Enhanced Observational Studies

Multicenter Perioperative Outcomes Group (MPOG)
Enhanced Observational Studies Grant Program
Call for Proposals

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The Enhanced Observational Studies process is described on this page. For more information see our EOS FAQ page.

Background: Although the MPOG database contains rich electronic health record (EHR) and administrative data for millions of patients, many important perioperative research questions require additional data not collected consistently and routinely across all MPOG centers.  The MPOG coordinating center will organize an annual “enhanced” observational study across the member centers that integrates existing MPOG automated data collection infrastructure with focused, prospective observational data collection.  The result will be a unique perioperative pragmatic observational dataset that takes advantage of the best of various data collection methodologies.  Each year, all MPOG centers participating in the enhanced observational study program will dedicate a 2-4 week period to shift existing research personnel to collect additional data elements that cannot be reliably extracted from the EHR or administrative systems.  Using an MPOG research data collection application, research personnel at each center would manually collect prospectively defined structured data elements for all eligible patients.  The MPOG coordinating center software development, data extraction, statistical analysis, research investigator, and collaboration services will be offered free of charge to the selected proposal’s principal investigators.  Each participating center’s data collection efforts would also be granted to the winning proposal.  Building upon the lessons learned from the Royal College of Anaesthetists’ NAP and European Society of Anaesthesiology’s CTN infrastructure, we request submission of proposals by active MPOG centers. 

Key Dates:

Nov 2, 2016

Call For Proposals released

Dec 2, 2016

Compulsory 1-page Letter of intent (LOI) emailed to MPOG coordinating center by 8pm EST

Dec 5, 2016

LOIs posted to MPOG research website (behind login) for collaboration, transparent feedback

Dec 14, 2016

5pm EST deadline for combining two or more LOIs or withdrawal of LOI

Dec 15, 2016

LOI scoring opens

Dec 19, 2016

LOI scoring closes 8pm EST

Dec 21, 2016

MPOG executive board invites ~9 LOIs for solicitation of full proposal

Jan 27, 2017

Final full proposals emailed to MPOG CC by 8pm EST, posted to website

Feb 7, 2017

Proposal scoring closes at 8pm EST.

Feb 8, 2017

Three finalists announced, summary statements released

Feb 13, 2017

Finalists present proposals at PCRC meeting, Finalist scoring opens

Feb 15, 2017

Finalist scoring closes

Feb 17, 2017

MPOG executive board “ratifies” winning proposal

Feb - Jun 2017

Data collection software development, IRB review, staff planning

May - Jun 2017

Each center selects 2-4 week period for data collection

No funds will flow from one organization to another, so there are no grants administration activities, direct costs, or indirect costs associated with this grant program.  However, the grant coordination, software development costs, underlying MPOG data, and data collection personnel are highly skilled and valuable resources available to the winning proposal.

Submission process:

Any MPOG provisional or active or inactive center may submit a non-binding Letter of Intent (LOI).  Each center may submit more than one LOI or proposal.  An LOI is required to submit a full proposal.  LOI are limited to a 1 page, single-spaced, 11 point Arial or Calibri font, 1/2” margins. The LOI should include:

  1. Project title
  2. Investigators
  3. Background & Hypothesis
  4. Data collection & Research plan
  5. Impact

The LOIs will be posted to the research section of the MPOG website, and will require a log in to view.  The purpose of the LOI is to encourage collaboration across MPOG sites that may have overlapping or complementary project ideas. In addition, MPOG members will be able to post public comments on the website in order to provide constructive feedback to colleagues.  The process will enable investigators to create a full proposal that reflects the realities and perspectives of other MPOG centers.  Multiple LOI may be combined into a single LOI, or LOI may be withdrawn.  Final LOI submissions will be scored by PCRC members and approximately 9 will be invited for full proposal submissions.

Full proposals are invited and must be based upon a LOI submission.  Applicants are encouraged to incorporate early feedback from their LOI submission and collaborate with centers that have proposed complementary or overlapping proposals to maximize the impact of the final proposal.  Each proposal is limited to a total of 6 pages, single-spaced, 11point Arial or Calibri font, 1/2” margins and should include the standard MPOG PCRC proposal elements.

  1. Project title
  2. Principal investigator(s) from MPOG centers.  PIs must be from active MPOG centers.
  3. Co-investigators.  Co-Is may include collaborators from non-MPOG centers
  4. Background: What is the clinical problem or question that needs to be addressed? What is the epidemiology of the problem, what is already known, and what are the gaps in knowledge that need to be addressed? What preliminary data are already available
  5. Inherency: Why is an enhanced MPOG data collection methodology the logical next step in investigation for the problem?  Why are alternative research methodologies (other observational datasets, single center data collection, randomized controlled trial of an intervention) not the logical next steps
  6. Hypothesis
  7. Research plan:
    1. Patient inclusion/exclusion criteria
    2. Expectations for IRB review, patient consent, opt-out, or waiver of consent
    3. What centers are eligible for participation?
    4. What types of data would be collected manually via the enhanced data collection methodology? What data elements are assumed to be available via existing MPOG data collection? 
    5. Primary and secondary outcomes
    6. Proposed statistical analysis with management of missing data and confounder/selection bias.  Planned sensitivity analysis
  8. Expected personnel requirements: Needs from each data collection site and coordinating center
  9. Known limitations and next steps

Appendix must include (not counted toward 6 page maximum)

  1. Detailed data element list and description for proposed manual data collection.  Must include information regarding each proposed field to be retrieved: required/optional; data type (boolean, continuous numerical, categorical, free text)
  2. Data elements assumed to be available via existing MPOG automated data contribution.  Must include MPOG concept ID, MPOG concept name, MPOG standardized view, or MPOG variable
  3. Letter of support from Department of Anesthesiology Chairperson or Head of practice

Eligible applicants:

In order to maximize innovation and collaboration, any MPOG center that meets the MPOG bylaw definitions of provisional or active or inactive center is eligible to submit an LOI .

