Value In Health: Policies And Procedures

GENERAL MISSION AND POLICY STATEMENT

VH is committed to providing papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based.

Our interest in pharmacoeconomic and outcomes research issues is motivated by two basic propositions we hold as axiomatic. VH is open to all original papers bearing on these two propositions:

(a) the ultimate purpose of health care is to increase the overall health-related well being of the individual and of society as a whole; and

(b) society’s health care resources ought to be allocated in a way that maximizes total health-related well being, given the resources available.

Value in Health focuses on health care worth. Health care cost containment is not a matter of simply purchasing the cheapest drugs or other medical inputs. Increasingly, health care leaders need pharmacoeconomic studies, outcomes research and information that can guide them in health care resource allocation, and in evaluating alternative therapies and interventions. We see our role as encouraging and disseminating pharmacoeconomics and outcomes research and concepts that will be rigorous, methodologically or theoretically solid, ethically sound, and valuable to real-world decision-makers. As the official journal of ISPOR, our vision is to bring researchers and decision-makers together, translating science into practice.

Our goal is to set a high scientific standard, using editorial review and peer review not just to screen manuscripts, but also to foster dialog for researchers in the fields of pharmacoeconomics and outcomes research. Sound underlying theory and attention to detail enhances the credibility of pharmacoeconomics and its real world applicability. We feel that some of the theoretical foundations of pharmacoeconomics and health outcomes analyses need to be stronger.

VH invites research manuscripts based on coherent models, empirical studies, and theoretical work having pragmatic or policy-related implications. We don't intend VH to be a predominantly theoretical journal, but are seeking manuscripts that will influence thinking and decision-making in pharmacoeconomics, outcomes analysis, and heath care as a whole. VH invites editorials, policy pieces, letters-to-the-editor, and decision-maker commentary to create a dialog about how researchers can better respond to the needs of those making clinical and financial decisions in health care. We also welcome articles discussing specific examples of research that has had significant impact on health care decision-making.

VH hopes to invest pharmacoeconomics and outcomes analysis with high levels of rigor and a strong theoretical basis.

Appropriate valuation of pharmaceutical interventions requires multidisciplinary perspective and assessment of economic and outcomes data. Therefore, VH welcomes theoretical and empirical papers not only from economics, but also behavioral psychologists, sociologists, clinicians, ethicists, and others about health effects and health costs that further the foundations of this field and improve the quality and reliability of outcome evaluations of health care interventions.

There remain many challenging empirical and theoretical problems in the concept and measurement of both costs and health-related quality of life (QoL). VH hopes to attract interest in these problems and new, creative efforts to solve them. VH invites research on the development of standard tests for QoL instruments, especially innovative ways of assessing content or construct validity.

METHODOLOGICAL GUIDELINES

Critics point out that pharmacoeconomics and outcomes research lack consensus regarding methodological approaches, underlying theoretical paradigms and presentation of results. One major goal of VH is to serve as a forum where consensus can be built for development of conduct and reporting guidelines. We welcome articles on the philosophical foundations of pharmacoeconomics and outcomes research. Although these types of discussions risk being too esoteric for some of the journal’s anticipated audience, if written well, they can be thought provoking and insightful, and we feel they are an essential part of progress in developing methodological consensus.

The value of accepted methodology guidelines, even imperfect ones, far outweighs the confusion and skepticism that exists when no standards exist. Until a more comprehensive set of research guidelines is developed, we encourage authors where possible to include the Reference Case methodology advocated in the Russell et al. report on cost-effectiveness guidelines for the US Public Health Service ¹ for the purposes of comparability.

We would like VH to be an outlet for discussion and debate about the principles and substance of pharmacoeconomics and outcomes research. One suitable vehicle is the critical literature review. Reviews of methodology, theory, and empirical findings in special areas of health care or policy interest are welcomed. The last should incorporate author assessment of the validity and implications of the research as well as descriptions or summaries of results. Thoughtful, state-of-the-art reviews help bring bodies of research into clear focus.

