FROM:
Spine (Phila Pa 1976) 2001 (Nov 15); 26 (22): 2504–2513 ~ FULL TEXT
Bart W. Koes, PhD; Maurits W. van Tulder, PhD; Raymond Ostelo, MSc;
A. Kim Burton, PhD, DO; Gordon Waddell, DSc, MD, FRCS
Department of General Practice,
Erasmus University, Rotterdam
Study Design: Descriptive study.
Objectives: To compare national clinical guidelines on low back pain.
Summary of Background Data: To rationalize the management of low back pain, clinical guidelines have been issued in various countries around the world. Given that the available scientific evidence is the same, irrespective of the country, one would expect these guidelines to include more or less similar recommendations regarding diagnosis and treatment.
Methods: Guidelines were included that met the following criteria: the target group consisted of primary care health professionals, and the guideline was published in English, German, or Dutch. Only one guideline per country was included: the one most recently published.
Results: Clinical guidelines from 11 different countries published from 1994 until 2000 were included in this review. The content of the guidelines appeared to be quite similar regarding the diagnostic classification (diagnostic triage) and the use of diagnostic and therapeutic interventions. Consistent features were the early and gradual activation of patients, the discouragement of prescribed bed rest, and the recognition of psychosocial factors as risk factors for chronicity. However, there were discrepancies for recommendations regarding exercise therapy, spinal manipulation, muscle relaxants, and patient information.
Conclusion: The comparison of clinical guidelines for the management of low back pain showed that diagnostic and therapeutic recommendations were generally similar. Updates of the guidelines are planned in most countries, although so far produced only in the United Kingdom. However, new evidence may lead to stronger conclusions and enable future guidelines to become even more concordant.
Key words: clinical guidelines; low back pain; evidence based medicine; systematic reviews
From the FULL TEXT Article:
Background
Low back pain (LBP) is a major health problem in all
developed countries and is most commonly treated in
primary health care settings. The diagnostic and therapeutic
management of acute as well as chronic LBP seems
to vary substantially among general practitioners (GPs),
medical specialists, and physical therapists within
a country. [36] However, there are also considerable discrepancies
in the management of LBP between
countries. [9–11, 37]
To rationalize the approach of LBP and to take account
of emerging scientific evidence, clinical guidelines
on the management of LBP have been issued in various
countries around the world. The development, publication,
and dissemination of these guidelines is consistent
with the current international trend toward evidence
based medicine. This suggests that medical interventions
should be based as much as possible on the results of
clinical studies with sound methodologic quality. Within
this context, several national and international groups
are active in identifying, assessing, and summarizing all
randomized clinical trials (RCTs). The results of these
activities are included in systematic reviews and
meta-analyses. [12, 26, 37]
Many of these activities take place within the framework
of the Cochrane Collaboration, and the Cochrane
Back Review Group has now published nine systematic
reviews of RCTs, evaluating treatment for LBP. [12] The
evidence presented in these and other systematic reviews
provides, in theory, a robust basis for modern clinical
guidelines. Because the available evidence is international,
one would expect that each country’s guidelines
would give more or less similar recommendations regarding
diagnosis and treatment, although there may be
some variation to take account of local resources and
practice.
Since 1994, national clinical guidelines on LBP have
been issued in at least 11 different countries that the
authors have been able to identify. In this article, these
guidelines are compared regarding the content of their
recommendations, the target group, the guideline committee
and its procedures, and the extent to which the
recommendations were based on the available literature
(the scientific evidence).
Methods
The search for clinical guidelines consisted of a search in Medline
(key words: low back pain, clinical guidelines). Because
guidelines are only infrequently published in medical journals,
the search was extended to the Internet (key words: back pain,
guidelines), and guidelines were identified by personal communication
with experts in the field.
To be included in this review, the guidelines had to meet the
following criteria: (1) the guideline concerned the clinical management
of LBP, (2) the target group consisted of primary care
health professionals, and (3) the guideline was available in English, German, or Dutch (or had been translated into those
languages). Only one guideline was included per country (i.e.,
the one most recently issued).
