http://bmj.com/cgi/content/full/323/7327/1464
BMJ 2001;323:1464-1466 ( 22-29 December )
Publish and be damned
A practical guide to informed consent to treatment
Andrew D Oxman
a Health Services Research Unit, National Institute of Public
Health, Postboks 4404 Nydalen, 0403, Oslo, Norway, b UK
Cochrane Centre, Oxford OX2 6HE, c Trout Research and Education
Centre at Irish Lake, Markdale, ON, Canada N0C 1H0
Correspondence to: A D Oxman andrew.oxman@labmed.uio.no
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Summary points
Many alternative styles of
informed consent to treatment exist, along with much theory, a few
principles, and different standards of consent within and outside randomised
trials, but concise practical advice about the available alternatives is not
readily accessible We have assembled a menu of
options to help frontline clinicians and patients to select whichever form of
consent meets their particular needs and circumstances |
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Consent
to treatment within randomised controlled trials |
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Human sacrifice randomised controlled trial consent
"The research ethics committee that approved this trial on your
behalf would like you to know that future generations might (or
might not) appreciate it if you would put your life at risk by
joining this trial. Although we will keep your individual trial
results confidential (especially if they run contrary to our
hypothesis) and you are free to insist on conventional treatment or
withdraw at any time, let's face it
you are a human guinea pig. The
investigators responsible for the study may have conducted a
systematic review of relevant previous studies to see whether one of
the alternative treatments has already been shown to be superior,
but this sort of evidence is beyond the interest and competency of
our local research ethics committee, which is primarily interested
in protecting the host institution from lawsuits should we
accidentally kill you along the way. The study results may or may
not be submitted for publication, depending on whether they will
advance the careers of the investigators and improve the sponsor's
market share; but you may be long gone by then anyway."
Commercial randomised controlled trial for multicentre fun and profit
consent
"We would like you to participate in a treatment trial of a new
drug. We really don't know much about it because we didn't write the
protocol and the trial is being run by a for-profit contract
research organisation (since their future business depends on
achieving favourable results for their sponsors, we're confident that
this trial will turn out the way they want it to). We've joined the
study because we will receive a bounty of several thousand dollars
for recruiting you into it, plus a big bonus if we can talk a dozen
of you into it by the end of the month. The drug we are testing is a
trivial (but patentable) modification of a generic drug from the
same class. We don't really expect it to perform any better, but
we're pulling for `non-inferiority' and a tiny but statistically
significant difference in unimportant side effects. We'll be able to
use that result in a series of direct to consumer television ads, so
that future unsuspecting patients will demand this exorbitantly
priced, me-too drug from their physicians. Of course, if the results
do not favour the new drug, we will bury them without trace."
American consent to randomised controlled trial treatment for the
40 million uninsured
"This trial is the only way we can provide health care for
uninsured Americans. We promise you free drugs and high quality care
during the trial, but may have to abandon you as soon as our grant
runs out."
Randomised controlled trial consent for stockholding investigators
"I own stock in the company that manufactures this treatment,
so it must be good. Why else would I have invested so much in the
company that manufactures it?"
Kilgore Trout randomised controlled trial consent
"Because we are uncertain about the relative merits of the
treatment alternatives for your condition, we suggest that the best
option for you is to be treated as a participant in a properly
controlled comparison. Because we're deeply concerned about your
safety and that of other patients who take part in randomised
controlled trials, we subjected the oft heard `human guinea pig'
charge to a review of studies that compared the outcomes of patients
treated within randomised controlled trials with those of similar
patients treated outside such studies.2 To our
surprise, the great majority of the evidence shows that patients
treated within controlled trials have better outcomes (including
mortality). When we included this reassuring information in the
proposed informed consent portion of our submission to our local
ethics committee, they initially told us that we couldn't give you
this information because providing you with the information constituted
`coercion.' However, after a public debate in which we accused the
ethics committee of unethical behaviour in not bothering even to
attempt to overcome their massive ignorance about this evidence,
they reversed their decision and now permit us to tell you the truth
about what is known."
