Abstract
Given the scale and cost of the low back pain problem, it is imperative that healthcare professionals involved in the care of people with low back pain have access to up-to-date, evidence-based information to assist them in treatment decision-making. Clinical guidelines exist to promote the consistent best practice, to reduce unwarranted variation and to reduce the use of low-value interventions in patient care. Recent decades have witnessed the publication of a number of such guidelines. In this narrative review, we consider three selected international interdisciplinary guidelines for the management of low back pain. Guideline development methods, consistent recommendations and inconsistencies between these guidelines are critically discussed.
Introduction
Low back pain (LBP) is the leading cause of disability worldwide. This is now as apparent in low-income countries as it is in the more affluent and developed countries across the globe. Disappointingly, despite a significant increase in back pain expenditure over the last decade, the levels of disability associated with back pain over the same period have remained virtually unchanged . In addition, the healthcare resource and economic burden that back pain and related disability present remain the same. A recent survey of nearly 200,000 people across 43 countries showed that people with back pain are at least twice as likely to have one of five mental health conditions (depression, anxiety, stress, psychosis and sleep deprivation) when compared to those without back pain .
Given the scale of the problem, it is imperative that healthcare professionals involved in the care of people with LBP have access to up-to-date, evidence-based information to assist them in treatment decision-making. Over the last few decades, a myriad of treatment options for back pain and an ever expanding repository of clinical trial data and scientific publications have emerged. The results of this global research effort into the causes and treatment of back pain are often conflicting and of variable quality. This heterogeneity in the data and its sheer scale imply that for an individual clinician in the pursuit of best clinical practice, making sense of the literature can be difficult and bewildering.
To assimilate and formally evaluate this information, an increasing number of clinical practice guidelines (CPGs) have been developed by different countries. Since the publication of the first LBP CPG by the Quebec Task Force in 1987 , more than a dozen ‘national’ multidisciplinary LBP guidelines that were sponsored by professional societies, government agencies and healthcare payers within their parent countries have emerged . Each of the LBP guidelines is created by an expert panel through consensus.
In this chapter, we compare three clinical guidelines for the management of LBP. We outline where they agree on what comprises best practice for LBP. We consider inconsistencies in recommendations between these guidelines and some of the possible reasons for these; we also discuss the challenges faced in implementing the recommendations of guidelines and consider controversies and future directions of clinical guidelines for LBP.
We have selected three major, recent, well-recognised, multidisciplinary back pain guidelines. The three guidelines are as follows:
2016 NICE Guideline on Low Back Pain and Sciatica NG59 – United Kingdom
2015 Evidence-Informed Primary Care Management of Low Back Pain – Canada
2007/2009/2017 Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society – USA
These three guidelines were chosen either because they were judged as high-quality guidelines in a recent systematic review of clinical guidelines for back pain or because at the time of writing they represented the most up-to-date clinical guidelines available. We illustrate the differences and similarities between these clinical guidelines in terms of development and their recommendations as well as the challenges faced in guideline implementation.
What is a clinical practice guideline?
CPGs have been defined as ‘ … systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances’ and ‘statements that include recommendations, intended to optimise patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’
Clinical guidelines make an important contribution to effective dissemination and implementation science; CPGs provide the recommended information within the knowledge integration process . The overarching goal of dissemination and implementation science is to ensure that advances in health science become standards for care in all populations and in all health care settings. By recommending effective and evidence-based interventions and discouraging interventions lacking in scientific support, clinical guidelines seek to optimise quality of care while reducing waste and the potential harm associated with ineffective or unsafe interventions. By adhering to guideline-recommended practice, it is hoped that clinicians and patients can be reassured that the best current practice, which is supported by the best available evidence, is being delivered. Clinical guidelines can reduce variations in practice, provide a rational basis for referral and act as a mechanism of quality control. Importantly, clinical guidelines can also identify areas of scientific uncertainty and make recommendations for future research.
Clinical guidelines for the same condition across the world should in principle be broadly similar. Guideline development groups have access to the same scientific data and evidence base after all. Conflicting guideline recommendations do, however, emerge. Some expected and reasonable sources of variation might be related to differences in the local economic and healthcare infrastructure in the country in which the guideline is developed. However, other less desirable sources of divergent recommendations may include variations in review methodology and subjective differences in the interpretation of benefits and harms, the local political landscape and, potentially, the constitution of the guideline committee, with the risk that recommendations might unduly reflect the work of those within the committee .
