المؤلفون: Hutchinson, Peter J, Edlmann, Ellie, Hanrahan, John G, Bulters, Diederik, Zolnourian, Ardalan, Holton, Patrick, Suttner, Nigel, Agyemang, Kevin, Thomson, Simon, Anderson, Ian A, Al-Tamimi, Yahia, Henderson, Duncan, Whitfield, Peter, Gherle, Monica, Brennan, Paul M, Allison, Annabel, Thelin, Eric P, Tarantino, Silvia, Pantaleo, Beatrice, Caldwell, Karen, Davis-Wilkie, Carol, Mee, Harry, Warburton, Elizabeth A, Barton, Garry, Chari, Aswin, Marcus, Hani J, Pyne, Sarah, King, Andrew T, Belli, Antonio, Myint, Phyo K, Wilkinson, Ian, Santarius, Thomas, Turner, Carole, Bond, Simon, Kolias, Angelos G

المصدر: Health Technology Assessment , 28 (12) pp. 1-122. (2024)

الوصف: BACKGROUND: Chronic subdural haematoma is a collection of ‘old blood’ and its breakdown products in the subdural space and predominantly affects older people. Surgical evacuation remains the mainstay in the management of symptomatic cases. OBJECTIVE: The Dex-CSDH (DEXamethasone in Chronic SubDural Haematoma) randomised trial investigated the clinical effectiveness and cost-effectiveness of dexamethasone in patients with a symptomatic chronic subdural haematoma. DESIGN: This was a parallel, superiority, multicentre, pragmatic, randomised controlled trial. Assigned treatment was administered in a double-blind fashion. Outcome assessors were also blinded to treatment allocation. SETTING: Neurosurgical units in the UK. PARTICIPANTS: Eligible participants included adults (aged ≥ 18 years) admitted to a neurosurgical unit with a symptomatic chronic subdural haematoma confirmed on cranial imaging. INTERVENTIONS: Participants were randomly assigned in a 1 : 1 allocation to a 2-week tapering course of dexamethasone or placebo alongside standard care. MAIN OUTCOMES MEASURES: The primary outcome was the Modified Rankin Scale score at 6 months dichotomised to a favourable (score of 0–3) or an unfavourable (score of 4–6) outcome. Secondary outcomes included the Modified Rankin Scale score at discharge and 3 months; number of chronic subdural haematoma-related surgical interventions undertaken during the index and subsequent admissions; Barthel Index and EuroQol 5-Dimension 5-Level utility index score reported at discharge, 3 months and 6 months; Glasgow Coma Scale score reported at discharge and 6 months; mortality at 30 days and 6 months; length of stay; discharge destination; and adverse events. An economic evaluation was also undertaken, during which the net monetary benefit was estimated at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year. RESULTS: A total of 748 patients were included after randomisation: 375 were assigned to dexamethasone and 373 were assigned to placebo. The mean age of the ...

وصف الملف: application/pdf

العلاقة: https://discovery.ucl.ac.uk/id/eprint/10189644/1/3044937.pdfTest; https://discovery.ucl.ac.uk/id/eprint/10189644Test/

الإتاحة: https://discovery.ucl.ac.uk/id/eprint/10189644/1/3044937.pdfTest
https://discovery.ucl.ac.uk/id/eprint/10189644Test/

المؤلفون: Edlmann, Ellie, Thelin, Eric P., Caldwell, Karen, Turner, Carole, Whitfield, Peter, Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z., Gatt, Daniel, Thomson, Simon, Anderson, Ian A., Richards, Oliver, Gherle, Monica, Toman, Emma, Nandi, Dipankar, Kane, Phillip, Pantaleo, Beatrice, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J., Chari, Aswin, Belli, Antonio, Bond, Simon, Gafoor, Rafael, Dawson, Sarah, Whitehead, Lynne, Brennan, Paul, Wilkinson, Ian, Kolias, Angelos G., Hutchinson, Peter J. A.

