Editorial Council Resolution 0013: medical disclaimers

[Martin Baldwin-Edwards]

The period for open comments will start from Saturday, 12 July 2008 and will end 18 July, 2008. You may post your comments here on the Forum, or members of the Editorial Council may post an official statement on a page for that purpose, linked to the Resolution page.

The text of the resolution can be found at http://en.citizendium.org/wiki/CZ:Editorial_Council_Resolution_0013

[Tom Morris]

I support this resolution's intentions, but am not sure about the wording. The wording needs to state that the reader should seek advice from their physician - and that is about it.

Perhaps the other alternative is to follow the guidelines provided by the Health on the Net Foundation. For approved articles on medicine, may it not be sensible to seek HONcode accreditation?

[Howard C. Berkowitz]

The period for open comments will start from Saturday, 12 July 2008 and will end 18 July, 2008. You may post your comments here on the Forum, or members of the Editorial Council may post an official statement on a page for that purpose, linked to the Resolution page.

The text of the resolution can be found at http://en.citizendium.org/wiki/CZ:Editorial_Council_Resolution_0013

After looking at the text, the first thing that occurred to me is "Method of execution" is a singularly inappropriate heading for a medically-related page.  Quite a few medical societies have ruled that it is unethical for a physician to participate in execution...

Seriously, can we back off a little and identify the problem we are trying to solve? I just glanced through my Harrison's Textbook of Internal Medicine, a couple of NEJMs that came to hand, and The Biochemical Basis of Neuropharmacology, and not one had such a disclaimer. Why? Why not?

I am fully sympathetic to the problem of the spectrum of levels of understanding of medical information. While I am not a physician, I do simulate them on computers, and have spent more time making textual information physician-friendly than layman-friendly. At the same time, I understand that terminology and medical writing style can be extremely nuanced and highly dependent on a shared context; one can look up every word in a medical dictionary and still not really understand a study or even a textbook section on differential diagnosis.

Is the intent to avoid a specific liability problem for Citizendium? Clearly, that's why fast food coffee cups are marked "hot". Words begin to fail me when I find the preprinted pharmacy sticker, "warning; may cause drowsiness" on my prescription sleeping pills. WTH does "do not operate equipment?" mean in a label? If "equipment" includes can openers, I'm in real trouble with the cats. Were I totally drug free, I'd still have trouble with a race car because I never learned to drive a manual transmission.

Assuming the intent is avoiding liability, under what system of law?  I assume Citizendium is a U.S. corporation, but could Larry, on a visit to Germany, be detained for a hearing about how CZ misled a German citizen about a health matter?

I'm all in favor of a disclaimer that serves a specific purpose, and is structured to work for an international resource. In this case, I need more of a problem statement.

[Robert_W_King]

The problem is precisely as you stated.  The problem is that we (us citizens) know that the coffee is hot before it goes into the cup, but we can't trust the rest of our reading audience to know that.  Unfortunately the world is full of people who would do themselves harm should we not put in a disclaimer.

[Howard C. Berkowitz]

The problem is precisely as you stated.  The problem is that we (us citizens) know that the coffee is hot before it goes into the cup, but we can't trust the rest of our reading audience to know that.  Unfortunately the world is full of people who would do themselves harm should we not put in a disclaimer.

We agree.

While I haven't stopped doing it, a long time back, I was advised not to simply write (copyright (name), year), but also "all rights reserved". The person telling me to do it, on the staff of the U.S. Copyright Office at the Library of Congress, said that leaving off the additional three words caused jeopardy under certain South American legal systems.

A disclaimer such as this MAY protect in a U.S. court, although I suspect that there have been cases where the plaintiff one because there was nothing that said the plaintiff had read and understood the disclaimer. Citizendium is international.  Is there a phrasing that will work under all common legal systems?

On the other hand, is there case law that suggests that not having a disclaimer, in a member-driven forum such as this, is a significant risk? My gut says it is not.

Incidentally, I am confused --- should member comments on resolutions go here, on the discussion page of the resolution, or someplace yet again?  Or should I assume the Council has heard this.

[Martin Baldwin-Edwards]

This is the appropriate place for discussion, Howard. i have asked members of the Council to participate in this debate on the Forum.

[Larry Sanger]

I would favor a disclaimer not on legal grounds but on moral grounds.  There is no need to resort to analogies to make this plausible: we already know that it is possible that people will read an article on a medical topic and, assuming that it's correct because they "read it on the Internet," they do whatever it says.  But as we know, CZ articles are works in progress.

I want to ask the Secretary or the resolution's sponsor to clarify what text the Council will be voting on: the "Complete explanation" text or the "Suggested amendment" text?

