TY - STD TI - National Institute for Health and Care Excellence. Guide to the methods of technology appraisal. 2013. http://www.nice.org.uk/article/pmg9/chapter/foreword. Accessed 12 July 2017. UR - http://www.nice.org.uk/article/pmg9/chapter/foreword ID - ref1 ER - TY - STD TI - Ottawa: Canadian Agency for Drugs and Technologies in Health. Guidelines for the economic evaluation of health technologies: Canada. Technical report. 2006. https://www.cadth.ca/about-cadth/how-we-do-it/methods-and-guidelines/guidelines-for-the-economic-evaluation-of-health-technologies-canada. UR - https://www.cadth.ca/about-cadth/how-we-do-it/methods-and-guidelines/guidelines-for-the-economic-evaluation-of-health-technologies-canada ID - ref2 ER - TY - STD TI - Australian Government: Department of Health and Ageing. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3). Technical report. 2008. https://pbac.pbs.gov.au/. UR - https://pbac.pbs.gov.au/ ID - ref3 ER - TY - BOOK AU - Drummond, M. F. AU - Sculpher, M. J. AU - Claxton, K. AU - Stoddart, G. L. AU - Torrance, G. W. PY - 2015 DA - 2015// TI - Methods for the economic evaluation of health care programmes PB - Oxford University Press CY - Oxford ID - Drummond2015 ER - TY - STD TI - Chilcott J, Brennan A, Booth A, Karnon J, Tappenden P. The role of modelling in prioritising and planning clinical trials. Health Technol Assess. 2003; 7(23). https://doi.org/10.3310/hta7230. ID - ref5 ER - TY - JOUR AU - Strong, M. AU - Oakley, J. E. AU - Brennan, A. AU - Breeze, P. PY - 2015 DA - 2015// TI - Estimating the expected value of sample information using the probabilistic sensitivity analysis sample: a fast, nonparametric regression-based method JO - Med Dec Making VL - 35 UR - https://doi.org/10.1177/0272989X15575286 DO - 10.1177/0272989X15575286 ID - Strong2015 ER - TY - JOUR AU - Bauer, P. AU - Brannath, W. PY - 2004 DA - 2004// TI - The advantages and disadvantages of adaptive designs for clinical trials JO - Drug Discov Today VL - 9 UR - https://doi.org/10.1016/S1359-6446(04)03023-5 DO - 10.1016/S1359-6446(04)03023-5 ID - Bauer2004 ER - TY - JOUR AU - Chow, S. AU - Chang, M. PY - 2008 DA - 2008// TI - Adaptive design methods in clinical trials - a review JO - Orphanet J Rare Dis VL - 3 UR - https://doi.org/10.1186/1750-1172-3-11 DO - 10.1186/1750-1172-3-11 ID - Chow2008 ER - TY - BOOK AU - Jennison, C. AU - Turnbull, B. W. PY - 2000 DA - 2000// TI - Group sequential methods with applications to clinical trials PB - Chapman and Hall/CRC CY - Boca Raton ID - Jennison2000 ER - TY - STD TI - Hatfield I, Allison A, Flight L, Julious SA, Dimairo M. Adaptive designs undertaken in clinical research: a review of registered clinical trials. Trials. 2016; 17(1). https://doi.org/10.1186/s13063-016-1273-9. ID - ref10 ER - TY - JOUR AU - Flight, L. AU - Arshad, F. AU - Barnsley, R. AU - Patel, K. AU - Julious, S. AU - Brennan, A. AU - Todd, S. PY - 2019 DA - 2019// TI - A review of clinical trials with an adaptive design and health economic analysis JO - Value Health VL - 22 UR - https://doi.org/10.1016/j.jval.2018.11.008 DO - 10.1016/j.jval.2018.11.008 ID - Flight2019 ER - TY - BOOK AU - Creswell, J. W. PY - 2013 DA - 2013// TI - Research design: qualitative, quantitative, and mixed methods approaches PB - SAGE Publications CY - Thousand Oaks ID - Creswell2013 ER - TY - STD TI - Dimairo M, Boote J, Julious SA, Nicholl JP, Todd S. Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials. Trials. 2015; 16(1). https://doi.org/10.1186/s13063-015-0958-9. ID - ref13 ER - TY - STD TI - Flight L. Adaptive design clinical trials and their impact on the health economic analysis of healthcare technologies. https://www.sheffield.ac.uk/scharr/sections/dts/statistics/msg-research/lfnihrdrf. Accessed 24 Feb 2020. UR - https://www.sheffield.ac.uk/scharr/sections/dts/statistics/msg-research/lfnihrdrf ID - ref14 ER - TY - JOUR AU - Fugard, A. J. B. AU - Potts, H. W. W. PY - 2015 DA - 2015// TI - Supporting thinking on sample sizes for thematic analyses: a quantitative tool JO - Int J Soc Res Methodol VL - 18 UR - https://doi.org/10.1080/13645579.2015.1005453 DO - 10.1080/13645579.2015.1005453 ID - Fugard2015 ER - TY - BOOK AU - Clarke, V. AU - Braun, V. PY - 2013 DA - 2013// TI - Successful qualitative research: a practical guide for beginners PB - SAGE Publications Inc. CY - London ID - Clarke2013 ER - TY - JOUR AU - Guest, G. AU - Bunce, A. AU - Johnson, L. PY - 2006 DA - 2006// TI - How many interviews are enough? An experiment with data saturation and variability JO - Fam Health Int VL - 18 ID - Guest2006 ER - TY - BOOK AU - Pope, C. AU - Mays, N. PY - 2000 DA - 2000// TI - Qualitative research in health care, 2nd ed PB - BMJ Publishing CY - Oxford ID - Pope2000 ER - TY - JOUR AU - Creswell, J. W. AU - Hanson, W. E. AU - Clark Plano, V. L. AU - Morales, A. PY - 2007 DA - 2007// TI - Qualitative research designs: selection and implementation JO - Couns Psychol VL - 35 UR - https://doi.org/10.1177/0011000006287390 DO - 10.1177/0011000006287390 ID - Creswell2007 ER - TY - JOUR AU - Carlsen, B. AU - Glenton, C. PY - 2011 DA - 2011// TI - What about N? A methodological study of sample-size reporting in focus group studies JO - BMC Med Res Methodol VL - 11 UR - https://doi.org/10.1186/1471-2288-11-26 DO - 10.1186/1471-2288-11-26 ID - Carlsen2011 ER - TY - JOUR AU - Francis, J. J. AU - Johnston, M. AU - Robertson, C. AU - Glidewell, L. AU - Entwistle, V. AU - Eccles, M. P. AU - Grimshaw, J. M. PY - 2010 DA - 2010// TI - What is an adequate sample size? Operationalising data saturation for theory-based interview studies JO - Psychol Health VL - 25 UR - https://doi.org/10.1080/08870440903194015 DO - 10.1080/08870440903194015 ID - Francis2010 ER - TY - STD TI - Ritchie J, Spencer L. Qualitative data analysis for applied policy research. Analysing Qual Data. 1993:;173–94. ID - ref22 ER - TY - JOUR AU - Gale, N. K. AU - Heath, G. AU - Cameron, E. AU - Rashid, S. AU - Redwood, S. PY - 2013 DA - 2013// TI - Using the framework method for the analysis of qualitative data in multi-disciplinary health research, JO - BMC Med Res Methodol VL - 13 UR - https://doi.org/10.1186/1471-2288-13-117 DO - 10.1186/1471-2288-13-117 ID - Gale2013 ER - TY - JOUR AU - Tong, A. AU - Sainsbury, P. AU - Craig, J. PY - 2007 DA - 2007// TI - Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups JO - Int J Qual Health Care VL - 19 UR - https://doi.org/10.1093/intqhc/mzm042 DO - 10.1093/intqhc/mzm042 ID - Tong2007 ER - TY - BOOK AU - Beauchamp, T. L. AU - Childress, J. F. PY - 2001 DA - 2001// TI - Principles of biomedical ethics PB - Oxford University Press CY - Oxford ID - Beauchamp2001 ER - TY - BOOK AU - Rawls, J. PY - 1971 DA - 1971// TI - A theory of justice PB - Belknap CY - Cambridge ID - Rawls1971 ER - TY - BOOK AU - Daniels, N. PY - 1985 DA - 1985// TI - Just health care PB - Cambridge University Press CY - Cambridge UR - https://doi.org/10.1017/CBO9780511624971 DO - 10.1017/CBO9780511624971 ID - Daniels1985 ER - TY - JOUR AU - Williams, A. PY - 1992 DA - 1992// TI - Cost-effectiveness analysis: is it ethical? JO - J Med Ethics VL - 18 UR - https://doi.org/10.1136/jme.18.1.7 DO - 10.1136/jme.18.1.7 ID - Williams1992 ER - TY - STD TI - Food and Drug Administration. Adaptive designs for clinical trials of drugs and biologics. Center for Biologics Evaluation and Research (CBER). 2018. https://www.fda.gov/media/78495/download. Accessed 24 Feb 2020. UR - https://www.fda.gov/media/78495/download ID - ref29 ER - TY - JOUR AU - Chow, S. -. C. AU - Corey, R. AU - Lin, M. PY - 2012 DA - 2012// TI - On the independence of data monitoring committee in adaptive design clinical trials, JO - J Biopharm Stat VL - 22 UR - https://doi.org/10.1080/10543406.2012.676536 DO - 10.1080/10543406.2012.676536 ID - Chow2012 ER - TY - BOOK AU - Whitehead, J. PY - 1997 DA - 1997// TI - The design and analysis of sequential clinical trials PB - Wiley CY - Chichester UR - https://doi.org/10.2307/2533535 DO - 10.2307/2533535 ID - Whitehead1997 ER - TY - JOUR AU - Pallmann, P. AU - Bedding, A. W. AU - Choodari-Oskooei, B. AU - Dimairo, M. AU - Flight, L. AU - Hampson, L. V. AU - Holmes, J. AU - Mander, A. P. AU - Sydes, M. R. AU - Villar, S. S. PY - 2018 DA - 2018// TI - Adaptive designs in clinical trials: why use them, and how to run and report them JO - BMC Med VL - 16 UR - https://doi.org/10.1186/s12916-018-1017-7 DO - 10.1186/s12916-018-1017-7 ID - Pallmann2018 ER - TY - JOUR AU - Bothwell, L. E. AU - Avorn, J. AU - Khan, N. F. AU - Kesselheim, A. S. PY - 2018 DA - 2018// TI - Adaptive design clinical trials: a review of the literature and ClinicalTrials. gov JO - BMJ Open VL - 8 UR - https://doi.org/10.1136/bmjopen-2017-018320 DO - 10.1136/bmjopen-2017-018320 ID - Bothwell2018 ER - TY - JOUR AU - Mohiuddin, S. AU - Fenwick, E. AU - Payne, K. PY - 2014 DA - 2014// TI - Use of value of information in UK health technology assessments JO - Int J Technol Assess Health Care VL - 30 UR - https://doi.org/10.1017/S0266462314000701 DO - 10.1017/S0266462314000701 ID - Mohiuddin2014 ER - TY - JOUR AU - Dimairo, M. AU - Coates, E. AU - Pallmann, P. AU - Todd, S. AU - Julious, S. A. AU - Jaki, T. AU - Wason, J. AU - Mander, A. P. AU - Weir, C. J. AU - Koenig, F. PY - 2018 DA - 2018// TI - Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design JO - BMC Med VL - 16 UR - https://doi.org/10.1186/s12916-018-1196-2 DO - 10.1186/s12916-018-1196-2 ID - Dimairo2018 ER - TY - STD TI - ISPOR. Value of Information Analysis for Research Decisions Task Force. 2018. https://www.ispor.org/member-groups/task-forces/value-of-information-analysis-for-research-decisions. Accessed 15 Oct 2018. UR - https://www.ispor.org/member-groups/task-forces/value-of-information-analysis-for-research-decisions ID - ref36 ER - TY - STD TI - Heath A, Kunst NR, Jackson C, Strong M, Alarid-Escudero F, Goldhaber-Fiebert JD, Baio G, Menzies NA, Jalal H. Calculating the expected value of sample information in practice: considerations from three case studies. arXiv preprint arXiv:1905.12013. 