Predictors of poor outcome following lumbar spinal fusion surgery: a prospective observational study to derive two clinical prediction rules using British Spine Registry data.

PURPOSE: Lumbar spinal fusion surgery (LSFS) is common for lumbar degenerative disorders. The objective was to develop clinical prediction rules to identify which patients are likely to have a favourable outcome to inform decisions regarding surgery and rehabilitation. METHODS: A prospective observational study recruited 600 (derivation) and 600 (internal validation) consecutive adult patients undergoing LSFS for degenerative lumbar disorder through the British Spine Registry. Definition of good outcome (6 weeks, 12 months) was reduction in pain intensity (Numerical Rating Scale, 0-10) and disability (Oswestry Disability Index, ODI 0-50) > 1.7 and 14.3, respectively. Linear and logistic regression models were fitted and regression coefficients, Odds ratios and 95% CIs reported. RESULTS: Lower BMI, higher ODI and higher leg pain pre-operatively were predictive of good disability outcome, higher back pain was predictive of good back pain outcome, and no previous surgery and higher leg pain were predictive of good leg pain outcome; all at 6 weeks. Working and higher leg pain were predictive of good ODI and leg pain outcomes, higher back pain was predictive of good back pain outcome, and higher leg pain was predictive of good leg pain outcome at 12 months. Model performance demonstrated reasonable to good calibration and adequate/very good discrimination. CONCLUSIONS: BMI, ODI, leg and back pain and previous surgery are important considerations pre-operatively to inform decisions for surgery. Pre-operative leg and back pain and work status are important considerations to inform decisions for management following surgery. Findings may inform clinical decision making regarding LSFS and associated rehabilitation.

Immediate patient perceptions following lumbar spinal fusion surgery: semi-structured multi-centre interviews exploring the patient journey and experiences of lumbar fusion surgery (FuJourn).

PURPOSE: To understand the patient journey to Lumbar Spinal Fusion Surgery (LSFS) and patients' experiences of surgery. METHODS: Qualitative study using interpretive phenomenological analysis. Adult participants following LSFS were recruited from 4 UK clinical sites using purposive sampling to ensure representation of key features (e.g. age). Semi-structured interviews informed by a piloted topic guide developed from the literature were audio-recorded and transcribed verbatim. Framework analysis for individual interviews and then across participants (deductive and inductive) identified emerging themes. Trustworthiness of data analyses was enhanced using multiple strategies (e.g. attention to negative cases). RESULTS: Four emerging themes from n = 31 patients' narratives were identified: decision for surgery, coping strategies, barriers to recovery and recovery after surgery. Decision for surgery and recovery after surgery themes are distinguished by the point of surgery. However, barriers to recovery and coping strategies are key to the whole patient journey encompassing long journeys to surgery and their initial journey after surgery. The themes of coping strategies and barriers to recovery were inter-related and perceived by participants as parallel concepts. The 4 multifactorial themes interacted with each other and shaped the process of an individual patient's recovery. Factors such as sporadic interventions prior to surgery, time-consuming wait for diagnosis and surgery and lack of information regarding recovery strongly influenced perceptions of outcome. CONCLUSION: Patient driven data enables insights to inform research regarding surgery/rehabilitation through depth of understanding of the patient journey. Awareness of factors important to patients is important; ensuring that patient-driven data informs research and patient care.

Lumbar spine fusion surgery versus best conservative care for patients with severe, persistent low back pain.

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. Results: There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). Conclusion: This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK.

Patients' expectations and experiences of accelerated access to physiotherapy for sciatica: qualitative findings from a mixed-methods study.

OBJECTIVES: Physiotherapy is often utilised in the management of sciatica and yet little research has been undertaken to examine patient expectations and experiences of physiotherapy and its timing. This study reports patient expectations and experiences of accelerated access to physiotherapy for sciatica. SETTING & PARTICIPANTS: Participants with clinically diagnosed sciatica (n=33) were recruited for individual interviews (n=46) from 14 National Health Service (NHS) primary care general practices, and one physiotherapy service provider in the same city in England. DESIGN: This was a nested qualitative study within a pilot randomised controlled trial evaluating accelerated access to physiotherapy for sciatica. Interviews with consenting participants were undertaken with some participants prior to randomisation and again after completion of physiotherapy (n=13), some before treatment commencement (n=7) and others only after cessation of treatment (n=13). All interviews were audio recorded and thematically analysed. RESULTS: Three themes emerged from the interviews: participants' expectations of physiotherapy, with negative expectations of physiotherapy being associated with experiences of previous unhelpful physiotherapy. Secondly, the perceived therapeutic value of accelerated physiotherapy in managing sciatica and preventing physical and psychological deterioration. Finally, the value of a personalised approach, with a physiotherapist who actively listened in partnership, and who provided a bespoke multimodal regimen. CONCLUSION: Findings from this study suggest that accelerated access to physiotherapy has value in terms of aiding perceived recovery and/or halting further physical and psychological decline. An individualised patient approach alongside accelerated access to physiotherapy should be considered for patients with sciatica.

