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Integrating conflicting professional roles: Physician participation in randomized clinical trials
Sot. SC;. Med. Vol. 35, No. 2, pp. 217-224, 1992 Printed in Great Britain. All rights reserved
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0277-9536/92 $5.00 + 0.00 1992 Pergamon Press Ltd
INTEGRATING CONFLICTING PROFESSIONAL ROLES: PHYSICIAN PARTICIPATION IN RANDOMIZED CLINICAL TRIALS KATHRYN Centre
for Health
Studies,
M. TAYLOR
York University, Ontario, Canada
York Lanes, M3J lP3
Suite 214, North
York,
Abstract-The traditional identification of physicians as either clinician or researcher is challenged by the emergence of randomized clinical trials (RCTs) where research and clinical care are performed simultaneously. A mail survey using a self-administered questionnaire, the Physician Orientation Profile, was conducted of 101 physicians from the Collaborative Ocular Melanoma Study (COMS), a set of trials which compares surgical removal of the eye with radiation in the treatment of medium sized eye cancers. A 95% response rate was obtained; follow-up telephone interviews were conducted with 87% of respondents. Key findings suggest that RCTs challenge traditional definitions of physician’s ‘core task,’ because they participate in a social process that requires them to integrate the formerly disparate and sometimes competing roles of researcher and clinician. Three implications of this integration are discussed: amending the expert reward system, altering customary clinical practice and redefining reference groups for professional interaction. Key words-physician
behaviour
randomized
clinical
Randomized clinical trials (RCTs) are currently considered to be the ‘gold standard’ for scientific investigation in numerous areas of medicine [l-4]. Randomized trials are controlled experiments using human subjects to determine which of two or more treatments is most beneficial, especially when there is no single ‘treatment of choice’ for a particular disease [S-7]. In contrast to clinical practice in which the physician and/or patient usually selects the treatment to be used, clinic trial patients are assigned randomly to receive one of the treatments being studied. A comparison is then made of the outcomes obtained for each of the two or more patient groups and the findings applied to treatment decisions for future generations of patients. RCTs can also be viewed as a social process-an attempt to apply the scientific rigour of the research laboratory to clinical practice. The goal is to assess efficiently and rapidly the risks and benefits of one or more promising therapies. Should an encouraging experimental treatment be proven effective, it could then be used for a large segment of the target population. However, despite the acknowledgment by the medical profession that randomized studies are often critical to advance science, these experiments have proven to be particularly challenging to complete [8-lo]. A key, but poorly understood, factor has been physician reluctance to enter their eligible patients [l l-l 51. To better understand physicians’ decision to participate, or not to participate in RCTs, a group of ophthalmologists and radiation oncologists were surveyed prior to the entry of the first 217
trials,
ocular
melanoma
patient on a major randomized trial for cancer of the eye. BACKGROUND
In the 1950s and 60s physicians’ roles as primary care giver or research scientist were clearly differentiated. The medical profession put high value on its ability to provide personalized attention, and most doctors defined their core task as being the care of the individual patient [16, 171. Treatment regimens were usually selected through a complex combination of the physicians’ esoteric knowledge, personal experience and anecdotal advice from professional colleagues. The outcomes of individual treatment decisions were regarded as confidential information, meant only for individual patient records; rarely has this information been collected or analyzed systematically. In contrast to this traditional pattern, however, small subgroups of physicians concentrated exclusively on medical research, focusing on the evaluation of the effectiveness of experimental therapies [ 18, 191. The experimentation often imposed a rigid protocol of prescribed care and reporting, contrasting with the more flexible approach taken by their clinically-oriented colleagues [20]. Each group of physicians, those using traditional treatment methods and those evaluating experimental treatments, functioned in settings designed to facilitate their work. The clinicians, who deal with a predominantly outpatient population and admit their patients to hospital only when necessary, have usually worked in single or group practice [21]. The
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researchers, by contrast, have usually been hospitalbased academic staff, whose patients have been cared for in specialized research units of large teaching hospitals [18]. Overall, there seems to have been a good fit between the professional activities of each group of physicians and their work environment. In their private offices, clinicians have been expected to take a pragmatic approach in addressing the immediate needs of ambulatory sick people. On the other hand, researchers analyzing less accepted therapies, which often have severe side effects, have worked in highly specialized laboratories with complex equipment in which dosages, methods of administration and the long-term implications and outcomes of different treatments could be precisely calculated and methodically recorded. Not only have the work environments of the two physician groups been separate, they have also required distinctive tools. The work done by researchers, for example, has often necessitated the use of sophisticated instruments and high technology equipment, which contrasts with the more conventional implements used by clinicians. The contrast between the two groups of doctors has also applied to the composition of their patient populations. Clinicians typically have treated large numbers of patients with ailments of varying degrees of severity and ranging from the common to the unusual. Researchers, however, have cared for smaller numbers of patients who often suffered from very serious diseases. They have commonly depended on referrals of patients who were seen initially by private practice physicians [22]. Also differing for the two groups of physicians has been the way in which each group has defined professional success. Clinicians traditionally have been regarded and have regarded themselves as ‘healers’: sources of unique knowledge, advice, reassurance, technical expertise and practical solutions [23,24]. They generally have been approached by patients in the expectation that physicians could cure their maladies. By contrast, researchers and their patients have been aware that many of the therapies being tested were still in the experimental stage [25]. Given the imminently life-threatening nature of most of these patients’ illnesses, the expectations of both patients and physician researchers have been a combination of high hopes and limited expectation for success in any individual case [ 19,261. Each of the two groups of physicians has regarded the other as necessary for the practice of medicine, but different and separate. Limited interaction between the two groups has been documented. However, in the 1960s and 1970s more emphasis began to be placed on caring for less severely ill patients with relatively new and untested treatment plans. The randomized clinical trial gained in popularity as an efficient method to test the efficacy of these new treatment options. Practising physicians were now
asked to perform the researcher and clinician task simultaneously since they are expected to give standard medical treatment within the confines of an experimental program. The Collaborative
Ocular Melanoma Study (COMS)
To better understand the social impact of this unique integration of previously disparate roles, we surveyed the 101 physician-investigators of the Collaborative Ocular Melanoma Study (COMS) [27,28]. This major multicentre trial is designed to provide definitive answers to questions concerning appropriate treatment for selected patients with choroidal melanoma (primary eye cancer) [29-331. To demonstrate that either radiation or enucleation offers a better chance for survival, or that there is no difference in survival, 6 central units and 29 clinical centers in the United States and Canada proposed to conduct a randomized controlled study. The organizers approached North American institutions known to provide care for patients with ocular melanoma to participate in the study, and initially 29 hospitals agreed to form a consortium. The physicians, (primarily ophthalmic surgeons and radiation therapists), caring for ocular patients within each of the 29 participating centers thus constitute the population of the 101 research investigators of the COMS. The COMS consists of two large randomized clinical trials and is projected to cost over $30 million dollars over the predicted 15-20 year timespan required to complete the study. Eligible patients with medium size tumours are approached by the research investigator, and those who agree to participate are assigned randomly to receive enucleation of the eye (removal) or radiation therapy. To have sufficient numbers of patients to complete the study in a timely fashion, participating physicians and organizers must enrol the majority of all new cases of choroidal melanoma of appropriate size in the United States and parts of Canada. METHODS
Prior to the first patient being entered onto the COMS study in November 1986, we completed a mailed survey of the 101 physician participants. To better understand the attitudes and behaviour of these physicians, a tailored version of the Physician Orientation Projle, a self-administered questionnaire consisting of 15 demographic questions, 45 binary option questions and 6 open-ended questions was used [34]. This questionnaire had been developed and used in other studies of physician participation in randomized clinical trials. A 95% response rate was obtained after two mailings. Follow-up tape-recorded telephone interviews were conducted with 87% of respondents to expand and amplify the questionnaire responses. Each interview averaged between 30 and 45 min. The interviews were conducted utilizing a structured interview guide-a
Integrating conflicting professional roles companion document to the Physician Orientation Profile self-administered questionnaire. The guide included the following key questions; amplification of the respondents’ interest and motivation in participating in the trial, elaboration of the primary reasons they believed or did not believe they would have difficulty accruing patients to this trial, their perception of the key benefits and deterrents to participation, and the potential negative and positive impact of the trial on their professional activities. The data obtained from the open-ended questions on the questionnaires and from the telephone interviews were transcribed verbatim and entered onto the computer. The data were then analyzed in the style of grounded theory as described by Glaser and Strauss [35] and tabulated and analyzed with regard to content. Results of the qualitative data were coded and grouped into the conceptual model of the Physician Orientation Projile. These include five key constructs which purport to differentiate respondents along a continuum ranging from the extremes of ‘pure clinician’ to ‘pure research scientist’. They include; Primary Allegiance (to the individual patient or to the aggregate), Professional Activities (clinically or research based), Doctor-Patient Relationship (caring for patients or supervising research-subjects), Perceived Rewards, (immediate or deferred), and Peer Group (local or international). This information was then analyzed in relation to elemental physician demographics. Descriptive statistical tests were conducted using SPSS [36]. Specifically, significance tests were conducted using x2. This report draws primarily from the qualitative data of the open-ended sections of the Physician Orientation Profile and the telephone interviews. RESULTS
The demographic characteristics of the sample are presented in Table 1. Selected results of analysis of the quantitative data as well as qualitative data analyzed within the framework of the Physician Orientation Profile are presented below. Overall, 72% of physicians believed that care for the individual patients is the physician’s core task, while 28% believed that the core task is adding to scientific knowledge. However, when divided by medical speciality, 60% of the radiation therapists and only 20% of the ophthalmologists believed that a physicians’ core task was adding to scientific knowledge (P > 0.05). Fifty-eight percent of physicians were salaried and 43% were fee-forservice. Ninety-five percent of salaried physicians said they would approach more than 50% of their eligible patients, whereas only 82% of fee-for-service physicians agreed (P > 0.04). Sixty-nine percent of physicians believed they have a ‘high’ research profile while 31% believed they had a ‘low’ profile. Sixty-two percent of physicians who said they had a ‘high’
Table
219
1. Characteristics of participating N = 96
Range: 27-72 yr
Median: 44 yr
physicians
Mean: 41 yr NO. %’
sex Male 90 Female 6 Speciality Ophthalmology 66 Radiation therapy 30 Training Oncology 40 Not oncology 54 Income source Fee-for-service 40 Salaried 56 CIinicol setting Private practice 27 General hospital 42 Cancer centre 13 Patient poputation Mixed 60 Early disease stage 17 Advanced disease stage 18 Participation in randomized clinical trials Non-participation 20 l-5 trials entered 48 6+ trials entered 17
94 8 69 31 43 57 42 58 33 51 16 63 I8 19 24 56 20
@Percentages are calculated as valid percentages: missing values are not included.
