Potential benefits, limitations, and harms of clinical guidelinesBMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7182.527 (Published 20 February 1999) Cite this as: BMJ 1999;318:527
All rapid responses
Woolf et al have prepared a thoughtful summary of the potential
advantages and disadvantages of clinical guidelines1. Many of the points
which they made can be applied to the British Thoracic Society guidelines
for the management of asthma2,3. These guidelines have helped to ensure
that thousands, perhaps millions of asthma patients have received better
However, Woolf and colleagues warned that guidelines can also produce
harm to patients and health care professionals. They mentioned that
"outdated recommendations may perpetuate outmoded practices and
technologies". Unfortunately this exact problem has arisen in the
otherwise excellent BTS guidelines.
The guidelines recommend that intravenous aminophylline should be
given to all patients with "life threatening features" such as a Peak
Expiratory Flow below 33% predicted. 25-30% of asthma patients may have
this feature on arrival in hospital Emergency Departments. I noticed that
trainees who had rotated from one particular hospital used this
potentially toxic treatment in a high proportion of cases. Further enquiry
revealed that they had all received a copy of the BTS guidelines and they
followed it literally. They had all read the above recommendation but not
the subsequent explanatory note which admits that there is little evidence
to support the use of aminophylline in patients who have received
nebulised bronchodilators and oral steroids. A meta analysis of 13 such
trials up to 1988 found no overall difference in outcome in aminophylline-
I recently performed a Medline search (1988-1999) for
further randomized controlled trials of IV aminophylline added to standard
therapy in acute asthma. This revealed 14 studies of which 11
demonstrated no extra benefit when aminophylline was added to modern
treatment. This is particularly important in the case of a drug which is
difficult to use safely because of a low therapeutic index and a multitude
of drug and disease interactions. The report of Eason and Markowe
suggested that up to 10% of asthma deaths in hospital could be due to
When the BTS guidelines were debated by the society, several younger
members expressed these concerns but many of the more senior members were
reluctant to relinquish a time honoured treatment. I reported my concerns
to the Standards of Care Committee of the BTS in 1997 but no action has
followed. This demonstrates one of the great weaknesses of guidelines, it
is difficult to eradicate outmoded (and potentially harmful) practice if
it is posted to the wall of every Emergency Department in the land!
Dr Ronan O'Driscoll MD FRCP
Consultant Chest Physician,
1. Woolf SH, Grol R, Hutchinson A, Eckles M, Grimshaw J. Potential
benefits, limitations and harma of clinical guidelines. BMJ 1999; 318: 527
2. British Thoracic Society. Guidelines on the management of asthma.
Thorax 1993; 48: S1-S24
3. British Thoracic Society. The British guidelines on asthma
management. 1995 review and position statement. Thorax 1997; 52:
Supplement 1 S1-S21
4. Littenberg B Aminophylline treatment in severe, acute asthma. A
meta-analysis. JAMA 1988; 259: 1178-84
5. Eason J, Markowe HL. Aminophylline toxicity-how many hospital
asthma deaths does it cause. Respir Med 1989; 83: 219-26
Competing interests: No competing interests
EDITOR – I read with interest the article on clinical guidelines by
Woolf et al. (1). They mention three limitations to the usefulness of
clinical guidelines but omit one of the most important. Even when sound
evidence based guidelines are in existence they are often not available to
health care professionals.
Extracorporeal membrane oxygenation (ECMO) is a complex technique for
providing life support in respiratory failure. ECMO support has been shown
to be both clinically (2) and economically (3) justifiable for mature
newborn infants with severe respiratory failure. As a result of the UK
trial, the Department of Health (England and Wales) have decided to fund
centrally three centres to provide an ECMO service for these children.
Prompt and appropriate referral are essential to maximise the potential
benefits from ECMO. Recent data has shown that the success of ECMO is
inversely associated with the number of days pre-ECMO ventilation (4). It
is vital that information regarding eligibility for ECMO referral, and
contact numbers for referral should be readily available.
