REFERENCES
Additional references
1 Center for Devices and Radiological Health (CDRH). 2015. Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling: DRAFT GUIDANCE for Industry, Food and Drug Administration Staff, and Other Stakeholders. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm446680.pdf. Last access on 03 June 2015.
2 Medical Device Innovation Consortium (MDIC) Patient centered benefit-risk project report. 2015. A framework for incorporating information on patient preferences regarding benefit and risk into rgulatory assessments of new medical technology. Available from: http://mdic.org/wp-content/uploads/2015/05/MDIC_PCBR_Framework_Proof5_Web.pdf. Last access on 03 June 2015.
References used within PROTECT work
1 Ades, A.E. and Sutton, A.J. (2006). Multiparameter evidence synthesis in epidemiology and medical decision-making: Current approaches. Journal of the Royal Statistical Society: Series A (Statistics in Society), 169(1): 5-35.
2 Agarwal MMCS, Hachamovitch MMR, Menon MV. Current Trial-Associated Outcomes With Warfarin in Prevention of Stroke in Patients With Nonvalvular Atrial FibrillationA Meta-analysis. Archives of Internal Medicine. 2012; 172(8): p. 623-631.
3 Agency EM. Committee for proprietary medicinal products opinion following an article 31 referral. 2002 [updated 2002; cited 2013 January]; Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Sibutramine/human_referral_000159.jsp&mid=WC0b01ac05805c516f.
4 Agency EM. EPAR Rimonabant Scientific Discussion. 2010 [updated 2010; cited 2013 January]; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Sibutramine_107/WC500094238.pdf.
5 Agency EM. Questions and answers on the suspension of medicines containing sibutramine.
6 Aguilar MI,HR. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane database of systematic reviews (Online). 2005;(3): p. CD001927.
7 Ahrens I. What do the RE-LY, AVERROES and ROCKET-AF trials tell us for stroke prevention in atrial fibrillation? Thrombosis and Haemostasis. 2011; 105(4): p. 574-578.
8 Albers GW. Stroke prevention in nonvalvular atrial fibrillation. Annals of Internal Medicine. 1991; 115(9): p. 727-736.
9 Albers GW. Antithrombotic therapy in atrial fibrillation. Chest. 2001; 119(1 SUPPL.): p. 194S-206S.
10 Altman DG. Confidence intervals for the number needed to treat. BMJ. 1998;317(7168):1309-12.
11 Andersen LV, Vestergaard P, Deichgraeber P, Lindholt JS, Mortensen LS, Frost L. Warfarin for the prevention of systemic embolism in patients with non-valvular atrial fibrillation: a meta-analysis. Heart. 2008 Dec; 94(12): p. 1607-1613.
12 Andersen PK, Geskus RB, , Putter H. Competing risks in epidemiology: possibilities and pitfalls. Int J Epidemiol. 2012 Jun; 41(3): p. 861-870.
13 Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G, et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun; 133(6 Suppl): p. 160S--198S.
14 Ashby, D. and Smith, A.F. (2000). Evidence-based medicine as Bayesian decision-making. Statistics in Medicine, 19(23): 3291-3305.
15 Assessment report for natalizumab. EMA/H/C/000603/A20/0029. [Internet]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000603/WC500095872.pdf.
16 Atrial Fibrillation Investigators S. Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. 1991 Aug; 84(2): p. 527-539.
17 Attia J, Page J, Heller RF, Dobson AJ. Impact numbers in health policy decisions. J Epidemiol Community Health 2002 Aug;56(8):600-5.
18 Attia, J., Page, J., Heller, R.F., and Dobson, A.J. (2002). Impact numbers in health policy decisions. Journal of Epidemiology and Community Health, 56(8): 600-605.
19 Baker WL, Cios DA, Sander SD, Coleman CI. Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. J Manag Care Pharm. 2009 Apr; 15(3): p. 244-252.
20 Bakhai A, Chhabra A, Wang D. (2006). Meta- Analysis. In: D Wang, F Clemens & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 439-461.
21 Bakris G, Calhoun D, Egan B, Hellmann C, Dolker M, Kingma I. Orlistat improves blood pressure control in obese subjects with treated but inadequately controlled hypertension. J Hypertens. 2002 Nov;20(11):2257-67.
22 Beckmann, J. Basic aspects of risk-benefit analysis. Seminars in Thrombosis and Hemostasis, 1999;25(1): 89-95.
23 Belot A, Remontet L, Launoy G, Jooste V, Giorgi R. Competing risk models to estimate the excess mortality and the first recurrent-event hazards. BMC Med Res Methodol. 2011; 11: p. 78.
24 Belton V, Stewart TJ. Multiple Criteria Decision Analysis: An Integrated Approach. United Kingdom: Springer; 2002.
25 Belton, K.J. (1997). Attitude survey of adverse drug reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. European Journal of Clinical Pharmacology, 52(6): 423-427.
26 Berne C. A randomized study of orlistat in combination with a weight management programme in obese patients with Type 2 diabetes treated with metformin. Diabet Med. 2005 May;22(5):612-8.
27 Berry SM, Berry DA. Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture model. Biometrics 2004 Jun;60(2):418-26.
28 Beyer, A.R., Fasolo, B., Phillips, L.D., deGraeff, P.A., and Hillege, H.L. (2013). Risk perception of prescription drugs: Results of a survey among experts in the European Regulatory Network. Medical Decision Making, Dol: 10.1177 / 0272989X12472397.
29 Beyerbach DMaZDPab. Mortality as an endpoint in atrial fibrillation. Heart Rhythm. 2004; 1(2 SUPPL.): p. B8-B19.
30 Boada JN, Boada C, Garcia-Saiz M, Garcia M, Fernandez E, Gomez E. Net efficacy adjusted for risk (NEAR): a simple procedure for measuring risk:benefit balance. PLoS One 2008;3(10):e3580.
31 Boada, J., Boada, C., Garcia, M.M., Rodriguez, C., Garcia, M., and Fernandez, E. (2009). Net efficacy adjusted for risk: Further developments. Expert Opinion on Drug Safety, 8(6): 649-654.
32 Boada, J.N., Boada, C., Garcia-Saiz, M., Garcia, M., Fernandez, E., and Gomez, E. (2008). Net efficacy adjusted for risk (NEAR): A simple procedure for measuring risk:benefit balance. PLoS One, 3(10): e3580.
33 Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators B. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med. 1991 Jul; 325(2): p. 129-132.
34 British Association of Dermatologists Guidelines for use of biological interventions in psoriasis 2005 c.h. Smith, and al. British Journal of Dermatology volume 153, issue 3, pages 486¨C497, September 2005.
35 Broom I, Wilding J, Stott P, Myers N. Randomised trial of the effect of orlistat on body weight and cardiovascular disease risk profile in obese patients: UK Multimorbidity Study. Int J Clin Pract. 2002 Sep;56(7):494-9.
36 Bujkiewicz S FAU - Jones, Hayley,E., FAU JH, FAU LM, FAU CN, Hawkins NF, Squires H FAU - Abrams, Keith,R., et al. Development of a transparent interactive decision interrogator to facilitate the decision-making process in health care. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research JID - 100883818. 1007.
37 Camm AJ, Kirchhof P, Lip GYH, Schotten U, Savelieva I, Ernst S, et al. Guidelines for the management of atrial fibrillation. European Heart Journal. 2010.
38 Cammax Limited (2011). The drugs box ¨C easy-to-use educational tool about drugs and alcohol. http://www.thedrugsbox.co.uk/
39 Carlin BP, Louis T. Bayes and Empirical Bayes methods for data analysis. 2 ed. Chapman & Hall/CRC; 2000.
40 Caro JJ, Flegel KM, Orejuela ME, Kelley HE, Speckman JL, Migliaccio-Walle K. Anticoagulant prophylaxis against stroke in atrial fibrillation: effectiveness in actual practice. CMAJ. 1999 Sep; 161(5): p. 493-497.
41 Carswell, C.M. Choosing specifiers: An evaluation of the basic tasks model of graphical perception. Human Factors, 1992;34(5): 535-554.
42 Catalyze Ltd. Catalyze: Enabling Effective Decisions. http://www.catalyze.co.uk. 2012.
43 Cave CB, Kosslyn SM. Only a piece of the pie: Commentary on Graphical Perception by W. S. Cleveland and R. McGill. Journal of the Royal Statistical Society Series A (General) 1987;150:220-1.
44 Centre for Innovation in Regulatory Science. The Unified Methodologies for Benefit-Risk Assessment (UMBRA). http://cirsci.org/UMBRA. 2012.
45 Chevalier PaTPb. Pharmacotherapy of atrial fibrillation. Annals of Noninvasive Electrocardiology. 1998; 3(2): p. 153-161.
46 CHMP / EMA (2005). Guideline on risk management systems for medicinal products for human use. http://eudravigilance.ema.europa.eu/human/evriskmanagement.asp.
47 CHMP(Dabigatran). EPAR - CHMP assessment report, Pradaxa (Dabigatran etexilate). Tech. rep. EMA; 2011.
48 CHMP(Rivaroxaban). EPAR - CHMP assessment report Xarelto (Rivaroxaban). Tech. rep. EMA; 2011.
49 CHMP-EMA. Guideline on risk management systems for medicinal products for human use. http://eudravigilance.ema.europa.eu/human/evriskmanagement.asp. 2005.
50 Christensen R, Kristensen PK, Bartels EM, Bliddal H, Astrup A. Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials. Lancet. 2007 Nov 17;370(9600):1706-13.
51 Chuang-Stein C, Entsuah R, Pritchett Y. Measures for conducting comparative benefit: Risk assessment. Drug Information Journal 2008;42(3):223-33.
52 Chuang-Stein C, Mohberg NR, Sinkula MS. Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials. Stat Med 1991 Sep;10(9):1349-59.
53 Chuang-Stein C. A New Proposal for Benefit-Less-Risk Analysis in Clinical Trials. Controlled Clinical Trials 1994;15:30-43.
54 CIOMS Working Group III. Guidelines for preparing core clinical-safety information on drugs. 1995. Geneva, Council for International Organizations of Medical Sciences.
55 CIOMS Working Group IV. Benefit-Risk Balance for Marketed Drugs. Evaluating Safety Signals. 1998. Geneva, Council for International Organizations of Medical Sciences.
56 CIRS Workshop Synopsis on Benefit-Risk. Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? http://cirsci.org/system/files/private/CIRS_June_2012_Workshop_Synopsis.pdf. 20-6-2012. Washington, DC, Centre for Innovation in Regulatory Science.
57 Clarkson, A. and Choonara, I. (2002). Surveillance for fatal suspected adverse drug reactions in the UK. Archives of Disease in Childhood, 87(6): 462-466.
58 Cleland JGF,CPJFRH. Should all patients with atrial fibrillation receive warfarin? Evidence from randomized clinical trials. European Heart Journal. 1996; 17(5): p. 674-681.
59 Clemen RT, Reilly T. Making hard decisions with decision tools suite: Update. Brooks/Cole; 2005.
60 Cleveland WS, Mcgill R. Graphical Perception - Theory, Experimentation, and Application to the Development of Graphical Methods. Journal of the American Statistical Association 1984;79(387):531-54.
61 Cleveland WS, Mcgill R. Graphical perception and graphical methods for analyzing scientific data. Science 1985 Aug;229(4716):828-33.
62 Cleveland WS, McGill R. Graphical Perception: The Visual Decoding of Quantitative Information on Graphical Displays of Data. Journal of the Royal Statistical Society Series A (General) 1987 Jan 1;150(3):192-229.
63 Cleveland WS. The elements of graphing data. 2 ed. Hobart Press; 1994.
64 Cleveland WS. Visualizing data. AT&T Bell Laboratories; 1993.
65 Compston A, Coles A. Multiple sclerosis. The Lancet 2002 Apr 6;359(9313):1221-31.
66 Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep; 361(12): p. 1139-1151.
67 Connolly SJ, Laupacis A, Gent M, Roberts RS, Cairns JA, Joyner C. Canadian Atrial Fibrillation Anticoagulation (CAFA) Study. J Am Coll Cardiol. 1991 Aug; 18(2): p. 349-355.
68 Coplan PM, Noel RA, Levitan BS, Ferguson J, Mussen F. Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines. Clin Pharmacol Ther. 2011 Feb;89(2):312-5.
69 Cota D. CB1 receptors: emerging evidence for central and peripheral mechanisms that regulate energy balance, metabolism, and cardiovascular health. Diabetes Metab Res Rev. 2007 Oct;23(7):507-17.
70 Coury BG, Boulette MD. Time Stress and the Processing of Visual Displays. Human Factors 1992;34(6):707-25.
71 Darkow T, Henk HJ, Thomas SK, Feng W, Baladi JF, Goldberg GA, et al. Treatment interruptions and non-adherence with imatinib and associated healthcare costs: a retrospective analysis among managed care patients with chronic myelogenous leukaemia. Pharmacoeconomics. 2007; 25(6): p. 481-496.
72 Darwiche, A. Bayesian networks. Communications of the ACM, 2010;53(12): 80-90.
73 Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber D, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. JAMA. 1999 Jan 20;281(3):235-42.
74 Deal L, Gold BD, Gremse DA, Winter HS, Peters SB, Fraga PD, et al. Age-specific questionnaires distinguish GERD symptom frequency and severity in infants and young children: development and initial validation. J Pediatr Gastroenterol Nutr 2005 Aug;41(2):178-85.
75 Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 9: Analysing data and undertaking meta-analyses. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org.
76 Department of H. Health Survey for England. Adult trends tables 2009.
77 Department of Health. Communicating about risks to public health: pointers to good practice. http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4039670.pdf. 1-1-1997. Crown Copyright.
78 Derosa G, Cicero AF, Murdolo G, Piccinni MN, Fogari E, Bertone G, et al. Efficacy and safety comparative evaluation of orlistat and sibutramine treatment in hypertensive obese patients. Diabetes Obes Metab. 2005 Jan;7(1):47-55.
79 Derosa G, Mugellini A, Ciccarelli L, Fogari R. Randomized, double-blind, placebo-controlled comparison of the action of orlistat, fluvastatin, or both an anthropometric measurements, blood pressure, and lipid profile in obese patients with hypercholesterolemia prescribed a standardized diet. Clin Ther. 2003 Apr;25(4):1107-22.
80 Despres JP, Golay A, Sjostrom L. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34.
81 Dickersin, K., Chan S., Chalmersx, T.C., Sacks, H.S., and Smith Jr., H. (1987). Publication bias and clinical trials. Controlled Clinical Trials, 8(4): 343-353.
82 Dodgson J, Spackman M, Pearman A, Phillips LD. Multi-Criteria Analysis: A Manual. 2000. London, Department of the Environment, Transport and the Regions.
83 Dolan, J.G., Qian, F., and Veazie, P.J. (2012). How well do commonly used data presentation formats support comparative effectiveness evaluations? Medical Decision Making, Nov, 32(6): 840-850.
84 Droitcour J, Silberman G, Chelimsky E. A new form of meta-analysis for combining results from randomized clinical trials and medical-practice databases. Int J Technol Assess Health Care 1993;9(3):440-9.
85 Drummond MF, Sculpher M, Torrance G, O'Brien B, Stoddart G. Methods for the Economic Evaluation of Health Care Programmes. 3 ed. Oxford: Oxford University Press; 2005.
86 Druzdzel MJ, van der Gaag LC. Building probabilistic networks: where do the numbers come from? - a guide to the literature. IEEE Transactions on Knowledge and Data Engineering 2000;12:481-6.
87 DuMouchel WH, Harris JE. Bayes Methods for Combining the Results of Cancer Studies in Humans and Other Species. Journal of the American Statistical Association 1983 Jun 1;78(382):293-315.
88 Easterbrook, P.J., Berlin, J.A., Gopalan, R., and Matthews, D.R. (1991). Publication bias in clinical research. Lancet, 337(8746): 867-876.
89 Eddy DM, Hasselblad V, McGivney W, Hendee W. The Value of Mammography Screening in Women Under Age 50 Years. JAMA: The Journal of the American Medical Association 1988 Mar 11;259(10):1512-9.
90 Eddy DM. The confidence profile method: a Bayesian method for assessing health technologies. Oper Res 1989 Mar;37(2):210-28.
91 Eddy, D.M., Hasselblad, V., McGivney, W., and Hendee, W. (1988). The value of mammography screen in women under age 50 years. JAMA: The Journal of the American Medical Association, 259(10): 1512-1519.
92 Edwards A, Elwyn G, Mulley A. Explaining risks: turning numerical data into meaningful pictures. BMJ 2002 Apr;324(7341):827-30.
93 Edwards D. Introduction to Graphical Modelling. 2 ed. New York: Springer-Verlag; 2000.
94 Edwards R, Wiholm BE, Martinez C. Concepts in risk-benefit assessment. A simple merit analysis of a medicine? Drug Saf 1996 Jul;15(1):1-7.
95 Efron B, Tibshirani RJ. An introduction to the bootstrap. New York: Chapman & Hall; 1993.
96 Eichler HG, Abadie E, Breckenridge A, Flamion B, Gustafsson LL, Leufkens H, et al. Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat Rev Drug Discov. 2011 Jul; 10(7): p. 495-506.
97 Eikelboom JW. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: An analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) Trial. Circulation. 2011; 123(21): p. 2363-2372.
98 Elam K. Geometry of Design: Studies in Proportion and Composition. Princeton Architectural Press; 2001.
99 Elliott WJ, Meyer PM. Incident diabetes in clinical trials of antihypertensive drugs: a network meta-analysis. Lancet 2007 Jan 20;369(9557):201-7.
100 Elm Ev, Altman DG, Egger M, Pocock SJ, G?tzsche PC, Vandenbroucke JP. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 2007 Oct 20;335(7624):806-8.
101 EMA CHMP. (2008). Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medical products for human use in London. European Medicines Agency.
102 Erev I. Signal detection by human observers: A cutoff reinforcement learning model of categorization decisions under uncertainty. Psychological Review 1998 Apr;105(2):280-98.
103 Ericson L, Bergfeldt L, Bj?rholt I. Atrial fibrillation: the cost of illness in Sweden. Eur J Health Econ. 2011 Oct; 12(5): p. 479-487.
104 European Atrial Fibrillation Trial Study Group E. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group. Lancet. 1993 Nov; 342(8882): p. 1255-1262.
