Publications
2024
What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials.
Griffiths, J., Adshead, F., Al-Shahi Salman, R., Anderson, C., Bedson, E., Bliss, J., . . . Williamson, P. R. (2024). What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials.. BMJ open, 14(10), e088600. doi:10.1136/bmjopen-2024-088600
Characteristics and outcomes of COVID-19 patients admitted to hospital with and without respiratory symptoms.
Citarella, B. W., Kartsonaki, C., Ibáñez-Prada, E. D., Gonçalves, B. P., Baruch, J., Escher, M., . . . ISARIC Clinical Characterisation Group. (2024). Characteristics and outcomes of COVID-19 patients admitted to hospital with and without respiratory symptoms.. Heliyon, 10(10), e29591. doi:10.1016/j.heliyon.2024.e29591
Seizure control via pH manipulation: a phase II double-blind randomised controlled trial of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus (Carbogen for Status Epilepticus in Children Trial (CRESCENT)).
Forsyth, R., Allen, M., Bedson, E., Downes, A., Gough, C., Hartshorn, S., . . . Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) collaborative. (2024). Seizure control via pH manipulation: a phase II double-blind randomised controlled trial of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus (Carbogen for Status Epilepticus in Children Trial (CRESCENT)).. Trials, 25(1), 349. doi:10.1186/s13063-024-08188-5
Quantifying the carbon footprint of academic clinical trials: building the evidence base and hotspot identification
The overlap between randomised evaluations of recruitment and retention interventions: An updated review of recruitment (Online Resource for Recruitment in Clinical triAls) and retention (Online Resource for Retention in Clinical triAls) literature.
Kearney, A., Butlin, L., Coffey, T., Conway, T., Cotterill, S., Evans, A., . . . Gamble, C. (2024). The overlap between randomised evaluations of recruitment and retention interventions: An updated review of recruitment (Online Resource for Recruitment in Clinical triAls) and retention (Online Resource for Retention in Clinical triAls) literature.. Clinical trials (London, England), 17407745241238444. doi:10.1177/17407745241238444
Good Statistical Practice-development of tailored Good Clinical Practice training for statisticians.
Stocken, D. D., Mossop, H., Armstrong, E., Lewis, S., Dutton, S. J., Peckitt, C., . . . Brown, J. (2024). Good Statistical Practice-development of tailored Good Clinical Practice training for statisticians.. Trials, 25(1), 113. doi:10.1186/s13063-024-07940-1
Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study.
Deja, E., Weeks, A., Van Netten, C., Gamble, C., Meher, S., Gyte, G., . . . Woolfall, K. (2024). Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study.. doi:10.1136/bmjopen-2023-081874
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials.
Gamble, C., Lewis, S., Stocken, D., Juszczak, E., Bradburn, M., Doré, C., & Kean, S. (2024). Determining a risk-proportionate approach to the validation of statistical programming for clinical trials.. Clinical trials (London, England), 21(1), 85-94. doi:10.1177/17407745231204036
Guidance to inform research recruitment processes for studies involving critically ill patients
Woolfall, K., Paddock, K., Watkins, M., Kearney, A., Neville, K., Frith, L., . . . Young, B. (2023). Guidance to inform research recruitment processes for studies involving critically ill patients. JOURNAL OF THE INTENSIVE CARE SOCIETY. doi:10.1177/17511437231197293
The use of healthcare systems data for RCTs
Toader, A. -M., Gamble, C. L., Dodd, S., & Williamson, P. R. (n.d.). The use of healthcare systems data for RCTs. Trials, 25(1). doi:10.1186/s13063-023-07846-4
Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.
Toader, A. -M., Campbell, M. K., Quint, J. K., Robling, M., Sydes, M. R., Thorn, J., . . . Williamson, P. (2024). Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.. Trials, 25(1), 94. doi:10.1186/s13063-024-07926-z
2023
Para-infectious brain injury in COVID-19 persists at follow-up despite attenuated cytokine and autoantibody responses.
Michael, B. D., Dunai, C., Needham, E. J., Tharmaratnam, K., Williams, R., Huang, Y., . . . Menon, D. K. (2023). Para-infectious brain injury in COVID-19 persists at follow-up despite attenuated cytokine and autoantibody responses.. Nature communications, 14(1), 8487. doi:10.1038/s41467-023-42320-4
Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): A delphi survey.
Goulão, B., Morris, T. P., Blazeby, J., Gamble, C., Gillies, K., Laidlaw, L., . . . Totton, N. (2023). Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): A delphi survey.. PloS one, 18(12), e0292257. doi:10.1371/journal.pone.0292257
Timing of Primary Surgery for Cleft Palate. Reply.
Gamble, C., & Munro, K. (2023). Timing of Primary Surgery for Cleft Palate. Reply.. The New England journal of medicine, 389(23), 2209. doi:10.1056/nejmc2311517
Correction: Medicines and Healthcare products Regulatory Agency's "Consultation on proposals for legislative changes for clinical trials": a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing.
Law, M., Couturier, D. -L., Choodari-Oskooei, B., Crout, P., Gamble, C., Jacko, P., . . . Jaki, T. (2023). Correction: Medicines and Healthcare products Regulatory Agency's "Consultation on proposals for legislative changes for clinical trials": a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing.. Trials, 24(1), 744. doi:10.1186/s13063-023-07763-6
The development and acceptability of an educational and training intervention for recruiters to neonatal trials: the TRAIN project.
Smith, V., Delaney, H., Hunter, A., Torgerson, D., Treweek, S., Gamble, C., . . . Devane, D. (2023). The development and acceptability of an educational and training intervention for recruiters to neonatal trials: the TRAIN project.. BMC medical research methodology, 23(1), 265. doi:10.1186/s12874-023-02086-1
A multi-country analysis of COVID-19 hospitalizations by vaccination status.
Gonçalves, B. P., Jassat, W., Baruch, J., Hashmi, M., Rojek, A., Dasgupta, A., . . . ISARIC Clinical Characterisation Group. (2023). A multi-country analysis of COVID-19 hospitalizations by vaccination status.. Med (New York, N.Y.), 4(11), 797-812.e2. doi:10.1016/j.medj.2023.08.005
Good Statistical Practice - Good Clinical Practice for Statisticians
The use of healthcare systems data for RCTs
Medicines and Healthcare products Regulatory Agency's "Consultation on proposals for legislative changes for clinical trials": a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing.
Law, M., Couturier, D. -L., Choodari-Oskooei, B., Crout, P., Gamble, C., Jacko, P., . . . Jaki, T. (2023). Medicines and Healthcare products Regulatory Agency's "Consultation on proposals for legislative changes for clinical trials": a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing.. Trials, 24(1), 640. doi:10.1186/s13063-023-07576-7
Quantifying neutralising antibody responses against SARS-CoV-2 in dried blood spots (DBS) and paired sera.
Roper, K. J., Thomas, J., Albalawi, W., Maddocks, E., Dobson, S., Alshehri, A., . . . Pollakis, G. (2023). Quantifying neutralising antibody responses against SARS-CoV-2 in dried blood spots (DBS) and paired sera.. Scientific reports, 13(1), 15014. doi:10.1038/s41598-023-41928-2
A second update on mapping the human genetic architecture of COVID-19.
COVID-19 Host Genetics Initiative. (2023). A second update on mapping the human genetic architecture of COVID-19.. Nature, 621(7977), E7-E26. doi:10.1038/s41586-023-06355-3
Timing of Primary Surgery for Cleft Palate.
Gamble, C., Persson, C., Willadsen, E., Albery, L., Soegaard Andersen, H., Zattoni Antoneli, M., . . . TOPS Study Group. (2023). Timing of Primary Surgery for Cleft Palate.. The New England journal of medicine, 389(9), 795-807. doi:10.1056/nejmoa2215162
Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs
Knapp, P., Moe-Byrne, T., Martin-Kerry, J., Sheridan, R., Roche, J., Coleman, E., . . . Ainsworth, J. (2023). Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs. BMC MEDICINE, 21(1). doi:10.1186/s12916-023-02936-1
GWAS and meta-analysis identifies 49 genetic variants underlying critical COVID-19
Pairo-Castineira, E., Rawlik, K., Bretherick, A. D., Qi, T., Wu, Y., Nassiri, I., . . . Baillie, J. K. (2023). GWAS and meta-analysis identifies 49 genetic variants underlying critical COVID-19. NATURE, 617(7962), 764-+. doi:10.1038/s41586-023-06034-3
Validation of extracorporeal membrane oxygenation mortality prediction and severity of illness scores in an international COVID-19 cohort.
Shah, N., Xue, B., Xu, Z., Yang, H., Marwali, E., Dalton, H., . . . ISARIC Clinical Characterisation Group. (2023). Validation of extracorporeal membrane oxygenation mortality prediction and severity of illness scores in an international COVID-19 cohort.. Artificial organs. doi:10.1111/aor.14542
The P323L substitution in the SARS-CoV-2 polymerase (NSP12) confers a selective advantage during infection.
Goldswain, H., Dong, X., Penrice-Randal, R., Alruwaili, M., Shawli, G. T., Prince, T., . . . Hiscox, J. A. (2023). The P323L substitution in the SARS-CoV-2 polymerase (NSP12) confers a selective advantage during infection.. Genome biology, 24(1), 47. doi:10.1186/s13059-023-02881-5
Characteristics and outcomes of an international cohort of 600 000 hospitalized patients with COVID-19.
Kartsonaki, C., Baillie, J. K., Barrio, N. G., Baruch, J., Beane, A., Blumberg, L., . . . ISARIC Clinical Characterisation Group. (2023). Characteristics and outcomes of an international cohort of 600 000 hospitalized patients with COVID-19.. International journal of epidemiology, dyad012. doi:10.1093/ije/dyad012
Factors affecting ventriculoperitoneal shunt revision: a post hoc analysis of the British Antibiotic and Silver Impregnated Catheter Shunt multicenter randomized controlled trial
Sunderland, G. J., Conroy, E. J., Nelson, A., Gamble, C., Jenkinson, M. D., Griffiths, M. J., & Mallucci, C. L. (2023). Factors affecting ventriculoperitoneal shunt revision: a post hoc analysis of the British Antibiotic and Silver Impregnated Catheter Shunt multicenter randomized controlled trial. JOURNAL OF NEUROSURGERY, 138(2), 483-493. doi:10.3171/2022.4.JNS22572
Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study
Iflaifel, M., Sprange, K., Bell, J., Cook, A., Gamble, C., Julious, S. A., . . . Partlett, C. (2023). Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. TRIALS, 24(1). doi:10.1186/s13063-022-06992-5
Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS)
Willadsen, E., Cooper, R., Conroy, E., Gamble, C., Albery, L., Andersen, H., . . . Persson, C. (n.d.). Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS). Clinical Linguistics & Phonetics, 1-22. doi:10.1080/02699206.2021.2012259
Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.
McCarthy, M., Gillies, K., Rousseau, N., Wade, J., Gamble, C., Toomey, E., . . . Houghton, C. (2023). Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.. HRB open research, 6, 10. doi:10.12688/hrbopenres.13667.1
SARS-CoV-2-specific nasal IgA wanes 9 months after hospitalisation with COVID-19 and is not induced by subsequent vaccination
Liew, F., Talwar, S., Cross, A., Willett, B. J., Scott, S., Logan, N., . . . Openshaw, P. J. M. (2023). SARS-CoV-2-specific nasal IgA wanes 9 months after hospitalisation with COVID-19 and is not induced by subsequent vaccination. EBIOMEDICINE, 87. doi:10.1016/j.ebiom.2022.104402
The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs.
Knapp, P., Martin-Kerry, J., Moe-Byrne, T., Sheridan, R., Coleman, E., Roche, J., . . . Stones, C. (2023). The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs.. Health and social care delivery research, 11(24), 1-112. doi:10.3310/htpm3841
2022
Query Resolution of Literature Knowledge Graphs using Hybrid Document Embeddings.
Coenen, F., Muhammad, I., Gamble, C., Kearney, A., & Williams, P. (2022). Query Resolution of Literature Knowledge Graphs using Hybrid Document Embeddings..
Response to Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”
Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study.
Paddock, K., Woolfall, K., Kearney, A., Pattison, N., Frith, L., Gamble, C., . . . Young, B. (2022). Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study.. BMJ open, 12(11), e066149. doi:10.1136/bmjopen-2022-066149
Managing clustering effects and learning effects in the design and analysis of randomised surgical trials: a review of existing guidance
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. (2022). Managing clustering effects and learning effects in the design and analysis of randomised surgical trials: a review of existing guidance. TRIALS, 23(1). doi:10.1186/s13063-022-06743-6
Viral Coinfections in Hospitalized Coronavirus Disease 2019 Patients Recruited to the International Severe Acute Respiratory and Emerging Infections Consortium WHO Clinical Characterisation Protocol UK Study
Vink, E., Davis, C., MacLean, A., Pascall, D., McDonald, S. E., Gunson, R., . . . Ho, A. (2022). Viral Coinfections in Hospitalized Coronavirus Disease 2019 Patients Recruited to the International Severe Acute Respiratory and Emerging Infections Consortium WHO Clinical Characterisation Protocol UK Study. OPEN FORUM INFECTIOUS DISEASES, 9(11). doi:10.1093/ofid/ofac531
Alternative pathway dysregulation in tissues drives sustained complement activation and predicts outcome across the disease course in COVID-19.
Siggins, M. K., Davies, K., Fellows, R., Thwaites, R. S., Baillie, J. K., Semple, M. G., . . . ISARIC4C Investigators. (2022). Alternative pathway dysregulation in tissues drives sustained complement activation and predicts outcome across the disease course in COVID-19.. Immunology. doi:10.1111/imm.13585
Respiratory support in patients with severe COVID-19 in the International Severe Acute Respiratory and Emerging Infection (ISARIC) COVID-19 study: a prospective, multinational, observational study
Reyes, L. F., Murthy, S., Garcia-Gallo, E., Merson, L., Ibanez-Prada, E. D., Rello, J., . . . Olliaro, P. L. (2022). Respiratory support in patients with severe COVID-19 in the International Severe Acute Respiratory and Emerging Infection (ISARIC) COVID-19 study: a prospective, multinational, observational study. CRITICAL CARE, 26(1). doi:10.1186/s13054-022-04155-1
ISARIC-COVID-19 dataset: A Prospective, Standardized, Global Dataset of Patients Hospitalized with COVID-19
Garcia-Gallo, E., Merson, L., Kennon, K., Kelly, S., Citarella, B. W., Fryer, D. V., . . . Reyes, L. F. (2022). ISARIC-COVID-19 dataset: A Prospective, Standardized, Global Dataset of Patients Hospitalized with COVID-19. SCIENTIFIC DATA, 9(1). doi:10.1038/s41597-022-01534-9
Opportunities and challenges for the development of "core outcome sets" in neuro-oncology
Millward, C. P., Armstrong, T. S., Barrington, H., Brodbelt, A. R., Bulbeck, H., Byrne, A., . . . Jenkinson, M. D. (2022). Opportunities and challenges for the development of "core outcome sets" in neuro-oncology. NEURO-ONCOLOGY, 24(7), 1048-1055. doi:10.1093/neuonc/noac062
Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units
Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C., Julious, S., . . . Sprange, K. (2022). Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units. TRIALS, 23(1). doi:10.1186/s13063-022-06481-9
SURG-13. The COMBAT Project - Core post operative morbidity set for paediatric brain tumours
Trichinopoly Krishna, S., Millward, C., Mallucci, C., Gamble, C., Jenkinson, M., & Pizer, B. (2022). SURG-13. The COMBAT Project - Core post operative morbidity set for paediatric brain tumours. Neuro-Oncology, 24(Supplement_1), i144-i145. doi:10.1093/neuonc/noac079.531
Increased transparency was required when reporting imputation of primary outcome data in clinical trials
Kearney, A., Rosala-Hallas, A., Rainford, N., Blazeby, J. M., Clarke, M., Lane, A. J., & Gamble, C. (2022). Increased transparency was required when reporting imputation of primary outcome data in clinical trials. JOURNAL OF CLINICAL EPIDEMIOLOGY, 146, 60-67. doi:10.1016/j.jclinepi.2022.02.008
Visualising harms in publications of randomised controlled trials: consensus and recommendations.
