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

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

c

Chartered Society of Physiotherapy, 14 Bedford Row, London WC1R 4ED, UK b Judy Mead – previously of CSP, 14 Bedford Row, London WC1R 4ED, UK 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 statements 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 implementing 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 generally 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 conclusions are uncertain. Leaving guidelines incomplete does not provide the basis for decision-making needed by clinicians 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 conjunction 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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Both use groups of expert participants who complete questionnaires on which they vote privately. For the Delphi method, after the first-round questionnaire, in which panel members rate their agreement/disagreement with statements relevant to the topic on which consensus is being sought, participants receive a summary of results from the whole group, as well as their own response, and are invited to vote again. This is repeated until it is deemed that a consensus has been reached. Participants do not meet or interact. The NGT also involves at least two rounds of private voting, but also includes face-to-face discussion at the outset to identify the issues that are to be the subject of attempts to reach consensus. Face-to-face discussion is also held between the two voting rounds to review and discuss the results of the first voting round and to seek clarification, if needed. Commonly, guideline developers use a ‘modified NGT’ in which participants express their initial ideas via a mailed questionnaire, and meet face-to-face on a single occasion between the two voting rounds. More information and analysis about these methods can be found in a review by Murphy et al. [8]. This paper focuses on the development of guidelines for the use of exercise for patients aged between 18 and 65 years with non-specific low back pain (LBP) lasting 6 weeks or more. The central clinical question was: Is exercise more effective in terms of improving health status of people with persistent LBP than no active intervention? This broke down into 24 discrete clinical questions (Table 1) because: • eight types of exercise were found in the literature (mobilising, strengthening, aerobic, unsupervised walking, general, core stability, hydrotherapy and McKenzie); and • the eight types of exercises related to three definitions of health status (reducing pain, improving function and improving psychological status). Specifically, the use of the NGT to generate consensus evidence to answer the clinical questions unanswered by the research evidence is described. The guideline development group (GDG) sought to discuss the questions between rounds of voting, and thus based these methods on the NGT. However, the NGT was adapted and streamlined by using electronic communication throughout.

Methods Looking to the research evidence to answer the clinical questions Research evidence is most reliable and RCTs can potentially give the least biased research evidence. Thus, the search for literature from 1966 to June 2005 was for RCTs relating to physiotherapy exercise for LBP published in English. The databases searched were: Medline, EMBASE, CINAHL, AMED, PEDro, the Cochrane Library and Sports Discus.

303

In addition, the European guidelines for the management of chronic non-specific LBP were used to identify RCTs [9]. The references for the studies were imported into bibliographic software (Endnote, version 5) and duplicates were eliminated. Titles and abstracts were scanned for RCTs relevant to this review. Full-text paper copies of relevant RCTs were obtained for the reviewers. The 31 relevant RCTs identified were assessed according to three quality criteria: • size, i.e. a trial was defined as large where there were 40 or more participants in the intervention group (there was an indication that this was an adequate size to demonstrate a difference between comparison groups [10], and very few of these RCTs contained a power analysis which is the preferred method of determining sample size); • methodological quality using a modification of the van Tulder Quality Scale [11] and two independent reviewers; a trial scoring the median as 5 or more was defined as a high-quality trial; and • robust statistical analysis, i.e. where trials compared the difference between the effectiveness of an exercise intervention and an alternative (or control) intervention. More information on the methods used in the systematic review is available in the article by Hettinga et al. [12]. Using only those trials defined as large, high in methodological quality and robust in statistical analysis, it was possible to ensure that the recommendations derived from research evidence were based on the most reliable evidence. Of the original 24 clinical questions, seven were answered in the systematic review [12] (Table 1, Questions 2, 3, 5, 8, 11, 13 and 15). This paper focuses on the process used to generate consensus evidence with a view to answering the remaining 17 questions. The consensus group established to generate consensus evidence Having established that there were unanswered questions, a consensus group was identified to consider these questions. Participants of this group were: • 14 members of the GDG, i.e. experts in various physiotherapy interventions (exercise including hydrotherapy, manual therapy, patient views, sports science), a patient representative, researchers and managers from throughout the UK; and • nine additional experts, chosen for their specialist knowledge in the field of physiotherapy for people with LBP. Thus, the 23 participants, selected for their wide-ranging expertise, included physiotherapists from throughout the UK from a range of clinical interest groups, academics, patient representatives, policy makers and guideline methodologists.

