Publications | Southampton Clinical Trials Unit

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Bate, J., Borrow, R., Chisholm, J., Clarke, S., Dixon, E., Faust, S. N., ... Gray, J. (2019). 13-valent Pneumococcal Conjugate Vaccine in children with acute lymphoblastic leukaemia: protective immunity can be achieved on completion of treatment. Clinical Infectious Diseases. DOI: 10.1093/cid/ciz965
Hunter, M. S., Nuttall, J., & Fenlon, D. (2019). A comparison of three outcome measures of the impact of vasomotor symptoms on women’s lives. Climacteric, 22(4), 419-423. DOI: 10.1080/13697137.2019.1580258
Hay, A. D., Downing, H., Francis, N. A., Young, G. J., Clement, C., Harris, S. D., ... Moore, M. V. (2019). Anaesthetic-analgesic ear drops to reduce antibiotic consumption in children with acute otitis media: the CEDAR RCT. Health Technology Assessment, 23(34), 1-48. DOI: 10.3310/hta23340, 10.3310/hta23340
Griffiths, G. O., Cowan, R. A., Grigor, K. M., Uscinska, B. M., Sydes, M., & Russell, M. (2019). BA08: An open-label, single-arm, non-randomised, phase 2 trial of cisplatin, methotrexate and vinblastine (CMV) for pure squamous cell cancer of the urinary tract. PLoS ONE, 14(1), [e0210785]. DOI: 10.1371/journal.pone.0210785
Johnson, L., Burridge, J., Demain, S., & Ewings, S. (2019). Comparing the impact of an implicit learning approach with standard care on recovery of mobility following stroke: Protocol for a pilot cluster randomized controlled trial. Journal of Medical Internet Research (JMIR) Research Protocols, 8(11), [e14222]. DOI: 10.2196/14222
Davies, A., Cummin, T., Barrans, S., Maishman, T., Mamot, C., Novak, U., ... Johnson, P. (2019). Gene expression profiling in an open-label randomised phase 3 trial (REMoDL-B) of bortezomib added to standard chemoimmunotherapy for diffuse large B-cell lymphoma. The Lancet Oncology, 20(5), 649-662. DOI: 10.1016/S1470-2045(18)30935-5
NBCS Collaborators (2019). Genome-wide association study of germline variants and breast cancer-specific mortality. British Journal of Cancer, 120(6), 647-657. DOI: 10.1038/s41416-019-0393-x
Whitehead, A., Simpson, C., Willcox, M., Webley, F., Hay, A., Butler, C., ... Moore, M. (2019). HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial. Pilot and Feasibility Studies, 5(1), [98]. DOI: 10.1186/s40814-019-0478-6
Mavaddat, N., Durcan, L., Michailidou, K., & et al. (2019). Polygenic risk scores for prediction of breast cancer and breast cancer subtypes. The American Journal of Human Genetics, 104(1), 21-34. DOI: 10.1016/j.ajhg.2018.11.002
Cook, J., Julious, S., Sones, W., Hampson, L., Hewitt, C., Berlin, J., ... Vale, L. (2019). Practical help for specifying the target difference in sample size calculations for RCTs: the DELTA2 five-stage study, including a workshop. Health Technology Assessment, 23(60), 1-118. DOI: 10.3310/hta23600
Gandhi, A., Copson, E., Eccles, D., Durcan, L., Howell, A., Morris, J., ... Harvie, M. (2019). Predictors of weight gain in a cohort of premenopausal early breast cancer patients receiving chemotherapy. The Breast, 1-6. DOI: 10.1016/j.breast.2019.02.006
Asbun, H., Moekotte, A. L., Vissers, F., & et al. (2019). The Miami International Evidence-Based Guidelines on Minimally Invasive Pancreas Resection. Annals of Surgery. DOI: 10.1097/SLA.0000000000003590
Moore, M., Trill, J., Simpson, C., Webley, F., Radford, M., Stanton, L., ... Griffiths, G. (2019). Uva-ursi extract and ibuprofen as alternative treatments for uncomplicated urinary tract infection in women (ATAFUTI): a factorial randomized trial. Clinical Microbiology and Infection, 1-8. DOI: 10.1016/j.cmi.2019.01.011
Gollins, S., West, N., Sebag-Montefiore, D., Susnerwala, S., Falk, S., Brown, N., ... Hurt, C. (2018). A prospective phase II study of pre-operative chemotherapy then short-course radiotherapy for high risk rectal cancer: COPERNICUS. British Journal of Cancer, 1-10. DOI: 10.1038/s41416-018-0209-4
Hall, C. C., Norris, L., Cook, J., Maddocks, M., Graham, C., Tuck, S., ... Dixon, E. (2018). A randomised, phase II, unblinded trial of an Exercise and Nutrition-based Rehabilitation programme (ENeRgy) versus standard care in patients with cancer: feasibility trial protocol. Pilot and Feasibility Studies, 4, [192]. DOI: 10.1186/s40814-018-0381-6