JOURNAL FORMAT AND STYLE

We also welcome letters to the editor and commentary on the papers published in VH. We will invite editorials from various sources pertaining to the contents of issues. The only restriction placed on editorial content in VH is that it is relevant to the mission and objectives of VH, and it should deal with public or private health care policy issues, insofar as policy is influenced by questions surrounding the value of health care interventions.

SPECIFIC ISSUES OF POLICY

Where no policy yet exists on any specific issue, VH default policy is that of the International Committee of Medical Journal Editors [Uniform Requirements for Manuscripts Submitted to Biomedical Journals].²

SPONSORED RESEARCH

VH is pleased to receive manuscripts based on studies financially supported by public and private sponsors. However, we ask contributors of sponsored studies to meet the usual conflict-of-interest requirements and two additional requirements.

The first concerns data and models used in empirical studies. We understand that sponsored research often produces data that, because of cost or privileged nature, sponsors are reluctant to make publicly available. We believe the importance of validation takes precedence over data ownership rights. As a consequence, we will follow the general policies of major medical and economic journals, such as JAMA and the American Economic Review, in requiring that, subject to legal or regulatory restrictions protecting research subject confidentiality, all authors of empirical research make their databases accessible to referees or other persons we designate for examination or re-analysis of results. If such requests are made, all editors and reviewers of such information will sign and abide by strict confidentiality agreements limiting the scope of their evaluations only to relevant and appropriate review of the submitted manuscript.

The use of proprietary models and methodologies in empirical research is less common, but we believe that results obtained from black boxes do not advance knowledge. Thus we will require that all empirical models and methodologies be presented lucidly and in enough detail to make them fully comprehensible to readers and accessible for critical evaluation. We reserve the right to request that all authors make their software models or equations accessible to referees or other persons we designate for examination or re-analysis of results. Here also, if such requests are made, all editors and reviewers of such information will sign and abide by strict confidentiality agreements limiting the scope of their evaluations only to relevant and appropriate review of the submitted manuscript. Editors and/or VH reviewers would disqualify themselves from reviewing such models, equations or data if they have a perceived or actual conflict of interest.

The second requirement we ask of authors bears on the content of sponsored research. Sponsors sometimes regard the results of research that they request and finance as proprietary. We do not object to such a position unless it affects the researcher’s decision to publish. We believe that all significant, competently derived research findings should be disseminated, whether or not they advance a particular cause or proprietary interest. We ask the contributors of sponsored research to state that at no time did the sponsors impose conditions on their plans or decisions to seek publication, excluding limitations protecting commercial trade secrets, information that will jeopardize the confidentiality of research subjects, or the security of ongoing research. We realize that this policy cannot guarantee disinterested delivery of knowledge, but we hope it will encourage impartiality by sponsors in their support of pharmacoeconomic and outcomes research.

BLINDED PEER REVIEW

From September 15, 2003 it is the policy of Value in Health that peer review of submitted manuscripts is double blinded, i.e., the reviewers do not know the names of the authors of manuscripts and the authors do not know that names of the reviewers. Blinded reviews are common practice at many important scientific and medical journals ³. The Value in Health editorial office will remove all authors names before the paper is sent out for peer review.

REVIEWERS

Reviewers from the private sector are welcome unless there is a conflict of interest (see below); this is something to evaluate on a case-by-case basis. All potential reviewers are asked to inform VH of any possible or apparent conflicts of interest when they are invited to review.

REVIEW APPEALS

If an author disagrees with an editorial decision, that decision may be challenged directly with the VH Editor-in-Chief. It is entirely at the discretion of the Editor-in-Chief whether further consideration will be given to a decision, or whether additional reviews will be requested.

CONFLICT OF INTEREST

If there is a possibility of conflict of interest for any VH Editor-in-Chief, Co-editor, Guest Editor or reviewer, all effort will be made to eliminate the possible appearance of bias. Editors or reviewers with a potential personal interest in the publication of a manuscript will disclose this interest and not participate in review or decision-making regarding the manuscript’s acceptance in VH.