A qualitative exploration of patient experiences of medication for sciatica.

BACKGROUND: Sciatica is often a painful and disabling condition, with medication routinely the first line of management. It is important to describe patients experiences of taking medication for sciatica, the reasons for commencing and reasons for cessation, the effects of the medication in symptom management and any other potential positive or deleterious effects. OBJECTIVES: To describe patient experiences of medication for the relief of symptoms of sciatica. STUDY DESIGN: Qualitative analysis of data from a mixed-methods randomised controlled pilot study. METHODS: A total of 46 semi-structured interviews were conducted with 33 consenting participants (19 female) recruited from 14 GP practices. A purposive sampling strategy ensured a range of age, severity of pain and disability. Interviews were recorded and transcribed verbatim prior to thematic analysis, which aimed to identify the important, interesting or divergent views within the data. FINDINGS: Participant experiences of pain were often severe with significant disability and fear. The use of a combination of medications was common, including the use of opioids and other medication inconsistent with national (NICE) guidance. Most participants found medication ineffective and reported significant side-effects, often necessitating cessation of the drugs or the use of alternatives. Despite the regularity of participants stopping all medication for sciatica, their pain levels still significantly eased over the 6-month period of the study. CONCLUSIONS: The study highlighted a lack of perceived effectiveness for prescribed medication, often with concomitant side-effects. Clinicians should be cognisant of the fears that patients hold in terms of the cause and severity of sciatica, as well as fears of prescribed medication.

Patient journey following lumbar spinal fusion surgery (FuJourn): A multicentre exploration of the immediate post-operative period using qualitative patient diaries.

The aim of this study was to capture and understand the immediate recovery journey of patients following lumbar spinal fusion surgery and explore the interacting constructs that shape their journey. A qualitative study using Interpretive Phenomenological Analysis (IPA) approach. A purposive sample of 43 adult patients (≥16 years) undergoing ≤4 level instrumented fusion for back and/or leg pain of degenerative cause, were recruited pre-surgery from 4 UK spinal surgery centres. Patients completed a weekly diary expressed in their own words for the first 4 weeks following surgery to capture their life as lived. Diary content was based on previous research findings and recorded progress, recovery, motivation, symptoms, medications, healthcare appointments, rehabilitation, positive/negative thoughts, and significant moments; comparing to the previous week. To maximise completion and data quality, diaries could be completed in paper form, word document, as online survey or as audio recording. Strategies to enhance diary adherence included a weekly prompt. A framework analysis for individual diaries and then across participants (deductive and inductive components) captured emergent themes. Trustworthiness was enhanced by strategies including reflexivity, attention to negative cases and use of critical co-investigators. Twenty-eight participants (15 female; n = 18 (64.3%) aged 45-64) contributed weekly diaries (12 withdrew post-surgery, 3 did not follow through with surgery). Adherence with diaries was 89.8%. Participants provided diverse and vivid descriptions of recovery experiences. Three distinct recovery trajectories were identified: meaningful recovery (engagement in physical and functional activities to return to functionality/mobility); progressive recovery (small but meaningful improvement in physical ability with increasing confidence); and disruptive recovery (limited purpose for meaningful recovery). Important interacting constructs shaped participants' recovery including their pain experience and self-efficacy. This is the first account of immediate recovery trajectories from patients' perspectives. Recognition of a patient's trajectory may inform patient-centred recovery, follow-up and rehabilitation to improve patient outcomes.

Does early intervention improve outcomes in the physiotherapy management of lumbar radicular syndrome? Results of the POLAR pilot randomised controlled trial.

