Equipoise and the ethics of clinical research.The ethics of clinical research deflne equipoise--a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic define equipoise in medical, he or she is ethically obliged to offer that treatment. The current understanding of this requirement, which entails that the investigator have no "treatment preference" throughout the course of the trial, dedine nearly insuperable obstacles to the ethical commencement or completion of a controlled trial and may also contribute to the termination of trials define equipoise in medical of the failure to enroll enough patients. I suggest an alternative concept of equipoise, which would be based on present or imminent boldenona dosis caballos in the clinical community over the preferred treatment. According to this concept of "clinical equipoise," the requirement is satisfied if there is genuine uncertainty within the expert medical community--not necessarily on the part of the individual investigator--about the preferred treatment.
Is the concept of clinical equipoise still relevant to research? | The BMJ
For most manual therapy trials, equipoise does not likely exist. Although there are methodological mechanisms to reduce the risk of bias associated with a lack of equipoise, most of the manual therapy trials to date are likely guilty of this form of bias. A true state of equipoise exists when one has no good basis for a choice between two or more care options.
Clinical equipoise provides the principled basis for medical research involving patients randomly assigned to different treatment arms of a clinical trial, 4 and is considered a necessary feature for clinical service practitioners to ethically enroll patients into clinical trials. In truth, it is somewhat naive to assume that all RCTs were and are investigated in a state of equipoise, regardless of whether ethics are the driving force behind the assumption. Consequently, it is arguable whether an environment can exist in a complete state of equipoise, especially when manual therapy is the treatment intervention.
On the other hand, it is also naive to assume that the results of all manual therapy interventions reported in comparative trials are purely associated with the effects of an intervention and are not influenced by an absence of clinical and personal equipoise. Manual therapy interventions are personalized techniques, which often require careful, long-term study and skill acquisition. The assimilation of these skills, as well as the required interaction between clinicians and patients, means that the majority of manual therapy RCTs have a very high risk of violating personal and clinical equipoise.
RCTs have traditionally involved the use of a null hypothesis, whereby the researcher assumes that there will be no statistical difference between groups. More recently, however, most RCTs have migrated toward directional hypotheses, intended to demonstrate the effectiveness of one intervention over another.
One of the reasons for this change is publication bias, which is the tendency for journals to accept papers for publication based on the direction or strength of the study findings; studies have a higher likelihood of being published if they show a significant difference between groups. This number depends largely on the estimated effect size. Despite, and perhaps, due to the challenges of meeting statistical significance with a directional hypothesis, the risks associated with experimenter and patient biases are compelling.
Within manual therapy, two types of interventions are generally compared. The first involves selected techniques such as manipulation, mobilization, selected neurodynamics, or any procedure that is specific to a particular manual therapy philosophy paired against one another, while the second involves comparison of particular systems such as McKenzie versus orthopaedic manipulative therapy.
This effect may be observed when the control treatment does not reflect an intervention in a way that it is typically used in clinical practice e. Nearly all manual therapy interventions, with the possible exception of thrust manipulation, have been used both as treatments and sham interventions. An intervention that — through intention or training — would have a meaningful effect when applied by one clinician may be no more than a sham control when applied by another.
There are a number of means for correcting for this potentially problematic element. A method called an expertise-based RCT 25 involves randomizing patients to practitioners who specialize in the dedicated intervention within a trial. For example, for a trial comparing manipulation versus soft tissue mobilization, four clinicians who specialize in manipulation of the cervical spine could serve as research participants as could four clinicians who specialize in soft tissue mobilization.
Each patient enrolled in the study could be randomized to a specific clinician, versus randomization to a particular treatment. Ideally, this would involve practitioners of similar levels of training, and include multiple therapists in each group. This would increase the likelihood that the variable examined is the technique or method, rather than the skill of a particular clinician.
A similar method to expertise-based RCTs is an equipoise-stratified design. This design 26 involves full pre-randomization recognition of clinician biases toward a specific intervention and balancing of these biases during the study groupings through matching.
Equipoise-stratified designs are more appropriate for models, which involve numerous interventions or interventions that are multimodal. This also results in questionable randomization, which among other concerns will eliminate the ability to assess treatment modifiers. Additionally, this design introduces another variable, as the ability of the clinician to choose the correct treatment is confounded with the effect of the treatment.
Consequently the trials would need to involve a large number of subjects for the process to work. Clinician blinding is an important step in maintaining equipoise and should be a goal of clinical trials, yet achieving this goal is so difficult in manual therapy studies that some reviewers have excluded it as a factor in quality assessment.
A systematic review by Kent et al. Clinicians trained in Mechanical Diagnosis and Therapy may interact differently with patients who received treatment matched to their classification versus movement in the opposite direction, which they expect will increase symptoms. This study shows the challenges to maintaining equipoise, as patients may not agree to the intended research design.
Because of the intimate nature of manual therapy interventions, personal and clinical equipoise are two ingredients necessary for a truly unbiased manual therapy-based RCT. Further work is needed to define the full extent to which a lack of personal and clinical equipoise influences the findings of a manual therapy-based randomized clinical trial.
This will require careful evaluation of the presence of clinical and personal equipoise prior to the implementation of the study. Until clinical equipoise is clearly accounted for, studies at risk for violating equipoise should be interpreted with caution. National Center for Biotechnology Information , U. J Man Manip Ther. Chad Cook 1 and Charles Sheets 2. This article has been cited by other articles in PMC. Randomized Controlled Trials RCTs have traditionally involved the use of a null hypothesis, whereby the researcher assumes that there will be no statistical difference between groups.
Manual Therapy and Equipoise Within manual therapy, two types of interventions are generally compared. Correcting for Biases of Non-equipoise There are a number of means for correcting for this potentially problematic element. Summary Because of the intimate nature of manual therapy interventions, personal and clinical equipoise are two ingredients necessary for a truly unbiased manual therapy-based RCT.
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Informed consent may be hazardous to health. At what level of collective equipoise does a clinical trial become ethical? J Med Ethics ; Perceptions of equipoise are crucial to trial participation: Controlled Clin Trials ; The uncertainty principle and industry-sponsored research.
There is another exchange on equipoise and uncertainty. Equipoise and the ethics of clinical research. New Engl J Med ; Evidence-based practice in clinical psychology: J Clin Psych ; Equipoise, a term whose time if it ever came has surely gone. The existence of publication bias and risk factors for its occurrence. Use of effect sizes in describing data. J Man Manip Ther ; Phys Ther Rev ; The relationship between patient and practitioner expectations and preferences and clinical outcomes in a trial of exercise and acupuncture for knee osteoarthritis.
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