Joint Bone Spine 2012 (Mar); 79 (2): 176–185 ~ FULL TEXT
Paolo Pillastrini, Ivan Gardenghia, Francesca Bonettia, Francesco Capraa, Andrew Guccioneb, Raffaele Mugnaia, Francesco S. Violantea
Occupational Medicine Unit,
Department of Internal Medicine,
Geriatrics and Nephrology,
Alma Mater Studiorum-University of Bologna,
OBJECTIVES: In the past decade many countries around the world have produced clinical practice guidelines to assist practitioners in providing a care that is aligned with the best evidence. The aim of this study was to present and compare the most established evidence-based recommendations for the management of chronic nonspecific low back pain in primary care derived from current high-quality international guidelines.
METHODS: Guidelines published or updated since 2002 were selected by searching PubMed, CINAHL, EMBASE, guidelines databases, and the World Wide Web. The methodological quality of the guidelines was assessed by three authors independently, using the Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument. Guideline recommendations were synthesized into diagnostic and therapeutic approaches that were supported by strong, moderate or weak evidence.
RESULTS: Thirteen guidelines were included. In general, the quality was satisfactory. Guidelines had highest scores on clarity and presentation and scope and purpose domains, and lowest scores on applicability. There was a strong consensus among all the guidelines particularly regarding the use of diagnostic triage and the assessment of prognostic factors. Consistent therapeutic recommendations were information, exercise therapy, multidisciplinary treatment, and combined physical and psychological interventions.
CONCLUSION: Compared to previous assessments, the average quality of the guidelines dealing with chronic low back pain has improved. Furthermore, all guidelines are increasingly aligning in providing therapeutic recommendations that are clearly differentiated from those formulated for acute pain. However, there is still a need for improving quality and generating new evidence for this particular condition.
From the FULL TEXT Article:
Low back pain (LBP) is a common problem affecting both genders
and most age groups such that about one in four adults seeks
care in a six-month period. LBP has substantial direct and indirect
costs to the person, workplace and society.  Although most
episodes of LBP appear self-limiting , recurrence with a variable
course is common , with 10–15% of cases leading to chronic
pain.  In order to decrease this burden, the use of interventions
with demonstrated effectiveness is essential.  Clinical practice
guidelines (CPGs) can be powerful tools for promoting evidence-based
practice (EBP), as they integrate research findings in order
to support decision-making. Following the publication of the first
LBP guideline in 1987 by the Quebec Task Force, which also highlighted
the absence of high-quality evidence , there has been
a steady worldwide interest on this subject, culminating with the
publication of specific CPGs in many countries over the past few
Nevertheless, previous reviews [7-9] reported disappointing
results with regard to the methodological quality of guidelines
assessed using the Appraisal of Guidelines for Research and Evaluation
(AGREE) Instrument.  Furthermore, although many
guideline recommendations were similar with respect to diagnosis
and therapeutic interventions especially for acute LBP, researchers
repeatedly indicated the need to place additional emphasis on differentiating
acute from chronic LBP (CLBP) and providing more
consistent recommendations for the management of this distinct
condition.  Recently, separate reviews by Koes et al.  and
Dagenais et al.  structured their findings to provide comprehensive
guidance to clinicians. However some important mono and
multidisciplinary guidelines dealing with the management of
CLBP were not included. The purpose of the present study was to
assess the literature and rate the methodological quality of currently
available guidelines for the management of nonspecific CLBP
in primary care using the validated AGREE tool, and to provide a
specific, updated and evidence-based overview of the most important
clinical recommendations regarding the management of this
CPGs were identified using specific search strategies in various sources:
MEDLINE and PubMed, CINAHL, EMBASE (from 2002 to December
2010). The search included combinations of the following
keywords (MeSH terms): low back pain plus guideline or practice
guideline or clinical practice guideline and the same combination
using the plural form “guidelines”.
Guideline databases (up to December 2010), including the
National Guideline Clearinghouse, Canadian Medical Association
InfoBase, Guidelines International Network, National Institute
for Clinical Excellence, National Library for Health guidelines
database and Scottish Intercollegiate Guidelines Network. The
search term used was low back pain.
World Wide Web (up to December 2010), by means of the Google
and Google Scholar browsers, using the term low back pain guideline
and the same combination using the plural form “guidelines”.