Phillips, R., Cro, S., Wheeler, G., Bond, S., Morris, T. P., Creanor, S., . . . Cornelius, V. (2022). Visualising harms in publications of randomised controlled trials: consensus and recommendations.. BMJ (Clinical research ed.), 377, e068983. doi:10.1136/bmj-2021-068983
Implementation of corticosteroids in treatment of COVID-19 in the ISARIC WHO Clinical Characterisation Protocol UK: prospective, cohort study
Narhi, F., Moonesinghe, S. R., Shenkin, S. D., Drake, T. M., Mulholland, R. H., Donegan, C., . . . Docherty, A. B. (2022). Implementation of corticosteroids in treatment of COVID-19 in the ISARIC WHO Clinical Characterisation Protocol UK: prospective, cohort study. LANCET DIGITAL HEALTH, 4(4). Retrieved from https://www.webofscience.com/
Early phase clinical trials extension to guidelines for the content of statistical analysis plans
Homer, V., Yap, C., Bond, S., Holmes, J., Stocken, D., Walker, K., . . . Gaunt, P. (2022). Early phase clinical trials extension to guidelines for the content of statistical analysis plans. BMJ-BRITISH MEDICAL JOURNAL, 376. doi:10.1136/bmj-2021-068177
SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses.
Dejnirattisai, W., Huo, J., Zhou, D., Zahradník, J., Supasa, P., Liu, C., . . . Screaton, G. R. (2022). SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses.. Cell, 185(3), 467-484.e15. doi:10.1016/j.cell.2021.12.046
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)
Kearney, A., Ashford, P. -A., Butlin, L., Conway, T., Cragg, W. J., Devane, D., . . . Gamble, C. (2022). Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2). CLINICAL TRIALS, 19(1), 71-80. doi:10.1177/17407745211053803
A Concept Analysis of 'trial recruitment' using a modified Hybrid Model
Delaney, H., Devane, D., Hunter, A., Treweek, S., Gamble, C., Mills, N., & Smith, V. (2019). A Concept Analysis of 'trial recruitment' using a modified Hybrid Model. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Prospective validation of the 4C prognostic models for adults hospitalised with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol
Knight, S. R., Gupta, R. K., Ho, A., Pius, R., Buchan, I., Carson, G., . . . Harrison, E. M. (2022). Prospective validation of the 4C prognostic models for adults hospitalised with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol. THORAX, 77(6), 606-615. doi:10.1136/thoraxjnl-2021-217629
THE COMBAT PROJECT - CORE POST OPERATIVE MORBIDITY SET FOR PAEDIATRIC BRAIN TUMOURS
Krishna, S. T., Millward, C., Mallucci, C., Gamble, C., Jenkinson, M., & Pizer, B. (2022). THE COMBAT PROJECT - CORE POST OPERATIVE MORBIDITY SET FOR PAEDIATRIC BRAIN TUMOURS. In NEURO-ONCOLOGY Vol. 24 (pp. 144-145). Retrieved from https://www.webofscience.com/
2021
Mapping the human genetic architecture of COVID-19
Niemi, M. E. K., Karjalainen, J., Daly, M., Ganna, A., Mehtonen, J., Cordioli, M., . . . Dopazo, X. (2021). Mapping the human genetic architecture of COVID-19. NATURE, 600(7889), 472-+. doi:10.1038/s41586-021-03767-x
The value of open-source clinical science in pandemic response: lessons from ISARIC
The value of open-source clinical science in pandemic response: lessons from ISARIC (2021). LANCET INFECTIOUS DISEASES, 21(12), 1623-1624. doi:10.1016/S1473-3099(21)00565-X
A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol.
Patel, S. R., Ormesher, D. C., Smith, S. R., Wong, K. H. F., Bevis, P., Bicknell, C. D., . . . Vallabhaneni, S. R. (2021). A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol.. BMJ open, 11(11), e054493. doi:10.1136/bmjopen-2021-054493
The impact of viral mutations on recognition by SARS-CoV-2 specific T cells
de, S. T. I., Liu, G., Lindsey, B. B., Dong, D., Moore, S. C., Hsu, N. S., . . . Dong, T. (2021). The impact of viral mutations on recognition by SARS-CoV-2 specific T cells. ISCIENCE, 24(11). doi:10.1016/j.isci.2021.103353
Reducing bias in trials due to reactions to measurement: experts produced recommendations informed by evidence.
French, D. P., Miles, L. M., Elbourne, D., Farmer, A., Gulliford, M., Locock, L., . . . MERIT Collaborative Group. (2021). Reducing bias in trials due to reactions to measurement: experts produced recommendations informed by evidence.. Journal of clinical epidemiology, 139, 130-139. doi:10.1016/j.jclinepi.2021.06.028
A prenylated dsRNA sensor protects against severe COVID-19
Wickenhagen, A., Sugrue, E., Lytras, S., Kuchi, S., Noerenberg, M., Turnbull, M. L., . . . Wilson, S. J. (2021). A prenylated dsRNA sensor protects against severe COVID-19. SCIENCE, 374(6567). doi:10.1126/science.abj3624
COVID-19 symptoms at hospital admission vary with age and sex: results from the ISARIC prospective multinational observational study
Abdukahil, S. A., Abe, R., Abel, L., Absil, L., Acker, A., Adachi, S., . . . Zucman, D. (2021). COVID-19 symptoms at hospital admission vary with age and sex: results from the ISARIC prospective multinational observational study. INFECTION, 49(5), 889-905. doi:10.1007/s15010-021-01599-5
Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient-public involvement contributors
Paddock, K., Woolfall, K., Frith, L., Watkins, M., Gamble, C., Welters, I., & Young, B. (2021). Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient-public involvement contributors. BMJ OPEN, 11(9). doi:10.1136/bmjopen-2020-048193
Investigation of SARS-CoV-2 faecal shedding in the community: a prospective household cohort study (COVID-LIV) in the UK
Vaselli, N. M., Setiabudi, W., Subramaniam, K., Adams, E. R., Turtle, L., Iturriza-Gomara, M., . . . Hungerford, D. (2021). Investigation of SARS-CoV-2 faecal shedding in the community: a prospective household cohort study (COVID-LIV) in the UK. BMC INFECTIOUS DISEASES, 21(1). doi:10.1186/s12879-021-06443-7
Co-infections, secondary infections, and antimicrobial use in patients hospitalised with COVID-19 during the first pandemic wave from the ISARIC WHO CCP-UK study: a multicentre, prospective cohort study
Russell, C. D., Fairfield, C. J., Drake, T. M., Turtle, L., Seaton, R. A., Wootton, D. G., . . . Ho, A. (2021). Co-infections, secondary infections, and antimicrobial use in patients hospitalised with COVID-19 during the first pandemic wave from the ISARIC WHO CCP-UK study: a multicentre, prospective cohort study. LANCET MICROBE, 2(8), E354-E365. doi:10.1016/S2666-5247(21)00090-2
Characterisation of in-hospital complications associated with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, multicentre cohort study
Drake, T. M., Riad, A. M., Fairfield, C. J., Egan, C., Knight, S. R., Pius, R., . . . Semple, M. G. (2021). Characterisation of in-hospital complications associated with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, multicentre cohort study. LANCET, 398(10296), 223-237. Retrieved from https://www.webofscience.com/
Changes in in-hospital mortality in the first wave of COVID-19: a multicentre prospective observational cohort study using the WHO Clinical Characterisation Protocol UK
Docherty, A., Mulholland, R., Lone, N. I., Cheyne, C., De Angelis, D., Diaz-Ordaz, K., . . . Semple, M. (2021). Changes in in-hospital mortality in the first wave of COVID-19: a multicentre prospective observational cohort study using the WHO Clinical Characterisation Protocol UK. LANCET RESPIRATORY MEDICINE, 9(7), 773-785. doi:10.1016/S2213-2600(21)00175-2
Non-steroidal anti-inflammatory drug use and outcomes of COVID-19 in the ISARIC Clinical Characterisation Protocol UK cohort: a matched, prospective cohort study.
Drake, T. M., Fairfield, C. J., Pius, R., Knight, S. R., Norman, L., Girvan, M., . . . ISARIC4C Investigators. (2021). Non-steroidal anti-inflammatory drug use and outcomes of COVID-19 in the ISARIC Clinical Characterisation Protocol UK cohort: a matched, prospective cohort study.. The Lancet. Rheumatology, 3(7), e498-e506. doi:10.1016/s2665-9913(21)00104-1
Obesity, Ethnicity, and Risk of Critical Care, Mechanical Ventilation, and Mortality in Patients Admitted to Hospital with COVID-19: Analysis of the ISARIC CCP-UK Cohort
Yates, T., Zaccardi, F., Islam, N., Razieh, C., Gillies, C. L., Lawson, C. A., . . . Khunti, K. (2021). Obesity, Ethnicity, and Risk of Critical Care, Mechanical Ventilation, and Mortality in Patients Admitted to Hospital with COVID-19: Analysis of the ISARIC CCP-UK Cohort. OBESITY, 29(7), 1223-1230. doi:10.1002/oby.23178
Risk of adverse outcomes in patients with underlying respiratory conditions admitted to hospital with COVID-19 a national, multicentre prospective cohort study using the ISARIC WHO Clinical Characterisation Protocol UK
Bloom, C. I., Drake, T. M., Docherty, A. B., Lipworth, B. J., Johnston, S. L., Nguyen-Van-Tam, J. S., . . . Openshaw, P. J. M. (2021). Risk of adverse outcomes in patients with underlying respiratory conditions admitted to hospital with COVID-19 a national, multicentre prospective cohort study using the ISARIC WHO Clinical Characterisation Protocol UK. LANCET RESPIRATORY MEDICINE, 9(7), 699-711. doi:10.1016/S2213-2600(21)00013-8
Importance of patient bed pathways and length of stay differences in predicting COVID-19 hospital bed occupancy in England
Leclerc, Q. J., Fuller, N. M., Keogh, R. H., Diaz-Ordaz, K., Sekula, R., Semple, M. G., . . . Knight, G. M. (2021). Importance of patient bed pathways and length of stay differences in predicting COVID-19 hospital bed occupancy in England. BMC HEALTH SERVICES RESEARCH, 21(1). doi:10.1186/s12913-021-06509-x
Neurosurgical CSF Diversion in Idiopathic Intracranial Hypertension: A Narrative Review
Sunderland, G. J., Jenkinson, M. D., Conroy, E. J., Gamble, C., & Mallucci, C. L. (2021). Neurosurgical CSF Diversion in Idiopathic Intracranial Hypertension: A Narrative Review. LIFE-BASEL, 11(5). doi:10.3390/life11050393
Genetic mechanisms of critical illness in COVID-19
Pairo-Castineira, E., Clohisey, S., Klaric, L., Bretherick, A. D., Rawlik, K., Pasko, D., . . . Baillie, J. K. (2021). Genetic mechanisms of critical illness in COVID-19. NATURE, 591(7848), 92-+. doi:10.1038/s41586-020-03065-y
Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial
Roper, L., Lyttle, M. D., Gamble, C., Humphreys, A., Messahel, S., Lee, E. D., . . . Woolfall, K. (n.d.). Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial. Emergency Medicine Journal. doi:10.1136/emermed-2020-209487
Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials
Roper, L., Lyttle, M. D., Gamble, C., Humphreys, A., Messahel, S., Lee, E. D., . . . Woolfall, K. (2021). Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials. EMERGENCY MEDICINE JOURNAL, 38(3), 198-204. doi:10.1136/emermed-2020-209488
Adding a fourth rater to three had little impact in pre-linguistic outcome classification
Persson, C., Conroy, E. J., Gamble, C., Rosala-Hallas, A., Shaw, W., & Willadsen, E. (2021). Adding a fourth rater to three had little impact in pre-linguistic outcome classification. CLINICAL LINGUISTICS & PHONETICS, 35(2), 138-153. doi:10.1080/02699206.2020.1758793
A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan
Conroy, E. J., Cooper, R., Shaw, W., Persson, C., Willadsen, E., Munro, K. J., . . . Gamble, C. (2021). A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan. TRIALS, 22(1). doi:10.1186/s13063-020-04886-y
A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.
Houghton, C., McCarthy, M., Gillies, K., Rousseau, N., Wade, J., Gamble, C., . . . Biesty, L. (2021). A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.. HRB open research, 4, 47. doi:10.12688/hrbopenres.13269.2
Document Ranking for Curated Document Databases Using BERT and Knowledge Graph Embeddings: Introducing GRAB-Rank
Muhammad, I., Bollegala, D., Coenen, F., Gamble, C., Kearney, A., & Williamson, P. (2021). Document Ranking for Curated Document Databases Using BERT and Knowledge Graph Embeddings: Introducing GRAB-Rank. In BIG DATA ANALYTICS AND KNOWLEDGE DISCOVERY (DAWAK 2021) Vol. 12925 (pp. 116-127). doi:10.1007/978-3-030-86534-4_10
2020
A concept analysis of ‘trial recruitment’ using the hybrid model – Phase 1 findings
Delaney, H., Devane, D., Hunter, A., Treweek, S., Mills, N., Gamble, C., & Smith, V. (n.d.). A concept analysis of ‘trial recruitment’ using the hybrid model – Phase 1 findings. HRB Open Research, 3, 92. doi:10.12688/hrbopenres.13173.1
RTID-10. SURGEONS TRIAL OF PROPHYLAXIS FOR EPILEPSY IN SEIZURE NAÏVE PATIENTS WITH MENINGIOMA: A RANDOMIZED CONTROLLED TRIAL (STOP ‘EM)
Jenkinson, M., Helmy, A., Huckey, H., Mills, S., Grant, R., Hughes, D., . . . Gamble, C. (2020). RTID-10. SURGEONS TRIAL OF PROPHYLAXIS FOR EPILEPSY IN SEIZURE NAÏVE PATIENTS WITH MENINGIOMA: A RANDOMIZED CONTROLLED TRIAL (STOP ‘EM). Neuro-Oncology, 22(Supplement_2), ii195. doi:10.1093/neuonc/noaa215.815
Antimicrobial-impregnated central venous catheters for preventing neonatal bloodstream infection: the PREVAIL RCT
Gilbert, R., Brown, M., Faria, R., Fraser, C., Donohue, C., Rainford, N., . . . Oddie, S. J. (n.d.). Antimicrobial-impregnated central venous catheters for preventing neonatal bloodstream infection: the PREVAIL RCT. Health Technology Assessment, 24(57), 1-190. doi:10.3310/hta24570
Antimicrobial-impregnated central venous catheters for preventing neonatal bloodstream infection: the PREVAIL RCT.
