المؤلفون: Rowe, Fiona J, Hepworth, Lauren R, Conroy, Elizabeth J, Rainford, Naomi EA, Bedson, Emma, Drummond, Avril, Garcia-Finana, Marta, Howard, Claire, Pollock, Alex, Shipman, Tracey, Dodridge, Caroline, Johnson, Stevie, Noonan, Carmel, Sackley, Catherine

المصدر: Rowe , F J , Hepworth , L R , Conroy , E J , Rainford , N EA , Bedson , E , Drummond , A , Garcia-Finana , M , Howard , C , Pollock , A , Shipman , T , Dodridge , C , Johnson , S , Noonan , C & Sackley , C 2019 , ' Visual Function Questionnaire as an outcome measure for homonymous hemianopia: subscales and supplementary questions, analysis from the VISION trial ' , Eye , vol. 33 , pp. 1485-1493 . https://doi.org/10.1038/s41433-019-0441-zTest

مصطلحات موضوعية: homonymous hemianopia, pilot trial, prism therapy, randomised controlled trial, standard care, stroke, visual search training, Visual Function Questionnaire-25, quality of life, Single-Blind Method, Prospective Studies, Sickness Impact Profile, Hemianopsia/physiopathology, Humans, Middle Aged, Stroke/physiopathology, Male, Visual Acuity/physiology, Visual Fields/physiology, Female, Surveys and Questionnaires, Aged, Outcome Assessment, Health Care

الوصف: Background:: We conduct supplementary analyses of the NEI VFQ-25 data to evaluate where changes occurred within subscales of the NEI VFQ-25 leading to change in the composite scores between the three treatment arms, and evaluate the NEI VFQ-25 with and without the Neuro 10 supplement. Methods:: A prospective, multicentre, parallel, single-blind, three-arm RCT of fourteen UK acute stroke units was conducted. Stroke survivors with homonymous hemianopia were recruited. Interventions included: Fresnel prisms for minimum 2 h, 5 days/week over 6-weeks (Arm a), Visual search training for minimum 30 min, 5 days/week over 6-weeks (Arm b) and standard care-information only (Arm c). Primary and secondary outcomes (including NEI VFQ-25 data) were measured at baseline, 6, 12 and 26 weeks after randomisation. Results:: Eighty seven patients were recruited (69% male; mean age (SD) equal to 69 (12) years). At 26 weeks, outcomes for 24, 24 and 22 patients, respectively, were compared to baseline. NEI VFQ-25 (with and without Neuro 10) responses improved from baseline to 26 weeks with visual search training compared to Fresnel prisms and standard care. In subscale analysis, the most impacted across all treatment arms was ‘driving’ whilst the least impacted were ‘colour vision’ and ‘ocular pain’. Conclusions:: Composite scores differed systematically for the NEI VFQ-25 (Neuro 10) versus NEI VFQ-25 at all time points. For subscale scores, descriptive statistics suggest clinically relevant improvement in distance activities and vision-specific dependency subscales for NEI VFQ-25 scores in the visual search treatment arm. Trial Registration: Current Controlled Trials ISRCTN05956042.

وصف الملف: application/pdf

الإتاحة: https://doi.org/10.1038/s41433-019-0441-zTest
https://researchonline.gcu.ac.uk/en/publications/9c9779cc-c5a6-43e0-b2e2-51dc949954b0Test
https://researchonline.gcu.ac.uk/ws/files/27107195/A.Pollock_EYE_19_NEI_VFQ_paper_18.02.19_accepted_author_version.pdfTest

المؤلفون: Mallucci, Conor L, Jenkinson, Michael D, Conroy, Elizabeth J, Hartley, John C, Brown, Michaela, Dalton, Joanne, Kearns, Tom, Moitt, Tracy, Griffiths, Michael J, Culeddu, Giovanna, Solomon, Tom, Hughes, Dyfrig, Gamble, Carrol, Pettorini, Benedetta, Parks, Christopher, Sinha, Ajay, van Tonder, Libby, Foster, Mitchel T, McMahon, Catherine, Buxton, Neil, Chavredakis, Emmanuel, Brodbelt, Andrew R, Lawson, David DA, Eldridge, Paul R, Farah, Jibril O, Zakaria, Rasheed, Geraint, Sunderland, Solanki, Guirish, Rodrigues, Desiderio, Edwards, Richard, Williams, Adam, Garnett, Matthew, Kolias, Angelos, Hutchinson, Peter JA, Caldwell, Karen, Tarantino, Silvia, Leach, Paul, Zaben, Malik, Zilani, Gulam, Shastin, Dmitri, Merola, Joseph, Hussain, Rahim, Vemaraju, Ravindra, Selezneva, Liudmila, Radford, Georgina, Lloyd, Nadine, Crimmins, Darach, Caird, John, Sayar, Maria N, O'Mahoney, Noelle

