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

BMC Musculoskeletal Disorders

Study Protocol

Bernadette Bartlam¹  Kika Konstantinou¹  Benjamin Saunders¹  Christian Mallen¹  Elaine M. Hay¹  Majid Artus¹  Kate M. Dunn¹  Danielle van der Windt¹  Jonathan C. Hill¹  Jesse Kigozi²  Sue Jowett²  Martyn Lewis³  Nadine E. Foster³  Reuben Ogollah³  Ruth Beardmore⁴ 

[1] Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, ST5 5BG, Staffordshire, UK;Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, ST5 5BG, Staffordshire, UK;Health Economics Unit Institute of Applied Health Research, University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK;Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, ST5 5BG, Staffordshire, UK;Keele Clinical Trials Unit, Keele University, ST5 5BG, Staffordshire, UK;Keele Clinical Trials Unit, Keele University, ST5 5BG, Staffordshire, UK;

关键词: Stratified care;    Sciatica;    Primary care;    Randomised controlled trial;   

DOI  :  10.1186/s12891-017-1513-5

 received in 2017-03-17, accepted in 2017-03-31,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundSciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of ‘wait and see’ for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care.Methods/DesignMulticentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care.DiscussionThis paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care.Trial registrationISRCTN75449581, date: 20.11.2014.

【 授权许可】

CC BY   
© The Author(s). 2017