Additional guidelines were identified by manually searching the
reference lists of retrieved guidelines, reports and review articles. 
Selection of guidelines
Only guidelines published or updated since 2002 were considered.
Only the most recent CPG was included when multiple
versions were available. Additionally, guidelines had to meet the
following criteria for inclusion in the study:
(a) addressed the clinical management of nonspecific CLBP in primary care;
(b) published by a professional group;
(c) available in English, Italian or German languages/versions;
(d) stated recommendations for therapeutic interventions explicitly.
Guidelines were excluded on the basis of the following criteria:
(a) addressed only the management of acute LBP, occupational-related LBP, secondary care of LBP or prevention of LBP;
(b) developed by one individual or one regional health care centre/hospital;
(c) copied or summarized another included guideline;
(d) comprised a single report or article on guideline evaluation/implementation;
(e) provided a narrative review without evidence-based recommendations or limited its objectives to
Additional information (other publication or website) was only taken into account when the guideline explicitly referred to it.
All guidelines were reviewed independently by three authors
(I.G., F.B., R.M.) and scored for methodological quality according
to the AGREE instrument , which has been shown to be reliable
when used by physiotherapists to assess the quality of clinical
guidelines relevant to physical therapy practice.  This tool consists
of 23 items organized in six domains (Table 1) so that each
domain is intended to capture a separate dimension of guideline
quality. Each item is rated on a four-point scale ranging from
4 = “Strongly Agree” to 1 = “Strongly Disagree,” with two midpoints:
3 = “Agree” and 2 = “Disagree.”
The scale measures the extent to
which a criterion (item) has been fulfilled. Discrepancies between
the scores of the three reviewers were resolved in a consensus
meeting only when there was a difference in positive and negative
assessment (e.g., scoring 1 or 2 vs. 3 or 4). Domain scores
were calculated by summing the scores of all the individual items
in a domain and then dividing the difference between the obtained
score and the minimum possible score by the difference between
the maximum possible and minimum possible score.
There is no validated measure for distinguishing among “excellent,”
“good,” “fair”, and “poor” guidelines. Therefore, we adapted
the novel approach used by the Institute of Health Economics to
fill this gap.  The TOP research team used a modification of
the AGREE tool to reduce the ambiguity and subjectivity associated
with item scoring and enable the differentiation of good from
poor quality guidelines.  We similarly identified ten “essential”
criteria (AGREE items) for categorizing guidelines on the basis
of their quality. In addition to the seven items already considered
“essential” by the Evidence-based Medicine Working Group , we included all three items from AGREE’s Scope and purpose
domain. Guidelines were therefore rated on how well they
described their scope and purpose (items 1-3), how their methods
excluded bias by examining the search strategy used (item 8),
how the recommendations were formulated and presented (item
10 and 15), whether the recommendations were directly linked to
the evidence (item 12), the external review process (item 13), and
whether funding sources (item 22) and conflicts of interest of developers
(item 23) were reported. The average quality rating score for
these items was derived by calculating the arithmetic mean of the
scores given on each item by the three reviewers. This mean score
was then categorized as follows: Excellent - average score of 36 to
40, Good - average score of 31 to 35, Moderate - average score of
21 to 30, Poor - average score of 0 to 20.
This nonlinear four-level scale was devised a posteriori to allow
a clear distinction between the guidelines included in the study and
to obtain a correlation with the overall assessment categories provided
by the AGREE instrument (strongly recommend, recommend,
would not recommend, not recommend or unsure).
Diagnostic and therapeutic recommendations
Finally, we selected only the most established recommendations
that had been included in those guidelines we assessed as
“excellent” by our criteria. The methods for grading the levels of
evidence and the strength of recommendations were highly variable
across all the examined guidelines so that making comparisons
was highly problematic.  We decided to extract these diagnostic
and therapeutic recommendations and report them maintaining
the original, albeit different, grading systems used by the authors
of each guideline.
To provide greater utility to the reader, we formulated a measure,
“clinical inference”, to adjudicate the strength of similar
recommendations drawn from different guidelines and summarize
our own opinions about each kind of recommendation.
Each “clinical inference” was derived by considering three evidence elements:
(1) the strength of each recommendation as judged and reported by each guideline development group (GDG),
(2) the levels of evidence supporting each recommendation as ranked in each guideline and
(3) the number of studies concerning each recommendation. 