Lester, J., Casbard, A., Al-Taei, S., Harrop, R., Katona, L., Attanoos, R. L., ... Griffiths, G. (2018). A single centre phase II trial to assess the immunological activity of TroVax® plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma – the SKOPOS trial. OncoImmunology, 7(12), 1-11. [e1457597]. DOI: 10.1080/2162402X.2018.1457597
Wu, L., Shi, W., Long, J., Guo, X., Michailidou, K., Beesley, J., ... NBCS Collaborators (2018). A transcriptome-wide association study of 229,000 women identifies new candidate susceptibility genes for breast cancer. Nature Genetics, 50(7), 968-978. DOI: 10.1038/s41588-018-0132-x
Solheim, T. S., Laird, B. J. A., Balstad, T. R., Bye, A., Stene, G., Baracos, V., ... Fearon, K. (2018). Cancer cachexia: Rationale for the MENAC (Multimodal - Exercise, Nutrition and Anti-inflammatory medication for Cachexia) trial. BMJ Supportive & Palliative Care. DOI: 10.1136/bmjspcare-2017-001440
Fennell, D. A., Kirkpatrick, E., Cozens, K., Nye, M., Lester, J., Hanna, G., ... Griffiths, G. (2018). CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial. Trials, 19(233), 1-10. DOI: 10.1186/s13063-018-2602-y
Hutchings, N., Wood, W., Reading, I., Walker, E., Blazeby, J. M., van't Hoff, W., ... Hall, N. J. (2018). CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): Study protocol for a randomised controlled Trial. Trials, 19(1), 1-10. [153]. DOI: 10.1186/s13063-018-2520-z, 10.1186/s13063-018-2520-z
Cook, J., Julious, S., Sones, W., Hampson, L., Hewitt, C., Berlin, J., ... Vale, L. (2018). DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials, 19, [606]. DOI: 10.1186/s13063-018-2884-0
Cook, J. A., Julious, S. A., Sones, W., Hampson, L. V., Hewitt, C., Berlin, J. A., ... Vale, L. D. (2018). DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ, [363]. DOI: 10.1136/bmj.k3750
Bidmon, N., Kind, S., Welters, M. J. P., Joseph-Pietras, D., Laske, K., Maurer, D., ... van der Burg, S. H. (2018). Development of an RNA-based kit for easy generation of TCR-engineered lymphocytes to control T-cell assay performance. Journal of Immunological Methods, 458, 74-82. DOI: 10.1016/j.jim.2018.04.007
Turner, S., Bull, A., Chinnery, F., Hinks, J., McArdle, N., Moran, R., ... Wyatt, J. C. (2018). Evaluation of stakeholder views on peer review of NIHR applications for funding: A qualitative study. BMJ Open, 8(12), [e022548]. DOI: 10.1136/bmjopen-2018-022548
Copson, E. R., Maishman, T. C., Tapper, W. J., Cutress, R. I., Greville-Heygate, S., Altman, D. G., ... Eccles, D. (2018). Germline BRCA mutation and outcome in young-onset breast cancer: POSH, a prospective cohort study. The Lancet Oncology, 19(2), 169-180. DOI: 10.1016/S1470-2045(17)30891-4
Chorozoglou, M., Reading, I., Eaton, S., Hutchings, N., & Hall, N. J. (2018). Health economics and quality of life in a feasibility RCT of paediatric acute appendicitis: a protocol study. BMJ Paediatrics Open, 2(1), [e000347]. DOI: 10.1136/bmjpo-2018-000347
Fenlon, D., Nuttall, J., May, C., Raftery, J., Fields, J., Kirkpatrick, E., ... Hunter, M. (2018). MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol. BMC Women’s Health, 18(1), 1-10. DOI: 10.1186/s12905-018-0550-z
Ceriani, L., Milan, L., Martelli, M., Ferreri, A. J. M., Cascione, L., Zinzani, P. L., ... Zucca, E. (2018). Metabolic heterogeneity on baseline 18FDG-PET/CT scan is a predictor of outcome in primary mediastinal B-cell lymphoma. Blood, 132(2), 179-186. DOI: 10.1182/blood-2018-01-826958
Sha, C., Barrans, S., Cucco, F., Bentley, M. A., Care, M. A., Cummin, T., ... Westhead, D. R. (2018). Molecular high-grade B-Cell lymphoma: defining a poor-risk group that requires different approaches to therapy. Journal of Clinical Oncology, 37(3), 202-213. [37]. DOI: 10.1200/JCO.18.01314
Cucco, F., Clipson, A., Kennedy, H., Sneath Thompson, J., Wang, M., Barrans, S., ... Du, M. Q. (2018). Mutation screening using formalin-fixed paraffin-embedded tissues: a stratified approach according to DNA quality. Laboratory Investigation, 98, 1084–1092. DOI: 10.1038/s41374-018-0066-z
Prout, H. C., Barham, A., Bongard, E., Tudor-Edwards, R., Griffiths, G., Hamilton, W., ... Nelson, A. (2018). Patient understanding and acceptability of an early lung cancer diagnosis trial: A qualitative study. Trials, 19(1), [419]. DOI: 10.1186/s13063-018-2803-4
