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Physiotherapy 94 (2009) 302–313 Using consensus methods in developing clinical guidelines for exercise in managing persistent low back pain Anne Jackson a,, Dries M. Hettinga a , Judy Mead b , Chris Mercer c a Chartered Society of Physiotherapy, 14 Bedford Row, London WC1R 4ED, UK b Judy Mead – previously of CSP, 14 Bedford Row, London WC1R 4ED, UK c Western Sussex Hospitals NHS Trust, Worthing Hospital, Worthing BN11 2DH, UK Abstract Objectives To generate expert consensus evidence for the purpose of developing more complete guidelines for people with persistent low back pain than is possible using current research evidence alone. Gaps in research evidence lead to incomplete practice recommendations unless a scientific process can provide supplementary consensus evidence that is a basis for additional recommendations. Design A modified Nominal Group Technique (NGT). This followed a systematic review indicating incomplete research evidence. Setting UK-wide coordinated by the Chartered Society of Physiotherapy. Participants Twenty-three individuals selected for their expertise as clinicians, researchers, managers and patients. Methods Three stages: a first-round questionnaire of clinical questions unanswered by the systematic review; an electronic conference for outstanding questions unanswered by the first questionnaire; and a second-round questionnaire for these outstanding questions. All three stages were carried out electronically. Results Of 17 clinical questions unanswered by the systematic review, consensus evidence was generated for 14 questions by the modified NGT and this led to 14 recommendations for practice. Consensus was not reached for the remaining three questions. Conclusions The modified NGT was a practical and cost-effective way of generating consensus evidence from a UK-wide group. The consensus evidence was the basis of appropriately graded recommendations for effective care of people with persistent low back pain. Consensus methods have been little used in physiotherapy to date but are likely to be valuable in developing clinically useful, evidence-based tools for future practice. © 2009 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved. Keywords: Consensus; Practice guidelines; Low back pain Introduction Clinical guidelines or ‘systematically developed state- ments to assist practitioner and patient decisions about appropriate health care for specific circumstances’ [1] are increasingly important. They assess, and apply to practice, the increasing volume of clinical research evidence. By imple- menting quality clinical guidelines, clinicians are confident that they are providing consistent patient care that is most effective according to the best knowledge that is currently available [2]. The highest level of evidence, a systematic Corresponding author. Tel.: +44 0 20 7314 7863; fax: +44 0 20 7306 6611. E-mail address: [email protected] (A. Jackson). review of randomised controlled trials (RCTs) [3], is gen- erally used to analyse the research evidence [4]. However, guideline developers have a major problem where there are gaps in the evidence, the evidence is of poor quality or the con- clusions are uncertain. Leaving guidelines incomplete does not provide the basis for decision-making needed by clin- icians and policy makers [5,6]. One way to overcome this problem is to use a structured and systematic process of consensus development, based on scientific methods. This is advocated, for example, by England and Wales’s National Institute for Health and Clinical Excellence (NICE) in con- junction with a detailed description in the documentation to demonstrate an explicit and transparent process [7]. Two methods of development are commonly used: the Delphi method and the Nominal Group Technique (NGT). 0031-9406/$ – see front matter © 2009 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

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Page 1: Using consensus methods in developing clinical guidelines for exercise in managing persistent low back pain

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Physiotherapy 94 (2009) 302–313

Using consensus methods in developing clinical guidelines forexercise in managing persistent low back pain

Anne Jackson a,∗, Dries M. Hettinga a, Judy Mead b, Chris Mercer c

a Chartered Society of Physiotherapy, 14 Bedford Row, London WC1R 4ED, UKb Judy Mead – previously of CSP, 14 Bedford Row, London WC1R 4ED, UK

c Western Sussex Hospitals NHS Trust, Worthing Hospital, Worthing BN11 2DH, UK

bstract

bjectives To generate expert consensus evidence for the purpose of developing more complete guidelines for people with persistent lowack pain than is possible using current research evidence alone. Gaps in research evidence lead to incomplete practice recommendationsnless a scientific process can provide supplementary consensus evidence that is a basis for additional recommendations.esign A modified Nominal Group Technique (NGT). This followed a systematic review indicating incomplete research evidence.etting UK-wide coordinated by the Chartered Society of Physiotherapy.articipants Twenty-three individuals selected for their expertise as clinicians, researchers, managers and patients.ethods Three stages: a first-round questionnaire of clinical questions unanswered by the systematic review; an electronic conference for

utstanding questions unanswered by the first questionnaire; and a second-round questionnaire for these outstanding questions. All threetages were carried out electronically.esults Of 17 clinical questions unanswered by the systematic review, consensus evidence was generated for 14 questions by the modifiedGT and this led to 14 recommendations for practice. Consensus was not reached for the remaining three questions.onclusions The modified NGT was a practical and cost-effective way of generating consensus evidence from a UK-wide group. The