2019. ID - ref37 ER - TY - STD TI - Kunst NR, Wilson E, Alarid-Escudero F, Baio G, Brennan A, Fairley M, Glynn D, Goldhaber-Fiebert JD, Jackson C, Jalal H, et al.Computing the expected value of sample information efficiently: expertise and skills required for four model-based methods. arXiv preprint arXiv:1910.03368. 2019. ID - ref38 ER - TY - JOUR PY - 2005 DA - 2005// TI - A proposed charter for clinical trial data monitoring committees: helping them to do their job well JO - Lancet VL - 365 UR - https://doi.org/10.1016/S0140-6736(05)70939-9 DO - 10.1016/S0140-6736(05)70939-9 ID - ref39 ER - TY - STD TI - NIHR Statistics Group. Linking independent statisticians and investigators of clinical trials. 2018. https://statistics-group.nihr.ac.uk/stat-link/. Accessed 15 Oct 2018. UR - https://statistics-group.nihr.ac.uk/stat-link/ ID - ref40 ER - TY - STD TI - Glasziou P, Chalmers I. How systematic reviews can reduce waste in research. https://blogs.bmj.com/bmj/2015/10/29/how-systematic-reviews-can-reduce-waste-in-research/. Accessed 23 Dec 2019. UR - https://blogs.bmj.com/bmj/2015/10/29/how-systematic-reviews-can-reduce-waste-in-research/ ID - ref41 ER - TY - JOUR AU - Thorn, J. AU - Ridyard, C. AU - Hughes, D. AU - Wordsworth, S. AU - Mihaylova, B. AU - Noble, S. M. AU - Hollingworth, W. PY - 2017 DA - 2017// TI - Health economics analysis plans: the current state of play JO - Trials VL - 18 ID - Thorn2017 ER - TY - STD TI - Forster M, Brealey S, Chick S, Keding A, Corbacho B, Alban A, Rangan A, et al.Cost-effective clinical trial design: application of a Bayesian sequential stopping rule to the ProFHER pragmatic trial. Technical report. 2019. ID - ref43 ER - TY - STD TI - Husbands SK. PhD Thesis, Model-building process. University of Birmingham. 2016; (February). ID - ref44 ER - TY - JOUR AU - Koerkamp, B. AU - Nikken, J. AU - Oei, E. AU - Stijnen, T. PY - 2008 DA - 2008// TI - Value of information analysis used to determine the necessity of additional research: MR imaging in acute knee trauma as an example JO - Radiology VL - 246 UR - https://doi.org/10.1148/radiol.2462070093 DO - 10.1148/radiol.2462070093 ID - Koerkamp2008 ER - TY - JOUR AU - Legocki, L. J. AU - Meurer, W. J. AU - Frederiksen, S. AU - Lewis, R. J. AU - Durkalski, V. L. AU - Berry, D. A. AU - Barsan, W. G. AU - Fetters, M. D. PY - 2015 DA - 2015// TI - Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis JO - BMC Med Ethics VL - 16 UR - https://doi.org/10.1186/s12910-015-0022-z DO - 10.1186/s12910-015-0022-z ID - Legocki2015 ER - TY - JOUR AU - Meurer, W. J. AU - Legocki, L. AU - Mawocha, S. AU - Frederiksen, S. M. AU - Guetterman, T. C. AU - Barsan, W. PY - 2016 DA - 2016// TI - Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project JO - Trials VL - 17 UR - https://doi.org/10.1186/s13063-016-1493-z DO - 10.1186/s13063-016-1493-z ID - Meurer2016 ER - TY - JOUR AU - Mullins, C. D. AU - Vandigo, J. AU - Zheng, Z. AU - Wicks, P. PY - 2014 DA - 2014// TI - Patient-centeredness in the design of clinical trials JO - Value