Gilbert, R., Brown, M., Faria, R., Fraser, C., Donohue, C., Rainford, N., . . . Oddie, S. J. (2020). Antimicrobial-impregnated central venous catheters for preventing neonatal bloodstream infection: the PREVAIL RCT.. Health technology assessment (Winchester, England), 24(57), 1-190. doi:10.1093/ije/dyw098
Duration of initial antibiotic course is associated with recurrent relapse in protracted bacterial bronchitis
Gross--Hodge, E., Carroll, W. D., Rainford, N., Gamble, C., & Gilchrist, F. J. (2020). Duration of initial antibiotic course is associated with recurrent relapse in protracted bacterial bronchitis. ARCHIVES OF DISEASE IN CHILDHOOD, 105(11), 1111-1113. doi:10.1136/archdischild-2019-317917
Levetiracetam as an alternative to phenytoin for second-line emergency treatment of children with convulsive status epilepticus: the EcLiPSE RCT.
Appleton, R. E., Rainford, N. E., Gamble, C., Messahel, S., Humphreys, A., Hickey, H., . . . Lyttle, M. D. (2020). Levetiracetam as an alternative to phenytoin for second-line emergency treatment of children with convulsive status epilepticus: the EcLiPSE RCT.. Health technology assessment (Winchester, England), 24(58), 1-96. doi:10.3310/hta24580
Prospective reporting of statistical analysis plans for randomised controlled trials
Hemming, K., Kearney, A., Gamble, C., Li, T., Juni, P., Chan, A. -W., & Sydes, M. R. (2020). Prospective reporting of statistical analysis plans for randomised controlled trials. TRIALS, 21(1). doi:10.1186/s13063-020-04828-8
Detection of neutralising antibodies to SARS-CoV-2 to determine population exposure in Scottish blood donors between March and May 2020
Thompson, C. P., Grayson, N. E., Paton, R. S., Bolton, J. S., Lourenco, J., Penman, B. S., . . . Simmonds, P. (2020). Detection of neutralising antibodies to SARS-CoV-2 to determine population exposure in Scottish blood donors between March and May 2020. EUROSURVEILLANCE, 25(42), 33-41. doi:10.2807/1560-7917.ES.2020.25.42.2000685
Development and validation of the 4C Deterioration model for adults hospitalised with COVID-19
Gupta, R., Harrison, E., Ho, A., Docherty, A., Knight, S., van Smeden, M., . . . Noursadeghi, M. (2020). Development and validation of the 4C Deterioration model for adults hospitalised with COVID-19. doi:10.1101/2020.10.09.20209957
Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score.
Knight, S. R., Ho, A., Pius, R., Buchan, I., Carson, G., Drake, T. M., . . . ISARIC4C investigators. (2020). Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score.. BMJ: British Medical Journal, 370. doi:10.1136/bmj.m3339
Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score
Knight, S., Ho, A., Pius, R., Buchan, I., Carson, G., Drake, T., . . . Harrison, E. (2020). Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. doi:10.1101/2020.07.30.20165464
Statistical models to predict recruitment in clinical trials were rarely used by statisticians in UK and European networks
Gkioni, E., Dodd, S., Rius, R., & Gamble, C. (2020). Statistical models to predict recruitment in clinical trials were rarely used by statisticians in UK and European networks. JOURNAL OF CLINICAL EPIDEMIOLOGY, 124, 58-68. doi:10.1016/j.jclinepi.2020.03.012
Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials
Coulman, K. D., Nicholson, A., Shaw, A., Daykin, A., Selman, L. E., Macefield, R., . . . Lane, J. A. (2020). Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials. TRIALS, 21(1). doi:10.1186/s13063-020-04495-9
Ethnicity and Outcomes from COVID-19: The ISARIC CCP-UK Prospective Observational Cohort Study of Hospitalised Patients
Harrison, E., Docherty, A., Barr, B., Buchan, I., Carson, G., Drake, T., . . . Investigators, I. (2020). Ethnicity and Outcomes from COVID-19: The ISARIC CCP-UK Prospective Observational Cohort Study of Hospitalised Patients. doi:10.2139/ssrn.3618215
P154: "Do the best you can until you know better": Why, how and when Pilot and Feasibility Studies (PFS) should be utilised to optimise surgical trials
Fairhurst, K., Potter, S., Blazeby, J., Gamble, C., & Avery, K. (2020). P154: "Do the best you can until you know better": Why, how and when Pilot and Feasibility Studies (PFS) should be utilised to optimise surgical trials. European Journal of Surgical Oncology, 46(6), e51. doi:10.1016/j.ejso.2020.03.193
Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials [version 2]
McKay, A., Jones, A., Gamble, C., Farmer, A., & Williamson, P. (2020). Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials [version 2]. F1000Research. doi:10.12688/f1000research.23316.2
Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice.
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. (2020). Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice.. Trials, 21. doi:10.1186/s13063-020-04318-x
Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.
Docherty, A. B., Harrison, E. M., Green, C. A., Hardwick, H. E., Pius, R., Norman, L., . . . ISARIC4C investigators. (2020). Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.. BMJ (Clinical research ed.), 369. doi:10.1136/bmj.m1985
Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials [version 1]
McKay, A. J., Jones, A. P., Gamble, C. L., Farmer, A. J., & Williamson, P. R. (2020). Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials [version 1]. F1000Research, 9. doi:10.12688/f1000research.23316.1
Features of 16,749 hospitalised UK patients with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol
Docherty, A. B., Harrison, E. M., Green, C. A., Hardwick, H., Pius, R., Norman, L., . . . Semple, M. G. (2020). Features of 16,749 hospitalised UK patients with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol. doi:10.1101/2020.04.23.20076042
Challenges Conveying Clinical Equipoise and Exploring Patient Treatment Preferences in an Oncology Trial Comparing Active Monitoring with Radiotherapy (ROAM/EORTC 1308)
Sherratt, F. C., Brown, S. L., Haylock, B. J., Francis, P., Hickey, H., Gamble, C., . . . Young, B. (2020). Challenges Conveying Clinical Equipoise and Exploring Patient Treatment Preferences in an Oncology Trial Comparing Active Monitoring with Radiotherapy (ROAM/EORTC 1308). ONCOLOGIST, 25(4), E691-E700. doi:10.1634/theoncologist.2019-0571
A third trial oversight committee: Functions, benefits and issues
Lane, J. A., Gamble, C., Cragg, W. J., Tembo, D., & Sydes, M. R. (2020). A third trial oversight committee: Functions, benefits and issues. CLINICAL TRIALS, 17(1), 106-112. doi:10.1177/1740774519881619
Maintaining Curated Document Databases Using a Learning to Rank Model: The ORRCA Experience
Muhammad, I., Bollegala, D., Coenen, F., Gamble, C., Kearney, A., & Williamson, P. (2020). Maintaining Curated Document Databases Using a Learning to Rank Model: The ORRCA Experience. In Unknown Conference (pp. 345-357). Springer International Publishing. doi:10.1007/978-3-030-63799-6_26
Open Information Extraction for Knowledge Graph Construction
Muhammad, I., Kearney, A., Gamble, C., Coenen, F., & Williamson, P. (2020). Open Information Extraction for Knowledge Graph Construction. In Unknown Conference (pp. 103-113). Springer International Publishing. doi:10.1007/978-3-030-59028-4_10
SURGEONS TRIAL OF PROPHYLAXIS FOR EPILEPSY IN SEIZURE NAIVE PATIENTS WITH MENINGIOMA: A RANDOMIZED CONTROLLED TRIAL (STOP 'EM)
Jenkinson, M., Helmy, A., Huckey, H., Mills, S., Grant, R., Hughes, D., . . . Gamble, C. (2020). SURGEONS TRIAL OF PROPHYLAXIS FOR EPILEPSY IN SEIZURE NAIVE PATIENTS WITH MENINGIOMA: A RANDOMIZED CONTROLLED TRIAL (STOP 'EM). In NEURO-ONCOLOGY Vol. 22 (pp. 195). Retrieved from https://www.webofscience.com/
Silver-impregnated, antibiotic-impregnated or non-impregnated ventriculoperitoneal shunts to prevent shunt infection: the BASICS three-arm RCT
Mallucci, C. L., Jenkinson, M. D., Conroy, E. J., Hartley, J. C., Brown, M., Moitt, T., . . . Gamble, C. (2020). Silver-impregnated, antibiotic-impregnated or non-impregnated ventriculoperitoneal shunts to prevent shunt infection: the BASICS three-arm RCT. HEALTH TECHNOLOGY ASSESSMENT, 24(17), 1-+. doi:10.3310/hta24170
2019
A systematic review describes models for recruitment prediction at the design stage of a clinical trial
Gkioni, E., Rius, R., Dodd, S., & Gamble, C. (2019). A systematic review describes models for recruitment prediction at the design stage of a clinical trial. Journal of Clinical Epidemiology, 115, 141-149. doi:10.1016/j.jclinepi.2019.07.002
What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study
Brunsdon, D., Biesty, L., Brocklehurst, P., Brueton, V., Devane, D., Elliott, J., . . . Gillies, K. (2019). What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study. Trials, 20. doi:10.1186/s13063-019-3687-7
Allowance for learning and clustering effects in the design and analysis of multicentre randomised trials: current practice and experiences
Conroy, E. J., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. (2019). Allowance for learning and clustering effects in the design and analysis of multicentre randomised trials: current practice and experiences. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Managing learning and clustering effects at the design stage in randomised surgical trials: a retrospective cohort of trial funding applications
Conroy, E., Rosala-Hallas, A., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. (2019). Managing learning and clustering effects at the design stage in randomised surgical trials: a retrospective cohort of trial funding applications. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Measuring speech development in infants: methodological considerations based on experiences within the TOPS trial
Cooper, R., Conroy, E. J., Gamble, C., Willadsen, E., Persson, C., & Shaw, W. (2019). Measuring speech development in infants: methodological considerations based on experiences within the TOPS trial. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Exploring patient treatment preferences enhances trial recruitment, so why do trial recruiters often avoid doing it?
Sherratt, F. C., Beasant, L., Crawley, E., Hall, N. J., Francis, P., Hickey, H., . . . Young, B. (2019). Exploring patient treatment preferences enhances trial recruitment, so why do trial recruiters often avoid doing it?. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
ORRCA and ORRCA2: A large-scale, international, collaboration to map recruitment and retention literature
Kearney, A., Rosala-Hallas, A., Cragg, W. J., Devane, D., Gillies, K., Harman, N. L., . . . Gamble, C. (2019). ORRCA and ORRCA2: A large-scale, international, collaboration to map recruitment and retention literature. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Duration of initial antibiotic course is associated with recurrent relapse in protracted bacterial bronchitis
Grose-Hodge, E., Carroll, W., Rainford, N., Gamble, C., & Gilchrist, F. (2019). Duration of initial antibiotic course is associated with recurrent relapse in protracted bacterial bronchitis. In EUROPEAN RESPIRATORY JOURNAL Vol. 54. doi:10.1183/13993003.congress-2019.PA5002
A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
Rosala-Hallas, A., Gamble, C., Blazeby, J., & Williamson, P. R. (2019). A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials. TRIALS, 20(1). doi:10.1186/s13063-019-3669-9
Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: A survey to establish current practice
Conroy, E., Blazeby, J., Burnside, G., Cook, J., & Gamble, C. (2019). Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: A survey to establish current practice. doi:10.21203/rs.2.14122/v1
Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery
Conroy, E. J., Rosala-Hallas, A., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. (2019). Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery. JOURNAL OF CLINICAL EPIDEMIOLOGY, 113, 28-35. doi:10.1016/j.jclinepi.2019.05.007
Clinical trial data sharing: here's the challenge.
Kochhar, S., Knoppers, B., Gamble, C., Chant, A., Koplan, J., & Humphreys, G. S. (2019). Clinical trial data sharing: here's the challenge.. BMJ open, 9(8), e032334. doi:10.1136/bmjopen-2019-032334
Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age
Shaw, W., Semb, G., Lohmander, A., Persson, C., Willadsen, E., Clayton-Smith, J., . . . Williamson, P. (2019). Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age. BMJ OPEN, 9(7). doi:10.1136/bmjopen-2019-029780
Value of surgical pilot and feasibility study protocols
Fairhurst, K., Blazeby, J. M., Potter, S., Gamble, C., Rowlands, C., & Avery, K. N. L. (2019). Value of surgical pilot and feasibility study protocols. British Journal of Surgery, 106(8), 968-978. doi:10.1002/bjs.11167
DIABRISK-SL trial: further consideration of age and impact of imputations
Gkioni, E., Glonti, K., Dodd, S., & Gamble, C. (2019). DIABRISK-SL trial: further consideration of age and impact of imputations. BMC MEDICINE, 17. doi:10.1186/s12916-019-1361-2
A descriptive study of syllable inventory in 12 month old infants with isolated cleft palate: results from 485 infants
Persson, C., Cooper, R., Conroy, E. J., Gamble, C., & Willadsen, E. (2019, June 12). A descriptive study of syllable inventory in 12 month old infants with isolated cleft palate: results from 485 infants. In European Cleft Palate Craniofacial Association. Utrecht, the Netherlands.
Assessment of canonical babbling status in infants with cleft palate: agreement between parents and speech therapists: results of 485 infants in a randomised controlled trial
Willadsen, E., Cooper, R., Conroy, E. J., Persson, C., & Gamble, C. (2019, June 12). Assessment of canonical babbling status in infants with cleft palate: agreement between parents and speech therapists: results of 485 infants in a randomised controlled trial. In European Cleft Palate Craniofacial Associate Congress. Utrecht, The Netherlands.
Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial
Gilbert, R., Brown, M., Rainford, N., Donohue, C., Fraser, C., Sinha, A., . . . Team, P. R. E. V. A. I. L. T. (2019). Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial. Lancet Child and Adolescent Health, 3(6), 381-390. doi:10.1016/S2352-4642(19)30114-2
Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial
Lyttle, M., Rainford, N., Gamble, C., Messahel, S., Humphreys, A., Hickey, H., . . . Appleton, R. (2019). Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial. The Lancet, 393(10186), 2125-2134. doi:10.1016/S0140-6736(19)30724-X
G320(P) Successful conduct of a UK multi-centre emergency department led paediatric clinical trial: lessons from the eclipse trial
Woolfall, K., Roper, L., Lyttle, M. D., Gamble, C., Humphreys, A., Messahel, S., . . . Appleton, R. (2019). G320(P) Successful conduct of a UK multi-centre emergency department led paediatric clinical trial: lessons from the eclipse trial. In ASSOCIATION OF PAEDIATRIC EMERGENCY MEDICINE (pp. A131.1-A131). BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health. doi:10.1136/archdischild-2019-rcpch.311
P6 The emergency treatment with levetiracetam or phenytoin in status epilepticus in children: a pragmatic, randomised controlled trial (the ‘eclipse’ trial)
Appleton, R. E., Lyttle, M. D., Gamble, C., Bacon, N., Woolfall, K., Messahel, S., & Lee, E. (2019). P6 The emergency treatment with levetiracetam or phenytoin in status epilepticus in children: a pragmatic, randomised controlled trial (the ‘eclipse’ trial). In PLENARY (pp. A3.1-A3). BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health. doi:10.1136/archdischild-2019-rcpch.6
Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation
Blair, J. C., Mckay, A., Ridyard, C., Thornborough, K., Bedson, E., Peak, M., . . . Investigators, S. C. I. P. I. (2019). Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation. BMJ: British Medical Journal, 365. doi:10.1136/bmj.l1226
Enhancing practitioners' confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training - a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study
Woolfall, K., Roper, L., Humphreys, A., Lyttle, M. D., Messahel, S., Lee, E., . . . Appleton, R. (2019). Enhancing practitioners' confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training - a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study. TRIALS, 20. doi:10.1186/s13063-019-3273-z
What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership – The PRioRiTy II (Prioritising Retention in Randomised Trials) Study
Brunsdon, D., Biesty, L., Brocklehurst, P., Brueton, V., Devane, D., Elliott, J., . . . Gillies, K. (2019). What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership – The PRioRiTy II (Prioritising Retention in Randomised Trials) Study. doi:10.21203/rs.2.439/v1
Randomized trials involving surgery did not routinely report considerations of learning and clustering effects
Conroy, E. J., Rosala-Hallas, A., Blazeby, J. M., Burnside, G., Cook, J. A., & Gamble, C. (2019). Randomized trials involving surgery did not routinely report considerations of learning and clustering effects. Journal of Clinical Epidemiology, 107, 27-35. doi:10.1016/j.jclinepi.2018.11.004
Assessing attrition in Randomised Control Trials, the identification of attrition risk factors and the challenges of poor reporting: A comparison of reports from 2013 and 2018
Kearney, A., Rosala-Hallas, A., Rainford, N., Blazeby, J. M., Clarke, M., Lane, A. J., . . . Gamble, C. (2019). Assessing attrition in Randomised Control Trials, the identification of attrition risk factors and the challenges of poor reporting: A comparison of reports from 2013 and 2018. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Enhancing practitioner explanations and parental understandings of recruitment and consent- an adapted model for paediatric emergency medicine trials
Roper, L., Woolfall, K., Lyttle, M. D., Gamble, C., Humphreys, A., Hickey, H., . . . Appleton, R. E. (2019). Enhancing practitioner explanations and parental understandings of recruitment and consent- an adapted model for paediatric emergency medicine trials. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Good Statistical Practice: GCP for Statisticians
Mossop, H., Armstrong, E., Lewis, S., Dutton, S., Peckitt, C., McParland, L., . . . Stocken, D. (2019). Good Statistical Practice: GCP for Statisticians. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Identifying trial retention uncertainties using a James Lind Alliance Priority Setting Partnership - The PRioRiTy II (Prioritising Retention in Randomised Trials) Study
Gillies, K., Brunsdon, D., Biesty, L., Brocklehurst, P., Brueton, V., Devane, D., . . . Wren, S. (2019). Identifying trial retention uncertainties using a James Lind Alliance Priority Setting Partnership - The PRioRiTy II (Prioritising Retention in Randomised Trials) Study. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Internal pilots in clinical trials: Current practice in design and assessment
Rosala-Hallas, A., Gamble, C., Blazeby, J., & Williamson, P. R. (2019). Internal pilots in clinical trials: Current practice in design and assessment. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Making a challenging trial possible: Lessons from the Emergency Department led EcLiPSE trial
Woolfall, K., Roper, L., Lyttle, M. D., Gamble, C., Humphreys, A., Messahel, S., . . . Appleton, R. (2019). Making a challenging trial possible: Lessons from the Emergency Department led EcLiPSE trial. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials
Coulman, K., Nicholson, A., Shaw, A., Daykin, A., Cramer, H., Gamble, C., . . . Lane, J. A. (2019). Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Prediction and monitoring of patient recruitment in clinical trials: gaps between current practice and available methodology
Gkioni, E., Dodd, S., Rius, R., & Gamble, C. (2019). Prediction and monitoring of patient recruitment in clinical trials: gaps between current practice and available methodology. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
The MRC HTMR recruitment working group: Driving recruitment research through collaboration
Harman, N. L., Elliott, D., Gamble, C., Gillies, K., McAneney, H., Realpe, A., . . . Shorter, G. W. (2019). The MRC HTMR recruitment working group: Driving recruitment research through collaboration. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Unique challenges and proposed solutions for designing and conducting pilot and feasibility work to optimise surgical trials
Fairhurst, K., Potter, S., Blazeby, J., Gamble, C., & Avery, K. (2019). Unique challenges and proposed solutions for designing and conducting pilot and feasibility work to optimise surgical trials. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
Use of routinely collected data from electronic health records for outcomes in NIHR HTA trials
Mckay, A. J., Farmer, A. J., Gamble, C., Jones, A. P., & Williamson, P. R. (2019). Use of routinely collected data from electronic health records for outcomes in NIHR HTA trials. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
When is enough enough? Patient, relative, and health care professionals experiences of research information provision in the intensive care unit
Paddock, K., Frith, L., Gamble, C., Welters, I., Woolfall, K., & Young, B. (2019). When is enough enough? Patient, relative, and health care professionals experiences of research information provision in the intensive care unit. In TRIALS Vol. 20. Retrieved from https://www.webofscience.com/
2018
Development of an online resource for recruitment research in clinical trials to organise and map current literature
Kearney, A., Harman, N. L., Rosala-Hallas, A., Beecher, C., Blazeby, J. M., Bower, P., . . . Gamble, C. (2018). Development of an online resource for recruitment research in clinical trials to organise and map current literature. CLINICAL TRIALS, 15(6), 533-542. doi:10.1177/1740774518796156
Phase III randomized controlled trials are essential to properly evaluate the role of radiotherapy in WHO grade II meningioma
Jenkinson, M. D., Weber, D. C., Haylock, B. J., Sherratt, F. C., Young, B., Weller, M., . . . Gamble, C. (2018). Phase III randomized controlled trials are essential to properly evaluate the role of radiotherapy in WHO grade II meningioma. JOURNAL OF NEUROSURGERY, 129(4), 1104-1105. doi:10.3171/2018.6.JNS181418
Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets
Kearney, A., Rosala-Hallas, A., Bacon, N., Daykin, A., Shaw, A. R. G., Lane, A. J., . . . Gamble, C. (2018). Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets. PLOS ONE, 13(10). doi:10.1371/journal.pone.0204886
Outcome reporting bias in trials: a methodological approach for assessment and adjustment in systematic reviews
Kirkham, J. J., Altman, D., Chan, A. -W., Gamble, C. L., Dwan, K. M., & Williamson, P. (2018). Outcome reporting bias in trials: a methodological approach for assessment and adjustment in systematic reviews. BMJ: British Medical Journal, 2018(362). doi:10.1136/bmj.k3802
Children’s views on research without prior consent in emergency situations: a UK qualitative study
Roper, L., Sherratt, F., Young, B., Mcnamara, P., Dawson, A., Appleton, R., . . . Woolfall, K. (2018). Children’s views on research without prior consent in emergency situations: aUK qualitative study. BMJ Open, 8(6). doi:10.1136/bmjopen-2018-022894
Statistical Analysis Plans for Clinical Trials Reply
Gamble, C., Lewis, S., & Senn, S. (2018). Statistical Analysis Plans for Clinical Trials Reply. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 319(18), 1938-1939. doi:10.1001/jama.2018.2585
Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study
Healy, P., Galvin, S., Williamson, P. R., Treweek, S., Whiting, C., Maeso, B., . . . Devane, D. (2018). Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study. Trials, 19. doi:10.1186/s13063-018-2544-4
Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention
Mills, N., Gaunt, D., Blazeby, J. M., Elliott, D., Husbands, S., Holding, P., . . . Donovan, J. L. (2018). Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention. JOURNAL OF CLINICAL EPIDEMIOLOGY, 95, 34-44. doi:10.1016/j.jclinepi.2017.11.015
Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital
Rowlands, C., Rooshenas, L., Fairhurst, K., Rees, J., Gamble, C., & Blazeby, J. M. (2018). Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital. BMJ OPEN, 8(2). doi:10.1136/bmjopen-2017-018581
'Recruitment, recruitment, recruitment' - the need for more focus on retention: a qualitative study of five trials
Daykin, A., Clement, C., Gamble, C., Kearney, A., Blazeby, J., Clarke, M., . . . Shaw, A. (2018). 'Recruitment, recruitment, recruitment' - the need for more focus on retention: a qualitative study of five trials. TRIALS, 19. doi:10.1186/s13063-018-2467-0
2017
'<i>We all want to succeed, but we've also got to be realistic about what is happening</i>': an ethnographic study of relationships in trial oversight and their impact
Daykin, A., Selman, L. E., Cramer, H., McCann, S., Shorter, G. W., Sydes, M. R., . . . Shaw, A. (2017). '<i>We all want to succeed, but we've also got to be realistic about what is happening</i>': an ethnographic study of relationships in trial oversight and their impact. TRIALS, 18. doi:10.1186/s13063-017-2305-9
Guidelines for the content of statistical analysis plans in clinical trials
Gamble, C. L., Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Dore, C., . . . Loder, E. (2017). Guidelines for the content of statistical analysis plans in clinical trials. JAMA: Journal of the American Medical Association, 318(23), 2337-2343. doi:10.1001/jama.2017.18556
A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials
Conroy, E. J., Arch, B., Harman, N. L., Lane, J. A., Lewis, S. C., Norrie, J., . . . Gamble, C. (2017). A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials. TRIALS, 18. doi:10.1186/s13063-017-2300-1
Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process
Kearney, A., Williamson, P., Young, B., Gamble, C., Bagley, H., Denegri, S., . . . woolfall, K. (2017). Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process. Health Expectations, 20(6), 1401-1410. doi:10.1111/hex.12583
Cost-Effectiveness of Pediatric Central Venous Catheters in the UK: A Secondary Publication from the CATCH Clinical Trial
Ridyard, C. H., Plumpton, C. O., Gilbert, R. E., & Hughes, D. A. (2017). Cost-Effectiveness of Pediatric Central Venous Catheters in the UK: A Secondary Publication from the CATCH Clinical Trial. FRONTIERS IN PHARMACOLOGY, 8. doi:10.3389/fphar.2017.00644
Identifying research priorities for effective retention strategies in clinical trials
Kearney, A., Daykin, A., Shaw, A. R. G., Lane, A. J., Blazeby, J. M., Clarke, M., . . . Gamble, C. (2017). Identifying research priorities for effective retention strategies in clinical trials. Trials, 18. doi:10.1186/s13063-017-2132-z
Emergency treatment with levetiracetam or phenytoin in status epilepticus in children-the EcLiPSE study: study protocol for a randomised controlled trial
Lyttle, M. D., Gamble, C., Messahel, S., Hickey, H., Iyer, A., Woolfall, K., . . . Appleton, R. E. (2017). Emergency treatment with levetiracetam or phenytoin in status epilepticus in children-the EcLiPSE study: study protocol for a randomised controlled trial. TRIALS, 18. doi:10.1186/s13063-017-2010-8
Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials
Martin-Kerry, J., Bower, P., Young, B., Graffy, J., Sheridan, R., Watt, I., . . . Knapp, P. (2017). Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials. TRIALS, 18. doi:10.1186/s13063-017-1962-z
Response to letter to editor: 'Comment on Arch et al., <i>Trials</i>. 2016;17:517'
Arch, B. N., Blair, J., Mckay, A., Gregory, J. W., Newland, P., & Gamble, C. (2017). Response to letter to editor: 'Comment on Arch et al., <i>Trials</i>. 2016;17:517'. TRIALS, 18. doi:10.1186/s13063-017-1981-9
"To have and to hold, from this day forward": understanding current practice regarding retention of trial participants
Clement, C., Daykin, A., Gamble, C., Kearney, A., Blazeby, J., Clarke, M., . . . Heawood, A. (2017). "To have and to hold, from this day forward": understanding current practice regarding retention of trial participants. In TRIALS Vol. 18. Retrieved from http://gateway.webofknowledge.com/
Design and analysis of the learning curve and clustering effects in randomised surgical trials - A review of current practice
Conroy., Blazeby, J., Burnside, G., Cook, J., & Gamble, C. (2017). Design and analysis of the learning curve and clustering effects in randomised surgical trials - A review of current practice. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Site training to improve healthcare practitioners? Confidence in recruiting to a challenging critical care trial
Woolfall, K., Roper, L., Humphreys, A., Lyttle, M. D., Messahel, S., Lee, E., . . . Hickey, H. (2017). Site training to improve healthcare practitioners? Confidence in recruiting to a challenging critical care trial. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
G275 Children and Young People’s Views on Research Without Prior Consent in Life Threatening Situations: A Qualitative Study
Roper, L., Sherratt, F., Young, B., McNamara, P., Appleton, R., Crawley, E., . . . Woolfall, K. (2017). G275 Children and Young People’s Views on Research Without Prior Consent in Life Threatening Situations: A Qualitative Study. In Association of Paediatric Emergency Medicine (pp. A108.2-A108). BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health. doi:10.1136/archdischild-2017-313087.269
P12.10 The ROAM / EORTC 1308 trial: Radiation versus observation following surgical resection of atypical meningioma - study update
Jenkinson, M. D., Javadpour, M., Haylock, B. J., Young, B., Bulbeck, H., Farrell, M., . . . Weber, D. (2017). P12.10 The ROAM / EORTC 1308 trial: Radiation versus observation following surgical resection of atypical meningioma - study update. Neuro-oncology, 19(Suppl 3), iii97.