The Editor-in-Chief will be assumed to have a conflict of interest for any paper where he/she is an author or where his/her colleagues at work are authors. In such cases, the editorial assistant will assign the paper to one of the co-editors (on a rotating basis) to serve as the acting Editor-in-Chief for that paper. That co-editor will then assign the paper to another co-editor and the paper will go through the normal review process. The acting Editor-in-Chief will make the final decision about acceptance or rejection of the paper. Similarly, conflict of interest will be assumed for any co-editor who is an author on a paper or whose colleagues at work are authors on the paper. If the co-editor has a conflict of interest, the paper will not be assigned the paper. In addition to these assumed conflicts, the Editor-in-Chief or co-editors may declare a conflict of interest for any paper submitted based on other factors. In this case, the same actions will be taken as described above.

Reviewers will not be chosen to review a manuscript concerning research or a product where they have a real or potential financial interest or other personal stake (e.g., they are employed by¾or act as consultant to¾the pharmaceutical manufacturer that produces a product evaluated in a manuscript; they have direct financial interests that would be affected by the research, or they are in the same academic department as the author). The VH Editor will rely on potential reviewers to self-disclose such possible conflicts.

VH also requires authors to list all sources of support or other potential conflicts of interest. These are noted in the VH manuscript database, and in the acknowledgement section of published VH articles. At the discretion of the VH Editor, some conflicts of interest (e.g., stock positions) will not be publicly revealed to protect author privacy.

REVIEWER INFORMATION AND ACKNOWLEDGEMENT

We believe that it is important that reviewers are informed of the disposition of a manuscript once the Editor-in-Chief has made an editorial decision. This has the benefit of allowing a reviewer to learn from the suggestions made by other reviewers and to be aware of the opinions of the other reviewers. It is VH policy that once an editorial decision has been made for a manuscript, all reviewers of that manuscript receive a copy of all reviewer comments and a copy of the decision letter sent to the author. It is left to the discretion of the Co-editor to determine when a revised manuscript should be returned to reviewers for a second review; this will not be done routinely.

PUBLICATION OF ISPOR ANNUAL INTERNATIONAL MEETING AND EUROPEAN CONGRESS PLENARY PRESENTATIONS

The Conference Program Committees and the VH Editor-in-Chief will work together to decide which plenary session presentations are potential candidates for publication. The Editor-in-Chief, in consultation with Co-editors, will decide which presentations to select, and presenters will be contacted concerning publication. VH editorial staff will coordinate communication with the presenter, transcription, and editing. Manuscripts will be reviewed by two or three members of the VH Editorial Advisory Board to identify undesirable content or errors. This policy will be indicated as such in the published article. The VH Editorial Office will make final content decisions on these manuscripts. The presenter has the right of final approval or withdrawal.

SPECIAL SPONSORED SUPPLEMENT ISSUES

On 17 September 1999, the ISPOR Executive Board unanimously passed a motion to allow VH to solicit and publish single-sponsored Special issues. The ISPOR Executive Board encouraged the VH Editor and Editorial Advisory Board to develop rigorous standard to apply to these special issues, to ensure that VH scientific standards, independence, and quality were maintained. These policies were amended by the ISPOR Board of Directors on January 8, 2004.

Upon request, the policies and procedures for publication of a single-sponsored, peer-reviewed Special Issue of VH will be sent to potential sponsors. If the potential sponsor accepts the policies, ISPOR and the sponsor, in consultation with the VH Editor-in-Chief, will enter into a contractual agreement outlining the theme process, final product, and fee structure. Financial support for the publication of the Special Issue will be provided as an unrestricted grant to ISPOR.

ISPOR requires that the Special Issue development and production costs be determined and a contract agreed between ISPOR and the supplement sponsor(s) prior to issue development and production.

Supplements can only be feasible if they are, and are perceived to be, fair, balanced, and without sponsor bias. On the other hand, potential sponsors cannot feel that the conditions are too onerous or restrictive. Both the VH Editor-in-Chief and the sponsor will have certain decision points at which they may withdraw if either feels that the material is biased, or does not meet their objectives.

All content for a special issue is under the ultimate control of the VH Editor. A Guest Editor is appointed by the VH Editor for each special issue. The sponsor will suggest contributors for the supplement, but the final decision on publication of these contributions will be made by the Editor-in-Chief and the Guest Editor to ensure fairness, balance, and accuracy of content.