Health VL - 17 UR - https://doi.org/10.1016/j.jval.2014.02.012 DO - 10.1016/j.jval.2014.02.012 ID - Mullins2014 ER - TY - JOUR AU - Cook, J. AU - Drummond, M. AU - Heyse, J. PY - 2004 DA - 2004// TI - Multiple primary endpoints in clinical trials JO - Stat Methods Med Res VL - 13 UR - https://doi.org/10.1191/0962280204sm359ra DO - 10.1191/0962280204sm359ra ID - Cook2004 ER - TY - JOUR AU - Koerkamp, B. G. AU - Spronk, S. AU - Stijnen, T. AU - Hunink, M. G. M. PY - 2010 DA - 2010// TI - Value of information analyses of economic randomized controlled trials: the treatment of intermittent claudication JO - Value Health VL - 13 UR - https://doi.org/10.1111/j.1524-4733.2009.00656.x DO - 10.1111/j.1524-4733.2009.00656.x ID - Koerkamp2010 ER - TY - JOUR AU - Tuffaha, H. W. AU - Reynolds, H. AU - Gordon, L. G. AU - Rickard, C. M. AU - Scuffham, P. PY - 2014 DA - 2014// TI - Value of information analysis optimizing future trial design from a pilot study on catheter securement devices JO - Clin Trials (London, England) VL - 11 UR - https://doi.org/10.1177/1740774514545634 DO - 10.1177/1740774514545634 ID - Tuffaha2014 ER - TY - JOUR AU - Trotta, F. AU - Apolone, G. AU - Garattini, S. AU - Tafuri, G. PY - 2008 DA - 2008// TI - Stopping a trial early in oncology: for patients or for industry? JO - Ann Oncol VL - 19 UR - https://doi.org/10.1093/annonc/mdn042 DO - 10.1093/annonc/mdn042 ID - Trotta2008 ER - TY - JOUR AU - Ashby, D. AU - Tanb, S. -. B. PY - 2005 DA - 2005// TI - Where’s the utility of clinical trials? Bayesian data-monitoring JO - Clin Trials VL - 2 UR - https://doi.org/10.1191/1740774505cn088oa DO - 10.1191/1740774505cn088oa ID - Ashby2005 ER - TY - JOUR AU - Hollingworth, W. AU - McKell-Redwood, D. AU - Hampson, L. AU - Metcalfe, C. PY - 2013 DA - 2013// TI - Cost–utility analysis conducted alongside randomized controlled trials: are economic end points considered in sample size calculations and does it matter? JO - Clin Trials VL - 10 UR - https://doi.org/10.1177/1740774512465358 DO - 10.1177/1740774512465358 ID - Hollingworth2013 ER - TY - JOUR AU - Briggs, A. H. AU - Gray, A. M. PY - 1998 DA - 1998// TI - Power and sample size calculations for stochastic cost-effectiveness analysis JO - Med Decis Making Int J Soc Med Decis Making VL - 18 UR - https://doi.org/10.1177/0272989X98018002S10 DO - 10.1177/0272989X98018002S10 ID - Briggs1998 ER - TY - JOUR AU - O’Brien, B. J. AU - Drummond, M. F. AU - Labelle, R. J. AU - Willan, A. PY - 1994 DA - 1994// TI - In search of power and significance: issues in the design and analysis of stochastic cost-effectiveness studies in health care JO - Medical Care VL - 32 UR - https://doi.org/10.1097/00005650-199402000-00006 DO - 10.1097/00005650-199402000-00006 ID - O’Brien1994 ER - TY - JOUR AU - Briggs, A. PY - 2000 DA - 2000// TI - Economic evaluation and clinical trials: size matters, JO - BMJ VL - 321 UR - https://doi.org/10.1136/bmj.321.7273.1362 DO - 10.1136/bmj.321.7273.1362 ID - Briggs2000 ER - TY - STD TI - Dimairo M, Pallmann P, Jaki T, et al.A Practical Adaptive & Novel Designs and Analysis (PANDA) Toolkit. 2019. https://www.sheffield.ac.uk/scharr/sections/dts/ctru/panda. Accessed 24 Feb 2020. UR - https://www.sheffield.ac.uk/scharr/sections/dts/ctru/panda ID - ref58 ER -