Bruton, A., Lee, A., Yardley, L., Raftery, J., Arden-Close, E., Kirby, S., ... Thomas, M. (2018). Physiotherapy breathing retraining for asthma: a randomised controlled trial. The Lancet Respiratory Medicine, 6(1), 19-28. DOI: 10.1016/S2213-2600(17)30474-5
Lim, S. H., Linton, K. M., Collins, G. P., Dhondt, J., Caddy, J., Rossiter, L., ... Griffiths, G. (2018). RIVA - a phase IIa study of rituximab and varlilumab in relapsed or refractory B-cell malignancies: study protocol for a randomized controlled trial. Trials, 19(1), 1-14. [619]. DOI: 10.1186/s13063-018-2996-6
Blatch-Jones, A., Ashton-Key, M., Kirkpatrick, E. V., & Pek, W. (2018). Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open, 8(9), 1-9. [e022233]. DOI: 10.1136/bmjopen-2018-022233, 10.1136/bmjopen-2018-022233
McKenzie, H. S., Mead, G., Huddart, R., White, J. D., Rustin, G. J. S., Hennig, I. M., ... Wheater, M. J. (2018). Salvage chemotherapy with gemcitabine, paclitaxel, ifosfamide, and cisplatin for relapsed germ cell cancer. Clinical Genitourinary Cancer. DOI: 10.1016/j.clgc.2018.07.006
Crabb, S., Danson, S. J., Catto, J. W. F., McDowell, C., Lowder, J. N., Caddy, J., ... Kalevras, M. (2018). SPIRE - combining SGI-110 with cisplatin and gemcitabine chemotherapy for solid malignancies including bladder cancer: study protocol for a phase Ib/randomised IIa open label clinical trial. Trials, 19(1), 216. DOI: 10.1186/s13063-018-2586-7
Cutress, R., Copson, E., Shaaban, A. M., Maishman, T., Moseley, P. M., Mckenzie, H., ... Berditchevski, F. (2018). The presentation, management and outcome of inflammatory breast cancer cases in the UK: data from a multi-centre retrospective review. The Breast, 42, 133-141. DOI: 10.1016/j.breast.2018.09.003
Sonuga-Barke, E. J. S., Barton, J., Daley, D., Hutchings, J., Maishman, T., Raftery, J., ... Thompson, M. J. J. (2017). A comparison of the clinical effectiveness and cost of specialised individually delivered parent training for preschool attention-deficit/hyperactivity disorder and a generic, group-based programme: a multi-centre, randomised controlled trial of the New Forest Parenting Programme versus Incredible Years. European Child & Adolescent Psychiatry. DOI: 10.1007/s00787-017-1054-3
Candido do Reis, F. J., Wishart, G. C., Dicks, E. M., Greenberg, D., Rashbass, J., Schmidt, M. K., ... Pharoah, P. D. P. (2017). An updated PREDICT breast cancer prognostication and treatment benefit prediction model with independent validation. Breast Cancer Research, 19(58). DOI: 10.1186/s13058-017-0852-3
Pugh, S., Thiebaut, R., Bridgewater, J., Grisoni, M-L., Moutasim, K., Rousseau, F., ... Laurent-Puig, P. (2017). Association between miR-31-3p expression and cetuximab efficacy in patients with KRAS wild-type metastatic colorectal cancer: a post-hoc analysis of the New EPOC trial. Oncotarget. DOI: 10.18632/oncotarget.21291
Papadakis, E. S., Reeves, T., Robson, N. H., Maishman, T., Packham, G., & Cutress, R. (2017). BAG-1 as a biomarker in early breast cancer prognosis: a systematic review with meta-analyses. British Journal of Cancer, 116, 1585–1594. DOI: 10.1038/bjc.2017.130
Crabb, S. J., Martin, K., Abab, J., Ratcliffe, I., Thornton, R., Lineton, B., ... King, E. (2017). COAST (Cisplatin ototoxicity attenuated by aspirin trial): A phase II double-blind, randomised controlled trial to establish if aspirin reduces cisplatin induced hearing-loss. European Journal of Cancer, 87, 75-83. DOI: 10.1016/j.ejca.2017.09.033
Hind, D., Reeves, B. C., Bathers, S., Bray, C., Corkhill, A., Hayward, C., ... Bradburn, M. (2017). Comparative costs and activity from a sample of UK clinical trials units. Trials, 18(1), [203]. DOI: 10.1186/s13063-017-1934-3
Reynolds, J. V., Preston, S. R., O’neill, B., Baeksgaard, L., Griffin, S. M., Mariette, C., ... Mc Dermott, R. (2017). ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS). BMC cancer, 17(1). DOI: 10.1186/s12885-017-3386-2
Milne, R. L., Kuchenbaeker, K. B., Michailidou, K., Eccles, D., Durcan, L., & Maishman, T. (2017). Identification of ten variants associated with risk of estrogen receptor negative breast cancer. Nature Genetics, 1-15. DOI: 10.1038/ng.3785
