26. I have no idea what this paper is about. I don’t think the authors do either.
That sounds a little harsh. From trying to read it, I felt like the main difficulty was that the authors assumed the reader to know what “the ethical and conceptual framework (ECF)” and “a learning health‐care system (LHS)” were. But they did open with a pretty clear list of questions they said the article was about:
(a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine?
Some of these were a little unclear to me (I don’t know what the “principle of clinical equipoise” is), but again that just reflects my lack of knowledge rather than any problem with the authors.
In case anybody else doesn’t know the definition seems to be “Clinical and personal equipoise exists when a clinician has no good basis for a choice between two or more care options or when one is truly uncertain about the overall benefit or harm offered by the treatment to his/her patient.”
If that principle holds you are not allowed to run replication trials because in a replication trial you already have a good basis for believing that one of the groups gets a better treatment.
I’ll agree that I worded it pretty harshly, but I do think I’ll stand by it not being a useful paper. Imagine a science paper that claimed to be about the following list of questions:
a) What is the difference between iron and xenon? b) What is the relationship between solid matter and gaseous matter? c) What is the practical relevance of the principle of least action? d) Does investigating radioactive materials require different experimental procedures than investigating other physics? e) What kind of statistics should be used in physics papers?
Assuming that we weren’t clear on the answers to those hypothetical questions, they do seem like they’d be important to address? You could fairly argue that trying to address all of them was packing too much content into a single paper, but then even raising them for the purpose of drawing attention to them could be useful.
I do think that packing five separate questions into one paper is too much, but also going through those questions one at a time:
(a) What is the difference between practice and research?
This question seems...obviously stupid? It might be intended as a Socratic lead-in of some sort, I suppose.
(b) What is the relationship between research ethics and clinical ethics?
This question seems extremely vague. I can imagine related sub-questions that could be meaningful: e.g. ‘does research need to use different ethical standards than clinical ethics’ (like (d) below), ‘does research need separate ethical regulations from clinical treatment, or can it use the same ones’, ‘should clinicians be worried about the ethics of researchers who give them treatments/vice versa’, but in the absence of a more specific question I’m not clear on what this means or what an answer would be.
(c) What is the ethical relevance of the principle of clinical equipoise?
I hadn’t heard of this. Per Christian’s answer above it might be a reasonable question, although it seems a bit tautological asking for the ethical relevance of a principle if the principle itself is an ethical principle. Still willing to accept it as a probably-okay question.
(d) Does participation in research require a higher standard of informed consent than the practice of medicine?
This is a good question. If it were the only question in the paper I would like it.
(e) What ethical principle should take precedence in medicine?
We take a kind of abrupt turn here into a very high-level meta-question. It’s weird to combine this with a bunch of lower-level questions, and even weirder to put it at the end—surely if you need to decide what ethical principle to use that needs to be the first thing you do?
So I think we’ve got either 2 or 3 reasonable questions muddled together into one paper along with some silly/poorly defined ones. Then, looking at the ending, the main thrust of their conclusion appears to be ‘our approach is useless for thinking about these questions’:
It can be concluded that [our approach] has not provided us with conceptual instruments that would resolve the ethical debate between proponents of the segregation and integration models…
...[our approach] also does nothing to resolve the problem of a researcher’s clinical obligation. Rather, it creates a new source of moral obligation: a health‐care system. Next, [our approach] seems not to resolve the controversy over the concept of clinical equipoise.
I am overall not very impressed by this paper. I don’t think it sounds actively evil or anything, I just think it sounds like a waste of (a great deal of) paper.
That sounds a little harsh. From trying to read it, I felt like the main difficulty was that the authors assumed the reader to know what “the ethical and conceptual framework (ECF)” and “a learning health‐care system (LHS)” were. But they did open with a pretty clear list of questions they said the article was about:
Some of these were a little unclear to me (I don’t know what the “principle of clinical equipoise” is), but again that just reflects my lack of knowledge rather than any problem with the authors.
In case anybody else doesn’t know the definition seems to be “Clinical and personal equipoise exists when a clinician has no good basis for a choice between two or more care options or when one is truly uncertain about the overall benefit or harm offered by the treatment to his/her patient.”
If that principle holds you are not allowed to run replication trials because in a replication trial you already have a good basis for believing that one of the groups gets a better treatment.
I’ll agree that I worded it pretty harshly, but I do think I’ll stand by it not being a useful paper. Imagine a science paper that claimed to be about the following list of questions:
a) What is the difference between iron and xenon? b) What is the relationship between solid matter and gaseous matter? c) What is the practical relevance of the principle of least action? d) Does investigating radioactive materials require different experimental procedures than investigating other physics? e) What kind of statistics should be used in physics papers?
Assuming that we weren’t clear on the answers to those hypothetical questions, they do seem like they’d be important to address? You could fairly argue that trying to address all of them was packing too much content into a single paper, but then even raising them for the purpose of drawing attention to them could be useful.
I do think that packing five separate questions into one paper is too much, but also going through those questions one at a time:
(a) What is the difference between practice and research?
This question seems...obviously stupid? It might be intended as a Socratic lead-in of some sort, I suppose.
(b) What is the relationship between research ethics and clinical ethics?
This question seems extremely vague. I can imagine related sub-questions that could be meaningful: e.g. ‘does research need to use different ethical standards than clinical ethics’ (like (d) below), ‘does research need separate ethical regulations from clinical treatment, or can it use the same ones’, ‘should clinicians be worried about the ethics of researchers who give them treatments/vice versa’, but in the absence of a more specific question I’m not clear on what this means or what an answer would be.
(c) What is the ethical relevance of the principle of clinical equipoise?
I hadn’t heard of this. Per Christian’s answer above it might be a reasonable question, although it seems a bit tautological asking for the ethical relevance of a principle if the principle itself is an ethical principle. Still willing to accept it as a probably-okay question.
(d) Does participation in research require a higher standard of informed consent than the practice of medicine?
This is a good question. If it were the only question in the paper I would like it.
(e) What ethical principle should take precedence in medicine?
We take a kind of abrupt turn here into a very high-level meta-question. It’s weird to combine this with a bunch of lower-level questions, and even weirder to put it at the end—surely if you need to decide what ethical principle to use that needs to be the first thing you do?
So I think we’ve got either 2 or 3 reasonable questions muddled together into one paper along with some silly/poorly defined ones. Then, looking at the ending, the main thrust of their conclusion appears to be ‘our approach is useless for thinking about these questions’:
I am overall not very impressed by this paper. I don’t think it sounds actively evil or anything, I just think it sounds like a waste of (a great deal of) paper.