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Here is a Medscape article on current LBP Guidelines.

Lyndon McGill, D.C.

Salem, Oregon

www.SalemSpineClinic.com

www.lyndon.myevolv.com

From Spine

Quality of Low Back Pain Guidelines Improved

Walter Bouwmeester, PT; Annefloor van Enst, BSc;

Maurits van Tulder, PhD

Posted: 03/01/2010;

Spine. 2009;34(23):2562-7. © 2009 Lippincott & Wilkins

Abstract and Introduction

Abstract

Study Design. Systematic review of clinical guidelines.

Objective.

To assess the methodological quality of clinical guidelines for the

management of acute and chronic low back pain (LBP) in primary care and

compare their recommendations.

Summary of Background Data.

A guideline evaluation performed in 2004 concluded that the quality and

transparency of the development process and consistency in the

reporting of primary care guidelines for LBP need to be improved. At

present, several guidelines have been revised and new guidelines are

published. We evaluated if the quality of guidelines has improved.

Methods.

Guidelines published since 2004 were selected by electronically

searching in MEDLINE, Cochrane Back Review Group database, Guideline

Clearing House, Google, and contacting experts. The methodological

quality of the guidelines was assessed by 2 authors independently,

using the Appraisal of Guidelines, Research, and Evaluation in Europe

instrument. Also, the diagnostic and therapeutic recommendations were

compared.

Results. Fourteen

guidelines were included. In general, the quality was satisfactory. The

guidelines had best scores on clarity and presentation. The domain

scores of scope and purpose were often moderate due to the absence of

description of the clinical questions. The domain of stakeholder

involvement scored moderate, mostly because guidelines were not tested

among target users. Domains that had generally low scores were

applicability and editorial independence. Four guidelines scored low on

the rigor of development, but the other guidelines scored high on this

domain.

The diagnostic and therapeutic recommendations in the guidelines for

acute LBP were mainly comparable while the recommendations for the

management of chronic LBP varied widely.

Conclusion.

Compared to the quality assessment performed in 2004, the average

quality of guidelines has improved. However, guideline developers

should still improve the quality transparency of the development

process. Especially the applicability of guidelines and the editorial

independence need to be ensured in future guidelines.

Introduction

Evidence-based

medicine has become increasingly more important over the past decade.

The management of low back pain (LBP) has been positively affected by

the availability of more clinical quality trials and better use of

critical appraisal techniques to evaluate and apply research findings.[1]

A large number of systematic reviews are available within and outside

the framework of the Cochrane Back Review Group that have evaluated the

diagnostic and therapeutic interventions or LBP.[2] This

large body of evidence has greatly improved our understanding of what

does and does not work for LBP. However, in clinical practice this

evidence should be integrated with clinical expertise of the care

provider and patient's preferences and expectations.[3]

In

2001, a comparison of the content of back pain guidelines was published

that showed that diagnostic and therapeutic recommendations were

generally similar, although some discrepancies were identified.[4]

Subsequently, a quality assessment of guidelines published before 2001

was performed.[5]

At that time an instrument regarding the quality of clinical guidelines

had just been developed, namely, the AGREE (Appraisal of Guidelines,

Research, and Evaluation in Europe) instrument (http://www.agreecollaboration.org;

April 2002).[6]

Although originally developed as a set of criteria for developing

guidelines, the instrument was useful for assessing the quality of

guidelines in a systematic review as well. The authors concluded that

on average the quality of the guidelines was low.

The

aim of the present study was to assess if the quality of guidelines on

LBP in primary care has improved since 2001. Furthermore, the main

recommendations for diagnosis and treatment of available guidelines

were compared.