profile maintained that they secured more satisfaction from the work itself rather than from interaction with individual patients, while only 3 1% of those with a ‘low’ profile derived primary satisfaction from the work (P > 0.003). Fifty-five percent of respondents believed that patients/families had the final responsibility with regard to medical decision-making while 45% believed it was the physicians’ responsibility. At the same time, 53% of physicians with mixed patient population, 41% of physicians with early stage and only 12% of physicians with advanced stage patients said physicians had the concluding responsibility. Fifty-three percent of physicians said that in their setting, physicians were given more reward for ‘adding to science’, while 47% were given more reward for interpersonal skills. Overall, 85% of those who worked primarily in cancer institutes, 64% of those in general hospitals and only 20% of physicians in private practice thought physicians in their setting were given more compensation for advancing science. Respondents planned to approach 81% of all eligible patients, and assumed that 68% of those approached would agree to participate in the study. Responses to the interviews strongly suggested that few respondents were concerned that patients might withdraw from the study. In summary, overall, the respondents appeared to be clinically rather than research oriented, while at the same time, expressing great optimism that they would be able to enter eligible patients onto the trial.
DISCUSSION
Given the relatively small size of the sample of physicians and the anticipatory nature of the
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KATHRYN M. TAYLOR
questions, all results must be generalized with caution. However, the high response rate and the richness of the qualitative data may provide useful insights into the complex realm of physician behaviour with regard to human experimentation. First, the results of both the open-ended questionnaire responses and telephone interviews strongly suggest that physicians anticipated participation in the COMS trial as a challenge to their traditional professional self-definition. They believed that their attempts to integrate two roles that were formerly viewed as different-or even conflicting-would be particularly evident in three areas: the reward system, which may have to be reconsidered; customary clinical practice, which may have to be altered; and professional interaction, where reference groups may have to be redefined.
1. The reward system One of the most striking effects of RCTs has been a modification of the reward system for physicians. In the past, clinicians and researchers tended to have unique sets of compensations. These rewards were developed and maintained by both formal and informal means. As Freidson [37] points out, clinicians have been likely to prize and expect direct personal appreciation from individual patients and their families. They have also looked for status in the general community and for direct compensation for their work. Such rewards contrast with the more indirect and abstract gratification sought by researchers that rests in expanding the boundaries of medical knowledge. In contrast to clinicians, researchers tend to look for status within their specialized professional community and are often willing to defer financial rewards. Fox and Swazey [19] point out that the researchers’ ability to find reward on a macro-level is in sharp contrast to the training given to doctors, which reinforces the micro-level, direct and immediate gratification of clinical practice. The two types of gratification are often mutually exclusive: it has often been necessary to forego one in order to obtain the other. However, it appears that for RCTs, physicians are expected to obtain their gratification from both sources simultaneously [38]. They are expected to provide strong individual support to patients using highly refined interpersonal skills, having made clear to patients the details of their role as research subjects. The physicians participating in the COMS anticipated some difficulty with regard to a clear definition of rewards and compensations. Many questioned their ability to easily integrate both direct and indirect sources of gratification. For example, 47% of the COMS physicians said they worked in settings where they were most rewarded for adding to science. At the same time, each group of physicians within this relatively even split showed concern with having to seek rewards in an unfamiliar area. In a typical
comment, customed
one ophthalmologist who was mainly acto individual patient-based rewards said:
I’m not really sure how I feel about all of this. The patients, that’s where I really get my strokes from. I feel good when I can help a patient retain vision. They come to me for my advice, experience and expertise. For the trial, I guess 1’11 have to start to learn to say ‘I don’t know which is best.’ I’m not sure I will be very comfortable doing that for too long
(088) Another traditional characteristic of the medical profession has been its high social status. The expectation of being awarded status concurrently with the medical degree is often cited as an inducement for students to withstand the rigours of medical training [39,40]. In the case of clinicians, status is mainly derived from the patients’ trust in the doctors’ esoteric knowledge, technical skills and personal experience [41,42]. This interpersonal skill-based status contrasts with the status accorded to researchers, which can be described as knowledge-based [43,44]. As researchers’ patients have usually been referred to them by other physicians, who are aware of researchers’ specialized training, the status of these doctors largely stems from the high opinion of their professional colleagues [25]. Again, however, the advent of RCTs has clouded the once relatively clear picture. In order for trials to be worth carrying out, large numbers of eligible patients must participate. This means that professional referral alone cannot provide an adequate number of patients. For the COMS to be successful, participating physicians must approach the majority of all diagnosed ocular melanoma patients with tumors of suitable size in North America each year throughout the accrual phase of the study. This need requires actively soliciting referrals from other physicians, something some responding physicians anticipated as an aggravation. Many respondents were unaccustomed to soliciting referrals and they viewed the need to ‘sell the study’ by means of brochures, posters in their offices and personal calls to other physicians as potentially undercutting the traditional status that accompanied referrals, both lay and professional. Fifty-seven percent of respondents cited this concern. One physician explained: I’m not really used to ‘advertising’ I guess. The idea of having to ‘sell’ the trial is one that feels antithetical to what I normally do. Posters, TV talks all the things that I guess will work, that feels very foreign to me. To be truthful, I wonder how I will feel being on the selling end. I’m much more used to being courted-not doing the courting. (059) Clinicians have traditionally been able to optimize financial compensation for their work by structuring their practices. Researchers, on the other hand, have often been salaried by their institutions and thus their financial rewards were not as directly related to the amount of time they spent with each of their patients [44]. When they participate in randomized clinical trials, clinicians in particular give up some of their ability to control their direct monetary gains. The
Integrating conflicting professional roles time they are required to spend explaining the intricacies of their patients’ participation in the trial and in filling out forms to ensure its scientific rigour is often not recompensed [45]. Sixty-seven percent of the survey respondents alluded to concern with this issue. One clinician said: One thing is for sure, no one can ever say we are in it for the money. By the time I will have spoken to the patient, explained the trial, gotten consent, done all the extra testing, called back to make sure we don’t lose the patient to follow-up I’ll have spent 10 times the energy I’ll spend on a non-trial patient. What little money we get won’t come close to covering my time never mind the emotional energy. Since few people around me care much about trials, it’s going to be hard to stay motivated. I just hope my patients don’t start giving me a hard time. That would finish me, I think. (048) 2. Changes in clinical practice
Another notable effect of the advent of RCTs has been the modification of traditional clinical practice, particularly physician responsibility and accountability. On that question, clinicians have customarily taken the view that their major allegiance is to the welfare of the individual patient, a view strongly reinforced by physician’s professional socialization [46,47]. For researchers, who although aspiring to provide optimal care to individual patients, frequently use less tested treatment regimens that are not necessarily of direct benefit to those patients, key loyalty has of necessity been to the potential usefulness of the data they gather for future generations of patients [48-501. With the advent of RCTs, however, these differences of view of primary responsibility have become less obvious. Given that at present many trials include patients at relatively early stages of their disease, who still might be able to benefit should one area of the trial arms prove superior to the other, participating physicians often find themselves focusing less on the theoretical benefit to future patients than on the possible benefit to the immediate patient [51, 521. When physicians taking part in the COMS survey were asked whether they felt their primary allegiance was to either the present OR future patients, many had difficulty selecting one over the other. However, when asked to choose their primary allegiance, 72% mentioned present patients, while only 28% indicated future patients. One ophthalmologist explained his difficulty with choosing one loyalty over another: I know we are dealing with cancer, and this is very different for me, and I think it will be very hard for me to be truly objective, and think of patients down the road when a patient sitting in front of me asks for my opinion. How can I possibly think of future patients and the importance of knowing whether enucleation is indeed better, when a patient says to me ‘Doctor, I really don’t want to lose my eye unless you think it is absolutely necessary’ (009) Another change
has
aspect occurred
of
clinical relates
practice to the
role
in
which
assigned
a to
221
