Background. Disability is an important multifaceted construct. Identifying sources of disability could help optimise
Background. Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. Objectives. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions. Methods. Three Delphi rounds with 64 experts in placebo research and/or non-pharmacological clinical trials were conducted. The panel was presented with a systematic review and meta-analysis of control and blinding methods. A draft guidance document included 63 consensus items (≥80% agreement) and was discussed with patient partners. Finally, the draft guidance and results from stakeholder interviews were discussed at consensus meetings with Delphi participants and patient representatives. Results. Forty-four experts completed the process. When treatment efficacy or mechanisms are to be studied, the advocated principle is to design control interventions as similar as possible to the tested intervention, apart from the components that the study examines. Structured reasoning in the planning phase, early engagement with stakeholders, feasibility work, and piloting will enhance the quality and acceptability of control interventions. With participant blinding being a primary objective, blinding effectiveness should be routinely assessed and reported. Transparent and detailed reporting will improve interpretability and repeatability of clinical trials. Conclusion. This guideline provides the much-needed standards to enhance the quality of efficacy clinical trials in physical, psychological, and self-management intervention research, ultimately improving
Background. Involving research users in setting priorities for research is essential to ensure research outcomes are patient-centred and to maximise research value and impact. The Musculoskeletal (MSK) Disorders Research Advisory Group Versus Arthritis led a research priority setting exercise across MSK disorders. Methods. The Child Health and Nutrition Research Initiative (CHRNI) method of setting research priorities with a range of stakeholders were utilised. The MSKD RAG identified, through consensus, four research Domains: Mechanisms of Disease; Diagnosis and Impact; Living Well with MSK disorders and Successful Translation. Following ethical approval, the research priority exercise involved four stages and two surveys, to: 1) gather research uncertainties; 2) consolidate these; 3) score uncertainties using agreed criteria of importance and impact on a score of 1–10; and 4) analyse scoring, for prioritisation. Results. The first survey had 209 respondents, who described 1290 research uncertainties, which were refined into 68 research questions. 285 people responded to the second survey. The largest group of respondents represented
Patients with cauda equina syndrome (CES) require emergency imaging and surgical decompression. The severity and type of symptoms may influence the timing of imaging and surgery, and help predict the patient’s prognosis. Categories of CES attempt to group patients for management and prognostication purposes. We aimed in this study to assess the inter-rater reliability of dividing patients with CES into categories to assess whether they can be reliably applied in clinical practice and in research. A literature review was undertaken to identify published descriptions of categories of CES. A total of 100 real anonymized clinical vignettes of patients diagnosed with CES from the Understanding Cauda Equina Syndrome (UCES) study were reviewed by consultant spinal surgeons, neurosurgical registrars, and medical students. All were provided with published category definitions and asked to decide whether each patient had ‘suspected CES’; ‘early CES’; ‘incomplete CES’; or ‘CES with urinary retention’. Inter-rater agreement was assessed for all categories, for all raters, and for each group of raters using Fleiss’s kappa.Aims
Methods
This study aimed, through bioinformatics analysis and in vitro experiment validation, to identify the key extracellular proteins of intervertebral disc degeneration (IDD). The gene expression profile of GSE23130 was downloaded from the Gene Expression Omnibus (GEO) database. Extracellular protein-differentially expressed genes (EP-DEGs) were screened by protein annotation databases, and we used Gene Ontology (GO) and the Kyoto Encyclopedia of Genes and Genomes (KEGG) to analyze the functions and pathways of EP-DEGs. STRING and Cytoscape were used to construct protein-protein interaction (PPI) networks and identify hub EP-DEGs. NetworkAnalyst was used to analyze transcription factors (TFs) and microRNAs (miRNAs) that regulate hub EP-DEGs. A search of the Drug Signatures Database (DSigDB) for hub EP-DEGs revealed multiple drug molecules and drug-target interactions.Aims
Methods
Historically, patients undergoing surgery for adolescent idiopathic scoliosis (AIS) have been nursed postoperatively in a critical care (CC) setting because of the challenges posed by prone positioning, extensive exposures, prolonged operating times, significant blood loss, major intraoperative fluid shifts, cardiopulmonary complications, and difficulty in postoperative pain management. The primary aim of this paper was to determine whether a scoring system, which uses Cobb angle, forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and number of levels to be fused, is a valid method of predicting the need for postoperative critical care in AIS patients who are to undergo scoliosis correction with posterior spinal fusion (PSF). We retrospectively reviewed all AIS patients who had undergone PSF between January 2018 and January 2020 in a specialist tertiary spinal referral centre. All patients were assessed preoperatively in an anaesthetic clinic. Postoperative care was defined as ward-based (WB) or critical care (CC)Aims
Methods
Purpose. A Virtual Spinal Clinic (VSC) was set-up at a regional spinal referral centre to see if
This review provides a concise outline of the advances made in the
With resumption of elective spine surgery services in the UK following the first wave of the COVID-19 pandemic, we conducted a multicentre British Association of Spine Surgeons (BASS) collaborative study to examine the complications and deaths due to COVID-19 at the recovery phase of the pandemic. The aim was to analyze the safety of elective spinal surgery during the pandemic. A prospective observational study was conducted from eight spinal centres for the first month of operating following restoration of elective spine surgery in each individual unit. Primary outcome measure was the 30-day postoperative COVID-19 infection rate. Secondary outcomes analyzed were the 30-day mortality rate, surgical adverse events, medical complications, and length of inpatient stay.Aims
