THE POLITICAL PROCESS
The new generation broad-spectrum penicillin INDICATIONS AND DOSAGE Infections of the ear, nose and throat due to streptococci, pneumococci, and penicillinsensitive staphylococci; infections of the upper respiratory tract due to H. influenzae; infections of the genitourinary tract due to E. coli, P. mirabilis, and S. faecalis; infections of the skin and soft tissues due to streptococci, penicillin-sensitive staphylococci and E. coil: USUAL DOSE: ADULTS 250 mg every 8 hours CHILDREN 25 mg/kg/day in divided doses every 8 hours In severe infections or infection associated with organisms where sensitivity determinations indicate higher blood levels may be advisable: 500 mg every 8 hours for adults, and 50 mg/kg/day in divided doses every 8 hours for children may be needed. This dosage should not exceed the recommended adult dosage. Infections of the lower respiratory tract due to streptococci, pneumococci, penicillinsensitive staphylococci and H. influenzae: USUAL DOSE: ADULTS 500 mg every 8 hours CHILDREN 50mg/kg/day in divided doses every 8 hours This dosage should not exceed the recommended adult dosage. Urothrltis due to N. gonorrhoeae: 3 g as a single oral dose. CONTRAINDICATION In patients with a history of allergy to the penicillins and cephalosporins. Product Monograph available on request. SUPPLIED AMOXIL-250 Capsules-each contains 250 mg amoxicillin (as the trihydrate) AMOXIL-SQO Capsules-each contains 500 mg amoxicillin (as the trihydrate) AMOXIL-125 Suspension-125 mg amoxicillin per 5 ml, in 75 ml & 100 ml bottles AMOXIL-250 Suspension-250 mg amoxicillin per 5 ml, in 75 ml & 100 ml bottles AMOXIL Pediatric Drops-is ml (50 mg/mI) in dropper bottle
Ayersf. *. AYERST LABORATORIES Division of Ayerst, McKenna & Harrison Limited Montreal, Canada Made in Canada by arrangement with BEECHAM, INC. .Regd
Guidelines: what are they and how will they be used? MILAN KORCOK
Words like "standards" and "criteria", Milan Korcok was coming from the mouths of health mincommissioned by istry bureaucrats, often trigger strong CMAJ to write reflex actions among independentthis article on minded physicians. So when Dr. Derek development of Gellman, director general of health guidelines. His standards for DNH&W, in 1974 invited terms of referthe major national medical organizaence were to detions in to discuss formulation of guidescribe the present lines for physicians' clinical services, situation as he sees it, and the opinions he expresses there was a certain amount of suspicion are his own. Mr. Korcok is a freelance about what the government was up to. medical journalist resident in Toronto. (These guidelines would set out in He is a regular contributor to CMAJ. specific terms what a physician would normally be expected to do by way of procedures, tests and judgements in the eminent regulations or guidelines or diagnosis and treatment of given ill- both. But standards in clinical practice are nesses.) The suspicions ran deep: might guide- not well defined, said the working lines at some point be taken over by paper. Until recently, provincial licenspaying agencies as criteria for payment ing authorities have confined their at- or nonpayment - of fees for serv- tention to ensuring that a medical canice? Might cost-conscious governments didate had reached a recognized standuse criteria checklists as means to "cut ard to qualify for a medical licence. the fat" out of patient services? Might It was only if any complaints were governments not end up with all the received or a physician was involved tools they need to dictate how any in criminal proceedings that the licensing bodies acted further. physician should treat his patient? Individual hospitals too are responThe message from Gellman, sent in to do the job by a federal/provincial sible for standards of care given by advisory committee on health stand- their medical staffs, but in few places ards, was clear: the point of the exercise are these guidelines written down; was not intrusion, but objective assess- much of the evaluation rendered depends on how the individual evaluator ment of the quality of care. Said Gellman in a working paper: himself sees things, not on an objective "There is... nothing new in the idea set of criteria. "True, I could not guarantee that of developing standards and guidelines in the health field. The health profes- government would never, ever, allow sions have had educational standards these guidelines to be used by paying agencies," said Gellman. "But I could for years." The Canadian Council on Hospital assure them (participating groups) that Accreditation also has standards against this was not what the federal governwhich it assesses certain physical char- ment had in mind." Suspicion aside, and given the posacteristics of the different types of institutions it inspects, he noted. Med- sibility that government might just go ical equipment, drugs and special care ahead, unilaterally, and carve out its units in hospitals are all subject to gov- own guidelines, the Canadian Medical CMA JOURNAL/NOVEMBER 6, 1976/VOL. 115 9$7
fear lies in the unsavory prospect of government meddling in a jurisdiction that rightly belongs to the medical profession. Dr. Manning Mador, CMA board member who served as the association's representative to the early meetings of Geliman's committee, is highly suspicious of what government is up to. To him, the most critical question is what political use might be made of clinical guidelines. "All their pious statements to the contrary, I don't think many of the politicians and officials in the health field are all that interested in quality. They talk about it, but what they really are interested in is economics. Mador claims it is not Gellman he mistrusts, but the government for which Gellman works. "He is being used," says Mador bluntly. When the CMA withdrew its participation, the scenario dictated that the other medical organizations would follow. To CMA's surprise, they did not. Even when the royal college canvassed some of the specialty groups across Canada and found much opposition to the guidelines program, the college stayed in. Why? Mador believes there is a psychology of consentient participation rampant in Canadian society. "Canadians seem to believe that if government embarks on something, it is too big to be stopped, and so we believe it is better to hang on. "I don't believe in the sanction of the victim; it only adds to the government's strength. They not only screw you, but they want you to participate in the process." Other views Not all remaining participants in Gellman's committee share Mador's cynical view of consent by participation. Dr. Murray Cathcart, steering committee member representing the College of Family Physicians of Canada, admits there is a good deal of caution vis-.-vis government in the guidelines program - "We are aware of CMA's concerns; we don't dismiss them." The family physicians' college has been advancing some imaginative assessment models of its own in recent years, but the chances to work out guidelines across the disciplines adds another dimension. Cathcart is pleased with the opportunity to work at the definition of guidelines. He has seen the first drafts of the guidelines and he likes what he sees especially the way the expert panels have avoided the "cookbook" criteria that have characterized medical audit prototypes and some US guidelines.
Assessment of professional performance has proved a difficult task likened to an impenetrable swamp. Much of the activity to date has been hospital-based, much of it focused on retrospective surveys of hospital records. The Canadian Council on Hospital Accreditation has been active in helping institutions initiate and conduct clinical appraisal programs in hospitals. With the aid of a Kellogg Foundation grant, the CCHA has organized a pilot do-it-yourself project among a group of hospitals in the Niagara peninsula. In the United States, the Joint Commission on Accreditation of Hospitals has developed guides and standards in a variety of clinical practice fields. As well, professional standards review organizations (PRSOs) have worked out detailed criteria against which to measure physicians' activities. But a prevailing emphasis throughout these appears to be a centralized control for medicare and medicaid programs. If medical services given by a physician don't meet the national standards as encoded in the criteria, the doctor doesn't get paid for his medicare and medicaid patients. These programs are geared more to utilization data than to assessment of "quality" of care. The development and application of "guidelines" requires something: more than a charting of all the procedures and tests that might be appropriate given any particular condition. And in many of the US criteria this is the case - largely because of the defensive medicine forced upon many American physicians by malpractice threats.
Different in Canada The practice of medicine in Canada is widely diversified - not all physicians have access to the same facilities, not all have the same training background. And so it would be ludicrous to expect all to be able to adhere to one rigid set of national "guidelines" which list, from A to Z, the tests and procedures that must be checked off in appropriate boxes. Dr. Mador is sceptical of this national approach. "We felt it was a terribly retrograde step to draw up an arbitrary set of 100 or so items which you checklisted as if you were doing a tuneup on your car. "The practice of medicine is different across Canada. Physicians were trained to know how to investigate specific types of cases. They have their protocols built in. So why do we need national guidelines?" But what Gellman envisions, and what his committee colleagues have taken as an article of faith, is that
out of its own purse. At least there won't be any taint of government "meddling".