Materials and Methods

Selection of Guidelines

Guidelines

where identified through searching in the electronic databases of

MEDLINE ("Guideline" [Publication Type] or "Guidelines" [Mesh] or

"Practice Guideline" [Publication Type] or "Health Planning

Guidelines"[Mesh] and low back pain; Clinical guideline and low back

pain; and "Guideline" [Publication Type] and low back pain and primary

care) Cochrane Back Review Group, Guideline Clearing House (NGC) (http://www.guideline.gov),

and

the personal files of the principal investigator (M.v.T.). The

database of the NGC was only used to track guidelines. Furthermore,

personal communication was initiated to check if some of the guidelines

(Finland and England) had been revised or not.

Only

guidelines published after 2001 were included in this review, because

guidelines published before 2001 were already included and assessed in

the previous guideline evaluation.[5] Since guidelines are

infrequently published in medical journals, the search engine Google

was also perused using the keywords "guideline," "low back pain," and

"primary care" (http://www.google.com;

we checked the first 100 of a total of 208,000 links identified).

Guidelines

included in this review had to meet the following criteria: (1) the

guideline addressed the clinical management of acute or chronic LBP,

(2) the target group consisted of primary health care providers, (3)

the guideline must be published by a professional group, and (4) the

guideline was available in English, German, or Dutch (including

authorized English translations of foreign-language guidelines).

Guidelines were excluded if they addressed the management of specific

LBP (including lumbosacral radicular syndrome), occupational-related

LBP, secondary care of LBP provided by medical specialists, prevention

of LBP, or if they were developed by one individual or one health care

center/hospital. Additional information (other publication or website)

was only taken into account when the guideline explicitly referred to

it.

Quality Assessment

The

quality of the guidelines was assessed by 2 authors, independently. The

guidelines were reviewed using the Dutch version of the AGREE

instrument (http://www.cbo.nl;

April 2006).[6]

The AGREE instrument consists of 23 items in 6 domains (Table 1). Each

item is rated on a 4-point scale: 1, strongly disagree; 2, disagree; 3,

agree; and 4, strongly agree. We used the additional information on the

operationalization of the items, provided in the user guide of the

AGREE instrument, to determine clear definitions of each. Domain scores

were calculated by dividing the difference between the obtained score

and the minimum possible score by the difference between the maximum

possible and minimum possible score. The AGREE group stated that it is

not yet possible to set a threshold score for the domain scores to make

a distinction between "good" and "bad" guidelines.

Table 1. Domains and Items of the AGREE Instrument

AGREE Domain

AGREE Item

Scope and purpose

The overall objective of the guideline is specifically

described

The clinical question covered by the guideline is specifically described

The patients to whom the guideline is meant to apply are specifically

described

Stakeholder involvement

The guideline development group includes individuals from all

the relevant professional groups

The patients' views and preferences have been sought

The target users of the guideline are clearly defined

The guideline has been piloted among target users

Rigor of development

Systematic methods were used to search for evidence

The criteria for selecting the evidence are clearly described

The methods used for formulating the recommendations are clearly

described

The health benefits, side effects and risks have been considered in

formulating the recommendations

There is an explicit link between the recommendations and the

supporting evidence

The guideline has been externally reviewed by experts prior to its

publication

A procedure for updating the guideline is provided

Clarity and presentation

The recommendations are specific and unambiguous

The different options for the management of the condition are clearly

presented

Key recommendations are easily identifiable

The guideline is supported with tools for application

Applicability

The potential organizational barriers in applying the

recommendations have been discussed

The potential cost implications of applying the recommendations have

been considered

The guideline presents key review criteria for monitoring and/or audit

purposes

Editorial independence

The guideline is editorially independent from the funding body

Conflicts of interest of guideline development members have been

recorded

Discrepancies between the scores of

the 2 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). If discrepancies remained, they were

discussed with the principal investigator (M.v.T.).