Approaches to guideline development
Clinical guidelines should be based on a systematic review of the available evidence developed by a panel of multidisciplinary experts. The review(s) should focus on the strength and quality of the evidence and result in a set of recommendations. This should involve both the evidence and value judgements regarding benefits and harms of alternative care options, thus addressing how patients with a particular condition ought to be managed, everything else being equal.
There are usually five steps in the initial development of a CPG .
- 1.
Identifying and refining the subject area.
- 2.
Convening and running a guideline development group.
- 3.
Assessing the evidence about the clinical question or condition, on the basis of systematic reviews.
- 4.
Translating the evidence into a recommendation within a CPG.
- 5.
External review of the guideline.
Although these steps represent the broad principles of guideline development, there are variations in the processes and methodologies of different guideline groups and centres across the world. To illustrate some of the methodological variations in LBP CPG development, a summary of the processes adopted by NICE, the American Pain Society and American College of Physicians and the Canadian ‘Towards Optimised Practice’ program is presented below.
NICE Guideline on Low Back Pain and Sciatica (NG59) 2016
The National Institute of Health and Care Excellence is a state-funded organisation in the United Kingdom whose stated goal is to improve outcomes for people by using the NHS and other public health and social care services. One key aspect to this is the development of clinical guidelines. The remit for all NICE guidelines comes from NHS England, and published guidelines are usually reviewed for update every 2 years (with a guaranteed review at least every 4 years from the date of publication). NG59 was commissioned in response to the review of the 2009 NICE Low Back Pain guideline (CG88) in 2012.
NICE commissioned the National Clinical Guideline Centre (NCGC) to develop the guideline, and the NCGC produced a draft scope. The draft scope was reviewed by stakeholder groups, and the final scope was agreed. Review questions were agreed by the multidisciplinary Guideline Development Group (GDG). The GDG comprised 12 healthcare professionals from a range of backgrounds and two lay members. Conflicts of interest were declared at the start of the process and at the beginning of each of the 25 GDG meetings.
The population covered by the guideline included people over the age of 16 years with LBP and/or sciatica. The duration of symptoms was not specified. People undergoing treatment for back pain prevention, those having persistent back pain following surgery and those having back pain during pregnancy were excluded. The NCGC technical team performed the literature searches and prepared the systematic reviews of the evidence and the economic analyses. Randomised controlled trials were given primacy, but uncontrolled cohort studies were reviewed where there was insufficient evidence from randomised trials. Existing systematic reviews were identified primarily to ensure adequate capture of the relevant data. Twenty-two de novo systematic reviews were performed by the technical team. The GDG discussed these systematic evidence reviews along with expert testimony (from within the guideline development group, from invited expert witnesses with particular specialist expertise not represented in the guideline development group and from this developed draft recommendations).
The methods used by NICE to conduct evidence reviews are transparent and explicit . Where possible, data were meta-analysed and the quality of the body of evidence underpinning comparisons was assessed using the GRADE methodology . The strength of each recommendation is reflected in the wording (e.g. ‘offer’ implies a strong recommendation, whereas ‘consider’ reflects a weaker recommendation, usually on the basis of the strength of the underpinning evidence). The strength of the evidence, the relative benefits and risks, cost effectiveness and, importantly, the patient perspective were also considered.
The draft guideline was submitted to the public for stakeholder consultation and revised where appropriate considering stakeholder comments. The revised guideline was submitted to NICE for internal peer review and sign off by the NICE executive. Once ratified by the NICE executive, the guideline was published.
2007/2009/2017 Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society
This guideline was initiated by the American Pain Society. The first stage, published in October 2007 , focused on initial (primary care) evaluation and management of LBP and was conducted in partnership with the American College of Physicians (ACP). The second stage, published in May 2009, focused on the use of conservative management , interdisciplinary rehabilitation and surgery and interventional therapies for LBP . An updated version focusing on non-invasive pharmacologic and non-pharmacologic treatment was published in February 2017 . A challenge in using the 2007/2009/2017 documents is that although the information was created by the same guideline group, the method of dissemination varies depending on the paper accessed. That said, there are seven papers that collectively introduce the ACP guidelines .