onsensus evidence was the basis of appropriately graded recommendations for effective care of people with persistent low back pain.onsensus methods have been little used in physiotherapy to date but are likely to be valuable in developing clinically useful, evidence-based

ools for future practice.2009 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

reggcnip

eywords: Consensus; Practice guidelines; Low back pain

ntroduction

Clinical guidelines or ‘systematically developed state-ents to assist practitioner and patient decisions about

ppropriate health care for specific circumstances’ [1] arencreasingly important. They assess, and apply to practice, thencreasing volume of clinical research evidence. By imple-

enting quality clinical guidelines, clinicians are confident

hat they are providing consistent patient care that is mostffective according to the best knowledge that is currentlyvailable [2]. The highest level of evidence, a systematic

∗ Corresponding author. Tel.: +44 0 20 7314 7863;ax: +44 0 20 7306 6611.

E-mail address: [email protected] (A. Jackson).

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031-9406/$ – see front matter © 2009 Chartered Society of Physiotherapy. Publis

eview of randomised controlled trials (RCTs) [3], is gen-rally used to analyse the research evidence [4]. However,uideline developers have a major problem where there areaps in the evidence, the evidence is of poor quality or the con-lusions are uncertain. Leaving guidelines incomplete doesot provide the basis for decision-making needed by clin-cians and policy makers [5,6]. One way to overcome thisroblem is to use a structured and systematic process ofonsensus development, based on scientific methods. Thiss advocated, for example, by England and Wales’s Nationalnstitute for Health and Clinical Excellence (NICE) in con-

unction with a detailed description in the documentation toemonstrate an explicit and transparent process [7].

Two methods of development are commonly used: theelphi method and the Nominal Group Technique (NGT).

hed by Elsevier Ltd. All rights reserved.

Page 2: Using consensus methods in developing clinical guidelines for exercise in managing persistent low back pain

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oth use groups of expert participants who complete ques-ionnaires on which they vote privately. For the Delphi

ethod, after the first-round questionnaire, in which panelembers rate their agreement/disagreement with statements

elevant to the topic on which consensus is being sought,articipants receive a summary of results from the wholeroup, as well as their own response, and are invited to votegain. This is repeated until it is deemed that a consensusas been reached. Participants do not meet or interact. TheGT also involves at least two rounds of private voting, but

lso includes face-to-face discussion at the outset to identifyhe issues that are to be the subject of attempts to reach con-ensus. Face-to-face discussion is also held between the twooting rounds to review and discuss the results of the firstoting round and to seek clarification, if needed. Commonly,uideline developers use a ‘modified NGT’ in which partic-pants express their initial ideas via a mailed questionnaire,nd meet face-to-face on a single occasion between the twooting rounds. More information and analysis about theseethods can be found in a review by Murphy et al. [8].This paper focuses on the development of guidelines for

he use of exercise for patients aged between 18 and 65 yearsith non-specific low back pain (LBP) lasting 6 weeks orore. The central clinical question was: Is exercise more

ffective in terms of improving health status of people withersistent LBP than no active intervention?

This broke down into 24 discrete clinical questionsTable 1) because:

eight types of exercise were found in the literature(mobilising, strengthening, aerobic, unsupervised walk-ing, general, core stability, hydrotherapy and McKenzie);andthe eight types of exercises related to three definitionsof health status (reducing pain, improving function andimproving psychological status).

Specifically, the use of the NGT to generate consensusvidence to answer the clinical questions unanswered byhe research evidence is described. The guideline develop-

ent group (GDG) sought to discuss the questions betweenounds of voting, and thus based these methods on the NGT.owever, the NGT was adapted and streamlined by using

lectronic communication throughout.

ethods

ooking to the research evidence to answer the clinicaluestions

Research evidence is most reliable and RCTs can poten-ially give the least biased research evidence. Thus, the search

or literature from 1966 to June 2005 was for RCTs relat-ng to physiotherapy exercise for LBP published in English.he databases searched were: Medline, EMBASE, CINAHL,MED, PEDro, the Cochrane Library and Sports Discus.

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py 94 (2009) 302–313 303

n addition, the European guidelines for the management ofhronic non-specific LBP were used to identify RCTs [9].he references for the studies were imported into biblio-raphic software (Endnote, version 5) and duplicates wereliminated. Titles and abstracts were scanned for RCTs rel-vant to this review. Full-text paper copies of relevant RCTsere obtained for the reviewers.The 31 relevant RCTs identified were assessed according

o three quality criteria:

size, i.e. a trial was defined as large where there were 40 ormore participants in the intervention group (there was anindication that this was an adequate size to demonstrate adifference between comparison groups [10], and very fewof these RCTs contained a power analysis which is thepreferred method of determining sample size);methodological quality using a modification of the vanTulder Quality Scale [11] and two independent reviewers;a trial scoring the median as 5 or more was defined as ahigh-quality trial; androbust statistical analysis, i.e. where trials compared thedifference between the effectiveness of an exercise inter-vention and an alternative (or control) intervention.

