Research commentaries

Research methods commentaries David Aldridge Collected Papers

The reflective practitioner in a community of enquiry: case study designs David Aldridge

My work encourages practitioners from different fields of healthcare delivery t o do

PhD, Drmed hub11 FRSM Char of Qualitative Research in Medicine, University Witten Herdecke

interest is in what people have t o say and how they understand the processes of falling

research. I have concentrated on qualitative research methods because my principal I , being sick and becoming well.Throughout the years I have tried t o encourage debate about the role of beauty and spirituality in healthcare. I believe we must learn t o broaden our expressive vocabulary of what it means t o be human - t o suffer and t o celebrate.

Introduction Summary Qualitative research is the poor relation of research studies.What is needed is flexibility in case study designs. From a rich and varied source of data theories can be generated.

Far from being limiting, it is the fact that case studies are context-based that makes them important to, for instance, music therapy.

David Aldridge

The first issue of / t f H mentioned where the BHMA's instigators (and the whole debate about reductionism and holism in medicine) started out from in the 80s. My own launch pad was developing approaches to clinical research appropriate for the healing modality being used1and how this would influence healthcare delivery3 The debate was lively and extended throughout Europe, engaging medical practitioners of varying persuasions and social scientists.4,j A central feature of the arguments around complementary medicine was that it had n o research base and was not scientific. Since then, there has been a steadily burgeoning development of research articles and the establishment of dedicated journals that would demonstrate the sound base of the varying healing endeavours. There has also been the rise o f evidence based medicine.

My argument then, and now, is that we have a broad spectrum

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of research methods available for understanding how we fall sick and become well One approach amongst them is the clinical controlled trial. But there is also a broader approach that promotes the understanding of being ill and the process of healing, and that is qualitative research methods.10-'3 While we have made some inroads and these methods are becoming accepted, the incorporation of qualitative methods into the mainstream of research activity has been poor. One reason for this is the poor research training of most practitioners. The other is that research is generally seen as instrumental to the ends of a particular healthcare philosophy, particularly when profit is the driving force. Rarely is a researcher encouraged to explore a question that fits in with their own development as a person and practitioner.

To this end, my research endeavours have been concerned with encouraging practitioners conventional or unconventional,

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The reflective practitioner in a community of enquiry: case study designs

art therapists, music therapists, nurses or medical doctors - to research the questions they find important, using a method of their choice to find their answers, We are finding that practitioners at a particular stage in their career want to deepen their knowledge and gain a formal qualification, though not for the money or the glory, but to satisfy a personal need.

Yet this reflective approach not only satisfies the practitioner but also creates new kinds of knowledge for the whole community of practitioners. Such reflective inquiry heals the researcher/practitioner split when research pertains to real practice. Then science becomes not some disembodied set of theories and data, but lived at the bedside, in the clinic and in our families; and knowledge comes as a story to be told. Mentors have to consider how to develop the candidates who want to learn to tell them. But although many of us are trained methodologists, few have been educated as mentors, so it is a great challenge when we invite practitioners to look again - literally to re-search - their own practice.

A story told from practice "Language, before being a code or a depository of estab/i.rhed meanings, is but a generali~edstyle, a way of .fin& the world' Maurice Merleau-Ponty quoted by Michael B. srnith.l4

My colleague and I visited a man at his bedside in hospital. He was a participant in a research programme and one of the treatment options was music therapy. As it was a controlled trial, he had given his permission to be part of the treatment group or the control group. Before the session started, he was given a questionnaire to complete.

We duly sang for him and his family. Both he and his wife talked about their life together, what songs they enjoyed singing, some from 'way back when', and we played some of those songs. They were also given a list of favourite songs chosen by other people in the hospital. Both identified songs from this list that they liked to hear and sing along with. Interspersed with the songs we sang together came reminiscences about the past along with a generous sprinkling of anxiety about the near David Aldridge

David Aldridge (right): case studies are important in music therapy

future from the man and his wife. He had only just been admitted to the hospital and the first stage of the treatment was imminent that same evening.

After we had sung, he asked, 'was that the music therapy or the placebo'?

Now most therapists when talking to colleagues will use such vignettes from practice. When we talk to each other, we tell stories that work on different levels of meaning. This anecdote is also a commentary on the possibility of 'blinding' in clinical trails, of music therapy placebos and the questionable quality of my singing! It also reminds us how songs bring out reminiscences and singing can oil the wheels of conversation. As academics we present lectures in formalised styles and write papers according to customary formats, but when talking to each other about life we use stories; stories about people, about cases we have worked with. Not that we turn people into objects, for we give those cases names, albeit pseudonyms. T h e case' is an abstraction we use for talking about the generic. A case may be a person, or a collection of illustrative examples, or it may be a group; it may be an event like the implementation of a new service, or a situation.

Case study research designs are a formalised rigorous presentation of practice. We can formalise our studies to understand what we do and communicate this to others. Together we can contribute to a body of knowledge. We have an array of approaches to practice-based research, and case study design is a flexible form that adapts itself well to what we do. Research methods are ways of formalising our knowledge, so that each therapeutic situation though seemingly unique can be compared and our knowledge shared with one another.

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The reflective practitioner in a community of enquiry: case study designs

Staying close to practice What I am arguing for is a flexible structure that can be applied to clinical practice.13'l i The practice is allowed to remain true to itself, although any research endeavour, by the nature of its reflexive scrutiny, alters practice. In doing such research we ask questions of ourselves as clinicians, and when we involve our patients in the process, then they too will reflect about what is going on. Indeed Robson now uses the term flexible designs, as opposed to fixed designs, and case studies are categorised by him as flexible designs in the qualitative tradition16

Rich empirical inquiry Case study designs are research strategies based on empirical investigation. A particular case is identified and located in a context, whether social, temporal or spatial. It is the bounding of the case in a context that makes the case study a 'case' study. The case may be a person, several persons, a group or a situation. Because the case itself is specific, and the context bounded, some authors contend that it is difficult to generalise from such re~earch.l(*~8 However, it is the very context-related feature of case studies that make the approach important for music therapy. Case studies relate what is being studied to real life situations and this allows us to use a multiplicity of variables.

Qualitative research literature emphasises the significance of the sampling method used, because case selection is one crucial variable that in effect creates the 'population' to be studied. The selection process will obviously colour the study; cases selected on theoretical grounds will offer a different view to when the population is determined solely by the situation at hand. Many of us have to be content that our sample will be the people we meet in practice, and I would like to introduce the term 'reality sampling' to express choosing who, or what, is introduced into the case study.

Deciding what data to collect is the other central focus of case designs. In an experimental design, the data are decided beforehand and strictly controlled, and the researcher actively defines the cases to be studied. However, some researchers will construct cases out of a naturally occurring David Aldridge @ lournal of holistic healthcars 0 Volume I Issue 2August 2004

situation. What is important is that case studies can incorporate multiple levels of analysis within a single study, if necessary even using mixed sets of quantitative and qualitative data.19 As patients change, so does the therapy. To incorporate this aspect of practice, we need to include flexible designs that occur in naturalistic settings.

In-depth approaches encourage a rich source of data sources from tape recordings, questionnaires, interviews, photographs, letters and observations.

In my study of suicidal behaviour I collected material from newspaper reports over a given time, from observations in a psychiatric hospital ward, letters from women who had attempted suicide, questionnaires and observations from an admissions ward in a general hospital and videotaped recordings from a family therapy day clinic.10' 20 When we have such rich sources then we can begin to generate theories. Building theories from practice examples is a particular strength of the case study approach to therapies in general .21

Historical context The folklore of case study methods suggests that these designs emerged from the practice of experimental psychology and psychoanalysis. This myth ignores the simple fact that human ideas have been conveyed in story form for centuries. 'Once upon a time.. .' until 'they lived happily ever after' reflects this basic narrative form. When therapists of whatever therapeutic persuasion gather together their clinical discussions, they focus on cases perhaps diverse, difficult or dangerous cases.

Indeed, patient narratives are a valid form of health care research.ll

Making sense: the pursuit of 'meaning' in researching therapeutic realities We live in an age of evidence based medicine.

In the complementary therapies, we have been

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The reflective practitioner in a community of enquiry: case study designs

constantly challenged to provide a basis for what we do that is grounded in research results. To that end we are developing research traditions and provide a reasonable preliminary foundation that substantiates our work. This work is far from complete and, really, we have only just begun. While I have argued that we should indeed provide sound evidential basis for healthcare practices based on rigorous studies, we also need to consider what counts as evidence. This is not a new question and both general practice medicine and complementary medicine, now also appearing as integrative medicine, are still facing the challenge.1' 2322-24 Healing endeavours occur in a psychological and social context. The way people respond in therapeutic situations is determined by their experience and interpretation of that situation. By studying how people express their symptoms in the context of their intimate relationships, we glean valuable insights into illness experience. Real life case studies keep us in a close relationship with this natural social world of people, a social world of which we ourselves are part. The knowledge we have of the world, and what counts as evidence, is not just something we gain solely from empirical sources but also from aesthetics, personal knowledge and ethical ~nderstandin~s.

We have rich and diverse cultures and this rich diversity shapes the way we come to understand therapeutic practice.

altered state of consciousness and her physician, who had been present all the time, asked her "Where are you now?'

And her reply was 'I am in beauty'.

Now, every person working in palliative care that I have discussed this with, including the main palliative care team at their ward rounds the next day, has understood the significance of this story.

After this intervention the medical team was allowed to get on with its treatment unhindered.

She continued to request music until the last few days before she died. The story is powerful and even more impressive when you hear the audiorecording. So does this not demonstrate how valuable music therap? is? Though there are important clinical controlled trials2s, this study actually brings the content of such trials to life. My argument is not for one or the other; we need both, for the telling of stories is necessary not adjuvant.

A coda

4 Aldridge D. Pluralism of practice in West Germany.

Complementary Medical Research 1990; 4: 14- 15 .

I would like to end with a story. We visited a

5 Lewith G, Aldridge D. Complementary medicine and the European Community. Saffron Walden: O X ' Daniel Co, 1991.

woman in a large modern cancer centre at the invitation of her physician who was concerned both with her increasing withdrawal and her unwillingness to co-operate with the treatment.

The woman was dying. She had an advanced cancer of the uterus and was clearly in pain. Although resistant to medical interventions, she was willing to try music therapy. We asked about her musical likes and dislikes and her current concerns. She told us about her eldest son who had died as she was admitted to hospital and the death of her husband whom she still missed and whose arms were waiting for her. We included her thoughts into a song and sang this improvised chant for 15 minutes. At the end, she was obviously in an David Aldridge

References 1 Aldridge D, Pietroni P. Research trials in general practice: towards a focus on clinical practice. F a d y Practice 19S7; 4: 311-315.

2 Aldridge D, Pietroni P. The clinical assessment of acupuncture for asthma therapy. Journal of the Roj1a/ Society of Medicine 1987; 80: 222-224.

3 Aldridge D. The delivery of health care alternatives.

Journal of the R y a / Society of Medicine 1990; 83: 179-1 82.

6 Aldridge D. Single case research designs for the clinician,Jounza/ of the Kya/Society of Medicine 1991; 84: 249-252.

7 Aldridge D. Meaning and expression: the pursuit of the aesthetics in research. HolisticMediri~~e 1991: 5: 177-1 86.

8 Aldridge D. The needs of individual patients in clinical research. Advances 1992; 8 (4):58-65.

9 ,Vldridgc D. Observational methods: a search for methods in an ecosystemic paradigm. In: G Lcwith, D Aldridge (eds). Clinical research methodology for complementary therapies. London: Hodder and Stoughton, 1993.

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The reflective practitioner in a community of enquiry: case study designs

10 Aldridge D. Suicide. The Tragedy of Hopelessness.

London: Jessica Kingsley, 1998.

18 Stake R. The art of case study research. London: Sage, 1995.

11 Aldridge D. Spirituality, healing and medicine.

London: Jessica Kingsley, 2000.

19 Hiscnhardt K. Building theories from case study research. In: A Hubermann, EW Miles (eds). The qualitative researcher's companion. London: Sage, 2002.

12 Aldridge D. A qualitative research perspective on healing. In: WB Jonas, C Crawford (eds). Healing intention and energy medicine: Science, research methods and clinical implications. London: Churchill livingstone, 2003.

13 Aldridge D. The individual, health and integrated medicine: In search o f an health care aesthetic.

London: Jessica Kingsky, 2004.

21 Higgins R. Approaches to case study. A handbook for those entering the field. London: Jessica Kmgsley, 1993.

14 Smith M. Merleau-Ponty's aesthetics. In: G Johnson

(ed). The Merleau-Ponty aesthetics reader. Evanston, Illinois: Nortwestern L'niversity Press, 1993.

15 Aldridge D. Music therapy research and practice in medicine. From out of the silence. London: Jessica Kingsley, 1996.

16 Robson C. Real World Research (2nd edition).

Oxford: Blackwell, 2002.

22. Aldr~dgeD. The personal implications o f change.

Journal of the Institute of Re&on and Medicine 1988; 3: 310-312.

23 Aldridge D. The single case in clinical research. In: S Hoskyns (ed). Proceedings of the Fourth Music Therapy Research Conference. London: City University, 1988.

24 Aldridge .-D. Aesthetics and the individual in the practice of medical research: a discussion paper.

Journal of the R?ya/Society of Medicine l99 1; 84: 147-50.

17 Gomm R, Hammersky M, Foster P. Case study method. London: Sage, 2000.

EL5EVIFR

20 Aldridge D. Suicidal behaviour: an ecosystemic approach [Ph. D]. Milton Keynes: The Open University,! 985.

25 Cassileth BR, Vickers AJ, Magill LA. Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. Cancer 2003; 98 (12): 2723-9.

Complementary Therapies in New Editors-in-Chief: Dr Joanne Barnes & Dr Philip Tovey

Reduced Rate in 2004 for all BHMA members S55 2002 impact factor 1.507, number 1 in the Integrative and Complementary Medicine category Complementary Therapies in Medicine is a valuable resource t o those seeking information and critical guidance within the field of complementary therapies. The broad scope of this scientific and professional journal makesits . content relevant to those with a background in trad+ma~::&~ health practices as well as complementary practitionew;':, ' """' For Further information including the benefits Complementary Therapies in Medicine or subscribe online please visit: ,

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EXCHANGE

Exchange The Needs of Individual Patients in Clinical Research David Aldridge David Aldridge, PhD., is associate professor of clinical research in the Faculty of Medicine at the University of Witten Herdecke. This article has been developed from a presentation at the Eighth Mediterranean Congress of Chemotherapy, Athens, Greece, 1992. Aldridge, European editor of The Arts in Psychotherapy, is the coeditor, with George Lewith, of a forthcoming handbook of clinical research methods for complementary medicine (Hodder and Stonghton 1992) and the coauthor, with Lewith, of Complementary Medicine and the European Community (C.W. Daniel: Saffron Warden, 1991).

A recent discussion in this journal on the possible detrimental use of randomization in studies of psychosocial interventions for cancer (LeShan 1991, "Exchange" 1992) has highlighted the recurring controversy about appropriate methods for medical research with human subjects. The contention of this paper is that while the large-scale, randomized controlled clinical trial is clearly of importance in medical research, it has limitations and is only one of the possible methods available for researching the health of human beings.

Critics have argued that the strict methodology of natural science is often wanting when applied to the study of human behavior (Aldridge & Pietroni 1987; Burkhardt & Kienle 1980; Burkhardt & Kienle 1983), a critique that has stimulated calls for innovation in clinical medical research (Aldridge 1991a; Cvitkovic 1992; Freireich 1981,1990). A significant factor in this concern is a growing awareness by doctors of the importance of a patient's social and cultural milieu, and a recognition that the health beliefs and personal understandings of a patient should be incorporated in treatment.

What we need in clinical research are methods that identify clinical changes as they occur in the individual rather than methods that reflect a group average. How clinical change occurs and is recognized will depend on not only the

view of the researcher and clinician but also the beliefs and understandings of the patient and his or her family (Aldridge 1990).

The Difference between Clinical Research and Clinical Usefulness There is often a split in medical science between researchers and clinicians. Researchers see themselves as rational and rigorous in their thinking and tend to see clinicians as sentimental and biased, which, in turn, elicits comments from clinicians about inhuman treatment and reductionist thinking. We are faced with the problem of how to promote in clinical practice, research that has scientific validity in terms of rigor and at the same time a clinical validity for the patient and clinician.

The randomized trial is theoretically relevant for the clinical researcher, but all too often it randomizes away what is specifically relevant for the clinician and patient. A comparative trial of two chemotherapy regimes assumes that the treatment and control groups contain evenly balanced populations. What is sought from such a trial is evidence that one regime works significantly better than another when comparing group averages. Yet, as clinicians, we want to know which method works best for the individual patient. Our interest lies not in the group average but with the patients who d o well with a particular treatment and those who d o not respond so well.

Furthermore, randomizing patients with specific prognostic factors obscures different therapeutic effects. Rather than searching for, say, a nonspecific chemotherapy treatment of a particular cancer, we may be better advised to seek out the factors that allow u s to deliver a specific treatment for particular individuals with a particular cancer.

This is not to argue against randomization in general but to note that we have randomized the patient rather than the treatment. AS Weinstein (1974) says, "Randomization tends to obscure rather than illuminate interactive effects between treatments and personal characteristics.

Thus, if Treatment A is best for one type of patient and Treatment B is best for another type,

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a randomized study would only be able to indicate which treatment performs best overall. If we wanted to discover the effect o n subgroups, one would have to separate out the variable anyway."

Today, molecular biologists identify specific particular cytogenetic targets for cancer therapy and oncopharmacologists develop cytotoxic drugs deliverable to specific sites (Gutierrez, Lemoine, & Sikora 1992). In cancer studies the continuing random assignment of patients to different treatment groups misses two vital points: first, nonspecific chemotherapy of specific cancers lacks both scientific rigor and clinical validity; and second, human metabolisms, while sharing common characteristics, may also have idiosyncratic responses to challenges.

The Limits of "Objective" Contemporary Scientific Medicine Modern science implies that there is a common map of the territory of healing, with particular coordinates and given symbols for finding our way around, and that this map derives from scientific medicine. We need to recognize that scientific medicine emphasizes only one particular way of knowing.

Although the standard contemporary approach maintains that to know anything, we must be scientists, many examples show this view is mistaken-a myth. People who live in vast desert areas find their way across trackless terrains without any understanding of scientific geography. They also know the pattern of the weather without recourse to what we know as the science of meteorology. In a similar way people know about their own bodies and have understandings about their own lives without the benefit of anatomy or psychology. They may not confer the same meanings on their experiences of health and illness as w e researchers do, yet our research might most wisely be directed toward an understanding of personal and idiosyncratic beliefs. . When we speak of scientific or experimental validity, we speak of a validity one group of people confers on the work or actions of another group. This is a political process. With the obsession of "objective truth" in the scientific community, other "truths" are likely to be ignored. As clinicians, we have many ways of knowing: by intuition, through experience, and by observation. If we disregard these areas of

The large-scale, randomized clinical trial is only one of the possible methods available for researching the health of human beings.

knowing, we promote the idea that there is an objective definitive external truth that exists as if written in stone and to which only we, the initiated, have access.

The people with whom clinicians work in a therapeutic relationship are not experimental units, nor are the measurements made on these people "independent" of the person.

While at times it may be necessary to treat the data this way, we must be aware that we are adopting this position. Otherwise, when we come to measure particular personal variables, we likely face many complications. consider a person with chronic leukemia who has been treated unsuccessfully with a bone marrow transplant. In such a case the clinical measurements of blood status, weight, and temperature are important. However, they belong to a different realm of understanding than d o issues of anxiety about the future, the experience of pain, the anticipation of personal and social losses, and the existential feeling of abandonment. These defy quantitative measurement. Yet, if we are to investigate therapeutic approaches to chronic disease, we need to investigate these subjective and qualitative realms.

While we may be able to make little change in blood status, we can take heed of emotional status and propose initiatives for treatment. The goal of therapy is not always to cure; it can also be to comfort and relieve. The virtually exclusive involvement of today's physicians with the biologic dimension of disease has resulted in blindness to the need to understand suffering in the patient (Cassell 1991).

In terms of outcome measurements, we face further difficulties. The people we see in our clinics do not live in isolation, apart from a world of meaning. The way people respond in situations is sometimes determined by the way in which they have understood the meaning of that situation. The meaning of hair loss, weight loss, loss of potency, loss of libido, impending death, and the nature of suffering will be differently perceived in different cultures. To this

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Randomization tends t o obscure rather than illuminate interactive effects between treatments and personal characteristics.

balding, middle-aged researcher, hair loss is a daily occurrence. To m y Greek neighbor it would be a source of constant distress. When we deliver a powerful therapeutic agent, then, we are not treating a "freestanding" clinical entity but intervening in a n ecology of responses and beliefs which are somatic, psychological, and social. Indeed, as others have noted as well, the whole notion of "placebo" presumes that belief can exert a n influence o n the body.

In a similar way, what Western medicine understands as surgery, intubation, and medication, others may perceive as mutilation, invasion, and poisoning. Cultural differences regarding the integrity of the body will influence ethical issues such as abortion and bodily transplants. For a given culture, treatment initiatives may be standardized in terms of the subculture of the administrating researchers, but the perceptions of the subjects of the research and their families can differ variously. Actually, we know from studies of treatment options in breast cancer that the beliefs of physicians also vary and that these beliefs influence the information the physicians give to their patients (Ganz 1992).

Challenges to the Orthodoxy of Controlled Clinical Trials The controlled clinical trial is regarded as the basis of modern medical practice, but this belief is largely based on mythology. Many practices of modern medicine have been introduced without the benefit of controlled trials, and treatments are often introduced because doctors believe they are of value~chemoprophylaxisfor infective endocarditis (The Lancet 1992b) is a n example, as is the type of bypass called "warm heart surgery" (The Lancet 1 9 9 2 c ) ~ obecause r professional groups and opinion leaders decide they are of value (Nattinger et al. 1992). Again, this is not to argue against control-led studies, but rather to show that the practice of medicine is not exclusively a scientific enterprise based upon systematic research.

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Randomized controlled trials are sometimes inappropriate to detect small changes in outcome or to discover what is useful for the clinician. In a prospective observational study of the prophylactic administration of antibiotics in surgery (Classen et al. 1992), the authors remind u s that "randomized clinical trials d o not provide data on the way in which clinicians use interventions in clinical practice." The Classen study points out that the appropriate administration of antibiotics would have prevented wound infection in a number of cases, as could be noted by observation. Observational studies allow the clinician to assess what kind of care brings what kind of results. The point here is that the appropriate research method is a matter to be determined-and that one should not blindly adopt randomized controlled studies simply to perform the "liturgy" of conventional research.

I n regard to the use of antibiotics, w e should note also the problem of emerging resistance to such drugs (O'Brien 1992). Resistance to any drug occurs after a time, as we are seeing with antibacterial agents on a community scale and cytotoxic agents on an individual scale.

That such resistance is a product of misapplication both in terms of specificity and dosage should alert us to our scientific myopia-the poor link between medicine as i t is practiced and the ignorance of research results in the literature-and our singular failure to understand the ecology of pharmaceutical activity, whether on a world scale or an individual basis.

