BACKGROUND: While randomized controlled trials represent the highest level of evidence we can generate in comparative effectiveness research, there are clinical scenarios where this type of study design is not feasible. The Comparative Effectiveness Analyses of Surgery and Radiation in localized prostate cancer (CEASAR) study is an observational study designed to compare the effectiveness and harms of different treatments for localized prostate cancer, a clinical scenario in which randomized controlled trials have been difficult to execute and, when completed, have been difficult to generalize to the population at large. METHODS: CEASAR employs a population-based, prospective cohort study design, using tumor registries as cohort inception tools. The primary outcome is quality of life after treatment, measured by validated instruments. Risk adjustment is facilitated by capture of traditional and nontraditional confounders before treatment and by propensity score analysis. RESULTS: We have accrued a diverse, representative cohort of 3691 men in the USA with clinically localized prostate cancer. Half of the men invited to participate enrolled, and 86% of patients who enrolled have completed the 6-month survey. CONCLUSION: Challenging comparative effectiveness research questions can be addressed using well-designed observational studies. The CEASAR study provides an opportunity to determine what treatments work best, for which patients, and in whose hands.
BACKGROUND: While randomized controlled trials represent the highest level of evidence we can generate in comparative effectiveness research, there are clinical scenarios where this type of study design is not feasible. The Comparative Effectiveness Analyses of Surgery and Radiation in localized prostate cancer (CEASAR) study is an observational study designed to compare the effectiveness and harms of different treatments for localized prostate cancer, a clinical scenario in which randomized controlled trials have been difficult to execute and, when completed, have been difficult to generalize to the population at large. METHODS: CEASAR employs a population-based, prospective cohort study design, using tumor registries as cohort inception tools. The primary outcome is quality of life after treatment, measured by validated instruments. Risk adjustment is facilitated by capture of traditional and nontraditional confounders before treatment and by propensity score analysis. RESULTS: We have accrued a diverse, representative cohort of 3691 men in the USA with clinically localized prostate cancer. Half of the men invited to participate enrolled, and 86% of patients who enrolled have completed the 6-month survey. CONCLUSION: Challenging comparative effectiveness research questions can be addressed using well-designed observational studies. The CEASAR study provides an opportunity to determine what treatments work best, for which patients, and in whose hands.
Authors: Ian Thompson; James Brantley Thrasher; Gunnar Aus; Arthur L Burnett; Edith D Canby-Hagino; Michael S Cookson; Anthony V D'Amico; Roger R Dmochowski; David T Eton; Jeffrey D Forman; S Larry Goldenberg; Javier Hernandez; Celestia S Higano; Stephen R Kraus; Judd W Moul; Catherine M Tangen Journal: J Urol Date: 2007-06 Impact factor: 7.450
Authors: Paul A Harris; Robert Taylor; Robert Thielke; Jonathon Payne; Nathaniel Gonzalez; Jose G Conde Journal: J Biomed Inform Date: 2008-09-30 Impact factor: 6.317
Authors: James Mohler; Robert R Bahnson; Barry Boston; J Erik Busby; Anthony D'Amico; James A Eastham; Charles A Enke; Daniel George; Eric Mark Horwitz; Robert P Huben; Philip Kantoff; Mark Kawachi; Michael Kuettel; Paul H Lange; Gary Macvicar; Elizabeth R Plimack; Julio M Pow-Sang; Mack Roach; Eric Rohren; Bruce J Roth; Dennis C Shrieve; Matthew R Smith; Sandy Srinivas; Przemyslaw Twardowski; Patrick C Walsh Journal: J Natl Compr Canc Netw Date: 2010-02 Impact factor: 11.908