More information on the methods used in the systematiceview is available in the article by Hettinga et al. [12].

Using only those trials defined as large, high in method-logical quality and robust in statistical analysis, it wasossible to ensure that the recommendations derived fromesearch evidence were based on the most reliable evidence.f the original 24 clinical questions, seven were answered

n the systematic review [12] (Table 1, Questions 2, 3, 5, 8,1, 13 and 15). This paper focuses on the process used toenerate consensus evidence with a view to answering theemaining 17 questions.

he consensus group established to generate consensusvidence

Having established that there were unanswered questions,consensus group was identified to consider these questions.articipants of this group were:

14 members of the GDG, i.e. experts in various phys-iotherapy interventions (exercise including hydrotherapy,manual therapy, patient views, sports science), a patientrepresentative, researchers and managers from throughoutthe UK; andnine additional experts, chosen for their specialist knowl-edge in the field of physiotherapy for people with LBP.

Thus, the 23 participants, selected for their wide-rangingxpertise, included physiotherapists from throughout the UKrom a range of clinical interest groups, academics, patientepresentatives, policy makers and guideline methodologists.

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hysiotherapy94

(2009)302–313

Table 1Expert consensus evidence augmented research evidence.

Question no. Clinical question Quality researchevidence

Yes – consensusfirst round

Number of contributions tothe electronic conference

Yes – consensussecond round

When the aim of treatment is reducing pain for people with persistent low back pain1 Are mobilising exercises more effective than no active intervention? x 60% 4 83%2 Are strengthening exercises more effective than no active

intervention?Donchin [23] – – –

3 Are aerobic exercises more effective than no active intervention? Manion [24] – – –4 Is unsupervised walking more effective than no active intervention? x 56% 3 74%5 Are general exercises more effective than no active intervention? Klaber Moffett [25], UK BEAM

[26,27]– – –

6 Are core stability exercises more effective than no activeintervention?

x 56% 7 74%

7 Are hydrotherapy exercises more effective than no activeintervention?

x 52% 7 83%

8 Are McKenzie exercises more effective than no active intervention? Petersen [28], Donchin [23] – – –

When the aim of treatment is improving function for people with persistent LBP9 Are mobilising exercises more effective than no active intervention? x 64% 4 91%

10 Are strengthening exercises more effective than no activeintervention?

x 80% – –

11 Are aerobic exercises more effective than no active intervention? Manion [24] – –12 Is unsupervised walking more effective than no active intervention? x 76% – –13 Are general exercises more effective than no active intervention? Klaber Moffett [25], UK BEAM

[26,27]– – –

14 Are core stability exercises more effective than no activeintervention?

x 72% 3 83%

15 Are hydrotherapy exercises more effective than no activeintervention?

McIlveen [29] – – –

16 Are McKenzie exercises more effective than no active intervention? x 60% 4 87%

When the aim of treatment is improving psychological status for people with persistent low back pain17 Are mobilising exercises more effective than no active intervention? x 56% 1 83%18 Are strengthening exercises more effective than no active

intervention?x 60% 3 87%

19 Are aerobic exercises more effective than no active intervention? x 96% – –20 Is unsupervised walking more effective than no active intervention? x 84% – –21 Are general exercises more effective than no active intervention? x 88% – –22 Are core stability exercises more effective than no active

intervention?x 32% 3 61%

23 Are hydrotherapy exercises more effective than no activeintervention?

x 60% 3 83%

24 Are McKenzie exercises more effective than no active intervention? x 52% 6 83%

x, no; –, not applicable, evidence exists (research or consensus) making this stage unnecessary. Percentage is given when consensus (75% agreement or more) was reached. Bold text indicates that an evidencestatement was derived from this.

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he Nominal Group Technique

For people with persistent LBP, the systematic reviewmphasised uncertainty in 17 clinical questions (Table 1,uestions 1, 4, 6, 7, 9, 10, 12, 14, 16, 17, 18, 19, 20, 21,2, 23 and 24). To fill these gaps, the GDG sought consensusvidence using a modified NGT [8] which is summarised inig. 1.

There is no standard threshold for consensus and, after dis-ussion, the GDG decided that they would define consensuss 75% agreement or more. Some reasons for this decisionncluded that:

this was in keeping with a previous Chartered Society ofPhysiotherapy (CSP) GDG that had defined consensus as75% or more [13], and it made sense to have continuity inthe series of publications;the previous GDG had considered consensus levels set inother healthcare studies at 51% [14], 66% [15] and 75%[16]; andthe current GDG were confident to make a recommenda-tion, appropriately graded, with 75% expert agreement ormore.