Vitamin supplements have a particularly interesting history in illuminating the value of observational studies, the dogged insistence of some scientists on controlled trials, and the challenge of clinicians to research orthodoxy.

In 1980, Smithells and colleagues suggested that vitamin supplements could possibly be used in the prevention of neural tube defects (Smithells et al. 1980). There then followed a vigorous debate in the medical press about the necessity for clinical controlled studies. As the vitamin supplements seemed harmless, however, both clinicians and mothers of future children boycotted controlled studies. Mothers were not willing to accept a placebo control, and the ethics of withholding vitamin supplements were seen as dubious. An observational study, comparing incidence of neural tube defects before and after the supplements, could have provided a satisfactory solution. A recent world

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congress of scientists and health officials have now recommended the elimination of vitamin A deficiency throughout the world to promote child health and decrease morbidity and mortality, although the "precise mechanisms by which vitamin A exerts its impact on mortality are not yet known" (Sommer 1992).

While controlled trials d o have their use, they are not necessarily the ultimate stage in medical knowledge. On the basis of controlled clinical trials, bronchodilators are extensively prescribed for asthmatic children with an episode of wheezing. Yet, the prescription of such bronchodilators seems to be involved with the worldwide increase in asthma prevalence-the "cure" has become a cause (Crane et al. 1992).

Observational studies which sought to understand the appropriate clinical application of such bronchodilators, careful research into child and family ideas of when to use a bronchodilator, and long-term studies of asthma episodes, including self-management techniques, may have generated substantial clinical data.

"Informed Consent" Randomized trials also present a problem for the patient. We label this problem "informed consent," but in many instances such consent cannot truly be informed.

Paradoxically, clinical practice requires no informed consent, while inclusion in a controlled study does. Yet sometimes the data to inform such consent are limited, and often the data cannot be understood by the patient.

Patients cannot be easily informed when, as is often the case, they lack the intellectual background and cultural perspectives of clinical researchers.

If we consider, as an example, ductal carcinoma in situ (Joslin 1992)-that is, cancerous cells that lack the behavioral characteristics of cancer-most of the evidence about the clinical significance of the lesion comes from uncontrolled studies done before mammographic screening was widespread. Thus, the patient is asked to make a decision on a treatment about which the doctor can give little objective advice. The advice is dependent on the doctor's beliefs and prejudices, and the patient may have a limited ability to assess it. horn ton (1992) a patient's view of being asked to take part in a randomized trial of breast cancer treatment. She was given a diagnosis of which she had never previously n i 7 A x v r c TL

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How clinical change occurs and is recognized will depend on not only the view of the researcher and the clinician but also the beliefs and understandings of the patient and his or her family.

heard, a leaflet offering four different treatment options, and two weeks in which to seek further information and come to a decision. She reasonably asks, "What is informed consent?"

With radiotherapy, which was involved in two of the treatment options, appearing to offer no improvement in survival and also carrying with it the possibility of serious aftereffects and a possible reduction of quality of life, she was being offered alternatives that to her were unacceptable.

A trial by its very nature is an investigation of the unknown, and the clinician is asked to advise the patient to choose uncertainty at a time of maximum anxiety. Informed consent about inclusion in a clinical trial would best be served by intensive counseling at the time of diagnosis, followed by the clear presentation of treatment alternatives (Warren 1992). Yet we need to remember that the priorities of patients are often different from those of their medical informants. The mental state of a patient after a diagnosis is rather different from that of the doctor, and the implications of the diagnosis for the patient and the patient's family are likely to influence how the patient reacts.

O n e way in which a clinician can help a patient in arriving at informed consent is by interpreting research findings published in the professional medical press. However, for the clinician in daily practice, it is questionable whether such evidence can be assessed and understood without spending a large amount of time.

A recent analysis of the systemic treatment of early breast cancer (Early Breast Cancer Group 1992) has highlighted the clinician's problems of understanding the relevant research. First, it is difficult for the clinician to interpret the findings of large group studies: (a) there is a tendency for clinicians to draw conclusions based on indirect comparisonsfor example, ovarian ablation vs. polychemoFall 1992

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Indeed, as others have noted as well, the whole notion of "placebo" presumes that belief can exert an influence on the body.

therapy (Bonadonna & Valaguassa 1992)-and (b)substantial efficacy can be masked in the research when results are pooled. Second, although differing therapies have different consequences for life quality, such consequences are rarely addressed. For example, although the benefits of hormonal and cytotoxic adjuvant therapy appear to improvewith time (The Lancet 1992a), other considerations might be equally important: on long-term follow-up, ovarian ablation shows an advantage of the same order as that achieved by chemotherapy (Powles & Smith 19921, cytostatic treatment leads to a certain rate of secondary leukemia (Reizenstein 19921, and chemotherapy has a devastating effect on female sexual response (Kaplan 1992).

Low toxicity, as one patient remarks (Thornton 1992), depends upon your point of view and whether you are giving the treatment or receiving it.

O r , again, while some authors urge the use of alternative endocrine therapies, noting that the therapies d o not compromise the cardiovascular system, the bones (Love et al. 1992), and the psychosexual function of women (Fitzgerald, Eelstein & Manse1 1992); other authors warn about the side effects of such therapies"hot flushes" (Rostom & Gershuny 1992), cessation of menstruation in 50 percent of premenopausal women, and alterations of the singing voice (Goodare 1992).

The question we may then ask is, "How can w e offer informed consent when being informed is such a major problem?" Even when there may be particularly successful interventions, such as in the case of Hodgkin's disease, for which there is a 75 percent cure rate (Urba & Longo 19921, it is possible that in some patients the therapy will cause a second cancer.

The longer chemotherapy is given, the higher the risk of leukemia. Furthermore, in the case of small-cell lung cancer, it is clear that the curative effect is weak and the hematological effects of chemotherapy are worrying; further, survival time has not increased in the last decade (Carney 1992; Hansen 1992).

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All this raises doubt about the indiscriminate use of randomized controlled trials. Eventually, we must bring into this debate treatment strategies that enhance life quality, studies that offer specifically targeted therapeutic agents, clinical research that is flexible, and a recognition that the individual response to chemotherapy is an important factor.

The Advantages of Single Case Designs Single case designs (Barlow & Hersen 1984; Guyatt et al. 1986; Louis et al. 1984) are one way of meeting both patient needs and the standards of scientific rigor. Such designs appear to satisfy clinicians who see their patients as individuals rather than statistics (Watts 19921, patients who prefer to be treated as individuals (Goodare 1992), and researchers who would recommend life quality as an important variable.

In a single case design the patient is his or her own control. Single case approaches may be a useful middle ground from which clinicians can begin to research their everyday practice.

These forms of clinical study can collect multivariate data over time, and they, therefore, lend themselves to the study of regulatory processes within an individual for whom deviance is a departure from a personal norm (Aldridge 1991b).

Such designs d o not have a uniform approach. There are differing levels of formality and experimentation. A common feature of the designs is that they stay close to the practice of the clinician, minimizing the dilemma of clinical priorities or research priorities. In some cases patient and clinician are the researchers. An important feature of single case trials is the identification of a specific evaluative index (or battery of tests) challenging the clinician to link clinical changes to the treatment.

Guyatt and colleagues (1986) describe a single case trial using oral theophylline and a placebo on a blind randomized basis to treat uncontrolled asthma in a 65-vear-old man.

Specific possible targets of improvement were self-rated by the patient at the end of each tenday treatment period: labored breathing on bending, hurrying, and climbing stairs; the patient's perceived need for albuterol during the day; and the extent to which breathlessness disturbed the patient's sleep. When the code was broken and the placebo periods appeared to be superior, the medication was discontinJ

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ued, and a further randomized single case trial of ipratropium and a placebo began. This time the active treatment was superior to the placebo.

Thus, doctor and patient, through controlled observation, found a suitable treatment regime.

We can say that treatment was randomized within the patient, rather than the patient being randomized to a treatment.

I a m not suggesting that such a single case trial would be appropriate for all diseasesadvanced breast cancer, for example, for which there likely would not be enough time to move from one therapy to another. A s with all clinical research, it is essential to find the appropriate method. This entails a number of considerations that include the material resources available, the experience of the clinician, the willingness of the patient to be involved, and the nature and staging of the disease.

Single case study designs are an attempt to formalize clinical stories. These designs take as their basis the clinical process of diagnosis, treatment, monitoring, and evaluation. It is possible to vary systematically the management of the patient's illness during a series of treatment periods using randomization of treatment and blind assessment where appropriate. Effective treatments are linked with specific patient characteristics which are immediately relevant to the clinician and the patient. Any decisions about the design of the trial and the choice of outcome measures can be made with the patient (and the patient's family, if need be). The primary focus of the research is upon the treatment for the individual, whereas conventional studies are more concerned with changes in groups of patients.

A weakness of single case designs is that they make it difficult to argue for the general validity of a treatment. To overcome this problem, groups of cooperating practitioners could collect single case data according to a common format and then analyze the data as a group (although the problem of polled data remains).

If a case study is to be part of a systematic research approach, the measure, of course, will need to be replicable. Similarly, if the research is intended to speak to other practitioners, it is important to develop a measure that they, too, can validate.

Where the patient and clinician cannot be blind to the treatment intervention, an outside assessor can be. Such an outside assessor can also act as a monitor of the trial and can halt the trial if this is in the best interests of the patient.

In all, the advantages of single case research designs are their flexibility of approach, the opportunity they provide to include differing levels of rigor, and the possibility of incorporating ethical considerations pertinent t o the individual case.

Statistical analysis can be used to identify subtle changes in the data that are not immediately apparent or when many variables from an individual need to be correlated with each other. A time series analysis-which traces changes over t i m e - c a n provide important information, sometimes clinically relevant information. For example, a time series analysis of serum levels of the amino acid creatine in renal transplant patients is sensitive enough to detect rejection of the transplant before this is observed by experienced clinicians (Gordon 1986). Time series analysis can also be sensitive to the circadian rhythms of physiological processes and can influence the administration of drug regimens.

I n all, the advantages of single case research designs are their flexibility of approach, the opportunity they provide to include differing levels of rigor, and the possibility of incorporating ethical considerations pertinent to the individual case. Such designs are appropriate for clinicians who wish to introduce research into their own practice, particularly for developing hypotheses to be tested by other methods of clinical validation. Furthermore, with the development of statistical methods suitable for monitoring subjective, rhythmic, or episodic data-methods that are not dependent on the collection of equally spaced recording and that not only can detect change but also can discriminate between changes-clinicians and researchers have an opportunity to validate their clinical findings with a standard approach.

What w e must keep in mind is that the pattern of reactivity in an individual is like a weather pattern: it constantly changes, never arriving at a steady state. A time series analysis of outcome changes is pertinent to the individual in that the changes are always compared to the individual's own physiology (Aldridge - -

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enough to see that science can accommodate multiple viewpoints and thereby develop a wide range of therapeutic possibilities.

Our intellectual endeavors should be astute enough - t o see that science can accommodate multiple viewpoints and thereby develop a wide range of therapeutic possibilities.

REFERENCES Aldridge, D. 1991a. "Aesthetics and the Individual in the Practice of Medical Research: A Discussion Paper."

Journal of the Royal Society of Medicine. 84:147-150.

Aldridge, D. 1991b. "Single Case Designs for the Clinician." Journal of the Royal Society of Medicine.

84:249-252.

1991~).

The person acts as his or her own norm.

Furthermore, as in the study of transplant rejection (Gordon 1986), physiological changes relevant to clinical change can sometimes occur in the normal range of reactivity. When this happens, it is possible to act before a crisis occurs.

If the clinician needs to relate data from a single case study to other forms of research, it is possible to develop a prognosis from the baseline data and clinical history and then examine it in the light of statistics: for example, survival data based on cancer site and staging. By using an outside assessor, the prognosis can be made blind to the patient and practitioner.

To facilitate further studies, it is imperative that we develop two things: (1) a central research agency for the consultation, coordination, and analysis of single case designs, with connections between different countries (such an agency would coordinate research initiatives in smaller institutions, give advice and support on research methods, and help with the analysis of data); and (2) methods of data acquisition, statistical analysis, and data presentation suitable for clinicians to use in their daily practice (for example, the time series analysis of multivariate data).

Aldridge, D. 1991c. "Single Case Designs: An Extended Bibliography." Complementary Medical Research. 5:99109.

Aldridge, D. 1990. "Making and Taking Health Care Decisions." Journal of the Royal Society of Medicine.

83:720-723.

Aldridge, D. & P. Pietroni. 1987. "Research Trials in General Practice: Towards a Focus on Clinical Practice." Family Practice. 4:311-315.

Barlow, D. H. &M. Hersen. 1984. Single Case Experimenial Designs: Strategies for Studying Behavior Change.

New York: Pergamon Press.

Bonadonna, G. & P. Valaguassa. 1992. 'Treating Early Breast Cancer (letter)." The Lancet. 339:675.

Burkhardt, R. & G. Kienle. 1983. "Basic Problems in Controlled Trials." Journal of Medical Ethics. 9:80-84.

Burkhardt, R. & G. Kienle. 1980. "Controlled Clinical Trials and Drug Regulations." Controlled Clit~icalTrials.

1:151-164.

Carney, D. 1992. "Biology of Small-Cell Lung Cancer."

The Lancet. 339~843-846.

Cassell, E. 1991. The Nature of Suffering and the Goals of Medicine. New York: Oxford University Press.

Classen, D., R. Scott Evans, S. Pestonik, S. Horn, R. Menlove & J. Burke. 1992. 'The Timing of Prophylactic Administration of Antibiotics and the Risk of Surgical Wound Infection." The New England Journal of Medicine.

326:281-286.

Conclusion It is vital that we pursue academic rigor in our research, but we must not bury our heads in the sand of dogma. Rigor without imagination leads to stagnation, just as imagination alone leads to anarchy. Modern clinical research can combine the two. A combination of rigor and imagination is necessary to have different approaches to understanding the world. This pluralist position offers an acceptance of orthodox clinical trials together with a promotion of new understanding and methods. In this way, differing studies inform each other. This is not a retreat to old methods but the development of a new approach, including new ideas in statistics.

Our intellectual endeavors should be astute

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Crane, J., N. Pearce, R. Beasley & C. Burgess. 1992.

"Worldwide Worsening Wheezing-Is the Cure the Cause? (letter)." The Lancet. 3395314.

Cvilkovic, E. 1992. New Anticancer Agents in Current Clinical Development. Athens Publishing Co. Early Breast Cancer Trialists' Collaborative Group.

1992. "Systemic Treatment of Early Breast Cancer by Hormonal, Cytotoxic, or Immune Therapy." The Lancet.

339:l-15,7145.

Exchange. 1992. "Can Randomized Studies of Psychosocial Interventions for Cancer Harm the Control Groups?" Advances. 8:80-87.

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Fitzgerald, C., M. Eelstein & R. Mansel. 1992. 'Treating Early Breast Cancer (letter)." The Lancet. 339:676.

Freireich, E. 1990. "Is There Any Mileage Left in the Randomized Clinical Trial?" Cancer Investigation.

8(2):231-232.

Freireich, E. 1981. "Informed Consent Versus Prerandomization." S. Salmon & S. Jones, eds. Adjurant Therapy of Cancer. 111. Tucson: Grune and Stratton.

Ganz, P. 1992. 'Treatment Options for Breast CancerBeyond Survival." The New England Journal ofMedicine.

326:1147-1149.

Goodare, H. 1992. "Adjuvant Treatment in Breast Cancer (letter)." The Lancet. 339:424.

Gordon, K. 1986. 'The Multi-State Kalman Filter in Medical Monitoring." Computer Methods (&Ă&#x201A; Programs in Biomedicine. 23:147-54.

Louis, T., P. Lavori, J. Bailar & M. Polansky. 1984.

"Cross-Over and Self-Controlled Trials in Clinical Research." The New England Journal of Medicine.

310:24-31.

Love, R., R. Mazess, H. Harden, S. Epstein, P. Newcomb, C. Jordan, P. Carbone & D. DeMets. 1992. "Effects of Tamoxifen on Bone Mineral Density in Postmenopausal Women with Breast Cancer." The New England Journal of Medicine. 326:852-856.

Nattinger, A., M. Gottlieb, J. Veum, D. Yahnke & J. Goodwin. 1992. "Geographic Variation in the Use of Breast-Conserving Treatment for Breast Cancer." The New England Journal of Medicine. 326:1102-1107.

O'Brien, T. 1992. "Global Sun~eillanceof Antibiotic Resistance." The Lancet. 326:339-340.

Powles, T. & I. Smith. 1992. "Adjuvant Treatment in Breast Cancer (letter)." The Lancet. 339:423.

Gutierrez, A., N. Lemoine & K. Sikora. 1992. "Gene Therapy for Cancer." The Lancet. 339:715-721.

Reizenstein, P. 1992. 'Treating Early Breast Cancer (letter)." The Lancet. 339:676.

Guyatt, T., D. Satchett, D. Taylor, J. Chong, R. Roberts & S. Pugsley. 1986. "Determining Optimal Therapy Randomized Trials in Individual Patients." The New England Journal ofMedicine. 314:889-892.

Rostom, A. &A. Gershuny. 1992. "Adjuvant Treatment in Breast Cancer (letter)." The Lancet. 339:424.

Hansen, H. 1992. "Management of Small-Cell Cancer of the Lung." The Lancet. 339:846-849.

Smithells, R., S. Sheppard, C. Schorah, M. Seller, N. Nevin, R. Harris, A. Read & D. Fielding. 1980. "Possible Prevention of Neural-Tube Defects by Penconceptional Vitamin Supplements." The Lancet. 1:339-340.

Joslin, C. 1992. "The Patient's View of Breast Cancer Trials (letter)." The Lancet. 339:314.

Sommer, A. 1992. 'Vitamin A Deficiency and Childhood Mortality." The Lancet. 339:864.

Kaplan, H . 1992. "Adjuvant Treatment in Breast Cancer (letter)." The Lancet. 339:424.

Thornton, H. 1992. "Breast Cancer Trials: A Patient's Viewpoint." The Lancet. 339:44-45.

The Lancet. 1992a. "Adjuvant Systemic Treatment for Early Breast Cancer (editorial)." 339:27.

Urba, W. & D. Longo. 1992. "Hodgkin's Disease."

The New England Journal of Medicine. 326:678-687.

The Lancet. 1992b. "Chemoprophylaxis for Infective Endocarditis: Faith, Hope and Charity Challenged (editorial)." 339:525-526.

Warren, R. 1992. "The Patient's View of Breast Cancer Trials (letter)." The Lancet. 339:315.

The Lancet. 1992c. "Warm Heart Surgery (editorial)."

3392341.

LeShan, L. 1991. "A New Question in Studying Psychosocial Interventions and Cancer." Advances. 8:2.

Watts, G. 1992. 'Treating Early Breast Cancer (letter)."

The Lancet. 339:675-676.

Weinstein, M. 1974. "Allocation of Subjects in Medical Experiments." The New England Journal of Medicine.

291:1278-1285.

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Editorials

Military doctor

The late Major General William Officer said that he required his medical officers to give one hundred per cent as soldiers and one hundred per cent as doctors.

With the recent deployment of the medical services of the Armed Forces to support the British military effort in the Gulf it is worth examining this requirement to determine whether General Officer's criteria are appropriate and whether they can be met.

The first reaction is that the medical officer of the Armed Forces may be serving in the Royal Navy, the Army or the Royal Air Force. Each service has its own special requirements for medical support in times of war but it is essential that the management of casualties should follow a coordinated plan. The direction of the three medical services under a Surgeon General a t the Ministry of Defence has ensured that this is the case and that there is close cooperation between the three medical services at all levels from Forward Treatment Unit back to National Health Service Hospitals in the United Kingdom. It is essential that every medical officer understands the special requirements of his or her own service in the maintenance of the health of the Force, in appropriate deployment to their special tasks and the threats inherent in their deployment and in current military weapons technology.

In the Gulf area it can be readily appreciated that the climate imposes its own burdens which can be greatly added to by the threat of chemical weapons.

The vast areas of empty desert pose special dficulties in the collection, first aid, treatment and evacuation of casualties to base hospitals in Saudi Arabia and to hospital ships prior to evacuation by air to the United Kingdom. Ten years ago the military medical professors coordinated regular courses of instruction in war surgery and war medicine, held a t the Royal Army Medical College but involving participants from all three services and including reserve medical and nursing officers. Guest lecturers included senior doctors from the Middle East with recent combat experience.

These courses began before the Falklands Campaign (19821, which was a testing ground for all three medical services and the experience so gained was fed

back in to these instructional courses and also in to the Annual Field Exercises of forward Medical Units of the Regular and Reserve Forces.

The Armed Forces Medical Services in peace time cannot effectively employ the number of doctors and nurses required for operational support in war.

Fortunately the system of granting short service commissionsto doctors and nurses with an emphasis on training for their peace time and war time roles has provided a large pool of experienced medical and nursing staff on the regular reserve or serving with volunteer reserve units. Thus the reserve units are as well trained as their regular colleagues and the volunteers bring to their tasks an enthusiasm and commitment which is impressive to behold.

Medical resources on a battlefield will always be limited by the war environment. The enormous technical advances in surgery which have transformed the outlook for patients with congenital or degenerative conditions may not have immediate application on the battlefield but the developments in resuscitation, intensive care and anaesthesia which has accompanied them have greatly increased the chances of survival of the seriously injured. Surgery and medicine on the battlefield are aimed a t preserving life and minimizing disability1. By the time the patients reach base hospital they should be in a stable condition and ready for restorative treatments, convalescence and rehabilitation.

All medical and nursing disciplines can make a significant contribution to the medical care of our sailors, soldiers and airmen. From the medical support in the front line through the dramatic intervention of the surgical teams and the specialist support of the physicians to the psychiatric social worker back in the United Kingdom all have been trained and exercised in their role, and those of us who can only watch and wait are assured that they carry it out with the utmost professional dedication.