المصدر: Dex-CSDH trial collaborative and BNTRC collaborative , Edlmann , E , Thelin , E P , Caldwell , K , Turner , C , Whitfield , P , Bulters , D , Holton , P , Suttner , N , Owusu-Agyemang , K , Al-Tamimi , Y Z , Gatt , D , Thomson , S , Anderson , I A , Richards , O , Gherle , M , Toman , E , Nandi , D , Kane , P , Pantaleo , B , Davis-Wilkie , C , Tarantino , S , Barton , G , Marcus ....

مصطلحات موضوعية: /dk/atira/pure/subjectarea/asjc/1000, name=General

الوصف: The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.

وصف الملف: application/pdf

العلاقة: https://discovery.dundee.ac.uk/en/publications/0f039f74-36bf-4161-809d-168ce24bba68Test

الإتاحة: https://doi.org/10.1038/s41598-019-42087-zTest
https://discovery.dundee.ac.uk/en/publications/0f039f74-36bf-4161-809d-168ce24bba68Test
https://discovery.dundee.ac.uk/ws/files/33271340/s41598_019_42087_z.pdfTest
http://www.scopus.com/inward/record.url?scp=85064252691&partnerID=8YFLogxKTest

المؤلفون: Kolias, Angelos G, Edlmann, Ellie, Thelin, Eric P, Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z, Gatt, Daniel, Thomson, Simon, Anderson, Ian A, Richards, Oliver, Whitfield, Peter, Gherle, Monica, Caldwell, Karen, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J, Chari, Aswin, Brennan, Paul, Belli, Antonio, Bond, Simon, Turner, Carole, Whitehead, Lynne, Wilkinson, Ian, Hutchinson, Peter J, British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators

مصطلحات موضوعية: British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators

الوصف: After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled.

وصف الملف: Electronic; application/pdf

العلاقة: https://www.repository.cam.ac.uk/handle/1810/293770Test

الإتاحة: https://doi.org/10.17863/CAM.40883Test
https://www.repository.cam.ac.uk/handle/1810/293770Test

المؤلفون: Allison, Annabel, Edlmann, Ellie, Kolias, Angelos G, Davis-Wilkie, Carol, Mee, Harry, Thelin, Eric P, Turner, Carole, Hutchinson, Peter J, Bond, Simon

مصطلحات موضوعية: Chronic subdural haematoma, Dexamethasone, Randomised trial, Steroid, Clinical Trials, Phase III as Topic, Data Interpretation, Statistical, Disability Evaluation, Double-Blind Method, Glucocorticoids, Hematoma, Subdural, Chronic, Humans, Multicenter Studies as Topic, Pragmatic Clinical Trials as Topic, Recovery of Function, Recurrence, Time Factors, Treatment Outcome, United Kingdom

الوصف: Background: The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the six month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate. Methods and design: Dex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a two-week course of dexamethasone following a CSDH. 750 patients were randomised to either dexamethasone or placebo. The primary outcome is the modi ed Rankin Scale at six months which is dichotomised to favourable (score of 0-3) versus unfavourable (score of 4-6). Conclusions: This paper and the accompanying additional material describes the statistical analysis plan for the trial. ; NIHR, Royal College of Surgeons Rosetrees Trust Research Fellowship, Swedish Society for Medical Research Stipend

وصف الملف: application/vnd.openxmlformats-officedocument.wordprocessingml.document; application/pdf

العلاقة: https://www.repository.cam.ac.uk/handle/1810/299802Test

الإتاحة: https://doi.org/10.17863/CAM.46872Test
https://www.repository.cam.ac.uk/handle/1810/299802Test

المؤلفون: Edlmann, Ellie, Thelin, Eric P, Caldwell, Karen, Turner, Carole, Whitfield, Peter, Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z, Gatt, Daniel, Thomson, Simon, Anderson, Ian A, Richards, Oliver, Gherle, Monica, Toman, Emma, Nandi, Dipankar, Kane, Phillip, Pantaleo, Beatrice, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J, Chari, Aswin, Belli, Antonio, Bond, Simon, Gafoor, Rafael, Dawson, Sarah, Whitehead, Lynne, Brennan, Paul, Wilkinson, Ian, Kolias, Angelos G, Hutchinson, Peter J A

مصطلحات موضوعية: WL Nervous system. Neurology

الوصف: The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.

