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  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. Article

    Open Access

    The trials and tribulations of accessing data from routine sources

    Graham Powell, Tony Marson, Dyfrig Hughes, Paula Williamson, Catrin Tudur-Smith in Trials (2015)

  15. Article

    Open Access

    The CONSENSUS Study: Preliminary results of a mixed methods study to develop a core outcome set for late phase clinical trials in Oropharyngeal Cancer

    Aoife M I Waters, Catrin Tudur Smith, Bridget Young, Terry M Jones in Trials (2015)

  16. Article

    Open Access

    Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities

    Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruit...

    Peter Bower, Valerie Brueton, Carrol Gamble, Shaun Treweek, Catrin Tudur Smith in Trials (2014)

  17. Article

    Open Access

    The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer

    The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes shoul...

    Aoife MI Waters, Catrin Tudur Smith, Bridget Young, Terry M Jones in Trials (2014)

  18. Article

    Open Access

    Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit

    Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is incr...

    Catrin Tudur Smith, Paula Williamson, Ashley Jones, Alan Smyth in Trials (2014)

  19. Article

    Open Access

    The trials methodological research agenda: results from a priority setting exercise

    Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from...

    Catrin Tudur Smith, Helen Hickey, Mike Clarke, Jane Blazeby, Paula Williamson in Trials (2014)

  20. Article

    Open Access

    External validation of a prognostic index

    Laura Bonnett, Anthony Marson, Tony Johnson, Lois Kim, Ley Sander, Nicholas Lawn in Trials (2013)

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