Selection of Guidelines

We identified 9 references to guidelines in Medline;[7–15]

4 in the Cochrane Back Review Group database;[16–18] 2 on

the Guideline Clearing House website;[19–20] and 4 in Google.[21–24]

Guidelines were excluded for different reasons. The guideline of the

North American Spine Society[15] and the guideline of

Veterans Health Administration, Department of Defense[20]

were both officially withdrawn. The Norwegian and Israeli guidelines

were excluded because they were only available in Norwegian and Hebrew.[11,14]

At the end, 14 guidelines for the primary care management of LBP were

included:

COST B13 Working Group on Guidelines for the Management of Acute

Low Back Pain in Primary Care, European, 2004,[13]

Drug Committee of the German Medical Society, Germany, 2007,[8]

American College of Physicians; American Pain Society Low Back

Pain Guidelines Panel, United States, 2007,[9]

Center of Excellence for Orthopedic Pain Management Speising,

Austria, 2007,[10]

The Care and Research Institute (IRCCS), Italy, 2006,[12]

COST B13 Working Group on Guidelines for Chronic Low Back Pain in

Primary Care, European, 2004,[7]

National Health and Medical Research Council, 2003, Australia,[16]

National Health Committee.

National Advisory Committee on Health and Disability, Accident

Rehabilitation and Compensation Insurance Corporation; New Zealand,

2004,[17]

Clinic on Low-Back Pain in Interdisciplinary Practice (Clip)

Guidelines; Canada, 2007,[18]

Institute for Clinical Systems Improvement (ICSI); United States,

2005,[19]

Royal Dutch Association for Physiotherapy; physiotherapy

guidelines; the Netherlands, 2003,[21]

Royal Dutch Association for Physiotherapy; Manual Therapy

Guidelines; the Netherlands, 2003,[22]

Dutch College for General Practice; the Netherlands, 2005,[23]

Dutch Quality Institute for Healthcare; the Netherlands, 2003.[24]

Quality Assessment

In

general, the quality of most guidelines was satisfactory (Table 2). The

domains that had low scores (50% or less of the maximum possible score)

were, like in the previous review, stakeholder involvement,

applicability, and editorial independence. On average, the score for

editorial independence was better compared to 2004, but the range was

wide. The applicability has improved as well. The score of the domain

scope and purpose has decreased, however, the rigor of development

improved adequately. The assessors had a difference in AGREE score per

article of 3.5 of 23. After a consensus meeting this was reduced to a

score difference of 2.4.

Table 2. Domain Scores of the Guidelines (Percentages)

AGREE Domain

A

B

C

D

E

F

G

H

I

J

K

L

M

N

Scope and purpose

61

56

89

67

39

61

61

61

22

56

89

89

56

61

Stakeholder involvement

50

38

46

54

46

46

79

58

25

50

71

50

83

75

Rigor of development

81

88

95

48

62

74

98

88

43

50

95

93

48

76

Clarity and presentation

67

96

92

46

88

75

92

100

92

88

96

100

96

100

Applicability

72

56

56

11

44

44

56

44

22

89

39

28

33

61

Editorial independence

92

83

83

8

17

83

50

42

25

42

100

58

0

33

A, Guidelines: COST B13 Working Group on Guidelines for the

Management of Acute Low Back Pain in Primary Care, European, 2004.[13]

B, Drug Committee of the German Medical Society, Germany, 2007.[8]

C, American College of Physicians; American Pain Society Low Back Pain

Guidelines Panel, United States, 2007.[9] D, Centre of

Excellence for Orthopaedic Pain management Speising, Austria, 2007.[10]

E, The Care and Research Institute (IRCCS), Italy, 2006.[12]

F, COST B13 Working Group on Guidelines for Chronic Low Back Pain in

Primary Care, European, 2004.[7] G, National Health and

Medical Research Council, 2003, Australia.[16]

H, National Health Committee. National Advisory Committee on Health and

Disability, Accident Rehabilitation and Compensation Insurance

Corporation, New Zealand, 2004.[17] I, Clinic on Low-Back

Pain in Interdisciplinary Practice (Clip) Guidelines, Canada, 2007.[18]