THE ROAM / EORTC 1308 TRIAL: RADIATION VERSUS OBSERVATION FOLLOWING SURGICAL RESECTION OF ATYPICAL MENINGIOMA - STUDY UPDATE
Jenkinson, M. D., Javadpour, M., Haylock, B. J., Young, B., Bulbeck, H., Farrell, M., . . . Weber, D. (2017). THE ROAM / EORTC 1308 TRIAL: RADIATION VERSUS OBSERVATION FOLLOWING SURGICAL RESECTION OF ATYPICAL MENINGIOMA - STUDY UPDATE. In NEURO-ONCOLOGY Vol. 19 (pp. 97). Retrieved from https://www.webofscience.com/
Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis (vol 17, pg 517, 2016)
Arch, B. N., Blair, J., Mckay, A., Gregory, J. W., Newland, P., & Gamble, C. (2017). Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis (vol 17, pg 517, 2016). TRIALS, 18. doi:10.1186/s13063-017-1914-7
Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies
Avery, K. N. L., Williamson, P. R., Gamble, C., Francischetto, E. O., Metcalfe, C., Davidson, P., . . . Blazeby, J. M. (2017). Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ OPEN, 7(2). doi:10.1136/bmjopen-2016-013537
An evaluation of the impact of quintet RCT recruitment training on the self-confidence and self-assessed recruitment practice of recruiters to surgical trials
Mills, N., Blazeby, J. M., Gaunt, D., Elliott, D., Husbands, S., Holding, P., . . . Donovan, J. L. (2017). An evaluation of the impact of quintet RCT recruitment training on the self-confidence and self-assessed recruitment practice of recruiters to surgical trials. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Changing roles and relationships within trial oversight: an ethnographic study of eight clinical trials facing challenges
Daykin, A., Selman, L. E., Cramer, H., McCann, S., Shorter, G. W., Sydes, M. R., . . . Lane, J. A. (2017). Changing roles and relationships within trial oversight: an ethnographic study of eight clinical trials facing challenges. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Duration of intravenous antibiotic therapy for children with acute osteomyelitis or septic arthritis: a feasibility study
de Graaf, H., Sukhtankar, P., Arch, B., Ahmad, N., Lees, A., Bennett, A., . . . Faust, S. N. (2017). Duration of intravenous antibiotic therapy for children with acute osteomyelitis or septic arthritis: a feasibility study. HEALTH TECHNOLOGY ASSESSMENT, 21(48), 1-+. Retrieved from https://www.webofscience.com/
Identifying effective retention strategies: a research agenda
Kearney, A., Daykin, A., Heawood, A. J., Lane, A., Blazeby, J., Clarke, M., . . . Gamble, C. (2017). Identifying effective retention strategies: a research agenda. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Improving the planning and monitoring of recruitment to clinical trials
Gkioni, E., Rius, R., & Gamble, C. (2017). Improving the planning and monitoring of recruitment to clinical trials. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Key design features of pilot and feasibility studies to inform successful surgical trials: a systematic analysis of funded studies
Fairhurst, K., Blazeby, J., Potter, S., Blatch-Jones, A., Rowlands, C., Gamble, C., & Avery, K. (2017). Key design features of pilot and feasibility studies to inform successful surgical trials: a systematic analysis of funded studies. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
More than the emperor's new clothes: enhancing meaningful patient and public involvement in trial oversight committees through qualitative research with eight clinical trials facing challenges
Nicolson, A., Daykin, A., Coulman, K., Clement, C., Cramer, H., Gamble, C., . . . Sydes, M. R. (2017). More than the emperor's new clothes: enhancing meaningful patient and public involvement in trial oversight committees through qualitative research with eight clinical trials facing challenges. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Online resource for recruitment research in clinical trials research (ORRCA)
Kearney, A., Harman, N. L., Bacon, N., Daykin, A., Heawood, A. J., Lane, A., . . . Bower, P. (2017). Online resource for recruitment research in clinical trials research (ORRCA). In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Outcome selection in clinical trials - Looking back at the problems and moving forward with solutions
Williamson, P., Kirkham, J. K., Gamble, C., & Dwan, K. (2017). Outcome selection in clinical trials - Looking back at the problems and moving forward with solutions. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Recruitment to randomised controlled trials in patients receiving unplanned hospital care: a systematic review and in-depth analysis using the ORRCA database
Rowlands, C., Rooshenhas, L., Rees, J., Fairhurst, K., Gamble, C., & Blazeby, J. M. (2017). Recruitment to randomised controlled trials in patients receiving unplanned hospital care: a systematic review and in-depth analysis using the ORRCA database. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Reducing attrition: the communication of retention and withdrawal within patient information sheets
Kearney, A., Rosala-Hallas, A., Bacon, N., Daykin, A., Heawood, A. J., Lane, A., . . . Gamble, C. (2017). Reducing attrition: the communication of retention and withdrawal within patient information sheets. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
Reported reasons for missing data
Kearney, A., Rosala-Hallas, A., Bacon, N., Daykin, A., Heawood, A. J., Lane, A., . . . Gamble, C. (2017). Reported reasons for missing data. In TRIALS Vol. 18. Retrieved from https://www.webofscience.com/
2016
CHILDREN AND YOUNG PEOPLE SUPPORT RESEARCH WITHOUT PRIOR CONSENT IN LIFE THREATENING SITUATIONS: A QUALITATIVE STUDY
Woolfall, K., Roper, L., Sherratt, F., McNamara, P., Appleton, R., Crawley, E., . . . Young, B. (2016). CHILDREN AND YOUNG PEOPLE SUPPORT RESEARCH WITHOUT PRIOR CONSENT IN LIFE THREATENING SITUATIONS: A QUALITATIVE STUDY. In EUROPEAN JOURNAL OF PEDIATRICS Vol. 175 (pp. 1525-1526). Retrieved from https://www.webofscience.com/
Measurement of HbA1c in multicentre diabetes trials – should blood samples be tested locally or sent to a central laboratory: an agreement analysis
Arch, B., Blair, J., McKay, A., Gregory, J. W., Newland, P., & Gamble, C. L. (2016). Measurement of HbA1c in multicentre diabetes trials – should blood samples be tested locally or sent to a central laboratory: an agreement analysis. Trials, 17. doi:10.1186/s13063-016-1640-6
What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges
Daykin, A., Selman, L. E., Cramer, H., McCann, S., Shorter, G. W., Sydes, M. R., . . . Shaw, A. (2016). What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges. TRIALS, 17. doi:10.1186/s13063-016-1425-y
A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.
Bagley, H. J., Short, H., Harman, N. L., Hickey, H. R., Gamble, C. L., Woolfall, K., . . . Williamson, P. R. (2016). A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.. Research involvement and engagement, 2, 15. doi:10.1186/s40900-016-0029-8
Impregnated central venous catheters for prevention of bloodstream infection in children (the CATCH trial): a randomised controlled trial
Gilbert, R. E., Mok, Q., Dwan, K., Harron, K., Moitt, T., Millar, M., . . . Investigators, C. A. T. C. H. T. (2016). Impregnated central venous catheters for prevention of bloodstream infection in children (the CATCH trial): a randomised controlled trial. The Lancet, 387(10029), 1732-1742. doi:10.1016/S0140-6736(16)00340-8
Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ
Weston, J., Dwan, K., Altman, D., Clarke, M., Gamble, C., Schroter, S., . . . Kirkham, J. J. (2016). Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ. BMJ Open, 6(4). doi:10.1136/bmjopen-2015-010075
Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials
Hodkinson, A., Gamble, C., & Smith, C. T. (2016). Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. TRIALS, 17. doi:10.1186/s13063-016-1327-z
CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children
Harron, K., Mok, Q., Dwan, K., Ridyard, C. H., Moitt, T., Millar, M., . . . Gilbert, R. E. (2016). CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children. HEALTH TECHNOLOGY ASSESSMENT, 20(18), 1-+. doi:10.3310/hta20180
Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials
Woolfall, K., Frith, L., Dawson, A., Gamble, C., & Lyttle, M. D. (2016). Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials. ARCHIVES OF DISEASE IN CHILDHOOD-EDUCATION AND PRACTICE EDITION, 101(1), 49-53. doi:10.1136/archdischild-2015-309245
Limits of Agreement between HbA1c Levels Measured in Different Laboratories Following the Introduction of the International Federation of Clinical Chemistry and Laboratory Medicine Standardised Values
Arch, B., McKay, A., Newland, P., Blair, J., Gregory, J., Peak, M., . . . Gamble, C. (2016). Limits of Agreement between HbA1c Levels Measured in Different Laboratories Following the Introduction of the International Federation of Clinical Chemistry and Laboratory Medicine Standardised Values. In HORMONE RESEARCH IN PAEDIATRICS Vol. 86 (pp. 83). Retrieved from https://www.webofscience.com/
2015
Exploring the role and function of trial steering committees: results of an expert panel meeting
Harman, N. L., Conroy, E. J., Lewis, S. C., Murray, G., Norrie, J., Sydes, M. R., . . . Gamble, C. (2015). Exploring the role and function of trial steering committees: results of an expert panel meeting. Trials, 16. doi:10.1186/s13063-015-1125-z
"To have, to hold, from this day forward": understanding current practice regarding the retention of trial participants
Daykin, A., Lane, A., Gamble, C., Kearney, A., Blazeby, J., Clarke, M., . . . Heawood, A. (2015). "To have, to hold, from this day forward": understanding current practice regarding the retention of trial participants. In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-P104
A review of the description of patient withdrawal in trial protocols and patient information sheets (PIS)
Kearney, A., Daykin, A., Heawood, A., Lane, A., Blazeby, J., Clarke, M., . . . Gamble, C. (2015). A review of the description of patient withdrawal in trial protocols and patient information sheets (PIS). In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-P46
Development of an online resource for recruitment research in clinical trials (ORRCA)
Harman, N., Treweek, S., Clarke, M., Williamson, P., Bower, P., & Gamble, C. (2015). Development of an online resource for recruitment research in clinical trials (ORRCA). TRIALS, 16. doi:10.1186/1745-6215-16-S2-P98
Development of guidance for statistical analysis plans (SAPs) for clinical trials
Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Dore, C., Williamson, P., . . . Gamble, C. (2015). Development of guidance for statistical analysis plans (SAPs) for clinical trials. TRIALS, 16. doi:10.1186/1745-6215-16-S2-O41
Enhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges
Nicholson, A., Daykin, A., Macefield, R., McCann, S., Shorter, G., Sydes, M., . . . Lane, J. A. (2015). Enhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges. In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-P78
Exploring the role and functionality of trial steering committees
Harman, N., Conroy, E., Lewis, S., Murray, G., Norrie, J., Sydes, M., . . . Gamble, C. (2015). Exploring the role and functionality of trial steering committees. In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-P189
Optimising the design of internal pilot work to inform efficient randomised controlled trials: issues to consider when developing progression criteria
Avery, K., Williamson, P., Gamble, C., Francischetto, E. O., Metcalfe, C., Davidson, P., & Blazeby, J. (2015). Optimising the design of internal pilot work to inform efficient randomised controlled trials: issues to consider when developing progression criteria. In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-P10
Pragmatic approaches to mitigating missing data and research priorities to assess the effectiveness of interventions
Kearney, A., Daykin, A., Heawood, A., Lane, A., Blazeby, J., Clarke, M., . . . Gamble, C. (2015). Pragmatic approaches to mitigating missing data and research priorities to assess the effectiveness of interventions. In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-P238
Realising the potential of patient and public involvement to make a difference: what can trial teams do?
Young, B., Dudley, L., Williamson, P., & Gamble, C. (2015). Realising the potential of patient and public involvement to make a difference: what can trial teams do?. In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-O93
Reporting remit and function of trial steering committees in randomised controlled trials: review of published literature
Conroy, E. J., Arch, B., Lewis, S., Lane, A., Sydes, M. R., Norrie, J., . . . Gamble, C. (2015). Reporting remit and function of trial steering committees in randomised controlled trials: review of published literature. In Trials Vol. 16. Springer Science and Business Media LLC. doi:10.1186/1745-6215-16-s2-p177
Selective reporting in clinical trials - an examination of discrepancy rates in pre-specified and reported outcomes in articles submitted to the BMJ
Weston, J., Dwan, K., Altman, D., Clarke, M., Gamble, C., Groves, T., . . . Kirkham, J. (2015). Selective reporting in clinical trials - an examination of discrepancy rates in pre-specified and reported outcomes in articles submitted to the BMJ. In TRIALS Vol. 16. doi:10.1186/1745-6215-16-S2-O72
Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences
Conroy, E. J., Harman, N. L., Lane, J. A., Lewis, S. C., Murray, G., Norrie, J., . . . Gamble, C. (2015). Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences. CLINICAL TRIALS, 12(6), 664-676. doi:10.1177/1740774515589959
Reported reasons for missing data and the interplay with trial setting
Kearney, A., Bacon, N., Rosala-Hallas, A., Daykin, A., Heawood, A., Lane, A., . . . Gamble, C. (2015). Reported reasons for missing data and the interplay with trial setting. Poster session presented at the meeting of 3rd International Clinical Trials Methodology Conference. Glasgow UK.
The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
Jenkinson, M. D., Javadpour, M., Haylock, B. J., Young, B., Gillard, H., Vinten, J., . . . Weber, D. C. (2015). The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial. TRIALS, 16. doi:10.1186/s13063-015-1040-3
Deferred Consent for Randomized Controlled Trials in Emergency Care Settings
Harron, K., Woolfall, K., Dwan, K., Gamble, C., Mok, Q., Ramnarayan, P., & Gilbert, R. (2015). Deferred Consent for Randomized Controlled Trials in Emergency Care Settings. PEDIATRICS, 136(5), E1316-E1322. doi:10.1542/peds.2015-0512
How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study
Woolfall, K., Frith, L., Gamble, C., Gilbert, R., Mok, Q., & Young, B. (2015). How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study. BMJ Open, 5(9). doi:10.1136/bmjopen-2015-008522
An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study
Gamble, C., Dudley, L., Allam, A., Bell, P., Buck, D., Goodare, H., . . . Young, B. (2015). An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study. Health Services and Delivery Research, 3(39). doi:10.3310/hsdr03390
What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials
Dudley, L., Gamble, C., Preston, J., Buck, D., The EPIC Patient Advisory Group., Hanley, B., . . . Young, B. (2015). What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials. PLOS ONE, 10(6). doi:10.1371/journal.pone.0128817
Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform
Treweek, S., Altman, D. G., Bower, P., Campbell, M., Chalmers, I., Cotton, S., . . . Clarke, M. (2015). Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform. TRIALS, 16. doi:10.1186/s13063-015-0776-0
A little more conversation please? Qualitative study of researchers’ and patients’ interview accounts of training for patient and public involvement in clinical trials
Dudley, L., Gamble, C., Allam, A., Bell, P., Buck, D., Goodare, H., . . . Young, B. (2015). A little more conversation please? Qualitative study of researchers’ and patients’ interview accounts of training for patient and public involvement in clinical trials. Trials, 16. doi:10.1186/s13063-015-0667-4
E-health data to support and enhance randomised controlled trials in the United Kingdom
Harron, K., Gamble, C., & Gilbert, R. (2015). E-health data to support and enhance randomised controlled trials in the United Kingdom. CLINICAL TRIALS, 12(2), 86-88. doi:10.1177/1740774514562030
Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections
Blair, J., Gregory, J. W., Hughes, D., Ridyard, C. H., Gamble, C., Mckay, A., . . . Peak, M. (2015). Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections. TRIALS, 16. doi:10.1186/s13063-015-0658-5
Quality-of-life outcomes of initiating treatment with standard and newer antiepileptic drugs in adults with new-onset epilepsy: Findings from the SANAD trial
Jacoby, A., Sudell, M., Smith, C. T., Crossley, J., Marson, A. G., & Baker, G. A. (2015). Quality-of-life outcomes of initiating treatment with standard and newer antiepileptic drugs in adults with new-onset epilepsy: Findings from the SANAD trial. EPILEPSIA, 56(3), 460-472. doi:10.1111/epi.12913
The natural history of conducting and reporting clinical trials: interviews with trialists
Smyth, R., Jacoby, A., Altman, D. G., Gamble, C., & Williamson, P. (2015). The natural history of conducting and reporting clinical trials: interviews with trialists. Trials, 16. doi:10.1186/s13063-014-0536-6
A review of the description of patient withdrawal in trial protocols and patient information sheets (PIS)
Kearney, A., Daykin, A., Heawood, A., Lane, A., Blazeby, J., Clarke, M., . . . Gamble, C. (2015). A review of the description of patient withdrawal in trial protocols and patient information sheets (PIS). Trials, 16(Suppl 2), P46.