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Consent
to treatment in routine clinical practice |
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Customary consent
"Here's a prescription, Ms Jones. Let me know if you have any
troubles."
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(Credit: SUE SHARPLES) |
Alternative forms of standard consent to treatment
The following can be reproduced and attached to the patient's chart:
"My colleagues, lawyers, accountants, and I are careful to
obtain the consent of all our patients to treatment. After carefully
considering your needs, my needs, my financial aspirations (and
possibly your preferences), I suggest you consent to treatment X
because (tick all that apply):
"I was taught this treatment at medical school 30 years ago, and
since it's the most time honoured treatment for your condition, it
must be the best."
"It's the newest treatment for your condition, so it must be the best."
(To avoid confusion, we advise that only one of the foregoing
reasons is offered to a particular patient about the same treatment.)
"It's the most expensive treatment for your condition, so it must be the
best. Why else would I have bought so much stock in the company that
manufactures it?"
"A famous movie star/professional athlete/politician wrote a heart warming
endorsement of this treatment in Readers' Digest last year.
Indeed, Mrs Reagan's astrologer recommends it."
"I get a kickback from the manufacturer every time I stick one of these
gizmos into a patient."
"This drug's manufacturer pays for pizza at our lunchtime conferences, and
the pens they distribute are very reliable."
"This drug's manufacturer has given me a hand held computer that's full of
all the latest drug prescribing information (they update it on line
every month), and it even writes my prescriptions for me. Moreover,
I've just learnt that the software they use to update my computer
also secretly downloads my prescriptions for the previous month, and
I don't want to appear ungrateful by prescribing products made by
their competitors."
"Carruthers, who is a member of my lodge, told me that his company makes
the kit, and I feel it's only right to support a fellow freemason."
"My medical school/hospital has sold out to the firm that manufactures
this drug. They give us huge grants for our research programmes, and
we give them first call on any discoveries we make. Their
stockholders may vote this money to somebody else if our prescribing
behaviour threatens their bottom line."
"I am indebted to the company that makes this drugnot just for first class travel and
accommodation at some very enjoyable conference holidays during the
conference season but also for paying me huge fees for lecturing
about their drugs in a way that minimises their shortcomings and
warns against other drugs in their class."
This is not an exhaustive list of options, but we are
confident that it provides readers with a starting point from which they
can mix and match and generate additional alternatives.
American emergency consent to treatment
"Before we can operate on you, our lawyers insist that you sign
this piece of paper. You may request a magnifying glass to read the
fine print. A charge for this will be added to your bill. If you
have received narcotics to relieve your pain before signing this
form, please indicate this on pages 12, 21, and
54. If you are still in severe pain, you may rip up pages 56 to
75 and chew on page 76. A charge for this will be added to
your bill. If you would like to consult a lawyer before signing this
form, we have a highly paid staff of lawyers on call who can assist
you. Charges for this service are listed on pages 77 to
80. If you would like to know what the evidence is that the procedure
will help you, we would be happy to tell you about our excellent
experience with patients just like yourself. Fortunately, no one has
ever conducted a proper evaluation of this procedure, so our
excellent experience is the best available evidence. Trust us. If
you would like to question our excellent experience, we would be
happy to call a taxi for you. If you are currently unconscious, aphasic,
illiterate, unable to communicate in English, or uninsured, please
get out of our emergency room at once."
Cultural imperialism consent to treatment
"I must insist that you tell the patient's family members and
the village headman that they must leave the consulting room. They
have no part to play here. Although it may be customary for these
people to be involved in treatment decisions in your culture, the
superior ethical position we have developed in Western culture is
that the primacy of the individual is recognised in all thingsapart from corporate power, that is. After
receiving detailed documents that he or she is unable to read about
treatment options and effects, the patient must sign (or make some
sort of mark on) the treatment contract. This contract will be
unambiguously between the patient and the corporation for which I
work. Because the customer is always right, it is important that the
patient should shoulder the responsibility for treatment decisions.
