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Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 29 - 29
1 Oct 2022
Hohenschurz-Schmidt D Vase L Scott W Annoni M Barth J Bennell K Renella CB Bialosky J Braithwaite F Finnerup N de C Williams AC Carlino E Cerritelli F Chaibi A Cherkin D Colloca L Côte P Darnall B Evans R Fabre L Faria V French S Gerger H Häuser W Hinman R Ho D Janssens T Jensen K Lunde SJ Keefe F Kerns R Koechlin H Kongsted A Michener L Moerman D Musial F Newell D Nicholas M Palermo T Palermo S Pashko S Peerdeman K Pogatzki-Zahn E Puhl A Roberts L Rossettini G Johnston C Matthiesen ST Underwood M Vaucher P Wartolowska K Weimer K Werner C Rice A Draper-Rodi J
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Background

Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial.

Objectives

To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions.


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 830 - 839
1 May 2021
Ahmed I Chawla A Underwood M Price AJ Metcalfe A Hutchinson CE Warwick J Seers K Parsons H Wall PDH

Aims

Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery.

Methods

We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay.


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 828 - 829
1 May 2021
Ahmed I Chawla A Underwood M Price AJ Metcalfe A Hutchinson CE Warwick J Seers K Parsons H Wall PDH


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 15 - 15
1 Sep 2019
de Zoete A Rubinstein S de Boer M van Tulder M Underwood M Hayden J Buffart L Ostelo R
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Purpose of the study and background

A 2011 Cochrane review concluded that spinal manipulative therapy (SMT) is no better than other interventions for reducing pain and improving function in chronic low back pain (CLBP). Using individual participant data (IPD) from trials has advantages, among others: a more precise estimate of the effect and the potential to identify moderators. Our objective was to assess the effect of SMT in adults with CLBP and to identify relevant moderators.

Methods

All trials from the 2011 Cochrane review were included in this IPD. We updated the search (April 2016) IPD from eligible studies was requested. Primary outcomes were pain intensity (VAS/NRS) and back-specific function (RMDQ). Risk of bias was assessed. For the treatment effect, an one-stage approach (mixed model technique, intention-to-treat principle) was used; a second-stage approach was conducted as confirmation. For the moderator analyses, one-stage approach was conducted for 19 variables.


Bone & Joint Research
Vol. 4, Issue 4 | Pages 65 - 69
1 Apr 2015
Kearney RS Parsons N Underwood M Costa ML

Objectives

The evidence base to inform the management of Achilles tendon rupture is sparse. The objectives of this research were to establish what current practice is in the United Kingdom and explore clinicians’ views on proposed further research in this area. This study was registered with the ISRCTN (ISRCTN68273773) as part of a larger programme of research.

Methods

We report an online survey of current practice in the United Kingdom, approved by the British Orthopaedic Foot and Ankle Society and completed by 181 of its members. A total of ten of these respondents were invited for a subsequent one-to-one interview to explore clinician views on proposed further research in this area.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 22 - 22
1 Feb 2014
Patel S Hee S Yang Y Ngunjiri A Brown S Friede T Griffiths F Lord J Sandhu H Thistlethwaite J Tysall C Woolvine M Underwood M
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Background

The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up.

Methods

We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 31 - 31
1 Feb 2014
Underwood M Sutcliffe P Connock M Shyangdan D Court R Ngianga-Bakwin K Clarke A
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Study Purpose

To review systematically review literature on the early diagnosis of spinal metastases and prediction of spinal cord compression (SCC) due to spinal metastases

Methods and results

From 13 electronic bibliographic databases were searched we identified 2,425 potentially relevant articles of which 31 met the inclusion criteria. These were quality appraised. Seventeen studies reported retrospective data, 10 were prospective studies, and three were other study designs. There was one systematic review. There were no randomised controlled trials. There were approximately 7,900 participants in the included studies and 5,782 participants were analysed. The sample sizes ranged from 41 to 859. Cancers reported were: lung alone (n=3); prostate alone (n=6); breast alone (n=7); mixed cancers (n=13); and unclear (n=1). Ninety-three prognostic factors were identified as potentially significant in predicting risk of SCC or collapse. Many of the included studies provided limited information about patient population and selection criteria and they varied in methodological quality, rigour and transparency. Several studies with mixed case populations identified type of cancer (e.g. breast, lung or prostate cancer) as a significant factor in predicting SCC, but determining the risk differential is difficult because of residual bias in studies. Overall the quality of the research was poor. The only predictors identified for SCC were number of spinal metastases, duration of disease, total disease burden and immediate symptomatology of cord involvement.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 30 - 30
1 Feb 2014
Morris T Hee SW Stallard N Underwood M Patel S
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Background