Guidelines from the following agencies and countries (year of publication) were included:
Agency for Health Care Policy and Research (AHCPR),
United States (1994) [3]
Dutch College of General Practice (NHG), Netherlands
(1996) [13]
Israeli Low back Pain Guideline Group, Israel (1997) [5]
National Advisory Committee on Health and Disability,
New Zealand (1997) [2]
Finnish Medical Association (Duodecim), Finland (1999) [23]
National Health and Medical Research Council, Australia
(1999) [4]
Royal College of General Practitioners (RCGP, United
Kingdom (1999) [30]
Swiss Medical Society (FMH), Switzerland (1999) [20]
Drug Committee of the German Medical Society in Germany
(2000) [16]
Danish Institute for Health Technology Assessment, Denmark
(2000) [25]
The Swedish Council on Technology Assessment in Health
Care (2000) [26]
The information used for the comparison was directly extracted
from the publications of these guidelines. The comparison
focused on the content of the recommendations for diagnosis
and therapy, the membership of the guideline committee
responsible for the content of the guideline, the target population,
and the extent to which the recommendations were based
on the evidence in the literature. If relevant information on one
or more of these topics was not presented in the guideline, the
authors of the guidelines at issue were contacted for additional
information.
Guidelines were excluded if they were not available in English,
Dutch or German, [17, 19, 28, 33, 34] if they specifically focused
on the management of LBP in occupational health
care, [7, 18, 27, 35, 38, 39] if they dealt primarily with health care delivery [29]
or social policy, [15] if they were limited to activity/
exercises only, [1] if they were specifically for the management of
lumbosacral radicular syndrome, [8, 32] or if they dealt with
chronic nonmalignant pain and not exclusively with LBP. [31]
Reports that mainly provided reviews of the evidence were also
excluded. [37]
Results
Patient Population
An important difference between the guidelines concerns
the patient group at issue. The guidelines from the United
Kingdom (UK), the United States (USA), New Zealand,
and Australia all focus on patients with acute LBP (,12
weeks), whereas the others also include recommendations
for the management of chronic LBP (.12 weeks).
The differentiation between acute and chronic, based on
the cutoff point of 12 weeks, is not always fully clear. For
instance, most guidelines do not clearly differentiate between
12 weeks from onset and 12 weeks from presentation
to the health care professional.
Diagnostic Recommendations
Table 1 compares the diagnostic classification and the
recommendations on diagnostic procedures in the various
guidelines. All guidelines propose some form of diagnostic
triage in which patients are classified as having
(1) nonspecific LBP, (2) specific LBP (“red flag” conditions
such as tumor, infection, or fracture), and (3) sciatica/
radicular syndrome. In some guidelines, sciatica is
not considered as a separate classification but is variously
included for management in the category of nonspecific
or specific LBP.
All guidelines are consistent in their recommendations
that diagnostic procedures should focus on the identification
of red flags and the exclusion of specific diseases
(sometimes including radicular syndrome). Red flags include,
for example, age at onset (,20 or .55 years),
significant trauma, thoracic pain, weight loss, widespread
neurologic changes. [40] The types of physical examination
and physical tests that are recommended
show some variation. Neurologic screening, which is
largely based on the straight leg raising test, plays an
important role in most guidelines.
The guidelines are consistent in their recommendation
that plain radiographs are not useful in acute nonspecific
LBP and that radiographs should be restricted to patients
suspected of having specific underlying pathologic
changes (based on red flags). In some guidelines (e.g., US,
UK, Denmark, and Israel), radiographs are suggested as
optional in case of persistent LBP (.4–6 weeks). [3, 5, 25, 30]
None of the guidelines recommend any form of radiologic
imaging for acute, nonspecific LBP, whereas the US
and UK guidelines overtly advise against it. [3, 30]
All guidelines, with varying emphasis, mention the
importance of considering psychosocial factors as risk
factors for the development of chronic disability. There
is, however, considerable variation in the amount of detail
given about how to assess psychosocial factors or the
optimal timing of the assessment, and specific tools for
identifying these factors are scarce. The UK guideline
gives a list describing four main groups of psychosocial
risk factors, whereas the New Zealand guideline gives by
far the most attention to explicit screening of psychosocial
factors, using a standardized questionnaire. [2, 21]
None of the guidelines (with the exception of some general
principles in the New Zealand Yellow Flags) give
any specific advice on what to do about psychosocial risk
factors that are identified.
