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  1. Article

    Open Access

    Opening up ideas: an advent calendar for patient and public engagement in clinical trials research

    The involvement of patients and the public in research is now an expectation in research with funders requesting a clear plan of involvement and engagement. In the United Kingdom involvement typically focuses ...

    Nicola L. Harman, Kerrie McGiveron in Research Involvement and Engagement (2023)

  2. Article

    Open Access

    The impact of parent treatment preference and other factors on recruitment: lessons learned from a paediatric epilepsy randomised controlled trial

    In paediatric epilepsy, the evidence of effectiveness of antiseizure treatment is inconclusive for some types of epilepsy. As with other paediatric clinical trials, researchers undertaking paediatric epilepsy ...

    Bernie Carter, Lucy Bray, Nadia al-Najjar, Agnès Tort Piella, Catrin Tudur-Smith in Trials (2023)

  3. Article

    Open Access

    Assessing metacognitive beliefs in test anxiety: Psychometric properties of the metacognitions questionnaire, 30 (MCQ-30) among university students

    The Metacognitions Questionnaire-30 (MCQ-30) measures maladaptive metacognitive beliefs considered central to the metacognitive model of psychopathology. However, the psychometric properties of the MCQ-30 in t...

    Christopher D. Huntley, Bridget Young, Catrin Tudur Smith, Vikram Jha in Current Psychology (2022)

  4. Article

    Open Access

    Testing times: the association of intolerance of uncertainty and metacognitive beliefs to test anxiety in college students

    Test anxiety has a detrimental effect on test performance but current interventions for test anxiety have limited efficacy. Therefore, examination of newer psychological models of test anxiety is now required....

    Christopher Huntley, Bridget Young, Catrin Tudur Smith, Vikram Jha in BMC Psychology (2022)

  5. No Access

    Protocol

    Practical Considerations and Challenges When Conducting an Individual Participant Data (IPD) Meta-Analysis

    This chapter provides a broad overview of the use of individual participant (sometimes referred to as patient) data (IPD ) within meta-analyses, the associated advantages of using IPD in meta-analysis compare...

    Sarah J. Nevitt, Catrin Tudur Smith in Meta-Research (2022)

  6. Article

    Open Access

    Develo** a topic-based repository of clinical trial individual patient data: experiences and lessons learned from a pilot project

    Building a dataset of individual participant data (IPD) for meta-analysis represents considerable research investment as well as collaboration across multiple institutions and researchers. Making arrangements ...

    Nancy Medley, Anna Cuthbert, Richard Crew, Lesley Stewart in Systematic Reviews (2021)

  7. Article

    Open Access

    Determining the effectiveness of fibrin sealants in reducing complications in patients undergoing lateral neck dissection (DEFeND): study protocol for a randomised external pilot trial

    Complications after major surgery are a significant cause of morbidity and mortality. Neck dissection is one of the most commonly performed major operations in Head and Neck Surgical Oncology. Significant surg...

    Mandeep S. Bajwa, Stacey Carruthers, Rob Hanson in Pilot and Feasibility Studies (2020)

  8. Article

    Open Access

    Ketogenic diets as an adjuvant therapy for glioblastoma (KEATING): a randomized, mixed methods, feasibility study

    We conducted a feasibility study to investigate the use of ketogenic diets (KDs) as an adjuvant therapy for patients with glioblastoma (GBM), investigating (i) trial feasibility; (ii) potential impacts of the ...

    Kirsty J. Martin-McGill, Anthony G. Marson, Catrin Tudur Smith in Journal of Neuro-Oncology (2020)

  9. Article

    Open Access

    Protocol for a systematic review of prognostic models for recurrent events in chronic conditions

    Prognostic models for repeated events of the same type are highly useful in predicting when a patient may have a recurrence of a chronic disease or illness. Whilst methods are currently available for analysing...

