services: May prevent hospital admission. 1 To check if on \200 -blocker & ACE-i post-MI + up-titration of \200 -blocker dose & ACE -i in heart failure. 92 489 Evidence-based medicine (EBM) This is the conscientious and judicious use of current best e vidence from clini- cal care research in the management of individual patients \200\224taki ng into ac- count their values. The problem 2,000,000 papers are published each year. Patie nts may bene \201 t from a tiny fraction of these. How do we \201 nd them? A partial sol ution 50 journals are scanned not by experts in neonatal neph- rology or the left nostril, but by searchers trained to spot papers which have a direct message for practice, and meet prede \201 ned criteria of rigor (below). Summaries are then published in Evidence-based M edicine. Questions used to evaluate papers: 1 Are the results valid? (Randomized? Blinded? Were all patients accounted for who entered the trial? Was follow- up complete? Were the gr oups similar at the start? Were the groups treated equally, apart from the experimental int ervention?) 2 What are the results? (How large was the treatment eff ect? How precise was t he treatment ef- fect?) 3 Will the results help my patients (cost \200\223bene \201 t sum) . Problems with the solution The concept of scienti \201 c rigor is opaque. What do we wan t? The science, the rigor, the truth, or what will be most useful to our patients? These ma y overlap, but they are not the same. \200 Will the best be the enemy of the good? Are us eful papers rejected due to \200 e r a c y r a m i r P some blemish? Answer: all evidence needs appraising (often impossible!). \200 By reformul ating patients in terms of answerable questions, EBM risks miss- ing the point of the patie nt \200\231s consultation. He might simply want to express his fears, rather than be used a s a substrate for an intellectual exercise. Is the standard the same for the evidence for all changes to our practice? We might not wan t to prescribe drug X for constipation if there is even a slim chance that it might cause c olon cancer. There are many other drugs to choose from. We might need far more robust evide nce than a remote chance to persuade us to do something rather counter-intuitive, such as g iving hep- arin in DIC. How robust do the data need to be? There is no science to tell us t he answer: we decide off the top of our head (albeit a wise head, we hope). \200 EBM is a lucky dip if gathering all the evidence on a topic proves impossible. \200 What of journ al letter columns? It may be ages before fatal \202 aws are aired. \200 There is a dang er that by always asking \200\234What \200\231s the evidence \200 \200\235 we divert res ources from hard-to-prove areas that may be very valuable, eg physio- therapy for cerebral palsy, to easy-to-prove ones. The unique personal attrib- utes of therapists are as importa nt as the objective regimen. It is all too easy to transfer resources to easy-to-quantify a ctivity, eg neonatal screening. \200\234My increased knowledge gradually permeated or repressed the world of in- Jung These premonitions may be vital! \200\207See p505. tuitive premonitions \200 \200\235Carl Evidence-based medicine is rarely 100% up to date. Reworking meta-analy- ses in the light of new trials takes time \200\224if it is ever done at all. EBM contributes to the problem of data overload by churning out endless guidelines that don \200\231t quite apply to the patient sitting in front of you. Advantages of evidence-based medicine \200 It improves our reading habits. \200 It lead s us to ask questions, and then to be skeptical of the answers. \200 As taxpayers, we sho uld like it (wasteful practices can be abandoned). \200 Evidence-based medicine presuppos es that we keep up to date, and makes it worthwhile to take trips around the perimeter of our knowledge. Evidence-based medicine opens decision-making processes to patients. Conclusion There is li ttle doubt that, where available, EBM is better than what it is superseding. It may not hav e much impact, as gaining evidence is time-consuming and expensive. Despite these caveats, evidence-based medicine is one of the most rational recent medical developments. Let \200 \231s all join in by subscribing to ideals and its journal (http://ebm.bmj.com). Protocols, targets, and guidelines \200\207Freedom from only doing ordained tasks is essen tial for mental health. \200\207There is nothing better (for the doctor and the patient) t han doing a job for the love of it \200\224and not many people love targets set by other pe ople \200\224so the target has to entail great bene \201 ts to outweigh its unintended con sequences. \200\207Beware accepting a protocol without knowing if it will aff ect your sym pathy and time to communicate. \200\207Is the protocol independently validated. What is it s hidden objective, eg cost-containment, conformity, self-advertisement, empire-building, o r care? \200\207Reject protocols that don \200\231t specify con \202 icts of interest: mo st protocols (87%) are written by people with \201 nancial links to drug companies or pub lic bodies wishing to curtail expense. 54,93 \200\22396 Sympathy is a \202 ower which has often withered before the end of morning surgery. If a protocol says that you must do 9 th ings to Mrs James who has diabetes, both of you may be irritated by item 5: the doctor is r unning out of time, and the patient is running out of goodwill. She is worrying about her h us- band \200\231s dementia, having long since stopped worrying about her own illnesses. Sh e does not mind being assailed by forks, stix, and lancets, if this is the price for a port ion of her doctor \200\231s sympathy. But if she \201 nds that this sympathy has withered , who knows how she will view her doctor? 490 \200 e r a c y r a m Guidelines are seen as friendly, if \202 exible, allowing for the frailties of clinical s cience as it meets bedside reality; they can also be interactive, if computer programming i s skillful. Protocols, particularly if they have been handed down from some supposedly high er authority, have a reputation for being strict, sin- ister, and stultifying instruments f or thought control. How well do these stereo- types stand up in practice? It is known that doctors working in highly regulated environments with strict protocols perform suboptimally . 