Neal, R. D., Barham, A., Bongard, E., Edwards, R. T., Fitzgibbon, J., Griffiths, G., ... Hurt, C. N. (2017). Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial. British Journal of Cancer, 116(3), 293-302. DOI: 10.1038/bjc.2016.414
Cook, A., Streit, E., & Davage, G. (2017). Involving clinical experts in prioritising topics for health technology assessment: a randomised controlled trial. BMJ Open, 7, [e016104]. DOI: 10.1136/bmjopen-2017-016104
Hurt, C. N., Falk, S., Crosby, T., McDonald, A., Ray, R., Joseph, G., ... Mukherjee, S. (2017). Long-term results and recurrence patterns from SCALOP: a phase II randomised trial of gemcitabine- or capecitabine-based chemoradiation for locally advanced pancreatic cancer. British Journal of Cancer, 116, 1264-1270. DOI: 10.1038/bjc.2017.95
Mukherjee, S., Hurt, C. N., Gwynne, S., Sebag-Montefiore, D., Radhakrishna, G., Gollins, S., ... Crosby, T. (2017). NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma. European Journal of Cancer, 74, 38-46. DOI: 10.1016/j.ejca.2016.11.031
Crabb, S. J., Birtle, A. J., Martin, K., Downs, N., Ratcliffe, I., Maishman, T., ... Jones, R. J. (2017). ProCAID: a phase I clinical trial to combine the AKT inhibitor AZD5363 with docetaxel and prednisolone chemotherapy for metastatic castration resistant prostate cancer. Investigational New Drugs, 1-9. DOI: 10.1007/s10637-017-0433-4
Abu Hilal, M., Aldrighetti, L., Dagher, I., Edwin, B., Troisi, R. I., Alikhanov, R., ... Cherqui, D. (2017). The Southampton Consensus Guidelines for laparoscopic liver surgery: from indication to implementation. Annals of Surgery, 268(1), 11-18. DOI: 10.1097/SLA.0000000000002524
Williams, C. L., Weller, S., Roberts, L., Reading, I., Cook, A., Little, L., ... Clarke, N. M. P. (2017). Timing of surgical Intervention for developmental dysplasia of the hip: a randomised controlled trial (Hip ‘Op). Health Technology Assessment. DOI: 10.3310/hta21630
Trill, J., Simpson, C., Webley, F., Radford, M., Stanton, L., Maishman, T., ... Moore, M. (2017). Uva-ursi exract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial. Trials, 18(421), 1-9. DOI: 10.1186/s13063-017-2145-7
Ferreri, A. J. M., Cwynarski, K., Pulczynski, E., Fox, C. P., Schorb, E., La Rosée, P., ... International Extranodal Lymphoma Study Group (IELSG) (2017). Whole-brain radiotherapy or autologous stem-cell transplantation as consolidation strategies after high-dose methotrexate-based chemoimmunotherapy in patients with primary CNS lymphoma: results of the second randomisation of the International Extranodal Lymphoma Study Group-32 phase 2 trial. The Lancet Haematology, 4(11), e510-e523. DOI: 10.1016/S2352-3026(17)30174-6
Little, P., Stuart, B., Andreou, P., McDermott, L., Joseph, J., Mullee, M., ... Yardley, L. (2016). A primary care randomised controlled trial of a tailored interactive website for the self-management of respiratory infections (Internet Doctor). BMJ Open, 6(e009769), 1-9. DOI: 10.1136/bmjopen-2015-009769
Qureshi, N. R., Rintoul, R. C., Miles, K. A., George, S., Harris, S., Madden, J., ... Gilbert, F. J. (2016). Accuracy and cost-effectiveness of dynamic contrast-enhanced CT in the characterisation of solitary pulmonary nodules-the SPUtNIk study. BMJ Open Respiratory Research, 3(1), [e000156]. DOI: 10.1136/bmjresp-2016-000156
Ferreri, A. J. M., Cwynarski, K., Pulczynski, E., Ponzoni, M., Deckert, M., Politi, L. S., ... International Extranodal Lymphoma Study Group (IELSG) (2016). Chemoimmunotherapy with methotrexate, cytarabine, thiotepa, and rituximab (MATRix regimen) in patients with primary CNS lymphoma: results of the first randomisation of the International Extranodal Lymphoma Study Group-32 (IELSG32) phase 2 trial. The Lancet Haematology, 3(5), e217-27. DOI: 10.1016/S2352-3026(16)00036-3
Qureshi, N. R., Shah, A., Eaton, R. J., Miles, K., Gilbert, F. J., & Sputnik Investigators (2016). Dynamic contrast enhanced CT in nodule characterization: How we review and report. Cancer imaging : the official publication of the International Cancer Imaging Society, 16(1), 16. DOI: 10.1186/s40644-016-0074-4
