Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
A wider perspective
- Saravana Kumar (10 January 2005)
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Developing the Evidence: CPA Response to "Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference"
- Dawn L. Burnett PT, PhD (11 January 2005)
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Too little benefit for too few patients
- MARTIN CAICOYA (12 January 2005)
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Error in Figure 2
- Roland A. Ammann (12 January 2005)
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Patient preferences and random allocation of treatment
- Pythia T Nieuwkerk, Erwin Birnie, Department of Social Medicine / Public Health Epidemiology, Academic Medical Center, 1105 AZ Amsterdam, Netherlands (13 January 2005)
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Is there an alternative conclusion?
- John A Mathews, London SE1 7EH (29 January 2005)
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What is "Usual Physiotherapy?"
- Diane U. Jette (4 February 2005)
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Interventions with similar efficacy to placebo: a useless randomised controlled trial
- Francisco M. Kovacs, Luis González Luján, Jenny Moix, Francisco Martínez, Sergio Luna, Víctor Abraira, Pablo Lázaro, The Spanish Back Pain Research Network (18 February 2005)
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Saravana Kumar, Doctoral candidate University of South Australia, SA 5000
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Dear Sir/Madam, I would like to take this opportunity to pass on my sincere thanks and congratulations to Klaber Moffett and colleagues for undertaking this research which adds further knowledge and evidence on best practice for the management of neck pain. In the current health care scenario, where there is ongoing need and justification for the care provided, research evidence from such publications helps better inform practitioners in every day care. The researchers also should be congratulated for undertaking methodologically rigorous and sound research project as evidenced when critical appraised using the PEDro scale (http://www.pedro.fhs.usyd.edu.au/index.html), the publication scoring reasonably well. The findings of this research project, where “usual” Physiotherapy treatment was found to be only marginally better than brief physiotherapy intervention for neck pain which had Cognitive Behavioural approach, is supported by a recent systematic review undertaken by The Centre for Allied Health Evidence (CAHE www.unisa.edu.au/cahe), where patient education, empowerment and early return to active life were identified to have strong and credible literature evidence and producing better patient outcomes. These findings again add further evidence to support the work undertaken by Gwen Jull on the evidence based physiotherapy management of whiplash injuries of which chronic neck pain is a common symptom. I would also like to draw readers’ attention on the role played by the relationship between the patient and the therapist and its influence on pain and disability. Klaber Moffett and colleagues have produced foundational evidence to suggest that consultation sessions of merely 1-3 sessions might produce fairly similar results to “usual” physiotherapy which I assume lasted for more than 1-3 sessions. During the “brief” intervention, the treatment principles seemed to be underpinned by communication, education and self-management strategies. I believe this produces an opportunity for rich environment of patient-therapist interaction where the physiotherapist can influence the outcome of care. Klaber Moffett and Richardson (1997) have highlighted key strategies that can be undertaken, which underpins some concepts of Cognitive Behavioural Approach, to positively influence pain and disability. Recent research by May (2001) and Potter et al (2003) have also highlighted patient expectations of physiotherapy care to include key components of education and self management strategies which are underpinned by effective communication and patient centered care approach. These findings have also been currently validated in a doctoral research undertaken at University of South Australia, where physiotherapy patients’ expectations (n=74) of quality physiotherapy care to include key aspects of patient empowerment and patient centred care (Kumar 2005). These findigns suggest that there is an expectation from the patient population that physiotherapsits will provide strategies for self management (education, exercises, advise etc) and address and involve the patients as part of routine physiotherapy service delivery. This is an opportunity, which the physiotherapy profession should embrace and explore further. I believe the findings from Klaber Moffett and colleagues provides us with an opportunity to explore further the importance of therapist-patient interaction (how we do it), rather than focus entirely merely the technical aspects of care (what we do). Once again my thanks and wishes to Klaber Moffett and her colleagues. References (1). Klaber Moffett JA and Richardson PH (1997). The influence of the physiotherapist-patient relationship on pain and disability. Physiotherapy Theory and Practice, 13, 89-96. (2). May S (2001). Part 2. An explorative, Qualitative Study into Patients Satisfaction with Physiotherapy. Physiotherapy,87, 10-20 (3). Potter M, Gordon S, Hamer P (2003). Identifying Physiotherapist and Patient Expectations in Private Practice Physiotherapy. Physiotherapy Canada, 55,4, 1-8. (4) Kumar S (2005). Key elements underpinning Allied Health Service Quality: A qualitative and quantitative investigation. Doctoral Research currently being undertaken, University of South Australia. Competing interests: Currently undertaking doctoral research at University of South Australia, Adelaide |
