Honesty about new screening programmes is best policy
BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7238.872 (Published 25 March 2000) Cite this as: BMJ 2000;320:872
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Doctors no longer have any choice in the matter of informed consent -
the GMC has spelt out their responsibilities. Last year the General
Medical Council has sent every doctor on its register a copy of Seeking
patients consent: the ethical considerations. If you have misplaced your
copy you can obtain another from http://www.gmc-
uk.org/n_hance/good/consent.htm. Amongst other things this guidance
states that a doctor must obtain informed consent from a patient before he
performs a non-emergency test.
What is informed consent? There are three components to informed
consent:
1. Information
2. Comprehension
3. Voluntariness.
Let us see how these principles apply when a woman visits her GP for a
routine NHS Cervical Screening program (NHSCSP) Pap smear.
Information:
The guidance makes it quite clear that at a minimum, The GP must inform
the woman of the benefit she will get by submitting to the test. The
benefit is calculated quite simply. It is the difference between the
woman's prognosis if she does or doesn't have the Pap smear. So what
should he tell her, how great is this benefit? Surprisingly even after
searching the literature and speaking to experts, we could find not find
out. We suspect that few doctors reading this journal know either. If
this is so it means that most women are not giving informed consent to
cervical smear examinations! To rectify this lack of knowledge we have
calculated the benefit of a patient attending the NHSCSP and present our
findings in the table attached. The table gives a clear visual indication
of the chance of a woman surviving for 10 years if she does - or doesn't -
have her routine Pap smears. It is apparent that to an individual woman
the absolute benefit of having a Pap smear is small.
Table 1 - to show the benefit gained by women attending the NHS
cervical cancer-screening programme
________________________________________________________
Age No of Alive 10 Alive 10
at start women alive years later years later
of 10 at start of if they attend if they do
year period 10 year NHSCSP not attend
period NHSCSP
_______________________________________________________
25 10,000 9963 9962
35 10,000 9863 9859
45 10,000 9713 9708
55 10,000 9457 9450
______________________________________________________
Women must also be told about the inaccuracy of the Pap test and
the disadvantages of being tested. For instance, they must be told that
it is quite likely that the laboratories that examine her smear will quite
likely miss abnormalities if they are present. We suggest that a
statement suggesting that "even in the best laboratories, at least 5-15%
of abnormal smears may be reported as normal", is appropriate. They should
also be told that there is about a 7% chance that they will require
further testing and about a 3% chance that they will need to attend a
hospital and undergo colposcopy.
2) Comprehension.
A doctor should never perform an elective test, such as
a Pap smear, if there is any doubt of the woman's ability to understand
its significance. The rule is that a patient must consciously opt into
testing. A doctor must not make a decision on behalf of the woman - no
matter how well intentioned - unless she asks him to do so. If he does
make a decision on her behalf he must inform her of any potential conflict
of interest.
3) Voluntariness - potential conflict of interest.
The GMC states that if
a doctor has a financial interest in recommending a test then he must
inform the patient of a potential conflict in interest. Now it is a fact
that GPs typically earns hundreds or thousands of pounds a year by
performing smear examinations. Therefore it is quite clear that a GP
should tell a woman attending for Pap smear of this potential conflict of
interest.
Recommendations
In order to obtain informed consent, GPs should at a minimum:
1. Inform women of the absolute benefit of their participation in the
cervical screening programme. The benefit to an individual woman of
attending the NHSCSP is extremely small.
2. Inform women of the inaccuracy of the test and disadvantages of being
tested.
3. Always make sure that women understand what they have been told
4. Inform women that because the Health Authority pays them to perform Pap
smears that there may be a conflict of interest.
5. Familiarise themselves with the GMC's booklet: Seeking patients
consent: the ethical considerations.
An article based on data presented in the table in this letter
appeared in Pulse (13 May. 2000)
Andrew Rouse & Tom Marshall
Department of Public Health and Epidemiology,
University of Birmingham , Edgbaston, Birmingham, B15 2TT
e-mail: A.M.Rouse@bham.ac.uk or e-mail: MarshaTP@PCR-FS1.bham.ac.uk
Competing interests: Table 1 - to show the benefit gained by women attending the NHS cervical cancer-screening programme ________________________________________________________Age No of Alive 10 Alive 10at start women alive years later years laterof 10 at start of if they attend if they do year period 10 year NHSCSP not attend period NHSCSP _______________________________________________________25 10,000 9963 996235 10,000 9863 985945 10,000 9713 970855 10,000 9457 9450______________________________________________________
Editor
We support Angela Raffle's suggestion (BMJ 25 March 2000; 320: 872) that
honesty about screening is the best policy. But how can that be achieved?
Practitioners and planners rightfully complain that individual informed
consent to screening is too time-consuming: the provision of information
and the necessary discussion and reflection on it requires considerable
effort, time and skill.
We have recently suggested a community informed
consent process: a survey to establish the distribution of preferences
among fully informed potential screenees, for example from a random sample
of the target population to whom screening will be offered (1). First, if
the majority of the target population think the harms of screening
outweigh the benefits, then there is no need to consider further whether
screening should be provided. Second, if the majority of the target
population think the benefits of screening outweigh the harms, screening
can be offered, subject to an acceptable cost-effectiveness ratio. People
should be informed that a representative sample of people like them who
have been given detailed information about the screening process thought
that the benefits outweighed the disadvantages. For many, that may be
sufficient for them to decide about screening. Some may still want more
information, which should then be provided. Finally, if the target
population are divided about benefits versus harms, then there is a need
for individualised decisions.
Clearly, the first step is providing good evidence about all the
effects of screening, based on randomised trials. We do not see it as a
dilemma if people are deterred from 'effective' screening when they know
its consequences -both the good and the bad. If they are truly well
informed, that represents their preferences and reflects how they trade
the benefits against the harms. Rather the dilemma is how to ensure that
people indeed have sufficient information to make the choice. The
community informed consent process represents a practical solution. Only
when adequate community surveys of preferences show that the majority of
potential screenees would choose to be screened does it seem ethical to
actively promote screening without detailed individual consent.
Les Irwig
Professor of Epidemiology
Department of Public Health and Community Medicine,
University of Sydney,
NSW 2006, Australia
Paul Glasziou
Professor of Evidence-Based Medicine
Department of Social and Preventive Medicine,
University of Queensland,
Australia
Conflict of interest: None
Reference:
Irwig L and Glasziou P. Informed consent for screening by community
sampling. Effective Clinical Practice 2000;3: 47-50.
Also available at:
http://www.acponline.org/journals/ecp/janfeb00/irwig.htm (last accessed 30
March 2000)
Competing interests: No competing interests
Informed Consent and Public Health Interventions
Does this raise other issues?
How many procedures do doctors carry out which attract an additional
payment, or which might cause cancellation of a bonus payment if not
carried out?
I understand infant vaccinations fall into this category.
If so does the literature given to parents make this clear?
Then there is the question of information about risk.
I've been researching the background to passive versus active
surveillance of adverse vaccination reactions, and there is much evidence
that in general terms the authorities do not know the full incidence of
adverse reactions to vaccinations - not enough to assess the causal
relationships of more than a very few reactions at any event, as I
understand it.
How does this fit in with the GMC's circular on informed consent?
Competing interests: No competing interests