Major General Robert Scott Totnes, Devon Reference 1 Ryan JM,Cooper GJ, Haywood IR, et al. Field surgery on a future conventional battlefield: strategy and wound management. Ann R Coil Surg Engl 1991;73:13-20

0141-0768/91/ 050249-01/$02.00/0 t3 1991 The Royal Society of Medicine

basis the clinical process where the illness is assessed 0141-0768/91/ and diagnosed, a treatment is prescribed, the patient 050249-04/$02.00/0 1991 is monitored during the application of that treatment, and the success of the treatment is then evaluated. The Introduction However, the validity of this therapeutic 'success' is of Medicine Single-case study d e ~ i g n s l -are ~ an attempt to open to question. There may be a subjective bias influenced by the expectations of the clinician and the 14 formalize stories. These designs take as their Davidclinical Aldridge Collected research papers

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the patient. This is negotiated with the patient and patient. Similarly, the patient may appear to improve is understood by both clinician and patient as being through willingness to please the physician. In some appropriate and relevant to the patient's well-being cases, the disease may have run its course and or clinical improvement. A critical feature of this improvement would have occurred without a therapeutic intervention. Finally, the initial assesstarget behaviour is that it will be susceptible to rapid ment of the patient may have represented temporary improvement when therapy begins. This target extreme values which are lessened at a subsequent behaviour then becomes the baseline measure in an assessment; ie a 'regression towards the mean7. initial period of observation. The initial period of The experimental approach attempts to observation is sometimes called the 'A' phase. The accommodate these difficulties by systematically intention of this phase is to enable a stable pattern varying the management of the patient's illness or trend to emerge. This is based on the natural frequency of the symptoms. Any treatment effects can during a series of treatment periods4using randomthen be seen clearly in contrast to this baseline. It ization of treatment periods and blind assessment. In is important that the method of measuring the the single case approach the patient is the source of his or her own statistic, randomized treatment and observed behaviour is specified accurately. There can blind assessment may be incorporated within the of course be more than one form of assessment; the therapeutic plan. The patient is not compared with clinician may want to rely upon physiological, a group norm, his or her progress is in accord with immunological or biochemical markers while the individual constitution, which is subject to statistical patient may devise a self-report index. Apart from its verification using the analysis of data trend^^-^. clinical value, the choice of measure has a secondary research value. If the case study is to be part of a Single-case research designs are not a unified systematic research approach the measure will need approach. There are differing levels of formality and to be replicable. Similarly, if the research is also experimentation: ie randomized single-case study intended to speak to other practitioners it is important and , ~single-case *~ designs, often called N=I s t u d i e ~ ~ to develop a measure which they can validate. experimental designs2J0.A common feature of these The development of a specific evaluative index12, designs is that they stay close to the practice of the clinician. An advantage is that there are no or battery of tests, is an important task which challenges the clinician to relate theory to clinical difficulties of recruiting large groups of patients, or practice. The main requirement of such an index is having to collect and analyse large data sets. that it will be sensitive to change over time and will A criticism of group designs is that they mask include all the clinically important effects. It is individual changell. Improvement or deterioration is important to be able to link those clinical changes to not evident for particular patients. Furthermore, the the treatment. results of large-scale trials are not always easy to Once the baseline has been established then the translate into clinical terms for the practitioner. agreed treatment variable is introduced. There can Single-case designs highlight individual change in be multiple treatment courses during this period, daily clinical practice. Furthermore the dilemma of and these can include placebo. In the randomized clinical priorities or research priorities is minimized. case design these treatment courses are randomly This type of research is applied as part of the clinical assigned. This design is strengthened by the possibility treatment and is relevant to both clinician and for the patient and the clinician to be blind to the patient. In some cases patient and clinician are the researchers4. treatment variable if a medicament is used. Where the patient and clinician cannot be blind to the The principal feature of single-case study designs treatment intervention an external assessor can be is that they are feasible. The problems of recruitment blind to the treatment period. Such an external are minimized, the study is cheap and the results are assessor can also act as a monitor of the trial and halt generally evident. Much research flounders because the trial if it is in the best interests of the patient. of the difficulties of finding large groups of patients Where the treatment variables cannot be with similar symptoms, a lack of resources (time, randomized, single-case experimental designs are personnel and money) or an absence of clear statistical used with an assessor blind to the treatment phase. analysis which is often compounded by initial The initial baseline 'A' period is followed by a confusions in the methodological approach. In this treatment period, 'B'. This is an improvement on the approach each person serves as his or her own control.

Effective treatments are linked with specific patient case history in that it offers comparative data in two characteristics which are immediately relevant to the clear phases. This design can be extended by an clinician and the patient. Any decisions about the additional assessment 'A' phase. There are problems design of the trial, and the choice of outcome here in that a decision about when to stop treatment measures, can be made with the patient9. The has to be made, and the treatment may not be primary focus of the research is upon the treatment continued to conclusion. This is compounded by the benefit for the individual, whereas conventional difficulty of ending on a 'no treatment' phase. studies are more concerned with changes in groups If a further treatment period is introduced, then an of patients. A weakness of single-case designs is that, 'A B A B' design occurs. The intention in these designs while individual change is specific, it is difficult to is to keep the length of the treatment phases identical. argue for a general validity of the treatment. To These designs can become quite complex and include overcome this problem it may be feasible for groups composite treatments. Parts of the treatment can then of co-operating practitioners to collect single case data be omitted or included systematically. For example; according to a common format and then analyse that after the baseline data are gathered, 'A', then a collected data as a group. composite treatment is administered 'BC'. This could The first step in this approach is to identify the be a treatment which included manipulation of the target behaviour. This can be a symptom or physical body and a medicament. In the following phase the Collected research papers sign, aDavid resultAldridge of a test, or an indicator suggested by medicament could be withdrawn, the 'B' phase. The

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next phase returns to the composite treatment. This Perhaps the major criteria for using a single-case then becomes an 'A BC B BC' design. design are that the treatment should exert its effect Multiple baseline designs have been used to test in a moderately short time, and the effect will some psychological behaviour approaches1Ă&#x201A;°J3The be temporary and reversible once treatment is treatment variable stays the same, but there are discontinued. If not, then a group design must be multiple baseline target behaviours of differing considered. These single-case methods are generally duration. Ideally these target behaviours are specific reliant upon a stable baseline period in the 'A' phase. and independent.

This means that they are not particularly relevant The patient diary can be part of an evaluative index. to acute or labile problems. They are appropriate for In diary studies the principal collector of data is the chronic problems, or patterns of recurring behaviour, patient. The use of subjects making their own which have become stable over time. assessments of symptomatology is not new14, and The advantages of these single-case research offers a non-intrusive means of gathering data. designs are their flexibility of approach and the The use of diaries in clinical practice has several opportunity to include differing levels of rigour. advantages. First, there is the opportunity to provide Such designs are appropriate for practitioners a daily scoring which eliminates recall error and wishing to introduce research into their own pracproduces consistent reporting. Second, there is a tice, and particularly for developing hypotheses which comprehensive view of the person's health15. Third, may be submitted for other methods of clinical symptoms are treated as episodes rather than solely validation at a later date. Furthermore, with the static events16J7. Fourth, diffuse conditions are development of statistical methods suitable for the included which may not be disabling or necessitate monitoring of subjective, rhythmic or episodic data, intervention but which contribute to the profile of the which is not dependent upon the collection of patient's symptomatology. equally spaced recording, and which provides a In single-case designs there are possibilities for a method which can detect changes and also disstatistical analysis of each single study1s9.However, criminate between those changes5, clinicians have the main appeal of working in this way is that daily an opportunity to validate their clinical finding. measures are plotted on a chart and can be seen by This analysis is pertinent to the individual in that eye. Clinical improvement can also be assessed they are always compared to their own individual by reports from the patient and various persons physiology. connected with the patient (spouses, relatives, experts) who can also suggest that the change is of applied D Aldridge significance.

Universitat WittedHerdecke Statistical analysis can be used where subtle Medizinische Fakultat significant changes occur in the data which are not Beckweg 4, D-5804 Herdecke, Germany immediately visually apparent, or where many variables are collected from an individual and need to be correlated one with another. If data are serially References dependent then it is possible to perform a time 1 Aldridge DR. Single case research designs. Compleseries analysis of the data. This provides important mentary Medical Research 1988;3:37-46 2 Barlow DH, Hersen M. Single case experimental designs: information about the different characteristics of strategies for studying behaviour change. New York: behaviour change across phases, and a statistic which Pergamon Press, 1984 indicates significant change5. Such time series 3 Kazdin A. Single case research designs: methods for analysis requires large samples of data points to select clinical and applied settings. New York: Oxford the processes within the series itself. This time series University Press, 1982 analysis of data has proved to be clinically relevant.

4 Guyatt G, Satchett D, Taylor D, Chong J, Roberts R, It has been demonstrated that the time series analysis Pugsley S. Determining optimal therapy randomized of serum creatinine levels from renal transplant trials in individual patients. New Engl J Med 1986; patients is sensitive enough to detect transplant 314:889-92 rejection which precedes that of experienced 5 Gordon K. The multi state Kalman filter in medical monitoring. Computer Methods and Programs in clinicians6. Furthermore, time series analysis of Biomedicine 1986;23:147-54 trends in data can also be sensitive to the circadian 6 Smith A, West M, Gordon K, Knapp M, Trimble I. rhythms of physiological processes and influence the Monitoring kidney transplant patients. Statistician administration of drug regimens7.

1983;32:46-54 A difficulty which can arise in single-case studies 7 Kowanko I, Pownall R, Knapp S, Swannell A, is when they are used following a period of standard Mahoney P. Time of day of prednisolone administration treatment which has not worked. Some general in rheumatoid arthritis. Ann Rheumatic Dis 1982; improvement may occur which is nothing to do with 41:447-52 the treatment being used but is a 'regression towards 8 Louis T,Lavori P, Bailar J, Polansky M. Cross-overand the mean', ie the tendency of an extreme value when self-controlledtrials in clinical research. N Engl J Med 1984;310:24-31 it is remeasured to be closer to the mean. This can 9 McLeod R,Taylor D, Cohen Z, Cullen J. Single patient be overcome by including a washout period between randomised clinical trials. Lancet 1986;29:726-8 the treatments. Such a period would serve to establish 10 Barlow D, Hersen M, Jackson M. Single-caseexperimental the patient's eligibility for the trial. Following this designs. Arch Gen Psychiatry 1973;23:319-25 there would be a set of measurements which would 11 Aldridge D, Pietroni P. Research trials in general be considered as the baseline data. The consistent practice towards a focus on clinical practice. Fam Pract recording of longitudinal multiple data in these 1987;4:311-15 studies requires great perseverance on behalf of the 12 Kirshner B, Guyatt G. A methodological framework collector and the patient. This is mitigated by the for assessing health indices. J Chronic Dis 1985;38: David Aldridge Collected research papers 16 sample size of one.

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13 Murphy R, Doughty N, Nunes D. Multi-elementdesigns: an alternativeto reversal and multi-element evaluative strategies. Mental Retardation 1979;17:23-7 14 Murray J. The use of health care diaries in the field of psychiatric illness in general practice. Psychol Med 1985;11:551-60 15 Monck E, Dobbs R. Measuring life events in an adolescent population: methodological issues

76 17 Aldridge D, Rossiter J. A strategic assessment of deliberate self harm. J Fam Ther 1984;6:119-32

Community and asylum care: plus qa change

physical environment of the asylum was significant.

Turner3 quotes Browne writing in the 1830s:

and related findings. Psychol Med 1985;15:84150 16 Aldridge D, Rossiter J. Difficult patients, intractable symptoms and spontaneous recovery in suicidal behaviour. J Systemic Strategic Ther 1985;4:66-

'Conceive a spacious building resembling the palace of a peer,

airy, and elevated and elegant . . . the sun and air are allowed

to enter at every window . . . the inmates all seem to be Controversy still surrounds the future of Britain's activated by the common purpose of enjoyment, all are busy mental hospitals1 despite 15 years of consistent and delighted by being so.'

Government policy2. Little attention has been paid to the lessons of the past, despite parallels between However, the asylums quickly came to be perceived contemporary developments and those of 150 years as falling far short of the ideals of the Reformers. ago3. Common themes are therapeutic optimism, the Mortimer Granville (quoted by Scull9),for example, expansion of the scope of cure and political economy. in 1887 described the Middlesex County asylum at The latter is made much of e l s e ~ h e r e ~The . ~ . 19th Colney Hatch (later to be called Friern Hospital) century-builtasylums are now seen as a bad thing, but as a: this in itself is not new. What is different about this 'colossal mistake . . . it combines and illustratesmore faults revolution in mental health is the absence of the wider in construction and errors of arrangement than might have societal changes which characterized the 19th century been supposed possible in a single effort of bewildered or revolution7.The pressure for change has been directed misdirected ingenuity . . .the wards are long, narrow, gloomy a t stamping out organizational bad practice. The and oppressive,the atmosphere of the place dingy, the halls therapeutic revolution of rehabilitation and normalhuge and cheerless. The airing courts, although in some ization can be seen as being more apparent than instances carefully planted, are uninviting and prison-like.' real.

Scull7 argues that the 'asylum' movement did The Reformers plans for achieving more cures thus represent a major shift in the way the insane depended on the virtues of staff morality and landscape were treated. This change was mirroring wider architecture. These plans for 'moral cure' seemed to societal/philosophicalchanges which laid emphasis on be destroyed by: individual responsibility and rationality. As the (1) Increasing numbers of the insane, few of whom industrial revolution progressed and the system of seemed to be curable. They soon filled up the feudal patronage broke down, the industrious poor existing services defying the reformers notion that came to be valued chiefly in terms of the marketpeople would return to good mental health and the ability of their labour. Thus, it became increasingly community. important to distinguish the deserving poor (who (2) The pressure to economize in the light of the were supposedly incapable of supporting themselves) demise of Britain's international competitiveness from the undeserving poor (who were poor, but were a t the end of the 19th century. supposedly capable of earning a wage and could (3) The medical profession's keenness to monopolize therefore support themselves). The insane were seen the care of the mentally il19J1,required them to as being part of the deserving poor and so were have large hospitals like those of their medical separated out. This was most efficiently done by colleagues. bringing them together in one place.

Scull7 argues that 'there was a change in the However, the 'Reformers' (such as Tuke and cultural meaning of madness' in the 19th century.

Connolly) envisaged 'the model institution' where the This involved a change in perspective consistent with patient might be returned to good health, not just an increasingly technological age, when people came warehoused. The treatment in these institutions to be seen as less 'god given'. They were seen as ('moral treatment') identified the social environment rational beings, internally motivated and regulated as being the therapeutic agent, acting through the by rules internalized from the environment. Similarly, patient's mind8. Two aspects of the social environthe insane came to be seen as rational beings, capable ment were regarded as especially important. First, of being influenced by the same forces as those acting the attitudes and demeanour of the attendant staff, upon sane people. Previously the insane were seen as were significant. In Tuke's words 'treating the patient having lost entirely the human features of reason, and as much in the manner of a rationale being as the were left in a state of 'animality'lO. These changes state of his mind will possibly allow . . . whatever helped fuel 'the moral outrage which did so much to tends to promote the happiness of the patient is animate the lunacy reformers . . .' of the 19th therefore considered of the highest importance in a century7.Today there is no equivalent radical change David Aldridge Collected research papers of the mentally ill. On the contrary the curative point of view' (Tuke 18139).Secondly, in the perception

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The Arts in Psychotherapy, Vol. 21, No. 5, pp. 333-342, 1994 Copyright 0 1994 Elsevier Science Ltd Printed in the USA. All rights reserved 0197.4556194 $6.00 + .00

Pergamon

SINGLE-CASE RESEARCH DESIGNS FOR THE CREATIVE ART THERAPIST DAVID ALDRIDGE, PhD*

m

' . . the basic problem confronting therapeutic science is that the important therapeutic phenomena exist only in actual therapeutic contexts, and yet it seems impossible to test and verify causal theories of psychotherapy and therapeutic change in these settings. " (Martin, 1993, p. 371)

Each method has its own range of applicability and each generates differing sets of data. Each method has a different range of validity and ethical constraints. In this paper one group of the available research methods is introduced, that of single-case study designs (Barlow & Hersen, 1984; Hilliard, 1993; Kazdin, 1982, 1983; Yin, 1989).

Single-case designs are particularly important for the creative arts therapies as they allow for a close analysis of the therapist-patient interaction (Aldridge, 1992; Jones, 1993). Furthermore, within this approach there are possibilities for comparing differing sets of data throughout a course of treatment so that intra-individual comparisons can be made. Personal change is considered within the patient, not by comparison with a group norm. A music therapist can, for example, treat a patient over the course of a year and compare his or her findings (changes in the music) with colleagues in other creative arts disciplines (changes in painting or movement), with colleagues from psychological disciplines (changes in mood rating scales or personality inventories) and with what the client or patient has to say. These findings can then be compared with the timing, and reasoning, behind those varying therapeutic interventions. Such process research allows thitherapists to see, or hear, how the emerging phenomena of therapeutic change are related to their therapeutic activities, hence the emphasis on single-case designs for the promotion of theory building based on clinical practice and in generating data to support new models of intervention (Moras, Telfer & Barlow, 1993).

The folk-lore of single-case study methods suggests that these designs emerged from the practice of

Single-case research designs are a part of a whole spectrum of case-study research models applied to the investigation of individual change in clinical practice.

Such designs have the advantage of being adaptable to the clinical needs of the patient and the particular approach of the therapist. The designs are appropriate for the development of research hypotheses, testing those hypotheses in daily clinical practice and refining clinical techniques. Single-case designs, if systematically replicated, can provide an ideal developmental collaborative research tool for uniting creative arts therapists from differing backgrounds. Most appropriately, they allow for the assessment of individual development and significant incidents in the patienttherapist relationship. Whereas single-case experimental designs in medicine can ascertain significant change in a physiological variable leading to timely intervention, psychotherapy studies concentrate on both changes in the symptoms that the patient displays and interactive events in the ongoing process of therapy.

This paper attempts to describe a methodological approach suitable for research initiatives in the creative arts therapies. In clinical medicine, psychology and social science there is a snectrum of research methods applicable to the study of the arts therapies.

*David Aldridge is Professor of Clinical Research Methods in the Faculty of Medicine at the University Witten Herdecke, Germany 333

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experimental psychology and psychoanalysis. Such a myth ignores the simple fact that human ideas have been conveyed in story form for centuries. "Once upon a time . . ." until "They lived happily ever after" reflects this basic form. Bruscia (1991) endorsed this position in his book of 42 collected case studies of music therapy when he wrote in acknowledgment, "To the individuals whose stories are told in these case studies." When therapists of whatever therapeutic persuasion gather together their clinical discussions, they focus on cases, whether these be diverse, difficult or dangerous. Even research scientists at conferences adopt a style, usually when away from the podium, that reflects the human story as epitomized by the single case.

Single cases bring an important facet to clinical research-that of personal application. Although clinical medicine demands the study of groups as its research convention, it accepts single cases as special examples drawing attention to anomalies in practice, alerting practitioners to matters of urgent attention (in the case of dangerous side-effects, for example) or as falsifiers of a particular theory (Velanovitch, 1992).

In the creative arts we are looking for methods that say what happens when we do our therapy, and the reasons for doing what we do. Ideally as research practitioners, we would want to be so clear about what we were doing that another practitioner could try it in a similar situation. Such clarity of practice description leads to replication and is one way of conferring validity on what we do as individuals but also builds up the common research stock of our professional groups.

Single-case study designs are an attempt to formalize clinical stories. These designs take as their basis the clinical process where the illness is assessed and diagnosed, a treatment is prescribed, the patient or client is monitored during the application of that treatment and the success of the treatment is then evaluated (Aldridge, 1993).

However, the validity of this therapeutic "success" is open to question. There may be a subjective bias influenced by the expectations of the therapist and the patient. Similarly, the patient may appear to improve through willingness to please the physician.

In some medical cases, the disease may have run its course and improvement may have occurred without a therapeutic intervention. Furthermore, the initial assessment of the patient may have represented temporary extreme values that are lessened at a subsequent assessment (i.e., in statistical terms, a "regression

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toward the mean"). The experimental approach in single-case research attempts to accommodate these difficulties by "systematically varying the management of the patient's illness during a series of treatment periods" using randomization of treatment periods and blind assessment (Guyatt et al., 1986; Guyatt et al., 1988; Louis, Lavori, Bailar & Polansky, 1984). Randomization here means that treatment and control periods do not always occur in the same, or chosen, order. Blind assessment refers to the fact that the person assessing change does not know whether the patient was or was not receiving treatment.

Single-case research designs are not a unified approach. There are differing levels of formality and experimentation. The three approaches introduced in this paper are: randomized single-case study designs, often called N = I studies (Guyatt et al., 1986; McLeod, Taylor, Cohen & Cullen, 1986), single-case experimental designs (Barlow, Hersen & Jackson, 1973) and case study research (Hilliard, 1993; Yin, 1989), which may include diary or calendar methods (Murray, 1985) and traditionally includes qualitative data. As Hilliard (1993) wrote, "Single-case research is best viewed as a sub-class of intrasubject research" (p. 373). Rather than considering a cross-section of a group of similar subjects, this approach looks at the variation of selected variables within one subject over time.

General Approach A common feature of all these designs is that they stay close to the practice of the therapist. A further advantage is that there are no difficulties of recruiting large groups of patients or having to collect and analyze large data sets. These methods are, therefore, feasible for the practitioner interested in beginning research. The problems of recruitment (finding enough willing subjects who satisfy rigorous inclusion criteria) are minimized, the study is inexpensive and the results are generally evident. Much research flounders because of the difficulties of finding large groups of patients with similar symptoms, a lack of resources (time, personnel and money) or an absence of clear statistical analysis that is often compounded by initial confusions in the methodological approach.

A criticism of group designs is that they mask individual change, and the results of large-scale trials are not always easy to translate into clinical terms for the therapist (Aldridge, 1992). Improvement or deteriorationis not evident for particular patients in a

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SINGLE-CASE RESEARCH DESIGNS group. Single-case designs highlight individual change in daily clinical practice and allow the practitioner to relate those changes to therapeutic interventions. Furthermore, the dilemma of clinical priorities or research priorities is minimized. This type of research is applied as part of the clinical treatment and is relevant to both therapist and patient. In some stud* ies, patient and therapist are the researchers.

1n this approach each person serves as his or her own control. Effective treatments are linked with specific patient characteristics that are immediately relevant to the therapist and the patient. Any decisions about the design of the trial and the choice of outcome measures can be made with the patient (Cook, Guyatt, Davis, Willan & McIlroy, 1993; McLeod et al., 1986). It is this practical cooperation that makes these designs favorable for creative arts therapists. The primary focus of the research is upon the treatment benefit for the individual, whereas conventional studies are more concerned with changes between groups of patients. (The word "group" is being used here as an aggregate of patients for statistical purposes, not as in group therapy .)

A weakness of single-case designs is that, although individual change is specific, it is difficult to argue for a general validity of the treatment. Hilliard (1993) counterargues that the generalization of findings is addressed through replication on a case-by-case basis.

For such renlication to occur there has to be a formal level of research design applied to the case study, and it is this formal rigor, with the inclusion of specific assessment instruments, that extends a normal case history into a case study.

Randomized Single-Case Designs

The first step in this approach is to identify the target behavior. This can be a symptom or physical sign, a result of a test or an indicator suggested by the patient. This is negotiated with the patient and is understood by both therapist and patient as being appropriate and relevant to the patient's well-being or clinical improvement. A critical feature of this target behavior is that it will be susceptible to rapid improvement when therapy begins.

This target behavior then becomes the baseline measure in an initial period of observation. The initial period of observation is sometimes called the A phase.

The intention of this phase is to enable a stable pattern or trend to emerge. This is based on the natural frequency of the symptoms. Any treatment effects can

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then be seen clearly in contrast to this baseline. Barlow and Hersen (Barlow, Hersen & Jackson, 1973) recommended a minimum period of three observation points in a given period of time.

It is important that the method of measuring the observed behavior is specified accurately. There can, of course, be more than one form of assessment. The therapist may want to rely upon markers of physiological, immunological and biochemical status or indicators of symptomatic, affective and behavioral change. The patient may devise a self-report index.

Apart from its clinical value, the choice of measure has a secondary research value. If the case study is to be part of a systematic research approach the measure will need to be reliable (i.e., will it produce consistent repeatable results?). Similarly, if the research is also intended to speak to other therapists it is important to develop a measure that they too can validate (i.e., does the measure measure what it says it does?).