Development of an online resource for recruitment research in clinical trials (ORRCA)
Harman, N., Treweek, S., Clarke, M., Williamson, P., Bower, P., & Gamble, C. (2015). Development of an online resource for recruitment research in clinical trials (ORRCA). Trials, 16(Suppl 2), P98.
Development of guidance for statistical analysis plans (SAPs) for clinical trials
Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Dore, C., Williamson, P., . . . Gamble, C. (2015). Development of guidance for statistical analysis plans (SAPs) for clinical trials. Trials, 16(Suppl 2), O41.
Enhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges
Nicholson, A., Daykin, A., Macefield, R., McCann, S., Shorter, G., Sydes, M., . . . Lane, J. A. (2015). Enhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges. Trials, 16(Suppl 2), P78.
Exploring the role and functionality of trial steering committees
Harman, N., Conroy, E., Lewis, S., Murray, G., Norrie, J., Sydes, M., . . . Gamble, C. (2015). Exploring the role and functionality of trial steering committees. Trials, 16(Suppl 2), P189.
Optimising the design of internal pilot work to inform efficient randomised controlled trials: issues to consider when developing progression criteria
Avery, K., Williamson, P., Gamble, C., Francischetto, E. O., Metcalfe, C., Davidson, P., & Blazeby, J. (2015). Optimising the design of internal pilot work to inform efficient randomised controlled trials: issues to consider when developing progression criteria. Trials, 16(Suppl 2), P10.
Pragmatic approaches to mitigating missing data and research priorities to assess the effectiveness of interventions
Kearney, A., Daykin, A., Heawood, A., Lane, A., Blazeby, J., Clarke, M., . . . Gamble, C. (2015). Pragmatic approaches to mitigating missing data and research priorities to assess the effectiveness of interventions. Trials, 16(Suppl 2), P238.
Realising the potential of patient and public involvement to make a difference: what can trial teams do?
Young, B., Dudley, L., Williamson, P., & Gamble, C. (2015). Realising the potential of patient and public involvement to make a difference: what can trial teams do?. Trials, 16(Suppl 2), O93.
Reported reasons for missing data and the interplay with trial setting
Kearney, A., Bacon, N., Rosala-Hallas, A., Daykin, A., Heawood, A., Lane, A., . . . Gamble, C. (2015). Reported reasons for missing data and the interplay with trial setting. Trials, 16(Suppl 2), P101.
Reporting remit and function of trial steering committees in randomised controlled trials: review of published literature
Conroy, E. J., Arch, B., Lewis, S., Lane, A., Sydes, M. R., Norrie, J., . . . Gamble, C. (2015). Reporting remit and function of trial steering committees in randomised controlled trials: review of published literature. Poster session presented at the meeting of Unknown Conference. Retrieved from https://www.webofscience.com/
Selective reporting in clinical trials - an examination of discrepancy rates in pre-specified and reported outcomes in articles submitted to the BMJ
Weston, J., Dwan, K., Altman, D., Clarke, M., Gamble, C., Groves, T., . . . Kirkham, J. (2015). Selective reporting in clinical trials - an examination of discrepancy rates in pre-specified and reported outcomes in articles submitted to the BMJ. Trials, 16(Suppl 2), O72.
2014
From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials
Buck, D., Gamble, C., Dudley, L., Preston, J., Hanley, B., Williamson, P., . . . The EPIC Patient Advisory Group. (2014). From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials. BMJ Open, 4(12). doi:10.1136/bmjopen-2014-006400
Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews
Saini, P., Loke, Y. K., Gamble, C., Altman, D. G., Williamson, P., & Kirkham, J. (2014). Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ: British Medical Journal, 349(7985). doi:10.1136/bmj.g6501
Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities
Bower, P., Brueton, V., Gamble, C., Treweek, S., Smith, C. T., Young, B., & Williamson, P. (2014). Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. TRIALS, 15. doi:10.1186/1745-6215-15-399
Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays
Kearney, A., McKay, A., Hickey, H., Balabanova, S., Marson, A. G., Gamble, C., & Williamson, P. (2014). Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays. BMJ OPEN, 4(9). doi:10.1136/bmjopen-2014-005874
Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays
Kearney, A., McKay, A., Hickey, H., Balabanova, S., Marson, A. G., Gamble, C., & Williamson, P. (2014). Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays. BMJ Open, 4(9). doi:10.1136/bmjopen-2014-005874
Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation
Gamble, C., Dudley, L., Allam, A., Bell, P., Goodare, H., Hanley, B., . . . Young, B. (2014). Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open, 4(7). doi:10.1136/bmjopen-2014-005234
Doing challenging research studies in a patient centred way: qualitative study to inform a randomised controlled trial in the paediatric emergency care setting
Woolfall, K., Young, B., Frith, L., Appleton, R., Iyer, A., Messahel, S., . . . Gamble, B. (2014). Doing challenging research studies in a patient centred way: qualitative study to inform a randomised controlled trial in the paediatric emergency care setting. BMJ Open, 4(e005045), 11 pages. doi:10.1136/bmjopen-2014-005045
ABSTRACT 621
de Graaf, H., Ramakrishnan, K. A., Pappachan, J., Nadel, S., Levin, M., Wolf, A., . . . Faust, S. N. (2014). ABSTRACT 621. Pediatric Critical Care Medicine, 15, 141. doi:10.1097/01.pcc.0000449347.12742.89
Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit
Smith, C. T., Williamson, P., Jones, A., Smyth, A., Hewer, S. L., & Gamble, C. (2014). Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit. TRIALS, 15. doi:10.1186/1745-6215-15-127
The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol
Jenkinson, M. D., Gamble, C., Hartley, J. C., Hickey, H., Hughes, D., Blundell, M., . . . Mallucci, C. L. (2014). The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol. TRIALS, 15. doi:10.1186/1745-6215-15-4
Effect of thyroxine on brain microstructure in extremely premature babies: magnetic resonance imaging findings in the TIPIT study.
Ng, S. M., Turner, M., Gamble, C., Didi, M., Victor, S., Atkinson, J., . . . Weindling, A. M. (2014). Effect of thyroxine on brain microstructure in extremely premature babies: magnetic resonance imaging findings in the TIPIT study.. Pediatric Radiology, 44, 987-996. doi:10.1007/s00247-014-2911-6
Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials
Dwan, K., Altman, D. G., Clarke, M., Gamble, C., Higgins, J. P. T., Sterne, J. A. C., . . . Kirkham, J. J. (n.d.). Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PLoS Medicine, 11(6). doi:10.1371/journal.pmed.1001666
Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study
Wolf, A., McKay, A., Spowart, C., Granville, H., Boland, A., Petrou, S., . . . Gamble, C. (2014). Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study. Health Technology Assessment, 18(71), 1-212. doi:10.3310/hta18710
2013
CENTRAL VENOUS CATHETERS Impregnated central venous catheters should be readily used to reduce risk of bloodstream infection
Gilbert, R., Harron, K., Mok, Q., & Gamble, C. (2013). CENTRAL VENOUS CATHETERS Impregnated central venous catheters should be readily used to reduce risk of bloodstream infection. BMJ-BRITISH MEDICAL JOURNAL, 347. doi:10.1136/bmj.f7169
How experience makes a difference: practitioners' views on the use of deferred consent in paediatric and neonatal emergency care trials
Woolfall, K., Frith, L., Gamble, C., & Young, B. (2013). How experience makes a difference: practitioners' views on the use of deferred consent in paediatric and neonatal emergency care trials. BMC MEDICAL ETHICS, 14. doi:10.1186/1472-6939-14-45
Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension
Hodkinson, A., Kirkham, J. J., Tudur-Smith, C., & Gamble, C. (2013). Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension. BMJ Open, 3(9). doi:10.1136/bmjopen-2013-003436
An explanatory randomised placebo controlled trial of levothyroxine supplementation for babies born <28 weeks' gestation: results of the TIPIT trial
Ng, S. M., Turner, M. A., Gamble, C., Didi, M., Victor, S., Manning, D., . . . Weindling, A. M. (2013). An explanatory randomised placebo controlled trial of levothyroxine supplementation for babies born <28 weeks' gestation: results of the TIPIT trial. TRIALS, 14. doi:10.1186/1745-6215-14-211
Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias - An Updated Review
Dwan, K., Gamble, C., Williamson, P. R., & Kirkham, J. J. (2013). Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias - An Updated Review. PLOS ONE, 8(7). doi:10.1371/journal.pone.0066844
Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis
Dwan, K., Kirkham, J. J., Williamson, P. R., & Gamble, C. (2013). Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis. BMJ OPEN, 3(6). doi:10.1136/bmjopen-2013-002709
The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials
Jones, A. P., Conroy, E., Williamson, P. R., Clarke, M., & Gamble, C. (2013). The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials. BMC MEDICAL RESEARCH METHODOLOGY, 13. doi:10.1186/1471-2288-13-50
The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial
Gamble, C., Wolf, A., Sinha, I., Spowart, C., & Williamson, P. (2013). The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial. PLOS ONE, 8(3). doi:10.1371/journal.pone.0051787
New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations
Gamble, C., Woolfall, K., Williamson, P., Appleton, R., & Young, B. (2013). New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations. BMJ-BRITISH MEDICAL JOURNAL, 346. doi:10.1136/bmj.f667
A mapping and gapping analysis of patient and public involvement in a clinical trials unit
Bagley, H., Williamson, P., & Gamble, C. (2013). A mapping and gapping analysis of patient and public involvement in a clinical trials unit. Trials, 14(Suppl 1), P93. doi:10.1186/1745-6215-14-s1-p93
An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct
Daykin, A., Heawood, A., Lane, A., Macefield, R., Gamble, C., McCann, S., . . . Sydes, M. R. (2013). An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct. Trials, 14(Suppl 1), O79. doi:10.1186/1745-6215-14-s1-o79
Evidence base for patient and public involvement in clinical trials (EPIC)
Gamble, C., Dudley, L., & Newman, J. (2013). Evidence base for patient and public involvement in clinical trials (EPIC). Trials, 14(Suppl 1), O34. doi:10.1186/1745-6215-14-s1-o34
Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications
Dwan, K., Williamson, P. R., Gamble, C., Higgins, J., Sterne, J., Altman, D. G., . . . Kirkham, J. J. (2013). Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications. Trials, 14(Suppl 1), O91. doi:10.1186/1745-6215-14-s1-o91
How experience makes a difference: practitioners' views on deferred consent in paediatric and neonatal emergency care trials
Woolfall, K., Frith, L., Gamble, C., & Young, B. (2013). How experience makes a difference: practitioners' views on deferred consent in paediatric and neonatal emergency care trials. BMC Medical Ethics, 14(45). doi:10.1186/10.1186/1472-6939-14-45
Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays
Williamson, P., Gamble, C., Kearney, A., & Hickey, H. (2013). Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays. Trials, 14(Suppl 1), O59. doi:10.1186/1745-6215-14-s1-o59
Optimising the design and evaluation of pilot work to inform the main trial: a review of current evidence and consideration of future practices
O'Connell Francischetto, E., Avery, K., Metcalfe, C., Williamson, P., Gamble, C., & Blazeby, J. (2013). Optimising the design and evaluation of pilot work to inform the main trial: a review of current evidence and consideration of future practices. Trials, 14(Suppl 1), O17.
Practitioner views and experiences of deferred consent in paediatric and neonatal emergency care trials: the connect study
Woolfall, K., Frith, L., Gamble, C., & Young, B. (2013). Practitioner views and experiences of deferred consent in paediatric and neonatal emergency care trials: the connect study. Trials, 14(Suppl 1), P104. doi:10.1186/1745-6215-14-s1-p104
Systematic Review of the Selective Reporting of Analyses
Dwan, K., Gable, C., Williamson, P. R., Higgins, J. P., Sterne, J. A., Altman, D. G., . . . Kirkham, J. J. (2013). Systematic Review of the Selective Reporting of Analyses. In Peer Review Congress (pp. 1). Chicago: BMJ.
Systematic Review of the Selective Reporting of Analyses
Dwan, K., Gamble, C., Williamson, P. R., Higgins, J. P. T., Sterne, J. A. C., Altman, D. G., . . . Kirkham, J. J. (2013). Systematic Review of the Selective Reporting of Analyses. In The Cochrane Colloquium (pp. 1). Quebec City: Wiley-Blackwell.
The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials
Jones, A., Conroy, E., Williamson, P., Clarke, M., & Gamble, C. (2013). The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials. In Trials Vol. 14 (pp. O92). doi:10.1186/1745-6215-14-s1-o92
Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience
Conroy, E. J., Lewis, S., Lane, A., Sydes, M. R., Norrie, J., Murray, G., . . . Gamble, C. (2013). Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience. In Trials Vol. 14 (pp. P128). doi:10.1186/1745-6215-14-s1-p128
2012
Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial
Gringras, P., Gamble, C., Jones, A. P., Wiggs, L., Williamson, P. R., Sutcliffe, A., . . . Appleton, R. (2012). Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial. BMJ, 345(nov05 1), e6664. doi:10.1136/bmj.e6664
Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial
Gringras, P., Gamble, C., Jones, A. P., Wiggs, L., Williamson, P. R., Sutcliffe, A., . . . Appleton, R. (2012). Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial. BRITISH MEDICAL JOURNAL, 345. doi:10.1136/bmj.e6664
The use of MElatonin in children with Neurodevelopmental Disorders and impaired Sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS)
Appleton, R. E., Jones, A. P., Gamble, C., Williamson, P. R., Wiggs, L., Montgomery, P., . . . Gringras, P. (2012). The use of MElatonin in children with Neurodevelopmental Disorders and impaired Sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS). HEALTH TECHNOLOGY ASSESSMENT, 16(40), 1-+. doi:10.3310/hta16400
Making Co-Enrolment Feasible for Randomised Controlled Trials in Paediatric Intensive Care
Harron, K., Lee, T., Ball, T., Mok, Q., Gamble, C., Macrae, D., & Gilbert, R. (2012). Making Co-Enrolment Feasible for Randomised Controlled Trials in Paediatric Intensive Care. PLOS ONE, 7(8). doi:10.1371/journal.pone.0041791
Repeated Origin and Loss of Adhesive Toepads in Geckos
Gamble, T., Greenbaum, E., Jackman, T. R., Russell, A. P., & Bauer, A. M. (2012). Repeated Origin and Loss of Adhesive Toepads in Geckos. PLOS ONE, 7(6). doi:10.1371/journal.pone.0039429
The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep; a randomised, double-blind, placebo-controlled, parallel study (MENDS)
Appleton, R. E., Jones, A., Gamble, C., Williamson, P. R., Wiggs, L., Montgomery, P., . . . Gringras, P. (2012). The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep; a randomised, double-blind, placebo-controlled, parallel study (MENDS). HTA monograph.