وصف الملف: text

العلاقة: http://www.repository.uhblibrary.co.uk/id/eprint/2015/1/Scientific%20Reports.pdfTest; Edlmann, Ellie, Thelin, Eric P, Caldwell, Karen, Turner, Carole, Whitfield, Peter, Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z, Gatt, Daniel, Thomson, Simon, Anderson, Ian A, Richards, Oliver, Gherle, Monica, Toman, Emma, Nandi, Dipankar, Kane, Phillip, Pantaleo, Beatrice, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J, Chari, Aswin, Belli, Antonio, Bond, Simon, Gafoor, Rafael, Dawson, Sarah, Whitehead, Lynne, Brennan, Paul, Wilkinson, Ian, Kolias, Angelos G and Hutchinson, Peter J A (2019) Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase. Scientific reports, 9 (1). p. 5885. ISSN 2045-2322. This article is available to all UHB staff and students login using a UHB Athens Account. Register for Athens here - https://openathens.nice.org.ukTest/

الإتاحة: http://www.repository.uhblibrary.co.uk/id/eprint/2015Test/
https://www.nature.com/articles/s41598-019-42087-z#Abs1Test
http://www.repository.uhblibrary.co.uk/id/eprint/2015/1/Scientific%20Reports.pdfTest

المؤلفون: Allison, Annabel, Edlmann, Ellie, Kolias, Angelos G., Davis-Wilkie, Carol, Mee, Harry, Thelin, Eric P., Turner, Carole, Hutchinson, Peter J., Bond, Simon

المصدر: Trials ; volume 20, issue 1 ; ISSN 1745-6215

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

الوصف: Background The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the 6-month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate. Methods and design Dex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a 2-week course of dexamethasone following a CSDH. Seven hundred fifty patients were randomised to either dexamethasone or placebo. The primary outcome is the modified Rankin Scale at 6 months which is dichotomised to favourable (a score of 0–3) versus unfavourable (a score of 4–6). Conclusions This paper and the accompanying additional material describe the statistical analysis plan for the trial. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810Test . EudraCT, 2014-004948-35. Registered on 20 March 2015.

الإتاحة: https://doi.org/10.1186/s13063-019-3866-6Test

المؤلفون: Kolias, Angelos G., Edlmann, Ellie, Thelin, Eric P., Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z., Gatt, Daniel, Thomson, Simon, Anderson, Ian A., Richards, Oliver, Whitfield, Peter, Gherle, Monica, Caldwell, Karen, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J., Chari, Aswin, Brennan, Paul, Belli, Antonio, Bond, Simon, Turner, Carole, Whitehead, Lynne, Wilkinson, Ian, Hutchinson, Peter J.

المصدر: Trials ; volume 20, issue 1 ; ISSN 1745-6215

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

الإتاحة: https://doi.org/10.1186/s13063-019-3283-xTest

المؤلفون: Davis-Wilkie, Carol, Hutchinson, Peter, Gregson, Barbara, Turner, Carole, Kolias, Angelos

مصطلحات موضوعية: acute subdural haematoma, craniectomy, Medicine and Health Sciences, Medical Specialties, randomized trial, craniotomy, Surgery, randomised trial, RESCUE-ASDH, health care economics and organizations, humanities, acute subdural hematoma, ASDH

الوصف: The Final SAP (statistical analysis plan) and protocol for the above trial prior to analysis of trial data. Funding acknowledgement This research was funded by the NIHR HTA Programme (Project number 13/15/02) Department of Health and Social Care disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::fd80b8dc474bb00748e020085c227aa3Test