The development of a specific evaluative index (Kirshner & Guyatt, 1985), or battery of tests, is an important task that challenges the therapist to relate theory to clinical practice. The main requirement of such an index is that it will be sensitive to change over time and will include all the clinically important effects. It is important to be able to link those clinical changes to the treatment.

The next step is to introduce the agreed treatment, and there can be multiple treatment courses during this period. In the randomized case design these treatment courses are randomly assigned. For example, a selected piece of taped music may be used in the treatment period and "white noise" or therapeutically meaningless music used as the nontreatment phase.

Such a design is strengthened when an external assessor is used who is "blind" to the treatment period.

An external assessor can also act as a monitor of the trial and halt the trial if it is in the best interests of the patient.

Single-Case Experimental Designs

Where the treatment variables cannot be randomized, single-case experimental designs are used. The intention is to stay as close to experimental method as possible with an assessor blind to the treatment phase.

The initial baseline A period is followed by a treatment period, B. This is an improvement on the case history in that it offers comparative data in two clear phases. This design can be extended by an additional assessment A phase after treatment. There are prob-

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DAVID ALDRIDGE lems here in that a decision about when to stop treatment has to be made, and the treatment may not be continued to conclusion. This is compounded by the difficulty of ending on a "no treatment" phase. If a further treatment period is introduced, then an A.B.A.B. design occurs. The intention in these designs is to keep the length of the treatment phases identical.

These designs can become quite complex. An example of an A.C.A.B. C.B.C.B. design was demonstrated by Rose (1978). The A refers to the baseline phase of the behavior of a girl on a particular diet that contained no artificial flavors or colors and no natural salicylates. The B phase was another type of baseline and involved the introduction of an oatmeal biscuit that contained no additives. The C phase included the introduction of an oatmeal biscuit that contained an artificial yellow dye. This artificial biscuit appeared to be the same color as the other biscuit. The girl's behavior was then observed by her parents and others who were blind to the introduction of the biscuit containing artificial coloring. In the C phases of the experiment the girl became hyperactive, leading to the author concluding that artificial coloring led to her hyperactivity.

A further elaboration of this method is to introduce composite treatments. Parts of the treatment can then be omitted or included systematically. For example, after the baseline data are gathered, A, then a composite treatment is administered, BC. This could be a treatment that included a creative arts therapy and medication. In the following B phase the medication may be withdrawn. The next phase returns to the composite treatment. This then becomes an A. BC. B. BC. design. These composite designs are particularly useful when the therapist-patient relationship is assumed to be a significant part of the treatment. Anyone familiar with composing a rondo form will understand the underlying principles of such research designs.

Multiple baseline designs have been used to test some psychological behavior approaches (Murphy, Doughty & Nunes, 1979). The treatment variable stays the same, but there are multiple baseline target behaviors of differing duration. Ideally these target behaviors are specific and independent.

The application of the treatment variable is staggered. First, after assessment, the treatment is applied to one particular target behavior. If the target behaviors are independent then the chosen target behavior will change and the others remain stable. The behav-

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iors are monitored constantly. Then the treatment variable is also applied to a second target behavior, which should demonstrate a change at the onset of therapy. This treatment may be administered by another therapist. The other target variables continue to be monitored and treated in turn.

Clinical Applications of Experimental and Randomized Designs As might be expected of research methods thai were formally developed from the field of psychology, the majority of the clinical literature has its origin in psychological or psychotherapeutic applications.

Single-case studies have been used to assess the impact of behavior therapy for the treatment of mental handicap (Hoefkens & Alien, 1990), epileptic seizures (Brown & Fenwick, 1989), infantile autism (Bernard-Opitz, Roos & Blesch, 1989; Gillberg, Winnergard-I & Wahlstrom-J, 1984), obsessive ruminations and compulsive behavior (Salkovskis, 1983; Salkovskis & Westbrook, 1989), delusional experiences (Brett-Jones, Garety & Hemsley, 1987), pain (Bryant, 1989; Fagen, 1982; Lavigne, Schulein & Hahn, 1986; Moss, Wedding & Sanders, 1983), depression (Jones, Glannon, Nigg & Dyer, 1993; Richter & Benzenhofer, 1985), agoraphobia and panic disorders (Cottraux, 1984), anxiety-based disorders (Hayes, Hussian, Turner, Anderson & Grubb, 1983) and multiple personality disorder (Coons, 1986).

They lend themselves well to individual problems where diagnostic categories are broad yet symptoms are idiosyncratic, and where it is necessary to combine both behavior and existential considerations (Butcher, 1984).

These techniques are also seen as useful for encouraging structured learning. Milne (1984) used single-case designs to introduce behavior therapy techniques and skills to nurses. With their emphasis on methodological awareness (Lavigne, Schulein & Hahn, 1986) and formal experimental decisions while retaining the patient as the primary focus of research, these approaches are particularly useful for teaching and developing research methods (Aldridge, 1991).

In more recent years the field of neurology has also developed these single-case approaches. In assessing the cognitive competence of patients following brain injury and the effects of therapeutic interventions intended to remedy the effects of injury, it has been important to develop specific, often idiosyncratic, in-

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SINGLE-CASE RESEARCH DESIGNS dices and treatment plans (as in the creative arts therapies). These methods have been applied to the study of aphasia (Karanth & Rangamani, 1988), apraxia and alexia (Wilson, 1987), problems after stoke (Edmans & Lincoln, 1989), attentional difficulties after brain injury (Gray & Robertson, 1989) and memory problems (McLean, Stanton, Cardenas & Bergerud, 1987).

The study of individual brain-damaged persons has also led to inferences about normal cognitive functions (Caramazza, 1986; McCloskey, Sokol & Goodman, 1986) although the validity of these assumptions has been challenged (Marshal1 & Newcombe, 1984).

The reasoning behind this challenge reflects both the strength and the weakness of the single-case approach; namely, while arguing for the specific validity as applied to individual patients, it is not acceptable to argue for a generalized validity as applied to the group.

However, 12 patients were studied using singlecase designs to see how they coped with the stress of being diagnosed as having breast cancer (Wittig, 1989). This design used standardized diaries during the first 90 days after diagnosis and surgery to obtain a multivariate description of individual mood states and coping responses. By using such a time-based approach, which evaluated different modes of coping, it was possible to propose specific intervention strategies for individuals albeit with a common problem.

The secret to understanding such studies lies in understanding what is common to the methodological approach and what is specific to the treatment intervention, what is common to the overall problem and what is specific to the individual patients in the way they respond to such a problem. Unfortunately, many arguments revolve around either the group or the individual without realizing that there are intermediary levels (i.e., not all individuals behave idiosyncratically, or all the same, and there may be clusters of common responses).

Statistical Analysis In single-case designs there are possibilities for a statistical analysis of each single study (Barlow & Hersen, 1984; McLeod et al., 1986). However, the main appeal of working in this way is that daily measures are plotted on a chart and can be seen by eye.

Clinical improvement can also be assessed by reports from the patient and various persons connected with the patient (spouses, relatives, experts) who can also

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suggest that the change is of applied significance.

Statistical analysis can be used where subtle significant changes occur in the data that are not immediately visually apparent or where many variables are collected from an individual and need to be correlated one with another.

The most familiar tests are the t and F test depending on the number of different conditions or phases during treatment. The main difficulty in applying these tests is an artifact of the research design itself.

The collection of data over time may mean that the data are serially dependent (i.e., that each measure affects the next one). Serial dependence occurs when successive observations in a time series are correlated and this dependence seriously violates the premise of analysis of variance. It is necessary in these studies to test data to see if they are auto-correlated. If the data are serially dependent then it is possible to perform a time series analysis of the data (Jones et al., 1993; LeBlanc, 1986; Moran & Fonagy, 1987; Onghena, 1992; Salkovskis, 1983). Such time series analysis requires large samples of data points to selectthe processes within the series itself.

A difficulty that can arise in single-case studies is when they are used following a period of standard treatment that has not worked. Some general improvement may occur that has nothing to do with the treatment being used but is a regression toward the mean (i.e., thetendency of an extreme value when it is remeasured to be closer to the mean). This can be overcome in studies where medication has been previously used for treatment by including a washout period between the former treatment and the time when the case-study begins. A washout period is a phase when no treatment occurs and offers the opportunity for previous effect to leave the body by natural means. Such a period would serve to establish the patient's eligibility for the trial and to discuss and plan the research approach together. Following this, there would be a period in which baseline data are collected.

The consistent recording of longitudinal multiple data in these studies requires great perseverance on behalf of the collector and the patient. This is mitigated by the fact that only one person is being studied.

There may be a temptation by some researchers to lump together single-case designs and treat them as a group. To do so contains all the pitfalls of post hoe hypothesizing (i.e., making up the ideas to support the results you get), loses the primary advantage of individual consideration and means handling vast

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amounts of often disparate data. Like all methods, it is vitally important that the research design is clearly thought out before the research begins.

Jones et al. (1993) described the long-term psychotherapeutic treatment of a woman who was 35 years old when the treatment began. Their concern was to articulate the reciprocal influence processes between the patient and therapist during the course of therapy over a two and one-half year period. Timeseries analysis was used to demonstrate the causal relationships between therapeutic phenomena-in this case, shifts in the nature of the therapy process, therapist acceptance, therapist activity and patient symptom change. Such a method can be used to test whether the therapist influences the patient, the patient influences the therapist, there is a concurrent mutual influence or that no influence occurs. Indeed, the authors conclude that therapist and patient mutually influenced one another, that the therapist used clearly identified techniques of support and expression that were related to specific stages in the therapy process and the dysphoric mood of the patient. What is impressive about this study is the battery of measures used in assessment, ranging from clinical evaluation rating scales, well-validated patient self-report measures to the 100-item psychotherapy process Q-Set. The Q-Set is a "language and rating procedure for the comprehensive description, in clinically relevant terms, of the patient-therapist interaction in a form suitable for quantitative comparison and analysis" (Jones, 1993, p. 384). Furthermore, videotapes of the sessions were independently rated by two judges blind to each other's ratings.

Case Study Methods The case study is perhaps characteristic of the single-case approach in psychotherapy and has its roots in the traditional studies of psychoanalysis. A story is related about what happens without any efforts at quantification of given variables. Indeed, the general approach is qualitative, relying on the passive description of identified variables as they change throughout the process of therapy. The researcher often selects specific parameters for therapeutic change and identifies how such change would be expressed.

This way of working would be similar to a hypothesis-confirming approach. Other researchers may be convinced that setting hypotheses and indicators restricts them, allowing no room for new ideas to develop. A patient in this approach would be treated,

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observed and described quite freely without any attempt to set formal parameters. This way of working would be an exploratory approach.

Whatever the method used, there has to be a way of recording data for analysis. Material is collected on audiotape, videotape, film, pictures or as written documents. One special way of collecting written data is the patient diary (Murray, 1985). Not only does the diary bring the minimal element of formal structure to observations, it is culturally acceptable as a way of setting down thoughts and recording what has happened.

Although a research approach in itself, the patient diary can also be part of the evaluative index mentioned in the previous approaches. The patient diary is rather a "catch-all" term. Some researchers will ask the client to collect personal data according to specific rating scales on a daily basis, and this technique may be more appropriately termed a calendar method. An extension of this technique of daily rating to include a brief subjective commentary may be appropriately called a diary method. The detailed daily recording of patient commentaries involving introspective accounts, and even dreams or fantasies, may be likened to a journal and is the least formal, in experimental terms, of the three methods mentioned here.

In diary studies the principal collector of data is the patient. One of the tasks ofresearch scientists working in the field of clinical practice is to discover what happens in the context of the patient's daily life and to make some attempt to discover how the patient's problem impinges upon his or her daily routine. Similarly, it is important to discover who in the family of that person is involved at the time of onset of the symptoms and in the management of those symptoms.

The use of subjects making their own assessments of symptomatology is not new (Murray, 1985) and offers a non-intrusive means of gathering data. Perhaps as significantly, the diary also offers the patient a neutral stance whereby the symptoms are assessed methodically and in accordance with a particular framework designed to be ultimately beneficial.

Health care diaries have been used to discern the content of clinical practice with all its diversity of complaints and problems (Beresford, Walker, Banks & Wale, 1977; Freer, 1980; Robinson, 1971; Scambier, Scambler & Craig, 1981). Most symptom episodes are transient and limited in extent (Dunnell & Cartwright, 1972; Horder & Horder, 1954). Retrospective interviews cannot provide sufficient or precise data about the events that precede the onset of

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SINGLE-CASE RESEARCH DESIGNS symptoms or the details of the management of such episodes.

Clinical Applications of Case-Study Methods Bruscia (1991) highlighted the breadth of methods available even within this one approach. Most of these studies are qualitative and often rely on the specific language relevant to particular musical and psy, chotherapeutic direction. Such richness in diversity makes for an interesting mix in papers intended to inform practice. For researchers, however, there is the constant problem of finding a common base from which one can build further replicative studies.

Clair (1992) described the influence of 15 months of weekly group therapy with a man suffering from dementia. She used videotaped analysis by a trained independent observer of five behavioral categories (communicating, watching, sitting, interacting with an instrument and remaining seated without restraint).

Despite the man's cognitive and physical deterioration, he chose to respond to music and musical stimuli. In quite an elegant little paper, Clair brings to the simple case study an extra dimension of validity resulting from independent observations pertinent to her criteria of what is valuable in therapeutic assessment.

In the same volume of studies, and from a psychoanalytical perspective, is a stunningly impressive case report of a boy showing signs of autism. Lecourt (1992) takes us through an overview of 88 sessions of music therapy. Her case descriptions focused on the structuring of the boy's experience of sounds and relationships. From such a focus she elicited examples of principles relevant to understanding the process of therapy itself. In this way the case study maintains its cardinal position among psychotherapeutic research methods. What is necessary for the single-case study to work as a piece of informative research, as is exhibited in this example, is the ability to weave a number of behaviors together with such therapeutic insights that therapy makes sense to both the therapist and the reader at a number of different levels.

The ability to analyze material at a higher level, to see the connections between themes and to discern the emerging meanings in the therapeutic process, is to engage in a meta-level analysis. Lett (1993) utilized this form of analysis in the supervision of three female counsellors over 10 weeks. He illustrated this work through the medium of a single-case study, basing the reports on Pam, one of the counsellors. Each session David Aldridge

was videotaped and the participants wrote their own texts of their expressions of their feelings toward a particular client. From the resulting transcripts, both the supervisor and the counsellors selected themes and significant incidents relating to feelings and occasions of learning. Apart from transcripts of the texts there are also opportunities for the counsellors to express themselves in a combination of arts modes, and Lett used a variety of visual images to illustrate his paper.

Lett argues powerfully for a phenomenological approach that abdicates a prejudged analytical system and returns to the "least contaminated" condition of therapeutic supervision (p. 383). Given the explanatory power of such work when it appears formally as a paper, it is difficult to argue against the method for the experienced practitionerlresearcher. However, for the novice researcher, or the inexperienced practitioner, springing to the conclusion of "no method other than the practice" can be a disguise for aimlessness and lack of focus in the research. Unfortunately, the rigor that Lett and Lecourt bring to their work is assumed by some researchers who lack the background of experience and who read the politically correct material about research methods without having actually done the practice. In some ways this received knowledge of "no system" has led to the paucity of research in the creative arts therapies where practitioners have carefully rehearsed the arguments against adopting a scientific method and thereby have done nothing.

Some music therapists, with psychotherapeutic colleagues, have attempted to forge new methodological ground. Langenberg (Langenberg, Frommer & Tress, 1992) used a method of audiotape evaluation that includes the assessments of the patient, independent describers and the therapist herself. These descriptions are qualitative in that they attempt to define both the qualities of what is heard as content (Quality 1) and the feelings or emotional experiences released by what is heard (Quality 2). In addition, the taped material was assessed to discover what thematic motifs occur in the individual accounts, and as each motif was identified the accounts were compared to see if there were any motifs in common. In addition, a musical analysis of the improvisation was carried out by two composers. Although this research approach is only in its preliminary stages, the richness of the data based on musical phenomena and therapeutic descriptions is proving to be a valuable research tool that has resonance with other psychotherapeutic practitioners.

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A benefit of the single-case approach is that it generates empirical data suitable for proposing further work. Stanley and Miller's (1993) work about shortterm art therapy with an adolescent demonstrates how such a belief approach can bring about significant positive changes in self-esteem and an improvement in the adolescent-parent relationship as measured by a recognized self-esteem instrument. Similarly, in evaluating the quality of the child-parent relationship using structured observations from dance and drama therapy, Harvey and Kelly (1993) succeed in weaving both quantitative observations (time spent in interaction) with qualitative evaluations (avoidance, resistance, proximity seeking, use of transitional objects).

The phenomenological approach has value for the arts therapies in that it helps in understanding the client's experience during the therapy. Quail (Quail & Peavy, 1994) wanted to overcome the tendency to focus on the art object apart from the person. She used tape-recorded narratives of the client's retrospective descriptions of her own artworks as created in previous art therapy sessions. The recordings were made of unstructured interviews that elicited descriptions about the art therapy process itself, the relationship between the artwork and art therapy and everyday life and the experience of the artwork in the current context of the research interview. Descriptions, rather than interpretations or explanations, were sought. The audiotapes were transcribed, read several times, and categorized in terms of the meanings inherent in the texts, which led to the recognition of specific themes of "temporality, spatiality , deep connection and contact, motivation, being visible and vulnerable, increasing awareness, and intense emotion and energy" (p. 55) in the client's account of the therapeutic process.

Conclusion The use of single-case research designs, but concentrating on symptomatic relief and the possibility of immediate observable improvement, may itself promote clinical insights. Single-case experimental methods are generally reliant upon a stable baseline period in the A phase. This means that they are not particularly relevant to acute or labile problems. With their emphasis on change over time within the one person, these methods are appropriate for the study of chronic problems or patterns of recurring behavior that have become stable over time.

The advantages of single-case research designs are their flexibility of approach and the opportunity to

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include differing levels of rigor. Such designs are appropriate for therapists wishing to introduce research into their own practice, and particularly for developing hypotheses that may be submitted for other methods of clinical validation at a later date.

Moreover, single-case research captures the natural context in which therapist and patient interact, making explicit the mutual influences of both (Jones et al.. 1993).

Case-study methods broaden the spectrum further, with exploratory studies using standardized measures and descriptive data, to the full-blown phenomenological investigations that allow the modes of creation themselves to dictate form and content. When standardized measures are discarded, most researchers either refer to an overarching theoretical structure at a meta-level or they utilize the technique of triangulation by involving independent colleague observers or involving a supervisor who analyzes the material.

Such steps are necessary to lend some element of validity to what we do when we call our work research.

For creative arts therapists there is the possibility to use the artifacts of their own discipline as they emerge in time. Paintings are not always finished in one session and it is possible to describe both the way in which a painting develops and the way in which it may fit into a series of paintings. Combined with a diary account written by the patient, a series of structured therapeutic process observations on the part of the therapist and an analysis of these paintings, there would be a wealth of data sufficient for an exploratory case study. Similarly, in music therapy we may hear a restriction in the patient's ability to $ay rhythmically and an ability to paint rhythmically. Using musical examples and graphic illustrations throughout the therapeutic process, and including patient and therapist accounts, it is possible to demonstrate a common link between therapeutic modalities and therapeutic change (Aldridge, Brandt & Wohler, 1989). As the reader will realize, such a collection of data is not too far removed from the usual practice of therapy. What is required is either a formal framework by which the data can be interpreted, a standardized evaluative instrument suitable for assessment and for replication or a panel of clinical assessors to validate findings.

For those therapists working in psychiatric, psychotherapeutic or medical settings where there are opportunities for the implementation of formal measurement instrument and rating scales, there is the possibility of comparing the significance of varying

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SINGLE-CASE RESEARCH DESIGNS

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phenomena as they occur over time, perhaps using time-series analysis. Where mixed therapeutic endeavors occur, it is possible to see what individual contributions make to therapeutic regimes. The single-case approach, given a framework of consistent assessment procedures, allows for flexibility in treatment while challenging our intellectual rigor and fostering the relationship between theory and clinical practice. Perhaps the most important feature for many of us is that such an approach, while staying close to the practice of therapy, also allows the patient or client to be a partner in the research endeavor, and what they produce, say or do is considered an important and valid component in the process. Thus, the ethical considerations of doing research on a patient are replaced with that of working with a collaborative partner. Although we as practitioners and researchers may continue to reap the benefits of academic reward in terms of publication or a formal qualification following research, perhaps the balance will swing toward also actively benefiting the person who has come to us for help.

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Aldridge, D. (1992). The needs of individual patients in clinical research. Advances, 8(4), 58-65.

Aldridge, D. (1993). Single case research designs. In G. Lewth & D. Aldridge (Eds.), Clinical research methodology for complementary therapies (pp. 136168). London: Hodder and Stoughton.

Aldridge, D., Brandt, G., & Wohler, D. (1989). Towards a common language among the creative art therapies. The Arts in Psychotherapy, 17, 189-195.

Barlow, D., Hersen, M , , & Jackson, M. (1973). Single-case experimental designs. Archives of General Psychiatry, 23, 319325.

Barlow, D. H., & Hersen, M. (1984). Single case experimental designs: Strategies for studying behaviour change. New York: Pergamon Press.

Beresford, S., Walker, J., Banks, M., &Wale, C. (1977). Why do women consult doctors? Social factors and the use of the general practitioner. British Journal of Social and Preventive Medicine, 31, 220-226.

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Brown, S., & Fenwick, P. (1989). Evoked and psychogenic epileptic seizures: 11. Inhibition. Acta Neurologica Scandanavia, 80(6), 541-547.

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Bmscia, K. (1991). Case studies in music therapy. Phoenixville, PA: Barcelona.

Bryant, G. (1989). Myofascial pain dysfunction and viola playing.

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Butcher, P. (1984). Existential-behaviour therapy: A possible paradigm? British Journal of Medical Psychology, 57(Pt 3), 265274.

Caramazza, A. (1986). On drawing inferences about the structure of normal cognitive systems from the analysis of patterns of impaired performance: The case for single-patient studies.

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Clair, A. (1992). Music therapy for a severely regressed person with a probable diagnosis of Alzheimer's disease (pp. 570580). (K. Bmscia, Ed.). Phoenixville, PA: Barcelona.

Cook, D., Guyatt, G. Davis, C., Willan. A., & Mcllroy, W. (1993). A diagnostic and therapeutic N-of-1 Randomized Trial.

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Coons, P. (1986). Treatment progress in 20 patients with multiple personality disorder. Journal of Nervous and Mental Disorders, 174(12), 715-721.

Cottraux, J. (1984). [Agoraphobia and panic attacks. Biological and behavioural approaches.] Encephale., 10(1), 13-19.

Dunnell, K., & Cartwright, A. (1972). Medicine-takers, prescribers and hoarders. London: Routledge and Kegan Paul.

Edmans, J., & Lincoln, N. (1989). Treatment of visual perceptual deficits after stroke: Four single case studies. InternationalDisability Studies. 11(1), 25-33.

Fagen, T. S. (1982). Music therapy in the treatment of anxiety and fear in terminal pediatric patients. Music Therapy, 2(1), 13-23.

Freer, C. (1980). Self care: A health diary study. Medical Care, 18, 853-861.

