Comment
icantly by providing the foundations for a strong health workers’ report. Once we have such measures we should look
system, well able to deliver the DOTS strategy. General
economic development can also be expected to lead to a
reduction in tuberculosis transmission as a result of better
living conditions and improved access to health services.
What about a closer look at the non-DOTS provinces? The
Chinese Ministry of Health also adopted the DOTS strategy in
the 15 provinces not supported by the World Bank. Imple-
mentation was not, however, backed by the same level of
funding. Why did tuberculosis prevalence not fall as much in
these areas? Was it because poorly funded DOTS does not
work, or because strong health systems in the overall richer
areas were responsible for effective tuberculosis control, not
the DOTS strategy? There is some support for this heretical
notion in the article by Dye and colleagues: Shanghai has had
strong health systems and tuberculosis control that does not
involve either free treatment or DOTS, but has, nonetheless,
effectively controlled tuberculosis.
So, should we dismiss DOTS? Indeed we should not. Dye and
colleagues’ paper gives strong support to expanded imple-
mentation of the strategy, both in China and worldwide. It is
important, however, that wider implementation comes with
careful and critical appraisal of what is needed to make DOTS
work, especially where people, health infrastructures, and
human resources are poor.5 Also, we need better measures of
socioeconomic development than the crude proxies of geo-
graphy and urbanisation that have been used in Dye and co-
Beyond the evidence in clinical guidelines
Unlike research reports and literature reviews, clinical guide-
lines provide specific recommendations for practice and are
fairly new. Systematic development of guidelines within a
well-defined programme began in the late 1970s, when the
US National Institutes of Health started to produce consensus
statements.1 During the 1980s, various other organisations
outside the USA adopted this programme to develop their
own consensus statements and standards for good medical
care.2 In the 1990s, however, under the impetus of the
movement of evidence-based medicine, the method changed
and systematic literature review and explicit linkage of
recommendations to supporting evidence became essen-
tial.3–5 Nevertheless, despite the availability of the same body
of evidence in databases—eg, MEDLINE and The Cochrane
Library—recommendations on the same topic often differ.6–8
The translation of evidence into recommendations is not
straightforward; data can be interpreted in different ways
dependent on mindsets and experiences.9
See Articles page 429 In this issue of The Lancet, Rosalind Raine and colleagues
examine the effect that judgment has on interpretation of
evidence, by using 16 nominal guideline-development
groups with the group as unit of analysis. This unique design
reflects how guidelines are often developed in the UK. Their
main finding was that only 51% of the 192 group judgments
(based on medians of 9–14 individuals, using a 9-point Likert
scale) was in agreement with the results of a systematic
392
carefully at the way in which they influence the success, or
otherwise, of DOTS.
S Bertel Squire, Shenglan Tang
EQUI-TB Knowledge Programme, Liverpool School of Tropical
Medicine, Liverpool L3 5QA, UK
sbsquire@liv.ac.uk
We both know Christopher Dye and Sang Jae Kim through the work of their
research programme (EQUI-TB) with the STOP-TB Partnership on Poverty and
Tuberculosis. EQUI-TB has helped co-fund (with WHO) two of the contributors
(Wang Lixia and Wan Liya) on study tours and international conferences in
recent years. EQUI-TB has a specific research link with Fudan University,
Shanghai, fostering research on equity and access to TB services for the poor in
China. EQUI-TB is funded by the Department for International Development,
UK.
1 Chen X, Zhao F, Duanmu H, et al. The DOTS strategy in China; results and
lessons after 10 years. Bull World Health Organ 2002; 80: 430–36.
2 World Health Organization. An expanded DOTS framework for effective
tuberculosis control: stop TB communicable diseases. WHO Document
WHO/CDS/TB/2002·297. Geneva: WHO, 2002: 1–20.
3 China Tuberculosis Control Collaboration. Results of directly observed
short-course chemotherapy in 112 842 Chinese patients with
smear-positive tuberculosis. Lancet 1996; 347: 358–62
4 Tang S, Wang L, Wang X, Squire SB. Does rapid economic growth reduce
TB prevalence in the absence of effective TB control. Int J TB Lung Dis
2002; 6 (suppl 1): S149.
5 Tang S, Squire SB. What lessons can be drawn from TB Control in China in
the 1990s? An analysis from a health system perspective. Health Policy
(in press).
review of the evidence. The strength of the study is that the
researchers confirmed their findings by doing a qualitative
analysis of the group discussions with audiotapes. The com-
parison would have been more appropriate, however, if the
same scales had been used and the nominal group technique
applied in assessment of the research evidence.
On the basis of the principles of evidence-based medicine,
one would expect full agreement with the data, if the indi-
viduals involved were familiar with the published work.
Nevertheless, even in the eight groups that were supplied
with the literature review, no more than 60% of the group
ratings were in agreement with the evidence. Factors other
than the evidence available obviously affect group decisions.
In Raine and colleagues’ study, mixed groups of family
doctors and mental-health professionals had lower scores of
agreement with the evidence than did groups of family
doctors only. This finding concurs with that of a study done
by Pagliari et al,10 which indicated that the composition and
dynamics of a group involved in the development of a
guideline is crucial to the final recommendations. Further-
more, in a Dutch study,11 a multidisciplinary group formed to
produce a guideline for treatment of major depression could
not reach a consensus on the first-choice antidepressant
because of different interpretations of the data and different
professional perspectives—the psychiatrists favoured selective
serotonin-reuptake inhibitors over tricyclic antidepressants,
www.thelancet.com Vol 364 July 31, 2004
 Comment

