PHAR P&P Policy and Instructions

Dataset Access and Publication Policies
Last updated September 2018

Recent changes:

11/2019: Updated submission instructions

10/2019: Updated authorship guidelines and suggestions for circulating proposals to site PIs

03/2019: Review for consistency and harmonization

11/2018: Updated Administrative Structure section. Updated instructions for citing authors and circulating proposals to PHAR PIs.

09/2018: Clarified authorship and proposal submission requirements

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Purpose of Guidelines

The intent of these policies is to facilitate the use of the PHAR data, to encourage collaboration among PHAR investigators, as well as to provide a mechanism for tracking intended analyses, presentations, and publications related to and resulting from PHAR data. These guidelines are to ensure appropriate use of the PHAR data, timely completion of projects, and adherence to timelines and principles of authorship.

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Administrative Structure

The Publications and Presentations (P&P) Committee will provide scientific and analytic review of concept proposals utilizing PHAR data. The Committee shall consist of at least one representative from the Coordinating Center (CC) and PHCC sites.

P&P Committee members will serve three-year terms, with members beginning their term on the first day of July. One-third of the members will rotate off the Committee yearly. Committee members can be reappointed, but new candidates will be prioritized for selection. Qualified candidates will be clinicians, researchers, or patients with experience in the publication and/or dissemination of quality improvement, observational, or interventional research in pulmonary hypertension (PH) and participating in the PHAR. New candidates will be nominated (self-nominations accepted) annually. The Committee will review nominations and recommend appointments to be approved by the PHAR steering committee.

The Committee should have at least one member at the level of Assistant Professor or Instructor if at all possible. Committee members will elect a member in the second or third year of their term as the chair of the committee for the subsequent year. If the Committee desires, the same chair can be selected for his/her second AND third year for a two-year term as Committee Chair.

All communications to the P&P Committee should be sent to the P&P Coordinator. The P&P Coordinator will be responsible for ensuring that the committee receives all necessary materials and communication for concept proposals, conference abstract presentations, and manuscripts/pen drafts.

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Investigators Eligible to Submit Proposals

The following investigators are eligible to submit concept proposals entailing use of the PHAR data:

1. PHCC Directors who have contributed data to the PHAR.
2. Members of the contributing PHCC Director’s team, including co-investigators, local colleagues (e.g. nurses and study coordinators), and/or other approved investigators (i.e. students, postdocs). Approval from a sponsoring PHCC Director is required prior to concept proposal submission.
3. Members of the PHAR Coordinating Center.
4. Representatives of the Pulmonary Hypertension Association, including allied health professionals and patients.
5. Members of the PHAR steering and liaison committees.
6. Individuals or organizations not previously referenced purchasing a Results Report through the PHAR Data Analysis Service (PHAR-DAS)

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Concept Proposals

Formal P&P review and approval of all concept proposals will be required prior to authors or analysts being provided with analytic data. Concept proposals are summarized research plans and are required for any investigator seeking to analyze the PHAR data. Concept proposals are also used to request analytic support from the CC. All coauthors must have seen and approved the manuscript proposal prior to submission.

 

Concept Proposal Content

Each concept proposal should be submitted online via the PHAR Submissions page. Click on 'Submit a new proposal' to get started. The concept proposal should include the following:

1. Introduction: Rationale and background, brief.
2. Research Hypothesis: Clearly state scientific questions to be addressed.
3. Data: List variables to be used, sample inclusions/exclusions.
4. Analysis plan and methods: Give detailed description of proposed statistical analyses. Please include the total sample size and any subsets of interest.
5. References

Concept proposals should be no more than 2-4 pages in length, excluding the references. Proposals longer than 4 pages will not be reviewed. P&P policy requires authors to include the study name ("The Pulmonary Hypertension Association Registry") at the end of their paper title. The only exceptions to this policy are when the Journal restricts the number of words allowed in the title or the paper combines data from multiple studies (then an abbreviation such as “The PHA Registry” or “PHAR” may be used, if possible).

