Perioperative Clinical Research Committee (PCRC)

The Perioperative Clinical Research Committee (PCRC) coordinates the clinical research efforts of MPOG, by reviewing all submitted research proposals and tracking the progress of ongoing research projects. MPOG supports a wide range of research projects, with examples including:

On a selective basis, MPOG additionally supports competitive high-impact projects:

The purpose of the committee is to ensure the appropriateness of the clinical research conducted within MPOG and the rational use of MPOG resources. It is primarily the responsibility of the institution’s MPOG Site Principal Investigator / Research Champion to review all proposals before submission to the PCRC.

Only colleagues from active MPOG sites can submit a research proposal to the PCRC for review. The following steps outline the process for submitting a research proposal:

Step One: Determine Feasibility

Prior to drafting a proposal, the primary author should discuss with their institution’s MPOG Site PI:

  • Proposed research question / study aims
  • How MPOG data will be used to answer the research question

The MPOG Site PI should provide the primary author with guidance on whether the research question is potentially answerable using MPOG data. If challenges are anticipated, the MPOG Site PI should work with the primary author to develop a strategy to mitigate these challenges, or develop an alternative research question.

After a discussion with the MPOG Site PI and review of MPOG data (as available via MPOG DataDirect, MPOG Concept Browser, and MPOG Phenotype Browser, if questions remain about the feasibility of the proposed research, the primary author and MPOG Site PI may consider contacting the coordinating center at mpog-research@med.umich.edu.  

Step Two: Draft Research Proposal

Completed Concurrently with Steps 3 and 4

After identifying a research question answerable using MPOG data, the primary author must draft a proposal to include the following:

  • Cover sheet - one page maximum
  • Full study protocol including Introduction, Methods, Statistical Analyses, and References
  • Data query specification (see Step Three)
  • PCRC Proposal Submission Checklist

Templates for drafting the PCRC proposal are available here:

An example of a completed PCRC proposal is available here:

  • Example PCRC Proposal - Coming soon
  • Example Data Query specification - Coming soon

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.

Step Three: Data Query Specification

Completed Concurrently with Steps 2 and 4

To accompany each research proposal must be a Data Query Specification, identifying 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.

Once familiarized with the content and quality of the data available within MPOG, the primary author must create a Data query specification through MPOG DataDirect. To obtain access to DataDirect, the primary author (and/or analysts) will need to complete the DataDirect Security Checklist and Authorization form and return it to the MPOG Central Team.

For ease of tracking, MPOG DataDirect enables users to save and share MPOG query IDs. To enable access to the necessary data for the proposed research, a Data query specification may be composed of multiple individual MPOG query IDs. At a minimum, the primary author should plan to develop at least two MPOG query IDs:

1. MPOG query for inclusion criteria - in order to generate a cohort of patients/cases to be analyzed, an MPOG query including all concepts/phenotypes, institutions, and date ranges must be developed in a unique MPOG query.

  • Importantly, the research team may refine their queried cohort via additional exclusion criteria, in order to develop a final analytic dataset. This is analogous to the starting population of a CONSORT flow diagram (inclusion criteria), and final population analyzed (exclusion criteria). However, such plans for exclusion criteria must be specified a priori in the PCRC proposal.

2. MPOG query for exposure variables, covariates, outcomes, and exclusion criteria - within the cohort of patients/cases identified from the inclusion criteria (#1 above), all data necessary for executing an analysis of a curated dataset must be separately developed in a unique MPOG query. Often, this will include both:

  • Variables occurring once per case (i.e. single measures); such as patient comorbidities, case type, and postoperative outcomes.
  • Variables occurring multiple times per case (i.e. repeated measures); such as physiologic, medication, and anesthesia provider data.

For more information on how to properly submit MPOG query IDs comprising a full MPOG Data Query Specification.  Information will soon be added to the MPOG DataDirect User Guide, please check back for the updated user guide.

Step Four: Estimate MPOG Cohort Sample Size / Refine Inclusions & Exclusions

Completed Concurrently with Steps 2 and 3

Based on the Data query specification developed (with both inclusion and exclusion criteria), the primary author must determine the approximate study sample size.

In some instances, sample sizes may be unexpectedly small. In such cases, the primary author will need to inspect each individual inclusion/exclusion criteria, through sequentially adding/removing the criteria within Cohort Identification Mode of MPOG DataDirect, and assessing the impact to final sample size. If continued difficulties are encountered at this stage, the primary author should first contact their institution’s MPOG Site PI for guidance. After a discussion with the institution’s MPOG Site PI, the primary author may consider contacting the coordinating center at mpog-research@med.umich.edu for additional guidance.

In other instances, sample sizes may be exceptionally large. For very large datasets (>500,000 patients and/or using variables with multiple values per case, e.g. physiologic or medication data), the study team must contact the coordinating center to develop a plan for a computationally feasible Data query specification.

Step Five: Institutional PI Review and Test Data Download

All study materials must be reviewed by the institution’s MPOG Site PI for completeness and appropriateness, including the clinical question, introduction/methods, the literature review, the Data query specification, and the adequacy of sample size for the proposed analyses.

The MPOG Site PI must also confirm that the institutional IRB is complete and appropriate for the study. Please note that all MPOG research projects require a separate IRB to allow for analysis and use of a limited dataset (containing dates of service) for research.