304

Table 1 Expert consensus evidence augmented research evidence. Question no.

Clinical question

When the aim of treatment is reducing pain for people with persistent low back pain 1 Are mobilising exercises more effective than no active intervention? 2 Are strengthening exercises more effective than no active intervention? 3 Are aerobic exercises more effective than no active intervention? 4 Is unsupervised walking more effective than no active intervention? 5 Are general exercises more effective than no active intervention? 6

8

When the aim of treatment is improving function for people with persistent LBP 9 Are mobilising exercises more effective than no active intervention? 10 Are strengthening exercises more effective than no active intervention? 11 Are aerobic exercises more effective than no active intervention? 12 Is unsupervised walking more effective than no active intervention? 13 Are general exercises more effective than no active intervention? 14 15 16

Are core stability exercises more effective than no active intervention? Are hydrotherapy exercises more effective than no active intervention? Are McKenzie exercises more effective than no active intervention?

Yes – consensus first round

Number of contributions to the electronic conference

Yes – consensus second round

x Donchin [23]

60% –

4 –

83% –

Manion [24] x Klaber Moffett [25], UK BEAM [26,27] x

– 56% –

– 3 –

– 74% –

56%

7

74%

x

52%

7

83%

–

–

–

x x

64% 80%

4 –

91% –

Manion [24] x Klaber Moffett [25], UK BEAM [26,27] x

– 76% –

– –

– – –

72%

3

83%

–

–

–

60%

4

87%

56% 60%

1 3

83% 87%

96% 84% 88% 32%

– – – 3

– – – 61%

60%

3

83%

52%

6

83%

Petersen [28], Donchin [23]

McIlveen [29] x

When the aim of treatment is improving psychological status for people with persistent low back pain 17 Are mobilising exercises more effective than no active intervention? x 18 Are strengthening exercises more effective than no active x intervention? 19 Are aerobic exercises more effective than no active intervention? x 20 Is unsupervised walking more effective than no active intervention? x 21 Are general exercises more effective than no active intervention? x 22 Are core stability exercises more effective than no active x intervention? 23 Are hydrotherapy exercises more effective than no active x intervention? 24 Are McKenzie exercises more effective than no active intervention? x

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 evidence statement was derived from this.

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

7

Are core stability exercises more effective than no active intervention? Are hydrotherapy exercises more effective than no active intervention? Are McKenzie exercises more effective than no active intervention?

Quality research evidence

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

The Nominal Group Technique For people with persistent LBP, the systematic review emphasised uncertainty in 17 clinical questions (Table 1, Questions 1, 4, 6, 7, 9, 10, 12, 14, 16, 17, 18, 19, 20, 21, 22, 23 and 24). To fill these gaps, the GDG sought consensus evidence using a modified NGT [8] which is summarised in Fig. 1. There is no standard threshold for consensus and, after discussion, the GDG decided that they would define consensus as 75% agreement or more. Some reasons for this decision included that: • this was in keeping with a previous Chartered Society of Physiotherapy (CSP) GDG that had defined consensus as 75% or more [13], and it made sense to have continuity in the series of publications; • the previous GDG had considered consensus levels set in other healthcare studies at 51% [14], 66% [15] and 75% [16]; and • the current GDG were confident to make a recommendation, appropriately graded, with 75% expert agreement or more. For both rounds of the questionnaire, participants were asked to take into account all their knowledge and experience (clinical, research, service user) and the systematic review