Paper proposals will generally not be considered by the P&P committee unless it is feasible to begin data analysis within 12 months of proposal approval, based on the availability of sufficient endpoint data. This does not include unavailability of data due to technical problems, delays in data cleaning, or delays in data release. Some projects, like grant applications, may require a PHAR investigator to assure access to the data more than a year before a planned analysis. Exceptions to the 12-month analysis criterion may be made on a case by case basis, but the rationale for the exception should be explicitly stated in the proposal. This rationale should include a description of why an investigator needs to "reserve" a specific analysis far in advance of their intent or ability to conduct this analysis. The intent of this guideline is to prevent a large number of "placeholder" proposals, which may decrease the likelihood of ultimate publication and limit broader participation by investigators in the PHAR.

Lead authors may have a maximum of 2 active proposals at a given time.

Upon approval by the P&P Committee, the proposal will be assigned a manuscript number in the PHAR P&P database and will be visible online in the Table of Active and Completed Projects (located at http://phccregistry.org/Account/PHCCInternal/PublicationsPresentations). A copy of the submitted proposal will also be made available.

The P&P Committee, in consultation with the CC, will determine priorities for data analyses of manuscripts and abstracts to be performed by the CC. Analyses for other papers may start as soon as they are approved.

Concept proposals supported by grant funding from for-profit entities shall be processed through the PHAR-DAS mechanism, with all analyses occurring at the Coordinating Center. Concept proposals support by grant funding from peer-reviewed non-profits will be processed through a normal P&P process and analyses may be performed by the investigator or at the coordinating center if requested and resources permit. 

 

Submission

Submission of all concept proposals will occur on the PHAR publications website, https://pubs.phccregistry.org. Submissions require a confirmation of the following:

• All listed coauthors have read and approved the current version of the text.
• All PHAR PIs have been invited to participate in the proposal. A list of PIs is available at https://phccregistry.org/Account/PHCCInternal/RStatusAuthorshipInfo.

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Concept Proposal Guidelines and Policies

Authorship

Named authors will be determined by the final author list of the writing group on the Proposal Submission Form. All named authors must fulfill the criteria for authorship established by the International Committee of Medical Journal Editors and are expected to take an active role in formulating the research question, analyzing the data, drafting the manuscript, and assuring the integrity of the results.

All PHAR PIs should be invited to participate as coauthors on the writing group for new proposals. Those who do not respond, demur, or do not meet the ICMJE criteria for authorship will still be considered “collaborators” in an appendix referenced in the author list (e.g., named authors  “on behalf of the PHAR Investigators”). Collaborators denoted in this way are usually searchable on PubMed and other search engines. More information can be found here.

A complete list of PIs is available here. No more than two Steering Committee members should serve as named authors on each proposal and the inclusion of junior investigators in lead roles is encouraged.

Proposals with more than 3 authors at one site require justification from the first author. First authors are asked to explain how each coauthor will contribute to the paper. Proposals with more than 12 total authors will also require justification in their proposal.

When sharing a proposal with the site PIs, we suggest that the chair of the writing group use the following language or similar language when inviting site PIs to be named authors in the writing group:

“I would appreciate your review of the attached paper proposal for the PHAR. All site PIs are welcome to make comments and all will be included as “collaborators” for PHAR publications. Collaborators are usually searchable on PubMed. That is the hope for this project as well.

If anyone has a particular interest in this project and would like to be considered as a named writing author, please let me know. If you would like to be a named author in the writing group, please consider whether you plan on having a substantive role in the formulation of the research question, analysis of the data, and drafting of the manuscript as defined by the ICMJE criteria for authorship. If you think that you fulfill these criteria and are interested -please contact me, as the chair of this writing group, to discuss your potential role in this project.”

 

Formation of Writing Groups

Usually the manuscript proposer will be designated as the Writing Group Chairperson and first author of the paper. In general, an investigator should not have more than two approved and active, unpublished manuscripts which haven’t yet progressed to the pen draft stage in which he/she is the Writing Group Chairperson.

 

Writing Group Responsibilities

The Writing Group Chairperson is responsible for all phases of manuscript preparation, from conception through publication. These responsibilities include:
 

• Preparation of concept proposal, paper outlines, the identification of data analyses needed, and submission of any interim status reports to the P&P Committee;
• Assignment of tasks to Writing Group members with clear deadlines for completion of these tasks and determination that the tasks are completed on schedule;
• Preparation and circulation of drafts for approval by each member of the Writing Group before submission of a Penultimate Draft to the P&P Committee and before submission to a journal;
• Determination of the order of authorship on the manuscript. A major criterion will be the effort and contribution made by each member of the Writing Group in the preparation of the manuscript;
• Choice of a journal to which the manuscript will be submitted;
• Correspondence with coauthors, communication with the CC and the P&P Committee, responses to reviews, and to journal editors.
   

