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Method for Establishing Authorship in a Multicenter Clinical Trial

David J. Whellan, MD, MHS; Stephen J. Ellis, PhD; William E. Kraus, MD; Katie Hawthorne, MD; Ileana L. Piña, MD; Steven J. Keteyian, PhD; Dalane W. Kitzman, MD; Lawton Cooper, MD; Kerry Lee, PhD; and Christopher M. O'Connor, MD
[+] Article, Author, and Disclosure Information

From Jefferson Medical College, Philadelphia, Pennsylvania; Duke University Medical Center and the Duke Clinical Research Institute, Durham, and Wake Forest University School of Medicine, Winston-Salem, North Carolina; Massachusetts General Hospital, Boston, Massachusetts; Case Western Reserve University, Cleveland, Ohio; Henry Ford Hospital, Detroit, Michigan; and the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.

Acknowledgment: The authors thank Sue Russell, MFA, for her assistance in developing, editing, and submitting this manuscript for publication.

Grant Support: By the National Heart, Lung, and Blood Institute, National Institutes of Health, for the HF-ACTION trial (NIH/NHLBI U01HL063747).

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: David J. Whellan, MD, MHS, Department of Cardiology, Jefferson Medical College, 1015 Chestnut Street, Suite 317, Philadelphia, PA 19107.

Current Author Addresses: Dr. Whellan: Department of Cardiology, Jefferson Medical College, 1015 Chestnut Street, Suite 317, Philadelphia, PA 19107.

Drs. Ellis, Kraus, Lee, and O'Connor: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.

Dr. Hawthorne: Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114.

Dr. Piña: Case Western Reserve University School of Medicine, Cleveland, OH 44106.

Dr. Keteyian: Division of Cardiovascular Medicine, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202.

Dr. Kitzman: Wake Forest University, Medical Center Boulevard, Winston-Salem, NC 27157-1045.

Dr. Cooper: Clinical Applications and Prevention Branch, Division of Prevention and Population Sciences, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Suite 10018, MSC 7936, Bethesda, MD 20892.

Ann Intern Med. 2009;151(6):414-420. doi:10.7326/0003-4819-151-6-200909150-00006
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With the emergence of large multicenter trials over the past 20 years, the numbers of investigators involved and publications resulting from each study have grown exponentially. An efficient, fair, and effective way to establish authorship on study-related manuscripts could diminish conflict among the investigators and help ensure robust and timely dissemination of study results. This article describes a process developed by the investigators in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial (ClinicalTrials.gov registration number: NCT00047437) to establish authorship of the manuscripts describing the baseline characteristics, study design, and trial outcomes in an equitable and transparent manner based on objective, quantifiable contributions to the study as a whole. The HF-ACTION investigators developed a scoring system that assigned points to investigators by using the criteria established for enrollment, adherence to the exercise program, data completion, committee service, and other trial efforts. The scoring system has been successfully implemented for baseline manuscripts and has allowed many investigators to participate in the HF-ACTION publication process.


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Figure 1.
Trial organization, as illustrated in the HF-ACTION design and rationale article.

Reproduced from reference (4), with permission from Elsevier. CPX = cardiopulmonary exercise; DSMB = data and safety monitoring board; Echo = echocardiography; HF-ACTION = Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training; Lab = laboratory; NHLBI = National Heart, Lung, and Blood Institute.

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Figure 2.
Flow chart outlining the process and tasks developed by the executive and publications committee for establishing authorship in HF-ACTION.

EC = executive committee; HF-ACTION = Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training; PC = publications committee.

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Figure 3.
Assignment of authorship by the publications committee in HF-ACTION.

HF-ACTION = Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training.

* Authors include principal investigator, co–principal investigator, and other study personnel.

† Assign available positions: lead author (first author), senior author (second, third, or last), and coauthor (all other positions).

‡ Points for assignment are as follows: lead author = 150 points; senior author = 100 points; and coauthor = 50 points.

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