Accepted for Publication: January 30, 2014.
Published Online: March 24, 2014. doi:10.1001/jamaneurol.2014.131.
Study concept and design: Beal, Oakes, Shoulson, Henchcliffe, Galpern, Haas, Juncos, Nutt, Voss, Ravina.
Acquisition of data: Beal, Henchcliffe, Ravina, Helles, Snively, Lew, Griebner, A. Watts, Pourcher, Bond, Kompoliti, Agarwal, Sia, Jog, Cole, Sultana, Kurlan, Richard, Deeley, Waters, Figueroa, Arkun, Brodsky, Ondo, Hunter, Jimenez-Shahed, Palao, Miyasaki, So, Tetrud, Reys, Smith, Singer, Blenke, Russell, Cotto, Friedman, Lannon, Zhang, Drasby, Kumar, Subramanian, Stuppy Ford, Grimes, Cote, Conway, Siderowf, Evatt, Sommerfeld, Lieberman, Okun, Rodriguez, Merritt, Swartz, Martin, King, Stover, Guthrie, R. L. Watts, Ahmed, Fernandez, Winters, Mari, Dawson, Dunlop, Feigin, Shannon, Nirenberg, Ogg, Ellias, C.-A. Thomas, Frei, Bodis-Wollner, Glazman, Mayer, Hauser, Pahwa, Langhammer, Ranawaya, Derwent, Sethi, Farrow, Prakash, Litvan, Robinson, Sahay, Gartner, Hinson, Markind, Pelikan, Perlmutter, Hartlein, Molho, Evans, Adler, Duffy, Lind, Elmer, Davis, Spears, Wilson, Leehey, Hermanowicz, Niswonger, Shill, Obradov, Rajput, Cowper, Lessig, Song, Fontaine, Zadikoff, Williams, Blindauer, Bergholte, Schindler Propsom, Stacy, Field, Mihaila, Chilton, Uc, Sieren, Simon, Kraics, Silver, Boyd, Hamill, Ingvoldstad, Jennifer Young, K. Thomas, Kostyk, Wojcieszek, Pfeiffer, Panisset, Beland, Reich, Cines, Zappala, Rivest, Zweig, Lumina, Hilliard, Grill, Kellermann, Tuite, Rolandelli, Kang, Joan Young, Rao, Cook, Severt.
Analysis and interpretation of data: Beal, Oakes, Shoulson, Henchcliffe, Galpern, Haas, Juncos, Nutt, Voss, Ravina, Shults, Gao.
Drafting of the manuscript: Beal, Oakes, Shoulson, Henchcliffe, Galpern, Haas, Juncos, Nutt, Voss, Jog.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Oakes, Gao.
Obtained funding: Beal, Oakes, Shoulson.
Administrative, technical, and material support: Beal, Helles, Snively, Griebner, A. Watts, Bond, Sia, Cole, Sultana, Arkun, Palao, Tetrud, Reys, Blenke, Cotto, Friedman, Zhang, Kumar, Cote, Evatt, Rodriguez, King, Stover, Feigin, Shannon, Glazman, Sethi, Farrow, Gartner, Pelikan, Hartlein, Hermanowicz, Song, Williams, Field, Chilton, Hamill, Jennifer Young, Panisset, Cines, Zappala, Lumina, Tuite, Rao, Cook, Severt, Boyar.
Study supervision: Beal, Oakes, Shoulson, Henchcliffe, Galpern, Haas, Juncos, Nutt, Voss, Ravina, Jog, Hartlein.
Conflict of Interest Disclosures: None reported.
Funding/Support: The study was funded by grants from the National Institute of Neurological Disorders and Stroke to the Cornell University (U01 NS 050324; Dr Beal, PI) and to the University of Rochester (U01 NS050573; Dr Oakes, PI). We were also supported by the Parkinson’s Disease Foundation with regard to facilitating minority enrollment.
Role of the Sponsor: Under the terms of the U01 funding mechanism, the steering committee included a National Institute of Neurological Disorders and Stroke representative (Dr Galpern), and the sponsor determined the charge to and membership of the DSMB, and approved all major protocol changes and the publication of this report.
The Parkinson Study Group QE3 steering committee: David Oakes, PhD (PI); M. Flint Beal, MD (PI); Ira Shoulson, MD (co-PI), Wendy R. Galpern, MD, PhD; Richard Haas, MD; Claire Henchcliffe, MD, DPhil; Jorge L. Juncos, MD; John Nutt, MD; Bernard Ravina, MD, MSCE; Tiffini Voss, MD; and Clifford Shults, MD (co-PI, deceased).
The Parkinson Study Group QE3 writing committee: Steering Committee and Emmanuelle Pourcher, MD; Pinky Agarwal, MD; Katie Kompoliti, MD; and Mandar Jog, MD.