patients. Traditionally in medicine, the patient’s role has been unequivocal and clearly defined: he or she was expected to seek medical care, comply with the physician’s recommendations and recover as quickly as possible [53,54]. In conventional research, the role of the research subject has been equally clearly defined: he or she was expected to agree to treatments that carry an elevated risk of grave side effects and to accept the guarded optimism that surrounds such endeavour [55-571. But within the process of RCTs, physicians often find themselves challenged to identify the role of the person they are treating. The person is referred to as a ‘patient’, as he or she would be in standard clinical practice, but is now also a research subject [58, 591. The patient must, for example, sign an informed consent document that clearly outlines the primacy of the research component of his or her treatment [60]. Once the document is signed, however, the long-term care is usually given in a clinical setting. The confusion that arises regarding the role of the individual receiving the treatment was cited by 76% of the COMS physicians as the underlying rationale for doctors choosing not to participate in the trial. One oncologist explained: You know, it is very different being a patient and being a research subject. I think that research subjects are perhaps, more willing to accept risk. I also think they are hoping that a little more risk also gives them a little better chance for cure. With these kind of studies, I think it must be very confusing for patients. The ones who are not on study get exactly the same care from me as those on study, with the exception that the computer, and not the physician and patient, have chosen therapy. I think some patients feel like they are neither fish nor fowl. Sort of a research subject, but lots like a patient. No matter how much I explain, I think that many of the patients remain confused about what it is they are getting into, and I must say that enters heavily in
my decision to approach them. (094) Another facet of clinical practice that has been affected by RCTs is physicians’ management of uncertainty. Some degree of uncertainty has always been associated with medical treatment [57]. Customarily, a principal element of the clinician’s role has been to reduce that uncertainty for the patient by selecting what they believe to be the most appropriate therapy given the particulars of the specific case [61]. By contrast, researchers have not been able or expected to reduce clinical uncertainty, as, by definition, unproven treatments entail uncertain outcomes [62]. Under research conditions, however, uncertainty may take on a different meaning. Since the patients receiving experimental treatment usually suffer life-threatening diseases, research physicians may present uncertainty in a positive light, as a way of giving their patients hope; thus, the certainty of death is replaced by the uncertainty of a possible cure
1631. But these familiar patterns of management of uncertainty are altered by the clinical trial process. In order for a trial to be justified, there must be
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significant question as to the benefit of the experimental therapy; at the same time, the trial must include as the control arm the standard treatment of choice [64,6]. This means that participating physicians are obliged to inform the patients of both the relatively predictable outcome of the standard treatment as well as the less foreseeable, but possibly more effective, results of the experimental treatment. They must also explain that only one of the treatments will be selected for a given patient, and that the selection will be made randomly. As the choice of the treatment is outside of the physician’s control, he or she cannot apply familiar techniques for reducing the patient’s uncertainty until after the random treatment assignment has been made [55,65,66]. Of the physicians taking part in the COMS survey, 58% anticipated being uncomfortable discussing uncertainty so openly with their patients. One radiation oncologist explained: I’m used to uncertainty. In my work, it’s a major part of what I do all day. I deal with cancer a lot. Most people I see either know they have cancer, or are afraid they have. I can never tell them ‘for sure’ that the treatments I recommend will work. But I can at least cut down on the options for them. I can say, now if you try this treatment, these are the potential outcomes, and if you try those treatments, these are the potential outcomes. All things being equal, the choice is pretty clear. However, in a trial, I say, now if you get Treatment A the effects are these and with Treatment B the effects are those, but the uncertainty as to which treatment they will get, or will turn out to be best for them is not removed. That’s hard for both my patient and me. (016)
The final aspect of clinical practice to have altered as a result of the conduct of trials is that of physicians’ relationships with colleagues. Traditionally, clinicians have carried on their practices with little obligation to account for many facets of their relationship with patients [23,24]. They have, for example, used their own discretion with regard to the disclosure of information to patients. On the other hand, as research is predicated on routine sharmg of information, researchers have been expected to be aggressive in the distribution of even the earliest results of their patients’ treatments [671. Randomized trials require a systematic collection of detailed information on each patient’s progress, in order to make possible meaningful comparisons [68]. Thus the physician becomes highly accountable. The clinically-oriented doctor loses his or her customary independence of action, although, at the same time, he or she may be administering similar treatment to non-trial patients with the same disease with less accountability. Given the large number of patients included in the trials, physicians working in traditional clinical settings are obliged to collect detailed patient information, which must be made available for external review at any time. Of the COMS physicians participating in the survey, 64% stated their reluctance to be openly accountable for their
daily work may lead them to resist putting patients protocol. One doctor said:
on
I am used to being a one man show. I think I take very good care of my patients. I’m not sure that I’11 be. very comfortable adhering to regulations that I think are much more restrictive than necessary. All those forms, the site visits, the review of patient records, I’m not sure that is the kind of medicine I’11 be comfortable practising. (025)
3. Professional interaction An interesting feature of the introduction of RCTs is its effect on professional interaction within the field of medicine. According to the traditional pattern, clinicians have belonged to meaningful subgroups within the medical profession by virtue of their chosen specialization. Specialties such as ophthalmic surgery, internal medicine or radiation therapy have individual training programs, separate professional activities and distinct goals for the future development of their field [69, 701. Physicians who belong to specialty groups spend both social and professional time together [46] which facilitates significant identification with colleagues and the emergence of powerful reference groups. The professional interaction of researchers has generally followed a different pattern. A research group, such as a heart transplant team, has usually been limited in number, focused in purpose and included a variety of specialties working toward a narrow common goal [71]. Randomized trials, however, suggest new affiliations that incorporate elements familiar to both the clinical and research setting. The large number of physicians involved in any given trial facilitates interaction along specialty lines, while at the same time, couples specialists from different fields who otherwise might never interact. The COMS physicians represent two specialities with little history of working together. Participating in COMS brings them together for a prolonged period, with the potential development of a mutually dependent relationship between previously separate specialty fields. One ophthalmologist remarked on this fact: Well, to tell you the truth, I think one of the best things about the trial is the chance to work with the cancer guys. I’ve always been kind of interested in doing trials, but haven’t had much of a chance to participate. Most of my ophthalmologist colleagues are really sceptical about this clinical trial stuff, and the COMS will give me a chance, I think, to work and talk with people who share my interest in science. I’m really looking forward to the experience. (041)
CONCLUSIONS
It appears that a significant behaviourai consequence of the potential integration of conflicting professional roles brought on by the advent of randomized clinical trials is the potential for the development of a new paradigm. Trial-induced innovations such as revisions of existing reward systems, specific
Integrating conflicting professional roles modifications of clinical practices and novel constellations of reference groups, suggest that a new clinical research discipline is being defined. All doctors who participate in clinical trials, whether their previous orientation is towards contributing to research or direct clinical practice, find themselves challenged to incorporate the two formerly conflicting physician roles into a single function. As a result, goals, values and professional identities are brought into question, a process which, although not necessarily clearly evident to the participants, is neither simple nor comfortable. Many physicians appear to select socially acceptable frameworks within which to express their uneasiness with the trial process. For example, some adopt an ‘ethical’ position, claiming that human experimentation is somehow morally wrong. Others complain that the trials are time-consuming and cite economic reasons for not participating in them. Still others charge that randomized trials fail to elevate the interests of the individual patient above the goal of potential benefits to future patients. Concerns are typically expressed with intense emotion, which stands in contrast to the more detached response physicians make to most other issues in medicine. Our survey of the COMS participants strongly suggests that what has sometimes been described as physician resistance to science or physician reluctance to support research is, in fact, a predictable consequence of the attempting to integrate previously conflicting professional roles. Acknowledging the complexities that might result from this integration could facilitate productive discussion within the medical profession to replace the currently divisive arguments. Such discussions might also lead to improvements in the training of medical personnel and in the delivery of health care. Training programs could prepare physicians for such integration at an earlier stage of the professionalization process, and health care delivery could be reorganized to sustain attempts to merge previously conflicting tasks. Finally, open discussion may facilitate the arduous evolution of this emerging paradigm.
Acknowledgements-The author gratefully acknowledges the support of the leadership of the Collaborative Ocular Melanoma Studv and the uarticination of COMS physicians in this reasearcd. This study was supported by Health and Welfare (Canada) Grant 6606-3534-53 and Health and Welfare (Canada) Research Scholar Award to Dr K. Taylor and Cooperative Agreement Vl-EY06287 from the National Eye Institute, National Institutes of Health (U.S.). REFERENCES
Freidman L. M., Furberg C. and DeMets D. L. Fundumentals of Clinical Trials. Wriaht PSG. Boston, 1981. Byar D. P., Simon R. M., Friedewald T: et al. Randomized clinical trials: perspectives on some recent ideas. N. Engl. J. Med. 295, 74-80, 1976. Chalmers T. C., Sacks H. S. and Smith H. Jr Historical versus randomized controls for clinical trials. Controlled clin. Trials 1, 177, 1980.