J, Institute for Clinical Systems Improvement (ICSI), United States,

2005.[19] K, Royal Dutch Association for Physiotherapy, the

Netherlands, 2005.[21] L, Royal Dutch Association for

Physiotherapy; manual therapy the Netherlands, 2003.[22] M,

Dutch College for General Practice, the Netherlands, 2005.[23]

N, Dutch Orthopedic Society of Quality institute for Healthcare, the

Netherlands, 2003.[24]

The guidelines scored best on the

domain clarity and presentation. Many presented unambiguous

recommendations, different options for management and key

recommendations were easily identifiable. Furthermore, almost every

guideline had good scores on the domain of rigour of development. The

average score was 74.2% of the maximum possible score. Only 4 of the 14

guidelines had a moderate score around 50% of the maximum possible

score in this domain.[10,18,19,23] This was mainly because

no information was reported about search strategies and selection of

the literature in these 4 guidelines. The Dutch college of general

practice[23] gave additional information about search

strategy on their website, but did not refer to it. When guidelines are

compiled using all current available evidence, the quality of the

guideline will not be influenced by selection bias. A description of

the review process by an expert, before publication, was frequently

missing.[7,12,13,17,18,24] In contrast, the health benefits,

side effects, and risk were mostly well described. The recommendations

for diagnosis and treatment were mostly explicitly linked to the

available evidence, except for the Italian guideline.[12]

All but one[18]

of the guidelines clearly described their scope and purpose. However,

many guidelines still did not get the maximum score for this item due

to poor description of expected health gain. The target patient

population was well described in most guidelines. Nevertheless, the

clinical questions were missing in almost every guideline; only the

Royal Dutch Association of Physiotherapy and the US guideline paid

attention to this aspect.[9,21,22]

The

involvement of stakeholders in the development of guidelines was

moderate. In almost every guideline the working group covered all

relevant disciplines. The target users of the guidelines are often

especially mentioned, except for the guideline of the Clinic on

Low-Back Pain in Interdisciplinary Practice (CLIP).[19] Many

guidelines lack a description of how they include the views and

preferences of patients or had not performed a test among target users.

Editorial

independence was mostly not completely described. Only 5 of the 14

guidelines gave satisfying information on the editorial independence

and described possible conflicts of interests.[7–9,13,21]

Scores

were lowest on the domain of applicability. Especially the item of

presentation of key criteria for monitoring and/or audit got low

scores. The reviewers scored 17 times "strongly disagree" and 7 times

"disagree." The ICSI guideline gave a full description on the method of

monitor guideline adherence, and the European guidelines on acute and

chronic back pain[7,13] gave some options. All the other

guidelines lacked a description of this subject. Guideline developers

also need to consider the possible costs and barriers, but few have

taken this into account.[6] Organizational or financial

aspects, such as the availability of multidisciplinary centers for

treatment of LBP, may also limit the implementation of guidelines.

Since implementation of scientific evidence is a major target of

guideline development, these items should be taken in account.

Diagnostic and Therapeutic Recommendations

Most guidelines had similar recommendations for the diagnosis of

acute and chronic LBP:

Assess red flags to exclude specific pathology.[7–10,12,13,16–19,21–24]

History taking and examination were recommended in most guidelines.

Many guidelines recommended to assess red flags if patients do not

improve.

Only in case of red flags additional investigation, such as

diagnostic imaging or laboratory tests, should be considered.[7–10,12,13,16–19,22–24]

Make a distinction between nonspecific LBP, radicular syndrome,

and specific pathology; the so-called diagnostic triage.[7–10,12,13,18,19,21,22]

Assess psychosocial factors directly or in case of no

improvement, to assess the risk of chronic LBP.[7–10,12,13,16–19,21–24]

These factors are know as "yellow flags."