What Parents of Children Who Have Received Emergency Care Think about Deferring Consent in Randomised Trials of Emergency Treatments: Postal Survey
Gamble, C., Nadel, S., Snape, D., McKay, A., Hickey, H., Williamson, P., . . . Young, B. (n.d.). What Parents of Children Who Have Received Emergency Care Think about Deferring Consent in Randomised Trials of Emergency Treatments: Postal Survey. PLoS ONE, 7(5), e35982. doi:10.1371/journal.pone.0035982
2011
Working length determination in general dental practice: a randomised controlled trial
Jarad, F. D., Albadri, S., Gamble, C., Burnside, G., Fox, K., Ashley, J. R., . . . Preston, A. J. (2011). Working length determination in general dental practice: a randomised controlled trial. BRITISH DENTAL JOURNAL, 211(12), 595-598. doi:10.1038/sj.bdj.2011.1052
Working length determination in general dental practice: a randomised controlled trial
Jarad, F. D., Albadri, S., Gamble, C., Burnside, G., Fox, K., Ashley, J. R., . . . Preston, A. J. (2011). Working length determination in general dental practice: a randomised controlled trial. British Dental Journal, 211(12), 595-598. doi:10.1038/sj.bdj.2011.1052
DIFFUSION TENSOR IMAGING OF THE INTERNAL CAPSULE AND CORPUS CALLOSUM OF PRETERM INFANTS BORN UNDER 28 WEEKS GESTATION
Atkinson, J. J., Parkes, L. M., Gamble, C., Ng, S. M., Turner, M., Weindling, A. M., . . . Sluming, V. (2011). DIFFUSION TENSOR IMAGING OF THE INTERNAL CAPSULE AND CORPUS CALLOSUM OF PRETERM INFANTS BORN UNDER 28 WEEKS GESTATION. PEDIATRIC RESEARCH, 70, 149. doi:10.1038/pr.2011.374
Consistency between guidelines and reported practice for reducing the risk of catheter-related infection in British paediatric intensive care units
Harron, K., Ramachandra, G., Mok, Q., & Gilbert, R. (2011). Consistency between guidelines and reported practice for reducing the risk of catheter-related infection in British paediatric intensive care units. INTENSIVE CARE MEDICINE, 37(10), 1641-1647. doi:10.1007/s00134-011-2343-9
Comparison of protocols and registry entries to published reports for randomised controlled trials
Dwan, K., Altman, D. G., Cresswell, L., Blundell, M., Gamble, C. L., & Williamson, P. R. (2011). Comparison of protocols and registry entries to published reports for randomised controlled trials. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (1). doi:10.1002/14651858.MR000031.pub2
Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists
Smyth, R. M. D., Kirkham, J. J., Jacoby, A., Altman, D. G., Gamble, C., & Williamson, P. R. (2011). Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ-BRITISH MEDICAL JOURNAL, 342. doi:10.1136/bmj.c7153
Comparison of root canal treatment completed using apex locators versus periapical radiograph for working length determination in general dental practice: A pilot randomised controlled trial.
Jarad, F. D., Gamble, C., Burnside, G., Albadri, S., Fox, K., & Preston, A. J. (2011). Comparison of root canal treatment completed using apex locators versus periapical radiograph for working length determination in general dental practice: A pilot randomised controlled trial.. Br Dent J, 211(12), 595-598.
MENDS: The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep - a randomised, double-blind, placebo-controlled, parallel trial
Appleton, R. E., Jones, A. P., Gamble, C., Williamson, P. R., Wiggs, L., Montgomery, P., . . . the MENDS StudyGroup, O. B. O. (2011). MENDS: The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep - a randomised, double-blind, placebo-controlled, parallel trial. In RCPCH Annual Conference (pp. 10). Warwick: RCPCH.
Risk-adapted approaches to the management of clinical trials: guidance from the Department of Health (DH)/Medical Research Council(MRC)/Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Trials Working Group
Meredith, S., Ward, M., Booth, G., Fisher, A., Gamble, C., House, H., & Landray, M. (2011). Risk-adapted approaches to the management of clinical trials: guidance from the Department of Health (DH)/Medical Research Council(MRC)/Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Trials Working Group. Trials, 12(Suppl 1), A39. doi:10.1186/1745-6215-12-s1-a39
The use of Systematic reviews in the design of randomised controlled trials
Jones, A. P., Williamson, P. R., Clarke, M., & Gamble, C. (2011). The use of Systematic reviews in the design of randomised controlled trials. In MRC North West Hub for Trials Methodology Research 'Showcase Meeting' Vol. -. Liverpool: -.
The use of Systematic reviews in the design of randomised controlled trials
Jones, A. P., Williamson, P. R., Clarke, M., & Gamble, C. (2011). The use of Systematic reviews in the design of randomised controlled trials. In Clinical Trials Methodology conference Vol. -. -: MRC Network of HUBS for trials methodology Research.
The use of systematic reviews in the design of randomised trials
Gamble, C., Jones, A. P., & Williamson, P. R. (2011). The use of systematic reviews in the design of randomised trials. In Clinical Trials Methodology Conference (pp. 1). Bristol: Trials Journal.
The use of systematic reviews in the design of randomised trials
Jones, A. P., Gamble, C., Clarke, M., & Williamson, P. R. (2011). The use of systematic reviews in the design of randomised trials [Undetermined].
2010
Indirect Comparisons: A Review of Reporting and Methodological Quality
Donegan, S., Williamson, P., Gamble, C., & Tudur-Smith, C. (2010). Indirect Comparisons: A Review of Reporting and Methodological Quality. PLOS ONE, 5(11). doi:10.1371/journal.pone.0011054
FREE THYROXINE LEVELS IN THE INITIAL FOUR WEEKS OF LIFE IN EXTREME PRETERM INFANTS AFFECT BRAIN GROWTH
Ng, S. M., Turner, M. A., Didi, M., Gamble, C., Victor, S., Manning, D., . . . Weindling, A. M. (2010). FREE THYROXINE LEVELS IN THE INITIAL FOUR WEEKS OF LIFE IN EXTREME PRETERM INFANTS AFFECT BRAIN GROWTH. In PEDIATRIC RESEARCH Vol. 68 (pp. 206-207). doi:10.1203/00006450-201011001-00401
Assessing the potential for outcome reporting bias in a review: a tutorial
Dwan, K., Gamble, C., Kolamunnage-Dona, R., Mohammed, S., Powell, C., & Williamson, P. R. (2010). Assessing the potential for outcome reporting bias in a review: a tutorial. TRIALS, 11. doi:10.1186/1745-6215-11-52
Parent/carer views about deferred consent in trials of emergency treatments in children with life-threatening illness
Nadel, S., Young, B., Gamble, C., Hickey, H., Williamson, P., Snape, D., . . . Glennie, L. (2010). Parent/carer views about deferred consent in trials of emergency treatments in children with life-threatening illness. Archives of Disease in Childhood, 95(Suppl 1), A39.2-A39. doi:10.1136/adc.2010.186338.87
The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews
Kirkham, J. J., Dwan, K. M., Altman, D. G., Gamble, C., Dodd, S., Smyth, R., & Williamson, P. R. (2010). The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ-BRITISH MEDICAL JOURNAL, 340. doi:10.1136/bmj.c365
A randomized comparative trial of generalized vs targeted physiotherapy in the management of childhood hypermobility
Kemp, S., Roberts, I., Gamble, C., Wilkinson, S., Davidson, J. E., Baildam, E. M., . . . Beresford, M. W. (2010). A randomized comparative trial of generalized vs targeted physiotherapy in the management of childhood hypermobility. RHEUMATOLOGY, 49(2), 315-325. doi:10.1093/rheumatology/kep362
Abstracts of the 2010 Joint Colloquium of The Cochrane and Campbell Collaborations
Abstracts of the 2010 Joint Colloquium of The Cochrane and Campbell Collaborations (n.d.). In Abstracts of the 2010 Joint Colloquium of The Cochrane and Campbell Collaborations. Wiley. doi:10.1002/14651858.cd000002
Comparison of protocols and registry entries to published reports for randomised controlled trials
Dwan, K., Altman, D. G., Blundell, M., Gamble, C. L., & Williamson, P. R. (n.d.). Comparison of protocols and registry entries to published reports for randomised controlled trials. In K. Dwan (Ed.). John Wiley & Sons, Ltd. doi:10.1002/14651858.mr000031
Comparison of protocols and registry entries to published reports for randomised controlled trials (Protocol)
Dwan, K., Altman, D. G., Blundell, M., Gamble, C. L., & Williamson, P. R. (2010). Comparison of protocols and registry entries to published reports for randomised controlled trials (Protocol). The Cochrane Library, (10).
Enhanced relapse prevention for bipolar disorder by community mental health teams: cluster feasibility randomised trial
Lobban, F., Taylor, L., Chandler, C., Tyler, E., Kinderman, P., Kolamunnage-Dona, R., . . . Morriss, R. K. (2010). Enhanced relapse prevention for bipolar disorder by community mental health teams: cluster feasibility randomised trial. BRITISH JOURNAL OF PSYCHIATRY, 196(1), 59-63. doi:10.1192/bjp.bp.109.065524
Longitudinal FT4 levels in the first 4 weeks of life are an independent factor affecting brain growth in extreme preterm babies born
Ng, S. M., Turner, M. A., Gamble, C., Didi, M., Newland, P., Victor, S., . . . Weindling, A. M. (2010). Longitudinal FT4 levels in the first 4 weeks of life are an independent factor affecting brain growth in extreme preterm babies born . In British Society for Paediatric Endocrinology and Diabetes (pp. OC1.1). Manchester: BIOScientifica.
2009
Training Staff in Enhanced Relapse Prevention for Bipolar Disorder: Rates of Uptake and Measures of Skill and Confidence
Lobban, F., Taylor, L., Chandler, C., Sellwood, W., Gamble, C., Tyler, E., . . . Morriss, R. (2009). Training Staff in Enhanced Relapse Prevention for Bipolar Disorder: Rates of Uptake and Measures of Skill and Confidence. PSYCHIATRIC SERVICES, 60(5), 702-706. doi:10.1176/ps.2009.60.5.702
Vaccines for preventing anthrax
Donegan, S., Bellamy, R., & Gamble, C. L. (2009). Vaccines for preventing anthrax. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (2). doi:10.1002/14651858.CD006403.pub2
An encouraging assessment of methods to inform priorities for updating systematic reviews
Sutton, A. J., Donegan, S., Takwoingi, Y., Garner, P., Gamble, C., & Donald, A. (2009). An encouraging assessment of methods to inform priorities for updating systematic reviews. JOURNAL OF CLINICAL EPIDEMIOLOGY, 62(3), 241-251. doi:10.1016/j.jclinepi.2008.04.005
Commentary: Cochrane review on ITNs for preventing malaria in pregnancy.
Yartey, J. (2009). Commentary: Cochrane review on ITNs for preventing malaria in pregnancy.. International journal of epidemiology, 38(1), 35-36. doi:10.1093/ije/dyn272
DIFFUSION TENSOR IMAGING OF THE BRAIN IN INFANTS BORN PREMATURELY: FEASIBILITY AND REPRODUCIBILITY OF MEASUREMENTS IN A CLINICAL SETTING
Tietze, A., Atkinson, J., Parkes, L. M., Abernethy, L. J., Gamble, C., Ng, S. M., . . . Weindling, A. M. (2009). DIFFUSION TENSOR IMAGING OF THE BRAIN IN INFANTS BORN PREMATURELY: FEASIBILITY AND REPRODUCIBILITY OF MEASUREMENTS IN A CLINICAL SETTING. In ACTA PAEDIATRICA Vol. 98 (pp. 60). Retrieved from https://www.webofscience.com/
Outcome reporting bias in trials (ORBIT)
Kirkham, J. J., Dwan, K., Altman, D., Gamble, C., Dodd, S., Jacoby, A., . . . Williamson, P. R. (2009). Outcome reporting bias in trials (ORBIT). In Cochrane Colloquium (pp. 12). Singapore: Wiley-Blackwell.
The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: A systematic review
Hockenhull, J. C., Dwan, K. M., Smith, G. W., Gamble, C. L., Boland, A., Walley, T. J., & Dickson, R. C. (2009). The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: A systematic review. CRITICAL CARE MEDICINE, 37(2), 702-712. doi:10.1097/CCM.0b013e3181958915
Training staff in enhanced relapse prevention for bipolar disorder: Rates of uptake and measures of skill and confidence
Lobban, F., Taylor, L., Chandler, C., Sellwood, W., Gamble, C., Tyler, E., . . . Morriss, R. (2009). Training staff in enhanced relapse prevention for bipolar disorder: Rates of uptake and measures of skill and confidence. Psychiatric Services, 60(5), 702-706. doi:10.1176/ps.2009.60.5.702
2008
Reporting of clinical trials: a review of research funders' guidelines
Dwan, K., Gamble, C., Williamson, P. R., & Altman, D. G. (2008). Reporting of clinical trials: a review of research funders' guidelines. TRIALS, 9. doi:10.1186/1745-6215-9-66
Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias
Dwan, K., Altman, D. G., Arnaiz, J. A., Bloom, J., Chan, A. -W., Cronin, E., . . . Williamson, P. R. (2008). Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias. PLOS ONE, 3(8). doi:10.1371/journal.pone.0003081
TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: Magnetic Resonance Imaging and Magnetic Resonance Angiography protocol
Ng, S. M., Turner, M. A., Gamble, C., Didi, M., Victor, S., Malamateniou, C., . . . Weindling, A. M. (2008). TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: Magnetic Resonance Imaging and Magnetic Resonance Angiography protocol. BMC PEDIATRICS, 8. doi:10.1186/1471-2431-8-26
The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematic review and economic evaluation.
Hockenhull, J. C., Dwan, K., Boland, A., Smith, G., Bagust, A., Dündar, Y., . . . Dickson, R. (2008). The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematic review and economic evaluation.. Health technology assessment (Winchester, England), 12(12), iii-154. doi:10.3310/hta12120
The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematic review and economic evaluation: Abstract
Hockenhull, J. C., Dwan, K., Boland, A., Smith, G., Bagust, A., Duendar, Y., . . . Dickson, R. (2008). The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematic review and economic evaluation: Abstract. HEALTH TECHNOLOGY ASSESSMENT, 12(12), 1-+. Retrieved from https://www.webofscience.com/
TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation
Ng, S. M., Turner, M. A., Gamble, C., Didi, M., Victor, S., & Weindling, A. M. (2008). TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation. TRIALS, 9. doi:10.1186/1745-6215-9-17
TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation.