For both rounds of the questionnaire, participants weresked to take into account all their knowledge and experienceclinical, research, service user) and the systematic review

part

able 2ummary of electronic conference – exercise and function.

uestion no. Question and agreement in first round Some main

Mobilising exercises are more effective thanno active intervention in improving function

For mobilis

Agree 64%Can help a pcan improve

Mid 28% Are often ramovement lDisagree 8%May benefithappens is lAgainst mobMay improv

4 Core stability exercises are more effectivethan no active intervention in improvingfunction

For core sta

Agree 72%

Any study cactive interv

Mid 16%Against/mid

Disagree 12%May or may

6 McKenzie exercises are more effective thanno active intervention in improving function

For McKenz

Agree 60%Petersen [28improving f

Mid 24% Clare’s systconcluded tterm) than s

Disagree 16% The Europeclearly founmore effect

a Petersen’s trial was included in the systematic review but there was no definitivhus the GDG were unable to conclude that McKenzie exercises improved function

b Clare’s review included trials involving participants with acute low back pain anvidence for these guidelines.

py 94 (2009) 302–313 305

containing results of some small and less methodologicallyound papers). For the discussion, participants were asked tondicate the reasons for their agreement/disagreement.

he first round of the questionnaireParticipants were asked to indicate whether they agreed or

isagreed on a three-point Likert scale (agree, neither agreeor disagree, disagree). This led to 75% expert agreement orore for five questions (Table 1, Questions 10, 12, 19, 20 and

1) and five evidence statements were written. For example,or Question 10:

trengthening exercises may be more effective than no activentervention in improving function (80% consensus, firstound).

he electronic conferenceThe 12 questions for which expert group agreement was

ess than 75% in this first-round questionnaire went to anlectronic conference for discussion (Table 1, Questions 1,, 6, 7, 9, 14, 16, 17, 18, 22, 23 and 24).

The electronic conference was conducted in a 2-week timeeriod on a specific network (open only to the 23 partici-

ants) of the interactive CSP, an electronic peer networkingnd sharing tool. Percentage group agreement in the first-ound questionnaire was given and participants were askedo explain the reasons for their votes with the aim of adding

points made by participants

ing exercises:erson feel more confidence in getting on with normal activities and thusfunction

ted highly by clinicians for those who are immobile or have poor range ofate in their rehabilitationpeople in that they gain more movement and the mechanism by which this

ikely to be complex, involving factors such as reducing fear of movementilising exercises:e range of movement but this does not mean function will be improved

bility exercises:omparing core stability exercises, delivered by physiotherapists, with noention will demonstrate improved function using a robust toolcore stability exercises:not improve function

ie exercises:

] found McKenzie exercises as effective as strengthening exercises forunction, thus McKenzie exercises should improve functiona

ematic review [30] of McKenzie exercises for spinal pain (five trials)hat McKenzie therapy results in a greater improvement in function (shorttandard therapiesb

an guidelines group concluded that no specific form of exercise has beend to be better than another [9], so it is likely that McKenzie exercises areive than no treatment

e evidence to demonstrate that strengthening exercises improved function,from this comparison.d hence it was excluded from consideration in the systematic review of the

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upplementary information that could be used by others wheneconsidering how to vote in the second-round questionnaire.

Engagement in the electronic conference was as follows:

13 (57%) of 23 participants contributed to the electronicconference;the 13 participants made 48 separate contributions;each expert made between one and 10 separate contribu-tions (median 4);there were between one and seven separate contributionsto each question (median 3.5);participants generally indicated whether or not they agreedwith the question; and17 (74%) participants visited the electronic conferenceduring the 2 weeks that it was live.

A brief summary of some the major points made in thelectronic conference in relation to whether mobilising, coretability and McKenzie exercises improve function for people

ith persistent LBP is given (Table 2). This overview givesfeel of the points made by participants.

To demonstrate how the electronic conference worked,more complete discussion string is given for Question 7

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ig. 1. Details of the consensus methods.

py 94 (2009) 302–313

hydrotherapy exercises are more effective than no activentervention in reducing pain) (Table 3). Although doubt wasxpressed, there was mostly agreement with this statementnd consensus was reached in the second-round question-aire. Note that participants cited patient views, workplaceudits and unpublished student projects as reasons for theirgreement with the statement. These arguments, togetherith the response to the query about whether the inter-ention has a long-term benefit, i.e. that this may notatter as control is with the patient, were probably cru-

ial in shifting agreement with this statement from 52%o 83%.

he second round of the questionnaireParticipants were asked to indicate whether they agreed

r disagreed on a three-point Likert scale, as before, andhis time they were asked to consider the discussion in thelectronic conference in addition to all their knowledge and

xperience.