whereas the family doctors had no preference. The discussion

between the groups focused on the extent to which the
evidence obtained from selected populations of patients
could be extrapolated to the general population. In our
20 years of experience in developing guidelines, we have
come across this issue many times, and believe it needs to be
addressed. A strong but neutral chairman and a balanced
group should prevent one professional group from biasing Rights were
the outcome. The chairman should encourage individuals to
separate their beliefs from the evidence presented, particularly
when evidence is controversial or lacking. Additionally, a
not granted
declaration of conflicts of interest could contribute to
unmasking any hidden agendas of the individuals within a
to include
group.
Most issues addressed in clinical guidelines can be solved by
this image in
consensus, but what should be done if a consensus cannot be
reached? If guidelines reflect clinical practice, some issues will electronic media.
remain unresolved. Medicine is a probabilistic science and
clinical practice often involves trial and error. Therefore, un- Please refer to the
certainty should be incorporated and not excluded from
guidelines, which address patients’ needs for information.12 A
guideline should clearly present the pros and cons of the
printed journal.
different options for managing a condition or disease, esp-
ecially if there is no clear first-choice treatment, in which case
a patient’s individual circumstances and preferences should
be taken into account.
As Raine and colleagues conclude, evidence is only one
factor in the development of evidence-based guidelines. Clin-
ical judgment and patients’ perspectives are also important.13
Moreover, the main aim of guidelines is to improve quality of 4 Miller J, Petrie J. Development of practice guidelines. Lancet 2000; 355: 82.
health care by changing the behaviour of providers. Effect- 5 The AGREE Collaboration. Development and validation of an international
appraisal instrument for assessing the quality of clinical practice guidelines:
iveness in daily practice, therefore, depends on the guidelines the AGREE project. Qual Saf Health Care 2003; 12: 18–23.
being acceptable and credible. 6 Thomson R, McElroy H, Sudlow M. Guidelines on anticoagulant treatment
in atrial fibrillation in Great Britain: variation in content and implications for
treatment. BMJ 1998; 316: 509–13.
*Jako S Burgers, Jannes J E van Everdingen
7 Eisinger F, Geller G, Burke W, Holtzman NA. Cultural basis for differences
Dutch Institute for Healthcare Quality, 3502 LB Utrecht, between US and French clinical recommendations for women at increased
Netherlands (JSB, JJEvE); and Centre for Quality of Care Research, risk of breast and ovarian cancer. Lancet 1999; 353: 919–20.
University Medical Centre Nijmegen, Nijmegen, Netherlands 8 Burgers JS, Bailey JV, Klazinga NS, et al for the AGREE Collaboration. Inside
guidelines: comparative analysis of recommendations and evidence in
(JSB) diabetes guidelines from 13 countries. Diabetes Care 2002; 25: 1933–39.
burgersj@knmg.nl 9 Malterud K. The art and science of clinical knowledge: evidence beyond
measures and numbers. Lancet 2001; 358: 397–400.
We have no conflict of interest to declare.
10 Pagliari C, Grimshaw J, Eccles M. The potential influence of small group
1 Field MJ, Lohr KN. Guidelines for clinical practice: from development to use. processes on guideline development. J Eval Clin Pract 2001; 7: 165–73.
Washington: National Academy Press, 1992. 11 Pronk E. Herrie om een ongeboren kindje: Richtlijnontwikkelaars steggelen
2 Goodman C, Baratz SR. Improving consensus development for health over eerstekeusantidepressivum. Med Contact 2004; 59: 493–96.
technology assessment: an international perspective. Washington: 12 Edwards A. Communicating risks. BMJ 2003; 327: 691–92.
National Academy Press, 1990.
13 Garfield FB, Garfield JM. Clinical judgement and clinical practice guidelines.
3 Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Developing guidelines. Int J Technol Assess Health Care 2000; 16: 1050–61.
BMJ 1999; 318: 593–96.

Anthrax and bioterrorism: are we prepared?

The intentional release of only 1 kg of Bacillus anthracis spores
could lead to the deaths of over 100 000 people in a city of
10 million.1 Although the likelihood of such an event occur-
ring is difficult to estimate, the devastation that would follow
demands that we are prepared. In this issue of The Lancet,
Demetrios Kyriacou and co-workers identify clinical indicators
that would help doctors recognise anthrax infection and
differentiate it from community-acquired pneumonia and
influenza-like illness. The early detection of an outbreak and
the rapid identification of infected individuals within an
exposed population would allow for a fast and effective
response. See Research Letters page 449

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