In the past, guidelines in the form of a brief pamphlet giving
information about the service have been circulated to regional neonatal
units and special care baby units. We decided to ascertain what was known
about the service we offered.
We undertook a simple postal questionnaire survey of all 238 neonatal
intensive care units and special care baby units in England, Northern
Ireland and Wales. This asked whether guidelines for ECMO referral were
available on their unit. If these were, then the respondents were asked to
send a photocopy of these with the reply in the accompanying stamped
We had a high response rate, with 162 completed replies (71% response
rate) within 6 weeks of posting. However, only 20 units had guidelines for
ECMO referral (12.3% of responders). The potential delay that this may
cause has obvious clinical implications. It is estimated that 100 to 200
neonates per year will benefit from ECMO. The criteria for ECMO are not
rigid but in neonates we would suggest the following guidelines:
Figure 1. Guidelines for ECMO referral
. Oxygenation index >40
. Gestational age >34 weeks
. Weight >2 kg
. Reversible lung disease (<10 days high pressure ventilation)
. No major (>grade 1) intacranial haemorrhage
. No lethal congenital abnormalities
Oxygenation index = Mean airway pressure x FiO2 x 100
Post ductal PaO2 (mmHg)
IF IN DOUBT DISCUSS WITH YOUR NEAREST ECMO CENTRE
Contact telephone numbers:
Glenfield Hospital, Leicester 0116 287 1471 and ask for the ECMO co-
Great Ormond Street. London 0171 405 9200 and ask for Cardiac ICU.
Freeman Hospital, Newcastle-Upon-Tyne 0191 284 3111 and ask for Paediatric
Will Carroll Specialist Registrar
Department of Paediatrics, City General Hospital, Stoke-on-Trent.
Hillary Killer ECMO Coordinator
Heartlink ECMO Office, The Glenfield Hospital NHS Trust, Groby Road,
Leicester, LE3 9QP.
1. Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Potential
benefits, limitations, and harms of clinical guidelines. BMJ 1999; 318:527
2. UK Collaborative ECMO Trial Group. UK collaborative randomised
trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348:
3. Roberts TE. Economic evaluation and randomised controlled trial of
extracorporeal membrane oxygenation: UK collaborative trial. BMJ; 317: 911
4. Pranikoff T, Hirschl RB, Steimle CN, Anderson HL, Bartlett RH.
Mortality is directly related to the duration of mechanical ventilation
before the initiation of extracorporeal life support for severe
respiratory failure. Crit Care Med 1997; 25(1): 28-32.
Competing interests: No competing interests
Clinical guidelines (CPGs) are increasingly common in the German
health care system.
Since the fifties, the German Medical Association (Federal Chamber of
Physicians) has developed CPGs for different topics with interdisciplinary
Furthermore, the Association of the Scientific Medical Societies (ASMS) -
with more than 120 members - has introduced a CPG programm 4 years ago.
Today about 500 ASMS CPGs are availble via internet. , with 3 key problems
- from the users' point of view -:
· not more than 10 % of the ASMS CPGs mention the recommendations'
· most of them contain no information regarding the CPG development
process, sponsorship, implementation, and other attributes of good CPGs;
· cost-benefit-questions are explicitly excluded as topic from the ASMS
Against this background, the federal physicians' self governmental
bodies (GMA and NASHIP = National Association of Statutory Health
Insurance Physicians) in 1996 commissioned the Agency for Quality in
Medicine in to develop a German Guidelines Quality Program, containing
the following tools :
· The " German Guideline for Guidelines" - (2) - ,based mainly on the work
of the Institute of Medicine (3), and SIGN - the Scottish Intercollegiate
Guidelines Network (4).
· The "German Instrument for Critical Appraisal of Guidelines" (5), which
refer to instruments from Scotland (4) and England (6).