223
4. TygstrupN. and Lachin J. M. The Randomized Clinical Trial and Therapeutic Decisions. Marcel Dikker, New
York, 1982. 5. Klimt C. R. The conduct and principles of randomized clinical trials. Controlled clin. Trials 1, 283-293, 1981. 6. Chalmers T. C. The impact of controlled trials on the practice of medicine. MI Sinai J. Med. 41, 753-759, 1974. 7. Ruthstein D. D. The ethical design of human experiments. Daedalus 98, 523-541, 1969. 8. Silverman W. A. Human Experimentation: A Guided Step into the Unknown. Oxford University Press, New
York, 1985. 9. Collins J. F., Williford W. O., Weiss D. G. et al.
Planning patient recruitment: fantasy and reality. Stat. Med. 3, 435-443, 1984. 10. Schafer A. The randomized clinical trial: for whose benefit? IRB: A Rev. Hum. Subjects Res. 1, 46, 1985. 11. Benson Al. B., Pregler J. P., Bean J. A. et al. Oncolo-
gist’s reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study. J. clin. Oncol. 9, 2067-2975, 1991. 12. Lee J. Y. and Breauz S. R. Accrual of radiotherapy to clinical trials. Cancer 52, 10141016, 1983. 13. Taylor K. M. et al. Physicians’ reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N. Engl. J. Med. 310, 1363-1367, 1984.
14. Levine R. J. Referral of patients with cancer for participation in randomized clinical trials: ethical considerations. CA: J. Clinicians 36, 95-99, 1986. 15. Prout T. E. Patient recruitment techniques in clinical trials. Controlled clin. Trials 1, 313-318, 1981. 16. Bloom S. The Doctor and His Patienf. Russell Sage, New York, 1963. 17. Daniels A. K. How free should professions be? In The Professions and Their Prospects (Edited by Friedson E.), DD. 39-57. Sane. Beverlv Hills. 1973. 18. ‘Fbx R. C. Ex&iment Perilous. The Free Press, Glentoe, Illinois, 1959. 19. Fox R. C. and Swazey J. P. The Courage to Fail. The University of Chicago Press, Chicago, 1974. 20. Taylor K. M. and Kelner M. Interpreting physician participation in randomized clinical trials: the physician orientation profile. J. Hlth sot. Behav. 28, 389400, 1987.
21. Friedson E. The Profession of Medicine: A Study of the Sociology of Applied Knowledge. Harper and Row, New York, 1970. 22. Spaight, S. J., Nash S., Finison L. et al. Medical Oncologists’ Participation in Cancer Clinical Trials. In Advances in Cancer Control (Edited by Engstrom P.), pp. 4961. Alan R. Liss, New York, 1984. 23. Freidson E. and Lo&r J. (Eds) Medical Men and Their Work. Aldine, Chicago, 1972. 24. Taylor K. Telling bad news: physicians and the disclosure of undesirable information. Social. Hlth Illness 10, 109-132, 1988. 25. Barber B. Science and the Social Order. Collier Books, New York, 1952. 26. Spiro H. M. Constraint and consent: on being a patient and a subject. N. Engl. Med. 293, 11341135, 1975. 27. Straatsama B. R., Fine S. L., Earle J. D. et al. Enucleation versus plaque irridiation for choroidal melanoma. Oothalmoloav 95. 1000-1004, 1985. 28. Cbllaborati;k Melanoma Study COMS Manual of Procedures Springfield Va. National Technical Information Service 1989, NTIS Accession No. PB9(t 115536. 29. Augsberger J. J. er al. Enucleation versus cobalt plaque radiotherapy for malignant melanomas of choroid and cilary body. Arch. Ophthalmol. 104, 656661, 1986.
224 30
31
32 33
34
35
36
31.
38.
39. 40.
41. 42. 43. 44. 45. 46. 41.
48.
49.
50.
51.
KATHRYN M. TAYLOR Dom H. F. and Cutler S. J. Morbidity from cancer in the United States. Publ. Hlth Monograph No. 56, United States Government Printing Office, Washington, 1969. Straatsama B. R., Fine S. L., Earle J. D. et al. Enucleation versus plaque irradiation for choroidal melanoma. Ophthalmology 95, 1000-1004, 1985. Fine S. L. Do I take the eye out or leave it in? (editorial) Arch. Opthalmol. 104, 6533654, 1986. Fine S. L. Clinical trials and the practice of ophthalmology (editorial). Arch. Ophthalmol. 102, 1282-1285, 1984. Taylor K. M. and Kelner M. Informed consent: the physicians’ perspective. Sot. Sri. Med. 24, 135-143. 1987. Glaser B. G. and Strauss A. L. The Discovery of Grounded Theory: Strategies ,for Qualitative Research. Aldine, Chicago, 1967. SPSS Inc. SPSS/PC+ V2.0 base manual for the IBM PC/XT/AT & PS2. SPSS Marketing Department. Chicago, IL, 1988. Fried&n E. The organization of medical practice. In Handbook ofMedical Sociology (Edited bv Freeman H.. Levine S. and Reeder L. G.).Prentice-Hall. Englewood Cliffs, NJ, 1972. Hellman S. Randomized clinical trials and the doctor-patient relationship: an ethical dilemma. Cancer c/in. Trials 2, 1899193, 1979. Becker H. S. Boys in White: Student Culture in Medical School. University of Chicago Press, Chicago, 1961. Coombs, R. H. Mastering Medicine: Professional Socialization in Medical &hool. The Free Press, New York, 1978. Starr P. The Social Transformation o/’ American Medicine. Basic Books, New York, 1982. Blum R. H. The Management of the Doctor-Patient Relationship. McGraw-Hill. New York, 1960. Katz Jay (Ed.) Experimentation with Human Beings. Russell Sage. New York, 1972. Babbie E. R. Science and Morality, in Medicine. University of California Press, Berkeley, 1970. Meinert C. L. Funding for clinical trials. Controlled C/in. Trials 3, 1655171. 1982. Mumford E. Interns: From Students to Physicians. Harvard University Press, Cambridge, MA, 1970. Bergman Da Pantell R. H. The impact of reading a clinical study on treatment decisions of physicians and residents. J. Med. Educ. 61, 380-386, 1986. Jonas H. Philosophical Reflections on Experimenting with Human Subjects. In Ethical Issues in Modern Medicine (Edited by Hunt R. and Arras J.). Mayfield, Pa.10 Alto, 1977. Gifford F. The conflict between randomized clinical trials and the therapeutic obligation. J. Med. Philo. It, 347 364, 1986. Gelber R. D. and Goldhirsh J. Can a clinical trial be the treatment of choice for patients with cancer? J. ham. Cancer Institut. 80, 886-776, 1988. Bradford G. H. Human Subjects in Experimentation. Wiley. New York, 1975.
52. Freidman, M. A. Patient accrual to clinical trials (editorial) Cancer Treat. Rep. 71, 557-558, 1987. 53. Parsons, T. The Social System. The Free Press, New York, 1951. 54. Parsons T. Definitions of Health and Illness in the Light of American Values and Social Structure. In Patients, Physicians and Illness: A Sourcebook in Behavioural Science and Health (Edited by Jaco E. G.). The Free Press, New York, 1972. 55. Sorenson J. R. Biomedical innovation, uncertainty and doctor-patient interaction. J. Hlth sot. Behav. 15, 366374, 1974. 56. Gillon R. The patient’s interest always come first? Br. Med. J. 292, 3988399, 1986. 57. Light D. Uncertainty and control in professional training. J. Hlth sot. Behav. 20, 310-322; 1979. 58. Mattson M. E.. Curb J. D.. McArdle R. and the AMIS and BHAT Research Groups. Participation in a clinical trial: the patient’s point of view. ControBed C/in. Trials 6, 1566167, 1985. controlled clinical trials: the 59. Spodick D. H. Randomized behavioural case. J. Am. Med. Assoc. 247, 225882260, 1986. M. F. and Steinberg J. A. Informed Consent: 60. Kraushar Surrender or Salvation? Arch. Opthal. 104, 352-355, 1986. 61. Cartwright A. Patients and Their Doctors: A Study of Genera/ Practice. Atherton Press, New York, 1980. in medical prognosis: clinical and 62. Davis F. Uncertainty functional. Am. J. Social. 66. 47-52, 1960. 63. Lasagna L. Some ethical problems in clinical investigation. In Ethical issues in Modern Medicine (Edited by Hunt R. and Arras J.). Maytield, Palo Alto, 1977. 64. Byar D. P. The necessity and justification of randomized clinical trials. In Controversies in Cancer (Edited by Tagnon H. S. and Staquet M. J.). Masson, New York, 1979. 65. Barber B. Research on Human Subjects: Problems of Social Control in Medical E.rperimentation. Russell Sage, New York, 1973. Physician: 66. Lally J. and Barber B. The Compassionate frequency and social determinants of physicianinvestigator concern for human subjects. Social Forces 53, 289-296, 1974. share raw data 67. Reilly P. When should an investigator with the subjects? IRB: A Rev. of Hum. Subjects Res. 2, 45, 12, 1980. P. M. (Ed.) Randomized Clinical Trials in 68. Wortman Methods for Evaluating Health Services. Sage, Beverly Hills, CA, 1985. 69. Halpern S. A. American Paediatrtcs: The Social Dynamics of Professionalism 1880&1980. Universitv of California Press: Berkeley, 1988. 70. Kane R. L. and Kane R. A. Physicians attitudes of omnipotence in a university hospital. J. Med. Educ. 44, 684490, 1969. 71. Swazey J. P. Social Controls and the Medical Profession (Edited by Scher S. R.). Oelgeschlager, Gunn and Hain, Boston, 1985.
