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Creativity in clinical research is alive and well in Canadian family practice. Do we know it when we see it?

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1194 Canadian Family Physician • Le Médecin de famille canadien dVOL 50: SEPTEMBER • SEPTEMBRE 2004

Editorials

Family Medicine Researcher of the Year 2003

Moira Stewart

his editorial celebrates the first Family Medicine Researcher of the Year. The Section of Researchers of the College of Family Physicians of Canada (CFPC) initiated this award to honour a family medicine researcher who has been a pivotal force in the definition, development, and dissemination of concepts cen- tral to the discipline and who has made origi- nal contributions to research and knowledge in family medicine. Th e award will be given annu- ally; the recipient will be chosen by the Section of Researchers Executive and an international selection committee. Th e 2003 Family Medicine Researcher of the Year is Dr Ian R. McWhinney, Professor Emeritus in the Department of Family Medicine at the University of Western Ontario (UWO) in London.

Dr McWhinney has mentored several genera- tions of researchers, not only at UWO, but also across Canada. Students have been inspired by his vision of family medicine research and by Dr McWhinney as a role model.

Dr McWhinney has made at least three impor- tant intellectual contributions to research over the course of his career. The first was his emphasis on the part of medicine that only family medicine

research can illuminate: the early signs of illness.

Th e second was a unique concept of family med- icine: following patients over time. Th is was illus- trated by the Headache Study Group, a network of family physicians who conducted a seminal study of headache patients over 1 year. Dr McWhinney’s current emphasis, and the topic of three recent keynote speeches, is clinical research that uses the observations of family physicians over time to make new discoveries about conditions and treat- ments. He advocates for “discovery research” in family medicine.

Dr McWhinney’s third contribution was the investigation of “deeper diagnosis.” Th e research program built on these concepts has led to impor- tant papers on patients’ experience of illness and the patient-centred clinical method.

Part of Dr McWhinney’s acceptance speech for the 2003 Family Medicine Researcher of the Year award is reproduced below.

Dr Stewart is a Professor in the Department of Family Medicine at the University of Western Ontario in London and is Director of the Centre for Studies in Family Medicine and the Th ames Valley Family Practice Research Unit.

his editorial celebrates the first Family Medicine Researcher of the Year. The Section of Researchers of the College of Family Physicians of Canada (CFPC) initiated this

T

Creativity in clinical research is alive and well in Canadian family practice

Do we know it when we see it?

I.R. McWhinney, OC, MD, FRCGP, FCFP

I

defi ne descriptive clinical research as research that is part and parcel of our day-to-day practice.1,2 It does not begin as research. It begins as some- thing we observe: perhaps an experience that contra- dicts what the textbooks say, a prognostic symptom

or symptom cluster we have noticed, or a therapeutic practice we have developed that seems to work.

Clinical research is “observing, recording, clas- sifying and analyzing.”3 Clinician scientists are participant observers. As patients’ doctors, they

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VOL 50: SEPTEMBER • SEPTEMBRE 2004d Canadian Family Physician • Le Médecin de famille canadien 1195

Editorials

acquire knowledge that can be gained in no other way. In trusting relationships, confidences are shared that might be concealed from a stranger and omitted from responses to questionnaires. Family doctors know how illness starts, how it progresses, and how it is determined by contextual factors.

One of the myths about clinical research is that you need to be trained in epidemiology and biosta- tistics. Not so. Epidemiology is an important study for us in family practice, but it comes after the cre- ative work has been done. At the creative stage, a clinician gets immersed in the experience, becomes a reliable clinical observer, and keeps good records of the observations. The first fruits might be a case report or a case series that provides plausibility for the observations. A retrospective case series might be followed by a prospective cohort study, which could be regarded as the point at which more for- mal research begins. Even at this stage the method is very simple.

Creative stage

At the early creative stage, our method does not have to fit into the pigeonholes developed for other disciplines. It does not have to be given a name.

The main thing is that it should be true to the expe- rience of family practice. If asked what our hypoth- esis is, we might say, “I don’t have one yet.” If asked how we got our sample size, we might say, “I didn’t.

The sample is my patients with the condition I’m studying.” Did I get ethical approval? “No, because I wasn’t doing formal research. I was just trying to improve my usual care.” Is it not all just anecdotal?

Of course it is. So was Fleming’s discovery of peni- cillin. So was Jenner’s discovery of vaccination. The word anecdotal has become a mindless cliché. Let us stop using it.

Much useful research is done without a creative phase. Thomas Kuhn4 called this “normal science,” a process of “mopping up,” filling gaps in our knowl- edge and pursuing the questions raised when the early creative work has been done, validating the insights of original thinkers. Normal science fol- lows methodologic principles and has a creativity of its own, but tends to be more routine.

Clinical studies are sometimes classified as qual- itative. This is not so. Clinical research stands by itself. It transcends the qualitative-quanitative dichotomy. Clinicians might note, for example, that patients with depression disclose marital unhappi- ness and report the percentage of patients who did so, classified by age and sex. Clinical research can be qualitative and quantitative at the same time.