[Howard C. Berkowitz]

I would favor a disclaimer not on legal grounds but on moral grounds.  There is no need to resort to analogies to make this plausible: we already know that it is possible that people will read an article on a medical topic and, assuming that it's correct because they "read it on the Internet," they do whatever it says.  But as we know, CZ articles are works in progress.

While I'm not adamant about it, I tend to be against a disclaimer. To take Larry's point about a moral argument, I suppose I'd have to ask "whose morality, and how will someone be affected by a disclaimer?" When I've worked with medical ethicists with various aspects of informed consent, there is a substantial amount of data that suggests that even with a formal, human-interactive disclosure, understanding is fairly poor. See, for example, Campbell et al.,  "Impact of a Clinical Trials Information", IRB: Ethics & Human Research (2008)).  Perhaps even more pertinent to the effectiveness of informed consent is ( Ågård "Informed Consent: Theory Versus Practice" Nature Clinical Practice Cardiovascular Medicine (2005).   Another, especially the section on Ethical Issues Regarding Readability, in Freda, "Issues in Patient Education" Journal of Midwifery & Women's Health (2004)

Emphatically, I am not saying to do away with informed consent; I want to make them more informative. My concern here, however, is that when there is actual counseling and much more written information, understanding is still poor. If these techniques have so little efficacy, why do we believe that a disclaimer will have much effect?  Reread Freda's comments about patients often not understanding the material given, and then estimate the impact of a disclaimer.

As an aside, I'm most active in discussing the opposite end of the spectrum with ethicist working on informed consent. Paraphrasing, the Declaration of Helsinki requires patients be given  information they can reasonably be expected to understand, which usually means having a simple version.  My question, which is causing some doubletakes and discussion, is whether a patient, who reasonably can be expected to understand the details of the experiment or treatment, has a right to read the full protocol?

[Martin Baldwin-Edwards]

I would favor a disclaimer not on legal grounds but on moral grounds.  There is no need to resort to analogies to make this plausible: we already know that it is possible that people will read an article on a medical topic and, assuming that it's correct because they "read it on the Internet," they do whatever it says.  But as we know, CZ articles are works in progress.

I want to ask the Secretary or the resolution's sponsor to clarify what text the Council will be voting on: the "Complete explanation" text or the "Suggested amendment" text?

As fas as I'm concerned, we are voting on the original text because that is what everyone has read. The sponsors have 24 hours to put their amendment forward, so that we can then vote on the amended text.

[Larry Sanger]

I would favor a disclaimer not on legal grounds but on moral grounds.  There is no need to resort to analogies to make this plausible: we already know that it is possible that people will read an article on a medical topic and, assuming that it's correct because they "read it on the Internet," they do whatever it says.  But as we know, CZ articles are works in progress.

While I'm not adamant about it, I tend to be against a disclaimer. To take Larry's point about a moral argument, I suppose I'd have to ask "whose morality, and how will someone be affected by a disclaimer?" When I've worked with medical ethicists with various aspects of informed consent, there is a substantial amount of data that suggests that even with a formal, human-interactive disclosure, understanding is fairly poor. See, for example, Campbell et al.,  "Impact of a Clinical Trials Information", IRB: Ethics & Human Research (2008)).  Perhaps even more pertinent to the effectiveness of informed consent is ( Ågård "Informed Consent: Theory Versus Practice" Nature Clinical Practice Cardiovascular Medicine (2005).   Another, especially the section on Ethical Issues Regarding Readability, in Freda, "Issues in Patient Education" Journal of Midwifery & Women's Health (2004)

Emphatically, I am not saying to do away with informed consent; I want to make them more informative. My concern here, however, is that when there is actual counseling and much more written information, understanding is still poor. If these techniques have so little efficacy, why do we believe that a disclaimer will have much effect?  Reread Freda's comments about patients often not understanding the material given, and then estimate the impact of a disclaimer.

As an aside, I'm most active in discussing the opposite end of the spectrum with ethicist working on informed consent. Paraphrasing, the Declaration of Helsinki requires patients be given  information they can reasonably be expected to understand, which usually means having a simple version.  My question, which is causing some doubletakes and discussion, is whether a patient, who reasonably can be expected to understand the details of the experiment or treatment, has a right to read the full protocol?

Howard, what does a disclaimer really have to do with informed consent?  That's the part you didn't explain.  Informed consent, I thought, involved doctors giving advice directly to their patients, and patients making decisions based on information they can understand.  That's a different kettle of fish from someone getting general medical information, which might or might not apply to conditions they or those they know might or might not have.  The disclaimer's purpose is very simple: let the people who read it (which admittedly might not be many) know, or remind them, that an Internet article is not an adequate substitute for a doctor's care.  And this, not just because they might misinfer things from the article, but because the article itself might contain mistakes that more carefully-edited resources might not.