Copyright 0
0277-9536/92 $5.00 + 0.00 1992 Pergamon Press Ltd
INTEGRATING CONFLICTING PROFESSIONAL ROLES: PHYSICIAN PARTICIPATION IN RANDOMIZED CLINICAL TRIALS KATHRYN Centre
for Health
Studies,
M. TAYLOR
York University, Ontario, Canada
York Lanes, M3J lP3
Suite 214, North
York,
Abstract-The traditional identification of physicians as either clinician or researcher is challenged by the emergence of randomized clinical trials (RCTs) where research and clinical care are performed simultaneously. A mail survey using a self-administered questionnaire, the Physician Orientation Profile, was conducted of 101 physicians from the Collaborative Ocular Melanoma Study (COMS), a set of trials which compares surgical removal of the eye with radiation in the treatment of medium sized eye cancers. A 95% response rate was obtained; follow-up telephone interviews were conducted with 87% of respondents. Key findings suggest that RCTs challenge traditional definitions of physician’s ‘core task,’ because they participate in a social process that requires them to integrate the formerly disparate and sometimes competing roles of researcher and clinician. Three implications of this integration are discussed: amending the expert reward system, altering customary clinical practice and redefining reference groups for professional interaction. Key words-physician
behaviour
randomized
clinical
Randomized clinical trials (RCTs) are currently considered to be the ‘gold standard’ for scientific investigation in numerous areas of medicine [l-4]. Randomized trials are controlled experiments using human subjects to determine which of two or more treatments is most beneficial, especially when there is no single ‘treatment of choice’ for a particular disease [S-7]. In contrast to clinical practice in which the physician and/or patient usually selects the treatment to be used, clinic trial patients are assigned randomly to receive one of the treatments being studied. A comparison is then made of the outcomes obtained for each of the two or more patient groups and the findings applied to treatment decisions for future generations of patients. RCTs can also be viewed as a social process-an attempt to apply the scientific rigour of the research laboratory to clinical practice. The goal is to assess efficiently and rapidly the risks and benefits of one or more promising therapies. Should an encouraging experimental treatment be proven effective, it could then be used for a large segment of the target population. However, despite the acknowledgment by the medical profession that randomized studies are often critical to advance science, these experiments have proven to be particularly challenging to complete [8-lo]. A key, but poorly understood, factor has been physician reluctance to enter their eligible patients [l l-l 51. To better understand physicians’ decision to participate, or not to participate in RCTs, a group of ophthalmologists and radiation oncologists were surveyed prior to the entry of the first 217
trials,
ocular
melanoma
patient on a major randomized trial for cancer of the eye. BACKGROUND
In the 1950s and 60s physicians’ roles as primary care giver or research scientist were clearly differentiated. The medical profession put high value on its ability to provide personalized attention, and most doctors defined their core task as being the care of the individual patient [16, 171. Treatment regimens were usually selected through a complex combination of the physicians’ esoteric knowledge, personal experience and anecdotal advice from professional colleagues. The outcomes of individual treatment decisions were regarded as confidential information, meant only for individual patient records; rarely has this information been collected or analyzed systematically. In contrast to this traditional pattern, however, small subgroups of physicians concentrated exclusively on medical research, focusing on the evaluation of the effectiveness of experimental therapies [ 18, 191. The experimentation often imposed a rigid protocol of prescribed care and reporting, contrasting with the more flexible approach taken by their clinically-oriented colleagues [20]. Each group of physicians, those using traditional treatment methods and those evaluating experimental treatments, functioned in settings designed to facilitate their work. The clinicians, who deal with a predominantly outpatient population and admit their patients to hospital only when necessary, have usually worked in single or group practice [21]. The
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researchers, by contrast, have usually been hospitalbased academic staff, whose patients have been cared for in specialized research units of large teaching hospitals [18]. Overall, there seems to have been a good fit between the professional activities of each group of physicians and their work environment. In their private offices, clinicians have been expected to take a pragmatic approach in addressing the immediate needs of ambulatory sick people. On the other hand, researchers analyzing less accepted therapies, which often have severe side effects, have worked in highly specialized laboratories with complex equipment in which dosages, methods of administration and the long-term implications and outcomes of different treatments could be precisely calculated and methodically recorded. Not only have the work environments of the two physician groups been separate, they have also required distinctive tools. The work done by researchers, for example, has often necessitated the use of sophisticated instruments and high technology equipment, which contrasts with the more conventional implements used by clinicians. The contrast between the two groups of doctors has also applied to the composition of their patient populations. Clinicians typically have treated large numbers of patients with ailments of varying degrees of severity and ranging from the common to the unusual. Researchers, however, have cared for smaller numbers of patients who often suffered from very serious diseases. They have commonly depended on referrals of patients who were seen initially by private practice physicians [22]. Also differing for the two groups of physicians has been the way in which each group has defined professional success. Clinicians traditionally have been regarded and have regarded themselves as ‘healers’: sources of unique knowledge, advice, reassurance, technical expertise and practical solutions [23,24]. They generally have been approached by patients in the expectation that physicians could cure their maladies. By contrast, researchers and their patients have been aware that many of the therapies being tested were still in the experimental stage [25]. Given the imminently life-threatening nature of most of these patients’ illnesses, the expectations of both patients and physician researchers have been a combination of high hopes and limited expectation for success in any individual case [ 19,261. Each of the two groups of physicians has regarded the other as necessary for the practice of medicine, but different and separate. Limited interaction between the two groups has been documented. However, in the 1960s and 1970s more emphasis began to be placed on caring for less severely ill patients with relatively new and untested treatment plans. The randomized clinical trial gained in popularity as an efficient method to test the efficacy of these new treatment options. Practising physicians were now
asked to perform the researcher and clinician task simultaneously since they are expected to give standard medical treatment within the confines of an experimental program. The Collaborative
Ocular Melanoma Study (COMS)
To better understand the social impact of this unique integration of previously disparate roles, we surveyed the 101 physician-investigators of the Collaborative Ocular Melanoma Study (COMS) [27,28]. This major multicentre trial is designed to provide definitive answers to questions concerning appropriate treatment for selected patients with choroidal melanoma (primary eye cancer) [29-331. To demonstrate that either radiation or enucleation offers a better chance for survival, or that there is no difference in survival, 6 central units and 29 clinical centers in the United States and Canada proposed to conduct a randomized controlled study. The organizers approached North American institutions known to provide care for patients with ocular melanoma to participate in the study, and initially 29 hospitals agreed to form a consortium. The physicians, (primarily ophthalmic surgeons and radiation therapists), caring for ocular patients within each of the 29 participating centers thus constitute the population of the 101 research investigators of the COMS. The COMS consists of two large randomized clinical trials and is projected to cost over $30 million dollars over the predicted 15-20 year timespan required to complete the study. Eligible patients with medium size tumours are approached by the research investigator, and those who agree to participate are assigned randomly to receive enucleation of the eye (removal) or radiation therapy. To have sufficient numbers of patients to complete the study in a timely fashion, participating physicians and organizers must enrol the majority of all new cases of choroidal melanoma of appropriate size in the United States and parts of Canada. METHODS
Prior to the first patient being entered onto the COMS study in November 1986, we completed a mailed survey of the 101 physician participants. To better understand the attitudes and behaviour of these physicians, a tailored version of the Physician Orientation Projle, a self-administered questionnaire consisting of 15 demographic questions, 45 binary option questions and 6 open-ended questions was used [34]. This questionnaire had been developed and used in other studies of physician participation in randomized clinical trials. A 95% response rate was obtained after two mailings. Follow-up tape-recorded telephone interviews were conducted with 87% of respondents to expand and amplify the questionnaire responses. Each interview averaged between 30 and 45 min. The interviews were conducted utilizing a structured interview guide-a
Integrating conflicting professional roles companion document to the Physician Orientation Profile self-administered questionnaire. The guide included the following key questions; amplification of the respondents’ interest and motivation in participating in the trial, elaboration of the primary reasons they believed or did not believe they would have difficulty accruing patients to this trial, their perception of the key benefits and deterrents to participation, and the potential negative and positive impact of the trial on their professional activities. The data obtained from the open-ended questions on the questionnaires and from the telephone interviews were transcribed verbatim and entered onto the computer. The data were then analyzed in the style of grounded theory as described by Glaser and Strauss [35] and tabulated and analyzed with regard to content. Results of the qualitative data were coded and grouped into the conceptual model of the Physician Orientation Projile. These include five key constructs which purport to differentiate respondents along a continuum ranging from the extremes of ‘pure clinician’ to ‘pure research scientist’. They include; Primary Allegiance (to the individual patient or to the aggregate), Professional Activities (clinically or research based), Doctor-Patient Relationship (caring for patients or supervising research-subjects), Perceived Rewards, (immediate or deferred), and Peer Group (local or international). This information was then analyzed in relation to elemental physician demographics. Descriptive statistical tests were conducted using SPSS [36]. Specifically, significance tests were conducted using x2. This report draws primarily from the qualitative data of the open-ended sections of the Physician Orientation Profile and the telephone interviews. RESULTS
The demographic characteristics of the sample are presented in Table 1. Selected results of analysis of the quantitative data as well as qualitative data analyzed within the framework of the Physician Orientation Profile are presented below. Overall, 72% of physicians believed that care for the individual patients is the physician’s core task, while 28% believed that the core task is adding to scientific knowledge. However, when divided by medical speciality, 60% of the radiation therapists and only 20% of the ophthalmologists believed that a physicians’ core task was adding to scientific knowledge (P > 0.05). Fifty-eight percent of physicians were salaried and 43% were fee-forservice. Ninety-five percent of salaried physicians said they would approach more than 50% of their eligible patients, whereas only 82% of fee-for-service physicians agreed (P > 0.04). Sixty-nine percent of physicians believed they have a ‘high’ research profile while 31% believed they had a ‘low’ profile. Sixty-two percent of physicians who said they had a ‘high’
Table
219
1. Characteristics of participating N = 96
Range: 27-72 yr
Median: 44 yr
physicians
Mean: 41 yr NO. %’
sex Male 90 Female 6 Speciality Ophthalmology 66 Radiation therapy 30 Training Oncology 40 Not oncology 54 Income source Fee-for-service 40 Salaried 56 CIinicol setting Private practice 27 General hospital 42 Cancer centre 13 Patient poputation Mixed 60 Early disease stage 17 Advanced disease stage 18 Participation in randomized clinical trials Non-participation 20 l-5 trials entered 48 6+ trials entered 17
94 8 69 31 43 57 42 58 33 51 16 63 I8 19 24 56 20
@Percentages are calculated as valid percentages: missing values are not included.
