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Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 14 - 14
1 Oct 2022
Williamson E Boniface G Marian I Dutton S Maredza M Petrou S Garrett A Morris A Hansen Z Ward L Nicolson P Barker K Fairbank J Fitch J Rogers D Comer C French D Mallen C Lamb S
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Purpose and background. To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. Methods and results. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds. Conclusions. The BOOST programme improves mobility and reduces falls in older adults with NC compared to BPA at 12 months follow-up. It is good value for the NHS. Future iterations of the programme will consider ways to reduce symptoms and disability long-term. Conflicts of interest: No conflicts of interest. Sources of funding: National Institute of Health Research – Programme for Applied Research NIHR - PTC-RP-PG-0213-20002: Better Outcomes for Older people with Spinal Trouble (BOOST). Publication and presentations: The clinical effectiveness paper has just been accepted for publication in the Journal of Gerontology Series A. The health economic analysis is not yet published. It was presented at the Physiotherapy UK conference and the International Back and Neck Pain Forum in 2021


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 23 - 23
1 Oct 2019
Hall J Konstantinou K Lewis K Oppong R Jowett S
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Background and Purpose. The STarT Back approach comprises subgrouping of LBP patients according to risk of persistent LBP-related disability, and matches patients to appropriate treatments. In a clinical trial and implementation study, this stratified care approach was clinically and cost-effective compared to usual non-stratified care. However, the long-term cost- effectiveness is unknown, and could be established with decision modelling. A systematic review of model-based economic evaluations in LBP found shortcomings with existing models, including inadequate characterisation of the condition in health states and absence of long-term modelling. This study conceptualises the first decision model of this stratified care approach for LBP management, and assesses long-term cost-effectiveness. Methods. A cost-utility analysis from the NHS perspective compared stratified care with usual care, in patients consulting in primary care with non-specific LBP. A Markov state-transition model was constructed where long-term patient prognosis over ten years was dependent upon physical function achieved at twelve months. Consultation with experts helped define condition health states, inform the long-term modelling, and choice of sensitivity analyses. Results. Preliminary base-case results indicate this model of stratified care is cost-effective over a ten-year time horizon, delivering 0.10 additional quality-adjusted life years (QALYs) at a cost-saving of £100.27 per patient. Sensitivity analyses indicate the approach is likely to be cost-effective in all scenarios, and cost-saving in most, although sensitive to assumptions regarding long-term patient prognosis. Analysis from the societal perspective improved the associated cost-savings. Conclusion. It is likely that implementation of this stratified care model will help reduce unnecessary healthcare usage, whilst improving patient quality of life. No conflicts of interest. Funding: Research stipend for JAH by the Institute for Primary Care & Health Sciences, Keele University


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 37 - 37
7 Aug 2024
Wilson M Cole A Hewson D Hind D Hawksworth O Hyslop M Keetharuth A Macfarlane A Martin B McLeod G Rombach I Swaby L Tripathi S Wilby M
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Background. Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques. Methods. PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios. Results. Differences in the primary outcome at 24 hours will be estimated by mixed-effects linear regression modelling, with fixed effects for randomisation factors and other important prognostic variables, and random effects for centre, using the as-randomised population. Treatment effects with 95% confidence intervals will be presented. Conclusion. The study is due to open in May 2024 and complete in 2026. Conflicts of Interest. No conflicts of interest declared. Sources of Funding. NIHR Health Technology Award – grant number NIHR153170. Trial presentations so far. APOMP 2023 and 2024; RCOA conference, York, November 2023; Faculty of Pain Management training day, London, February 2024


