Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Rushton AB

PROVIDER: S-EPMC5988074 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Publications

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.

Rushton Alison B AB Verra Martin L ML Emms Andrew A Heneghan Nicola R NR Falla Deborah D Reddington Michael M Cole Ashley A AA Willems Paul P Benneker Lorin L Selvey David D Hutton Michael M Heymans Martijn W MW Staal J Bart JB

BMJ open 20180522 5

<h4>Introduction</h4>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).<h4>Methods and analysis</h4>Prospective observational study with a defined episode inception of the point of surgery. ...[more]

PMID: 29789351

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Project description:BackgroundPatients receiving lumbar spinal fusion surgery often have persisting postoperative pain negatively affecting their daily life. These patients may be helped by interdisciplinary cognitive-behavioral therapy which is recognized as an effective intervention for improving beneficial pain coping behavior, thereby facilitating the rehabilitation process of patients with chronic pain.PurposeThe purpose of this study was to describe the lived experience of patients recovering from lumbar spinal fusion surgery and to explore potential similarities and disparities in pain coping behavior between receivers and nonreceivers of interdisciplinary cognitive-behavioral group therapy.MethodsWe conducted semistructured interviews with 10 patients; 5 receiving cognitive-behavioral therapy in connection with their lumbar spinal fusion surgery and 5 receiving usual care. We conducted a phenomenological analysis to reach our first aim and then conducted a comparative content analysis to reach our second aim.ResultsPatients' postoperative experience was characterized by the need to adapt to the limitations imposed by back discomfort (coexisting with the back), need for recognition and support from others regarding their pain, a relatively long rehabilitation period during which they "awaited the result of surgery", and ambivalence toward analgesics. The patients in both groups had similar negative perception of analgesics and tended to abstain from them to avoid addiction. Coping behavior apparently differed among receivers and nonreceivers of interdisciplinary cognitive-behavioral group therapy. Receivers prevented or minimized pain by resting before pain onset, whereas nonreceivers awaited pain onset before resting.ConclusionThe postoperative experience entailed ambivalence, causing uncertainty, worry and insecurity. This ambivalence was relieved when others recognized the patient's pain and offered support. Cognitive-behavioral therapy as part of rehabilitation may have encouraged beneficial pain coping behavior by altering patients' pain perception and coping behavior, thereby reducing adverse effects of pain.

Project description:IntroductionThere 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 analysisA 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 disseminationThe 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.

Dataset Information

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

Methods and analysis

Exclusion criteria

Ethics and dissemination

Publications

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.

Similar Datasets

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