305

(containing results of some small and less methodologically sound papers). For the discussion, participants were asked to indicate the reasons for their agreement/disagreement. The first round of the questionnaire Participants were asked to indicate whether they agreed or disagreed on a three-point Likert scale (agree, neither agree nor disagree, disagree). This led to 75% expert agreement or more for five questions (Table 1, Questions 10, 12, 19, 20 and 21) and five evidence statements were written. For example, for Question 10: Strengthening exercises may be more effective than no active intervention in improving function (80% consensus, first round). The electronic conference The 12 questions for which expert group agreement was less than 75% in this first-round questionnaire went to an electronic conference for discussion (Table 1, Questions 1, 4, 6, 7, 9, 14, 16, 17, 18, 22, 23 and 24). The electronic conference was conducted in a 2-week time period on a specific network (open only to the 23 participants) of the interactive CSP, an electronic peer networking and sharing tool. Percentage group agreement in the firstround questionnaire was given and participants were asked to explain the reasons for their votes with the aim of adding

Table 2 Summary of electronic conference – exercise and function. Question no.

Question and agreement in first round

Some main points made by participants

9

Mobilising exercises are more effective than no active intervention in improving function Agree 64% Mid 28% Disagree 8%

For mobilising exercises: Can help a person feel more confidence in getting on with normal activities and thus can improve function Are often rated highly by clinicians for those who are immobile or have poor range of movement late in their rehabilitation May benefit people in that they gain more movement and the mechanism by which this happens is likely to be complex, involving factors such as reducing fear of movement Against mobilising exercises: May improve range of movement but this does not mean function will be improved

14

Core stability exercises are more effective than no active intervention in improving function Agree 72% Mid 16% Disagree 12%

For core stability exercises: Any study comparing core stability exercises, delivered by physiotherapists, with no active intervention will demonstrate improved function using a robust tool Against/mid core stability exercises: May or may not improve function

16

McKenzie exercises are more effective than no active intervention in improving function Agree 60%

For McKenzie exercises: Petersen [28] found McKenzie exercises as effective as strengthening exercises for improving function, thus McKenzie exercises should improve functiona

Mid 24%

Clare’s systematic review [30] of McKenzie exercises for spinal pain (five trials) concluded that McKenzie therapy results in a greater improvement in function (short term) than standard therapiesb The European guidelines group concluded that no specific form of exercise has been clearly found to be better than another [9], so it is likely that McKenzie exercises are more effective than no treatment

Disagree 16%

a Petersen’s trial was included in the systematic review but there was no definitive evidence to demonstrate that strengthening exercises improved function, thus the GDG were unable to conclude that McKenzie exercises improved function from this comparison. b Clare’s review included trials involving participants with acute low back pain and hence it was excluded from consideration in the systematic review of the evidence for these guidelines.

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supplementary information that could be used by others when reconsidering how to vote in the second-round questionnaire. Engagement in the electronic conference was as follows: • 13 (57%) of 23 participants contributed to the electronic conference; • the 13 participants made 48 separate contributions; • each expert made between one and 10 separate contributions (median 4); • there were between one and seven separate contributions to each question (median 3.5); • participants generally indicated whether or not they agreed with the question; and • 17 (74%) participants visited the electronic conference during the 2 weeks that it was live. A brief summary of some the major points made in the electronic conference in relation to whether mobilising, core stability and McKenzie exercises improve function for people with persistent LBP is given (Table 2). This overview gives a feel of the points made by participants. To demonstrate how the electronic conference worked, a more complete discussion string is given for Question 7

Fig. 1. Details of the consensus methods.