105 European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers (2013).
106 European Medicines Agency (2009). Work Package 1 Report: Description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network (pp.23). London: Access at www.ema.europa.eu, Specific topics, Benefit-risk methodology.
107 European Medicines Agency (2012). Benefit-risk methodology project: Report on risk perception study module. http://www.ema.Europa.eu/docs/en_GB/document_library/Report/2012/02/WCS00123226.pdf, 1-68.
108 European Medicines Agency (2013a). The Benefit-risk methodology project documents currently available on EMA website at http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580223ed6.
109 European Medicines Agency (2013b). Draft Policy on Publication and access to clinical-trial data.
110 European Medicines Agency (2013c). European Medicines Agency recommends changes to the use of metoclopramide, 26Jul2013, currently available on EMA website at http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580223ed6.
111 European Medicines Agency. Benefit-risk methodology project: report on risk perception study module. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/02/WC500123226.pdf, 1-68. 2012.
112 European Medicines Agency. Benefit-risk methodology project: Work package 4 report: Benefit-risk tools and processes. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/03/WC500123819.pdf, 2012.
113 European Medicines Agency. Third report on the progress of the interaction with patients' and consumers' organisations during 2009. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/11/WC500099257.pdf, 2010.
114 European Public Assessment Report, Product: Xenical [Orlistat]. In: Agency EM, editor.; 2003.
115 European Public Assessment Report, Product: Zimulti (Acomplia). In: Agency EM, editor. London 2007.
116 European Public Assessment Report, Product: Zimulti (Acomplia). In: Agency EM, editor. 2006.
117 Evans A, Kalra L. Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice? Arch Intern Med. 2001 Jun; 161(11): p. 1443-1447.
118 Ezekowitz MD, Bridgers SL, James KE, Carliner NH, Colling CL, Gornick CC, et al. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators. N Engl J Med. 1992 Nov; 327(20): p. 1406-1412.
119 Ezekowitz MD, Levine JA. Preventing stroke in patients with atrial fibrillation. JAMA. 1999 May; 281(19): p. 1830-1835.
120 Fagerlin A, Zikmund-Fisher BJ, Ubel PA. Helping Patients Decide: Ten Steps to Better Risk Communication. Journal of the National Cancer Institute 2011;103(19):1436-43.
121 Fang MC, Go AS, Hylek EM, Chang Y, Henault LE, Jensvold NG, et al. Age and the risk of warfarin-associated hemorrhage: the anticoagulation and risk factors in atrial fibrillation study. J Am Geriatr Soc. 2006 Aug; 54(8): p. 1231-1236.
122 Fang MCaSDEbc. Anticoagulation for atrial fibrillation. Cardiology Clinics. 2004; 22(1): p. 47-62.
123 Felli, J., Noel, R.,& Cavazzoni, P. (2009). A Multi-attribute Model for Evaluating the Benefit-Risk Profiles of Treatment Alternatives. Medical Decision Making, vol. 29 , 104-115.
124 Few S. Dashboard Confusion. Intelligent Enterprise. March 2004.
125 Few S. Information dashboard design. 1st ed. Sebastopol, CA: O'Reilly Media, Inc.; 2006.
126 Few S. Information Dashboard Design: The Effective Visual Communication of Data. O'Reilly Media, Incorporated; 2006.
127 Few S. Now You See It: Simple Visualization Techniques for Quantitative Analysis. Analytics Press; 2009.
128 Figueira, J., Greco, S., and Ehrgott, M. (eds.) (2005). Multiple Criteria Decision Analysis: State of the art surveys. NY: Springer Science + Business Media Inc, ISBN 0-387-23067-X.
129 Finer N, James WP, Kopelman PG, Lean ME, Williams G. One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor. Int J Obes Relat Metab Disord. 2000 Mar;24(3):306-13.
130 Fischhoff B. Communicating risks and benefits: An evidence-based user's guide. Food and Drug Administration, US Department of Health and Human Services; 2011 Aug.
131 French S, Maule J, Papamichail N. Decision Behaviour, Analysis and Support. Cambridge University Press; 2009.
132 French S, Xu DL. Comparison study of multi-attribute decision analytic software. J Multi-Crit Decis Anal 2005;13(2-3):65-80.
133 French S. Modelling, making inferences and making decisions: The roles of sensitivity analysis. TOP 2003 Dec 1;11(2):229-51.
134 French, S., Maule, J., and Papamichail, N. (2009). Decision behaviour, analysis and support. Cambridge University Press.
135 Frey P. Benefit-risk considerations in CDER: Development of a Qualitative Framework. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM317788.pdf . 28-6-2012. Philadelphia, PA, US Food and Drug Administration.
136 Friberg L, Hammar N, Pettersson H, Rosenqvist M. Increased mortality in paroxysmal atrial fibrillation: report from the Stockholm Cohort-Study of Atrial Fibrillation (SCAF). Eur Heart J. 2007 Oct; 28(19): p. 2346-2353.
137 Friendly M. The Golden Age of Statistical Graphics. Statistical Science 2008 Nov;23(4):502-35.
138 Fry B, Reas C, Resig J. Processing.js: a port of the Processing Visualization Language. Processing.js team, editor. http://processingjs.org/. 2012.
139 Galesic M, Garcia-Retamero R. Graph literacy: A cross-cultural comparison. Medical Decision Making 2011;31(3):444-57.
140 GAO/PEMD. Cross design synthesis. A new strategy for medical effectiveness research. Washington, D.C.: United States General Accounting Office / Program Evaluation and Methodology Division; 1992 Mar 17. Report No.: B-244808.
141 Gapminder. Gapminder: Unveiling the beauty of statistics for a fact-based world view. http://www.gapminder.org. 2011 [cited 2011 Dec 14].
142 Garrison, L.P., Towse, A., and Bresnahan, B.W. (2007). Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysis. Health Affairs (Millwood), 26(3): 684-695.
143 Gattellari MabdWJcZNa. Warfarin: An inconvenient truth. Stroke. 2009; 40(1): p. 5-7.
144 Gelber RD, Cole BF, Gelber S, Aron G. Comparing Treatments Using Quality-Adjusted Survival: The Q-Twist Method. The American Statistician 1995 May 1;49(2):161-9.
145 Gelber RD, Goldhirsch A, Cole BF, Wieand HS, Schroeder G, Krook JE. A quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of adjuvant radiation therapy and chemotherapy for resectable rectal cancer. J Natl Cancer Inst 1996 Aug 7;88(15):1039-45.
146 Gelber RD, Lenderking WR, Cotton DJ, Cole BF, Fischl MA, Goldhirsch A, et al. Quality-of-Life Evaluation in a Clinical Trial of Zidovudine Therapy in Patients with Mildly Symptomatic HIV Infection. Annals of Internal Medicine 1992 Jun 15;116(12 Part 1):961-6.
147 Gelber, R.D., Cole, B.F., Gelber, S., and Aron, G. (1995). Comparing treatments using quality-adjusted survival: The Q-Twist method. The American Statistician, 49(2): 161-169.
148 Gelman A, Unwin A. Infovis and statistical graphics: Different goals, different looks (with discussion). Journal of Computational and Graphical Statistics. In press 2012.
149 Gephi. Gephi: makes graphs handy. https://gephi.org/. 2012.
150 Gersh BJab. Antithrombotic therapy in nonrheumatic/nonvalvular atrial fibrillation. Journal of Cardiovascular Electrophysiology. 1999; 10(3): p. 461-471.
151 Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping doctors and patients make sense of health statistics. Psychological Science in the Public Interest, Supplement 2007;8(2):53-96.
152 Gladstone DJ, Bui E, Fang J, Laupacis A, Lindsay MP, Tu JV, et al. Potentially preventable strokes in high-risk patients with atrial fibrillation who are not adequately anticoagulated. Stroke. 2009 Jan; 40(1): p. 235-240.
153 GlaxoSmithKline (GSK) (2010) Information for healthcare professionals-Avandia: [online] available from http://en.wikipedia.org/wiki/Rosiglitazone. [15 August 2012]
154 Go AS, Hylek EM, Chang Y, Phillips KA, Henault LE, Capra AM, et al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003 Nov; 290(20): p. 2685-2692.
155 Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May; 285(18): p. 2370-2375.
156 Go AS,FMCSDE. Antithrombotic therapy for stroke prevention in atrial fibrillation. Progress in Cardiovascular Diseases. 2005; 48(2): p. 108-124.
157 Goldhirsch A, Gelber RD, Simes RJ, Glasziou P, Coates AS. Costs and benefits of adjuvant therapy in breast cancer: a quality-adjusted survival analysis. J Clin Oncol 1989 Jan;7(1):36-44.
158 Goodwin P, Wright G. Decision Analysis for Management Judgment. Chicester: John Wiley & Sons; 2009.
159 Google. Google Drive. http://drive.google.com. 2012.
160 Gorter JW. Major bleeding during anticoagulation after cerebral ischemia: patterns and risk factors. Stroke Prevention In Reversible Ischemia Trial (SPIRIT). European Atrial Fibrillation Trial (EAFT) study groups. Neurology. 1999 Oct; 53(6): p. 1319-1327.
161 Gottlieb LK, Slaem-Schatz S. Autocoagulation in atrial fibrillation, does efficacy in clincial trials translate into effectiveness in practise? Arch Intern Med. 1994; 154: p. 1945-1953.