The Writing Group Chairperson should contact each member of the Writing Group to discuss the outline of the paper, data analysis plan, and the responsibilities and assignments for each member. Members of the Writing Group are responsible for performance of tasks assigned by the Chairperson within the allotted time period. Each member is expected to actively participate in the preparation of the manuscript.

All coauthors should alert the Writing Group Chairperson to changes in contact information. Failure to respond within a reasonable amount of time to a Chairperson’s request for coauthor feedback could result in removal from the Writing Group.

If a Writing Group member does not accomplish the tasks assigned to him/her and has not contributed to the manuscript, the Writing Group Chairperson may request that P&P approve removal of the member from the writing group. The chairperson must send an email to the P&P Coordinator requesting the removal of non-contributing members.

If the Writing Group Chairperson is unable to complete their responsibilities, they must select a new Chairperson after discussion with coauthors and request approval for the change from the P&P Committee. The authorship list should be edited on the publications website, and the P&P Coordinator should be notified.

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Schedule for Manuscript Preparation

The expected schedule for the development of a manuscript is described below. Deviation from this schedule must be approved by the P&P Committee. Failure to adhere to this schedule will prompt a review of circumstances. If it is determined that a manuscript is delinquent, this could be the basis for replacing member(s) of the Writing Group responsible for the delay, or for disbanding the Writing Group.

If the initial results lead to a split of the original paper into more than one manuscript, a new proposal should be submitted to the P&P Committee, along with a revision of the original proposal that matches the scope of the first manuscript.

 

Draft

For concept proposals that require CC statistical support, after notification by the P&P Committee of concept approval, an analyst will be assigned to the Writing Group. The Writing Group Chair, with consultation from the Writing Group, will have an initial discussion with the analyst to discuss the analysis plan and timeline for analysis completion.  After the analysis is completed, the Writing Group will prepare a first draft. This process will be managed by the Writing Group Chair. A first draft will consist, at a minimum, of an Introduction, Methods and Results Sections. A draft compiled by the Writing Group Chair should be sent to the other members of the Writing Group for review. It is recommended that a response deadline of 4 (four) weeks be given to Writing Group members for comments back to the Writing Group Chair to prevent unnecessary delays.

 

Penultimate Draft

The penultimate draft (“pen draft”) becomes due 4-6 weeks after the first draft comments are received from the Writing Group (see above). A pen draft should be sufficiently developed for subsequent submission to a journal. After review and approval of the pen draft by Writing Group members, the pen draft should be uploaded on the publications website on the same page as the concept proposal. Concept proposals are expected to reach pen draft stage within six months of P&P approval, or within six months of the availability of a CC analyst and related data readiness for the Writing Group.

The following information will be required on the online submission form:

1. Confirmation that all coauthors have seen and approved the manuscript version sent for P&P review
2. A cover letter listing any changes to authorship or the analysis plan that have occurred since concept approval
3. One target journal for publication submission.
4. A 1-2 paragraph lay summary of the research for possible release by the PHA after publication

 

Journal

Within thirty (30) days of receiving P&P Committee comments and verification confirmation, the revised manuscript will be circulated by the Writing Group chair to the Writing Group for final sign-off. The manuscript will immediately be submitted to a journal. A copy of the journal cover letter and final draft of the manuscript must be sent to the P&P Committee in addition to all coauthors.

The Writing Group Chairperson must keep the P&P Committee and the coauthors informed as to the manuscript’s progress through journal review. Upon publication of the manuscript, the Writing Group Chairperson must provide either a reprint or copies of the final publication to the P&P Committee. If there are substantive changes made in the manuscript during journal review (major findings or conclusions, alterations of the sample, exclusion/inclusion of major covariates), the revised manuscript should be submitted to the P&P Committee for re-review.