Methods
Background. There is growing evidence for an important role of central sensitization (CS) in the development and maintenance of chronic pain. This accounts for patients with chronic low back pain radiating to the leg (CLBPr) as well. Care as Usual (CaU) in these patients consists of diagnostic segmental nerve root blocks (dSNRB) followed by therapeutic interventions, i.e. a therapeutic segmental nerve root block (tSNRB) or pulsed radiofrequency (pRF). However, it is unknown if these procedures affect the amount of CS in these patients. Aim. The aim of the present study is to determine the alterations in the presentation of CS in CLBPr
Purpose & Background. The STarT Back risk-stratification approach uses the STarT Back Tool to categorise patients with low back pain (LBP) at low, medium or high-risk of persistent disabling pain, in order to match treatments. The MATCH trial (NCT02286141) evaluated the effect of implementing an adaptation of this approach in a United States healthcare setting. Methods. This was a pragmatic cluster randomised trial with a pre-intervention baseline period. Six primary care clinics were pair-randomised, three to an intensive stratified care quality improvement intervention and three as controls. LBP patients were invited to provide outcomes two weeks after their primary care visit, and two and six months later. Primary outcomes were physical function (RMDQ) and pain (0–10 NRS), and secondary outcomes including healthcare use and treatments provided received. Analysis was intention-to-treat. Results. Patient outcomes were obtained from intervention (n=690) and control (n=864) clinics. At six months between-group differences in adjusted mean change scores did not significantly favour stratified care for RMDQ; 0.50 (95%CI −0.55, 1.55) or pain NRS 0.13 (95%CI −0.37, 0.63). There were no significant between group differences in any secondary patient outcome. Process data showed that the STarT Back tool was used with 47% of LBP patients in the intervention clinics but there was no differences in the treatments provided. Conclusions. Implementation of a LBP stratified care approach in this United States healthcare setting showed moderate use of the STarT Back tool, but no change in treatments received by patients, and no benefits on patient outcomes. Conflicts of interest: None. Sources of funding: Funding for this trial was provided by the
To report the outcome of spinal deformity correction through anterior spinal fusion in wheelchair-bound patients with myelomeningocele. We reviewed 12 consecutive patients (7M:5F; mean age 12.4 years (9.2 to 16.8)) including demographic details, spinopelvic parameters, surgical correction, and perioperative data. We assessed the impact of surgery on patient outcomes using the Spina Bifida Spine Questionnaire and a qualitative questionnaire.Aims
Methods
The aim of this study was to determine the influence of developmental spinal stenosis (DSS) on the risk of re-operation at an adjacent level. This was a retrospective study of 235 consecutive patients who had undergone decompression-only surgery for lumbar spinal stenosis and had a minimum five-year follow-up. There were 106 female patients (45.1%) and 129 male patients (54.9%), with a mean age at surgery of 66.8 years (Aims
Patients and Methods
We present the results of correcting a double or triple curve
adolescent idiopathic scoliosis using a convex segmental pedicle
screw technique. We reviewed 191 patients with a mean age at surgery of 15 years
(11 to 23.3). Pedicle screws were placed at the convexity of each
curve. Concave screws were inserted at one or two cephalad levels
and two caudal levels. The mean operating time was 183 minutes (132
to 276) and the mean blood loss 0.22% of the total blood volume
(0.08% to 0.4%). Multimodal monitoring remained stable throughout
the operation. The mean hospital stay was 6.8 days (5 to 15).Aims
Patients and Methods
Patients seeking cervical spine surgery are thought to be increasing
in age, comorbidities and functional debilitation. The changing
demographics of this population may significantly impact the outcomes
of their care, specifically with regards to complications. In this
study, our goals were to determine the rates of functionally dependent
patients undergoing elective cervical spine procedures and to assess
the effect of functional dependence on 30-day morbidity and mortality
using a large, validated national cohort. A retrospective analysis of the American College of Surgeons
National Surgical Quality Improvement Program data files from 2006
to 2013 was conducted to identify patients undergoing common cervical
spine procedures. Multivariate logistic regression models were generated
to analyse the independent association of functional dependence
with 30-day outcomes of interest.Aims
Patients and Methods
Using the United States Nationwide Inpatient
Sample, we identified national trends in revision spinal fusion
along with a comprehensive comparison of comorbidities, inpatient
complications and surgical factors of revision spinal fusion compared
to primary spinal fusion. In 2009, there were 410 158 primary spinal fusion discharges
and 22 128 revision spinal fusion discharges. Between 2002 and 2009,
primary fusion increased at a higher rate compared with revision
fusion (56.4% In the multivariable logistic regression model for all spinal
fusions, depression (odds ratio (OR) 1.53, p <
0.001), psychotic
disorders (OR 1.49, p <
0.001), deficiency anaemias (OR 1.35,
p <
0.001) and smoking (OR 1.10, p = 0.006) had a greater chance
of occurrence in revision spinal fusion discharges than in primary
fusion discharges, adjusting for other variables. In terms of complications,
after adjusting for all significant comorbidities, this study found
that dural tears (OR 1.41; p <
0.001) and surgical site infections
(OR 3.40; p <
0.001) had a greater chance of occurrence in revision
spinal fusion discharges than in primary fusion discharges (p <
0.001). A p-value <
0.01 was considered significant in all final
analyses. Cite this article: