Independent prescribing by advanced physiotherapists for patients with low back pain in primary care: A feasibility trial with an embedded qualitative component

PLOS ONE RESEARCH ARTICLE Independent prescribing by advanced physiotherapists for patients with low back pain in primary care: A feasibility trial with an embedded qualitative component Tim Noblet ID1,2‡*, John Marriott3‡, Amanda Hensman-Crook4‡, Simon O’Shea ID5‡, Sarah Friel6‡, Alison Rushton1‡ a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 1 Centre of Precision Rehabilitation for Spinal Pain, School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, Birmingham, England, United Kingdom, 2 Physiotherapy Department, St George’s University Hospitals Foundation Trust, London, England, United Kingdom, 3 Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, England, United Kingdom, 4 Windermere Health Centre, Windermere, England, United Kingdom, 5 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England, United Kingdom, 6 Guys and St Thomas’ NHS Foundation Trust, London, England, United Kingdom ‡ TN is the primary author. JM and AR contributed equally to this work as second authors. AH-C, SO, and SF contributed equally to this work as site primary investigators. * OPEN ACCESS Citation: Noblet T, Marriott J, Hensman-Crook A, O’Shea S, Friel S, Rushton A (2020) Independent prescribing by advanced physiotherapists for patients with low back pain in primary care: A feasibility trial with an embedded qualitative component. PLoS ONE 15(3): e0229792. https:// doi.org/10.1371/journal.pone.0229792 Editor: Johannes Fleckenstein, University of Bern, SWITZERLAND Received: November 10, 2019 Abstract Background Low back pain (LBP) is the most prevalent musculoskeletal condition. Guidelines advocate a multimodal approach, including prescription of medications. Advanced Physiotherapy Practitioners (APPs) are well placed to manage LBP. To date no trial has evaluated the efficacy of physiotherapist-prescribing for LBP. Accepted: February 13, 2020 Published: March 17, 2020 Objectives Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: https://doi.org/10.1371/journal.pone.0229792 To evaluate the feasibility, suitability and acceptability of assessing the effectiveness of physiotherapist-prescribing for LBP in primary care; informing the design of a future definitive stepped-wedged cluster trial (SWcRCT). Copyright: © 2020 Noblet et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: The data underlying the results presented in the study are available from CPR Spine, School of sports, exercise and Methods Mixed-methods, single-arm feasibility design with two components. 1) Trial component: participants with medium-risk LBP +/-leg pain were recruited across 3 sites. Outcome measures (primary outcome measures-Pain/RMDQ) were completed at baseline, 6 and 12 weeks Physical activity/sedentary behaviour were assessed over 7 days using accelerometery. A CONSORT diagram analysed recruitment/follow-up rates. Descriptive analysis evaluated procedure/floor-effects. 2) Embedded qualitative component: focus groups (n = 6) and semi-structured interviews (n = 3) evaluated the views/experiences of patients and APPs about feasibility/suitability/ PLOS ONE | https://doi.org/10.1371/journal.pone.0229792 March 17, 2020 1 / 33 PLOS ONE rehabilitation sciences, University of Birmingham. Please email: . Funding: Health Education England (HEE) funding has allowed for the procurement of accelerometers and the associated IT programmes to ensure that innovative physical measures can be evaluated alongside patient reported outcome measures. The Private Physiotherapy Educational Fund has allowed for the procurement of x3 tablet computers for use in data collection and 7.5hrs per week of the principal Investigators time for 18 months. The funders have no direct role in study design, data collection and analysis decision to publish, or preparation of the manuscript. There were no conditions attached to funding. Identification of the trial funders provides transparency and accountability. Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje. org/coi_disclosure.pdf and declare that they have no competing interests: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. Physiotherapist prescribing for LBP in primary care acceptability of the proposed trial. Thematic analysis synthesised the qualitative data. Findings were evaluated against a priori success criteria. Results n = 29 participants were recruited. 90% of success criteria were met. Loss to follow-up at 12 weeks (65.5%) did not satisfy success criteria. Primary and secondary outcome measures were suitable and acceptable with no floor effects. The addition of a sleep assessment tool was advised. Accelerometer use was acceptable with 100% adherence. APPs felt all patients presenting with non-specific LBP +/- leg pain and capture data representative of the full scope of physiotherapist independent prescribing should be included. Data collection methods were acceptable to APPs and patients. APPs advocated necessity for using research assistants owing to time limitations. Conclusions Methods evaluated are feasible, suitable and acceptable for a definitive SWcRCT, with modification of eligibility criteria, and use of research assistants to overcome limited clinician capacity. A definitive SWcRCT is feasible with minor modifications. Registration ISRCTN15516596. Background In the UK, over 30 million working days are lost per year owing to musculoskeletal conditions [1]. Low back pain (LBP) is the most common musculoskeletal disorder, with 28.5% of the population over 25 years old experiencing LBP at any one time [2]. Seven percent of the UK population experience LBP associated with high levels of disability [2, 3]. Despite advances in knowledge, understanding and awareness regarding the complex biopsychosocial nature of this prevalent and multifaceted problem, the health and function of those with LBP continues to decline [4]. Novel approaches to the assessment and management of LBP, such as the use of stratification tools and shared decision-making, have been introduced across health sectors in an attempt to reduce overall costs to the health economy. It is theorised that by ensuring that biopsychosocial risk factors are a (...truncated)