We have developed a LBP (low back pain) repository with IPD (individual patient data) from therapist-delivered intervention RCT's from various institutions, nationally and internationally (19 trials, 9328 patients). We will perform IPD meta-analyses to identify and determine the most effective and cost-effective treatments for subgroups of patients. Disability due to LBP is a key outcome of interest. However, there was no common disability measurement that was used in all the RCT's. We report here our assessment as to whether different disability measures are sufficiently comparable to allow pooling across trials.

Method

We used data from seven trials (n = 5015 patients) that had at least two of the following measurements: RMDQ (Roland Morris Disability Questionnaire), MVK (Modified Von Korff disability score), physical component scale of SF-12/36, Patient Specific Functional Scale, and Hannover Functional Ability Questionnaire. Within each trial, the change score between baseline and short-term follow-up was computed. These change scores were then converted from one outcome measure to another with linear regression and ridge-reroughed linear models. They were also tested for correlation and responsiveness (the ability to detect changes in condition, measured by standardised response means).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 30 - 30
1 Apr 2013
Vogel S Pincus T Marlin N Mars T Froud R Eldridge S Underwood M
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Background and purpose

There is on-going debate about a possible link between manipulation and stroke in patients, and a growing interest in other treatment reactions such as increased pain. Evidence about manipulation is contradictory. There is little published information about outcomes in osteopathy. We aimed to address this gap.

Methods and results

A survey was sent to all UK practising osteopaths. Another survey was sent to patients recruited by osteopaths. Patients were surveyed before treatment, one day and two days after treatment and at six weeks. 1,082 (27.8%) osteopaths completed the practitioner survey. 2,057 patients, recruited from 212 osteopaths, completed questionnaires before, and directly after their treatment. 1,387 patients provided data six weeks after treatment.

Between 10% and 20% of patients experienced increased symptoms/pain related to their main complaint in the days directly following treatment. This was highest for new patients. At 6 weeks, 4% of patients reported temporary disability, which they attributed to osteopathic treatment. 10% of patients reported seeking further consultation for worsening symptoms associated with osteopathic care. The comparison between those that received manipulation and those that did not suggests that manipulation was not linked to worsening outcomes.

In the preceding year, 4% of osteopaths reported that they had patients who experienced a range of serious events. The most common event described was the occurrence of peripheral neurological symptoms. There were also 7 reports of stroke-like symptoms.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 16 - 16
1 Jan 2013
Froud R Patterson S Eldridge S Patel S Pincus T Seale C Underwood M
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Study purpose and background

There is growing concern that current outcome measures of back pain trials do not comprehensively capture what is important to patients. Some researchers believe we need to incorporate patients in the development of ‘next-generation’ outcomes. As a preliminary step to patient-interviews, we aimed to articulate ‘important change’ from the patients' perspective, as represented in reports of qualitative investigations inadvertently or directly exploring this.

Summary of methods used and results

We adopted a multi-strand search of electronic databases, and citation and reference tracking. Two researchers identified qualitative investigations relating to low back pain. Data were abstracted and synthesised using meta-ethnographic processes. Provisional results, based on 41 studies, indicate few studies have directly addressed this issue, but that data regarding experience and expectations may be useful. Whilst results suggest that practically, patients are concerned with (re-)engagement in meaningful activities, the more experientially focused literature suggests that patients want to be believed and have validated their experiences and identity as someone ‘doing battle’ with pain. Patients seek not only diagnoses, treatment and cure, but simultaneously reassurance of the absence of pathology. In the absence of tenable diagnoses, some feel they must not adopt a ‘sick role’. Some struggle, but manage to meet others' expectations; thereby undermining the credibility of their pain/disability claims. Others withdraw, fearful of disapprobation and unable or unwilling to accommodate social demands. Patients generally seek to regain their pre-pain healthy, and emotionally robust state.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 11 - 11
1 Jan 2013
Pincus T Underwood M Vogel S Taylor S
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Purpose and background

Effective reassurance is an essential element of treatment for conditions that do not require further investigations, referrals and on-going monitoring. However, research defining what reassurance should consist of and how to deliver it is scarce. The aim of this review was to identify consultation-related processes that improved patients' outcomes, in order to build an evidence-based model of effective reassurance in primary care.