Gillberg, C., Winnergard-I, & Wahlstrom-J. (1984). The sex chromosomesĂ&#x192;â&#x20AC;&#x2DC;on key to autism? An XYY case of infantile autism. Applied Research in Mental Retardation, 5(3), 353-366.

Gray, J., & Robertson, I. (1989). Remediation of attentional difficulties following brain injury: Three experimental single case studies. Brain Injury, 3(2), 163-170.

Guyatt, G., Sackett, D., Taylor, D., Chong, J., Roberts R., & Pugsley, S. (1986). Determining optimal therapy randomized trials in individual patients. New England Journal of Medicine, 314. 889-892.

Guyatt, G., Sackett, D., Adachi, J . , Roberts, R., Chong, J., Rosenbloom, D., & Keller, J. (1988). A clinician's guide for conducting randomized trials in individual patients. Canadian Medical Association Journal, 139(6), 497-503.

Harvey, S., & Kelly, E. (1993). Evaluation of the quality of parent-child relationships: A longitudinal case study. The Arts in Psychotherapy, 20, 387-395.

Hayes, S., Hussian, R., Turner, A., Anderson, N., & Gmbb, T. (1983). The effect of coping statements on progress through a desensitization hierarchy. Journal of Behavior Therapy and Environmental Psychiatry, 14(2), 117-129.

Hilliard, R. B. (1993). Single-case methodology in psychotherapy process and outcome research. Journal of Consulting and Clinical Psychology. 61(3), 373-380.

Hoefkens, A., & Alien, D. (1990). Evaluation of a special behaviour unit for people with mental handicaps and challenging behaviour. Journal of Mental Deficiency Research, 34(3), 21328 (discussion 229-235).

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Jones, E. E. (1993). Introduction to special section-Single-case

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DAVID ALDRIDGE research in psychotherapy. Journal of Consulting and Clinical Psychology, 61(3), 37 1-372.

Jones, E. E., Ghannam, J . , Nigg, J. T., & Dyer, J. F. P. (1993).

A paradigm for single-case research-The time series study of a long-term psychotherapy for depression. J. Consult. Clin.

Psychol., 61(3), 381-394.

Karanth, P,, & Rangamani, G . (1988). Crossed aphasia in multilingual~.Brain and Lungrage, 34(1), 169-1 80.

Kazdin, A. (1982). Single case research designs: Methods for clinical and applied settings. New York: Oxford University Press.

Kazdin, A. (1983). Single-case research designs in clinical child psychiatry. Journal of the American Academy of Child Psychiairy, 22(5), 423-432.

Kirshner, B., & Guyatt, G. (1985). A methodological framework for assessing health indices. Journal of Chronic Diseases, 38, 27-36.

Langenberg, M,, Frommer, J., & Tress, W. (1992). A qualitative research approach to analytical music therapy. Musiktherapeutische Umschau, 13, 258-298.

Lavigne, J., Schulein, M , , & Hahn, Y . (1986). Psychological aspects of painful medical conditions in children. 11. Personality factors, family characteristics and treatment. Pain, 27(2), 147169.

LeBlanc, A. (1986). Quantitative analysis of cardiac arrhythmias.

Critical Review of Biomedical Engineering, 14(1), 1 4 3 .

Lecourt, E. (1992). Off-beat music therapy: A psychoanalytic approach to autism (pp. 73-98). (K. Bruscia, Ed.) Phoenixville, PA: Barcelona.

Lett, W. (1993). Therapist creativity: The art of supervision. The Arts in Psychotherapy, 20, 371-386.

Louis, T., Lavori, P., Bailar, J., & Polansky, M. (1984). Crossover and self-controlled trials in clinical research. New England Journal of Medicine, 310, 2 6 3 1.

Marshall, J., & Newcombe, F. (1984). Putative problems and pure progress in neuropsychological single-case studies. Journal of Clinical Neuropsychology, 6(1), 65-70.

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McCloskey, M., Sokol, S., & Goodman, R. (1986). Cognitive processes in verbal-number production: Inferences from the performance of brain-damaged subjects. Journal of Experimental Psychology and Genetics, 115(4), 307-330.

McLean, A., Stanton, K., Cardenas, D., & Bergerud, D. (1987).

Memory training combined with the use of oral physostigmine.

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Moran, G., & Fonagy, P. (1987). Psychoanalysis and diabetic

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control: A single-case study. British Journal of Medical Psychology, 60(Pt 4), 357-372.

Moras, K., Telfer, L., & Barlow, D. (1993). Efficacy and specific effects data on new treatments: A case study strategy with mixed anxiety-depression. Journal of Consulting and Clinical Psychology, 61, 412420.

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Quail, J . , & Peavy, V. (1994). A phenomenologic research study of a client's experience in art therapy. The Arts in Psychotherapy, 21(1), 45-57.

Richter, P., & Benzenhofer, U. (1985). Time estimation and chronopathology in endogenous depression. Acta Psychiatra Scandanavia. 72(3), 246-253.

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Salkovskis, P. (1983). Treatment of an obsessional patient using habituation to audiotaped ruminations. British Journal of Clinical Psychology, 22(Pt 4 ) , 3 11-3 13.

Salkovskis, P,, & Westbrook, D. (1989). Behaviour therapy and obsessional ruminations: Can failure be turned into success?

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Stanley, P,, & Miller, M. (1993). Short-term art therapy with an adolescent male. The Arts in Psychotherapy, 20, 397-401.

Velanovitch, V. (1992). The function of the case report in medical epistemology. Theoretical Surgery, 7, 91-94.

Wilson, B. (1987). Single-case experimental designs in neuropsychological rehabilitation, Journal of Clinical and Experimental Neuropsychology, 9(5), 527-544.

Wittig, R. (1989). Adjustment, stress and coping with stress in breast cancer. Results of single case studies. Zeitschrift fur Klinische Psychologie, Psychopathologie, Psychotherapie, 37(3), 303-316.

Yin, R. (1989). Case study research: Design and methods. Newbury Park, CA: Sage.

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The Arts in Psychotherapy, Vol. 23, No. 3, pp. 225-236, 1996 Copyright Cl 1996 Elsevier Science Ltd Printed in the USA. All rights reserved 0197.4556196 $15.00 + .OO

Pergamon

A PERSONAL CONSTRUCT METHODOLOGY FOR VALIDATING SUBJECTIVITY IN QUALITATIVE RESEARCH DAVID ALDRIDGE, PhD and GUDRUN ALDRIDGE Dip1 MTh.*

Validity is a general term used in scientific research to establish the truthfulness of a piece of work.

Within our culture valid is used to comment on whether something is correct, either correct in its conclusions or correct in the way in which those conclusions are reached. In some forms of research, notably the quantitative approach, this term has relatively strict meanings and is divided into sub-categories related to internal validity and external validity associated with both the way in which the work is carried out and to the meanings that are argued from the methods. Within qualitative work, the word validity has come to be represented by establishing trustworthiness and credibility (Koch, 1994).

The way in which we choose to use the word validity here leans toward methods found in qualitative research (Denzin & Lincoln, 1994; Lincoln & Guba, 1985) and attempts to return to the archaic meaning of the word. The old root of the word stems from the Latin roots of validus, that is, robust and valere, to be strong. In this way we are proposing that the validity of a piece of work rests upon a strong robust argument, and the strength of that argument is to establish the premises upon which that argument is based. The basis of establishing validity as trustworthiness, in the sense of qualitative research, is to show that the work is well-grounded, to make transport the premises that are being used, to develop a set of sound interpretations and relevant observations and to make these interpretations credible. Although it appears that we are questioning the nature of the data, and the interpretations that are being made of the data, we are

often also questioning the credibility of the researcher. Although we may pretend to be asking purely methodological questions, much of what goes on in methodological debate is a questioning of the credibility of the researcher, not the data. One step in establishing credibility is to state what the researcher's own perspectives and biases are. This paper will propose one such method of making those understanding~clear.

In this paper we shall see that a music therapist is analyzing her own responses to listening to melody.

Her overall research project is concerned with the development of melodic playing within the context of music therapy. (See companion paper, "A Walk Through Paris" in this issue.) This work can only be subjective. It is about her way of listening and therefore partly to do with her way of working. Two questions remain for us. First, is there anything from this work that we can learn for our own practice? In formal terms this would be expressed as "Is there anything that is generalizable from this work?" and is therefore a question of external validity. Second, we can ask the question, "Are there any blind spots that the music therapist has herself toward her own playing?" This would be more concerned with internal validity. One of the ways of finding out is to discuss with a sympathetic listener or, more formally, a supervisor. Bruscia (1995) referred to this as a process of self-inquiry and referred to the supervisory role as that of consultant, thereby removing the hierarchical or therapeutic overtones often associated with supervision. What we attempt to demonstrate in this paper

*David Aldridge is Professor for Clinical Research Methods, Universitat Witten Herdecke, Germany. cudrun Aldridge is music therapist and lecturer, Universitat Witten Herdecke, Germany.

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is that the conventional paradigm is useful in eliciting the researcher's understandings about her own work and the structure of those understandings that are not apparent in everyday life. From this perspective our work is hermeneutic. We are concerned with the significance of human understandings and their interpretation.

Many of the terms that are used in qualitative research-trustworthiness, credibility, legitimacy-are value judgments and it is therefore difficult to separate out the results from the investigator. We are really attempting to find out the bias of the person doing the research and how this influences what they do.

Such work is, therefore, inevitably subjective. It is the premises for subjectivity that we need to discover. We argue that our task is not to establish the legitimacy of the person as researcher-we must accept that the researcher is acting in good faith-but to clarify the bias with which the data are gathered and interpreted.

Meaning is not inherent in the data, it is influenced by the way in which the researcher interprets reality and that the interpretation may differ from situation to situation (Dzurec, 1989). Once that interpretation bias is made clear, then we as readers are able to discern how that work resonates with our own premises of interpretation and, indeed, our own bias.

A strength of qualitative research is that it concerns itself with interpretation. It is hermeneutic (Moustakas, 1990) and therefore has a resonance with the very processes involved in the creative arts as therapies. For the music therapistlresearcher in this study, her focus of interest is the development of melodic playing. A first step, in this qualitative way of working, is to investigate how she, the researcher, understands melodies and what significance they have for her. It is important to note here that we are working from the premise that novice researchers, and particularly doctoral students, invest their research with an element of deep personal meaning. The process of doctoral work is concerned with the personal development of the student and that the choice of foci in the work is not haphazard. An elicitation of personal meanings related to the content of the research is an important step forward for the student understanding the work and can be a valuable asset for research supervision.

Personal Construct Theory The personal construct theory of George Kelly (1995), and the repertory grid method that is allied to

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it, were designed specifically to elicit such systems of meaning. This approach does not concern itself with identifying a normative pattern, rather it makes explicit idiosyncratic meanings. However, although each set of meanings is personal, and therefore unique, there is built into the theory that we live in shared cultures and that we can share experiences and meanings with others. The personal construct theory method allows us to make our understandings, our construings, of the world clear to others so that we can identify shared meanings. As Kelly devised this conversational method for teaching situations, counselling and therapy, we can see the potential relevance for the creative arts therapies and for supervision. Indeed, Kelly discussed human beings as having a scientific approach. He proposed that we develop ideas about the world as hypotheses and then test them out in practice. According to the experiences we have, we then revise our hypotheses in the light of what has happened. Our experiences then shape, and are shaped by, our construings. Each situation offers the potential for an alternative construction of reality. The personal construct approach allows us to elicit meanings about specific natural settings as we have experienced or can imagine them.

Qualitative methods, and particularly, those proposed by Lincoln and Guba (Denzin & Lincoln, 1994; Guba & Lincoln, 1989; Lincoln & Guba, 1985), present themselves as being constructivist. Therefore, there should be a historical link with Kelly's personal construct theory. However, nowhere in any of the major books related to qualitative research cited above do we find any reference to Kelly. It is only in Moustakas (1 990) that we find a reference to Kelly in terms of "immersion" where, during the collection of research data, the researcher as "subject" is asked what he or she thinks is being done. Although some commentators have found Kelly to be rather cognitive in his approach, this may be due to the way in which he is taught. A reading of Kelly himself stresses the application of beliefs about the world in practice, and that the words that are used to identify constructs are NOT the constructs themselves. He argued that each of us has a personal belief system by which we actively interpret the world. We create and change the world according to our theories.

The purpose of the work presented here is to find out how the music therapist as doctoral student organizes her world of musical experience in one particular realm of activity, melody. As melody is her chosen focus for study (see companion paper), then it is here

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A PERSONAL CONSTRUCT METHODOLOGY Table 1 The Eight Selected Melodies or Melodic Themes 1. Richard Strauss (1864-1949), Lieder, "Die Nacht" op. 1013.

2. Dimitri Schostakowitch (1906-1975), Sonata op. 40 fur Violoncello und Klavier. Theme from the fourth movement, Allegro.

3. J.S. Bach (1685-1750), Choralvorspiel "Ich ruf zu dir, Herr Jesu Christ" BWV 639. Arranged: Ferruccio Busoni.

4. Frederic Chopin (1810-1849), Piano Concerto No. 2 in F minor, op. 21. Theme from the second movement, Larghetto.

5. Leos Janacek (1 854Ă&#x192;â&#x20AC;&#x2DC;I928) Auf verwachsenem Pfade, "Unsere Abende."

6. Enrique Granados (1 867-1 9 16), Danzas espanolas, Nr, 4 "Villanesca."

7. Richard Strauss (1864-1949), Tod und Verklarung op. 24, Tondichtung fur grol3es Orchester "VerklarUngsthema."

8. Antonin Dvorak (1841-1904), Symphonic Nr. 8 G-Dur op.

88.. Theme from the third movement: Allegretto grazioso.

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for her. This request was not worded as an expectation regarding personal meaning in terms of emotions or as intellectual associations, although such expressions may occur. An advantage of this way of working, as Kelly himself proposed, is that it elicits verbal labels for constructs that may be preverbal. In terms of a researcher's understanding and bias, the explications from a musical realm of experience into a verbal realm may prove to be of benefit. Certainly, when the expectation is to present research results and to discuss them in terms of supervision, then the verbalization of musical experiences is one step on the way to establishing credibility.

Eight melodies were selected from various compact discs (see Table 1). Excerpts, or complete melo-

-

Step 1 that it makes sense to initially focus the work. Making clear her constructions of the world is important for establishing credibility, that is, we can see how her world is constructed, but it also allows her to reflect upon her own construction of the world of melody.

This position stands in contrast to beliefs that only the teacher or research supervisor knows best or that the student alone knows best (If so, how can they learn anything new?). A third option is that there is a "conversational paradigm" (Thomas & Harri-Augstein, 1985) where each person has their own personal meanings, but these can be communicated, and influenced mutually, in interaction with another person. In this way of working, the personal construing of the world is primary in evaluating the world. Sharing those meanings with others must be negotiated and is therefore a social activity. To establish our credibility and trustworthiness as researchers, we need to make explicit our understandings of the world in some form or other. The repertory grid approach is one such way of formally presenting our understandings.

Step 2

difference - Janacek

hovering in the air Janacek

melodies and themes

Die Nacht Chopin Granados Verklarungsthema Dvorak

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Schostakowitch similarity

Method

The music therapy researcher was asked to select a variety of melodies that were significant for her. The limited focus of this piece of work was to elicit the personal meaning of melody for her as a listener. She was asked to select melodies that had some meaning

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Bach-1

tied down

In Step I the construct poles are differentiated according to contrasted elements (Schostakowitch and Janacek).

In Step 2 the construct poles are labelled and the melodies are rank-ordered.

Figure 1. The labeling of construct poles and the ranking of elements.

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ALDRIDGE AND ALDRIDGE Bach determined by melodic flow turbulent melody fewer harmony changes predictable tied down moves in steps distanced indifferent succinct holding back coarse superficial closed balance remaining the same indivisible energetic

.

I

I

I b

.

b #

determined by metrical-harmony rhythmically uniform harmonically directive surprise changes hovering in the air big leaps intimate arousing playful urge to move forward tender deep open tension becoming intense separable soft

Schostakowitch The upward tick represents the rank-placingof the Bach melody element on the respective construct.

The downward tick represents the rank-placingof the Schostakowitch melody element on the respective construct.

Figure 2. Two melodic elements as they are ranked on all the elicited constructs

dies, were then recorded onto audio-tape. These recordings were then used as an aid to memorizing the melodies if, during the process of eliciting the constructs, the melodies were imprecisely remembered.

These same recordings were used one year later to verify the original constructs. Each of these melodies acts as an element in the elicitation of a repertory grid.

To be accurate, each of the experiences of hearing these melodies is an element in the grid.

Using the standardized form of triad elicitation, that is, comparing three chosen melodies for two that are similar and one that is different, the constructs are elicited. This process can be computerized and the RepGrid* program is used here to prompt the constructs and to analyze the data. We see in Figure 1 that Schostakowitch, Bach and Janacek melodies are compared. Schostakowitch is contrasted to Janacek in the music therapist's listening experience, although until now no label has been given to either pole of the construct (Step 1). Once the poles of the construct are given labels (Step 2), then the remaining melodies, the elements of the grid, can be assigned to their positions on the construct pole. While this is a process of rank ordering, it involves no obvious numbers and is an ordering of relative position. When working with

therapist-researchers skeptical about the use of number and critical of being forced to categorize, this method has an intuitive appeal. The elements must be ranked in terms of the labels supplied, but this ranking is done visually in terms of relative distance and can be manually adjusted until the relations are felt to be adequate.

In Figure 2 we see how two melodic elements have been allocated to the totality of elicited bi-polar constructs. Once the constructs have been elicited, that is the person being interviewed can find no further significant similarities and differences, then the data are analyzed.

There are two principal forms of data analysis and presentation. One is in the form of a principal components analysis that shows a spatial conceptual structure of the data. The other is in the form of a Focus analysis that shows an hierarchical conceptual structure of the constructs. Each can be graphically displayed. Both displays offer ways of presenting the data for further analysis with the student. The discussion of the presented data is a part of the technique. It is not a finished analysis in terms of unequivocal results. Like all methods of research, the results demand interpretation. The student is then asked if this pre-

*RepGrid 2 V2. lb. Centre for Person-Computer Studies, Calgary, Canada

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A PERSONAL CONSTRUCT METHODOLOGY X

Janacek

rhythmically uniform;

Schostakowitch

armonically directive

determined by melodic flow

Granados X '

Dvorak The dotted lines representing the horizontal (intimate-distanced)and the vertical (surprise changespredictable) axes represent the two principal axes accounting for variation in the data.

The elements as melodies are represented at their spatial locations by X Name; e.g. X Die Nacht.

Figure 3. A principal components analysis of the original constructs relating to melody

sentation makes any sense, and the supervisor can then also suggest the patterns that he or she recognizes within the data that make sense for them. This negotiating of a common sense is a part of the supervisory activity and the ground for establishing validity in a qualitative paradigm.

The computational analysis is to take the values of the construct as they are assigned to the elements as if they represented points in space. The dimensions of that space are determined by the number of elements involved. The purpose of the analysis is to determine the relationship between the constructs as defined by the elemental space. The computation is looking for patterns in the data and organizes the constructs and elements until patterns are found. This is termed cluster analysis, in that clusters of similar data are organized together. What we see is how similar the constructs are when they are plotted in space. Two constructs that appear close together may be being used in

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the same way. Other constructs may not be equivalent and will affect the whole of the data as a constellation.

Indeed, the principal components analysis of the data presents such a stellar appearance (see Figure 3). Here the two principal components of the data are used as axes onto which the constructs are projected. This allows the researcher to gauge the major dimensions on which the experiences of melody are being construed. In this case, the construct intimate-distanced provides one major axis, and surprise changespredictable accounts for the rest of the analysis.

The Focus analysis structures constructs and elements that are closest together in the dimensional space into a linear order. These are then sorted into matching rated scores and mapped according to their similarity (as percentages). Clusters of constructs are then computed by selecting the most similar ratings and presented as an hierarchical tree diagram. We see in Figure 4 that the constructs coarse-tender and dis-

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ALDRIDGE AND ALDRIDGE 107 90 80 70 60

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tance-intimate are ranked similar and therefore could have a similar function and meaning.

The results of both forms of analyses are then presented to the subject to see if any sense emerges from the analysis. The supervisor can also suggest relationships that appear, to see if they have any relevance for the researcher. At this stage the researcher is encouraged to find labels for construct groupings (see Figures 5 and 10), and these labels themselves represent constructs at a greater level of abstraction. These labels are a step in finding categories for use in analyzing case material in qualitative research. There are analogies here with the process of category generation in grounded theory methods. For phenomenological research, such categories, once they have been articulated in this way, could be bracketed out of the analysis.

As a further refinement, the same grid was rated one year later to see if the constructs were stable after the researcher herself had been listening to case examples (see Figures 6,7, 8, and 9). Because the initial focus was restricted to listening to given melodies, we also considered eliciting constructs related to a num-

David Aldridge

ber of patients currently being treated in her practice (Figure 10). This offers some contrast with differing realms of experience, listening to "art" music and considering music therapeutic practice.

Results

In Figure 3 we see that there are two main axes and these are related to distance and intimacy, and surprise changes and predictability. Moving to Figure 4, these main constructs belong themselves to two clusters of descriptions. Intimacy is related to tenderness, softness and depth, what the researcher herself labels as "feeling" in Figure 5. The construct "predictable" is linked with harmony, rhythm and melodic flow as an overall category of "musical." Such categories conform to musicological analyses; "feeling" would be an equivalent of expressivity and "predictable" appears to reflect the aspect of originality in the inspiration aesthetic (Abraham & Dahlhaus, 1982).

Yet, if we look to Figure 5 other properties emerge that are related to both feeling and musical form. A category emerges that is much more dynamic. The

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A PERSONAL CONSTRUCT METHODOLOGY

orientation

succinct playful

~~

>1movement

-.,..-v."-------

moves in steps big leaps becoming intense remaining the same tension balance -

tension

Figure 5. Constructs related to melody and their groupings

researcher herself labels this as "forming." Indeed, the constructs here are quite ambiguous; separableindivisible leans toward "feeling," as does the related indifferent-arousing, while tied down-hovering in the air links also ties in to the "musical" category. The other dynamic categories, "orientation," "movement" and "tension," relate to prevalent musicological concepts associated with melody (Dahlhaus & Eggebrecht, 1979) and which one would expect from a professional musician with an academic background.

While there are refined constructs relating to musical form, it is the constructs related to expressivity, in this sense "feeling," that appear to be significant in the researcher's relationship to melody. As her doctoral thesis is related to the development of melody in music therapy practice, then it is possible that feelings, particularly related to intimacy and distance, are going to play an important role in the process of assessment in therapy. Whether this intimacy is related to the patient-therapist relationship or to the therapist1 patient-music relationship is not as yet clear and can

David Aldridge

be an area for discussion between researcher and academic supervisor.

Although the ratings of the constructs remain generally the same after one year, there are some changes.

The "musical" category and "feeling" category have become merged (see Figure 7). Now, open-closed assumes prior position as a unifying concept for the feeling constructs related to intimacy and the musical concepts related to playfulness (Figure 6). Remaining the same-becoming intense and indifferent-arousing are the constructs exhibiting the greatest difference (see Figure 8). Indeed the researcher herself chooses to re-label the construct soothing-arousing rather than indifferentarousing. We might hypothesize that a prolonged period of exposure to melodic material in the first year of the research study has broadened the category related to "feeling" and "musical" emphasizing intensity and arousal (Figure 9).