profile maintained that they secured more satisfaction from the work itself rather than from interaction with individual patients, while only 3 1% of those with a ‘low’ profile derived primary satisfaction from the work (P > 0.003). Fifty-five percent of respondents believed that patients/families had the final responsibility with regard to medical decision-making while 45% believed it was the physicians’ responsibility. At the same time, 53% of physicians with mixed patient population, 41% of physicians with early stage and only 12% of physicians with advanced stage patients said physicians had the concluding responsibility. Fifty-three percent of physicians said that in their setting, physicians were given more reward for ‘adding to science’, while 47% were given more reward for interpersonal skills. Overall, 85% of those who worked primarily in cancer institutes, 64% of those in general hospitals and only 20% of physicians in private practice thought physicians in their setting were given more compensation for advancing science. Respondents planned to approach 81% of all eligible patients, and assumed that 68% of those approached would agree to participate in the study. Responses to the interviews strongly suggested that few respondents were concerned that patients might withdraw from the study. In summary, overall, the respondents appeared to be clinically rather than research oriented, while at the same time, expressing great optimism that they would be able to enter eligible patients onto the trial.
DISCUSSION
Given the relatively small size of the sample of physicians and the anticipatory nature of the
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questions, all results must be generalized with caution. However, the high response rate and the richness of the qualitative data may provide useful insights into the complex realm of physician behaviour with regard to human experimentation. First, the results of both the open-ended questionnaire responses and telephone interviews strongly suggest that physicians anticipated participation in the COMS trial as a challenge to their traditional professional self-definition. They believed that their attempts to integrate two roles that were formerly viewed as different-or even conflicting-would be particularly evident in three areas: the reward system, which may have to be reconsidered; customary clinical practice, which may have to be altered; and professional interaction, where reference groups may have to be redefined.
1. The reward system One of the most striking effects of RCTs has been a modification of the reward system for physicians. In the past, clinicians and researchers tended to have unique sets of compensations. These rewards were developed and maintained by both formal and informal means. As Freidson [37] points out, clinicians have been likely to prize and expect direct personal appreciation from individual patients and their families. They have also looked for status in the general community and for direct compensation for their work. Such rewards contrast with the more indirect and abstract gratification sought by researchers that rests in expanding the boundaries of medical knowledge. In contrast to clinicians, researchers tend to look for status within their specialized professional community and are often willing to defer financial rewards. Fox and Swazey [19] point out that the researchers’ ability to find reward on a macro-level is in sharp contrast to the training given to doctors, which reinforces the micro-level, direct and immediate gratification of clinical practice. The two types of gratification are often mutually exclusive: it has often been necessary to forego one in order to obtain the other. However, it appears that for RCTs, physicians are expected to obtain their gratification from both sources simultaneously [38]. They are expected to provide strong individual support to patients using highly refined interpersonal skills, having made clear to patients the details of their role as research subjects. The physicians participating in the COMS anticipated some difficulty with regard to a clear definition of rewards and compensations. Many questioned their ability to easily integrate both direct and indirect sources of gratification. For example, 47% of the COMS physicians said they worked in settings where they were most rewarded for adding to science. At the same time, each group of physicians within this relatively even split showed concern with having to seek rewards in an unfamiliar area. In a typical
comment, customed
one ophthalmologist who was mainly acto individual patient-based rewards said:
I’m not really sure how I feel about all of this. The patients, that’s where I really get my strokes from. I feel good when I can help a patient retain vision. They come to me for my advice, experience and expertise. For the trial, I guess 1’11 have to start to learn to say ‘I don’t know which is best.’ I’m not sure I will be very comfortable doing that for too long
(088) Another traditional characteristic of the medical profession has been its high social status. The expectation of being awarded status concurrently with the medical degree is often cited as an inducement for students to withstand the rigours of medical training [39,40]. In the case of clinicians, status is mainly derived from the patients’ trust in the doctors’ esoteric knowledge, technical skills and personal experience [41,42]. This interpersonal skill-based status contrasts with the status accorded to researchers, which can be described as knowledge-based [43,44]. As researchers’ patients have usually been referred to them by other physicians, who are aware of researchers’ specialized training, the status of these doctors largely stems from the high opinion of their professional colleagues [25]. Again, however, the advent of RCTs has clouded the once relatively clear picture. In order for trials to be worth carrying out, large numbers of eligible patients must participate. This means that professional referral alone cannot provide an adequate number of patients. For the COMS to be successful, participating physicians must approach the majority of all diagnosed ocular melanoma patients with tumors of suitable size in North America each year throughout the accrual phase of the study. This need requires actively soliciting referrals from other physicians, something some responding physicians anticipated as an aggravation. Many respondents were unaccustomed to soliciting referrals and they viewed the need to ‘sell the study’ by means of brochures, posters in their offices and personal calls to other physicians as potentially undercutting the traditional status that accompanied referrals, both lay and professional. Fifty-seven percent of respondents cited this concern. One physician explained: I’m not really used to ‘advertising’ I guess. The idea of having to ‘sell’ the trial is one that feels antithetical to what I normally do. Posters, TV talks all the things that I guess will work, that feels very foreign to me. To be truthful, I wonder how I will feel being on the selling end. I’m much more used to being courted-not doing the courting. (059) Clinicians have traditionally been able to optimize financial compensation for their work by structuring their practices. Researchers, on the other hand, have often been salaried by their institutions and thus their financial rewards were not as directly related to the amount of time they spent with each of their patients [44]. When they participate in randomized clinical trials, clinicians in particular give up some of their ability to control their direct monetary gains. The
Integrating conflicting professional roles time they are required to spend explaining the intricacies of their patients’ participation in the trial and in filling out forms to ensure its scientific rigour is often not recompensed [45]. Sixty-seven percent of the survey respondents alluded to concern with this issue. One clinician said: One thing is for sure, no one can ever say we are in it for the money. By the time I will have spoken to the patient, explained the trial, gotten consent, done all the extra testing, called back to make sure we don’t lose the patient to follow-up I’ll have spent 10 times the energy I’ll spend on a non-trial patient. What little money we get won’t come close to covering my time never mind the emotional energy. Since few people around me care much about trials, it’s going to be hard to stay motivated. I just hope my patients don’t start giving me a hard time. That would finish me, I think. (048) 2. Changes in clinical practice
Another notable effect of the advent of RCTs has been the modification of traditional clinical practice, particularly physician responsibility and accountability. On that question, clinicians have customarily taken the view that their major allegiance is to the welfare of the individual patient, a view strongly reinforced by physician’s professional socialization [46,47]. For researchers, who although aspiring to provide optimal care to individual patients, frequently use less tested treatment regimens that are not necessarily of direct benefit to those patients, key loyalty has of necessity been to the potential usefulness of the data they gather for future generations of patients [48-501. With the advent of RCTs, however, these differences of view of primary responsibility have become less obvious. Given that at present many trials include patients at relatively early stages of their disease, who still might be able to benefit should one area of the trial arms prove superior to the other, participating physicians often find themselves focusing less on the theoretical benefit to future patients than on the possible benefit to the immediate patient [51, 521. When physicians taking part in the COMS survey were asked whether they felt their primary allegiance was to either the present OR future patients, many had difficulty selecting one over the other. However, when asked to choose their primary allegiance, 72% mentioned present patients, while only 28% indicated future patients. One ophthalmologist explained his difficulty with choosing one loyalty over another: I know we are dealing with cancer, and this is very different for me, and I think it will be very hard for me to be truly objective, and think of patients down the road when a patient sitting in front of me asks for my opinion. How can I possibly think of future patients and the importance of knowing whether enucleation is indeed better, when a patient says to me ‘Doctor, I really don’t want to lose my eye unless you think it is absolutely necessary’ (009) Another change
has
aspect occurred
of
clinical relates
practice to the
role
in
which
assigned
a to
221
patients. Traditionally in medicine, the patient’s role has been unequivocal and clearly defined: he or she was expected to seek medical care, comply with the physician’s recommendations and recover as quickly as possible [53,54]. In conventional research, the role of the research subject has been equally clearly defined: he or she was expected to agree to treatments that carry an elevated risk of grave side effects and to accept the guarded optimism that surrounds such endeavour [55-571. But within the process of RCTs, physicians often find themselves challenged to identify the role of the person they are treating. The person is referred to as a ‘patient’, as he or she would be in standard clinical practice, but is now also a research subject [58, 591. The patient must, for example, sign an informed consent document that clearly outlines the primacy of the research component of his or her treatment [60]. Once the document is signed, however, the long-term care is usually given in a clinical setting. The confusion that arises regarding the role of the individual receiving the treatment was cited by 76% of the COMS physicians as the underlying rationale for doctors choosing not to participate in the trial. One oncologist explained: You know, it is very different being a patient and being a research subject. I think that research subjects are perhaps, more willing to accept risk. I also think they are hoping that a little more risk also gives them a little better chance for cure. With these kind of studies, I think it must be very confusing for patients. The ones who are not on study get exactly the same care from me as those on study, with the exception that the computer, and not the physician and patient, have chosen therapy. I think some patients feel like they are neither fish nor fowl. Sort of a research subject, but lots like a patient. No matter how much I explain, I think that many of the patients remain confused about what it is they are getting into, and I must say that enters heavily in