Method and results

A literature search identified prospective observational studies that explicitly measured consultation-related factors in appropriate primary care patient groups. The findings from empirical studies were combined with theoretical and systematic reviews to develop a model of effective reassurance. Scrutiny of 8193 Abstracts yielded 29 empirical studies fitting inclusion criteria, and 64 reviews. The majority of studies measured patient satisfaction. Clinical outcomes (e.g. health status / symptom reduction) appear to improve with patients' active participation in the consultation. Behavioural outcomes (e.g. adherence/ health care utilization) were only measured in a handful of studies, but may improve when information was given in the final stage of the consultation. Psychological outcomes (e.g. health concerns) were consistently improved by patient-centred approaches.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 5 - 5
1 Jan 2013
Ngunjiri A Underwood M Patel S
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Aims

To develop a decision aid - Decision Support Package (DSP) - that will provide low back pain (LBP) patients, and their treating physiotherapists with information on the treatment options available to the patients

To develop a training package for physiotherapists on how to use the DSP

To encourage and evaluate the informed shared decision making (ISDM) process between patients and physiotherapists during consultation.

Method

We developed a DSP informed by existing research and collaboration with physiotherapists, patients and experts in the field of decision aids and LBP. We did six pieces of exploratory work: literature review; 2009 NICE LBP guidelines review; qualitative screening of transcripts of interviews of LBP patients; focus groups (patients); nominal group (physiotherapists), and Delphi study (experts). We collated these data to develop the DSP. We also developed a training package for physiotherapists.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 486 - 486
1 Nov 2011
Froud R Underwood M Eldridge S
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Background and Purpose: How outcomes of clinical trials are reported alters the way treatment effectiveness is perceived. Clinicians interpret outcomes of trials more favourably when results are presented in relative rather than in absolute terms. However, the face validity of different methods is unclear. We aimed to explore which methods clinicians find clearest, most interpretable, and useful.

Methods and Results: We purposively sampled clinicians who see patients with low back pain (LBP) and presented them with summary reports of a hypothetical trial, reporting the results using a variety of different methods. We explored participants’ preferences for these different methods and how they would like to see future trials reported. We interviewed 14 clinicians (GPs, manual therapists, psychologists, a rheumatologist, and surgeons). Participants felt that clinical trial reports were not written with them in mind. They were familiar with mean differences, proportion improved, and number needed to treat (NNT); and unfamiliar with standardised mean difference (SMD), odds ratios and relative risk. They found the proportion improved, relative risk and NNT more intuitively understandable, and were concerned that between-group mean difference, relative risk and odds ratios may mislead. Participants thought each method uniquely contributed to their overall understanding, and that using a variety of methods to report future trials may prevent erroneous portrayal of treatment effect.

Conclusion: Clinicians who see patients with low back pain currently find it difficult to interpret LBP trials. Using a suite of methods to report outcomes may aid clinicians’ interpretation and the transition of research into practice.

Conflict of Interest: None

Sources of Funding: Barts and the London Charity


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 486 - 486
1 Nov 2011
Froud R Eldridge S Underwood M
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Background and Purpose: Clinicians have expressed frustration at the difficulty of interpreting low back pain (LBP) trial outcomes. Using a suite of methods to report outcomes may aid interpretation and transition of research into practice. We aimed to facilitate consensus between LBP experts on how future trials are reported.

Methods and Results: We invited SBPR and LBP Forum members, and authors of LBP trials to participate. In the first round, participants were presented with results of a qualitative study on clinicians’ preferences for different reporting methods. They were asked to rate and comment on the appropriateness of including different reporting methods in a standardised set. In the second round, they reviewed other participants’ ratings and comments, re-rated methods, and edited a statement of recommendation for future reporting. In the final round, participants were asked if they approved of a revised statement. Consensus was measured using the RAND/UCLA appropriateness method and ratified in a meeting at LBP Forum X. Sixty-three experts participated in the study. Ninety-eight percent of participants approved a statement recommending that, where possible, results of LBP trials are reported using between-group mean differences (including advice on clinically important difference), proportion of patients improving in each group, NNT to achieve a minimally important change, and the proportion of deteriorating in each group (all with 95% CIs). Also, additional reporting methods were recommended according to needs of particular trials.