If we look at the constructs related to therapeutic practice describing six female patients (Figure 10), then another set of constructs emerges. The main category is that named as "music-therapeutic" and is

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ALDRIDGE AND ALDRIDGE Bach X

Janacek

remaining th$ same

X

determined by metrical-h

Schostakowitch X

becoming intense X

:

Verklarungsthema Figure 6. A principal components analysis of constructs one year later relating to melodies

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Figure 7. A focus analysis of constructs one year later relating to melodies

David Aldridge

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A PERSONAL CONSTRUCT METHODOLOGY 6

1

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Figure 8. Comparison of original melodies and melodies one year later using the same grid constructs and elements.

concerned with technical factors related to the musical playing, although being co-operative and being open may have some significance for the therapeutic relationship. Indeed, the overarching construct for all these constructs, tying them all in together, is that of relation to the therapist. The "musical" category is similar to that used in construing melodies.

"Relation to the music" is a category that has a technical element related to flexibility in playing, but the construct near-distant also appears. "Distance and intimacy" and "Being closed and being open" occur in both sets of constructs. Although both sets of terms are used differently in both sets of construings, it is tempting to assume that the playing of melody is related to the therapist's assessment of how the patient is relating to her, and that melody is a prime factor in assessing therapeutic change. Indeed the researcher acknowledges that melody is that musical component for her that unites the musical factors of rhythm and harmony and is indicative of therapeutic change.

David Aldridge

In Table 2, we see that there are some related categories we would expect from the same person; however, the researcher's personal construings of performed melody are separate from her construings of patients in music therapy. A more sensible use of this approach would be to take selected melodies from therapy sessions.

Conclusion The value of working in this way is that both researcher, as subject, and supervisor become aware of the way in which the world of melody is constructed by the researcher. This construing is mutual and elicited through shared conversation. The grid data, when presented as a focus analysis (Figure 4) or principal components analysis (Figure 3), are maps of the same territory, the meaning of melody for the researcher.

However, those constructs are not the territory itself.

What we have are verbal constructs plotted in space

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ALDRIDGE AND ALDRIDGE

Bach X

X

Janacek

I

remaining the same X

X

Schostakowitch

!

X

indifferent

Schostakowitch

....

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,

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X

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X

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Figure 9. Contrasts in constructs and elements, one year later.

and presented as artefacts that are open to discussion.

In being made presentable and conscious, they are open to negotiation and, thereby, validation. It is this perspective of consciousness that Giorgio (1994) claimed is the starting point for phenomenological research. We see what the researcher's perspectives and biases are. The supervisor comes to know what near flexible in play

the researcher means through the process of construing. This is a means of establishing internal validity.

In an earlier paper we have referred to three different levels of interpretation (Aldridge, Brandt & Wohler, 1989). Although musical expression occurs at the experiental level 1, as revelation and disclosure construing occurs at level 2, at a phenomenologically

distant - rigid in play

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relation to music

utic

shy in musical-contact

open to musical-contact -

r e l a t i o n to therapist

Figure 10. Constructs related to therapy and their groupings

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A PERSONAL CONSTRUCT METHODOLOGY Table 2 The Groupings of Constructs From Two Differing Realms of Musical Experience Melody Constructs

Therapy Constructs

orientation musical forming feeling movement tension

relation to music musical music-therapeutic relation to therapist

reduced level; the higher levels of interpretation where coding and categorization occur would be level 3. The verbalization of constructs is descriptive, yet stays close to the musical phenomena, in this case the meaning of melody itself. By using such a method we have a means of handling ideas and meanings as if they were objects themselves. The reason for emphasizing these levels of description is that in phenomenological and qualitative research it is the lived experience that we are trying to describe, and knowing at what level of description with which we are working helps to understand how such terms and categories relate to the meanings discovered. For researchers working in other creative arts therapy disciplines the artefacts could just as well be works of art, pictures, sculptures or movements. The method is flexible, accommodating the needs of both partners, while offering a structure in which to work. It is possible to refine the process further and develop the appropriate questions according to the stage of research. In this case, we have seen that taking selected melodies from therapy sessions and then eliciting constructs accordingly would be a future step.

The benefit for qualitative research is that from the research data itself it is possible to generate categories according to the researcher's perceptions that themselves can be compared to existing categories. Furthermore, as qualitative research takes time, and researchers become more conversant with their topic, the repetition of the grid elicitation allows researcher and supervisor to see how the researcher has changed.

We see in this instance that there is consistency over time, but subtle changes are also observed. If reality is constantly being revised according to our knowledge of the world, then it is pertinent to plot any changes as they occur during the passage of time (Seed, 1995).

One of the difficulties with using repertory grid theory is that it can be computerized and the elicita-

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235

tion becomes mechanical. Like any system, it is open to abuse and therefore in the hands of those without experience it simply becomes a blunt tool and the results are both coarse and meaningless. In any procedure that seeks to understand meaning, the process of eliciting that meaning has to make sense to those involved, and can only be as refined as the participants who use it.

This paper has been concerned with looking at the process of research for the researcher herself. It is a form of qualitative self-inquiry where the researcher continually checks out her understanding throughout the study period. This has led her to question not only the importance of melody in the process of therapy itself, but why melody is so important for her. As a form of research consultancy, it allows two researchers to work together as equals rather like the model of co-counselling (Reason & Rowan, 1981). How this inquiry relates to the research product itself can be seen in a companion paper. Subjective research means that the researcher herself is questioned as to her credibility. While we may try to hide behind a stance of "questioning the validity of the data," the experience for researchers is that their credibility is being questioned. What we are proposing here is one method for establishing credibility by establishing some of the concepts used by the researchers. Hopefully this will give others a view on how we have come to our conclusions.

Note: David Aldridge is currently preparing a paper on the broader relevance of Kelly's "Personal Construct Theory" for the creative arts therapist as researcher.

References Abraham, L. U., & Dahlhaus, C. (1982). Melodielehre [Teachings on melody]. Laaber-Verlag Dr. Henning Muller-Buscher.

Aldridge, D., Brandt, G., & Wohler, D. (1989). Towards a common language among the creative art therapies. The Arts in Psychotherapy, 17, 189-195.

Bruscia, K. (1995). The process of doing qualitative research: Part Three: The human side. In B. Wheeler (Ed.), In Music therapy research. Phoenixville: Barcelona.

Dahlhaus, C., & Eggebrecht, H. H. (1979). Brockhaus Riemann Musik Lexikon 2 [Brockhaus Riemann music lexicon 21. Wiesbaden-Mainz: F. A. Brockhaus, B. Schott's Sohne.

Denzin, N., & Lincoln, Y. (1994). Handbook of qualitative research. London: Sage.

Dznrec, L. (1989). The necessity for and evolution of multiple paradigms for nursing research: A poststructuralist perspective.

Advanced Nursing Science, Z l (4), 69-77.

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Giorgio, A. (1994). A phenomenological perspective on certain qualitative research methods. Journal of Phenomenological Psychology, 25(2), 190-220.

Guba, E., & Lincoln, Y. (1989). Fourth generation evaluation.

London: Sage.

Kelly, G. A. (1995). The psychology of personal constructs (Vols.

I and 11). New York: Norton.

Koch, T. (1994). Establishing rigour in qualitative research: The decision trail. Journal of Advanced Nursing, 19, 976-986.

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Lincoln, S., & Guba, E. (1985). Naturalistic inquiry. Beverly Hills, CA: Sage.

Moustakas, C. (1990). Heuristic research. London: Sage.

Reason, P., &Rowan, J. (1981). Human inquiry. Chichester: Wiley.

Seed, A. (1995). Conducting a longitudinal study: An unsantized account. Journal of Advanced Nursing, 21, 845-852.

Thomas, L., & Ham-Augstein, E. (1985). Self-organised learning: Foundations of a conversational science o f psychology. London: Routledge & Kegan Paul.

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The A r t s in

P.syclior/~er(~pv.

Vol.

16 pp. 91-97. *" I'c~-g:imon Press plc.

1989. Printed

in the U.S.A.

0197-4556189 $3.00 + .OO

A PHENOMENOLOGICAL COMPARISON OF THE ORGANIZATION OF MUSIC AND THE SELF DAVID ALDRIDGE, PhD*

This paper is concerned with an understanding of musical perception and how it is linked with the identity of the whole person. An extension of the understanding is the notion of being as it is characterized by the tradition of phenomcnological philosophy, which looks toward "being in the world" as a unified experience.

This phenomenological approach sees a corrclation between music form and biological form.

By regarding the identity of a person as a musical form that is continually being composed in the world, a surface appears on which to project our understanding of a person as a physiological and psychological whole being. The thrust of this endeavor is to view people as "symphonic" rather than "mechanic." By considering how persons come into the world as whole creative beings one can speculate on their potential for health and well-being.

most scientists would recognize here a gap in scientific knowledge and would not want to deny the fact of a connection.

The problem in understanding the perception of music is inherent too in understanding personal health. Health is complex, yet how is one to make a unified sense of the complexity that avoids fragmentation and reduction? Furthcrmore, how can one begin to understand qualitative aspects of personal life as they are expressed in terms of hope, joy, and beauty, which complement increasingly sophisticated quantitative knowledge of the human body?

Although there have been many attempts to describe the process underlying the perception of music there has been little success in presenting any satisfactory explanation. The perception is not limited solely by the acuity of the ear (Longuet-Higgins, 1979) and all that impinges on the listener, but is achieved in combination with the conceptual structure imposed by the listener.

In this way the knowledge of the phenomenon is intimately linked with the phenomenon itself.

Both the knower and the known are part of the same process. Perception in this sense is an holistic strategy.

Much scientific research into the perception of music has concentrated on those aspects that can be measured quantitatively. In this way nature is organized according to the concepts that are imposed on it. This is the analytic mode of consciousness that is predominantly a product of the

The Perception of Music As Dennis Fry (1971, p. 1) wrote, In the case of music there is also continuously interaction between the physical character of the musical stimulus and its physiological and psychological effects so that a more thorough study of music would demand at least the combining of a physical, physiological and psychological approach. Modern science has relatively little information about the links between physics, physiology and psychology and is certainly not in a position to specify how the effects are related in music, but *David Aldridge is

research consultant to the

Musikthcrapicablcilnng,

Univcrsitiits Witten

Herdecke, D5084 West

Germany.

1

91

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DAVID ALDRIDGE

verbal intellectual mind (Burtoft , 1980) where phenomena are represented by number, and variables in equations are represented by quantities.

This paper attempts to dcmonstnite the need for a phenomenological understanding tliat is isomorphic with the medium of music itself. An holistic consciousness that is qualitative, nonverbal, and participatory appears in the very phenomenon of music. What is more, Hie clement of participation by the knower spciiks directly to the aspect of music as performiincc, ; i n aspect that is sadly neglected by many reseiirc11ers who reduce research into the perception of music to a restricted range of received sounds.

Heidegger (1962) emphasized the intuitive element in the comprehension of phenomena.

When music is heard, the phenomenon becomes its own explanation. It is that which shows itself in itself. Perhaps one can begin to understand people as they come into the world, as music, i.e., composed as a whole.

The explanatory idea of a Frame of Reference is a common theme among a number of writers referring to musical perception and brain function (Longuet-Higgins, 1979; Safranek, Koshland, & Raymond, 1982; Steedman, 1977; Walker, 1979). Walker suggests an "Ursatz" (the essential underlying principle) to music thiitis aii all-embracing thought unifying the music and giving a musical structure accessible to analysis.

However, he also states that this musical structure is ultimately unknowable (i.e., beyond analysis). In this explanation lies the perennial difficulty of seeking a unifying explanation by an analysis into parts. Somehow that which is intuitively sought is lost in the process of description.

What results is a statement that what is sought is unknowable, rather than a questioning of the analytic method of knowing. This situation also prevails in the understanding of personal health.

According to the philosophy of empiricism, knowledge of the world is gleaned through experience. This knowledge comes through the senses. However, there is more to this sensory knowledge than meets the ear. There is always a nonsensory factor involved-that of cognitive perception, the dimension of the mind. This cognitive perception is a process ol' organizittion where meaning is imposed upon wh.11 is 1ie;iri.I. I n this way a seemingly nieaningless ground ol' sound is given meaning. To perceive tlien is lo

David Aldridge

give meaning to what is heard, an act of identity.

However the nonsensory process of cognition is transparent, or rather silent, and appears as if hearing were solely a sensory experience. The process of discovery in science is also one of the perception of meaning. What appears to be empirical is indeed cognitive.

If the ohenomenon of music is considered as a unified whole the question arises whether this unity is imposed on the senses by the mind, or whether it is the phenomenon itself that is a whole. To a great extent organizational frameworks are imposed on experience; hence there are descri~tionsthat call for a framework of reference in the perception of rhythm and of melody. However, there is a danger of being blinded to this imposed organization and thus to believe that this is the way the phenomenon really is.

Once an attempt is made to synthetically reproduce the act of n~usical perception the framework analogy is seen as limited. Longuet-Higgins' (1979, 1982) careful and inspiring work demonstrates the utility of a frame of reference approach using tempo and meter for the perception of rhythm. This approach fails, as he remarks, when it is understood how a particular choice of phrasing affects the rhythm. Furthermore, the perception of atonal and arhythmic music are still mysteries to analytical methods.

Yet one can hear and play arhythmically and atonally.

However, there is an approach to understanding phenomena as unified wholes. The roots of this approach are in the work of Goethe's scientific consciousness and the work of Franz Brentano (Bortol't, 1986). Both of these men were to be influential in the development of phenomenology. Goethe perceived the wholeness of the phenomena not as imposed by the mind but by a conscious act of experience. This experience could not be reduced to an intellectual construction in terms of the way the phenomena are organized. Bortoft uses the following example to explain this change of consciousness:

. . . if we watch a bird flying across the sky and put our attention into seeing flying, instead of sccing a bird which flies (implying a separation between an entity 'bird' and an action 'flying' which it performs), we can experience this in the

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MUSIC AND T H E S E L F

93

mode of dynamical simultaneity as one whole event. By plunging into seeingjlyit~gwe find that our attention expands to experience this moment as one whole which is its own present moment.

primacy of the word in speech, and to understand speech in terms of phrasing, rhythm, pitch, and melody, a different consciousness emerges. This consciousness reflects a different range of logics (P. 31) to the predicatory logic of language. Here are dynamic, movement, interval, and time-the very In this phenomenological approach sounds are essences of music and of biological function. heard as sensory information and as a unified I f consideration is given to what constitutes experience, which is music as consciousness. people as identity attention may be better diHow then can personal health be perceived as ;I rected to how they are composed not only in unified experience? qiiii~i~i~i-dvc terms of bones and blood, but how Iliey are composed as musical beings in regard to Language as Music relationship patterns, rhythms, and melodic contours. This may reflect the original biblical notion Whether or not music is a language is ;I riintlml in the beginning was "logos" (i.e., order). In ning debate through the literallire I-dnliiig lo I he music lies the phenomenon of a person coming perception of music. Morley (1981) iusis1.s lli:il into order. It may perhaps be that when a sense music is a form of conin~unic;itioii ;in;iloi:oiis Io . speech in that it has cadences :incl piincti~;i~iot~. ol' l liat order is lost a person experiences a loss of 11:illh.

Perhaps the restructuring of the primicy of l:in, guage over music to suggest Ihiil lii~igii;igeis ; I Hemispheric Processing form of music may be more enlightening. I t could be that speech is analogous to music and lhiil I he In support of the above argument, the realm of musical components of speech are ;ibilicittecl in cerebral processing and music perception may favor of the literal content. ;ilso be examined. Although language processing Most in academic life rarely question Hie primay be dominant in one hemisphere of the brain, macy of the word. As a form of conimunicu~ion music processing involves an holistic underthe word appears to be central to endeavor standing of the interaction of both cerebral whether written o r spoken. Underlying this conhemispheres (Altenmullcr, 1986; Brust, 1980; cern with language is an analytical consciousGates & Bradshaw, 1977). ness. A subject-predicate gramnitir is used that In attempting to understand the perception of gives a structure to language. This very strucmusic there have been a number of investigations ture, in turn, structures consciousness. l l is ;I into the hemispheric strategies involved. Much feature common to Western culture; in the beol' the literature considering musical perception ginning was "the word." To write that creittion concentrates on the significance of hemispheric beean with the "word" hides the fact thal the dominance. Gates and Bradshaw (1977) conclude author is a writer whose consciousness is structhat cerebral hemispheres are concerned with tured by the medium used. music perception and that no laterality differIt might profitably be asked "How would a cnces are apparent. Other authors (Wagner & musician communicate this primal understanding Hannon, 1981) suggest that two processing funcof consciousness? What is 'in the beginning' for a tions develop with training where left and right musician?" In communicating in a different way hemispheres are simultaneously involved, and perhaps communication with a different conthat musical stimuli are capable of eliciting both sciousness may take place. This understanding right and left ear superiority (Kellar & Bever, may also explain the difficulty ofwriting and talk1980). Similarly, when people listen to and pering about health using a verbal analytic language form music they utilize differing hemispheric when there is concern with a realm of bchavior processing strategies. necessitating an holistic mode of consciousness.

Perhaps an expression of health is something that could better be sung or played.

To move from a position that advocates the Evidence of the global strategy of music pro-

.

.a

David Aldridge

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cessing in the brain is found in the clinic;il literiiture. In two cases of aphasia (Moigan A 'I illuckdharry, 1982) singing was M-CII ;is ;I wclconurelease from the helplessness ofheiiq; i i p;itii.~i~t.

The authors hypothesized thal singing w;is ; I means to communicate thoughts externally. Although the "newer aspect" of speech was losi, the older function of music was rcl;iincd, possibly because music is a function di~trihi~teil over both hemispheres.

Berman (1981) suggests that recovery from aphasia is not a matter OS new learning by tinnondominant hemisphere but a taking over of responsibility for language by that henlisphere. The nondominant hemisphere may be a reserve of functions in case of regional failure. A less defensive alternative explanation is that the strategies underlying musical proccss are those same strategies underlying biological process and (lie maintenance of the identity of the organism.

Rhythm Rhythm is the key to the integrativc process underlying both musical perception and physiological coherence. Barfeld's ( 1978) approach suggests that when n~usicalform as tonal shape meets the rhythm of breathing there is the niusical experience. External auditory activity is mediated by internal perceptual shaping in the context of a personal rhythm. It is interesting to speculate here on the meaning of context, not as a container but as coiz textere, which is a weaving together. One pattern is then woven against another to produce an interference pattern, the basis for matter. Sound is woven together witli' rhythm.

When considering communication, rhythm is fundamental to organization. Before any consideration of content one must connect rhythmically with another person and establish some commonality. This connection of rhythms is seen as the phenomenon of entrainment, which occurs in the circadian rhythms of temperature and sleep.

Should they lose entrainment, then jet lag takes place. Scientists observing such phenomena often attempt to find an underlying mechanism for entrainment (Johnson & Woodland-Hastings, 1986), a master clock ils it were. However, when moving from a mechanical perspective a musical analogy for coordinating rhythm might be more appropriate.

David Aldridge

The rhythms and pulses that entrain the rhythmic patterns of the human body are nonmaterial. The senses-hearing, smell, taste, sight, touch-in addition to balancing and moving are integrated as a musical form. It is rhythm that provides the ground of being, and a rhythm of which being is generally unaware and that is perhaps the gestalt of identity.

Dossey (1982) writes of disorders of time being particularly prevalent in modern society. This may be rephrased as disorders of disrupted rhythm. The work of Safranek et al. (1982) demonstrates that subjects use a preferred personal tempo in the performance of a motor task.

This personal tempo is reflected as a functional reflex in the muscle. However, by introducing a n~usicalrhythm while a musical task is being performed, which is different from that of the personal tempo of the subject, then a different response is invoked in the subject. The authors see this as a "volitional response." Control over seemingly involuntary movements can be achieved by meeting the personal tempo of a subject and thcn changing to a slower, even beat.

Meeting this tempo has been a central strategy in hypnotherapy. The existence and role of a personal tempo are refined even further in creative music therapy (Nordoff & Robbins, 1977). It may be inferred thcn that people become aware of the ground of their being not in verbal logic, but in a logic analogous to the ground of their own functioning (i.e., music). In this sense insight is had about a person. not in a restricted verbal intellectual sense, but as being- in the world.

The frame of reference approach mentioned e;irlier is used indirectly by Povel (1984) to understand rhythm. Tones in sequence are seen as having a dual function. They are characterized by pitch, volume, timbre, and duration. They also mark points in time. These tones then produce both structure in time and of time. When tones are used in sequence only as temporal concepts they can be thought of as providing a temporal grid, which is a time scale on which the tone sequences can be mapped for duration and location. It might profitably be asked what the isomorphic events in terms of physiology are that would meet such a dual function. There may be regular sequential pulses of metabolic, cardiac, o r respiratory activity within the body that also have qualities of pitch, timbre, and duration.

What is important in these descriptions of musi-

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MUSIC A N 1) '1'1-l l< S171 , I T cal perception is the emphasis on conlexl where there are different levels of ;itlcntion ocenri i i i f ; sin~ultaneously against a bachgromnl Iciiipoi ; I I structure (Jones, Kidd, & Wct/x'I, 1981; Iiukl.

Boltz, & Jones, 1984).

Recent research in cardiology has eniph.isi/.cd the relationship between changes in bre;itliii~g patterns, personal tempo, and hypertension. The work of Lynch and his associates (I~iieilniiinn, Thomas, Kulick-Ciuffo, Lynch, & Suginoh;ira, 1982; Lynch, Long, Thomas, Malinov, & Katcher, 1981) has highlighted the link, between hypertension and fast speaking. A feature of type A behavior in patients with hypertension is that their blood pressure, which is alre;idy high, shows an increase when they comniunic;ite.

Such patients are seen to have diffici11tie-i in communication. They often appear disconnected from their feelings and have an underlying sense of hopelessness regal ding their ; h i l i t y lo cornmunicate effectively. When people do not expect to communicate effectively their blood pressure rises. Because they do not expect to be understood they do not listen. By not listening they miss the chance to lower their blood pressure.

Attention to the environment (i.e., listening) is seen as promoting a deceleration in heart late and a decrease in blood pressurc. Yet, attention to the self is seen as promoting heart rale (Sandman, 1984; Walker & Sandman, 1979, 1982). Changes then in tempo, and the promotion of listening o r sounding, will have implications for cardiac and respiratory activity. Lynch et al.

(1981) suggest therapeutic activities to proniote a reduction in hypertension utilizing slow and deep breathing. Playing improvised music as pure communication, with its absence of verbal content and its primary component of rhythmic activity related to personal tempo and volitional responsc (Safranek et al., 1982), may be the ideal medium for achieving such change.

It is important to introduce a word of caution here. The motor act of communicating is not the cause of the elevated blood pressure. Blood pressure is elevated whenever communication takes place. The elevation points to a process beyond the motor act, which is intent, a feature also evident in change of muscle activity (Safranek et al., 1982). This switch from physiology being proactive rather than merely reactive is a significant feature of modern physiological rcsearch (Walker & Sandman, 1979, 1982).