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 20 - 20
1 Oct 2022
Newton C Singh G O'Neill S Diver C Booth V Logan P O'Sullivan K O'Sullivan P
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Purposes of the study and background. Cognitive Functional Therapy (CFT) is a psychologically informed, physiotherapist-led intervention that targets the biopsychosocial complexity of persistent low back pain (LBP). CFT has demonstrated positive outcomes in two randomised controlled trials (RCT) but has not previously been evaluated in the United Kingdom National Health Service (NHS). This study aimed to determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care (UPC) for people with persistent LBP in the NHS. Methods and results. A two-arm parallel feasibility RCT compared CFT with UPC in participants with persistent LBP. Data concerning study processes, resources, management and patient reported outcome measures (disability, pain intensity, quality of life and psychosocial function) were collected at baseline, three and six-month follow-up, analysed and evaluated in order to establish feasibility. Sixty participants (n=30 CFT and n=30 UPC) were recruited with 71.6% (n=43) retained at six-month follow-up. CFT was delivered to fidelity, relevant and clinically important outcome data were rigorously collected and CFT was tolerated by participants with no safety concerns. The Roland-Morris disability questionnaire was the most suitable primary outcome measure and sample size calculations were completed for a definitive RCT. Intention to treat analysis indicated a signal of effect in favour of CFT with moderate and large between group effect sizes observed across outcome measures at six-month follow-up. Conclusion. It is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future fully powered clinical and cost effectiveness RCT could be completed. Conflicts of interest: No conflicts of interest. Sources of funding: Chartered Society of Physiotherapy, Physiotherapy Research Foundation


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 27 - 27
1 Oct 2019
Kigozi J Lewis M Konstantinou K Foster N Jowett S
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Funding. This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR HTA project number 12/201/09). NEF is a Senior NIHR Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). KK was supported by a HEFCE Senior Clinical Lectureship award. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Health Technology Assessment programme or the Department of Health. Background and Purpose. Stratified care (SC) has previously been found to be a cost-effective approach for primary care LBP patients. The SCOPiC trial compared the clinical and cost-effectiveness of a modified SC model combining prognostic and clinical characteristics to allocate sciatica patients into one of three groups (with matched care pathways) versus non-stratified, usual care (UC). Methods. Cost-utility analysis was undertaken over 12-months. Resource use and quality of life (EQ-5D-5L) data were obtained from postal questionnaires, mean costs and QALYs were calculated for each trial arm along with cost-effectiveness acceptability curves. The base case analysis was by intention-to-treat, and performed from NHS and personal social services (PSS) perspective. Sensitivity analyses included healthcare provider and societal perspectives, as well as analyses for each of the three patient groups. Results. 476 patients were randomised (238 per arm). Mean NHS/PSS costs (SD) recorded were £663.58 for SC and £617.37 for UC. Mean QALYs (SD) were 0.659 (0.173) for SC and 0.671 (0.168) for UC; the adjusted mean difference in QALYs was −0.011 (−0.035, 0.013). In this base-case analysis, the chance of SC being cost-effective at a threshold of £30,000 per QALY was only 19%. Similarly, low probabilities of effectiveness were observed in all sensitivity analyses. The chance of SC being cost-effective at a threshold of £30,000 ranged from 18% to 52% for each of the three patient groups. Conclusions. Overall, the SC model that we tested for sciatica in primary care was not a cost-effective option compared to usual, non-stratified care. No sources of funding. No conflicts of interest


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_11 | Pages 28 - 28
1 Sep 2021
Linhares D Fonseca JA Silva MRD Conceição F Sousa A Sousa-Pinto B Neves N
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Microdiscectomy is the most commonly performed spine surgery in the world. Due to its technical simplicity and low complication rate, this was the first spine surgical procedure transitioning for one-day surgery. However, the economic assessment of this outpatient transition was never performed and the question on the real impact in the burden of spine care remains. This economic study aims to access the cost-utility of outpatient lumbar microdiscectomy when compared with the inpatient procedure. To do so, a cost-utility study was performed, adopting the hospital perspective. Direct medical costs were retrieved from the assessment of 20 patients undergoing outpatient lumbar microdiscectomy and 20 undergoing inpatient lumbar microdiscectomy, from a in a Portuguese NHS hospital. Utilities were calculated with quality-adjusted life-years were derived from Oswestry Disability Index values (ODI). ODI was assessed prospectively in outpatients in pre and 3- and 6-month post-operative evaluations. Inpatient ODI data were estimated from a meta-analysis. both probabilistic and deterministic sensitivity analyses were performed and incremental cost-effectiveness ratio (ICER) calculated. A willingness to pay (WTP) threshold of €60000/QALY gained with inpatient procedure was defined. Out results showed that inpatient procedure was cost-saving in all models tested. At 3-month assessment ICER ranged from €135753 to €345755/QALY, higher than the predefined WTP. At 6-month costs were lower and utilities were higher in outpatient, overpowering the inpatient procedure. Probabilistic sensitivity analysis showed that in 65% to 73% of simulations outpatient was the better option. The savings with outpatient were about 55% of inpatient values, with similar utility scores. No 30-day readmissions were recorded in either group. The mean admission time in inpatient group was 2.5 days. Since there is an overall agreement among spine surgeons that an uncomplicated inpatient MD would only need a one-day admission, an analysis reducing inpatient admission time for one day was also performed and outpatient remained cost-effective. In conclusion, as the first economic study on cost-utility of outpatient lumbar microdiscectomy, this study showed a significant reduction in costs, with a similar clinical outcome, proving this outpatient transition as cost-effective