In the 2017 guidelines, the targeted population includes adults ( > 18 years of age) with acute, subacute and chronic LBP, radicular LBP or symptomatic spinal stenosis. In the original guidelines (2007–2009), the target population included adults (age >18 years) with acute and chronic LBP not associated with major trauma. Children or adolescents with LBP; pregnant women with LBP; patients with LBP from sources outside the back (non-spinal LBP), fibromyalgia or other myofascial pain syndromes, and thoracic or cervical back pain were not included.
For the 2017 update, The Agency for Healthcare Research and Quality’s (AHRQ) Pacific Northwest Evidence-Based Practice Centre completed all evidence reviews. Key questions included ‘what are the comparative benefits and harms of different pharmacologic therapies for acute or chronic non-radicular LBP, radicular back pain or spinal stenosis?’ and ‘what are the comparative benefits and harms of different non-pharmacologic therapies for acute or chronic non-radicular LBP, radicular back pain or spinal stenosis?’ The review researched databases from 2008 through April 2015 and then updated the search through November 2016. The previously published 2007 APC guidelines were used to detail any studies published prior to 2007. The authors incorporated published controlled clinical trials and systematic reviews. The majority of the 2017 ACP LBP guidelines are similar to those reported in 2007. The most notable differences include a lack of endorsement of paracetamol (acetaminophen) and tricyclic antidepressants in the 2017 guidelines, which contrast with the 2007 guidelines.
Members of the Clinical Guidelines Committee included physicians trained in internal medicine and its subspecialties and clinical experts and experts in evidence synthesis and guideline development. The committee performed quality assessment of randomised trials by using a form created by the Cochrane Back Review Group and the AHRQ and evaluated systematic reviews by using AMSTAR. Although patient preferences were considered, no patient representation was reported. Evidence was trichotomised as high quality, moderate quality and low quality.
2015 Evidence-Informed Primary Care Management of Low Back Pain – Canada
This guideline is the third edition of the Alberta CPG for the Evidence-Informed Primary Care Management of Low Back Pain , which was developed as part of the second phase of the Alberta Health Technology Assessment Ambassador Program.
The guideline was developed by a steering committee and an update committee. The update committee comprised a multidisciplinary group of primary care practitioners—most of whom were members of the group who developed the first edition of the guideline in 2009. Both the steering and update committees were supported by a research team.
The target population included adults with LBP of any duration. Pregnant women were excluded. The focus was diagnosis and conservative non-surgical treatment of LBP for use in primary healthcare settings. The guideline covers the diagnosis and treatment of radicular pain and a number of invasive interventions and injection procedures despite the proposed focus on primary care management but excluded in-patient interventions, such as surgical treatments.
Uniquely, the first edition of the guideline was developed by adapting existing good quality international and national guidelines on the management of LBP. The so-called ‘seed guidelines’ were identified and critically appraised and used to formulate the recommendations. These guidelines included some non-randomised study designs. Subsequent updates have identified more recent seed guidelines and recently published systematic reviews of new interventions that were considered important but were not included in the first edition of the guideline, but no new reviews of original studies were conducted as part of the development process.
Each recommendation from the CPG was sourced from one or multiple seed guidelines, and the recommendations were categorised into three groups: do , do not do (not recommended) and do not know . The strength and quality of the underlying empirical evidence were not formally assessed, however, and could not be defined by terms such as good, fair, poor, insufficient or conflicting. It is not clear whether patient or stakeholder comment was invited.
What is a clinical practice guideline?
CPGs have been defined as ‘ … systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances’ and ‘statements that include recommendations, intended to optimise patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’
Clinical guidelines make an important contribution to effective dissemination and implementation science; CPGs provide the recommended information within the knowledge integration process . The overarching goal of dissemination and implementation science is to ensure that advances in health science become standards for care in all populations and in all health care settings. By recommending effective and evidence-based interventions and discouraging interventions lacking in scientific support, clinical guidelines seek to optimise quality of care while reducing waste and the potential harm associated with ineffective or unsafe interventions. By adhering to guideline-recommended practice, it is hoped that clinicians and patients can be reassured that the best current practice, which is supported by the best available evidence, is being delivered. Clinical guidelines can reduce variations in practice, provide a rational basis for referral and act as a mechanism of quality control. Importantly, clinical guidelines can also identify areas of scientific uncertainty and make recommendations for future research.
