Search

Additional file 1.

Additional file 1. Appendix 1 – Search strategy one.

Additional file 2.

Additional file 4.

Additional file 3.

Additional file 3. Appendix 3 – Data collection table.

Additional file 2. Appendix 2 – Search strategy two.

Introduction Low back pain (LBP) is the most prevalent musculoskeletal condition in the UK. Guidelines advocate a multimodal approach, including prescription of medications. Advanced physiotherapy practitioners (APPs) are well placed to provide this care in primary care. Physiotherapist independent prescribing remains novel, with the first prescribers qualifying in 2014. This feasibility trial aims to evaluate the feasibility, suitability and acceptability of assessing the effectiveness of independent prescribing by APPs for patients with LBP in primary care, to inform the design of a future definitive stepped-wedged cluster trial. Method and analysis (1) Trial component. An APP (registered prescriber) will complete the initial participant consultation. If prescription drugs are required within the multimodal physiotherapeutic context, these will be prescribed. Patient-reported outcome measures will be completed prior to initial assessment and at 6 and 12 weeks to assess feasibility of follow-up and data collection procedures. Accelerometers will be fitted for 7 days to assess physical activity, sedentary behaviour and feasibility of use. (2) Embedded qualitative component. A focus group and semistructured interviews will be used to evaluate the views and experiences of the participants and APPs respectively, about the feasibility, suitability and acceptability of the proposed full trial. A Consolidated Standards of Reporting Trials diagram will be used to analyse feasible eligibility, recruitment and follow-up rates. Descriptive analysis of the data will be completed to evaluate procedures. Thematic analysis will be used to analyse and synthesise the qualitative data. Ethics and dissemination This feasibility trial is approved by the Health Research Authority (HRA). Ethical approval was sought and granted via the Integrated Research Application System (IRAS) ID 250734. Data will be disseminated via publication in peer reviewed journal and conference presentation. It is anticipated that the results of this study will be used in conjunction with ethical evaluation, economic and risk analyses, as well as consultation with key stakeholders including the British health consumer when contemplating change, enhancement or redesign of the essential full randomised controlled trial. Trial registration number ISRCTN15516596, Pre-results.

Introduction Pain following musculoskeletal trauma is common with poor outcomes and disability well documented. Pain is complex in nature and can include the four primary mechanisms of pain: nociceptive, neuropathic, inflammatory and central sensitisation (CS). CS can be measured in multiple ways; however, no systematic review has evaluated the measurement properties of such measures in the musculoskeletal trauma population. This systematic review aims to evaluate the measurement properties of current measures of CS in this population. Methods/analysis This protocol is informed and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis-P. MEDLINE, EMBASE, CINAHL, ZETOC, Web of Science, PubMed and Google Scholar as well as key journals and grey literature will be searched in two stages to (1) identify what measures are being used to assess CS in this population and (2) evaluate the measurement properties of the identified measures. Two independent reviewers will conduct the search, extract the data, assess risk of bias for included studies and assess overall quality. The Consensus-based Standards for the selection of Health Measurement Instruments Risk of Bias Checklist and a modified Grading of Recommendations, Assessment, Development and Evaluation guidelines will be used. Meta-analysis will be conducted if deemed appropriate. Alternatively, a narrative synthesis will be conducted and summarised per measurement property per outcome measure. Ethics and dissemination This review will aid clinicians in using the most appropriate tool for assessing central sensitisation in this population and is the first step towards a more standardised approach in pain assessment. The results of this study will be submitted to a peer reviewed journal and presented at conferences. PROSPERO registrationnumber CRD42018091531.

Objectives To examine care home resident and staff perceptions of the acceptability of participating in a feasibility trial evaluating nutritional interventions in the treatment of malnutrition. Design Exploratory qualitative methodology was used to gather descriptions of resident and staff perceptions of trial procedures, using semi-structured interviews with residents and focus groups with staff. The interviews were used to explore individual perceptions of the acceptability of the assigned intervention and the outcomes measured. Focus groups were used to explore staff experiences of trial participation and perspectives of nutritional support interventions. Setting The study was embedded within a cluster randomised feasibility trial, which randomised six care homes to provide standard care (SC), food-based (FB) intervention or oral nutritional supplement (ONS) intervention to residents with, or at risk of, malnutrition. Participants Residents in the trial with capacity to consent (n=7) formed the sampling frame for inclusion. Four agreed to be approached by the researcher and to take part in the individual interviews. All were women, representing two arms of the trial (ONS and SC). Twelve staff participated in six focus groups, one at each care home. All participants were women, representing all three arms of the trial. Results Major themes that emerged from both interviews and focus groups included the perceived acceptability of trial involvement, the value of residents completing participant-reported outcome measures and the challenges associated with outcomes measurement in this setting. Themes that emerged from the focus groups alone, included the importance of individualising an intervention, and the perceived value of FB and ONS interventions and dietetic input. Conclusions Residents and staff perceived involvement in a trial evaluating nutritional interventions to be acceptable, although the challenges associated with research in this setting were acknowledged. Resident preferences were highlighted by staff as an important consideration when implementing a nutrition support plan. Trial registration number ISRCTN38047922

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.