Welsh Institute for Health & Social Care, Glyntaff Campus, University of Glamorgan, Pontypridd CF37 1DL, UK. E-mail jthart{at}glam.ac.uk
John Bunker entered anaesthetics in the late 1940s, just when its leaders were starting its promotion from amateurism to its present status as the most rigorous and audited physiological practice in medicine. He thus became a participant yet but objective observer of surgical advance over the next 50 years, of its gains and of its collateral losses. His multi-authored book Costs, Risks and Benefits of Surgery1 revived interest in clinical health economics, pioneered by Codman in 1914.2
His important paper brings his work up to date, concluding that possibly half our added years of life gained over the past 50 years may be attributable to medical intervention.3 As McKee says in an excellent recent review of the efficacy of care,4 many of his assumptions are optimistic. McKee points to the yawning gap between what was possible in research trials, and what has been achieved in practice, and doubts whether this gap will close simply with passage of time.
Most research trials take place in a contrived world whose population and whose professional carers both differ profoundly from those in the world of real practice. Trials generally exclude people with complex problems. For manual workers and their families in areas of industrial decline, who present the greatest challenge to medical services in developed economies, single problems are exceptional. Using European self-reported data, morbidity (any chronic disease or disability) lies around 73% in the age group 5579, and comorbidity (two or more chronic diseases or disabilities) lies at 60%.5 Most studies of general practice detect far less comorbidity. For example five practices in Holland with 25 534 patients were searched for casually detected comorbidity, and showed isolated disorder for 89% of chronic lung disease, 88% of hypertension, 74% of ischaemic heart disease, 69% of diabetes, and 69% of degenerative arthritis.6 But where problems are sought more systematically and proactively (as they must be to define exclusions from trials) the higher subjective rates are confirmed. After more than 20 years of systematic proactive case-finding for major chronic health problems in Glyncorrwg, we accumulated 154 men and women with treated hypertension. Searching these for evidence of 12 other clinical problems, only 3% of the men and 7% of the women had hypertension as a single disorder.
Socially responsible clinicians in countries with populations registered for care (rather than undefined numbers of customers) are responsible for everyone. They cannot exclude people because their problems seem too complicated, though many seem in practice to limit the problems they recognize to whatever they feel competent to handle. Those excluded from most trials are precisely those in most urgent need of care, and for whom care might be most cost-effective. As Barbara Starfield has said, this is the most important and most neglected field of research for primary care.7 For routine practice to converge with routine research, researchers must stop making things so deceptively easy, and move closer to the real world.
The populations are too different, and so are the circumstances in which professionals both choose and are compelled to do their work. Research trials provide (usually within narrow limits) planned, proactive care for defined populations, implemented by clinicians with elementary public health skills and orientation. Routine practice provides unplanned, essentially reactive care, usually for undefined populations, often with resources of time, staff and training which are insufficient to their task. Where patients are still customers shopping around in a care market, rational planning of any kind becomes almost impossible. To bring research theory and routine practice together, the circumstances and attitudes of both sets of professionals must change.
Can We Narrow the Gap Between Trial Possibilities and Practised Realities?
The short answer has to be yes, but only with immense difficulty. Trial possibilities need to become more relevant, by ending the policy of simplifying but falsifying exclusions. And practised realities must stop using the products of science with little regard for elementary rules of scientific rigour and integrity.
Doctors in practice inherit a culture that dared not claim public health gain as its measurable outcome, because this product would have seemed so small. Instead, it wanted full marks simply for trying. Whatever merit this may once have had, advance in medical knowledge has nullified. To mean well is not enough, we must do well.8 This doing must be measurable as health gainlonger, healthier lives, and healthier deaths. If circumstances preclude good care, we share responsibility with our patients to change them: our patients have votes, and we have their names and addresses.
For problems amenable to treatment, affordable solutions depend chiefly on improved anticipatory care of impaired health. They depend much less than we or the public like to think, on crisis intervention and salvage.
Like the quality of research, the quality of anticipatory care depends on cumulative records rigorously maintained. These become the material and verifiable expression of continuity essential to effective care.9,10 In this context, continuity should be defined not as patients seeing the same doctor, but as patients not being compelled to repeat, simplify and ultimately distort their stories, to suit all the different and often uncoordinated professionals with whom they must deal. Real lives can only be understood (and changed) as cumulative stories. Effective care must reflect this reality, through clinical records that accumulate information, using personal stories as their stem. Naturally this is easier for patients to understand, but it is also indispensable for professionals, who need not just the bits they want for simple caricatures, but the entire context required for shared judgements resulting in ultimate health gain. If trials come to accept more representative problems as their material, they will have to accept these same requirements for patients' records.