my decision to approach them. (094) Another facet of clinical practice that has been affected by RCTs is physicians’ management of uncertainty. Some degree of uncertainty has always been associated with medical treatment [57]. Customarily, a principal element of the clinician’s role has been to reduce that uncertainty for the patient by selecting what they believe to be the most appropriate therapy given the particulars of the specific case [61]. By contrast, researchers have not been able or expected to reduce clinical uncertainty, as, by definition, unproven treatments entail uncertain outcomes [62]. Under research conditions, however, uncertainty may take on a different meaning. Since the patients receiving experimental treatment usually suffer life-threatening diseases, research physicians may present uncertainty in a positive light, as a way of giving their patients hope; thus, the certainty of death is replaced by the uncertainty of a possible cure
1631. But these familiar patterns of management of uncertainty are altered by the clinical trial process. In order for a trial to be justified, there must be
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significant question as to the benefit of the experimental therapy; at the same time, the trial must include as the control arm the standard treatment of choice [64,6]. This means that participating physicians are obliged to inform the patients of both the relatively predictable outcome of the standard treatment as well as the less foreseeable, but possibly more effective, results of the experimental treatment. They must also explain that only one of the treatments will be selected for a given patient, and that the selection will be made randomly. As the choice of the treatment is outside of the physician’s control, he or she cannot apply familiar techniques for reducing the patient’s uncertainty until after the random treatment assignment has been made [55,65,66]. Of the physicians taking part in the COMS survey, 58% anticipated being uncomfortable discussing uncertainty so openly with their patients. One radiation oncologist explained: I’m used to uncertainty. In my work, it’s a major part of what I do all day. I deal with cancer a lot. Most people I see either know they have cancer, or are afraid they have. I can never tell them ‘for sure’ that the treatments I recommend will work. But I can at least cut down on the options for them. I can say, now if you try this treatment, these are the potential outcomes, and if you try those treatments, these are the potential outcomes. All things being equal, the choice is pretty clear. However, in a trial, I say, now if you get Treatment A the effects are these and with Treatment B the effects are those, but the uncertainty as to which treatment they will get, or will turn out to be best for them is not removed. That’s hard for both my patient and me. (016)
The final aspect of clinical practice to have altered as a result of the conduct of trials is that of physicians’ relationships with colleagues. Traditionally, clinicians have carried on their practices with little obligation to account for many facets of their relationship with patients [23,24]. They have, for example, used their own discretion with regard to the disclosure of information to patients. On the other hand, as research is predicated on routine sharmg of information, researchers have been expected to be aggressive in the distribution of even the earliest results of their patients’ treatments [671. Randomized trials require a systematic collection of detailed information on each patient’s progress, in order to make possible meaningful comparisons [68]. Thus the physician becomes highly accountable. The clinically-oriented doctor loses his or her customary independence of action, although, at the same time, he or she may be administering similar treatment to non-trial patients with the same disease with less accountability. Given the large number of patients included in the trials, physicians working in traditional clinical settings are obliged to collect detailed patient information, which must be made available for external review at any time. Of the COMS physicians participating in the survey, 64% stated their reluctance to be openly accountable for their
daily work may lead them to resist putting patients protocol. One doctor said:
on
I am used to being a one man show. I think I take very good care of my patients. I’m not sure that I’11 be. very comfortable adhering to regulations that I think are much more restrictive than necessary. All those forms, the site visits, the review of patient records, I’m not sure that is the kind of medicine I’11 be comfortable practising. (025)
3. Professional interaction An interesting feature of the introduction of RCTs is its effect on professional interaction within the field of medicine. According to the traditional pattern, clinicians have belonged to meaningful subgroups within the medical profession by virtue of their chosen specialization. Specialties such as ophthalmic surgery, internal medicine or radiation therapy have individual training programs, separate professional activities and distinct goals for the future development of their field [69, 701. Physicians who belong to specialty groups spend both social and professional time together [46] which facilitates significant identification with colleagues and the emergence of powerful reference groups. The professional interaction of researchers has generally followed a different pattern. A research group, such as a heart transplant team, has usually been limited in number, focused in purpose and included a variety of specialties working toward a narrow common goal [71]. Randomized trials, however, suggest new affiliations that incorporate elements familiar to both the clinical and research setting. The large number of physicians involved in any given trial facilitates interaction along specialty lines, while at the same time, couples specialists from different fields who otherwise might never interact. The COMS physicians represent two specialities with little history of working together. Participating in COMS brings them together for a prolonged period, with the potential development of a mutually dependent relationship between previously separate specialty fields. One ophthalmologist remarked on this fact: Well, to tell you the truth, I think one of the best things about the trial is the chance to work with the cancer guys. I’ve always been kind of interested in doing trials, but haven’t had much of a chance to participate. Most of my ophthalmologist colleagues are really sceptical about this clinical trial stuff, and the COMS will give me a chance, I think, to work and talk with people who share my interest in science. I’m really looking forward to the experience. (041)
CONCLUSIONS
It appears that a significant behaviourai consequence of the potential integration of conflicting professional roles brought on by the advent of randomized clinical trials is the potential for the development of a new paradigm. Trial-induced innovations such as revisions of existing reward systems, specific
Integrating conflicting professional roles modifications of clinical practices and novel constellations of reference groups, suggest that a new clinical research discipline is being defined. All doctors who participate in clinical trials, whether their previous orientation is towards contributing to research or direct clinical practice, find themselves challenged to incorporate the two formerly conflicting physician roles into a single function. As a result, goals, values and professional identities are brought into question, a process which, although not necessarily clearly evident to the participants, is neither simple nor comfortable. Many physicians appear to select socially acceptable frameworks within which to express their uneasiness with the trial process. For example, some adopt an ‘ethical’ position, claiming that human experimentation is somehow morally wrong. Others complain that the trials are time-consuming and cite economic reasons for not participating in them. Still others charge that randomized trials fail to elevate the interests of the individual patient above the goal of potential benefits to future patients. Concerns are typically expressed with intense emotion, which stands in contrast to the more detached response physicians make to most other issues in medicine. Our survey of the COMS participants strongly suggests that what has sometimes been described as physician resistance to science or physician reluctance to support research is, in fact, a predictable consequence of the attempting to integrate previously conflicting professional roles. Acknowledging the complexities that might result from this integration could facilitate productive discussion within the medical profession to replace the currently divisive arguments. Such discussions might also lead to improvements in the training of medical personnel and in the delivery of health care. Training programs could prepare physicians for such integration at an earlier stage of the professionalization process, and health care delivery could be reorganized to sustain attempts to merge previously conflicting tasks. Finally, open discussion may facilitate the arduous evolution of this emerging paradigm.
Acknowledgements-The author gratefully acknowledges the support of the leadership of the Collaborative Ocular Melanoma Studv and the uarticination of COMS physicians in this reasearcd. This study was supported by Health and Welfare (Canada) Grant 6606-3534-53 and Health and Welfare (Canada) Research Scholar Award to Dr K. Taylor and Cooperative Agreement Vl-EY06287 from the National Eye Institute, National Institutes of Health (U.S.). REFERENCES
Freidman L. M., Furberg C. and DeMets D. L. Fundumentals of Clinical Trials. Wriaht PSG. Boston, 1981. Byar D. P., Simon R. M., Friedewald T: et al. Randomized clinical trials: perspectives on some recent ideas. N. Engl. J. Med. 295, 74-80, 1976. Chalmers T. C., Sacks H. S. and Smith H. Jr Historical versus randomized controls for clinical trials. Controlled clin. Trials 1, 177, 1980.
223
4. TygstrupN. and Lachin J. M. The Randomized Clinical Trial and Therapeutic Decisions. Marcel Dikker, New
York, 1982. 5. Klimt C. R. The conduct and principles of randomized clinical trials. Controlled clin. Trials 1, 283-293, 1981. 6. Chalmers T. C. The impact of controlled trials on the practice of medicine. MI Sinai J. Med. 41, 753-759, 1974. 7. Ruthstein D. D. The ethical design of human experiments. Daedalus 98, 523-541, 1969. 8. Silverman W. A. Human Experimentation: A Guided Step into the Unknown. Oxford University Press, New
York, 1985. 9. Collins J. F., Williford W. O., Weiss D. G. et al.