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Dawn L. Burnett PT, PhD, Director Practice and Policy Canadian Physiotherapy Association Ottawa, Ontario, Canada K1H 6C9
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The Canadian Physiotherapy Association (CPA) supports ongoing examination of current approaches to physiotherapy practice in order to inform best and evidence based practice. This approach is in the best interest of achieving positive individual client outcomes and promotes the most effective and efficient use of limited health care funds and resources. This study further confirms the essential role of physiotherapy in the treatment and management of patients with neck pain. It highlights the following points: 1.“Usual” physiotherapy is significantly more effective over the short (three months) and long term (12 months) than a brief (one to three sessions) intervention of physiotherapy aimed at promoting self management of the condition. The term “usual” applies to the most commonly used physiotherapeutic interventions for neck pain - over 20 possible interventions from five main treatment categories. However it is important to make the distinction that while there are a group of interventions commonly employed to treat neck pain, there is not a "usual" physiotherapy treatment applied to every patient. Physiotherapists use their professional judgement and experience to select the most appropriate techniques from a selection of available measures to promote best patient outcomes based on continual evaluation of the patients’ clinical findings and responses. This study adds further support to this practice of clinical appraisal and critical reasoning in physiotherapy practice. 2. This study suggests a brief session of physiotherapy aimed at the patients’ self management of their condition was not as effective as a regime of physiotherapy intervention. However those patients who indicated a preference for the brief physiotherapy intervention and received this treatment had similar outcomes to the “usual” treatment group. Client input, needs and preferences are critical factors in the successful management of neck pain. This study reinforces the essential role of client-centered practice and the importance of the physiotherapist/patient team in producing positive outcomes over the short and long term. In addition, this study supports the importance of addressing neck pain from a population health and psychosocial perspective as well as from an individual patient basis. A multi-faceted approach is clearly the most effective route to successful outcomes. 3. Interpretation of clinical research findings must be examined within the context of the broader evidence base of relevant quality studies on a particular topic. Changes to practice and policy must be guided by an understanding of the relevant evidence as well as an objective analysis of the methodology, sample size and findings of individual studies. The CPA acknowledges the important contribution of this study in the evolution of best and evidence based physiotherapy practice that will produce optimal patient outcomes in a manner that is both clinically effective and efficiently delivered. CPA actively supports the need for continuing research to promote practice guidelines and policy for the management of neck pain, one of the most predominant and costly conditions related to patient disability and health resource utilization. Quality clinical research studies of this nature support the physiotherapy profession’s continual objective to validate and refine practice. Competing interests: I am a physiotherapist and Director of Practice and Policy, Canadian Physiotherapy Association |
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MARTIN CAICOYA, Head of the Occupational Risk Prevention Departmente of the Principado de Asturias Hospital Monte Naranco. Oviedo. Asturias Spain 33174
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Dear sir, The study conducted by Klaber, Moffett et al is very interesting and sheds light both into the methodological issues and the therapeutic approaches to this problem. However, I think there are two questions I would like the authors to
consider: Thank you very much. Martin Caicoya Competing interests: None declared |
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Roland A. Ammann, MD Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, Switzerlan
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Dear Madam/Sir Please note that in Figure 2 of the article by Jennifer A Klaber Moffett, for the group treated with brief intervention with initial preference for brief intervention the mean score is correctly indicated as -2.811, but the 95% CI is incorrectly stated as -1.384 to +2.518. It should read, as in table 4, -5.431 to -0.190. This error does not change any conclusion of the study. Sincerely Roland A. Ammann, MD roland.ammann@insel.ch Competing interests: None declared |
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Pythia T Nieuwkerk, Lecturer Department of Medical Psychology, Academic Medical Center, 1105 AZ Amsterdam, Netherlands, Erwin Birnie, Department of Social Medicine / Public Health Epidemiology, Academic Medical Center, 1105 AZ Amsterdam, Netherlands