Perform

a physical examination that includes, for example, the straight leg

raise test, palpation for tenderness, and neuromuscular testing.[8–10,12,13,16–19,21–24]

Physical examination is part of triage diagnostics to exclude radicular

syndrome.[7–10,12,13,18,19,21,22]

Specific pathoanatomic diagnosis must not be used in

communication with the patient.[7,16,24]

Most guidelines did not describe

a timescale for further investigation, with the exception of the New

Zealand and ICSI guidelines.[17,20]

There

were also a number of recommendations for treatment of acute LBP that

were rather consistent among the various international guidelines:

Reassure patients on the favorable prognosis,[8–10,12,13,16–19,21–24]

if available provide printed patient information.[16,19]

Advise patients to stay active.[8–10,12,13,16–19,21–24]

Discourage bed rest.[8–10,12,13,16–19,21–24]

Prescribe medication if necessary (preferably time contingent).[8–10,12,13,16–19,23,24]

paracetamol/acetaminophen,

nonsteroidal anti-inflammatory drugs,

muscle relaxants or opioids on an individual basis.

If patients do not improve, spinal manipulation could be

considered.[9,12,13,24]

Spinal manipulation could be considered in the first month.[8,10,17–19,22]

Advise nonspecific exercises if patients did not improve.[8,9,12,13,16–19,21,22,24]

The

recommendations for the treatment of chronic LBP varied widely. The

following recommendations were rather consistent among the various

international guidelines:

Advise patients to stay active.[7–10,12,16–19,21–24]

Discourage bed rest.[7–10,12,16–19,21–24]

Advise time-contingent nonspecific exercises.[7,8,10,12,18,21,22,23,24]

Consider back-schooling.[7,8,10,12,18,19,24]

Refer to a multidisciplinary program if other options fail.[7,8,9,10,13,18,19,23,24]

Analgesics can be used supportively only for short-term, because

of potential for addiction.[7,8,10,12,18,19,24] The

guidelines recommended different analgesics, probably because of a

difference between countries.

The

following treatment options were less consistently recommended, but

were recommended in 3 or more guidelines. The strength of

recommendation was mostly moderate or weak:

Behavioral therapy;[8,10,18,24] cognitive-behavioral

therapy,[7,9,22]

Spinal manipulation,[7,8,9,10,12,18,22,24]

Massage,[8,9,10,12,18]

Prescription of antidepressants,[7,10,12,18]

Prescription of muscle relaxants,[7,8,10,12,18]

Surgery was recommended if all abovementioned options failed.[7,8,10,12]

Infiltration of trigger points, acupuncture, and epidural steroids

had conflicting recommendations.

Discussion

This article is an update of the previous published quality

assessment of guidelines on LBP in primary care.[5]

Compared to the quality assessment performed in 2004, the quality of

guidelines seems to have improved. However, several AGREE items (views

and preferences of patients, test among target users, clinical

questions, editorial independence, and applicability) still need to

improve.

Not all guidelines previously

assessed in 2004 were updated and new guidelines were included in the

present review. Eight of the 17 guidelines included in the previous

2004 review were updated, although more guidelines had stated plans for

revision. Consequently, some of the available guidelines may not be

based on current best evidence and recommendations may be out of date.

We identified possible updates of guidelines by searching the Internet

and initiating personal communication with experts in this field. This

Internet search may have introduced a bias, because large, established

institutes are more likely to be found on the Internet than smaller,

less established ones. Furthermore, English language guidelines will

probably be overrepresented when searching the Internet and the authors

were unable to read languages other than Dutch, German, and English.

However, we believe that the guidelines we included reflect the current

state-of-the-art of guidelines developed for the management of

nonspecific LBP in primary care.

