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North West Hub for Trials Methodology Research

 

Theme 1 Publications

[1] 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.

[2] 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

[3] 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

[4] Jaki T., Wolfsegger M. J., Lawo J. P. (2009) Establishing bioequivalence in complete and incomplete data designs using AUCs. Journal of Biopharmaceutical Statistics (accepted)

[5] 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

[6] Wolfsegger M. J., Jaki T. (2009) Non-compartmental Estimation of Pharmacokinetic Parameters in Serial Sampling Designs. Journal of Pharmacokinetics and Pharmacodynamics 36, 479-94

[7] 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

[8] Magirr, D. Block response-adaptive randomization in clinical trials with binary endpoints. Pharmaceutical Statistics, n/a. doi: 10.1002/pst.471

[9] 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

[10] Hughes DA. Biosimilars: Evidential standards for health technology assessment. Clin Pharmacol Ther 2010 Mar;87(3):257-61.
 
[11] 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.

[12] 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

[13] 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

[14] 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
[1] Jones AP, Whitehead A, Riley R, Smyth RL and Williamson PR. Meta-analysis of longitudinal data. Clinical Trials 2009.

[2] Tudur Smith C, Marson AG, Chadwick D, Williamson PR. Multiple treatment comparisons in epilepsy monotherapy trials. Trials 2007, 8:34

[3] Tudur Smith C and Williamson PR. Meta-analysis of individual patient data with time to event outcomes. Clinical Trials 2007; 4(6) 621-30

[4] 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.

[5] 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.

[6] 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.

[7] 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.

[8] 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.

Longitudinal data
[9] 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.

[10] 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.

[11] 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
[12] 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

[13] Dwan K, Gamble C, Williamson PR and Altman DG. Reporting of clinical trials: a review of research funders’ guidelines. Trials 2008; 9:66.

[14] 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.

[15] 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.

[16] 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.

[17] Hutton, J.L. and Williamson, P.R. Bias in meta-analysis due to outcome variable selection within studies. Applied Statistics 2000 49: 359-370.

[18] Williamson PR and C Gamble. Application and investigation of a bound for outcome reporting bias. Trials 2007, 8:9.

[19] Williamson PR, Gamble C, Altman DG and JL Hutton. (2005) Outcome selection bias in meta-analysis. Statistical Methods in Medical Research 14: 515-524.

[20] Williamson PR and Gamble C. Identification and impact of outcome selection bias in meta-analysis. Statistics in Medicine 2005; 24(10):1547-1561.

Economic Evaluation
[21] 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.

[22] 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

[1] 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

[2] 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  

[3] 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

[4] 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)

[5] 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

[6] 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

[7] 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

[8] 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

[9] 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

[10] 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

Outcome measurement

[11] 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

[12] 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.

[13] 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.

[14] 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)

[15] Buck D, Jacoby A (2005) Health Outcomes and Quality of Life. In: Dyck PJ, Thomas PK ed(s). Peripheral Neuropathy. Philadelphia, Elsevier Saunders.

[16] Smyth RL. (2005) Daily activity and disease status in cystic fibrosis: an important area for research. J Paediatr. 147(3): 281-283.

[17] 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.

[18] 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.

[19] 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

[20] 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.

[21] 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.

[22] 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.

[23] 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.

[24] 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.

[25] 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.

[26] 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

[27] 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

[28] 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

[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

[30] 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

[31] 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

[32] 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

[33] 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

[34] 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

[35] 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

[36] 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

[37] 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

[38] 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

[39] Jacoby, A (1996) Assessing quality of life in patients with epilepsy. Pharmacoeconomics vol 9 pp 399-416

[40] 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

[41] 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

[42] 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

[43] 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

[44] 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

[45] Bamford, C. and Jacoby, A (1992) Development of Patient Satisfaction Questionnaires. I Methodological Issues. Quality in Health Care vol 1 pp 153-157

[46] 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

[47] 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

[48] 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

[49] 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

[50] 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

[51] Smyth RL.  (2001) Research with children: paediatric practice needs better evidence-gained in collaboration with parents and children. BMJ, 322: 1377-1378.

[52] 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.

[53] 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.