After the questionnaire, agreement was collated as a per-entage of the expert group (Table 1). More than 75% ofarticipants agreed with a further nine statements at this stage;

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A. Jackson et al. / Physiotherapy 94 (2009) 302–313 307

Table 3Some main points made in the electronic conference – Question 7.

Participant Contribution

1 I agree. People with persistent LBP attending hydrotherapy self-help groups say that if they miss sessions, their pain increases andtheir mobility decreases.If fear is an important factor in pain, and people report that exercising in warm water feels ‘safer’, then hydrotherapy exercises canreduce fear and thus reduce pain.

2 But to what extent does ‘feeling safe’ in the water transfer to the dry world? For me, an effective treatment does not require ongoing‘maintenance sessions’.

3 We advise people to stay active to reduce their pain (these guidelines) but exercise can be difficult because of co-morbidity (e.g.arthritis in other joints, fear avoidance). Exercise may be more comfortable with the buoyancy and warmth of the water.Some people choose to exercise in water, they enjoy it, and compliance is improved.Most hydrotherapy programmes include an element of other types of exercise, e.g. aerobic and general exercise.In a recent questionnaire that I carried out (110 hydrotherapy patients with LBP), 62% reported less pain immediately aftertreatment. I only have 13 replies for a 4-month follow-up but again 62% report less pain.Group hydrotherapy programmes (as with group land treatment) are extremely cost-effective.Exercise is not a ‘cure’ and it would be unrealistic to expect this especially for the complex patients referred to hydrotherapy.Whatever the choice of exercise, it must be ongoing.

4 One of my BSc students completed a qualitative study on the effects of hydrotherapy and a core theme was pain reduction. Thesample was biased, those who did not perceive benefits were unlikely to continue, but hydrotherapy was highly rated.With hydrotherapy, significant non-treatment effects are a likely part of the experience.We consider other forms of exercise preferable to ‘no active intervention’ in reducing pain and I cannot see how hydrotherapy isdifferent.There are also the physiological effects of immersion on nerve conduction; pain is reduced.

5 [From Participant 1] it seems that hydrotherapy may reduce pain in the short term but it may increase dependency and fear ofnormal activity.People with severe LBP-related disability can exercise on land but may prefer hydrotherapy.Hydrotherapy may or may not reduce pain but is likely to have functional benefits.

6 I agree with [Participant 4], if we recommend exercise then we must recommend hydrotherapy. It is a form of general exercise thatmany choose and continue with in the long term.

7 In reply to [Participant 2], where people are not over medicalised then a self-referral or request to repeat hydrotherapy demonstratesa patient-centred locus of control, which is good. It is not particularly important if there are no measurable effects on dry land.

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aquestionnaire, and the remaining 12 went to electronic con-ference and to the second-round questionnaire. Of these, nineachieved group consensus at this stage and three remainedunanswered. Thus, 14 clinical questions achieved expert

Table 4Grading guideline recommendations adapted from the National Institute forHealth and Clinical Excellence [3].

Grade Evidence

A At least one randomised controlled trial of overallhigher quality and consistency addressing the specificrecommendation

B Well-conducted clinical studies but not randomisedcontrolled trials on the topic of the recommendation

C Evidence from the Nominal Group Technique or other

People who benefit from hydrotherapy are often eimproved function from their general satisfaction

BP, low back pain.

hus, nine more consensus statements could be written. Forxample, for Question 9:

obilising exercises may be more effective than no activentervention in improving function (91% consensus, secondound).

By indicating whether or not consensus was achieved dur-ng the first or second round, guideline users can see the staget which consensus was achieved in addition to the level ofgreement.

There is no discussion of response rates for the two roundsf the questionnaire because all participants fully completednd returned both questionnaires; they were recruited on thenderstanding that they would do this.

ormulating the recommendations

Using both the research evidence and the consensus evi-

ence, the GDG was able to formulate the recommendationsor practice. Recommendations were graded according touidance from the National Institute for Health and Clinicalxcellence (Table 4).

D

ly enthusiastic and it may be difficult to separate their pain relief andgh it can be done with validated outcome measures.

esults

Of the 17 clinical questions unanswered by the system-tic review, five achieved group consensus in the first-round

expert committee reports. This indicates that directlyapplicable clinical studies of higher quality are absentRecommended good practice based on the clinicalexperience of the guideline development group

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roup consensus, and from this consensus evidence, 14 rec-mmendations for clinical practice were formulated by theDG (Grade C). The seven recommendations (Grade A)

orming the basis of the research evidence are included forompleteness.