That way, the patient can take the blame if the treatment doesn't
work. If this way of securing consent to treatment is unacceptable
in your culture, I am not prepared to enter into the contract. To
do so would risk professionally damaging public criticism from ethicists
who have made the rules in my culture."
Patients' rights consent to treatment
"If you expect me, as your patient, to accept the treatment you
are prescribing for me, it is only fair that I inform you about my
requirements. Firstly, I expect you to have consulted systematic
reviews of reliable evidence about the relative merits and demerits
of the various treatment alternatives available to me. And don't try
telling me that you have decided to ignore that evidence because the
people in the research studies weren't very like me. That's an
admission that all research is irrelevant because it was all done in
the past and all done on other people. I'll only accept a specific
argument that the research evidence is clearly irrelevant to me and
my circumstances. If you give me a treatment that has been shown to
be harmful in a high quality systematic review, I will sue you, even
though I am British. If, after considering my needs and preferences,
you are uncertain about the relative merits of the treatment options
available to me, I expect you to invite me to participate in a
randomised comparison. This is because I am aware of the evidence
suggesting that people treated within randomised controlled trials
do better than others, so that I can hedge my bets in the face of
this uncertainty, and to increase the chances that I will benefit
from reduced uncertainty in future as a result of the evaluation.
None of the foregoing is to suggest that I expect you to behave like
an unthinking, insensitive automaton in responding to my request for
your help. On the contrary, I expect you to use the clinical skills,
judgment, and intangible personal resources that characterise a
thoughtful, reflective, evidence based practitioner. But I thought I
should make my position clear because I can't abide the arrogance of
those doctors who continue to maintain that systematically assembled
research evidence is irrelevant to them and their patients."
Interactive, personalised approach to informed consent
"Good morning Mrs Jones, my name is Dr Smith. Please sit down
and make yourself comfortable. Your general practitioner has
probably explained to you that he has asked me to see you because
your breathlessness doesn't seem to be getting any better, and he
wondered whether I might be able to suggest ways of helping. I hope
I will be able to do so, but this may well mean seeing you on
several occasions over the next few months and working together to
find the best treatment for your condition.
"I'm more likely to be able to help if I can get to
know more about you and your priorities and preferences. As this is the first
time we've met, I thought it might be helpful to mention briefly how
I will try to do this. Patients vary in the amount of information
that they want to give to and receive from their doctors. Most
patients seem to get less information from their doctors than they
want, but others would rather not be told some of the things that
some doctors assume that they must want to know. Because you and I
don't know each other yet, I'm going to need your help in learning
how much information you want about your problem, and about the
possible treatment options. I'm going to depend on you to prompt me
to give you more information if you think I'm not being sufficiently
forthcoming, or to tell me that you've heard enough if you think I'm
overdoing it. You also need to know that I will never lie in
response to a straight question from you, and if I don't know the
answer I will do my best to find it for you. Does that seem to you
to be an acceptable way of proceeding?"
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Acknowledgments |
We are grateful to Jan Chalmers, Brian Haynes,
and Robert Levine for helpful comments on earlier drafts of this paper.
Contributors: AO, IC, and DS all contributed equally and will all act as
guarantors.
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Footnotes |
Funding: None.
Competing interests: DS has been wined, dined, supported, transported, and paid
to speak by countless pharmaceutical firms for over 40 years
(see bmj.com).
Potential competing
interests for DLS appear on bmj.com
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References |
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1. |
Doyal L, Tobias JS, eds. Informed consent in medical
research. London: BMJ Publications, 2000. |
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2. |
Trout Research and Education Centre. How do the outcomes
of patients treated within randomised control trials compare with those of
similar patients treated outside these trials? http://hiru.mcmaster.ca/ebm/trout/
(accessed 1 Sep 2001). |
(Accepted 1 November 2001)
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