Conclusion: A high level of consensus was reached amongst LBP experts on a statement recommending a standardised set of reporting methods.

Conflict of Interest: None

Source of Funding: Barts and the London Charity


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 486 - 487
1 Nov 2011
Carnes D Mars T Mullinger B Froud R Underwood M
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Background: We aimed to explore the incidence and risk of adverse events associated with manual therapies.

Method: The main health electronic databases, plus those specific to allied medicine and manual therapy professions, were searched. Our inclusion criteria for relevant studies were: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported. We performed a meta-analysis using incident estimates of proportions and random effects models from relevant prospective cohort studies and randomised controlled trials (RCTs) published after 1997.

Results: Eight prospective cohort studies and 31 manual therapy RCTs were identified and analysed. The incidence estimate of proportions of minor or moderate transient adverse events after manual therapy was ~41% (CI 95% 17–68%) in the cohort studies and 22% (CI 95% 11.1–36.2%) in the RCTs. The estimate for major adverse events was between 0.007 and 0.13%. No deaths or vascular accidents occurred in any studies. The pooled relative risk (RR) for experiencing adverse events with exercise, or with sham, passive or control interventions compared to manual therapy was similar, but compared to drug therapies greater (RR 0.05, CI 95% 0.01–0.20) and less when compared to general practitioner or usual care (RR 1.91, CI 95% 1.39–2.64).

Conclusions: Our data indicate a very low risk of major adverse events with manual therapy, but around half manual therapy patients may experience minor to moderate adverse events after treatment. The relative risk of adverse events appears greater with drug therapy but less with usual medical care.

Conflicts of Interest: D Carnes & T Mars

Source of Funding: National Council for Osteopathic Research


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 233 - 233
1 Mar 2010
Froud R Eldridge S Lall R Underwood M
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Background and Purpose: Using numbers needed to treat (NNT) to report trial outcomes has been publicised as improving the interpretability of trial results. However, authors of back pain trials rarely report continuous outcomes using NNT, and if they do, rarely consider deteriorating patients. We performed a reanalysis of the UK BEAM dataset to explore the effects of reporting NNT on interpretation, and articulate difficulties with this approach.

Method and Results: 1,334 patients consulting for low back pain were randomised to receive either best GP care alone, or best GP care and exercise, manipulation or combined exercise and manipulation. The primary outcome was Roland Morris Disability Questionnaire (RMDQ) score at three and 12 months. Patient-response to a health transition question (TQ) was used as a secondary outcome. Using consensus thresholds for individual change on the RMDQ, and using the TQ, we calculated NNTs for improvement, and for benefit (incorporating one additional improvement gained or an additional deterioration prevented). In contrast to the small-to-moderate mean differences originally reported, NNTs were low, ranging from two to eight. Detailed results have been submitted for publication and will be presented at the meeting. Estimating NNT can be challenging due to difficulties in defining thresholds of individual change on continuous scales. However, using a TQ avoids some of these challenges.

Conclusion: In contrast to the small-to-moderate mean effects originally reported, corresponding numbers needed to treat for the interventions are attractive. Where possible, NNT should be considered for future use alongside more conventional reporting methods.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 233 - 233
1 Mar 2010
Froud R Eldridge S Underwood M
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Background and Purpose: A number of authors have calculated thresholds of individually minimally important individual change (MIC) for the Roland Morris Disability Questionnaire (RMDQ). However, at an individual level, the imprecision of the measurement instrument often exceeds the MIC. In recognition of this, there is some consensus on appropriate individual change thresholds (absolute and baseline-specific) for the RMDQ. These were intended to be re-evaluated as further data become available. With this in mind, we calculated the MIC and minimally detectable change (MDC) of the RMDQ in the UK BEAM population.

Method and Results: 1,334 patients enrolled in the UK BEAM trial completed the RMDQ. We calculated MIC using ROC curves from three and 12 month follow-up data, and using a seven-point health transition question as the external criterion. We performed sub-analyses of MIC for bands of baseline severity and considered adjusting these for regression to the mean (RTM). We calculated MDC based on within-person and residual error variances of stable patients’ repeated measurements. The overall MIC was four points and the MDC 7.6 points. These values fall around the centre of the ranges considered by the consensus study team. Higher MIC values were observed for more disabled patients; this may be partially an artefact of RTM. In our positively skewed population, more disabled patients required more than the consensus recommendation of 30% change from baseline.