Professionals actually responsible for delivering care to whole populations know that the people with most to gain from relatively simple but effective care are those with the least access to it, who are the most difficult to reach by proactive measures, and the least attractive to traders in care as a marketed commodity.11 In terms of health gain, the key to rapid improvement in clinical productivity lies in better treatment for poor, chronically sick, unprofitable people.12 The most neglected but also the most productive opportunities for effective care are concentrated among the poorest people, so that resources concentrated on them will normally give higher health gains per unit of investment, benefiting not only these patients, but the whole of society.
In the English language literature, I know only three examples of valid comparison between the results of ordinary reactive care, prompted by individual complaints, and continuing anticipatory proactive care, prompted both by complaints and by perceived personal and community needs. These are: a 2-year study in New York which finished too soon to prove anything except that patients liked it more, and it detected many more problems than the ordinary reactive care then available;13 the US Hypertension Detection and Follow-up Program (HDFP);1416 and my own comparison between mortality rates in two South Wales coal-mining communities,17 one managed proactively, the other reactively. All three were sick populations, typical of those posing our most intractable problems for health care.
US Hypertension Detection & Follow-up Project 19761979
In 1976, when the HDFP began, treatment of mild to moderate hypertensives in the diastolic range below 105 mmHg was unsupported by controlled trials. Without such evidence, 78% of doctors in New York State were already routinely prescribing antihypertensive drugs from a diastolic threshold of 90 mmHg. By 1979 (when HDFP results were available) this had risen to 90%.18 It was therefore ethically indefensible to randomize patients either to active treatment or placebo. Instead, the HDFP first identified a large (11 000) hypertensive subset randomly sampled from generally poorer populations (with most to gain and therefore most likely to co-operate) and then allocated them randomly either to whatever care was usually available from the US care market (usual care) or to free, planned proactive care by specially trained nurse practitioners (stepped care). The results represent the only randomized controlled trial we are ever likely to see, between marketed reactive care and socialized proactive care in terms of their efficiency in producing net health gain, measured as mortality from all causes, on an intention-to-treat basis.
As expected, results after five years showed 26% fewer cardiovascular deaths for people randomized to proactive care than for people randomized to usual reactive care. Completely unexpected, and still unconvincingly explained, this group also had 13% fewer non-cardiovascular deaths. These results implied some substantial advantage for free, proactive organized care for a whole population according to need, compared with operation of the usual US commodity market in medical care. The reality of this conclusion was accepted (though not in these terms) at the 89th annual meeting of the Association of Life Insurance Medical Directors of America.19 Retrospectively, it seems that many, probably most, of the nurse practitioners giving stepped care had helped patients in many ways other than by controlling their blood pressures, rightly believing that continued compliance largely depended on comprehensive approaches to care and willingness to listen to the wider concerns. Usual care from usual doctors remained predominantly reactive and narrowly focused. As the trial was not planned to address such questions, this interpretation is necessarily speculative, but it seems the most obvious and plausible.
Another anomaly was that whereas in virtually all trials benefits of treatment are greatest in patients with most deviant indices of disease, in the HDFP differences in death rates were greatest for hypertensives in the lowest diastolic range 90104 mmHg. In this group there was no significant difference between results of usual care and proactive care for white women, but for black women deaths from all causes were 28% lower in the proactive care group.15 Overall, 77% of the difference in deaths between proactive and reactive care occurred in black patients, though they composed only 44% of the trial population,20 and only about 11% of the whole US population. Though the trial population was drawn from screened random samples, these were selected from localities served by US medical schools, which are generally poorer and sicker than the US population as a whole.
They were also much poorer, and very much sicker, than the UK populations sampled by the superficially similar Medical Research Council (MRC) trial of treatment for mild hypertension, whose results appeared six years later, showing barely significant benefits from treatment in this diastolic range. With economic incentives to minimize rather than maximize their patients' needs, UK doctors were more sceptical than their US colleagues, and less eager to act beyond the evidence.21 The MRC trial could therefore be a straightforward comparison between screened people in the diastolic range 90104 mmHg randomized to active or placebo treatment, double blind within the same care system.22 Death rates during this trial, both from stroke and from all causes, were almost one-third, and coronary deaths were less than half, of those in the HDFP. Mortality and morbidity differences between these two trials were probably socioeconomic rather than racial.23 The HDFP was selective for poor communities, and thus may have exaggerated benefits for the US population as a whole. The MRC study was selective for affluent communities, and may well have understated potential benefits for poorer UK communities.