Authors: Colin B Begg; Elyn R Riedel; Peter B Bach; Michael W Kattan; Deborah Schrag; Joan L Warren; Peter T Scardino Journal: N Engl J Med Date: 2002-04-11 Impact factor: 91.245
Authors: Scott D Ramsey; Steven B Zeliadt; Catherine R Fedorenko; David K Blough; Carol M Moinpour; Ingrid J Hall; Judith Lee Smith; Donatus U Ekwueme; Megan E Fairweather; Ian M Thompson; Thomas E Keane; David F Penson Journal: World J Urol Date: 2010-10-20 Impact factor: 4.226
Authors: Gunnar Steineck; Fred Helgesen; Jan Adolfsson; Paul W Dickman; Jan-Erik Johansson; Bo Johan Norlén; Lars Holmberg Journal: N Engl J Med Date: 2002-09-12 Impact factor: 91.245
Authors: Patrick A Kupelian; Louis Potters; Deepak Khuntia; Jay P Ciezki; Chandana A Reddy; Alwyn M Reuther; Thomas P Carlson; Eric A Klein Journal: Int J Radiat Oncol Biol Phys Date: 2004-01-01 Impact factor: 7.038
Authors: J B Eifler; J Alvarez; T Koyama; R M Conwill; C R Ritch; K E Hoffman; M J Resnick; D F Penson; D A Barocas Journal: J Urol Date: 2016-10-27 Impact factor: 7.450
Authors: Kathryn L Taylor; George Luta; Richard M Hoffman; Kimberly M Davis; Tania Lobo; Yingjun Zhou; Amethyst Leimpeter; Jun Shan; Roxanne E Jensen; David S Aaronson; Stephen K Van Den Eeden Journal: Transl Behav Med Date: 2018-03-01 Impact factor: 3.046
Authors: Mark D Tyson; JoAnn Alvarez; Tatsuki Koyama; Karen E Hoffman; Matthew J Resnick; Xiao-Cheng Wu; Matthew R Cooperberg; Michael Goodman; Sheldon Greenfield; Ann S Hamilton; Mia Hashibe; Lisa E Paddock; Antoinette Stroup; Vivien W Chen; David F Penson; Daniel A Barocas Journal: Eur Urol Date: 2016-11-03 Impact factor: 20.096
Authors: Daniel A Barocas; JoAnn Alvarez; Matthew J Resnick; Tatsuki Koyama; Karen E Hoffman; Mark D Tyson; Ralph Conwill; Dan McCollum; Matthew R Cooperberg; Michael Goodman; Sheldon Greenfield; Ann S Hamilton; Mia Hashibe; Sherrie H Kaplan; Lisa E Paddock; Antoinette M Stroup; Xiao-Cheng Wu; David F Penson Journal: JAMA Date: 2017-03-21 Impact factor: 56.272
Authors: Heather L Huelster; Aaron A Laviana; Daniel D Joyce; Li-Ching Huang; Zhiguo Zhao; Tatsuki Koyama; Karen E Hoffman; Ralph Conwill; Michael Goodman; Ann S Hamilton; Xiao-Cheng Wu; Lisa E Paddock; Antoinette Stroup; Matthew Cooperberg; Mia Hashibe; Brock B O'Neil; Sherrie H Kaplan; Sheldon Greenfield; David F Penson; Daniel A Barocas Journal: Urol Oncol Date: 2020-07-29 Impact factor: 3.498
Authors: Aaron A Laviana; Zhiguo Zhao; Li-Ching Huang; Tatsuki Koyama; Ralph Conwill; Karen Hoffman; Michael Goodman; Ann S Hamilton; Xiao-Cheng Wu; Lisa E Paddock; Antoinette Stroup; Matthew R Cooperberg; Mia Hashibe; Brock B O'Neil; Sherrie H Kaplan; Sheldon Greenfield; David F Penson; Daniel A Barocas Journal: Eur Urol Date: 2020-02-22 Impact factor: 20.096
Authors: Maximilian F Lang; Mark D Tyson; JoAnn Rudd Alvarez; Tatsuki Koyama; Karen E Hoffman; Matthew J Resnick; Matthew R Cooperberg; Xiao-Cheng Wu; Vivien Chen; Lisa E Paddock; Ann S Hamilton; Mia Hashibe; Michael Goodman; Sheldon Greenfield; Sherrie H Kaplan; Antoinette Stroup; David F Penson; Daniel A Barocas Journal: Urology Date: 2017-02-09 Impact factor: 2.649
Authors: Matthew J Resnick; Daniel A Barocas; Alicia K Morgans; Sharon E Phillips; Tatsuki Koyama; Peter C Albertsen; Matthew R Cooperberg; Michael Goodman; Sheldon Greenfield; Ann S Hamilton; Karen E Hoffman; Richard M Hoffman; Sherrie H Kaplan; Dan McCollum; Lisa E Paddock; Janet L Stanford; Antoinette M Stroup; Xiao-Cheng Wu; David F Penson Journal: Eur Urol Date: 2014-08-28 Impact factor: 20.096
Authors: Matthew J Resnick; Daniel A Barocas; Alicia K Morgans; Sharon E Phillips; Vivien W Chen; Matthew R Cooperberg; Michael Goodman; Sheldon Greenfield; Ann S Hamilton; Karen E Hoffman; Sherri H Kaplan; Lisa E Paddock; Antoinette M Stroup; Xiao-Cheng Wu; Tatsuki Koyama; David F Penson Journal: Cancer Date: 2014-02-07 Impact factor: 6.860