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Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 25 - 25
1 Feb 2018
Konstantinou K Rimmer Y Huckfield L Stynes S Burgess N Foster N
Full Access

Background

Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations.

Methods

We used recruitment data from the SCOPiC trial and its internal pilot, to show the differences between estimated and actual numbers of patients from consultation to participation in the trial. Patients were consented to the trial if they had a clinical diagnosis of sciatica (with at least 70% confidence) and met the trial eligibility criteria.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 29 - 29
1 Feb 2018
Chiarotto A Boers M Deyo R Buchbinder R Corbin T Costa L Foster N Grotle M Koes B Kovacs F Lin C Maher C Pearson A Peul W Schoene M Turk D van Tulder M Terwee C Ostelo R
Full Access

Background & purpose

Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains.

Methods & Results

The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 16 - 16
1 May 2017
Harrisson S Ogollah R Dunn K Foster N Konstantinou K
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Purpose of study and background

Neuropathic pain is a challenging pain syndrome to manage. Low back-related leg pain (LBLP) is clinically diagnosed as either sciatica or referred leg pain and sciatica is often assumed to be neuropathic. Our aim was to describe the prevalence and characteristics of neuropathic pain in LBLP patients.

Methods

Analysis of cross-sectional data from a prospective, primary care cohort of 609 LBLP patients. Patients completed questionnaires, and received clinical assessment including MRI. Neuropathic characteristics (NC) were measured using the self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs scale (SLANSS; score of ≥12 indicates pain with NC).


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 5 - 5
1 Feb 2016
Beneciuk J Hill J Campbell P George S Afolabi E Dunn K Foster N
Full Access

Purpose and Background:

To identify treatment effect modifiers within the STarT Back Trial which demonstrated prognostic stratified care was effective in comparison to standard care for patients with low back pain.

Methods:

Secondary analysis of the STarT Back Trial using 688 patients with available 4-month follow-up data. Disability (baseline and 4 months) was assessed using the Roland Morris Disability Questionnaire (RMDQ) using continuous and dichotomized (>7) outcome scores. Potential treatment effect modifiers were evaluated with group x predictor interaction terms using linear and logistic regression models. Modifiers included: age, gender, education, socio-economic status (SES), employment status, work satisfaction, episode duration, general health (SF-12), number of pain medications, and treatment expectations.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 4 - 4
1 Feb 2016
Geraghty A Stanford R Roberts L Little P Hill J Foster N Hay E Yardley L
Full Access

Background:

Internet interventions provide an opportunity to encourage patients with LBP to self-manage and remain active, by tailoring advice and providing evidence-based support for increasing physical activity. This paper reports the development of the ‘SupportBack’ internet intervention, designed for use with usual primary care, as the first stage of a feasibility RCT currently underway comparing: usual primary care alone; usual care plus the internet intervention; usual care plus the internet intervention with physiotherapist telephone support.

Methods:

The internet intervention delivers a 6-week, tailored programme focused on graded goal setting, self-monitoring, and provision of tailored feedback to encourage physical activity/exercise increases or maintenance. 22 patients with back pain from primary care took part in ‘think aloud’ interviews, to qualitatively explore the intervention, provide feedback on its relevance and quality and identify any extraneous content or omissions.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 31 - 31
1 Feb 2016
Bishop F Dima A Ngui J Little P Moss-Morris R Foster N Lewith G
Full Access

A statement of the purposes of the study and background:

Merely publishing clinical guidelines is insufficient to ensure their implementation in clinical practice. We aimed to clarify the decision-making processes that result in the delivery of particular treatments to patients with low back pain (LBP) in primary care and to examine clinicians' perspectives on the National Institute for Health and Care Excellence (NICE) clinical guidelines for managing LBP in primary care.

A summary of the methods used and the results:

We conducted semi-structured interviews with 53 purposively-sampled clinicians from south-west England. Participants were: 16 General Practitioners (GPs), 10 chiropractors, 8 acupuncturists, 8 physiotherapists, 7 osteopaths, and 4 nurses. Thematic analysis showed that official guidelines comprised just one of many inputs to clinical decision-making. Clinicians drew on personal experience and inter-professional networks and were constrained by organisational factors when deciding which treatment to prescribe, refer for, or deliver to an individual patient with LBP. Some found the guideline terminology - “non-specific LBP” - unfamiliar and of limited relevance to practice. They were frustrated by disparities between recommendations in the guidelines and the real-world situation of short consultation times, difficult-to-access specialist services and sparse commissioning of guideline-recommended treatments.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_2 | Pages 27 - 27
1 Feb 2015
Whitehurst D Bryan S Lewis M Hay E Mullis R Foster N
Full Access

Purpose and background

To explore the cost-utility of implementing stratified care for low back pain (LBP) in general practice, compared with usual care, within patient risk subgroups (low, medium and high risk of persistent disabling pain determined by the STarT Back tool).

Methods

Adopting a cost-utility framework alongside a prospective, sequential comparison of separate patient cohorts (922 patients in total) with six-month follow-up, the base case analysis estimated the incremental LBP-related healthcare cost per additional quality-adjusted life year (QALY) by risk subgroup. Uncertainty was explored with cost-utility planes and acceptability curves. Sensitivity analyses examined alternative approaches (a complete case analysis, the incorporation of non-LBP-related healthcare use and estimation of societal costs relating to work absence).


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_2 | Pages 12 - 12
1 Feb 2015
Bartlam B Waterfield J Lloyd A Holden M Ismail K Foster N
Full Access

Purpose and background

Over two-thirds of pregnant women experience low back pain (LBP) that interferes with everyday activities, work and sleep. Acupuncture appears a safe, promising intervention but there are no high quality trial data, regarding its clinical or cost-effectiveness in comparison to standard care.

Methods

EASE Back was a feasibility and pilot RCT designed to inform a full trial evaluating the addition of acupuncture to standard care for pregnancy-related LBP. In preparation for the pilot trial, phase 1 of EASE Back consisted of semi-structured interviews exploring the views of pregnant women, midwives and physiotherapists about pregnancy-related LBP, use of acupuncture, and participation in clinical trials. Transcript data were anonymised and analysed using thematic analysis. Three members of the team independently coded a sample of transcripts to develop the coding framework.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 27 - 27
1 Feb 2014
Mesner S Foster N French S
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Background

Recommendations in clinical practice guidelines for non-specific low back pain (NSLBP) are not necessarily translated into practice. Multiple research studies have investigated different strategies to implement best evidence into practice yet no synthesis of these studies is available.

Objectives

To systematically review available studies to determine whether implementation efforts in this field have been successful; to identify which strategies have been most successful in changing healthcare practitioner behaviours and patient outcomes.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 15 - 15
1 Jan 2012
Grotle M Foster N Dunn K Croft P
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Purpose

To compare the contribution of physical, psychological and social indicators to predicting disability after one year between consulters with low back pain (LBP) of less than 3 months duration and more than 3 months duration.

Methods

Data from two large prospective cohort studies of consecutive patients consulting with LBP in general practices were merged, with disability measured by the Roland Morris Disability Questionnaire (RMDQ). There were complete data for 258 cases with acute/subacute LBP and 668 cases with chronic LBP at 12 months follow-up. Univariate and adjusted multivariate regression analyses of various potential prognostic indicators for disability at 12 months were carried out.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 4 - 4
1 Jan 2012
Hider S Foster N
Full Access

Background

Patient preferences have been shown to be associated with treatment effects (1) and recent national guidelines suggest using patient preferences to help inform clinical interventions (2).

Aim

To determine the treatment preferences of LBP patients and whether these affect clinical outcome.