Recent Submissions

  • The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vertebral fragility fractures.

    Fakis, Apostolos
    INTRODUCTION: Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients. METHOD: A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data. ETHICS AND DISSEMINATION: Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion. TRIAL REGISTRATION NUMBER: ISRCTN18334053.
  • Highlighting Risk in Sponsored Studies: A Risk Categorisation Tool

    Skirrow, Sarah; Thornhill, Joanne; Jones, Michael (2019)
  • Quantitative analysis of qualitative information from interviews: A systematic literature review

    Fakis, Apostolos (2014-04)
    Background: A systematic literature review was conducted on mixed methods area. Objectives: The overall aim was to explore how qualitative information from interviews has been analyzed using quantitative methods. Methods: A contemporary review was undertaken and based on a predefined protocol. The references were identified using inclusion and exclusion criteria and specific key terms in 11 search databases. Results: Evidence was synthesized from 14 references that included the methods used for quantifying qualitative information, analyzing it statistically and the rationale behind this. Gaps in the existing literature and recommendations for future research were identified. Conclusions: This review highlights the need for a new mixed method based on advanced statistical modeling method that will explore complex relationships arising from qualitative information.
  • Knowledge, attitude and barriers towards research in the national health service (NHS)

    Ahmed, Mansoor; Boswell, Stephanie (2014-10)
    In the 21st century, healthcare professionals know a great deal about health, disease and medicine. However, much remains uncertain and continued investment in research aims to find better ways of managing patients, improving public health, reducing health inequalities and keeping people in a state of good health. Clinical Research Networks are well established across the NHS to ensure that all patients and clinicians are able to share the benefits of participating in clinical research. Barriers to research can deter healthcare professionals from contributing towards useful research projects. Aim To ascertain knowledge and attitude towards research and identify barriers amongst healthcare professionals in a district general hospital setting. Methods All the healthcare professionals were emailed a questionnaire via 'survey monkey' in March 2014. An email reminder to non-respondents was sent 2 weeks later. Questions focussed on participant's knowledge and attitude towards research and identifying perceived barriers to undertaking research. Results 87 responses were received (26 doctors and 61 allied health professionals). Following table outlines key study findings in %. Conclusions Majority of participants perceived time commitment and bureaucracy as barrier to research. Dedicated time allocated in the job plan and administrative support would be imperative in improving research outcomes leading to innovative treatments that can significantly improve patient health in future.
  • A prospective study of adverse drug reactions to antiepileptic drugs in children.

    Fakis, Apostolos (2015-06)
    Antiepileptic drugs (AEDs) and to prospectively evaluate the effect of AEDs on behaviour. SETTING: A single centre prospective observational study. PARTICIPANTS: Children (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit. PRIMARY AND SECONDARY OUTCOMES: Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes. RESULTS: 180 children were recruited. Sodium valproate and carbamazepine were the most frequently used AEDs. A total of 114 ADRs were recorded in 56 of these children (31%). 135 children (75%) were on monotherapy. 27 of the 45 children (60%) on polytherapy had ADRs; while 29 (21%) of those on monotherapy had ADRs. The risk of ADRs was significantly lower in patients receiving monotherapy than polytherapy (RR: 0.61, 95% CI 0.47 to 0.79, p<0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue their AED due to an ADR. CONCLUSIONS: Behavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children. TRAIL REGISTRATION NUMBER: EudraCT (2007-000565-37).