(hydrotherapy exercises are more effective than no active intervention in reducing pain) (Table 3). Although doubt was expressed, there was mostly agreement with this statement and consensus was reached in the second-round questionnaire. Note that participants cited patient views, workplace audits and unpublished student projects as reasons for their agreement with the statement. These arguments, together with the response to the query about whether the intervention has a long-term benefit, i.e. that this may not matter as control is with the patient, were probably crucial in shifting agreement with this statement from 52% to 83%. The second round of the questionnaire Participants were asked to indicate whether they agreed or disagreed on a three-point Likert scale, as before, and this time they were asked to consider the discussion in the electronic conference in addition to all their knowledge and experience. After the questionnaire, agreement was collated as a percentage of the expert group (Table 1). More than 75% of participants agreed with a further nine statements at this stage;

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307

Table 3 Some 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 and their mobility decreases. If fear is an important factor in pain, and people report that exercising in warm water feels ‘safer’, then hydrotherapy exercises can reduce 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 after treatment. 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. The sample 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 is different. 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 of normal 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 that many 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 demonstrates a patient-centred locus of control, which is good. It is not particularly important if there are no measurable effects on dry land. People who benefit from hydrotherapy are often extremely enthusiastic and it may be difficult to separate their pain relief and improved function from their general satisfaction, although it can be done with validated outcome measures.

LBP, low back pain.

thus, nine more consensus statements could be written. For example, for Question 9: Mobilising exercises may be more effective than no active intervention in improving function (91% consensus, second round). By indicating whether or not consensus was achieved during the first or second round, guideline users can see the stage at which consensus was achieved in addition to the level of agreement. There is no discussion of response rates for the two rounds of the questionnaire because all participants fully completed and returned both questionnaires; they were recruited on the understanding that they would do this. Formulating the recommendations Using both the research evidence and the consensus evidence, the GDG was able to formulate the recommendations for practice. Recommendations were graded according to guidance from the National Institute for Health and Clinical Excellence (Table 4).

Results Of the 17 clinical questions unanswered by the systematic review, five achieved group consensus in the first-round questionnaire, and the remaining 12 went to electronic conference and to the second-round questionnaire. Of these, nine achieved group consensus at this stage and three remained unanswered. Thus, 14 clinical questions achieved expert Table 4 Grading guideline recommendations adapted from the National Institute for Health and Clinical Excellence [3]. Grade

Evidence

A

At least one randomised controlled trial of overall higher quality and consistency addressing the specific recommendation Well-conducted clinical studies but not randomised controlled trials on the topic of the recommendation Evidence from the Nominal Group Technique or other expert committee reports. This indicates that directly applicable clinical studies of higher quality are absent Recommended good practice based on the clinical experience of the guideline development group

B C

D

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group consensus, and from this consensus evidence, 14 recommendations for clinical practice were formulated by the GDG (Grade C). The seven recommendations (Grade A) forming the basis of the research evidence are included for completeness. To reduce pain, one or more of the following should be considered: • 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 should be 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 following 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 unsupervised walking 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 is made to Table 1. The full set of recommendations is given in the full document [17]. No recommendations were made for Questions 4, 6 and 22 because consensus (75% agreement) was not reached after the second-round questionnaire.

Discussion Increasing life expectancy and a growing demand for health services, together with the need for cost containment, has led to the current emphasis on efficiency and evidencebased health care. In the absence of high-quality research evidence that is capable of answering all clinical questions, it

