Pharmacoepidemiology and Drug Safety

Cover image for Vol. 23 Issue 5

Edited By: B.L. Strom, USA; J. Hasford, Germany; S Hennessy, USA; B.J. Park, Korea

Impact Factor: 2.897

ISI Journal Citation Reports © Ranking: 2012: 81/261 (Pharmacology & Pharmacy)

Online ISSN: 1099-1557


Author Guidelines


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Author Guidelines


1. AIMS AND SCOPE

The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology, defined broadly.

Particular areas of interest include:

  • design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
  • comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
  • methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
  • assessments of harm versus benefit in drug therapy;
  • patterns of drug utilization;
  • relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
  • evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.

2. MANUSCRIPT CATEGORIES

Pharmacoepidemiology and Drug Safety invites the following types of submission:

Original Reports

Original Reports are the Journal’s primary mode of scientific communication. Original Reports typically do not exceed 3000 words of body text, excluding abstract, tables, figures and references.

Reviews

Reviews of ‘hot topics’, controversies, and pharmacoepidemiologic methods are welcome. Reviews should be of a critical nature, discussing all sides of a question in a balanced manner. Experts considering offering such a review should feel free to contact one of the Regional Editors, as appropriate, in order to avoid unnecessary effort. All reviews will be peer-reviewed. Reviews typically should not exceed 3000 words of body text (excluding abstract, figures, tables and references), and be limited to 150 references.

Brief Reports

Succinct data papers, and in highly unusual situations case reports (Pharmacoepidemiol Drug Saf 2007; 16 :473), will be considered for publication as Brief Reports. Brief Reports should not exceed 1500 words excluding abstract, and be limited to 1 table, 1 figure and 15 references.

Commentaries

Commentaries cover a variety of topics of current interest in pharmacoepidemiology and pharmacovigilance, and the intersection between these disciplines and society. The Journal welcomes submissions and proposals. Commentaries are limited to 1500 words and 15 references. No abstract is required for a commentary.

Letters to the Editor

Letters to the Editor are encouraged, and may be in response to issues arising from recently published articles, or short, free-standing pieces expressing an opinion. No abstract is required, and text should be formatted in one continuous section. Letters are limited to 1000 words.

Research Protocol

PDS does not ordinarily publish study protocols without results. Rather, we strongly recommend that investigators post their research protocols in a publicly available archive such as ClinicalTrials.gov (http://clinicaltrials.gov/) or ENCePP (http://www.encepp.eu/encepp/studiesDatabase.jsp) and ask that they describe that posting in their manuscripts submitted to PDS. However, in unusual circumstances, PDS will consider publishing descriptions of the design and rationale of pharmacoepidemiologic studies, before study results are available. Characteristics of such descriptions that support consideration for publication include:

  • the study is of unusually high public health importance and interest to the readership of PDS
  • the study is of a scale that is likely to lead to multiple different subsequent results-oriented publications, each then able to refer to this original methods paper, rather than having to repeat the methods in detail
  • the rationale for important aspects of the research design is discussed in more depth than could be accommodated in a paper reporting the results, and in more detail than would usually be included in the protocol that would be posted on ClinicalTrials.gov or the ENCePP database.
  • the description will serve as an instructive teaching example

The format for the manuscript should be: Introduction, Design and Research Plan, Results (optional), and Discussion. Data describing the study population recruited can be included, if available, in the Results section of the publication. Please select ‘Research Protocol’ as the category for submission of the manuscript. The remainder of the format should be the same as that of Original Articles.

Other

Reviews of books and other media may be submitted only at the invitation of the Editors. However, suggestions are welcome.

3. EDITORS AND PEER-REVIEW

The Editor-in-Chief (Brian Strom) will apportion manuscripts to a Regional Editor based on location, unless there are conflicts of interest between the paper's authors and that regional office.