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Dear Editor: While it is generally acknowledged that the randomised clinical trial is the only valid way to compare therapies, there is no clear view of how best to proceed when randomisation is hardly acceptable to patients as they have a preference for one of the treatment arms. Klaber Moffett et al address the issue of patients’ treatment preference serving as a potential confounding factor in a trial when it is impossible to blind patients to the treatment they receive.1 This problem is often dealt with using a patient preference design, in which patients without a preference are randomised and those with a preference are allocated to their preferred treatment group. The authors believe this design does not take us very far, as any comparisons between the preference groups and randomised arms could be confounded. Instead, they propose to randomise all consenting patients but to elicit preferences before randomisation and use these in subsequent analysis. We are not convinced their data demonstrate a clear advantage of the proposed alternative design over the patient preference design, and do believe it is associated with other disadvantages. The potential for generalisation of a randomised trial may be limited if many patients show an outspoken treatment preference, with consequent refusal to participate in such a study. In the study of Klaber Moffett et al, 552 out of 952 potentially eligible patients were excluded of which many were only willing to consider the usual care treatment arm. A patient preference trial would allow for quantifying the external validity of the trial by enrolling such patients in a preference arm. Patients who hold a treatment preference and are randomly allocated to receive the treatment alternative they do not prefer, may be more likely not to complete the assigned treatment.2 In the study of Klaber Moffett et al, 20 of 139 patients allocated to the experimental group crossed over to the standard treatment group, and about 17% of the patients in each treatment arm withdrawn of were lost to follow-up. We wonder what treatment preference these patients had before randomisation. The group of patients who had a preference for the usual care arm before randomisation but were assigned to the experimental arm was the only group showing deterioration in outcomes after randomisation. We wonder whether it would have been preferable to have managed these patients according to their preference. References 1. Klaber Moffett JA, Jackson DA, Richmond S, et al. Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients’ preference. BMJ 2005; 330: 75- 81. 2. Silverman WA. Patients’ preferences and randomised trials. Lancet 1994; 343: 1586. Competing interests: None declared |
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John A Mathews, Consultant Rheumatologist St Thomas' Hospital, London SE1 7EH
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Could your study be said to have shown that your treatment regimes both slowed recoverey, but at different rates? Competing interests: None declared |
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Diane U. Jette, Professor of Physical Therapy Simmons College, Boston, MA, USA 02115
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A title including the term "usual therapy" should be a red flag for physical therapists and other health professionals trying to understand the evidence that supports practice. Imagine the response an article that used the term "usual medicine" or "usual surgery" in its title would get from physicians! As physical therapists well recognize, the diagnosis of a patient's musculoskeletal condition leads to the appropriate selection of interventions, just as the diagnosis of a medical condition leads to the selection of the appropriate medication or surgery. The description of study participants provided in this article suggests the lack of a specific diagnosis and the possibility of a wide range of cervical pathologies and impairments related to neck pain. For this reason, it is unclear whether the physiotherapists made appropriate selections of interventions. The interventions, as displayed in Table 1 are broad, incompletely described in terms of dosage, and reported only as the number of applications over epidsodes of care for 129 patients. It is not clear whether the appropriate interventions, at the appropriate intensity were provided to manage the various impairments or contellation of impairments that suggest a specific cervical pathology. Additionally, the "brief" intervention was not well described. A "neck book for patients" implies that all participants with neck pain might be managed by the same self- management techniques. It is well recognized that trials that include participants with heterogeneous conditions may well result in insignificant results. In designing and describing the methods of such studies as this, it is prudent,therefore, to consider careful selection of a homogeneous group of patients or, at the very least, provide a full description of their relevant characteristics. Additionally, the interventions should never be described as "usual", but should be described carefully and fully in terms of their type, frequency, intensity and duration. Until we accomplish this level of precision in our research designs and detail in its description, physical therapists will not be able to answer the question of whether the results of trial apply to their patients and rehabilitation research is likely to provide little usable evidence. Competing interests: None declared |
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Francisco M. Kovacs, Director of Scientifc Department Fundación Kovacs, Paseo de Mallorca 36, 07012 Palma de Mallorca, Spain, Luis González Luján, Jenny Moix, Francisco Martínez, Sergio Luna, Víctor Abraira, Pablo Lázaro, The Spanish Back Pain Research Network