Although no validated tool was available to assist this procedure,
and the results were simply based on group discussion of
all relevant criteria, they conformed to the following scheme for
implementing a recommendation based on the strength of the
aggregated evidence for an intervention:
Do - recommendations with strong supporting evidence,
Might do - recommendations with moderate supporting evidence,
Don’t do - recommendations with strong evidence against intervention,
Don’t know - recommendations with limited or inconclusive evidence.
Selection of guidelines
Our search strategy identified 34 guidelines, of which 21 were potentially relevant but were excluded for different reasons (Figure 1).
Ultimately, 13 guidelines for primary care management of CLBP were included, listed below indicating country and year of publication:
Institute for Clinical Systems Improvement (ICSI); United States, 2008. 
American College of Physicians (ACP); American Pain Society Low Back Pain Guidelines Panel (APS); United States, 2007. 
Institute of Health Economics, Toward Optimized Practice (TOP) Program; Canada, 2009. 
Clinic on Low-Back Pain in Interdisciplinary Practice (CLIP) Guidelines; Canada, 2007. 
New South Wales Therapeutic Assessment Group (NSW TAG); Australia, 2002. 
COST B13 Working Group on Guidelines for Chronic Low Back Pain in Primary Care; Europe, 2004. 
The Care and Research Institute (IRCCS) Don Carlo Gnocchi Foundation, ONLUS; Italy, 2006. 
Royal Dutch Society for Physiotherapy (KNGF); physiotherapy guidelines; the Netherlands, 2003. 
The National Collaborating Centre for Primary Care (NCCPC); Royal College of General Practitioners (RCGP); United Kingdom, 2009. 
The Chartered Society of Physiotherapy (CSP); United Kingdom, 2006. 
Centre of Excellence for Orthopaedic Pain Management Speising (CEOPS); Austria, 2007. 
Drug Committee of the German Medical Society (AKDA); Germany, 2007. 
The German College of General Practitioners and Family Physicians (DEGAM); Germany, 2003. 
In general, the quality of many guidelines was satisfactory
(Table 2). The domain that received the lowest mean score (less
than 50% of the maximum possible score) was “Applicability”, with
49.54%. On the other hand, the best domains were “Clarity and
presentation” and “Scope and purpose” (82.69% and 81.23% respectively).
It was also verified that three guidelines [15, 27, 28] achieved
high results in each domain with an overall average quality above
80%. Specifically, in the domain of clarity and presentation, most
guidelines presented unambiguous recommendations and well
listed management options. Moreover, key recommendations were
easily identifiable and all the guidelines were supported by some
tools for application, except for one. 
Similarly, all guidelines
except one  clearly described their scope and purpose, even if
many of them did not get the maximum score for this domain due to
missing descriptions of clinical questions and of the target patient
population. [22–26, 29, 30]
Most guidelines scored well also on the
domain of rigor of development with only three of them [20, 22, 23] showing several low-moderate scores. However, the description
of an external review process by experts before publication was
frequently absent. In addition, some guidelines did not provide a
procedure for their update. [22–24, 29]
The involvement of stakeholders in the development of guidelines
was moderate. The working group often included individuals
from all the relevant disciplines and the target users were almost
always mentioned. On the other hand, most guidelines did not
perform a pilot test among target users [20–25, 29], and many
of them did not take into account patients’ views and preferences [20, 22, 24, 30] or lacked a description on how they had been
“Editorial independence” was not wholly described, and
ratings were generally poor, although the domain mean score was
not the worst (61.54%). Only two [15, 26] of the 13 guidelines clearly
stated their independence from the funding body; however, most
of them described possible conflicts of interests of their members. [15, 20, 21, 24, 26–31]
Finally, scores were lowest on the domain of
applicability. This was particularly evident on item 21, which concerns
the presentation of key review criteria for monitoring and/or
audit. Potential organizational barriers and cost implications were
largely often ignored by the authors of guidelines, with only two [15, 27] taking these issues into account.