The mathematics is a matter of classifying patients into categories with predictive power. Taxonomic research, so important in diagnosis, prognosis, and therapy, can be done without a knowledge of statis- tics. An ability to classify, to count, and to calculate percentages is the main requirement.

The world of creativity has a different logic from the world of normal science. Creativity often springs from the unconscious. Koestler5 describes some creative acts as the bridging of two previ- ously separate matrices, thus fusing frames of ref- erence hitherto thought to be unconnected. Jenner discovered vaccination by connecting the dreaded smallpox with the mild skin eruption called cow- pox. “The great field for new discoveries,” wrote William James,6 “is always the unclassified resid- uum.” General practice is the field where much of medicine’s unclassified residuum is to be found.

Validation

The journey from creativity and discovery to pub- lication and dissemination raises the issue of vali- dation. There are several levels of validation, from demonstration of clinical and biological plausi- bility7 to intuitive acceptance and replication by our peers, to prospective cohort studies, and ulti- mately to controlled trials. The necessary valida- tion will vary from topic to topic. A therapy that has an immediate and dramatic effect in changing the course of a disease will probably not need to go so far as a randomized trial. Clinical trials were not necessary when penicillin was introduced or when Bagratuni recognized polymyalgia rheumatica as a category separate from rheumatoid arthritis.8

It is difficult to make rules for clinical research.

Making rules for the creative phase of a study is especially difficult. All we can ask is that researchers

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1196 Canadian Family Physician • Le Médecin de famille canadien dVOL 50: SEPTEMBER • SEPTEMBRE 2004

Editorials

be open about the sources of their ideas and the process by which they were developed. Participant observers in conventional qualitative research must show in their field notes that they have reflexively identified the preconceptions and motivations they bring to the research. The same could be expected of clinical observers. How have they prepared themselves as observers? Are their interpretations transparent? Are their methods described and recorded, and are their records good enough to be scrutinized by others?

Further validation usually consists of answer- ing two questions. For therapeutic research, is the therapy effective? For taxonomic research, do the categories have explanatory and predic- tive power? Not all clinical research is designed to show causal relationships. Its aim might be to develop new and better theories that can be tested by others. The question is then: does the theory have biological and clinical plausibility?

Malterud9 cautions that human interaction is dif- ficult to replicate and “predictive power is not always an adequate validity measure for consul- tation contents.” The aim of a study might be to describe how certain people respond to certain experiences, strategies, or therapies.

Future of clinical research

How can we restore clinical research to its right- ful place at the core of our discipline? We must consider some key issues. Do our course materi- als and textbooks truly represent the creative ori- gins of family practice research? Are we trying to force family medicine research into boxes that were not designed for it? Are we sending the wrong messages to our students and intimidating them in the process? Can we restore case reports and case series as sources of knowledge and develop standards for them that are appropriate to family practice? What kinds of validation are appropriate

for the different stages of the process? Can we learn to spot the ideas that show real promise?

In the early stages of original work, ideas might seem inelegant and unclear. They often challenge conventional wisdom and raise hackles. They are liable to be rejected by experts. But they are just as much a part of science as the reasoned logic of nor- mal science. The beauty of clinical research is that it is exciting, and it does not require grants or pro- tected time. It is also essential to the future of aca- demic family medicine.

Dr McWhinney is Professor Emeritus in the Department of Family Medicine at The University of Western Ontario in London.

The opinions expressed in editorials are those of the authors and do not imply endorsement by the College of Family Physicians of Canada.

Acknowledgment

I thank Moira Stewart and Fred Arthur for their review of my presentation and Sandra Richard-Mohamed for preparing the manuscript. I also thank Lynn Dunikowski and the Canadian Library of Family Medicine for biblio- graphic assistance.

Correspondence to: Dr I.R. McWhinney, Centre for Studies in Family Medicine, Suite 245, 100 Collip Circle, London, ON N6G 4X8; e-mail [email protected] References

1. McWhinney IR. Why are we doing so little clinical research? Part 1: clinical descriptive research. Can Fam Physician 2001;47:1701-2 (Eng), 1713-5 (Fr).

2. McWhinney IR. Why are we doing so little clinical research? Part 2: why clinical research is neglected. Can Fam Physician 2001;47:1944-6 (Eng), 1952-5 (Fr).

3. Ryle J. The physician as naturalist. In: Ryle J. The natural history of disease. London, Engl:

Oxford University Press; 1936. p. 1-23.

4. Kuhn TS. The structure of scientific revolutions. 2nd ed. Chicago, Ill: University of Chicago Press; 1970.

5. Koestler A. The act of creation. London, Engl: Pan Books Ltd; 1970.

6. Murphy G, Ballou RO, editors. William James on psychical research. London, Engl: Chatto

& Windus; 1961.

7. Hoffer LJ. Complementary or alternative medicine: the need for plausibility. CMAJ 2003;168(2):180-2.

8. Bagratuni L. Prognosis in the anarthritic rheumatoid syndrome. BMJ 1963;1:513-8.

9. Malterud K. The issue of validity regarding the contents of consultations. Scand J Prim Health Care 1993;11(Suppl 2):64-7.

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