Papers from The Americas will be handled by:

Sean Hennessy
University of Pennsylvania School of Medicine, Center for Clinical Epidemiology and Biostatistics, 824 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021, USA
Tel: 1 215 898 9112. E-mail: kinman@pobox.upenn.edu

Papers from Europe and UK will be handled by:

Joerg Hasford
Ludwig Maximilian University of Munich, Marchioninistr. 15, D-81377 Munich, Germany
Tel: 49 89 7095 7480. E-mail: has-pds@ibe.med.uni-muenchen.de

Papers from Asia, Africa, the Middle East, and Oceania will be handled by:

Byung Joo Park
28 Yongon-Dong, 103 Daehakno, Chongno-Gu, Seoul 110-799, Korea
Tel: 44 23 9259 7220. E-mail: bjpark@snu.ac.kr

A fast-track review and publication process is in place for particularly time-sensitive findings of urgent public health importance. The Editor-in-Chief should be contacted to begin this process.

Authors are encouraged to propose reviewers who have special competence to review their work. Authors may also ask that, due to a possible conflict of interest, named members of the Editorial Board or other individuals should not be selected to review a particular submission. The Editors will pay close attention to such requests, but must reserve to themselves the final choice of reviewers.

4. SUBMISSION OF MANUSCRIPTS

All submissions should be made online at the Pharmacoepidemiology and Drug Safety ScholarOne Manuscripts site— http://mc.manuscriptcentral.com/pds. New users should first create an account. Once a user is logged onto the site, submissions should be made via the ‘Author Centre’.

Authors must also supply:

  • Completed Conflict of Interest Disclosure Form(s). Conflict of Interest (COI) disclosure forms must be uploaded with your manuscript files at submission. Please choose the file designation ‘Conflict of Interest form’ when submitting each of your forms. Please note: a separate COI form must be completed by the corresponding author and each co-author. If you do not submit separate COI forms for each of the authors, your manuscript will be un-submitted back to you.
  • Copyright and Permissions - If your paper is accepted, the author identified as the formal corresponding author for the paper will receive an email prompting them to login into Author Services; where via the Wiley Author Licensing Service (WALS) they will be able to complete the license agreement on behalf of all authors on the paper.

    For authors signing the copyright transfer agreement
    If the OnlineOpen option is not selected the corresponding author will be presented with the copyright transfer agreement (CTA) to sign. The terms and conditions of the CTA can be previewed in the samples associated with the Copyright FAQs below:

    CTA Terms and Conditions http://authorservices.wiley.com/bauthor/faqs_copyright.asp

    For authors choosing OnlineOpen
    If the OnlineOpen option is selected the corresponding author will have a choice of the following Creative Commons License Open Access Agreements (OAA):

    Creative Commons Attribution License OAA
    Creative Commons Attribution Non-Commercial License OAA
    Creative Commons Attribution Non-Commercial -NoDerivs License OAA

    To preview the terms and conditions of these open access agreements please visit the Copyright FAQs hosted on Wiley Author Services and visit http://www.wileyopenaccess.com/details/content/12f25db4c87/Copyright--License.html.

    If you select the OnlineOpen option and your research is funded by The Wellcome Trust and members of the Research Councils UK (RCUK) you will be given the opportunity to publish your article under a CC-BY license supporting you in complying with Wellcome Trust and Research Councils UK requirements. For more information on this policy and the Journal’s compliant self-archiving policy please visit: http://www.wiley.com/go/funderstatement.


  • 5. PREPARATION OF MANUSCRIPTS

    Manuscripts must be written in English.

    Text should be supplied in a format compatible with Microsoft Word for Windows (PC). Charts and tables are considered textual and should also be supplied in a format compatible with Word. All figures (illustrations, diagrams, photographs) should be supplied in jpg, tiff or eps format.

    All manuscripts must be typed in 12pt font with margins of at least 2.5 cm.

    Submissions must comply with the word limits defined in section 2, and include:

    Title Page

    The first page of the manuscript should contain the following information:

    • the title of the paper;
    • a running head not exceeding 50 characters;
    • names of authors;
    • names of the institutions at which the research was conducted;
    • name, address, telephone and fax number, and email address of corresponding author;
    • 2–6 article keywords;
    • up to 5 bulleted ‘take-home’ messages, or key points;
    • name(s) of any sponsor(s) of the research contained in the paper, along with grant number(s);
    • a Conflict of Interest statement, summarizing the information from each author (see section 4);
    • word count excluding abstract, tables, figures and references
    • a statement about prior postings and presentations.

    Abstracts

    Authors should note that structured abstracts (maximum 250 words) are required. The structured abstract should adopt the format: Purpose, Methods, Results, Conclusions. Abstracts should not contain citations to other published work.

