An Updated Overview of Clinical Guidelines for
Chronic Low Back Pain Management in Primary CareThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: Joint Bone Spine 2012 (Mar); 79 (2): 176–185 ~ FULL TEXT
OPEN ACCESS 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:
Introduction
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. [1] Although most episodes of LBP appear self-limiting [2], recurrence with a variable course is common [3], with 10–15% of cases leading to chronic pain. [4] In order to decrease this burden, the use of interventions with demonstrated effectiveness is essential. [5] 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 [6], there has been a steady worldwide interest on this subject, culminating with the publication of specific CPGs in many countries over the past few years.
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. [10] 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. [9] Recently, separate reviews by Koes et al. [11] and Dagenais et al. [12] 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 particular condition.
Methods
Data sources
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. [13]
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 teaching.Additional information (other publication or website) was only taken into account when the guideline explicitly referred to it.
Quality assessment
Table 1 All guidelines were reviewed independently by three authors (I.G., F.B., R.M.) and scored for methodological quality according to the AGREE instrument [10], which has been shown to be reliable when used by physiotherapists to assess the quality of clinical guidelines relevant to physical therapy practice. [14] 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.
Guideline assessment
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. [15] 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. [16] 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 [17], 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. [18] 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. [19]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.
Results
Selection of guidelines
Figure 1 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. [20]
American College of Physicians (ACP); American Pain Society Low Back Pain Guidelines Panel (APS); United States, 2007. [21]
Institute of Health Economics, Toward Optimized Practice (TOP) Program; Canada, 2009. [15]
Clinic on Low-Back Pain in Interdisciplinary Practice (CLIP) Guidelines; Canada, 2007. [22]
New South Wales Therapeutic Assessment Group (NSW TAG); Australia, 2002. [23]
COST B13 Working Group on Guidelines for Chronic Low Back Pain in Primary Care; Europe, 2004. [24]
The Care and Research Institute (IRCCS) Don Carlo Gnocchi Foundation, ONLUS; Italy, 2006. [25]
Royal Dutch Society for Physiotherapy (KNGF); physiotherapy guidelines; the Netherlands, 2003. [23]
The National Collaborating Centre for Primary Care (NCCPC); Royal College of General Practitioners (RCGP); United Kingdom, 2009. [27]
The Chartered Society of Physiotherapy (CSP); United Kingdom, 2006. [28]
Centre of Excellence for Orthopaedic Pain Management Speising (CEOPS); Austria, 2007. [29]
Drug Committee of the German Medical Society (AKDA); Germany, 2007. [30]
The German College of General Practitioners and Family Physicians (DEGAM); Germany, 2003. [31]
Quality assessment
Table 2 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. [29]
Similarly, all guidelines except one [22] 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 included.
“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. [11] or Dagenais et al. [12] One CPG [27] was included only in Dagenais et al. study, while another [21] 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.
Discussion
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. [32] 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]
Guidelines evaluation
Similarly to a recent review of Bouwmeester et al. [13], 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. [33]
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. [34] 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. [35] 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 patient outcomes.
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. [36] 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. [19] 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. [13] 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 consensus.
Diagnostic recommendations 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. [11] and Dagenais et al. [12] in their recent reviews.
All authors agree that clinicians should conducta focused history,
physical and neurologic examination,
undertaking diagnostic triage to assess severity and
identify the type of LBP.The assessment of
red flags,
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
patients expectationsare 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 [37] and in current guidelines than a decade ago.
Therapeutic recommendations 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 [21], also for subacute pain. Nevertheless, explicit recommendations are still often ambiguous with respect to clear indications for implementation for a considerable proportion of these interventions.
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. [38], which identified multidisciplinary treatment, behavioural treatment and exercise therapy as the most promising interventions to be provided as conservative treatments in daily management of CLBP.
On the other hand, the recommendations regarding spinal manipulation continue to show some discrepancies probably due to the underlying conflicting evidence. [11] In some guidelines manipulation is recommended, or at least presented as a therapeutic option [21, 27], but others find inconclusive evidence [15] or do not recommend it. [28] 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 [39] 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 demonstrate.
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 [18], 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 this article.
Acknowledgements
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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