    Victoria Watson, Catrin Tudur Smith, Laura Bonnett in Diagnostic and Prognostic Research (2020)

  10. Article

    Open Access

    Individualised prediction of psychosis in individuals meeting at-risk mental state (ARMS) criteria: protocol for a systematic review of clinical prediction models

    Psychotic disorders affect about 3% of the population worldwide and are associated with high personal, social and economic costs. They tend to have their first onset in adolescence. Increasing emphasis has bee...

    Laura J. Bonnett, Filippo Varese, Catrin Tudur Smith in Diagnostic and Prognostic Research (2019)

  11. Article

    Open Access

    Pharmacological management of post-traumatic seizures in adults: current practice patterns in the UK and the Republic of Ireland

    Patient selection for seizure prophylaxis after traumatic brain injury (TBI) and duration of anti-epileptic drug treatment for patients with early post-traumatic seizures (PTS), remain plagued with uncertainty...

    Harry Mee, Angelos G. Kolias, Aswin Chari, Ari Ercole, Fiona Lecky in Acta Neurochirurgica (2019)

  12. Article

    Open Access

    Correction to: joint models for longitudinal and time-to-event data: a review of reporting quality with a view to meta-analysis

    Following publication of the original article [1] the authors reported that reference 15 (Cella et al.) had been incorrectly replaced with a duplicate of Brombin et al. during publication.

    Maria Sudell, Ruwanthi Kolamunnage-Dona in BMC Medical Research Methodology (2018)

  13. Article

    Open Access

    Core Health Outcomes In Childhood Epilepsy (CHOICE): protocol for the selection of a core outcome set

    There is increasing recognition that establishing a core set of outcomes to be evaluated and reported in trials of interventions for particular conditions will improve the usefulness of health research. There ...

    Christopher Morris, Colin Dunkley, Frances M. Gibbon, Janet Currier in Trials (2017)

  14. Article

    Open Access

    Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial): study protocol for a randomised pilot study

    Glioblastoma is the commonest form of malignant brain tumour in adults, affecting 2–3 people per 100,000 per year. Despite current treatment options including surgical resection, radiotherapy and temozolomide ...

    Kirsty J. Martin-McGill, Anthony G. Marson in Pilot and Feasibility Studies (2017)

  15. Article

    Open Access

    Resource implications of preparing individual participant data from a clinical trial to share with external researchers

    Demands are increasingly being made for clinical trialists to actively share individual participant data (IPD) collected from clinical trials using responsible methods that protect the confidentiality and priv...

    Catrin Tudur Smith, Sarah Nevitt, Duncan Appelbe, Richard Appleton, Pete Dixon in Trials (2017)

  16. Article

    Open Access

    Does the low prevalence affect the sample size of interventional clinical trials of rare diseases? An analysis of data from the aggregate analysis of clinicaltrials.gov

    Clinical trials are typically designed using the classical frequentist framework to constrain type I and II error rates. Sample sizes required in such designs typically range from hundreds to thousands of pati...

    Siew Wan Hee, Adrian Willis, Catrin Tudur Smith in Orphanet Journal of Rare Diseases (2017)

  17. Article

    Open Access

    Joint models for longitudinal and time-to-event data: a review of reporting quality with a view to meta-analysis

    Joint models for longitudinal and time-to-event data are commonly used to simultaneously analyse correlated data in single study cases. Synthesis of evidence from multiple studies using meta-analysis is a natu...

    Maria Sudell, Ruwanthi Kolamunnage-Dona in BMC Medical Research Methodology (2016)

  18. Article

    Open Access

    Best practice for analysis of shared clinical trial data

    Greater transparency, including sharing of patient-level data for further research, is an increasingly important topic for organisations who sponsor, fund and conduct clinical trials. This is a major paradigm ...

    Sally Hollis, Christine Fletcher, Frances Lynn in BMC Medical Research Methodology (2016)

  19. Article

    Open Access

    Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

    The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and infor...

    Alex Hodkinson, Carrol Gamble, Catrin Tudur Smith in Trials (2016)

  20. Article

    Open Access

    Good practice principles for sharing individual participant data from publicly funded clinical trials

    Catrin Tudur Smith, Carolyn Hopkins, Matt Sydes, Kerry Woolfall, Mike Clarke in Trials (2015)

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