162 Gotz V. Grids for the Internet and Other Digital Media. Bloomsbury; 2002.
163 Granger CB. Apixaban versus warfarin in patients with atrial fibrillation. New England Journal of Medicine. 2011; 365(11): p. 981-992.
164 Grieve AP. The number needed to treat: a useful clinical measure or a case of the Emperor's new clothes? Pharmaceutical Statistics. 2003;2(2):87-102.
165 Grieve R, Hutton J, Green C. Selecting methods for the prediction of future events in cost-effectiveness models: a decision-framework and example from the cardiovascular field. Health Policy 2003 Jun;64(3):311-24.
166 Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis, cpmp/ewp/561/98 rev. 1. [internet]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/10/WC500133438.pdf.
167 Guo JJ, Pandey S, Doyle J, Bian B, Lis Y, Raisch DW. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value Health 2010 Aug;13(5):657-66.
168 Guyatt GH, Sackett DL, Sinclair JC, Hayward R, Cook DJ, Cook RJ. Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA 1995 Dec 13;274(22):1800-4.
169 Guyatt GH, Sinclair J, Cook DJ, Glasziou P. Users' guides to the medical literature: XVI. How to use a treatment recommendation. Evidence-Based Medicine Working Group and the Cochrane Applicability Methods Working Group. JAMA 1999 May 19;281(19):1836-43.
170 Guyatt, G.H., Sinclair, J., Cook, D.J., and Glasziou, P. (1999). Users' guide to the medical literature: XVI. How to use a treatment recommendation. Evidence-Based Working Group and the Cochrane Applicability Methods Working Group. JAMA: The Journal of the American Medical Association, 281(19): 1836-1843.
171 Hammond JS, Keeney RL, Raiffa H. Smart choices. A practical guide to making better life decisions. New York: Broadway Books; 2002.
172 Hammond JS, Keeney RL, Raiffa H. Smart Choices: A Practical Guide to Making Better Decisions. Boston, MA: Harvard Business School Press; 2002.
173 Hankey GJ. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: A subgroup analysis of ROCKET AF. The Lancet Neurology. 2012; 11(4): p. 315-322.
174 Harrington J. The desirability function. Industrial Quality Control 1965;21(10):494-8.
175 Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med. 1999 Oct; 131(7): p. 492-501.
176 Hart RG, Boop BS, Anderson DC. Oral anticoagulants and intracranial hemorrhage. Facts and hypotheses. Stroke. 1995 Aug; 26(8): p. 1471-1477.
177 Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun; 146(12): p. 857-867.
178 Hart RG,BOMR. Review: Antithrombotic agents prevent stroke in non-valvular atrial fibrillation: Commentary. Evidence-Based Medicine. 2000; 5(3): p. 82.
179 Hart RG,BOMR. The sin of omission: A systematic review of antithrombotic therapy to prevent stroke in atrial fibrillation: Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: A meta-analysis. Journal of the American Geriatrics Society. 2001; 49(1): p. 91-94.
180 Hart RG,HJL. Atrial fibrillation and stroke concepts and controversies. Stroke. 2001; 32(3): p. [d]803-808.
181 Hauner H, Meier M, Wendland G, Kurscheid T, Lauterbach K. Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study. Exp Clin Endocrinol Diabetes. 2004 Apr;112(4):201-7.
182 Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med. 2000 Feb;9(2):160-7.
183 Havet N, Morelle M, Remonnay R, Carrere MO. Cancer patients' willingness to pay for blood transfusions at home: results from a contingent valuation study in a French cancer network. The European Journal of Health Economics 2011 Jun 10;1-12.
184 Hawley ST, Zikmund-Fisher B, Ubel P, Jancovic A, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns 2008 Dec;73(3):448-55.
185 Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50.
186 Heiberger RM, Holland B. Statistical analysis and data display: An intermediate course with examples in S-PLUS, R, and SAS. New York, USA: Springer; 2004.
187 Heiser D. Microsoft Excel 2000 and 2003 faults, problems, workarounds and fixes. Computational Statistics and Data Analysis 2006;51:1442-3.
188 Heller RF, Buchan I, Edwards R, Lyratzopoulos G, McElduff P, Leger SS. Communicating risks at the population level: application of population impact numbers. BMJ 2003 Nov 15;327(7424):1162-5.
189 Heller RF, Dobson AJ, Attia J, Page J. Impact numbers: measures of risk factor impact on the whole population from case-control and cohort studies. J Epidemiol Community Health 2002 Aug;56(8):606-10.
190 Heller RF, Dobson AJ. Disease impact number and population impact number: population perspectives to measures of risk and benefit. BMJ. 2000;321(7266):950-3.
191 Heller RF, Edwards R, McElduff P. Implementing guidelines in primary care: can population impact measures help? BMC Public Health. 2003;3:7.
192 Hird M. A simple paper-based patient decision aid. Evidence-Based Medicine 2008;13(6):166.
193 Holbrook AM, Pereira JA, Labris R, McDonald H, Douketis JD, Crowther M, et al. Systematic Overview of Warfarin and Its Drug and Food Interactions. Arch Intern Med. 2005; 165: p. 10951106.
194 Holden WL, Juhaeri J, Dai W. Benefit-risk analysis: a proposal using quantitative methods. Pharmacoepidemiol Drug Saf 2003 Oct;12(7):611-6.
195 Holden WL, Juhaeri J, Dai W. Benefit-risk analysis: examples using quantitative methods. Pharmacoepidemiol Drug Saf 2003 Dec;12(8):693-7.
196 Holden, W.L. Benefit-Risk analysis: A brief review and proposed quantitative approaches. Drug Safety, 203;26(12): 853-862.
197 Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, et al. Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study. Diabetes Care. 1998 Aug;21(8):1288-94.
198 Hollnagel E, Mancini G, Woods DD. Intelligent decision support in process environments. New York: Springer-Verlag; 1986.
199 http://phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf
200 http://transparency.efpia.eu/responsible-data-sharing
201 http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500144730.pdf
205 Hughes GJaPPNaSNb. Effect of acetaminophen on international normalized ratio in patients receiving warfarin therapy. Pharmacotherapy. 2011; 31(6): p. 591-597.
206 Hunink M, Glasziou P, Siegel J, Weeks J, Pliskin J, Elstein A, et al. Decision making in health and medicine: Integrating evidence and values. Cambridge: Cambridge University Press; 2001.
207 Hunink, M., Glaszious, P., Siegel, J., Weeks, J.C., Pliskin, J.S., Elstein, A.S., and Weinstein, M.C. (2001). Decision making in health and medicine: Integrating evidence and values. Cambridge: Cambridge University Press.
208 Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med. 1994 Jun; 120(11): p. 897-902.
209 IBM (2011). Many Eyes, http://www-958.ibm.com/software/data/cognos/manyeyes/
210 IBM Corporation. IBM SPSS Visualization Designer. 2008.
211 IBM. Many Eyes. http://www-958.ibm.com/software/data/cognos/manyeyes/. 2011. 14-12-2011.
212 ICH (2012). ICH E2C (R2). Periodic Benefit-Risk Evaluation Report (PBRER) E2C (R2). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/periodic-benefit-risk-evaluation-report.html.
213 Intelligent Decision Systems Ltd. Intelligent Decision System. http://www.e-ids.co.uk/. 2010.
214 Investigators AF. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994 Jul; 154(13): p. 1449-1457.
215 Jacobs L, Cookfair D, Rudick R, Herndon R, Richert J, Salazar A, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. the multiple sclerosis collaborative research group (MSCRG). Annals of neurology JID - 7707449. 1996.
216 Jacobs LG, Billett HH, Freeman K, Dinglas C, Jumaquio L. Anticoagulation for stroke prevention in elderly patients with atrial fibrillation, including those with falls and/or early-stage dementia: a single-center, retrospective, observational study. Am J Geriatr Pharmacother. 2009 Jun; 7(3): p. 159-166.
217 James PT, Rigby N, Leach R. The obesity epidemic, metabolic syndrome and future prevention strategies. Eur J Cardiovasc Prev Rehabil. 2004 Feb;11(1):3-8.
218 James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010 Sep 2;363(10):905-17.
219 Jarvinen TL, Sievanen H, Kannus P, Jokihaara J, Khan KM. The true cost of pharmacological disease prevention. BMJ 2011;342:d2175.
220 Jenkins J. A United States Regulator's Perspective on Risk-Benefit Considerations. Rockville, MD: Shady Grove Conference Center; 2010.
221 Jensen FV, Nielsen TD. Bayesian Networks and Decision Graphs. New York: Springer; 2007.
222 Jensen FV. An introduction to Bayesian Networks. 1 ed. Secaucus, NJ: Springer-Verlag New York, Inc.; 1996.
223 John S.Hammond, Ralph L.Keeney, Howard Ra?ffa. Smart choices: a practical guide to making better decisions. Harvard Business Press; 1999.
224 Johnson FR, Ozdemir S, Mansfield C, Hass S, Siegel CA, Sands BE. Are adult patients more tolerant of treatment risks than parents of juvenile patients? Risk Anal 2009 Jan;29(1):121-36.
225 Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: Results of a phase III multicenter, double-blind placebo-controlled trial. the copolymer 1 multiple sclerosis study group. Neurology. 1995;45(7):1268.