All contributions will be reviewed according to VH scientific peer review standards. Each article will be peer-reviewed individually with the understanding that there is no guarantee that all articles submitted will be published; contributions may be rejected on scientific merit.

Once ISPOR has contracted with a sponsor for VH to produce a Special Issue:

a. The sponsor will suggest papers for publication with the understanding that a Guest Editor will determine the final selection of papers for publication of the Special Issue.
b. VH Editor-in-Chief, in consultation with the VH Co-Editors, will choose a Guest Editor, who will be independent of the sponsor and have acknowledged expertise in the specified field. The Guest Editor may not be a member of the VH Editorial Staff, but may be a member of the VH Editorial Advisory Board or an ISPOR member.
c. All submissions require the same author financial disclosures, statement of intellectual contribution, and copyright transfer as standard VH articles.
d. The VH Editorial Office will coordinate all manuscript processing as for regular issues, working directly with the Guest Editor. All VH manuscript review policies will apply to review of special issue manuscripts
e. The Guest Editor will determine the final selection of papers.
f. Once a final line-up has been determined by the Guest Editor, a list of authors, titles, abstracts, and sources of support for all contributions will be circulated to the VH Editorial Advisory Board and to the sponsor, who may request copies of any manuscripts for preview and commentary, prior to publication. All final modifications will be under the control of the Guest Editor.
g. A policy statement regarding publication of single-sponsored, peer-reviewed Special Issue of VH will be included on the inside cover of each Special Issue.
h. ISPOR-sponsored supplements will be called "Special Issues," and industry-sponsored supplements will be called "Supplements" in the final printed version of the issue.

PUBLISHING PROCEEDINGS FROM ISPOR-SPONSORED OR CO-SPONSORED CONFERENCES

The following policy for the publication of Proceedings of ISPOR-sponsored or co-sponsored Conferences in VH as a Supplement to VH apply only to those conferences, meetings, or events for which sponsorship and adequate financial resources were approved by the Board of Directors. All papers presented at any ISPOR sponsored or co-sponsored conferences will pass a peer review process, and final decision regarding acceptability for publication with rest with the VH Editor-in-Chief. All efforts will be made to evaluate these papers fairly and expeditiously.

Representation from the VH Editorial Office will be invited to all ISPOR-sponsored meetings where VH is planning a conference proceedings supplement. ISPOR will negotiate financial coverage for recording, transcribing, and VH Editorial Office travel and production costs (ensuring printing of sufficient issues for all VH subscribers).

Reviewers for VH conference proceeding supplements will be asked to review submitted papers in the context of the conference itself; some conference presentations may be technical, some policy-oriented and some may review current knowledge in specialized fields or topics. When papers based on presentations are not technical or path breaking, they should be evaluated on their contribution to the conference. In cases where the material is not original, reviewers should evaluate its potential usefulness to conference participants or readers of the supplement.

AUTHOR INSTRUCTIONS

VH Author Instruction Guidelines are available in each issue of VH, and at the ISPOR website: http://www.ispor.org/publications/value/submit.asp.

All authors of VH articles must transfer copyright to VH prior to manuscript review. This copyright transfer is invalid if VH decides not to publish the manuscript, or if the corresponding author withdraws the manuscript prior to publication.

COMPLIMENTARY COPIES OF VH

All VH editors, Co-editors, and the Editorial Advisory Board are entitled to complimentary subscriptions to VH. Corresponding VH authors are sent a complimentary copy of the full issue of VH in which their article appears. This gives them an opportunity to see their article in the context in which it is read by VH subscribers.

MEETING REGISTRATION

The VH Editor-in-Chief and Managing Editor are entitled to complimentary registration at ISPOR Annual and Regional Meetings.

Co-editors receive a $150 discount off registration to the Annual International Meeting and/or European Congresses. To be eligible, the Editor-and-Chief and co-editors must have participated in at least 3 conference calls in the past calendar year and the Editor-in-Chief must have submitted a Board of Directors report prior to the BOD meeting at the International Meeting and/or Congress.

