(New) Institutionally Funded - STS Analysis

• Principal Investigator Requirements and Limitations:  
  • A principal investigator (PI) requesting research-related access to Institutionally Funded with STS Analysis research from the STS RAC 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 Institutionally Funded with STS Analysis 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 Institutionally Funded with STS Analysis projects.  
  • A PI cannot submit more than one Institutionally Funded with STS Analysis research application within one year of a previously approved Institutionally Funded with STS Analysis application.  
     
• Data & Output Limitations:  
  • Analysis results reports provided to investigator(s) for Institutionally Funded with STS Analysis projects may be used only for the approved project and are limited to output of one abstract and one manuscript.
  • Analysis results reports corresponding to approved Institutionally Funded with STS Analysis projects will not include Protected Health Information (PHI) or any information that could identify ND participants (surgeons, physicians, or institutions) associated with any patient records provided. Accordingly, each analysis report falls outside the scope of the Health Insurance Portability and Accountability Act and does not contain STSND participant information.
  • Access to the provided Analysis results reports should be restricted to the PI and listed co-investigators. Investigators may not copy and distribute analysis reports outside their investigative teams.  

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 

Endpoints and Outcomes  

• Be specific. Indicate the 30-day outcomes that will be examined (and if so, specify which ones).
• NOTE: Longitudinal outcomes are available through the Institutionally Funded STS Analysis program. Clearly specify whether external linkage (e.g., CMS and/or NDI linkage) is required and whether longitudinal outcomes will be examined.

Statistical Methods and Analysis Plan  

• Be as specific as possible.  
• Shell tables are required for presentation of anticipated results. Applications without shell tables may be deemed incomplete.  
  • Examples of shell tables can be found 
    here.

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 STSND.  

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

• 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. 

• 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. 

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.