The research committee coordinates the clinical research efforts of MPOG, by reviewing all submitted research proposals and tracking the progress of ongoing research projects. The committee ensures the appropriateness of the clinical research conducted within MPOG and the use of MPOG resources. Only colleagues from active MPOG sites can submit a research proposal to the PCRC for review and it is the responsibility of the MPOG site's Principal Investigator (PI) to review all proposals before submission to the PCRC.

The following steps outline the process for submitting a research proposal:

Prior to developing an MPOG research project, new users should obtain access to necessary research tools by completing an MPOG DataDirect Security Checklist & Authorization.

Additionally, it is highly recommended that researchers review the MPOG user Tips and Tricks video modules.

Members of the Coordinating Center research team are willing to help through the process of writing a proposal as well.  

MPOG Coordinating Center members can be found below:

 

  • MPOG Research Director – Sachin Kheterpal, MD, MBA

  • MPOG Associate Research Director – Michael Mathis, MD

  • MPOG Research Facilitator – Shelley Vaughn

  • MPOG Research Facilitator – Sandy Rozek

  • MPOG Research Assistant – Rachel Hurwitz

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As the primary author begins formulating an idea but prior to drafting a proposal, they should discuss with their local institution’s MPOG Site PI:

If the MPOG Site PI anticipates challenges, they should work with the primary author to develop a strategy to mitigate these challenges, or develop an alternative research question.

As part of determining project feasibility, the primary author should complete a  preliminary review of what MPOG data is available and pertinent to the research proposal (via MPOG DataDirect, MPOG Concept Browser, and MPOG Phenotype Browser). This usually includes an initial Data Direct query and/or site-level analysis to ensure that the data quantity and quality are sufficient.

After a discussion with the MPOG Site PI and review of data, the primary author must submit a cover sheet (one-page limit) to the coordinating center briefly outlining the proposed research via the Research Consultation Form. The cover sheet can be found on the first page of the PCRC Proposal Template (see Step 3 below).

 

Submitting the cover sheet allows the MPOG Coordinating Center to maintain current records and  to provide preliminary feedback, or connect the primary author with other MPOG researchers with overlapping research interests. 

Completed Concurrently with Steps 4 and 5

The primary author must obtain additional project-specific IRB approval at their institution to allow for analysis of a limited dataset (containing dates of service) for research. If required by the IRB, language to describe the HIPAA-compliant MPOG external statistical server can be found here

The primary author should then draft a PCRC proposal that includes the following:

  • Cover sheet (from Step 2)

  • Full study protocol including Introduction, Methods, Statistical Analyses, and References

  • Data query specification (see Step 4)

  • PCRC Proposal Submission Checklist

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Templates for drafting the PCRC proposal are available here:

An example of a completed PCRC proposal is available here:

 

The primary author must identify an individual or a group within their institution to serve as the statistician(s) on the project. The research proposal should include a curated analytic plan that specifies the statistical techniques and methodologies for analyzing big data. These details are covered in the Cover sheet / study protocol template above.

 

Additionally, research proposals should be designed with an intent to publish a single manuscript. Exceptions may be made at the discretion of the PCRC committee at the time of PCRC review. However, in most cases, if multiple manuscripts are intended, each manuscript should be addressed via a separate research proposal and PCRC voting decision.

Completed Concurrently with Steps 3 and 5

Each research proposal must be accompanied by a Data Query Specification that identifies MPOG concepts and phenotypes to be analyzed. To develop this specification, it is recommended that the primary author first review the structure of MPOG data, as available within the MPOG Concept Browser and MPOG Phenotype Browser. Additional directions and a sample query spec template can be found here

The primary author must download their local institution’s data to gain valuable insight as to the quality of the MPOG data, and they may elect to revise study methodology (i.e. study inclusion/exclusion criteria, analytic plan, exposure variables/covariates/outcomes collected) in order to mitigate obstacles to the proposed research. Although a complete single-center study using local institution data does not need to be performed as a prerequisite to PCRC, such data downloaded should be used to develop the “Preliminary Single Center Data” section of the PCRC proposal (including items such as summary statistics, data missingness/accuracy, etc.). Should difficulties be encountered at this stage, the MPOG Site PI and the MPOG Coordinating Center can be contacted to provide guidance.