97 It is also worth not- ing that very few laws de \201 ne their own exceptions. You cou ld say that patients have a right to be asked if they want to participate in a protocol, an d if so, that it should be done properly. But what if it is the child \200\231s birthday to day, and he really does not want to have his \201 nger pricked for a glucose test, but he is most willing to go along with all other aspects of a protocol? If you are \202 exible , the price may be ketoacidosis after the party. Herein lies the paradox of protocols. They are designed to remove the many indefensible inconsistencies found in clinical medicine, y et protocols depend on the individual doctor \200\231s own \202 air and instinctive judgm ent so that they are applied in the best way. i r P The best approach is to welcome good protocols, and develop meta-protocols to be answered w henever (or almost whenever) such protocols are not adhered to. Why did you not adhere to t he protocol? Please tick the appropriate box: \235\222 My own convenience, eg if too many other more important tasks to do. \235\222 My patient \200\231s preference (well-informed or otherwise). \235\222 Evidence is shaky and may not apply to my practice population. \235\222 Ineffi cient use of resources, eg scarce consultations are used up in follow-up. \235\222 My instinct warned me not to apply the protocol in this case.1 To get round the pr oblems of non-implementation of guidelines, some NHS primary care trusts send in visits fro m pharmaceutical advisers who have trained in outreach visiting (it is unfair to call them thought-police). But when this has been evaluated in randomized trials, no impact could be detected. 98 Can we square guidelines & targets with patient-centered care? (p478) Answer: No; discussing this issue with purveyors of guidelines is a good way reveal the hidden agen das described above. Point out that leading authorities are now saying patients must decide their own target BP, HbA1c, etc. 99 1 Understandably, many GPs don \200\231t follow protocols despite high awareness of them: o ther reasons include the fact that precise targets (eg for BP control) are always arbitrary , and should allow for some variation. \200\22599 491 The placebo and Hawthorne eff ects Placebo eff ects are very powerful and are important not just in research, but also in demonstrating to us how our demeanor may be just as importan t as the drugs we give. Both doctors and patients are susceptible to placebo ef- fects \200 \224and unintentionally we use the placebo eff ect every day \200\224as so few of our thera pies are validated for the exact individual patient in front of us. In one placebo-controll ed study of antihypertensives the partners of the enthu- siastic doctor broke the code, and told him that his experimental treatment appeared similar to existing treatments without t elling him who was having the active drug and who was having the placebo. \200\207From thi s point, there was an immediate, marked increase in BP in both groups, although the diff er ence between the drug and the placebo was maintained. 100,101 \200\207Our beliefs and our behavior sometimes matter more than our drugs. What is the mechanism of the placebo eff ect ? Psychological: Expec- tancy, anxiety reduction, and Pavlovian conditioning may operate. P sycho- somatic linkages: Endorphins, catecholamines, cortisol, and psychoneuroim- mumunolog y play a part. 102 Functional neuroanatomy: Placebos have real eff ects on brain and body: \200\207they are not just response biases. 103 The nucleus accumbens (NAC), a CNS region i nvolved in reward expectation, may mediate placebo responses. Dopamine release is seen duri ng placebo administration, and is related to its anticipated eff ects. Individual variation s in NAC response to reward expectation account for 28% of the variance in the formation of placebo analgesia. 104 Placebo in Latin means I will please e r a c y r a m i r P Don \200\231t conclude that we should give placebos to all our patients. This book is found ed on the idea that we must be honest and straightforward with patients. Nevertheless, it m ay be unwise to share too many doubts: one GP randomly as- signed his consulting style in t hose with apparently minor illness to a \200\230positive encounter \200\231 or a \200\230 negative encounter \200\231. In the former, patients were given a di- agnosis and told they would be better in a few days; the latter group were told that it was not certain what the matter was. \205\223 of patients having negative en- counters got better in 2 weeks, but over \205\224 of the positive group did so. We conclude that in medicine context matters, and we must all take steps to optimize contex t and expectation in holistic, positive, and optimistic ways. 103 Mandatory placebos? Some practitioners use evidence-based medicine (EBM) as a rationale for using placebos \200\224i ntentionally. The argument goes like this: if there isn \200\231t a gold-standard treatment for the condition, and if EBM shows that a placebo has above-baseline eff ects, and if a p lacebo response wouldn \200\231t mask serious pathology, and if the patient gives informed consent and is told about other options, then a placebo is warranted \200\224or even man- d ated. 105 There is one problem with this neat argument. The patient may well need to know t hat he or she has a chance of having an active drug for the placebo eff ect to work. Nocebo s Pharmacists often \200\230lea \202 et \200\231 customers with long lists of their drugs \200\231 side eff ects, that, like voodoo death, may be self-ful \201 lling prophesies. W e often underplay side eff ects like impotence on the grounds that in such a sensitive area , the mere mention of impotence might bring it about. Too paternalistic? The Hawthorne eff ect What is the optimal level of lighting for making circuit boards? Whatever level the exp erimenter tried (in the Hawthorne plant near Chicago in the 1930s), there was an increase i n productivity, even at very low levels, showing that the act of doing an experiment change s people \200\231s behavior. Special attention leads to special results. Similarly, in a tr ial of Ginkgo biloba in dementia, the placebo arm had two levels of follow-up, intensive an d minimal: patients showed better cognitive function in the former group. 106 We conclude t hat because of these eff ects, generalizing from research is fraught with danger. Bedside manners in a multicultural world \200\207Your patient is assessing you as much as you are assessing your patient. We come to this enterprise in a spirit of humility. There a re no culturally neutral or coherent encounters: all cultures have oddities and inconsisten cies. Use cross- cultural encounters as a metaphor for exploring your own prejudices, fears , and ideas of selfhood, 107 and come to accept that mastery here is counter-produc- tive,