Incorporating considerations of resources use into grading recommendationsBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39504.506319.80 (Published 22 May 2008) Cite this as: BMJ 2008;336:1170
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Increasingly, health authorities around the world use economic
evaluation, typically cost-effectiveness analyses, in order to set
priorities in health care. Priority setting involves much wider
consideration than medical effectiveness. Long term health consequences,
valuation of health states, and value of resources are key elements when
societies set priorities. Few clinical trials explore all of these issues,
and clinicians and policy makers may in practice make implicit assumptions
when they make recommendations. Such assumptions are usually made explicit
in economic evaluation, and this may leave the impression that such
evaluation is much more uncertain than clinical practice based on “best
In the 24 May 2008 edition of the British Medical Journal Gordon
Guyatt and co-workers suggest a system for ”rating quality of evidence and
strength of recommendations” in relation to ”considerations of resource
use” . Surprisingly, they conclude that “a guideline panel may
legitimately choose to omit costs as a consideration”, presumably because
resource use and unit costs vary across jurisdictions. In fact, it would
be against the law not to consider costs in some countries such as Norway.
Here, the Patient’s Rights Act states that “the patient has the right to
therapy only when the costs are reasonable in relation to the health
benefit”. The Health Personnel Act requires that health personnel shall
not incur unnecessary expenses for patients or the health care system. The
simple and compelling argument for such regulations is that “resources
that are used for an intervention cannot be used for something else and
not affect the ability of the health system to best meet the needs of
those it serves” .
Guyatt and co-workers state that “published cost effectiveness
analyses, particularly of drugs, have a high probability of being flawed
or biased. This sweeping statement is based on a review of 44 economic
analyses published 1988-98 of six different pharmaceuticals. In the review
the authors conclude that “although we did not identify bias in individual
studies, these findings
indicate that pharmaceutical company sponsorship of economic analyses is
associated with reduced likelihood of reporting unfavorable results” .
In comparison, the Centre for Reviews and Dissemination in York
encompasses 7000 quality assed economic evaluations
(www.york.ac.uk/inst/crd/crddatabases.htm). It is surprising that
advocates of evidence based medicine are able to draw conclusions about
thousands of studies based on a review of 44 of them.
Guidelines should be based on critical thinking and explicit value
judgment rather than on opinions or prejudice.
Conflict of interest: Ivar Sønbø Kristiansen has edited a critical
book on evidence based medicine
1. Guyatt G H, Oxman A D, Kunz R, Jaeschke R, Helfand M, Liberati A, Vist
G E, Schunemann H J. Incorporating considerations of resources use into
grading recommendations. BMJ 2008; (336): 1170-1173.
2. Friedberg M, Saffran B, Stinson T J, Nelson W, Bennett C L. Evaluation
of conflict of interest in economic analyses of new drugs used in
oncology. JAMA 1999; (282): 1453-1457.
Ivar Sønbø Kristiansen has edited a critical book on evidence based medicine
Competing interests: No competing interests
What sort of evidence do we need in guidelines? The bioethical approach.
Guyatt and al.’s paper is good. However, the authors are not clear
enough about (1) what sort of the evidence is needed in guidelines, and
about (2) what distinguishes the two important and distinct elements in
guidelines, i.e. evidence, and judgments.
a) Evidence. Bearing in mind the four core principles of medical
ethics, i.e. patients autonomy, beneficence, non-malevolence and justice
, the evidence that we need in medical guidelines is bound to be about
clinical benefits, about clinical harms, but also about individual patient
preferences, and about justice (for example about costs compared to
alternatives, and about accessibility of tests or treatments in local
b) Judgments. A little bit like judges in courts, guidelines panels
make judgments based on the evidence that is presented to them. This is
why different guidelines panels can make different judgments. Authors of
guidelines need to be explicit about what sort of evidence they use to
make their judgments. This would help users of guidelines to understand
that whereas most guidelines panels use evidence about clinical benefits,
they tend to less thoroughly examine the evidence about clinical harms,
and even less so the evidence about individual patient preferences, and
the situation seems to be even worse when it comes to justice issues. This
in turn might explain, at least partly, why many doctors and patients do
not put guidelines into practice.
The GRADE group should be clearer about ethical issues in guidelines
if they wish to clarify the status of guidelines for the best.
 Beauchamp TL, Childress J. Principles of Biomedical Ethics (5th
edition), New-York/Oxford, Oxford University Press, 2001.
Some of the questions that I raise have been discussed on the Internet in the GRADE group discussion list
Competing interests: No competing interests