High-quality guidelines and their recommendations
According to our ten criteria for categorizing guidelines, we judged five [15, 21, 26–28] of the 13 guidelines included in the study as “excellent.” Of these CPGs, three of them [15, 26, 28] were not included in the reviews of Koes et al.  or Dagenais et al.  One CPG  was included only in Dagenais et al. study, while another  could be found in both. All of these guidelines provide recommendations on the diagnosis and treatment of CLBP, providing a comprehensive picture of the management of this condition in primary care.
For each guideline, Table 3 reports the levels of evidence and
the recommendation grading systems used by their authors. Finally
the seven most important diagnostic recommendations with strong
supporting evidence (Do) are summarized in Table 4, while Table 5
reports findings from CPGs pertinent to the management of CLBP.
The most important therapeutic recommendations included are
categorized by: general behaviour, pharmacologic therapy, conservative
nonpharmacologic therapy, invasive procedures, referral for surgery.
Currently, many guidelines have directed their attention to
CLBP, providing specific recommendations for this particular condition,
which still remains a very important clinical challenge in
medicine.  After the evaluation of 13 international CPGs on
the management of nonspecific CLBP using the validated AGREE
instrument, this study presents an overview of the most important
diagnostic and therapeutic recommendations found within
five high-quality guidelines. [15, 21, 26–28]
Similarly to a recent review of Bouwmeester et al. , the quality
of CPGs has improved over time compared to the disappointing
overall quality assessed by previous reviews. [8, 9] These results are
almost certainly related to the fact that AGREE is internationally
more known and widely accepted at present than in 2004 when
it had just been published. Some GDGs indeed explicitly mention
the use of this instrument to improve the methodological quality
of their guidelines. [15, 28, 29]
However, although the direction
taken seems to be the right one, some AGREE components still need
special attention. Consistent improvement in applicability and editorial
independence are needed since these domains are essential
for effective guideline implementation. Furthermore, there must
be assurance that recommendations have not been biased by third
parties. Guideline authors should specifically describe the development
of the CPG, particularly the affiliations of contributors and
external reviewers. Finally, CPGs should be pilot tested among
target users to further validate a GDG’s conclusions and increase
practitioners’ awareness. 
From guidelines to clinical practice
While methodological high-quality guidelines are becoming
increasingly available, implementation of their recommendations
into concrete daily practice remains a thorny task. 
Although the reason for this difficulty could be initially attributed
to guidelines themselves, in reality we found that three of
our five selected high-quality guidelines [15, 27, 28] examined in
detail the issue of their implementation, identifying potential
facilitators and barriers as well as strategies to manage them.
However, agreed-upon quality might not necessarily be followed
by acceptance and use.  Research is needed to study the
effectiveness of these guideline implementation plans, particularly
in health professions other than medicine, and demonstrate
that implementing these guideline recommendations improves
AGREE limitations and strengths
As others authors have reported previously [8, 14, 19], the AGREE
instrument proved itself easy-to-use and transparent providing a
useful way to score CPGs’ methodological quality. However, it does
not assess the clinical content of the guidelines nor the quality of
evidence supporting the recommendations, which is a common
deficit in all the existing appraisal tools.  Nevertheless, by using
AGREE, guideline users can undertake preliminary evaluation of
recommendations respective to overall guideline quality and then
undertake further targeted evaluations of individual high-quality
guidelines.  For this very reason, we decided not to report the
recommendations of all the included guidelines, but to use the
methodological quality of a guideline as the basis to explore its
clinical context, considering this aspect crucial to ensuring target
users are provided with a global overview of rigorous work from
every point of view.
Evidence and Recommendations
Along with the importance of assessing and guaranteeing the
methodological quality of a guideline, it is also fundamental for
potential users to trust the validity and clinical relevance of its
recommendations. In this regard, the authors of previous reviews [8, 9] underscored that many guidelines did not explicitly describe
how they had identified, selected, and summarized the available
evidence. Bouwmeester et al.  concluded recently that
this item has improved. Moreover our study shows that also
the methods used to formulate the recommendations appear to
be generally more rigorous, more explicit and better explained,
although it is sometimes unclear which recommendations are
based mainly on scientific evidence and which on a common
The content of the diagnostic recommendations has remained
unchanged over the past years and is strongly similar across all
the guidelines, as also was found by Koes et al.  and Dagenais
et al.  in their recent reviews.
All authors agree that clinicians
a focused history,
physical and neurologic examination,
undertaking diagnostic triage to assess severity and
identify the type of LBP.