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 12 - 12
1 Apr 2012
Stamuli E Grevitt M Freeman B Posnett J Claxton K Righetti C
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To evaluate the cost-effectiveness IDET relative to circumferential lumbar fusion with femoral ring allograft (FRA). Cost-effectiveness analysis. Patient-level data were available for patients with discogenic low back pain treated with FRA (n=37) in a randomized trial of FRA vs. titanium cage, and for patients recruited to a separate study evaluating the use of IDET (n=85). Patients were followed-up for 24 months. Oswestry Disability Index, visual analogue scale, quality of life (SF-36), radiographic evaluations, and NHS resource use. Cost-effectiveness was measured by the incremental cost per quality-adjusted life year (QALY) gained. Both treatments produced statistically significant improvements in pain, disability and quality of life at the 24-month follow-up. Costs were significantly lower with IDET due to a shorter mean procedure time (377.4 minutes vs. 49.9 minutes) and length of stay (7 days vs. 1.2 days). The mean incremental cost of IDET was -£3,713 per patient; the mean incremental QALY gain was 0.03. At a threshold of £20,000 per QALY the probability that IDET is cost-effective is 1, and the net health benefit is 0.21 QALY per patient treated. Both treatments led to significant improvements in patient outcomes which were sustained for at least 24 months. Costs were lower with IDET, and for appropriate patients IDET is an effective and cost-effective treatment alternative. Ethics approval: Ethics committee COREC. This cost-effectiveness analysis was carried out by the York Health Economics Consortium at the University of York, and was funded by Smith & Nephew. Smith & Nephew had no financial or other involvement in the collection or analysis of the data on which the CEA is based


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 19 - 19
1 Oct 2019
Hill J Tooth S Cooper V Chen Y Lewis M Wathall S Saunders B Bartlam B Protheroe J Chudyk A Dunn K Foster N
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Background and aims. The Keele STarT Back approach is effective for stratifying patients with low back pain in primary care, but a similar approach has not been tested with a broader range of patients with musculoskeletal (MSK) pain. We report a feasibility and pilot trial examining the feasibility of a future main trial of a primary care based, risk-stratification (STarT MSK) approach for patients with back, neck, knee, shoulder or multi-site pain. Methods. A pragmatic, two-parallel arm, cluster randomised controlled trial (RCT) in 8 GP practices (4 stratified care involving use of the Keele STarT MSK tool and matched treatment options: 4 usual care). Following screening, adults with one of the five most common MSK pain presentations were invited to take part in data collection over 6 months. Feasibility outcomes included exploration of selection bias, recruitment and follow-up rates, clinician engagement with using the Keele STarT MSK tool and matching patients to treatments. Results. 524 participants (231-stratified care, 293-usual care) were recruited (target n=500) over 7 months (target 3 months), with 15-withdrawals (5-intervention, 10-controls). Minimal selection bias was identified between participants/non-participants, or trial arms. The pain-intensity follow-up rate was 88%. Clinicians used the STarT MSK tool in 41% of relevant consultations (judged as ‘partial success’) and adhered to recommended matched treatments in 69% of cases (judged as ‘success’). Conclusions. A future main RCT is feasible, with some amendments in the wording of the tool and the matched treatment options, to determine the clinical and cost-effectiveness of stratified care versus usual care for patients with MSK pain. Conflicts of interest: ‘No conflicts of interest’. Sources of Funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1211-20010). Nadine Foster is a NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 431 - 438
15 Mar 2023
Vendeuvre T Tabard-Fougère A Armand S Dayer R

Aims

This study aimed to evaluate rasterstereography of the spine as a diagnostic test for adolescent idiopathic soliosis (AIS), and to compare its results with those obtained using a scoliometer.