To reduce pain, one or more of the following should beonsidered:

Strengthening exercises, Grade A (Question 2 – Table 1)Organised aerobic exercises, Grade A (Question 3 –Table 1)General exercises, Grade A (Question 5 – Table 1)McKenzie exercises, Grade A (Question 8 – Table 1)Mobilising exercises, Grade C (Question 1 – Table 1)Hydrotherapy exercises, Grade C (Question 7 – Table 1)

To improve function, one or more of the following shoulde considered:

Organised aerobic exercises, Grade A (Question 11 –Table 1)General exercises, Grade A (Question 13 – Table 1)Hydrotherapy exercises, Grade A (Question 15 – Table 1)Mobilising exercises, Grade C (Question 9 – Table 1)Strengthening exercises, Grade C (Question 10 – Table 1)Core stability exercises, Grade C (Question 14 – Table 1)McKenzie exercises, Grade C (Question 16 – Table 1)

To improve psychological status, one or more of the fol-owing should be considered:

Organised aerobic exercises, Grade C (Question 19 –Table 1)General exercises, Grade C (Question 21 – Table 1)Hydrotherapy exercises, Grade C (Question 23 – Table 1)Mobilising exercises, Grade C (Question 17 – Table 1)Strengthening exercises, Grade C (Question 18 – Table 1)McKenzie exercises, Grade C (Question 24 – Table 1)

People may be advised of the benefits of unsupervisedalking in:

improving function, Grade C (Question 12 – Table 1)improving psychological status, Grade C (Question 20 –Table 1)

To emphasise the origin of each recommendation, a link isade to Table 1. The full set of recommendations is given in

he full document [17]. No recommendations were made foruestions 4, 6 and 22 because consensus (75% agreement)as not reached after the second-round questionnaire.

iscussion

Increasing life expectancy and a growing demand for

ealth services, together with the need for cost containment,as led to the current emphasis on efficiency and evidence-ased health care. In the absence of high-quality researchvidence that is capable of answering all clinical questions, it

tept

py 94 (2009) 302–313

s suggested that recommendations for clinical practice maye based on scientific consensus evidence, and the modifiedGT, a transparent and scientific tool, is advocated.It has been argued that consensus methods lead to guide-

ines that are more complete and hence more clinicallyseful than guidelines based solely on a systematic reviewf research evidence. Despite this, other guidelines for non-pecific LBP did not include scientific consensus methods,.g. the European guidelines [9] and the guidelines of theoyal Dutch Association of Physical Therapy [18], and it isrgued that consensus methods may lead to recommendationshat are subsequently found to be wrong. The problem withhis is that people with LBP need treatment today, and usingscientific process to generate the evidence, and grading it

ccordingly, gives clinicians and patients the benefit of expertpinion based on what we know now. This was the authors’hilosophical reason for including consensus evidence wherehere were gaps in the review.

The authors’ decision to use consensus evidence was alsoased on a careful consideration of the extremely complexssues. Firstly, there are inevitably cases where consen-us evidence conflicts with evidence outside the review.rofessionals form their opinions about available evidencesing their experience. The consensus participants wereelected because they were particularly research aware phys-otherapists. They were asked to consider, and bring to theiscussion, all their experience and evidence outside theeview. In this way, through the participant group’s knowl-dge, the consensus methods included consideration of theider evidence. Secondly, any review of evidence from

tudies that are not RCTs must include a critical appraisalf the literature. The inevitable result would be difficultomparisons between non-RCT findings of varied qualitynd consensus/professional opinion. By incorporating non-CT literature into developing the guidelines indirectly,

.e. through consensus methods, potentially insurmountableifficulties were avoided. Thirdly, the volume of non-RCT lit-rature in the area of LBP made it impractical and impossibleo critically appraise all the literature in the guideline devel-pment period. A pragmatic strategy was needed. Fourthly,uidelines are a tool to assist in clinical decision-making. Its stressed that these recommendations are not recipes forractice and should be applied after assessment of individualatients. Thus, the authors decided to use a combination ofCT and consensus evidence in developing the guidelines,s is standard practice [3].

Table 5 (Question 6) illustrates how the consensus par-icipants considered evidence outside the systematic review.he evidence brought to the discussion was that core stabil-

ty exercises reduce pain, but consensus was not achievednd a recommendation was not made. The evidence was dis-ussed and the participants as a whole did not believe that

hese research papers indicated sufficiently that core stabilityxercises should be generally recommended. Whilst it is notossible to assess the case for all evidence that conflicts withhe recommendations, the authors believe that systematically
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A. Jackson et al. / Physiotherapy 94 (2009) 302–313 309

Table 5Some main points made in the electronic conference – Question 6.

Participant Contribution

1 I responded ‘agree’ in the light of two papers: Goldby [31] and Critchley [32]. Both were published since our review andboth indicate reduced pain with core stability exercises.