Ng, S. M., Turner, M. A., Gamble, C., Didi, M., Victor, S., & Weindling, A. M. (2008). TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation.. Trials, 26(9), 17.
TIPIT: a randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: magnetic resonance imaging and magnetic resonance angiography protocol.
Ng, S. M., Turner, M. A., Gamble, C., Didi, M., Victor, S., Malamateniou, C., . . . Weindling, A. M. (2008). TIPIT: a randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: magnetic resonance imaging and magnetic resonance angiography protocol.. BMC Pediatr., 8(26). Retrieved from http://www.biomedcentral.com/1471-2431/8/26
TIPIT: a randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: magnetic resonance imaging and magnetic resonance angiography protocol.
Ng, S. M., Turner, M. A., Gamble, C., Didi, M., Victor, S., Malamateniou, C., . . . Weindling, A. M. (2008). TIPIT: a randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: magnetic resonance imaging and magnetic resonance angiography protocol.. BMC Pediatr, 8, 26.
The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: A systematic review and economic evaluation
Hockenhull, J. C., Dwan, K., Boland, A., Smith, G., Bagust, A., Dündar, Y., . . . Dickson, R. (2008). The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: A systematic review and economic evaluation. Health Technology Assessment, 12(12). doi:10.3310/hta12120
2007
Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder
Lobban, F., Gamble, C., Kinderman, P., Taylor, L., Chandler, C., Tyler, E., . . . Morriss, R. K. (2007). Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder. BMC Psychiatry, 7(1). doi:10.1186/1471-244x-7-6
Vaccines for preventing anthrax
Donegan, S., Bellamy, R., & Gamble, C. L. (n.d.). Vaccines for preventing anthrax. doi:10.1002/14651858.cd006403
A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial.
Marson, A. G., Appleton, R., Baker, G. A., Chadwick, D. W., Doughty, J., Eaton, B., . . . Williamson, P. R. (2007). A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial.. Health technology assessment (Winchester, England), 11(37), iii-134. doi:10.3310/hta11370
Artemether-lumefantrine for treating uncomplicated falciparum malaria (Withdrawn Paper. 2003, art no. CD003125)
Omari, A. A. A., Gamble, C., & Garner, P. (2005). Artemether-lumefantrine for treating uncomplicated falciparum malaria (Withdrawn Paper. 2003, art no. CD003125). COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (4). doi:10.1002/14651858.CD003125.pub2
Cochrane review: Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations
Macfadyen, C. A., Acuin, J. M., & Gamble, C. (2007). Cochrane review: Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations. Evidence-Based Child Health: A Cochrane Review Journal, 2(2), 611-690. doi:10.1002/ebch.132
Quality of life outcomes of immediate or delayed treatment of early epilepsy and single seizures
Jacoby, A., Gamble, C., Doughty, J., Marson, A., & Chadwick, D. (2007). Quality of life outcomes of immediate or delayed treatment of early epilepsy and single seizures. NEUROLOGY, 68(15), 1188-1196. doi:10.1212/01.wnl.0000259411.78423.50
Application and investigation of a bound for outcome reporting bias
Williamson, P. R., & Gamble, C. (2007). Application and investigation of a bound for outcome reporting bias. TRIALS, 8. doi:10.1186/1745-6215-8-9
Insecticide-treated nets for the prevention of malaria in pregnancy: A systematic review of randomised controlled trials
Gamble, C., Ekwaru, P. J., Garner, P., & Kuile, F. O. T. (2007). Insecticide-treated nets for the prevention of malaria in pregnancy: A systematic review of randomised controlled trials. PLOS MEDICINE, 4(3), 506-515. doi:10.1371/journal.pmed.0040107
The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial
Marson, A. G., Al-Kharusi, A. M., Alwaidh, M., Appleton, R., Baker, G. A., Chadwick, D. W., . . . Williamson, P. R. (2007). The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial. LANCET, 369(9566), 1000-1015. doi:10.1016/S0140-6736(07)60460-7
The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial
Marson, A. G., Al-Kharusi, A. M., Alwaidh, M., Appleton, R., Baker, G. A., Chadwick, D. W., . . . Williamson, P. R. (2007). The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial. LANCET, 369(9566), 1016-1026. doi:10.1016/S0140-6736(07)60461-9
Application and investigation of a bound for outcome reporting bias.
Williamson, P. R., & Gamble, C. (2007). Application and investigation of a bound for outcome reporting bias.. Trials, 8, 9. doi:10.1186/1745-6215-8-9
Enhanced relapse prevention for bipolar disorder - ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder
Lobban, F., Gamble, C., Kinderman, P., Taylor, L., Chandler, C., Tyler, E., . . . Morriss, R. K. (2007). Enhanced relapse prevention for bipolar disorder - ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder. BMC PSYCHIATRY, 7. doi:10.1186/1471-244X-7-6
A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial
Marson, A. G., Appleton, R., Baker, G. A., Chadwick, D. W., Doughty, J., Eaton, B., . . . Williamson, P. R. (2007). A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial. HEALTH TECHNOLOGY ASSESSMENT, 11(37), IX-+. Retrieved from https://www.webofscience.com/
A randomised controlled trial of postoperative radiotherapy following breast-conserving surgery in a minimum-risk older population. The PRIME trial.
Prescott, R. J., Kunkler, I. H., Williams, L. J., King, C. C., Jack, W., van der Pol, M., . . . Cairns, J. (2007). A randomised controlled trial of postoperative radiotherapy following breast-conserving surgery in a minimum-risk older population. The PRIME trial.. Health technology assessment (Winchester, England), 11(31), 1-iv. doi:10.3310/hta11310
Enhanced relapse prevention for bipolar disorder - ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder
Lobban, F., Gamble, C., Kinderman, P., Taylor, L., Chandler, C., Tyler, E., . . . Morriss, R. K. (2007). Enhanced relapse prevention for bipolar disorder - ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder. BMC Psychiatry, 7(6).
Quality of Life Outcomes of Immediate or Delayed Treatment of Early Epilepsy and Single Seizures.
Jacoby, A., Gamble, C., Doughty, J., Marson, A., Chadwick, D., & on behalf of the Medical Research Council MESS Study Group.. (2007). Quality of Life Outcomes of Immediate or Delayed Treatment of Early Epilepsy and Single Seizures.. Neurology, 68, 118-196.
2006
Response
Proudfoot, C., & Gamble, C. (2006). Response. Paediatric Nursing, 18(7), 7. doi:10.7748/paed.18.7.7.s11
Site-specific skin reactions to amethocaine
Proudfoot, C., & Gamble, C. (2006). Site-specific skin reactions to amethocaine. Paediatric Nursing, 18(5), 26-28. doi:10.7748/paed.18.5.26.s26
Site-specific skin reactions to amethocaine.
Proudfoot, C., & Gamble, C. (2006). Site-specific skin reactions to amethocaine.. Paediatric nursing, 18(5), 26-28. doi:10.7748/paed2006.06.18.5.26.c1034
A meta-analysis of individual patient responses to lamotrigine or carbamazepine monotherapy
Gamble, C., Williamson, P. R., Chadwick, D. W., & Marson, A. G. (2006). A meta-analysis of individual patient responses to lamotrigine or carbamazepine monotherapy. NEUROLOGY, 66(9), 1310-1317. doi:10.1212/01.wnl.0000210517.03902.6e
Artemether-lumefantrine (four-dose regimen) for treating uncomplicated falciparum malaria
Omari, A. A. A., Gamble, C., & Garner, P. (2006). Artemether-lumefantrine (four-dose regimen) for treating uncomplicated falciparum malaria. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (2). doi:10.1002/14651858.CD005965
Insecticide-treated nets for preventing malaria in pregnancy
Gamble, C., Ekwaru, J. P., & ter Kuile, F. O. (2006). Insecticide-treated nets for preventing malaria in pregnancy. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (2). doi:10.1002/14651858.CD003755.pub2
Lamotrigine versus carbamazepine monotherapy for epilepsy
Gamble, C. L., Williamson, P. R., & Marson, A. G. (2006). Lamotrigine versus carbamazepine monotherapy for epilepsy. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (1). doi:10.1002/14651858.CD001031.pub2
Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations
Macfadyen, C. A., Acuin, J. M., & Gamble, C. (2006). Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (1). doi:10.1002/14651858.CD005608
A meta-analysis of individual patient responses to lamotrigine or carbamazepine
Gamble, C., Williamson, P. R., Chadwick, D. W., & Marson, A. G. (2006). A meta-analysis of individual patient responses to lamotrigine or carbamazepine. Neurology., 66(9), 1310-1317. doi:10.1212/01.wnl.0000210517.03902.6e
A study of site-specific local skin reactions to Amethocaine
Proudfoot, C., & Gamble, C. (2006). A study of site-specific local skin reactions to Amethocaine. Paediatric Nursing, 18, 26-28.
2005
Albendazole for lymphatic filariasis
Critchley, J., Addiss, D., Gamble, C., Garner, P., Gelband, H., & Ejere, H. (2005). Albendazole for lymphatic filariasis. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (4). doi:10.1002/14651858.CD003753.pub3
Artemether-lumefantrine (six-dose regimen) for treating uncomplicated falciparum malaria
Omari, A. A. A., Gamble, C., & Garner, P. (2005). Artemether-lumefantrine (six-dose regimen) for treating uncomplicated falciparum malaria. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (4). doi:10.1002/14651858.CD005564
Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations
Macfadyen, C. A., Acuin, J. M., & Gamble, C. (2005). Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, (4). doi:10.1002/14651858.CD004618.pub2
Outcome selection bias in meta-analysis
Williamson, P. R., Gamble, C., Altman, D. G., & Hutton, J. L. (2005). Outcome selection bias in meta-analysis. STATISTICAL METHODS IN MEDICAL RESEARCH, 14(5), 515-524. doi:10.1191/0962280205sm415oa
Immediate versus deferred antiepileptic drug treatment for early epilepsy and single seizures: a randomised controlled trial
Marson, A., Jacoby, A., Johnson, A., Kim, L., Gamble, C., & Chadwick, D. (2005). Immediate versus deferred antiepileptic drug treatment for early epilepsy and single seizures: a randomised controlled trial. LANCET, 365(9476), 2007-2013. doi:10.1016/S0140-6736(05)66694-9
Identification and impact of outcome selection bias in meta-analysis
Williamson, P. R., & Gamble, C. (2005). Identification and impact of outcome selection bias in meta-analysis. STATISTICS IN MEDICINE, 24(10), 1547-1561. doi:10.1002/sim.2025
Topical quinolone vs. antiseptic for treating chronic suppurative otitis media: a randomized controlled trial
Macfadyen, C., Gamble, C., Garner, P., Macharia, I., Mackenzie, I., Mugwe, P., . . . Williamson, P. (2005). Topical quinolone vs. antiseptic for treating chronic suppurative otitis media: a randomized controlled trial. TROPICAL MEDICINE & INTERNATIONAL HEALTH, 10(2), 190-197. doi:10.1111/j.1365-3156.2004.01368.x
Albendazole for the control and elimination of lymphatic filariasis: systematic review
Critchley, J., Addiss, D., Ejere, H., Gamble, C., Garner, P., & Gelband, H. (2005). Albendazole for the control and elimination of lymphatic filariasis: systematic review. TROPICAL MEDICINE & INTERNATIONAL HEALTH, 10(9), 818-825. doi:10.1111/j.1365-3156.2005.01458.x
Topical quinolone <i>vs</i>. antiseptic for treating chronic suppurative otitis media:: a randomized controlled trial
Macfadyen, C., Gamble, C., Garner, P., Macharia, I., Mackenzie, I., Mugwe, P., . . . Williamson, P. (2005). Topical quinolone <i>vs</i>. antiseptic for treating chronic suppurative otitis media:: a randomized controlled trial. CLINICAL OTOLARYNGOLOGY, 30(2), 193-194. doi:10.1111/j.1365-2273.2005.01012_1.x
Uncertainty method improved on best-worst case analysis in a binary meta-analysis
Gamble, C., & Hollis, S. (2005). Uncertainty method improved on best-worst case analysis in a binary meta-analysis. JOURNAL OF CLINICAL EPIDEMIOLOGY, 58(6), 579-588. doi:10.1016/j.jclinepi.2004.09.013
2004
Public knowledge, private grief: A study of public attitudes to epilepsy in the United Kingdom and implications for stigma
Jacoby, A., Gorry, J., Gamble, C., & Baker, T. A. (2004). Public knowledge, private grief: A study of public attitudes to epilepsy in the United Kingdom and implications for stigma. EPILEPSIA, 45(11), 1405-1415. doi:10.1111/j.0013-9580.2004.02904.x
Adjusting for publication bias: modelling the selection process
Preston, C., Ashby, D., & Smyth, R. (2004). Adjusting for publication bias: modelling the selection process. JOURNAL OF EVALUATION IN CLINICAL PRACTICE, 10(2), 313-322. doi:10.1111/j.1365-2753.2003.00457.x
Artemether-lumefantrine for uncomplicated malaria: a systematic review
Omari, A. A., Gamble, C., & Garner, P. (2004). Artemether-lumefantrine for uncomplicated malaria: a systematic review. TROPICAL MEDICINE & INTERNATIONAL HEALTH, 9(2), 192-199. doi:10.1046/j.1365-3156.2003.01186.x
Albendazole for lymphatic filariasis (Cochrane Review)
Julia, C., Henry, E., Paul, G., Carrol, G., & Hellen, G. (2004). Albendazole for lymphatic filariasis (Cochrane Review). The Cochrane Library, (1).
Albendazole for lymphatic filariasis.
Addiss, D., Critchley, J., Ejere, H., Garner, P., Gelband, H., Gamble, C., & International Filariasis Review Group. (2004). Albendazole for lymphatic filariasis.. The Cochrane database of systematic reviews, (1), CD003753. doi:10.1002/14651858.cd003753.pub2
2003
Pregnancy outcome in severe placental abruption
Kayani, S. I., Walkinshaw, S. A., & Preston, C. (2003). Pregnancy outcome in severe placental abruption. BJOG: An International Journal of Obstetrics & Gynaecology, 110(7), 679-683. doi:10.1046/j.1471-0528.2003.02088.x
Pregnancy outcome in severe placental abruption
Kayani, S. I., Walkinshaw, S. A., & Preston, C. (2003). Pregnancy outcome in severe placental abruption. BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 110(7), 679-683. doi:10.1016/S1470-0328(03)02988-4
Artemether-lumefantrine for treating uncomplicated falciparum malaria.
Omari, A. A., Preston, C., & Garner, P. (2003). Artemether-lumefantrine for treating uncomplicated falciparum malaria.. The Cochrane database of systematic reviews, (2), CD003125. doi:10.1002/14651858.cd003125
2002
Insecticide-treated nets for preventing malaria in pregnancy
Ekwaru, J. P., & Gamble, C. (n.d.). Insecticide-treated nets for preventing malaria in pregnancy. In J. P. Ekwaru (Ed.). John Wiley & Sons, Ltd. doi:10.1002/14651858.cd003755
Zanamivir for the treatment of influenza in adults: a systematic review and economic evaluation.
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