The Doctor-Patient Relationship, Partnership Theory, and the Patient as Partner: Finding a Balance Between Domination and Partnership.

It is perhaps most useful to approach the Doctor-Patient relationship (DPR) by admitting that it's complicated. We review some of the strategies that have been employed to mitigate this complexity, zeroing in on one that promises to capture the main features of the DPR without eliminating some of its more important, existential components; pieces of the puzzle that must be retained if we are to avoid oversimplification and the errors that can arise by ignoring important foundational properties. We believe that a useful way to look at the DPR and to capture essential features that must be balanced in the process is provided by Partnership Theory and its definition in terms of the so-called domination and partnership systems.

The transition from inquiry to evidence to actionable clinical knowledge: A proposed roadmap.

Rationale, Aims, And Objectives: We consider the question "What should we do?" in the context of clinical research/practice. There are several steps along the way to providing a satisfactory answer, many of which have received considerable attention in the literature. We aim to provide a unified summary and explication of these "steps along the way".

Scientism recognizes evidence only of the quantitative/general variety.

Rationale, Aims And Objectives: McHugh and Walker introduced a model of knowledge to demonstrate that EBM is a form of scientism that ignores important sources of knowledge thereby impairing the practice of medicine. We study the development of this model and explore additional applications.

Methods: Review of the relevant literature and identification of possible areas for fruitful application.

Schemata, CONSORT, and the Salk Polio Vaccine Trial.

In this essay, we defend the design of the Salk polio vaccine trial and try to put some limits on the role schemata should play in designing clinical research studies. Our presentation is structured as a response to de Freitas and Pietrobon (de Freitas, R. S.

The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.

The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts.

Beware Dichotomies.

This essay combines our thoughts concerning the generally destructive practice of dichotomization with a selective review of the literature supporting our critique. The apparent simplicity of dichotomous thinking encourages its use even when a dyadic representation is totally inadequate to understanding complex situations, and this "simpler is better" mantra continues to stymie our understanding of many of the world's complexities. The identification and naming of two distinct, opposing categories often results in their being seen as in opposition to one another, and that it is somehow incumbent upon us to choose one or the other.

Comparative effectiveness research: decision-based evidence.

In the clinical research context, comparative effectiveness research (CER) refers to the comparison of several health-care interventions administered under real-world conditions to individuals representative of the day-to-day clinical practice target population. We provide a brief history of CER and argue that CER can be used to deliver useful, but currently lacking information. Three study designs that can accomplish this are discussed, and incorporating CER into cost-benefit analyses is examined.

When ethics precludes randomization: put prospective, matched-pair observational studies to work.

Randomized, controlled clinical trials (RCTs) may be possible, permissible, and practical in certain circumstances, but ethical or practical considerations often preclude their utilization. In many such cases, ethical objections will not apply to a similarly oriented, prospective, matched-pair observational study. Additionally, if the methodological rigor associated with the RCT is maintained, potential epistemic losses due to eliminating randomization will be mitigated.

Patient preference clinical trials: why and when they will sometimes be preferred.

In a preference clinical trial (PCT), two or more health-care interventions are compared among several groups of patients, at least some of whom have purposefully chosen the intervention to be administered to them. This stands in contrast to the randomized, controlled clinical trial (RCT), where patients are randomly assigned to receive one of the available test interventions. This article argues that when comparing two interventions, A and B, when blinding (or masking) the interventions is difficult or impossible and at least some of the potential participants prefer one or the other of the interventions, then the use of a PCT merits consideration.

Felicitometric hermeneutics: interpreting quality of life measurements.

The use of quality of life (QOL) outcomes in clinical trials is increasing as a number of practical, ethical, methodological, and regulatory reasons for their use have become apparent. It is important, then, that QOL measurements and differences between QOL scores be readily interpretable. We study interpretation in two contexts: when determining QOL and when basing decisions on QOL differences.

Pragmatic problems with clinical equipoise.