OBJECTIVE: To investigate the feasibility of undertaking a definitive randomised controlled trial (RCT). SETTING: This was a pilot, pragmatic superiority RCT with a qualitative element, recruiting from 14 general practitioner (GP) practices in England. PARTICIPANTS: Patients over 18 years of age presenting to their GP with unilateral lumbar radicular syndrome (LRS), defined as radicular pain and/or neurological symptoms originating from lumbar nerve roots, were eligible to participate in the study, those who did not have a clear understanding of the English language or had comorbidities preventing rehabilitation were ineligible. INTERVENTIONS: Participants were randomised into early intervention physiotherapy or usual care with the former receiving their treatment within 2 weeks after randomisation and the latter 6 weeks postrandomisation. Both groups received a patient-centred, goal-orientated physiotherapy programme specific to their needs. Participants received up to six treatment sessions over an 8-week period. OUTCOME MEASURES: Process outcomes to determine the feasibility of the study and an exploratory analysis of patient-reported outcomes, including self-rated disability, pain and general health, these were collected at baseline, 6, 12 and 26 weeks postrandomisation. RESULTS: 80 participants were recruited in 10 GP practices over 34 weeks and randomised to (early intervention physiotherapy n=42, usual care n=38). Follow-up rates at 26 weeks were 32 (84%) in the usual care and 36 (86%) in the early intervention physiotherapy group. The mean area under the curve (larger values indicating more disability) for the Oswestry Disability Index over the 26 weeks was 16.6 (SD 11.4) in the usual care group and 16.0 (SD 14.0) in the intervention group. A difference of -0.6 (95% CI -0.68 to 5.6) in favour of the intervention group. CONCLUSIONS: The results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with LRS. TRIAL REGISTRATION NUMBER: NCT02618278, ISRCTN25018352.

Patient journey following lumbar spinal fusion surgery (LSFS): protocol for a multicentre qualitative analysis of the patient rehabilitation experience (FuJourn).

INTRODUCTION: There has been a 65% increase in lumbar spinal fusion surgery (LSFS) worldwide over the last 13 years, with costs of £26 million to the UK National Health Service annually. Patient dissatisfaction with outcome and persistent pain and disability incurs further costs. Three trials provide low-quality evidence for the role of physiotherapy. Our UK surveys investigating physiotherapy/surgeon practice concluded rehabilitation should be tailored to the individual patient owing to considerable clinical heterogeneity. This study will explore the perceptions of patients who undergo LSFS to inform precision rehabilitation. METHODS AND ANALYSIS: A qualitative study, using interpretive phenomenological analysis, will recruit a purposive sample (n=40) to ensure patterns of similarity and difference in their journeys can be explored. In-depth semistructured interviews will be undertaken following discharge from hospital and at 12 months postsurgery. Patients' preoperative and postoperative experiences, underlying attitudes and beliefs towards the surgical intervention, facilitators and barriers to recovery, adherence to advice and physiotherapy, experiences of rehabilitation and return to normal function/activity/work will be explored. A 12-month patient diary will provide real time access to patient data, capturing a weekly record of life as lived, including symptoms, medication, experiences of stages of recovery, rehabilitation adherence, healthcare professional appointments, attitudes, their feelings and experiences throughout their journey. Data will be analysed in a number of stages in accordance with interpretive phenomenological analysis, supported using NVivo software. Analysis of the first interviews and patient diaries will afford a rich density of data to build an overall understanding of the patients' lived experiences, informing the 12-month interview. Strategies (eg, reflexivity) will ensure trustworthiness. ETHICS AND DISSEMINATION: The study has ethical approval (IRAS 223283). Findings will ensure that patient-driven data inform precision rehabilitation by understanding the patient journey. Findings will be disseminated through peer-reviewed journals and conferences.

Development and validation of two clinical prediction models to inform clinical decision-making for lumbar spinal fusion surgery for degenerative disorders and rehabilitation following surgery: protocol for a prospective observational study.