المصدر: The Lancet ; volume 394, issue 10208, page 1530-1539 ; ISSN 0140-6736

مصطلحات موضوعية: General Medicine

الإتاحة: https://doi.org/10.1016/s0140-6736Test(19)31603-4
https://api.elsevier.com/content/article/PII:S0140673619316034?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0140673619316034?httpAccept=text/plainTest

المؤلفون: Conroy, Elizabeth J., Rosala-Hallas, Anna, Blazeby, Jane M., Burnside, Girvan, Cook, Jonathan A., Gamble, Carrol

المساهمون: National Institute for Health Research (NIHR) Doctoral Fellowship Programme, Medical Research Council ConDuCT-II Hub, Medical Research Council North West Hub for Trials Methodology Research

المصدر: Journal of Clinical Epidemiology ; volume 113, page 28-35 ; ISSN 0895-4356

مصطلحات موضوعية: Epidemiology

الإتاحة: https://doi.org/10.1016Test/j.jclinepi.2019.05.007
https://api.elsevier.com/content/article/PII:S0895435619300630?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0895435619300630?httpAccept=text/plainTest

المؤلفون: Conroy, Elizabeth J., Rosala-Hallas, Anna, Blazeby, Jane M., Burnside, Girvan, Cook, Jonathan A., Gamble, Carrol

المساهمون: National Institute for Health Research, Medical Research Council, University Hospitals Bristol NHS Foundation Trust, University of Bristol

المصدر: Journal of Clinical Epidemiology ; volume 107, page 27-35 ; ISSN 0895-4356

مصطلحات موضوعية: Epidemiology

الإتاحة: https://doi.org/10.1016Test/j.jclinepi.2018.11.004
https://api.elsevier.com/content/article/PII:S0895435618305419?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0895435618305419?httpAccept=text/plainTest

المؤلفون: Mylvaganam, Senthurun, Conroy, Elizabeth J., Williamson, Paula R., Barnes, Nicola L.P., Cutress, Ramsey I., Gardiner, Matthew D., Jain, Abhilash, Skillman, Joanna M., Thrush, Steven, Whisker, Lisa J., Blazeby, Jane M., Potter, Shelley, Holcombe, Christopher

وصف الملف: text

العلاقة: https://eprints.soton.ac.uk/417305/1/Guidelines_paper_for_submission_23rd_October.docxTest; Mylvaganam, Senthurun, Conroy, Elizabeth J., Williamson, Paula R., Barnes, Nicola L.P., Cutress, Ramsey I., Gardiner, Matthew D., Jain, Abhilash, Skillman, Joanna M., Thrush, Steven, Whisker, Lisa J., Blazeby, Jane M., Potter, Shelley and Holcombe, Christopher (2018) Adherence to best practice consensus guidelines for implant-based breast reconstruction: Results from the iBRA National Practice Questionnaire Survey. European Journal of Surgical Oncology. (doi:10.1016/j.ejso.2018.01.098 ).

الإتاحة: https://doi.org/10.1016Test/j.ejso.2018.01.098
https://eprints.soton.ac.uk/417305Test/
https://eprints.soton.ac.uk/417305/1/Guidelines_paper_for_submission_23rd_October.docxTest

المؤلفون: Wilby, Martin J., Hopkins, Carolyn, Bedson, Emma, Howlin, Sue, Burnside, Girvan, Conroy, Elizabeth J., Hughes, Dyfrig A., Sharma, Manohar, Marson, Anthony, Clark, Simon R., Williamson, Paula

المساهمون: Health Technology Assessment Programme

المصدر: Trials ; volume 19, issue 1 ; ISSN 1745-6215

مصطلحات موضوعية: Pharmacology (medical), Medicine (miscellaneous)

الإتاحة: https://doi.org/10.1186/s13063-018-2677-5Test

المؤلفون: Sunderland, Geraint J., Conroy, Elizabeth J., Nelson, Alexandra, Gamble, Carrol, Jenkinson, Michael D., Griffiths, Michael J., Mallucci, Conor L.

المصدر: Journal of Neurosurgery; Feb2023, Vol. 138 Issue 2, p483-493, 11p

المؤلفون: Conroy, Elizabeth J., Arch, Barbara, Harman, Nicola L., Lane, J. Athene, Lewis, Steff C., Norrie, John, Sydes, Matthew R., Gamble, Carrol

المصدر: Conroy , E J , Arch , B , Harman , N L , Lane , J A , Lewis , S C , Norrie , J , Sydes , M R & Gamble , C 2017 , ' A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials ' , Trials , vol. 18 , 590 . https://doi.org/10.1186/s13063-017-2300-1Test

مصطلحات موضوعية: /dk/atira/pure/core/keywords/btc_bristol_trials_centre_, BTC (Bristol Trials Centre), /dk/atira/pure/core/keywords/btc_brtc, BRTC, /dk/atira/pure/core/keywords/centre_for_surgical_research, Centre for Surgical Research, Clinical Trial, Data Monitoring Committee, Executive Committee, Oversight committee, Randomised controlled trial, Trial Steering Committee, Trials