Participating Sites (investigators and coordinators):Clinique Sainte-Anne “Memoire et Mouvement”: Emmanuelle Pourcher, MD; Louisette Bond, RN; Rush University Medical Center: Katie Kompoliti, MD; Booth Gardner Parkinson’s Care Center: Pinky Agarwal, MD; Cherissa Sia, MD; London Health Sciences Centre: Mandar Jog, MD; Linda Cole, RN; Munira Sultana, MD; University of Rochester: Roger Kurlan, MD; Irene Richard, MD; Cheryl Deeley, MS, RNC; Columbia University Medical Center: Cheryl Waters, MD; Angel Figueroa, CCRC; Ani Arkun; Oregon Health and Science University: Matthew Brodsky, MD; Baylor College of Medicine: William Ondo, MD; Christine Hunter, RN, CCRC; Joohi Jimenez-Shahed, MD; Alicia Palao, MA; Toronto Western Hospital, University Health Network: Janis Miyasaki, MD; Julie So; The Parkinson’s Institute: James Tetrud, MD; Liza Reys, CCRP; Katharine Smith, RN; University of Miami: Carlos Singer, MD; Anita Blenke; Institute for Neurodegenerative Disorders: David Russell, MD, PhD; Candace Cotto, RN; Butler Hospital: Joseph Friedman, MD; Margaret Lannon, RN, MS; University of California, Davis, Medical Center: Lin Zhang, MD, PhD; Port City Neurology, Inc: Edward Drasby, MD; Margaret Lannon, RN, MS; Colorado Neurological Institute: Rajeev Kumar, MD; Milton S. Hershey Medical Center: Thyagarajan Subramanian, MD; Donna Stuppy Ford, LPN; Ottawa Hospital Civic Site: David Grimes, MD; Diane Cote, RN; Jennifer Conway, RN; University of Pennsylvania: Andrew Siderowf, MD; Emory University School of Medicine: Marian Evatt, MD; Barbara Sommerfeld, MSN; Barrow Neurological Institute: Abraham Lieberman, MD; University of Florida: Michael S. Okun, MD; Ramon Rodriguez, MD; Stacy Merritt, MA; Camille Swartz, BA; University of Alberta: Wayne Martin, MD; Pamela King, BSN, RN; University of Alabama at Birmingham: Natividad Stover, MD; Stephanie Guthrie; Ray Watts; Cleveland Clinic: Anwar Ahmed, MD; Hubert Fernandez, MD; Adrienna Winters, BS; Johns Hopkins University: Zoltan Mari, MD; Ted Dawson, MD, PhD; Becky Dunlop, RN; North Shore–LIJ Health System: Andrew Feigin, MD; Barbara Shannon, RN; Weill Medical College of Cornell University: Melissa J. Nirenberg, MD, PhD; Mattson Ogg, BA; Boston University: Samuel Ellias, MD, PhD; Cathi-Ann Thomas, RN, MS; The Parkinson’s and Movement Disorder Institute: Karen Frei, MD; State University of New York Downstate Medical Center: Ivan Bodis-Wollner, MD, DSc; Sofya Glazman, MD; Thomas Mayer, PsyD; University of South Florida: Robert A. Hauser, MD, MBA; University of Kansas Medical Center: Rajesh Pahwa, MD; April Langhammer; University of Calgary: Ranjit Ranawaya, MD; Lorelei Derwent, RN; Georgia Health Science University: Kapil Sethi, MD; Buff Farrow, BS, ED; Rajan Prakash, MD, MPH; University of Louisville: Irene Litvan, MD; Annette Robinson, RN, BSN; University of Cincinnati/ Cincinnati Children’s Hospital: Alok Sahay, MD; Maureen Gartner, RN; Medical University of South Carolina: Vanessa Hinson, MD, PhD; Associated Neurologists, PC: Samuel Markind, MD; Melisa Pelikan, RN; Washington University: Joel S. Perlmutter, MD; Johanna Hartlein; Albany Medical Center: Eric Molho, MD; Sharon Evans, LPN; Mayo Clinic Arizona: Charles Adler, MD, PhD; Amy Duffy, CRC; Marlene Lind, RN; Medical University of Ohio: Lawrence Elmer, MD, PhD; Kathy Davis, RN; Julia Spears, CCRC; Stephanie Wilson, RN, MSN; University of Colorado Denver: Maureen Leehey, MD; University of California, Irvine: Neal Hermanowicz, MD; Shari Niswonger, RN; Banner Research Institute: Holly Shill, MD; Sanja Obradov, BA; Saskatoon District Health Board Royal University Hospital: Alexander Rajput, MD; Marilyn Cowper, BSc, Adv; University of California, San Diego: Stephanie Lessig, MD; David Song, MD; Deborah Fontaine, RNCS, MS; Northwestern University: Cindy Zadikoff, MD; Karen Williams; Medical College of Wisconsin: Karen Blindauer, MD; Jo