    Letters and Commentaries do not require abstracts.

    Text

    This should in general, but not necessarily, be divided into sections with the headings: Introduction, Methods, Results, Discussion.

    Letters should be formatted in one continuous section. Commentaries should be formatted as appropriate to content.

    Tables and Figures

    Tables and figures should not be inserted in the appropriate place in the text but should be included at the end of the paper, each on a separate page.

    Tables and figures should be referred to in text as follows: Figure 1, Figure 2; Table 1, Table 2. The place at which a table or figure is to be inserted in the printed text should be indicated clearly on a manuscript. Each table and/or figure must have a legend that explains its content without reference to the text.

    Any figure submitted as a colour original will appear in colour in the Journal's online edition free of charge. Colour figures will be printed in the Journal on condition that authors contribute to the associated costs.

    Authors are responsible for obtaining permission to reproduce previously published figures or tables (see section 4).

    Abbreviations

    All abbreviations should be preceded the first time they appear by the full name except the SI symbols for units which are to be used without explanation. If systems other than SI units of measurement are employed, give conversion factors.

    Nomenclature

    Use generic names of drugs unless the specific trade name of a drug is essential to the discussion. Indicate sources of unusual materials and chemicals, and the manufacturer and model of equipment used.

    Reference Style

    PDS prefers references to primary sources when appropriate rather than reviews, and to permanent, archival sources when available rather than references to the web. Citations of sources that are continually changing are particularly problematic1.

    References should be indicated in the text by superscript Arabic numbers and listed at the end of the paper in the order in which they appear in the text. All references must be complete and accurate. Where possible the DOI for the reference should be included at the end of the reference. Online citations should include the date of access.

    Use Index Medicus abbreviations for journal names. For correct abbreviations visit ftp://ftp.ncbi.nih.gov/pubmed/J_Medline.txt.

    If necessary, cite unpublished or personal work in the text but do not include it in the reference list.

    References should be listed in the following style:

    • Emerson A, Martin RM, Tomlin M, et al. Prospective cohort study of adverse events monitored by hospital pharmacists. Pharmacoepidemiol Drug Saf 2001; 10: 85–92. DOI:10.1002/pds.574
    • Meichenbaum D and Turk D. Facilitating Transplant Adherence: A Practitioner's Guide. Plenum Press: New York, NY, 1987;44.
    • Cramer JA and Mattson RH. Monitoring compliance with antiepileptic drug therapy. In Patient Compliance in Medical Practice and Clinical Trials. Cramer JA and Spiker B (eds). Raven Press: New York, NY, 1991; 123–138.
    • FDA. Guidance for industry. Premarketing risk assessment. FDACDER/CBER, Rockville; March 2005. http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0187-gdl0002.pdf (accessed 1 January 2007).

    Supporting Information

    Supplementary materials are not proofed, so the contents should be considered final at the time the manuscript is accepted. Appendices will be treated as supplementary materials, so will be published online only as well. Supplementary files or appendices should be uploaded separately as Supplementary Material for Review.



    6. DECLARATION

    Original Publication

    Submission of a manuscript will be held to imply that it contains original unpublished work and is not being submitted for publication elsewhere at the same time.

    Prior posting on the internet normally constitutes publication. However, manuscripts based on reports to government agencies that are posted on the government agency’s website can be considered for publication. Similarly, manuscripts based on theses published on university websites can be considered for publication. The author must supply a full statement to the respective Editor about all postings, providing a link to the related report. If accepted for publication, a link to the published article on the journal website may then be inserted on the government or university website. The final published article, under copyright agreement, may not be posted on any other website without permission from the publisher.

    A statement about prior postings (with link to website) and public presentations must be included on the title page of the submitted manuscript.

    PDS encourages authors to release results of studies of public health importance to regulators as appropriate. This reporting is the responsibility of the author and the sponsor, however, not the journal. When relevant, it should be specified in the report that the manuscript is in press in PDS.

    Conflict of Interest

    Authors are responsible for disclosing all financial and personal relationships between themselves and others that might appear to bias their work. To prevent ambiguity, authors must state explicitly in the Conflict of Interest form whether potential conflicts do or do not exist. Authors should describe the role of the study sponsor(s), if any, in study design, in the collection, analysis and interpretation of data, in the writing of the report and in the decision to submit the report for publication. If the supporting source(s) had no such involvement, the authors should so state. (See section 4.)