226 Juhaeri J, Amzal B, Chan K, Genov G, Hirsch I, Hockley KS, et al. Wave 2 case study report: Rimonabant. http://www.imi-protect.eu/results.shtml . 2012. London.
227 Juice Analytics. A Guide to Creating Dashboards People Love to Use. White paper. http://www.juiceanalytics.com/. 2012.
228 Kalra LaYGbPIaLAcDNd. Prospective cohort study to determine if trial efficacy of anticoagulation for stroke prevention in atrial fibrillation translates into clinical effectiveness. British Medical Journal. 2000; 320(7244): p. 1236-1239.
229 Kamath S,LGYH. Risk stratification for thromboprophylaxis in atrial fibrillation. Cardiac Electrophysiology Review. 2001; 5(2-3): p. 171-176.
230 Kangelaris KNabcBSbNRLdGDAeTJAb. Genetic testing before anticoagulation? A systematic review of pharmacogenetic dosing of warfarin. Journal of General Internal Medicine. 2009; 24(5): p. 656-664.
231 Kappos L, Bates D, Edan G, Eraksoy M, Garcia-Merino A, Grigoriadis N, et al. Natalizumab treatment for multiple sclerosis: updated recommendations for patient selection and monitoring. The Lancet Neurology 2011 Aug;10(8):745-58.
232 Kasper JA, Heesen C, Kopke S, Muhlhauser I, Lenz M. Why not? - Communicating stochastic information by use of unsorted frequency pictograms - a randomised controlled trial. Psychosoc Med 2011;8:Dec08.
233 Kasperson RE, Renn O, Slovic P, Brown HS, Emel J, Goble R, et al. The Social Amplification of Risk - A Conceptual-Framework. Risk Analysis 1988 Jun;8(2):177-87.
234 Keeney RL, Raiffa H. Decisions With Multiple Objectives: Preference and Value Tradeoffs. New York: John Wiley; 1976.
235 Keeney RL. Value-focused thinking: a path to creative decision making. Harvard University Press; 1992.
236 Kelley DE, Bray GA, Pi-Sunyer FX, Klein S, Hill J, Miles J, et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial. Diabetes Care. 2002 Jun;25(6):1033-41.
237 Kirkwood BR, Sterne JAC. Essential Medical Statistics. 2 ed. Blackwell; 2003.
238 Kirkwood CW. Strategic Decision Making: Multiobjective decision analysis with spreadsheets. Belmont, CA: Duxbury Press; 1997.
239 Klein S, Burke LE, Bray GA, Blair S, Allison DB, Pi-Sunyer X, et al. Clinical implications of obesity with specific focus on cardiovascular disease: a statement for professionals from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: endorsed by the American College of Cardiology Foundation. Circulation. 2004 Nov 2;110(18):2952-67.
240 Korting H, Schafer-Korting M. The benefit-risk ratio. A handbook for the rational use of potentially hazardous drugs. Boca Raton: CRC Press LLC; 1999.
241 Kosslyn SM. Graph design for the eye and mind. Oxford University Press; 2006.
242 Krantz, D. H., Luce, R.D., Tversky, A., and Suppes, P. (1971). Foundations of measurement Volume I: Additive and polynomial representations. New York: Academic Press.
243 Krempf M, Louvet JP, Allanic H, Miloradovich T, Joubert JM, Attali JR. Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity. Int J Obes Relat Metab Disord. 2003 May;27(5):591-7.
244 Kurz-Milcke E, Gigerenzer G, Martignon L. Transparency in risk communication: graphical and analog tools. Ann N Y Acad Sci 2008 Apr;1128:18-28.
245 Lahdelma R, Hokkanen J, Salminen P. SMAA - Stochastic multiobjective acceptability analysis. European Journal of Operational Research 1998 Apr 1;106(1):137-43.
246 Lahdelma R, Salminen P. SMAA-2: Stochastic Multicriteria Acceptability Analysis for Group Decision Making. Operations Research. 2001 May;49(3): 444-454.
247 Lathrop RG. Perceived variability. J Exp Psychol 1967 Apr;73(4):498-502.
248 Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med 1992 Jul 23;327(4):248-54.
249 Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988 Jun 30;318(26):1728-33.
250 Levitan B. A Concise Display of Multiple End Points for Benefit-Risk Assessment. Clin Pharmacol Ther 2011 Jan;89(1):56-9.
251 Levitan, B.S., Andrews, E.B., Gilsenan, A., Ferguson, J., Noel, R.A., Coplan, P.M., and Mussen, F. (2011). Application of the BRAT framework to case studies: Observations and insights. Clinical Pharmacology and Therapeutics, Feb2011, 89(2): 217-224.
252 Liberti L, McAuslane N, Walker S. Progress on the development of a benefit/risk framework for evaluating medicines. Regulatory Focus 2010;1-6.
253 Lim R. Modernizing drug regulatory decisions to manage benefits, risks and uncertainties: Health Canada Perspective. Rockville, MD: Shady Grove Conference Center; 2010.
254 Linda S Elting, Charles GM, Scott BC, Edward BR. Influence of data display formats on physician investigators' decisions to stop clinical trials: prospective trial with repeated measures. BMJ 1999 Jun 5;318.
255 Lindgarde F. The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: the Swedish Multimorbidity Study. J Intern Med. 2000 Sep;248(3):245-54.
256 Lip GYH, Edwards SJ. Stroke prevention with aspirin, warfarin and ximelagatran in patients with non-valvular atrial fibrillation: a systematic review and meta-analysis. Thromb Res. 2006; 118(3): p. 321-333.
257 Lip GYH, Tello-Montoliu A. Management of atrial fibrillation. Heart. 2006; 92(8): p. 1177-1182.
258 Lipkus IM, Hollands JG. The visual communication of risk. Journal of the National Cancer Institute Monographs 1999;25:149-63.
259 Lipkus IM. Numeric, verbal, and visual formats of conveying health risk: Suggested best practices and future recommendations. Medical Decision Making 2007 Sep;27(5):696-713.
260 Louviere JJ, Flynn TN, Carson RT. Discrete choice experiments are not conjoint analysis. Journal of Choice Modelling 3[3], 57-72. 2010.
261 Louviere JJ, Hensher DA, Swait J. Stated choice methods: analysis and application. Cambridge: Cambridge University Press; 2000.
262 Loveman E, Frampton GK, Shepherd J, Picot J, Cooper K, Bryant J, et al. The clinical effectiveness and cost-effectiveness of long-term weight management schemes for adults: a systematic review. Health Technol Assess. 2011 Jan;15(2):1-182.
263 Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Stat Med 2004 Oct 30;23(20):3105-24.
264 Lumley T. Network meta-analysis for indirect treatment comparisons. Stat Med 2002 Aug 30;21(16):2313-24.
265 Lunn DJ, Spiegelhalter D, Thomas A, Best N. The BUGS project: Evolution, critique and future directions. Statist Med 2009;28:3049-67.
266 Lynd LD, Marra CA, Najafzadeh M, Sadatsafavi M. A quantitative evaluation of the regulatory assessment of the benefits and risks of rofecoxib relative to naproxen: an application of the incremental net-benefit framework. Pharmacoepidemiol Drug Saf 2010 Nov;19(11):1172-80.
267 Lynd LD, Najafzadeh M, Colley L, Byrne MF, Willan AR, Sculpher MJ, et al. Using the incremental net benefit framework for quantitative benefit-risk analysis in regulatory decision-making--a case study of alosetron in irritable bowel syndrome. Value Health 2010 Jun;13(4):411-7.
268 Lynd LD, O'Brien BJ. Advances in risk-benefit evaluation using probabilistic simulation methods: an application to the prophylaxis of deep vein thrombosis. J Clin Epidemiol 2004 Aug;57(8):795-803.
269 MacLean SaMSaAEAaeJMcVPOfESaMSdBNbGGHa. Patient values and preferences in decision making for antithrombotic therapy: A systematic review - Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012; 141(2 SUPPL.): p. e1S-e23S.
270 Man-Son-Hing M, Gage BF, Montgomery AA, Howitt A, Thomson R, Devereaux PJ, et al. Preference-based antithrombotic therapy in atrial fibrillation: implications for clinical decision making. Med Decis Making. 2005; 25(5): p. 548-559.
271 Man-Son-Hing M, Laupacis A. Balancing the risks of stroke and upper gastrointestinal tract bleeding in older patients with atrial fibrillation. Arch Intern Med. 2002 Mar; 162(5): p. 541-550.
272 Man-Son-Hing M, Nichol G, Lau A, Laupacis A. Choosing antithrombotic therapy for elderly patients with atrial fibrillation who are at risk for falls. Arch Intern Med. 1999 Apr; 159(7): p. 677-685.
273 Mant J, Hobbs FDR, Fletcher K, Roalfe A, Fitzmaurice D, Lip GYH, et al. Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet. 2007 Aug; 370(9586): p. 493-503.
274 Marini C, , Sacco S, Russo T, Olivieri L, Totaro R, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun; 36(6): p. 1115-1119.
275 Mazur DJ, Merz JF. Patients' interpretations of verbal expressions of probability: implications for securing informed consent to medical interventions. Behav Sci Law 1994;12(4):417-26.