Kirkpatrick, E., Pearse, J., James, P., & Basu, A. (2016). Effect of parent-delivered action observation therapy on upper limb function in unilateral cerebral palsy: a randomized controlled trial. Developmental Medicine & Child Neurology, 1-8. DOI: 10.1111/dmcn.13109
Little, P., Stuart, B., Mullee, M., Thomas, T., Johnson, S., Leydon, G., ... Moore, M. (2016). Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial. Canadian Medical Association Journal, 118(13), 940-949. DOI: 10.1503/cmaj.160362
Eccles, D. M., Li, N., Handwerker, R., Maishman, T., Copson, E. R., Durcan, L. T., ... Campbell, I. (2016). Genetic testing in a cohort of young patients with HER2 amplified breast cancer. Annals of Oncology, 27(3), 467-73. DOI: 10.1093/annonc/mdv592
Maishman, T., Cutress, R., Hernandez, A., Gerty, S., Copson, E., Durcan, L., & Eccles, D. (2016). Local recurrence and breast oncological surgery in young women with breast cancer: the POSH observational cohort study. Annals of Surgery, 1-8. DOI: 10.1097/SLA.0000000000001930
Cathomas, R., Crabb, S. J., Mark, M., Winterhalder, R., Rothermundt, C., Elliott, T., ... Gillessen, S. (2016). Orteronel switch maintenance therapy in metastatic castration resistant prostate cancer after first-line docetaxel: a multicenter, randomized, double-blind, placebo-controlled trial (SAKK 08/11). The Prostate, 76(16), 1519-1527. DOI: 10.1002/pros.23236
Arriola, E., Wheater, M., Galea, I., Cross, N., Maishman, T., Hamid, D., ... Ottensmeier, C. (2016). Outcome and biomarker analysis from a multi-centre phase 2 study of ipilimumab in combination with carboplatin and etoposide (ICE) as first line therapy for extensive stage small cell lung cancer. Journal of Thoracic Oncology, 11(9), 1511-1521. DOI: 10.1016/j.jtho.2016.05.028
Pugh, S. A., Bowers, M., Ball, A., Falk, S., Finch-Jones, M., Valle, J. W., ... Primrose, J. N. (2016). Patterns of progression, treatment of progressive disease and post-progression survival in the New EPOC study. British Journal of Cancer, 115, 420-424. DOI: 10.1038/bjc.2016.208
Cipriani, F., Rawashdeh, M., Stanton, L., Armstrong, T., Takhar, A., Pearce, N. W., ... Abu Hilal, M. (2016). Propensity score-based analysis of outcomes of laparoscopic versus open liver resection for colorectal metastases. British Journal of Surgery, 103(11), 1504-12. DOI: 10.1002/bjs.10211
Macbeth, F., Noble, S., Evans, J., Ahmed, S., Cohen, D., Hood, K., ... Griffiths, G. (2016). Randomized phase III trial of standard therapy plus low molecular weight heparin in patients with lung cancer: FRAGMATIC Trial. Journal of Clinical Oncology, 34(5), 488-94. DOI: 10.1200/JCO.2015.64.0268
Illidge, T., McKenzie, H., Mayes, S., Bates, A., Davies, A., Pettengell, R., ... Johnson, P. (2016). Short duration immunochemotherapy followed by radioimmunotherapy consolidation is effective and well tolerated in relapsed follicular lymphoma: 5-year results from a UK National Cancer Research Institute Lymphoma Group study. British Journal of Haematology, 173(2), 274-282. DOI: 10.1111/bjh.13954
Pugh, S. A., Shinkins, B., Fuller, A., Mellor, J., Mant, D., & Primrose, J. N. (2016). Site and stage of colorectal cancer influence the likelihood and distribution of disease recurrence and postrecurrence survival: data from the FACS randomized controlled trial. Annals of Surgery, 263, 1143-7. DOI: 10.1097/SLA.0000000000001351
Schünemann, H. J., Ventresca, M., Crowther, M., Briel, M., Zhou, Q., Garcia, D., ... IPDMA heparin use in cancer patients research group (2016). Use of heparins in patients with cancer: individual participant data meta-analysis of randomised trials study protocol. BMJ Open, 6(4), 1-11. [e010569]. DOI: 10.1136/bmjopen-2015-010569
Harrop, E., Kelly, J., Griffiths, G., Casbard, A., Nelson, A., & Published on behalf of the BOLERO Trial Management Group (TMG) (2016). Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy). Trials, 17(35). DOI: 10.1186/s13063-016-1173-z
Maishman, T., Copson, E., Stanton, L., Gerty, S., Dicks, E., Durcan, L., ... Eccles, D. (2015). An evaluation of the prognostic model PREDICT using the POSH cohort of women aged ⩽40 years at breast cancer diagnosis. British Journal of Cancer, 112(6), 983-991. DOI: 10.1038/bjc.2015.57
