The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581)

Foster, Nadine E; Konstantinou, Kika; Lewis, Martyn; Ogollah, Reuben; Dunn, Kate M.; Windt, Daniëlle van der; Beardmore, Ruth; Artus, Majid; Bartlam, Bernadette; Hill, Jonathan; Jowett, Sue; Kigozi, Jesse; Mallen, Christian; Saunders, Benjamin; Hay, Elaine M

doi:10.1186/s12891-017-1513-5

Cited by 14 publications

(20 citation statements)

References 49 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…10 Using this, and working closely with clinicians, we developed an algorithm combining information about patients' risk of persistent pain-related disability (using the STarT Back Screening Tool) and key findings from the clinical assessment that were associated with referral to spinal specialist services to allocate patients to matched care pathways, including an early, fast-track referral to MRI and specialist spinal opinion. 21 The stratification algorithm is described in Chapter 2.…”

Section: Stratified Care Model and Rationale For The Scopic Trialmentioning

confidence: 99%

See 1 more Smart Citation

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT

Foster

Konstantinou

Lewis

et al. 2020

Health Technol Assess

Self Cite

View full text Add to dashboard Cite

Background Sciatica has a substantial impact on patients and society. Current care is ‘stepped’, comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. Objectives The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. Design This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. Setting Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. Participants Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. Interventions In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. Main outcome measures The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost–utility analysis was undertaken over 12 months. A qualitative study explored patients’ and clinicians’ views of the fast-track care pathway to a spinal specialist. Results A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. Conclusions The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. Limitations Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. Future work Other approaches to stratified care may provide superior outcomes for sciatica. Trial registration Current Controlled Trials ISRCTN75449581. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.

show abstract

Section: Stratified Care Model and Rationale For The Scopic Trialmentioning

confidence: 99%

“…The personal, social and economic burdens are significant, 19,20 with UK annual costs estimated at £268M in direct medical costs and £1.9B in indirect costs. 21 Treatments for, and current clinical management of, sciatica…”

Section: Introductionmentioning

confidence: 99%

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT

Foster

Konstantinou

Lewis

et al. 2020

Health Technol Assess

Self Cite

View full text Add to dashboard Cite

show abstract

“…Greater patient and public involvement could offer insights into how to explore this. Two of the clinical sites were going to recruit participants using the same methods as the ATLAS cohort, which have been used successfully in another RCT of primary care-delivered treatment for sciatica [ 44 ]. However, these two sites signed their contracts just prior to trial closure.…”

Section: Discussionmentioning

confidence: 99%

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)

Williams

Jenkins

Goulden

et al. 2018

Trials

Self Cite

View full text Add to dashboard Cite

BackgroundAdalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.MethodsA pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months’ duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.ResultsThe internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.ConclusionsImproved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.Trial registrationCurrent Controlled Trials, ISRCTN14569274. Registered on 15 December 2014.

show abstract

“…The most common reasons for sciatica are compression or irritation of a lumbar spinal nerve root by a prolapsed disc, or tightening of the spinal or lateral canal, causing the condition termed spinal stenosis which may also give sciatic type of symptoms [6] [7]. Whilst the prevalence of sciatica is much less than that of LBP alone [8], it is considered responsible for much of the indirect costs and lost workdays associated with back pain [9] [10]. Whilst the management of non-specific LBP is almost exclusively conservative, sciatica management options can potentially include, spinal epidural injections and spinal surgery, for patients not improving sufficiently with conservative management [11].…”

Section: Introductionmentioning

confidence: 99%

Systematic Review of Decision Analytic Modelling in Economic Evaluations of Low Back Pain and Sciatica

Hall

Konstantinou

Lewis

et al. 2019

Appl Health Econ Health Policy

Self Cite

View full text Add to dashboard Cite

Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document. When citing, please reference the published version. Take down policy While the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive.

show abstract

The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581)

Cited by 14 publications

References 49 publications

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)

Systematic Review of Decision Analytic Modelling in Economic Evaluations of Low Back Pain and Sciatica

Contact Info

Product

Resources

About