INTRODUCTION: Potential predictors of poor outcome will be measured at baseline: (1) preoperatively to develop a clinical prediction model to predict which patients are likely to have favourable outcome following lumbar spinal fusion surgery (LSFS) and (2) postoperatively to predict which patients are likely to have favourable long-term outcomes (to inform rehabilitation). METHODS AND ANALYSIS: Prospective observational study with a defined episode inception of the point of surgery. Electronic data will be collected through the British Spine Registry and will include patient-reported outcome measures (eg, Fear-Avoidance Beliefs Questionnaire) and data items (eg, smoking status). Consecutive patients (≥18 years) undergoing LSFS for back and/or leg pain of degenerative cause will be recruited. EXCLUSION CRITERIA: LSFS for spinal fracture, inflammatory disease, malignancy, infection, deformity and revision surgery. 1000 participants will be recruited (n=600 prediction model development, n=400 internal validation derived model; planning 10 events per candidate prognostic factor). The outcome being predicted is an individual's absolute risk of poor outcome (disability and pain) at 6 weeks (objective 1) and 12 months postsurgery (objective 2). Disability and pain will be measured using the Oswestry Disability Index (ODI), and severity of pain in the previous week with a Numerical Rating Scale (NRS 0-10), respectively. Good outcome is defined as a change of 1.7 on the NRS for pain, and a change of 14.3 on the ODI. Both linear and logistic (to dichotomise outcome into low and high risk) multivariable regression models will be fitted and mean differences or ORs for each candidate predictive factor reported. Internal validation of the derived model will use a further set of British Spine Registry data. External validation will be geographical using two spinal registries in The Netherlands and Switzerland. ETHICS AND DISSEMINATION: Ethical approval (University of Birmingham ERN_17-0446A). Dissemination through peer-reviewed journals and conferences.

Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol.

INTRODUCTION: Lumbar radicular syndrome (LRS) can be a painful and debilitating condition. The optimum management strategies and their timing remain elusive despite extensive research. Surgery provides good short-term outcomes but has concomitant risks and costs. Physiotherapy is commonly practised for patients with LRS but its effects remain equivocal and there is a lack of consensus on the type, duration and timing of physiotherapy intervention. There is a lack of high-quality evidence into new and innovative management strategies and the timings of those strategies for LRS. This pilot trial is an essential preliminary to a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of early physiotherapy intervention for patients with LRS. The study will test the protocol, the intervention, the use of outcome measures and the ability to set-up and run the trial to enable refinement of a future definitive RCT. METHODS AND ANALYSIS: This is a mixed-methods study encompassing an external pilot RCT with integrated qualitative interviews with patients, clinicians and other key stakeholders. 80 patients will be recruited from primary care and randomised, after consent into 1 of 2 groups. Both groups will receive individually tailored, goal orientated physiotherapy. The usual care group will begin their physiotherapy 6 weeks after randomisation and the intervention group at 2 weeks after randomisation. Outcome measures will primarily be feasibility parameters including the ability to recruit and retain patients and to deliver the intervention. Data will be collected at baseline, and 6, 12 and 26 weeks following randomisation. ETHICS AND DISSEMINATION: The study has received favourable ethical review from the East of Scotland Research Ethics Service (EoSRES) on the 20 August 2015 (15/ES/0130). Recruitment began on the 1 March 2016 and is expected to close in January 2017. Data collection is anticipated to be complete in July 2017. The study results will be made available to participants, clinicians involved in the study and the wider clinical community through publication in a peer reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN: 25018352, Pre-results; Clinical Trials.Gov: NCT02618278 Document version V1.1 23.9.2016.

Physiotherapy for Patients with Sciatica Awaiting Lumbar Micro-discectomy Surgery: A Nested, Qualitative Study of Patients' Views and Experiences.

BACKGROUND AND PURPOSE: Sciatica is a common clinical condition that can be extremely painful, disabling and life-changing. Whether conservative or surgical treatment for sciatica secondary to an intervertebral disc prolapse is most effective is still much debated. An important component of conservative treatment is physiotherapy, which aims to promote physical and psychological health for the patient, whilst resorption of the disc takes place. This paper reports a qualitative study of patients' views and experiences of a bespoke physiotherapy intervention for the treatment of sciatica. METHODS: A qualitative study nested within a pilot randomized controlled trial of bespoke physiotherapy for the treatment of patients with sciatica awaiting lumbar microdiscectomy surgery. Patients randomized to receive bespoke physiotherapy in the intervention arm of the trial were invited to take part in semi-structured interviews. Twenty-one in-depth, semi-structured interviews took place. All interviews were recorded, fully transcribed and thematically analysed. RESULTS: Most patients in the sample found the physiotherapy valuable, appreciating the individual nature of the approach, the exercises to reduce pain and discomfort, techniques for improving functional spinal movement, walking and dynamic posture, and manual therapy and cardiovascular exercise. A small number did not find the physiotherapy of benefit. Sixteen patients in the sample went on to proceed with surgery, but most of these found value in having had the physiotherapy first. DISCUSSION: Many patients with sciatica appreciate the value of physiotherapy prior to surgery. Future research should examine patients' experiences of bespoke physiotherapy delivered within primary care. Copyright © 2016 The Authors Physiotherapy Research International published by John Wiley & Sons Ltd.