Methods

Adolescents suspected of AIS and scheduled for radiographs were included. Rasterstereographic scoliosis angle (SA), maximal vertebral surface rotation (ROT), and angle of trunk rotation (ATR) with a scoliometer were evaluated. The area under the curve (AUC) from receiver operating characteristic (ROC) plots were used to describe the discriminative ability of the SA, ROT, and ATR for scoliosis, defined as a Cobb angle > 10°. Test characteristics (sensitivity and specificity) were reported for the best threshold identified using the Youden method. AUC of SA, ATR, and ROT were compared using the bootstrap test for two correlated ROC curves method.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 74 - 74
1 Apr 2012
Sundaram R Schratt W Hegarty J Whynes D Grevitt M
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To determine the cost-effectiveness of Lumbar Total Disc Replacement (LTDR) with circumferential spinal fusion surgery. Cost utility analysis. We prospectively reviewed a cohort of 32 consecutive patients who underwent LTDR between 2004 and 2008 with a mean follow-up for 3.75 years. Identical data was compared to a similar group of patients (n=37) who underwent fusion in our institution. Oswestry Disability Index, visual analogue scale, quality of life (SF-36) and NHS resource use. Cost-effectiveness was measured by the incremental cost per quality-adjusted life year (QALY) gained. QALY gains were estimated from SF-36 data using standard algorithms. There was no significant intergroup difference in the ODI, VAS and SF-36 pre and post-op. Both treatments produced statistically significant and equivalent improvements in mean health state utility at the 24-month follow-up (0.078 for LTDR, 0.087 for fusion). Costs were significantly lower with LTDR than with fusion due to a shorter mean procedure time (193.6 vs 377.4 minutes) and shorter length of stay (5.8 vs 7 days). The mean cost difference was £2,878 per patient. At 2 years, the cost per QALY gain of the lower-cost option (LTDR) was £48,892 although the cost effectiveness ratio would fall to below £30,000 if it is assumed that the patient benefits of LTDR last for at least 4 years. Both treatments led to significant improvements in patient outcomes which were sustained for at least 24 months. Costs were lower with LTDR which is effective and a more cost-effective alternative


Bone & Joint Open
Vol. 5, Issue 7 | Pages 612 - 620
19 Jul 2024
Bada ES Gardner AC Ahuja S Beard DJ Window P Foster NE

Aims

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial).

Methods

An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials.


Bone & Joint Open
Vol. 5, Issue 8 | Pages 662 - 670
9 Aug 2024
Tanaka T Sasaki M Katayanagi J Hirakawa A Fushimi K Yoshii T Jinno T Inose H

Aims

The escalating demand for medical resources to address spinal diseases as society ages is an issue that requires careful evaluation. However, few studies have examined trends in spinal surgery, especially unscheduled hospitalizations or surgeries performed after hours, through large databases. Our study aimed to determine national trends in the number of spine surgeries in Japan. We also aimed to identify trends in after-hours surgeries and unscheduled hospitalizations and their impact on complications and costs.

Methods

We retrospectively investigated data extracted from the Diagnosis Procedure Combination database, a representative inpatient database in Japan. The data from April 2010 to March 2020 were used for this study. We included all patients who had undergone any combination of laminectomy, laminoplasty, discectomy, and/or spinal arthrodesis.


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 64 - 71
1 Jan 2023
Danielsen E Gulati S Salvesen Ø Ingebrigtsen T Nygaard ØP Solberg TK

Aims

The number of patients undergoing surgery for degenerative cervical radiculopathy has increased. In many countries, public hospitals have limited capacity. This has resulted in long waiting times for elective treatment and a need for supplementary private healthcare. It is uncertain whether the management of patients and the outcome of treatment are equivalent in public and private hospitals. The aim of this study was to compare the management and patient-reported outcomes among patients who underwent surgery for degenerative cervical radiculopathy in public and private hospitals in Norway, and to assess whether the effectiveness of the treatment was equivalent.