is suggested that recommendations for clinical practice may be based on scientific consensus evidence, and the modified NGT, a transparent and scientific tool, is advocated. It has been argued that consensus methods lead to guidelines that are more complete and hence more clinically useful than guidelines based solely on a systematic review of research evidence. Despite this, other guidelines for nonspecific LBP did not include scientific consensus methods, e.g. the European guidelines [9] and the guidelines of the Royal Dutch Association of Physical Therapy [18], and it is argued that consensus methods may lead to recommendations that are subsequently found to be wrong. The problem with this is that people with LBP need treatment today, and using a scientific process to generate the evidence, and grading it accordingly, gives clinicians and patients the benefit of expert opinion based on what we know now. This was the authors’ philosophical reason for including consensus evidence where there were gaps in the review. The authors’ decision to use consensus evidence was also based on a careful consideration of the extremely complex issues. Firstly, there are inevitably cases where consensus evidence conflicts with evidence outside the review. Professionals form their opinions about available evidence using their experience. The consensus participants were selected because they were particularly research aware physiotherapists. They were asked to consider, and bring to the discussion, all their experience and evidence outside the review. In this way, through the participant group’s knowledge, the consensus methods included consideration of the wider evidence. Secondly, any review of evidence from studies that are not RCTs must include a critical appraisal of the literature. The inevitable result would be difficult comparisons between non-RCT findings of varied quality and consensus/professional opinion. By incorporating nonRCT literature into developing the guidelines indirectly, i.e. through consensus methods, potentially insurmountable difficulties were avoided. Thirdly, the volume of non-RCT literature in the area of LBP made it impractical and impossible to critically appraise all the literature in the guideline development period. A pragmatic strategy was needed. Fourthly, guidelines are a tool to assist in clinical decision-making. It is stressed that these recommendations are not recipes for practice and should be applied after assessment of individual patients. Thus, the authors decided to use a combination of RCT and consensus evidence in developing the guidelines, as is standard practice [3]. Table 5 (Question 6) illustrates how the consensus participants considered evidence outside the systematic review. The evidence brought to the discussion was that core stability exercises reduce pain, but consensus was not achieved and a recommendation was not made. The evidence was discussed and the participants as a whole did not believe that these research papers indicated sufficiently that core stability exercises should be generally recommended. Whilst it is not possible to assess the case for all evidence that conflicts with the recommendations, the authors believe that systematically

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309

Table 5 Some 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 and both 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 of the 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 all statements. 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, is thought to be important in recovery from acute and subacute low back pain [33,34]. It makes sense that, if it is needed, this type 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 an emphasis 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 stability is 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 used indiscriminately. When we are able to subclassify people with LBP more effectively, I think we will be better equipped to decide 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 have improved visual analogue scale scores for pain and Oswestry scores but not everybody improves. Also consider that many patients that we see in practice (outside the rigorously controlled RCTs that we are using as our evidence base) are probably more complex than trial participants. An incidental point, the confidence and experience of the therapist appears to be the most important indicator of attendance for 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 are about LBP pain in general, then I think that core stability exercises may improve muscle control but may or may not improve pain.

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

developed consensus evidence is useful to clinicians where recommendations are clearly graded. The NGT was adapted; discussion between private voting rounds took place electronically rather than face-to-face. The decision to do this was pragmatic. Developing the guidelines had taken longer than expected, and there were financial constraints and pressures to complete the project. Although the GDG had some face-to-face meetings in the earlier stages of guideline development, at the stage of generating the consensus evidence, most GDG business was conducted electronically using an interactive CSP network; it was a logical step for the consensus conference to use this facility. This decision had many advantages: participants from across the UK did not need to commit to a day’s meeting in a central location, it was not necessary to identify a meeting date to suit busy schedules, money on travel and meeting costs was saved, participants could access the conference at a time and in a place that was convenient to them, and contribution (57%) and participation (74%) was high. In addition, the use of electronic methods for the two rounds of voting resulted in all 23 participants voting in both rounds of the questionnaire. Thus the modified NGT was carried out over a 6-week period (Fig. 1); it was a practical and cost-effective way of generating consensus evidence.

The participant group was carefully selected to ensure inclusion of as full a range of experts as was possible. To ensure rigour, participants of consensus groups should comprise experts in the field, respected for both their knowledge and clinical experience [19]. They should also be credible to guideline users and represent a range of interests. In their review, Murphy et al. found that members of a particular specialty are more likely to advocate treatments that involve their specialty [8]. The inclusion of a wide range of participants with a range of clinical, managerial and methodological experience in this expert consensus group prompted a balanced view and reduced the risk of bias from vested interests. Furthermore, the expert participant group included a representative of a patient group. This is in line with UK government agenda, which began with the NHS and Community Care Act of 1990 [20]. The representative in this study was a layperson who worked for the charity BackCare. Her ongoing interaction with people with persistent LBP gave her an excellent understanding of the range of interventions available to people with persistent LBP and their reactions to them. An example of the way in which patients’ views were represented in the consensus process can be seen in Participant 1s contribution to Question 7 (Table 3). This extremely practical view comes from many years of lay communication