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Kliylhin too plays a role in the perception of iiirlnily. The perceptions of speech and music are (01~iiidabletasks of pattern perception. The lisI C I I V I hiis to extract meaning from lengthy seqiirin..cs of rapidly changing elements distributed in I ime (Morrongiello, Trehub, Thorpe, & I'oililupo, 1985).

Temporal predictability is important for tracking melody lines (Jones et al., 1981; Kidd et al., 1984). Kidd et al. also refer to melody as having a sinicture in time and that a regular rhythm acilitates the detection of a musical interval and its subsequent integration into a cognitive represcnt;ition of the serial structure of the musical ptitt ern. Adults identify familiar melodies on the basis of relational information about intervals betwccn toncs rather than the absolute information ol"p;irlicular tones. In the recognition of unfamiliar melodies, less precise information is gathered iihoul the tone itself. The primary concern is with successive frequency changes o r melodic contour. The rhythmical context prepares the listener in advance for the onset of certain musical intervals and therefore a structure from which to discern, or predict, change.

'Die implication of this work is that change, whether it be melody o r rhythm, is dependent on a global rhythmic strategy. To extend this understanding to biological processes, it can be hypothesized that differences in contour (melody) (as in the release of hormones, fluctuations in temperature) and changes in rhythm are detected in reference to a global rhythmic context of the body. This global context may be regulated by the heart or breathing patterns, or may be an emergent property of the varying rhythmic patterns of the body. Disruption in this overall global strategy will influence a person's ability to detect new or changed nontemporal information (Cuddy, Cohen, & Miller, 1979; Jones e t al., l98 1 ; Kidd et al., 1984). One may not be aware of certain changes and become either out of tune o r out of time.

Conclusion The perception of music requires an holistic strategy where the play of patterned frequencies is recognized within a matrix of time. People may be described in similar terms as beings in the world who are patterned frequencies in time.

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A phenomenological approach presses the scimusic). Music is the ideal medium to discover entist to understand phenomena as dircct cxpcrihow people are composed and how they come ences before being translated into thoughts and into the world as whole beings both to create and feelings. The practice of creative music therapy sustain identity. Not only can such personal exadopts such a position. A person is invited to pression be recorded for analysis, it can be heard improvise music creatively with a therapist. It and experienced directly as a whole. may be inferred from this playing that one is hearing a person directly in the world as a dircct References expression of those patterned frequencies in a matrix of time. Rather than subject a person to Altenmuller, E. (1986). Brain correlates of cerebral music processing in Ihe human. European Archive's q / ' P s y c l ~ i measurement, to be reduced to what is quantifiairy. 23.5, 342-354. able, he or she may be experienced directly. This Btirteld, 0. (1978). The case for t i ~ ~ ~ l i r o p o s o p hLondon: y. experience requires no verbal translation as in Rudolf Steiner Press. psychotherapy. What can be heard is the person Bcrnian, 1. W. (1981). Musical functioning, speech lateralizabeing in the world. An extension of such imlion and the amusias. South Afkican Medical Journal, 59, 78-8 1. provised playing as an expression of the whole llortoft, H. ( 1986). Goethe's scientific consciousness. Instiperson is that tendencies to play in differing ways tute for Cultural Research (Monograph Series No. 22). may be heard. There may bc limitations in Tunbridge Wells, England. rhythm, melody, or musical structure. By chiilB ~ L I J. s ~C. , (1980). Music and language: Musical alexia and lenging personal tempo one may he;ir the extent agraphia. Briiiii, 103, 367-392.

Cuddy. L. L., Cohen, A. J., & Miller, J. (1979). Melody of his o r her intent. recognition: the experimental application of musical rules.

If musical form and biologic;il lonn are Cuiiiulidii Journal of'Psychology, 33, 148- 157.

I isomorphic, improvised music nii~yiilso pix~vitlc l k i s s c y . L. ( 1982). Spiicc, l i n (~I I I ~inccliriiir. Boulder, CO: Shanibliaki. an holistic strategy for thc ;isscssniei~t01" Iie;il~li 'cinstein, A. R. (1966). Symptoms as an index of biological and well-being. Feinstein ( 1900) st rcssivl I lir ini-. tic1i:ivior in human cancer. Nature. 209. 241-245. portance of clinical logic i n tlic ili;i^ini,sis 01' Ii'icdni;~nn,E., Thomas, S. A . , Kulick-CiutTo, D., Lynch, J . cancer, and the iniportancc 01' iillowin~i,~ l i rpii .l,& Suginoliiira, M. (1982). The cl'l'ects of normal and tient to speak: "The complexity ol' I I I ~ I I Ii ~ ~ c n ~ i i s r ? ; rapid speech on blood pressure. I'syclio.so~~~iitic Modicinc, 4-1, 545-553. the difficulty of studying hiimi~iidisciise, Iml i 1 l . s ~ I'ry, 0. ( 1971). Sonic (:/fic~.so f music. Institute for Cultural enables a diseased man 10 I i i l k . 11is ilcscriplion 01' Kcsearch (Monograph Series No. 9). Tunbridgc Wells, symptoms gives crucial iiilbi~n~iilioii;ilionl IInlingland. diseased structures under iiivcstij~:a~ioii"(p. liiiles, A., & Bradshaw, J. (1977). The role of the cerebral Speech itself is limiting both in conleiit ;nul in hcniisphcrcs in mu5ic. Brain ond Lang~iai".~,4. 403-43 1. l-lcidcgger, M. (1962). Being u ~ i dtime. London: SCM Press. form. The creative playing ol' improvised music .lohnson, C. H., & Woodland-Hastings, J. (1986). The elusive offers an holistic form of assessment tliul is rcliirnechanisni of the circadian clock. American Scienti.sl 74. tional, noninvasive, and nonvcrlx;i, ;ind l l i i i l 29-36. allows the identity of the patient to be revealed Joncs, M. R., Kidd, G., & Wetzel, R. (1981). Evidence for rhythmic attention. Journal ofE,vperi~rienliilPsychology, and experienced in the world. This context 7. 1059-1073. allows the expression of tendencies that have poKclliir, L. A., & Bever, T. G. (1980). Hemispheric asymmettential~for those states called health and illness. rics in the perception of musical intervals as a function of If music is an earlier form of communication musical expcricncc. Brain mid L t i i i f i i d ~ i ' 10, , 2438.

Kidd, G . , Boltz, M,, & Jones, M. R. (1984). Some effects of than language, and the processing strategies lor rhythmic content on melody recognition. Amrriciin Jourthe perception of music are distributcd over both mil o f ' l ' s y r l i o l o ~ y ,97, 153-173. hemispheres, it is possible to infer that this holisLonguet-Higgins, H . C. (1979). The perception of music. tic strategy is closer in developmental terms to I ' r ~ c c r d i ~ i f of s the Royal Society qf London, 205, 307physiological processes and autonomic activity 322.

Longuet-Higgins, 1-1. C. (1982). The perception of musical than language. There is an emerging tolerance rhythms. fJcrwpfion, / I , 115-128. and even acceptance of the inllucncc of 1:mgii;tge Lynch, .l. J., Long, J. M., Thomas, S. A., Malinov, K. L., & on physiology. However, there is a more subtle Katchcr, A. H. (1981). The effects of talking on the blood and more precise medium with potcntials lbr pressure of hypertensive and normotensive individuals. representation and influence (i.e., the playing of Psyclioso~~iulic Medicine, 43, 25-53.

-!8I.").

David Aldridge

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MUSIC AND THE SELF Morgan, 0. S., & Tilluckdharry, R. (1982). Presentation of singing function in severe aphasia. West Indian Medical Journal, 31, 159-161.

Morley, J. B. (l98 1). Music and neurology. Clinical am1 Ex' periine~ztulNeurology, 17, 15-25.

Morrongiello, B., Trehub, S. E., Thorpe, L. A., & Podilupo, S. (1985). Children's perception of melodies: The role o l contour, frequency and rate of presentation. Journal of' Experimental Child P.sycliolof~,40, 279-292.

Nordoff, P., & Robbins, C. (1977). Crcutivc music tlu-nipy.

Individualized treatment / o r tlie luinciicapped cliilcl. New York: John Day. Povel, D. J. (1984). A theoretical framework Ibr rhythni pcrception. Psycholofical Rfsecircli, 45, 315-337.

Safranek, M. G., Koshland, G . F., & Raymond, G . (1982).

Effect of auditory rhythm on muscle activity. l'l~y,\icul TIti-rapy, 62, 16 1- 168.

David Aldridge

Sandman, C. A. (1984). Afferent influences on the cortical evoked response. In M. Coles, J. R. Jennings, & J. A. Stern (Eds.), Psycliological perspectives (Festschrift for Beatrice and John Lacey). Stroudberg, PA: Hutchinson & Ross.

Steedman, M. J . (1977). The perception of musical rhythm ;ind metre. Perception, 6, 555-569.

Wiigncr, M . T., & Haniton, R. (1981). Hemispheric asymm e t r i c ~ in faculty and student musicians and nonmusicians duriny melody recognition tasks. Brain and L t ~ t ~ g u a g e13, , 379-388.

Walker, A. (1979). Music and the unconscious. British Medicul Jmirnul, 2 , 164 1-1643.

Walker, B. B., & Sandman, C. A. (1979). Human visual evoked responses are related to heart rate. Journal of Comparative rind I'liysiolofficul Psychology, 93, 7 17-729.

Walker, B. B., & Sandman, C. A. (1982). Visual evoked potcntiiils change ;is heart rate and carotid pressure change.

Psyrliopliysiolo~y,19, 520-526.

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THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 6, Number 3, 2000, pp. 245-251 Mary Ann Liebert, Inc.

Guidelines for Clinical Research in Complementary Medicine DAVID ALDRIDGE, Ph.D.

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ABSTRACT There are several stages in preparing clinical research studies. Stage 1includes identifying the purpose of the inquiry and finding the essential financial resources. Careful thinking about the clinical practice to be investigated and the allocation of time for research is also necessary. Stage 2 involves assessing the feasibility of the study. Statistical decisions are best made before data are collected, and this means consultation with a statistician or methodologist. There has to be ethical approval from the cooperating institution. A thorough search of the literature is fundamental. In Stage 3, the final trial is designed, ethical approval obtained, and the proposal is submitted for funding. In the final stage, Stage 4, the trial is carried out, analyzed, and prepared for publication.

INTRODUCTION

P

erhaps the most important question to ask before we begin clinical research is what are the specific guidelines for clinical research within your own institution or the institution where the research is to take place. Hopefully clinicians intending to do research will find sufficient advice to plan a research proposal from the institution where they are working. This will also mean that sufficient advice is given concerning the scientific ethics committee of the institution. One of the keys to successful planning is to ask crucial questions early in the research process. Here are some considerations that a research methodologist would ask of you.

MOTIVATION

Why are you doing this anyway?

First you need a good idea. The difficulty about having good ideas is that they do not al-

ways withstand the rigors of questioning. What may seem to be a good idea in the early hours of the morning, while driving home in the afternoon, or after a meal with enthusiastic friends in a restaurant is that in the cool light of the next day, the idea is not as world-shattering as you thought. The next stages of writing the ideas down for colleagues to criticise and making overtures to funding agencies are far more grueling.

For whom are you doing this study?

This question ultimately determines the scope of your research and what resources you bring to the research.

First, if it is a study that will bring you a research qualification then the study is for you.

It is part of your training and will give you the basic qualification as a scientific researcher or the platform from which you can do further research. It does not necessarily mean that you will be doing anything of a broader consequence.

Universitat WittedHerdecke, Witten, Germany.

David Aldridge

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ALDRIDGE

It may be that your immediate working group or institution has a research program and this research is to meet their needs. The contents of the study will be debated within the group and they will too be part of bringing resources to bear on what you need.

If you are hoping to make a significant development in medical practice, then prepare for disappointment. Single initiatives will rarely have an impact. As we know from the research into the influence of Helicobacter pylori, the research was basic and scientifically impressive.

However, bringing these findings into everyday practice was another matter altogether, exposing the myth of medical practice being based on a foundation of scientific research.

There is another group for whom you may be researching, that of the patients themselves.

It is quite possible that a self-help group, or an interested group of patients may wish research to be carried out on their behalf.

RESOURCES

How are you going to pay for this research? or Do you have the money?

It is important to bear in mind that research is greedy for resources. A good idea is in itself of little value unless it can be realized in practice. Clinical research can be expensive particularly if it takes you away from clinical practice.

Do you have the time to do this research?

It is essential to plan your own time carefully as a researcher. Before the research and during the progress of the work, even in preparation, it is important to have time to think about what you are doing. It is also vital to read research literature thoroughly and perhaps with a different approach to the one which is used to scan journals for articles of interest.

sidering, from a known expert in the field, or from the funding agency you intend to approach. It is at this stage that statistical or methodological advice must be sought, not after data are collected. It is also necessary to find out which colleagues will be willing to cooperate with your work.

PURPOSE OF THE INQUIRY

Are you asking a question or making a clinical statement?

It is important to ask your questions precisely. A question must be clear and simple.

This process of clarifying your own emerging question so that it can be understood by others, is a vital stage for your work and for finding funds. To a certain extent the purpose of the study will help define the target audience for your work. This will in turn influence the research methods you use.

If you are making a clinical statement, then the work is not necessarily research, it is more in the direction of clinical audit. The process of research is re-search, looking again at what you know. When knowledge is questioned it leads the questioner further, that is the purpose of research.

Most clinicians, when they do research, are attempting to convince someone of the validity of their approach. Either they are trying to convince other practitioners, licensing authorities, journal editors, consumers, or patients. It is important then to be able to see the purpose of what you are doing and why. In the field of complementary practice it is important to state where such practice could be used within a current health care framework. In addition, it is important to show where the proposed work will improve research expertise, current clinical practice, or have an educational component.

AIMS OF THE STUDY

Do you have help and support?

Research is a serious activity and cannot be tacked on to other activities. If possible, find some specialist advice either from a colleague who has researched in the field you are con-

David Aldridge

The aims of clinical studies are varied. The exploration and generation of hypotheses, the refinement of those hypotheses, the discovery of the optimal use of a therapeutic regimen, the

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GUIDELINES FOR CLINICAL RESEARCH

safety of that regimen, or the active ingredient in a composite therapy are common aims. Similarly, complementary practitioners often want to make a definitive demonstration of their therapeutic regime in comparison with another regimen or to demonstrate feasibility or efficacy in a particular setting.

Such clinical trials usually pose two radically different types of problem that demand different types of solution and different methodological considerations. The first is an explanatory trial. In this approach we seek information that will give answers to scientific questions often at the biologic level. The second type of trial is a comparison of treatments as applied in practice. This is a pragmatic trial.

In such a trial treatment conditions would be optimized and our purpose would be to make a decision about which treatment modality to use. In these trials we can incorporate factors other than the biologic or psychologic. These factors might be concerned with cost, efficacy, ease of use, acceptability by the patient, and possibility for inclusion in general practice.

Pilot studies It is important to make exploratory or pilot studies, not as an easy option. By attempting to try out our ideas in practice, we can see the pitfalls and the possibilities of what we are attempting. Some of these pitfalls can be avoided by asking expert opinion beforehand. Pilot studies are not any easier to construct methodologically than later trials. Definitive studies cannot be generated from poorly thought out exploratory studies.

BACKGROUND TO THE STUDY

In your preliminary thinking you will have begun to understand the gaps in present knowledge. You will then need to say how your study will begin to fill these gaps and contribute to that knowledge. This understanding is based on your own clinical knowledge, that of current expertise from other practitioners but is based predominantly on reviewing the clinical literature. Reviewing literature can be a research study in itself. It demands a great

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deal of application to search, collect, and read the relevant material. There are numerous databases available for searching the literature (Wootton, 1997). These searches are made easier and less expensive by your being clear about what categories you wish to search under, in what range of publications, published in which languages, and over what period of time.

If your work is based on a literature review then it will have an influence on the statistical methods that you use. Once you know in which direction you expect improvement, then this will influence the statistical test. Most clinical studies are confirmatory studies, they expect the effect to be in one particular direction.

There is, therefore, no "null hypothesis." This means that the danger of finding no significance and thereby committing a Type I1 error, falsely concluding that the treatment has no effect when it actually does have an effect. The inclusion of confidence intervals is important in telling the reader how the statistics may be best understood. These confidence intervals can then be used to compute the probability that the population treatment effect is positive as an inference probability. We can then estimate not only that the treatment has an effect, but the magnitude of that effect (Hunter, 1997; Shrout, 1997).Once we know effect size we can then begin to accumulate comparative data.

DESIGN OF THE STUDY In this stage, you will determine what research strategy is to be used. Will you use a laboratory style explanatory approach or embark on a survey? Are you using a controlled trial with randomized or matched controls, or are you carrying out a series or related single case designs? Are you attempting to describe a service within a hospital setting or is this a formal trial of a therapeutic procedure?

It is possible to be innovative in clinical trials design. The Research Council for Complementary Medicine application emphasises that, "Studies should not conflict with the best practices in the complementary discipline involved; they should be planned so that the main source of error and bias are avoided; provided that this

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ALDRIDGE

248

rigor is sought, they need not conform to the have to be made about randomization of subtraditional patterns of clinical trials methodol- jects to groups, how many patients are needed ogy." in those groups to achieve statistical significance, and more importantly, what is the Selection of subjects for the study power of those statistics. It is vital that approIt is important to describe the class of pa- priately sized groups are chosen in clinical tritients to be included in the study. If you are als designs so that clinically meaningful differstudying a particular disease, then it is impor- ences are not missed. tant to define a subclass of patients who are suitable for that trial. This will mean giving discrete criteria for patient inclusion and exclusion (e.g., by age, gender, chronicity, previous treatment). Beware of defining this group too narrowly such that they become unrepresentative.

The study that accepts a broad spectrum of patients has a generalizability and persuasiveness that is essential to influencing a target audience of practitioners. Although hand-picking patients may be desirable in statistical terms, there is a trade off between efficiency and generalizability.

There is also a further subclass of patients: those who complete the trial, i.e., those about whom you actually gather data. Withdrawals cause serious difficulties, especially if they occur during the treatment regime. People may leave trials because they are frightened of what is going on; they may believe that they are not receiving an important life-saving medication; the regime or data collection may be tedious; the medicine may taste terrible, or the procedure may be painful. Some patients do not see the point of the study after a while and their commitment to research does not match that of the researcher. Some patients at follow-up are found to have left the area. Some patients die.

Some researchers call this process one of patient attrition. While withdrawals may throw important light on a particular practice and provide useful information, it is always better to structure such a possibility into the trial if you believe this is going to happen. A careful pilot study should give some ideas about whether a treatment regime can be sustained or not.

Another important consideration is that of sample size. This is why it is emphasised that statistical thinking is vital at this stage of the study, not after data have been collected. If groups are to be compared, then decisions will

David Aldridge

Choice of data Perhaps the greatest challenge is to sift out which data to collect. There is a temptation to collect masses of data in some mistaken belief that more data are somehow representative of the whole person. It is important to collect multiple data sets that are indicators of therapeutic influence but these data have to be analyzed at the end of the trial. The challenge then is to define how the criteria that are used for evaluation are related to the treatment intervention, and one with another. The variables measured by the experimenter in this way are the dependent variables. The panel that assesses your application will want to know why you have chosen particular measures or indices.

When assessing the effects of a treatment regimen we may use several diverse criteria: regression of a tumor, decrease in pain, return to work, or mean survival time compared with a given prognosis. Return to work may be an important variable as identified by the patient but it offers no biologic information. Regression of tumor size may be biologically important but this may have no effect on survival. It is therefore important to develop an instrument for measuring clinical change appropriate to the study. Explanatory studies will seek to find separate criteria. A pragmatic approach will look for a single index that can be used to indicate therapeutic efficacy. As the political climate changes to accepting complementary medicine, we will then need to include some estimation of economic evaluation such as a preference-weighted measure concerning the utility of the treatment (Chancellor et al., 1997).

It may be that the aim of the research design itself will concentrate on developing an index.

This may be in the form of a questionnaire or a battery of measures. In constructing such an instrument, you will be able to use your own

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GUIDELINES FOR CLINICAL RESEARCH

expert knowledge, the clinical experience of colleagues, the clinical literature you have reviewed, and the experience of patients. It is essential to bear in mind how patient status will change in relationship to the therapeutic application, and that your instrument measures all clinically important treatment effects. (If you take this route beware! Questionnaire design and validation is a project within itself.)

What most of us seek is some sort of gold standard measure that is reliable and valid. Reliable in this sense refers to the consistency of a research instrument when applied to a stable population. Valid refers to whether those measures are genuine, i.e., do they measure what you say they are measuring? In addition the measure must be responsive enough to measure a small, but real, difference when one is present. There are three main types of index that can be developed: The discriminative index that helps to distinguish between individuals or groups where no gold standard exists.

The predictive index that is used to classify individuals into predefined categories. This is evident in screening measures which identify specific individuals who will have a target condition or outcome. We see this in prognostic indicators or predictors of mortality.

The evaluative index that is used to measure longitudinal change in an individual or group on the given criteria of interest. Such an index can utilise both quantitative and qualitative data and is often used to evaluate functional change.

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Data collection is tedious. Missing data are a calamity.

With the advent of modern computing methods it is easy to store and manipulate data.

Putting data into a database or spreadsheet is relatively straightforward, getting it out again in a meaningful way is not. The statistical decisions that you made earlier, and your understanding of the relationships between sets of data will be invaluable at this stage.

It is important to describe how any specialist laboratory tests will be carried out, the nature of those tests and who will carry them out.

Specialist testing is expensive and another potential source of error so it is important to be clear about how valid or necessary such measures are. Some specialist tests can be therapeutic interventions in themselves and it is important to bear this in mind when designing the study and perhaps consider them as control variables. (A control variable is a potential independent variable that is held constant.)

Treatment variables

Treatment variables are the independent variables. They refer to the techniques or the program of treatment you will use as a clinician. For complementary practitioners working together it is vital that they achieve some standardization of practice while remaining true to their therapeutic discipline, thereby maintaining their own therapeutic integrity and validity. If your therapeutic discipline contains its own idiosyncratic terms it may be necessary to provide a glossary of terms within the application document. When a control group is used, then it is essential to define how, when, and where they will be treated, even if they reData collection ceive no treatment.

It is necessary to say when the measures will If you are carrying out a clinical trial it will be implemented, who will implement them, be necessary to incorporate some time when and design a form for data collection. In plan- baseline data can be collected before treatment ning the collection of data, allow time for ques- begins. The time when treatment periods begin tionnaires to be completed. If postal question- and end must be planned and recorded. Critenaires are used, make an allowance for the ria must be made for when the trial period of follow-up of unreturned questionnaires, and be treatment is to end, and when a follow-up asprepared to visit if necessary. Ideally if data are sessment is to be made (Aldridge, 1991a, collected by more than one person then one 1991b).It is also important to say what will happerson must be placed in a position to collate pen to patients discovered to have new needs those data. Research is an obsessive activity. during the process of the study.

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ADMINISTRATION OF THE STUDY

Analysis of the results If the data are stored on a computer and the researchers understand their data, then a statistical package can be used to analyze those data. If statistical data is sought at the beginning of the trial and the trial designed according to certain principles, then the appropriate routines will be clear. With the implementation of statistical analysis packages on microcomputers it is possible to view and analyze the data in a variety of ways. Such retrospective data analysis, sometimes called post hoc hypothesizing, is dangerous. While it may suggest new hypotheses and correlations between data, those relationships may be completely spurious. Analyses of data are only spurs to critical thinking, they cannot replace it.

