The STS Institutionally/Investigator Funded & Analyzed Research Program allows analysis of national-scale de-identified data, or participant user file, from the STS National Database at investigators’ institutions.  

STS RAC Analyzed | De-identified Data  

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Purpose

The Institutionally/Investigator Funded & Analyzed research program based on the STS National Database (STSND), or equivalently the Participant User File (PUF) program, was established in late 2016. It is a unique program in many aspects and was designed primarily to give investigators the opportunity to pose research questions, quickly obtain quality de-identified data, conduct analyses at their own institutions, receive insightful reviewer feedback, and develop their efforts into an abstract and manuscript.  

This program is guided by three primary principles: 1) facilitating research by STSND participants, 2) ensuring research output of the highest quality, and 3) protecting the confidentiality of STS and participant data, while maintaining patient privacy. 

Eligibility & Guidelines
  • Principal Investigator (PI) Requirements and Limitations:  
    • A PI requesting research-related access to Investigator Funded & Analyzed or PUF data or PUF must be an STSND surgeon participant in good standing.  
      • A research scientist affiliated with an STSND surgeon participant in good standing may also be eligible (i.e., an STSND participant must be a listed co-investigator in this case).  
    • A PI can have only one approved active Investigator Funded & Analyzed or PUF study in which he or she is PI at any given time, where active means before formal submission of manuscript for publication.  
      • However, a PI can be a co-investigator on other Investigator Funded & Analyzed or PUF projects.  
  • Statistical Requirements:
    • Assessment of the statistical analysis team’s experience and capacity to carry out the proposed research and analyses is an integral part of the review process. To be eligible for approval, the proposal’s analytic team must include a PhD-level biostatistician or an individual with equivalent, approved experience (subject to formal Research Task Force approval – justification required).
  • Data & Output Limitations:  
    • An Investigator Funded & Analyzed or PUF proposal should request only data fields that are pertinent to the research aims of the proposal. The Research Task Forces will not approve broad requests for STSND data.
    • Deidentified data or PUF provided to investigators projects will not include Protected Health Information (PHI) or any information that could identify ND participants (surgeons, physicians, or institutions), and may be used only for the approved project and are limited to production of one abstract and one manuscript.
    • De-identified data files corresponding to approved Investigator Funded & Analyzed projects may not be used to link to other sources of medical data (e.g., CMS data).  
      • Research utilizing linked data is covered under other STS RAC research programs, and ND participants can utilize them accordingly.
    • Access to the provided data file is restricted to the PI, study statistician, and listed co-investigators. Investigators may not copy or distribute data files.
    • Volume Outcome Analysis: Proposal submissions focused on Volume-Outcome relationships research are NOT considered via the Investigator Funded & Analyzed research program. Interested investigators may submit to STS programs with STS RAC Analysis.
Required Application Materials

Applicants should familiarize themselves with the Program Description Document and gather the following required information and files:  

  1. STS National Database Participant ID: The 5-digit number corresponding to the investigator's participating active institution in the ACSD, GTSD, CHSD, or the 4-letter code for Intermacs/Pedimacs participants;
  2. Principal Investigator contact information and biosketch (NIH format preferred – 5 pages max);
  3. Study Statistician contact information and biosketch (NIH format preferred – 5 pages max);
  4. File identifying any co-investigators (if applicable) and their contact information (e.g., email address);
  5. File providing a full description of the research plan (shell tables are required); and
  6. Completed variable file that corresponds to your study.  

Additional Variable List Details  

  • Choose the tab that has a start date closest to your study time frame start date.  
  • Next, mark an “X” in column A next to each variable you want included in your data file, save the file starting with PI initials, and then upload in the corresponding section of the application.
     