276 McMahon FG, Fujioka K, Singh BN, Mendel CM, Rowe E, Rolston K, et al. Efficacy and safety of sibutramine in obese white and African American patients with hypertension: a 1-year, double-blind, placebo-controlled, multicenter trial. Arch Intern Med. 2000 Jul 24;160(14):2185-91.
277 McNulty SJ, Ur E, Williams G. A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. Diabetes Care. 2003 Jan;26(1):125-31.
278 Meyer J, Shinar D, Leiser D. Multiple factors that determine the performance with tables and graphs. Human Factors 1997;39:268-86.
279 Microsoft. Microsoft Office. 2010.
280 Miles JM, Leiter L, Hollander P, Wadden T, Anderson JW, Doyle M, et al. Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. Diabetes Care. 2002 Jul;25(7):1123-8.
281 Minelli C, Abrams KR, Sutton AJ, Cooper NJ. Benefits and harms associated with hormone replacement therapy: clinical decision analysis. BMJ 2004 Feb 14;328(7436):371.
282 Mitchell RC, Carson RT. Using surveys to value public goods: the contingent valuation method. Washington, D.C.: The Johns Hopkins University Press; 2005.
283 Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001 Apr 14;357(9263):1191-4.
284 Morgan SV. Between the devil and the deep blue sea - Balancing the risks and potential benefits of warfarin for older people with atrial fibrillation. Age and Ageing. 2004; 33(6): p. 544-547.
285 Mt-Isa S, Peters R, Phillips LD, Chan K, Hockley KS, Wang N, et al. Review of visualisation methods for the representation of benefit-risk assessment of medication: Stage 1 of 2. http://www.imi-protect.eu/results.shtml. 2012. London.
286 Mt-Isa, S., Hallgreen, C.E., Asiimwe, A., Downey, G., Genov, G., Hermann, R., Hughes, D., Lieftucht, A., Noel, R., Peters, R., Phillips, L.D., Shepherd, S., Micaleff, A., Ashby, D., and Tzoulaki, I. on behalf of the PROTECT Work Package 5 participants (2013b). Review of visualisation methods for the representation of benefit-risk assessment of medication: Stage 2 of 2. London, Report No. PROTECT WP5, Version 1 (15Feb2013).
287 Mt-Isa, S., Peters, R., Phillips, L.D., Chan, K., Hockley, K.S., Wang, N., Ashby, D., and Tzoulaki, I. on behalf of PROTECT Work Package 5 participants (2013a). Review of visualisation methods for the representation of benefit-risk assessment of medication: Stage 1 of 2. London, Report No. PROTECT WP5, Version 1 (15Feb2013).
288 Mt-Isa, S., Tzoulaki, I., Callreus, T., Micaleff, A., and Ashby, D. (2011). Weighing benefit-risk of medicines: Concepts and approaches. Drug Discovery Today: Technologies, 8: e29-e35.
289 Mt-Isa, S., Wang, N., Hallgreen, C.E., Callreus, T., Genov, G., Hirsch, I., Hobbiger, S., Hockley, K.S., Luciani, D., Phillips, L.D., Quartey, G., Sarac, S.B., Stoeckert, I., Micaleff, A., Ashby, D., and Tzoulaki, I. on behalf of PROTECT Work Package 5 participants (2012). Review of methodologies for benefit and risk assessment of medication. London, Report No. PROTECT WP5, Version 4 (14Feb2012).
290 Muller J, Polansky D, Novak P, Foltin C, Polivaev D. Freemind - free mind mapping software. http://freemind.sourceforge.net/wiki/index.php/Main_Page . 2012.
291 Muller-Brockmann J. Grid systems in graphic design: a visual communication manual for graphic designers, typographers, and three dimensional designers. Verlag Gerd Hatje; 1988.
292 Mussen F, Salek S, Walker S. A quantitative approach to benefit-risk assessment of medicines - part 1: the development of a new model using multi-criteria decision analysis. Pharmacoepidemiol Drug Saf 2007 Jul;16 Suppl 1:S2-S15.
293 Mussen F, Salek S, Walker S. Benefit-Risk Appraisal of Medicines. John Wiley & Sons, Ltd.; 2009.
294 Mussen F, Salek S, Walker S. Development and Application of a Benefit-Risk Assessment Model Based on Multi-Criteria Decision Analysis. Benefit-Risk Appraisal of Medicines. John Wiley & Sons, Ltd.; 2009. p. 111-49.
295 Mussen F, Salek S, Walker S. Review of the Current Benefit-Risk Assessment Models. Benefit-Risk Appraisal of Medicines. 1 ed. John Wiley & Sons, Ltd.; 2009. p. 63-97.
296 Mustajoki J, Hamalainen RP. Web-HIPRE: Global decision support by value tree and AHP analysis. INFOR 2000;38(3):208-20.
297 Nademanee K. Long-term antithrombotic treatment for atrial fibrillation. American Journal of Cardiology. 1998; 82(8 A): p. 37N-42N.
298 National Research Council (2013). Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press.
299 Nisen, P. and Rockhold, F. (2013). Access to patient-level data from GlaxoSmithKline clinical trials. ?New England Journal of Medicine, Aug 1, 369(5): 475-478.
300 Nissen, S. E., & Wolski, K. (2007). Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. New England Journal of Medicine, 356(24), 2457-2471.
301 Nixon R, Hockley KS, Mt-Isa S, Elmachtoub A, Gelb D, Hermann R, et al. Wave 2 case study report: Natalizumab. http://www.imi-protect.eu/results.shtml. 2012. London.
302 Nixon R, Nguyen T.S.T., Stoeckert I, Dierig C, Kuhls S, Hodgson G, et al. Wave 1 case study report: Natalizumab. http://www.imi-protect.eu/results.shtml. 2011. London.
303 Nixon RM, Bansback N, Brennan A. Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis. Stat Med 2007 Mar 15;26(6):1237-54.
304 Nutt, D.J., King, L.A., Phillips, L.D., and on behalf of the Independent Scientific Committee on Drugs (2010). Drug harms in the UK: A multi-criteria decision analysis. The Lancelet, 376: 1558-1565.
305 Okan Y, Garcia-Retamero R, Cokely ET. Individual Differences in Graph Literacy: Overcoming Denominator Neglect in Risk Comprehension. Journal of Behavioral Decision Making 2001.
306 Organisation WH. Integrated management of cardiovascular risk: report of a WHO meeting. 2002.
307 Ouellet D, Werth J, Parekh N, Feltner D, McCarthy B, Lalonde RL. The use of a clinical utility index to compare insomnia compounds: a quantitative basis for benefit-risk assessment. Clin Pharmacol Ther 2009 Mar;85(3):277-82.
308 Ouellet D. Benefit-risk assessment: the use of clinical utility index. Expert Opin Drug Saf 2010 Mar;9(2):289-300.
309 Outcome of a procedure under Article 107 of Directive 2001/83/EC. 2010 [updated 2010; cited 2013 January]; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Sibutramine_107/WC500094238.pdf.
310 Padwal R, Li SK, Lau DC. Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev. 2004(3):CD004094.
311 Patel MR. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. New England Journal of Medicine. 2011; 365(10): p. 883-891.
312 Payne JT, Loken MK. A survey of the benefits and risks in the practice of radiology. CRC Critical Reviews in Clinical Radiology and Nuclear Medicine 1975;6(3):425-39
313 Pearce D, ?zdemiroglu E, Bateman I, Carson RT, Day B, Hanemann M, et al. Economic valuation with stated preference techniques. Summary guide. Norwich: Queen's Printer and Controller for Her Majesty's Stationery Office; 2002. Report No.: 01 SCSG 1158.
314 Pearl J. Probabilistic reasoning in intelligent systems: networks of plausible inference. San Francisco, CA: Morgan Kaufmann Publishers, Inc.; 1988.
315 Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet. 1989 Jan; 1(8631): p. 175-179.
316 Phillips LD, Fasolo B, Zafiropoulos N, Beyer A. Benefit-risk methodology project work package 2 report: Applicability of current tools and processes for regulatory benefit-risk assessment. London: European Medicines Agency; 2010 Aug 31. Report No.: EMA/549682/2010.
317 Phillips LD, Fasolo B, Zafiropoulos N, Beyer A. Is quantitative benefit-risk modelling of drugs desirable or possible? Drug Discovery Today: Technologies 2011;8(1):e3-e10.
318 Phillips LD. A theory of requisite decision models. Acta Psychol. (Amst.). 1984; 56: p. 29-48.
319 Phillips LD. Decision conferencing, in advances in decision analysis: from foundations to applications, w. Edwards, rf miles and d von winterfeldt, eds, cambridge university press, Cambridge. 2007.
320 Phillips LD. Requisite decision modelling: a case study. Journal of the Operational Research Society 1982;33(4):303-11.
321 Philllips, L.D. (1986). Decision analysis and its application in industry. In Mitra, Gautam (ed.), Computer assisted decision making expert systems, decision analysis, mathematical programming, North-Holland, ISBN 9780444878878.
322 Pink J, Lane S, Pirmohamed M, Hughes DA. Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses. BMJ. 2011; 343: p. d6333.
323 Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75.
324 Pliskin JS, Shepard DS, Milton CW. Utility Functions for Life Years and Health Status. Operations Research 1980 Jan 1;28(1):206-24.