Timetable of the study In the process of making the previous decision you will have some idea of how long the study will take. The most common mistake that novice researchers make is to underestimate the amount of time necessary to complete a study. First, you will need to assess how long it will take to recruit the requisite number of patients.

Second, plot the time it will take for all the subjects of the research to be treated and make a definite date for the trial to end. Ensure that any specialist testing will have been carried out by that date and the results received. Allow for any missing questionnaire data to be followed UP. Third, allow time to analyze the results. Initial data are raw data; they can do nothing by themselves, you as researcher must process it.

Unlike patients, data is not self-actualizing.

Fourth, consider that the results must be thought about and then written up in some form for publication or as a presentation to your target audience. Because we are practitioners, it does not always mean that we are writers. If you are writing a joint report then allow time for discussion.

Finally, if you are writing and working with colleagues make sure that you have made a decision about who is to be senior author, or at

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least to have final say on the finished report and who is to be accredited in the list of authors.

Ethical considerations If your professional group has a code of ethical consideration for research then it will be necessary to consider this code. Mention such a code of practice in your research application.

If you are working with an institution there will be an ethical committee that will need to see your research submission.

As soon as data are collected, and particularly if it is stored on a computer, those data must be protected and made confidential. Similarly, if the research is to be written as a report that can potentially be published, arrangements must be made to maintain confidentiality and this must be stated in the application.

The consent of patients and cooperating practitioners must also be obtained. Be clear how you are to obtain this consent, and what information you will give to the patient in the trial.

The rights of the patient to refuse to participate in, or withdraw from, the trial must be observed. It is essential that any possible risks to the patient are made clear and harmful consequences removed.

Cost of the project As mentioned earlier, research is greedy for resources and particularly for money. Do not underestimate your requirements. Find out what is the minimum or maximum trial budget that they will consider.

The principle considerations are: Staffing costs: the salary of the investigat o r ( ~and ) the hidden pension and insurance cost over a given period of time. Allow for annual increments; secretarial costs; specialist consultancy services for data handling, statistical advice and analysis and research supervision; specialist consultancy services for patient assessment.

Treatment costs: any tests will need to be costed, particularly when carried out by an external agency, and the cost of treatments or medicines will need to be considered.

Handling charges: most sponsors will sup-

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GUIDELINES FOR CLINICAL RESEARCH

CONCLUSION port an institution rather than an individual.

Such institutions will often charge a hanIf you can incorporate all these consideradling cost as a percentage of the funds retions, then the research itself should be easy. ceived.

Administrative costs: there will be accom- Applying for funds is the worst part. It takes a modation charges, telephone bills, sta- lot of work and organization with no guarantionery needs, printing requirements, tee of results.

Remember that research takes time: personal postage and overheads.

Travel costs: visits to expert informants, vis- time, reading time, thinking time, and time away from your routine practice. It is prudent its to follow up patients.

Hardware costs: any specialist equipment to negotiate such changes with your friends, colleagues and family. which must be rented or bought.

Be clear about the intended audience for Computing costs: it may be necessary to purchase software for computing or to have your research.

Research is expensive. It may be worthwhile software adapted or written for your trial. If investing in preliminary research planning to you have access to a computer center that include a systematic review of the literature center may charge for such support.

Library services: searching for references in and statistical or methodological advice. the literature, collecting literature and photocopying literature is costly.

Sometimes it is necessary to break these costs down into yearly requirements.

Personnel For the main personnel working on the project, it is important to include curricula vitae, and their appropriate clinical and academic qualifications. Some sponsors require you to nominate a key person to oversee the work. If you are using an external supervisor, then his or her qualifications will need to be included.

Research experience can be included in this section. Hopefully lack of experience should not preclude the clinician from a research grant providing the sponsor is satisfied that there is adequate research supervision otherwise it would be impossible to gain research experience.

REFERENCES Aldridge D. Single case designs for the clinician. J R Soc Med 1991a;84:249-252.

Aldridge D. Single case designs an extended bibliography. Complement Med Res 1991b;5:99-109.

Chancellor JVM, Coyle D, and Drummond MF. Constructing health state preference values from descriptive quality of life outcomes: Mission impossible? Quality Life Res 1997;6:159-168.

Hunter JE. Needed: A ban on the significance test. Psychol Sci 1997;8:3-7.

Reuther I, Aldridge D. Qigong Yangsheng as a complementary therapy in the management of asthma: A single-case appraisal. J Altern Complement Med 1998;4: 173-183.

Shrout PE. Should significance tests be banned? Psycho1 Sci 1997;8:1-2.

Wootton JC. Directory of databases for research into alternative and complementary medicine. J Altern Complement Med 1997;3:179-190.

Address reprint requests to: David Aldridge, Ph.D.

Submitting the research Send the completed design with a cover letter. It may be that you can submit your design for a preliminary review before a formal submission to a full committee. Be prepared to revise and negotiate. Most big committees meet only once or twice a year so it is important to find the final date for submission.

David Aldridge

Chair of Qualitative Research in Medicine Faculty of Medicine Universitat Witten/Herdecke Alfred Herrhausen Strafie 50 58448 Witten, Germany

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A social scientist reflects on 15 years of research in complementary medicine D. Aldridge, Universitat WittenIHerdecke, Germany

David Aldridge has the chair for qualitative research in medicine at the University of Witten Herdecke. He is not a medical practitioner, but trained as a social scientist. Part of his academic work is concerned with promoting the use of complementary medicine and much of what he does is to build bridges of understanding between various practitioners engaged in health care delivery. He was in the first wave of European researchers interested in complementary medicine while working at the Marylebone Centre in the mid

Complementary Therapies in Medicine takes the view that systematic research is not the only way to deepen our understanding of health care. As such, we positively encourage the submission of papers that aim to express personal opinions or which describe personal experiences.

INTRODUCTION

David Aldridge Universitat WittenIHerdecke, Medizinische Fakultat, Alfred Herrhausen Strasse eckweg4 D 5804, Germany

The story began in 1980.1 had been working voluntarily for the Samaritans on the night shift. It was the usual Friday night with the regular callers and some new voices requiring comfort during the dark hours of the morning. As the shift closed, a colleague came into the centre from her nursing shift on the ward of the local hospital. There had been five new admissions for attempted suicide in the night. From their ages, and what she knew of them it was clear that none had called the previous night.

Either we were failing in our service to provide adequate counselling or the service itself was missing a group of young people completely. Most of my callers had been older and known to me. I then began a search to find out why we were missing such distress in what was a rural community where it should have been easy to coordinate our initiatives. By asking doctors and psychologists, nurses and social workers, priests and teachers, it was clear that a need was easily recognized but we were all at a loss what to do. Then the breakthrough came, 'Why not ask the patients themselves?' This perspective has been at the heart of my research since then. We know it now as qualitative research, but as far as I knew then it just seemed a sensible way of finding out what we needed to know. Ask and peopie will tell you. What I didn't realize at the time

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was that this would be seen as a rather unusual stance to take.

At the same time as this methodological breakthrough was taking place, I also realized how angry many of us were that we were so helpless in the face of the challenge of suicide. Suicidal behaviour threatened us in a way that made our every effort appear redundant. How easy it was to blame these deviant patients for their non-compliance with our carefully structured and well-meaning interventions. However, when we heard the stories of what was happening, most of us knew how fortunate we were not to have been faced by their difficulties.

Yet, in the face of this helplessness, there was an anger at the psychiatric services. Over and over again I was hearing medical practitioners say that suicide was a completely unpredictable phenomenon. Although there was a vast literature about suicide, the act was a result of individual choice and this choice was totally unreasonable and a sign of a disturbed personality. Working with the suicidal revealed a completely different reality. From the patients' perspective, the causal chain of events leading to suicide was very clear. This was no idiosyncratic response by a deviant personality but a final response to hopelessness in a context of unmitigated distress. Knowing that, what was I going to do about it? and what was I going to do with the anger that I felt at a profession?

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ACADEMIA CALLS There was only one way to go and that was to change the world with a PhD study. Now, everybody except doctoral students knows that you do not change the world with research. In those heady days of 1982, aged 35 and with a grant from the Open University, the world of academia beckoned seductively. At last, the chance to do something seriously and make some contribution to science.

Remember that this motivation was fuelled by an anger aiming to set the world to rights. This motivation is what I seek in my doctoral students today, albeit in the medical faculty, that small flame that burns to understand, to make sense, to make a contribution. The whole process of researching will attempt to douse that flame. Idealism will become tempered by the ways of the world and the arrogance of anger will become refined in the face of broadened knowledge. That is the process of researching but the initial flame has to be present.

My research lasted 3 years and I emerged as a proud doctoral fellow from the Open University with the conviction that this piece of research about suicidal behaviour from an ecosystemic perspective would change the landscape of professional practice.

Wasn't that why I had done research? At last I could begin a job where students would be taught from my perspective, and, as I thought then, the only true perspective. Now, my academic career could really begin, there would surely be an offer to publish and universities would see how audaciously new such ideas were. Out with the old and redundant and in with the new, dynamic systems perspective. Remember the 1980s, everything was systems this, systems this, ripe for holism, we had outgrown both socialism and reductionism. How life has a wonderful way of bringing us down to earth. From doctoral student to the ranks of the unemployed in one fell swoop. So much for research as passport to a golden future.

What was I going to do? When asked, I could only think of doing research. It was a totally impractical stance to take as nobody wanted research.

Community services were being faced with massive cutbacks, teachings posts were being lopped from university budgets, research was seen as a luxury.

As synchronicity will have it, I made contact with a bishop in the Church of England who was interested in the practice of healing in the Church. While it was difficult enough to get other Church members interested in healing, it was even more difficult getting medical researchers interested in the phenomenon. Although there were general practitioners (GPs) interested in healing, who in a university department was going to jeopardize their career in looking at such a concept? Fortunately, someone without a career to jeopardize could take a look at what was happening and this is what I did. It was the focus of my first book about healing in the Church. Like the work with suicidal patients, it was concerned with what both practitioners and patients

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had to say. Both were expert informants. Linking both pieces of work was a concern with dying. The central part of healing ministries was working with the chronically ill and the dying. Just as suicide patients had exhausted the resources of those with whom they had lived, many of the cancer patients and their families had exhausted the resources both of their own bodies and their medical practitioners.

Furthermore, for the suicidal and the dying, all hope had gone. From this perspective, I began to understand the spiritual need being expressed by those in distress. At that time expressing such a need, or saying that you had lost your relationship to your God, was to invite doubts about your psychological condition. Again, that flame of anger burned fiercer; 'Why, in the very hour of our deepest distress, is it not possible to speak openly with our primary caregiver about what distresses us, about what lies heavy in our hearts?'

Anyone with a smattering of psychological knowledge will see that this was an angry young man seeking justification in the world, a rampant narcissism determined to prove others wrong and himself right. All well and true. Yet, somehow there was a small truth about the advocacy needs of patients, that they knew best about their lives, that if we openly listened we could indeed bring, with them as partners, a resolution of distress. What I could not understand then, as I fail to understand now, is why medical practitioners, with their claims to being scientists, systematically deny knowledge from the human social sciences of anthropology, psychology and sociology.

THE STREETS OF LONDON During my doctoral work I had made friends with Derek Chase who was a GP trainee. He knew my family well and we shared similar interests. If you like cricket you can say that you share similar interests. Eventually, he moved away from the rural town where I was living and made his mark in London. While there he began to write to me about the exciting work he was doing in general practice, the concept of holistic medicine, and how he was working for a man called Patrick Pietroni. This was in 1986 and there was a sudden eruption of discourse about medical alternatives and holistic practice, complementary medicine and healing.

Suddenly, what had seemed esoteric and confined to the Church was finding a resonance in other initiatives springing up throughout Europe. We knew already, at least those of us involved with different psychotherapeutic movements, that the humanistic psychology and family therapy movements in the USA had begun to challenge orthodox approaches.

For someone who was an undergraduate in the 1960s, these movements weren't strange. We would have said they were karma then but fortunately the word has fallen out of favour.

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There was a holistic medicine conference around this time and I was fortunate enough, and probably cheap enough, to make an analysis of a questionnaire enquiry used at the conference. With that money I bought my first computer, an Amstrad word-processor and was set upon the road writing my own papers. For those of us who have struggled with typewriters and two-finger typing, literally cutting copy and pasting it together, the word-processor was a boon. With a hot word processor and data from the conference I was able to knit together a little paper for the newsletter of the organization responsible for the conference. It was hardly the New England Journal of Medicine but from this modest start I was contacted by Derek Chase and Patrick Pietroni about an innovatory, exciting project that was being started in the Department of General Practice at St Mary's Hospital Medical School in London.

Our first meeting was in Derek Chase's flat over the ubiquitous pot of English tea where we weaved all sorts of plans for research. At that heady time, Patrick Pietroni had the promise of substantial funding for the Marylebone Crypt project and it looked like we could do the research that we wanted to do.

I remember being adamant about not wanting to concentrate on clinical controlled trials of general practice nor alternative medicine because the methodology was alien to the questions and interests that we seemed to have together about health care delivery. A substantial consideration was that I also had no experience of such clinical trials but, lacking any sense of modesty, that consideration failed to dawn upon me at that moment. Throughout the years I have experienced the same problem over and over again; many of us talk about research, and debate actively about which methods to use, without having any real research experience, or perhaps more importantly, any clinical research experience.

We had the situation in Germany recently where a study was planned by a statistician that satisfied all the needs of scientific rigour in trial design but was unworkable in practice. Clinical practice is a messy laboratory and the purity of academia is often polluted by day-to day realities. This is not to say that I am against controlled clinical trials. My position is that they are one of the research methods that we have in the toolbox of research. There are many methods; finding the appropriate method to answer the question that we are asking is the central issue.

To force all questions into one method is methodolatry, not methodology.

T H E CRYPT PROJECT Anyway, to return to the Crypt project. At first I turned the project down. Somehow, it did not sound quite right. However, as my friend pointed out, I was unemployed and where would I ever get the chance again as a social scientist to work in such a

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prestigious medical project? How true, and how easy it is to succumb to vanity. But it was work and before long I was grateful to have the chance to work in such a project. What it also meant was working away from my home and family in the week. This was both a curse and a blessing and is something that I now take into consideration when planning research projects with colleagues. For protracted projects it is important to consider the personnel management of those involved. We learn how to research, we learn how to do clinical practice, some learn how to manage clinical practice, but how many of us learn how to manage research projects?

Once the project was underway, we began to come up against the difficulties of doing research with a third-party budget. Unfortunately, the prime sponsor died and a trust was set up to administer the funds. Their expectations about research were different to those that we had planned initially and the trust administrators themselves suggested a research committee. Things were going rapidly downhill as I was expecting to be in control of the research and now a committee was going to decide on issues of which I had previously been in charge. It is from these experiences that I emphasize the politics of research management. For Patrick Pietroni it was even more difficult. He was stuck between a loyalty to me as his researcher and a loyalty to the supervising research committee. That I was a social scientist researcher became a thorn in the medical flesh, so to speak, as I will now illustrate.

We identified chronic asthma as a problem then, as it is today, that challenged conventional health care practice. At the same time, we wanted to introduce acupuncture into general medical practice.

From the literature it appeared that acupuncture could provide some relief that we could assess both subjectively, through patient diaries, and objectively, through airway impedance measures. The literature was quite diffuse and varied in its findings.

A point of focus was the methodology to be used.

The main points were that I thought it important to use the acupuncture sites that the acupuncturist wanted to use, which might vary from patient to patient, and not use pre-specified sites. Otherwise, we would have a trial of needling not acupuncture as I, or my colleague as acupuncturist, understood it. I then wrote a paper, to which Patrick lent his name as project leader and he also reviewed, about the proposal for a clinical trial of acupuncture for the treatment of chronic asthma in adult patients.

For the project this was a first, submitting a paper about a specific alternative medicine to an established medical journal and I was excited about the outcome. Once we could break into the mainstream of medical publishing I believed that we would be setting a precedent. At this time, we have to remember, the British Medical Association was criticising alternative medicine very strongly.

One morning, I was confronted by an irate

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Patrick Pietroni, who was fresh from a visit to a member of the research committee. A former senior official in the GP hierarchy, informed me that such a paper, as the committee member saw it, would never be published. He felt terribly let down in the situation as he had relied upon me to give him that research support he needed for the project. Research itself was to lend credibility and validity to what we were attempting to do. The major criticism of the paper, as I heard it, and in the disappointment of the news from the committee I must admit to partial hearing, was that the paper was too controversial and political. True, I write like that, that is how social scientists are taught to write. In that moment the writing was on the wall, for me. However, all was not gloom and doom.

As Patrick was delivering the news about the paper, the postman was delivering a letter about the very paper itself. The Journal of the Royal Society of Medicine has accepted the paper with the commentary from the editor that it was exactly what they needed. The Royal Society of Medicine at that time was active in promoting a sensible debate between alternative medical practitioners and conventional medical approaches through a series of symposia supported by the Prince of Wales. This threw the ball neatly back to Patrick. We had the first success that we had sought, but this too was hollow. I believed myself to be vindicated but as we all know, there is nothing more annoying than a self-righteous researcher. In the end, it is he that holds the purse strings that calls the tune. That the tune being called was varied according to the commission members is perhaps secondary; what it meant was that my days were numbered at the project. I was causing conflict for the research committee and was becoming unhappy about not being able to do the work that I wanted to do. I know now that this is not an isolated incident for researchers. While clinicians work in teams and have support from their colleagues, researchers have often failed to recognize the need for research support. In planning research, it is vital to offer the researcher a clear management structure for support, and supervision when necessary.

OVERTHE SEAS AND FARAWAY Within the Crypt project we also had an independent department for music therapy with whom we were attempting to collaborate on research projects.

One of my colleagues at that time, the music therapist Rachel Verney, said that although we were the avant garde in our own eyes, many of our ideas had already been put into practice in Germany. She had worked in the general hospital in Herdecke, a hospital based on anthroposophic principles using the teachings of Rudolf Steiner. The debate about medical alternatives had been a hot one in Germany, particularly concerning the use of herbal medicines and, coincidentally, I had used the papers from two

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researchers at this hospital to support my ethical arguments against the sole use of clinical controlled trials in medical practice. So packing up my bags, and without any knowledge of German, I visited the university hospital to see what they were doing.

Indeed, they were practising holistic medicine using conventional medical practice with herbal remedies, massage, oils, dietary practices, creative arts therapies, the use of fairy tales in psychiatry, physiotherapy, and eurhythmy as they had been for years.

Admittedly, the structure was not that of general medical practice in England, but the principle on which German medicine is based is that there was a freer access to the hospital for patients. The gatekeeper function of the GP was not so strong in Germany.

The situation was worsening for me in England; there were researchers knocking at the door who could do the job better than I could. Yet, redemption was in sight. Konrad Schily, the president of the University at Witten Herdecke, had heard that I was visiting the university and wanted to speak with me.

He and I had the same vision for the way in which medicine and the arts could work together, that both sets of knowledge were necessary for the practice of medicine, and more importantly, for the training of medical practitioners. We both questioned the efficiency of clinical trials when conducted in isolation from other forms of research, we also questioned the purpose for which medical research was being done. In this environment it was also possible to talk about the spiritual dimension of knowledge, about the ramifications of hope and despair for clinical practice and patient recovery, even the process of dying.

Eventually, I was offered a job at the University after being a self-employed research consultant (another term for saying that I would do anything rather then be unemployed). Once in Germany I could work as I saw fit, being paid a good salary but being given no research budget. Over the following years, everything that we had planned together over Derek Chase's dining table came to pass. Not in the time span that we had hoped, and not in the working configuration that we had hoped. My impulse to be a researcher proved to be the right one though I did need to find the appropriate setting.

CODA What did I learn from all this? First, if you want to do research it is a lonely road. It is advisable to organize research supervision and ask for regular research support, even if this is informal. Simply organizing someone to talk with on a regular basis helps, even if they are not a researcher. Research may take you away from your home and family for lengths of time. Time is needed to think, and writing needs seclusion. Both these resources need to be negotiated with a partner.

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Second, be clear about who holds and controls the purse strings, who is going to make the decisions about the research approach and the publication of research results. For some academic researchers, the research supervisor will demand to be a co-author on all papers produced from the project. Some institutions will demand that any paper produced from their institute is submitted for departmental scrutiny before it can be sent to a journal. Research has its own politics based on the control of money, access to being published and the needs of institutions. For the naive researcher, as I was, these politics are easily over-looked. They can be debilitating in the long term if not understood. As a senior academic, I believe it is important to foster the development of our younger and junior colleagues. That means also giving them the chance to publish alone and develop their own ideas.

Another aspect of the politics of research is that what I found out was not always what others wanted me to find out for them. That is, some people wanted me to say that one form of holistic medical treatment for cancer in children was better than treatment in comparative conventional hospitals in terms of being humane and acceptable to patients, siblings and the parents of the children. It turned out not to be the case; paediatric medicine has been at the forefront of incorporating new initiatives and there was no difference.

Third, there is a real difference between doing academic research for a qualification and working as a researcher in a project. An academic project for a masters qualification or a doctoral thesis focuses on the student and his or her needs. While needing to be academically sound and methodologically rigorous, it is the training of the scientist that is the principal guiding force. When working for a research project, the focus shifts to a group need and to the needs of the target population in clinical research. Both types of work need not exclude each other but for the purposes of supervision it is important to identify and establish whose needs are to be met.

Finally, it really is satisfying to be finding things out. The ramifications of what you discover are not always comfortable for those with whom you may

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be working. In one study of music therapy, we discovered that music therapy was indeed beneficial.

However, that benefit tailed off after 10 weekly sessions. This meant that the practice of seeing children over a prolonged period of time, as was the current practice, was questionable in terms of the efficacy it brought. For the therapists who had always worked in the long term, it demanded a major change in their thinking to contemplate a change in practice. To their credit, this has been achieved.

My thinking concerning clinical controlled trials remains the same. It is a useful approach when applied to the appropriate question, but it is just one approach among many possibilities. What I do find is that when such trials are used, insufficient rigour is brought to establishing the conditions for the controls and that the statistical assumptions by many clinicians are naive. There is seldom a null hypothesis when they have made a thorough literature review, the literature usually suggests that a treatment will have an effect. Tests of significance are often found wanting and we may be better advised to think more about confidence intervals.

This year my book about suicide has been published. It is based on the material that I collected 13 years ago for my doctoral thesis. A long ripening period for such ideas perhaps, but the ideas are being put into practice, from what various correspondents tell me, and that is gratifying. My anger at the incalcitrance of medical administration has not abated. What I have learned is that patience is a virtue not easily achieved but necessary if we are to do any work that is of benefit for the communities to whom we have responsibility. Perhaps a lesson to be learned from these experiences is that we can trust that our work will have its day, ideas will find their niche and our writings do find resonance. The time frame may be other than we, or our employers, may expect. What I still fail to understand is the unwillingness of medical approaches, in terms of health care delivery, to address themselves to what we know from the social sciences, and in particular, medical anthropology. My project for the coming years is to try and build bridges between these realms of understanding.

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