Summary of Recommendations for Diagnosis of Low Back Pain
Diagnostic triage (nonspecific LBP, radicular syndrome,
specific pathologic change).
History taking and physical examination to exclude
red flags.
Physical examination for neurologic screening (including
straight leg raising test).
Consider psychosocial factors if there is no
improvement.
Radiographs not useful for nonspecific LBP.
Therapeutic Recommendations
Table 2 compares therapeutic recommendations given in
the various guidelines. Patient advice and information
play an important role in most guidelines. In general,
patients should be reassured that they do not have a
serious disease and that the prognosis is generally favorable,
even recognizing that many patients continue to
have some persistent or recurrent symptoms. Patients
should be advised to stay active and to progressively
increase their activity level. There are some differences in
the recommendations. The UK guidelines, for example,
give specific advice on messages the general practitioner
should give under different circumstances. [30]
Recommendations for the prescription of medication
are generally consistent. Paracetamol/acetaminophen is
recommended as a first choice because of the lower incidence
of gastrointestinal side effects. Nonsteroidal antiinflammatory
preparations are the second choice in cases
where paracetamol is not sufficient. There is some variation in the recommendation of muscle relaxants (optional
in some guidelines and not recommended in others),
opioids, local anesthetic, and compound medication.
Some guidelines explicitly recommend a time-contingent
prescription of the pain medication (e.g., UK and
Netherlands). [13, 30]
There now appears to be a broad consensus that bed
rest should be discouraged as a treatment for LBP. Some
guidelines state that if bed rest is indicated because of
severity of pain, than it should not be advised for more
than 2 days (e.g., Germany, Netherlands). [13, 16] Others
suggest that some patients may be confined to bed for a
few days, but that should be regarded as a consequence
of their pain and should not be considered a treatment
(e.g., UK). [30]
There also appears to be a consensus that the vast
majority of cases of LBP should be managed in a primary
care setting. Referral to a medical specialist (hospital setting)
is restricted to patients in whom a specific pathologic
change is suspected from the presence of red flags
or those with sciatica/radicular syndrome or neurologic
problems that require surgical assessment or
investigation.
Summary of Recommendations for Treatment of Low Back Pain
Acute or Subacute Pain
Reassure patients (favorable prognosis).
Advise to stay active.
Prescribe medication if necessary (preferably timecontingent): paracetamol, nonsteroidal antiinflammatory agents, consider muscle relaxants or opioids.
Discourage bed rest.
Consider spinal manipulation for pain relief.
Do not advise back-specific exercises.
Chronic Pain
Recommendations regarding exercise therapy also
show some variation. In several guidelines, back-specific
exercises are considered not useful during the first weeks
of an episode (Netherlands and UK guidelines). [13, 30]
Other guidelines state that low-stress aerobic exercises
are a therapeutic option in acute LBP (USA). [3] The Danish
guidelines specifically mention McKenzie exercise
therapy as a therapeutic option in some patients with
acute or chronic LBP. [25] Those guidelines that extend
their advice beyond the acute stage all recommend exercise
therapy as a useful intervention (Netherlands, Germany,
Denmark, UK). [13, 16, 25, 30] However, recommendations
regarding the type and intensity of the exercises are
not consistent.Recommendations regarding spinal manipulation
for acute LBP show some variation. In most
guidelines, spinal manipulation is considered to be a
therapeutic option in the first weeks of an LBP episode.
In the Dutch, Australian, and Israeli guidelines, spinal
manipulation is not recommended for acute LBP. However,
spinal manipulation is considered a useful therapeutic
option for chronic LBP in the Dutch and Danish
guidelines [13, 25] but not in the others (in part because
chronic LBP was not included).
Setting
Table 3 shows some background variables related to the
development of the guidelines in the various countries.