325 Politi MC, Han PKJ, Col NF. Communicating the uncertainty of harms and benefits of medical interventions. Medical Decision Making 2007;27(5):681-95.
326 Polman C, O'Connor P, Havrdova E, Hutchinson M, Kappos L, Miller DH, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. The New England journal of medicine JID - 0255562. 2006.
327 Potter, K.. Methods for presenting statistical information: The box plot. Salt Lake City, UT: University of Utah, School of Computing. 2006.
328 Qliktech International AB. QlikView Software. http://qlikview.com. 2012.
329 R Development Core Team. R: A language and environment for statistical computing. http://www.R-project.org. 2008. Vienna, Austria, R Foundation for Statistical Computing.
330 Raiffa H. Decision analysis: Introductory lectures on choices under uncertainty. McGraw Hill; 1968.
331 Raiffa, H. Decision Analysis. Reading, MA: Addison-Wesley; 1968.
332 Rakow T. Differences in belief about likely outcomes account for differences in doctors' treatment preferences: But what accounts for the differences in belief? Quality in Health Care 2001;10(SUPPL. 1):i44-i49.
333 Rasmussen J. Information processing and human-machine interaction. New York: North-Holland; 1986.
334 Relative or Attributable Risk? The Lancet. 1981; 318(8257): p. 1211-1212.
335 Renard D, Wu K, Wada R, Flesch G. Using desirability indices for decision making in drug development. Population Approach Group Europe (PAGE); 2009 Jun 23; St. Petersburg, Russia.: Novartis Pharma AG, Basel, Switzerland; 2009.
336 Reynolds MW, Fahrbach K, Hauch O, Wygant G, Estok R, Cella C, et al. Warfarin anticoagulation and outcomes in patients with atrial fibrillation: a systematic review and metaanalysis. Chest. 2004 Dec; 126(6): p. 1938-1945.
337 Ried, W. (1998). QALYs versus HYEs--what's right and what's wrong: A review of the controversy. Journal of Health Economics, 17(5): 607-625.
338 Riegelman R, Schroth WS. Adjusting the number needed to treat: incorporating adjustments for the utility and timing of benefits and harms. Med Decis Making 1993 Jul;13(3):247-52.
339 Rietbrock S, Plumb JM, Gallagher AM,. How effective are dose-adjusted warfarin and aspirin for the prevention of stroke in patients with chronic atrial fibrillation? An analysis of the UK General Practice Research Database. Thromb Haemost. 2009 Mar; 101(3): p. 527-534.
340 Robbins NB. Creating more effective graphs. Hoboken, NJ: Wiley; 2005.
341 Rosati G. The prevalence of multiple sclerosis in the world: an update. Neurological sciences 2001;22(2):117-39.
342 Rosendaal FR, Cannegieter SC, , Bri?t E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost. 1993 Mar; 69(3): p. 236-239.
343 Rosenstock J, Hollander P, Chevalier S, Iranmanesh A. SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes. Diabetes Care. 2008 Nov;31(11):2169-76.
344 Rossner S, Sjostrom L, Noack R, Meinders AE, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Obes Res. 2000 Jan;8(1):49-61.
345 Rowland M, Tozer TN. Therapeutic response and toxicity. Clinical pharmacokinetics: concepts and applications. 1 ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 1980.
346 Ryan M, Bate A, Eastmond CJ, Ludbrook A. Use of discrete choice experiments to elicit preferences. Quality in Health Care 2001 Sep;10:I55-I60.
347 Ryan M, Gerard K, Amaya-Amaya M. Using Discrete Choice Experiments to Value Health and Health Care. Dordrecht, The Netherlands: Springer; 2008.
348 Ryan M, Hughes J. Using Conjoint Analysis to Assess Women's Preferences for Miscarriage Management. Health Econ 1997;6(3):261-73.
349 Ryan, M., Bate, A., Eastmond, C.J., and Ludbrook, A. (2001). Use of discrete choice experiments to elicit preferences. Quality in Health Care, 10: I55-I60.
350 Sacristan JA, Soto J, Galende I, Hylan TR. A review of methodologies for assessing drug effectiveness and a new proposal: randomized database studies. Clinical Therapeutics 1997;19(6):1510-7.
351 Sacristan, J.A., Gomez, J.C., Bandia, X., and Kind, P. (2001). Global index of safety (GIS): A new instrument to assess drug safety. Journal of Clinical Epidemiology, 54(11): 1120-1125.
352 Samara T. Making and Breaking the Grid: A Graphic Design Layout Workshop. Quayside Publishing Group; 2005.
353 Samsa GP, Matchar DB, Goldstein LB, Bonito AJ, Lux LJ, Witter DM, et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from 2 communities. Arch Intern Med. 2000 Apr; 160(7): p. 967-973.
354 Sanchez-Reyes L, Fanghanel G, Yamamoto J, Martinez-Rivas L, Campos-Franco E, Berber A. Use of sibutramine in overweight adult hispanic patients with type 2 diabetes mellitus: a 12-month, randomized, double-blind, placebo-controlled clinical trial. Clin Ther. 2004 Sep;26(9):1427-35.
355 Sarac SB, Rasmussen CH, Rasmussen MA, Hallgreen CE, Soeborg T, Colding-Jorgensen M, et al. Balancing benefits and risks: Data-driven clinical benefit-risk assessment. 2011.
356 Sarac, S.B., Rasmussen, C.H., Rasmussen, M.A., Hallgreen, C.E., Soeborg, T., Colding-Jorgensen, M., Christensen, P.K., Thirstrup, S., and Mosekilde, E. (2012). A comprehensive approach to benefit-risk assessment in drug development. Basic Clinical Pharmacology and Toxicology, 111(1):65-72.
357 SAS Institute Inc. SAS Software. 2012. Cary, NC, USA.
358 Sassi, F. (2006). Calculating QALYs, comparing QALY and DALY calculations. Health Policy Plan, 21(5): 402-408.
359 Saxena R, Koudstaal PJ. Anticoagulants for preventing stroke in patients with nonrheumatic atrial fibrillation and a history of stroke or transient ischaemic attack. Cochrane Database Syst Rev. 2004;(2): p. CD000185.
360 Schapira MM, Nattinger AB, McHorney CA. Frequency or probability? A qualitative study of risk communication formats used in health care. Med Decis Making 2001;21(6):459-67.
361 Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006 Nov 11;368(9548):1660-72.
362 Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
363 Schulzer M, Mancini GB. 'Unqualified success' and 'unmitigated failure': number-needed-to-treat-related concepts for assessing treatment efficacy in the presence of treatment-induced adverse events. Int J Epidemiol 1996 Aug;25(4):704-12.
364 Schwartz CE, Cole BF, Gelber RD. Measuring Patient-Centered Outcomes in Neurologic Disease: Extending the Q-TWiST Method. Arch Neurol 1995 Aug 1;52(8):754-62.
365 Segal JB, McNamara RL, Miller MR, Kim N, Goodman SN, Powe NR, et al. Prevention of thromboembolism in atrial fibrillation. A meta-analysis of trials of anticoagulants and antiplatelet drugs. J Gen Intern Med. 2000 Jan; 15(1): p. 56-67.
366 Siegel CA. Review article: Explaining risks of inflammatory bowel disease therapy to patients. Alimentary Pharmacology and Therapeutics 2011;33(1):23-32.
367 SIMUL8 Corporation. V.I.S.A. http://www.visadecisions.com/. 2012.
368 Sinclair JC, Cook RJ, Guyatt GH, Pauker SG, Cook DJ. When should an effective treatment be used?: Derivation of the threshold number needed to treat and the minimum event rate for treatment. J Clin Epidemiol. 2001 3;54(3):253-62.
369 Singer DE, Chang Y, Fang MC, Borowsky LH, Pomernacki NK, Udaltsova N, et al. Should patient characteristics influence target anticoagulation intensity for stroke prevention in nonvalvular atrial fibrillation?: the ATRIA study. Circ Cardiovasc Qual Outcomes. 2009 Jul; 2(4): p. 297-304.
370 Singer DE, Chang Y, Fang MC, Borowsky LH, Pomernacki NK, Udaltsova N, et al. The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann Intern Med. 2009 Sep; 151(5): p. 297-305.
371 Singer DE. Antithrombotic therapy in atrial fibrillation: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126(3 SUPPL.): p. 429S-456S.
372 Singer DE,HRGPLA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation [1] (multiple letters). Annals of Internal Medicine. 2000; 132(10): p. 841.
373 Sjostrom L, Rissanen A, Andersen T, Boldrin M, Golay A, Koppeschaar HP, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Lancet. 1998 Jul 18;352(9123):167-72.
374 Slovic P, Weber EU. Perception of Risk Posed by Extreme Events. Risk Management strategies in an Uncertain World Conference . 2002. Palisades, New York.
375 Smith EE, Kosslyn SM. Cognitive Psychology: Mind And Brain. Prentice Hall; 2007.
376 Smith IG, Goulder MA. Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. J Fam Pract. 2001 Jun;50(6):505-12.
377 Smith RD. Construction of the contingent valuation market in health care:a critical assessment. Health Econ 2003;12(8):609-28.
378 Smith T, Noble S, Avenell D, Lally G. DataViz: improving data visualisation for the public sector. http://www.improving-visualisation.org/downloads/DataViz_Improving_data_visualisation_for_the_public_sector_Sep_2009.pdf. 2009. London, Queen's Printer and Controller of Her Majesty's Stationery Office.