الوصف: Background The DAMOCLES project established a widely used Data Monitoring Committee (DMC) Charter for Randomised Controlled Trials (RCTs). Typically, within the UK, the DMC is advisory and recommends to another executive body; the Trial Steering Committee (TSC). Despite the executive role of the TSC, the CONSORT statement doesn't explicitly require reporting of TSC activity, although is included as an example of good reporting. A lack of guidance on TSC reporting can impact transparency of trial oversight, ultimately leading to a misunderstanding regarding role and subsequently further variation in practice. This review aimed to establish reporting practice of TSC involvement in RCTs, and thus make recommendations for reporting. Methods A cohort examination identifying reporting practice was undertaken. The cohort comprised RCTs published in three leading medical journals (British Medical Journal, Lancet and New England Journal of Medicine) within six months in 2012 and the full HTA Monograph series. Details of TSC constitution and impact were extracted from main publications and published supplements. Results Of 415 publications, 264 were eligible. These were typical in terms of trial design. Variations in reporting between journals and monographs was notable. TSC presence was identified in approximately half of trials (n=144), of which 109 worked alongside a DMC in 109 of these. No publications justified not convening a TSC. When reported, the role of the committee and examples of impact in design, conduct and analysis were summarised. Conclusions We present the first review of reporting TSC activity in the published literature. An absence of reporting standards with regards to TSC constitution, activity and impact on trial conduct was identified which can influence transparency of reporting trial oversight. Consistent reporting is vital for the benefits and impact of the TSC role to be understood to support adoption of this oversight structure and reduce global variations in practice.

وصف الملف: application/pdf

الإتاحة: https://doi.org/10.1186/s13063-017-2300-1Test
https://hdl.handle.net/1983/4c4befa7-711c-4f49-a51b-d8491bcb4328Test
https://research-information.bris.ac.uk/en/publications/4c4befa7-711c-4f49-a51b-d8491bcb4328Test
https://research-information.bris.ac.uk/ws/files/141316206/s13063_017_2300_1.pdfTest
http://www.scopus.com/inward/record.url?scp=85037326931&partnerID=8YFLogxKTest

المؤلفون: Conroy, Elizabeth J., Blazeby, Jane M., Burnside, Girvan, Cook, Jonathan A., Gamble, Carrol

الوصف: Additional file 1: Supplementary Material 1. List of eligible guidance documents. Supplementary Material 2. Additional information on documents obtained by the targeted search. Supplementary Table 1. Key criteria coverage across documents summary.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::14e304b843585ee185a415d38aa9c862Test

المؤلفون: Potter, Shelley, Conroy, Elizabeth J., Williamson, Paula R., Thrush, Steven, Whisker, Lisa J., Skillman, Joanna M., Barnes, Nicola L.P., Cutress, Ramsey I., Teasdale, Elizabeth M., Mills, Nicola, Mylvaganam, Senthurun, Branford, Olivier A., McEvoy, Katherina, Jain, Abhilash, Gardiner, Matthew D., Blazeby, Jane M., Holcombe, Christopher

الوصف: BACKGROUND: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR. METHODS/DESIGN: The iBRA study is a trainee-led research collaborative project with four phases:Phase 1 - a national practice questionnaire (NPQ) to survey current practicePhase 2 - a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and patient-reported outcomesPhase 3- an IBBR-RCT acceptability survey and qualitative work to explore patients' and surgeons' views of proposed trial designs and candidate outcomes.Phase 4 - phases 1 to 3 will inform the design and conduct of the future RCT All centres offering IBBR will be encouraged to participate by the breast and plastic surgical professional associations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons). Data collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues surrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria, trial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients and collect data. DISCUSSION: The preliminary work undertaken within the iBRA study will determine the feasibility, design and conduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an infrastructure of research-active breast and plastic surgeons which ...

وصف الملف: text

العلاقة: https://eprints.soton.ac.uk/413489/1/art_3A10.1186_2Fs40814_016_0085_8.pdfTest; Potter, Shelley, Conroy, Elizabeth J., Williamson, Paula R., Thrush, Steven, Whisker, Lisa J., Skillman, Joanna M., Barnes, Nicola L.P., Cutress, Ramsey I., Teasdale, Elizabeth M., Mills, Nicola, Mylvaganam, Senthurun, Branford, Olivier A., McEvoy, Katherina, Jain, Abhilash, Gardiner, Matthew D., Blazeby, Jane M. and Holcombe, Christopher , Breast Reconstruction Research Collaborative (2016) The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction. Pilot and Feasibility Studies, 2 (41), 1-11. (doi:10.1186/s40814-016-0085-8 ).

الإتاحة: https://doi.org/10.1186/s40814-016-0085-8Test
https://eprints.soton.ac.uk/413489Test/
https://eprints.soton.ac.uk/413489/1/art_3A10.1186_2Fs40814_016_0085_8.pdfTest