Concurrent with MPOG Site PI review, the primary author must perform a test data download of their institution’s data (access to multicenter data granted only after PCRC proposal approved). After a download of local data as relevant to the proposed research, the primary author will gain valuable insight as to the quality of the MPOG data, and 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. Should difficulties be encountered at this stage, the MPOG Site PI and the MPOG coordinating center can be contacted to provide guidance.

To aid in visualizing data quality, MPOG provides valuable research tools, including:

  • MPOG Data Explorer
    • Note: process for linking MPOG DataDirect Queries to Data Explorer currently under construction; check back for more updates.
  • MPOG Case-by-Case auditor
    • Coming soon

As an example of how such tools may be used to gain insight into quality of MPOG data, please review the Example Guide to Visualizing and Inspecting MPOG Data Quality (coming soon).

Uncommonly, 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 (mpog-research@med.umich.edu) and provide a brief explanation for not performing the test data download within the PCRC Proposal Submission Checklist.

Step Six: Submit Proposal to Coordinating Center

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 materials as e-mail enclosures. 

  • Cover Sheet
  • Full study protocol including Introduction, Methods, Statistical Analyses, and References
  • Data Query Specification
  • PCRC Proposal Submission Checklist Document

Once receiving PCRC proposal materials, a member of the MPOG Coordinating Center will contact the primary author to confirm receipt, address any unresolved issues, and - following addressing of unresolved issues - schedule a PCRC Review date.

Upon scheduling a PCRC review date, a statistician at the MPOG Coordinating center will liaise with the primary author’s statistician / statistical team to provide feedback on proposed statistical methods and quality of MPOG data used for the proposed research.

MPOG Coordinating Center members:

Step Seven: PCRC Review

The PCRC meets on the second Monday of each month, from 10:00am – 12:00pm Eastern Time Zone.  Proposals 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 Introduction and Methods complete and comprehensive?
  2. Is the specific study question concisely presented?
  3. Will the data requested be suitable for answering the study question?
  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?

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 Coordinating Center can display the PCRC proposal document on the presentation screen), or a short presentation (e.g. Powerpoint). The presentation length should target 10 minutes.

Following the presentation, a PCRC Review Committee member (independent from the study team) will provide a short critique followed by a moderated discussion open to all PCRC members. An example PCRC schedule is below:

  • PCRC Welcome
    • Address any housekeeping issues - 5 minutes
  • PCRC Presentation #1
    • Primary author / presenting author presents proposal - 10 minutes
    • PCRC Review Committee member provides critique - 5 minutes
    • Moderated open discussion - 5-10 minutes
    • Voting
  • PCRC Presentation #2
    • (repeat as above)
  • PCRC Presentation #3
    • (repeat as above)
  • Closing remarks - 2 minutes

The PCRC Review Committee is a rotating group of methods and clinical content experts, familiar MPOG research infrastructure, serving to provide focused feedback to the study team. One member from the PCRC Review Committee will serve as moderator for all PCRC proposals presented on a specific date. When possible, a PCRC Review Committee member will be selected to moderate, as matched by methodologic and clinical content expertise to the proposals presented.

Following discussion of each PCRC presentation, eligible participating MPOG sites will vote on the presented project. Four voting decisions can be made:

  • Approve
    • Proposal accepted as-is; no revisions necessary.
  • Approve with revisions
    • Proposal must be re-circulated electronically by the study team, addressing any feedback discussed during the PCRC review.
    • Re-circulation of the revised proposal must occur within four weeks; for revisions extending past four weeks, the study team must provide written explanation to the MPOG Coordinating Center for delays incurred.
    • Revisions made to the PCRC proposal should be made transparent (for example, use bold/red font, or summarize changes made in a cover letter).
  • Revise and re-present PCRC proposal
    • Following revisions addressing feedback discussed during the PCRC review, the study team will schedule a re-presentation of the proposed work at a future PCRC review, and undergo an additional round of voting.
  • Reject
    • Study team may not re-present the proposed work at a future PCRC review.
Step Eight: Register Study, Access Data, and Perform Analysis

Following PCRC approval and prior to multicenter data access, the study team must publicly register their research protocol, as required by 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.

Once registered, the study team will be given access to multicenter data via MPOG Central to perform the proposed analyses.

Step Nine: Create Project Manuscript

It is the obligation of the primary researcher to write a manuscript and abstract for all approved PCRC proposals.

The goal of the research project is to produce high quality original research which is submitted for publication in a peer-reviewed journal. If the primary author does not complete a draft of a manuscript within nine months of receiving the completed statistics on the data, a co-author may request primary authorship and assume the responsibility of authoring the manuscript. At this point the original primary author will assume a co-authorship role.

Immediately prior to manuscript submission at a target journal, the manuscript draft will be sent by the primary author to the MPOG Coordinating Center.  The manuscript will be processed via plagiarism detection software (iThenticate - service freely provided by the MPOG Coordinating Center); this report will be provided to the primary author.  The manuscript draft and the original PCRC proposal will then be circulated to the PCRC review committee to ensure that the data were used in the manner proposed. This review is not to evaluate the results or conclusions, simply to confirm that the data usage is consistent.