Theme 1 Publications
 Whitehead, J., Valdés-Márquez, E. and Lissmats, A. (2009). A simple two-stage design for quantitative responses with application to a study in diabetic neuropathic pain. Pharmaceutical Statistics 8, 125-135.
 Whitehead, J. and Jaki, T. (2009) One- and two-stage design proposals for a phase II trial comparing three active treatments with control using an ordered categorical endpoint. Statistics in Medicine 28, 828-847
 Whitehead, J., Bolland, K., Valdés-Márquez, E., Lihic, A., Ali, M. and Lees, K. (2009) Using historical lesion volume data in the design of a new phase II clinical trial in acute stroke. Stroke 40, 1347-1352
 Jaki T., Wolfsegger M. J., Lawo J. P. (2009) Establishing bioequivalence in complete and incomplete data designs using AUCs. Journal of Biopharmaceutical Statistics (accepted)
 Wolfsegger M. J., Jaki T. (2009) Assessing systemic drug exposure in repeated dose toxicity studies in the case of complete and incomplete sampling. Biometrical Journal 51, 1017-29
 Wolfsegger M. J., Jaki T. (2009) Non-compartmental Estimation of Pharmacokinetic Parameters in Serial Sampling Designs. Journal of Pharmacokinetics and Pharmacodynamics 36, 479-94
 Whitehead, J., Thygesen, H. and Whitehead, A. (2010), A Bayesian dose-finding procedure for phase I clinical trials based only on the assumption of monotonicity. Statistics in Medicine, 29: 1808–1824. doi: 10.1002/sim.3963
 Magirr, D. Block response-adaptive randomization in clinical trials with binary endpoints. Pharmaceutical Statistics, n/a. doi: 10.1002/pst.471
 Higgins, J. P. T., Whitehead, A. and Simmonds, M. Sequential methods for random-effects meta-analysis. Statistics in Medicine, n/a. doi: 10.1002/sim.4088
 Hughes DA. Biosimilars: Evidential standards for health technology assessment. Clin Pharmacol Ther 2010 Mar;87(3):257-61.
 Bodger K, Kikuchi T, Hughes DA. Cost-effectiveness of biological therapy for Crohn's disease: Markov cohort analyses incorporating United Kingdom patient-level cost data. Aliment Pharmacol Ther. 2009 Aug;30(3):265-74. Epub 2009 May 5.
 Sorensen S, Baker T, Fleurence R, Haider S, Roberts C, Hughes DA. Cost and clinical consequence of antibiotic non-compliance in acute exacerbations of chronic bronchitis. Int J Tuberc Lung Dis. 2009 Aug;13(8):945-54
 Ridyard CH, Hughes DA. Methods for the collection of resource use data within clinical trials: A systematic review of clinical trials funded by the UK Health Technology Assessment programme. Value in Health Volume 13, Issue 8, Article first published online: 12 OCT 2010
 Hughes, D. A. (2010), From NCE to NICE: the role of pharmacoeconomics. British Journal of Clinical Pharmacology, 70: 317–319. doi: 10.1111/j.1365-2125.2010.03708.x
Theme 2 Publications
Systematic Reviews and meta-analysis
 Jones AP, Whitehead A, Riley R, Smyth RL and Williamson PR. Meta-analysis of longitudinal data. Clinical Trials 2009.
 Tudur Smith C, Marson AG, Chadwick D, Williamson PR. Multiple treatment comparisons in epilepsy monotherapy trials. Trials 2007, 8:34
 Tudur Smith C and Williamson PR. Meta-analysis of individual patient data with time to event outcomes. Clinical Trials 2007; 4(6) 621-30
 Tudur Smith C, Williamson P.R, Marson A.G. Investigating heterogeneity in meta-analysis of time-to-event outcomes. Statistics in Medicine 2005; 24:1307-1319.
 Tudur Smith C, Williamson P.R, Marson A.G. An overview of methods and empirical comparison of aggregate data and individual patient data results for investigating heterogeneity in meta-analysis of time-to-event outcomes. Journal of Evaluation in Clinical Practice 2005; 11:468-478.
 Tudur C, Williamson P.R., Khan S, Best L.Y. The value of the aggregate data approach in meta-analysis with time-to-event outcomes. Journal of the Royal Statistical Society Series A 2001; 164(2): 357-370.
 Williamson P.R, Tudur Smith C, Hutton J, Marson A.G. Aggregate data meta-analysis with time-to-event outcomes. Statistics in Medicine 2002; 21:3337-51.