 

Occasionally, the study team may determine that a test data download of their institution’s data is infeasible for the proposed research. Most often, this is due to the study team targeting a cohort of patients primarily at other MPOG institutions. In such cases, the study team must discuss this issue with the MPOG Coordinating Center and provide a brief explanation for not performing the test data download within the PCRC Proposal Submission Checklist.

After completing all the PCRC proposal materials, the primary author must contact the MPOG Coordinating Center at mpog-research@med.umich.edu, and provide the following attachments. 

  • Cover sheet (from Step 2) – one page maximum

  • Full study protocol including Introduction, Methods, Statistical Analyses, and References

  • Data query specification (see Step 4)

  • PCRC Proposal Submission Checklist Document

  • Response to Reviewers (revised PCRC presentations only)

Within the Cover Sheet, we recommend that the primary author list individuals considered eligible for by-line authorship, with attention given to ICMJE requirements for authorship. Please review the MPOG Guidelines on authorship and collaborator status for manuscripts, which can be found here

Once the PCRC proposal materials have been received, a member of the MPOG Coordinating Center will confirm receipt and address any unresolved issues.

 

Upon scheduling a PCRC review date, the MPOG Coordinating Center will liaise with that month’s moderator and the study team.

The PCRC meets on the second Monday of each month, from 10:00 a.m. – 11:30 a.m. Eastern Time Zone. Finalized proposals (including any recommended revisions from the MPOG Coordinating Center) must be received four weeks prior to a meeting to be considered for review.

Members of the PCRC will evaluate proposals based on the following questions:

  1. Is the study as presented in the introductions and methods complete and comprehensive?

  2. Is the specific study question concisely presented?

  3. Will the data requested be suitable for answering the study questions?

  4. Are the proposed statistical techniques appropriate?

  5. Is the literature review complete and comprehensive?

  6. Does the study address a clinically significant healthcare issue?

  7. Revised PCRC presentations only: Does the study team adequately respond to the addressable feedback from the previous PCRC presentation? 

Prior to the PCRC Review, the primary author (or study team presenter) must communicate to the MPOG Coordinating Center the presentation plan. This can simply be an oral summary of the proposed research (and the Coordinating Center can display the PCRC proposal document on the presentation screen), or a short presentation (e.g. Powerpoint). The presentation should last approximately 10 minutes.

Following the presentation, a PCRC Moderator Committee member (independent from the study team) will provide a short critique followed by a moderated discussion open to all PCRC members. 

 

Following discussion of each PCRC presentation, eligible participating MPOG sites will vote on the presented project. Each MPOG site has one vote, collaboratively made by the site PI Champion, or site faculty designated by the site PI Champion, in discussion with other site faculty (e.g. Surgery Clinical Champion, Anesthesia IT Champion). There are four possible voting decisions: Approve, Approve with Revisions, Revise and Represent, and Reject. More details on voting decisions can be found here. 

Following PCRC approval, multicenter data inspection (e.g. descriptive statistics), and additional data cleaning/pre-processing (e.g. exclusion of outliers, transformation of continuous variables to categorical variables), but prior to analyses (e.g. univariate and multivariable associations), the study team should consider publicly registering their research protocol, as required by some scientific journals. The goal of a priori research protocol registration is to improve the openness, integrity, and reproducibility of the research performed.

Study registration can be performed via the Open Science Framework, a scholarly commons for tracking projects through the research cycle. For the majority of MPOG projects, the recommended pathway is the Open-Ended Registration option on the OSF website.

Projects requiring a data query, or expansion of centers included in the initial data query, more than one year after approval require re-review by the PCRC community per the following protocol:

 

  • Between 1-2 years after approval – verbal communication during a PCRC meeting, with an electronic survey vote to current active PCRC members

  • Greater than 2 years after approval – re-presentation at PCRC with a new PCRC community vote

Please note: only active sites will have access to PCRC meeting notes and recordings.