    Clinical Trials Registration

    In accordance with the trials registration policy of the International Committee of Medical Journal Editors ( http://www.icmje.org ), Pharmacoepidemiology and Drug Safety encourages the registration of all interventional trials, whether early or late phase. The registry must be electronically searchable and accessible to the public at no charge (see http://www.who.int/ictrp/en/).

    Ethical Approval of Studies and Informed Consent

    For all manuscripts reporting data from studies involving human participants (i.e., human subjects research), formal review and approval by an appropriate institutional review board (IRB) or ethics committee is required, and should be confirmed in the Methods section. That board should be named in the paper. The authors should also state whether informed consent was obtained, or whether this requirement was waived by the IRB/ethics committee. Authors should be able to submit, upon request, a statement from the IRB/ethics committee indicating approval of the research, as well as either a sample of a patient consent form or a statement from the IRB/ethics board waiving the requirement for informed consent. For studies judged by the authors not to constitute human subjects research (e.g., computer simulations or epidemiologic studies performed in persons who cannot be identified or have the study information associated with them), the authors should specify the reason they believe the study is not human subjects research, and whether this determination was confirmed by an IRB/ethics committee.

    Authors are expected to follow the Guidelines for Good Pharmacoepidemiology Practices as described in Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. (link to article, with free access) PDS recommends that authors use STROBE (http://www.strobe-statement.org) as a guideline for the reporting of observational studies and CONSORT (http://www.consort-statement.org) as a guideline for the reporting of randomized controlled clinical trials.

    Authorship

    All persons designated as authors should qualify for authorship and all those who qualify should be listed. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. One or more authors should take responsibility for the integrity of the work as a whole, from inception to published article. Authorship credit should be based only on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; 3) final approval of the version to be published. Conditions 1, 2 and 3 must all be met. Acquisition of funding, the collection of data or general supervision of the research group, by themselves, do not justify authorship.

    Committee on Publication Ethics (COPE)

    As a member of the Committee on Publication Ethics (COPE), adherence to the aforementioned submission criteria is considered essential for publication in Pharmacoepidemiology and Drug Safety; mandatory fields are included in the online submission process to ensure this. If, at a later stage in the submission process or even after publication, a manuscript or authors are found to have disregarded these criteria, it is the duty of the Editor-in-Chief to report this to COPE. COPE may recommend that action be taken, including but not exclusive to, informing the authors' professional regulatory body and/or institution of such a dereliction.

    The website for COPE may be accessed at: http://www.publicationethics.org.uk

    7. ADDITIONAL INFORMATION ON ACCEPTANCE

    Proofs

    Proofs of accepted articles will be sent to the corresponding author for checking. This stage is to be used only to correct errors that may have been introduced during the production process. Prompt return of the corrected proofs, preferably within two days of receipt, will minimise the risk of the paper being held over to a later issue.

    Offprints

    Free access to the final PDF offprint or your article will be available via Author Services. Please therefore sign up for Author Services if you would like to access your article PDF offprint and enjoy the many other benefits the service offers.

    Early View

    Early View is Wiley's exclusive service presenting individual articles online as soon as they are ready before the release of the compiled print issue. Early View articles are complete, citable and are published in an average time of 6 weeks from acceptance.

    Note to NIH grantees

    Pursuant to NIH mandate, Wiley Blackwell will post the accepted version of contributions authored by NIH grant-holders to PubMed Central upon acceptance. This accepted version will be made publicly available 12 months after publication. For further information, click here

    Best Paper Award

    Pharmacoepidemiology and Drug Safety provides an annual Best Paper Award to the first author of the strongest contribution within a given volume, as determined by the Editors and a representative of the International Society for Pharmacoepidemiology (ISPE). The Award is open to all authors. Certificates and prizes are awarded at ISPE's annual meeting.

    PLEASE NOTE: PDS employs a plagiarism detection system. By submitting your manuscript to this journal you accept that your manuscript may be screened for plagiarism against previously published works.

1. Bould, MD, Hladowicz, ES, Pigford, A-A, et al. References that anyone can edit: review of Wikipedia citations in peer reviewed health science literature.
BMJ 2014;348:g1585 doi: 10.1136/bmj.g1585 (Published 5 March 2014)

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