The principal investigator’s organization for the winning proposal must be an active center, per MPOG bylaws, and have contributed the MPOG minimum data set within the previous 3 months to be eligible to apply.  The determination of active status will be made on May 1, 2017.  If the principal investigator’s organization is not deemed to be active as of May 1, 2017, a collaborator from an active MPOG site will then serve as the principal investigator and lead author. The principal investigator must be a faculty member in the MPOG center’s department of anesthesiology or anesthesia practice.

Criteria for review / selection will include, but are not limited to:

  1. Significance: Does the proposal address an important clinical and/or scientific question in the field of perioperative medicine? Does the question necessitate the use of an enhanced observational MPOG study design? Would the results of the analysis lead to a fundable RCT of an intervention?  Are there follow-up studies that are fundable and/or impactful?
  2. Innovation: Does the proposal represent a novel approach or address a novel, understudied problem?  What is the potential for a novel, disruptive finding?
  3. Approach: Can the data be collected by a majority of MPOG research centers using existing research personnel and resources?  Will the data quality of manual data collection be adequate for impactful research publication?
  4. Investigators and environment:  Do the proposed investigators and center possess the skills and experience to successfully execute multicenter coordination?  Is there a track record of execution?

Final proposed scoring criteria are in development and will be circulated to PCRC and Executive Board members for review and comment.

Review process

1)      LOI review: There are two phases of LOI review

  1. Phase 1: After the initial LOI submissions are received, they will receive informal commentary using an MPOG collaboration website or confidential BaseCamp infrastructure.  This review and commentary will not affect final proposal review.  This is an opportunity for overlapping or complementary proposals to integrate into a single, stronger proposal.  Multiple LOIs submitted by Dec 2, 2016 may be combined into a single LOI by Dec 14, 2016. LOIs may be withdrawn by Dec 14, 2016.  No de-novo LOIs will be accepted after the initial submission deadline of Dec 2, 2016.
  2. Phase 2: Starting Dec 15, 2016, all LOIs will be confidentially scored by each active member organization.  Each organization will identify a single voting staff, assumed to be the MPOG research champion unless notified otherwise.  A single overall impact score will be provided, based upon NIH methodology, with a range from 1 (no weaknesses) to 9 (significant weaknesses that cannot be addressed).  Using these scores, the MPOG Executive Board will invite approximately nine LOIs to provide a full proposal submission.

2)      Full proposal review: There are three distinct phases of full proposal review

  1. Phase 1: In phase 1, all valid research proposals received by January 27th will be confidentially scored by each active member organization.  Each organization will provide a single voting staff, assumed to be the MPOG research champion unless notified otherwise.  Scoring will be based upon NIH criteria, with a range from 1 (no weaknesses) to 9 (significant weaknesses that cannot be addressed) across each criteria.  An overall impact score with prose comments will be required for each vote.  A center will not be able to vote on its own proposals.  Scoring will close on February 7th
  2. Phase 2: the top 3 scoring proposals will be announced on February 8th and will present a 10 minute proposal synopsis + 20 minutes question and answer session during the February 13th PCRC.  The presentation can incorporate changes to the proposal based upon the summary statements released to each proposal’s lead investigator.  The PCRC session will be recorded and available for viewing by close of business.  The three proposals will be scored by each active MPOG contributing site’s research champion.  Each proposal will be given a confidential priority score of 1 (highest impact), 2, or 3 (lowest impact) and prose comments. An organization must recuse itself from assigning a priority score to proposals for which it is the lead organization.  The average priority score and text of each proposal will be and forwarded to the MPOG executive board.
  3. Phase 3: The MPOG Executive Board, composed of 9 anesthesiology chairs and 3 ex-officio members (MPOG Executive Director, Research Director, and Quality Improvement Director), will review the average priority scores of the three finalists.  The final determination of the winning proposal will be made by the board, based upon the priority scores and prose comments.

Confidentiality Statement

By agreeing to participate in the Enhanced Observational Studies program, each MPOG institution and investigator acknowledges that each application represents significant work on behalf of the authors and that these proposals have been submitted in the spirit of good-faith collaboration among participating centers. Accordingly, in reviewing and commenting on these proposals, each institution’s investigators will maintain the confidentiality of proposals. They will not be forwarded to any individuals outside the MPOG Enhanced Observational Studies contributing or reviewing community.   Each center and investigator further agrees to defer to and offer collaboration with the relevant PIs before pursuing materially equivalent studies outside of the MPOG consortium (unless such studies have already been planned or are presently underway).

Please contact the MPOG coordinating center research and analysis staff at anes-mpog@med.umich.edu with any questions.  Email anes-mpog@med.umich.edu with the LOI, full proposals, and any other communications.

For more information see our EOS FAQ page