 

Acknowledgements

All publications using PHAR data shall use the following acknowledgement:

The Pulmonary Hypertension Association Registry (PHAR) is supported by Pulmonary Hypertension Care Centers, Inc., a supporting organization of the Pulmonary Hypertension Association. The authors thank the other investigators, the staff, and particularly participants of the PHAR for their valuable contributions. A full list of participating PHAR sites and institutions can be found at www.PHAssociation.org/PHAR.

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Data Analysis of PHAR Integrated Data

Following approval of a concept proposal, investigators may request a dataset for local data analysis or may request analysis support from the Coordinating Center. Investigators requesting datasets must first have a fully executed Data and Materials Distribution Agreement (DMDA) and complete a Data Request Form describing the complete list of variables requested for the analysis. The Data Coordinating Center will review all DMDAs prior to release of data to ensure that Data Use Agreements between PHCCs and the CC will be honored. Data will only be released for analysis to investigative groups with a qualified statistical analyst, as determined by the CC. Only de-identified data will be released for paper proposals using solely PHAR data. Sharing of data or results beyond the approved authors/analysts or analyses beyond those approved in the proposal or other violations of the DMDA may result in institutional and individual sanctions.

Guidelines for investigators to use in dealing with the Coordinating Center are:

• Plan systematically for the analysis of your data.
• Communicate with the assigned CC representative on the Writing Group for all requests and questions on analyses.
• Generate data requests in a timely fashion; requests will be allowed within the time window before and after the first draft.

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Preparation and Submission of Abstracts for Submission to Conferences

• New abstracts must be based exclusively on an approved concept proposals or submitted or published manuscripts.
• An abstract based on an approved paper should be submitted for review on the publications website no less than 2 weeks before the conference (abstract) submission deadline. It is strongly advised that authors submit abstracts well before this deadline, in order to allow sufficient time for revisions. There is no guarantee that abstracts submitted after the P&P deadline will be approved prior to the conference deadline.
• The P&P Coordinator will notify the first author (via email) when a decision from the P&P Committee is received.
• No abstract shall be submitted to any national or international organization for consideration prior to review and approval by the PHAR P&P Committee and sign-off from all coauthors. Any abstract submitted without these approvals may be asked to be withdrawn.
• If an abstract is not accepted upon its original submission, please let the P&P Coordinator know via email before you resubmit it to another conference.  
• If the abstract is accepted, a copy of presentation materials (including tables and graphs) and text are to be submitted to the P&P Program Coordinator as an email attachment, or uploaded to the submission's record on the publications website.

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Review of Proposal Materials

The P&P committee currently meets on an as-needed basis. Allow 1-2 weeks for review of proposals and abstracts. As submissions increase in number, the committee will shift to the process described below.

All publication materials—concept proposals, penultimate drafts, and abstracts—will be reviewed by the P&P Committee on a monthly basis. The P&P Committee will meet on the second Tuesday of each month. The P&P Coordinator will review all proposal materials to verify that P&P policies have been followed, so as to avoid unnecessary delays upon review. The goal of P&P review is to ensure that research proposals are scientifically sound, use appropriate methodology, and are not duplicative of ongoing or past efforts.

 

Review/Deadlines

The P&P Program Coordinator will make every effort to include all submissions in the next available P&P Committee teleconference. To allow sufficient time for processing and review, please submit all manuscripts by noon Pacific Time on Monday of the week before the next P&P teleconference. Refer to the PHAR publications website for teleconference dates and deadlines.

All materials submitted to the P&P Committee must first be reviewed and approved by all co-authors, with the status of coauthor approval indicated to the Committee at time of submission. If full Writing Group review and approval is not obtained, the Writing Group Chairperson must inform the P&P Committee.

The P&P Committee will provide all review of concept proposals, penultimate drafts, and abstracts followed by a discussion during a P&P Committee conference call. Afterward, the author will be sent a summary of reviewers’ comments.

If a proposal/pen draft/abstract is not approved by the P&P Committee, the draft will be returned to the Writing Group Chairperson with comments regarding the necessary revisions before resubmission. The Writing Group Chairperson will be responsible for the revision process, and should circulate the P&P Committee feedback to all authors, ensure that a plan is developed for responding to the requested revisions, and receive approval from all writing group members before a final draft is resubmitted to P&P.