For information about codes and values for each data variable in the final data set sent to investigators, please visit the following links:

Research Plan

1. Study Background 
2. Overview -

     2.1 Research Question, Aims, & Hypotheses
     2.2 Rationale for Research Question

3. Study Plan/Approach 
        3.1   Study Patients

  • Provide a clear logic for patient inclusion and exclusion criteria.  
  • Make sure to include study years and corresponding database versions.  
  • Specific database fields/variables (including sequence number and variable short names) and corresponding inclusion or exclusion “value” should be clearly indicated for each database version in your desired study time frame.  
  • Consult with your team (and/or the project biostatistician if applying for de-identified data) and use “AND” and “OR” statements to construct your logic.

               3.1.1   Study Inclusion Criteria  
               3.1.2   Study Exclusion Criteria  

TIP: Providing inclusion and exclusion variables for each database version in your study time frame of interest via the following format will help with data file creation, should your proposal be approved: Variable Short Name (Sequence Number) = Harvest Codes.  

Harvest Codes correspond to the response options for a given ND variable (e.g., 1 = Yes, 2 = No).

For example, if your team is interested in the GTSD variable History of Cardiopulmonary Disease (HistCarPulDis) and would like to include only patients with Hypertension and Pulmonary Hypertension, your team would specify: HistCarPulDis (590) = 2 and HistCarPulDis (590) = 5  

3.1.3 Endpoints and Outcomes  

  • Be specific. Indicate the 30-day outcomes that will be examined (and if so, specify which ones).
    • NOTE: Longitudinal outcomes are not available for this program; only 30-day, de-identified outcomes may be provided.

3.2 Statistical Methods and Analysis Plan  

  • Be as specific as possible.  
  • Shell tables (figures) are required for presentation of anticipated results. Applications without shell tables may be deemed incomplete.  

3.3   Dissemination Plans

STS strongly suggests that investigators target the STS Annual Meeting and The Annals of Thoracic Surgery as the meeting and publication forums, respectively, for dissemination of research using the STS National Database.  

3.3.1 Peer-reviewed Journal to which submission is anticipated (if any)

 3.3.2 National meetings at which abstract presentation is anticipated (if any)

Literature Cited 

Application Process
  • Institutionally Funded with STS Analysis – Proposal Submission and Assessment  
  • Prior to preparing an Institutionally Funded with STS Analysis proposal application, prospective investigators are strongly encouraged to review the Current Projects and Published Research web pages.  
    • This review helps ensure that your proposed research does not overlap with previously approved STS projects.
  • Investigators will complete a web-based application. A $500 application review fee will be required at the time of submission.
  • The STS RAC will work with investigators to confirm completeness of application and forward it to the appropriate Research Task Force for review.  
  • The proposal review will focus on various key criteria, including 1) the scientific merit of the proposed research, 2) the feasibility of the research, and 3) overlap with ongoing approved STS research.
  • Once proposal review is complete, STS RAC staff will notify the principal investigator of the Research Task Force’s decision.  
  • Investigators for approved Institutionally Funded with STS Analysis research projects must complete and sign the STS Data Use Agreement prior to the initiation of the project. 
Costs
  • A $500 application fee is required to process your Institutionally Funded with STS Analysis application. You will be directed to the payment site after submitting your completed application. Incomplete applications will not be considered.  
  • The total fees will vary based on the extensiveness of the approved analysis plans, research aims, linkages needed for the research and other factors.
    • Upon receipt of payment and proposal approval, the assigned STS RAC analysis team will initiate analysis planning and execution. 
Data Use Agreement (DUA)

Investigators with approved Institutionally Funded with STS Analysis research projects must complete and sign a DUA prior to the initiation of the project. Early review of the DUA template is encouraged.  

Note, a DUA is always specific to the project approved by the Research Task Force and will include the project title, as well as a unique study number (e.g., IF-RAC-202X-ACSD-00X) assigned by STS RAC staff.  

 

Refer to the Institutionally Funded with STS Analysis Processes and Procedures Document for detailed information regarding the Institutionally Funded with STS Analysis proposal review process and submit your application today.

For more information, contact the STS Research and Analytic Center.