Geilman: flexibility essential
whatever guidelines are developed, they will not be distorted into Mador's auto tuneup paradigm. "No standards can be formulated which cover all conceivable complications. Flexibility and adaptability are essential in order to allow the physician discretion in choosing what service he feels would be most beneficial for his patient," insists Gellman. "They would have to be very flexible to allow for individualized care in special circumstances. "In the majority of cases, if things go as they are supposed to, there are relatively few things one would insist upon seeing every time. And once you begin to get into complications you can forget about criteria." CMA withdrawal When the CMA board withdrew in 1975 it did not act in consensus. Had the Ontario caucus not been strong, the association might, right now, be involved in evaluating a pilot set of guidelines. There is irony in the sequence. Though in June 1976 the general council reiterated its rejection of the Gellman guidelines program, in September the board gave approval to the establishment of a "patient care appraisal subcommittee". It would be within the Council on Medical Education and would have representation from the Council on Medical Services. Now, instead of developing guidelines at federal expense, I wonder whether the CMA will end up doing it
Subcommittee's task The subcommittee is charged with developing a plan to outline ways in which the CMA might help its divisions develop patient care appraisal mechanisms. How much, if any, dovetailing there might be with the Gellman group is at this point speculative. If the subcommittee survives in 1977 (its funding past 1976 is not confirmed) it may face the problem of support for the concept of patient care appraisal. Tactically, the best way to do this appears to be by emphasizing the educational aspects of patient care appraisal. That is what Joseph Chouinard, coordinator of the Council on Medical Education, has been doing in his proPCA lobbying. Some excerpts from Chouinard's presentation: * The primary purpose of patient care appraisal is to improve patient care by educating physicians. * The CMA should encourage physicians to use patient care appraisal in their practices as a basis for determining their needs for continuing medical education. * The CMA should prepare a climate of acceptance in the medical community for systems of patient care appraisal for continuing self-evaluation and education. * The objective of PCA is not medical audit, utilization review or claims review by paying agencies. The purpose of PCA is to define the real educational needs of practising physicians in order to gear continuing medical education accordingly. More than a list Within this broader objective, it may become necessary to define just the kind of criteria and standards being patterned by the Gellman committee. But there is more to patient care appraisal than that, says Chouinard, certainly more than the delineation of "shopping lists". What seems a more likely result or at least a goal - might be the development of expertise (a full-time staff or resource person) available to hospitals, groups, clinics etc. in the provinces, to help them devise an appraisal system most appropriate for them. This would allow appraisal techniques to get away from rigid national criteria and would encourage provincial divisions to work up their own systems. The purposes would be to involve local physicians in their own appraisals and establish realistic expectations related to the level of diagnostic and
CMA JOURNAL/NOVEMBER 6, 1976/VOL. 115 941
Bactrim DS Roche Rx summary Inicatlons The following types of infections when caused by susceptible pathogens: * Upper end lower respiratory tract infections (particularly chronic bronchitis and including acute and chronic otitis media) * Genitourinary tract infectiona: acute, recurrent, and chronic cyatitia, pyelonephritis, urethritia (including uncomplicated gonococcal urethritia), prostatia, vaginitia, cervicitia, aalpingitis * Gastrointestinal tract infections It is not indicated in infections due to Pseudomonas, Mycoplasma, or viruses. Contralnicatlons Evidence of marked liver damage; blood dyscrasias; known hypersensitivity to trimethoprim or sulfonamides; or marked renal impairment where repeatedserum assays cannot be carried out. Infants during the first few weeks of life (especially premature infants). For the time heing, during pregnancy. Adverse reactIons Most frequent: nausea; vomiting; gastric intolerance; and rash. Less frequent; diarrhea; constipation; flatulence; anorexia; pyrosis; gastritis; gastroenteritis; urticaria; headache; and liver changes (abnormal elevations in alkaline phosphatase and serum transaminase). Occasionally reported: glossitis; oliguria; hematuria; tremor; vertigo; alopecia; and elevated BUN, NPN, and serum creatinine. Hermatological changes, occurring particularly in the elderly, are mostly transient and reversible (primarily, neutropenis and thrombocytopenia; less frequently, leukopenia, aplastic or hemolytic anemia, agranulocytosis, and bone marrow depression). Precautions As with other sulfonamide preparations, benefit should be critically appraised against risk in patients with liver damage, renal damage, urinary obetruction, blood dyscrasias, allergies, or bronchial asthma. The possibility of superinfection with a non-sensitive organism should be borne in mind. Dosage and admlnlefratlon Adulrs andchildren over i2 years of age: Standerd dosage; 1 Bactrim OS Roche tablet or 2 aduit tablets, twice daily. Minimum dosage and dosage for long-term treatment; '/2 Bactrim DS Roche tablet or 1 adult tablet, twice daily. Maximum dosage (overwhelming infections); 1/2 Bactrim' DS Roche tablets or 3 adult tablets, twice daily. Supply OS tablets, containing 160mg trimethoprim and 800 mg sulfamethoxazole. Bottles of 100 and 500. Adult tablets, containing 80mg trimethoprim and 400mg sulfamethoxazole. Bottles of 100 and 500. Bactrim Roche is also available as suspension (aniseedflavoured) and pediatric tablets. Product monograph available on request. * Trade Mark of Hoffmann-La Roche Limited ®Reg. Trade Mark
But what next? So far, much of the debate has revolved about the techniques of developing guidelines. It should be fair to ask: after the guidelines what? Having information does not always lead to changing an attitude, and even a shift in attitude is no guarantee that behaviour will change. Dr. Robert H. Brook, a systems scientist with the US Department of Health, Education and Welfare, urges caution in assuming that, because a set of groundrules are set up, all the players will abide by them. Dr. Brook notes that in two distinct criteria evaluations - one done by the American Society of Internal Medicine, and the other by a committee of the American Academy of Pediatrics - compliance with a given list of criteria was low, even though the physicians themselves approved the lists. Apparently, there were no positive correlations between what the physicians actually did and what they thought they should have done. Brook postulates that "unexpected results occur when physicians, espe-
Noludar Roche. (methyprylon) Rx summary: Indications Insomnia due to mental 'iflrest, excitement, fear, worry or 3xtreme tatigue. Adverse reactions Nausea, headache, drowsiness, vertigo, paradoxical excitation, and skin rash. Precautions As with other hypnotic agents, patients should be advised to abstain from alcohol during treatment with Noludar as the individual response cannot be foreseen. Dosage Adults: 1 capsule at bedtime. Children: over 6 years - 100 mg at bedtime. 2 to 6 years - 75 mg at bedtime. 6 months to 2 years - 50 mg at bedtime. Supply Capsules, 300 mg; 100, 500. Elixir, 50 mg/tsp. (5 ml); 400 ml. Complete prescribing information available on request. ®Reg. Trade Mark Hoffm ann-La Roche Limited XEUU.UUI.DIII../'
942 CMA JOURNAL/NOVEMBER 6, 1976/VOL. 115
cially practising physicians, are asked to develop criteria. Unfortunately, they tend to select and accept a laundry list of unimportant process criteria. Yet their actual behaviour tends to indicate that they already have rejected this list. "Perhaps the development and acceptance of these criteria lists is a function of the practising physician's desire to demonstrate his knowledge to his superior. Or perhaps it is a result of the artificial nature of the criteriasetting sessions." Says Brook: "If the state of the art in assessing the quality of medical care is not sufficiently dismal, the state of the art in examining ways to change physician or institutional behaviour certainly is." For example, claims of members of a California medical foundation go through a peer review system that uses previously defined criteria to determine acceptability for payment. A Johns Hopkins study of this system, examining 3½ years of experience, showed that even denial of payment for specific services didn't substantially change physician-practice behaviours. Physicians who had more than 7% of their claims denied in 1969 still had, a large percentage of their claims denied in 1972. And those physicians who had the largest number of claims denied didn't change their behaviour any more than did physicians who had only a few denials. Says Brook: "The hope that improvement in the health of American people will occur as a result ot requiring that a laundry list of process criteria be developed and implemented, that physicians retake board examinations or that they attend continuing education courses in San Francisco, Miami or Europe must be firmly rejected..