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with people with LBP; it was re-inforced by some health professionals, i.e. Participants 3, 4 and 6 (Table 3), and group consensus was reached. As stated, the authors are less sure of recommendations based on consensus evidence than those based on research evidence. This is made clear by the grade allocated to each recommendation (Table 4). Grade A practice recommendations are derived directly from robust research, i.e. from at least one RCT, whereas Grade C recommendations are derived from the modified NGT. Thus all guidelines users, whether they are managers, clinicians, patients, researchers or healthcare commissioners, can appreciate the strength of the evidence on which a treatment is based. The clear grading system also highlights potential future research questions, i.e. all Grade C recommendations. Despite the 21 recommendations listed here, it remains unclear which type of exercise is recommended for an individual person with persistent LBP. The reason for this is two fold. Firstly, this issue lies outside the scope of these guidelines. The GDG did write some additional recommendations to assist clinicians in implementing the guidelines, but these additional recommendations were formulated by GDG interpretation rather than being included in the modified NGT, hence they are not discussed here. Secondly, the research evidence has not yet addressed issues of this nature; researchers are just beginning these investigations. Consensus methods are becoming increasingly important. In addition to this work, they were used in the CSPcommissioned guidelines for whiplash-associated disorder [13]. In 2007, following the guidelines review [21], the CSP initiated the Supporting Knowledge in Physiotherapy Practice (SKIPP) project [22] which is currently being piloted. The SKIPP project has produced a framework to facilitate the development of evidence-based tools for physiotherapy practice which are housed on the CSP website and accessed via the CSP library management system. SKIPP tools or products will include not only clinical guidelines but also consensus statements in areas where there is insufficient research evidence for full clinical guidelines. Developers of SKIPP products should be familiar with consensus methods and their potential to assist clinicians with recommendations for best practice. It is hoped that this paper will be a useful and practical reference.

Conclusion Developing consensus evidence to fill the gaps in research is likely to become increasingly important in a world where evidence-based health care is expected. One is never likely to be in possession of all the quality research evidence needed to treat patients in a rapidly changing world. Using NGT techniques, adapted as described here, can produce consensus evidence statements and, ultimately, recommendations for clinical intervention. These statements are the best evidence

for treating patients today and lead to questions for research tomorrow.

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Commentary Innovation in health care and physiotherapy often comes from clinicians and experts seeking to better manage health problems that they or society believe are not adequately addressed. Clinicians and experts develop hypotheses to better manage these problems, therefore playing a vital role in physiotherapy development. To foster this, clinicians should be encouraged to disseminate their hypotheses through the publication of case studies or collaboration with researchers. In the absence of scientific evidence, it is also more appropriate to guide our management choices with theoretically driven knowledge and reasoning developed by experts than with intuition, as is appropriately stated by Jackson et al. [1]. This study has successfully transformed, through a formal and structured process, tacit knowledge of clinicians and experts into explicit hypotheses. As mentioned by Jackson et al. [1], hypotheses must be tested with scientific methods for confirmation. The level of confirmation depends on the robustness of the research methods used to test the hypotheses. The more robust the research method, the more certain one can be that X (e.g. the exercise) is related to Y (the outcome, e.g. pain). For interventions, randomised controlled trials (RCTs) are traditionally viewed as the highest form of evidence, and correspond to Grade A evidence in the study. Although RCTs are the gold standard and referred to as true experimental designs, other research methods still allow one to study the relationship between X and Y but with less certainty because of confounding factors. These include, in decreasing robustness: quasi-experimental, pre-experimental, cohort, case–control and transversal studies. These designs correspond to Grade B evidence in this study. Although less robust than RCTs, these research meth-