[Howard C. Berkowitz]

Howard, what does a disclaimer really have to do with informed consent?  That's the part you didn't explain.  Informed consent, I thought, involved doctors giving advice directly to their patients, and patients making decisions based on information they can understand.  That's a different kettle of fish from someone getting general medical information, which might or might not apply to conditions they or those they know might or might not have.  The disclaimer's purpose is very simple: let the people who read it (which admittedly might not be many) know, or remind them, that an Internet article is not an adequate substitute for a doctor's care.  And this, not just because they might misinfer things from the article, but because the article itself might contain mistakes that more carefully-edited resources might not.

If one accepts the idea of patient-centric decisionmaking, they are equivalent. The papers I cited indicate many patients, in fact, do not understand the information from their doctor. When one signs an informed consent, much of what is involved is agreeing to the doctor's disclaimer.

Informed consent involves patient-centric decisionmaking within the context of a clinician-patient interaction, many of which are more impersonal than a CZ article. Reading an article and making decisions based on it is simply another form of patient-centric decisionmaking.

I see them as part of the same kettle of fish stew, although of different flavors. Further, given the problems of medical knowledge transfer in direct interaction, I see a disclaimer as far less likely to convey useful information. 

Thinking of disclaimers and what they solve, there's the classic "coffee is hot",  "do not use hair dryer while showering", and, on my bottle of prescription sleeping pills, "may cause drowsiness".  I see them as legal defenses, not as anything likely to give useful information.

Direct-to-consumer prescription drug advertising is full of meaningless disclaimers. "Tell your doctor if you have liver disease"?  Does that mean that I, as a patient, went out and got, on my own, ALT, AST, direct and indirect bilirubin, etc., to find I had subclinical liver disorders?

Seriously, I have to be convinced that a disclaimer is likely to make a would-be fool less of a fool.

If anything, for some perfectly reasonable medical articles, I'd rather see a practical disclaimer of "You need to have a basic knowledge of organic chemistry, pharmacokinetics, and microbiology to make any sense out of these articles."

"Ask your doctor" comes across as feel-good. Again, I'd like to know what problem it is intended to solve, and the probability it will do so.  Should there be a disclaimer saying "don't bother asking your doctor if you understand the difference among non-selective cyclooxygenase inhibitors, selective COX-2 inhibitors, and leukotriene inhibitors"?

[Tom Morris]

The way I see it is that as a "Citizen's Compendium", what distinugishes us from an encyclopedia is that we should try to act with something of a social conscience - the same reason that seems to be behind things like the policy on obscenity and sexual materials on Citizendium. Part of that social conscience is understanding that we are not simply a resource detached from readers providing only academic information. I think that those publishing academic material have some responsibility to ensure that readers approach the material carefully. The people reading an online encyclopedia like Citizendium are not going to solely be those with an academic interest in a particular subject, but often those with some personal interest in that subject. I think it is absolutely justified that we provide information to help those who are in distress, in the same way that after documentaries on television about difficult topics often a helpline is provided.

Rather than it being a disclaimer ("we need to cover our butts!"), it ought to really be a positive thing ("we might be able to help people!"): if you are suffering from this condition or think you may be, there are people who can help you who you should get in contact with - obviously, one's doctor (or relevant medical practitioner), but also patient advocacy charities like, say, the American Cancer Society. Of course, we would need to have some way of vetting groups that we provide links to, and I think here it would be best if an editor with clear expertise on a particular topic were consulted.

Other cases I think would be a good fit for "positive disclaimers" would be articles on suicide and abortion. The latter perhaps providing a link to one of the many counselling services like BPAS or Planned Parenthood, and for suicide perhaps providing a link to Samaritans or Befrienders. Others I can think of that would probably be worth including such notices on would be bereavement, alcoholism, maybe some articles on particular drugs and related articles, domestic violence and child abuse.

I would suggest that the process for placing such notices on articles would be as follows: authors and editors would discuss which organisations and resources would be best for listing on the article on the talk page or on a forum thread, and then if a small number of resources are chosen, a banner would be created which could be placed at the top of the article - if more than a small handful of resources are chosen, it could be placed on a subpage - "/Support", maybe - and then a banner would be created that would link to the Support page. The Support page would then list resources: web pages, telephone lines and organisations that can help people with these issues. This would be overseen by the usual editorial process. If we can reliably do geolocation, we could also make it so that the template contains the telephone number of a service local to the reader. Obviously, on some topics - abortion, for one - there will be some controversy as to which care organisations are listed, and editorial judgment will have to play a role here to work out which to list.