Clinical guidelines for the same condition across the world should in principle be broadly similar. Guideline development groups have access to the same scientific data and evidence base after all. Conflicting guideline recommendations do, however, emerge. Some expected and reasonable sources of variation might be related to differences in the local economic and healthcare infrastructure in the country in which the guideline is developed. However, other less desirable sources of divergent recommendations may include variations in review methodology and subjective differences in the interpretation of benefits and harms, the local political landscape and, potentially, the constitution of the guideline committee, with the risk that recommendations might unduly reflect the work of those within the committee .
Approaches to guideline development
Clinical guidelines should be based on a systematic review of the available evidence developed by a panel of multidisciplinary experts. The review(s) should focus on the strength and quality of the evidence and result in a set of recommendations. This should involve both the evidence and value judgements regarding benefits and harms of alternative care options, thus addressing how patients with a particular condition ought to be managed, everything else being equal.
There are usually five steps in the initial development of a CPG .
- 1.
Identifying and refining the subject area.
- 2.
Convening and running a guideline development group.
- 3.
Assessing the evidence about the clinical question or condition, on the basis of systematic reviews.
- 4.
Translating the evidence into a recommendation within a CPG.
- 5.
External review of the guideline.
Although these steps represent the broad principles of guideline development, there are variations in the processes and methodologies of different guideline groups and centres across the world. To illustrate some of the methodological variations in LBP CPG development, a summary of the processes adopted by NICE, the American Pain Society and American College of Physicians and the Canadian ‘Towards Optimised Practice’ program is presented below.
NICE Guideline on Low Back Pain and Sciatica (NG59) 2016
The National Institute of Health and Care Excellence is a state-funded organisation in the United Kingdom whose stated goal is to improve outcomes for people by using the NHS and other public health and social care services. One key aspect to this is the development of clinical guidelines. The remit for all NICE guidelines comes from NHS England, and published guidelines are usually reviewed for update every 2 years (with a guaranteed review at least every 4 years from the date of publication). NG59 was commissioned in response to the review of the 2009 NICE Low Back Pain guideline (CG88) in 2012.
NICE commissioned the National Clinical Guideline Centre (NCGC) to develop the guideline, and the NCGC produced a draft scope. The draft scope was reviewed by stakeholder groups, and the final scope was agreed. Review questions were agreed by the multidisciplinary Guideline Development Group (GDG). The GDG comprised 12 healthcare professionals from a range of backgrounds and two lay members. Conflicts of interest were declared at the start of the process and at the beginning of each of the 25 GDG meetings.
The population covered by the guideline included people over the age of 16 years with LBP and/or sciatica. The duration of symptoms was not specified. People undergoing treatment for back pain prevention, those having persistent back pain following surgery and those having back pain during pregnancy were excluded. The NCGC technical team performed the literature searches and prepared the systematic reviews of the evidence and the economic analyses. Randomised controlled trials were given primacy, but uncontrolled cohort studies were reviewed where there was insufficient evidence from randomised trials. Existing systematic reviews were identified primarily to ensure adequate capture of the relevant data. Twenty-two de novo systematic reviews were performed by the technical team. The GDG discussed these systematic evidence reviews along with expert testimony (from within the guideline development group, from invited expert witnesses with particular specialist expertise not represented in the guideline development group and from this developed draft recommendations).
The methods used by NICE to conduct evidence reviews are transparent and explicit . Where possible, data were meta-analysed and the quality of the body of evidence underpinning comparisons was assessed using the GRADE methodology . The strength of each recommendation is reflected in the wording (e.g. ‘offer’ implies a strong recommendation, whereas ‘consider’ reflects a weaker recommendation, usually on the basis of the strength of the underpinning evidence). The strength of the evidence, the relative benefits and risks, cost effectiveness and, importantly, the patient perspective were also considered.
The draft guideline was submitted to the public for stakeholder consultation and revised where appropriate considering stakeholder comments. The revised guideline was submitted to NICE for internal peer review and sign off by the NICE executive. Once ratified by the NICE executive, the guideline was published.