Patient outcome Brook denies that he is a therapeutic nihilist arguing that nothing works and that everything is doomed to failure, but he does push for a clearer definition of what works and what does not work in terms of patient outcome. And clearly, patient outcome should be the bottom line of any quality assessment program. But how do you measure patient outcome and how do you relate that directly to the effects of criteria? The only way to achieve that would be to run randomized, large-scale experiments on patients who went through certain "guideline" processes, and others who didn't. That becomes expensive. St. Joseph's Hospital in Hamilton, which adapted University of Michigan criteria to its own situation, found that
1 year after the emplacement of pneumonia treatment criteria, physicians were more consistent in their treatment of that illness. In effect, the treatment process was "better" because it corresponded more closely to preset criteria. But what this evaluation could not do was define whether the criteria were good criteria or bad' criteria. And then there would always remain the judgement about what constituted optimal outcome; was it a higher cure rate,
period? Was it a more equitable balance between high cure rate and moderate public expenditur&. Or was it a reasonable cure rate at a lower expenditure? The questions about what constitute good and bad criteria are difficult enough without mixing in the issue of government intrusion in professional activities. But Geliman does see a justifiable federal role in choosing areas of priority for health standards and coordinat-
ing the efforts of various national organizations to do the job. The role of government as he sees it is of a catalyst. To him it would be "just wonderful" if one or all of the professional groups wanted to get together to develop criteria that could be used for medical audit and peer review. "I have a small directorate and a small budget. There are many other things we could be doing." But in the meantime, a little push here, a nudge there...E
Discussion of alcohol becomes more rational when the issue moves from morality to health MIL.... KORCOK Wolfgang Schmidt, Canada's most prolific scientific resource on the epidemiology of alcoholism, was somewhat bemused by the steady rattle of typewriters and the whirr of television cameras that blocked out one end of the Royal York conference mezzanine. "It is marvelous to me that the press has become so interested in the subject of alcoholism. Every day since this conference started we seem to have had headlines, and most of the articles have really been quite accurate . amazing!" The conference was organized in June by the Canadian Foundation On Alcohol and Drug Dependencies in Toronto, and for a week it delivered a steady stream of information - and lots of opinion - about the extent of alcohol use in modern society, the status of treatment, the frontiers of research and the tentative advances of public education. To Schmidt, associate research director of Ontario's Addiction Research Foundation, the wonder of this conference-media process was that it was so objective, so free of proselytizing. "It seems that an understanding of the public health consequences of alcohol abuse are starting to get through," he suggested. If "getting through" means that facts and reports are being read and being heard, then he is probably right. But if "getting through" means causing certain impulses to travel from the eye, through the brain, to the elbow, that is another story. And that is the critical reflex that is going to determine whether the federal and provincial "safe-drinking" educational programs now in process are going to be worth the money. Ii was at this conference (reported in CMAJ 115: 260, 1976) that Minister of National Health and Welfare Marc Lalonde announced Ottawa's
"Dialogue on drinking", now becoming visible in newspapers across the country. In Saskatchewan, Manitoba and Ontario public education programs using print and broadcast media have been operative for more than a year. Some, such as Saskatchewan, claim to have changed some public attitudes toward existing drinking practices. Of course, such claims are hard to substantiate. But it is significant that so many politicians and health bureaucrats see the alcoholism-health issue as one worth spending money on. For years, the counterweight to the alcohol manufacturers and distributors was the evangelical zeal of temperance organizations and some churches. But when these influences went into demise, the forces of liberalization became virtually unopposed. One after another governments yielded to pressures to open up consumption, allow a variegation of drinking locales, lower drinking ages and reduce restrictions on merchandising. Now, as reflected by political concern about drinking drivers and teenage drinkers, there seems a backlash to this liberalization. But it is a backlash stirred up not by the temperance forces, but by growing evidence that alcoholism is in fact an insidious public health problem, one placing a heavy burden on the public purse. Well before Health Minister Lalonde issued the booklet "A New Perspective on the Health of Canadians" in spring 1974, the Ontario Addiction Research Foundation (ARF) was urging its parent government in Queen's Park against further liberalization, at least until evidence could be gathered to assess the consequences. The ARF argued strongly that changes in drinking and marketing regulations be allowed only after the
potential health consequences had been studied - if regulations were changed to allow drinking at a park picnic, for example, might this have health consequences? At first glance, it is hard to see how a plastic cup of sauterne, sipped under a tree, could have any impact on the health system. As an isolated incident it probably wouldn't. But trends are made up of a lot of isolated incidents strung together. However, if politicians were to involve themselves on the issue of drinking in parks or at the baseball game, or if they were to nasty their hands on so tacky an issue as booze price increases, they would have to be convinced that such isolated incidents did in fact make up a continuum of hazard. Because alcoholism manifests itself in so many ways, sociological research in this area has often been imprecise and the results subject to many interpretations. But one of the lines of research that did not suffer from lack of substance was that concerning consumption patterns within populations. At the ARF and organizations such as the Finnish Foundation for Alcohol Studies, the development of consumption models received the highest priority. What these studies showed was that alcoholism was everybody's business. Each individual by his own attitudes influenced the environment about him, and in turn this helped influence the drinker in trouble. It was a French mathematician, Sully Ledermann, who in 1956 first provided the empirical model needed to show that the rate of heavy alcohol use in a population has a correlation with overall consumption. This led to subsequent conclusions that control of alcoholism must extend beyond efforts to
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