 Williamson PR, Marson AG, Tudur C, Hutton JL, Chadwick DW. Individual patient data meta-analysis of randomized anti-epileptic drug monotherapy trials. Journal of Evaluation in Clinical Practice 2000; 6:205-14.
 Williamson PR, Kolamunnage-Dona R, Philipson P and Marson AG. Joint modelling of longitudinal and competing risks data. Statistics in Medicine 2008; 27:6426–6438.
 Hickey G, Philipson P, Jorgensen A, Kolamunnage-Dona R (2016). Joint modelling of time-to-event and multivariate longitudinal outcomes: recent developments and issues. BMC Medical Research Methodology 16 :117.
 Kolamunnage-Dona R, Powell C, Williamson PR (2016). Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study. Trials17:222. DOI 10.1186/s13063-016-1342-0
Standardising outcomes for clinical trials
 Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R and Williamson PR. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 2010; 340:c365
 Dwan K, Gamble C, Williamson PR and Altman DG. Reporting of clinical trials: a review of research funders’ guidelines. Trials 2008; 9:66.
 Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W, et al. Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias. PLoS ONE 2008; 3(8): e3081.
 Hahn S, Williamson PR, Hutton JL. Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee. Journal of Evaluation in Clinical Practice 2002; 8; 3: 353-359.
 Hahn S, Williamson PR, Hutton JL, Garner P and Flynn EV. Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies. Statistics in Medicine 2000; 19: 3325-3336.
 Hutton, J.L. and Williamson, P.R. Bias in meta-analysis due to outcome variable selection within studies. Applied Statistics 2000 49: 359-370.
 Williamson PR and C Gamble. Application and investigation of a bound for outcome reporting bias. Trials 2007, 8:9.
 Williamson PR, Gamble C, Altman DG and JL Hutton. (2005) Outcome selection bias in meta-analysis. Statistical Methods in Medical Research 14: 515-524.
 Williamson PR and Gamble C. Identification and impact of outcome selection bias in meta-analysis. Statistics in Medicine 2005; 24(10):1547-1561.
 Ridyard CH, Hughes DA. Methods for the Collection of Resource Use Data within Clinical Trials: A Systematic Review of Studies Funded by the UK Health Technology Assessment Program. Value Health. 2010 Oct 12. doi: 10.1111/j.1524-4733.2010.00788.x.
 Hughes DA, Tilson L, Drummond M. Estimating drug costs in economic evaluations in Ireland and the UK: an analysis of practice and research recommendations. Pharmacoeconomics. 2009;27(8):635-43
Theme 3 Publications
Recruitment to and retention in trials
 Shilling V, Williamson PR, Hickey H, Sowden E, Smyth RL, Young B (2011) Processes in recruitment to randomised controlled trials (RCTs) of medicines for children (RECRUIT): a qualitative study. Health Technology Assessment 15:15
 Byrne-Davis LMT, Salmon P, Gravenhorst K, Eden T, Young B. (2010) Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the ‘look and feel’ of clinical trial discussions: BMC Medical Research Methodology, 10, 101
 Shilling, V. and Young, B. (2009) How do parents experience being asked to enter a child in a randomised controlled trial? BMC Medical Ethics 10:1
 Canvin, K. and Jacoby, A. (2006) Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial. Trials 7(32)
 Donovan, J., Mills, N., Smith, M., Brindle, L., Jacoby, A., et al (2002) Improving the design and conduct of randomised trials by embedding them in qualitative research: ProtecT Study (prostate testing for cancer and treatment) study. BMJ 766: 70
 Mills, N., Donovan, J., Smith, M., Jacoby, A., et al. (2003) Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Controlled Clinical Trials 24: 272-82
 Dixon-Woods, M., Cavers, D., Jackson, C., Young, B., Forster, J., Heney, D., Pritchard-Jones, K. (2008) Tissue samples as gifts to research. Medical Law International 9: 131-150
 Jackson, C., Dixon-Woods, M., Tobin, M., Young, B., Heney, D., Pritchard-Jones, K. (2009) Seeking consent for tumour banking: A survey of health professionals in childhood cancer. European Journal of Cancer Care 18: 391-400
 Smyth, R., Dulley, L., Jacoby, A., Elbourne, D. (2009) Women’s experiences of participating in the Magpie trial: A UK survey by postal questionnaire. Birth 36(3): 220-29
 Jacoby, A., Gamble, C., Doughty, J., Marson, A., Chadwick, D. (2007) QoL outcomes of immediate versus delayed treatment of early epilepsy and single seizures. Neurology, 68: 1188-96
 Sinha I, Jones L, Smyth RL, Williamson PR (2008) A Systematic Review of Studies Which Address the process of Selecting Outcomes for use in Clinical Trials in Children. PLOS Medicine vol 5
 Sinha I, Williamson PR, Smyth RL. Outcomes in Clinical Trials of Inhaled Corticosteroids for Children with Asthma are Narrowly Focussed on Short Term Disease Activity. PLoS One 2008; 4 (7): e6276.