This

quality assessment was performed by other reviewers than in the

previous article, which may have lead to different results in rating

the items. MacDermid et al [25]

showed that the AGREE instrument is reliable and valid for assessing

the quality of clinical guidelines relevant to physical therapy

practice. Pairs of appraisers out of 69 physical therapists showed good

reliability, although there was variation across AGREE domains. Adding

more than 3 appraisers did not consistently improve reliability.[25]

Therefore, we do not expect that having different reviewers in this

review compared with the 2004 review has led to a substantial bias. We

have also attempted to minimize this potential bias by using a

consensus meeting in which we critically reviewed our quality

assessment and by discussing the quality assessment with the principal

investigator who was also involved in an earlier article.

This

review showed that there still is room for improvement of the quality

of guidelines and identified which AGREE items needs especially

attention in future guidelines or updates of existing guidelines. At

present, the AGREE instrument is probably more known among guideline

developers than in 2004 when it was just published. Probably this has

led to an improvement of the quality of guidelines as predicted in the

previous article.[5] In some guidelines, the use of the

AGREE instrument was specifically mentioned.[10,16,24]

However, these guideline did not get higher scores than those that had

no specific reference to the AGREE instrument.

Compared

to the previous assessment there was an improvement in applicability,

but this improvement should continue since the absence of good

applicability tools could lead to insufficient implementation, an

important target of guidelines.[26] Also, authors should pay

more attention to the editorial independence as there is evidence that

the pharmaceutical industry has influence on guideline development and

guideline recommendations.[27]

Patient

involvement and tests among target users were mostly not explicitly

described in the guidelines. Especially the latter is an important item

for further validation of guidelines.[6]

In the previous review,[5]

many guidelines did not explicitly describe how they had identified,

selected, and summarized the available evidence. This item has

improved, and search strategies and selection criteria were overall

clearly described. Although the quality of underlying literature is

high, good guidelines also take into consideration other aspects of

treatment such as side effects, risks, costs, and ethical

considerations. Future updates or future guidelines should spent more

attention to these aspects.

The

diagnostic tools recommended were similar for acute and chronic LBP.

Recommendations for acute LBP were quite consistent. Instead, there is

little consensus among guidelines on the treatment of chronic LBP and

more disciplines seem to be involved in treating chronic patients with

LBP. Breen et al recommended developing multidisciplinary

guidelines, which may be important especially in case of chronic LBP.[26]

There is still room for generating evidence on management of chronic

LBP, overcoming the flaws of currently published trials.[28]

It is important to disseminate and implement this evidence and clinical

guidelines seem useful tools for this purpose.[26]

Successful implementation should lead to better adherence to guidelines

of care providers and patients and consequently to better patient

outcomes.[29]

Concluding,

the quality of guidelines for the management of acute and chronic LBP

in primary care has improved during the last decade. Still, guideline

developers should try to further improve guidelines using the AGREE

instrument.

Key Points

We

conducted a systematic review to assess the methodological quality of

clinical guidelines for the management of acute and chronic LBP in

primary care and compare their recommendations.

Fourteen clinical guidelines were included.

The 23 items of the AGREE instrument were used to assess the

quality.

Clarity

and presentation of guidelines, scope and purpose, stakeholder

involvement were domains which were met by the majority of guidelines.

Applicability and editorial independence were domains where most

guidelines scored low.

The quality of recent guidelines is good, but there is still room

for improvement.

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Authors and Disclosures

Walter Bouwmeester, PT, Annefloor van Enst, BSc, and

Maurits van Tulder, PhD

Department of Health Sciences, Faculty of Earth and Life Sciences, VU

University Amsterdam, Amsterdam, The Netherlands.

Address correspondence and reprint requests to

Maurits van Tulder, PhD, Department of Health Sciences, Faculty of

Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085,

1081 HV Amsterdam, The Netherlands; E-mail: maurits.van.tulder@...

The manuscript submitted does not contain information about medical

device(s)/drug(s).

No funds were received in support of this work. No benefits in any form

have been or will be received from a commercial party related directly

or indirectly to the subject of this manuscript.

Spine. 2009;34(23):2562-7. © 2009 Lippincott & Wilkins

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