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A Priority of Archives of Neurology

Arch Neurol. 2004;61:20-21.

The maturation of neuroscience, insights into fundamental mechanisms, and applications of molecular genetics and cellular biology have fueled an unprecedented opportunity to carry out population-based clinical research aimed at identifying key risk factors and therapeutic interventions to relieve the burden of neurologic disease. The reporting of population-based clinical research, particularly of randomized controlled trials (RCTs), represents the final common pathway for translational research and the accrued knowledge base for our health and public policies. The Archives of Neurology editorial board is mindful of this importance and places high priority on the solicitation and publication of excellent reports of RCTs and other population-based neurologic research.

Excellent reporting is primarily dependent on the quality standards of the reported research. We seek well-conceived and scientifically grounded clinical research studies that are controlled and fashioned by statistical expertise, a documented protocol, and a prespecified plan of analysis. To aid comprehension and assessment of RCTs, we require a CONSORT¹ (Consolidated Standards of Reporting Trials) format that includes a flow diagram depicting enrollment, intervention allocation, follow-up, and analysis. We also require declarations from authors about human subject protections, sponsors and their relationships to authors, access to study data, and potential conflicts of interest (see "Instructions to Authors" in this issue of the ARCHIVES). We depend on peer review to evaluate the submitted report for accuracy and balanced presentation. When appropriate, we engage critical editorial comment about the scientific rigor, interpretation of data, and public health implications of the study.

Successful reporting of clinical research is also dependent on effective solicitation of authors and manuscripts, scrupulous and balanced peer review, and timely publication of informative articles and comments. Many large-scale RCTs examining neurologic interventions involve lengthy enrollment and require longitudinal observation for many months or even years. As an initiative, we intend to identify promising RCTs (and other population-based research) that have completed enrollment with a well-characterized cohort, including baseline clinical features, a specified plan of follow-up and analysis, and relevant biomarkers when appropriate. Even prior to the completion of follow-up and analysis of the prespecified (therapeutic) outcomes, investigators of these trials are invited to submit concise preliminary reports describing the fully enrolled cohort and study methods. Such reports of the baseline population and its clinical characteristics, prespecified methods of study and analysis, and the plans and timetable for longitudinal follow-up will provide readers with requisite knowledge of important studies in progress and opportunities for critical review. These publications will also set the stage for the eventual reporting of longitudinal data, including the epidemiologic and therapeutic outcomes of interest. This initiative is in keeping with the unmet need to "register" RCTs² and will help ensure that important negative as well as positive study results reach the scientific public.

The sister ARCHIVES and flagship JAMA publications have substantive resources and experience in the review, copyediting, and publication of RCTs and other population-based clinical research. As a member of the family of American Medical Association publications, Archives of Neurology enjoys distinct advantages in consortium reporting, including an accelerated process of editorial review. JAMA-Express and Archives Express provide authors with an opportunity for expedited review and publication of significant research reports that may affect public health. Submitted articles not judged to merit express publication but still worthy of regular publication do not ordinarily require another round of peer review. With the approval of the authors, submitted express or regular articles that are favorably reviewed but not best suited for JAMA may be considered without additional peer review for publication in Archives of Neurology. Like JAMA, Archives of Neurology will also accept group authorship in the authorship byline with a full appendix listing of all authors and their roles in the research.³ Archives of Neurology also maintains online electronic publishing and an interactive Web site (htttp://www.archneurol.com), inviting reader comments and containing links to other American Medical Association publication sites.

We trust that our initiatives in reporting excellent RCTs and other population-based research will benefit our authors and better inform our readers. We have assembled a subgroup of editors (Louis R. Caplan, MD; Mahlon R. DeLong, MD; James A. Ferendelli, MD; and John H. Growdon, MD) who are experienced in the conduct and reporting of clinical research and who will assist in facilitating this initiative and benchmarking our progress. We invite our authors and readers to comment to us directly (ira.shoulson{at}ctcc.rochester.edu or Roger.Rosenberg{at}UTSouthwestern.edu) on how to improve and expand our reporting of RCTs and other population-based clinical research. We believe that these new initiatives will become a vibrant centerpiece for Archives of Neurology and thus encourage submission and publication of the very best clinical research.

Ira Shoulson, MD
Department of Neurology
University of Rochester
1351 Mount Hope Ave, Suite 218
Rochester, NY 14618

Roger N. Rosenberg, MD, Editor

REFERENCES
1. Moher D, Schulz K, Altman D, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:1987-1991. FREE FULL TEXT 2. Dickersin K, Rennie D. Registering clinical trials. JAMA. 2003;290:516-523. FREE FULL TEXT 3. Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship for research groups. JAMA. 2002;288:3166-3168. FREE FULL TEXT

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