379 Solomon CG, Manson JE. Obesity and mortality: a review of the epidemiologic data. Am J Clin Nutr. 1997 Oct;66(4 Suppl):1044S-50S.
380 Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making 1993 Oct;13(4):322-38
381 Spence I. No humble Pie: The origins and usage of a statistical chart. Journal of Educational and Behavioral Statistics 2005;30(4):353-68.
382 Spiegelhalter D, Abrams K, Myles JP. An Overview of the Bayesian Approach: Decision Making. Bayesian Approaches to Clinical Trials and Health-Care Evaluation.Chicester, West Sussex: John Wiley & Sons Ltd.; 2004. p. 49-120.
383 Spiegelhalter D, Abrams K, Myles JP. Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Chicester, West Sussex: John Wiley & Sons Ltd.; 2004.
384 Spiegelhalter, D. (2010). Understanding uncertainty website, http://understandinguncertainty.org.
385 Spirtes P, Glymour C, Scheines R. Causation, Prediction, and Search. 1 ed. MIT Press; 1993.
386 Sramek JJ, Leibowitz MT, Weinstein SP, Rowe ED, Mendel CM, Levy B, et al. Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by beta-adrenergic blocking agents: a placebo-controlled, double-blind, randomised trial. J Hum Hypertens. 2002 Jan;16(1):13-9.
387 StataCorp. Statistical Software: Release 10. College Station, TX: Stata Corporation. 2007.
388 Stevens SS. Psychophysics. New York: John Wiley; 1975.
389 Sutton AJ, Cooper NJ, Abrams KR, Lambert PC, Jones DR. A Bayesian approach to evaluating net clinical benefit allowed for parameter uncertainty. J Clin Epidemiol 2005 Jan;58(1):26-40.
390 Sutton, A.J., Abrams, K.R., Jones, D.R., Sheldon, T.A., and Dong, F. (2000). Methods for meta-analysis in medical research. John Wiley & Sons, Chichester, ISDN 0 471 49066 0, Published October 2000.
391 Swinburn BA, Carey D, Hills AP, Hooper M, Marks S, Proietto J, et al. Effect of orlistat on cardiovascular disease risk in obese adults. Diabetes Obes Metab. 2005 May;7(3):254-62.
392 Tableau Software Inc. Tableau Software. http://www.tableausoftware.com/. 2012.
393 Tait AR, Voepel-Lewis T, Zikmund-Fisher BJ, Fagerlin A. The effect of format on parents' understanding of the risks and benefits of clinical research: a comparison between text, tables, and graphics. J Health Commun 2010 Jul;15(5):487-501.
394 Tan JKH, Benbasat I. The Effectiveness of Graphical Presentation for Information Extraction - A Cumulative Experimental Approach. Decision Sciences 1993 Jan;24(1):167-91.
395 Team TB-RA. The PhRMA BRAT Framework for Benefit-Risk Assessment--User's Guide to the Process: Final'. 2011.
396 Tervonen T, Figueira JR. A survey on stochastic multicriteria acceptability analysis methods. Journal of Multi-Criteria Decision Analysis. 2008;15(12):1-14.
397 Tervonen T, van Valkenhoef G, Buskens E, Hillege HL, Postmus D. A stochastic multicriteria model for evidence-based decision making in drug benefit-risk analysis. Stat Med. 2011;30(12):1419-28.
398 Tervonen T. JSMAA: an open source software for SMAA computations. In: C. Henggeler Antunes, D. Rios Insua, L.C. Dias (eds.), Proceedings of the 25th Mini EURO Conference on Uncertainty and Robustness in Planning and Decision Making (URPDM2010), Coimbra, Portugal, 2010.
399 Tervonen T. JSMAA: Open source software for SMAA computations. International Journal of Systems Science 2012; To appear.
400 Tervonen, T. and Figueira, J.R. (2008). A survey on stochastic multicriteria acceptability analysis methods. Journal of Multi-Criteria Decision Analysis, 15(1-2): 1-14.
401 Third report on the progress of the interaction with patients' and consumers' organisations during 2009. EMA/MB/117170/2010. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/11/WC500099257.pdf. 2010 October 7.
402 Thompson, J.P., Noyes, K., Dorsey, E.R., Schwid, S.R., and Holloway, R.G. (2008). Quantitative risk-benefit analysis of natalizumab. Neurology, 71(5): 357-364.
403 TIBCO Software Inc. TIBCO Spotfire. http://spotfire.tibco.com/. 2012.
404 Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, et al. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23.
405 Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care. 2004 Jan;27(1):155-61.
406 Townsend J, Buxton M, Harper G. Prioritisation of health technology assessment. The PATHS model: methods and case studies. Health Technol Assess 2003;7(20):iii, 1-iii,82.
407 Transatlantic workshop on Drug-related Progressive Multifocal Leukoencephalopathy (PML): Workshop Proceedings. EMA/674403/2011 Rev. 1. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500111562.pdf. 2011 September 8.
408 Trautmann H, Weihs C. On the distribution of the desirability index using Harrington's desirability function. Metrika 2006;63:207-13.
409 Tufte ER. Envisioning information. Graphics Press; 1990.
410 Tufte ER. The Visual Display of Quantitative Information. 1 ed. Cheshire, CT: Graphics Press; 1983.
411 Tufte ER. Visual explanations: images and quantities, evidence and narrative. Graphics Press; 1998.
412 UC Berkeley Visualization Lab. flare: data visualization for the web. http://flare.prefuse.org/ . 2009.
413 Uchino K,HAV. Dabigatran association with higher risk of acute coronary events: Meta-analysis of noninferiority randomized controlled trials. Archives of Internal Medicine. 2012; 172(5): p. 397-402.
414 Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rossner S. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97.
415 van Staa TP, Cooper C, Barlow D, Leufkens HG. Individualizing the risks and benefits of postmenopausal hormone therapy. Menopause 2008 Mar;15(2):374-81.
416 van Staa TP, Leufkens HG, Zhang B, Smeeth L. A comparison of cost effectiveness using data from randomized trials or actual clinical practice: selective cox-2 inhibitors as an example. PLoS Med 2009 Dec;6(12):e1000194.
417 van Staa TP, Smeeth L, Persson I, Parkinson J, Leufkens HGM. What is the harm-benefit ratio of Cox-2 inhibitors? Int J Epidemiol. 2008 Apr; 37(2): p. 405-413.
418 van Valkenhoef G, Tervonen T, Zwinkels T, de Brock B, Hillege H. ADDIS: A decision support system for evidence-based medicine. Decision Support Systems(0).
419 Wainer H. How to display data badly. The American Statistician 1984 May;38(2):137-47.
420 Walker S, McAuslane N, Liberti L, Salek S. Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment. Clin Pharmacol Ther 2009 Mar;85(3):241-6.
421 Weber EU, Shafir S, Blais AR. Predicting risk sensitivity in humans and lower animals: Risk as variance or coefficient of variation. Psychological Review 2004 Apr;111(2):430-45.
422 Weber EU. Perception and expectation of climate change: Precondition for economic and technological adaptation. In: Bazerman M, Messick D, Tenbrunsel A, Wade-Benzoni K, editors. Psychological Perspectives to Environmental and Ethical Issues.
423 Weinstein MC, Torrance G, McGuire A. QALYs: the basics. Value Health 2009 Mar;12 Suppl 1:S5-S9.
424 West SL, Squiers L, McCormack L, Southwell B, Brouwer E, Ashok M, et al. Quantitative summary of the benefits and risks of prescription drugs: a literature review. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM275355.pdf.
425 WHO-UMC. WHO Adverse Reaction Terminology - Critical Term List. http://www.umc-products.com/DynPage.aspx?id=73589&mn1=1107&mn2=1664. 1996. WHO Collaborating Centre for International Drug Monitoring.
426 Wickens CD, Lee J, Liu YD, Gordon-Becker S. An introduction to human factors engineering. 2nd ed. Upper Saddle River, New Jersey: Pearson Prentice-Hall; 2004.
427 Wilkinson L, Wills D, Rope D, Norton A, Dubbs R. The Grammar of Graphics. Springer; 2005.
428 Wintzen AR, , Loeliger EA, Bots GT. The risk of intracerebral hemorrhage during oral anticoagulant treatment: a population study. Ann Neurol. 1984 Nov; 16(5): p. 553-558.
429 Wolbers M, Koller MT, Witteman JCM, Steyerberg EW. Prognostic models with competing risks: methods and application to coronary risk prediction. Epidemiology. 2009 Jul; 20(4): p. 555-561.
430 Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug; 22(8): p. 983-988.
431 Wolf PA, Dawber TR, Thomas JH, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study. Neurology. 1978 Oct; 28(10): p. 973-977.
432 Woloshin S, Schwartz LM. Communicating data about the benefits and harms of treatment: a randomized trial. Ann Intern Med 2011 Jul 19;155(2):87-96.
433 York DA, Rossner S, Caterson I, Chen CM, James WP, Kumanyika S, et al. Prevention Conference VII: Obesity, a worldwide epidemic related to heart disease and stroke: Group I: worldwide demographics of obesity. Circulation. 2004 Nov 2;110(18):e463-70.