OFFPRINTS AND REPRINTS

Offprints are created when the journal is on the presses. They are extra copies of the articles that are printed at the same time that the journal is printed. Reprints are created after the journal has already published; they are more expensive because the printer has to put the journal back on the presses, remount the plates, etc.

All corresponding authors receive an order form for offprints when they receive page proofs of their article. If they place their orders within two weeks or so (before the journal is printed), the printer knows how many extra copies of their article to run. If authors don’t decide that they want copies of their articles until after the journal has published, then they need to fill out a reprint order form (available from the Blackwell Production Editor). Authors should send offprint and reprint order forms (and payment) directly to Odyssey Press, not to either Blackwell or the VH Editorial Office. All contact information is on the forms.

ON-LINE PUBLICATION

Beginning with Volume 8, Issue 4 of VH, accepted manuscripts of be published on-line a minimum of 2-3 weeks prior to assigned issue’s hard-copy publication date. The VH Editorial Office will adhere to the schedule provided by the Blackwell Production Office. As of March 1, 2005, cost for this will be $27.00 per article (includes manuscripts, scientific reports, editorials, commentaries, and correspondence), to be billed to ISPOR annually.

REPRINT OR REPRODUCTION PRICING POLICY FOR 1-PAGE ABSTRACTS

Quantity Ordered Price for Reprints (as of March 2005)

Photocopies no charge [request and reproduction permission must be in writing]*

100 copies $641
500 copies $1670
1000 copies $2803

* No reprints will be provided by Blackwell for less than 100 copies, although electronic versions are available through the Blackwell-Synergy website. For less than 100 copies, the requestor must, in writing (email/fax), state their purpose and request permission from the VH editorial office to reproduce copies. Upon request, ISPOR will send (email/fax) the permission.

The permission issued by Value in Health will sent in writing to the requestor and will read:

Permission is granted to reproduce not more than 100 copies of the abstract titled <title> from Value in Health, <Vol (issue): pg> for <purpose> with the following stipulations:

The copies are to be used only as described and this permission is for one-time use. Permission is expressly NOT granted for electronic reproduction.
Any reproduction of Value in Health, the Journal of the International Society for Pharmacoeconomics and Outcomes Research, remains the exclusive copyrighted property of the International Society for Pharmacoeconomics and Outcomes Research.

REPRODUCTION PRICING POLICY FOR 1-PAGE ABSTRACTS REPRODUCED ELECTRONICALLY

For-profit or sponsored websites will pay ISPOR $1000/yr to reproduce an abstract electronically; they must include the above permission statement. If this is done on a website, they will also provide a link to the ISPOR website. Alternatively, for no cost they may cite the abstract and provide a direct link to ISPOR's website, where VH abstracts and full-text articles can be obtained.

Academic and other non-profit organizations may reproduce single abstracts on their websites free of charge as long as they are not sponsored by a for-profit organization. They must request written permission from the VH editorial office and also include a like to the ISPOR website and permission statement.

REPRODUCTION OF A TABLE OR FIGURE FROM A VH ARTICLE

Because ISPOR retains copyright to all material published in VH, permission from the VH editorial office must be requested in writing (fax/email) before any component of an article from VH (table, figure, etc.) may be reproduced in another document. The use, to which the component will be put and potential circulation, must be described. Upon request, VH will send (email/fax) the permission, which will read:

Permission is granted to reproduce <component>, published in <title of article> from Value in Health, <Vol (issue): pg> for <purpose> with the following stipulations:

It is to be used only as described and this permission is for one-time use.
Any reproduction of Value in Health, the Journal of the International Society for Pharmacoeconomics and Outcomes Research, remains the exclusive copyrighted property of the International Society for Pharmacoeconomics and Outcomes Research.

REFERENCES

¹Russell et al reference

² International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Ann Intern Med 1997;126:36-47. [http://www.acponline.org/journals/annals/01jan97/unifreqr.htm, last updated May 1999]

³Davidoff, Frank. Masking, blinding and peer review: the blind leading the blinded. Ann Intern Med 1998;128:66-8.

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