 Baker GA, Jacoby A. (2007) Epilepsy and Quality of Life - how important is seizure freedom? In: Trimble, M ed(s). Seizure Freedom: clinical, research and quality of life perspectives. Godalming, Clarius Press Ltd.
 Marson, A.G., Appleton, R., Baker, G.A., Chadwick, D.W., Doughty, J., Eaton, B., Gamble, C., Jacoby, A., Shackley, P., Smith, D.F., Tudur-Smith, C., Vanoli, A., 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)
 Buck D, Jacoby A (2005) Health Outcomes and Quality of Life. In: Dyck PJ, Thomas PK ed(s). Peripheral Neuropathy. Philadelphia, Elsevier Saunders.
 Smyth RL. (2005) Daily activity and disease status in cystic fibrosis: an important area for research. J Paediatr. 147(3): 281-283.
 McColl E, Jacoby A, Thomas L et al . (2000) The conduct and design of questionnaire surveys in health care research. In: Stevens A, Abrams K, Brazier J, Fitzpatrick R, Lilford R ed(s). The Advanced Handbook of Methods in Evidence Based Healthcare. London, Sage Publications.
 Jacoby A, Baker GA, Chadwick D (2000) Measurement of QoL in epilepsy. In: Jenkinson C, Fitzpatrick R, Jenkinson D ed(s). Health status measurement in neurology. Oxford, Radcliffe Medical Press.
 Baker GA (ed), Jacoby A (ed). ed(s) (2000) Quality of Life in Epilepsy: beyond seizure counts in assessment and treatment. Harwood Academic Press, Reading
 Jacoby A . (1999) Assessing quality of life in patients with epilepsy. In: Palmer KJ and Mallarkey G ed(s). Issues in Epilepsy. New Zealand, Adis Books.
 McColl E, Jacoby A, Thomas L et al . (1998) Designing and using patient and staff questionnaires. In: Black N, Brazier J, Fitzpatrick R and Reeves B ed(s). Health Services Research Methods: a guide to best practice. London, BMJ Books.
 Baker, G.A. and Jacoby, A. (1995) Assessment of quality of life in children and adolescents with epilepsy. In: Aldenkamp, A.P., Dreiffus, F.E., Reinier, W. and Suurmeijer, Th. B. ed(s). Epilepsy in Children and Adolescents. London, Boca Raton.
 New York: Raven Press. (1994) Using QOL measures to assess the outcome of treatment in children with epilepsy. In: Dulac, O. and Pons, G ed(s). Proceedings of a Symposium on Antiepileptic Drugs in Children. Paris, Springer-Verlag.
 Baker, G.A., Jacoby, A., Smith, D.F. and Chadwick, D.W. (1994) The Liverpool Initiative for QOL assessment in epilepsy. In: Trimble, M.R., Dodson, W.E ed(s). Epilepsy and Quality of Life. New York, Raven Press.
 Chadwick, D., Jacoby, A. (1993) Global assessments in epilepsy. In: Meinaidi, H., Cramer, J., Baker, G.A. and Da Silva, A.M. ed(s). Quantitative assessment in epilepsy care. New York, Plenum Press.
