To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.

In order to understand the lived experiences of physicians in clinical practice, we interviewed eleven expert, respected clinicians using a phenomenological interpretative methodology. We identified the essence of clinical practice as engagement. Engagement accounts for the daily routine of clinical work, as well as the necessity for the clinician to sometimes trespass common boundaries or limits. Personally engaged in the clinical situation, the clinician is able to create a space/time bubble within which the clinical encounter can unfold. Engagement provides an (...) account of clinical practice as a unitary lived experience. This stands in stark contrast to the prevailing notion, referred to as a dual discourse, that describes medicine as the addition of humanism to science. Drawing on Aristotle’s notion of phronesis and Sartre’s definition of the situation, we illustrate how this novel perspective entwines clinical practice, the person of the clinician, and the clinician’s situation. (shrink)

The personhood of the physician is a crucial element in accomplishing the goals of medicine. We review claims made on behalf of the humanities in guiding professional identity formation. We explore the dichotomy that has evolved, since the Renaissance, between the humanities and the natural sciences. The result of this evolution is an historic misconstrual, preoccupying educators and diverting them from the moral development of physicians. We propose a curricular framework based on the recovery of Aristotelian concepts that bridge identity (...) and activity. The humanities and the natural sciences, jointly and severally, can fulfill developmental, characterological and instrumental purposes. (shrink)

The practice of medicine involves continual change, driven by a constant stream of developments in the understanding of biological structure and function relevant to human diseases, and the parallel improvements in pharmacologic and other technological interventions. This change is also driven by evolving social philosophies, ethical trends, and lifestyles. As products of society, doctors absorb contemporary values and norms. Indeed, it would appear that the ethical norms and standards of medical practice are flexible, and that the characteristics of medical practice (...) at any particular point in history may reflect the mores of the times rather than any enduring moral imperatives.However, a common perception .. (shrink)

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The (...) authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. (shrink)

This article is intended to revive, through a critical reinterpretation, the bio-psychosocial model of George Engel. Engel’s first description in 1977, was very broad, encompassing too many aspects of medicine. In his later work, he focused his model as an epistemology for clinical medicine. However, what medicine mostly retained were minor aspects of the 1977 article, namely a multi-factorial approach to the etiology of diseases and a call to complement biomedicine with a psychosocial concern in order to re-humanize medicine. We (...) suggest that, properly understood as a clinical epistemology, Engel’s model retains its transformative potential for contemporary medicine.Our discussion begins with a.. (shrink)

Reflection has been proclaimed as a means to help physicians deal with medicine’s inherent complexity and remedy many of the shortcomings of medical education. Yet, there is little agreement on the nature of reflection nor on how it should be taught and practiced. Emerging neuroscientific concepts suggest that human thought processes are largely nonconscious, in part inaccessible to introspection. Our knowledge of the world is fraught with uncertainty, ignorance and indeterminacy, and influenced by emotion, biases and illusions, including the illusion (...) of not having illusions. Neuroscience also documents that lifelong learning processes may hone nonconscious cognition to high levels of sophistication, allowing rapid and precise perceptions, judgments and actions in complex situations. We argue that knowledge of mechanisms underlying human thought may be useful in designing educational programs to foster desired attributes such as curiosity, critical self-awareness and intuitive acumen in medical professionals. The juxtaposition of neuroscientific insights with ideas from Kant on reflective judgement, van Manen on tact, and Aristotle on phronésis, supports a concept of reflection that manifests as wise practice. We suggest that reflection in medical education should be an imperative for educators seeking to guide learners to manage the complexity and “messiness” of medical practice, and a role-modelling mode of medical practice characterized by self-correcting behaviors that culminate in good and right professional actions. An example illustrates reflective practice in the teaching and learning of physicianship. (shrink)

The clinical trial is the major investigational tool of clinical medicine. Two recent reports highlight the fact that the most often quoted mechanisms for the protection of research subjects, viz., research ethics board review and eligibility criteria, are insufficient to achieve this end. In this paper, we argue that the prime mechanism for the protection of persons in clinical trials should be the clinical judgement of the physician-investigator. The clinical investigator has a duty to protect subjects from both harm and (...) undue risk. It is argued that the clinical investigator has a duty to screen for, and exclude, potential research subjects who may be unduly vulnerable to the risks of a particular clinical trial. In order to fulfill this obligation, the investigator should personally screen each potential research subject at the time of accrual. In larger trials in which this is not feasible, this task could be delegated to another appropriately qualified health care professional, with the principal investigator retaining personal responsibility. To reinforce and make explicit this legal and moral duty, we propose that the investigator sign a statement, appended to each subject's consent form, to attest that this duty has been responsibly discharged. (shrink)

Phronesis is often described as a ‘practical wisdom’ adapted to the matters of everyday human life. Phronesis enables one to judge what is at stake in a situation and what means are required to bring about a good outcome. In medicine, phronesis tends to be called upon to deal with ethical issues and to offer a critique of clinical practice as a straightforward instrumental application of scientific knowledge. There is, however, a paucity of empirical studies of phronesis, including in medicine. (...) Using a hermeneutic and phenomenological approach, this inquiry explores how phronesis is manifest in the stories of clinical practice of eleven exemplary physicians. The findings highlight five overarching themes: ethos (or character) of the physician, clinical habitus revealed in physician know-how, encountering the patient with attentiveness, modes of reasoning amidst complexity, and embodied perceptions (such as intuitions or gut feeling). The findings open a discussion about the contingent nature of clinical situations, a hermeneutic mode of clinical thinking, tacit dimensions of being and doing in clinical practice, the centrality of caring relations with patients, and the elusive quality of some aspects of practice. This study deepens understandings of the nature of phronesis within clinical settings and proposes ‘Clinical phronesis’ as a descriptor for its appearance and role in the daily practice of (exemplary) physicians. (shrink)