2 But Goldby’s trial did not have a group that received ‘no active intervention’, it considered the comparative effectiveness ofthe treatments. Your rationale for the ‘agree’ response is at odds with the statement under consideration.I responded ‘agree’ because any intervention is highly likely to be better than ‘no active intervention’.

3 I agree that some active intervention would be better than nothing but I am not sure that means you have to agree with allstatements.Some types of exercise are rather minimal and physically active patients might need more extensive and intensive exercise.

4 I understand that core stability, in particular the early activation of the transversus abdominis and multifidus muscles, isthought to be important in recovery from acute and subacute low back pain [33,34]. It makes sense that, if it is needed, thistype of retraining should be done for those with persistent back pain.I am aware that the Medical Exercise Therapy (combined approach) programme used in the Tortensen trial [35] has anemphasis on retraining spinal stability in functional positions.I recall that the Goldby exercise programme [31] was not practiced in functional positions? My opinion is that core stabilityis effective in reducing back pain but that this training should be done in functional positions.Clinically I feel core stability exercises work with a select subgroup of people with LBP only and should not be usedindiscriminately. When we are able to subclassify people with LBP more effectively, I think we will be better equipped todecide on this statement.

5 I strongly agree with [Participant 4]. We have run a workplace audit of a group doing core stability exercises for LBP.Exercises include aerobic exercises and core stability exercises in functional positions. Many attending the group haveimproved visual analogue scale scores for pain and Oswestry scores but not everybody improves. Also consider that manypatients that we see in practice (outside the rigorously controlled RCTs that we are using as our evidence base) are probablymore complex than trial participants.An incidental point, the confidence and experience of the therapist appears to be the most important indicator of attendancefor group work. It is another issue but it should be recognised.

6 I agree with [Participants 4 and 5]. There may be a subgroup that do well with core stability exercise but if the guidelines areat core

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BP, low back pain; RCT, randomised controlled trial.

eveloped consensus evidence is useful to clinicians whereecommendations are clearly graded.

The NGT was adapted; discussion between private votingounds took place electronically rather than face-to-face. Theecision to do this was pragmatic. Developing the guidelinesad taken longer than expected, and there were financial con-traints and pressures to complete the project. Although theDG had some face-to-face meetings in the earlier stagesf guideline development, at the stage of generating theonsensus evidence, most GDG business was conductedlectronically using an interactive CSP network; it was aogical step for the consensus conference to use this facil-ty. This decision had many advantages: participants fromcross the UK did not need to commit to a day’s meet-ng in a central location, it was not necessary to identify a

eeting date to suit busy schedules, money on travel andeeting costs was saved, participants could access the con-

erence at a time and in a place that was convenient tohem, and contribution (57%) and participation (74%) wasigh. In addition, the use of electronic methods for the twoounds of voting resulted in all 23 participants voting in

oth rounds of the questionnaire. Thus the modified NGTas carried out over a 6-week period (Fig. 1); it was aractical and cost-effective way of generating consensus evi-ence.

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stability exercises may improve muscle control but may or may not

The participant group was carefully selected to ensurenclusion of as full a range of experts as was possible. Tonsure rigour, participants of consensus groups should com-rise experts in the field, respected for both their knowledgend clinical experience [19]. They should also be credi-le to guideline users and represent a range of interests. Inheir review, Murphy et al. found that members of a par-icular specialty are more likely to advocate treatments thatnvolve their specialty [8]. The inclusion of a wide range ofarticipants with a range of clinical, managerial and method-logical experience in this expert consensus group promptedbalanced view and reduced the risk of bias from vested

nterests.Furthermore, the expert participant group included a rep-

esentative of a patient group. This is in line with UKovernment agenda, which began with the NHS and Commu-ity Care Act of 1990 [20]. The representative in this studyas a layperson who worked for the charity BackCare. Herngoing interaction with people with persistent LBP gaveer an excellent understanding of the range of interventionsvailable to people with persistent LBP and their reactions to

hem. An example of the way in which patients’ views wereepresented in the consensus process can be seen in Partici-ant 1s contribution to Question 7 (Table 3). This extremelyractical view comes from many years of lay communication
Page 9: Using consensus methods in developing clinical guidelines for exercise in managing persistent low back pain

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ith people with LBP; it was re-inforced by some health pro-essionals, i.e. Participants 3, 4 and 6 (Table 3), and grouponsensus was reached.

As stated, the authors are less sure of recommendationsased on consensus evidence than those based on researchvidence. This is made clear by the grade allocated to eachecommendation (Table 4). Grade A practice recommenda-ions are derived directly from robust research, i.e. fromt least one RCT, whereas Grade C recommendations areerived from the modified NGT. Thus all guidelines users,hether they are managers, clinicians, patients, researchersr healthcare commissioners, can appreciate the strength ofhe evidence on which a treatment is based. The clear gradingystem also highlights potential future research questions, i.e.ll Grade C recommendations.

