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Table 2 Definitions

From: What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics

Coded as:

Defined as:

Number of PI respondents

Number of REB responses

Number of philosopher of science responses

Total responses

Relative frequency

Representative quote

MD community uncertainty

Benjamin Freedman’s classic conceptualization of equipoise as disagreement in the physician community

2

1

11

14

31.11%

So, if we're talking about clinical equipoise, then, it's about there being uncertainty in the expert community – Phil 10

Evidence-based uncertainty

This is a demonstrated difference of opinion — typically established through a systematic review of the literature

5

4

2

11

24.44%

Equipoise, to me, means that in the scientific landscape, in the scientific literature, the treatment has not been determined to be beneficial or not beneficial to an individual with a particular condition – PI 2

Uncertainty not otherwise specified

A statement that ‘there must be uncertainty’, without specification of whose uncertainty or how it should be established

4

3

0

7

15.56%

For me it means that there is a level of uncertainty in the decision making process so that you don't know something or that there is just a reasonable level of indecision or lack of clarity about the best method of action – PI 8

Risk vs. benefit

Equipoise as a balancing of health benefits vs side effects or research burdens for the patients

1

2

2

5

11.11%

Well, you’re balancing the risks and benefits of the study, basically. The risk to the patient and the benefit for the gain of the knowledge. – REB 7

Individual MD uncertainty

Uncertainty of one physician making a decision about whether the trial is justified or if a particular patient is a viable candidate for a trial

3

0

0

3

6.67%

I view it as the concept that with respect to the trial that if it’s equally likely in my mind, based on all the data that exist or don’t exist, that these two treatments could be equal or one better than the other, and there’s nothing pointing me to say which one is better than the other, then I think that in my mind, I have equipoise. – PI 4

No/unknown definition

No definition offered

0

2

0

2

4.44%

Well, equipoise, I think is a term, just sort of invoked to a large extent in order to justify something – REB 5

Honest null hypothesis

Equipoise exists when the groups are the same

0

1

0

1

2.22%

So, clinical equipoise to me means that, given everything that I know about these two arms, the outcomes should be the same. That this is not an inferiority design, that we don't think one will be worse than the other, it's really based that they are the same – REB 11

Equal opportunity

This definition is unclear

0

1

0

1

2.22%

That they are giving equal opportunities to every possibility – REB 10

Inaudible

Inaudible

0

1

0

1

2.22%

 
 

Total responses:

15

15

15

 

100.00%