Lei, J., Rudolph, A., Moysich, K. B., Rafiq, S., Behrens, S., Goode, E. L., ... KConFab Investigators (2015). Assessment of variation in immunosuppressive pathway genes reveals TGFBR2 to be associated with prognosis of estrogen receptor-negative breast cancer after chemotherapy. Breast Cancer Research, 17(18). DOI: 10.1186/s13058-015-0522-2
Primrose, J. N., Cunningham, D., Garden, O. J., Maughan, T. S., Pugh, S. A., Stanton, L., ... Bridgewater, J. A. (2015). Cetuximab is contraindicated in the perioperative treatment of colorectal liver metastases. Journal of Clinical Oncology, 33(21), 2405-2406. DOI: 10.1200/JCO.2014.60.1344
Eccles, B. K., Copson, E. R., Cutress, R., Maishman, T., Altman, D. G., Simmonds, P., ... Eccles, D. M. (2015). Family history and outcome of young patients with breast cancer in the UK (POSH study). British Journal of Surgery, 102(8), 924-935. DOI: 10.1002/bjs.9816
Hurt, C. N., Mukherjee, S., Bridgewater, J., Falk, S., Crosby, T., McDonald, A., ... Johnson, C. (2015). Health-related quality of Life in SCALOP, a randomized phase 2 trial comparing chemoradiation therapy regimens in locally advanced pancreatic cancer. International Journal of Radiation Oncology*Biology*Physics, 93(4), 810-818. DOI: 10.1016/j.ijrobp.2015.08.026
Mukherjee, S., Hurt, C. N., Gwynne, S., Bateman, A., Gollins, S., Radhakrishna, G., ... Crosby, T. (2015). NEOSCOPE: a randomised Phase II study of induction chemotherapy followed by either oxaliplatin/capecitabine or paclitaxel/carboplatin based chemoradiation as pre-operative regimen for resectable oesophageal adenocarcinoma. BMC cancer, 15(48). DOI: 10.1186/s12885-015-1062-y
Copson, E. R., Cutress, R. I., Maishman, T., Eccles, B. K., Gerty, S., Stanton, L., ... Jones, L. (2015). Obesity and the outcome of young breast cancer patients in the UK: the POSH study. Annals of Oncology, 26(1), 101-112. DOI: 10.1093/annonc/mdu509
Rees, J., Hurt, C. N., Gollins, S., Mukherjee, S., Maughan, T., Falk, S. J., ... Crosby, T. (2015). Patient-reported outcomes during and after definitive chemoradiotherapy for oesophageal cancer. British Journal of Cancer, 113(4), 603-610. DOI: 10.1038/bjc.2015.258
Thursz, M. R., Richardson, P., Allison, M., Austin, A., Bowers, M., Day, C. P., ... Forrest, E. H. (2015). Prednisolone or pentoxifylline for alcoholic hepatitis. New England Journal of Medicine, 372(17), 1619-1628. DOI: 10.1056/NEJMoa1412278
Geldart, T., Chester, J., Casbard, A., Crabb, S., Elliott, T., Protheroe, A., ... Griffiths, G. (2015). SUCCINCT: An open-label, single-arm, non-randomised, phase 2 trial of gemcitabine and cisplatin chemotherapy in combination with Sunitinib as first-line treatment for patients with advanced urothelial carcinoma. European Urology, 1-4. DOI: 10.1016/j.eururo.2014.11.003
Thursz, M., Forrest, E., Roderick, P., Day, C., Austin, A., O'Grady, J., ... Ternent, L. (2015). The clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis (STOPAH): a 2 × 2 factorial randomised controlled trial. Health Technology Assessment, 19(102), 1-104. DOI: 10.3310/hta191020
Eccles, B. K., Copson, E., Maishman, T., Abraham, J. E., & Eccles, D. M. (2015). Understanding of BRCA VUS genetic results by breast cancer specialists. BMC cancer, 15, 936. DOI: 10.1186/s12885-015-1934-1
Ceriani, L., Martelli, M., Zinzani, P. L., Ferreri, A. J. M., Botto, B., Stelitano, C., ... Zucca, E. (2015). Utility of baseline 18FDG-PET/CT functional parameters in defining prognosis of primary mediastinal (thymic) large B-cell lymphoma. Blood, 126(8), 950-6. DOI: 10.1182/blood-2014-12-616474
Martelli, M., Ceriani, L., Zucca, E., Zinzani, P. L., Ferreri, A. J. M., Vitolo, U., ... Johnson, P. W. M. (2014). [¹⁸F]fluorodeoxyglucose positron emission tomography predicts survival after chemoimmunotherapy for primary mediastinal large B-cell lymphoma: results of the International Extranodal Lymphoma Study Group IELSG-26 Study. Journal of Clinical Oncology, 32(17), 1769-75. DOI: 10.1200/JCO.2013.51.7524
Li, J., Lindström, L. S., Foo, J. N., Rafiq, S., Schmidt, M. K., Pharoah, P. D. P., ... Czene, K. (2014). 2q36.3 is associated with prognosis for oestrogen receptor-negative breast cancer patients treated with chemotherapy. Nature Communications, 5, 4051-[9pp]. DOI: 10.1038/ncomms5051