Conclusion: This is further evidence that five RMDQ points is an appropriate threshold by which to judge individual change on the RMDQ. Proportional change from baseline may be more population-specific than previously thought.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 283 - 283
1 May 2009
Parsons S Harding G Underwood M Breen A Foster N Pincus T Vogel S
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Background: Chronic musculoskeletal pain is a major and costly health problem which is difficult to treat from both patients’ and practitioners’ perspectives. Gaining a greater understanding of patients’ and practitioners’ decision making may be one way of achieving more successful chronic pain consultations.

Aim: To explore the influences on patients’ decision making regarding care seeking, and practitioners’ decision making regarding care delivery for chronic musculoskeletal pain.

Method: In-depth qualitative interview study of chronic musculoskeletal pain patients and of NHS and private, mainstream and CAM practitioners who treat patients. Topic guides were developed which explored, patients’ and practitioners’ beliefs about the causes of pain and expectations of treatment, and the factors influencing decision making within the consultation. All interviews were audio taped and transcribed for analysis, and data was analysed using Framework.

Results: Fifteen patients and 21 practitioners (two GPs, five chiropractors, five osteopaths and 10 physiotherapists) were interviewed. Themes identified as influencing the process of care and decision making, were the level of trust within the patient-practitioner relationship, beliefs about whom should be responsible for patients’ health, the role of patients’ self identity on the management of pain, and beliefs about whom should hold the expertise within the consultation.

Conclusions: To improve primary care for chronic musculoskeletal pain, the level of trust within the patient-practitioner relationship may need to be increased. This may help practitioners to recognise and accept patients’ growing expertise within the consultation, which in turn may facilitate patients in taking more responsibility for their pain.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 281 - 281
1 May 2009
Carnes D Underwood M
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Background: Societal, clinician and patient expectations of treatment outcomes may differ due to different measures of success. This may have implications for measuring progress, monitoring treatment success and patient satisfaction.

Aim: To explore patient expectations about outcome

Method: A qualitative study using in depth interviews with people with chronic pain.

Results: Thirteen chronic pain patients were interviewed, five males and eight females. Age ranged between 24 and 83 years and all had chronic pain in at least one location. Ten interviewees had low back pain. We found that the most important outcome markers for patients were functional tasks that affected every day living. The achievement of these tasks became personal goals. Patients used task achievement to determine treatment success, regardless of whether they had to modify the way they achieved these tasks.

Conclusion: Treatment progress can be monitored using patient determined goals, rather than clinical outcomes which are relatively meaningless to the patient. The additional use of aids or encouraging adaptive behaviour should not be under estimated as part of the treatment process. Patient criteria for success were determined by achieving functional tasks/goals that had previously been difficult. However realistic goal setting remains an important issue that patients and clinicians can jointly negotiate and address.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 282 - 282
1 May 2009
Parsons S Underwood M Breen A Foster N Pincus T Vogel S
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Background – Patients with chronic musculoskeletal pain seek care from a wide range of practitioners, both mainstream and complementary and alternative (CAM). Previous research suggests that patients’ social class and educational level may strongly influence their consulting behaviour. The role of health outcomes in influencing patients’ consulting behaviour has been less frequently studied.

Aims – To explore the relationship between health outcomes and consulting behaviour of chronic musculoskeletal pain patients.

Method – Secondary analysis of data collected as part of a population questionnaire survey of chronic pain. Univariate and multi variate analyses were undertaken to explore the relationship between health outcomes (e.g. health related quality of life) and consulting behaviour.

Results – The survey response rate was 62% and the prevalence of chronic pain was 38% (987/2504). 53% of patients had consulted mainstream practitioners only, 4% CAM practitioners only, 18% mainstream and CAM practitioners and 25% no one.

Patients’ who had consulted both mainstream and CAM practitioners reported the poorest health outcomes (EQ 5D = 0.55), followed by those who consulted just mainstream practitioners (EQ 5D = 0.61), and those who had consulted no one (EQ 5D = 0.72). The best health outcomes were reported amongst those who had just consulted CAM practitioners (EQ 5D =0.78). In multivariate analyses, the most powerful predictors of consulting both mainstream and CAM practitioners were working and having high levels of pain related disability.

Conclusions – This analysis suggests that poorer health outcomes may be powerful predictors of consulting CAM practitioners, in some cases, amongst those who do not have access to the financial resources to pay for such treatment.