Despite the 21 recommendations listed here, it remainsnclear which type of exercise is recommended for anndividual person with persistent LBP. The reason forhis is two fold. Firstly, this issue lies outside the scopef these guidelines. The GDG did write some additionalecommendations to assist clinicians in implementing theuidelines, but these additional recommendations were for-ulated by GDG interpretation rather than being included

n the modified NGT, hence they are not discussed here.econdly, the research evidence has not yet addressed

ssues of this nature; researchers are just beginning thesenvestigations.

Consensus methods are becoming increasingly important.n addition to this work, they were used in the CSP-ommissioned guidelines for whiplash-associated disorder13]. In 2007, following the guidelines review [21], the CSPnitiated the Supporting Knowledge in Physiotherapy Prac-ice (SKIPP) project [22] which is currently being piloted.he SKIPP project has produced a framework to facilitate theevelopment of evidence-based tools for physiotherapy prac-ice which are housed on the CSP website and accessed viahe CSP library management system. SKIPP tools or productsill include not only clinical guidelines but also consen-

us statements in areas where there is insufficient researchvidence for full clinical guidelines. Developers of SKIPProducts should be familiar with consensus methods andheir potential to assist clinicians with recommendations forest practice. It is hoped that this paper will be a useful andractical reference.

onclusion

Developing consensus evidence to fill the gaps in researchs likely to become increasingly important in a world wherevidence-based health care is expected. One is never likely toe in possession of all the quality research evidence needed

o treat patients in a rapidly changing world. Using NGTechniques, adapted as described here, can produce consensusvidence statements and, ultimately, recommendations forlinical intervention. These statements are the best evidence

py 94 (2009) 302–313

or treating patients today and lead to questions for researchomorrow.

ote

As a result of the pragmatic methods used, i.e. well-onducted clinical studies that were not RCTs were notonsidered, there are no Grade B recommendations in theseuidelines.

cknowledgements

The authors wish to thank fellow members of the GDG,n particular, Panos Barlos, Sarah Ferguson, Susan Green-algh, Vicki Harding, Deirdre Hurley Osing, Jennifer Klaberoffett, Dennis Martin, Stephen May, Jude Monteath, Lisaoberts, Nia Taylor and Steve Woby. The authors also wish to

hank the members of the expert consensus group, numerousmployees of what is now the CSP’s Practice and Develop-ent function, and many other experts who gave their time

reely to develop the CSP’s clinical guidelines for the phys-otherapy management of persistent LBP.

unding: CSP as a part of the commissioned guidelines pro-ramme (2003–2007).

onflict of interest: None.

eferences

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[2] Mead J, van der Wees P. WCPT keynotes/EBP clinical guidelines 1– an introduction. World Conference of Physical Therapy. Vancouver,Canada, 2–6 June, 2007.

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[4] Burgers JS, Grol R, Klazinga NS, Makela M, Zaat J. Towards evidence-based clinical practice: an international survey of 18 clinical guidelineprograms. Int J Qual Health Care 2003;15:31–45.

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oi:10.1016/j.physio.2009.08.001

ommentary

Innovation in health care and physiotherapy often comesrom clinicians and experts seeking to better manage healthroblems that they or society believe are not adequatelyddressed. Clinicians and experts develop hypotheses toetter manage these problems, therefore playing a vitalole in physiotherapy development. To foster this, clini-ians should be encouraged to disseminate their hypotheseshrough the publication of case studies or collaborationith researchers. In the absence of scientific evidence, it

s also more appropriate to guide our management choicesith theoretically driven knowledge and reasoning devel-ped by experts than with intuition, as is appropriatelytated by Jackson et al. [1]. This study has success-ully transformed, through a formal and structured process,acit knowledge of clinicians and experts into explicitypotheses.

As mentioned by Jackson et al. [1], hypotheses must beested with scientific methods for confirmation. The level ofonfirmation depends on the robustness of the research meth-ds used to test the hypotheses. The more robust the researchethod, the more certain one can be that X (e.g. the exercise)

s related to Y (the outcome, e.g. pain). For interventions,andomised controlled trials (RCTs) are traditionally vieweds the highest form of evidence, and correspond to Grade Avidence in the study. Although RCTs are the gold standardnd referred to as true experimental designs, other researchethods still allow one to study the relationship between X

nd Y but with less certainty because of confounding factors.

hese include, in decreasing robustness: quasi-experimental,re-experimental, cohort, case–control and transversal stud-es. These designs correspond to Grade B evidence in thistudy. Although less robust than RCTs, these research meth-