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Publications

Download our "Top tips" papers by the Working Groups- more to follow in 2014!tOPTIPS BOX-et

 

Adaptive Designs 

Trial Recruitment

These documents should be cited as follows: e.g. “HTMR Network Top-tips for Trial Recruitment, V0.1 July 2013” 

Abstracts from the 2nd Clinical Trials Methodology Conference are online now:  

www.trialsjournal.com/supplements/14/S1/all

Some recent publications from the Hub members include:

>Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences. Mills N, Blazeby JM, Hamdy FC, Neal DE, Campbell B, Wilson C, Paramasivan S, Donovan JL http://www.trialsjournal.com/content/15/1/323%20

>Feasibility trial of a film-based educational intervention for increasing boys' and girls' intentions to avoid teenage pregnancy: study protocol. Lohan M, Aventin A, Maguire L, Clarke M, Linden M, McDaid L. International Journal of Educational Research 2014;68:35–45  Journal of Oral Rehabilitation 2014

>Quality of reporting of dental survival analyses Layton DM, Clarke M.

>Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities Bower  Peter, Brueton  Valerie, Gamble  Carrol, Treweek  Shaun, Smith Tudur Catrin, Young  Bridget, Williamson  Paula. http://www.trialsjournal.com/content/15/1/399

>   Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays Kearney A, McKay A, Hickey H, Balabanova S, Marson AG, Gamble C, Williamson P  http://bmjopen.bmj.com/content/4/9/e005874.full?keytype=ref&ijkey=8i54Sq0kEK4Vc7u

>   Choosing important health outcomes for comparative effectiveness research: a systematic review.  Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, Williamson PR. PLoS One. 2014 Jun 16;9(6):e99111  http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0099111

Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository. Tudur Smith C, Dwan K, Altman DG, Clarke M, Riley R, Williamson PR PLoS One. 2014 May 29;9(5):e97886.

>Patient-reported outcomes in randomised controlled trials of gynaecological cancers: Investigating methodological quality and impact on clinical decision-making.   Efficace F, Jacobs M, Pusic A, Greimel E, Piciocchi A, Kieffer JM, Gilbert A, Fayers P, Blazeby J; EORTC Quality of Life Group (Patient Reported Outcome Measurements Over Time In ONcology-PROMOTION Registry). European Journal of Cancer,  2014 June Pages 50;11: 1925–1941 http://www.sciencedirect.com/science/article/pii/S0959804914005905%20

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer. Trials. 2014 May 13;15(1):168 Waters AM, Tudur Smith C, Young B, Jones TM.  http://www.trialsjournal.com/content/15/1/168%20

Evidence for the Selective Reporting of Analyses and Discrepancies in Clinical Trials: A Systematic Review of Cohort Studies of Clinical Trials. PLoS Med. 2014 Jun 24;11(6):e1001666 Dwan K, Altman DG, Clarke M, Gamble C, Higgins JP, Sterne JA, Williamson PR, Kirkham JJ

 http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001666

More multiarm randomised trials of superiority are needed M Parmar, J Carpenter, M Sydes The Lancet, Volume 384, Issue 9940, Pages 283 – 284  http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2961122-3/fulltext

The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Kahan BC1, Jairath V, Doré CJ, Morris TP. Trials. 2014 Apr 23;15:139.  http://http://www.trialsjournal.com/content/15/1/139%20%20 

Adaptive designs for clinical trials assessing biomarker-guided treatment strategies Wason J, Marshall A, Dunn J, Stein R, Stallard N.. British Journal of Cancer 2014: 110, 1950–195.  http://www.nature.com/bjc/journal/v110/n8/full/bjc2014156a.html

>Tuning multiple imputation by predictive mean matching and local residual draws. TP Morris, IR White, P Royston. BMC Medical Research Methodology 2014; 14(75) Article:  http://www.biomedcentral.com/1471-2288/14/75/abstract%20

>Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary Free full text: http://www.biomedcentral.com/1471-2288/14/24%20

>A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials. Wason JM, Trippa L. Stat Med. 2014 Jan 14. doi: 10.1002/sim.6086. [Epub ahead of print]   

>The trials methodological research agenda: results from a priority setting exercise Tudur Smith C1, Hickey H, Clarke M, Blazeby J, Williamson P.  Trials. 2014; 15: 32. Now published- available online: http://www.trialsjournal.com/content/15/1/32

> Reducing waste from incomplete or unusable reports of biomedical research. Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, Michie S, Moher D, Wager E. Lancet 2014; 383(9913): 267-276.- now in print available online: http://www.sciencedirect.com/science/article/pii/S014067361362228X

>Dicing with chance, life and death in systematic reviews and meta-analyses: D.I.C.E. 3, a simulation study.  Clarke M, Halsey J.  J R Soc Med. 2014 Feb 13. [Epub ahead of print] Full text::  http://jrs.sagepub.com/content/107/3/116.long

>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) BMC Medical Ethics 14(45). doi:10.1186/1472-6939-14-45. http://www.biomedcentral.com/1472-6939/14/45/abstract

>Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. O'Neill J, Tabish H, Welch V, Petticrew M, Pottie K, Clarke M, Evans T, Pardo Pardo J, Waters E, White H, Tugwell P. Journal of Clinical Epidemiology 2014; 67(1): 56-64. http://www.jclinepi.com/article/S0895-4356(13)00334-X/abstract

>Evaluating many treatments and biomarkers in oncology: a new design. Kaplan R, Maughan T, Crook A, Fisher D, Wilson R, Brown L, Parmar M. J Clin Oncol. 2013 Dec 20.  http://jco.ascopubs.org/content/31/36/4562.abstract 

>A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials. Wason JM, Trippa L. Stat Med. 2014 Jan 14 http://onlinelibrary.wiley.com/doi/10.1002/sim.6086/abstract

>Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews. BMJ Open. 2014 Jan 24;4(1):e003835. Brueton VC, Stevenson F, Vale CL, Stenning SP, Tierney JF, Harding S, Nazareth I, Meredith S, Rait G. Free full text: http://bmjopen.bmj.com/content/4/1/e003835.long 

>Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials. 2014 Feb 5;15(1):49. Macefield RC, Jacobs M, Korfage IJ, Nicklin J, Whistance RN, Brookes ST, Sprangers MA, Blazeby JM. Free full text: http://www.trialsjournal.com/content/15/1/49 

>Selecting and measuring optimal outcomes for randomised controlled trials in surgery. Macefield RC, Boulind CE, Blazeby JM. Langenbecks Arch Surg. 2013 Nov 14. [Epub ahead of print]. http://link.springer.com/article/10.1007%2Fs00423-013-1136-8   

>When Mice Mislead: NewFocus article Malcolm Macleod (contributor) Full article: http://www.sciencemag.org/content/342/6161/922.full

>Selecting and measuring optimal outcomes for randomised controlled trials in surgery.            Langenbecks Arch Surg. 2013 Nov 14. [Epub ahead of print] Macefield RC, Boulind CE, Blazeby JM. http://link.springer.com/article/10.1007%2Fs00423-013-1136-8

> Patient-Reported Outcome Alerts Ethical and Logistical Considerations in Clinical Trials. Kyte D, Draper H, Calvert M. JAMA. 2013;310(12):1229-1230. doi:10.1001/jama.2013.277222.

>Patient-Reported Outcomes (PROs) in Clinical Trials: Is 'In-Trial' Guidance Lacking? A Systematic Review. PLoS ONE 8[4], e60684. 2013. Kyte DG, Draper H, Ives J, Liles C, Gheorghe A, Calvert M.

SWAT 1: what effects do site visits by the principal investigator have on recruitment in a multicentre randomized trial? Journal of Evidence-Based Medicine 2013; 6(3): 136-137. Smith V, Clarke M, Devane D, Begley C, Shorter G, Maguire L http://onlinelibrary.wiley.com/doi/10.1111/jebm.12049/abstract

>Adaptive Designs for Dual-Agent Phase 1 Dose-Escalation Studies                                                      Nature Reviews Clinical Oncology, 10, pp. 277–288. Harrington, J.A., Wheeler, G.M., Sweeting, M.J., Mander, A.P. and Jodrell, D.I. (2013). http://www.nature.com/nrclinonc/journal/v10/n5/full/nrclinonc.2013.35.html

>Evidence Synthesis for Decision Making 1: Introduction
Med Decis Making 2013;33 597-606. Sofia Dias, Nicky J. Welton, Alex J. Sutton, and A. E. Ades. http://mdm.sagepub.com/cgi/content/abstract/33/5/597?etoc

>Evidence Synthesis for Decision Making 2: A Generalized Linear Modeling
Framework for Pairwise and Network Meta-analysis of Randomized Controlled
Trials
Med Decis Making 2013;33 607-617. Sofia Dias, Alex J. Sutton, A. E. Ades, and Nicky J. Welton http://mdm.sagepub.com/cgi/content/abstract/33/5/607?etoc

>Can a core outcome set improve the quality of systematic reviews? A survey of the Co-ordinating Editors of Cochrane Review Groups. Kirkham JJ, Gargon E, Clarke M, Williamson PR. Trials 2013, 14:21 http://www.trialsjournal.com/content/14/1/21/abstract

>Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome. 2013 Jan 23;14(1):23. [Epub ahead of print] Choodari-Oskooei B, Parmar MK, Royston P, Bowden J. Trials. http://www.trialsjournal.com/content/14/1/23/abstract

>Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013 Feb 27;309(8):814-22. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. http://jama.jamanetwork.com/article.aspx?articleid=1656259

>Principles of dose finding studies in cancer: a comparison of trial designs.  Cancer Chemotherapy and Pharmacology 2013, DOI 10.1007/s00280-012-2059-8 http://link.springer.com/article/10.1007%2Fs00280-012-2059-8

>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 2013;13:50. Jones AP, Conroy E, Williamson PR, Clarke M, Gamble C. http://www.biomedcentral.com/1471-2288/13/50

For older publications see HERE