Most of the guidelines focus exclusively on primary care
physicians. The UK guideline, although led by and usually
referenced to the Royal College of General Practitioners,
is actually a common guideline for all primary care
health professionals, including GPs, physiotherapists,
osteopaths, and chiropractors. [30] Furthermore, the
Dutch guideline is mostly focused on a GP setting. [13] The
Finnish guidelines cover secondary as well as primary
care settings, [23] and the Swiss guidelines consider occupational
health care as well as primary care. [20]
Guideline Committee
The various committees responsible for the development
and publication of guidelines appear to be different in
size and in the professional disciplines involved. Most
committees are characterized by their multidisciplinary
membership. However, the Dutch guideline committee
consisted of only five GPs and one epidemiologist/
methodologist. [13] The number of members varied from 6
to 23. Only two committees included consumer representation
(UK and Australia). [4, 30]
Evidence-Based Review
All guidelines are more or less based on a comprehensive
literature search. Some committees based their recommendations,
entirely or in part, on previously issued
guidelines (e.g., the AHCPR guidelines published in December
1994). [3] Most guidelines use an explicit weighing
of the strength of the evidence by a 3-point or 4-point
rating scale. The Dutch, UK, and Australian guidelines
give direct links between the actual recommendations
and the evidence (via specific references) on which the
recommendations are based. [4, 13, 30] The UK and Australian
guidelines present an extensive evidence table, in
which the evidence for the most important recommendations
is given in a comprehensive way. [4, 30] Most committees
used some form of consensus method for situations
where the evidence was not convincing or not available.
Dissemination and Implementation
The activities related to the publication and dissemination
of the various guidelines show some differences and
some similarities. In most cases, the guidelines are accompanied
by easily accessible summaries for practitioners
and booklets for patients.
Systematic implementation activities are rare. In most
cases, the printed versions of the guidelines are published
in national journals and/or disseminated through professional
organizations to the target practitioners. In the
Netherlands, specific courses are offered to GPs to provide
training in the knowledge and skills required for use
of the guidelines. In many countries, regular updates of
the guidelines are planned, but only the UK has actually
produced a new edition as new evidence became available.
In the UK, local ownership is seen as being an important
part of implementation, and various local health
care groups have issued their own versions of the core
recommendations.
Discussion
In general, clinical guidelines in all the countries studied
give similar advice on the management of LBP. Because
of the differences in health care systems and culture in the
various countries, and because of the differences in membership
of the guideline committees, it might have been
anticipated that there would have been rather more differences.
The scientific evidence regarding diagnostic and
therapeutic interventions is apparently sufficiently strong
and transparent to enable all these groups in such different
settings to reach similar conclusions. In previous articles,
one of which was published in Dutch only, and
based on a limited number of guidelines, the present authors
came to broadly similar conclusions. [6, 22] Common
recommendations of all guidelines are the diagnostic triage
of patients with LBP, restricted use of radiographs,
advice on early and progressive activation of patients,
and the related discouragement of bed rest. The recognition
of psychosocial factors as risk factors for chronicity
is also consistent across all guidelines, though with varying
emphasis and detail.
Use of Available Evidence
On the whole, the various guidelines were based on the
same body of literature. Of course, it has to be acknowledged
that there are differences in the dates of issue. For
example, the USA guidelines were based on the literature
up to 1991, whereas the most recently issued UK and
Australian guidelines were based on the literature up to
1999. This difference in time frame may account for differences
in recommendations because of new evidence
and new insights. For example, there is a general shift
from recommending 2 to 3 days of bed rest to actually
recommending against bed rest as stronger evidence has
become available. Further, after 1991, new RCTs evaluating
the efficacy of exercise therapy (back-specific exercises
as opposed to general exercise) for acute LBP indicated
that this therapy was not effective. [14, 24]
Most guideline committees performed some literature
searches themselves, although with the increasing
amount of evidence available it is increasingly difficult to
review all the relevant evidence de novo. Almost all
guideline committees now increasingly rely on information
from published systematic reviews and metaanalyses
in the area of concern, together with earlier
clinical guidelines from other countries. There are not yet
any references to Cochrane reviews of treatments for
LBP in any of the guidelines reviewed because these have
become available only since 1999. Reviewers of future
guidelines should consider the evidence from Cochrane
reviews. [12]
In some guidelines, the use of the evidence was not
always appropriate. For instance, the US guidelines for
acute LBP based part of the recommendations—for example,
for antidepressants and biofeedback — solely on
literature evaluating the effectiveness of these interventions
for patients with chronic LBP. There was a great
deal of variation in the amount and detail of evidence
and references given, the use of strength rating of the
evidence, and the use of explicit linking between the evidence
and the recommendations.