OBJECTIVE: Pilot study to characterize treatment differences between patients treated in clinical trials and those treated in a clinical setting. Previous studies have shown higher survival rates for participants in trials of cancer therapy. This difference is observed even after rates are adjusted for important covariates such as age and stage of disease. DESIGN: Retrospective chart review. SETTING: Oncology outpatient department in a tertiary care hospital. PATIENTS: Ninety women 18 to 70 years of age with early-stage breast cancer who were (...) diagnosed in 1990. Fifty-one of the women were treated through clinical trials and 39 were treated outside of clinical trials. OUTCOME MEASURES: Number of blood tests, telephone calls, clinic visits and imaging procedures as well as intensity of chemotherapy and use of radiation therapy. The age of the patient and the stage of disease were important covariates. RESULTS: After the analysis was controlled for patient age and stage of disease, patients treated through a clinical trial were more likely to receive standard-dose chemotherapy (p = 0.020, 95% confidence interval 1.20 to 200.73) and more frequent blood tests (p < 0.001, 95% confidence interval 1.02 to 1.13) than other patients treated in the clinic. CONCLUSIONS: Our results provide a plausible mechanism for the observed survival advantage for participants in clinical trials in oncology. Further study is called for. If these results are confirmed, they have important implications for informed consent to participate in clinical trials and for clinical practice. (shrink)

ABSTRACT:The objective of this essay is to develop the argument that placebos are a species of metaphor and to demonstrate that an analysis of the figurative trope can help us elucidate the power of the placebo response. The cognitive and embodied responses to both metaphors and placebos stem from the transfer of meaning between two domains, each with rich allusive properties that in turn depend on highly ramified and interconnected neural webs. Metaphors and placebos require an appropriate cultural backdrop for (...) their linguistic and cognitive work and are dependent on shared social forms of life. More specifically, metaphors rely on an intersubjective connection and imply that a relational entanglement between doctor and patient is necessary to the effect of placebos in the clinical setting. (shrink)

We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (explanatory (...) trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. We recommend that: (1) the inclusion/exclusion criteria distinction be abandoned; (2) eligibility criteria be explicitly justified; (3) the need for each criterion be assessed when new trials are planned; (4) criteria in phase III trials restricting patient accrual be minimized; and (5) further research be done to assess the impact of criteria on generalizability. (shrink)

OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they would (...) enrol the patient in a trial and how sure they were of this decision. Demographic characteristics of the investigators were also collected. OUTCOME MEASURES: The difference in enrolment decisions between subjective and objective criteria, and the difference in the certainty associated with these decisions. RESULTS: Of 365 questionnaires sent out, 224 usable ones were returned. Compared with the objective criteria, the subjective criteria were associated with more variable enrolment decisions (p = 0.07 for the "eligible" scenario and p = 0.0001 for the "ineligible" and "uncertain" scenarios), and investigators were less sure about the decisions they made (p = 0.0001 for all scenarios). Demographic characteristics of the investigators failed to explain the observed differences. CONCLUSIONS: Subjective eligibility criteria may interfere with the conduct and interpretation of RCTs and, therefore, their use ought to be justified explicitly in the study protocol. RCT designers, funding agencies and research ethics boards have an important role in reviewing eligibility criteria for their necessity. (shrink)

Medical students gather lessons from what they observe and experience in the hospital and the clinic. The daily, generally undocumented events constitute significant formative influences on the developing identities of these nascent physicians. These experiences shape the students' attitudes towards their patients, help form their own identities, and affect their confidence in their chosen profession. And yet, these critical pedagogical forces rarely come to the attention of their teachers, who remain unaware of the powerful formative features of the clinical learning (...) environment. As a result, attending physician-teachers fail to... (shrink)

BackgroundPrevious empirical work among physicians has led us to propose that clinical practice is experienced by clinicians as an engagement-in-the-clinical-situation. In this study, we pursue our exploration of clinical practice ‘on its own terms’ by turning to the experience of patients.MethodsPhenomenological analysis of in-depth individual interviews with 8 patients.ResultsWe describe the patient experience as a set of three motifs: the shock on the realization of the illness, the chaos of the health care environment, and the anchor point provided by an (...) engaged physician. We draw on Heidegger’s notion of solicitude to show that patients are actively ascertaining the physician’s engagement in their care.ConclusionsThese findings lead us to question the classical “dual discourse” of medicine that offers a dichotomous account of clinical practice as the addition of care to cure, art to science, humanism to technique, and person to medical case. We found no such distinctions in our empirical investigation of clinical practice. Rather, in our synthesis, practice appears as a unitary experience. The physician’s solicitude for the patient entrains engagement in the clinical situation. Moreover, the solicitous, engaged physician constitutes an anchor point for the patient. (shrink)