It is widely accepted that if one is to follow the ethical tenets of clinical equipoise, phase III controlled clinical trials must be designed pragmatically, to measure effectiveness rather than efficacy. This choice of a pragmatic rather than an explanatory approach to phase III clinical trial design has a number of consequences, some of which may be considered problematic. These include changes in what the trial is expected to accomplish, the way treatments are defined, the selection of subjects, the ways in which treatments are compared, and the assessment of the results.

Data and safety monitoring boards: some enduring questions.

Data Safety and Monitoring Boards (DSMBs) have been referred to as a "growth industry," and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This may be about to change.

Human histological research: is it necessary? Humane? Ethical?

A review of the dental literature in the United States over the past 60 years is replete with studies utilizing human histological evidence for research. The first reference found for the use of human tissue for histological study was published in 1941 in the Journal of Dental Research.(1) Much of this literature focuses on the use of block sections, in which teeth scheduled for extraction are removed along with portions of the surrounding soft tissue and bone in order to study the effects of various interventions.

Muscle pain inhibits cutaneous touch perception.

The processing of noxious and non-noxious sensations differs between chronic pain syndromes, and we believe that studies of sensory processing in the presence of pain will help to clarify the aetiology of the conditions. Here we measured in humans the threshold-level mechanosensitivity in tonic experimental muscle pain. We found (1) that muscle pain induced by hypertonic saline reduced cutaneous threshold-level mechanosensitivity at the site of pain and at the mirror site in the contralateral face, (2) that this effect outlasted the sensation of pain, (3) that it was more pronounced when the painful area was reported to be large, and (4) that the loss of mechanosensitivity was greater in males than females.

PC program for comparing tracking indices in several independent groups.

A method for computing a measure of tracking based on Cohen's kappa statistic for one-sample longitudinal data sets was previously described and implemented. This paper shows how one may test the equality of several kappas, each computed from an independent longitudinal sample. Thus, it is possible to formally compare groups of individuals with regard to stability in growth (or adaptive) patterns.

PC program for obtaining orthogonal polynomial regression coefficients for use in longitudinal data analysis.

Much of longitudinal data analysis begins with dimensionality reduction, i.e., the replacement of the T observations x , x , …, x on an individual taken at times t , t , …, t (not necessarily equally spaced) by a smaller number, P, of parameters which are then used to describe and compare growth processes.

Computation of Foulkes and Davis' nonparametric tracking index using GAUSS.

Foulkes and Davis (1981) define tracking as the maintenance of relative rank over a given time span. This paper outlines the development of their statistic, based on a set of individual growth profiles, which estimates the degree of tracking observed in a one-sample longitudinal data set and shows how confidence intervals for the corresponding population parameter may be constructed. An example using a measure of skeletal growth is given and a GAUSS program to do the computations is provided.

PC program for analyzing one-sample longitudinal data sets which satisfy the two-stage polynomial growth curve model.

The two-stage polynomial growth curve model is described and a GAUSS program to perform the associated computations is documented and made available to interested readers. The two-stage model is similar to that considered by us earlier (Schneiderman and Kowalski: American Journal of Physical Anthropology 67:323-333, 1985; American Journal of Human Biology 1:31-42, 1989), i.e.

A GAUSS program for computing an index of tracking from longitudinal observations.

Tracking can be defined as the tendency of individuals or collections of individuals to stay within a particular course of growth over time relative to other individuals. Thus, tracking describes stability in growth patterns. This paper outlines a statistical procedure for examining tracking in a single sample of measurements made on humans or other animals.

Implementation of Hills' growth curve analysis for unequal-time intervals using GAUSS.

Longitudinal data are widely regarded as the most efficient and informative type of data with which to investigate growth. Paradoxically, appropriate statistical methods for analyzing longitudinal data have been unavailable; with the exception of a computer program for executing Rao's (Biometrika 46:49-58, 1959) one-sample polynomial growth curve analysis (Schneiderman and Kowalski, Am. J.