Methods

This was a comparative study using prospectively collected data from the Norwegian Registry for Spine Surgery. A total of 4,750 consecutive patients who underwent surgery for degenerative cervical radiculopathy and were followed for 12 months were included. Case-mix adjustment between those managed in public and private hospitals was performed using propensity score matching. The primary outcome measure was the change in the Neck Disability Index (NDI) between baseline and 12 months postoperatively. A mean difference in improvement of the NDI score between public and private hospitals of ≤ 15 points was considered equivalent. Secondary outcome measures were a numerical rating scale for neck and arm pain and the EuroQol five-dimension three-level health questionnaire. The duration of surgery, length of hospital stay, and complications were also recorded.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 31 - 31
1 Feb 2018
Snidvongs S Taylor R Ahmad A Thomson S Sharma M Fitzsimmons D Poulton S Mehta V Langford R
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Purposes of the study and background. Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure. Summary of methods and results. This was a blinded parallel two-arm pilot randomised controlled trial. Adult patients referred to the pain and orthopaedic clinics at Barts Health NHS Trust with non-specific low back pain of at least three months' duration were considered for inclusion. Participants who had a positive result following diagnostic single medial branch nerve blocks were randomised to receive either intra-articular lumbar facet-joint injections with steroid or a sham procedure. All participants were invited to attend a combined physical and psychological programme. Questionnaires were used to assess a range of pain and disability-related issues. Healthcare utilisation and cost data were also assessed. Of 628 participants screened for eligibility, 9 were randomised to receive the study intervention and 8 participants completed the study. Conclusions. Due to the small numbers of participants recruited to the study, we were unable to draw any conclusions on the effectiveness of intra-articular lumbar facet-joint injections in the management of non-specific low back pain. We however demonstrated our ability to develop a robust study protocol and deliver the intended interventions safely, thus addressing many of the feasibility objectives. Stronger collaborations with primary care may improve the recruitment of patients earlier in their pain trajectory, suitable for inclusion in a future trial. Conflicts of interest: None. Sources of funding: National Institute for Health Research Health Technology Assessment programme grant (reference number 11/31/02)


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
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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. Results. Initial recruitment estimates suggested we needed a source population of 146,000 adults registered at approximately 30 GP practices, and a monthly trial recruitment target of 22 patients per month over 22 months. The internal pilot trial phase resulted in revisions of these estimates to 256,000 and 42 GP practices. To date, 1,623 patients have been screened for eligibility and 450 randomised. The main reason for ineligibility is low confidence in the diagnosis of sciatica. Conclusion. Our experience highlights the challenge of recruitment to clinical trials of sciatica, particularly in terms of case definition, and the need for careful planning and an internal pilot phase prior to a main trial. We believe our experience will be helpful to others conducting trials with sciatica patients. No conflicts of interest. Funding. NEF is an NIHR Senior Investigator. KK is supported through a HEFCE Senior Clinical Lecturer award. The SCOPiC trial is funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA project number 12/201/09). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 265 - 273
1 Feb 2022
Mens RH Bisseling P de Kleuver M van Hooff ML

Aims

To determine the value of scoliosis surgery, it is necessary to evaluate outcomes in domains that matter to patients. Since randomized trials on adolescent idiopathic scoliosis (AIS) are scarce, prospective cohort studies with comparable outcome measures are important. To enhance comparison, a core set of patient-related outcome measures is available. The aim of this study was to evaluate the outcomes of AIS fusion surgery at two-year follow-up using the core outcomes set.

Methods

AIS patients were systematically enrolled in an institutional registry. In all, 144 AIS patients aged ≤ 25 years undergoing primary surgery (median age 15 years (interquartile range 14 to 17) were included. Patient-reported (condition-specific and health-related quality of life (QoL); functional status; back and leg pain intensity) and clinician-reported outcomes (complications, revision surgery) were recorded. Changes in patient-reported outcome measures (PROMs) were analyzed using Friedman’s analysis of variance. Clinical relevancy was determined using minimally important changes (Scoliosis Research Society (SRS)-22r), cut-off values for relevant effect on functioning (pain scores) and a patient-acceptable symptom state (PASS; Oswestry Disability Index).