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A non-inferiority randomised controlled trial (RCT) in patients with neck pain1 concludes that a brief physiotherapy intervention based on cognitive behavioural principles,--which is not a true cognitive behavioural therapy--, provided by a physiotherapist should be available for patients who prefer this modality rather than usual physiotherapy. Some aspects of the study should be commented on. The same 12 physiotherapists delivered both types of care, and their preferences were not assessed. An observational study of eight participating physiotherapists carried out by an independent researcher indicated that there was treatment fidelity. However, the authors recognise that there could have been a "contamination" effect, whereby usual physiotherapy patients benefited from some of the cognitive behaviour treatments used in the brief intervention. Why not a "contamination effect" in the opposite direction? Physiotherapists agreed to take part in a non-inferiority trial and they accepted to be trained in the "new" approach. It seems logical to assume that they were probably convinced of the advantages of the "new" brief intervention and confident of its usefulness. Therefore, their enthusiasm may have been greater than with usual physiotherapy, favouring the brief physiotherapy intervention. Most procedures used in the "usual physiotherapy" group (electrotherapy, traction, acupuncture) have not proven to be more effective than placebo.2-4 Because results in the brief intervention group were clinically and statistically worse for pain, disability or quality of life, this may be interpreted as the experimental treatment being worse than placebo. On the other hand, the findings cannot be used to claim the efficacy of treatments used in the "usual physiotherapy" group. Since there was no sham or control group, slight improvements might be explained by the higher amount of time devoted to each patient, or by the non- specific (placebo) effect triggered by the procedures used. If the experimental treatment worsened patients' evolution, the potential influence of the Hawthorne effect and the natural course of the condition in the "usual physiotherapy" group should also have been taken into account. Actual results in the experimental group may have been worse than reported. Twenty patients (17%) in the brief intervention group crossed over to usual physiotherapy. No patient in the usual physiotherapy group crossed over to the experimental group. The effect of the patients' flow should be analysed in the per-protocol data set, since the intention to treat approach may have artificially improved the results in the brief intervention group. The sample size was calculated to reach a "non-inferiority" conclusion but, in spite of the actual study population being approximately 30% lower than planned, there was sufficient statistical power to demonstrate the inferiority of the brief physiotherapy intervention. Having led to these results, the possibility that the experimental treatment was simply useless or even worsening the patients' evolution should have been at least discussed, although it was not. Accordingly, 1) the conclusion that these results do not "show clearly that the brief intervention based on cognitive behaviour principles was as effective as usual physiotherapy" may be seen as misleading since, in fact, the brief intervention was worse than the usual physiotherapy; 2) the conclusion that "physiotherapy as usual (five sessions) can result in small benefits" could be seen as misleading, since it should be mentioned that this is true "when compared to an experimental treatment on which evidence on efficacy or effectiveness is (also) lacking"; 3) the conclusion that "for some patients a brief intervention (two sessions) can be as beneficial if this is their treatment preference and costs less" may be also misleading, since results do not prove that any one of those treatments is much better than doing nothing, and no cost assessment was included in this study; and 4) the conclusion that "in a clinical setting, patients should be given a choice of treatment approaches to include a brief intervention encouraging self management" and the statement that "some may argue that there is a role for the brief intervention for all patients" are not supported by the results obtained. Evidence based medicine states that clinical management should be based, as far as possible, on proofs of efficacy and effectiveness. Therefore, the conclusion that the brief intervention "should in any case be available for those who prefer it" seems contrary to that principle. This study further confirms that it makes no sense to compare the effectiveness of two procedures when neither one has previously shown its efficacy versus placebo. References: 1. Klaber Moffet JA, Jackson AD, Richmond S, Hahn Seokyung, Coulton S, Farrin A, Manca A, Torgerson DJ. Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference. BMJ doi:10.1136/bmj.38286.493206.82 2. Jette AM, Delitto A (1997) Physical therapy treatment choices for musculoskeletal impairments. Phys Ther, 77(2): 145-54. 3. van der Heijden GJ, Beurskens AJ, Koes BW, Assendelft WJ, de Vet HC, Bouter LM (1995) The efficacy of traction for back and neck pain: a systematic, blinded review of randomized clinical trial methods. Phys Ther, 75(2): 93-104. 4. White P, Lewith G, Prescott P, Conway J. Acupuncture versus Placebo for the Treatment of Chronic Mechanical Neck Pain. A Randomized, Controlled Trial. Ann Intern Med. 2004;141:911-919. ƒ ÉÍ Competing interests: None declared |
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