 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 vol 68 pp 1188-1196
 Buck D, Smith M, Appleton R, Baker GA, Jacoby A (2007) Development and validation of the Epilepsy and Learning Disability Quality of Life (ELDQOL) Scale. Epilepsy & Behavior vol 10 pp 38-43
 Jacoby, A (2005) Development, validation and evaluation of the PBC-40, a disease specific health related quality of life measure for primary biliary cirrhosis. Gut vol 43 pp 1622-29
 Parkin D, Rice N, Jacoby A, Doughty J (2004) Use of a visual-analogue scale in a daily patient diary: modelling cross-sectional time-series data on health-related quality of life. Social Science and Medicine vol 59 pp 351-60
 Rannard A, Buck D, Jones DEJ, James OFW, Jacoby A (2004) Assessing quality of life in Primary Biliary Cirrhosis. Clinical Gastroentreology and Hepatology vol 2 pp 164-74
 Buck D, Jacoby A, Massey A, Steen N, Sharma A, Ford GA (2004) Development and validation of NEWSQOL, the Newcastle Stroke-Specific Quality of Life Measure. Cerebrovascular Diseases vol 17 issue 2-3 pp 143-152
 Cramer J, Baker GA, Jacoby A (2002) Development of a new seizure severity quiestionnaire: item generation and reliability testing. Epilepsy Research vol 48 pp 187-97
 McColl E, Jacoby A, Thomas L, Soutter J et al (2001) Designing and using patient and staff questionnaires: a review of best practice. Health Technology Assessment vol 5 issue 31
 Buck D, Jacoby A, Massey A, Ford G (2000) Evaluation of measures used to assess quality of life after stroke. Stroke vol 31 issue 8 pp 2004-10
 Abetz L, Jacoby A, Baker GA, McNaulty P (2000) Psychometric validation of a new measure of QoL in epilepsy. Epilepsia vol 41 issue 9 pp 1119-28
 Jacoby, A., Baker, G.A., Steen, N., Buck, D. (1999) The SF-36 as a health status measure for epilepsy: a psychometric assessment. Quality of Life Research vol 8 pp 351-64
 Baker, G.A., Smith, D.F., Jacoby, A., Hayes, J.A., Chadwick, D.W (1998) Liverpool Seizure Severity Scale revisited. Seizure vol 7 issue 3 pp 201-205
 Espie, C.A., Kerr, N., Paul, A. et al (1997) Learning disability and epilepsy: a review of available outcome measures and position statement priorities. Seizure vol 6 pp 337-50
 Jacoby, A (1996) Assessing quality of life in patients with epilepsy. Pharmacoeconomics vol 9 pp 399-416
 Wagner, A.K., Keller, S.O., Kosinski, M., Baker, G.A., Jacoby, A. et al (1995) Advances in methods for assessing the impact of epilepsy and antiepileptic drug therapy on patients' health-related quality of life. Quality of Life Research vol 4 pp 115-134
 Baker, G.A., Jacoby, A., Smith, D., Dewey, M. and Chadwick, D.W. (1994) Development of a novel scale to assess life fulfilment as part of the further refinement of a quality of life model for epilepsy. Epilepsia vol 35 pp 591-96
 Jacoby, A., Baker, G.A., Smith, D.F. et al (1993) Measuring the impact of epilepsy: the development of a novel scale. Epilepsy Research vol 16 pp 83-88
 Baker, G.A., Smith, D., Jacoby, A., Dewey, M. and Chadwick, D.W (1993) Development of a health-related quality of life model as an outcome measure in epilepsy. Epilepsy Research vol 16 pp 65
 Eccles, M., Bamford, C. and Jacoby, A. (1992) Development of Patient Satisfaction Questionnaires. II Collaboration in Practice. Quality in Health Care vol 1 pp 158-160
 Bamford, C. and Jacoby, A (1992) Development of Patient Satisfaction Questionnaires. I Methodological Issues. Quality in Health Care vol 1 pp 153-157
 Young B, Rice H, Dixon-Woods M, Colver A, Parkinson, K (2007) A qualitative study of the health-related quality of life of disabled children. Developmental Medicine and Child Neurology, 49, 660-665
Processes and outcomes of patient involvement
 Litva, A., Canvin, K., Shepherd, M., Jacoby, A. and Gabbay, M. (2009) Lay perceptions of the desired role and type of user involvement in clinical governance. Health Expectations 12(1): 81-91
 Young, B., Dixon-Woods, M., Windridge, K.C. and Heney, D. (2003) Managing communication with young people who have a potentially life threatening chronic illness: qualitative study of patients and parents. BMJ 326(7384): 305-8B
 Dixon-Woods, M., Young, B. and Heney, D. (2002) Childhood cancer and users’ views: a critical perspective. European Journal of Cancer Care 11(3): 173-77
 Dixon-Woods, M., Anwar, Z., Young, B. and Brooke, A. (2002). Lay evaluation of services for childhood asthma. Health and Social Care in the Community 10(6): 503-11
 Smyth RL. (2001) Research with children: paediatric practice needs better evidence-gained in collaboration with parents and children. BMJ, 322: 1377-1378.
 Jacoby A and Baker GA. (2000) Patient satisfaction and patient advocacy in epilepsy. In: Schmidt D and Schachter S ed(s). Epilepsy: Problem Solving in Clinical Practice. London, Martin Dunitz Ltd.
 Jacoby, A. & Cartwright, A. (1990) Finding out about the views and experiences of maternity service users. In: Richards, M. & Garcia, J. ed(s). The Politics of Maternity Care. Oxford, Clarendon.