2007/2009/2017 Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society
This guideline was initiated by the American Pain Society. The first stage, published in October 2007 , focused on initial (primary care) evaluation and management of LBP and was conducted in partnership with the American College of Physicians (ACP). The second stage, published in May 2009, focused on the use of conservative management , interdisciplinary rehabilitation and surgery and interventional therapies for LBP . An updated version focusing on non-invasive pharmacologic and non-pharmacologic treatment was published in February 2017 . A challenge in using the 2007/2009/2017 documents is that although the information was created by the same guideline group, the method of dissemination varies depending on the paper accessed. That said, there are seven papers that collectively introduce the ACP guidelines .
In the 2017 guidelines, the targeted population includes adults ( > 18 years of age) with acute, subacute and chronic LBP, radicular LBP or symptomatic spinal stenosis. In the original guidelines (2007–2009), the target population included adults (age >18 years) with acute and chronic LBP not associated with major trauma. Children or adolescents with LBP; pregnant women with LBP; patients with LBP from sources outside the back (non-spinal LBP), fibromyalgia or other myofascial pain syndromes, and thoracic or cervical back pain were not included.
For the 2017 update, The Agency for Healthcare Research and Quality’s (AHRQ) Pacific Northwest Evidence-Based Practice Centre completed all evidence reviews. Key questions included ‘what are the comparative benefits and harms of different pharmacologic therapies for acute or chronic non-radicular LBP, radicular back pain or spinal stenosis?’ and ‘what are the comparative benefits and harms of different non-pharmacologic therapies for acute or chronic non-radicular LBP, radicular back pain or spinal stenosis?’ The review researched databases from 2008 through April 2015 and then updated the search through November 2016. The previously published 2007 APC guidelines were used to detail any studies published prior to 2007. The authors incorporated published controlled clinical trials and systematic reviews. The majority of the 2017 ACP LBP guidelines are similar to those reported in 2007. The most notable differences include a lack of endorsement of paracetamol (acetaminophen) and tricyclic antidepressants in the 2017 guidelines, which contrast with the 2007 guidelines.
Members of the Clinical Guidelines Committee included physicians trained in internal medicine and its subspecialties and clinical experts and experts in evidence synthesis and guideline development. The committee performed quality assessment of randomised trials by using a form created by the Cochrane Back Review Group and the AHRQ and evaluated systematic reviews by using AMSTAR. Although patient preferences were considered, no patient representation was reported. Evidence was trichotomised as high quality, moderate quality and low quality.
2015 Evidence-Informed Primary Care Management of Low Back Pain – Canada
This guideline is the third edition of the Alberta CPG for the Evidence-Informed Primary Care Management of Low Back Pain , which was developed as part of the second phase of the Alberta Health Technology Assessment Ambassador Program.
The guideline was developed by a steering committee and an update committee. The update committee comprised a multidisciplinary group of primary care practitioners—most of whom were members of the group who developed the first edition of the guideline in 2009. Both the steering and update committees were supported by a research team.
The target population included adults with LBP of any duration. Pregnant women were excluded. The focus was diagnosis and conservative non-surgical treatment of LBP for use in primary healthcare settings. The guideline covers the diagnosis and treatment of radicular pain and a number of invasive interventions and injection procedures despite the proposed focus on primary care management but excluded in-patient interventions, such as surgical treatments.
Uniquely, the first edition of the guideline was developed by adapting existing good quality international and national guidelines on the management of LBP. The so-called ‘seed guidelines’ were identified and critically appraised and used to formulate the recommendations. These guidelines included some non-randomised study designs. Subsequent updates have identified more recent seed guidelines and recently published systematic reviews of new interventions that were considered important but were not included in the first edition of the guideline, but no new reviews of original studies were conducted as part of the development process.
Each recommendation from the CPG was sourced from one or multiple seed guidelines, and the recommendations were categorised into three groups: do , do not do (not recommended) and do not know . The strength and quality of the underlying empirical evidence were not formally assessed, however, and could not be defined by terms such as good, fair, poor, insufficient or conflicting. It is not clear whether patient or stakeholder comment was invited.
Related posts:
Evidence and methods in back pain research
Health economic evidence gaps and methodological constraints in low back pain and neck pain: Results of the Research Agenda for Health Economic Evaluation (RAHEE) project
The prevalence, risk factors, prognosis and treatment for back pain in children and adolescents: An overview of systematic reviews
Causal mechanisms in the clinical course and treatment of back pain
Developing implementation science to improve the translation of research to address low back pain: A critical review
Decision support tools in low back pain
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