Smith, J. D., Baillie, J., Baglin, T., Griffiths, G. O., Casbard, A., Cohen, D., ... Noble, S. I. (2014). A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective anticoagulation length with low molecular weight heparin in the treatment of cancer associated thrombosis (ALICAT): study protocol for a mixed-methods study. Trials, 15(1), [122]. DOI: 10.1186/1745-6215-15-122
Tristram, A., Hurt, C. N., Madden, T., Powell, N., Man, S., Hibbitts, S., ... Griffiths, G. (2014). Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT3VIN): a multicentre, open-label, randomised, phase 2 trial. The Lancet Oncology, 15(12), 1361-1368. DOI: 10.1016/S1470-2045(14)70456-5
Primrose, J. N., Perera, R., Gray, A., Rose, P., Fuller, A., Corkhill, A., ... Mant, D. (2014). Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial. Journal of the American Medical Association, 311(3), 263-270. DOI: 10.1001/jama.2013.285718
Turner, S., Davidson, P., Stanton, L., & Cawdeary, V. (2014). Features of successful bids for funding of applied health research: a cohort study. Health Research Policy and Systems, 12, [54]. DOI: 10.1186/1478-4505-12-54
Purrington, K. S., Slager, S., Eccles, D., Yannoukakos, D., Fasching, P. A., Miron, P., ... Couch, F. J. (2014). Genome-wide association study identifies 25 known breast cancer susceptibility loci as risk factors for triple-negative breast cancer. Carcinogenesis, 35(5), 1012-1019. DOI: 10.1093/carcin/bgt404
Barrett-Lee, P., Casbard, A., Abraham, J., Hood, K., Coleman, R., Simmonds, P., ... Murray, N. (2014). Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial. The Lancet Oncology, 15(1), 114-122. DOI: 10.1016/S1470-2045(13)70539-4
Adamson, D., Blazeby, J., Nelson, A., Hurt, C., Nixon, L., Fitzgibbon, J., ... Byrne, A. (2014). Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial. Trials, 15, [402]. DOI: 10.1186/1745-6215-15-402
McCann, D. C., Thompson, M., Daley, D., Barton, J., Laver-Bradbury, C., Hutchings, J., ... Sonuga-Barke, E. (2014). Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD. Trials, 15(1), 142. DOI: 10.1186/1745-6215-15-142
Primrose, J., Falk, S., Finch-Jones, M., Valle, J., O'Reilly, D., Siriwardena, A., ... Bridgewater, J. (2014). Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis: the New EPOC randomised controlled trial. The Lancet Oncology, 15(6), 601-611. DOI: 10.1016/S1470-2045(14)70105-6
Loveman, E., Jones, J., Clegg, A. J., Picot, J., Colquitt, J., Mendes, D., ... Primrose, J. (2014). The clinical effectiveness and cost-effectiveness of ablative therapies in the management of liver metastases: systematic review and economic evaluation. Health Technology Assessment, 18(7), 1-283. DOI: 10.3310/hta18070
Hurt, C. N., Roberts, K., Rogers, T. K., Griffiths, G. O., Hood, K., Prout, H., ... Neal, R. D. (2013). A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial. Trials, 14(1), [405]. DOI: 10.1186/1745-6215-14-405
Byrne, A., Sampson, C., Baillie, J., Harrison, K., Hope-Gill, B., Hubbard, R., ... Nelson, A. (2013). A mixed-methods study of the Care Needs of individuals with idiopathic Pulmonary fibrosis and their carers--CaNoPy: a study protocol. BMJ Open, 3(8), [e003537]. DOI: 10.1136/bmjopen-2013-003537
Zucca, E., Conconi, A., Laszlo, D., López-Guillermo, A., Bouabdallah, R., Coiffier, B., ... Thieblemont, C. (2013). Addition of Rituximab to Chlorambucil Produces Superior Event-Free Survival in the Treatment of Patients With Extranodal Marginal-Zone B-Cell Lymphoma: 5-Year Analysis of the IELSG-19 Randomized Study. Journal of Clinical Oncology. DOI: 10.1200/JCO.2011.40.6272
Crosby, T., Hurt, C. N., Falk, S., Gollins, S., Mukherjee, S., Staffurth, J., ... Griffiths, G. (2013). Chemoradiotherapy with or without cetuximab in patients with oesophageal cancer (SCOPE1): a multicentre, phase 2/3 randomised trial. The Lancet Oncology, 14(7), 627-637. DOI: 10.1016/S1470-2045(13)70136-0
Blatch-Jones, A., Raftery, J., Stanton, L., & Cook, A. (2013). Do NIHR health technology assessment randomised clinical trials perform as well as expected? Trials, 14(Suppl 1), P92. DOI: 10.1186/1745-6215-14-S1-P92
Copson, E., Maishman, T., Gerty, S., Eccles, B., Stanton, L., Cutress, R. I., ... Eccles, D. (2013). Ethnicity and outcome of young breast cancer patients in the United Kingdom: the POSH study. British Journal of Cancer, 110(1), 230-41. DOI: 10.1038/bjc.2013.650