Planning patient recruitment: fantasy and reality. Stat. Med. 3, 435-443, 1984. 10. Schafer A. The randomized clinical trial: for whose benefit? IRB: A Rev. Hum. Subjects Res. 1, 46, 1985. 11. Benson Al. B., Pregler J. P., Bean J. A. et al. Oncolo-
gist’s reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study. J. clin. Oncol. 9, 2067-2975, 1991. 12. Lee J. Y. and Breauz S. R. Accrual of radiotherapy to clinical trials. Cancer 52, 10141016, 1983. 13. Taylor K. M. et al. Physicians’ reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N. Engl. J. Med. 310, 1363-1367, 1984.
14. Levine R. J. Referral of patients with cancer for participation in randomized clinical trials: ethical considerations. CA: J. Clinicians 36, 95-99, 1986. 15. Prout T. E. Patient recruitment techniques in clinical trials. Controlled clin. Trials 1, 313-318, 1981. 16. Bloom S. The Doctor and His Patienf. Russell Sage, New York, 1963. 17. Daniels A. K. How free should professions be? In The Professions and Their Prospects (Edited by Friedson E.), DD. 39-57. Sane. Beverlv Hills. 1973. 18. ‘Fbx R. C. Ex&iment Perilous. The Free Press, Glentoe, Illinois, 1959. 19. Fox R. C. and Swazey J. P. The Courage to Fail. The University of Chicago Press, Chicago, 1974. 20. Taylor K. M. and Kelner M. Interpreting physician participation in randomized clinical trials: the physician orientation profile. J. Hlth sot. Behav. 28, 389400, 1987.
21. Friedson E. The Profession of Medicine: A Study of the Sociology of Applied Knowledge. Harper and Row, New York, 1970. 22. Spaight, S. J., Nash S., Finison L. et al. Medical Oncologists’ Participation in Cancer Clinical Trials. In Advances in Cancer Control (Edited by Engstrom P.), pp. 4961. Alan R. Liss, New York, 1984. 23. Freidson E. and Lo&r J. (Eds) Medical Men and Their Work. Aldine, Chicago, 1972. 24. Taylor K. Telling bad news: physicians and the disclosure of undesirable information. Social. Hlth Illness 10, 109-132, 1988. 25. Barber B. Science and the Social Order. Collier Books, New York, 1952. 26. Spiro H. M. Constraint and consent: on being a patient and a subject. N. Engl. Med. 293, 11341135, 1975. 27. Straatsama B. R., Fine S. L., Earle J. D. et al. Enucleation versus plaque irridiation for choroidal melanoma. Oothalmoloav 95. 1000-1004, 1985. 28. Cbllaborati;k Melanoma Study COMS Manual of Procedures Springfield Va. National Technical Information Service 1989, NTIS Accession No. PB9(t 115536. 29. Augsberger J. J. er al. Enucleation versus cobalt plaque radiotherapy for malignant melanomas of choroid and cilary body. Arch. Ophthalmol. 104, 656661, 1986.
224 30
31
32 33
34
35
36
31.
38.
39. 40.
41. 42. 43. 44. 45. 46. 41.
48.
49.
50.
51.
KATHRYN M. TAYLOR Dom H. F. and Cutler S. J. Morbidity from cancer in the United States. Publ. Hlth Monograph No. 56, United States Government Printing Office, Washington, 1969. Straatsama B. R., Fine S. L., Earle J. D. et al. Enucleation versus plaque irradiation for choroidal melanoma. Ophthalmology 95, 1000-1004, 1985. Fine S. L. Do I take the eye out or leave it in? (editorial) Arch. Opthalmol. 104, 6533654, 1986. Fine S. L. Clinical trials and the practice of ophthalmology (editorial). Arch. Ophthalmol. 102, 1282-1285, 1984. Taylor K. M. and Kelner M. Informed consent: the physicians’ perspective. Sot. Sri. Med. 24, 135-143. 1987. Glaser B. G. and Strauss A. L. The Discovery of Grounded Theory: Strategies ,for Qualitative Research. Aldine, Chicago, 1967. SPSS Inc. SPSS/PC+ V2.0 base manual for the IBM PC/XT/AT & PS2. SPSS Marketing Department. Chicago, IL, 1988. Fried&n E. The organization of medical practice. In Handbook ofMedical Sociology (Edited bv Freeman H.. Levine S. and Reeder L. G.).Prentice-Hall. Englewood Cliffs, NJ, 1972. Hellman S. Randomized clinical trials and the doctor-patient relationship: an ethical dilemma. Cancer c/in. Trials 2, 1899193, 1979. Becker H. S. Boys in White: Student Culture in Medical School. University of Chicago Press, Chicago, 1961. Coombs, R. H. Mastering Medicine: Professional Socialization in Medical &hool. The Free Press, New York, 1978. Starr P. The Social Transformation o/’ American Medicine. Basic Books, New York, 1982. Blum R. H. The Management of the Doctor-Patient Relationship. McGraw-Hill. New York, 1960. Katz Jay (Ed.) Experimentation with Human Beings. Russell Sage. New York, 1972. Babbie E. R. Science and Morality, in Medicine. University of California Press, Berkeley, 1970. Meinert C. L. Funding for clinical trials. Controlled C/in. Trials 3, 1655171. 1982. Mumford E. Interns: From Students to Physicians. Harvard University Press, Cambridge, MA, 1970. Bergman Da Pantell R. H. The impact of reading a clinical study on treatment decisions of physicians and residents. J. Med. Educ. 61, 380-386, 1986. Jonas H. Philosophical Reflections on Experimenting with Human Subjects. In Ethical Issues in Modern Medicine (Edited by Hunt R. and Arras J.). Mayfield, Pa.10 Alto, 1977. Gifford F. The conflict between randomized clinical trials and the therapeutic obligation. J. Med. Philo. It, 347 364, 1986. Gelber R. D. and Goldhirsh J. Can a clinical trial be the treatment of choice for patients with cancer? J. ham. Cancer Institut. 80, 886-776, 1988. Bradford G. H. Human Subjects in Experimentation. Wiley. New York, 1975.
52. Freidman, M. A. Patient accrual to clinical trials (editorial) Cancer Treat. Rep. 71, 557-558, 1987. 53. Parsons, T. The Social System. The Free Press, New York, 1951. 54. Parsons T. Definitions of Health and Illness in the Light of American Values and Social Structure. In Patients, Physicians and Illness: A Sourcebook in Behavioural Science and Health (Edited by Jaco E. G.). The Free Press, New York, 1972. 55. Sorenson J. R. Biomedical innovation, uncertainty and doctor-patient interaction. J. Hlth sot. Behav. 15, 366374, 1974. 56. Gillon R. The patient’s interest always come first? Br. Med. J. 292, 3988399, 1986. 57. Light D. Uncertainty and control in professional training. J. Hlth sot. Behav. 20, 310-322; 1979. 58. Mattson M. E.. Curb J. D.. McArdle R. and the AMIS and BHAT Research Groups. Participation in a clinical trial: the patient’s point of view. ControBed C/in. Trials 6, 1566167, 1985. controlled clinical trials: the 59. Spodick D. H. Randomized behavioural case. J. Am. Med. Assoc. 247, 225882260, 1986. M. F. and Steinberg J. A. Informed Consent: 60. Kraushar Surrender or Salvation? Arch. Opthal. 104, 352-355, 1986. 61. Cartwright A. Patients and Their Doctors: A Study of Genera/ Practice. Atherton Press, New York, 1980. in medical prognosis: clinical and 62. Davis F. Uncertainty functional. Am. J. Social. 66. 47-52, 1960. 63. Lasagna L. Some ethical problems in clinical investigation. In Ethical issues in Modern Medicine (Edited by Hunt R. and Arras J.). Maytield, Palo Alto, 1977. 64. Byar D. P. The necessity and justification of randomized clinical trials. In Controversies in Cancer (Edited by Tagnon H. S. and Staquet M. J.). Masson, New York, 1979. 65. Barber B. Research on Human Subjects: Problems of Social Control in Medical E.rperimentation. Russell Sage, New York, 1973. Physician: 66. Lally J. and Barber B. The Compassionate frequency and social determinants of physicianinvestigator concern for human subjects. Social Forces 53, 289-296, 1974. share raw data 67. Reilly P. When should an investigator with the subjects? IRB: A Rev. of Hum. Subjects Res. 2, 45, 12, 1980. P. M. (Ed.) Randomized Clinical Trials in 68. Wortman Methods for Evaluating Health Services. Sage, Beverly Hills, CA, 1985. 69. Halpern S. A. American Paediatrtcs: The Social Dynamics of Professionalism 1880&1980. Universitv of California Press: Berkeley, 1988. 70. Kane R. L. and Kane R. A. Physicians attitudes of omnipotence in a university hospital. J. Med. Educ. 44, 684490, 1969. 71. Swazey J. P. Social Controls and the Medical Profession (Edited by Scher S. R.). Oelgeschlager, Gunn and Hain, Boston, 1985.