Publications

Below you can find a list of the groups most recent publications.

Theme 1 publications.

[1] 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.

[2] 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

[3] 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

[4] Jaki T., Wolfsegger M. J., Lawo J. P. (2009) Establishing bioequivalence in complete and incomplete data designs using AUCs. Journal of Biopharmaceutical Statistics (accepted)

[5] 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

[6] Wolfsegger M. J., Jaki T. (2009) Non-compartmental Estimation of Pharmacokinetic Parameters in Serial Sampling Designs. Journal of Pharmacokinetics and Pharmacodynamics 36, 479-94

[7] 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

[8] Magirr, D. Block response-adaptive randomization in clinical trials with binary endpoints. Pharmaceutical Statistics, n/a. doi: 10.1002/pst.471

[9] 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

[10] Hughes DA. Biosimilars: Evidential standards for health technology assessment. Clin Pharmacol Ther 2010 Mar;87(3):257-61.
 
[11] 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.

[12] 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

[13] 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

[14] 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
[1] Jones AP, Whitehead A, Riley R, Smyth RL and Williamson PR. Meta-analysis of longitudinal data. Clinical Trials 2009.

[2] Tudur Smith C, Marson AG, Chadwick D, Williamson PR. Multiple treatment comparisons in epilepsy monotherapy trials. Trials 2007, 8:34

[3] Tudur Smith C and Williamson PR. Meta-analysis of individual patient data with time to event outcomes. Clinical Trials 2007; 4(6) 621-30

[4] 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.

[5] 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.

[6] 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.

[7] 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.

[8] 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.

Longitudinal data
[9] 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.

[10] 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.

[11] 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
[12] 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

[13] Dwan K, Gamble C, Williamson PR and Altman DG. Reporting of clinical trials: a review of research funders’ guidelines. Trials 2008; 9:66.

[14] 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.

[15] 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.

[16] 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.

[17] Hutton, J.L. and Williamson, P.R. Bias in meta-analysis due to outcome variable selection within studies. Applied Statistics 2000 49: 359-370.

[18] Williamson PR and C Gamble. Application and investigation of a bound for outcome reporting bias. Trials 2007, 8:9.

[19] Williamson PR, Gamble C, Altman DG and JL Hutton. (2005) Outcome selection bias in meta-analysis. Statistical Methods in Medical Research 14: 515-524.

[20] Williamson PR and Gamble C. Identification and impact of outcome selection bias in meta-analysis. Statistics in Medicine 2005; 24(10):1547-1561.

Economic Evaluation
[21] 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.

[22] 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

[1] 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

[2] 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  

[3] 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

[4] 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)

[5] 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

[6] 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

[7] 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

[8] 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

[9] 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

[10] 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

Outcome measurement

[11] 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

[12] 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.

[13] 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.

[14] 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)

[15] Buck D, Jacoby A (2005) Health Outcomes and Quality of Life. In: Dyck PJ, Thomas PK ed(s). Peripheral Neuropathy. Philadelphia, Elsevier Saunders.

[16] Smyth RL. (2005) Daily activity and disease status in cystic fibrosis: an important area for research. J Paediatr. 147(3): 281-283.

[17] 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.

[18] 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.

[19] 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

[20] 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.

[21] 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.

[22] 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.

[23] 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.

[24] 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.

[25] 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.

[26] 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

[27] 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

[28] 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

[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

[30] 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

[31] 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

[32] 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

[33] 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

[34] 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

[35] 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

[36] 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

[37] 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

[38] 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

[39] Jacoby, A (1996) Assessing quality of life in patients with epilepsy. Pharmacoeconomics vol 9 pp 399-416

[40] 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

[41] 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

[42] 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

[43] 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

[44] 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

[45] Bamford, C. and Jacoby, A (1992) Development of Patient Satisfaction Questionnaires. I Methodological Issues. Quality in Health Care vol 1 pp 153-157

[46] 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

[47] 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

[48] 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

[49] 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

[50] 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

[51] Smyth RL.  (2001) Research with children: paediatric practice needs better evidence-gained in collaboration with parents and children. BMJ, 322: 1377-1378.

[52] 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.

[53] 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.