المؤلفون: Kolias, Angelos G., Edlmann, Ellie, Thelin, Eric P., Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z., Gatt, Daniel, Thomson, Simon, Anderson, Ian A., Richards, Oliver, Whitfield, Peter, Gherle, Monica, Caldwell, Karen, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J., Chari, Aswin, Brennan, Paul, Belli, Antonio, Bond, Simon, Turner, Carole, Whitehead, Lynne, Wilkinson, Ian, Hutchinson, Peter J., Badran, Khaled, Coulter, Ian, Gallagher, Mathew J., Hogg, Florence R.A., Pringle, Catherine, Razak, Adam, Soleiman, Hamzah, Piper, Rory, Toman, Emma, Vintu, Marian, Wahba, Adam, Wiggins, Anthony, Yakoub, Kamal Makram, Zaben, Malik, Zolnouria, Ardalan, Bodkin, Peter, Cirstea, Emanuel, Critchley, Giles, Eglinton, Charlotte, Finlay, Louise, Myint, Phyo, Smith, Martin, Cook, Jonathan

الوصف: Background: Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions. Methods: Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis. Discussion: This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic ...

وصف الملف: application/pdf

العلاقة: https://ueaeprints.uea.ac.uk/id/eprint/69654/1/Published_Version.pdfTest; Kolias, Angelos G., Edlmann, Ellie, Thelin, Eric P., Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z., Gatt, Daniel, Thomson, Simon, Anderson, Ian A., Richards, Oliver, Whitfield, Peter, Gherle, Monica, Caldwell, Karen, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J., Chari, Aswin, Brennan, Paul, Belli, Antonio, Bond, Simon, Turner, Carole, Whitehead, Lynne, Wilkinson, Ian, Hutchinson, Peter J., Badran, Khaled, Coulter, Ian, Gallagher, Mathew J., Hogg, Florence R.A., Pringle, Catherine, Razak, Adam, Soleiman, Hamzah, Piper, Rory, Toman, Emma, Vintu, Marian, Wahba, Adam, Wiggins, Anthony, Yakoub, Kamal Makram, Zaben, Malik, Zolnouria, Ardalan, Bodkin, Peter, Cirstea, Emanuel, Critchley, Giles, Eglinton, Charlotte, Finlay, Louise, Myint, Phyo, Smith, Martin and Cook, Jonathan (2018) Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial:Study protocol for a randomised controlled trial. Trials, 19 (1). ISSN 1745-6215

الإتاحة: https://doi.org/10.1186/s13063-018-3050-4Test
https://ueaeprints.uea.ac.uk/id/eprint/69654Test/
https://ueaeprints.uea.ac.uk/id/eprint/69654/1/Published_Version.pdfTest

المؤلفون: Kolias, Angelos G, Edlmann, Ellie, Thelin, Eric P, Bulters, Diederik, Holton, Patrick, Suttner, Nigel, Owusu-Agyemang, Kevin, Al-Tamimi, Yahia Z, Gatt, Daniel, Thomson, Simon, Anderson, Ian A, Richards, Oliver, Whitfield, Peter, Gherle, Monica, Caldwell, Karen, Davis-Wilkie, Carol, Tarantino, Silvia, Barton, Garry, Marcus, Hani J, Chari, Aswin, Brennan, Paul, Belli, Antonio, Bond, Simon, Turner, Carole, Whitehead, Lynne, Wilkinson, Ian, Hutchinson, Peter J, British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators

مصطلحات موضوعية: Chronic subdural haematoma, Dexamethasone, Neurology, Neurosurgery, Randomised control trial, Cost-Benefit Analysis, Double-Blind Method, Drug Administration Schedule, Drug Costs, Glucocorticoids, Hematoma, Subdural, Chronic, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome, United Kingdom

الوصف: BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions. METHODS: Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis. DISCUSSION: This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic ...

وصف الملف: Electronic; application/pdf

العلاقة: https://www.repository.cam.ac.uk/handle/1810/288897Test

الإتاحة: https://doi.org/10.17863/CAM.36160Test
https://www.repository.cam.ac.uk/handle/1810/288897Test