Bergholte, BS, MS; Clara Schindler Propsom; Duke University: Mark Stacy, MD; Joanne Field, BSN, RN; State University of New York Upstate Medical Center and Syracuse VA Medical Center: Dragos Mihaila, MD; Mark Chilton; University of Iowa: Ergun Uc, MD; Jeri Sieren, RN; Beth Israel Deaconess Medical Center: David K. Simon, MD, PhD; Lauren Kraics; Althea Silver, MPH, BSN, RN; University of Vermont: James Boyd, MD; Robert Hamill, MD; Christopher Ingvoldstad, BA; Jennifer Young, CCRP; Ohio State University: Karen Thomas, DO; Sandra Kostyk, MD, PhD; Indiana University School of Medicine: Joanne Wojcieszek, MD; University of Tennessee Health Science Center: Ronald F. Pfeiffer, MD; CHUM–Hôpital Notre-Dame: Michel Panisset, MD; Monica Beland, RN; University of Maryland School of Medicine: Stephen Reich, MD; Michelle Cines, RN; Nancy Zappala; University of Sherbrooke: Jean Rivest, MD; Louisiana State University Health Science Center Shreveport: Richard Zweig, MD; L. Pepper Lumina; Colette Hilliard, MS; Parkinson and Movement Disorders Center of Maryland: Stephen Grill, MD, PhD; Marye Kellermann, RN; University of Minnesota: Paul Tuite, MD; Susan Rolandelli, RN; University of Chicago: Un Jung Kang, MD; Joan Young, CCRC; Ochsner Clinic Foundation: Jayaraman Rao, MD; Maureen Cook, RN, BSN; Beth Israel Medical Center: W. Lawrence Severt, MD; Karyn Boyar, RN, CNS, FNP.
Biostatistics/Coordination Center: David Oakes, PhD; Michael McDermott, PhD; Arthur Watts, BS; Shan Gao, MS; Brian Griebner, BA, MBA; Karen Helles, MS, NP, CCRA; Sandra Plumb, BS; and Victoria Snively, CCRC.
Medical Monitor: Mark Lew, MD; Tiffini Voss, MD.
Data and Safety Monitoring Committee: Cynthia Gross, PhD; Roger Albin, MD; Karen L. Bell, MD; Donna T. Chen, MD, MPH; and David E. Levy, MD.
Coordination Center: Amy Beimler, Rory Doolan, Sue Henderson, Lisa Lang, Gina Lau, Nichole McMullen, and Karen Rothenburgh.
Disclaimer: Dr Shoulson is the Clinical Trials Editor for JAMA Neurology and was not involved in the editorial review of the manuscript.
Additional Contributions: We thank the following QE3 investigators and coordinators who worked on the study from time of first enrollment. Arita McCoy (Johns Hopkins University); Bari J. Dorward (Booth Gardner Parkinson’s Care Center); Michelle Tran and Jassie Sombai (The Parkinson’s and Movement Disorder Institute); Monica Quesada (University of Miami); Roxana Hupcey (University of California, Davis Medical Center); Dawn Miracle (Colorado Neurological Institute); Lisa Altin (University of Pennsylvania); Mary Louise Weeks (Emory University School of Medicine); Edith Simpson (Barrow Neurological Institute); Michele Suelter (University of Florida); Ingrid Scott (University of Alberta); Rebecca McMurray (University of Alabama at Birmingham); Malinka Velcheva (Weill Medical College of Cornell University); Theresa McClain and Leyla Khavarian (University of South Florida); Jennifer Zimmerman (Medical University of South Carolina); Marci Zomok (Mayo Clinic Arizona); Mary E. Scott (Medical University of Ohio); Heena Olalde (University of Iowa); Jared Miller (Beth Israel Deaconess Medical Center); Colette Oesterle (University of Vermont); Paige Pancake (Ohio State University); Joann Belden (Indiana University School of Medicine); Daniel Soucy (University of Sherbrooke); Labrillia Johnson (Louisiana State University Health Science Center Shreveport); Rabih Kashouty and Lauren Roth (Beth Israel Medical Center); Lisa Niles, MS (Butler Hospital); and Breanna Nickels (Colorado Neurological Institute). These investigators and coordinators were compensated for their work in this study. The investigators served as individual site directors and performed the primary neurologic assessments. The site coordinators worked with their investigator and the coordination center staff to perform tasks designated to them by the study protocol and operations manual.