Differences in Recommendations
Recommendations about the prescription of analgesic
medication are fairly consistent, with most guidelines
recommending paracetamol as the first option and nonsteroidal
antiinflammatory preparations as the second
option, but further recommendations about other drugs
vary quite considerably. The same holds true for the recommendation
whether the drug prescription should be
on a time-contingent or a pain-contingent basis. There
was no clear explanation for these variations: it is possible
that they reflected the setting and custom in different
countries, though perhaps they were influenced by personal
preferences of the members of the guideline
committees.
The recommendations regarding spinal manipulation
differed more obviously. The Dutch, Australian, and Israeli
guidelines do not recommend spinal manipulation
for acute LBP. [4, 5, 13] The other guidelines do recommend
manipulation, although they report different time frames
for its indication. For example, the Danish guideline recommends
manipulation after 2 to 3 days, the US guideline
within 4 weeks, and the New Zealand guideline between
4 and 6 weeks, whereas the UK guideline advises
“consider manipulative treatment for patients who need
additional help with pain relief or who are failing to
return to normal activities.” In general, the type of manipulation
or discipline is not specified. Apparently the
available evidence for this therapy is not sufficiently consistent
to enable similar recommendations to be reached
on whether, and at which point, manipulation is indicated
for acute LBP, or by whom it should be performed.
There are also differences in the recommendations
about back-specific exercises for acute LBP. The US,
Swiss, and German guidelines do consider exercises as a
therapeutic option, whereas other guidelines do not recommend
exercise therapy for acute LBP. Part of the explanation
may be in the use or not of the more recently
published RCTs in this area, as previously mentioned. [14, 24] The Danish guidelines specifically mention
McKenzie exercises as a therapeutic option, whereas the
others do not. This may result from a different interpretation
of the available evidence or from a different constitution
of the guideline committee.
Recommendations in guidelines are based not only on
scientific evidence but also on consensus. Guideline committees
may consider various arguments such as the magnitude
of the effects, potential side effects, cost effectiveness,
and current routine practice and available resources
in their country. Guidelines may put particular emphasis
on what is perceived as a current problem in that country,
e.g., overaggressive surgical investigations and interventions
(e.g., US). [3] The constitution of the guideline
committee and the professional bodies they represent
may introduce bias, either for or against a particular
treatment.
Implementation
Guidelines appear to be published in national journals
and disseminated as reports, including handy summaries
for practitioners. Provision of summaries and booklets
for patients is variable. Beyond these dissemination activities,
no systematic implementation strategies directed
at changing the behavior of health care providers, patients,
and policy makers seem to be scheduled in the
various countries. The extent to which currently available
guidelines are used and followed in the various
countries remains largely unknown. Future research in
this area is clearly needed. Because there are indications
from other fields of medicine that the publication and
dissemination of guidelines alone is not enough to
change the behavior of health care providers, more effort
should be put into developing and evaluating effective
implementation strategies.
Future Developments in Research and Guideline Development
The present study was primary aimed at presenting the
status quo regarding the clinical guidelines for the management
of low back pain, not to critically assess and
grade the validity of the clinical guidelines. A systematic
assessment of the various guidelines using a standardized
checklist might be recommended for future studies.
The present study clearly focuses on guidelines for
primary care settings. Clinical guidelines aimed at, for
example, secondary care settings, occupational care settings,
or specific subgroups of patients with lumbosacral
radicular syndrome were not considered. Separate studies
need to be undertaken to present an overview for
these settings.
The development of future guidelines in this field may
benefit from earlier experiences, evidence-based reviews,
and various national guidelines as presented in this overview.
Without intending to be comprehensive, the authors
suggest that future guidelines take into account the
aspects listed below.
Recommendations for the Development of Future Guidelines
for the Management of Low Back Pain
Make use of available (updated) evidence-based reviews
(e.g., Cochrane reviews).
Include relevant non-English publication (if
available).
Determine in advance the intended target groups (health care professions,
patient population, and policy makers).
Be aware that the makeup of the guideline committee may have a direct impact
on the content of the recommendations.
Specify exactly which recommendations are evidence based (and supply
the correct references to each of these recommendations).
Specify exactly which recommendation are consensus based (and explain the process).
Finally, and importantly, determine in advance the implementation strategy,
and set a time frame for future updates of the guideline.
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