The assessment of
prognostic factors (often indicated with the terms “yellow, blue and black flags”),
severity of pain and functional impact,
extreme symptom reporting,
prior episodes of LBP and
are almost always strongly recommended as well. In particular, recommendations regarding the assessment of clinical, work and especially psychosocial risk factors for chronicity are more firmly evident both in the literature  and in current guidelines than a decade ago.
The fact that many disciplines are involved in treating chronic
patients with LBP and the current state of research likely contribute
to a lower consensus regarding therapeutic recommendations.
However, our study shows that conflicting recommendations about
the effectiveness of various interventions have greatly decreased
in recent years and all the guidelines are slowly aligning in providing
them. Moreover, all the high-quality guidelines now provide
therapeutic recommendations for chronic pain that are clearly
differentiated from those formulated for acute and, with one
exception , also for subacute pain. Nevertheless, explicit recommendations
are still often ambiguous with respect to clear
indications for implementation for a considerable proportion of
The most established nongraded therapeutic recommendation
supports taking an individual’s expectations, beliefs and
preferences into account when weighing treatment alternatives.
Moreover, all the guidelines explicitly underline the importance
of educating and providing patients with information on LBP with
regard to their expected course and the possibility of effective prevention
and self-care options. An important role should be placed
also on advising patients to remain active and continue with normal
activities as far as possible.
Considering the broad array of conservative nonpharmacologic
therapeutic interventions practiced by physiotherapists, few are
consistently and widely recommended across various guidelines.
First of all, there is generally strong evidence that physical activity
and therapeutic exercise are effective for the management of
CLBP, even if it is not clear which type and quantity is the best. A
supervised, patient-specific, graded and active exercise program is
nearly always recommended. Next, multidisciplinary approaches
and combined physical and psychological (CPP) interventions with
cognitive-behavioural therapy and exercise are particularly recommended
for people who have received at least one course of
less intensive treatment and have high disability and/or significant
psychological distress. The same conclusion was reached in
a very recent systematic review by van Middelkoop et al. ,
which identified multidisciplinary treatment, behavioural treatment
and exercise therapy as the most promising interventions
to be provided as conservative treatments in daily management of
On the other hand, the recommendations regarding spinal
manipulation continue to show some discrepancies probably due to
the underlying conflicting evidence.  In some guidelines manipulation
is recommended, or at least presented as a therapeutic
option [21, 27], but others find inconclusive evidence  or do not
recommend it.  Finally, the evidence supporting physical agents
and modalities (tens, biofeedback, lumbar supports, ultrasound,
electro and laser therapy) is almost always limited or inconclusive.
These modalities are quite clearly discouraged among all the
guidelines, while traction is not recommended.
Future directions in research and guideline development
Overall, it seems that recommendations in current guidelines
regarding the diagnosis and treatment of CLBP have not changed
substantially compared to those included in old guidelines and
scientific literature  about a decade ago. However, some
refinements and valuable results have been obtained as the new
consensus in favour of exercise therapy and against traction surely
For the future, it will be very important to achieve consensus
on precise recommendations for manual therapy and educational
interventions that have currently conflicting, limited or moderate evidence of effectiveness. On the other hand, for some of the
already explicitly recommended treatments, i.e. behavioural and
exercise therapy, it will be important to describe their specific
characteristic and clarify which subgroups of patients can benefit
most from a particular type of intervention. [28, 40] Updates or
future guidelines should devote more attention to the definitions
of CLBP itself (chronic, persistent, recurrent, etc.), of the interventions,
their cost-effectiveness (especially psychological therapy
and multidisciplinary treatment), and what constitutes a successful
prognosis. Moreover, our work highlights the need to invest effort
and resources on developing an internationally validated method
to distinguish between “excellent” and “poor” guidelines, identifying
the most reliable and available CPGs, and implementing them
properly in local health care settings. Finally, a well-established system,
as the promising one proposed by the GRADE Working Group , should be internationally adopted to grade evidence and recommendations,
thus preventing confusion and allowing effective
communication and comparison across guidelines and target users.
Disclosure of interest
The authors declare that they have no conflicts of interest concerning
The authors would like to thank Angela Longo and Judith Herlemann
for technical support, Chiara Scardoni and Cristian Mugnai
for English language editing.
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