Community management of high blood pressure was, and still is, a useful model for community management of all chronic disorders. In the US, over 45% of non-institutionalized citizens have one or more chronic disorder. Their direct costs account for 70% of US health care expenditure,24,25 and the UK proportion is probably similar. Most of these patients are neither elderly nor disabled, though obviously prevalence and complexity rise steeply with age. Effective and economic management of all chronic problems and combinations of problems depends on enlisting patients as co-managers of their problems and co-producers of their own health, rather than passive and credulous consumers.26 No amount of technically excellent care can maximize health outcomes if patients are not actively engaged in managing their own problems, particularly chronic problems,27 with continuing support. These factors were evidently provided more consistently by free proactive care through the HDFP than by usual care through the medical market.
Afan Valley 25-year Study
From 1961 to 1987 I was responsible for organizing most of the primary care for a population of around 1800 in the coal-mining village of Glyncorrwg, remaining as research observer to 1992. Starting from a local census in 1965 to establish an accurate denominator, and screening of the whole population aged 2079 for blood pressure in 1968,28 all hypertensives meeting contemporary evidence-based criteria were offered treatment and indefinite follow-up at not more than 3-monthly intervals with proactive recall.29 Over the following 20 years we gradually extended systematic case-finding throughout this population (with proactive search for the small minority of non-consulters over a 5-year period) for other chronic disorders, including smoking, chronic lung diseases, diabetes, obesity, and alcohol excess.
In 1991 we compared mortality under 65 for 19811986 in this population, with that in Blaengwynfi, a neighbouring population of similar social composition receiving usual reactive care of a high standard. Ratio of actual to expected deaths (derived from mean UK rates) was 21:22 for Glyncorrwg (proactive care) and 48:30 for Blaengwynfi (reactive care). Using Townsend Index as a measure of social deprivation, Glyncorrwg and Blaengwynfi both ranked in the worst 5% of the distribution in 55 electoral wards of West Glamorgan County. For age-standardized mortality under 65, Glyncorrwg ranked fourth lowest, Blaengwynfi 32nd lowest out of 55.30 Note that though continuing proactive care seemed more effective than good reactive care, good reactive care did seem to have an effect.
So far as it goes, this evidence suggests that in poor communities which retain high social morale, planned, proactive continuing care within a public health-oriented strategy can compensate for some of the lethal effects of social deprivation, and do so more effectively than good reactive care alone. The italicized proviso is critical. Since defeat of the miners in 1985 and decline of most UK manufacturing industry, there has been a disintegration of social morale, particularly in young men, creating a new and for this purpose untested situation. This has occurred in Glyncorrwg as much as any other former mining community, with health consequences, which though no longer measured, are only too obvious.
This study was limited by small numbers, wide confidence limits, and opportunistic design. However, it provided detailed evidence on the extent of hitherto unmet needs,31 about how work was organized, the staff numbers, skills and attitudes required to perform it, and measures of exactly what was achieved in changing (or failing to change) indicators of risk. For example, male smokers fell from 61% in 196870 to 36% in 1985 (verified by urine cotinine measurement), but women showed no significant change (43% to 42%). There were also no significant changes in body mass index or total blood cholesterol (this was the pre-statin era).
All three examples suggest ways in which actual care can converge with scientific experiment. Epidemiological studies and trials need to learn from best practice in continuing primary care, with many more long-term cohort studies integrated with routine care, and far more active roles for patients in research as well as in care processes.32 Primary care practice must cease to be the personal fiefdom of GPs, and must become properly staffed and resourced to perform its full social function as the principal site for ambulatory and continuing care.
Conclusion
The gap between what research suggests may be possible, and what is actually achieved in routine practice, can and should be reduced. To some extent this can be done by designing trials that are socially more realistic, and addressing the problems of clinicians and patients on the ground, which means both these groups should be represented at the design stage. Chiefly it depends on redefinition of medical professionalism, to include social responsibilities once marginalized to Public Health as a subordinate and often homeless speciality, and a large redistribution (as well as expansion) of resources to allow this redefinition material expression.
Whatever its value compared with other social factors, the relative contribution of medical care is growing and will continue to do so. As Bunker says, this means that failure to implement existing medical knowledge for all who can benefit is becoming more rather than less important as a cause of social class differences in health. I am not convinced that attempts to quantify the relative contributions of medical care or of other social variables are useful, meaningful, or perhaps even possible. In practice, wider availability of good medical care has gone hand in hand with rising wages, rising employment, wider provision of social housing, and more generous provision of free public education. All these public services have advanced together, and in periods of social retreat, all have suffered. Voluntary retreat by one has not led to preferential advance for another, but simply reduced the overall burden of public services on those too rich to need them.
Acknowledgments
I am grateful to Tony Beddow, Nick Gould, Ben Hart, Sheila Ryan Johansson, Morton Warner and Graham Watt for necessary and helpful criticism.
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