Background. Osteoarthritis (OA) and chronic low back pain (CLBP > 12 weeks duration) are two of the most common and costly chronic musculoskeletal conditions globally. Healthcare service demands mean that group-based multiple condition interventions are of increasing clinical interest and a priority for research, but no reviews have evaluated the effectiveness of group-based physiotherapy-led self-management interventions (GPSMI) for both conditions concurrently. Rapid review methodologies are an increasingly valid means of expediting knowledge dissemination and are particularly useful for addressing focused research questions. Methods. The electronic databases of MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Register of Controlled Trials were searched from the earliest date possible to August 26. th. 2013. Structured group-based interventions that aimed to promote self-management and that were delivered by health-care professionals (including at least one physiotherapist) involving adults with OA and/or CLBP were eligible for inclusion. The screening and selection of studies, data extraction and risk of bias assessment were conducted independently by two reviewers. Results. 22 studies were found (10 OA, 12 CLBP). The most commonly assessed outcomes were pain, disability, quality of life and physical function. No significant difference was found between the effectiveness of GPSMI and individual physiotherapy or usual general practitioner care for any outcome. Conclusion. GPSMI is as clinically effective as individual physiotherapy, but the best methods of measuring clinical effectiveness warrant further investigation. Further research is also needed to determine the cost-effectiveness of GPSMI and its implications. Conflicts of interest: No conflicts of interest. Sources of funding: This review was conducted as part of Health Research Award HRA_HSR/2012/24 from the Health Research Board of Ireland


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
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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. Results. 17 women, 15 midwives and 21 physiotherapists were interviewed (total n=53). Findings highlighted the impact of LBP in pregnancy, the paucity of effective treatment options and the challenges of recruiting pregnant women with LBP into research. Women and midwives expressed few concerns over the use and safety of acupuncture; physiotherapists were more cautious and had concerns about safety. Conclusions. Acupuncture for pregnancy- related LBP appears to be acceptable to women and midwives. Future research needs to consider strategies to support recruitment and retention, and should consider including interviews with eligible women who decline to take part in order to understand their reasons, as well as with women receiving treatment so as to understand their experiences of taking part. This abstract has not been published in whole or substantial part, nor has it been presented previously at a national meeting. Conflicts of interest: No conflicts of interest. This project presents independent research funded by the National Institute for Health Research's Health Technology Assessment Programme (Grant Reference Number 10/69/05) and an NIHR Research Professorship for N.E. Foster (NIHR-RP-011-015). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the HTA or the Department of Health


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 128 - 128
1 Apr 2012
Harshavardhana N Ahmed M Ul-Haq M Greenough C
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Healthcare interventions are under increasing scrutiny regarding cost-effectiveness and outcome measures have revolutionised clinical research. To identify all available outcome questionnaires designed for lowback, lumbar spine pathologies and to perform qualitative analysis of these questionnaires for their clinimetric properties. A comprehensive e-search on PUBMED & EMBASE for all available outcome measures and published review articles for lowback and lumbar spine pathologies was undertaken over a two month period (Nov-Dec 2009). Twenty-eight questionnaires were identified in total. These outcomes questionnaires were evaluated for clinimetric properties viz:-. Validity (content, construct & criterion validity). Reliability (internal consistency & reproducibility). Responsiveness and scored on a scale of 0-6 points. Eight outcomes questionnaires had satisfied all clinimetric domains in methodological evaluation (score 6/6). Oswestry disability index (ODI). Roland-Morris disability questionnaire (RMDQ). Aberdeen lowback pain scale. Extended Aberdeen spine pain scale. Functional rating index. Core lowback pain outcome measure. Backpain functional scale. Maine-Seattle back questionnaire. Sixteen of these questionnaires scored =5 when evaluated for clinimetric domains. RMDQ had the highest number of published and validated translations followed by ODI. Criterion validity was not tested for NASS-AAOS lumbar spine questionnaire. 32%(9/28) of the outcome instruments have undergone methodological evaluation for =3 clinimetric properties. Clinicians should be cautious when choosing appropriate validated outcome measures when evaluating therapeutic/surgical intervention. We suggest use of few validated outcome measures with high clinimetric scores (=5/6) to be made mandatory when reporting clinical results