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Sebag-Montefiore, D., Stephens, R. J., Steele, R., Monson, J., Grieve, R., Khanna, S., ... Parmar, M. (2009). Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet, 373(9666), 811-820. DOI: 10.1016/S0140-6736(09)60484-0
Adams, R., Meade, A., Wasan, H., Griffiths, G., & Maughan, T. (2008). Cetuximab therapy in first-line metastatic colorectal cancer and intermittent palliative chemotherapy: review of the COIN trial. Expert Review of Anticancer Therapy, 8(8), 1237-45. DOI: 10.1586/14737140.8.8.1237
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Conferences

Nuttall, J., Lane, A., Blatch-Jones, A., Griffiths, G., & Wyatt, J. (2019). Digital tools for more efficient conduct of RCTs: trials unit survey. Trials, 20(Supplement 1), [P-244]. DOI: 10.1186/s13063-019-3688-6
Ziauddeen, N., Wilding, S., Roderick, P., Macklon, N., & Alwan, N. (2019). Predicting the risk of childhood overweight and obesity at 4–5 years using pregnancy and early life healthcare data. Journal of Epidemiology & Community Health, 73, [OP38]. DOI: 10.1136/jech-2019-SSMabstracts.38
Blatch-Jones, A. J., Bull, A., Nuttall, J., Griffiths, G., & Wyatt, J. (2019). User-focused research to identify the benefits of digital tools for the recruitment and retention in trials: a qualitative study. Trials, 20(Supplment 1), [P-119].
Schunemann, H., Ventresca, M., Crowther, M., Di Nisio, M., Briel, M., Zhou, Q., ... Zulian, G. (2017). An individual participant data meta-analysis of 13 randomized trials to evaluate the impact of prophylactic use of heparin in oncological patients. Abstract from 59th ASH Annual Meeting and Exposition, Atlanta, United States.
Davies, A. J., Barrans, S., Maishman, T., Cummin, T. E., Bentley, M., Mamot, C., ... Johnson, P. W. (2017). Differential efficacy of bortezomib in subtypes of diffuse large B‐cell lymphoma (dlbl): a prospective randomised study stratified by transcriptome profiling: remodl‐B. Hematological Oncology, 35(S2), 130-131. DOI: 10.1002/hon.2437_120
Cummin, T. E., Araf, S., Du, M., Barrans, S., Bentley, M. A., Clipson, A., ... Johnson, P. W. (2017). Prognostic significance and correlation to gene expression profile of EZH2 mutations in diffuse large B‐cell lymphoma (DLBL) in 2 large prospective studies. Hematological Oncology, 35(S2), 158-159. DOI: 10.1002/hon.2438_13
Van Es, N., Ventresca, M., Zhou, Q., Noble, S., Crowther, M., Di Nisio, M., ... Schunemann, H. (2017). The Khorana Score for the prediction of venous thromboembolism in patients with solid cancer: An individual patient data meta-analysis. Abstract from 59th ASH Annual Meeting and Exposition, Atlanta, United States.

Letters/Editorials

Cook, A. (2019). Commentary on Curtis et al. Clinical Trials, 16(4), 438-439. DOI: 10.1177/1740774519845680
Djebbari, F., Browning, J. A., Stanton, L., Booth, S., Hildyard, C., Willan, J., ... Eyre, T. A. (2019). Efficacy of R-GCVP in patients with late relapse of diffuse large B-cell lymphoma. British Journal of Haematology. DOI: 10.1111/bjh.16071
Papadakis, E. S., Reeves, T., Robson, N. H., Maishman, T., Packham, G., & Cutress, R. I. (2018). Reply to ‘Comment on ‘BAG-1 as a biomarker in early breast cancer prognosis: a systematic review with meta-analyses''. British Journal of Cancer, 118(1154), 1. DOI: 10.1038/s41416-018-0032-y

Reports

Thomas, M., Bruton, A., Little, P., Holgate, S., Lee, A., Yardley, L., ... Taylor, L. (2017). A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults. (Health Technology Assessment; Vol. 21, No. 53). NHS England. DOI: 10.3310/hta21530
Raftery, J., Young, A., Stanton, L., Milne, R., Cook, A., Turner, D., & Davidson, P. (2015). Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme. (Health Technology Assessment; No. 19). Southampton, GB: NIHR Journals Library. DOI: 10.3310/hta19110
Woodford Guegan, E., & Cook, A. (2014). European network for Health Technology Assessment Joint Action (EUnetHTA JA): a process evaluation performed by questionnaires and documentary analysis. (Health Technology Assessment; Vol. 18, No. 37). Southampton, GB: NIHR Journals Library. DOI: 10.3310/hta18370