· "Guidelines Critical Appraisal Reports", containing the results of CPGs
critical appraisal projects and distributed via the WWW. Some weeks ago,
the first report on Asthma has been published (7) , others dealing with
Diabetes, and Back Pain are in preparation.
· "GERGIS" - The German Guidelines Information Service (in German -
English version in preparation) - available via the world wide web (8),
and in published form. GERGIS informs on CPG programmes, on CPG quality
criteria, and offers a link service to most of German-, English- and
French-language CPG databases - regularly updated. In the future GERGIS
will be supplemented by "Intranet-Discussion-Groups" for physicians
working in regional quality circles on practice guidelines (9).
· The "German Guidelines Clearinghouse", according to a proposal by
Lauterbach and coworkers (10). GMA and NASHIP - in partnership with the
German Hospital Association and with the Federal Health Insurance Funds of
Germany - have commissioned the Agency for Quality in Medicine to operate
GGC will make use of the tools mentioned above. The Clearinghouse
will work in the fields of CPGs' accreditation, dissemination,
implementation and evaluation.
These activites hopefully will introduce a culture of evidence-and-
consensus-based guidelines with more benefits than harm (11) for
ambulatory and hospital care in Germany.
1. Helou A, Perleth M, Bitzer EM, Doerning H, Schwartz FW (1998)
Methodological quality of CPGs in Germany. Z arztl Fortb Qual sich 92:
421-428 (in German, English abstract)
2. German Medical Association, National Association of Statutory Health
Insurance Physicians (1997) Evaluation Criteria for Guidelines to be used
in Medical Care (Beurteilungskriterien für Leitlinien in der medizinischen
Versorgung). Dtsch Aerztebl 94: A2154-2155 - in German
3. Field MJ, Lohr KN (1990) Clinical Practice Guidelines. Washington DC
4. Petrie J, Barnwell E, Grimshaw J for the Scottish Intercollegiate
Guidelines Network (1995) Clinical Guidelines - Criteria for Appraisal for
National Use. Pilot Edition. http://pc47.cee.hw.ac.uk/sign/critmain.htm
5. Ollenschlaeger G, Helou A, Kostovic-Cilic L, et al (1998) A check list
for the methodological quality of guideline - a contribution to the
quality promotion of medical guidelines. Z arztl Fortb Qual sich 92: 191-
194 (in German, English abstract)
6. Cluzeau F, Littlejohns P, Grimshaw J, Feder G (1997) Appraisal
instrument for clinical guidelines. St. George's Hospital Medical School,
7. Agency for Quality in Medicine (1999) The Guidelines Critical
Appraisal Reports on Asthma Bronchiale (in German). http://www.azq.de -
"Leitlinien-In-Fo" - "Leitlinien-Bewertungen"
8. Agency for Quality in Medicine (1999) "GERGIS" - The German Guidelines
Information Service (in German - English version in preparation).
http://www.azq.de - "Leitlinien-In-Fo"
9. Gerlach FM, Beyer M, Römer A (1998) Quality circles in ambulatory care:
state of development and future perspective in Germany. Int J Qual Health
10. Lauterbach KW, Lubecki P, Oesingmann U, Ollenschlaeger G, Richard S,
Straub C (1998) Concepts of a clearing procedure for guidelines in
Germany. Z arztl Fortb Qual sich 91: 283-288 (in German, English abstract)
11. Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J (1999) Potential
benefits, limitations, and harms of clinical guidelines. BMJ 318: 527-530
Guenter Ollenschlaeger , Ulrich Oesingmann, Christian Thomeczek ,
Birgitta Bungart, Ulrike Lampert, Friedrich-Wilhelm Kolkmann
Agency for Quality in Medicine (Joint Institution of GMA and NASHIP)
D-50931 Koeln (Cologne)
Professor Guenter Ollenschlaeger firstname.lastname@example.org
Competing interests: No competing interests